The Ostomy-Q: Development and Psychometric Validation of an Instrument to Evaluate Outcomes Associated with Ostomy Appliances

Issue Number:

Index:

Ostomy Wound Management 2017;63(2):8–23

Yufitriana Amir, FISQua, PhD; Frans E.S. Tan, PhD; Ruud Halfens, FEANS, PhD; Christa Lohrmann, FEANS, PhD, Prof; and Jos Schols, MD, PhD, Prof

Topics:

Pressure Ulcer

Prevalence

Prevention

outcome process assessment

quality

Abstract

Although the number of studies on pressure ulcer (PU) occurrence continues to grow, research regarding the quality of PU care and its effect on outcomes is limited. Using an extended Donabedian model, a 1-day, multicenter, cross-sectional evaluation of the quality of PU care was conducted in a convenience sample of Indonesian hospitals among patients ≥18 years of age in the medical, surgical, and intensive care units. Structure (ie, hospital attributes), process (recommended PU preventive measures), and outcome indicators (nosocomial PU prevalence excluding nonblanchable erythema), along with patient characteristics (age, gender, ethnicity, admission days, diseases [per ICD-10], recent surgery, PU categorization [4 categories according to National Pressure Ulcer Advisory Panel-European Pressure Ulcer Advisory Panel guidelines], PU history, care dependency, and Braden score) were examined.

Patient data were collected by 2 nurses —1 from the patient’s unit and 1 from another unit — using the Landelijke Prevalentiemeting Zorgproblemen-International questionnaire, a paper-and-pencil survey translated into Indonesian. Heads of wards and nursing units completed the questionnaires at institutional and ward levels, respectively. The data were analyzed using descriptive and bivariate analyses, and multilevel logistic regression modeling was applied according to the generalized estimating equation approach. Among the 4 participating hospitals, 66 care units, 36 pairs of nurses, and 1132 adult patients (mean age 48.7 ± 17.4 years, 40.9% women) were involved. Ninety-one (91) patients developed 1 or more PUs; the nosocomial PU prevalence (excluding nonblanchable erythema, category I) was 3.6%. The most frequently used PU preventive measures were patient education (329, 29.1%), repositioning (269, 23.8%), and skin moisturizing (266, 23.5%). The factors most associated with nosocomial PU rate excluding category I were the inclusion of PU care in patient care files (P = .001), repositioning (P = .002), skin moisturizing (P = .009), age (P = .013), admission days (P = .001), care dependency scores (P = .047), immobility (P = .001), sensory perception limitation (P = .001), moist skin (P = .032, OR 13.74), and friction and shear problem (P = .001). The prevalence of nosocomial PUs in this study was comparable to previous research in the Netherlands and rather low, even though limited structural indicators and suboptimal preventive measures were noted. Also, outdated preventive measures such as massage, donuts, and water-filled gloves were still used. The quality of PU care in these hospitals may be improved by addressing the absence of structural factors, including protocols/guidelines. Future research is needed for guideline implementation programs in Indonesian hospitals.

A pressure ulcer (PU) is defined as a localized injury to the skin and/or underlying tissue, usually over a bony prominence, that results from pressure and/or shear.^1,2 PUs can be classified into 4 categories: category I (nonblanchable erythema), category II (partial-thickness), category III (full-thickness skin loss), and category IV (full-thickness tissue loss).¹ A qualitative study³ has shown a PU is harmful, painful, and reduces patient quality of life. A prevalence and cost study⁴ found owing to the need for ongoing wound care materials, prolonged nursing care time, and longer admission days in the hospital, PUs are the most costly medical problem in the United States, especially for elderly patients. PU care accounts for 1% of the total Dutch health care budget⁵ and approximately 2.6% of the total National Health Service budget in the UK.⁶

According to the literature⁷ and an earlier evaluation study,⁸ the prevalence of hospital-acquired (nosocomial) PUs excluding Category I (excl cat I) is considered a relevant indicator of nursing-sensitive care. A review of the literature⁹ found category I PUs are less reliable to diagnose⁹ and therefore frequently excluded in nosocomial PU prevalence reports on quality-of-care performance.^10,11 Various health care policies related to PUs have been implemented to stimulate hospital awareness of the importance of lowering nosocomial PU rates and providing high-quality PU care. In the Netherlands, PU prevalence rates are published,¹² in the UK evaluations are conducted on avoidable and unavoidable PUs,¹³ and in the United States and Japan financial penalties are issued for nosocomial PUs.^14,15

Published nosocomial PU rates (excl cat I) show a wide range of prevalence, from almost 0 (0.5% in Austrian hospitals,¹⁶ 0.8 % in a Chinese hospital,¹⁷ and 0.9% in US hospitals¹⁸) to 2.1% in Swiss hospitals,¹⁶ 3.9% in Dutch hospitals,¹⁶ and 5.1% in Swedish hospitals.¹⁸

Adequate preventive measures such as identifying patients at risk for PUs, repositioning, assessing tissue viability, moisturizing skin, providing nutrition support, and using pressure-redistribution devices are required and should be practiced in daily nursing care in hospitals.² However, PU occurrence does not depend exclusively on the quality of nursing interventions; it is also related to the availability of hospital resources such as PU prevention protocols/guidelines, staff training, specialized wound care nurses, and pressure-redistribution devices.^1,16,19-21

In Indonesia, where the number of nosocomial PU patients is registered monthly through the Hospital Information System,^19,22 PUs have been highlighted as one of the main health care problems in hospitals. Nevertheless, very few publications address PU occurrence, PU preventive measures, and other relevant aspects of the quality of PU care¹⁹ or the research^19,23 involves small sample sizes. This is also the case at an international level. Even though the number of studies on PU prevalence/incidence has increased tremendously internationally,² few published studies have evaluated the actual prevention measures and the availability of resources or facilities for PU care.^16,19-21 Assessing PU rates together with relevant aspects of PU care seems to indicate provision of more accurate and comprehensive information for monitoring the quality of care and prioritizing the quality of PU care will improve programs in hospitals.

Since 1998, the Landelijke Prevalentiemeting Zorgproblemen (LPZ; Dutch National Prevalence Survey of Care Problems) has measured PU prevalence and some relevant indicators of the quality of PU care in the Netherlands annually²¹ and has included other countries in Europe and New Zealand in the past few years.^24,25 The measurement follows Donabedian’s model of quality of care.²⁶ Donabedian classified the assessment of quality of care into 3 components: structure, process, and outcome indicators. Structure refers to the attributes of the facility in which health care is delivered, including material resources (eg, support surfaces, dressings), organizational structure (eg, PU committee, PU guideline, and PU registration), and human resources (the number and qualifications of professionals, including education, training, and experience). Process is defined as what is involved in terms of giving and receiving care and includes both patients’ and health care professionals’ activities related to PU prevention and treatment measures. Outcome measures include the effect of care on patients’ health status. Process indicators involve preventive measures and structure indicators are hospital and ward structural quality indicators.

The authors of this study developed an extended Donabedian model (see Figure 1). Specifically, patient characteristics were added to the model because they are highly associated with PU occurrence and PU preventive measures.²⁷ Patient characteristics can differ between hospitals/countries and therefore influence nosocomial PU rates.²⁸

This study aimed to evaluate the outcome indicator (nosocomial PU prevalence excl cat I), process indicators (PU preventive measures), and structural quality indicators (hospital/ward facilities and PU care resources), as well as patient characteristics related to PUs in Indonesian hospitals using the extended Donabedian model. This involved identifying specific determinant indicators and patient characteristics associated with the quality of PU care in Indonesian hospitals.

Research questions. The following research questions were addressed:

What is the nosocomial PU prevalence rate in Indonesian hospitals?
What are the characteristics of PU patients in Indonesian hospitals?
What PU preventive measures are used in Indonesian hospitals?
What structural quality indicators (including wound care nurses, mono- and multidisciplinary meetings, guidelines, documentation files, patient education, discharge planning, PU committee, and PU courses) are available in Indonesian hospitals at the ward and institutional level?
Are patient characteristics, preventive measures, and structural quality indicators at the ward and the institutional level associated with nosocomial PUs?

Methods

Design. This 1-day study followed a multicenter, multilevel (patient, ward, institution) cross-sectional design.^24,25 All adult patients (≥18 years old) in the medical, surgical, and intensive care units were included. The maternity/obstetric, psychiatric, rehabilitation, skin, eye, and nose and throat care units were excluded due to expected low PU prevalence rates.²⁹

Setting. Indonesia has 260 public and private referral hospitals with more than 200 beds located in 31 provinces,³⁰ each offering a complete range of facilities.³¹ These hospitals are managed by public and private sectors.³² Because of Indonesian communal culture, patients’ family members are directly involved in providing daily care, except in the intensive care unit.³³

This study used a convenience sample; 15 large general hospitals (10 public and 5 private) located on different islands and provinces in Indonesia were invited to participate by registered mail sent from the Nursing Program of Riau University in Indonesia on August 6, 2012. The research proposal and LPZ-international questionnaire data collection procedure were enclosed with the invitation letter.²⁹ The recruitment of participating hospitals took 2 months.

The ethics committee of each participating hospital approved the study. Patients gave their verbal informed consent and/or their relatives/legal representatives were asked for permission. The identities of patients were kept anonymous, and patients had the option to refuse to participate during the assessment procedure.

Measurement instrument. The LPZ-International questionnaire was developed based on a literature review and responses from a Delphi panel in 1997 and now is used as a uniform national registration system in the Netherlands to measure annual PU prevalence. The module consists of 6 parts: 1) the structural quality indicators at hospital level; 2) the structural quality indicators at ward level; 3) patient characteristics related to PU risk, including the Braden Scale and Care Dependency Scale (CDS); 4) PU preventive measures; 5) PU characteristics; and 6) PU wound dressings applied. This questionnaire also has been adopted in several European countries in various health care settings, but the content validity of the questionnaire for measuring the quality of PU care has not been evaluated.

The original LPZ questionnaire was translated into Indonesian³⁴; the document went through several phases (forward translation, backward translation, evaluation between the original English questionnaire, and backward translation results, along with assessment of the clarity of Indonesian wording) to reach equivalence between the English and Indonesian versions of the LPZ questionnaires. After the forward-backward translation, which is the most recommended technique for translating questionnaires,³⁵ 18 Indonesian experts evaluated the clarity of the Indonesian wording to ensure it was equivalent to the English version in terms of semantics and idiom.

The Indonesian experts evaluated the content validity of the questionnaire for measuring the quality of PU care in Indonesian hospitals.³⁴ Most questions (77.5%) had good Item Content Validity Index (I-CVI) results. The experts suggested adding items regarding number of bedridden days, previous PUs, skin allergies, wound infections, wound cleansing, and debridement to the questionnaire. Other psychometric properties (interrater agreement and reliability) of the categorization of PUs, the Braden Scale, and the CDS were evaluated as good.³⁴

Patient characteristics, PU preventive measures, and nosocomial PU prevalence were assessed at the patient level. The availability of structural quality indicators related to PU prevention was assessed at the ward and institutional levels. Patient characteristics such as age, gender, skin color related to ethnicity, number of admission days, diseases, surgery in the past 2 weeks, length of surgery, PU history in the past 5 years, care dependency (CDS),³⁶ and PU risk scale score (Braden Scale) were assessed related to PUs.³⁷ The patient’s diseases were categorized according to the adapted version of the Tenth Revision of the International Classification of Diseases (ICD-10).³⁸

Braden Scale score was assessed to determine patient PU risk. The scores ranged from 6 to 23; a low score indicates a high risk of PU.³⁷ A cut-off point of 21 was used to classify at-risk versus non-risk patients.^16,39 Care dependency was assessed using the CDS. The CDS assesses 15 care dependency items using 5 Likert scale categories from 1 (completely dependent) to 5 (almost independent). Patients with a CDS sum score <68 can be classified as care-dependent.⁴⁰

Data collection procedure. The first author trained a team of ward nurses to participate in the patient assessment on the selected measurement day. This involved instruction on the measurement procedure and practical use of PU categories, the Braden Scale, and the CDS. The team of ward nurses received a written data collection manual containing all of the information provided during training.

Each patient was assessed by 2 trained nurses together (1 from the patient’s own care unit and 1 from another care unit) to increase the reliability of the measurement results^24,34 and to preclude underreporting of PU patients and their categories.¹⁰ The trained nurses obtained/abstracted other patient variables (eg, length of admission, surgery, and so on) from patient charts. The heads of the nursing units in the hospital or their representatives completed the questionnaire on structural quality indicators at the institutional level. The heads of the wards completed the structural quality indicator questionnaires at ward level. All data were collected using the paper-and-pencil questionnaire.

Data analysis. Data were entered and analyzed using IBM SPSS Statistics 19 (SPSS, Chicago, IL). Nosocomial PU prevalence (excl cat I) was calculated as the proportion of patients who had developed a Category II or higher PU during their hospital stay.⁸ Descriptive analyses (frequencies and proportions) were performed on patient characteristics. Evaluation of preventive measures was conducted on interventions that included both recommended and nonrecommended preventive measures based on the European Pressure Ulcer Advisory Panel-National Pressure Ulcer Advisory Panel (EPUAP-NPUAP) guideline^1,2 and on the availability of structural quality indicators at the care unit and hospital levels.

Bivariate analyses (independent t-test or chi-squared test) were performed to evaluate the association between all variables (patient characteristics, the recommended preventive measures or process indicators, and structural indicators) and the outcome indicator (nosocomial PU excl cat I).

Subsequently, the significant variables (P <.05) from the bivariate analysis were subjected to multilevel logistic regression modeling according to the generalized estimating equation (GEE) approach and multiple imputations for the missing data.

Results

Of the 15 invited large hospitals, 4 public hospitals from 4 provinces located on 3 islands agreed to participate. One (1) private hospital refused to participate without mentioning a reason, and the other hospitals had not replied by September 30, 2012.

Two (2) weeks were spent preparing to collect measurements (ie, training, organizing, and recruiting nurses as data collectors) for each hospital. The actual data collection took place on 1 day for each hospital. Data collection including preparation time for collection for the 4 hospitals took a total of 2 months (from October 9 to December 9, 2012).

Sixty-six (66) care units participated and 36 pairs of nurses (72 care unit nurses) were involved in the data collection. Most patients (1132, 95.7%) agreed to participate. Reasons for nonparticipation included refusal (9 patients), unavailability (21 patients), too ill/terminal (10 patients), and unknown (10 patients). The assessment time lasted between 3 and 30 minutes per patient depending on the patient’s condition; the average assessment time was 9.2 minutes (SD 5.9).

Outcome indicator: nosocomial PU prevalence. Of the 91 PU patients, 51 developed 1 or more PUs (Category I to Category IV) during their hospital stay. The highest PU categories per patient were Category I (10 patients), Category II (22 patients), Category III (12 patients), and Category IV (7 patients). The nosocomial PU prevalence rate (excl cat I) for all patients was 3.6% (95% CI 2.5-4.7).

Patient characteristics. Table 1 shows all patients reviewed in the hospitals, including those with and without PU. The mean age of patients was 48.7 years (SD 17.4). The top 3 patient diseases/disorders were digestive disorders (13.8%), genitourinary disorders (13.0%), and neoplasms (11.4%). The mean duration of hospital stay was 9.5 days (SD 9.4). Slightly more than 1 quarter of the patients (25.7%) had a history of being bedridden, with an average of 3.7 bedridden days (SD 15.5). Most patients (70.7%) were at-risk PU patients (Braden Score ≤20) and care-dependent (70.7%).

The expected frequencies of patient diseases, PU history, skin color related to ethnicity, and skin allergy in relation to nosocomial PUs were <5. Age, length of admission, bedridden days, CDS score, and Braden Scale scores had significant P values (P <.05). Braden Scale items are described in Table 2.

Process indicators: PU preventive measures. The proportion of preventive measures related to specific patient circumstances (Braden Scale items) is described in Table 3. Of 771 at-risk PU patients (Braden Scale ≤20), 30% received information on PU prevention. Almost half of the bedridden patients (46.3%) were repositioned by nurses and/or family members; 35.9% who had friction issues received skin moisturization treatment. One (1) out of 4 patients with poor or probable inadequate nutrition status according to their Braden Scale subscores received nutrition support such as increased protein for preventing PUs. A small percentage of bedridden patients (11.2%) used a pressure-redistributing mattress (mattress overlay, air fluidized/low air loss, alternating air, or viscoelastic foam mattress). Floating the heels of bedridden patients was less common (16.5%). Non guideline-recommended preventive measures provided included massage, donuts, and water-filled gloves. Preventive measures associated with nosocomial PUs were repositioning (P = .001), skin moisturizing (P = .001), and nutrition support (P = .021).

Structural quality indicators. More than half of the wards had an admission and discharge handover policy (72.7%), included PU care in their patient care files (62.1%), and held nursing care team discussions about PU care (51.5%). Almost half of the wards had implemented multidisciplinary discussions on PU care (48.5%), had PU risk assessment files (45.5%), and monitored the implementation of PU care (40.9%). The availability of a PU/wound care nurse (25.8%) and PU prevention products (25.8%) was limited. Only 1 ward had a patient information brochure about PU prevention. Structural indicators associated with nosocomial PUs were the monitoring of prevention and treatment at ward level (P = .056), the availability of patient risk assessment care files (P = .033), the availability of prevention and/or treatment PU care files (P = .005), and the provision of discharge planning (P = .047) (see Table 4).

At the institutional level, the number of nosocomial PU patients was centrally registered in all hospitals. Only 1 of the 4 hospitals had a PU protocol/guideline. This hospital also organized a course for nurses about PU prevention and treatment.

Multilevel analysis. Thirteen (13) variables found to be significant at the patient level were selected for further multilevel logistic regression modeling: age, admission days, bedrest days, total CDS score, sensory perception, moisture, activity, mobility, nutrition, friction and shear, repositioning, skin moisturizing, and nutrition support. Four (4) additional variables found to be significant at ward level (monitoring of PU care, patient risk assessment care files, inclusion of PU care in patient care files, and discharge planning documentation files) also were further assessed. Mobility was divided into 2 categories: 1) completely immobile and 2) very limited, slightly limited, no limitation) because no PU patient experienced slight or no mobility limitation.

The data were sampled according to a 2-level design because patients were nested within wards. In total, 83 observations (7.3%) were missing. Assuming these were missing at random, a multiple imputation (with 5 imputations) procedure was performed. The imputed data then were analyzed using a GEE logistic regression method. When compared with the standard logistic regression, no substantial differences were found. This is because the ward differences (within-ward correlation) were very small and not significantly different from zero and the results did not differ from the standard logistic regression analysis. Moreover, the results based on the imputed data did not change much when compared to the data based on the nonimputed complete case situation.

Subsequently, the imputed data were analyzed using standard logistic regression (backward stepwise) methods, with a threshold P <.05 to identify the specific patient characteristic and determinant indicators of quality of PU care associated with the nosocomial PUs.

Table 5 identifies the most significant variables related to the outcome indicator (prevalence of PU categories II through IV). This table also shows the association of patient characteristics with nosocomial PUs excl cat I with a correction for structural quality indicators and preventive measures at the ward and hospital levels. A variation was found in nosocomial PU prevalence rates and quality of PU care among the hospitals. The variables associated with the nosocomial PU rate (excl cat I) were the inclusion of PU care in patient care files (OR 8.171; 95% CI 2.322-28.752), repositioning (OR 4.573; 95% CI 1.749-11.953), skin moisturizing with cream or oil (OR 3.629; 95% CI 1.382-9.533), age (OR 1.036; 95% CI 1.008-1.065), number of admission days (OR 1.079; 95% CI 1.040-1.120), CDS (OR 1.041; 95% CI 1.001-1.083), mobility (OR 0.055; 95% CI 0.013-0.232), completely limited sensory perception versus no limitation (OR 0.055; 95% CI 0.009-0.326), occasionally moist versus rarely moist skin (OR 13.738; 95% CI 1.247-151.370), and friction and shear problem versus no friction and shear problem (OR 24.456; 95% CI 3.757-159.209).

Discussion

This study is the first to depict the quality of PU care in 4 Indonesian hospitals using a multicenter study involving a large number of patients (N = 1132). The quality of PU care was evaluated by an extended Donabedian model of quality of care including patient characteristics. The overall nosocomial PU prevalence (excl cat I) as an outcome indicator was 3.6%. Despite the lower availability of structural quality indicators in these Indonesian hospitals, the nosocomial PU prevalence in these Indonesian hospitals (3.6%) was lower than in Swedish hospitals (5.1%)¹⁸ and comparable with Dutch hospitals (3.9%).¹⁶

The rather low PU prevalence in these 4 Indonesian hospitals might be explained by the patient characteristics: the average age of patients hospitalized in Indonesia (mean 48.7 years, percentile 25%–75%; range 35–61 years) was much lower than the hospitalized patients in the Netherlands (67.8 years).¹⁶ Because the Indonesian economy is growing, life expectancy also is increasing³²; this may result in an increasing number of elderly patients in Indonesian hospitals who will be more likely to have a PU.^41-43

Preventive measures used in the 4 Indonesian hospitals can best be compared with the results from the LPZ-International study in the Netherlands.¹⁶ Fewer pressure-redistributing mattresses were used for at-risk patients (6.1%) than in Dutch hospitals (94.5%). When fewer pressure-redistributing mattresses are used, repositioning should be performed more frequently.¹ The proportion of repositioning for at-risk patients in these Indonesian hospitals (28.8%) was somewhat similar to Dutch hospitals (27.9%). However, not all at-risk patients need repositioning. Half of the bedridden patients in the 4 Indonesian hospitals (46.3%) received repositioning from nurses and/or family members. Providing information on PU prevention can improve the proportion of repositioning measures. In this study, 30% of at-risk PU patients and/or their families received information and instructions on PU prevention measures. This is similar to the Dutch hospitals (30.3%). At-risk PU patients in Dutch hospitals received more prevention measures for dehydration and/or malnutrition (47.9%) than patients in the Indonesian hospitals (22.4%). The proportion of persons receiving skin moisturizing in the Indonesian hospitals was slightly higher than in Dutch hospitals (18.5%).

Although all 4 hospitals centrally registered the number of PU patients, the number of PU/wound care nurses and availability of guidelines, PU courses/training, PU preventive products, and information brochures at institutional level was limited. Only 1 of the 4 hospitals had a PU prevention protocol, even though international evidence-based PU guidelines are available^1,44 and have recently been updated.² As a result, outdated preventive measures such as massage, donuts, and water-filled gloves still were applied. Translating the most recent evidence-based guidelines into Indonesian, disseminating them to all hospitals, and providing refresher courses about PU care may contribute to better PU prevention in clinical practice.

In the multilevel analysis, differences among wards were small and not significantly different from zero. One reason could be some patients stayed in more than 1 ward during their admission time in the hospitals. However, the researchers did not register patient movement among wards.

The inclusion of PU care in patient care files (OR 8.171), repositioning (OR 4.573), and skin moisturizing with cream or oil (OR 3.629) was >1 (ie, patients with nosocomial PUs received more repositioning and skin moisturizing and had PU care noted in their files than non-PU patients).

Braden Scale items describe risk factors for PU.³⁷ In this study, mobility (OR 0.055; 95% CI 0.013-0.232) and sensory perception (OR 0.055; 95% CI 0.009-0.326) seemed to be protective variables or their potential effect on PU development was reduced because they were adjusted or corrected using preventive measures such as repositioning.²⁰ Patients with completely limited mobility and limited sensory perception stayed in the intensive care units, were repositioned regularly, and had pressure-redistributing mattresses. Interestingly, occasionally moist versus rarely moist skin (OR 13.738; 95% CI 1.247-151.370) and a friction and shear problem versus no friction and shear problem (OR 24.456; 95% CI 3.757-159.209) remained risk factors even though these variables could be addressed by applying moisture cream/oil to protect the skin. However, other preventive measures such us floating heels, using elbow or heel protectors, changing linen, patient lifting, and avoiding the use of diapers may influence skin moisture and friction and shear problems.

Furthermore, Indonesia has a warm, humid climate that could influence patients’ skin moisture and increase the risk of developing PUs and moisture lesions.⁴⁵ Preventive measures related to patients with skin moisture and friction and shear problems need to be improved.

Limitations

Of the 15 large hospitals that potentially could have participated, only 4 (26.6%) agreed, so the findings are not a full representation of the quality of PU care in all Indonesian hospitals. The low response rate possibly could have been improved by personal follow-up to every invited hospital, but the transportation costs due to the location of the hospitals, broadly dispersed over many islands, would have been prohibitive.

Furthermore, random sampling was not possible in this study because of the willingness of hospitals to support this study. A central organization of measurements and the support and recommendation of the Ministry of Health would be much more effective for evaluating the quality of PU care at a national level.

In addition, the hospitals in this study did not perform the measurements on the same day, which is not in line with the LPZ-International study protocol.²⁴ Distance learning for the institutional coordinators may help this become a future reality.

Even though this study involved a large number of patients, some patient characteristic variables and preventive measure indicators had expected frequencies <5 and therefore were excluded in the extended multilevel analyses. A larger national measurement might increase the proportion of the variables (ie, additional analyses could be done on the interaction between patient characteristics and preventive measures). Furthermore, the extended theoretical framework of Donabedian’s model showed an association between structural indicators and prevention measures. However, in this study, the association between structure and process indicators could not be evaluated as suggested in the Donabedian model because of the limited number of participating hospitals.

Conclusion

PUs represent an important health care problem in Indonesian hospitals. This study reveals several quality indicator issues related to PU care in these hospitals. The prevalence of nosocomial PUs in this study was comparable to Dutch hospitals, even though limited structural indicators and suboptimal preventive measures were noted. Also, a number of outdated preventive measures still were applied in these Indonesian hospitals.

Taking into account future demographics of an increasingly larger number of elderly people, steps are needed to improve the quality of PU care, starting with the availability of an evidence-based guideline. Also, courses on PU prevention should be offered and relevant process and structural quality indicators must be implemented and improved. A well-designed prevention program also is needed that focuses on skin moisture and patients with friction and shear problems to reduce the occurrence of PUs.

Larger studies using an extended Donabedian evaluation model to measure the quality of PU care are recommended to provide data-driven decision-making at hospital/national level and for continuous monitoring of care quality.

References

1. European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel, Prevention and treatment of pressure ulcers: quick reference guide. Washington DC: National Pressure Ulcer Advisory Panel;2009.

2. Haesler E, ed. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Perth, Australia: Cambridge Media;2014.

3. Gorecki C, Nixon J, Madill A, Firth J, Brown JM. What influences the impact of pressure ulcers on health-related quality of life? A qualitative patient-focused exploration of contributory factors. J Tissue Viability. 2012;21(1):3–12.

4. Mallow PJ, Pandya B, Horblyuk R, Kaplan HS. Prevalence and cost of hospital medical errors in the general and elderly United States populations. J Med Econ. 2013;16(12):1367–1378.

5. Severens JL, Habraken JM, Duivenvoorden S, Frederiks CM. The cost of illness of pressure ulcers in the Netherlands. Adv Skin Wound Care. 2002;15(2):72–77.

6. Franks PJ. The cost of pressure ulceration. EWMA J. 2007;7(2):15–17.

7. Brown DS, Donaldson N, Burnes Bolton L, Aydin CE. Nursing-sensitive benchmarks for hospitals to gauge high-reliability performance. J Healthc Qual. 2010;32(6):9–17.

8. Baharestani MM, Black JM, Carville K, et al. Dilemmas in measuring and using pressure ulcer prevalence and incidence: an international consensus. Int Wound J. 2009;6(2):97–104.

9. Bruce TA, Shever LL, Tschannen D, Gombert J. Reliability of pressure ulcer staging: a review of literature and 1 institution’s strategy. Crit Care Nurs Q. 2012;35(1):85–101.

10. Anderson J, Langemo D, Hanson D, Thompson PA, Hunter SM. Planning, conducting, and interpreting prevalence and incidence for the wound practitioner. Adv Skin Wound Care. 2013;26(1):35–44.

11. Defloor T, Clark M, Witherow A, et al. EPUAP statement on prevalence and incidence monitoring of pressure ulcer occurrence. J Tissue Viability. 2005;15(3):20–27.

12. Berg M, Meijerink Y, Gras M, et al. Feasibility first: developing public performance indicators on patient safety and clinical effectiveness for Dutch hospitals. Health Policy. 2005;75(1):59–73.

13. Black JM, Edsberg LE, Baharestani MM, et al. Pressure ulcers: avoidable or unavoidable? Results of the National Pressure Ulcer Advisory Panel consensus conference. Ostomy Wound Manage. 2011;57(2):24–37.

14. Wald HL, Richard A, Dickson VV, Capezuti E. Chief nursing officers’ perspectives on Medicare’s hospital-acquired conditions non-payment policy: implications for policy design and implementation. Implementation Sci. 2012;7:78.

15. Igarashi A, Yamamoto-Mitani N, Gushiken Y, Takai Y, Tanaka M, Okamoto Y. Prevalence and incidence of pressure ulcers in Japanese long-term-care hospitals. Arch Gerontol Geriatr. 2013;56(1):220–226.

16. Halfens RJ, Meesterberends E, van Nie-Visser NC, et al. International prevalence measurement of care problems: results. J Adv Nurs. 2013;69(9):e5–e17.

17. Zhao G, Hiltabidel E, Liu Y, Chen L, Liao Y. A cross-sectional descriptive study of pressure ulcer prevalence in a teaching hospital in China. Ostomy Wound Manage. 2010;56(2):38–42.

18. Gunningberg L, Donaldson N, Aydin C, Idvall El. Exploring variation in pressure ulcer prevalence in Sweden and the USA: benchmarking in action. J Eval Clin Pract. 2012;18(4):904–910.

19. Amir Y, Halfens RJ, Lohrmann C, Schols JM. Pressure ulcer prevalence and quality of care in stroke patients in an Indonesian hospital. J Wound Care. 2013;22(5):254–260.

20. Amir Y, Meijers J, Halfens R. Retrospective study of pressure ulcer prevalence in Dutch general hospitals since 2001. J Wound Care. 2011;20(1):18–25.

21. Bours GJ, Halfens RJ, Candel MJ, Grol RT, Abu-saad HH. A pressure ulcer audit and feedback project across multi-hospital settings in the Netherlands. Int J Qual Health Care. 2004;16(3):211–218.

22. Ministry of Health Republic of Indonesia. Sistem Informasi Rumah Sakit di Indonesia (Sistem Pelaporan Rumah Sakit Revisi V). Jakarta: Departemen Kesehatan Republik Indonesia, 2003.

23. Suriadi, Sanada H, Sugama J, et al. Risk factors in the development of pressure ulcers in an intensive care unit in Pontianak, Indonesia. Int Wound J. 2007;4(3):208–215.

24. van Nie N, Schols JM, Meesterberends E, Lohrmann C, Meijers JM, Halfens RJ. An international prevalence measurement of care problems: study protocol. J Adv Nurs. 2013;69(9):e18–e29.

25. Ghinescu M, Olaroiu M, Aurelian S, et al. Assessment of care problems in Romania: feasibility and exploration. J Am Med Dir Assoc. 2015;16(1):86 e9–86.e12.

26. Donabedian A. The quality of care. How it can be assessed. JAMA. 1988;260(12):1743–1748.

27. Coleman S, Gorecki C, Nelson EA, et al. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013;50(7):974–1003.

28. Tannen A, Bours G, Halfens R, Dassen T. A comparison of pressure ulcer prevalence rates in nursing homes in the Netherlands and Germany, adjusted for population characteristics. Res Nurs Health. 2006;29(6):588–596.

29. Bours GJ, Halfens RJ, Abu-Saad H, Grol RT. Prevalence, prevention, and treatment of pressure ulcers: descriptive study in 89 institutions in the Netherlands. Res Nurs Health. 2002;25(2):99–110.

30. Ministry of Health Republic of Indonesia. Data Rumah Sakit Online Keadaan 1 January 2012: Direktorat Jenderal Bina Upaya Kesehatan; 2012. Available at: http://202.70.136.52/rsonline/report/report_by_catrs_2011.php. Accessed June 22, 2015.

31. Ministry of Health Republic of Indonesia. Direktorat Jeneral Bina Upaya Kesehatan. Pedoman Penyelenggaraan Pelayanan Rumah Sakit. Jakarta, Indonesia: Kementerian Kesehatan Republik Indonesia 2012.

32. Ministry of Health Republic of Indonesia. Center for Data and Information. Indonesia Health Profile 2011. Jakarta, Indonesia: Ministry of Health Republic of Indonesia;2012:166–169.

33. Shields L, Hartati LE. Nursing and health care in Indonesia. J Adv Nurs. 2003;44(2):209–216.

34. Amir Y, Kottner J, Schols J, Lohrmann C, Halfens RJ Psychometric properties of the Dutch National prevalence measurement of care problems used to measure quality of pressure ulcer care in Indonesian hospitals. Adv Skin Wound Care. 2014;27(8):363–370.

35. Jones E. Translation of quantitative measures for use in cross-cultural research. Nurs Res.1987;36(5):324–327.

36. Dijkstra A, Buist G, Moorer P, Dassen T. A reliability and utility study of the Care Dependency Scale. Scand J Caring Sci. 2000;14(3):155–161.

37. Braden BJ. The Braden scale for predicting pressure sore risk: reflections after 25 years. Adv Skin Wound Care. 2012;25(2):61.

38. World Health Organization. International Statistical Classification of Diseases and Related Health Problems 2011. Available at: www.who.int/classifications/icd/en/. Accessed June 22, 2015.

39. Halfens RJ, Van Achterberg T, Bal RM. Validity and reliability of the Braden scale and the influence of other risk factors: a multi-centre prospective. Int J Nurs Stud. 2000;37(4):313–319.

40. Dijkstra A, Tiesinga LJ, Plantinga L, Veltman G, Dassen T. Diagnostic accuracy of the Care Dependency Scale. J Adv Nurs. 2005;50(4):410–416.

41. Fisher AR, Wells G, Harrison MB. Factors associated with pressure ulcers in adults in acute care hospitals. Adv Skin Wound Care. 2004;17(2):80–90.

42. de Vasconcelos Generoso S, Correia MI. Prevalence of pressure ulcers in hospitals in Brazil and association with nutritional status: a multicenter, cross-sectional study. Nutrition. 2013;29(4):646–649.

43. Dugaret E, Videau MN, Faure I, Gabinski L, Bourdel-Marchasson I, Salles N Prevalence and incidence rates of pressure ulcers in an emergency department. Int Wound J. 2014;11(4):386–391.

44. Australian Wound Management Association, New Zealand Wound Care Society, Hong Kong Enterostomal Therapists Association, Wound Healing Society of Singapore. Pan Pacific Guideline for the Prevention and Management of Pressure Injury. Rosanna, Victoria, Australia;2012.

45. Yusuf S, Okuwa M, Shigeta Y, et al. Microclimate and development of pressure ulcers and superficial skin changes. Int Wound J. 2015;12(1):40–46.

Potential Conflicts of Interest: This work was supported by the Direktorat Jenderal Pendidikan Tinggi (Indonesian Directorate General of Higher Education), Kementerian Pendidikan dan Kebudayaan (Indonesian Ministry of Education and Culture) grant number (No.1023/E4.4/K/2011).

Dr. Amir is a lecturer, Nursing Department, Universitas Riau, Pekanbaru, Indonesia. Dr. Tan is an associate professor, Department of Methodology and Statistics; and Dr. Halfens is an associate professor, Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands. Prof. Lohrmann is a university professor, Department of Nursing Science, Medical University of Graz, Graz, Austria. Prof. Schols is a professor, Department of Health Services Research and Department of Family Medicine, CAPHRI, Maastricht University. Please address correspondence to: Yufitriana Amir, PhD, Universitas Riau, Program Studi Ilmu Keperawatan, Jalan Pattimura no 9 Gedung G, Pekanbaru, Riau 28131, Indonesia; email: amiryufitriana@gmail.com or yufitriana.amir@lecturer.unri.ac.id.

SaveSave

Section:

Issue Number:

Index:

Ostomy Wound Management 2017;63(2):26–36

Ivy Razmus, PhD, RN, CWOCN; and Sandra Bergquist-Beringer, PhD, RN, CWCN

Topics:

health care process assessment

Pressure Ulcer

risk

pediatrics

nursing care

Abstract

Little is known about pressure ulcer prevention practice among pediatric patients. To describe the frequency of pressure ulcer risk assessment in pediatric patients and pressure ulcer prevention intervention use overall and by hospital unit type, a descriptive secondary analysis was performed of data submitted to the National Database for Nursing Quality Indicators^® (NDNQI^®) for at least 3 of the 4 quarters in 2012.

Relevant data on pressure ulcer risk from 271 hospitals across the United States extracted from the NDNQI database included patient skin and pressure ulcer risk assessment on admission, time since the last pressure ulcer risk assessment, method used to assess pressure ulcer risk, and risk status. Extracted data on pressure ulcer prevention included skin assessment, pressure-redistribution surface use, routine repositioning, nutritional support, and moisture management. These data were organized by unit type and merged with data on hospital characteristics for the analysis. The sample included 39 984 patients ages 1 day to 18 years on 678 pediatric acute care units (general pediatrics, pediatric critical care units, neonatal intensive care units, pediatric step-down units, and pediatric rehabilitation units). Descriptive statistics were used to analyze study data. Most of the pediatric patients (33 644; 89.2%) were assessed for pressure ulcer risk within 24 hours of admission. The Braden Q Scale was frequently used to assess risk on general pediatrics units (75.4%), pediatric step-down units (85.5%), pediatric critical care units (81.3%), and pediatric rehabilitation units (56.1%). In the neonatal intensive care units, another scale or method was used more often (55% to 60%) to assess pressure ulcer risk. Of the 11 203 pediatric patients (39%) determined to be at risk for pressure ulcers, the majority (10 741, 95.8%) received some kind of pressure ulcer prevention intervention during the 24 hours preceding the NDNQI pressure ulcer survey. The frequency of prevention intervention use among those at risk ranged from 99.2% for skin assessment to 70.7% for redistribution surface use. Most pediatric patients are being assessed for pressure ulcer risk, but the implementation of interventions to prevent pressure ulcers among children needs to be improved. Future qualitative research should be conducted to determine how and when clinical judgment is used to assess pressure ulcer risk and the type of pressure-redistribution surfaces used among younger pediatric patients.

Critically and acutely ill children develop hospital-acquired pressure ulcers (HAPU). Pressure ulcer incidence among pediatric patients has been reported to be 0.29% to 7.3%,^1-3 with 3.9% to 16% among children in neonatal intensive care units (NICUs),^4,5 and 0.8% to 27% among children in pediatric critical care units (PCCUs).^6,7 A recent descriptive analysis⁸ (N = 39 984) found a 1.1% rate of HAPU among pediatric patients ages 1 day to 18 years, but the rate varied by pediatric unit type, ranging from 0.57% in general pediatric units to 4.6% in pediatric rehabilitation units. The detrimental iatrogenic effects of pressure ulcers in children include compromised skin protection, altered thermoregulation, metabolism deficiencies, compromised immunity, and decreased sensation. A retrospective study of 5346 pediatric intensive care patients by Schindler et al⁶ found compromise of the epidermis or dermis from a pressure ulcer injury increases the risk for infection, other care complications, and later psychosocial effects related to tissue damage and scarring.

Clinical practice guidelines have served as the foundation for pressure ulcer prevention practice and treatment for more than 20 years; however, their application to pediatric patients is unknown because there are limited descriptive cohort, nondescriptive studies, such as comparative, correlational, case control, or case studies.^9-11 Moreover, research on pressure ulcer prevention for children is scarce. Little is known about pressure ulcer risk and skin assessment practice or the frequency of pressure-redistribution surface use, repositioning, moisture management, nutritional support, and ongoing skin assessment practice among pediatric patients in the acute care setting.

Risk assessment. According to the European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPUAP), and the Pan Pacific Pressure Injury Alliance (PPPIA), the first step in pressure ulcer prevention is to identify persons at risk.¹¹ Risk factors for pressure ulcers may be different for infants and children relative to adults. This has resulted in an assortment of risk assessment instruments (scales) that enable health care professionals to identify pediatric patients pressure ulcer risk by age group.¹² Instruments (scales) include the Braden Q Scale, the Neonatal Skin Risk Assessment Scale (NSRAS), the Glamorgan Scale, and the Waterlow Scale.^2,13-15 It is presumed the most commonly used scales to assess pressure ulcer risk among children in the United States are the Braden Q Scale and the NSRAS, but no studies confirm this. The Braden Q was developed by Quigley and Curley⁷ for use in pediatric patients and adapted from the adult-based Braden Scale to add a seventh subscale, Tissue Oxygenation and Perfusion, by modifying the pediatric-specific subscale descriptors and revising the friction and shear subscale to be a 4-point scale.¹³ The Braden Q was validated among 322 patients 1 month to 8 years of age and found to be 0.88 sensitive and 0.58 specific.⁷ Although the Braden Q was validated for this age group, Noonan et al¹⁶ encourage its use in all pediatric populations. The NSRAS was developed by Huffines and Logsdon¹⁴ for neonatal patients. The adult-based Braden Scale was modified to add the subscale General Condition, which is based on gestational age; neonate-specific subscale descriptors were provided, and the subscale Friction and Shear was removed. The validity and reliability of the NSRAS was tested among 32 neonates based on gestational age between 6 and 40 weeks, with higher scores indicating higher risk.

The NPUAP^10,11 recommends assessment of pressure ulcer risk on admission and periodically thereafter and should be considered with risk factors not included on assessment tools such as prematurity, birth weight, temperature and humidity, medical device use, critical illness, perfusion and oxygenation, neurological deficits, and length of hospital stay. The Institute for Healthcare Improvement¹⁷ (IHI) published a how-to guide for pressure ulcer prevention in pediatric patients that suggests the NSRAS be used in combination with individualized and subjective methods to assess pressure ulcer risk among neonates. The IHI also recommends assessment of pediatric patient pressure ulcer risk on admission to the hospital and every 48 hours thereafter or when a pediatric patient’s condition changes. Presently, it is unknown if children receive routine patient pressure ulcer risk assessment on admission or routine reassessment or the method by which this risk is assessed.

Interventions to prevent pressure ulcers. The aim of pressure ulcer prevention is to reduce or inhibit factors that may cause injury or tissue loss. Interventions to prevent pressure ulcers include support surface use, routine repositioning, moisture management, nutritional support, and ongoing skin and tissue assessment.^10,11,17 Recommendations on pressure ulcer prevention in pediatric patients often have been extrapolated from what is known about adult pressure ulcer prevention.

Pressure-redistribution surface use. The areas of the body at risk for pressure ulcers in children differ from adults, and evidence-based standards for children are lacking with regard to their different pressure points when compared to adult pressure points, rendering the adult redistribution surface nontherapeutic for children. Standard foam hospital mattresses are stiffer than the soft tissues of the infant’s and child’s body and may not adjust or conform to accidentally misplaced tubes. Using a quasi-experimental design, Turnage-Carrier et al¹⁸ examined interface pressures between the occiput of 13 healthy premature infants and 5 different bed surfaces and found standard crib mattresses had high interface pressure (>100 mm Hg), supporting the need for an alternative pressure-relief support surface. Levy et al¹⁹ used computational modeling to evaluate the deformation characteristics of flat foam and air cell-based mattresses when a tube is accidently left between an infant’s skin and the mattress. The study found the tubing was stiffer than infant soft tissues, highlighting the need for adjustable, adaptable, conformable mattresses among critically ill neonates and children. In the study by Schindler et al,⁶ multiple logistic regression analysis showed use of specialty beds was associated with a lower risk of pressure ulcers.

Routine repositioning. The strategy of pressure relief involves patient repositioning, and usual practice is to reposition patients every 2 hours, although this frequency rate may be increased or decreased based on patient risk or use of support surfaces.¹¹ Schindler et al⁶ found patients who were positioned every 2 to 4 hours using repositioning aids were less likely to develop a pressure ulcer. Repositioning medical equipment is also important to reducing tissue pressure and preventing medical device-related pressure ulcers that can be caused by respiratory devices, oximetry probes, casts, intravenous arm boards and tubing, and equipment such as cervical collars.²⁰ In an intervention study with the focus on pressure ulcer reduction, Pittman et al²¹ reported medical device-related pressure ulcers accounted for >50% of pressure ulcers in adults and children at 1 health care facility. Following the implementation of a quality improvement project to define and reduce medical device-related pressure ulcers, overall HAPU rates decreased 33% between 2011 and 2012.²¹

Moisture management. Moisture management to prevent pressure ulcers includes prompt cleansing of the skin using nonalkaline agents followed by application of a barrier cream.²² However, neonates are at risk for absorption of products applied to the skin because of the skin’s immaturity, condition, and sensitization.⁸ Few products have been tested in this vulnerable population; it is not clear whether barrier creams reduce the risk of pressure ulcer development in pediatric patients.^22-25 Schindler et al⁶ found interventions to manage moisture, such as use of dry-weave diapers, urinary catheters, and disposable underpads, were associated with lower pressure ulcer rates among pediatric intensive care patients.

Nutritional support. Nutrition is not well understood as it relates to prevention of pressure ulcers in pediatric patients. Adult criteria applied to the pediatric population may result in inappropriate nutrition management. Moreover, infants and children are thought to experience fluid and electrolyte imbalances more rapidly than older children and adults. In a prospective, cohort study of 102 infants with a birth weight <1250 g, Thibault et al²⁶ found early protein and energy intake in the first week of life improves electrolyte homeostasis and phosphorus requirements, suggesting parenteral nutrition guidelines for very low birth weight infants should be revised.

The 2014 NPUAP¹¹ guidelines recommend initiation of an age-appropriate nutritional assessment for at-risk pediatric patients and reassessment of the nutritional requirements of critically ill neonates and children at risk for pressure ulcers. Schindler et al⁶ reported an 80% decrease in risk for pressure ulcers when a registered dietitian was consulted during the admission process for those at risk.

Routine skin assessment. NPUAP guidelines^10,11 recommend skin and tissue assessment as part of risk assessment screening; this entails the evaluation of the patient’s entire skin (from head to toe) with emphasis on bony prominences and other areas at risk for pressure ulcer development for signs or symptoms of tissue injury.²⁷ Frequent assessment under and around blood pressure cuffs, transcutaneous oxygen probes, continuous positive airway devices, tracheostomies, traction, or tubes is important in the prevention of pressure ulcers from medical devices in children.²⁰

Study Purpose and Research Questions

This study was intended to add to knowledge regarding the frequency of pressure ulcer risk assessment in hospitalized pediatric patients and pressure ulcer prevention intervention use, overall and by unit type. Questions for the study included:

What was the frequency of patient skin and pressure ulcer risk assessments among pediatric patients in US hospitals in 2012? Specifically: a) What is the frequency of patient skin and pressure ulcer risk assessment within 24 hours of admission overall and by unit type? b) What is the timing of the last (ie, the most recent) assessment previous to the patient pressure ulcer risk assessment overall and by unit type? c) What methods are used to assess patient pressure ulcer risk overall and by unit type?
What is the frequency of pressure ulcer prevention intervention use among pediatric patients who are at risk for pressure ulcers by intervention and unit type in US hospitals?

Methods

The study was a secondary analysis of existing de-identified 2012 National Database of Nursing Quality Indicators® (NDNQI) data on patient pressure risk and prevention, unit type, and hospital characteristics. Approval for the study was granted by the University of Kansas Medical Center Institutional Review Board. Conceptually, the NDNQI is based on a model developed by Donabedian²⁸ that asserts the structure of care affects the processes of care; both, in turn, affect the outcomes of care. Participation in NDNQI data collection on pressure ulcer risk and prevention is voluntary. Submitted data are analyzed by NDNQI in order to provide participating hospitals standardized results across patient care units and hospitals for comparison purposes and use in quality improvement activities.

This study was limited to pediatric critical care units (PCCU), step-down units, medical units, surgical units, medical-surgical units, neonatal intensive care units IIIs (NICU IIIs), neonatal intensive care units IV (NICU IVs), and rehabilitation units that submitted pressure ulcer data to the NDNQI for a minimum of 3 out of 4 quarters in 2012. The NICU IIIs provide advanced care for premature, low birth weight, and critically ill infants; NICU IVs provide the highest level of care for premature and ill newborns. PCCUs provide the highest level of intensive care for pediatric patients; pediatric step-down units provide a higher level of care compared to medical, surgical, and medical-surgical pediatric units.²⁷

Data on pressure ulcer risk and prevention. NDNQI data on pressure ulcers are collected quarterly by trained nurses during a cross-sectional survey that is performed on 1 specified day. The data on pressure ulcer risk and prevention are gathered through chart review by members of the pressure ulcer data collection team who review each patient record to determine if a skin assessment and a pressure ulcer risk assessment were documented in the patient’s chart within 24 hours of admission (yes, no, or pending). The assessment was pending if the patient had been admitted within the last 24 hours and the admission assessment had not yet been completed. The method used to assess patient pressure ulcer risk (Braden Scale, Braden Q Scale, NSRAS, or other scale/clinical factors) and score (if applicable) also were recorded. Selection of “other scale/clinical factors” indicated a scale other than the Braden, Braden Q, or NSRAS was used to assess pressure ulcer risk; otherwise, clinical factors (eg, premature age) were used to determine pressure ulcer risk. To estimate the frequency of pressure ulcer risk reassessment among pediatric patients, documentation in the patient record was reviewed to identify how long before the NDNQI pressure ulcer survey the last risk assessment was performed. Patient pressure ulcer risk status was determined from the last pressure ulcer risk assessment.²⁷

If the patient was at risk for pressure ulcers, members of the pressure ulcer data collection team reviewed the patient record for documentation of pressure ulcer prevention performed within the 24-hour period before the NDNQI pressure ulcer survey. Type of pressure ulcer prevention interventions also were recorded and included daily skin assessment, pressure-redistribution surface use, routine repositioning, nutritional support, and moisture management.²⁷

Pressure-redistribution surface use was the application of any specialized support surface to redistribute pressure on skin and subcutaneous tissue or other parts of the body exposed to pressure. Routine repositioning involved determining the frequency of patient turning and repositioning relative to the plan of care or hospital unit policy. Nutritional support and moisture management entailed review of the patient’s chart for evidence of these interventions.²⁷ Response options for the prevention interventions included yes, no, documented contraindication, unnecessary for patient, or patient refused.²⁷ Evidence for the reliability of NDNQI data collection methods on pressure ulcer risk and prevention has been established.²⁹

Data analysis. Descriptive statistics were used to analyze patient and unit characteristics. Data on patient age were recoded regarding gestational age: 1 day to 30 days, 1 month to 11 months, 1 year to 2 years, 3 years to 4 years, 5 years to 8 years, and 9 years to 18 years of age. Gestational age included patients for whom gestational age only was reported; most were located in the NICU IIIs and NICU IVs.

Units are categorized by the NDNQI according to acuity level. A unit such as a medical unit or pediatric step-down unit is characterized as such if at least 90% of the patients receive this level of care. A unit such as pediatric rehabilitation may be characterized as a specialty unit if >80% of patient care services were related to the specialty category.²⁷ For this study, data from medical and medical-surgical pediatric units were aggregated to create a new unit type called General Pediatric Unit. No data on pressure ulcers from pediatric surgical units were available for inclusion in this study.

Descriptive statistics were used to determine the overall frequency of pressure ulcer risk assessments and their occurrence by unit type. Methods used to assess patient pressure ulcer risk (Braden Scale, Norton Scale, Braden Q Scale, NSRAS, or another scale/other clinical factors) and their frequencies were summarized, as was the frequency of pressure ulcer prevention by unit type. All analyses were performed in SPSS, Version 21 (SPSS, Chicago, IL).

Results

The study sample included 39 984 patients ages 1 day to 18 years from 678 pediatric care units in 271 US hospitals that participate in the NDNQI. Most of the hospitals were located in metropolitan areas (263, 97%), were general hospitals by type (229, 84.5%), >100 beds in size (258, 95.2%), and had non-Magnet status (146, 53.9%). Among the 678 reporting units, most were general pediatric units (289, 42.6%), 182 (26.8%) were NICUs III, 154 (22.7%) were PCCUs, 9 (1.3%) were NICUs IV, and 6 (0.9%) were pediatric rehabilitation units.

Frequency of skin and pressure ulcer risk assessment in pediatric patients. Most patients received a skin assessment (36 464, 96.7%) within 24 hours of hospital admission. Skin assessment on admission by unit type showed like distribution except for the pediatric rehabilitation unit where 5.7% did not receive a skin assessment on admission compared to 2.6% overall (see Table 1). Fewer patients (33 644, 89.2%) were assessed for pressure ulcer risk as compared to skin assessment within 24 hours of hospital admission; 3755 (10.0%) were not (see Table 2). Patients from the pediatric rehabilitation units (98.4%), the general pediatric care (94.6%), and pediatric step-down units (93.1%) most often received a pressure ulcer risk assessment within 24 hours of admission.

A similar proportion of patients (35 367, 89.2%) was assessed for pressure ulcer risk within the 24-hour period before the pressure ulcer survey. Interestingly, 2483 patients (6.3%) never were assessed for pressure ulcer risk. By unit type, NICU IV patients were assessed for pressure ulcer risk more frequently (1071, 92.1%) within this 24-hour period than NICU III patients (12 192, 81%).

Method used to assess pressure ulcer risk. The majority of patients (72.7 %) were assessed for pressure ulcer risk by means of a risk assessment scale. The Braden Q was used most frequently on pediatric step-down (85.5%), PCCU (81.3%), and general pediatric units (75.4%) (see Table 3). The NSRAS was used less frequently, even on NICUs III and NICUs IV. For 27% to 28% of all pediatric patients, pressure ulcer risk was assessed using a different scale or by clinical judgment (see Table 4).

Pressure ulcer risk status. Among the 37 077 study patients with available data on pressure ulcer risk, 11 203 (30.2%) were determined to be at risk for a pressure ulcer based on the last pressure ulcer risk assessment (see Table 5). By unit type, the proportion of patients at risk for pressure ulcers was highest among patients in the NICUs III (45.5%) and PCCUs (44.6%). The lowest proportion of patients at risk for pressure ulcers were located in the NICUs IV (22.5%), pediatric step-down units (18.1%), and general pediatric units (12.3%).

Pressure ulcer prevention in pediatric patients. Of the 11 203 pediatric patients at risk for pressure ulcers, 10 741 (95.8%) received some kind of pressure ulcer prevention within the 24-hour period before the survey. The type of intervention received varied among at-risk patients (see Table 6). Most patients had received a skin assessment (99.2%) within the 24-hour period before the survey. The intervention least frequently employed was pressure-redistribution surface use (70.7%). Interestingly, a pressure-redistribution surface was determined to be unnecessary for 15.4 % of the at-risk patients and not used for an additional 13.6%. The frequency of moisture management, nutritional support, and routine repositioning for pressure ulcer prevention ranged from 84.6% to 89.5%.

Pressure ulcer prevention intervention use varied by unit type except for skin assessment, which was high across all unit types (see Table 7). A pressure-redistribution surface was in use most often in the pediatric rehabilitation units (95%) and PCCUs (85%) and least often in NICUs III (67%) and general pediatric units (61%). Patients were repositioned as prescribed more often in units where the patient might be less mobile, such as in PCCUs (86.6%) and NICUs (96.3% to 100%). Moisture was managed most often in units where patients may be incontinent, such as in the rehabilitation units (92.1%) and those in the NICUs (85.5% to 88.8%). Patients were reported to have received nutritional support more often on units where patients are less likely to feed themselves, such as the rehabilitation units (100%) and the neonatal units (93.7% to 96%).

Discussion

This is the first known study to evaluate the frequency and timing of skin and pressure ulcer assessment among pediatric patients or the method by which pressure ulcer risk is assessed in pediatric patients. This is also the first known study to evaluate current pediatric pressure ulcer prevention practices among different pediatric units.

Skin and pressure ulcer risk assessment. Study results revealed skin and pressure ulcer assessments were performed as recommended by NPUAP guidelines,^10,11 skin assessment was performed within 24 hours of pediatric patient admission an average of 96.7% of the time, and a pressure ulcer risk assessment was performed within 24 hours an average of 89.2% of the time across pediatric units. Although still high, the lower proportion of neonates (92.1%) that were assessed for pressure ulcer risk in NICUs is a little concerning, given the 1.11% rate of HAPUs in the NICUs IV previously reported.⁸ Pressure ulcer risk assessment in this study was lower than the 92.9% reported across adult units such as critical care, step-down, medical, surgical, and medical-surgical units.³⁰

The NPUAP^10,11 guidelines recommend patient assessment for pressure ulcer risk status using a structured approach based on the use of clinical judgment and informed by knowledge of relevant risk factors. Among the patients assessed, approximately half (49.3%) were assessed using a pressure ulcer risk assessment scale and the other half (50.1%) were assessed per another scale or clinical judgment. The Braden Q was used most frequently in this study to assess pressure ulcer risk in children. The Braden Scale was used to assess pressure ulcer risk approximately 10% of the time, mostly on units and where one would expect older children such as general pediatric units and pediatric rehabilitation units. This is different than the frequency of scale use in the adult population, where 90% of the patients were assessed for risk using the Braden Scale.³⁰ Interestingly, only 25% of the neonatal patients were assessed for risk using the NSRAS; the majority of the neonatal patients were assessed using other scales or clinical judgment. Further research is needed to understand the role of pressure ulcer risk assessment in the neonatal population, scales used, and what factors are considered when determining pressure ulcer risk.

Among the sample of pediatric patients, 11 203 (30.2%) were determined to be at risk for pressure ulcers based on the last risk assessment. This was much higher than the 6% of hospitalized pediatric patients (14 out of 252) reported to be at risk by Noonan et al.³¹ This difference in findings may be related to dissimilarities in study sample size, unit type, and number of participating hospitals, but it also may be related to the method of risk assessment. In this study, risk status was determined by Braden Scale, Braden Q, and NSRAS scale score and also considered clinical factors, whereas in the Noonan study, risk status was determined by Braden Q score. However, the proportion of pediatric patients determined to be at risk for pressure ulcers (30.2%) in this study was somewhat lower than the 39.7% of adult acute care patients (282 500 of 710 626) reported to be at risk by Bergquist-Beringer et al.³⁰

NICUs III had the lowest proportion of patients assessed for pressure ulcer risk on admission, but they had the highest proportion of patients determined to be at risk for pressure ulcers. Interestingly, the lowest proportion of patients determined to be at risk for pressure ulcers was on the NICUs IV. This difference in pressure ulcer risk may be due to the variation in the methods by which nurses assessed patients for pressure ulcer risk in each unit. The majority of the NICU III patients were assessed for risk on admission by other scale/clinical judgment, as were NICU IV patients. It is unclear what clinical factors were used in determining risk among these patients. Moreover, 16.2% of the NICU IV patients were assessed for risk using the Braden Scale and 28.4% were assessed for risk using the Braden Q. However, the Braden Scale and Braden Q have not been validated for use in neonates. Additional information is needed on how nurses judge pressure ulcer risk in neonatal patients.

Frequency of pressure ulcer prevention. Most (95.8%) of the pediatric patients at risk for a pressure ulcer received at least 1 type of pressure ulcer prevention intervention. The frequency of pressure ulcer prevention interventions used for pediatric patients in the 24 hours before the survey was greater in the higher acuity units such as neonatal units, PCCUs, and pediatric step-down units where mobility might have been a factor. This study noted missing data for pressure ulcer prevention interventions was 15%, which is higher than the recorded 7% to 13% of missing data for pressure ulcer prevention interventions in a previous study of adult patients by Bergquist-Beringer et al.³⁰

For 70.7% of the pediatric patients at risk for pressure ulcers, a pressure-redistribution surface was applied. This is lower than the 81.8% of adult patients for whom a pressure-redistribution surface was in use as reported by Bergquist-Beringer et al.³⁰ Pressure-redistribution surfaces were used more often in pediatric rehabilitation units and PCCUs relative to the other pediatric units, which may be related to the acuity level of these patients populations. The EPUAP, NPUAP, PPPIA^10,11 guidelines recommend use of a pressure-redistribution surface compatible with the care setting and individual patient size and weight. It is not clear whether the pressure-redistribution surfaces used in the PCCUs or pediatric rehabilitation units were designed for pediatric or adult patients or whether pediatric redistribution surfaces were available. More quasi-experimental, cohort, nonexperimental descriptive, comparative, correlation, case control, and case series studies are needed to better understand the use of pressure-redistribution surfaces in pediatric patients, including which type of pressure-redistribution surface decreases HAPU in younger populations.

To prevent pressure ulcers, the EPUAP, NPUAP, PPPIA¹¹ guidelines recommended repositioning (turning) patients regardless of the type of support surface in use unless it is contraindicated. In this study, 90% of the pediatric patients were repositioned as prescribed, which is higher than the 82% of the patients repositioned as prescribed reported by Bergquist-Beringer et al.³⁰ Currently, scant research supports repositioning as an intervention to prevent pressure ulcers among children, although it is thought to reduce pressure, thereby increasing capillary blood flow; however, no studies met criteria for meta-analysis to support its association with pressure injury reduction.³²

Patients were most frequently repositioned as prescribed in the neonatal units. This is logical, because infants are not able to reposition themselves by rolling over or turning to their sides. Rolling over is a developmental task achieved during the first year of life; therefore, infants would need nursing assistance with repositioning. For 5.5% of pediatric patients, it was determined the intervention was unnecessary, likely because the patient was developmentally or physically able to reposition on his/her own. Interestingly, for 15.4% of the patients in the step-down units, repositioning was unnecessary. However, per previous research by Razmus⁸ the overall HAPU rate among pediatric step-down units was 1.03%. The frequency of medical device repositioning to alleviate pressure from skin surface also requires further exploration.

Moisture management is designed to maintain a patient’s tissue integrity. In this study, moisture was managed for 84.6% of the at-risk patients. This is higher than the 65% of adult patients receiving moisture management reported by Bergquist-Beringer et al.³⁰ The difference in study results may be associated with the large proportion of pediatric patients who were developmentally or situationally incontinent in this study. Moisture was managed most often among patients in NICU IIIs (88.8%), NICU IVs (85.5%), and pediatric rehabilitation units (92.1%). Although the NPUAP^10,11 guidelines recommend keeping the skin clean and dry while also protecting the skin from excessive moisture, no study has examined the use of moisture management as a pressure ulcer prevention intervention in unit types outside of PCCUs or with a larger sample. For example, neonatal skin is still developing and products may be absorbed through their skin; however, most products intended for moisture management have not been tested in this vulnerable population.⁸ Additional quasi-experimental, cohort, non-experimental descriptive, comparative, correlation, case control, case series, and qualitative studies are needed to determine the type of moisture management being used to prevent pressure ulcers among at-risk pediatric patients.

Close to 90% of the pediatric patients at risk for HAPU received nutritional support, which is substantially higher than what was reported in the adult population (56.3%) by Bergquist-Beringer et al.³⁰ The frequency of nutritional support was highest among NICU IIIs (96.0%) and NICU IVs (93.7%), suggesting this is standard care for neonatal patients due to the inability of these patients to feed themselves independently and often due to their low birth weight. In addition to neonatal patients, all rehabilitation patients at risk for pressure ulcers received nutritional support but only 68.3% of general pediatric and 78.7% of pediatric step-down patients received this support. This may occur because patients in general pediatric units and pediatric step-down units were independently able to feed themselves and reflected in the finding the intervention was determined to be unnecessary in 13.1% to 20.7% of these patients. Included in the NPUAP^10,11 guidelines was a recommendation for an individualized plan of nutritional support for patients at risk for pressure ulcers. However, no known studies have evaluated nutritional support as a preventive pressure ulcer nursing intervention for pediatric patients. Future research could evaluate what type of nutritional support is integrated into the prevention of pressure ulcers for different pediatric populations. As identified by Bernable,³³ prevention strategies in the pediatric patient need to be judicially studied, such as specific types of nutritional support, repositioning, and pressure-redistribution surface use and not solely adapted from adult care without more evidence-based data.

Clinical Implications and Research

This study provides data on pressure ulcer risk and prevention practices in acutely ill pediatric patients overall and by unit type from a large sample of patients and hospitals. These data can be used for comparison in future studies and quality improvement projects. However, more research regarding pressure ulcer risk and prevention practices in the pediatric population is needed, especially on pediatric units where medical devices are in frequent use, because emerging evidence shows repositioning medical devices to decrease skin surface pressure reduces HAPU.

Future studies are needed to validate established risk assessment tools in the pediatric population and further explore methods for determining pressure ulcer risk among neonates and the important clinical factors considered in establishing risk status. Because the least-used intervention in this study was a pressure-redistribution surface, more research is needed on support surfaces to prevent pressure ulcers, especially among NICU patients and hospital or unit policies governing their use and accessibility among children. More research evidence also is needed regarding the frequency of repositioning to prevent pressure ulcers in these populations. Future research describing the types of moisture management and their association with HAPU would provide important information for health care providers in caring for at-risk infants and children. Furthermore, the role of nutritional support in pediatric pressure ulcer prevention that describes best practices based on gestational age and developmental level would be meaningful in guiding practice.

Limitations

The study data are unique in that previous pressure ulcer studies have not focused on neonatal or general pediatric units. In this study, the reporting of pressure ulcer risk and prevention intervention data to NDNQI was voluntary. Therefore, data submitted may not be representative of all hospitals nationally and also resulted in instances of missing data. Not all of the pressure ulcer prevention interventions were available for analysis by the NDNQI, limiting the generalizability of this study. Information on interventions related to medical devices and pressure ulcers was not obtained. NDNQI provides detailed collection guideline directions for pressure ulcer data, but these guidelines might not have been followed. Although the data were thoroughly evaluated for errors by the NDNQI, a possibility for errors exists in the data submitted to the database. Since these data were collected, the pressure ulcer prevention guidelines were revised by the NPUAP, EPUAP, and PPPI and released in 2014, with increased focus on medical device-related pressure ulcer injury. This was important because the new guidelines include information on preventing pressure ulcers in children. However, more evidence is needed to support which pressure ulcer interventions are most beneficial in neonates and children.

Conclusion

A descriptive, secondary analysis of NDNQI data revealed most pediatric patients are being assessed for pressure ulcer risk, but there is room for improvement in pressure ulcer prevention among these patients. In addition, more information is needed on how pressure ulcer risk and prevention interventions are implemented across different at-risk pediatric patients in the acute care setting. n

References

1. Baldwin K. Incidence and prevalence of pressure ulcers in children. Adv Skin Wound Care. 2002;15(3):121–124. doi:10.1097/00129334-200205000-00007

2. Waterlow J. Pressure sore risk assessment in children. Paediatr Nurs. 1997;9(6):21–24.

3. Willock J, Hughes J, Tickel S, Rossiter G, Johnson C, Pye H. Pressure sores in children: the acute hospital perspective. J Tissue Viability. 2000;10(2):59–62. doi: 10.1016/20965-206X(00)80024-8.

4. Fujii K, Sugama J, Okuwa M, Sanada H, Mizokami Y. Incidence and risk factors of pressure ulcers in seven neonatal intensive care units in Japan: a multisite cohort prospective study. Int Wound J. 2010;7(5):323–328. doi:10.1111/j.1742-481X.2010.00688.x.

5. Visscher M, Taylor T. Pressure ulcers in the hospitalized neonate: rates and risk factors. Scientific Reports. 2014;4:7429. doi:10.1038/srep07429.

6. Schindler CA, Mikhailov TA, Kuhn EM, et al. Protecting fragile skin: nursing interventions to decrease development of pressure ulcers in pediatric intensive care. Am J Crit Care. 2011;20(1):26–34. doi:10.4037/ajcc201111754.

7. Curley MAQ, Razmus IS, Roberts KE, Wypij DJ. Predicting pressure ulcer risk in pediatric patients. Nurs Res. 2003;52(1):22–33. doi:10.1097/00006199-200301000-00004.

8. Razmus I. Pressure ulcers and prevention among pediatric patients and factors associated with their occurrence in acute care hospitals (Doctoral dissertation). University of Kansas 2015. Available at: www.kumc.edu. Accessed December 20, 2016.

9. Agency for Healthcare Research and Quality (AHRQ). Pressure Ulcer Guidelines. 1992. Available at: www.ahrq.gov. Accessed December 20, 2016.

10. National Pressure Ulcer Advisory Panel (NPUAP) and European Pressure Ulcer Advisory Panel (EPUAP). International Guideline: Pressure Ulcer Treatment Technical Report. 2009. Available at: www.npuap.org/wp-content/uploads/2012/03/Final-2009-Treatment-Technical-.... Accessed December 20, 2016.

11. European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPUAP), and Pan Pacific Pressure Injury Alliance

(PPPIA). Pressure Ulcers: Quick Reference Guide. 2014. Available at: www.npuap.org/wpcontent/uploads/2014/08/Quick-Reference-Guide-DIGITAL-NP.... Accessed December 20, 2016.

12. Gray M. Which pressure ulcer risk scales are valid and reliable in a pediatric population? J Wound Ostomy Continence Nurs. 2004;31(4):157–160. doi:10.1097/00152192-200407000-00002.

13. Quigley SM, Curley MAQ. Skin integrity in the pediatric population: preventing and managing pressure ulcers. J Specialists Pediatr Nurs. 1996;1(1):7–18. doi:10.1111/j.1744-6155.1996.tb00050.x.

14. Huffines B, Logsdon MC. The neonatal skin assessment scale for predicting skin breakdown in neonates. Issues Compr Pediatr Nurs. 1997;20(2):103–114. doi:10.3109/01460869709026881.

15. Willock J, Baharestani MM, Anthony D. The development of the Glamorgan paediatric pressure ulcer risk assessment scale. J Wound Care. 2009;18(1):17–21. doi: 10.12968/jowc.2009.18.1.32135.

16. Noonan C, Quigley S, Curley MAQ. Using the Braden Q scale to predict pressure ulcer risk in pediatric patients. J Pediatr Nurs. 2011;26(6):566–575. doi:10.1016/j.pedn.2010.07.006

17. Institute for Healthcare Improvement (IHI). How to Guide Pediatric Supplement: Preventing Pressure Ulcers. 2014. Available at: www.ihi.org/resources/Pages/Tools/HowtoGuidePreventPressureUlcersPediatr.... Accessed December 20, 2016.

18. Turnage-Carrier C, McLane KM, Gregurich MA. Interface pressure comparison of healthy premature infants with various neonatal bed surfaces. Adv Neonatal Care. 2008;8(3):176–184. doi:10.1097/01.ANC.0000324342.32464.83.

19. Levy A, Kopplin K, Gefen A. Adjustability and adaptability are critical characteristics of pediatric support surfaces. Adv Wound Care. 2015;4(10):615–622. doi:10.1089/wound.2015.0639.

20. Murray JS, Noonan C, Quigley S, Curley MAQ. Medical device-related hospital-acquired pressure ulcers in children: an integrative review. J Pediatr Nurs. 2013;28(6):585–595. doi: 10.1016/j.pedn.2013.05.004.

21. Pittman J, Beeson T, Kitterman J, Lancaster S, Shelly A. Medical device-related hospital-acquired pressure ulcers: development of an evidence based position statement. J Wound Ostomy Continence Nurs. 2015;42(2):151–154.

22. Lund C. Prevention and management of infant skin breakdown. Nurs Clin North Am. 1999;34(4):907–920.

23. Dealey C. Pressure sores and incontinence: a study evaluating the use of topical agents in skin care. J Wound Care. 1995;4(3):103–105.

24. Lund CH, Osborne JW, Kuller J, Lane AT, Lott JW, Raines DA. Neonatal skin care: clinical outcomes of the AWHONN/NANN evidence-based clinical practice guideline. J Obstetr Gynecol Neonatal Nurs. 2001;30(1):41–51. doi:10.1111/j.1552-6909.2001.tb01519.x.

25. Montoya C. Diaper dermatitis: smart and effective management. Am J Nurs Pract. 2008;12(9):11–20.

26. Senterre T, Abu ZI, Pieltain C, de Halleux C, Rigo J. Electrolyte and mineral homeostasis after optimizing macronutrient intakes in VLBW infants on parenteral nutrition. J Pediatr Gastroenterol Nutr. 2015;61(4):491–498.

27. National Database for Nursing Quality Indicators (NDNQI). Pressure Ulcer Definitions. 2012. Available at: www.pressganey.com/solutions/clinical-quality/nursing-quality. Accessed December 20, 2016.

28. Donabedian A. The quality of care: how can it be assessed? JAMA. 1988;260(12):1743–1748. doi: 10.1001/jama.260.12.1743.

29. Waugh SM, Bergquist-Beringer S. Inter-rater agreement of pressure ulcer risk and prevention measures in the National Database of Nursing Quality Indicators^® (NDNQI). Res Nurs Health. 2016;39(3):73–81.

30. Bergquist-Beringer S, Dong L, He J, Dunton N. Pressure ulcers and prevention among acute care hospitals in the United States. Joint Comm J Qual Patient Safety. 2013;39(9):404–410.

31. Noonan C, Quigley S, Curley MAQ. Skin integrity in hospitalized infants and children: a prevalence study. J Pediatr Nurs. 2006;21(6):445–453. doi:10.1016/j.pedn.2006.07.002.

32. Moore Z, Cowman S. Repositioning for treating pressure ulcers. Cochrane Wound Group. 2015. doi.19,1992/14651868.CD006898.pub2.

33. Bernable KQ. Pressure ulcers in the pediatric patient. Curr Opin Pediatr. 2012;24(3):352– 356. doi:10.1097MOP.0b013e32835334a0.

Potential Conflicts of Interest: none disclosed

Dr. Razmus is a wound ostomy continence nurse, Saint Francis Health System, Tulsa, OK. Dr. Bergquist-Beringer is a professor, University of Kansas School of Nursing, Kansas City, KS. Please address correspondence to: Ivy Razmus, PhD, RN, CWOCN, 305 N. Birch Court, Jenks, OK 74037; email: Ivy.Razmus@gmail.com.

SaveSave

Section:

Issue Number:

Index:

Ostomy Wound Management 2017;63(2):38–41

Hong-Lin Chen, MD; Ying-Juan Cao, PhD; Wang-Qin Shen, PhD; and Bin Zhu, MMed

Topics:

validation study

Pressure Ulcer

Risk Factors

hospitalization

mobility limitation

Abstract

The Braden Scale is the most widely used pressure ulcer risk assessment system in the world. To investigate its construct validity using structural equation modeling (SEM), a secondary analysis of retrospective data of patients admitted to an acute care facility was conducted using the records of 2588 patients who were at risk for pressure ulcers and admitted between January 2013 and December 2013. Data were extracted to an Excel sheet and analyzed, including demographic characteristics (ie, patients age, gender, weight, and disease spectrum), as well as total Braden scores and subscale scores.

The SEM was set according to modification indices suggestion. The original Braden Scale model was supported by χ²(9) = 22.854, CFI = 0.902, GFI = 0.974, root mean square error of approximation (RMSEA) = 0.092, indicating inadequate model fit. After modification according to software indices, χ²(2) = 2.052, CFI = 0.999, GFI = 0.999, RMSEA = 0.020 indicated an acceptable fit of the model (final model). The factor loadings of 6 subscales were all significant (P <.001), with .147 for nutrition, .137 for activity, .167 for friction and shear, .825 for sensory perception, .626 for mobility, and .556 for moisture subscale. The nutrition, activity, and friction and shear subscales were corrected to examine their relationships with other Braden Scale subscales (nutrition with activity [φ -0.063], activity with friction/shear [φ 0.136], and nutrition (φ friction/shear [0.159]). The factor loadings ranged from -0.067 to 0.159. These findings suggest the original Braden Scale has inadequate construct validity for acute care patients and that new risk-predicting scales should be designed based on data mining. Second, according to the factor loadings in the SEM, the most important risk factor in the Braden Scale for this patient population is sensory perception, followed by mobility and moisture. This suggests practitioners should pay particular attention to pressure ulcer prevention when patients have limited sensory perception, mobility limitations, and/or when moisture status is less than optimal.

The Braden Scale for pressure ulcer risk assessment is comprised of 6 subscales: sensory perception, skin moisture, activity, mobility, nutrition, and friction and shear. The assessment instrument was developed utilizing a theoretical model and clinical experience by Bergstrom et al in 1984 and published in 1987.^1,2 Subsequently, many studies have investigated its reliability and validity. Intraclass correlation coefficients for reliability range from 0.73 to 0.95 in nursing homes³ to 0.603 to 0.964 for hospitalized patients.⁴ In terms of validity, 1 meta-analysis⁵ of 9 publications revealed the pooled sensitivity, specificity, positive predictive value, and negative predictive values were 86%, 38%, 28%, and 93%, respectively, in long-term care; another meta-analysis⁶ involving 6070 hospitalized patients showed pooled sensitivity was 0.72 (95% CI 0.68, 0.75), pooled specificity was 0.81 (95% CI 0.80, 0.82), and the summary receiver-operating characteristic area under the curve was 0.84 (SE = 0.02). These results demonstrated the Braden Scale had validity in predicting pressure ulcer risk that was better than nursing judgment.

Although interrater reliability and predictive validity have been well investigated, construct validity (ie, whether a scale measures or correlates with the theorized scientific construct it purports to measure) for the Braden Scale has not been as well researched.

Structural equation modeling (SEM) is a family of statistical methods that includes confirmatory factor analysis, path analysis, and latent growth modeling. SEM is widely used in the social sciences because of its ability to isolate observational error from the measurement of latent variables such as pressure ulcer risk.⁷ SEM already has been used to test conceptual or theoretical models in nursing studies.^8,9

The purpose of this study was to investigate the construct validity of Braden scales using SEM.

Methods

Design. A secondary analysis of data from the authors’ previous study,¹⁰ a retrospective analysis of consecutive patients (N = 2625, mean age 59.8 ± 16.5, 1601 men), was conducted to investigate the construct validity of the Braden Scale using SEM. Inclusion criteria stipulated patients should be 1) at risk for pressure ulcers (eg, received care in the intensive care unit [ICU] between January 2013 and December 2013, bedbound for at least 1 month, >60 years of age, and post cardiothoracic surgery and/or lengthy procedure [>3 hours]); 2) age ≥18 years; and 3) have had total Braden scores and subscores recorded and available in the medical records. Patients with missing Braden score data were excluded. The study was approved by the medical ethics committee of the authors’ hospital.

Setting and sample. This study was conducted in a 3000-bed teaching hospital. Each year, approximately 2000 to 3000 patients who are at risk for pressure ulcer development are treated in the ICU and neurology, geriatric, cardiac surgery, neurosurgery, and orthopedics departments.

Data collection procedures. Medical records were retrospectively reviewed for demographic characteristics (ie, patients age, gender, weight, and disease spectrum) and Braden total and subscale scores. If more than 1 Braden score was noted, the lowest score was used. These procedures were described previously.¹⁰

SEM analysis. The significance of the relationships between the exogenous latent variable (Braden total score, which indicated pressure ulcer risk) and endogenous variables (ie, Braden Scale subcores for sensory perception, moisture, activity, mobility, nutrition, friction and shear) and the amount of variance explained in the endogenous variables were examined. Maximum likelihood estimation (MLE, an approach that utilizes available parameters to determine the likelihood of an event) was to used for discrepancy estimation, and the saturated and independence model was used for computing fit measures with incomplete data. The SEM was set according to modification indices (MI). MI can provide suggestions for modifications that likely will result in a better fit as shown by lower chi-squared values. The proposed model was assessed by widely accepted fit measures, which included χ² (χ²/df : <3 acceptable, <2 excellent), comparative fit index ([CFI] >0.90 acceptable, >0.95 excellent), goodness of-fit index ([GFI] >0.90 acceptable, >0.95 excellent), root mean square error of approximation ([RMSEA] <0.08 acceptable, <0.05 excellent), and Akaike information criterion ([AIC], the lower the better).¹¹ Factor loading represented how well factors (subscales) explained the variable (pressure ulcer risk). AMOS version 6.0 software (SPSS Inc, Chicago, IL) was used for the SEM analysis.

Results

Patient characteristics. Of the records of 2625 patients, 37 who were <18 years of age were excluded; no patients were excluded for missing Braden Scale/subscale information, leaving 2588 patients (1582 [61.1%] men, 1006 [38.9%] women; mean age 60.0 ± 15.6 [range 18–98] years) to be included in this study. The patients came from 7 clinical departments: neurosurgery, ICU, orthopedics, neurology, respiratory medicine, spine surgery, and cardiothoracic surgery. Mean Braden score was 15.4 ± 2.3 (range 6 to 22).

Model estimation. The original model was supported by χ²(9) = 22.854, CFI = 0.902, GFI = 0.974, RMSEA = 0.092, indicating inadequate model fit (see Table 1). The standardized parameter estimates are depicted in Figure 1 and Table 2. All of the factor loadings of subscales were significant (P <.001), with .193 for nutrition, .148 for activity, .276 for friction and shear, .776 for sensory perception, .694 for mobility, and .567 for moisture.

owm_0217_chen_figure1

According to the recommendations generated by the MI suggestion, the category friction and shear was added (φ) to assess its relationship to the nutrition pathway in model 2. Then friction and shear φ activity pathway (model 3), mobility φ friction and shear pathway (model 4), moisture φ nutrition pathway (model 5), moisture φ activity pathway (model 6), activity φ nutrition pathway (model 7), mobility φ activity pathway (final model) were successively added. The model fit parameters improved with each model modification.

In the final model, χ²(2) = 2.052, CFI = 0.999, GFI = 0.999, and RMSEA = 0.020, indicating an acceptable fit of the model (see Table 1). The factor loadings of subscales also were significant (P <.001), with .147 for the nutrition subscale, .137 for the activity subscale, .167 for the friction and shear subscale, .825 for the sensory perception subscale, .626 for the mobility subscale, and .556 for the moisture subscale (see Figure 2 and Table 2). The Braden subscales nutrition, activity, and friction and shear were related with other subscales. The factor loadings ranged from -0.067 to 0.159.

Discussion

The original Braden Scale showed inadequate model fit according to the fit measures (χ²(9) = 22.854, CFI = 0.902, GFI = 0.974, RMSEA = 0.092), and as such poor construct validity. Moreover, previous studies have shown the Braden Scale only has a moderate predictive validity level for pressure ulcer risk, which has been confirmed by systematic review and meta-analysis.^4,5,12-14 In use for more than 30 years, the Braden Scale has been subject to suggestions to revise.^12-14 In the past 2 decades, many data mining methods have been used successfully to predict risk with great success,¹⁵ implying pressure ulcer risk prediction will be more effective when data mining methods replace traditional theoretical models.

SEM also revealed an explanation for the inadequate validity of the Braden Scale. When the SEM of the Braden Scale was modified according to MI suggestion, the final model indicated an acceptable fit of the model (ie, the χ²(2) = 2.052, CFI = 0.999, GFI = 0.999, RMSEA = 0.020). In the final model, the nutrition, activity, and friction and shear subscales had complex correlations with other subscales. As interpreted, poor nutrition will increase friction and shear, increased activity will increase friction and shear, poor nutrition will decease activity, and low activity is related to limited mobility. These findings indicated nutrition, activity, and friction and shear were not independent risk factors for pressure ulcers.

In the final model, factor loading was 0.825 for the sensory perception subscale, followed by mobility subscale (0.626), moisture subscale (0.556), friction and shear (0.167), nutrition (0.147), and activity (0.137). The factor loadings of 3 subscales (sensory perception [0.825], mobility [0.626], and moisture [0.556]) were >0.5, and the other 3 subscales (friction and shear [0.167], nutrition [0.147], and activity [0.137]) were <0.2, indicating sensory perception, mobility, and moisture are 3 important subscales in the Braden scale. These findings suggest practitioners should pay more attention to pressure ulcer prevention, especially when patients have compromised sensory perception, mobility, and moisture status.

Limitations

This study has some limitations. First, it was a retrospective study. Shortcomings included recall bias and missing data points. Second, it was a single-center study, and pressure ulcer incidence can vary among different medical centers. Third, it was a hospital-based study. The construct validity of the Braden Scale in other facilities should be assessed. Prospective multicenter cohorts are needed to confirm the current conclusion.

Conclusion

A retrospective review and analysis of patient pressure ulcer data yielded 2 conclusions. First, the original Braden Scale has inadequate construct validity because the Braden Scale was based on a theoretical model. If data mining was used for building the pressure ulcer risk assessment model, the validity will be increased. Second, according to the factor loadings in the SEM, the most important risk factor in the Braden Scale is sensory perception, followed by mobility and moisture. The practitioner should pay particular attention to pressure ulcer prevention, particularly when patients have compromised sensory perception, mobility, and moisture status.

References

1. Bergstrom N, Braden BJ, Laguzza A, Holman V. The Braden Scale for Predicting Pressure Sore Risk. Nurs Res. 1987;36(4):205–210.

2. Bergstrom N, Demuth PJ, Braden BJ. A clinical trial of the Braden Scale for Predicting Pressure Sore Risk. Nurs Clin North Am. 1987;22(2):417–428.

3. Kottner J, Dassen T. An interrater reliability study of the Braden scale in two nursing homes. Int J Nurs Stud. 2008;45(10):1501–1511.

4. Wang LH, Chen HL, Yan HY, et al. Inter-rater reliability of three most commonly used pressure ulcer risk assessment scales in clinical practice. Int Wound J. 2015;12(5):590–594.

5. Wilchesky M, Lungu O. Predictive and concurrent validity of the Braden scale in long-term care: a meta-analysis. Wound Repair Regen. 2015;23(1):44–56.

6. Park SH, Choi YK, Kang CB. Predictive validity of the Braden Scale for pressure ulcer risk in hospitalized patients. J Tissue Viability. 2015;24(3):102–113.

7. Marsh HW, Morin AJ, Parker PD, Kaur G. Exploratory structural equation modeling: an integration of the best features of and confirmatory factor analysis. Ann Rev Clin Psychol. 2013;10:85–110.

8. Mallidou AA, Cummings GG, Estabrooks CA, Giovannetti PB. Nurse specialty subcultures and patient outcomes in acute care hospitals: a multiple-group structural equation modeling. Int J Nurs Stud. 2011;48(1):81–93.

9. Kang X, Dennison Himmelfarb CR, Li Z, Zhang J, Lv R, Guo J. Construct validity of the Chinese version of the Self-care of Heart Failure Index determined using structural equation modeling. J Cardiovasc Nurs. 2015;30(3):222–228.

10. Chen HL, Cao YJ, Wang J, Huai BS. A retrospective analysis of pressure ulcer incidence and modified Braden Scale score risk classifications. Ostomy Wound Manage. 2015;61(9):26–30.

11. Raykov T, Tomer A, Nesselroade JR. Reporting structural equation modeling results in psychology and aging: some proposed guidelines. Psychol Aging. 1991;6(4):499–503.

12. Chen HL, Shen WQ, Liu P. A meta-analysis to evaluate the predictive validity of the Braden Scale for Pressure Ulcer Risk Assessment in long-term care. Ostomy Wound Manage. 2016;62(9):20–28.

13. Park SH, Lee HS. Assessing predictive validity of pressure ulcer risk scales — a systematic review and meta-analysis. Iran J Public Health. 2016;45(2):122–133.

14. Park SH, Lee YS, Kwon YM. Predictive validity of pressure ulcer risk assessment tools for elderly: a meta-analysis. West J Nurs Res. 2016;38(4):459–483.

15. Bagherzadeh-Khiabani F, Ramezankhani A, Azizi F, Hadaegh F, Steyerberg EW, Khalili D. A tutorial on variable selection for clinical prediction models: feature selection methods in data mining could improve the results. J Clin Epidemiol. 2016;7:76–85.

Potential Conflicts of Interest: This work is supported by Nantong Municipal Science and Technology Bureau (grant number: BK2013014).

Dr. Chen is an associate professor, School of Nursing, Nantong University, Nantong City, Jiangsu Province, PR China. Dr. Cao is a director of nursing, Qilu Hospital of Shandong University, Jinan City, Shandong Province, PR China. Dr. Shen is an associate professor, School of Nursing, Nantong University. Mr. Zhu is Chief Physician, Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Nantong University and the First People’s Hospital of Nantong City, Jiangsu Province, PR China. Please address correspondence to: Bin Zhu, Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Nantong University and the First People’s Hospital of Nantong City, Haier Lane Road, No.6, Nantong City, Jiangsu Province, PR China; email: pphss@126.com.

SaveSave

Section:

Issue Number:

Index:

Ostomy Wound Management 2017;63(2):42–47

Holly Kirkland-Kyhn, PhD, FNP-c, GNP-c, CWCN; Oleg Teleten, MS, RN, CWCN; and Machelle Wilson, PhD

Topics:

outcome assessment

retrospective study

Pressure Ulcer

Risk Factors

critical care

Abstract

Deep tissue injury (DTI) may develop in critically ill patients despite implementation of preventive interventions. A retrospective, descriptive study was conducted in a 620-bed, level 1 trauma, academic medical center with 7 adult intensive care units ([ICUs] cardiac surgery, trauma surgery, burn surgery, med-surgery, neurosurgery, medical, and transfer) among patients treated from January 1, 2010 to January 1, 2015. All patients 18 years of age or older that developed a sacral DTI that evolved into a Stage 3, Stage 4, or unstageable hospital-acquired pressure ulcers (HAPU) in the ICU were included. Control group data were obtained from a sample of ICU patients who did not develop a DTI during 1 random day during that time period.

Data were extracted from electronic medical records to compare ICU patients that developed a DTI (n = 47; age 55 [range 28–93] years, 28 men) to those who did not develop a DTI (n = 72; age 58.9 [range 18–94] years, 46 men). Twenty-five (25) potential sociodemographic and clinical risk factors were identified from root cause analysis and measured for significance. Systolic and diastolic blood pressure, length of surgery, hematocrit levels, international ratio, dialysis treatments, history of shock or vasopressor use, and total Braden score were significantly (P <.05) different between the general and HAPU population. Braden scores were low for general ICU (15.0 ± 0.4) and HAPU patients (12.9 ± 0.3) (P = 0.03). Multivariate, univariate, and regression analysis showed patients with poor perfusion (low blood pressure) (OR 0.93; 95% CI 0.88-0.99), prolonged surgical procedures (time in surgery OR 1.20; 95% CI 1.07-1.33), or a history of dialysis (OR 4.0; 95% CI 0.060-0.99) and shock (OR 10.0; 95% CI 0.025-0.43) were at greatest risk for the development of DTI evolving into a Stage 3, Stage 4, or unstageable HAPU. For every mm Hg decrease in diastolic blood pressure, the odds of a DTI increased by approximately 7.5% (1/0.93 = 1.075). For every hour increase in surgery, the odds of developing a DTI increased by 20%. These data suggest when all modifiable (Braden Scale-identified) risk factors are addressed, as was the case in this population, patient-related risk factors may be more important for HAPU development in ICU patients than quality of nursing care variables. Future research should focus on the role of and methods to increase perfusion to prevent DTI development, especially during dialysis and surgical procedures.

Hospital-acquired pressure ulcers (HAPU) represent a major burden of illness and can develop across the continuum of care (acute care hospitals, long-term care, skilled nursing facilities, and at home) despite best practices for prevention. According to a review of the literature,¹ deep tissue injuries (DTI) may be a precursor to the development of a HAPU in critically ill patients in intensive care units (ICU). The National Pressure Ulcer Advisory Panel² (NPUAP) guidelines state DTI presents as a “purple or maroon localized area of discolored intact skin or blood-filled blisters, due to damage of underlying soft tissue from pressure and/or shear.” DTI may evolve into Stage 3, Stage 4, and unstageable pressure ulcers.^3,4 The incidence of HAPU in ICUs in the United States has been reported to range from 10% to 41%.^5,6

Both DTI and pressure ulcers are localized areas of tissue necrosis that develop most frequently over a bony prominence when soft tissue is compressed by an external surface over a period of time.² The consequences of pressure-induced injury to skin range from nonblanchable erythema of the skin (Stage 1) to full-thickness deep ulcers involving muscle and bone (osteomyelitis) in Stage 4.² Berlowitz and Brienza¹ posited clinically superficial (Stage 1 and Stage 2) pressure ulcers may have a different etiology than DTI or perhaps all pressure ulcers arise from DTI. The NPUAP guidelines² suggest applied pressure, shear, friction, and moisture contribute to the development of a pressure ulcer. However, other patient-related factors may provide a greater contribution to the development of DTI that evolve into Stage 3, Stage 4, or unstageable pressure ulcers, especially in patients who receive interventions designed to prevent the modifiable risk factors of pressure, shear, friction, and moisture. The 2009 white paper by the NPUAP² suggested occurrences of HAPUs, despite all prevention interventions in critically ill patients, may not be preventable.²

Although other scales and tools have been developed for risk assessment, the literature review by Kelechi et al⁷ found the Braden Scale is the most commonly used worldwide. The Braden Scale has 6 constructs in the areas of sensory perception, mobility, activity, moisture, friction/shear, and nutrition. These constructs are assigned a score on a scale of 1 to 4, with higher scores showing a lower risk for the development of HAPU. Modifiable risk factors included in the Braden Risk Assessment Scale include interface pressure, shearing forces, friction, moisture, and nutrition.²

According to the institutional policy of the authors’ facility, nurses are responsible for performing HAPU risk assessment at regular, predefined intervals. However, the Braden Scale was developed for use in long-term care facilities and has been adopted by the acute care setting without further validation for acute care patient risk assessment.⁸

A significant gap in the knowledge exists in identifying and quantifying patient-related risk factors that contribute to the development of DTIs that evolve into Stage 3, Stage 4, and unstageable HAPU in ICUs. It has been suggested hospitals use their own data, over time, for pressure injury prediction and to develop risk models for their specific population.⁸Hospital-specific data were used in this study to further the science on the development of DTIs and pressure injury in critically ill patients in ICUs.

Purpose

The purpose of this study was to identify common patient characteristics and factors (vulnerabilities) that contribute to the development of DTIs that evolved into Stage 3, Stage 4, and unstageable HAPU in ICU patients. The secondary purpose of this study was to define specific parameters for the risk factors to identify patients at risk for HAPU within the ICU population.

Methods

This retrospective, descriptive, comparative study was conducted in a 620-bed, level 1 trauma, academic medical center that has 7 adult ICUs (cardiac surgery, trauma surgery, burn surgery, med-surgery, neurosurgery, medical, and transfer). Hospital Institutional Review Board approval was obtained. Inclusion criteria specified participants should be patients 18 years of age or older that developed sacral DTIs that evolved into Stage 3, Stage 4, and unstageable HAPU in the ICU.

The data were abstracted following an electronic medical record (EMR) review to identify patients who met the study criteria and were in the hospital at any point from January 1, 2010 to January 1, 2015.

Data collected. A root cause analysis was performed on each HAPU and 25 characteristics and factors were identified, abstracted, and entered into an Excel spreadsheet: gender and age; type of ICU; length of stay (LOS) in ICU; Braden score on admission and on the discovery of pressure ulcer; primary and secondary medical diagnosis; HAPU location, date discovered, initial stage, and final stage; type and length of surgical procedures for the 2-week period before the DTI was identified; body mass index (BMI); albumen level; lowest measured hemoglobin and hematocrit (HCT) for the 2-week period before the DTI was identified; international ratio (INR) for clotting of blood; lowest measured systolic blood pressure (SBP) and diastolic blood pressure (DBP) for the 2-week period before the DTI was identified; and dialysis or no dialysis, vasopressor use or no vasopressor use, documented shock and type of shock (ie, neurogenic, hemorrhagic, septic, cardiogenic).

The demographic characteristics and factors collected were based on literature review and commonalities in patient characteristic findings in the data. The EMR data were abstracted by the primary investigator (a subject matter expert) and co-investigator (PI), who accessed the EMR of patients who had documented Stage 3, Stage 4, and unstageable HAPU. The EMR review process was performed by both the PI and co-investigator simultaneously to ensure the accuracy of the data collection.

Data processing. After all HAPU data were retrieved and entered into the Excel spreadsheet, a comparative group was created in order to define the differences between general, non-DTI ICU patients and patients that developed DTI. The EMR was accessed for all patients in the adult ICUs on 1 random day to have a comparison cohort of general ICU patients. The same risk data were abstracted from the general ICU patient group for comparison with the patients who developed DTI. Twelve (12) factors were eliminated after comparison analysis due to nonsignificance or no difference between ICU patients who did and did not develop DTI. The remaining characteristics and factors were gender, age, BMI, length of stay, SBP, DBP, LOS, HCT, INR, dialysis, shock, use of vasopressors, and Braden score.

Data analysis. The analysis of the data is both descriptive and comparative to determine common characteristics and factors in patients who developed DTIs that evolved into a Stage 3, Stage 4, or unstageable HAPU. The authors used a model selection procedure: first, possible risk factors were identified for a multivariable logistic regression model. A series of univariate tests was performed to identify the significant variables. Variables were considered for inclusion if they had a P value <.2. T-tests were conducted to assess for association between DTI and SBP, DBP, Braden score, HCT, BMI, length of surgery (hours), and INR. Fisher’s exact test was used to assess the association between DTI and dialysis, shock (hypovolemic, hemorrhagic, neurogenic, cardiogenic, or septic), and use of vasopressors. The authors also tested for multicollinearity between the continuous variables using Pearson’s correlation. If any correlation between 2 variables was >0.6, only the variable with the larger or more clinically relevant effect size was included. The analysis was performed using SAS version 9.3 (SAS Institute Inc, Cary, NC). A logistic regression model including all the candidates identified was fit, and a backward selection procedure was employed to identify covariates significant at the .05 level.

Results

A total of 119 patients with and without DTIs were included in the study. Of the 76 general ICU patients, 4 had developed DTI and a Stage 3, Stage 4, or unstageable HAPU; therefore, they were placed into the HAPU group, leaving 72 in the General ICU group (see Table 1). The general average age of the adult ICU population (n = 72) was 58.9 (range 18–94) years, with an average BMI of 29.9 (range 16–65.2) and average LOS of 12.8 (range 1–124) days. The HAPU population (n = 47) had an average age of 55 (range 28–93) years, with an average BMI of 30.6 (range 18.9–74.3) and average LOS of 24.9 (range 2–82) days.

The results of the univariate tests are shown in Table 2. Mean/average SBP was <92 mm Hg, DBP <49, cumulative length of surgery >6 hours, HCT <27, and elevated INR >1.3. Shock (documented by the physician), dialysis treatment, and vasopressor use were significant patient-related factors (P <.001) in the development of DTIs in critically ill patients. A Braden score <18 was considered significant (P = .03). BMI was not found to a significant risk factor.

SBP and DBP were strongly correlated, with an R = 0.7 (P <.001). No other continuous risk factors were correlated above 0.60. Because a decrease in DBP in a hypotensive patient is more clinically significant for perfusion, only DBP was included in the regression model.

To identify the most significant risk factors, a backward selection procedure was performed. During this procedure, HCT (P = .54), Braden score (P = .36), vasopressor use (P = .41), and INR (P = .12) were eliminated.

The significant variables remaining after backward selection and their odds ratios were dialysis, shock, DBP, and time in surgery (see Table 3). The results show, after controlling for the covariant risk factors, patients receiving dialysis had approximately 4 times greater odds of developing a DTI compared to patients without dialysis. For patients with shock, the odds of a DTI development were 10 times greater than those who had no diagnosis of shock. For every mm Hg decrease in DBP, the odds of a DTI increased by about 7.5% (1/0.93 = 1.075). For every hour increase in surgery, the odds of a DTI increased by 20%.

Discussion

In this level 1 trauma center, a decrease in perfusion (low SBP and DBP) due to shock states (sepsis, hemorrhagic, hypovolemia, neurogenic, cardiogenic) and prolonged procedure times were found to be the most significant factors contributing to DTIs in this population. Retrospective studies^9,10 and a literature review¹¹ suggest the patient-specific factors found to predict an increased risk for HAPU in the ICU setting were decreased perfusion, advanced age, procedures lasting >2 hours, and sepsis with multiple end organ system failure. Although similar findings were noted in the current study, patients that developed DTIs that evolved into Stage 3, Stage 4, and or unstageable HAPU were younger than the patients in previous studies.^10,12 Previous studies included outcomes of Stage 1 and Stage 2 pressure ulcers, which are usually caused by modifiable risk factors that are associated with the Braden risk assessment.¹⁰ This study focused on patients who developed DTIs that evolved into Stage 3, Stage 4, and unstageable HAPU only.

Combined low perfusion and high surface pressure over time was strongly associated with the development of DTIs in this ICU population. Longitudinal¹³ and prevalence studies¹⁴ (N = 102) also noted prolonged operating room or procedure time contribute to the development of HAPU; 1 study¹⁴ suggested as little as 2 to 4 hours of general anesthesia during a procedure may be a contributing factor. During a previous study¹⁵ (N = 49) on OR surfaces, the current authors showed standard OR surfaces do not provide pressure redistribution. This suggests pressure over the sacrum (pressure mapping >32 mm Hg) during patient low perfusion (DBP <50; SBP <90) and prolonged OR procedures may contribute to the development of DTI.

Previous studies measuring blood flow¹⁶ and skin perfusion¹⁷ found skin perfusion is decreased during hemodialysis because of hypovolemia related to fluid removal, inflammatory response, and blood flow redistribution. As a result, artificially lowered perfusion during hemodialysis treatment may contribute to DTI development. A prospective quasi-experimental repeat measure design study suggested low serum albumen,¹⁸ higher creatinine, higher blood urea nitrogen^13,19 levels, and low HCT¹⁹ are more significant predictors for the development of HAPU than the Braden score.⁸ The results of the current study seem to confirm some of these findings. Dialysis — when used for stage 5 kidney disease or acute kidney failure (higher creatinine, higher blood urea nitrogen, and low HCT) — significantly increased the risk of developing a DTI, while the Braden score was not predictive once other risk factors were considered.

In the univariate test, the Braden score was significant (P = .03); however, during the backward elimination procedure, the Braden score was not considered significant (P = .4) and therefore eliminated. It is possible the Braden score was not significant because all (Braden-related) prevention interventions were implemented for patients with scores of 18 or below. This suggests that when basic prevention measures have been implemented the Braden Scale is not sensitive or specific enough to identify other risk factors associated with the development of HAPU in ICU patients. Evidence supporting the use of the Braden in predicting HAPU in ICU patients is limited because the scale does not take into consideration unique factors of critically ill patients in the ICU setting.^8,20 In a retrospective medical review on characteristics of hospitalized patients with vascular disease, Corniello et al¹⁹ found 9 factors contribute to HAPU; the Braden score was the least sensitive for predicting risk of the development of HAPU. A retrospective electronic medical record review²⁰ on ICU patients showed poor predictive validity and poor accuracy when using the Braden Scale for risk assessment for the development of HAPU in an ICU. These findings are consistent with the current study results for ICU patients who developed a DTI.

Limitations

The limitations of this study are inherent to the retrospective design. All data were collected and reviewed at the end of 5 years and as risk factors were identified. The authors may have omitted risk factors that were unknown or unmeasurable at the time of this study. Previous identified possible nutrition-related risk factors such as weight fluctuations and prealbumen were not available for this study. A further limitation of the study may be in the comparative ICU patient data collection method.

Conclusion

In this study, ICU patients with poor perfusion (low blood pressure) or who had prolonged surgical procedures or dialysis were at greatest risk for the development of DTI evolving into a Stage 3, Stage 4, or unstageable HAPU. For every mm Hg decrease in DBP, the odds of a DTI increased by about 7.5% (1/0.93 = 1.075). For patients with a diagnosis of shock, the odds of developing a DTI were 10 times greater than those who had no diagnosis of shock. For every hour increase in surgery, the odds of developing a DTI increased by 20%. Data presented also indicate patients with hemodialysis treatments had approximately 4 times greater odds of developing a DTI compared to patients who did not need hemodialysis treatments.

This study advances the knowledge of the specific risk factors, including the parameters of risk factors, that contribute to the development of DTI. The univariate test of the Braden score was significant with confidence intervals for the general ICU population, ranging from 14.2 to 15.8, comparable with the Braden scores of the HAPU population (12.2–13.5), suggesting all ICU patients were at high risk for the development of HAPU. The use of the Braden risk assessment for patients in this study was not found to predict the risk for developing a HAPU, which may be because all Braden-related prevention interventions were implemented and documented.

In turn, this suggests when all modifiable risk factors are addressed, patient-related risk factors may be a more important variable for HAPU development in ICU patients than quality of nursing care variables. In addition, the NPUAP should consider changing the nomenclature of DTIs which evolve into Stage 3, Stage 4, and unstageable pressure ulcers. DTIs that originate in the ICU from poor perfusion should not be confused with pressure ulcers that occur from moisture, poor nutrition, and lack of repositioning (Braden-related risk factors).

In addition, the study found blood pressure increases the odds of developing DTI and HAPU — information that can guide hemodialysis treatment. New guidelines may be needed to modify hemodialysis in hopes of maintaining perfusion to the sacral area (and possibly feet) during low perfusion states. Pressure-redistribution surfaces should be used in all patients during low perfusion states to include outpatient dialysis, the ICU, and during surgical procedures. Nurses should have the authority to order evidence-based prevention interventions that include pressure-redistribution surfaces and dressings to ameliorate the effects of pressure, moisture, and shear.

This study confirms other reports about the role of perfusion and HAPUs, suggesting a potential role for measuring perfusion in combination with surface interface pressure, especially over bony prominences during immobile events (eg, prolonged surgery or hemodialysis). In addition, further research should focus on pressure ulcers on other bony prominences that occur in low perfusion states and to investigate additional patient-related risk factors that may contribute to the development of DTIs and HAPU, despite implementation of all prevention interventions. As such, the authors are working with another academic medical center in order to replicate this study in their adult ICU population.

References

1. Berlowitz DR, Brienza DM. Are all pressure ulcers the result of deep tissue injury? A review of the literature. Ostomy Wound Manage. 2007;53(10):34–38.

2. Haesler E, ed. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Perth, Australia: Cambridge Media;2014.

3. Black JM, Brindle CT, Honaker JS. Differential diagnosis of suspected deep tissue injury. Int Wound J. 2016;13(4):531–539.

4. Gefen A, Farid KJ, Shaywitz I. A review of deep tissue injury development, detection, and prevention: shear savvy. Ostomy Wound Manage. 2013;59(2):26–35.

5. VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009;55(11):39–45.

6. Nijs N, Toppets A, Defloor T, Bernaerts K, Milisen K, Van Den Berghe G. Incidence and risk factors for pressure ulcers in the intensive care unit. J Clin Nurs. 2009;18(9):1258–1266.

7. Kelechi TJ, Arndt JV, Dove A. Review of pressure ulcer risk assessment scales. J Wound Ostomy Continence Nurs. 2013;40(3):232–236.

8. Raju D, Su X, Patrician PA, Loan LA, McCarthy MS. Exploring factors associated with pressure ulcers: a data mining approach. Int J Nurs Stud. 2015;52(1):102–111.

9. Fogerty MD, Abumrad NN, Nanney L, Arbogast PG, Poulose B, Barbul A. Risk factors for pressure ulcers in acute care hospitals. Wound Repair Regen. 2008;16(1):11–18.

10. Alderden J, Whitney JD, Taylor SM, Zaratkiewicz S. Risk profile characteristics associated with outcomes of hospital-acquired pressure ulcers: a retrospective review. Crit Care Nurs. 2011;31(4):30–43.

11. Bauer K, Rock K, Nazzal M, Jones O, Qu W. Pressure Ulcers in the United States’ Inpatient Population From 2008 to 2012: results of a retrospective nationwide study. Ostomy Wound Manage. 2016;62(11):30–38.

12. Stekelenburg A, Gawlitta D, Bader DL, Oomens CW. Deep tissue injury: how deep is our understanding? Arch Phys Med Rehabil. 2008;89(7):1410–1413.

13. Bulfone G, Marzoli I, Quattrin R, Fabbro C, Palese A. A longitudinal study of the incidence of pressure sores and the associated risks and strategies adopted in Italian operating theatres. J Perioper Pract. 2012;22(2):50–56.

14. Schoonhoven L, Bousema MT, Buskens E, prePURSE study group. The prevalence and incidence of pressure ulcers in hospitalised patients in the Netherlands: a prospective inception cohort study. Int J Nurs Stud. 2007;44(6):927–935.

15. Kirkland-Walsh H, Teleten O, Wilson M, Raingruber B. Pressure mapping comparison of four OR surfaces. AORN J. 2015;102(1):e1–e9.

16. Mistrik E, Dusilova Sulkova S, Blaha V, et al. Evaluation of skin microcirculation during hemodialysis. Renal Failure. 2010;32(1):21–26.

17. Hiratsuka M, Koyama K, Yamamoto J, et al. Skin perfusion pressure and the prevalence of atherothrombosis in hemodialysis patients. Ther Apher Dial. 2016;20(1):40–45.

18. Serpa LF, Santos VL. Validity of the Braden Nutrition Subscale in predicting pressure ulcer development. J Wound Ostomy Continence Nurs. 2014;41(5):436–443.

19. Corniello AL, Moyse T, Bates J, Karafa M, Hollis C, Albert NM. Predictors of pressure ulcer development in patients with vascular disease. J Vasc Nurs. 2014;32(2):55–62.

20. Hyun S, Vermillion B, Newton C, et al. Predictive validity of the Braden scale for patients in intensive care units. Am J Crit Care. 2013;22(6):514–520.

Potential Conflicts of Interest: The project described was supported in part by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through grant #UL1 TR000002.

Dr. Kirkland-Kyhn is a Family and Geriatric Nurse Practitioner and Director of Wound Care; Mr. Teleten is a registered nurse certified in wound care; and Dr. Wilson is a senior statistician, University of California, Davis, Medical Center, Sacramento, CA. Please address correspondence to: Holly J. Kirkland-Kyhn, PhD, FNP, University of California, Davis, Medical Center, PCS, 2315 Stockton Boulevard, Sacramento, CA 95817; email: kirklandwalsh@ucdavis.edu.

SaveSave

Section:

Volume 63 - Issue 8 - August 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(8):22–29. doi: 10.25270/owm.2017.08.2229

Emel Yilmaz, PhD; Dilruba Çelebi, RN; Yavuz Kaya, MD; and Hakan Baydur, PhD

Topics:

clinical study

Colostomy

Quality of Life

sexual dysfunction

erectile dysfunction

Abstract

A stoma affects personality, self-esteem, and body image, inevitably impacting lifestyle and quality of life (QOL). A descriptive, cross-sectional study was conducted between May 1, 2015 and May 1, 2016 to evaluate the effect of a stoma on sexual function and QOL among patients receiving care in a general surgery clinic of a university hospital in the western region of Turkey.

Eligibility requirements included patients willing to participate, >18 years of age, with a colostomy for at least 4 months, who were married and/or with a sexual partner and in otherwise good physical and mental health with no rectal nerve damage or receiving radio- or chemotherapy. Data were collected during face-to-face interviews. Demographic variables (age, gender, body mass index [BMI], educational status, income level); and clinical information (duration of the precipitating disease, and stoma duration, cause, and type) were collected, and the International Index of Erectile Function (IIEF) measure; the Index of Female Sexual Function (IFSF); and a Stoma Quality of Life Scale (SQOLS) were completed. Statistical analyses were performed using descriptive statistics, Spearman’s correlation coefficient, and the Mann-Whitney U test. Of the 57 study participants, 57.9% were >60 years old (mean age: 59.81 ± 10.12), more than half (57.92%) were male, 33.3% had a permanent stoma, and the mean duration of the stoma was 9.60 ± 6.40 months. Scores for all 3 outcomes were low; mean IIEF score was 3.64 ± 2.47 (range 2–10), mean IFSF score was 13.04 ± 5.19 (range 9–29), and mean SQOLS was 45.10 ± 18.88 (range 0–100). Eighteen (18) of the 33 men (54.5%) had severe, 5 (15.2%) had moderate, and 9 (27.3%) had mild erectile dysfunction. The IFSF total score for all female patients was <30; all female patients experienced sexual dysfunction. A negative correlation between age and the SQOLS subscale sexuality/body image was found (rs = -0.305, P<.05). A positive correlation was found among BMI, erectile function (rs = 0.350, P<.05), sexual desire (rs = 0.474, P<.01), and intercourse satisfaction (rs = 0.385, P<.05). These study results provide reference data for future study and underscore the importance of assessing and addressing QOL and sexuality concerns among patients with a colostomy.

A stoma is a surgically created opening in the abdominal wall that facilitates the elimination of stool.¹ Descriptive studies^2-4 have shown a stoma can affect personality, self-esteem, and body image, inevitably impacting lifestyle and quality of life (QOL). A review⁵ and a randomized, controlled trial⁶(N = 59) reported patients with a stoma often exhibit specific physiological and psychological problems such as flatulence, stool leakage, bad odor, social isolation, persistent dissatisfaction with body image, anxiety, and lowered self-respect and self-esteem. Furthermore, personal and family relationships can be troublesome for these patients. Patients may isolate themselves from their families, spouses, and society; when patients feel sexually inadequate due to these body image alterations and physiological and psychological problems, the QOL and sexual life of the patients also can be negatively affected.^5-12 A review³ and a nonrandomized, prospective study¹³ (N = 50) found a stoma can cause long-term sexual dysfunction.

Results of a qualitative study (N = 14) by Dabirian et al¹⁴ reported that concern regarding colostomy- and stoma-related problems such as financial state, relationship with family and friends, entertainment, travel, physical activity, sexual function, and eating were factors that affected patients’ QOL. A prospective analysis¹⁵ of QOL after cancer surgery (N = 65) found QOL was better 1 year after stoma creation than before surgery, but sexual function decreased; a prospective study (N = 51) by Breukink et al¹⁶ found QOL improved despite worsening sexual functioning 1 year after surgery. A 2005 systematic review¹⁷ that investigated the social and psychological effects of a stoma on an individual’s life also underscored its negative influence on QOL with respect to self-respect and confidence as well as problems with sexuality.

Physical, psychological, and sexual problems of patients with a stoma should be evaluated and addressed to improve QOL. Stoma care nurses have an important responsibility in that area. Unfortunately, the number of nurses who specialize in ostomy care nursing is inadequate in Turkey and research on QOL and sexual activity of Turkish patients is lacking; these factors may explain why nurses in Turkey have not made QOL and sexual function of patients with a stoma a priority.

The purpose of this study was to evaluate the effect of a stoma on sexual function and QOL in persons with a colostomy.

Methods and Materials

Patients. A descriptive, cross-sectional study was conducted among patients receiving care in a general surgery clinic of a university hospital in the western region of Turkey between May 1, 2015 and May 1, 2016. Inclusion criteria stipulated patients must be willing to participate in the study, be >18 years of age, have a colostomy for at least 4 months, be married and/or with a sexual partner, and be in good physical and mental health. Any patient with emotional or psychological problems or a chronic disease affecting QOL, receiving chemotherapy or radiotherapy within the study timeframe, or with rectal nerve damage was excluded from the study.

The sample size was determined according to the results of a cohort study (N = 289) by Larson et al¹⁸ in which the sample size was calculated using mean and standard deviation of the International Index of Erectile Function (IIEF) overall satisfaction subscale. The minimum sample size for the study was calculated as 51 individuals with a 5% deviation, 80% power, and a 95% confidence interval.

The study was approved by the Scientific Ethics Committee (Reference number 30.04.2014/20478486-190). Permission was obtained from the hospital before the study. The study was performed in compliance with the Declaration of Helsinki. The research assistant explained the study in detail to potential participants and obtained written informed consent.

Instruments. Data were collected using the Personal Information Form, IIEF, Index of Female Sexual Function (IFSF), and the Stoma Quality of Life Scale (SQOLS).

Personal information form. This instrument, developed by researchers, consisted of 2 parts: the first part included demographic questions concerning age, gender, body mass index (BMI), educational status, and income level; the second facilitated the collection of information regarding the type of and time since diagnosis of the underlying disease and type (permanent or temporary) and duration of the stoma as well as treatment (radio- or chemotherapy), ability to provide self-care, and overall perceptions regarding QOL and sexuality.

IIEF. This index, developed by Rosen et al,¹⁹ includes 5 subscales for a total of 15 questions: erectile function (questions 1 through 5 and 15), sexual satisfaction (questions 6 through 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), and overall satisfaction (questions 13 and 14). Each question on the IIEF is scored from 1 to 5 points, where 1 = severe dysfunction and 5 = no dysfunction. The total score range is 5 to 75. Based on this score, the degree of erectile dysfunction (ED) is classified as normal (>25), mild (17 to 25), moderate (11 to 16), or severe (0 to 10). The Turkish version was tested for validity and reliability.²⁰

IFSF. This 9-question index was developed by Kaplan et al²¹ and includes 6 subscales: quality of sexual intercourse (questions 1 and 2), desire (questions 4 and 5), overall satisfaction with sexual function (questions 6 and 7), orgasm (question 8), lubrication (question 2), and clitoral sensation (question 9). Lower scores indicate dissatisfaction; the highest score is 49. The total IFSF score calculated at or below 30 is indicative of sexual dysfunction. Validity and reliability of the Turkish version of this index were established.²²

SQOLS. This 21-item questionnaire was developed by Baxter et al²³ and includes 3 subscales: work/social function (6 items), sexuality/body image (5 items), and stoma function (6 items). Three (3) additional 1 items measure financial impact (1 item), skin irritation (1 item), and overall satisfaction (2). Nineteen (19) items are scored using a Likert-type, 5-point scale (1 = never, 2 = seldom, 3 = occasionally, 4 = frequently, 5 = always), and 2 items measure overall life satisfaction from 0 to 100. Subscale scores on the SQOLS range from 0 to 100 (0 is the worst and 100 indicates the best QOL) for each item.^23,24 Turkish validity and reliability of this scale were established by Karadağ et al.²⁴

Data collection. Data were collected during outpatient clinic visits via face-to-face interviews using the instruments. Patients completed the questionnaires with the research assistant available to address any concerns. For some patients, the questions were read aloud by a research assistant. The questionnaire forms were completed individually in a separate room to ensure privacy. Patient names were not recorded to ensure confidentiality. Generally, the questionnaires took approximately 20 to 25 minutes to complete. Data were recorded using paper/pencil materials and entered into a computer by researchers.

Statistical analysis. Data were entered and analyzed using Statistical Package for Social Sciences (SPSS) version 15.0 (SPSS Inc, Chicago, IL). The Kolmogorov-Smirnov test was used to asseess whether data were normally distributed. Descriptive statistics (mean ± standard deviation; minimum and maximum; or median [interquartile range-IQR]) were used to analyze continuous variables; categorical data were calculated in numbers and percentages. Differences between groups for continuous variables were evaluated by the Mann-Whitney U test and Spearman’s correlation coefficient tests where applicable. The results were assessed using a 95% confidence interval and significant when P<.05.

Results

A total of 66 patients with a stoma were admitted to the outpatient clinic for the study period and screened for study eligibility; 57 met the inclusion criteria. One (1) patient refused to participate, 3 patients had a physical or psychological morbidity, and 5 patients had rectal region nerve damage from their ostomy surgery and were excluded.

Thirty-three (33, 57.9%) patients were >60 years old (mean age: 59.81 ± 10.12), the majority (33, 57.9%) were male, 32 (56.1%) were normal weight (mean BMI: 25.35 ± 5.29), for 41 (71.9%) the highest educational level was elementary school, 39 (68.4%) were unemployed (housewives/retired), 44 (77.2%) had an average monthly income $500 Turkey lira or above, 33 (57.9%) lived in an urban setting, and 9 (15.8%) were active smokers (see Table 1).

Most (40) patients (70.2%) received their first diagnosis within the previous 12 months (mean first diagnosis time: 12.35 ± 10.42 months); for more than half of patients (35, 61.4%), their stoma was created 9 months previous or less (mean stoma duration: 9.60 ± 6.40 months). The majority of patients (37, 64.9%) had surgery because of colon cancer; 19 (33.3%) had a permanent stoma and more than half (33, 57.9%) received treatment including chemotherapy and radiotherapy after stoma surgery. One third of patients (19, 33.3%) performed their own stoma care. The majority of participants reported their daily (43, 75.4%) and sexual lives (48, 84.2%) were seriously affected by the stoma (see Table 2).

Patients’ SQOLS scores were highest on the work/social function (47.00 ± 23.66) and lowest on sexuality/body image (43.86 ± 17.42) subscales. Patient scores in all 3 scales were low (see Table 3). Female patients with a stoma scored highest on the IFSF lubrication subscale (2.12 ± 1.57) and the lowest on sexual desire (2.46 ± 1.32) and intercourse satisfaction (2.46 ± 0.93) subscales. Men had the highest score on the IIEF erectile function subscale (13.06 ± 6.48) and the lowest score on the sexual desire (3.64 ± 2.07) and overall satisfaction subscales (3.64 ± 2.47). Among the 33 men, 18 (54.5%) had severe, 5 (15.2%) had moderate, and 9 (27.3%) had mild ED (see Table 4). The IFSF total score for all female patients was <30; all female patients experienced sexual dysfunction.

owm_0817_yilmaz_table4

When the correlation between independent variables and subscales scores was examined, a negative correlation between age and the SQOLS subscale sexuality/body image was found (rs = -0.305, P<.05). The sexuality/body image score decreased as age increased. A positive correlation was found among BMI, erectile function (rs = 0.350, P<.05), sexual desire (rs = 0.474, P<.01), and intercourse satisfaction (rs = 0.385, P<.05). As BMI increased, the scale scores also increased (see Table 5).

When the overall SQOLS and subscale scores were compared with the independent variables, the difference among type of stoma and overall SQOLS and sexuality/body image subscale scores was found to be statistically significant (P<.05). The median scores of patients with a temporary stoma were higher than persons with a permanent stoma. The difference between stoma effects on daily life and all subscale scores of the SQOLS was statistically significant (P<.05); patients that perceived the stoma seriously affected their daily lives scored lower than “mild.” The difference in overall SQOLS and sexuality/body image subscale scores and effect on sexuality was found to be statistically significant (P<.05). Patients whose sexual lives were severely affected had lower median scores (see Table 6).

Discussion

This study evaluated QOL and sexual function of patients with a stoma. The IIEF, IFSF, and SQOLS scores of patients with a stoma were found to be low, reflecting poor patient QOL and sexual function.

Participants had an overall SQOLS mean score of 45.10 ± 18.88 with low subscales in all domains. On the SQOLS, the highest subscale score was for work/social function and the lowest score was for sexuality/body image. QOL impairment was most significantly related to the sexuality/body image domains in these patients.

The lifestyles of patients with a stoma can be affected in different ways owing to physical and psychological problems. Physiological problems such as change in bowel habits, loss of stool control, and involuntary flatulence and odor may adversely affect body image, and the stoma may restrict daily and social activities. Consequently, descriptive and cross-sectional studies^9,12,25,26 have shown patients with a stoma may experience isolation, low self-esteem, and body image change, negatively affecting their daily lives and QOL.²⁷ Research that reports a decrease in the QOL in patients with a stoma includes a cross-sectional study (N = 2329) by Nichols²⁸ in the United States that compared patients with a stoma to a healthy general population and showed patients with a stoma have more difficulty engaging in physical activity. A cross-sectional survey (N = 255) by Ito et al²⁹ conducted among Japanese patients reported physical activity and social function were affected negatively by a colostomy. In a descriptive study that included 50 patients with a stoma, Zając et al³⁰ also found QOL was affected. A questionnaire survey³¹ involving Muslim patients (N = 100) indicated QOL was lower after creation of a stoma, which supports previous research showing a stoma adversely affects QOL and sexual life,^5,8-12 findings supported by the current study.

In the current study, most patients reported their sexual life and daily activities were affected negatively after creation of the stoma. A review study by Szczepkowski³² reported patients experience a change of body perception, decline in self-esteem, degeneration of sexual function, problems with spousal harmony, and many different psychiatric problems, most notably depression. The descriptive study by Karadağ et al¹¹ showed patients suffer social isolation due to odor and leakage (N = 43).

Men and women with a stoma commonly express fears about sexual problems and the appearance of the stoma, stool leakage, odor, noise, and opening of the colostomy bag during sexual intercourse, as well as refusal by their partners.^3,5,7,10 In a descriptive study by Nugent et al⁸ conducted among 542 patients with a stoma, 80% said QOL was affected and 40% suffered effects on their sexual life after stoma creation. According to a review of 17 studies by Sprangers et al,³³ individuals with a stoma have a higher rate of sexual and psychological problems. In open-ended, tape-recorded interview study of 9 Swedish patients with a stoma, Persson and Hellström¹⁰ indicated most experience anxiety about their sexual life and believe their sexual attraction was decreased. A systematic review by Brown and Randle¹⁷ reported individuals think their body is not like the old one after stoma surgery and they do not want to have sexual intercourse because they feel less attractive.

Stoma surgery affects the sexual lives of males and females differently.^3,8,27,34 Stoma surgery may lead to ED in men and loss of libido, dyspareunia, vaginal tightness, vaginal dryness, and sexual dysfunction in women.^5,10,34-37 Major physiological issues for men include ED and ejaculatory difficulties. For women, dyspareunia is the most common physiological problem.³⁴ A systematic review³³ of 17 studies reported 66% to 100% of men with a stoma suffer impotance, erection, and ejaculation problems; a study⁵ involving women showed 5% to 30% with an ostomy have sexual problems. Sexual problems are reported at different rates in studies by Karadağ et al¹¹ (74.4%), Nugent et al⁸ (40%), and Silva et al¹² (95% of ostomy patients and 81% of colostomy patients). A review by Bekkers et al³⁵ indicated sexual problems occurred within the first 4 months after stoma creation. A retrospective case control study (N = 42) by Ozturk et al³⁶ reported patients of both genders with a colostomy experienced sexual dysfunction. In a cross-sectional study in Iran among 96 stoma patients, Mahjoubi et al³⁷ found sexual dysfunction and satisfaction problems in both men and women, with women suffering to a greater extent. Results of a descriptive study (N = 261) by Milbury et al³⁸ showed 65% of men with colorectal cancer experience moderate to severe ED postoperatively and 42.5% of women experience severe sexual dysfunction. Additional studies underscore the extent of sexual problems in patients with a stoma.^7,39-42 The change of appearance, presence of a colostomy bag, and perceived compromise in personal hygiene after the stoma is created can lower the patient’s sexual desire.

In this study, the median scores of sexuality/body image and overall SQOLS of the patients with a temporary stoma were higher than persons with a permanent stoma; this could be a factor of collecting data within the first year of the patients having a stoma. In a retrospective, case controlled study in Turkey involving 42 male and female patients with a colostomy, Ozturk et al³⁶ reported a higher frequency of sexual problems in patients with a permanent colostomy. A descriptive study (N = 178) in Turkey by Kuzu et al² found sexual life was negatively affected in both male and female patients with a permanent stoma. Results of a prospective study (N = 131) by Konanz et al⁴³ also indicated sexual function was lower in persons with a permanent as compared to a temporary stoma. A multicenter, cross-sectional study (N = 737) in Poland by Golicki et al⁴⁴ found both genders with a temporary stoma had better QOL and sexual function. A cross-sectional study⁴⁵ (N = 102) found male and female stoma patients with cancer had more sexual problems than non-cancer patients.⁴⁵

However, other cross-sectional and descriptive research⁴⁶ has shown that type of stoma does not have either a positive or negative effect on self-esteem. These results can perhaps be explained by the elderly patient population of the study. Temporary stomas can be closed within 1 year, except in special conditions; permanent stomas are lifelong for the patient.³⁶ Moreover, permanent stomas usually are created in older age groups and for persons in the late stages of cancer.⁴⁷ Wide excisions to remove the malignant tissue increase the risk of damaging the nerves involved in stimulating sexual organs. Permanent stomas may affect all aspects of a patient’s life. In this study, 54.5% of men were diagnosed with severe ED, and all female patients experienced sexual dysfunction.

Limitations

The results of the study can be generalized only to patients representing the characteristics of this sample group. The small sample size and the lack of a control group also limit generelizability. Some of patients included in this study had a stoma for at least 4 months, which may have affected their sexual function and QOL scores. In addition, data were acquired via face-to-face interview. Because sexuality is commonly considered to be a taboo in Turkey, unwillingness to answer questions about sexuality may have compromised the size of the sample. Furthermore, not assessing the patients before they had a stoma and lack of long-term follow-up also may be limitations of this study.

Conclusion

This study was conducted to evaluate factors affecting QOL and sexuality in persons with a colostomy. Results indicated that creating a stoma had a negative effect on patient QOL and sexual function. The SQOLS scores of patients with a temporary stoma were higher (better) than persons with a permanent stoma. More than half of male patients (54%) had severe ED and all women experienced sexual dysfunction. Further research that compares a similar population with a control group is warranted.

References

1. Dorum H, Vural F. Why is sexuality important for patients with stomas? DEUHYO ED. 2012;5(4):171–174.

2. Kuzu MA, Topçu O, Uçar K, et al. Effect of sphincter sacrificing surgery for rectal carcinoma on quality of life in Muslim patients. Dis Colon Rectum. 2002;45(10):1359–1366.

3. Junkin J, Beitz JM. Sexuality and the person with a stoma: implications for comprehensive WOC nursing practice. J Wound Ostomy Continence Nurs. 2005;32(2):121–130.

4. Kanagiannis S, Heras P, Hatzopoulos A, Georgopoulou A, Kritikos K. Colorectal cancer patient’s informational needs about sexuality related issues. J Clin Oncol. 2006;24(18S):18569.

5. Weerakoon P. Sexuality and the patient with a stoma. Sex Disabil. 2001;19(2):121–129.

6. Cheung YL, Molassiotis A, Chang AM. The effect of progressive muscle relaxation training on anxiety and quality of life after stoma surgery in colorectal cancer patients. Psychooncology. 2003;12(3):254–266.

7. Ayaz S, Kubilay G. Effectiveness of the PLISSIT model for solving the sexual problems of patients with stomas. J Clin Nurs. 2009;18(1):89–98.

8. Nugent KP, Daniels P, Stewart B, Patankar R, Johnson CD. Quality of life in stoma patients. Dis Colon Rectum. 1999;42(12):1569–1574.

9. Monga U. Sexual functioning in cancer patients. Sex Disabil. 2002;20(4):277–295.

10. Persson E, Hellström AL. Experiences of Swedish men and women 6 to 12 weeks after ostomy surgery. J Wound Ostomy Continence Nurs. 2002;29(2):103–108.

11. Karadağ A, Menteş BB, Uner A, Irkörücü O, Ayaz S, Ozkan S. Impact of stomatherapy on quality of life in patients with permanent colostomies or ileostomies. Int J Colorectal Dis. 2003;18(3):234–238.

12. Silva MA, Ratnayake G, Deen KI. Quality of life stoma patients: temporary ileostomy versus colostomy. World J Surg. 2003;27(4):421–424.

13. Williams J. Psychological considerations in gastrointestinal nursing. Br J Nurs. 2005;14(17):931–935.

14. Dabirian A, Yaghmaei F, Rassouli M, Tafreshi MZ. Quality of life in ostomy patients: a qualitative study. Patient Prefer Adherence. 2011;5:1–5.

15. Camilleri-Brennan J, Steele RJ. Prospective analysis of quality of life and survival following mesorectal excision for rectal cancer. Br J Surg. 2001;88(12):1617–1622.

16. Breukink SO, van der Zaag-Loonen HJ, Bouma EM, et al. Prospective evaluation of quality of life and sexual functioning after laparoscopic total mesorectal excision. Dis Colon Rectum. 2007;50(2):147–155.

17. Brown H, Randle J. Living with a stoma: a review of the literature. J Clin Nurs. 2005;14(1):74–81.

18. Larson DW, Davies MM, Dozois EJ, et al. Sexual function, body image, and quality of life after laparoscopic and open ileal pouch-anal anastomosis. Dis Colon Rectum. 2008;51(4):392–396.

19. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49(6):822–830.

20. Turkish Society of Andrology IIEF Validation Group. Turkish version of the International Index of Erectile Function (IIEF). 4th Congress of National Sexual Function Disorders “Sexuality; pleasure and pain.” March 29–31, 2002. Istanbul, Turkey.

21. Kaplan SA, Reis RB, Kohn IJ, et al. Safety and efficacy of sildenafil in postmenopausal women with sexual disfunction. Urology. 1999;53(3):481–486.

22. Yılmaz CA, Eryılmaz HY. Validity/reliability study of female sexual function index (IFSF). Andrologia J. 2004;18:275–276.

23. Baxter NN, Novotny PJ, Jacobson T, Maidl LJ, Sloan J, Young-Fadok TM. A stoma quality of life scale. Dis Colon Rectum. 2006;49(2):205–212.

24. Karadağ A, Öztürk D, Çelik B. Adaptation of quality life scale for the ostomy patients into Turkish. Turk J Colorectal Dis. 2011;21(4):173–181.

25. Black PK. Psychological, sexual and cultural issues for patients with a stoma. Br J Nurs. 2004;13(12):692–697.

26. Yaşan A, Ünal S, Gedik E, Girgin S. Quality of life, depression and anxiety among patients who have undergone permanent or temporary ostomy. Anadolu Psikiyatr De. 2008;9(3):162–168.

27. Burch J. Exploring quality of life for stoma patients living in the community. Br J Community Nurs. 2016;21(8):378–382.

28. Nichols TR. Health-related quality of life in community-dwelling persons with ostomies: the physical functioning domain. J Wound Ostomy Continence Nurs. 2015;42(4):374–377.

29. Ito N, Tanaka M, Kazuma K. Health related quality of life among person living in Japan with a permanent colostomy. J Wound Ostomy Continence Nurs. 2005;32(3):178–183.

30. Zając O, Spychała A, Murawa D, Wasıewıcz J, Foltyn P, Połom K. Quality of life assessment in patients with a stoma due to rectal cancer. Rep Pract Oncol Radiother. 2008;13(3):130–134.

31. Khan MA, Jamal S, Rashid R, Ahmad N. Quality of life assessment in patients with stoma in Muslim population. Ann Pak Inst Med Sci. 2011;7(4):222–227.

32. Szczepkowski M. Do we still need a permanent colostomy in the XXIst century? Acta Chir Iugosl. 2002;49(2):45–55.

33. Sprangers MA, Taal BG, Aaronson NK, te Velde A. Quality of life in colorectal cancer. Stoma vs. nonstoma patients. Dis Colon Rectum. 1995;38(4):361–369.

34. Sprunk E, Alteneder RR. The impact of an ostomy on sexuality. Clin J Oncol Nurs. 2000;4(2):85–88.

35. Bekkers MJ, van Knippenberg FC, van den Borne HW, Poen H, Bergsma J, van Berge Henegouwen GP. Psychosocial adaptation to stoma surgery: a review. J Behav Med. 1995;18(1):1–31.

36. Ozturk O, Yalcin BM, Unal M, Yildirim K, Ozlem N. Sexual dysfunction among patients having undergone colostomy and its relationship with self-esteem. J Family Med Community Health. 2015;2(1):1028.

37. Mahjoubi B, Mirzaei R, Azizi R, Jafarinia M, Zahedi-Shoolami L. A cross-sectional survey of quality of life in colostomates: a report from Iran. Health Qual Life Outcomes. 2012;10:136.

38. Milbury K, Cohen L, Jenkins R, Skibber JM, Schover LR. The association between psychosocial and medical factors with long-term sexual dysfunction after treatment for colorectal cancer. Support Care Cancer. 2013;21(3):793–802.

39. Cotrim H, Pereira G. Impact of colorectal cancer on patient and family: implications for care. Eur J Oncol Nurs. 2008;12(3):217–226.

40. Symms MR, Rawl SM, Grant M, et al. Sexual health and quality of life among male veterans with intestinal ostomies. Clin Nurse Spec. 2008;22(1):30–40.

41. Cakmak A, Aylaz G, Kuzu MA. Permanent stoma not only affects patients’ quality of life but also that of their spouses. World J Surg. 2010;34(12):2872–2876.

42. Grant M, McMullen CK, Altschuler A, et al. Gender differences in quality of life among long-term colorectal cancer survivors with ostomies. Oncol Nurs Forum. 2011;38(5):587–596.

43. Konanz J, Herrle F, Weiss C, Post S, Kienle P. Quality of life of patients after low anterior, intersphincteric, and abdominoperineal resection for rectal cancer — a matched-pair analysis. Int J Colorectal Dis. 2013;28(5):679-688.

44. Golicki D, Styczen P, Szczepkowski M. Quality of life in stoma patients in Poland: multicentre cross-sectional study using WHOQOL-BREF questionnaire. Przegl Epidemiol. 2013;67(3):491–496,589–593.

45. Anaraki F, Vafaie M, Behboo R, Maghsoodi N, Esmaeilpour S, Safaee A. Clinical profile and post-operative lifestyle changes in cancer and non-cancer patients with ostomy. Gastroenterol Hepatol Bed Bench. 2012;5(suppl 1):S26–S30.

46. Harputlu D, Terzi C, Esrefgil G, Uz S, Sökmen S, Füzün M. Self-esteem in patients with colostomy and ileostomy. Turk J Colorectal Dis. 2007;17(4):178–185.

47. Engida A, Ayelign T, Mahteme B, Aida T, Abreham B. Types and indications of colostomy and determinants of outcomes of patients after surgery. Ethiop J Health Sci. 2016;26(2):117-120.

Potential Conflicts of Interest: none disclosed. This study was presented at the 2nd International Congress of Graduate Students, May 12–14, 2017, Manisa, Turkey.

Dr. Yilmaz is a lecturer and Associate Professor, Faculty of Health Science; Ms. Celebi is a master’s student in surgical nursing, Institute of Health Science, Department of Surgical Nursing; Dr. Kaya is a general surgeon and Professor, Faculty of Medical School, Department of General Surgery; and Dr. Baydur is a lecturer and Assistant Professor, Faculty of Health Science, Department of Social Work, Manisa Celal Bayar University, Manisa, Turkey. Please address correspondence to: Emel Yilmaz, PhD, Associate Professor, Manisa Celal Bayar University, Faculty of Health Science Department of Surgical Nursing, Şehitler Mah. İstasyon mevkii, 45020 Manisa, Turkey; email: emelyilmazcbu@gmail.com.

Section:

Volume 63 - Issue 8 - August 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(8):30–43. doi: 10.25270/owm.2017.08.3043

Lyndsay Orr, BScPT, MClSc (Wound Healing); Kathleen A. Klement, MClSc (Wound Healing), C Ped (C); Laura McCrossin, BScPT, MClSc (Wound Healing); Deirdre O’Sullivan Drombolis, BScPT, MClSc (Wound Healing); Pamela E. Houghton, PhD, Professor; Sandi Spaulding, PhD, Professor; and Shauna Burke, PhD

Topics:

systematic review

meta-analysis

exercise

venous insufficiency

effect

Abstract

Exercise intervention for individuals with chronic venous insufficiency (CVI) and venous leg ulcers (VLUs) is recommended to improve function of the calf muscle pump (CMP). A systematic review with meta-analysis was conducted to measure the effects of exercise (including function of the CMP, ankle strength, range of motion [ROM], and healing rates) for VLUs. Four (4) databases (Cumulative Index to Nursing and Applied Health Literature, 1981; MEDLINE, 1964; Scopus, 1966; and EMBASE, 1947) were searched for relevant articles from the date of index inception to January 2016. All study types that evaluated the effect of exercise on the function of the CMP in patients with CVI were included; narrative and systematic studies were excluded.

All data were extracted by 1 reviewer onto a predetermined form and verified by a second reviewer. Data extracted included number of patients, primary diagnosis, patient demographics, study location, wound characteristics, inclusion/exclusion criteria, exercise group details, control group details, co-interventions, primary outcome measures, secondary outcome measures, wound healing measures, blinding, intention to treat, and study design. A total of 1325 articles was screened; 14 met the inclusion criteria (total study participants = 519). CMP hemodynamics were assessed using air plethysmography measurement results from the included studies. A meta-analysis of 8 articles was distilled to 3 with relevant data (83 participants) that found a significant increase on CMP ejection fraction in favor of the exercise group (Hedge’s g = 0.83; 95% CI 0.35-1.30, P<.001) compared to control. CMP residual venous fraction also favored the exercise group (Hedge’s g = 0.42; 95% CI -0.03-0.862, P = .066). Ankle ROM was higher in the exercise group (116 participants; Hedge’s g = 0.62; 95% CI -0.15-1.39, P = .116); however, these differences were not significantly different from controls. Exercise directed at improving calf muscle strength and ankle ROM for individuals with or at risk for VLUs improves CMP hemodynamics and function. Additional research using larger sample sizes to confirm the role of exercise in healing VLUs is warranted.

Chronic venous insufficiency (CVI) is a common, progressive condition that results in lower extremity edema, skin changes, and often ulceration. CVI is partially caused by faulty valves in the lower extremity, resulting in venous reflux and venous hypertension. Additionally, calf muscle dysfunction affects venous function; poor calf muscle hemodynamics reduce venous outflow, causing blood to pool in the lower extremity.^1-4

Venous reflux, caused by a combination of valve dysfunction and failure of the calf muscle pump (CMP), is the main cause of CVI.^1-4 Multiple best practice guidelines^5-7 and 1 systematic review⁸ recommend the use of compression dressings to minimize venous hypertension in patients with CVI who have or are at risk for venous leg ulcers (VLUs) given the high correlation of VLU healing with the use of compression stockings.

Additionally, CMP impairment has a strong effect on VLU healing. The CMP is the primary mechanism by which blood returns to the heart from the lower extremities. Contraction of the calf muscles propels more than 60% of blood from the deep venous system toward the heart.⁹ In a 1993 case controlled study, Gross et al¹⁰ showed that in a group of 43 patients with leg ulcers, 60% of the patients who were considered to have valve deficiency also had an impaired CMP, 24% had no obvious signs of valve insufficiency, and 95% had a neuromuscular disorder that would impair CMP. A 2014 systematic review and meta-analysis by Williams et al¹¹ showed patients with symptomatic venous disease were 1.37 times more likely to have CMP dysfunction and more than 70% of patients presenting with a VLU have an impaired CMP, which also serves as a prognosis for delayed healing of VLUs.^12,13 This led to the realization that CMP function plays an imperative role in the development of VLUs.

Ankle movement or flexibility, also called range of motion (ROM), plays an important role in CMP function.⁹ Case controlled studies^2,14 have shown reduced ankle ROM has been linked to severe venous insufficiency as well as active ulceration. Without adequate ankle ROM, the CMP cannot optimally squeeze the blood out of the deep venous system back toward the heart.² Given these findings, it is important to discern what clinical interventions can be effective in maximizing CMP function in patients with chronic venous disease who have or are at risk for chronic VLUs.

The aim of this systematic review was to examine the effects of exercise on CMP function in patients with CVI with or without VLUs. Secondary outcomes evaluated included the effect of exercise on ankle strength, ankle ROM, and wound healing.

Methods

Data sources. The following electronic databases were searched from date of inception until January 2016: the Cumulative Index to Nursing and Applied Health Literature, (CINAHL) (1981), MEDLINE (1964), Scopus (1966), and EMBASE (1947) (see Table 1). Search strategies were modified as needed for the database utilized. An experienced librarian was consulted to develop an appropriate search strategy for each database. Reference lists of retrieved and review articles were hand-searched for potential secondary sources. Unpublished literature databases also were searched and included The New York Academy of Medicine: grey literature report; MEDLINE plus: National Institute of Health; National Information Center on Health Services Research and Health Care Technology; clinicaltrials.gov; The International Standard Randomised Controlled Trial Number registry; the World Health Organization: International Clinical Trials Registry platform search portal, European Union; and Google Scholar.

Selection of studies. This systematic review only included studies where exercise intervention was used as the treatment variable in adult humans with CVI or those at risk for developing VLUs. Before initiating the literature search, inclusion and exclusion criteria were established (see Table 2) according to the 4-factor (Problem/Population, Intervention, Comparison, and Outcome [PICO]) framework. All randomized and nonrandomized controlled trials, case studies, or case series assessing exercise intervention and its effect on the CMP in patients with CVI were included. Controlled trials comparing exercise intervention (alone or in conjunction with standard wound care and compression) to a control group receiving standard wound treatment were examined for inclusion in the meta-analysis. Narrative articles were not included in the meta-analysis. CMP outcomes could include calf muscle hemodynamics, ankle strength, ankle ROM, and wound healing. Studies were not excluded based on methodological quality.

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses, was completed.¹⁵ The PRISMA flow diagram is shown in Figure 1; 4 authors were involved in the process. In order to reduce selection bias for titles, abstracts, and full articles, a paired consensus process was utilized. Relevant citations were independently selected, then a paired consensus was conducted to decide which full articles were to be retrieved. This process was applied using the preset list of inclusion and exclusion criteria. Discrepancies were settled through discussion and, when in doubt, authors erred on the side of caution and full articles were obtained for assessment. From citations that met inclusion criteria, full articles were retrieved and evaluated. A similar paired consensus process was repeated after reading all of the full articles that were retrieved in order to select a final list of included studies.

Outcome measures. The primary outcome measure was the effect of exercise on calf hemodynamics in persons with CVI with or without VLUs. Secondary outcomes included ankle strength, ankle ROM, and wound healing (evaluated by mean change in ulcer area, months to wound recurrence, or healed versus not healed after a duration of time). Calf hemodynamics were assessed using air plethysmography (APG) measurements — specifically, ejection fraction (EF) and residual venous fraction (RVF). APG is a simple, noninvasive, and reproducible quantitative method of evaluating overall lower extremity CVI.^16,17 The measurements that quantify the effectiveness of the CMP include the EF and the RVF.¹⁸ The EF estimates the percentage of calf blood volume emptied with a single calf muscle contraction during a tiptoe exercise. The RVF measures the blood volume remaining in the calf after 10 consecutive tiptoe exercises. Ankle ROM reported in degrees, ankle strength, and endurance (using a variety of objective tools), with a statement of healed versus not healed were used to evaluate secondary outcomes.

Data extraction. All data were extracted by 1 reviewer onto a pre-determined form and verified by a second reviewer. Data extracted included number of patients, primary diagnosis, patient demographics, study location, wound characteristics, inclusion/exclusion criteria, exercise group details, control group details, co-interventions, primary outcome measures, secondary outcome measures, wound healing measures, blinding, intention to treat, and study design. Where data within a study were not fully available, the corresponding author was contacted and complete data were requested.

Methodological quality. Assessment of methodological quality of all included studies was completed using the Physiotherapy Evidence Database (PEDro) scale, a validated 11-item scale with a score ranging from 0 to 10 (the first criterion is not being counted numerically).^19,20 Detailed PEDro results can be found in Table 3. No studies were excluded based on the PEDro result.

Data analyses. Where outcome variables among studies were similar, a meta-analysis was performed. In the event that study outcomes could not be pooled, results were described narratively. Due to the variation in exercise programs administered as the treatment intervention, a random effects model was used for data analysis. Dichotomous outcomes were expressed as risk ratio (RR) and 95% confidence interval (CI). RR was interpreted as: RR <1, risk of healing is lower in the exercise group; RR = 1, risk of healing is the same between the control and exercise groups; and RR >1, risk of healing is greater in the exercise group. Hedge’s g was used to interpret the effect size of continuous variables due to the small sample sizes of the studies evaluated. A statistically significant difference was denoted as P<.05. All statistical analyses were conducted by 1 reviewer using the Comprehensive Meta-Analysis (CMA) software (Biostat, Englewood, NJ). Standard errors of means were converted to standard deviations when data were not available from the authors. Assessment of heterogeneity was completed by evaluating study characteristics, interventions, outcome measurements, and statistical analysis. Statistical homogeneity was assessed using the I² statistical test. I²>50% indicated significant heterogeneity, and the results were interpreted with caution.

Results

Systematic review. As outlined in Figure 1, electronic searches yielded 1325 results from MEDLINE (395), CINAHL (110), EMBASE (661), and Scopus (159), of which 330 were duplicates and 995 potentially relevant citations. Of these, 972 citations were excluded through a paired consensus process, leaving a total of 23 citations for which full articles were retrieved. An additional 9 full articles were identified by reviewing secondary sources. Of the 32 full articles retrieved, 14 met the inclusion criteria (Table 4)^4,12,21-32: 10 from primary sources and 4 from secondary sources. Eighteen (18) studies were excluded for the following reasons: no intervention (7), nonexercise-based intervention (4), no calf muscle or ankle ROM exercises (1), review article (1), industry report (1), incorrect patient population (3), or not available through the Western University Library (authors’ facility) (1).

owm_0817_orr_table4cntd4

Population. The 519 participants in all of the included studies (14) were community-dwelling individuals who walked independently. Minimal adverse events were reported in the included studies. The majority of studies (9) included participants with both CVI and VLUs. Three (3) studies included patients with no open wounds,^4,21,23 and 1 study included persons with post thrombotic syndrome.²⁷ The age range for study participants was 27 to 91 years. All but 2 studies^22,32 included both men and women in the data collection. Eight (8) studies had participants lost to follow-up for various reasons.^{21-25,27,28,30} Wound duration for the studies that included open ulcers varied; 1 study included a wound that was present for 51 years.²⁴ The study participants were recruited while receiving standard wound care either through a regional home care program or outpatient wound clinic for active or recently healed VLUs. One (1) of the studies required participants to have full ankle ROM to be included.¹²

Study types. Eight (8) studies were randomized controlled trials (RCTs),^22,25-31 1 was a prospective nonrandomized study,¹² 1 used a “randomized matched pairs” design,²¹ and 4 were prospective single-arm studies.^4,23,24,32 Control groups consisted of no treatment,²¹ education only,²⁹ usual care and compression,^12,25,28,31 and compression only.²² Three (3) of the studies included exercise as concurrent treatment in the control group with the addition of more intensive, supervised exercises as part of the intervention exercise program.^26-28

Leg compression was used at all times in 9 studies^{12,22,23,25,26,28-31} and during exercise only in 1 study.²¹ Compression was not used during exercise in 2 studies,^4,24 recommended as optional or at the discretion of the health care provider in 1 study,²⁷ and not at all in 1 study.³² The types of compression identified included compression stockings (108 study participants),^21,22,23,27 compression bandaging (104 study participants^12,26,29,30) either (184 study participants),²⁸ or not described (82 study participants).^25,31

Intervention. Exercise programs in the treatment groups included calf muscle strengthening programs,^4,12,25 calf muscle strengthening and ankle stretching ROM programs^{22-25,27,28,30,32}, walking programs,^28,29 and 1 unspecified.²¹ Of the 14 studies assessed, 13 discussed some form of supervision and education for the exercise intervention group; 5 noted the supervision and education for the exercise intervention were given by a health care provider with expertise in exercise prescription, such as a physiotherapist or exercise physiologist.^22-24,28,30 The duration of the exercise program also varied among the studies: exercise intervention ranged from 2 times per week to daily, 5-10 minutes to 1 hour per session, and varied between 7 days and 18 months.

Outcomes. Seven (7) studies (159 participants) measured calf hemodynamics using APG.^{4,12,21-23,25,30} CMP function was measured using venous hemodynamic values through APG.^13,16-18,33 Participants in all 7 had an improvement in CMP function after exercise. Six (6) of the 7 studies reported a greater increase in EF and decrease in RVF for the treatment group in comparison to the control group. The seventh study²¹ did not measure EF or RVF but also noted an improvement in CMP hemodynamics, with a 16% decrease in mean venous capacity in the treatment group, which was greater than the control group that did not show any change.

Changes in ankle ROM were measured in 6 studies (137 participants).^{22,24,26,27,30,32} All but 1 of the studies found an increase in ankle ROM in favor of the exercise intervention group.²² However, ankle ROM measurements were performed using different assessment tools including an inclinometer,²⁷ a goniometer,^26,27,30,32 and a biodex machine.²² Positioning during ankle ROM measurements was inconsistent: 3 studies assessed participants with their knees bent,^22,27,30 2 with the participant’s knee straight,^26,32 and 1 was unspecified.²⁴ One (1) study evaluated the effects of exercise on ROM of left and right ankles separately and then utilized the more conservative measurement for data analysis.³²

Calf muscle strength was assessed in 4 studies (114 participants).^4,12,22,27 All of the included studies demonstrated an increase in calf muscle strength and/or endurance in the treatment group compared to the control group. Strength measurements were completed using different measurement tools, including a biodex machine,^4,22 percentage of max plantar flexion with an ergometer,¹² and the heel lift test.²⁷

Five (5) studies (317 participants) assessed the effects of calf muscle exercise on wound healing.^{25,28,29,30,31} Four (4) demonstrated improved healing rates in the treatment group compared to the control group,^28-31 and for the study where healing rates showed no improvement the author stated the results may be due to the small study sample and that the study was not powered to show an effect on ulcer healing, allowing high risk for type II error.²⁵ The 2013 RCT (N = 40) by Ahmed et al³¹ showed a significant decrease in the Pressure Ulcer Scale for Healing (PUSH tool) score and reduction of the surface area in the treatment group versus control after 12 days. In the 2012 RCT by Heinen et al (N = 184),²⁸ patients with leg wounds occurring after initiating an exercise trial had significantly fewer wound months than patients who had wounds present at baseline in both the control and treatment groups. These findings suggest a potentially positive impact of exercise intervention on healing times.

Methodological quality of the controlled studies. Four (4) studies did not have PEDro appraisal because they were prospective, single-arm studies.^4,23,24,32 The remaining 10 studies scored between 4 and 7 out of 10 on the PEDro scale (see Table 3). The mean PEDro score was 5.8, indicating low overall methodological quality.¹⁹ Authors of all 10 studies conducted between-group statistical comparisons and reported both average values and measures of variability for at least 1 key outcome. None of the studies was able to meet the criteria of blinding of all therapists or of all assessors due to the nature of the intervention. All of the studies except Kan and Delis¹² had participants that were randomly assigned to groups.

Meta-analysis results. The present meta-analysis evaluated the evidence in the literature related to the effects of exercise intervention on the CMP in participants with CVI with or without VLUs. Although 14 articles met the inclusion criteria for review, only 8 were included for meta-analysis due to the variability of the study methodology and data available to calculate effect sizes.^22,25-31 Of the 7 studies that reported calf hemodynamics,^{4,12,21-23,25,30} 3 were included in a meta-analysis to calculate the effect of exercise on CMP function (83 participants), specifically for the values of EF and RVF.^{22, 25, 30} The results from the meta-analysis for EF showed a significant increase in favor of the treatment group with a large effect size (Hedge’s g = 0.83; 95% CI 0.35-1.30, P<.001) (see Figure 2). RVF also favored the intervention group although it was not statistically significant (Hedge’s g = 0.42; 95% CI -0.03-0.862, P = .066) (see Figure 3).

Eight (8) studies^{4,12,22,24,26,27,30,32} evaluated the effects of exercise intervention on ROM and/or ankle strength, both of which affect the efficiency of the CMP. Due to the heterogeneity of the outcomes used to assess CMP strength, none of the studies was included in meta-analysis. Four (4) RCTs (116 participants) assessing ankle ROM were similar and facilitated combining results.^22,26,27,30 The results from the meta-analysis for ankle ROM showed a moderate effect size toward increased ROM in the treatment group compared to control group, but it was not statistically significant (Hedge’s g = 0.62; 95% CI -0.15-1.39, P = .116) (see Figure 4).

Included in this review are 5 studies assessing the effect of exercise on wound healing.^{25,28,29,30,31} Three (3) measured whether wounds were healed or not healed after 12 weeks and were combined in a meta-analysis to calculate the effect of exercise on VLU healing (N = 93).^25,29,30 Results showed no significant difference in healing rates between exercise groups and control groups after 12 weeks of CMP exercises (RR: 1.027; 95% CI 0.77 to 1.38, P = .860) (see Figure 5).

Discussion

This systematic review and meta-analysis demonstrate the benefit of simple exercises for people with CVI and/or VLU. All of the 14 included studies (N = 519) produced results that showed incorporating exercise into standard practice with compression improves calf muscle function. Specifically, ankle exercises performed in a variety of ways resulted in better calf muscle hemodynamics compared to control treatments and increased ankle ROM compared to pre-treatment values.

A 2012 narrative review by O’Brien et al³⁴ identified the relationship between CMP exercises and improved venous return and ankle ROM. The authors also noted that the current literature contains only a few RCTs with small sample sizes. A 2016 Cochrane review also concluded the evidence available to assess the efficacy of physical exercise in people with CVI is insufficient.³⁵ Unfortunately, the authors’ search of relevant literature revealed only 2 RCTs (Padberg²² and Hartman²¹), and outcomes were not able to be combined using meta-analytical methods. These authors did not provide rationale as to why studies that were identified in the current research were not included in their review.

Using a systematic approach, the current authors were able to identify additional published work and complete a meta-analysis. By pooling the results, the overall effect of exercises on calf muscle function was determined. In this effort, all 7 studies that evaluated the effect of exercise on CMP functions reported positive findings — specifically, exercise was shown to significantly increase CMP EF and decrease RVF as compared to control treatments.

Of note, only 5 of 14 studies utilized health care professionals who were trained in exercise prescription (eg, physiotherapists) to provide or supervise the exercise intervention. All 5 of these studies reported positive changes in CMP function and ankle strength or ROM.^{21,22,23,27,32} The link between CMP function and gait impairments has not been established; however, it is clear that expertise is required to carry over gains in ankle ROM and strength to produce improved walking efficiency and proper foot biomechanics.

The strong association between CMP function and VLU severity and healing is well known. However, few studies have directly examined the effect of exercise on healing rates of people with VLUs. Four (4) of 5 studies in this systematic review found adding ankle exercises improved VLU healing. The method of measuring VLU healing was quite different across these studies. O’Brien et al³⁰ and Meagher et al²⁹ reported the proportion of people with healed ulcers after 12 weeks of exercise, whereas Ahmed et al³¹ used the PUSH tool to evaluate changes in wound appearance. Heinen et al²⁸ conducted by far the largest RCT in this review; however, they measured VLU recurrence rate. Only 3 studies measured VLU size before and after an exercise intervention; one, a study by Jull et al,²⁵ did not show exercise was associated with better healing outcomes. Therefore, when results were combined in the current research, an overall effect that favored exercise was not noted.

The current results are based on studies that had low to moderate overall scores for methodological quality. Most studies did not blind patients, therapists, or assessors, which is to be expected given the nature of this intervention. However, compliance with exercise prescriptions and drop-out rates across the studies were found to be acceptable (446 of 519 completed).

Of patients with a VLU, 70% also have CMP dysfunction; therefore, interventions that optimize ankle strength and flexibility should be considered mainstay treatment for people with a VLU.¹² Although compression has been associated with better healing of VLU, it may interfere with the ankle’s ability to move through full ROM during ambulation or activity causing an altered gait pattern.^34,35 CMP activation with ambulation is most effective with a heel-toe gait pattern with activity-appropriate footwear, which provides credibility to structured education sessions on exercise programs with expert clinicians.

Minimal adverse events were reported in the included studies, a finding that indicates exercise is a low-risk, feasible intervention for people who have CVI and/or VLU. Furthermore, physical activity is known to reduce hypertension and maintain fitness in this population.^36,37 Considering CMP exercises can produce favorable results with minimal risk, clinicians treating this relatively sedentary group of patients should prescribe these exercises or make a referral to a qualified professional who can improve ankle function and address gait impairments.

Limitations

Few studies exist in the published literature regarding the effects of exercises on individuals with CVI and persons at risk for VLU. Even fewer exist that recorded results using similar outcomes. In particular, studies assessing the outcomes of ROM, strength, and wound healing for CVI patients are lacking. A wide array of outcome measures is used in the included studies, which prevented the pooling of data from all of the studies into the meta-analysis. Considerable variation also exists in the exercise intervention, which includes exercise duration, frequency, and intensity. This makes it difficult if not impossible to assess the type of exercise that was most effective at improving CMP function.

Using a very conservative approach to the meta-analysis, the authors were able to combine results of 3 smaller studies and produce a pooled effect in favor of exercise. As with most systematic reviews, the authors were restricted to information provided by the original researchers (which was limited in some cases); data were converted when authors could not be contacted. This study also only included community-dwelling individuals (eg, no long-term care patients).

Conclusion

A review and meta-analysis showed exercise can increase CMP function. Ankle ROM and strength also were found to be improved, although by a statistically insignificant amount (P >.05). Because the conclusions reached were based on low to moderate quality controlled clinical trials, they need to be interpreted with caution, but evidence suggests exercises can increase EF. Additional research in larger studies that explore the effect of exercise on the healing rates of VLU is warranted. Once the body of literature on this subject increases, it will be possible to determine whether certain exercise regimens are optimal, as well as the connection between structured exercises and supervised versus unsupervised programs. This research could help support the role of clinicians specialized in exercise training within the interprofessional wound care team.

References

1. Araki CT, Back TL, Padberg FT, et al. The significance of calf muscle pump function in venous ulceration. J Vasc Surg. 1994;20(6):872–879.

2. Back TL, Padberg Jr FT, Araki CT, Thompson PN, Hobson RW 2nd. Limited range of motion is a significant factor in venous ulceration. J Vasc Surg. 1995;22(5):519–523.

3. Labropoulos N, Giannoukas AD, Nicolaides AN, Veller M, Leon M, Volteas N. The role of venous reflux and calf muscle pump function in nonthrombotic chronic venous insufficiency. Correlation with severity of signs and symptoms. Arch Surg. 1996;131(4):403–406.

4. Yang D, Vandongen YK, Stacey MC. Effect of exercise on calf muscle pump function in patients with chronic venous disease. Br J Surg. 1999;86(3):338–341.

5. Registered Nurses Association of Ontario (2004). Assessment and Management of Venous Leg Ulcers. Toronto, Canada: Registered Nurses Association of Ontario. Available at: http://rnao.ca/sites/rnaoa/files/Assessment_and_Management_of_Venous_Leg.... Accessed July 18, 2015.

6. Burrows C, Miller R, Townsend D, et al. Best practice recommendations for the prevention and treatment of venous leg ulcers: update 2006. Adv Skin Wound Care. 2007;20(11):611–621.

7. Scottish Intercollegiate Guidelines Network. Management of Chronic Venous Leg Ulcers: a national clinical guideline. Edinburgh, Scotland: Scottish Intercollegiate Guidelines Network (SIGN);2010. Available at: www.sign.ac.uk/assets/sign120.pdf. Accessed July 21, 2015.

8. O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. In: Wounds Group, ed. Cochrane Database Syst Rev. Chichester, UK: John Wiley & Sons, Ltd; 2012.

9. Meissner MH, Moneta G, Burnand K, et al. The hemodynamics and diagnosis of venous disease. J Vasc Surg. 2007;46(suppl):4S–24S.

10. Gross EA, Wood CR, Lazarus GS, Margolis DJ. Venous leg ulcers: an analysis of underlying venous disease. Br J Dermatol. 1993;129(3):270–274.

11. Williams KJ, Ayekoloye O, Moore HM, Davies AH. The calf muscle pump revisited. J Vasc Surg Venous Lymphat Disord. 2014;2(3):329–334.

12. Kan YM, Delis KT. Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulcers: a prospective controlled study. Arch Surg. 2001;136(12):1364–1369.

13. Simka M. Calf muscle pump impairment and delayed healing of venous leg ulcers: air plethysmographic findings. J Dermatol. 2007;34(8):537–544.

14. Dix FP, Brooke R, McCollum CN. Venous disease is associated with an impaired range of ankle movement. Eur J Vasc Endovasc Surg. 2003;25(6):556–561.

15. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264–269.

16. Weingarten MS, Czeredarczuk M, Scovell S, Branas CC, Mignogna GM, Wolferth CC Jr. A correlation of air plethysmography and color-flow–assisted duplex scanning in the quantification of chronic venous insufficiency. J Vasc Surg. 1996;24(5):750–754.

17. Christopoulos DG, Nicolaides AN, Szendro G, Irvine AT, Bull ML, Eastcott HHG. Air-plethysmography and the effect of elastic compression on venous hemodynamics of the leg. J Vasc Surg. 1987;5(1):148–159.

18. Criado E, Farber MA, Marston WA, Daniel PF, Burnham CB, Keagy BA. The role of air plethysmography in the diagnosis of chronic venous insufficiency. J Vasc Surg. 1998;27(4):660–670.

19. Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther. 2003;83(8):713–721.

20. De Morton NA. The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study. Aust J Physiother. 2009;55(2):129–133.

21. Hartmann BR, Drews B, Kayser T. Physical therapy improves venous hemodynamics in cases of primary varicosity: results of a controlled study. Angiology. 1997;48(2):157–162.

22. Padberg FT, Johnston MV, Sisto SA. Structured exercise improves calf muscle pump function in chronic venous insufficiency: a randomized trial. J Vasc Surg. 2004;39(1):79–87.

23. Zajkowski PJ, Draper T, Bloom J, Henke PK, Wakefield TW. Exercise with compression stockings improves reflux in patients with mild chronic venous insufficiency. Phlebology. 2006;21(2):100–104.

24. Davies JA, Bull RH, Farrelly IJ, Wakelin MJ. A home-based exercise programme improves ankle range of motion in long-term venous ulcer patients. Phlebology. 2007;22(2):86–89.

25. Jull A, Parag V, Walker N, Maddison R, Kerse N, Johns T. The prepare pilot RCT of home-based progressive resistance exercises for venous leg ulcers. J Wound Care. 2009;18(12):497–503.

26. Szewczyk MT, Jawień A, Cwajda-Białasik J, Cierzniakowska K, Mościcka P, Hancke E. Randomized study assessing the influence of supervised exercises on ankle joint mobility in patients with venous leg ulcerations. Arch Med Sci. 2010;6(6):956–963.

27. Kahn SR, Shrier I, Shapiro S, et al. Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial. CMAJ. 2011;183(1):37–44.

28. Heinen M, Borm G, van der Vleuten C, Evers A, Oostendorp R, van Achterberg T. The Lively Legs self-management programme increased physical activity and reduced wound days in leg ulcer patients: results from a randomized controlled trial. Int J Nurs Stud. 2012;49(2):151–161.

29. Meagher H, Ryan D, Clarke-Moloney M, O’Laighin G, Grace PA. An experimental study of prescribed walking in the management of venous leg ulcers. J Wound Care. 2012;21(9):421–426.

30. O’Brien J, Edwards H, Stewart I, Gibbs H. A home-based progressive resistance exercise programme for patients with venous leg ulcers: a feasibility study. Int Wound J. 2013;10(4):389–396.

31. Ahmed E, Maayah M, Asi Y. Anodyne therapy versus exercise therapy in improving the healing rates of venous leg ulcer. Int J Res Med Sci. 2013;1(3):101–106.

32. Leal FJ, Couto RC, da Silva TP, Tenório VO. Vascular physiotherapy in treatment of chronic venous disease. J Vasc Bras. 2015;14(3):224–230.

33. Asbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005;24(4):475–482.

34. O’Brien JA, Edwards HE, Finlayson KJ, Kerr G. Understanding the relationships between the calf muscle pump, ankle range of motion and healing for adults with venous leg ulcers: a review of the literature. Wound Pract Res. 2012;20(2):80–85.

35. Araujo DN, Ribeiro CTD, Maciel AC, Bruno SS, Fregonezi GA, Dias FA. Physical exercise for the treatment of non-ulcerated chronic venous insufficiency. Cochrane Datatbase Syst Rev. 2016;12:CD010637.

36. Roaldsen KS, Rollman O, Torebjörk E, Olsson E, Stanghelle JK. Functional ability in female leg ulcer patients — a challenge for physiotherapy. Physiother Res Int. 2006;11(4):191–203.

37. Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof P, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs. 2004;13(3):341–354.

Potential Conflicts of Interest: none disclosed

Ms. Orr is a physiotherapist and PhD student, School of Physical Therapy, Western University, Elborn College, London, Ontario, Canada. Ms. Klement is a Canadian Certified pedorthist, SoleScience Inc, Fowler Kennedy Sports Medicine Clinic, 3M Centre, Western University. Ms. McCrossin is a physiotherapist and instructor, School of Physiotherapy, Dalhousie University, Halifax NS, Canada. Ms. Drombolis is a physiotherapist, Riverside Health Care, Fort Frances, Ontario, Canada. Dr. Houghton is a Professor, School of Physical Therapy; Dr. Spaulding is a Professor, School of Occupational Therapy; and Dr. Burke is an associate professor, School of Health Studies, Western University, Elborn College. Please address correspondence to: Lyndsay Orr, BScPT, MCISC-WH, PhD(c), School of Physical Therapy, Western University, Elborn College, 1201 Western Road, London, Ontario, Canada N6G 1H1; email: lmacrae3@uwo.ca.

Section:

Volume 63 - Issue 9 - September 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(9):10–20 doi: 10.25270/owm.09.1020

Martin WF van Leen, MD, PhD; Prof Joseph MGA Schols, MD, PhD; Prof Steven ER Hovius, MD, PhD; and Ruud JG Halfens, PhD

Topics:

longitudinal study

nursing homes

Pressure Ulcer

guideline adherence

Risk Factors

Abstract

Pressure ulcers (PUs) are an important and distressing problem in Dutch nursing homes. A secondary analysis of longitudinal data from the Dutch National Prevalence Measurement of Care Problems (LPZ) — an annual, multicenter, point-prevalence survey — was conducted for the years 2005–2014 to determine the use of specific recommended PU preventive measures from the European Pressure Ulcer Advisory Panel 1998, the National Pressure Ulcer Advisory Panel/European Pressure Ulcer Advisory Panel 2009, and the 2002 and 2011 Dutch PU guidelines.

Preventive care was investigated among nursing home residents at risk for PUs and included skin care (moisturization); nutritional and hydration status assessment and optimization; and pressure redistribution involving mattresses, cushions, and heel pressure-relieving strategies and devices. Following abstraction from the study database, data for 3 at-risk groups were distinguished: 1) residents with a Braden score of 17, 18, or 19; 2) residents with a Braden score below 17; and 3) residents with a PU. Data were aggregated at the institutional level. Differences were tested with multiple regression analyses. The mean number of residents over the study period was 5435, the mean age was 82.8 years, and the mean Braden score was 15.3. None of the recommended preventive measures from the guidelines consulted was applied 100% of the time: preventive skin care measures were used in 25.1% to 63.8% of cases and dehydration and/or malnutrition were identified and managed in 27.8% to 65.6% of patients. Pressure redistribution with special types of mattresses was used in 85.2% of patients, cushions in (wheel)chairs were used in 64.8% of patients, and heels were offloaded in 57.8% of patients. The results regarding repositioning for the 3 groups, respectively, showed a maximum use of 9.7%, 30.3%, and 65.6%; the higher the PU risk, the more preventive measures were used. Although the results show a decrease in the percent of category 2 through category 4 PUs from 16.6% to 5.5% and a trend toward increased use of preventive measures (more skin care, attention for dehydration/malnutrition, use of floating heels/heel devices, and pressure-relieving systems when a PU was present), the reason why measurements were suboptimally used remains unclear. Further research to address the application of guidelines in daily practice is needed.

As the review conducted by Gorecki et al¹ indicates, pressure ulcers (PUs) have long been and remain an important and distressing care problem in nursing homes, causing suffering and loss of quality of life for residents. In addition, PUs are associated with considerable health care costs, as shown in the cost-analysis by Dealey et al.² International PU prevention guidelines^3-6 indicate the use of evidence- and/or practice-based preventive measures and may result in a lower incidence of PUs; the application of PU preventive measures can be facilitated by implementing the recommendations of current evidence-based national and international guidelines.

Appropriate preventive measures include applying a multifactorial approach that consists of PU risk assessment, skin care, nutritional status assessment and optimization, pressure redistribution (mattresses and cushions), and repositioning.^3-6 During the last 20 years, revisions of existing guidelines have led to no real changes in the advised preventive measures because most recommendations have been based mainly on expert opinion instead of evidence-based research.^3-6 Despite possible shortcomings, research has shown guideline recommendations for PU preventive measures provide benefits.^7-10

Assessment. To assess the risk of developing a PU, a structured instrument such as the Braden scale,¹¹ Waterloo scale,¹² or Norton scale¹³ can be used along with clinical assessment (daily skin inspection). In the Netherlands, the Braden scale is the most widely accepted instrument.^11,14 The scale assesses sensory perception, moisture, activity, nutritional intake, and friction and shear, with item scores ranging from 1 to 3 or 4 points. The maximum scale score is 23 points (no risk at all). A score below 20 indicates patients are at risk of a PU¹⁴; a score below 17 indicates being at medium/high risk of PU development.

Recommended preventive measures.

Skin appraisal. Proper skin care involves inspecting the skin daily for redness, localized heat, and edema or induration; as well as managing moisture, including use of emollients.^3-6

Nutrition assessment. Early identification and management of nutritional problems is important^3-6 because many PU patients have a compromised nutritional status.^15,16 Attention to adequate intake of food and liquids and to nonvoluntary weight loss are advised as a part of daily care.

Pressure redistribution. According to PU preventive guidelines published in the last 20 years,^3-6 pressure and shear are the main causal factors of PUs; therefore, preventing/relieving undesired pressure and shear forces is the most important preventive measure. All PU guidelines in this study advised the use of pressure-redistribution systems when the patient is in bed and/or seated utilizing either a passive and/or active system. A passive system involves use of a higher specification foam mattress (eg, a viscoelastic foam mattress) to replace a standard hospital foam mattress. An active system (alternating mattress system) combines redistribution with varying levels of pressure over time. The use of an alternating mattress (active system) is indicated when a viscoelastic foam mattress does not provide sufficient prevention. Combining repositioning with a viscoelastic foam mattress or an alternating air mattress is recommended.^3-6 Repositioning is advised every 3 hours during the day and every 4 hours during the night for individuals at risk, unless contraindicated.^3-6

Landelijke PrevaIentiemeting Zorgproblemen¹⁷(LPZ).

Every year since 1998, Maastricht University (Maastricht, the Netherlands) has conducted an annual 1-day national prevalence measurement, the LPZ,¹⁷ in Dutch hospitals, nursing homes, and home care organizations that considers relevant care problems such as PUs, malnutrition, falls, and incontinence. For each care problem, the LPZ measures structure, process, and outcome indicators according to Donabedian’s model of quality of care.¹⁸ More about the methodology of the LPZ is available online (https://nl.lpz-um.eu/).

The aim of this study was to explore which PU preventive measures were used in Dutch nursing homes in 2005–2014 as recommended by guidelines from the European Pressure Ulcer Advisory Panel 1998,⁵ the National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) 2009,³ and the 2002 and 2011 Dutch PU guidelines⁴ for the specific preventive factors discussed.

Methods

Design. A secondary analysis of data from the LPZ¹⁹ was performed. The study was approved by Maastricht University Medical Centre’s Ethical Committee. For this study, only LPZ nursing home data from 2005 to 2014 that involved PU prevention were analyzed.

Sample. Because participation of the health care institutions in the LPZ is voluntary, data reflect annual differences in the number of participating institutions and the total number of participating residents. To obtain representative results, nursing homes are encouraged to assess all residents of all wards. Data from residents who received palliative care or short-term rehabilitation or whose stay in the nursing home was <30 days were excluded from the study.

Several cutoff points were used to distinguish between residents at risk and not at risk. The complete data file for the years 2005 to 2014 was divided into 3 categories, based on the risk status of the residents per the original research by Braden¹¹ (risk cutoff of 16) and Halfens et al¹⁴ (cutoff of 20): 1) residents at low risk of a PU (Braden score 17–19), 2) residents at medium/high risk of PUs (Braden score <17), and 3) residents with 1 or more PUs category 2 or higher. All residents not at risk (Braden score >19) were excluded from the analyses because they do not require preventive measures. Stage 1 PUs were excluded because their diagnosis is less reliable; these ulcers frequently are excluded in prevalence reports.^21,22 Data were aggregated at the institutional level because the prevalence rate is an important care factor in the nursing home.

Instruments. In this study, only data related to PU risk (using the Braden scale¹¹), PU presence/classification, and preventive measures were used. PUs were classified in 4 categories according to the PU grading system of the EPUAP 1998 and NPUAP/EPUAP 2009 guidelines.^3,5 The following PU preventive measures, as recommended by the guidelines, were assessed: skin care (including use of emollients); identification and management of dehydration and/or malnutrition (including monitoring weight loss, body mass index [BMI], and nutritional intake and supplementation when there appeared to be nutritional deficiencies); repositioning regimens (repositioning in bed and chair according to a time schedule); floating heels (offloading or use of heel devices); and pressure-relieving systems (type of mattresses and cushions).^3-6 Questions regarding application of each preventive measure could be answered Yes/No.

In addition to demographic data that included gender and age, data relevant to the degree of care dependency according to Care Dependency Scale²⁰ (CDS) were considered to assess whether residents became more care-dependent over the years. The CDS comprises the following items, each measured on a 5-point Likert scale (ranging from completely agree to completely disagree): eating/drinking, continence, body posture, mobility, day/night pattern, dressing/undressing, body temperature, hygiene, avoiding danger, communication, contact with others, sense of rules and values, daily activities, recreational activities, and learning ability. The total score varied between 15 and 75 points. The higher the score, the less care-dependent the resident.

All data were gathered by 2 trained caregivers at each nursing home — 1 from the patient’s ward and 1 from another ward. Data were acquired directly from the patient (Braden scale, prevalence of PU, and when possible information on the preventive measures provided such as pressure-relief strategies) or gathered from the patient documentation/medical records (demographic characteristics and other preventive measures such as identification and management of dehydration and/or malnutrition).

Statistical analyses. Data were analyzed by Maastricht University using SPSS Statistics, version 23.0 (IBM Corp, Armonk, NY). Mean characteristics of the residents per group and the mean use of preventive measures were calculated, and differences between the years were tested using linear regression analyses, with year as an independent variable. Statistical significance was noted at <.05.

Results

The aggregated demographic characteristics of the study population over the years are shown in Table 1. During the study period (2005–2014), patients were mostly female (mean 73.6%, range 69.8%–76.8 %) with a mean age of 82.8 (range 81.8–83.9) years; P<.01) and a mean Braden score of 15.3 (range 14.9–15.7; P<.0001); the latter data differed significantly among the years. However, the differences do not indicate a specific trend and are very small; the maximum difference in age is 2.1 years, and the maximum difference in Braden score is 0.8. No significant difference was found regarding gender and care dependency.

Although these demographic characteristics do not show large differences between the years, the PU prevalence shows an almost linear decrease from 16.6% to 7.1% during the first years (2005–2009) and stabilization from 2010 to 2014 (from 7.0% to 4.0%).

Table 2 shows the results regarding the use of the 4 recommended measures for PU prevention for each at-risk group. The extent to which these measures were used increased with an increase of the PU risk.

Preventive skin care. Over the study years, a statistically significant difference was found for all 3 at-risk groups with regard to skin care practice. Although structured skin assessment increased over the years, by 2014 ~60% of the residents in the low-risk group, 45% in the medium/high risk group, and 40% in the group with PUs did not receive preventive skin care.

Identification and management of dehydration and/or malnutrition. Identification and management of dehydration and/or malnutrition differed among the years in all 3 at-risk groups. Preventive measures involving hydration and nutrition status increased significantly only among residents with a PU (from 39.3% to 58.6%, P<.00001). However, not all residents in all groups received structured assessment of possible dehydration and/or malnutrition.

Repositioning schedule. The use of repositioning differed among years; a significant decline in the use of repositioning occurred in the at-risk group with a Braden score below 17 starting in 2006. In 2014, only 18.4% of residents of this group received repositioning according to a time schedule.

Use of floating heels or heel devices. Floating the heels or using heel devices increased over the years from 20.3% to 31% (P<.0001) in the medium/high risk group as well as the group with a PU. In the group of residents at low risk for PUs, the use of these heel pressure offloading strategies remained very low and was not statistically significant (7.9% to 11.3%).

Pressure-relieving systems. Table 3 shows the use of pressure-redistributing bed systems. The data show that over the years no significant differences were found regarding the total percentage of use of pressure-redistributing mattresses/overlays. However, pressure-redistributing systems were used more often when the PU risk was higher (77.9% versus 71.5% in the high-risk group and 66.5% in the low-risk group).

Since 2012, the results show a decline in the use of alternating air mattresses in all groups in favor of the use of static air overlay mattresses. The use of foam mattresses in general was stable over the years, but they were used less frequently when the PU risk is higher.

Pressure-redistributing cushions. The total use of pressure-redistributing cushions was constant over the years. Since 2012, their use mostly seemed to trend upward in all 3 groups (group 1 from 20.8% to 33.4%, group 2 from 31.8% to 47.9%, and group 3 from 30.8% to 64.8%) (see Table 4), as noted by the increased use of air cushions (group 1 from 5.7% to 21.4%, group 2 from 10.4% to 31.5%, and group 3 from 16.7% to 50.0%). The use of foam cushions declined during the study period (especially in the low-risk and medium/high-risk groups, respectively) from 23.3% to 9.4% (P<.0001) and from 24.6% to 10.9% (P<.0001).

Discussion

This study shows PU preventive measures are used more often when the risk for PU development is greater or when PUs are already present. However, not all at-risk residents received the recommended PU preventive measures as advised in the guidelines, such as skin care or a pressure-redistributing mattress.^3-6 Over the years, data show an increase in the application of appropriate skin care and the use of static air overlays and preventive air cushions in all 3 risk groups, as well as an increase in the use of heel offloading or heel devices in groups 2 and 3. The use of repositioning and alternating air mattresses in group 2, as well as the use of foam cushions in groups 1 and 2, decreased. Overall, the use of pressure-relieving systems was fairly constant. Looking at the decrease of PU development during the study period, it is possible to conclude use of pressure-relieving systems may result in less PU development.

Use of appropriate skin care showed a statistically significant increase over the years for all groups but never reached a percentage higher than 60%. Because adequate skin care is very important, 100% use was expected by the study group. Attention to malnutrition and dehydration increased significantly over the study years in the group of residents with a PU but never reached a percentage higher than 65.6%. This is in line with the results of a prevalence study¹⁹ about prevention measures for residents at risk in Austrian nursing homes that showed attention to nutritional status occurred in only 53.5% of residents at risk of developing a PU.

Even though repositioning is an integral component of PU prevention and treatment and is widely recommended, this study shows it is not widely used in daily practice,²³ similarly noted in a prevalence study by Moore et al²⁴ where only 9% of older residents in Irish long-term care facilities were repositioned. Contrary to the current study findings, these authors found no difference in the use of repositioning strategies between residents with and without a PU. In a descriptive, comparative study, Breimaier et al²⁵ found that ~40% of Austrian nursing home residents at risk for a PU were provided regular repositioning; the same study showed 60% of residents were provided heel offloading, compared to the maximum of 55% among at-risk persons with a PU in the current study.

Pressure-relieving mattresses were used for 70% of residents in all the groups studied; this percentage increased by approximately 10% after a PU developed. In a prevalence study²⁴ involving nursing homes in Ireland, 50% had a pressure-redistribution device in bed, and in a descriptive, comparative study²⁵ conducted in Austrian nursing homes more than 80% of persons at risk for PUs were provided a pressure-redistributing device.²⁵

Possible reasons for insufficient implementation of recommended PU preventive measures. The main question that remains is why PU preventive measures are not fully implemented as advised in the guidelines. It is generally known that national and international guidelines often are challenging to read because they are extremely comprehensive, written in complicated language, and difficult to translate into daily practice. This may cause barriers to their implementation. Lack of awareness, knowledge, and skills and unfamiliarity with the recommended measures also may deter nurses from following the guidelines. A qualitative study by Meesterberends et al²⁶ indicated most nurses in Dutch nursing homes were not aware of the guideline recommendations regarding PU prevention, although the mean knowledge score regarding preventive measures was 71.3%. A longitudinal study by Demarré et al²⁷ conducted in Belgian elder care facilities found nurses’ knowledge about PU preventive measures was low and that the attitude of the nursing staff was a predictor of the application of prevention recommendations for residents at risk.

Because the current study implies the implementation of evidence-based PU preventive measures remains a challenge, the question also arises whether the current guideline recommendations are tailored sufficiently to the daily practice of PU prevention and care. PU guidelines should better explain which (combinations of) preventive measures should be used in specific patient situations. It is the opinion of the study group that this would allow PU preventive measures to be tailored to individual patients to a greater degree, facilitating their application in daily patient care.

Several literature and systematic reviews^28-33 underscore that the implementation of national and international guidelines in daily practice is often insufficient but might be facilitated by easy-to-use tools such as checklists, alerts, and apps. Active implementation strategies, as presented in implementation studies,^28-34 have been shown to be more effective than passive strategies in overcoming implementation barriers and also encourage better implementation of PU guidelines. Adequate and more continuous coaching and daily practice guidance should be provided instead of only providing hard-to-read, massive guideline documents.

Limitations

Secondary analyses of existing data inherently come with limitations. Patient demographic data showed that during the period 2005–2014 the mean age and mean Braden score differed significantly among the years. However, these differences were very small but statistically significant due to the large sample size. Whether such small differences are clinically relevant is unclear. In addition, because the methodology of the LPZ measurement involves a cross-sectional design, it is not possible to draw causal conclusions. Finally, although most of the participating nursing homes are involved annually in the national LPZ survey, not every nursing home participates every year.

Conclusion

A longitudinal study of national data found PU preventive measures are not provided to all persons deemed at risk, although application of guideline recommendations for PU prevention is increasing, especially in patients at high PU risk or who already have a PU. This study shows that guideline availability is only 1 step in the provision of evidence-based care. More research into the reasons for the lack of provision of preventive strategies and solutions for their implementation is needed.

References

1. Gorecki C, Brown JM, Nelson EA, et al. European Quality of Life Pressure Ulcer Project group. Impact of pressure ulcers on quality of life in older patients: a systematic review. J Am Geriatr Soc. 2009;57(7):1175–1183.

2. Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care. 2012;21(6):261–266.

3. National Pressure Ulcer Advisory Panel/European Pressure Ulcer Advisory Panel. Pressure Ulcer Prevention Quick Reference Guide. Available at: www.npuap.org/wpcontent/uploads/2012/02/Final_Quick_Prevention_for_web_2.... Accessed February 1, 2009.

4. Verpleging & Verzorgenden Nederland (V&VN). Dutch National Guidelines for Prevention and Treatment of Pressure Ulcers. Available at: www.venvn.nl/LinkClick.aspx?fileticket=8TrtENI2ZjE%3D&tabid=1852. Accessed November 1, 2011.

5. European Pressure Ulcer Advisory Panel. European Pressure Ulcer Advisory Panel Guidelines Prevention and Treatment. Available at: www.epuap.org. Accessed September 1, 1998.

6. Centraal Begeleidings Orgaan (Dutch institute for healthcare improvement). Prevention and Treatment of Pressure Ulcers, a Dutch Guideline. Utrecht, the Netherlands: CBO;2002.

7. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance; Haesler E, ed. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Perth, Australia: Cambridge Media;2014. Available at: www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Referenc.... Accessed October 16, 2014.

8. Expert Working Group. Pressure Ulcer Prevention: Pressure, Shear, Friction and Microclimate in Context. A Consensus Document. London, UK: Wounds International Enterprise House;2010.

9. Orsted HL, Ohura T, Harding K. Pressure Ulcer Prevention: Pressure, Shear, Friction and Microclimate in Context. A Consensus Document. London, UK: Wounds International Enterprise House;2010:1.

10. Reger SI, Ranganathan VK, Orsted HL, Ohura T, Gefen A. Shear and friction in context. Pressure Ulcer Prevention: Pressure, Shear, Friction and Microclimate in Context. A Consensus Document. London, UK: Wounds International Enterprise House;2010:12–18.

11. Norton D. Calculating the risk: reflections on the Nortonn Scale. Adv Wound Care. 1989;9:38–43.

12. Norton D, McLaren R, Exton-Smith AN, McLaren R. An investigation of geriatric nursing problems in hospital. Public Health. 1963;77(5):317.

13. Waterlow JA. Pressure sores; a risk assessment card. Nurs Times. 1985;81(48);:49–55.

14. Halfens RJG, van Achterberg T, Bal RM. Validity and reliability of the Braden scale and the influence of other risk factors: a multi-centre prospective study. Int J Nurs Stud. 2000;37(4):313–319.

15. Meijers JM, Schols JM, van Bokhorst-de van der Schueren MA, Dassen T, Janssen MA, Halfens RJ. Malnutrition prevalence in the Netherlands: results of the annual Dutch national prevalence measurement of care problems. Br J Nutr. 2009;101(3):417–432.

16. Shahin ES, Meijers JM, Schols JM, Tannen A, Halfens RJG, Dassen T. The relationship between malnutrition parameters and pressure ulcers in hospitals and nursing homes. Nutrition. 2010;26(9):886-889.

17. van Nie-Visser NC, Schols JM, Meesterberends E, Lohrmann C, Meijers JM, Halfens RJ. An international prevalence measurement of care problems: study protocol. J Adv Nurs. 2013;69:e18–e29.

18. Donabedian A. The quality of care. How it can be assessed. JAMA. 1988;260(12):1743–1748.

19. Halfens RJ, Meesterberends E, van Nie-Visser NC van, et al. International prevalence measurement of care problems: results. J Adv Nurs. 2013;69(9),e5–e17.

20. Dijkstra A, Tiesinga LJ, Plantinga L, Veltman G, Dassen TW. Diagnostic accuracy of the care dependency scale. J Adv Nurs. 2005;(50)4:410–416.

21. Bruce TA, Shever LL, Tschannen D, Gombert J. Reliability of pressure ulcer staging: a review of literature and 1 institution’s strategy. Crit Care Nurs Q. 2012;35(1):85–101.

22. Anderson J, Langemo D, Hanson D, Thompson PA, Hunter SM. Planning, conducting, and interpreting prevalence and incidence for the wound practitioner. Adv Skin Wound Care. 2013;26(1):35–42.

23. Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev. 2014;4. No.: CD009958. DOI: 10.1002/14651858.CD009958.pub2.

24. Moore Z, Cowman S. Pressure ulcer prevalence and prevention practices in care of the older person in the Republic of Ireland. J Clin Nurs. 2012;21(3-4):362–371.

25. Breimaier HE, Halfens RJ, Wilborn D, Meesterberends E, Haase Nielsen G, Lohrmann C. Implementation interventions used in nursing homes and hospitals: a descriptive, comparative study between Austria, Germany, and the Netherlands. ISRN Nurs. Available at: http://dx.doi.org/10.1155/2013/706054. Accessed June 1, 2013.

26. Meesterberends E, Halfens RJ, Lohrmann C, Schols JM. The implementation of pressure ulcer guidelines in Dutch and German nursing homes: a qualitative study. Pressure Ulcer Care in The Netherlands Versus Germany 0–1: What Makes the Difference? Enschede, The Netherlands: Ipskamp Drukkers;2013:59–73.

27. Demarré L, Vanderwee K, Defloor T, Verhaeghe S, Schoonhoven L, Beeckman D. Pressure ulcers: knowledge and attitude of nurses and nursing assistants in Belgian nursing homes. J Clin Nurs. 2012;21(9-10):1425–1434.

28. Davis DA, Taylor-Vaisey A. Translating guidelines into practice. A systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. CMAJ. 1997;157(4):408–416.

29. Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group. Br Med J. 1998;317(7156):465-468.

30. Effective Health Care: getting evidence into practice. York, England: National Health Service Centre for Reviews and Dissemination. 1999:1–16.

31. Feder G, Eccles M, Grol R, Griffiths C, Grimshaw J. Using clinical guidelines. Br Med J. 1999;318(7185):728–730.

32. Grimshaw JM, Shirran L, Thomas R, et al. Changing provider behavior: an overview of systematic reviews of interventions. Medical Care. 2001;39(8 suppl 2):112-145.

33. Tooher R, Middleton P, Babidge W. Implementation of pressure ulcer guidelines: what constitutes a successful strategy? J Wound Care. 2003;12(10):373–382.

34. Meesterberends E, Halfens RJ, Lohrmann C, Schols JM, de Wit R. Evaluation of the dissemination and implementation of pressure ulcer guidelines in Dutch nursing homes. J Eval Clin Pract. 2011;17(4):705–712.

Potential Conflicts of Interest: none disclosed

Dr. van Leen is an elderly care physician, Martin’s Geriatric & Wound Consultancy, Rotterdam, The Netherlands; and a researcher, Faculty of Health, Medicine and Life Sciences, Caphri/Department of General Practice, Maastricht University, Maastricht, The Netherlands. Prof Schols is an educator, old age medicine, Faculty of Health, Medicine, and Life Sciences, Caphri/Department of General Practice, Masstricht University. Prof Hovius is a plastic surgeon and Head, Orthopedic Ward, Department of Plastic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. Dr. Halfens is a project leader for Dutch National Prevalence Measurement of Care Problems (LPZ), Faculty of Health, Medicine, and Life Sciences, Caphri/Deptartment of Health Service Research, Maastricht University. Please address correspondence to Martin WF van Leen, MD, PhD, Martin’s Geriatric & Wound Consultancy, Helmbloem 15, 3068AC Rotterdam, The Netherlands; email: martinwfvl@gmail.com.

Section:

Volume 63 - Issue 9 - September 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(9):32–44 doi:10.25270/owm.2017.09.3244

Daniel L. Young, PT, DPT, PhD; Nancy Estocado, PT, BS, CWS; Du Feng, PhD; and Joyce Black, RN, PhD

Topics:

nursing assessment

Wounds

Pressure Ulcer

wound healing

face validity

Abstract

Accurate assessment and clear documentation are important aspects of wound care; they provide a basis for appropriate patient care decisions and reimbursement. A descriptive, qualitative study was conducted to develop and provide preliminary evidence of the validity of a new tool to measure wound healing (the Healing Progression Rate [HPR]), a modified version of the Pressure Ulcer Scale for Healing (PUSH).

Three (3) groups of current and future practitioners participated in the instrument development and evaluation process: 1) 3 wound care experts/authors (2 physical therapists, 1 nurse) with a minimum of 15 years of experience, 2) 6 additional wound care experts (4 nurses and 2 physical therapists) with a minimum of 10 years experience, and 3) 120 participants (77 [64.2%] RNs, 2 [1.7%] nursing students, 12 [10%] physical therapists [PTs], and 29 [24.2%] PT students). After the instrument was developed, the first group of 3 wound care experts used 2 photos of the same pressure injury at different points in time for 30 different wound cases to determine wound status (improved, worse, or the same) using the HPR and PUSH tools. The 6 experts from group 2 completed a similar exercise and, after completing a demographic questionnaire, the nonexpert participants scored 20 randomly selected cases (10 with the PUSH and 10 with the HPR) followed by a 4-question survey about the instruments. All data were collected on spreadsheets. Descriptive statistics were generated and mean HPR and PUSH scores for each image were compared to expert scores using a paired t-test. If the mean of participants’ image scores was significantly higher or lower than that of the experts, it was placed in the “higher” or “lower” group. If the difference was not statistically significant, the image was placed in the “same” group. Chi-squared tests (χ2) were used to compare the frequency distribution within each of these 3 groups for the HPR and PUSH tools. Due to violations of normality, the nonparametric Friedman’s analysis of variance and Wilcoxon signed rank test were used to compare the experts’ votes on which tool they thought captured the difference between the pre- and post-wound pictures and to perform post hoc testing, respectively. Qualitative data from the exit survey were reviewed and grouped into common themes. In 8 cases, a statistically significant difference was found among the number of votes (from the 6 experts) for which tool best reflected the change in wound status (χ2 (2) = 11.20; P = .004). Post hoc comparison revealed experts believed the change in HPR score better reflected the change in wound status compared to the PUSH tool (P = .026). Almost 75% of nonexpert participants preferred the HPR, rating it as more objective (73%). The results of this preliminary validation study suggest that further validation and reliability testing is warranted.

Chronic wounds, including pressure injuries (PI) or pressure ulcers (PU), vascular ulcers, and diabetic wounds, are a health care problem affecting 6.5 million people in the United States each year.^1,2 The costs associated with caring for these wounds likely add $25 billion every year to the American health care system.³ Annual expenditure on wound care products, only 1 component of care costs for these wounds, is approximately $15.3 billion.⁴

In a 2007 review paper,⁵ researchers agreed that accurate assessment and clear documentation are important aspects of wound care. According to reviews and overviews,^6–10 documentation provides the basis for appropriate patient care decisions and for payment from third-party payers; studies^5,6 also have noted how difficult it is to monitor progress in a wound, set goals for healing, design a comprehensive care plan, and select the correct dressings when assessment is not properly performed or incomplete and not clearly documented. Interestingly, standards for assessment and documentation of wounds are still being debated despite or maybe because of the availability of so many tools for this task.^11–14

A 1999 critical appraisal of the literature¹⁵ considered 5 wound assessment instruments specific to PUs and concluded that although assessment instruments could be completed in <15 minutes, training and wound care experience were needed in order for the tools to provide reliable results. One recent evaluation study¹⁴ used an author-developed audit tool to evaluate 14 selected wound assessment instruments on how closely their scores matched those of an “optimal wound assessment tool” as defined by the authors based on literature review. The authors concluded none of the wound assessment tools they evaluated fulfilled criteria for an optimal wound assessment tool, and most did not provide a score that allowed for quick comparison of wound status over time. The 2 tools the authors believed best fulfilled their criteria were the Applied Wound Management tool and the National Wound Assessment Form.

Two (2) assessment tools specific to PUs are commonly used in the United States: the Bates-Jensen Wound Assessment Tool (BWAT; formerly the Pressure Sore Status Tool) and the Pressure Ulcer Scale for Healing (PUSH). The BWAT has 13 separate items to complete for a total score from 13–65; it was originally designed as a tool for researchers.^16–18 The PUSH assesses 3 items (wound size, exudate amount, and tissue type); individual item scores are summed to provide a total score that can be used to track wound changes over time.^19,20 The validity of these items was reported by Thomas et al¹⁹ and Stotts et al²¹ using statistical analysis of existing wound data. Both studies found the PUSH tool accounted for somewhere between 31% and 74% of the variability in wound healing, but it is insensitive to changes in large wounds due to an inherent ceiling on size of 24 cm².¹⁸ The reliability of the PUSH tool has been tested for inter-rater agreement and found to be between 90% and 95%.^21,22

Despite the utility of the PUSH tool for quantification of wound status and healing, this instrument was designed only for PUs.¹⁵ The current authors have observed its use to assess other wound types and this is evidenced in the literature,²³ but its validity for other wounds is unknown. In addition to utility for a single wound type, the PUSH tool has other limitations. It was developed before the National Pressure Ulcer Advisory Panel (NPUAP) defined deep tissue pressure injury (DTPI) and unstageable PIs and has not been updated to reflect new staging.^15,24 In addition, a serum-filled blister, common over a new or evolving PI, also does not appear on the PUSH tool, making scoring difficult and leading to potential variation in the score.

Thus, the current wound care environment has few valid and reliable instruments to assess and quantify wound healing objectively, aside from documenting simple measurements and calculating percent healing. Without an objective assessment and score to compare over time, change in wound status may be based only on what a provider documented in a series of narrative observations and his/her memory of the wound’s appearance. Although wound size is the primary quantifiable measure of healing, it is a measurement primarily based on the wound border.¹⁵ However, clinical trials^25,26 have reported the border denoting the beginning of intact skin can be difficult to identify precisely, resulting in greater interrater variability. Additionally, nonexperts asked to assess wounds may require the help of experts who may use photographs of the wounds to aid in their assessment.^17,27

These limitations are compounded when language from the PUSH tool is used in other reports. For example, skilled nursing reporting forms (eg, Minimum Data Set – MDS 3.0) use PUSH language for staging but do not include important components that facilitate comparison of wound status between assessments (ie, comparisons of wound size or surface area changes over time), tissue types visible in the wound bed, and differentiation between an open or closed wound.^28–30 This creates a temptation to use stage numbers to indicate healing; however, the NPUAP specifically clarified this is not a correct use of the staging system.³¹

Although commonly used, the authors believe the PUSH tool’s 3 components have inherent limitations. First, the PUSH gives the same size score for all wounds larger than 24 cm². Second, they believe the amount of exudate is difficult to assess objectively because the amount visible may depend on the absorptive capacity of the dressing being used and that exudate is difficult to discern in a picture. Third, with regard to tissue type, maroon or purple/deep tissue injury cannot be included in the score, no option exists to score wounds that are not yet open to the air (such as a blood- or serum-filled blister), and full-thickness wounds with red granulation tissue are scored the same as partial-thickness wounds that have smooth red dermal tissue. Finally, no scoring option is available for superficial nonblanchable or blanchable erythema with intact tissue.²¹ Therefore, the purpose of this study was to describe the initial development of an alternative instrument — the Healing Progression Rate (HPR) tool — for measuring wound healing and to provide preliminary evidence of its construct validity.

Methods

Developing the new tool. The HPR was developed by 3 wound care experts — 1 nurse and 2 physical therapists — each with more than 15 years of experience in wound assessment) using the PUSH tool as a template. Over the course of ~1 year, 1 of the experts began to outline the HPR and to casually experiment with it in practice to see if different items and scoring structures could indicate numerically whether wounds were the same, better, or worse compared to expert opinion. The use of the PUSH score at the expert’s hospital facilitated comparison with HPR scores. These efforts were fueled by wound care team members at the hospital expressing frustration with the limited tissue type choices in the PUSH and the fact that PUSH scores showed no change in larger wounds that were healing. For example, the PUSH tool has no option for purple as the tissue type (as is seen in DTPI), so clinicians would have to decide to call it black (a score of 4) or red (a score of 1). Thus, a purple wound bed could go from a score of 4 on admission to a score of 1 on discharge without any change in wound status.

Table 1 presents the new tool. It comprises 3 sections: worst tissue type observed, surface area, and whether skin is intact. Items in each section are assigned a point value and tallied for a total score. Based on the casual experimentation done during clinical care, the same scoring and score weights used in the PUSH tool were used and expanded to include a larger surface area scale and a larger, more detailed tissue type scale. The other 2 experts reviewed item order and point values for face validity. The PUSH tool exudate section and its subscore were eliminated in the HPR because of the expert’s concern over the subjectivity of this metric. The 3 experts all believed exudate was important but could not be objectively verified in photo-documentation when nonexpert clinicians performed assessments.

Tissue types that have been identified by the NPUAP as essential markers for PI stages were added and include maroon or purple, blood- or serum-filled blister, and red granulation tissue separate from smooth red dermal tissue.²⁴ Additional size categories were added to raise the ceiling on surface area to 225 cm². Scores for the new tissue types and size categories were ordered based on NPUAP stage association or size and given the next whole number as their respective value; for example, a serum-filled blister would be scored 2 while a blood-filled blister would be scored 5. A new objective subscore for surface skin layers (intact or not intact) was added to represent a healed wound, a DTPI, Stage 1, intact blister, or intact eschar; this intact skin score was given a value of 0.5. The tissue type and size scores are in whole numbers and together could range from 0 (best — ie, less severe wound) to 27 (worst, most severe wound). The 0.5 addition for intact skin would clearly communicate the presence of an open wound versus a wound with intact surface layers because the tissue type and size scores are in whole numbers.

Once the new tool was developed, Institutional Review Board approval was obtained from the hospital where data collection would occur as well as from the university where data would be analyzed.

Photographs. The hospital obtained consent from all patients for deidentified pictures to be used in research. Photographs from hospital medical records were utilized and did not include any personally identifiable patient information. The pictures were selected by the research team to represent a variety of PIs and patient types to compare PUSH and HPR scores for different wounds. This was a nonrandom sample of wound images without specific inclusion or exclusion criteria beyond the requirement that the pictures be of the same PI taken at 2 clearly identified points in time. If the wounds were not clearly PIs with date and time marked, they were not considered for inclusion. Photographs of the wounds were needed at 2 different time points to compare wound change for each wound using both PUSH and HPR. With these goals in mind, 30 cases were selected and 2 photographs of the same wound were selected from 2 different points in time. Wound types and locations are shown in Table 2.

All wound photographs at this hospital are taken with the NE1 Wound Assessment Tool (NE1 WAT, originally called the NE One Can Stage “NEOCS”, N.E. Solutionz, Las Vegas, NV) framing the wound.^32,33 The NE1 WAT is an “L” shaped ruler with a slightly adhesive backing designed to aid in the assessment of PI. The tool has representative pictures of PI for the various NPUAP stages with descriptions of those stages. It also contains room for documentation of the patient, provider, date, and time of assessment. In 2011, the development and psychometric testing of the NE1 WAT was described and its reliability and validity were established.³² In the first of these tool psychometric studies, 101 clinical wound care providers (registered nurses, physical therapists, physicians, and nursing and physical therapy students) staged pictures of wounds with and without the NE1 WAT.³² In the second, 94 registered nurses staged pictures of wounds with and without the NE1 WAT.³³ In both studies, reliability coefficients were high (ICCs = 0.6–0.9) and accuracy of clinician wound staging improved by as much as 61% when they used the NE1 WAT compared to when they did not.^32,33 However, it does not provide a score indicative of wound healing or worsening.

Scoring by experts. Using print photographs and paper-and-pencil instruments, the 3 expert participants that initially developed the HPR viewed each of the 60 images (30 cases) and scored the wounds using the PUSH and HPR tools, yielding 3 scores for each case. Because the measurement instructions are different between the tools, experts were cautioned to strictly follow the directions of each tool for each element of scoring. For example, the PUSH tool requires measurements to be taken from the wound edge and the HPR directs that involved periwound should be included in the size measurement. Additionally, the instructions for obtaining length and width measurements are worded slightly differently. The HPR directs that measurements for length should be from 12 o’clock to 6 o’clock and width from 3 o’clock to 9 o’clock at the widest and longest portion of the wound, and the PUSH tool measurements are obtained using greatest length (head to toe) and the greatest width (side to side). The wound images were all taken with the NE1 WAT on the patient framing the wound, and the ruled border of the NE1 WAT was used for measurement in this assessment. These 3 experts then met to discuss their scores and came to consensus so each picture had 1 score from PUSH and 1 score from HPR. The HPR and PUSH scores for each case then were compared to determine if they were lower, higher, or the same in terms of change between the 2 photographs.

A convenience sample of 6 additional wound care experts (4 nurses and 2 physical therapists with a minimum of 10 years of clinical wound experience) were recruited via email. When the invitation was accepted, the criteria and further instructions were emailed to them and they were asked to review the same cases and existing expert scores and provide feedback comparing the HPR to PUSH along with suggestions on how to improve the HPR. In cases where the PUSH and HPR scores disagreed regarding direction of wound healing (same, better, worse), the 6 experts were asked to indicate if they thought the wound had improved, deteriorated, or remained the same. Once the test packets were sent out, a time frame of 2 weeks was given for completion.

Nonexpert testing. A convenience sample of 120 participants was recruited from a university and a community hospital. Participants were approached in person by members of the research team in the course of their work as students or clinicians in the university or hospital over a period of 2 months. If persons recruited met the inclusion criteria (ie, educated on PI management and assessment and expected to perform these skills in their professional roles now or in the future), they provided written informed consent and completed a demographic profile on paper and were assigned a subject number. The demographic profile included years of experience in wound care, specialty certifications related to wound care, a single question on self-perceived skill level in wound care (Likert-style scale with 5 choices from expert to none), and prior experience with either of the tools being tested (yes or no) (see Figure 1 and Table 3).

The participants used a computer in a hospital training room to view 30 cases (60 images) and score the photographs according to the HPR and the PUSH tools. The computer program was a training version of the clinical documentation interface used by the hospital for wound care documentation. Screenshots of the interface are provided in Figures 2–4. Participants were asked to read the scoring directions for the PUSH tool and then use the tool to score a semi-random selection of 10 of the 60 pictures. The study was designed so that each picture would be shown to at least 3 participants. Participants then were asked to read the scoring directions for the HPR and score a different semi-random selection of 10 pictures using the HPR. No other training was provided during the study. The computer program used a digital box, the size and placement of which was controlled by the participant, to measure wound size. Scoring was completed automatically by the computer program based on the participants’ selections.

Following the computer-based wound scoring exercise, all participants completed an exit survey on paper (see Figure 1) to provide feedback on the 2 tools that included 3 questions with Likert-scale responses and 1 free-response item. The first 2 questions asked the participants about their preference for HPR or PUSH and the Likert scales had “0 1 2 3 2 1 0” options with PUSH on the left and HPR on the right. The third question had a traditional 7-point Likert scale with 1 = not important and 7 = very important. All testing and survey completion was completed in a single session which lasted approximately 1 hour for each participant. The testing room had 10 computers and groups of participants were tested simultaneously whenever possible without allowing them to discuss the cases or their answers during testing.

Data collection and analysis. Nonexpert scores for each item of the PUSH and HPR were exported directly into a spreadsheet file; data from paper forms were manually entered into the same spreadsheet. Following data collection spreadsheets were imported and analyzed in SPSS Version 24 (SPSS Statistics for Windows, IBM Corp, Armonk, NY).

Descriptive statistics were generated and a paired t-test was performed to compare the mean score (HPR and PUSH) of nonexpert participants on each image to the expert score for each image. Images then were placed into 3 groups based on the result of the t-tests. If the mean of the participants’ score was significantly higher or lower than that of the expert for an image, that image was placed into the respective (“higher” or “lower”) group. If no statistical difference was noted between the participant mean and expert score, that image was placed in the “same” group. Chi-squared tests (χ²) were used to determine whether the frequency distribution within each of the above-mentioned 3 groups was significantly different between the 2 types of tools used (HPR and PUSH). Due to violations of normality, the nonparametric Friedman’s analysis of variance (ANOVA) and Wilcoxon signed rank test were used to compare the experts’ votes on which tool they thought captured the difference between the pre- and post-wound picture and to perform post hoc testing, respectively. Free-response comments to question 4 of the exit survey were grouped into common themes by the authors in a group setting.

Results

In 8 cases (5, 7, 15, 16, 21, 24, 28, 30), the single consensus scores for the PUSH and the HPR (from the first 3 experts wound assessment) did not agree concerning the change in wound condition between pre and post pictures of that case (see Table 2 for type of wound). The 6 additional experts then reviewed those cases and consensus scores and indicated which tool they thought better captured the difference in wound status (better, worse, same) between the pre- and post-pictures. A statistically significant difference was noted among the number of votes on these 8 cases for HPR, PUSH, or neither (χ² [2] =11.20, P = .004). Post hoc comparison showed experts believed the change in HPR score better reflected the change in wound status compared to the PUSH tool (P = .026) (see Figure 5).

The 120 nonexpert participants included registered nurses (77), nursing students (2), physical therapists (12), and physical therapy students (29) (see Table 3). More than 79% of participants were new graduates or students with <1 year of wound care experience; however, more than 50% of participants said their wound care skill level was better than fair.

Each of the 30 cases was scored with the PUSH and HPR by 21 nonexperts each; rarely did the same nonexpert score the same image with both PUSH and HPR due to the semi-random assignment of the images by the computer system. The mean nonexpert score was compared to the expert score with a t-test for each image. When wounds were scored by nonexperts using the PUSH tool and compared to expert scores, 27 were higher, 20 were lower, and 13 were the same. When wounds were scored by nonexperts using the HPR, 13 were higher, 29 were lower, and 18 were the same when compared to the expert score (see Figure 6).

A significant difference was found between the number of cases in the groups for the tool used (HPR or PUSH) and the higher, lower, same groups (χ² [2] = 7.4; P = .03). Post-hoc testing with a Bonferroni correction to the α-value (0.05/3 = 0.017) revealed nonexperts scored a wound higher more often than the experts when using the PUSH tool compared to when they used the HPR tool (27 PUSH, 13 HPR; P<.01). No differences were noted in the number of images with scores the same (13 PUSH, 18 HPR; P = .30) or lower than the expert score (20 PUSH, 29 HPR; P = .10) (see Figure 6).

Among nonexperts, answers to the first 2 questions of the exit survey revealed a strong preference for the HPR tool (see Table 4). The first question, which asked about preference for the HPR or PUSH, revealed 74% of participants preferred the HPR, 17% preferred the PUSH, and 10% had no preference. In response to the second question, which asked which tool they felt was more objective, 73% of participants preferred the HPR tool, 15% preferred the PUSH, and 11% thought they were equally objective. For the third question, How important are pictures in wound care, 100% of participants felt they were important; on a scale where 1 = not important and 7 = very important, 81% marked 7, 14% marked 6, and 5% marked 5 (see Table 4).

Among nonexperts, comments on the exit survey referencing the PUSH tool were grouped into 5 main themes by the authors: 1) Frustrated that a purple or DTPI option was not offered, 2) Difficult to score exudate amount; 3) Vague directions for measurement; 4) Poor selection of tissue types; and 5) Hard to score with just a picture. Comments from nonexperts on the exit survey referencing the HPR tool were grouped into 7 main themes by the authors: 1) Hard to score with just a picture; 2) Difficult to determine boundaries for measurement; 3) Better tissue type choices; 4) Picture scale for tissue types was helpful; 5) Liked having a purple or DTPI option; 6) Instructions for measurement more clear; and 7) Intact value score is confusing. As shown in Table 5, the comments for the PUSH were all negative and the HPR had both negative and positive comments.

Discussion

This study described the initial development of the HPR tool for measuring wound healing and provided preliminary evidence for its face and construct validity. This study highlighted that the PUSH tool may not reflect actual change in all PIs and that the HPR may help improve wound status assessment.

With the exception of 1 case, expert participants agreed the HPR score change best reflected their opinion about the change in wound status. In that 1 case, the photos showed a heel wound presenting as a DTPI in picture 1 and a serum-filled blister in picture 2. When examined by the experts, 3 agreed with the HPR score that the wound had improved from photo 1 to photo 2, 1 agreed with the PUSH score that no change in wound severity had occurred, and 2 did not agree with either the HPR or PUSH score, indicating they believed the wound status had worsened from photo 1 to photo 2. This was most likely due to difficulty identifying the DTPI in picture 1 and then comparing it to a more obvious serum- filled blister in picture 2, underscoring the importance of palpating the actual wound.³⁴

Wound care novices using the PUSH tool gave wounds a higher score than the experts significantly more often than they did when using the HPR. The reason the PUSH score provided by the nonexperts often was significantly higher than an expert score was not examined. The scale of the HPR allowed for large wounds to have a higher score overall than the same wound with the PUSH; however, that does not explain why an expert using the PUSH would score a wound lower than a novice scoring that same wound with the PUSH. It is possible the novices perceived exudate amount as greater than the expert, given their limited experience in seeing wound exudate, which would lead to a higher score. The authors propose this may highlight the difficulty of scoring exudate from a picture, something previous studies have noted¹²; however, this difference may simply be a spurious finding.

In this study, all participants evaluated wounds using pictures. Using live tissue when evaluating a wound has clear advantages; however, it has been shown in reliability studies^{17,27,35–37} of PU staging that pictures can be used with confidence in this type of study and, when combined with clinical information, also used in clinical wound care. The current authors believe pictures are an essential component of wound care practice. Although the variability of color reproduction and lighting can make comparison difficult, the authors believe standardized reference taken in the picture against the skin around the wound, such as the NE1 WAT, allows for comparison.²³ Having a picture also allows an expert to review the assessment of a bedside clinician and make appropriate adjustments to the plan of care or a wound care report. With a picture, measurements can be made at 2 different points in time by the same or different clinicians, underscoring the need for photographs to become standard of care for patients with wounds.⁷

In this study, PUSH and HPR scores tended to agree in terms of wound status. Of the 30 cases studied, 22 (73%) showed agreement between the HPR and PUSH scores regarding the change in wound status. Of the 8 wounds (27%) on which the HPR and PUSH scores did not agree regarding change in wound status, the 6 experts agreed with the HPR score 88% of the time and with the PUSH 8% of the time. Only 2 experts, on a single case, found neither the PUSH tool nor the HPR captured the change in wound condition correctly. This provides preliminary evidence for the face and construct validity of the HPR and captures information in its score that the PUSH tool does not. However, the PUSH tool was developed using principal component analysis of several possible variables to predict healing^19,21 and the elimination of exudate in HPR development was not similarly tested. Additionally, the reliability of the HPR was not tested.

Despite having more specific measuring directions for what should and should not be included in wound measurements, clinicians were inconsistent with using the measuring points for total surface area, a problem highlighted by other laboratory studies of wound measurement.^25,38 This finding would underscore the importance of having wound measurements validated by an expert using an image-based record, such that similar data points could be used when comparing wound size status at 2 different points in time.7 Additionally, length x width surface area measurements used by both PUSH and HPR include all skin/wound surface areas (damaged and some not damaged areas) that fall in the 12–6 and 3–9 o’clock square area. Therefore, wounds not shaped like a square or rectangle would have surface area measurements larger than their actual size. Rather than resorting to expensive or difficult measurement tools, the solution is to combine photo documentation with the bedside assessment.

Although this study leaves several questions unanswered including the reliability and sensitivity to change of the HPR, it provides valuable evidence for the face and construct validity of the HPR and gives direction to future research needed for the new instrument. Some important considerations for future research on the HPR include changing the instructions for the HPR to include hyperemic wound edges and hyperemic periwound in the measurements; making the green wound measuring box lines thinner (in the present version, the thick lines blocked some of the visual field); for the HPR itself, changing the words Intact Value to something more understandable by the novice clinician like, Are there any open areas?; adding open scar, fat, epibole, fascia, scab, and dried skin edge as tissue types that can be scored; assigning participants the same pictures to score for both PUSH and HPR to capture data for testing reliability; and serially measuring wounds over time to allow for sensitivity to change calculations.

Limitations

One goal for HPR development was to determine its ability to measure any wound, not just PIs. The design of this study did not include other wound types or assessment tools, so it was not possible to provide empirical evidence for the performance of the HPR on other wound types. Because the participants in this study did not score the same wounds with both the HPR and PUSH, reliability statistics cannot be calculated. This was done to minimize the chance that participants would use the same wound measurement points for both tools despite the different healing direction or the inclusion (or not) of periwound skin for the HPR. In hindsight, other study methods, such as a time delay of some days between assessments, may have better accomplished this goal and allowed for reliability calculations.

Conclusion

This study describes the initial development of the HPR tool for measuring wound healing and provides preliminary evidence of its face and construct validity. The HPR was initially created by 3 wound care experts, compared to the PUSH by another 6 experts, and used by a cohort of nonexperts. The reliability of the HPR was not tested, but evidence for the validity of the tool was presented. Specifically, experts and novice clinicians thought the HPR provided a better set of metrics for measuring wound status and change over time, compared to the PUSH tool. Testing the reliability of this new instrument is warranted. n

Acknowledgment

The authors recognize Sunrise Hospital and Medical Center, Las Vegas, Nevada, as well as its parent corporation, HCA, Nashville, Tennessee, for providing time and resources to conduct this study. They also are grateful to Shelby Estocado and Amber Bennett for assisting with data organization and Healthlines Information Systems Corporation, Charlotte, North Carolina for providing the testing program software.

References

1. Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999;341(10):738-746. doi:10.1056/NEJM199909023411006.

2. Pieper B. Pressure Ulcers: Prevalence, Incidence and Implications for the Future. 2nd ed. Washington, DC: National Pressure Ulcer Advisory Panel; 2012.

3. Spetz J, Brown DS, Aydin C, Donaldson N. The value of reducing hospital-acquired pressure ulcer prevalence: an illustrative analysis. J Nurs Adm. 2013;43(4):235-241. doi:10.1097/NNA.0b013e3182895a3c.

4. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009;17(6):763-771. doi:10.1111/j.1524-475X.2009.00543.x.

5. Fletcher J. Wound assessment and the TIME framework. Br J Nurs. 2007;16(8):462-466. doi:10.12968/bjon.2007.16.8.23415.

6. Collier M. The elements of wound assessment. Nurs Times. 2003;99(13):48-49.

7. Fife CE, Yankowsky KW, Ayello EA, et al. Legal issues in the care of pressure ulcer patients: key concepts for healthcare providers — a consensus paper from the International Expert Wound Care Advisory Panel©. Adv Skin Wound Care. 2010;23(11):493-507. doi:10.1097/01.ASW.0000390494.20964.a5.

8. Vargo DM. Make sense of wound care billing: turn your cents into reimbursement dollars. J Wound Ostomy Continence Nurs. 2008;35(2):186-198. doi:10.1097/01.WON.0000313641.14376.fd.

9. Lyder CH, Ayello EA. Annual checkup: the CMS pressure ulcer present-on-admission indicator. Adv Skin Wound Care. 2009;22(10):476-484.

10. Young DL, Shen JJ, Estocado N, Landers MR. Financial impact of improved pressure ulcer staging in the acute hospital with use of a new tool, the NE1 Wound Assessment Tool. Adv Skin Wound Care. 2012;25(4):158-166. doi:10.1097/01.ASW.0000413597.20438.d2.

11. Gartlan J, Smith A, Clennett S, et al. An audit of the adequacy of acute wound care documentation of surgical inpatients. J Clin Nurs. 2010;19(15-16):2207-2214. doi:10.1111/j.1365-2702.2010.03265.x.

12. Maylor ME. Establishing nurses’ preferences in wound assessment: a concept evaluation. J Clin Nurs. 2006;15(4):444-450. doi:10.1111/j.1365-2702.2006.01310.x.

13. Hess CT. The art of skin and wound care documentation. Adv Skin Wound Care. 2005;18(1):43-53.

14. Greatrex-White S, Moxey H. Wound assessment tools and nurses’ needs: an evaluation study. Int Wound J. 2015;12(3):293-301. doi:10.1111/iwj.12100.

15. Woodbury MG, Houghton PE, Campbell KE, Keast DH. Pressure ulcer assessment instruments: a critical appraisal. Ostomy Wound Manage. 1999;45(5):42–55.

16. Bates-Jensen BM. The Pressure Sore Status Tool a few thousand assessments later. Adv Wound Care. 1997;10(5):65-73.

17. Jesada EC, Warren JI, Goodman D, et al. Staging and defining characteristics of pressure ulcers using photographs by staff nurses in acute care settings. J Wound Ostomy Continence Nurs. 2013;40(2):150-156. doi:10.1097/WON.0b013e31828093a4.

18. Mullins M, Thomason SS, Legro M. Monitoring pressure ulcer healing in persons with disabilities. Rehabil Nurs. 2005;30(3):92-99.

19. Thomas DR, Rodeheaver GT, Bartolucci AA, et al. Pressure Ulcer Scale for Healing: derivation and validation of the PUSH Tool: The PUSH Task Force. Adv Wound Care. 1997;10(5):96-101.

20. Thomas DR. Existing tools: are they meeting the challenges of pressure ulcer healing? Adv Wound Care. 1997;10(5):86-90.

21. Stotts NA, Rodeheaver GT, Thomas DR, et al. An instrument to measure healing in pressure ulcers: development and validation of the Pressure Ulcer Scale for Healing (PUSH). J Gerontol A Biol Sci Med Sci. 2001;56(12):M795-M799.

22. Gardner SE, Frantz RA, Bergquist S, Shin CD. A prospective study of the pressure ulcer scale for healing (PUSH). J Gerontol A Biol Sci Med Sci. 2005;60(1):93-97.

23. de Gouveia Santos VL, Sellmer D, Massulo MM. Inter rater reliability of Pressure Ulcer Scale for Healing (PUSH) in patients with chronic leg ulcers. Rev Lat Am Enfermagem. 2007;15(3):391-396.

24. Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised pressure injury staging system. National Pressure Ulcer Advisory Panel Pressure Injury Staging System. J Wound, Ostomy Continence Nurs. 2016;43(6):585-597. doi:10.1097/WON.0000000000000281.

25. Langemo D, Spahn J, Spahn T, Pinnamaneni VC. Comparison of standardized clinical evaluation of wounds using ruler length by width and Scout length by width measure and Scout perimeter trace. Adv Skin Wound Care. 2015;28(3):116-121. doi:10.1097/01.ASW.0000461117.90346.0d.

26. Langemo D, Spahn J, Snodgrass L. Accuracy and reproducibility of the Wound Shape Measuring and Monitoring System. Adv Skin Wound Care. 2015;28(7):317-323. doi:10.1097/01.ASW.0000465900.04721.18.

27. Bergquist-Beringer S, Davidson J, Agosto C, et al. Evaluation of the National Database of Nursing Quality Indicators (NDNQI) Training Program on pressure ulcers. J Continence Educ Nurs. 2009;40(6):252-260, 279.

28. Roberson S, Ayello EA, Levine J. Clarification of pressure ulcer staging in long-term care under MDS 2.0. Adv Skin Wound Care. 2010;23(5):206-210.

29. Levine JM, Roberson S, Ayello EA. Essentials of MDS 3.0 section M: skin conditions. Adv Skin Wound Care. 2010;23(6):273-284.

30. Ayello EA, Levine JM, Roberson S. CMS updates on MDS 3.0 section M: skin conditions-change in coding of blister pressure ulcers. Adv Skin Wound Care. 2010;23(9):394-397.

31. The Facts about Reverse Staging in 2000. The NPUAP Position Statement. 2000. Washington, DC: National Pressure Ulcer Advisory Panel;2000.

32. Young DL, Estocado N, Landers MR, Black J. A pilot study providing evidence for the validity of a new tool to improve assignment of national pressure ulcer advisory panel stage to pressure ulcers. Adv Skin Wound Care. 2011;24(4):168-175. doi:10.1097/01.ASW.0000396304.90710.ea.

33. Lilly D, Estocado N, Spencer-Smith JB, Englebright J. Validation of the NE1 wound assessment tool to improve staging of pressure ulcers on admission by registered nurses. J Nurs Meas. 2014;22(3):438-450.

34. Pedley GE. Comparison of pressure ulcer grading scales: A study of clinical utility and inter-rater reliability. Int J Nurs Stud. 2004;41(2):129-140.

35. Stausberg J, Lehmann N, Kröger K, Maier I, Niebel W.; Interdiscioplinary Decubitus Project. Reliability and validity of pressure ulcer diagnosis and grading: an image-based survey. Int J Nurs Stud. 2007;44(8):1316-1323. doi:10.1016/j.ijnurstu.2006.06.006.

36. Defloor T, Schoonhoven L. Inter-rater reliability of the EPUAP pressure ulcer classification system using photographs. J Clin Nurs. 2004;13(8):952-959.

37. Buckley KM, Tran BQ, Adelson LK, Agazio JG, Halstead L. The use of digital images in evaluating homecare nurses’ knowledge of wound assessment. J Wound, Ostomy Continence Nurs. 2005;32(5):307-316.

38. Lucas C, Classen J, Harrison D, De H. Pressure ulcer surface area measurement using instant full-scale photography and transparency tracings. Adv Skin Wound Care. 2002;15(1):17-23.

Potential Conflicts of Interest: Nancy Estocado is the president of N.E. Solutionz, LLC, Las Vegas, NV, which owns the NE1 Wound Assessment Tool. Sunrise Hospital and Medical Center in Las Vegas, NV, is part of the HCA Hospital Corporation in Nashville, TN.

Dr. Young is an Associate Professor, Department of Physical Therapy, School of Allied Health Sciences, University of Nevada, Las Vegas, NV. Ms. Estocado is a Program Supervisor/Rehab Therapy, Sunrise Hospital and Medical Center, Las Vegas. Dr. Feng is a Professor, School of Nursing, University of Nevada, Las Vegas. Dr. Black is an Associate Professor, College of Nursing - Omaha Division, University of Nebraska Medical Center, Omaha, NE. Please address correspondence to: Daniel L. Young, PT, DPT, PhD, Associate Professor, Department of Physical Therapy, School of Allied Health Sciences, University of Nevada, Las Vegas, 4505 S. Maryland Parkway, Box 453029, Las Vegas, NV 89154-3029; email: daniel.young@unlv.edu.

Section:

Volume 63 - Issue 9 - September 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(9):24–31 doi: 10.25270/owm.2017.09.2431

Bianca Augusta Pereira de Paula, RPh; Geisa Cristina da Silva Alves, MSc; Álvaro Percínio; Mariana Linhares Pereira, PhD; Juliano Teixeira Moraes, PhD; and Cristina Sanches, PhD

Topics:

observational study

Colostomy

Ileostomy

pharmacoepidemiology

patient safety

Abstract

Research on the use of medications in people with intestinal stomas is lacking, creating gaps in knowledge of pharmacoepidemiology in these patients. A cross-sectional, descriptive study was conducted over a period of 4 months in Divinópolis, Brazil to describe the profile of medication use among people enrolled in the Health Support Service for People with Stoma - Level II (SSPS II) of a municipality in the state of Minas Gerais, Brazil.

All patients from SSPS II with a colostomy or ileostomy were invited by phone to participate; those with incomplete registration data and/or who were <18 years old, hospitalized for any reason, or had their stoma reversed were excluded from participation. During home interviews, researchers obtained sociodemographic profiles (age, gender, education, occupation, and family income) and information on comorbidities, medication use, adherence to medication protocols (per the Morisky Green Levine test), polypharmacy, and adult/pharmaceutical care (medication description and indication, expiration date, self-medication). Drug storage was assessed by visual evaluation. The information was entered onto individual data sheets, numbered to ensure patient anonymity. The data then were entered into and analyzed using SSPS II statistical software using frequency measurements, measures of central tendency, and dispersion of demographic variables, health conditions, and medicine use. The study population included 59 persons (average age 66.9 ± 13.27 years), 36 (61.0%) women, 38 (64.4%) with an incomplete/primary level education, and 44 (74.5%) retired. Forty-nine (49) patients had a colostomy and 10 had an ileostomy; cancer was the main reason for stoma creation (61.1%). Half of the survey participants reported having 1 or 2 comorbidities (average 2.3); the most prevalent (52) was circulatory system disease among which hypertension (38, 64.4%) was most common. Analysis of the pharmacotherapeutic profile (prescribed and used) showed 89.8% of the study population used medication, and 52.8% were prescribed >5 medications (polypharmacy). Low and medium level adherence with prescriptions was noted (37.7%); 39.6% reported receiving no guidance on the use of the medication associated with their condition. Improper storage was observed in 33.9% of participants. In this population, persons with a stoma had complex pharmacotherapy, a high rate of polypharmacy, and deficiency in guidance on the use of medication. Further research into determining whether investments in both inclusion of a pharmacist on the team and more pharmacoepidemiological studies would improve patient care and medication safety in patients with a stoma is warranted.

An intestinal stoma is precipitated by or related to various underlying diseases, including agenesis and anorectal atresia, neoplasia, colorectal trauma, diverticular disease, inflammatory bowel disease, and fistulas.¹ In Brazil, colorectal cancer is the leading reason for stoma creation²; surgical resection of the affected site and creation of a permanent colostomy are considered the most effective approaches.³

Having a stoma typically does not involve the use of specific medications, but underlying or concomittant disease may require treatment involving medication.^4-6 The major consequence of extensive bowel resection is the loss of absorptive area; this may result in malabsorption of macro- and micronutrients, electrolytes, and water, which may interfere with the absorption of medications. Most macronutrient absorption occurs in the first 100 cm to 150 cm of the proximal intestines and specific micronutrients are absorbed in certain areas of the small intestine. Therefore, the length of the remaining intestine is a determining prognostic factor for ostomy patients.⁷

Absorption processes are related to the permeation of compounds through the biological membranes and are influenced by the physiochemical characteristics of both the large and small intestines. Thus, the anatomical and physiological parameters of the gastrointestinal tract drastically affect the speed and extent of oral drug absorption. For example, although the highest amount of absorption occurs in the duodenum and the proximal part of the jejunum, acidic drugs also are absorbed in the stomach, because the acidic pH hinders their dissociation, promoting their passive diffusion through the lipophilic portion of the membrane bilayer. An in vitro study⁸ has shown that commonly used drugs such as popranolol, acetaminophen, morphine, and hidrochlorothiazide drugs are absorbed mainly in the first part of the intestine.

Pharmacoepidemiology aims to study and describe the use of medication and its effect in a given population. It is extremely important to know the medication usage profile of the population in order to develop strategies aimed at optimal medication use.⁵ Pharmacoepidemiological data for ostomy patients are scarce. According to a descriptive study by Barbosa et al⁵ and an integrative review study by Luz et al,² medication, nutrient, and electrolyte absorption among this population may be compromised,^2,5 so gastroresistant medications and prolonged release of pharmaceutical substances can be affected by a decrease of the intestinal portion, leading to a reduction of the absorbed drug concentration and possible ineffectiveness of treatment.^5,9,10

Knowing the profile of medication use in these patients is essential to understanding the frequency and distribution of medication use (prescribed and over-the-counter) in this population and in consequently ensuring its effectiveness and correct use. The purpose of this cross-sectional study was to describe the medication profile of persons with an intestinal stoma.

Methods

Data were collected after institutional approvals authorized the research; permission from the Brazilian Ethics Committee was obtained through opinion no. 862,133 (CAAE: 37653514.4.0000.5545). The study respected the ethical precepts determined by the Brazilian ethical criteria in agreement with the Declaration of Helsinki. All participants in the study signed the Free and Informed Consent Term Form and anonymity was ensured.

The cross-sectional study was conducted at the Health Support Service for People with Stoma - Level II (SSPS II) of a municipality in the state of Minas Gerais, Brazil. This type of service encompasses a multidisciplinary team including a physician, nurse, social worker, psychologist, and nutritionist. This team provides specialized and interdisciplinary assistance to people with a stoma, including instruction in the care and use of ostomy collection devices, prevention and treatment of stoma complications, health care professional training, and ostomy supplies and adjuvant equipment.¹¹

All patients from SSPS II were eligible for the study. A total of 98 persons with a colostomy or ileostomy who were registered with the service were invited by phone call to participate via the local public health service. For sampling purposes, a 95% confidence interval, an error of 5%, and hypothetical population frequency of 90% were considered, with a sample of 59 ostomy patients being calculated (49 patients with colostomy and 10 patients with ileostomy). Persons with incomplete registration data, <18 years old, and/or who were hospitalized for any reason or who had their stoma reversed were not invited to participate.

Data were collected through home interviews set up by phone and conducted from February to May 2015. Trained interviewers administered the questionnaires. Sociodemographic variables (gender, age, marital status, education, occupation, family income) and health information (disease reported, medication use, and comorbidities) were collected. Family income was calculated using the Brazilian minimum wage of 2015 as a base (US $180/month). Information regarding patient history and health conditions, the type of stoma, the underlying disease requiring the creation of the stoma, and self-reported health status (classified according to the International Statistical Classification System of Diseases and Related Health Problems¹²) were extracted from medical records at SSPS II.

In addition, a questionnaire on adult/pharmaceutical care, developed and validated by Ribeiro et al¹³ was used to collect information on medications, including the medication description and indication, verification of its expiration date, and whether the medication was used without the indication of a health professional (self-medication). One (1) open-ended question was added to this questionnaire: “What disease led to making your stoma?”

To evaluate adherence to treatment, the Morisky Green Levine¹⁴ test was used in which the following questions were asked: 1) Do you sometimes have trouble remembering to take your medication? 2) Do you sometimes neglect to take your medicine? 3) When you are feeling better, do you sometimes stop taking your medicine? 4) Sometimes, if you feel worse while taking the medication, do you stop taking it? Questions had dichotomous answer categories (Yes or No); no was the expected answer for good adherence.

Patient prescription data from the past 3 months and medication packaging information was used to obtain a description of medication. This information was acquired during the home interviews. The medications used were classified according to Anatomical-Therapeutic-Chemical (ATC) Classification System¹⁵ levels: the first level included medications for a main anatomical group (eg, for the alimentary tract or for metabolism) and the second level addressed therapeutic subgroups, such as drug use in diabetes.

Polypharmacy was evaluated and defined as 5 or more different medications in continuous use.¹⁶ Medications were acquired through public and private pharmacies of the public pharmacy program of Brazil; other means of access such as neighborhood and donation also were identified as well as whether a medication was included in the Municipal Register of Medicinal Products 2015 (REMUME - 2015) of Divinópolis, Minas Gerais.

Drug storage was assessed by evaluating room of storage and whether the primary package (box) or secondary pack (blister) was intact. Researchers recorded their observations as 1) medication stored in the package (blister and box) in the bedroom or in the living room; 2) medication stored in the package (blister) in the bedroom or in the living room; 3) medication stored in the package (blister and box) in the kitchen (on top of the refrigerator or cabinet); 4) medication stored only in the blister pack in the kitchen (on top of the refrigerator or cabinet); or 5) medication stored outside the package (blister) in a container. Items 3, 4, and 5 were considered inadequate storage because medication stored out of the blister package or in the kitchen (a humid and warm place) can be compromised.

To evaluate the perception of the instruction received by the patient on the use of their medication, each patient answered an 8-item questionnaire created by the researchers related to guidance on the use of medications as presented in the adult pharmaceutical care survey.¹³ Yes responses = 1 point, No responses = 0 (see Figure 1). A final score <3 was considered unsatisfactory guidance, between 3 and 6 satisfactory guidance, and >6 excellent guidance.

Data collection and analyses. Data were initially collected on an individual spreadsheet for each patient and subsequently collated into an Excel (Microsoft Corp, Redmond, WA) spreadsheet that included all patients, which was entered into SPSS, version 19 (SPSS Inc, Chicago, IL). Descriptive data were analyzed using frequency measurements, measurements of central tendency, and dispersion of the demographic variables, health conditions, and use of medications. Subsequently, bivariate analysis was performed to compare patients who reported receiving guidance to those who did not receive guidance on the use of their medication for the following characteristics; information compared included demographic and socioeconomic data, type of stoma, polypharmacy, and adherence to treatment. For these analyses, data from 6 patients who did not use medication were excluded.

Results

From a total of 98 persons with a colostomy or ileostomy registered at SSPS II and eligible to the study, 59 participants were included: 38 (61%) women, mean age 66.9 ± 13 years (range 40–96 years), of whom 49 (83.05%) were colostomy patients and 10 (16.95%) were ileostomy patients. The majority of participants (39, 66.10%) were >60 years of age, with an incomplete primary education (29, 49.15%) and an income ranging from 2 to 3 minimum salaries (42, 71.19%) (see Table 1).

The 59 participants reported a total of 135 diseases and health problems, with an average of 2.3 health conditions/patient (range 0–6); these included predominantly circulatory diseases (52, 88.13%) and nutritional and metabolic endocrine disorders (30, 50.84%) (see Table 2). Specific health problems included hypertension (38, 64.41%) and cardiac and coronary insufficiency (14, 23.71%) as part of 52 circulatory diseases, cancer (13, 22.03%), and depression (13, 22.03%).

In the majority of cases, stoma construction was due to malignant neoplasm of the digestive organs (36, 61.01%), unspecified malignant neoplasms (5, 8.47%), and other digestive diseases such as diverticulitis, obstruction, and intestinal polyp (8, 13.55%).

Of the 59 participants, 6 (10.16%) reported not using any medication (see Table 3); 53 patients used a total of 254 medications, averaging 4.3 ± 3 medications/patient (range 0–11). From patients who used medication, 29 (54.71%) were classified as utilizing polypharmacy (range 5–11 medications).The largest number of registered medications among patients taking any medication according to the first level of ATC were for cardiovascular system indications (95), followed by nervous system (64) and food and metabolic tract (55). For the second level of ATC, 29 (54.71%) were diuretics, 23 (43.39%) were agents acting on the renin-angiotensin system, 17 (32.07%) were psychoanaleptics, and 16 (30.18%) were medications for digestive disorders (see Table 4).

A medical professional was found to have recently prescribed 96.46% of the medications; 3.54% of medications were reported as self-medication or taken at the suggestion of a friend, relative, or neighbor. Of the 254 medications used, 87 (34.25%) were acquired from a municipal public pharmacy, 136 (53.54%) from retail chain pharmacies, 18 (7.09%) from the popular pharmacy program, and 13 (5.12%) from other unspecified places. Among the medications used, 61.81% appear in the Municipal Register of Medications (REMUME).

Twenty (20, 33.9%) participants improperly stored medications and 7 (11.86%) did not check the expiration date of the drugs.

Of the 53 patients using medications, 16 (30.19%) needed help taking them and 20 (37.73 %) had low or average adherence as indicated by the Morisky Green Levine test. Nine (9, 16.98%) participants reported discontinuing use of 42 medications. Twenty-one (21, 39.62%) said they had not received guidance from any health professional on the use of their medication. Of those who reported receiving some guidance (32), 2 (6.25%) received unsatisfactory guidance, 25 (78.13%) satisfactory guidance, and 5 (15.62%) excellent guidance.

Discussion

In international studies, the incidence of intestinal stomas is reported to be higher in men than in women.^17,18 In Brazil, as in this study, more women had a stoma.^19,20 This may be explained by the fact that Brazilian women seek health services more often than men and/or have a higher rate of colorectal cancer.²¹

Increasing age is a factor in the oncogenic process owing to increased exposure to risk factors over the years. Consequently, the number of ostomy patients increases in this population according to descriptive study by Da Paz et al.²² In addition, a descriptive study by Skeps et al²³(2012) has shown health professionals must understand the implications of age-related changes for persons with a stoma and how they can affect their self-care.

International, demographic, and cross-sectional multicenter studies^18,24 conducted in developed countries reveal a population with a high school education. According to a review,²⁵ the illiteracy rate is high (51.6%) in Brazil, especially among the elderly who had no access to school.

The population of Brazilian patients with a stoma includes the most vulnerable economic classes, with family incomes below 3 minimum salaries (<$540 US) and dependent on public health services, which are precarious in the country.²⁶ Pharmacoepidemiological demographic and descriptive studies of persons with a stoma that include a comorbidity profile are scarce.⁵ A pharmacoepidemiological study²⁷ among persons with a stoma that includes a comorbidity profile showed from 0 to 8 comorbidities, with a high prevalence of cardiovascular, gastrointestinal, endocrine, and neoplastic diseases — conditions commonly found in the elderly. Therefore, in most cases having a stoma does not necessarily imply a limiting condition or poorer quality of health than the general population.

In their qualitative research, Barros et al²⁸ and Silveira et al²⁹ showed chronic degenerative diseases were predominantly found in older populations, making this age group more dependent on health services. Barros et al²⁸ found the elderly with a stoma generally have more difficulties implementing daily care when compared to younger people and often depend on the care provided by other persons or professionals. The health care of this population should focus on disease specificity, the complication risks, and how to live with an ostomy. As such, the current authors believe training of care professionals must be continuous and policies that stimulate their implementation of good practice must be in place.

Polypharmacy and lack of a pharmacist. Chronic degenerative diseases are the factors most associated with polypharmacy.²⁹ Descriptive studies^30,31 conducted in different regions of Brazil among patients with chronic degenerative diseases found an average use of 3.6 to 4.67 medications per patient. Polypharmacy also was noted in the study population and contributes to the use of inappropriate and nonessential medication for treatment, which increases the risk of adverse reactions.²⁹ In this study, according to the ATC classification level, persons with a stoma had a medication profile similar to that of the elderly population in general; the most commonly used drugs are agents acting on the renin-angiotensin system, diuretics, calcium channel blockers, psychoanaleptics, and drugs used for diabetes and digestive disorders.^31,32

Although the stoma does not typically require use of specific medications, patients will need to use medication for their comorbidities.⁴ As such, the potential contribution of a pharmacist on a health team should be a considered.^32,33 Without proper guidance and monitoring by a professional, intestinal motility, for example, can be affected by medication and interfere with the absorption, effectiveness, and safety of other drugs used concomitantly^1,6,34; a pharmacist can provide recommendations on sustained-release medications as well as gastroresistant forms or coated tablets in capsules that can prevent release of the active ingredient at the gastric level in persons with a stoma and advise patients on the use of liquid forms, gelatin capsules, and noncoated tablets.^1,4

In this study, the medications used were acquired from retail chain pharmacies, even though 61.81% of the medications referred belong to REMUME. Study data revealed medication is not available through the municipal public health system. One of the factors contributing to this access deficit may be related to the fact that the actions of the pharmacist in drugstores, pharmacies, and basic health units in Brazil are focused on administrative and logistic activities instead of patient care.^8,35

Storage. The correct storage of drugs was also a potential problem found among the study population. Proper use of a drug begins with the condition of the product administered; an epidemiological study³⁶ found some people do not observe the drug’s expiration date. Maintaining the quality of the medication, which includes proper storage, is fundamental for maintaining drug effectiveness, and recommended measures always should be taken related to medicine care and stability, along with the dose.^36,37

Adherence to treatment. Adherence to treatment was another important factor and current study results corroborated a descriptive study³⁸ conducted among elderly persons with a stoma in which 35.4% were nonadherent to treatment. However, it should be noted that a previous descriptive study¹⁴ that used the Morisky Green Levine methodology showed lower scores in identifying low adherence to treatment compared to other methods. As such, reported nonadherence to treatment may be related to the use of a particular questionnaire and whether the interviewer had an expected response bias. Other adherence measurement options such as pill count or therapeutic drug monitoring were not available.

It is worth remembering that treatment adherence is a factor of the guidance received. Potential and urgent problems can arise when the patient does not accept or refuses to follow the treatment regimen. A descriptive study by Oenning et al³⁹ has shown this directly impacts patient safety because the correct medication and its proper administration is a strategic component in the treatment and maintenance of improved quality of life.

From 70% to 98% of patients reported receiving guidance on how to use their medication during their consultation or while the medication was dispensed. Because a method developed in this study to assess the use of medication is a new score created to assess self-reported guidance (see Figure 1), further studies are needed to evaluate the efficacy and reproducibility of the method.

Among patients in the current study who reported receiving (60.4%) and not receiving some guidance (39.6 %), 37% were elderly and 22% had not completed their elementary school education or were illiterate. Therefore, these data must be interpreted with caution because level of education and age could interfere with understanding and processing the instructions received. Information from health professionals promotes the appropriate use of medication, ensuring patient safety. Studies^32,39 have shown providing professional guidance is a simple, low-cost strategy for the health system. The level of education is a determining factor in adherence to pharmacological treatment; according to a review study in Ireland,⁴⁰data demonstrating a low level of education can contribute to an insufficient degree of adherence with treatment.

Limitations

Among the limiting factors of this research is that data collection did not include documentation of adverse drug events or efficacy. Results also are limited by the evaluation of self-reported patient perceptions and to this specific demographic and/or potential sampling limitations.

Conclusion

Ostomy patients in this study presented with complex pharmacotherapy needs, a high incidence of polypharmacy, and less-than-satisfactory guidance on medication use. The study population also presented a morbidity and medication use profile similar to that found in elderly persons without an intestinal stoma. Thus, it is of extreme importance to include a pharmaceutical professional on the interdisciplinary health team to guide and monitor the patient with an ostomy. Additional pharmacoepidemiological studies involving patients with a stoma would shed additional light on this concern and facilitate the development of health care guidance documents and recommendations. n

References

1. Rocha JJR. Estomias intestinais - (ileostomias e colostomias) e anastomoses intestinais. Medicina (Ribeirão Preto). 2011;44(1):51–56.

2. Luz ALA, Luz MHBA, Antunes A, Oliveira GS, Andrade EMLR, Miranda SM. Perfil de pacientes estomizados: revisão integrativa da literatura. Cultura de los Cuidados. 2014;18(39):115–123. .doi.org/10.7184/cuid.2014.39.13.

3. Vieira LM, Ribeiro BNO, Gatti MAN, Simeão SFAP, Conti MHS, Vitta A. Câncer colorretal: entre o sofrimento e o repensar na vida. Saúde Debate. 2013;37(97):261–269.

4. Santos VLCG, Cesaretti IUR. Assistência em Estomaterapia — Cuidando de Pessoas com Estomia, 2nd ed. Rio de Janeiro, Brazil: Atheneu;2015.

5. Barbosa MH, Poggetto MT, Barichello E, et al. Aspectos clínicos e epidemiológicos de estomizados intestinais de um município de minas gerais. REAS. 2014;3(1):64–73.

6. Williams D. Monitoring medicines use: the role of the clinical pharmacologist. Br J Clin Pharmacol. 2012;74(4):685–690.

7. Seetharam P, Rodrigues G. Short bowel syndrome: a review of management options. SaudiJ Gastroenterol. 2011;17(4):229–235.

8. Souza J, Freitas ZMF, Storpirtis S. Modelos in vitro para determinação da absorção de fármacos e previsão da relação dissolução/absorção. Brazil J Pharmaceut Sci. 2007;43(4):515–527.

9. Silva LD, Lisboa CD. Consequências da interação entre nutrição enteral e fármacos administrados por sondas: uma revisão integrativa. Cogitare Enfermagem. 2011;16(1):134–140.

10. Pereira APS, Cesarino CB, Martins MRI, Pinto MH, Netinho JG. Associação dos fatores sociodemográficos e clínicos à qualidade de vida dos estomizados. Rev Latino-Am Enfermagem. 2012;20(1):[08 telas].

11. Secretaria de Assistência a Saúde (Brasil). Portaria n.400 de 16 de novembro de 2009. Brasilia, Distrito Federal, Brazil;2009.

12. Organização Mundial da Saúde. Classificação estatística internacional de doenças e problemas relacionados a saúde, 10 a revisão. São Paulo: Centro Colaborador da OMS para Classificação de Doenças em Português; 2010. Available at: http://apps.who.int/classifications/icd10/browsw/2010/en. Accessed November 8, 2016.

13. Ribeiro AQ, Rozenfeld S, Klein CH, César CC, Acurcio FA. Survey on medicine use by elderly retirees in Belo Horizonte, Southeastern Brazil. Rev Saúde Pública. 2008;42(4):724–732.

14. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care.1986;24(1):67–74.

15. World Health Organization. Collaborating Centre for Drug Statistics Methodologhy. Guideline for ATC classification end DDD assignment. 2015. Oslo, Norway 2014. Available at: www.whocc.no/filearchive/publications/2016_guidelines_web.pdf. Accessed November 8, 2015.

16. Galato D, Silva ES, Tuburcio LS. Estudo de utilização de medicamentos em idosos residentes em uma cidade do sul de Santa Catarina (Brasil): um olhar sobre a polimedicação. Ciênc Saúde Coletiva. 2010;15(6):2899–2905.

17. Kenderian S, Stephens EK, Jatoi A. Ostomies in rectal cancer patients: what is their psychosocial impact? Eur J Cancer Care. 2014;23(3):328–332.

18. Jansen F, van Uden-Kraan CF, Braakman JA, van Keizerswaard PM, Witte BI, Verdonck-de Leeuw IM. A mixed-method study on the generic and ostomy-specific quality of life of cancer and non-cancer ostomy patients. Support Care Cancer. 2015;23(6):1689–1697.

19. Melotti LF, Bueno IM, Silveira GV, Silva MEN, Elenir-Fedosse E. Characterization of patients with ostomy treated at a public municipal and regional reference center. J Coloproctol. 2013;33(2):70–74.

20. Fernandes RM, Miguir ELB, Donoso TV. Perfil da clientela estomizada residente no município de Ponte Nova, Minas Gerais, Brasil. Rev Bras Coloproctol. 2011;30(4):385–392.

21. Ramos RS, Barros MD, Moura MS, Gawryszewiski ARB, Gomes AMT. O perfil dos pacientes estomizados com diagnóstico primário de câncer de reto em acompanhamento em programa de reabilitação. Cad Saúde Cole.2012;20(3):280–286.

22. Da Paz RC, Fortes RC, Toscano BAF. Processo de envelhecimento e câncer: métodos subjetivos de avaliação do estado nutricional em idosos oncológicos. Com Ciências Saúde. 2011;22(2):143–156.

23. Skeps R, McMullen CK, Wendel CS, et al. Changes in body mass index and stoma related problems in the elderly. J Geriatric Oncol. 2013;4(1):84–89.

24. Canova C, Giorato E, Roveron G, TurrinI P, Zanotti R. Validation of a stoma-specific quality of life questionnaire in a sample of patients with colostomy or ileostomy. Colorect Dis. 2013;15(11):e692–e698.

25. Santos LTM, Mansur HN, Paiva TFPS, Colugnati FAB, Bastos MG. Letramento em saúde: importância da avaliação em nefrologia. J Bras Nefrol. 2012;34(3):293–302.

26. Wilson IM, Lennon S, McCrum-Gardner E, Kerr DP. Factors that influence low back pain in people with a stoma. Disabil Rehabil. 2012;34(6):522–530.

27. Fattori A, Oliveira IM, Alves RMAA, Guariento ME. Cluster analysis to identify elderly people’s profiles: a healthcare strategy based on frailty characteristics. Sao Paulo Med J. 2014;132(4):224–230.

28. Barros EJL, Santos SSC, Gomes GC, Erdmann AL. Gerontotecnologia educativa voltada ao idoso estomizado à luz da complexidade. Rev Gaúcha Enferm. 2012;33(2):95–101.

29. Silveira EA, Dalastra L, Pagotto V. Polifarmácia, doenças crônicas e marcadores nutricionais em idosos. Rev Bras Epidemiol. 2014;17(4):818–829.

30. Ribas C, Oliveira KR. Perfil dos medicamentos prescritos para idosos em uma Unidade Básica de Saúde do município de Ijuí-RS. Rev Bras Geriatr Gerontol. 2014;17(1):99–114.

31. Santos TRA, Lima DM, Nakatani AYK, Pereira LV, Leal GS, Amaral RG. Consumo de medicamentos por idosos, Goiânia, Brasil. Rev Saúde Pública, São Paulo. 2013;47(1):94–103.

32. João WSJ. Reflexões sobre o Uso Racional de Medicamentos. Pharmacia Brasileira. 2010;78:15–16.

33. Carvalho MFC, Romano-Lieber NS, Bergsten-Mendes G, et al. Polifarmácia entre idosos do Município de São Paulo - Estudo SABE. Rev Bras Epidemiol. 2012;15(4):817–827.

34. Cuentro VS, Andrade MA, Gerlack LF, Bós AJG, Silva MVS, Oliveira AF. Prescrições medicamentosas de pacientes atendidos no ambulatório de geriatria de um hospital universitário: estudo transversal descritivo. Ciênc Saúde Coletiva. 2014;19(8):3355–3364.

35. Pereira LRL, Freitas O. A evolução da Atenção Farmacêutica e a perspectiva para o Brasil. Rev Bras Cienc Farm. 2008;44(4):601–612.

36. Bastos-Barbosa RG, Ferriolli E, Moriguti JC, et al. Adesão ao tratamento e controle da pressão arterial em idosos com hipertensão. Arq Bras Cardiol. 2012;99(1):636–641.

37. Schmitt AA Jr, Lindner S, Helena ETS. Avaliação da adesão terapêutica em idosos atendidos na atenção primária. Rev Assoc Med Bras. 2013;59(6):614–621.

38. Ben AJ, Neumann CR, Mengue SS. Teste de Morisky-Green e Brief Medication Questionnaire para avaliar adesão a medicamentos. Rev Saúde Pública [Internet]. 2012;46(2):279–289.

39 Oenning D, Oliveira BV, Blatt CR. Conhecimento dos pacientes sobre os medicamentos prescritos após consulta médica e dispensação. Ciênc Saúde Coletiva. 2011;16(7):3277–3283.

40. Williams D. Monitoring medicines use: the role of the clinical pharmacologist. Br J Clin Pharmacol. 2012;74(4):685–690.

Potential Conflicts of Interest: none disclosed

Ms. Pereira de Paula is a clinical pharmacist; Ms. da Silva Alves is a nurse; Mr. Percinio is a medical student; and Dr. Pereira, Dr. Moraes, and Dr. Sanches are adjunct professors, Federal University of São João Del Rei, Bairro Chanadour, Divinópolis, Brazil. Please address correspondence to: Geisa Cristina da Silva Alves, Federal University of São João Del Rei – Rua Sebastião Gonçalves Coelho, 400 – Bairro Chanadour, Divinópolis, Brazil; email: geisa.cristina@gmail.com.

Section:

Issue Number:

Index:

Ostomy Wound Management 2017;63(10):16–33 doi: 10.25270/owm.2017.1633

Christina N. Parker, RN, PhD; Kathleen J. Finlayson, PhD; and Helen E. Edwards, PhD

Topics:

Risk Assessment

Venous Ulcer

healing

recurrence

reliability

Abstract

Venous leg ulcers are characterized by a long healing process and repeated cycles of ulceration. A secondary analysis of data from multisite longitudinal studies was conducted to identify risk factors for delayed healing and recurrence of venous leg ulcers for development of risk assessment tools, and a single-site prospective study was performed to assess the new tools’ interrater reliability (IRR).

The development of the risk assessment tools was based on results from previous multivariate analyses combined with further risk factors documented in the literature from systematic reviews, randomized controlled trials, and cohort studies with regard to delayed healing and recurrence. The delayed healing tool contained 10 items, including patient demographics, living status, use of high-compression therapy, ulcer area, wound bed tissue type, and percent reduction in ulcer area after 2 weeks. The recurrence tool included 8 items, including history of deep vein thrombosis, duration of previous ulcer, history of previous ulcers, body mass index, living alone, leg elevation, walking, and compression. Using consensus procedures, content validity was established by an advisory group of 21 expert multidisciplinary clinicians and researchers. To determine intraclass correlation (ICC) and IRR, 3 raters assessed 26 patients with an open ulcer and 22 with a healed ulcer. IRR analysis indicated statistically significant agreement for the delayed healing tool (ICC 0.84; 95% confidence interval [CI], 0.70-0.92; P<.001) and the recurrence tool (ICC 0.88; 95% CI, 0.75-0.94; P<.001). The development and reliability results of these risk assessment tools meet the recommendations for evidence-based, reliable tools and may benefit clinicians and patients in the management of venous leg ulcers. Studies to examine the items with low ICC scores and to determine the predictive validity of these tools are warranted.

Although approximately 70% of venous ulcers heal within a 24-week period, 30% are unhealed after this time.¹ Venous leg ulcers are characterized by repeated cycles of ulceration and recur in 60% to 70% of patients.² The highest rates of recurrence occur within the first 3 months after healing.^3,4 Although the majority of venous leg ulcers recur within 12 months,^2,5 these recurrences often occur over decades.⁶

Comparing studies in the literature on recurrence is difficult due to a lack of a clear or consistent definition of recurrence. However, ongoing monitoring is essential after healing because the underlying venous disease remains.⁷ In a randomized controlled trial⁸ (N = 500) and a case series⁹ with long-term follow-up (N = 97 legs), episodes of recurrence decreased in patients who had undergone surgery for superficial venous reflux and/or perforator surgery in addition to wearing compression. However, surgery is not always an option for patients, particularly in this population where age and comorbidities restrict many patients’ suitability for surgery or where acceptance of surgery may be an issue.⁸ The long-term and often frequent recurrent nature of the ulcers can lead to uncertainty,¹⁰ disappointment, hopelessness, and worry among patients that fear they may never be free of the condition.¹¹ A large obstacle in the treatment of chronic venous leg ulcers is estimating long-term clinical outcomes. Although tools have been developed to assess the severity of a wound and healing progress,^12-17 few are specifically for patients with venous leg ulcers that are appropriate for clinicians to assess the risk for delayed healing outcomes, and none were found in the literature with regard to venous leg ulcer recurrence.

Currently, clinician observation indicates practitioners generally utilize their own expert judgment and previous experience to determine whether a wound will be difficult to heal, or once healed, whether it will recur. Five (5) risk assessment tools for delayed healing of venous leg ulcers have been discussed in the literature^18-22 and at least 1 has been used in research studies,^23,24 but none appear to be widely used in clinical settings to assist the clinician in detecting delayed healing in order to guide appropriate wound management. Skene et al²⁰ concluded from a secondary analysis of 200 participants, where 49% of ulcers healed within 4 months, that the risk factors ulcer area (P<.001), longer duration (P<.001), increased age (P = .002), and deep vein involvement shown on photoplethysmography (P = .006) were significantly related to nonhealing. From these risk factors, a prognostic index was developed to indicate nonhealing within 4 months. Margolis et al²² concluded from a retrospective cohort study of 260 participants, where 56% to 65% of leg ulcers healed within 24 weeks, that the risk factors wound area and wound duration were significantly related to nonhealing; the authors devised a simple prediction rule that was retrospectively and prospectively validated in participants with multilayered limb compression therapy.

Taylor et al²¹ concluded from a retrospective cohort study of 325 participants in which 78.6% healed by 24 weeks that the risk factors age, ulcer area, gender, and history of a previous leg ulcer were significantly related to nonhealing; from these findings, a complex prognostic index equation was developed and retrospectively validated. Falanga et al¹⁹ concluded from a prospective, randomized controlled trial of 177 participants, where 65% of venous ulcers healed within 12 months, that a previous wound bed score based on wound bed appearance, wound exudate, wound duration, and surrounding skin also could be used to predict wound closure. Kulkarni et al¹⁸ utilized a randomized controlled trial of 229 participants to determine that the risk factors age, ulcer duration, and venous refill time were significantly related to nonhealing at 24 weeks; they developed an equation based on these factors that was validated in 86 participants, again only in those using high-level compression. Although a few of these tools have been validated, there is no evidence of reliability testing.

These tools may be in limited use because 2 of the tools utilized variables¹⁹ and equations²¹ that would be difficult for many health care professionals to calculate and evaluate without significant time and education. Two (2) other tools used photoplethysmography to determine deep vein involvement²⁰ and venous refill time,¹⁸ a test that is mostly beyond the scope of many primary health wound clinics, severely limiting the everyday usability by many clinicians. However, these studies devised scoring systems that identified significant risk factors from their own research or had previously been shown to be significant predictors in the literature. Wound duration was used in 4 of the 5 tools and patient age and wound area in 3 of the 5 tools. Most of these tools have utilized only ulcer-specific variables without consideration of other holistic factors that may influence healing. Identifying a broader range of other potential risk factors could be of assistance in strengthening a tool for use by all clinicians in all settings to improve the ability to predict healing.

Delayed healing and ulcer recurrence are challenges for all practitioners involved in venous leg ulcer management. The lack of risk assessment tools may contribute to the current high levels of health service use for leg ulcers, which has been estimated in a retrospective study²⁵ of 104 participants to include a median of 3 different health disciplines (range 1–8) in the 12 months before admission to a wound specialist clinic. This also may contribute to poor rates of wound healing, because 46% of participants attending a specialist wound clinic were noted to have a wound duration of >6 months and 17% for a year or longer on admission.²⁵ It previously has been identified that any prognostic tool should include clinically relevant patient data that have been tested for inclusion in a risk assessment tool,²⁶ ensure it is easy to calculate the risk assessment score with a small number of items, and not require specialist assessment technology or skills.²⁷ A tool should be able to be used in a timely way to generate a prediction and guide decisions,²⁶ be reliable, and not require undue resources/expense.^26,27

The development of venous leg ulcer risk assessment tools for delayed healing and recurrence would be beneficial for clinicians to be able to determine realistic outcomes for their patients and make decisions on adjunctive interventions when standard care may be insufficient to achieve or maintain healing.²⁸ Health care professionals are under increasing pressure to justify their actions in terms of cost-effectiveness and clinical outcomes²⁹; thus, a risk factor profile could be helpful. In addition, a venous ulcer healing predictor also could be of benefit to a health care system, which requires information on the burden of care in order to make decisions on the needs of the population and the allocation of appropriate resources.²⁸

As such, this study aimed to develop tools for predicting the likelihood of delayed healing and recurrence of venous leg ulcers and to assess interrater reliability (IRR) of the tools.

Methods

Developing the risk assessment tools. Previously documented methods for development of a risk assessment tool were utilized^18,30,31 and included the results of a literature review on risk factors,³² results of analyses on significant predictors of failure to heal or recurrence from previous studies by the authors,^33,34 and content validation by consensus of an expert interdisciplinary Wound Advisory Group (WAG).^35,36

The WAG was formed to determine face validity³⁷ and assess content validity, as well as to provide expert guidance on the development and testing of the new tools. The development of the risk assessment tool was based on previous multivariate analysis.^33,34 Further to this, significant risk factors documented in the literature from systematic reviews, randomized controlled trials, and cohort studies were discussed among the group such as those included in a narrative review published in 2015 of 27 studies.³² The group included 21 multidisciplinary clinicians and researchers from different clinical and organizational settings who had specialist knowledge and expertise in wound healing and/or research and instrument development. The national and international wound care specialists included 3 community nursing managers, 2 nurse practitioners in wound care, 1 clinical nurse consultant, 1 clinical nurse, 4 nurse researchers, 2 podiatrists, 1 dietitian, 1 community care advisor, 2 medical practitioners, and 4 professors in nursing, exercise, and nutrition sciences with many years of combined wound care and research experience. This group also included 5 representatives from a national wound care professional association.

The WAG reviewed and discussed the proposed tools’ content and scoring. Responses of the WAG were not quantified; their consensus was obtained by agreement of all the WAG of variables included for content validity.³⁵ It was important to keep the tools simple for use across a variety of settings and to keep the risk assessment tool items to a minimum. As a side note, a “tool within a tool” (eg, a depression screening tool within a risk assessment tool), was deemed not appropriate by the WAG; therefore, it was not included in the final version of the risk assessment tools. However, single-item components of the Pressure Ulcer Scale for Healing (PUSH)³⁸ were included in the final tool. Consensus was reached that all suitable evidence-based items were included and that the response options were appropriate.

Point values for the items in the risk assessment tools identified from the multivariate analyses^33,34were determined utilizing the regression coefficients (β) of significant independent risk factors from the multivariate modeling.²⁷ To ensure a simplified prediction rule and easy computing, the regression coefficients (β) were rounded to the nearest whole number for item point values. Points for additional items were determined by published literature and the WAG. One point was given for any item without published effect size or coefficients.

IRR of the risk assessment tools. IRR was tested using intraclass correlation (ICC) analysis to compare the ratings of 1 nurse practitioner and 2 registered nurses for all items in the risk assessment tool. IRR was computed by comparing the risk assessment tool ratings made by each of the raters when using the risk assessment tool independently (without observation of each other) during the same clinical consultation visit of each patient in the sample. These 3 raters had between 5 and 15 years of clinical and/or research experience with chronic wounds. To avoid unnecessary physical and mental trauma to the patients who participated, only 1 rater performed an ulcer area tracing on each participant utilizing an acetate film tracing; the same rater performed all the tracings . This tracing then was retraced and the area measured and calculated using the Visitrak^™ pen planimetry system (Smith and Nephew, North Ryde, New South Wales, Australia) by an additional 2 raters independently. Rater reliability regarding area tracing was assessed utilizing an acetate grid by the same 3 raters on 7 ulcers on a training model, and ICCs were calculated for these assessments.

Sample for IRR. A power analysis determined the required sample for IRR was 30 participants, to be assessed by 3 raters. Sample size calculation was based on 80% power to detect an ICC of 0.8 when the ICC under the null hypothesis is 0.6 using an F-test with a significance level of 0.05.

Patient inclusion/exclusion criteria.

Inclusion criteria. Inclusion criteria stipulated patients must have leg ulcers of primarily venous etiology (defined as a loss of skin on the leg or foot that had been diagnosed as predominantly venous) as diagnosed by the clinician in charge of care (for the risk assessment tool for delayed healing); or a recently healed (within 4 weeks) leg ulcer of primarily venous etiology as diagnosed by the clinician in charge of care (for the risk assessment tool for recurrence), along with an ankle brachial pressure index ≥0.8 and <1.3 in the affected leg. A wound was considered healed when 100% epithelialization of the wound bed was achieved and maintained for at least 2 weeks. A recurrence of a venous leg ulcer was defined as a wound of venous etiology that had recurred on the same leg that had previously been affected by a venous leg ulcer.

Exclusion criteria. Patients with a cognitive impairment, as diagnosed by the clinician assessing the patient, or ulcers with malignancy present were excluded.

The participants were recruited from a community wound healing service where the 3 raters were all available to attend the necessary visits. All consecutive patients who met the inclusion/exclusion criteria were approached for inclusion in the IRR testing of the risk assessment tool between July 2012 and August 2014.

Data collection and assessment.

IRR. Data were collected during a participant’s wound treatment clinic visit. Health and medical history questions were first collected from clinical records; if these data were not able to be determined from clinical records, the raters queried the participant directly. Clinical examination and answers to social and preventive strategy questions were collected directly from the patients. For the delayed healing study, the clinician in the clinic removed the participant’s dressings and washed the affected area for participants with open leg ulcers, after which each risk assessment was performed independently at the same clinical consultation visit by 1 nurse practitioner and 2 registered nurses serving as raters. Due to clinic activities and the ability of the raters to attend the clinic at certain times, the raters maintained no consistent or specific order for assessment completion. The risk assessment tools were completed during or immediately following each visit, generating 3 sets of scores for each patient. If physical or emotional discomfort was evident at any point in the study process, the data collection was discontinued.

Data analyses.

IRR. Data on both risk assessment tools were analyzed using the Statistical Package for the Social Sciences (SPSS for Windows, version 19.0; IBM Corp, Armonk, NY) software. The 3 raters for both tools all had been involved in the development of the tools and required no further training on their use. The raters were requested not to exchange information on the variables associated with the risk assessment tools.

ICC. ICC provides a measure of reliability, indicating whether an assessment tool can be used effectively by a variety of health professionals³⁹ by analyzing the degree of concordance or the consistency of the performance of 2 or more observers recording the same responses on the risk assessment tool at the same visit.⁴⁰ ICC is the standard statistical method for assessing the agreement between 2 or more raters³⁹ and is a measure of the proportion of variance that is attributable to the objects of measurement,⁴¹ indicating the degree of agreement between raters. ICC coefficients are categorized between 0 and 1, with 1 indicating total agreement, 0.61 to 0.80 indicating good strength of agreement, and 0.81 to 0.99 indicating very good agreement.^40,42 A 1-way random effect analysis of variance model was used where raters were considered random, the risk assessment variables fixed, and confidence intervals (CI) were calculated. ICCs were calculated as average measures because the variables used were average observations of several single observations. A P value <.05 was used to identify statistical significance.

Ethical considerations. This study gained ethical approval from the University Human Research Ethics Committee. All participants were provided with an information package and all participants gave written informed consent.

Results

Development of risk assessment tools. Risk factors for failure to heal and for recurrence were based on results from previous studies by this team using multivariate modeling^33,34 in addition to risk factors documented in the literature from systematic reviews, randomized controlled trials, and cohort studies. Risk factors independently and significantly associated with failure to heal a venous leg ulcer by 24 weeks in a previous study³³ by this team were patients who lived alone, were not treated with high-level (ie, >30 mm Hg) compression therapy at enrollment to the study, had higher ulcer severity scores (PUSH) at enrollment, and had <25% reduction in ulcer area 2 weeks after initial assessment. Risk factors significantly associated with recurrence of a venous leg ulcer within 12 months after healing in a previous study by this team included history of deep vein thrombosis (DVT), longer duration of previous ulcer, history of more than 1 previous leg ulcer, not elevating legs for at least 30 minutes/day, walking <3 hours/day, and lower levels of self-efficacy.³⁴ These factors all were considered for inclusion in the respective risk assessment tools along with predictors and existing risk factors reported in the literature, such as those reported for delayed healing in a narrative review³² published in 2015 of 27 studies including ulcer duration, previous history of ulceration, venous abnormalities, decreased mobility and/or ankle range of movement, poor nutrition, and increased age; and a survey and retrospective chart review³ of 122 community living patients with a healed venous leg ulcer where risk factors included previous ulcer duration, cardiac disease, low body mass index (BMI), depression, and self-efficacy scores.³ Items were included if they contributed to improved discrimination of the risk assessment tool.

Three (3) teleconferences among the WAG members included 11 to 13 people each time. Email correspondence provided all relevant information in advance of the teleconferences so persons who could not attend the teleconference could provide feedback by email. The teleconferences provided information to the WAG on definitions, findings, potential scoring systems, and items, including questions about format, content, and response choices for each item. The final versions of the risk assessment tools were accepted by all members of the expert WAG as including all important items and that response options were appropriate.

Delayed healing assessment tool. The final risk assessment tool for delayed healing consisted of 8 items including health, medical, and social history items and ulcer characteristics, contributing to a baseline risk assessment score. The items at baseline were age (years), ulcer duration (weeks), history of previous DVT in leg with the ulcer, whether a patient lived alone, whether a patient used an assistive device to ambulate, whether the wound bed had >50% coverage of slough and/or necrotic tissue, ulcer area (cm²), and whether treatment currently involved compression <30 mm Hg. An additional 2 items (making 10 items overall) were added regarding changes in ulcer area and calf circumference to be measured 2 weeks from baseline; the baseline and 2-week scores were combined to determine an overall risk assessment score. The questions are generally yes/no and/or achieved/not achieved, and scores for individual items ranged between 0 and 6. The total risk assessment score for delayed healing ranged from 0 to 13 for the baseline score, 0 to 10 for the 2-week score, and 0 to 23 for the overall risk assessment score. The higher the score, the greater the risk of delayed healing (see Figure 1).

Recurrence assessment tool. The final risk assessment tool for recurrence consisted of 8 items including health, medical, and social variables along with level of preventive activities to determine a risk assessment score. The items were history of previous leg ulcers and history of DVT in the recently healed leg, previous ulcer duration (weeks), BMI <22, whether a patient lives alone, whether patient is ambulating on his/her feet for at least 3 hours/day, elevating legs for 30 minutes/day or more, and whether the patient is wearing compression hosiery Class 2 (20 mm Hg to 30 mm Hg) or higher for at least 5 days/week. The total risk assessment score for recurrence ranged from 0 to 16. The questions are generally yes/no and scores for individual items ranged between 0 and 4 (see Figure 2).

IRR. Due to difficulties in organizing the 3 raters’ availability at the same time as wound clinic appointments for all participants at all appropriate time points, 36 participants were recruited but only 26 had an overall risk assessment score calculated by all 3 raters for the delayed healing risk assessment tool study. In the recurrence risk assessment tool study, 24 participants were recruited and 22 participants had a risk assessment score calculated from all raters. All patients that were approached agreed to be involved.

Delayed healing risk assessment tool IRR. Among the 26 nonhealing risk group participants, 17 (65.4%) were men, the mean age of participants was 66.31 ± 17.47 years, and the median duration of participants’ ulcers at baseline was 18 (range 4–416) weeks. The median area of the ulcers was 2.4 cm² (range 0.1–23.6 cm²). The mean total risk assessment scores of the 3 raters were 11.35 ± 4.19, 10.58 ± 5.19, and 10.92 ± 5.36, respectively, with an ICC value of 0.84 (95% CI, 0.70-0.92; P<.001). Statistically significant agreement was noted among all raters for all individual item variables, baseline scores (ICC 0.95; 95% CI, 0.90-0.97; P<.001), 2-week scores (ICC 0.62; 95% CI, 0.27-0.82; P = .002), and total risk assessment scores (ICC 0.84; 95% CI, 0.70-0.92; P<.001) (see Table 1).

Statistically significant agreement was obtained among all 3 raters regarding assessment of the ulcer areas; acetate grid tracings of 7 ulcers on a training model achieved an ICC of 1.0 (95% CI, 0.99-1.00; P<.001). This indicated full agreement in reliability among these 3 raters with regard to the measurement of wounds using tracings with acetate grids.

Recurrence risk assessment tool IRR. Among the 22 participants, 14 (63.6%) were men, the mean age was 67.82 ± 11.73 years, and 13 (59.1%) had a history of previous leg ulcers in the same leg as the recently healed ulcer. The median duration of the participants’ recently healed ulcers was 11.0 (range 1–156) weeks. The mean total risk assessment scores of the 3 raters were 5.36 ± 3.22, 5.68 ± 4.34, and 6.23 ± 3.49, respectively, with an ICC value of 0.88 (95% CI, 0.75-0.94; P<.001). A statistically significant agreement was noted among all raters for all individual item variables, the health, medical and social history subtotal (ICC 0.85; 95% CI, 0.72-0.94, P<.001), the preventive subtotal (ICC 0.85; 95% CI, 0.70-0.93; P<.001), and total risk assessment score (ICC 0.88; 95% CI, 0.75-0.94; P<.001) (see Table 2).

Discussion

Risk assessment tool for delayed healing. The 10 variables in the newly developed risk assessment tool for delayed healing (whether patients lived alone, were not treated with high-level compression therapy, ulcer severity [area and tissue type], whether ulcer area decreased <25% in 2 weeks, age, ulcer duration, history of DVT, mobility, and reduction in calf circumference) are easily identifiable and measurable in the clinical area as determined by studies that have previously collected these variables in the clinical area.^25,33

Compression therapy and calf circumference reduction items in the risk assessment tool are important with regard to the etiology of a venous leg ulcer. The use of high-level compression therapy has long been identified as the cornerstone of evidence-based management of venous leg ulcers, which includes evidence from an extensive systematic review⁴³ of 22 trials that evaluated compression and concluded high compression (ankle compression 35 mm Hg to 45 mm Hg) was more effective than low compression (ankle compression 15 mm Hg to 25 mm Hg). However, a patient may not commence with treatment in this level of compression for many reasons, such as cost, concordance with recommendations, and lack of training and knowledge by clinical staff.^44-46 Previously developed risk assessment tools were limited as being based on data only from participants using high-level compression systems. A level-of-compression question was incorporated into the new tool so all patients with venous leg ulcers across all settings, regardless of type of compression, could be included. The addition of the item addressing calf circumference reduction of ≤2 cm within 2 weeks acknowledges an important potential risk factor in determining early response to treatment and risk of delayed healing in persons with venous disease.

The use of ulcer area and tissue type in the risk assessment tool is supported by evidence in the literature including the current authors’ previous analyses^20-22,47,48 along with ulcer area percent reduction also previously reported as a significant risk factor for delayed healing.^45,49,50 The 2-week time frame of percent area reduction provides an early marker for the risk assessment tool in this population.

Relatively few studies have concentrated on psychosocial or quality-of-life factors and the risks of delayed healing or recurrence in patients with venous leg ulcers. However, the authors were the first to identify that living alone was independently and significantly associated with failure to heal in a secondary analysis of 318 venous leg ulcers from hospital and community settings.³³ In addition, it has been reported that patients who lived alone had a higher incidence of venous leg ulceration,⁵¹ and a randomized controlled trial⁵² (N = 56) demonstrated significant benefits for ulcer healing in patient groups involved in a social model of care,⁵² an approach based on the Lindsay Leg Club^™ model that provides an informal, relaxed environment that is conducive to social interaction and peer support.

Age and ulcer chronicity or duration were included in the risk assessment tool because of consistent findings in the literature across multiple health sites and with large numbers of participants that demonstrated significant associations with delayed healing and consequent inclusion in previously developed risk assessment tools.^18-22,53-55 The literature also included 2 randomized controlled trials and 2 cohort studies^20,53,56,57(N = 200 patients and 121 ulcers and N = 153 patients and 32 ulcers, respectively) that found significant relationships between DVT and venous abnormalities with delayed healing (although measurement methods of abnormalities varied). The question of whether a person had a previous DVT in the ulcer leg was deemed the most appropriate venous abnormality question and hence was included in the risk assessment tool.

Despite a lack of consistency in mobility measurement, decreased mobility has been identified as a significant risk factor for delayed healing in a randomized controlled trial⁵⁸ (N = 40) — specifically, fewer steps per day — and in a prospective cohort study (N = 189) where decreased mobility was considered walking <200 m.⁵⁹ It was concluded that use of a walking aid was the optimal quantification of mobility for the purpose of a risk assessment tool; it was a quick, easy-to-answer item that would not involve a subjective measure of activity by the patient or the need for equipment and/or staff time in determining other measurements such as ankle range of motion.

Risk assessment tool for recurrence. The 8 variables in the newly developed risk assessment tool for recurrence (previous leg ulcers, history of DVT, duration of previous ulcer, BMI <22, whether the patient lives alone, leg elevation, walking activity, and compression therapy) are also easily identifiable and measurable in the clinical area as determined by studies that have previously collected these variables in the clinical area.³⁴

Based on previous literature and results from data analyses by the authors, history of a previous DVT or deep vein insufficiency and BMI were necessary inclusions in the risk assessment tool because they were found to be significant risk factors for recurrence of venous leg ulcers.^5,34 A BMI <22 also has been noted in a large cohort study (N = 4791) to increase the mortality risk in older people.⁶⁰

A critique of quantitative literature addressing health-related quality of life⁶¹ indicated limited mobility can lead to challenges in performing daily activities and pose a significant problem for persons with venous leg ulcers. Decreased mobility and physical activity have been shown in a randomized controlled trial,⁶² a quasi-experimental study,⁶³ and a literature review⁶⁴ of 16 studies (N ranging from 49 to 300 community-living participants) to be significant risk factors for recurrence. Guidelines for the prevention of venous leg ulcers^65,66 recommend encouragement of mobility and exercise — specifically, a 30-minute daily walk. However, comparison of studies is compromised by a lack of consistency in the measurements of mobility (ie, measuring general mobility, ankle range of motion, or physical activity). The authors identified that walking for at least 3 hours per day, as reported in the Yale Physical Activity Scale,⁶⁷ was significantly associated with a decreased risk of recurrence³⁴ and offered an easy quantification for use in the risk assessment tool.

Elevating legs at or above the level of the heart for at least 30 minutes/day was found to be significantly associated with a decreased risk of recurrence of venous leg ulcers in longitudinal studies.³⁴ Similarly, a quasi-experimental study⁶³ of 49 community-residing participants indicated persons who spent time with their legs elevated each day were significantly less likely to have their ulcers recur, and elevating legs when resting or immobile has been recommended in guidelines on venous leg ulcers to assist in the control of edema.^7,65,66 Abu-Own et al⁶⁸ concluded from a cohort study of 30 participants (15 with chronic venous insufficiency and 15 without chronic venous insufficiency) that limb elevation enhanced the microcirculatory flow velocity in skin of patients with chronic venous insufficiency.

A systematic literature review⁶⁹ of 4 randomized controlled trials (N = 979) concluded compression therapy is the primary conservative strategy for preventing the recurrence of venous leg ulcers. This systematic review reported high compression lowers recurrence rates when compared to moderate compression; however, rates of patient intolerance in relation to compression can be high because of issues related to cost, difficulties with application, and comfort.^4,69 Guidelines on venous leg ulcer recurrence recommend compression with at least 18 mm Hg to 40 mm Hg or the highest level able to be tolerated once the venous leg ulcer is healed.^7,66 The study by Finlayson et al³ of 122 community-living participants concluded that for every additional day/week participants wore Class 2 or 3 compression hosiery, the odds of recurrence were almost halved (OR 0.53; 95% CI, 0.34-0.81); therefore, this variable was included in the new risk assessment tool.

Similar to delayed healing in venous leg ulcers, investigation of psychosocial or quality of life factors and the risk of recurrence in patients with venous leg ulcer in the literature is scant. However, 1 case-controlled study⁵¹ of 113 participants found patients who live alone have a higher incidence of venous leg ulceration. The Lindsay Leg Club^® social model of care ensures management of wounds in a social atmosphere where patients are not discharged upon healing; instead, the focus is on continuing to attend clinics to participate in social and health promoting activities. This approach has been extremely successful in removing the stigma of leg ulceration for sufferers and has resulted in many encouraging benefits, including improved compliance with treatments and positive healing outcomes.^52,70 Low recurrence rates in these clubs also support the rationale of patient empowerment and the synergistic effect of ongoing health promotion and education in a supportive social environment.⁷⁰ Although the reasons for a higher risk of recurrence in persons who live alone are unknown, it is important to acknowledge this factor in the risk assessment tool as well as the need for further research in addressing these patients’ clinical needs.

IRR. A high level of IRR is an essential requirement of a risk assessment tool, because clinical practice risk assessment tools are used by many different members of the health care team at different points of time where they would be devalued by high degrees of error among users.⁷¹ IRR results on these venous leg ulcer tools indicate good agreement between raters. The majority of the ICC indices (0.6–1.0) obtained for the comparison between raters for individual items in the risk assessment tool confirmed the reliability of the tool with statistical significance (P<.05).

Implications for Practice

Healing venous leg ulcers and preventing recurrence are priorities for all health professionals working in wound care. Early availability of information on the risk of delayed healing or recurrence could contribute to improved outcomes for patients and hospital systems. Clinical credibility was ensured in these tools; the tool components were based on evidence from studies across a variety of settings and endorsed by an expert WAG. The tools also may assist in the estimation of health care costs.

Although these risk assessment tools can provide data to guide decisions for ongoing care of the patient (eg, when to refer for specialist care, include adjunctive treatment, and individually tailor interventions to improve healing and delay recurrence), it is also important that clinicians use reliable and valid instruments to ensure credibility and usefulness for evidence-based practice⁷² and to support accurate and effective decisions about patient care. The authors intend to validate these risk assessment tools in prospective cohorts of patients from different health facilities and across different countries to ensure the tools are valid in identifying the risk of delayed healing and/or recurrence and to provide evidence to facilitate use of the tools in clinical decision making internationally. Validation studies will assist in determining recommendations with regard to timing of completion of the risk assessment tools (ie, once only or at multiple time points) and to develop cutoff points to indicate if patients are at low, moderate, or high risk. An additional benefit is that instruments to assess the risk of delayed healing wounds and/or recurrence could help enhance communication among clinicians by defining a common language and standardizing assessment characteristics.⁷³

Limitations

The risk factors included were limited to those identified from studies by the authors, evidence found in the literature, and expert opinion. Other factors that have not been well investigated may be identified and provide items for an even more reliable scoring system. Further research also is required to identify why some variables, such as living alone, are producing poorer wound healing outcomes.

Although a power analysis determined a sample size of 30 was required for IRR, this study was only able to achieve 26 and 22 participants for each of the risk assessment tools. This was due to difficulties in the availability of the 3 raters. Further testing of reliability would be beneficial. The 3 variables on the risk assessment tool that were less reproducible (ICC <0.8) (ie, treatment compression level and calf reduction on the delayed healing tool and BMI on the recurrence tool) require further evaluation, modification, and clarification to improve reliability. The differences in ratings could have resulted from a misunderstanding of the compression and BMI question, with the less than symbol (<) often appearing to be misunderstood and mistakenly answered as <30 mm Hg although the compression type had been documented as a type which was higher than 30 mm Hg. The use of words rather than symbols may assist with clarifying this. Measurement of the calf circumference was less reliable between the 3 raters due to slightly differing measurements between raters, and the measurement of circumference reduction often was close to the 2-cm cutoff. Further research is required to determine whether this measurement can be achieved more accurately.

Conclusion

A secondary analysis of data from multisite longitudinal studies aimed to develop and a single site prospective study assessed the IRR of risk assessment tools for delayed healing and recurrence of venous leg ulcers. This has resulted in the development of 2 risk assessment tools for use in patients with chronic venous insufficiency. Both were found to have good IRR. These tools are not resource-intensive and provide a quick, easy way to identify persons at high risk of delayed healing or recurrence of a venous leg ulcer. Questions use plain language with simple responses and incur little or no expense to complete in a variety of settings.

The results of the IRR indicate the risk assessment tools for delayed healing and recurrence of venous leg ulcers (ICC 0.6–1.0; P<.05) meet recommendations for reliable tools that may benefit clinicians, patients, and the health care system. Providing the tools have sufficient predictive validity, the risk assessment tools may help health professionals be more confident in recognizing the necessity for early additional interventions in high-risk patients with venous leg ulcers.

Acknowledgment

The first author acknowledges the support of Queensland University of Technology; parts of this study were undertaken in partial fulfillment of a Doctor of Philosophy. The authors acknowledge and thank the members of the expert WAG for their contributions and all of the staff and participants at Queensland University of Technology’s Wound Healing Community Outreach Service who were involved in the reliability study.

References

1. Guest M, Smith JJ, Sira MS, Madden P, Greenhalgh RM, Davies AH. Venous ulcer healing by four-layer compression bandaging is not influenced by the pattern of venous incompetence. Br J Surg. 1999;86(11):1437–1440.

2. Abbade LPF, Lastória S. Venous ulcer: epidemiology, physiopathology, diagnosis and treatment. Int J Dermatol. 2005;44(6):449–456.

3. Finlayson K, Edwards H, Courtney M. Factors associated with recurrence of venous leg ulcers: a survey and retrospective chart review. Int J Nurs Studies. 2009;46(8):1071–1078.

4. Moffatt CJ, Dorman MC. Recurrence of leg ulcers within a community ulcer service. J Wound Care. 1995;4(2):57–61.

5. McDaniel HB, Marston WA, Farber MA, et al. Recurrence of chronic venous ulcers on the basis of clinical, etiologic, anatomic, and pathophysiologic criteria and air plethysmography. J Vasc Surg. 2002;35(4):723–728.

6. Abbade LPF, Lastória S, Rollo Hde A. Venous ulcer: clinical characteristics and risk factors. Int J Dermatol. 2011;50(4):405–411.

7. Australian Wound Management Association Inc, New Zealand Wound Care Society Inc. Australian and New Zealand Clinical Practice Guideline for Prevention and Management of Venous Leg Ulcers. Osborne Park, Australia: Cambridge Publishing;2011.

8. Gohel MS, Barwell JR, Taylor M, et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ. 2007;335(7610):83–87.

9. Nelzén O, Fransson I. True long-term healing and recurrence of venous leg ulcers following SEPS combined with superficial venous surgery: a prospective study. Eur J Vasc Endovasc Surg. 2007;34(5):605-612.

10. Chase SK, Melloni M, Savage A. A forever healing: the lived experience of venous ulcer disease. J Vasc Nurs. 1997;15(2):73–78.

11. Hareendran A, Bradbury A, Budd J, et al. Measuring the impact of venous leg ulcers on quality of life. J Wound Care. 2005;14(2):53–57.

12. Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen Wound Assessment Tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 2010;37(3):253–259.

13. Thomas DR, Rodeheaver GT, Bartolucci AA, et al. Pressure ulcer scale for healing: derivation and validation of the PUSH tool. The PUSH Task Force. Adv Wound Care. 1997;10(5):96–101.

14. Sussman C, Swanson G. Utility of the Sussman wound healing tool in predicting wound healing outcomes in physical therapy. Adv Wound Care. 1997;10(5):74–77.

15. Ferrell BA, Artinian BM, Sessing D. The Sessing scale for assessment of pressure ulcer healing. J Am Geriatr Soc. 1995;43(1):37–40.

16. Krasner D. Wound Healing Scale, version 1.0: a proposal. Adv Wound Care. 1997;10(5):82–85.

17. Houghton PE, Kincaid CB, Campbell KE, Woodbury MG, Keast DH. Photographic assessment of the appearance of chronic pressure and leg ulcers. Ostomy Wound Manage. 2000;46(4):20–30.

18. Kulkarni SR, Gohel MS, Wakely C, Minor J, Poskitt KR, Whyman MR. The ulcerated leg severity assessment score for prediction of venous leg ulcer healing. Br J Surg. 2007;94(2):189–193. doi:10.1002/bjs.5597.

19. Falanga V, Saap LJ, Ozonoff A. Wound bed score and its correlation with healing of chronic wounds. Dermatol Ther. 2006;19(6):383–390.

20. Skene AI, Smith JM, Doré CJ, Charlett A, Lewis JD. Venous leg ulcers: a prognostic index to predict time to healing. Br Med J. 1992;305(6862):1119–1121.

21. Taylor RJ, Taylor AD, Smyth JV. Using an artificial neural network to predict healing times and risk factors for venous leg ulcers. J Wound Care. 2002;11(3):101–105.

22. Margolis DJ, Berlin JA, Strom BL. Which venous leg ulcers will heal with limb compression bandages? Am J Med. 2000;109(1):15–19.

23. Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J. Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4VLU). J Adv Nurs. 2016;72(3):669–679.

24. Gethin GT, Cowman S, Conroy RM. The impact of Manuka honey dressings on the surface pH of chronic wounds [retracted in: Int Wound J. 2014;11(3):342]. Int Wound J. 2008;5(2):185–194.

25. Edwards H, Finlayson K, Courtney M, Graves N, Gibb M, Parker C. Health service pathways for patients with chronic leg ulcers: identifying effective pathways for facilitation of evidence based wound care. BMC Health Services Res. 2013;13(1):86.

26. Wyatt JC, Altman DG. Commentary: prognostic models: clinically useful or quickly forgotten? BMJ. 1995;311(7019):1539–1541.

27. El Miedany Y, El Gaafary M, Toth M, Palmer D, Ahmed I. Falls risk assessment score (FRAS): time to rethink. J Clin Gerontol Geriatr. 2011;2(1):21–26.

28. Moffatt CJ, Doherty DC, Smithdale R, Franks PJ. Clinical predictors of leg ulcer healing. Br J Dermatol. 2010;162(1):51–58.

29. European Wound Management Association. Position Document: Hard-to-heal Wounds: A Holistic Approach. London, UK: MEP Ltd; 2008.

30. Maguire R, Cowie J, Leadbetter C, et al. The development of a side effect risk assessment tool (ASyMS©-SERAT) for use in patients with breast cancer undergoing adjuvant chemotherapy. J Res Nurs. 2009;14(1):27–40.

31. McCaffrey R, Bishop M, Adonis-Rizzo M, et al. Development and testing of a DVT risk assessment tool: providing evidence of validity and reliability. Worldviews Evid Based Nurs. 2007;4(1):14–20.

32. Parker CN, Finlayson KJ, Shuter P, Edwards HE. Risk fators for delayed healing in venous leg ulcers: a review of the literature. Int J Clin Pract. 2015;69(9):967–977.

33. Parker CN, Finlayson KJ, Edwards HE. Ulcer area reduction at 2 weeks predicts failure to heal by 24 weeks in the venous leg ulcers of patients living alone. J Wound Care. 2016;25(11):626–634.

34. Finlayson K, Wu ML, Edwards HE. Identifying risk factors and protective factors for venous leg ulcer recurrence using a theoretical approach: a longitudinal study. Int J Nurs Stud. 2015;52(6):1042-1051.

35. Woodbury MG, Houghton PE, Campbell KE, Keast DH. Development, validity, reliability, and responsiveness of a new leg ulcer measurement tool. Adv Skin Wound Care. 2004;17(4 Pt 1):187–196.

36. Nandy S, Parsons S, Cryer C, et al; Falls Prevention Pilot Steering Group. Development and preliminary examination of the predictive validity of the Falls Risk Assessment Tool (FRAT) for use in primary care. J Public Health (Oxf). 2004;26(2):138–143.

37. Polit DF, Beck CT. Essentials of Nursing Research: Appraising Evidence for Nursing Practice International. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins;2010.

38. Stotts NA, Rodeheaver GT, Thomas DR, et al. An instrument to measure healing in pressure ulcers: development and validation of the Pressure Ulcer Scale for Healing (PUSH). J Gerontol A Biol Sci Med Sci. 2001;56(12):M795–M799.

39. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86(2):420–428.

40. Santos VLC, Sellmer D, Massulo MME. Inter rater reliability of Pressure Ulcer Scale for Healing (PUSH) in patients with chronic leg ulcers. Rev Latino-Am Enfermagem. 2007;15(3):391–396.

41. McGraw KO, Wong SP. Forming inferences about some intraclass correlation coefficients. Psycholog Methods. 1996;1(1):30–46.

42. Bower VM, Hobbs M. Validation of the basic foot screening checklist: a population screening tool for identifying foot ulcer risk in people with diabetes mellitus. J Am Podiatr Med Assoc. 2009;99(4):339–347.

43. O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous ulcers. Cochrane Database Syst Rev. 2012;11:CD000265.

44. Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Repair Regen. 2010;18(2):154–158.

45. Phillips TJ, Machado F, Trout R, Porter J, Olin J, Falanga V. Prognostic indicators in venous ulcers. J Am Acad Dermatol. 2000;43(4):627–630.

46. Woodward M. Wound management by aged care specialists. Aust J Wound Manage. 2002;10(2):70–76.

47. Margolis DJ, Berlin JA, Strom BL. Risk factors associated with the failure of a venous leg ulcer to heal. Arch Dermatol. 1999;135(8):920–926.

48. Jones KR. Why do chronic venous leg ulcers not heal? J Nurs Care Qual. 2009;24(2):116–124.

49. Arnold TE, Stanley JC, Fellows EP, et al. Prospective, multicenter study of managing lower extremity venous ulcers. Ann Vasc Surg. 1994;8(4):356–362.

50. Kantor J, Margolis DJ. A multicentre study of percentage change in venous leg ulcer area as a prognostic index of healing at 24 weeks. Br J Dermatol. 2000;142(5):960–964.

51. Moffatt CJ, Franks PJ, Doherty DC, Smithdale R, Martin R. Sociodemographic factors in chronic leg ulceration. Br J Dermatol. 2006;155(2):307–312.

52. Edwards H, Courtney M, Finlayson K, et al. Chronic venous leg ulcers: effect of a community nursing intervention on pain and healing. Nurs Stand. 2005;19(52):47–54.

53. Labropoulos N, Wang ED, Lanier ST, Khan SU. Factors associated with poor healing and recurrence of venous ulceration. Plast Reconstr Surg. 2012;129(1):179–186.

54. Barwell JR, Taylor M, Ghauri ASK, et al. Risk factors for delayed healing and long-term recurrence in chronic venous leg ulcers. Br J Surg. 2000;87(4):501.

55. Gohel MS, Taylor M, Earnshaw JJ, Heather BP, Poskitt KR, Whyman MR. Risk factors for delayed healing and recurrence of chronic venous leg ulcers—an analysis of 1324 legs. Eur J Vasc Endovasc Surg. 2005;29(1):74–77.

56. Szewczyk MT, Jawień A, Migdalski A, Piotrowicz R, Grzela T, Brazis P. Predicting time to healing by anatomical assessment of venous pathology. Med Sci Monit. 2009;15(2):CR74–CR81.

57. Chaby G, Viseux V, Ramelet AA, Ganry O, Billet A, Lok C. Refractory venous leg ulcers: a study of risk factors. Dermatol Surg. 2006;32(4):512–519.

58. Meagher H, Ryan D, Clarke-Moloney M, O’Laighin G, Grace PA. An experimental study of prescribed walking in the management of venous leg ulcers. J Wound Care. 2012;21(9):421–428.

59. Milic DJ, Zivic SS, Bogdanovic DC, Karanovic ND, Golubovic ZV. Risk factors related to the failure of venous leg ulcers to heal with compression treatment. J Vasc Surg. 2009;49(5):1242–1247.

60. Kulminski AM, Arbeev KG, Kulminskaya IV, et al. Body mass index and nine-year mortality in disabled and nondisabled older U.S. individuals. J Am Geriatr Soc. 2008;56(1):105–110.

61. Green J, Jester R. Health-related quality of life and chronic venous leg ulceration: part 2. Br J Community Nurs. 2010;15(3):S4-S10.

62. Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006;44(4):803–808.

63. Brooks J, Ersser SJ, Lloyd A, Ryan TJ. Nurse-led education sets out to improve patient concordance and prevent recurrence of leg ulcers. J Wound Care. 2004;13(3):111–116.

64. Brown A. Life-style advice and self-care strategies for venous leg ulcer patients: what is the evidence? J Wound Care. 2012;21(7):342–350.

65. Scottish Intercollegiate Guidelines Network. Management of Chronic Venous Leg Ulcers — A National Clinical Guideline. Edinburgh, Scotland: SIGN; 2010.

66. RCN Institute Centre for Evidence Based Nursing. Clinical Practice Guidelines: The Nursing Management of Patients with Venous Leg Ulcers. 2nd ed. York, UK: Royal College of Nursing;2006.

67. Dipietro L, Caspersen CJ, Ostfeld AM, Nadel ER. A survey for assessing physical activity among older adults. Med Sci Sports Exerc. 1993;25(5):628–642.

68. Abu-Own A, Scurr JH, Coleridge Smith PD. Effect of leg elevation on the skin microcirculation in chronic venous insufficiency. J Vasc Surg. 1994;20(5):705–710.

69. Nelson EA, Bell-Syer SEM. Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev. 2014;(9):CD002303.

70. Lindsay E. The Lindsay Leg Club® Model: a model for evidence-based leg ulcer management. Br J Community Nurs. 2004;9:17–22.

71. Kottner J, Dassen T, Tannen A. Inter- and intrarater reliability of the Waterlow pressure sore risk scale: a systematic review. Int J Nurs Stud. 2009;46(3):369–379.

72. Flahr D, Woodbury MG, Grégaoire D. Clinimetrics and wound science. Wound Care Canada. 2005;3(2):18–19.

73. Mullins M, Thomason SS, Legro M. Monitoring pressure ulcer healing in persons with disabilities. Rehabil Nurs. 2005;30(3):92–99.

Potential Conflicts of Interest: This study was supported by the Wound Management Innovation Cooperative Research Centre (established and supported under the Australian government’s Cooperative Research Centres Program) and partially supported by a Queensland University of Technology Faculty of Health Masters Scholarship, a National Health & Medical Research Council Primary Health Care Postgraduate Research Scholarship, an Australian College of Nursing Margaret Y Winning Queensland Nursing Scholarship.

Dr. Parker is a lecturer and researcher, Faculty of Health, Institute of Health & Biomedical Innovation, Queensland University of Technology; and affiliated with the Wound Management Innovation Cooperative Research Centre, Kelvin Grove, QLD, Australia. Dr. Finlayson is a research fellow, Faculty of Health, Institute of Health & Biomedical Innovation, Queensland University of Technology; and affiliated with the Wound Management Innovation Cooperative Research Centre. Professor Edwards is Assistant Dean (International and Engagement) and researcher, Faculty of Health, Institute of Health & Biomedical Innovation, Queensland University of Technology; and leads the Clinical Application Program of the Wound Management Innovation Cooperative Research Centre. Please address correspondence to: Christina Parker, RN, PhD, School of Nursing, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD 4059; email: christina.parker@qut.edu.au.

Section:

Issue Number:

Index:

Ostomy Wound Management 2017;63(10):34–41 doi: 10.25270/owm.2017.10.3441

Ayişe Karadag, MsN, PhD, ET/WOCN, Professor; Seval Hanönü, MSN; and Evrim Eyikara, MSN

Topics:

descriptive study

medical devices

pressure injuries

nursing care

Nursing Interventions

Abstract

Nurses play an important role in identifying patients at risk for medical device-related (MDR) pressure injuries and preventing their occurrence. A prospective, descriptive study was conducted across 6 hospitals in Ankara, Turkey between December 2014 and June 2015 to assess nursing perceptions about and interventions used for the prevention of MDR pressure ulcers.

A questionnaire was used to collect demographic information and data on experience with MDR pressure ulcers; in addition, participants completed a Nursing Interventions Form that included 10 statements regarding basic nursing interventions to prevent MDR pressure ulcers; answer options were I perform, I partly perform, I do not perform. Of the 1555 nurses invited, 606 (38%) participated. Nurses who chose to volunteer completed the study instruments independently at their convenience; their responses were entered directly into the statistical analysis system by the researchers. Demographic and interventions data were analyzed using frequency and percentage distributions. Participant mean age was 30.0 ± 6.83 years, most were women (86.9%), with a mean of 8.47 ± 6.70 years of experience. Most had a bachelor’s degree (55.1%), 38.2% worked in intensive care units, 50.2% participated in a scientific program regarding the prevention/treatment of pressure ulcers after their graduation, and 87.9% provided care to patients with pressure ulcers. A great majority (80.1%) of the nurses believed the use of medical devices can lead to pressure ulcers and 59.2% had experience with MDR pressure ulcers, but almost 20% did not believe medical devices can cause a pressure ulcer. The nurses identified 18 medical devices that posed the highest risk of causing MDR pressure ulcers; the 3 most commonly identified devices were endotracheal tubes (59.7%), tracheostomy ties (58.9%), and blood pressure cuffs (58.4%). The most common interventions used by these nurses included ensuring correct device positioning (87.9%) and loosening devices at least once every shift (80%) when medical conditions allowed. These findings suggest nurses may not be aware of the risk for pressure ulcers associated with a number of medical devices, indicating a need for comprehensive inservice training programs and research to identify optimal measures and methods to prevent MDR pressure ulcers.

A pressure ulcer is described as localized skin tissue and/or subcutaneous tissue damage at bony prominences formed through pressure alone or as part of a combination of laceration and pressure.¹ Pressure ulcers most commonly develop at bony prominences such as the sacrum and heels, but cases of pressure ulcers on the skin over mucous membranes and soft tissues also have been increasingly reported.²Until relatively recently, limited attention has been given to medical device-related (MDR) pressure ulcers.³

The National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP)¹ report pressure ulcers can develop in any tissue exposed to pressure and that medical devices pose a substantial risk for their formation. With the widespread use of medical devices for diagnosis and treatment, many patients are faced with this risk.⁴ Research that includes point prevalence, cross-sectional, retrospective review, descriptive pilot, and prospective, descriptive studies^3,5-13 has reported pressure ulcers largely triggered by the use of a medical device have occurred on the ears, nose, lips, neck, hands, legs, genitals, fingers, and head, as well as the mouth, shoulders, back, chin, abdomen, and around the face, forehead, and eye brows.

Point prevalence, cross-sectional, and quasi-experimental studies^3,14 also have found MDR pressure ulcers are mainly the result of using rigid materials in medical device manufacturing, incorrect fit, incorrect placement (eg, in areas of little or no adipose tissue), and using inappropriate methods to affix the medical devices. A point-prevalence, cross-sectional study by Black et al³ (N = 2178) of pressure ulcers occurring on the ears, lower legs, and heels found other reasons for MDR pressure ulcers include the presence of local tissue edema in the area where the medical device has been placed, a decline in tissue oxygenation, decreased sensory perception, and lack of efficient cooperation among members of the pateint’s health care team.

Several studies have indicated a higher prevalence of MDR pressure ulcers compared to non-MDR pressure injuries. The study by Black et al³ found a significantly higher prevalence of MDR pressure ulcers (34.5%) compared to nosocomial non-MDR pressure ulcers (5.4%). A descriptive, point prevalence study by Schlüer et al¹⁵ (N = 155) found Stage 1 MDR pressure ulcers in 84% of patients presenting with pressure ulcers. An observational, cross-sectional cohort study by Van Gilder et al¹⁶ found 1631 out of 17 911 pressure ulcers (9.1%) were due to medical devices; these were mainly observed on the ears (20%), sacrum (17%), heels (12%), and hips (10%). In a descriptive, prospective study performed across adult intensive care units (N = 175) in Turkey, the current authors found non-MDR pressure ulcers developed in 27 (15.4%) patients, while 70 (40%) of the patients presented with MDR pressure ulcers.¹³

The incidence and prevalence of pressure ulcers can be decreased by preventing MDR pressure ulcers, which may be both easier and less expensive than their treatment.⁵ The golden rule in the treatment of pressure ulcers is to find the cause of the pressure and remove it. However, removal of medical devices may cause adverse treatment outcomes. Medical devices, therefore, should be repositioned as much as possible (for example, moving an endotracheal tube from 1 side of the mouth to the other).³ Frequently adjusting the position of medical devices in patients presenting with pressure ulcers also is recommended.¹⁷ In the study by Black et al,³ it was recommended that medical devices be loosened at least once per shift to assess for skin problems if the patient’s condition allows. MDR pressure ulcers also can be prevented by avoiding ill-fitting medical devices. NPUAP/EPUAP and Pan Pacific Pressure Injury Alliance (PPPIA)¹⁷ guidelines note medical devices that are ill-fitting or tightly affixed on the skin increase the risk of pressure ulcers from friction and additional pressure. In both scenarios, skin tolerance of pressure decreases, resulting in the development of tissue damage. The placement of medical devices in areas with lower adipose tissue or with irritation caused by hard devices also accelerates skin damage.^3,17 When repositioning a medical device, it is not sufficient just to relieve the pressure; placing supportive or protective dressings or padding materials under tightly fixed medical devices has been shown to help redistribute excessive pressure and prevent shearing and rubbing by the devices.^17,18

Basic nursing interventions include regular skin inspections and assessing skin and mucous membranes for pressure ulcers at the end of every shift.^1,3 Moreover, when positioning patients, nurses should take special care of medical devices, cables, and catheters; these should be visible and not positioned beneath the patient.^3,9,17 Nurses may be reluctant to reposition medical devices, especially when the consequences of dislodgement could result in harm to the patient; however, several studies have shown nurses play important role in identifying patients at risk and subsequently preventing MDR pressure ulcers with early assessment and interventions.^5,10,18 Noninclusion of a systematic and detailed evaluation of medical devices in routine skin inspections may be an indication that awareness of MDR pressure ulcers requires improvement. Studies^3,5 have shown multidisciplinary teams that include a nurse with good pressure ulcer knowledge and skills can achieve positive outcomes in preventing and treating pressure ulcers.

A limited number of studies have investigated MDR pressure injuries in Turkey; no study has focused on nursing interventions aimed at preventing MDR pressure ulcers. To help increase information about nurses’ awareness of MDR pressure ulcers and identify effective nursing care applications to prevent MDR injury, a prospective, descriptive study was conducted to determine nurses’ perceptions of and interventions in the prevention of MDR pressure ulcers.

Methods

Ethical consideration. This study was conducted according to the ethical guidelines and principles set forth in the International Declaration of Helsinki. Before the start of the research, written consent was obtained from the participating hospitals (B.10.4.06.00.15-EPKK-619, 18744377-903.07.02, 69668506-3159, G.M-2755, BTEDK-18/14, MED/5148/2014). Nurses were informed of the aims and methods of the study by researchers; verbal consent for participation was acquired. Nurses were informed their personal information would be used for research purposes only, remain confidential, and not be shared with anyone. The data collection forms were numbered for identification, starting from 001. Descriptive or personal information, such as nurses’ names, was not collected.

Study setting and sample. The research sample included all nurses working in adult inpatient units of a university hospital, 2 public hospitals, and 3 private hospitals located in the province of Ankara, Turkey (N = 1555). All nurses who granted their consent on a voluntary basis were included. After obtaining written consent from the institutions, the researchers contacted the administrators of nursing services at each hospital and obtained monthly working lists. The researchers visited the hospitals during the day shift until all nurses were apprised of the study aims and methods and provided verbal consent for participation. The nurses who volunteered to participate completed the data collection forms at a time convenient for them.

Data collection. Research data were collected between December 2014 and June 2015. To obtain the data, 2 instruments were used. The Nurses Characteristics Form was developed by the authors and comprised 11 items regarding demographic information (eg, gender, age, education, hospital unit) and information on experience with MDR pressure ulcers (eg, previous experiences with patients with pressure ulcers and medical devices that can cause pressure ulcers). The nurses could select and check more than 1 option on the choice boxes; under the “other” option, they could write medical devices not listed. The Nursing Interventions Form, also developed by the researchers and based on the literature,^1,3,13,17 included 10 statements about basic nursing interventions to prevent MDR pressure ulcers presented in the A column of the form. In the B column, the nurses were asked to indicate their use of these practices according to 3 categories of options: I perform if they always performed the MDR pressure ulcer preventive interventions, I partly perform if they did not regularly perform MDR pressure ulcer interventions, and I do not perform if they never attempted MDR pressure ulcer interventions. The nurses’ responses were entered directly into the statistical analysis program by the researchers.

Data analysis. Data were stored according to research and publishing ethics and analyzed using Statistical Packages for Social Sciences (SPSS) for Windows, Version 20.0 (IBM Inc, Armonk, NY). The frequency and percentage distributions of the items pertaining to nurse characteristics and the data regarding nursing interventions in the prevention of MDR pressure ulcers were calculated.

Results

Questionnaire responses were received from 606 nurses, a response rate of 38%. The mean age of participants was 30.0 ± 6.83 years, most were women (86.9%), with a mean of 8.47 ± 6.70 years of service. Most nurses had a bachelor’s degree (55.1%), 38.2% worked in intensive care units, 50.2% participated in a scientific program regarding the prevention/treatment of pressure ulcers after their graduation, and 87.9% provided care to patients with pressure ulcers. A great majority (80.1%) of the nurses believed the use of medical devices can lead to pressure ulcers, and 59.2% said they already had experience with MDR pressure ulcers (see Table 1).

Participants identified 18 medical devices that pose a MDR pressure injury risk: endotracheal tubes (ETs) (59.7%), tracheostomy ties (58.9%), blood pressure (BP) cuffs (58.4%), nasal cannulas (54.8%), continuous positive airway pressure (CPAP) masks (54.1%), thromboembolism deterrents (TEDs) (52.6%), nasogastric tubes (47.4%), splints (44.6%), oxygen masks (44.6%), cervical collars (41.6%), electrocardiograph (ECG) leads and electrodes (40.3%), peripheral oxygen saturation of hemoglobin (SpO2) probes (38.0%), Foley catheters (37.1%), peripheral vascular lines (29.0%), central vascular lines (28.9%), arterial lines (25.4%), orogastric tubes (21.3%), and percutaneous endoscopic gastrostomy (PEG)/percutaneous endoscopic jejunostomy (PEJ) tubes (19.5%) (see Table 2).

Interventions marked most commonly as I always perform included proper placement of medical devices to prevent friction and pressure on the skin (87.9%); loosening/untying devices such as splints, corsets, nasal cannulas, and SpO2 probes at least once every shift when the medical condition of the patient allowed it (80%); assessing tissues underneath medical devices for pressure damage (79%); using supportive or protective dressings on areas with medical devices (78.5%); taking special care that no devices are placed on areas where skin integrity has been disrupted (77.4%); preventing areas with medical devices from getting too dry/wet (77.2%); evaluating oral mucosa of patients with ETs at least once every shift (76.6%); evaluating peristomal areas (72.4%); lubricating the bedpan before giving it to the patient and limiting patient time on the bedpan (64.5%); and changing the location of medical devices on the patient every shift (63.2%) (see Table 3).

Discussion

Nuru et al¹⁹ provided evidence from their cross-sectional research (N = 248) that 48.4% of nurse interventions for patients with pressure ulcers were good/satisfactory and that 54.4% of nurse study participants had good knowledge of pressure ulcers. A cross-sectional, multicenter study (N = 145) of the knowledge level of nurses in terms of the pressure ulcer prevention by Demarre et al²⁰ found an accurate/satisfactory rate of 29.3%; the same research further documented that 78.3% of the nurses exhibited a positive attitude toward of pressure ulcer prevention implementation. The current research did not examine the knowledge of nurses regarding MDR pressure ulcers; it only focused on the related interventions. The research also aimed to determine which medical devices, in the opinion of the nurses, cause pressure ulcers. Among participants, 80.1% believed medical devices can cause pressure ulcers of different categories/stages (see Table 2).

However, nurses responded that not all devices present a risk for pressure injury. Specifically, most nurses believed that PEG/PEJ tubes (80.5%), orogastric catheters (78.7%), arterial catheters (74.6%), central venous catheters (71.1%), peripheral venous catheters (71%), Foley catheters (62.9%), SpO2 probes (62%), ECG leads and electrodes (59.7%), cervical collars (58.4%), oxygen masks (55.4%), splints (55.4%), and nasogastric tubes (52.6%) do not pose a MDR pressure injury risk. This outcome was found to be important from 2 points of view. First, even though the nurses know medical devices can cause pressure ulcers, they may need more information about which devices are likely to cause them. Second, this outcome supports the presumption that although nurses may recognize general reasons for the occurrence of pressure ulcers, they may have difficulty realizing a medical device as a cause.

Approximately half of the nurses in the study did not receive any education on pressure ulcers after graduation. Although MDR pressure ulcers have garnered the attention of adminstrators and practitioners for the past 5 years in Turkey, these findings clearly demonstrate nurses need education about MDR pressure ulcers. Black et al³ concluded from their study that pressure ulcers developing at areas where such ulcers rarely occur (such as lips, cheeks, ears, nose bridge, back of the head, finger tips) are to be automatically categorized as pressure ulcers caused by medical devices. Of the nurses participating in the current research, 59.2% stated they have experience with MDR pressure ulcers (see Table 1).

In the current research, nurses were asked to specify which medical devices could cause pressure injuries; intubation tubes were chosen by the majority (59.7%) of participants. In prospective research in intensive care units (N = 483), Coyer et al² found 8 out of 20 MDR pressure ulcers were caused by nasogastric tubes and 7 pressure ulcers had developed due to intubation tubes. In the research by Schlüer et al¹⁵ (N = 155), most pressure ulcers developed due to medical devices such as tubes, splints, and monitoring cables.

Preventing pressure ulcers caused by medical devices in the course of proper nursing interventions is considered to be an indication of quality of care.⁵ According to pressure ulcer guidelines,¹nurses should be able to identify patients at risk as early as possible and accordingly implement preventive interventions.¹ In this regard, nurses should be especially careful of placing and fixing medical devices to avoid friction and pressure on the skin.⁹ In the current study, nurses frequently knew to “properly position medical devices so as to prevent friction and pressure on the skin.” However, almost half of the nurses think TEDs do not cause MDR pressure injuries, and more than half believe urinary/urethral catheters do not cause MDR pressure ulcers. This represents a critical outcome in terms of nursing care and may be attributed to nurses’ lack of awareness of the possible risks of these devices.

The current authors believe nurses have the responsibility to conduct head-to-toe skin inspections and to check medical devices. Ong et al²¹ reported a case where pressure ulcers developed in a patient because a compression stocking was improperly folded at the popliteal fossae; this inappropriate care was traced to an improper fitting of the stocking. Sivaraman Nair et al²² reported 2 cases where improperly positioned and fixed indwelling urethral catheters caused a Stage 2 pressure ulcer between the thighs.

In the current research, 79% of the participating nurses said they inspected the area beneath the medical device for pressure damage. In a prospective, epidemiological study by Compton et al,²³ regular skin inspections performed by nurses could be more effective in determining pressure ulcer risk than specific objective data used for the diagnosis of pressure ulcers. Several researchers have proposed that regular skin inspection is important for both non-MDR as well as MDR pressure ulcers.^3,5,24 Another finding with regard to skin inspection is that 77.4% of nurses knew to take special care to avoid placing medical devices where skin integrity has been compromised and, when possible, to place devices in a manner that avoids contact with the skin. When the medical condition of the patient allows, it is recommended that skin around and beneath devices be inspected at least twice a day.¹⁷

In this study, most of the nurses stated they inspected the skin at least once every shift by loosening devices such as splints, corsets, nasal cannulas, and SpO2 probes when the medical condition of the patient allowed it (80%) and ensured medical devices were not tightly fixed and were repositioned during every nursing shift (63.2%). In addition, because the most basic factor with respect to the prevention of pressure ulcer is the definition and elimination of the cause of the pressure, it is essential to remove the medical devices as early as possible to minimize the risk of MDR pressure ulcer development. A prospective, descriptive study conducted by Powers et al⁸ demonstrated that skin breakdown increased with the number of days of cervical collar wear (P<.0001). Coyer et al² showed that while the average number of medical devices per patient is 7.6, patients in whom MDR pressure ulcers develop had an average number of 8.6 devices.

Medical devices made of hard materials and that are improperly positioned on the skin increase pressure and friction, increase the risk of pressure ulcers,^5,18 and account for frequent peristomal skin complications.²⁵ Therefore, it may be essential for patients with a tracheostomy, colostomy, or other type of stoma that the peristomal area be inspected at every shift for indications of pressure ulcers. Among the nurses participating in the research, 72.4% stated they regularly inspected the peristomal area at every shift for probable inflammation and pressure ulcer development. In particular, tracheostomy tubes can compromise skin integrity because of the continuous pressure and moisture created by perspiration-respiration secretions.²⁴ Descriptive pilot research by Jaul⁹ (N = 32) demonstrated 4 pressure ulcers occurred around the neck at the edges of a tracheostomy tube. In the study by Boesch et al²⁴ (N = 834), 100 tracheostomy-related pressure ulcers occurred — among them, 14% were Stage 1, 50% were Stage 2, and 36% were Stage 3 ulcers. Most (73%) pressure ulcers developed around the stoma and 4% formed under twill ties.

Placement of protective supporting materials such as gel pads, film dressings, sprays, and foam dressings at areas where medical devices contact the skin has been shown to decrease the risk of MDR pressure ulcers.⁵ Dressing materials can be placed underneath medical devices at areas of risk such as ears and noses. In this research, 78.5% of nurses stated “they are using supportive or protective dressing materials where medical devices and fixing elements are placed” to protect new pressure injuries. The study by Acorda¹⁰ reported that placing supporting foam materials such as Mepilex (Mölnlycke Health Care, Norcross, GA) between the mask and skin in patients receiving bilevel positive airway pressure therapy gradually reduced the prevalence of pressure ulcers to 0. Weng¹⁴ conducted a quasi-experimental study (N = 90) using protective dressing materials in noninvasive ventilation treatment to examine the effects of lack of protective materials on the development of pressure ulcers. The research found that while Stage 1 pressure ulcers developed at a rate of 96.7% in the group not using protective materials, the rate of development was reduced to 53.3% and 40% in the groups where protective materials were used. The study also showed pressure ulcers developed in a much shorter time. Pressure ulcers developed in 1 group where no protection and 2 groups where protection was provided in 1111 ± 2169 minutes, 2628 ± 1655 minutes, and 3272 ± 2566 minutes, respectively (P<.01).

Limitations

Because the study population did not include nurses serving in pediatric units, those not serving in adult inpatient units, those who serve in inpatient units but do not provide patient care service, and those who hold an executive position, generalizations from this research are limited. In addition, the researchers did not observe the interventions provided by the nurses in connection with MDR pressure ulcers; the results of the study are solely based on the statements of the participating nurses, whose perceptions of the extent of their care may not have been accurate.

Conclusion

A prospective, descriptive study to assess nurses’ perception and implementation of measures to prevent MDR pressure ulcers indicated nurses provide preventive interventions at a rate of at least 60%. However, 19.9% of the nurses did not think medical devices can cause pressure ulcers. In light of the fact MDR pressure ulcers are increasingly recognized, comprehensive inservice training programs on MDR pressure ulcers need to be organized in health care institutions to inform nurses and enhance their awareness about prevention of MDR pressure ulcers caused by medical devices. Additionally, observation-based research on nurse provision of evidence-based practices for patient care of MDR pressure ulcers is warranted.

References

1. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Washington, DC: National Pressure Ulcer Advisory Panel, 2009. Available at: www.npuap.org/resources. Accessed October 10, 2015.

2. Coyer FM, Stotts NA, Blackman VS. A prospective window into medical device-related pressure ulcers in intensive care. Int Wound J. 2014;11(6):656–664.

3. Black JM, Cuddigan JE, Walko MA, Didier LA, Lander MJ, Kelpe MR. Medical device related pressure ulcers in hospitalized patients. Int Wound J. 2010;7(5):358–365.

4. Flodgren G, Conterno LO, Mayhew A, Omar O, Pereira CR, Shepperd S. Interventions to improve professional adherence to guidelines for prevention of device-related infections. Cochrane Database Syst Rev. 2013;(3):CD006559.

5. Dyer A. Ten top tips: preventing device-related pressure ulcers. Wounds Int J. 2015;6(1):9–13.

6. Fletcher J. Device related pressure ulcers made easy. Wounds UK. 2012;8(2):1–4.

7. Ham HW, Schoonhoven LL, Galer AA, Shortridge-Baggett LL. Cervical collar-related pressure ulcers in trauma patients in intensive care unit. J Trauma Nurs. 2014;21(3):94–102.

8. Powers J, Daniels D, McGuire C, Hilbish C. The incidence of skin breakdown associated with use of cervical collars. J Trauma Nurs. 2006;13(4):198–200.

9. Jaul E. A prospective pilot study of atypical pressure ulcer presentation in a skilled geriatric nursing unit. Ostomy Wound Manage. 2011;57(2):49–54.

10. Acorda DE. Nursing and respiratory collaboration prevents BiPAP-related pressure ulcers. J Pediatr Nurs. 2015;30(4):620–623.

11. Hogeling M, Fardin SR, Frieden IJ, Wargon O. Forehead pressure necrosis in neonates following continuous positive airway pressure. Pediatr Dermatol. 2012;29(1):45–48.

12. Wille J, Braams R, van Haren WH, van der Werken C. Pulse oximeter-induced digital injury: frequency rate and possible causative factors. Crit Care Med. 2000;28(10):3555–3557.

13. Hanönü S, Karadağ A. A prospective, descriptive study to determine the rate and characteristics of and risk factors for the development of medical device-related pressure ulcers in intensive care units. Ostomy Wound Manage. 2016;62(2):12–22.

14. Weng MH. The effect of protective treatment in reducing pressure ulcers for non-invasive ventilation patients. Intensive Crit Care Nurs. 2008;24(5):295–299.

15. Schlüer AB, Cignacco E, Müller M, Halfens RJ. The prevalence of pressure ulcers in four paediatric institutions. J Clin Nurs. 2009;18(23):3244–3252.

16. VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009;55(11):39–45.

17. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Perth, Australia: Cambridge Media; 2014. Available at: www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Referenc.... Accessed July 3, 2017.

18. Makic MBF. Medical device-related pressure ulcers and intensive care patients. J Perianesth Nurs. 2015;30(4):336–337.

19. Nuru N, Zewdu F, Amsalu S, Mehretie Y. Knowledge and practice of nurses towards prevention of pressure ulcer and associated factors in Gondar University Hospital, Northwest Ethiopia. BMC Nurs. 2015;14:34.

20. Demarré L, Vanderwee K, Defloor T, Verhaeghe S, Schoonhoven L, Beeckman, D. Pressure ulcers: knowledge and attitude of nurses and nursing assistants in Belgian nursing homes. J Clin Nurs. 2012;21(9-10):1425–1434.

21. Ong JC, Chan FC, McCann J. Pressure ulcers of the popliteal fossae caused by thromboembolic deterrent stockings (TEDS). Irish J Med Sci. 2011;180(2):601–602.

22. Sivaraman Nair KP, Taly AB, Roopa N, Murali T. Pressure ulcers: an unusual complication of indwelling urethral catheter. Spinal Cord. 2001;39(4):234–236.

23. Compton F, Hoffmann F, Hortig T, et al. Pressure ulcer predictors in ICU patients: nursing skin assesment versus objective parameters. J Wound Care. 2008;17(10):417–420, 422-424.

24. Boesch RP, Myers C, Garrett T, et al. Prevention of tracheostomy-related pressure ulcers in children. Pediatrics. 2012;129(3):e792–e797.

25. Karadağ A, Korkut H. Peristomal cilt komplikasyonları: önleme, tedavi ve bakım. Ulusal Cerrahi Dergisi. 2010;26(3):175–179.

Potential Conflicts of Interest: This information contained in this article was presented at The European Wound Management Association Conference, May 11–13, 2016, Bremen, Germany.

Dr. Karadag is a professor, Koç University School of Nursing, Istanbul, Turkey. Ms. Hanönü is a doctoral student, Gazi University Institute of Health Sciences, Department of Nursing, Ankara, Turkey. Ms. Eyikara is a research assistant, Gazi University Faculty of Health Sciences, Department of Nursing, Ankara, Turkey. Please address correspondence to: Evrim Eyikara, MSN, Research Assistant, Department of Nursing, Faculty of Health Sciences, Gazi University, Ankara, Turkey; email: evrimeyikara@gmail.com

Section:

Issue Number:

Index:

Ostomy Wound Management 2017;63(10):42–47 doi:10.25270/owm.2017.4247

Barbara Pieper, PhD, RN, CWOCN, ACNS-BC, FAAN; Janean Monahan, PhD, RN; Mary Kathryn Keves-Foster, MSN, RN; Julia Farner, DNP, BSN, RN, HHP; Dalia Alhasanat, PhD, BSN, RN; and Maha Albdour, PhD, RN, APHN-BC

Topics:

assessment

nursing

process

nursing education research

Wounds

Abstract

Nursing education research is lacking with regard to nursing care plans for patients who have a wound and use of the nursing diagnosis impaired skin integrity. The purpose of this quality improvement project was to inform teaching about nursing care planning for patients with wounds by examining what first-year nursing students attending a fundamentals of nursing course in a Bachelor of Science in Nursing program included in a nursing process assignment when caring for an assigned patient who had an acute or chronic wound.

Because they were in their clinical rotation, students had access to the patients’ medical records to facilitate composing the care plan; they also could ask the patient for information. Assessment data were entered on a predetermined form based on Gordon’s Functional Patterns. Using this information, students had to provide 3 possible diagnoses and select 1 upon which they developed the care plan intended to include patient description, wound description, dressing, and nursing diagnoses and impressions. The forms then were analyzed for assessment completeness. Thirty-eighty (38) care plans completed by students were collected on patients that included 23 men and 28 African-Americans; mean age of the patients was 60.11 ± 14.17 (range 20–87) years. Wounds included 25 surgical incisions, 4 pressure ulcers/injuries, 7 “other” wounds, and 2 not identified. None of the students’ assessments provided a detailed wound description. The most common wound descriptors were location (n =19) and drainage (n = 15). For 8 patients, students stated the wound was covered by a dressing. Thirty (30) nursing diagnoses were listed. The most common nursing diagnoses were impaired physical mobility or activity intolerance, impaired comfort, impaired skin integrity, imbalanced nutrition, and risk for infection. These nursing students had beginning skills in patient and wound assessment and writing nursing care plans about patients with impaired skin integrity. Students need to increase their depth of wound assessment and need more experience planning care for patients with wounds.

A wound is an injury to tissue caused by severing or impact; typically, the skin is cut or broken. A wound may be the result of surgery or an acute or complex health care problem. Approximately 51.4 million inpatient surgical procedures and 17 million outpatient surgeries, many of which include an incision, are performed in the United States each year; plus, 6.5 million patients have chronic wounds (eg, pressure injury, venous ulcer, diabetic neuropathic foot ulcer).^1-3 Thus, a wound is a common occurrence in health care.

Because nurses have a critical role in assessing, planning, and implementing care for patients with wounds, nursing students need to learn nursing care planning as it applies to patients with wounds. A plan for nursing care provides direction for the nursing team to individualize care and help patients meet their health goals. Publications^4-6 that address the nursing process note a nursing care plan: 1) helps with continuity of patient care and is compatible with the interdisciplinary team’s plan of care; 2) helps direct documentation; 3) is a guide for assigning staff to care for patients; 4) is responsive to the individual needs of patients and is culturally appropriate; 5) is based on scientific principles and incorporates research; 6) addresses patient discharge; and 7) has a developmental, psychosocial, spiritual, and physiologic focus.

Nursing care plan writing generally starts in beginning nursing courses and is a critical and indispensable part of nursing education. Instructors have observed learning to write a nursing care plan can be demanding and stressful for their students.⁷ The purpose of this quality improvement project was to examine what details first-year nursing students included in a nursing care plan assignment when a patient had an acute or chronic wound. The results of this project will be used to inform teaching about nursing care planning for patients with wounds and reinforce the importance of wound assessment.

Literature

There is not a great deal of research about nursing education with regard to nursing care plans for patients with wounds or the use of the nursing diagnosis impaired skin integrity. When impaired skin integrity is mentioned, it is often 1 of several variables of a nursing care plan project. For example, in their intervention study in Sweden, Falk and Bjorvell⁸ included impaired/risk skin integrity and risk for pressure injury. The study was not about wounds per se, but whether the use of the North American Nursing Diagnosis Association (NANDA) classification⁹ affected nursing students’ choice of nursing interventions. Thirty-three (33) nursing students assigned to an orthopedic unit participated; the intervention group (n = 19) had access to the NANDA classification textbook and attended a presentation on the subject while the comparison group (n = 14) did not. Nursing diagnoses/interventions about skin — namely, impaired/risk skin integrity and risk for pressure injury — were listed for 22 of 97 interventions (22.7%) in the intervention group and for 33 of 121 interventions (27.2%) in the comparison group. Both groups were similar in the frequencies of nursing diagnoses and interventions. The authors concluded nursing students were able to analyze patient data and formulate nursing care plans.

In a descriptive study, Can and Erol⁷ assessed the self-perceived levels of nursing students (N = 55) regarding their sufficiency at preparing patient care plans and determined the effects of nursing care plans on students’ occupational development. Self-perceived sufficiency was described as the student’s self-rating of ability to perform patient assessment, identify nursing diagnoses, and prepare nursing care plans. The study took place during oncology training in Turkey. Students completed a demographic form and a 40-question, self-perceived sufficiency form about all aspects of nursing care plans; 67.3% of students said they were capable of determining nursing diagnosis criteria for the skin and 63.6% were comfortable determining nursing diagnosis regarding direction of patient assessment when skin was a factor. The correlations between the patient’s assessment for skin and components of nursing care plans were significant for the aim, nursing interventions, evaluation, and nursing record (r = .33 to .50). Among the participating students, 60% reported that preparing and implementing nursing care plans had positive effects on their occupational development. They encouraged educators to think about the best curricular timing for teaching nursing care plans. Nursing care plan knowledge needs to be reviewed and used in a practical way to enhance occupational development.

Turk et al¹⁰ performed a descriptive study to determine nursing diagnoses that freshman nursing students used in their first clinical practice course in Turkey. Data were collected from 208 care plans developed by 61 nursing students. They used domains of Taxonomy II North American Nursing Diagnosis Association – International⁹(NANDA-I). The study found students identified 31 different diagnoses in 9 domains of NANDA-I. The most common domains were safety/protection, activity/rest, comfort, elimination and exchange, and nutrition. The most-used nursing diagnoses were risk of infection, acute pain, constipation, disturbed sleep pattern, anxiety, activity intolerance, impaired physical mobility, and risk of trauma. Risk for impaired skin integrity (2.7%) and impaired skin integrity (1.4%) were infrequently listed. The study authors concluded beginning students had insufficient knowledge about diseases and thus were not able to make holistic assessments of their patients. The students’ nursing diagnoses also were affected by their beginning assessment and novice critical thinking skills.

In a descriptive study in Turkey to determine use of and opinions regarding nursing diagnoses, Yönt et al¹¹ used a vignette developed by faculty to reflect content taught to 32 first-year students in the first semester. Students identified 15 out of the 18 predetermined nursing diagnoses for the vignette. The most frequently identified diagnoses were disturbed sleep pattern, nutritional imbalance, constipation, chronic pain, and anxiety. Impaired skin integrity was identified by 16 students (50%). A description of the vignette was not presented for comparison/accuracy; without this information, it was difficult to determine whether the nursing diagnosis about impaired skin integrity was critical to the patient’s plan of care. The authors concluded students were knowledgeable regarding commonly used nursing diagnoses even though they had limited clinical experience and recommended use of case study vignettes in nursing education.

Karadaq et al¹² compared the effects of using case studies and simulated patients in teaching 70 second-year nursing students in Turkey to plan their nursing care; these instructional approaches were believed to help students develop their critical thinking and problem-solving skills and transfer theory into practice. The case used in the study described a patient with spinal cord trauma. The students were placed into 2 equal groups using either the case study or simulation teaching method. Impaired skin integrity was one of the most commonly identified nursing diagnoses, and the majority of nursing diagnoses involved physiological versus psychosocial problems. The students in the simulation group identified more nursing diagnoses and interventions than those in the case study group (33 versus 20). The 2 methods did not differ significantly on contributing to planning care or interventions. Students’ perceptions were that the simulated patient experience contributed significantly more to learning than the case study.

To summarize, a limited amount of research has addressed students’ development of nursing care plans for patients who have wounds. However, patients with acute or chronic wounds are present in all health care settings and students need to plan care for them. Studies reported inconsistent findings regarding beginning students’ ability to perform holistic assessments and identify nursing diagnoses. For example, students were reported to be comfortable assessing the skin^7,12 but a nursing diagnosis about impaired skin integrity was infrequently included in their plans of care.^8,10 Because they had only beginning assessment and critical thinking skills, students experienced stress when learning care planning and may need the content repeated in subsequent nursing courses.⁷ Simulated patient experiences were effective in teaching care planning.¹²

Nursing education continues to evolve in terms of teaching strategies such as classroom hours, exposure to patients with varied health care needs, and use of case studies and simulations. Strengthening components of the nursing curriculum in terms of the nursing process may help nursing students increase their confidence and ability to work with patients with wounds.

This quality improvement project was conducted to inform teaching about nursing care planning for patients with wounds and to reinforce with students the importance of wound assessment by examining what first-year nursing students in a Bachelor of Science in Nursing program included in a nursing care plan assignment when caring for an assigned patient with a wound in an acute care setting.

Nursing Process Educational Experience During First-year Nursing Courses

Students in their first-year of nursing courses at an urban, research-intensive university received content related to the nursing process/nursing care plans in 2 courses: a professional development course and a fundamentals of nursing course. Both courses used the same textbook for content regarding the components of the nursing process. Faculty from both courses shared information regarding what the students were taught. The professional development course has 5, 1-hour lectures about the nursing process as well as practice with case studies. The fundamentals course includes 1) a theoretical/lecture component, 2) skills laboratory practice, and 3) clinical practice (1 day per week).

During the theoretical/lecture component of the course, students received 3 lecture hours about wounds and their care that included surgical incisions and pressure ulcers/injuries as the wound prototypes. The lecture content included photographs and discussed aspects of wound assessment such as wound type, location, size, depth, drainage, odor, induration, erythema, and infection.

The Skills Laboratory included a 1-hour DVD about wound care and practice with changing a dressing on an incision as well as information regarding the care of wound drains, irrigation, and wound packing. The Skills Laboratory was used for skill practice and was faculty-taught. By the end of the semester, students had to perform certain skills at a passing level.

The nursing process assignment with a patient was part of clinical practice. Students had clinical experiences in 1 of 3 acute care hospitals on medical/surgical units. During clinical practice, 6 hours were reserved for content, discussion, and practice with the nursing process. The nursing process content was presented to all students by the same clinical teacher for consistency. For practice, faculty gave students a case study of a patient and questions to answer about that case study. Based on that assessment and analysis of problem areas of the case study, students wrote their first care plan. After practice with the case study, students completed a detailed assessment and nursing care plan for 1 of their assigned patients in the hospital setting. The care plan exercise involving an assigned patient in the hospital was done 1 time at the end of the course.

Study Methods

Because this was a quality improvement project (not a human subjects research study), it was not necessary to request Institutional Review Board approval. The authors assessed a component of an internal educational program in terms of beginning nursing students’ use of the nursing process. Faculty examined students’ use of the nursing process for patients with wounds and improved the course in terms of wound assessment information and use of the nursing process.

This project was developed and conducted by the faculty of Wayne State University who taught fundamentals of nursing during the Fall 2015 and Winter 2016 semesters. Data were extracted from the students’ nursing care plans and analyzed in terms of components of wound assessment and care and nursing diagnoses. Student names were covered with a permanent marker or cut off to ensure confidentiality.

Across 2 semesters, 7 instructors taught 126 students in a clinical setting. A copy of each care plan submitted was duplicated before being returned to students. Of the 126 care plans submitted, 80 (63.5%) were available for analysis; of these, 46 were discarded because pages were missing, incorrect components of the nursing care plan were duplicated, and/or care plans were returned to the student before duplication.

Care plan components. The care plan was part of the syllabus and included several sections/components. The introduction included general information about the patient in terms of medical diagnoses, surgical history, and demographics. The assessment section was based on Gordon’s Functional Patterns.¹³ Students were required to describe the patient in terms of 10 functional patterns. Information about wounds was located in the nutrition/metabolism skin/wound pattern. The functional pattern was accompanied by information the student should consider in the patient’s assessment for that pattern and was included as a sidebar on the form. The information on the form was not all-inclusive but rather used to prompt the student to consider what to include. The students were asked to provide information about the patient’s diagnostic tests and medications and summarize content about the patient as nursing impressions. Finally, students were to provide what they thought were the top 3 nursing diagnoses and select 1 upon which to develop their care plans. Typically, the students took this information home and had 1 week to complete the assignment.

Care plan analysis. Components of the nursing care plan were analyzed by 2 of the study authors and assessed for inclusion of patient demographic information (ie, age, race, and gender); wound type and description (ie, location, size, drainage, granulation, epithelialization, necrotic tissue, induration, and erythema); signs/symptoms of infection; and wound treatment/dressing. The 3 nursing diagnoses listed for patients with wounds were written/recorded on a paper and counted. Data were tabulated/recorded in Excel and imported into IBM SPSS (Armonk, NY). Descriptive statistics were used to determine the presence/response to each item on the assessment form and mean ± SD for age.

Results

Patient description. Of the 80 patients with nursing care plans (23 men [60.5%], 28 African American [73.68%], mean age 60.11 ± 14.17 (range 20–87) years, 38 (47.5%) had a wound. Twenty-five (25) patients (65.8%) had surgical incisions, 4 (10.5%) had pressure ulcers/injuries, and 7 (18.4%) were other wounds (eg, stab, laceration, or burn) (see Table 1).

Wound description. None of the students’ assessments provided a detailed wound description. The most common wound descriptors were location (19) and drainage (15), followed by signs/symptoms of infection (6) and wound size (6). The presence or absence of granulation tissue (2) or necrotic tissue (2) was infrequently mentioned; none of the assessments reported epithelialization.

Dressing. For 8 patients (21.1%), students stated the wound was covered by a dressing: 3 wounds were covered with gauze, 1 with xeroform and petrolatum dressing, and in 2 triple antibiotic ointment was used. The most common treatment was negative pressure wound therapy (4).

Nursing diagnoses and impressions. Thirty (30) nursing diagnoses for the patients with wounds were listed. The most common nursing diagnoses were impaired physical mobility or activity intolerance (17), impaired comfort (14), impaired skin integrity (13), nutrition imbalance (7), and risk for infection (6) (see Table 2).

Twenty (20) students (52.6%) mentioned the wound when recording their nursing impressions. The most common nursing impression was the need to teach about the wound (3). Only 3 students opted to write their nursing care plan about the nursing diagnosis of impaired skin integrity; their patients had pressure ulcers/injuries.

Discussion

Clinical practice is one of the most anxiety-producing components of nursing education⁷— in part because learning to develop nursing care plans takes time. Comprehensive patient assessment is important for care planning; nursing students need multiple opportunities to develop nursing care plans for patients with wounds because the care plan may guide the patient care team. The purpose of this quality improvement project was to examine what first-year nursing students included in a nursing process assignment when a patient had an acute or chronic wound. The authors examined how students identified and described the wound and related nursing diagnoses. This was the students’ first nursing care plan assignment for an acutely ill, hospitalized patient. Even though students had received lecture content about wounds, their descriptions of the wound and wound care were poor. Multiple nursing diagnoses were identified; only 3 students developed the nursing care plan around the wound-related nursing diagnosis.

In this study, surgical incisions were the most common wound. To improve documentation, nursing students need an understanding of the assessment of the surgical patient.⁸ Clinical instructors assert postoperative assessment of the patient needs to include the incision as part of diagnostic reasoning; the incision’s description is crucial. Educators plan to reinforce the importance of surgical incision assessment in future semesters.

Wound descriptions are needed to document a patient’s level of care and identify patient self-care needs. Insufficient assessment of the wound can lead to failure of the problem-solving process for the patient.⁷ Wound descriptions by students in this study lacked depth of discernment. Content about wound description was part of the lecture component of the course; students need to integrate lecture and textbook content into clinical practice. During the lecture component of the course, a greater focus was placed on wound assessment than previously. Opportunities for practice describing wounds also can be provided in post-clinical conferences, learning laboratories, and other simulated experiences. Where necessary, faculty can provide pictures of wounds for students to practice writing wound descriptions, share these descriptions in class, and learn how to improve their notations. In this study, care plan forms were improved by adding more wound descriptors to the nutrition/metabolism skin/wound pattern portion of the form.

Students rarely mentioned wound dressings or treatments in their nursing care plans. The type of dressing and wound care will affect instruction of the patient and family regarding at-home care. Including wound care and dressings in care planning is important for documentation and for facilitating the support of continuity, quality, and safe care.¹³ As a result of this study, faculty enhanced their teaching about wound dressings and treatments. Students are encouraged to interact and question nurses and wound care specialists about dressings and treatments.

Generally, students participating in this project did not include a skin integrity nursing diagnosis in their nursing care plan. Learning to write and use nursing diagnoses can be difficult. The study by Yönt et al¹⁴ found determining an appropriate nursing diagnosis and developing a nursing process from data collected were the most difficult areas for nursing students. Approximately 32% of students were able to identify a patient problem and state a nursing diagnosis; 32% had difficulty stating patient care needs when using a nursing diagnosis. The most commonly used nursing diagnoses included pain, knowledge deficit, constipation, anxiety, and insufficient nutrition for body requirements. Impaired skin integrity was not mentioned.^11,14 In contrast, Karadag et al¹² reported impaired tissue integrity as one of the most common nursing diagnoses noted by nursing students.

Nursing faculty must prepare students to care for patients with acute clinical problems in a constantly changing health care environment.¹² Nursing faculty must balance assignments in terms of course content/objectives, experiences that students need, experiences available, and experiences students have had. Nursing instructors try to provide students exposure to and experience with providing care to patients with varying illnesses and levels of care needs. In this project, students may have provided care to patients with wounds during the course but not when the care plan assignment was due. The current authors did not ascertain how many other patients with wounds received care from the students, what nursing diagnoses were identified for those patients, how different patients were discussed with the instructor, or what students recorded about the wound on the medical record. Because of previous clinical experiences involving patients with wounds and the desire to broaden learning experiences, the student may have selected a nursing diagnosis other than skin integrity for the nursing care plan assignment. Faculty need to examine the findings and decide how to best incorporate more depth in wound care assessment. These data showed students need practice assessing wounds and documenting their findings. Possibly a skill laboratory practicum could require students to document their wound assessment after they completed wound care on a mannequin. Results of this project need to be shared with faculty teaching students in their junior and senior years. Learning is a growth process, and students should be held accountable for greater depth in use of the nursing process and documentation of patient care as they progress through the program.

As a result of this study, faculty have helped students understand what is included in a comprehensive wound description and wound treatment/dressing. Faculty carefully read and grade care plans and hold students accountable for accuracy and depth of content. Students’ learning expectations should be continued into subsequent courses so learning goals can incrementally increase. Faculty have used findings from this project to improve both the lecture component of the course and the cues for wound description on the nursing process form.

Limitations

This quality improvement study had limitations. Nursing care planning for patients with wounds was examined in only 1 course; how students enhanced their knowledge about wound assessment, nursing diagnoses, and care plans in subsequent courses is not known. The number of patients with wounds was small, thus making generalizations about depth of content difficult. In addition, the number of nursing process papers discarded because of missing data was high.

Conclusion

Professional nursing education is based on knowledge for critical thinking and decision- making.^7,15 Nursing students in this quality improvement study had beginning skills in writing nursing care plans about impaired skin integrity: wounds were poorly described and reports rarely stated if a dressing was present. Other researchers have noted insufficient and scattered documentation about wound care.^16-18 Because this was the students’ first clinical course and exposure to nursing process and nursing diagnosis, they hopefully will progress in depth of assessment and its application to care planning. Learning the steps of the nursing process takes time. Addressing the development and implementation of nursing care plans during clinical experiences allows students to integrate theoretical knowledge into practice and develop their skills to provide quality nursing care. n

References

1. Centers for Disease Control and Prevention. Inpatient Surgery. Available at: www.cdc.gov/nchs/fastats/inpatient-surgery.htm. Accessed May 12, 2015.

2. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009;17(6):763–771.

3. Wier LM, Steiner CA, Owens PL. Surgeries in Hospital Owned Outpatient Facilities. HCUP Statistical Brief #188. Agency for Health Care Research and Quality, 2015. Available at: http://h.cup-us.ahrq.gov/reports/statbriefs/sb188-Surgeries-Hospital-Out.... Accessed October 3, 2016.

4. Taylor CR, Lillis C, Lynn P, LeMone P. Outcome identification and planning. In: Taylor CR, Lillis C, Lynn P, LeMone P. Fundamentals of Nursing: The Art and Science of Person-Centered Nursing Care. Philadelphia, PA: Wolters Kluwer/Lippincott Williams Wilkins;2015;275–301.

5. RN Central. What is a Nursing Care Plan and Why is it Needed? Available at: http://www.rncentral.com/nursing-library/careplans/. Accessed July 26, 2016.

6. American Nurses Association. The Nursing Care Plan. Available at: www.nursingworld.org/EspeciallyforYou/StudentNurses/Thenursingprocess.aspx. Accessed July 26, 2016.

7. Can G, Erol O. Nursing students’ perceptions about nursing care plans: a Turkish perspective. Int J Nurs Pract. 2012;18(1):12–19.

8. Falk J, Björvell C. Does the use of a classification for nursing diagnoses affect nursing students’ choice of nursing interventions? Nurs Inform. 2012. 2012;2012:108.

9. Herdman TH, Kamitsuru S. NANDA International Nursing Diagnoses: Definitions and Classification 2018-2020, 11th ed. Stuttgard, Germany: Thieme Medical Publishing;2016.

10. Türk G, Tugrul E, Sahbaz M. Determination of nursing diagnoses used by students in the first clinical practice. Int J Nurs Knowl. 2013;24(3):129–133.

11. Yönt GH, Korhan EA, Erdemir F, Müller-Staub M. Nursing diagnoses determined by first year students: a vignette study. Int J Nurs Knowl. 2014;25(1):39–42.

12. Karadag M, Caliskan N, Iseri O. Effects of case studies and simulated patients on students’ nursing care plan. Int J Nurs Knowl. 2016;27(2):87–94.

13. Taylor C, Lillis C, Lynn P, LeMone P. Assessing. In: Taylor C, Lillis C, Lynn P, LeMone P (eds). Fundamentals of Nursing. The Art and Science of Person-Centered Nursing Care. Philadelphia, PA: Wolters Kluwer;2014:240.

14. Keenan GM, Yakel E, Tschannen D, Mandeville M. Documentation and the nurse care planning process. In: Hughes RG (ed). Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, MD: Agency for Healthcare Research and Quality; 2008. Available at: www.ncbi.nlm.nih.gov/books/NBK2674/. Accessed July 26, 2016.

15. Yönt GH, Khorshid L, Eser I. Examination of nursing diagnoses used by nursing students and their opinions about nursing diagnoses. Int J Nurs Terminol Classif. 2009;20(4):162–168.

16. Ballantyne H. Developing nursing care plans. Nurs Stand. 2016;30(26):51–60.

17. Ehrenberg A, Birgersson C. Nursing documentation of leg ulcers: adherence to clinical guidelines in a Swedish primary health care district. Scand J Caring Sci. 2003;17(3):278–284.

18. Gunningberg L, Lindholm C, Carlsson M, Sjödén PO. The development of pressure ulcers in patients with hip fractures: inadequate nursing documentation is still a problem. J Adv Nurs. 2000;31(5):1155–1164.

Potential Conflicts of Interest: none disclosed

Dr. Pieper is a Professor/Nurse Practitioner; Dr. Monahan is an Assistant Professor, Clinical; Ms. Keves-Foster and Dr. Farner are clinical instructors; and Dr. Alhasanat and Dr. Albdour are Assistant Professors, College of Nursing, Wayne State University, Detroit, MI. Please address correspondence to: Barbara Pieper, PhD, RN, CWOCN, ACNS-BC, FAAN, College of Nursing, Wayne State University, 5557 Cass Avenue, Detroit, MI 48202; email: bapieper@comcast.net.

Section:

Issue Number:

Index:

Ostomy Wound Management 2017;63(10):48–55 doi: 10.25270/owm.10.4855

Ayelet Levy, MSc; and Amit Gefen, PhD

Topics:

laboratory research

Pressure Ulcer

Prevention

Dressings

Abstract

The sacrum is the most susceptible anatomical site for developing pressure injuries, including deep tissue injuries, during supine lying. Prophylactic dressings generally are designed to reduce friction, alleviate internal tissue shear, manage the microclimate, and overall cushion the soft tissues subjected to sustained deformations under the sacrum. Using computational modeling, the authors developed a set of 8 magnetic resonance imaging-based, 3-dimensional finite element models of the buttocks of a healthy 28-year-old woman for comparing the biomechanical effects of different prophylactic sacral dressing designs when used during supine lying on a standard hospital foam mattress.

Computer simulation data from model variants incorporating an isotropic (same stiffness in every direction) multilayer compliant dressing, an anisotropic (directionally dependent stiffness properties) multilayer compliant dressing, and a completely stiff dressing were compared to control (no dressing). Specific outcome measures that were compared across these simulation cases were strain energy density (SED) and maximal shear stresses in a volume of interest (VOI) of soft tissues surrounding the sacrum. The SED and shear stress measurements were obtained in pure compression loading of the buttocks (ie, simulating a horizontal supine bed rest) and in combined compression-and-shear loads applied to the buttocks (ie, 45˚ Fowler position causing frictional and shear forces) on a standard foam mattress. Compared to the isotropic dressing design, the anisotropic dressing facilitated more soft tissue protection through an additional 11% reduction in exposure to SED at the VOI. In this model, use of the anisotropic compliant dressing resulted in the lowest exposures to internal tissue SED and shear stresses. Research to examine the clinical inference of this modeling technique and studies to compare the effects of prophylactic dressings on healthy volunteers and patients in different positions are warranted.

A pressure ulcer (PU), now termed a pressure injury (PI) in the United States, is defined in the international guidelines¹ as a localized injury to the skin and/or underlying tissues, usually over a bony prominence, resulting from sustained pressure (including pressure associated with shear). The soft tissues around the sacrum are known to be the most common anatomical site for patients to develop a PU while in bed.² During prolonged supine bed rest, the weight of the lower trunk and pelvis is transferred through the pelvic bones to the mattress, subjecting subcutaneous fat and skin tissues under the sacrum to sustained intensified deformations. In cases where impaired mobility, sensitivity, or both are present, these sustained tissue deformations may exceed tissue tolerance levels, increasing the risk for PUs and particularly for a deep tissue injury (DTI), which is especially dangerous due to the potential extent of tissue damage.³ Because the sacrum is a major body weight-bearing site for a supine patient, and the sacral bone is not only rigid but also highly curved (almost “sharp”), the soft tissues in the sacral area are extremely susceptible to compressive tensional and shear loads. As shown by magnetic resonance imaging (MRI) and computer modeling studies, shear, which is naturally present in deformed soft tissues due to the complex curved anatomy and stiffness gradients between hard/soft and layered tissue structures, is substantially magnified when a patient is positioned in a Fowler position and starts sliding down in bed, during repositioning, or when spontaneous movements occur.⁴

Minimizing magnitudes and exposure durations of mechanical compression and shear loads in soft tissues during weight-bearing, as well as reducing friction, have long been the main goals in PU prevention and management.^1,4,5 According to clinical guidelines,¹ conventional sacral PU prevention strategies mainly include manual periodical repositioning and use of pressure-redistributing mattresses, either static or alternating air pressure-based, which are designed to cushion the body of the patient and thereby minimize localized increased contact pressures between the skin and the support surface. However, several critical concerns are relevant regarding this approach; for example, how can it be determined whether reduced focal contact pressures on the skin also improve the mechanical state of the deep soft tissues in the context of DTI prevention? In addition, the effects of shearing forces that act on the internal soft tissues under the sacrum have not been evaluated for different prophylactic dressing designs. This is specifically relevant during manual repositioning or when a patient slides down in bed when the head of the bed is elevated due to gravity.

The use of dressings as preventive (prophylactic) measures is a relatively new concept that is attracting attention in academia, medical settings, and the industry worldwide.⁶ Sacral prophylactic dressings generally are designed to reduce friction and shear with the mattress, manage the microclimate of the skin by maintaining an appropriate humidity level, and redistribute pressure by adding a layer of soft, cushioning materials between the skin and the mattress.⁶ In the past few years, several clinical studies^7,8 have demonstrated the efficacy of prophylactic dressings. For example, Santamaria et al⁷ showed significantly fewer patients developed PUs in the intensive care unit when prophylactic heel and sacral dressings were applied in the emergency department, compared to when dressings were not used prophylactically (5 versus 20 patients, P = .001). Other evidence regarding the biomechanical effects of prophylactic dressings has been generated based on laboratory testing of shear and frictional properties.^9-12 Ohura et al¹⁰ used an experimental model consisting of porcine skin embedded with a force/shear sensor that demonstrated shear forces in the subcutaneous layer were reduced to within 31% to 45% when dressings were used, compared to a no-dressing scenario. Previously published mechanical studies^13,14 from the current authors’ group have shown biomechanical efficacy of compliant multilayer heel dressings (the Mepilex® Border Heel dressing [Mölnlycke Health Care, Gothenberg, Sweden] design) by means of computational finite element (FE) modeling. Briefly, the FE method is a computational technique used to evaluate the mechanical deformations, strains, and stresses deep within complex structures of multiple materials and amorphous shapes. The complex structure is divided into thousands of small elements, each having a simple geometry, and then the differential governing equations that describe the mechanical interactions of the problem are solved numerically per each element with respect to its surrounding elements to form the solution of the entire structure. Apart from its ability to evaluate the mechanical states deep within the soft tissues in clinically realistic scenarios as opposed to superficial pressure mapping which merely captures pressure (but not shear) on the skin, flexibility and robustness are what make the FE method such an important approach in preclinical PI prevention research. However, it is important to recognize that the credibility of any model relies on the quality and realism of the input data, such as geometric factors, material properties, and boundary conditions.¹⁵ Biomechanical modeling should generally be developed based on relevant clinical observations and data in order to avoid threats to valid clinical inference. Hence, modeling work is complementary to clinical research, and, in the case of clinical studies of prophylactic dressings,^7,8 it is particularly useful for explaining and interpreting the published clinical evidence of efficacy. As shown in the present study, modeling is specifically able to identify preferred design features and mechanisms of action of a prophylactic dressing technology that facilitate the reported clinically evident efficacy.^7,8

In the authors’ published modeling studies, the aforementioned multilayer dressing was found to have a beneficial effect on the mechanical states of the soft tissues of the heel of a single healthy subject, which may reduce the corresponding risk for heel ulceration (heel DTI) during supine bedrest.^13,14 Specifically, the aforementioned computer simulation studies employed an MRI-based FE model of the heel resting on a hospital foam mattress and with either healthy or diabetic tissue properties to evaluate internal tissue deformations and mechanical stresses in the soft tissues that are distorted by the weight of the foot.^13,14 Tissue deformations and stresses were compared between cases of the heel protected by a dedicated prophylactic dressing versus no protection and for the protected heel between multilayered and single-layer dressing designs. A 25.5% reduction of peak effective stresses occurred in the soft tissues of the heel in the healthy subject with the use of the multilayered prophylactic dressing that was modeled.¹³ The protective performance of the tested dressing was consistent across different plantar flexion positions of the foot subjected to various shearing forces.¹⁴

In the current study, previous modeling techniques^13,14 were applied to the sacral model to determine the biomechanical effects of different (sacral) prophylactic dressing designs on the state of mechanical loads in the soft tissues surrounding the sacrum for supine/Fowler posture on a hospital foam mattress. Furthermore, the modeling was expanded to investigate a new research question — namely, are there benefits in anisotropy of the dressing with regard to alleviation of internal soft tissue loads? Anisotropy, the characteristic of having directionally dependent stiffness (ie, the ratio of the force deforming the dressing over the actual deformation of the dressing) properties, is a design feature of the modeled anisotropic-compliant dressing. This is in contrast to conventional isotropy (ie, same stiffness in every direction) of other currently available prophylactic dressings.

The aim of this study was to compare mechanical states of simulated soft tissues surrounding the sacral bone across scenarios involving an anisotropic-compliant dressing, an isotropic-compliant dressing, and a completely stiff dressing using a set of computational FE model variants of the 3-dimensional (3D) buttocks and prophylactic dressing structures during supine weight-bearing or a 45˚ Fowler position. Outcome measures assessed were strain energy density (SED) — an indicator of mechanical stress — and maximal shear stresses in a volume of interest (VOI) of soft tissues surrounding the sacrum.

Methods

Eight (8) FE model variants were developed to investigate the effects of the design (particularly, the stiffness anisotropy) of prophylactic dressings on the mechanical states of the soft tissues at the sacral region in a supine weight-bearing position (see Table 1). The following conditions were simulated: 1) without a dressing, 2) with an isotropic multilayer compliant dressing, 3) with an anisotropic multilayer compliant dressing, and 4) with a completely stiff isotropic dressing. These mechanical states in soft tissues were simulated in pure compression loading of the buttocks (ie, simulating a horizontal supine bed rest) and in combined compression and shear loads applied to the buttocks (ie, 45˚ Fowler position).

Geometry. In order to develop a 3D, anatomically realistic geometrical model of the buttocks of a supine subject, 76 T1-weighted axial MRI slices were used. A 28-year-old healthy woman was scanned in a supine position, fully weight-bearing, on a designated rigid platform. Imaging was performed in a 1.5 Tesla MR system (MAGNETOM Aera, SIEMENS AG, Munich, Germany) utilizing T1-weighted images (TR/TE=550/10, field of view 42 mm × 420 mm, slice thickness 3 mm), at the Assaf Harofeh Hospital (greater Tel Aviv area), Israel. The MRI study was approved by the Institutional Review Board (Helsinki Committee) of Assaf Harofeh Hospital (Approval no. 190/14). The above MRI scan captured the entire region of the pelvis from the iliac crest to the shaft of the femurs. The image set was imported from the MRI to the ScanIP 3D image module of Simpleware® (Exeter, UK), where semi-automatic segmentation was performed in order to distinguish between the pelvic bones and soft tissue regions¹⁶ (see Figure 1a).

Next, 3 of the 5 layers of the isotropic and anisotropic multilayer dressings were applied in the modeling — namely, the polyurethane foam (PUR), the nonwoven (NW), and the airlaid (AL) layers, using the 3D image module. The innermost Safetac® layer (Mölnlycke Health Care) then was added as a tied interface between the skin and the polyurethane foam, preventing these layers from penetrating or sliding across each other in the modeling, and the backing film layer also was represented to address frictional sliding with the elastic (foam) support (as reported in previous papers from the authors^13,14).

The present modeling challenge of representing the modes of action of the sacral prophylactic dressing involved allocating greater computational power than demonstrated in the authors’ previous work^13,14 involving heel dressings. This is primarily due to the complexity of this 3D FE problem that includes elements with dimensions that vary from fractions of mm for the dressing components and up to tens of cm for the bone and soft tissue structures of the 3D buttocks. Accordingly, several measures were taken to simplify this large deformation problem to the extent that adequate numerical solutions could be obtained, despite the considerable challenge regarding the multiscales as explained previously. First, for these modeling procedures, skin, muscle and fat components were considered together and grouped as “soft tissue” structures. Second, the model volume for the FE analyses was decreased to include the dressing, the sacrum, and the surrounding soft tissues contained in the 3D block shown in Figure 1b. Adequate margins of soft tissue structures were intentionally kept around the dressing to avoid any boundary or edge effects (see Figure 1b).

Next, a flat standard foam mattress was added under the modeled buttocks (and under the dressing, in cases where a dressing was applied). Final FE meshing also was performed in the 3D imaging module using 139 964 to 212 585 linear tetrahedral elements describing the bones and soft tissues as well as 1 636 013 linear tetrahedral elements describing the 3 physical layers of the multilayer dressings. Hence, the FE analyses, which are described here, were conducted using meshes that contained nearly 2 million elements, which was essential given the multiscale challenge, and specifically, for adequate numerical transition between the microscale of the layered structure of the dressing and the macroscale of the buttocks tissues.

Mechanical properties of the tissues and dressing. The constitutive laws and mechanical properties of all tissues were adopted from the literature based on empirical data.^13,14 Specifically, the pelvic bone and femurs were assumed to be linear-elastic isotropic materials with elastic moduli of 7 GPa and Poisson’s ratios of 0.3. All soft tissues were considered together as 1 effective material as previously noted¹⁷ and were assumed to be nearly incompressible nonlinear isotropic materials, with their large deformation behavior described by an uncoupled Neo-Hookean constitutive model.

The material constants reported by Oomens et al¹⁷ were used to represent the effective soft tissue stiffness, assuming that skin contributes 60% to the effective stiffness and the other 40% are attributed to fat. The PUR, NW, and AL layers of the isotropic multilayer dressing were considered isotropic linear-elastic materials with elastic moduli of 24 kPa, 150 kPa, and 30.6 kPa, respectively, based on measurements previously performed in the authors’ laboratory and recently reported.^13,14 The Poisson’s ratio assigned to these dressing layers was 0.258 based on published experiments.¹² In cases where the completely stiff isotropic dressing was used (variants 4 and 8), the PUR, NW, and AL layers of the stiff dressing were considered isotropic linear-elastic materials with elastic modulus of 1 MPa and a Poisson’s ratio of 0.258. The mattress was considered isotropic linear-elastic as well, with an elastic modulus of 50 kPa and Poisson’s ratio of 0.3, again based on literature.^13,14,18

The anisotropic multilayer compliant dressing design comprises anisotropy — directional stiffness properties that constitute a stiffer longitudinal behavior in the direction of the spine versus more compliant “wings” that facilitate lateral stretching of the dressing. To capture this anisotropy feature, the stiffness properties of the PUR, NW, and AL layers of model variants 3 and 7 of the isotropic dressing were increased by 45% only in the axial (Z) direction to replicate the longitudinal stiffness characteristic of the anisotropic dressing based on measurements preformed in the authors’ laboratory to quantify this anisotropy (see Table 1).

Body loads applied to the buttocks model, shear, and friction conditions. Boundary conditions were chosen to simulate the descent of the weight-bearing pelvic bones during supine lying or a 45˚ Fowler position. The response of soft tissues to this descent was tested without and with each of 3 test dressings of the same shape. In all simulation cases, dressings were attached to exactly the same sacral region, ideally aligned, and symmetrically placed according to manufacturer’s guidelines (as these dressings would have been in a real-world scenario), as detailed in Table 1.

In terms of other relevant constraints, the bottom surface of the mattress was fixed for all translations and rotations. Tied interfaces were defined between the bones and soft tissues as well as between the soft tissues and the PUR layer of the dressing to account for the full adherence properties of the Safetac layer of the dressings. Frictional sliding was defined between the AL layer of the dressings and the mattress, with the coefficient of friction set as 0.35 to simulate the low-friction effect provided by the backing film layer of the dressings.¹² In model variants 1 and 5 (ie, simulations of the weight-bearing buttocks without a dressing), the coefficient of friction between the soft tissues and the mattress was set to be higher (0.4) because of the absence of the backing film.¹³

To simulate loading conditions, downward displacements in the range of 5.3 mm to 6.45 mm in all model variants were applied on the top surface of the reduced model volume (marked in Figure 1b) until the total reaction force acting back from the mattress reached 40 Newtons (roughly 7% of the total bodyweight of the subject), which were assumed to be transferred through this reduced model volume for the purpose of comparison across model variants. In model variants 5, 6, 7, and 8, the same extent of displacement also was applied in the axial (Z) direction, accounting for the shearing forces that may act due to sliding down in the bed (eg, when seated in bed in a 45˚ Fowler position) or due to some spontaneous movements or repositioning of the patient in the bed. The FE simulations all were created using the PreView module of FEBio (version 1.18), analyzed using the Pardiso linear solver of FEBio (version 2.3.1), and post-processed using PostView of FEBio (version 1.919) (University of Utah, Salt Lake City, UT).

Biomechanical outcome measures. Volumetric exposures of the soft tissues adjacent to the sacral bone to sustained deformations were examined and quantified in terms of the strain energy density (SED) in these soft tissues within the reduced model volume (see Figure 1b). Briefly, SED is a scalar measure in units of mechanical stress (eg, kPa) that describes the spatial dispersion of the elastic energy that is stored in an object that undergoes deformation. It is a factor of the stiffness of the material and of the mechanical strains and stresses that develop in every point within the deformed object.

Data analysis. The SED data were pooled from the soft tissues for all the elements in a 67 mm x 55 mm x 20 mm soft tissue cube located immediately under the sacrum, which had been defined as the volume of interest (VOI) for the purpose of SED data comparisons across the model variants (see Table 1), as depicted in Figure 1d. Converging time steps were chosen for data collection, so the resulting reaction forces between the buttocks and the support were within less than a 2.4% difference from the aforementioned target reaction force. The SED in the VOI were analyzed across the model variants to determine whether additional biomechanical efficacy is present in the anisotropic multilayer dressing design in terms of alleviation of tissue loads with respect to a no-dressing situation, to an isotropic multilayer dressing case, or to a completely stiff dressing. These simulations were repeated in either pure compression or compression combined with shear loads (see Figure 1c) and compared quantitatively by calculating the volumetric exposures to SED in the soft tissues in the VOI per each simulation case (see Table 1). The details of the method of FE analysis are explained in the authors’ previous publication¹⁴ that includes explanations with regard to calculation and data processing techniques.

Results

Contact pressure distributions on the skin surface with and without the isotropic multilayered dressing are shown in Figure 2a. Similar to previously published results^13,14 regarding contact pressure distributions under the heel protected by a border dressing, the isotropic multilayer dressing was able to reduce peak (maximal) contact pressures under the weight-bearing buttocks from 6 kPa to 2.9 kPa (52%) when loaded in pure compression, resulting in a more uniform distribution of contact pressures between the skin and the mattress at the sacral region (see Figure 2a).

Furthermore, with respect to a bare skin condition, the isotropic multilayer dressing consistently reduced the volumetric exposures of the soft tissues under the sacrum to sustained deformations across the entire range of SEDs from 0.1 kPa to 1.9 kPa (see Figures 2b, 3b, 4) and when loaded in either pure compression or in combined compression and shear. However, the anisotropic design, which is stiffer in the axial (Z) direction of the dressing, further reduced the volumetric exposures of the soft tissues under the sacrum to sustained large deformations when external shear was introduced, by an additional 11% with respect to the isotropic case (model variant 7) (see Figures 3, 4, and 5). Specifically, while the isotropic multilayer dressing lowered the average volumetric exposure of the soft tissues under the sacrum by 54% and 50% in the low (<0.5 kPa) and high (>0.5 kPa) SED domains, respectively, (as defined by Sopher et al¹⁸), the corresponding value for the anisotropic dressing was 61% (for both domains) (see Figure 5). Hence, the anisotropy feature of the anisotropic dressing facilitated more soft tissue protection (additional 11% reduction) in exposure to large tissue deformations.

While in theory applying a completely stiff dressing on the sacral region may shield the underlying soft tissues in the sacral bone region from sustained deformations, in the cases where completely stiff dressings were tested (model variants 4 and 8), tissue deformations were found to have shifted laterally, resulting in increased stress concentrations in the soft tissues near the perimeter of the dressing rather than under the sacrum (see Figure 3d). For example, in the cases where combined compression and shear were applied, the maximal shear stress above the midpoint of the dressing and just below the sacral bone decreased from 0.2 kPa to 0.16 kPa (21.5%) when a completely stiff dressing was used (compared to the corresponding no-dressing case) but increased from 0.15 kPa to 0.5 kPa (as high as 70%) upon analysis of the soft tissue volume above the perimeter of the dressing (see Figure 3).

Discussion

In the present study, a set of MRI-based 3D FE model variants of the buttocks in a supine position was used to evaluate the design features and biomechanical effects of sacral dressings designed to prevent PIs and DTIs. Focusing specifically on stiffness and anisotropy of stiffness properties of these sacral dressings, volumetric exposures of soft tissues under the sacrum to tissue deformations and loads (quantified as elevated SED values) during supine lying when using dressings were determined. The biomechanical effects of an isotropic multilayer dressing, an anisotropic dressing, and a completely stiff dressing were compared when loaded in either pure compression or in combined compression and shear. The primary objective of the present study was to determine whether anisotropy of the prophylactic sacral dressing, which allows it to be more stretchable in the lateral (buttock cheeks) direction than along the direction of the spine, is beneficial in protecting the soft tissues from deformation-inflicted tissue damage.

Similar to the authors’ previous modeling work regarding the risk for heel ulcers and the potential mitigating role of prophylactic dressings,^13,14 prophylactic dressings were found effective in lowering exposure to sustained tissue deformations under the sacrum as well. Peak contact pressures and SED values decreased 50% to 61% compared to the no-dressing equivalent cases (see Figures 2 and 4). Multilayered sacral dressings not only provided extra cushioning and pressure redistribution under the weight-bearing buttocks, but they also deformed themselves (particularly in shear), given their compliant-stiff-compliant layered structure, which then diverted deformation and load from the tissues to the structure of the dressing itself. An additional advantage specific to the multilayer dressings that were modeled may be offered by the smooth backing film layer of the dressings, which facilitates decreased friction and hence, reduced shear loads in the underlying tissues.^12,13 In addition, completely stiff isotropic dressings, which in theory could be effective in minimizing tissue deformations at the center of the dressing, were found to show a tradeoff effect, inflicting increased deformations and loads (SED values), especially elevated shear stresses in the soft tissues along the perimeter of the dressing. This was thought to be due to the sharp gradients in stiffness between the dressing material and the soft tissues, which was promoting shear in tissues at the borders. Hence, the concept of completely stiff dressings is not recommended for tissue protection; while stiff dressings will maintain the shape of tissues at the center of the dressing (much like a plaster cast will do), they may cause tissues at the border of the dressing to stretch and shear (see Figure 3d).

The most important finding from this modeling study concerns the benefit of using anisotropy as a design feature in prophylactic sacral dressings. The anisotropic structure of the modeled anisotropic dressing resulted in the lowest exposures to tissue SED values, particularly when the buttocks model was loaded in combined compression and shear, a common scenario in patients who require head-of-bed elevation and frequent repositioning.¹⁴ The stiffness anisotropy of the anisotropic dressing (ie, modeled here using greater stiffness in the direction of the spine) was shown in this model to provide extra protection to soft tissues around the sacrum when shear loads are present. Specifically, in this model, the compliant stretch range in the lateral direction of the dressing (pointing toward the buttock cheeks) facilitated an extra 11% reduction in soft tissue exposure to SED at the VOI. The anisotropic dressing mitigated tissue deformations and loads under the perimeter of the dressing as well as directly under the sacrum (see Figure 3c) as opposed to the isotropic dressing, which did not allow tissues to expand laterally, leading to stress concentrations under the lateral borders of the isotropic dressing (see Figure 3d). The authors concluded the stiffness anisotropy may be a critically important design feature in multilayer dressings for prophylactic use.

In order to quantify the potential for tissue damage, the authors opted to use the SED measure, believing it is optimal for quantifying the exposure to sustained tissue loads as related to PI and in particular to DTI risks. In the literature, SED distributions have been experimentally correlated with the severity and extent of tissue damage in rodent model experiments.²⁰ These findings made this scalar measure the first choice for characterizing tissue loads in the context of PI risks.¹⁸ Moreover, SED data are a weighed measure of all tissue deformation modes (ie, a strain tensor that includes compression, shear, and tension distortion components) with added tissue stiffness properties (ie, the stiffness tensor). This helps resolve the debate regarding which engineering load measures — strain or stress measures — are preferable for evaluating the risk for PIs in tissues.²¹

Limitations

The clinical inference of this study design is unknown and any modeling inevitably includes assumptions and limitations, which should be discussed for completeness and interpretation of the findings. First, the authors chose to use the deformed (weight-bearing) anatomy of the buttocks to develop the initial geometric model, with the aim to focus on tissue deformations at the nearly weight-bearing configuration of the buttocks as relevant to a resting supine patient. If they had used a completely underformed (nonweight-bearing) anatomy, slightly greater exposures to SED (manifested as higher curves in the graphs in Figure 4) would have been expected. However, this additional tissue deformation would have been mostly due to the lateral tensile component (tissue stretching) from the spreading of the cheeks of the buttocks during the weight-bearing process rather than from the compression and shear components resulting from interactions between hard and soft tissues under the sacrum. That being said, for the purpose of comparison of cases with prophylactic dressings versus without them or for comparing isotropic to anisotropic dressing designs, a deformed anatomical buttocks model was believed to be reasonable and practical to use. Furthermore, to reduce the required computer power and simplify this extremely complex 3D large deformation FE problem, soft tissues were considered as 1 entity and used an effective soft tissue material. Using a distinct geometrical and mechanical representation of each tissue could have resulted in a more accurate resolution of tissue loads, and with the development of computational modeling technologies in this field, it will probably be attempted in the future. For example, with the soft tissues considered together into 1 “soft tissue” material as was done in this study, lower stresses were more likely to be noted in the “skin” region than had the skin (which is stiffer than the underlying fat and muscles) been represented as a separate tissue layer. In other words, the observed stresses at the skin surface are likely slightly less than they would be if tissue layers had been assessed separately, but subdermal tissue stresses, which were the focus of this work, are adequately evaluated. Hence, given that this study focused on the prevention of DTIs and the potential role of prophylactic sacral dressings in doing so, the resolution of superficial tissue loads (on the skin) could be reasonably compromised for the benefit of achieving the 3D representation of the large deformation of the entire buttocks.

Lastly, although the geometrical model is anatomically accurate, it is based on an MRI scan of a single (healthy) subject, which is not necessarily representative of a patient at a high risk for PIs and DTIs. Future work should include modeling of the variations and changes in tissue structures and mechanical properties as associated with known risk factors for PIs (eg, type 2 diabetes).¹⁴ Likewise, more research is needed with regard to the variations in the shear loading schemes associated with the patient’s position in bed and guidelines for repositioning and general care, as well as to the use of advanced, more sophisticated support surfaces, which are commonly provided for at-risk patients. Specifically, more information is needed with regard to the interactions of sophisticated support surfaces with prophylactic dressings.

Conclusion

The FE modeling results obtained in this study suggest prophylactic sacral dressings may minimize exposure to sustained tissue deformations and as such protect tissues from PIs and DTIs during supine lying or a 45˚ Fowler position on a standard hospital foam mattress. Further, the differences in mechanical behavior observed between the modeled anisotropic, isotropic, and stiff dressings suggests the former may provide enhanced protection against unavoidable shear loads under the sacrum as well as in adjacent soft tissues underlying the perimeter of the dressing. Additional clinical research should be conducted to examine the clinical inference of this modeling technique and investigate the effects of prophylactic dressings on healthy volunteers and patients in different positions in bed or on operation tables, perhaps using force/shear sensors over and under the dressings.

References

1. European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPUAP), Pan-Pacific Pressure Injury Alliance (PPIAA). International Pressure Ulcer Guidelines, 2014. Available at: www.epuap.org/pu-guidelines/#2014guidelines&qrg. Accessed September 26, 2017.

2. Vangilder C, Macfarlane S, Meyer S. Results of nine international pressure ulcer prevalence surveys: 1989 to 2005. Ostomy Wound Manage. 2008;54(2):40–54.

3. Butcher M, Thompson G. Can the use of dressing materials actually prevent pressure ulcers: presenting the evidence. Wounds UK. 2010;6(1):119–125.

4. Shabshin N1, Zoizner G, Herman A, Ougortsin V, Gefen A. Use of weight-bearing MRI for evaluating wheelchair cushions based on internal soft-tissue deformations under ischial tuberosities. J Rehabil Res Dev. 2010;47(1):31–42.

5. Gefen A, van Nierop B, Bader DL, Oomens CW. Strain-time cell-death threshold for skeletal muscle in a tissue-engineered model system for deep tissue injury. J Biomech. 2008;41(9):2003-2012.

6. Gefen A, Kottner J, Santamaria N. Clinical and biomechanical perspectives on pressure injury prevention research: the case of prophylactic dressings. Clin Biomech (Bristol, Avon). 2016;38:29–34.

7. Santamaria N, Gerdtz M, Sage S, et al. A randomized controlled trial of the effectiveness of soft silicone foam multi-layered dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: the border trial. Int Wound J. 2015;12(3):302–308.

8. Santamaria N, Gerdtz M, Liu W, et al. Clinical effectiveness of a silicone foam dressing for the prevention of heel pressure ulcers in critically ill patients: Border II Trial. J Wound Care. 2015;24(8):340–345.

9. Forni C, Loro L, Tremosini M, et al. Use of polyurethane foam inside plaster casts to prevent the onset of heel sores in the population at risk. A controlled clinical study. J Clin Nurs. 2011;20(5-6):675-680.

10. Ohura T, Takahashi M, Ohura N Jr. Influence of external forces (pressure and shear force) on superficial layer and subcutis of porcine skin and effects of dressing materials: are dressing materials beneficial for reducing pressure and shear force in tissues? Wound Repair Regen. 2008;16(1):102–107.

11. Nakagami G, Sanada H, Konya C, Kitagawa A, Tadaka E, Matsuyama Y. Evaluation of a new pressure ulcer preventive dressing containing ceramide 2 with low frictional outer layer. J Adv Nurs. 2007;59(5):520–529.

12. Call E, Pedersen J, Bill B, et al. Enhancing pressure ulcer prevention using wound dressings: what are the modes of action? Int Wound J. 2015;12(4):408-413.

13. Levy A, Frank MB, Gefen A. The biomechanical efficacy of dressings in preventing heel ulcers. J Tissue Viability. 2015;24(1):1–11.

14. Levy A, Gefen A. Computer modeling studies to assess whether a prophylactic dressing reduces the risk for deep tissue injury in the heels of supine patients with diabetes. Ostomy Wound Manage. 2016;62(4):42–52.

15. Bader DL. Editorial. J Tissue Viability. 2013;2(2):23–24.

16. Simpleware^® Ltd. ScanIP, +FE, +NURBS and +CAD Reference Guide ver. 5.1, 2012. Available at: www.simpleware.com/software. Accessed September 26, 2017.

17. Oomens CW, Zenhorst W, Broek M, et al. A numerical study to analyse the risk for pressure ulcer development on a spine board. Clin Biomech (Bristol, Avon). 2013;28(7):736–742.

18. Sopher R, Nixon J, McGinnis E, Gefen A. The influence of foot posture, support stiffness, heel pad loading and tissue mechanical properties on biomechanical factors associated with a risk of heel ulceration. J Mech Behav Biomed Mater. 2011;4(4):572–582.

19. Maas SA, Ellis BJ, Ateshian GA, Weiss JA. FEBio: finite elements for biomechanics. J Biomech Eng. 2012;134(1):011005.

20. Loerakker S, Manders E, Strijkers GJ, et al. The effects of deformation, ischemia, and reperfusion on the development of muscle damage during prolonged loading. J Appl Physiol (1985). 2011;111(4):1168–1177.

21. Linder-Ganz E, Shabshin N, Gefen A. Patient-specific modeling of deep tissue injury biomechanics in an unconscious patient who developed myonecrosis after prolonged lying. J Tissue Viability. 2009;18(3):62–71.

Potential Conflicts of Interest: Dr. Gefen is Chair of the Scientific Advisory Board, Mölnlycke Health Care, Gothenburg, Sweden; and is funded by Mölnlycke Health Care for investigating the effects of dressing materials and designs on soft tissues during weight-bearing.

Ms. Levy is a doctoral student; and Dr. Gefen is a Professor of Biomedical Engineering, Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv, Israel. Please address correspondence to: Amit Gefen, PhD, Tel Aviv University, Tel Aviv 6997801 Israel; email: gefen@eng.tau.ac.il.

Section:

Volume 63 - Issue 11 - November 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(11):18–29

Sammy A. Zakhary, MD, CWS-P; Chris Davey, MD, CWS-P; Rebecca Bari, DPM; Jordan Bean, DPM; Tyler Reber, DPM; Kathy Gallagher, DNP, APRN-FNP, CWS, WCC; Kara Couch, MS, CRNP, CWS; Jennifer Hurlow, MSN, GNP, CWOCN; Karen Laforet, MCISc (WH), RN; Corrine McIsaac, PhD(c), RN; Karen Napier, RN, BScN, CETN(c), MClSc-WH; Diana Vilar-Compte, MD, MSc; Emily Zakhary, BA, OMS-1; Michel Hermans, MD; and Laura Bolton, PhD

Topics:

practice guideline

validation study

wound infection

checklist

interdisciplinary communication

Abstract

Acute and chronic wound infections create clinical, economic, and patient-centered challenges best met by multidisciplinary wound care teams providing consistent, valid, clinically relevant, safe, evidence-based management across settings. To develop an evidence-based wound infection guideline, PubMed, Cochrane Library, and Cumulative Index to Nursing and Allied Health Literature databases were searched from inception through August 1, 2017 using the terms (or synonyms) wound infection and risk factor, significant, diagnosis, prevention, treatment, or surveillance.

Studies on parasitic infections, in vitro studies, and non-English publications were excluded. The 19-member International Consolidated Wound Infection Guideline Task Force (ICWIG TF), hosted by the Association for the Advancement of Wound Care (AAWC), reviewed publications/assessed levels of evidence, developed recommendations, and verified representation of all major recommendations from 27 multidisciplinary wound infection documents. Using a web-based survey, practitioners were invited to assess the clinical relevance and strength of each recommendation using standardized scores. Survey responses from 42 practitioners, including registered nurses (RNs), Wound Care Certified and advanced practice RNs, physical therapists, physicians, podiatrists, and scientists from 6 countries were returned to AAWC staff, tabulated in a spreadsheet, and analyzed for content validity. Respondents had a median of >15 years of military or civilian practice and managed an average of 15.9 ± 23 patients with infected wounds per week. Recommendations supported by strong evidence and/or content validated as relevant by at least 75% of respondents qualified for guideline inclusion. Most (159, 88.8%) of the 179 ICWIG recommendations met these criteria and were summarized as a checklist to harmonize team wound infection management across specialties and settings. Most of the 20 recommendations found not to be valid were related to the use of antibiotics and antiseptics. After final ICWIG TF review of best evidence supporting each recommendation, the guideline will be published on the AAWC website.

Surgical site infection (SSI) increases patient mortality by up to 3%^1,2 and prolongs postsurgical hospital stays by 7 to 10 days,^1,3 raising related costs by $20 000 to $27 600 per United States hospital admission.³ For US hospital inpatients, SSIs are the most common health care-associated infections currently monitored by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN); SSIs represent 31% of the total number of infections,with incidence rising in the last 10 years from 2% to 5% in 2016.^4-7 In low and middle-income countries, the burden of SSI is much higher.⁸

Although these statistics are alarming and merit the rigorous efforts (underway) to reduce SSI, they are only part of the wound infection story. Infections are just as likely in nonsurgical wounds, with rates increasing with population age. Estimates of wound infection incidence vary among settings and countries that use differing criteria and reporting systems, highlighting the need for increased consistency of infection diagnosis, definitions, and surveillance recording tools.^9-12 A prospective SSI surveillance survey, standardized to CDC criteria,¹³ reported that 28% of SSIs occurred during the hospital stay for 1324 patients undergoing coronary artery bypass grafts; the remaining 72% of SSIs were reported when SSI surveillance was extended to 30 days post-discharge.¹⁴ This finding suggests the need for community-based surveillance for all acute and chronic wounds across all care settings. To explore this issue, focused literature searches were conducted of the MEDLINE database from inception to June, 2017, addressing the topic wound infection incidence for each wound type listed in Table 1. Example studies cited included registries, meta-analyses, or clinical trials reporting 100 or more patients.^14-28 Diabetic foot ulcers, burns, and pressure ulcers all have higher reported infection incidence than clean/contaminated surgical wounds. However, the only chronic wound subject to CDC NHSN standardized infection surveillance⁴ is the “decubitus ulcer” (ie, pressure injury). It remains to be explored whether parallel standardized surveillance and feedback programs for nonsurgical wound infections may improve chronic wound, burn wound, or trauma wound infection outcomes.

Acute and chronic wound infection similarities. Most definitions of chronic or acute surgical, trauma, or burn wound infection include 2 or more of the classic clinical signs and symptoms of infection (ie, increased tenderness or pain, local heat, erythema, edema, or purulent or excessive drainage^4,29-32), although wound infection is not recognized as a primary outcome for clinical trials.^30,33 Also, the wording of the SSI criterion “dehiscence and separation of surgical wound edges”³⁴ is applied to chronic wounds when stated as, “unexplained chronic wound breakdown despite addressing all causative host or environmental factors.”³⁵ These criteria demonstrate potential for harmonizing acute and chronic wound infection measurement.

Infection depth classification differs somewhat between chronic and acute wounds. SSI is classified by depth of infected tissue and noted as superficial incisional, deep incisional, and organ space.⁴ Chronic wound infections may use these criteria or report the level of tissue involvement as partial-thickness or full-thickness or involving underlying tendon, joint, or bone.⁹ To support risk-adjusted SSI surveillance in its National Nosocomial Infection Surveillance Risk Index,⁴ the CDC classifies surgeries according to wound contamination level, severity of patient systemic disease, and duration of surgery, adding 1 risk point on a 0 to 3 scale for each of the following: 1) the wound is contaminated or dirty-infected, 2) the patient has severe systemic disease, and 3) the surgery lasted longer than 75% of the average duration for that surgical procedure.³⁶ Margolis et al³⁷ have validated a risk scale for chronic venous ulcer delayed healing based on “wound duration >6 months” that parallels the third qualification for wound infection risk, but parallels between chronic and acute wound infection risk classification remain unclear.

Acute and chronic wound parallel management strategies. Preventing and treating wound infection requires management of patient, environmental, and microbial infection risk factors.^38,39 Typically, wound infection, identified using clinical signs, is confirmed by microbial culture and sensitivity testing and leukocytosis.^40,41Although these signs vary subtly with wound etiology,^40,41 chronic and acute surgical, burn, or trauma wounds typically are diagnosed by at least 2 of the 5 common signs and symptoms of wound infection.^41-43 Life-threatening situations are exceptions to the “culture only if infected” rule. These include necrotizing fasciitis, for which standard therapy involves immediate, high-dosage, broad-spectrum antibiotics followed by life-saving surgery and subsequent narrow-spectrum antibiotics focused on microbes identified from appropriately cultured involved tissue. Similar procedures are followed for patients with large burn wounds because of the elevated infection/sepsis risk and resulting need for preventing potentially lethal infection.^38,39

Although validating research is needed, the parallels noted in chronic and acute wound infection burdens, definitions, risk classification schema, and outcome measures signal opportunities to harmonize diagnostic language, practice, and outcome measures by multidisciplinary wound care teams as they manage patients with various acute or chronic wound infections across settings. The purpose of this work was to describe derivation from published literature and content validation of a set of wound infection diagnosis, prevention, and treatment recommendations to serve multidisciplinary wound care teams as they manage patients with acute or chronic wounds across settings.

Methods

To identify evidence-based wound infection management recommendations from structured systematic literature searches, 19 multidisciplinary wound care professional members of the Association for the Advancement of Wound Care (AAWC, the host society), the Wound Healing Society, the Canadian Association for Enterostomal Therapy, and the Mexican Wound Healing Society (AMCICHAC) collaborating as part of the International Consolidated Wound Infection Guideline Task Force (ICWIG TF) explored barriers to evidence-based wound infection practice; conducted structured literature searches to identify evidence supporting recommendations for wound infection diagnosis, prevention, and treatment; evaluated each recommendation’s multidisciplinary construct validity; and content-validated clinical relevance and strength of recommendation (SOR), described as benefit-to-harm derived from implementing the recommendation.

Exploring evidence-based practice barriers. Many simple, low-cost techniques have been known for decades to prevent SSIs.¹ These include hand washing,^7,8 preoperative clipping rather than shaving hair from the surgical site,^8,44 using a sterile swab to remove subincision fluid postoperatively until drainage subsides,⁴⁵ and avoiding gauze-type topical acute or chronic wound dressings.^46-48 Despite ample evidence, research that includes a review of microbiologic diagnostic procedures for chronic wounds in Germany,⁴⁹ a 7-week observational study of elective pediatric surgical cases at a US hospital,⁵⁰and a qualitative thematic analysis of institutional tools and protocols and transcripts of interviews with infection control supervisors at 7 Canadian hospitals⁵¹shows guideline interventions for reducing chances of wound infection are inconsistently used.

To address this inconsistency of use, ICWIG TF members used brainstorming based on their experience to identify reasons for gaps between science and practice. In the course of their discussions, they realized that reducing wound infections would be feasible only if concerns and practices of each professional specialty involved in managing wound infection across settings were adequately served. As such, the ICWIG TF resolved to examine the construct validity of all evidence-based wound infection recommendations found in structured literature searches to ensure each final recommendation also was congruent with wound infection guidelines previously developed by individual specialties, such as infectious disease, dermatology, surgical, advanced practice nursing, or other specialists or by organizations devoted to specialized settings, such as acute care, home care, or military settings.

Literature review. Using recognized guideline development processes,^52,53 the 19 members (ie, physicians, nursing professionals, and related doctoral candidates) of the ICWIG TF searched PubMed, Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases from inception through November 30, 2013, including up to 400 of the most recent English publications using the search term wound infection combined with the search terms or synonyms risk factor, significant, diagnosis, prevention, treatment, or surveillance. Auxiliary related searches were conducted in Google Scholar to obtain full text and to expand evidence on specific recommendations as needed. Studies on parasitic infections or in vitro studies were excluded. The final step of selecting best available evidence from these and added searches supporting each ICWIG recommendation according to standardized criteria (listed in Table 2) was ongoing at the time of this publication.

Interdisciplinary relevance and construct validity. To ensure interdisciplinary ICWIG relevance for all specialties managing wound infection across all settings, ICWIG TF members verified that all unique major recommendations from 21 post-2000, interdisciplinary wound infection reviews, position papers, or guidelines were addressed by ICWIG recommendations identified by evidence found in the literature searches. Additionally, they evaluated each ICWIG recommendation’s construct validity by checking “Yes” if it was included in at least 1 interdisciplinary post-2000 wound infection guideline or review or “No” if not. Ensuring consistency with published interdisciplinary guidelines, reviews, and position papers of all ICWIG wound infection recommendations addressed Institute of Medicine (IOM) criteria⁵²for developing trustworthy guidelines while supporting each ICWIG recommendation’s capacity to harmonize wound infection practices for all members of interdisciplinary wound care teams across settings and specialties.

Content validation. ICWIG developers abstracted recommendations from evidence found in the initial literature searches, removed redundancy, and condensed all recommendations into a comprehensive list of 179 actionable recommendations. To ensure interdisciplinary clinical relevance of these recommendations, formal content validity^54,55 was established by voluntary respondents to an online survey using judgment quantification to rate each recommendation’s clinical relevance on the 4-point scale shown in Table 2. Safety was estimated as SOR by each respondent rating the recommendation as “1” if more benefit than harm would be derived by implementing the recommendation or “0” if not as recommended by the IOM.⁵² Private ratings avoided potential bias from social pressures associated with consensus discussions. The content validation survey of recommendations compiled through November 30, 2013 was accessible online from December 1, 2013 through December 31, 2014. Invitations to complete the survey were published in major wound journals serving >40 000 readers and sent as eblasts to >5000 members of wound care societies in the United States, Europe, Asia, Australia, Canada, and Mexico.

Respondents downloaded the survey, completed it on their computers, then emailed the completed survey to an AAWC staff member who compiled all surveys into an Excel file for later analysis by an ICWIG TF member. In addition to the ratings described, the survey requested respondent credentials and practice demographics, along with their suggested changes or additions to the recommendations.

Updated literature searches. After the survey, the ICWIG TF conducted updated literature searches of PubMed and Google Scholar databases from December 31, 2014 through August 1, 2017, for the term wound infection combined with synonyms or derivatives of the terms reliable, valid, and significant, plus appropriate key words in each recommendation. Best available evidence from these and the prior searches currently is being reviewed, evaluated according to criteria in Table 2, added as appropriate supporting evidence to corresponding ICWIG recommendations, and abstracted into ICWIG evidence tables describing study patients, interventions, comparators, design, and outcomes of each of up to 5 best references supporting an ICWIG recommendation.

Updated interdisciplinary relevance and construct validity. The power of interdisciplinary teamwork in improving wound outcomes has been affirmed by expert consensus,⁹ randomized clinical trials,⁵⁶ and longitudinal cohort studies.^57,58 To ensure ICWIG interdisciplinary currency in empowering wound care team members to speak and act in harmony, ICWIG TF members evaluated a total of 27 interdisciplinary publications (literature reviews, position documents, or guidelines) to ensure 1) that each ICWIG recommendation was represented in at least 1 prior evidence-based published summary of wound infection recommendations, and 2) that every recommendation in these published summaries was addressed appropriately in the ICWIG. The construct validity check had been performed before the content validity survey for 21 publications^59-80 and was repeated for 6 more recent publications accessed after completion of the last content validation survey.^8,78,81-84

Data analysis and statistical methods. Relevance and benefit (SOR) content validity indexes (CVI) were calculated for each recommendation from all surveys returned as the percent of respondents rating that recommendation as 3 (relevant but needs minor improvement) or 4 (relevant and succinct) to their own clinical practice. A CVI of at least 0.75 is considered as having content validity,⁵⁵ calculated as follows:

Relevance CVI = (number of 3 ratings + number of 4 ratings)/total N responding for the recommendation.

Benefit (SOR) validity was the percentage of respondents rating the recommendation’s implementation as 1 (beneficial) = (number of 1 ratings)/total N responding with a rating of 0 or 1 for the recommendation.

A 1-page ICWIG Checklist was compiled of the guideline recommendations with the highest CVI and SOR ratings (>0.75) for patient and wound assessment to diagnose and manage wound infection risk factors, wound infection prevention, and treatment.

In the final guideline (accessible at aawconline.org once best evidence is summarized and aligned with each recommendation), each recommendation will be displayed with its evidence rating from Table 2, up to its 5 best supporting references, CVI, and SOR.

Results

Barriers to evidence-based management. Current guidelines reviewed differed in clarity, stated professional roles and accountability, and criteria for SOR, resulting in credibility gaps between specialties and across settings. Team members agreed with prior research^49-51 that evidence-based guideline interventions are inconsistently followed due to limited communication between specialties or across settings; confused perceptions about safety and efficacy of interventions such as timing of antibiotic use; and inadequate training, resources, or reimbursement. Patient and wound outcomes are not consistently measured and rarely tracked across settings, so wound professionals are rarely held accountable or receive feedback about the outcomes of their wound care.⁵¹

It was concluded that an adequately developed,⁵³ evidence-based wound infection guideline (ICWIG) meeting IOM standards for a trustworthy guideline⁵² designed to unify and serve all wound care team members and the patient with an acute or chronic wound would help resolve many barriers and subsequently enhance the consistency of care and outcomes for those at risk of or with a wound infection.

Interdisciplinary validation. All ICWIG recommendations were represented in at least 1 prior publication of evidence-based wound infection recommendations and, conversely, all evidence-based recommendations in the 27 reviews or guidelines evaluated^8,59-84 with different wound, specialty, or setting focus were represented in the ICWIG. Although these documents differed from each other in their recommendations (often due to their focus on a specific specialty or acute or chronic wound etiology), many commonalities were observed among recommendations for wound infection diagnosis, prevention, and treatment.

Content validation. Forty-two (42) clinicians with a median of >15 years of military or civilian practice on wounds completed and returned the content validation survey. They included 12 registered nurses (RNs); 10 RNs certified in wound ostomy continence (WOC) care; 8 physical therapists; 7 advanced practice nurses; 4 physicians specializing in surgical, dermatologic, or endocrinological care; 4 doctors of podiatric medicine (DPMs); 3 (2 RNs and one MD) Certified Wound Specialists; 3 specialists with PhDs in microbiology or authors of peer-reviewed continuing medical education literature reviews on wound infection; and 1 PhD patient advocate. Several respondents had more than one credential.

These participants managed an average of ~16 wound infections per week. Participant practice settings included acute (inpatient) care (43%), separate wound clinic (25%), acute (outpatient) care (21%), long-term acute care (17%), skilled nursing facility (17%), office practice (15%), medical school (11%), subacute care (7%), home care (3%), or extended care (2%), with <1% of respondents in a group practice organization or government agency. Most of the participants’ practice time was devoted to surgical wounds (29%), pressure ulcers (27%), diabetic foot ulcers (23%), venous ulcers (15%), burn/trauma or other acute open wounds healing by secondary intention (10%), mixed etiology wounds (eg, venous and arterial ulcers) (9%), dermatologic conditions (5%), or other wounds (3%) such as cancer, fungating, or lymphedema wounds or other unusual wounds. Respondents practiced in Australia, Canada, Slovenia, Sweden, Switzerland, the United Kingdom, and 13 of the United States, representing all regions except Hawaii.

Of the 179 recommendations, 159 (88%) were rated as relevant and recommended (CVI >0.75). Among the 179 recommendations, 82 (45.8%) had robust content validity with high relevance (CVI >0.90) and SOR >0.75. The 20 recommendations with the highest ratings focused mainly on consistent wound monitoring with feedback to care providers, avoiding contamination, and preventing tissue damage (see Table 3). Twenty (20) recommendations were judged to be of questionable relevance (CVI <0.75) and low SOR or not clearly beneficial in ratings from >75% of respondents (see Table 4). These recommendations mainly addressed the use of antibiotics or topical antimicrobial agents.

Wound Infection Checklist. A Wound Infection Checklist containing ICWIG recommendations with CVI and SOR >0.75 was developed as an implementation tool to simplify ICWIG use by interdisciplinary wound care teams, including patients, families, and all care providers across settings (see Figure 1). The Checklist organized recommendations into 3 columns. The first column lists actions recommended to identify wound infection risk factors during patient and wound assessment and evaluation. The second column lists actions recommended to prevent acute or chronic wound infection. The third column lists actions recommended to manage patients with wounds until wound healing occurs.

Discussion

To be useful and trustworthy for health care providers, a guideline requires clear, evidence-based, actionable recommendations with consistently defined parameters and measurable outcomes.^52,53 Specialty-, setting-, or wound-related discrepancies among wound infection definitions, assessment, or diagnostic parameters and prevention or treatment interventions can confuse professional caregivers and reduce the consistency of management and quality of outcomes. For example, a provider with mainly acute wound experience may assume increased pain, erythema, and discharge of a venous ulcer signals infection and prescribe unneeded antibiotics. The same patient receiving care designed to harmonize multidisciplinary team members in addressing all host, environmental, and organism risk factors would receive prompt, appropriate referral(s) to identify and address more likely needs for improved compression, nourishment, or vascular perfusion to resolve the problem without increasing patient risk of developing antibiotic-resistant microbes. Using trustworthy, content-validated guidelines that harmonize wound care team communications and actions may avoid costly errors and improve patient outcomes.

The literature reviewed documented an array of contradictions in wound infection management recommendations. Wound infection diagnostic criteria were varied and included clinical signs such as pain or increased discharge³⁴ and deep tissue biopsy harboring >10⁵ colony forming units.³¹ Despite commonalities in the evidence-generated recommendations, discrepancies were noted on how to diagnose, prevent, and treat wound infection.^9,34,36,38 These differences signaled the need for a wound infection guideline that could unify interdisciplinary wound care teams. Until communication and actions related to wound infections are seamless across specialties and settings, patients with or at risk of developing a wound infection are unlikely to receive recognized benefits of consistent care and outcomes derived from interdisciplinary teams adhering to evidence-based practice and sharing information about wound progress.^56,57

Two (2) European Wound Management Association publications addressed multidisciplinary wound infection management,^9,85 but the ICWIG literature review found no structured guidelines developed to meet IOM standards that fulfill that purpose. The ICWIG is designed to fill this void. Generally high CVI values for most recommendations’ relevance and SOR values reflecting safety supported the feasibility of developing such a guideline to harmonize wound infection management. This is underscored by the ICWIG’s congruence with prior guidelines for individual specialties and verifies its interdisciplinary functionality for acute and chronic wound infection diagnosis, risk management, prevention, and treatment.

However, sufficient commonality was found among acute and chronic wound infection diagnosis, prevention, treatment, and published risk factors to enable development of many relevant, beneficial recommendations supporting most aspects of managing chronic and acute wound infections, such as those in the Checklist (see Figure 1). Highly relevant and beneficial recommendations spanned wound etiology, professional specialties, and settings. Wound experts from a variety of professions, settings, and countries almost universally agreed that increased wound pain and discharge are key signals of infection for both acute and chronic wounds and that consistently monitoring and measuring wound area would help multidisciplinary wound care teams improve the consistency and quality of care and outcomes for their patients with acute and/or chronic wounds across care settings.

Acute and chronic wound infections share most of the common signs and symptoms and arise from the same interacting host, environmental, and organism risk factors. Microorganisms invade healthy tissue only when compromised host and environmental factors favor infection.^9,38Optimizing patient and wound infection outcomes takes a multidisciplinary team reinforcing each other’s work to manage all these risk factors for acute or chronic wounds across all settings.⁸⁵

Implications for Practice

The ICWIG Checklist (see Figure 1) summarizes the content-validated ICWIG recommendations with high SOR, and Table 5 illustrates measureable aspects of adherence to and outcomes derived from example recommendations. Researchers are continuing to compile newly published evidence to verify if all 179 recommendations represent good clinical practice and to identify which need more research. Twenty (20, 11.2%) recommendations were rated neither relevant nor beneficial by >75% of respondents and as such failed to meet acceptable standards of content validity (see Table 4), thus requiring careful consideration of available evidence and/or further research before use in clinical practice.

Resolving barriers to evidence-based wound infection practice. Infection-related costs and reimbursement vary across settings, states, regions, or provinces and may drive care decisions toward least expensive gauze wound dressings despite RCT evidence that their use doubles infection rates.^46-48 Encouraging use of or adequately reimbursing clearly defined,⁸⁶ moisture-retentive dressings could encourage their timely and appropriate use, preventing costly wound infections.

Highly relevant and beneficial guideline recommendations described in the ICWIG Checklist (see Figure 1) merit consistent use with reporting of adherence measures, documenting that the recommendation was followed, and measures of expected outcomes if the recommendation is followed, as illustrated in Table 5. These illustrate how to customize ICWIG recommendations for use in institutional protocols, practice settings, or as quality measures for wound registries,⁸⁷ informing all collaborating wound care team members what action was taken, when, and with what related outcomes.

Ready access to evidence-based ICWIG recommendations embedded in implementation tools or electronic health records could alert a primary provider to the need for specialist referral or help a patient understand importance of adhering to the plan of care. Hierarchical medical structure may obstruct team approaches to guideline use by promoting disputes instead of supporting team synergy and by limiting the authority of evidence users. Just as implementing wound infection prevention “bundles” has reduced SSI rates and costs,⁴⁴ embedding key ICWIG recommendations in protocols and medical records could support a cost effective, mutually respectful team approach, reducing delays between assessments and interventions. Developing a wound infection guideline to harmonize multidisciplinary teams is a small first step. Only consistent ICWIG use and documentation can measure and find ways to enhance its potential to improve clinical and economic outcomes.

It was not surprising that all recommendations in the 27 interdisciplinary guidelines and evidence-based position documents tested already were addressed in the ICWIG. All were based on the same evidence found in the ICWIG searches. This result supported the ICWIG’s comprehensive and interdisciplinary qualities. Ensuring that a guideline serves all wound care team members encourages a harmonized, team-based approach with timely referrals for wound infection diagnosis, prevention, or treatment by appropriate specialists applying their more detailed specialty evidence-based guidelines in time to optimize patient outcomes and reduce costs.

The literature reviewed clarified what is known and not known about wound infection. The implication for practice is that it benefits patients to avoid infection harm and costs (reported in Table 1) by rigorously managing host and environmental factors to prevent wound infection; doing so before surgery or developing a chronic wound also can limit unnecessary use of antibiotics to address inflamed or non-healing wounds.

Future ICWIG steps. The best 5 or fewer publications supporting each recommendation are currently being selected according to criteria listed in Table 2. The final ICWIG will feature each recommendation, CVI for clinical relevance and benefit, and up to 5 best available supporting references, plus an ICWIG Evidence Table summarizing those references and patient and professional implementation tools will be accessible at: aawconline.org/professional resources after ICWIG completion.

Future ICWIG updates will continuously improve its capacity to inform clinical decisions related to wound infection and identify related research and education gaps. For now, need is evident for research and clarification of the recommendations in Table 4. Methods are needed to differentiate wound infection from other causes of inflammation with improved diagnostic and screening validity.⁸⁸ It is time to answer questions regarding if/when to extract sutures or dressing fibers embedded in wounds⁸⁹ and whether CDC rules for antibiotic prophylaxis apply to surgical debridement of chronic wounds and if so, how to avoid proliferation of drug-resistant microorganisms⁹⁰ or delayed healing associated with prophylactic administration of antibiotics to uninfected chronic wounds.⁹¹ Harmonized care and collaborative research across specialties and settings should help answer these questions and improve consistency and quality of wound infection surveillance and outcomes as aging patients traverse settings with increasing frequency.

Among the strengths of this method of content-validating recommendation relevance and safety is that it replaces the social interactions of group consensus with independently expressed standardized ratings as a measure of the strength of opinion supporting the recommendation. Each professional with his/her own patients in mind contributes equally to the CVI, expressing the capacity of each recommendation to benefit (or harm) patients. This leaves little opportunity for the personal opinions of guideline developers to distort recommendations.

Limitations

This report’s focus on harmonizing acute and chronic wound infection management is not intended to minimize the vital importance of emergency management of severe burns, trauma, necrotizing fasciitis, or other serious conditions that threaten immunologic competence or homeostasis. These require immediate, appropriate referral to and management by experts in life and limb salvage and wound infection management. Additional resources provide more information regarding management of these wounds.^70,92

The sample of 42 respondents to the ICWIG content validation survey appears small but is ample in comparison to the 5 or more independent reviewers required to establish formal content validity of a practice recommendation.⁵⁵Independence of respondents, the breadth and duration of their wound care practices, and the variety of civilian and military practice settings and wounds they managed support this survey as a robust content validation process with broad relevance.

The ICWIG still needs best available evidence supporting the efficacy and safety of each recommendation before it becomes an evidence-based guideline. This vital step, currently being completed, will allow assessment of research and educational gaps, while placing it among the ICGTF guidelines accessible at aawconline.com later this year as a multidisciplinary resource supporting content-validated science-based practice.

Conclusion

Multidisciplinary wound care teams improve the consistency and quality of care and outcomes for patients with wounds. Multinational ICWIG guideline developers searched wound infection literature, confirming the need to develop an interdisciplinary wound infection guideline to harmonize team wound infection management across specialties and settings. Literature reviews found 179 ICWIG recommendations informing decisions about acute and chronic wound infection risk factors, diagnostic criteria, and prevention and treatment interventions. Standardized independent ratings by 42 multidisciplinary online survey respondents supported content validity and SOR of 159 (88.8%) of the recommendations for clinical relevance and patient benefit. These were condensed into a Wound Infection Checklist designed to harmonize interdisciplinary teams practicing across settings to improve the consistency and quality of care and outcomes for patients with or at risk of chronic or acute wound infection. n

Acknowledgment

The authors gratefully acknowledge the AAWC for supporting the teleconferences needed to develop ICWIG and the ICGTF collaborating organizations who helped develop ICWIG, as well as the thoughtful diligence of all 42 participants who completed the ICWIG content validation survey, for graciously sharing their time and expertise to benefit patients. In addition to the authors, the following ICWIG TF members selflessly donated considerable effort to conducting the literature searches and reviewing the results on which these wound infection clinical practice recommendations are based: Karen Bruton, RN, CETN(C), CAET Liaison; Vickie Driver, MS, DPM, FACFAS; Jerold Kaplan, MD, FACS; Michael Kerzner, DPM; Jordan Radandt, MD; and Renae Simpson, CWOCN.

References

Potential Conflicts of Interest: All authors reported no potential conflict of interest.

Dr. Zakhary is Medical Director, Valley Vein and Vascular Surgeons, Glendale, AZ. Dr. Davey is a family practice physician, St Petersburg, FL. Ms. Bari, Mr. Bean, and Mr. Reber are Doctor of Podiatric Medicine candidates, Midwestern University, Glendale, AZ. Dr. Gallagher is a Nurse Practioner Specialist and Acute Surgical Wound Service Coordinator, Christiana Care Health System, Newark, DE. Ms. Couch is a Nurse Practioner, Wound Healing and Limb Preservation Center, The George Washington University Hospital, Arlington, VA. Ms. Hurlow is a Nurse Practitioner, Faculty of Health and Wellbeing, Canterbury Christ Church University, School of Nursing, Tonbridge, United Kingdom. Ms. Laforet is Director, Clinical Services, Calea Home Care, Mississauga, ON, Canada. Ms. McIsaac is an Associate Professor of Nursing, Cape Breton University, New Waterford, NS Canada. Ms. Napier is a Clinical Nurse Specialist Enterostomal Therapy, Alberta Health Services, Sturgeon Community Hospital, St Albert, AB, Canada. Dr. Vilar-Compte is a professor, Depto de Infectologia, Instituto Nacional de Cancerologia, Tlalpan, México. Ms. Zakhary is a first-year student of osteopathic medicine, Texas College of Osteopathic Medicine, University of North Texas Health Science Center, Fort Worth, TX. Dr. Hermans is President and Owner, Hermans Consulting, LLC, Miami, FL. Dr. Bolton is an Adjunct Associate Professor of Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ. Please address correspondence to: Laura Bolton, PhD, 15 Franklyn Place, Metuchen, NJ 08840; email: llbolton@gmail.com.

Section:

Volume 63 - Issue 11 - November 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(11):30–43

Jill Cox, PhD, RN, APN-C, CWOCN

Topics:

systematic review

pressure ulcers

Risk Factors

intensive care units

Prevention

Abstract

Critically ill patients require complex care in a technologically sophisticated environment where they are highly vulnerable to pressure-related injuries. However, pressure injury (PI) development remains a multifactorial phenomenon in critically ill persons; true risk is both pervasive and elusive. The purpose of this comprehensive review of the empirical literature was to examine the risk factors associated with PIs among adult patients admitted to contemporary intensive care units (ICUs).

Inclusion criteria stipulated publications were to be peer-reviewed, quantitative studies with a focus on pressure ulcer (PU) risk factors in adult critical care patients published between 2010 and 2016 in which statistical analysis involved multivariate analysis using PU development as the outcome variable. Studies not available in English, those in which the primary focus was on PU prevention or treatment, and those that focused solely on the use of PU risk assessment scales were excluded. A comprehensive review of the OVID and PubMed computerized databases using the search terms pressure ulcer, critical care, intensive care, and risk factors yielded 540 reports; 358 remained after duplicates were eliminated and 28 after the inclusion/exclusion criteria were applied. Following examination, 16 studies were suitable for inclusion. A total of 43 risk factors emerged. Of those, 7 were identified in 3 or more studies in multivariate regression analysis; these included age, prolonged ICU admission, diabetes mellitus, cardiovascular disease, hypotension, prolonged mechanical ventilation, and vasopressor administration. To facilitate results interpretation, risk factors from multivariate analyses were grouped in 6 broad categories: demographic/patient characteristics, comorbidities, intrinsic factors, iatrogenic/care factors, PI risk assessment scales, and severity of illness/mortality risk. The shared attribute of the 7 risk factors identified was they are all potentially nonmodifiable. Advancing the science regarding the pathogenesis of PI development is imperative when trying to better understand unavoidable pressure-related injuries. The need for large multisite studies and studies using large datasets capable of validating risk factors unique to this population persists. Additionally, the need for enhanced PI risk quantification for adult ICU patients remains.

Almost 6 million people are admitted into intensive care units (ICUs) across the United States annually,¹ where they face life-threatening illnesses that require care in a technologically sophisticated environment. Of the top 5 patient conditions requiring admission to an ICU, respiratory failure requiring ventilator support is the most common, followed by acute myocardial infarction, intracranial hemorrhage, sepsis/septicemia requiring ventilator support, and percutaneous cardiovascular procedures.² To manage these and a myriad of other critical illnesses, modern day critical care units are equipped with many life-saving technologies of which a single patient may require concomitant use for treatment. As a result, critically ill patients are surviving illnesses today that just a decade ago may have proved fatal.

Critically ill patients, the most medically fragile and vulnerable population in the hospital setting, require care by highly trained professionals to minimize complications and improve outcomes. As a consequence of the complexity of their care and the high burden of illness, it is logical to deduce ICU patients would be highly vulnerable to pressure-related injuries. In fact, pressure ulcer (PU) prevalence in the ICU population is cited as the highest among hospitalized patients, ranging from 13% to 45.5%.³

However, determining PU or pressure injury (PI) risk becomes challenging in this population. Although standard PU risk assessment using a validated tool such as the Braden Scale⁴ addresses some of the risk factors that confront ICU patients, many patients are exposed to a multitude of risk factors not accounted for in PU risk assessment scales. In fact, a 2014 consensus meeting convened by the National Pressure Ulcer Advisory Panel (NPUAP)⁵ determined that potentially nonmodifiable extrinsic and intrinsic risk factors could influence PU development and may render the development of a pressure-related injury unavoidable — that is, injuries that occur despite the implementation and monitoring of evidenced-based PU prevention strategies aimed at an individual’s risk.⁵ Examples such as respiratory instability, an unstable spine, compromised tissue tolerance due to arterial insufficiency, neurologic deficits, medically necessary treatments such as fluid resuscitation and vasopressor administration, nutritional depletion, malnutrition/cachexia, septic shock, and impaired cardiopulmonary status all are purported to be related to unavoidable PUs and are all conditions likely to affect the critically ill population.⁵

Technology is omnipresent in the ICU setting. Consequently, PI risk factors may change as sequelae of technological advances coupled with the subsequent heightened burden of illness experienced by patients who require intensive care. Thus, the aim of this review was to examine the PI risk factors identified in the recent empirical literature that are associated with PIs in critically ill patients admitted to contemporary ICUs.

Methods

The author performed a comprehensive search of the OVID and PubMed computerized databases using the terms pressure ulcer, critical care, intensive care, and risk factors. Inclusion criteria established for this review stipulated publications needed to be English-language, peer-reviewed, published quantitative studies with a focus on PU risk factors in adult critical care patients published between 2010 and 2016 in peer-reviewed journals and subject to multivariate (eg, regression) analysis with PU development as the outcome variable of interest. Studies published before 2010 were excluded from review because the focus of this literature review was on critical care patients receiving care in present day ICU settings; also excluded were studies in which the primary focus was on PU prevention or treatment and studies focused solely on the use of PU risk assessment scales. In addition, ancestry searching (defined as using citations from relevant studies to track down additional potential research on the same topic) was employed as a secondary search technique. For this descriptive review, level of evidence was not a consideration.

Results

The initial search of the indices yielded 540 published reports; 358 publications remained after deleting duplications. When inclusion/exclusion criteria were applied, 28 were examined for possible inclusion; 12 studies were eliminated because they did not meet the predetermined inclusion criteria: no multivariate analysis (2); single risk factor (1); focus only on risk assessment scale (4); focus on nursing documentation (1); focus on PU healing (1); trauma population (1); conceptual model development (1); and comparison study (1). This exclusion yielded the 16 studies ultimately identified and included in this review.^6-21 Across these 16 studies, 43 potential risk factors were identified in multivariate analyses. For ease of interpretation, these risk factors were grouped under 6 broad headings: demographic/patient characteristics, comorbidities, intrinsic factors, iatrogenic/care factors, PI risk assessment scales, and severity of illness/mortality risk. After examination of these risk factors, 7 emerged in 3 or more studies and included age, ICU length of admission, diabetes mellitus, cardiovascular disease, hypotension, prolonged mechanical ventilation, and vasopressor agents.

Of the 16 studies, 7 were conducted in the United States^{7,8,13,14,16,18,20} and 9 were conducted internationally, representing Brazil,^9,17 Greece,¹⁰ Iran,¹¹ Italy,¹⁵ Japan,²¹ Saudi Arabia,⁶ Spain,¹⁹ and Turkey.¹² ICU settings represented included medical surgical ICUs (5),^7,8,10,11,18 cardiovascular ICUs (3),^7-9 and surgical ICUs (2)^16,20; 2 studies included multiple types of ICUs^7,8 and in 8 studies, the type of ICU was not specified.^{6,12-15,17,19,21} With regard to study design, 7 were retrospective^7,8,13-16,18, and 9 were prospective^{6,9-12,17,19-21} (see Table 1).

Study sample characteristics. Across the studies, the mean age of critical care patients ranged from 52 years⁶ to 71 years.⁸ The most common ICU admitting diagnoses were respiratory-^10,12,17,18 and cardiac-related.^8,9,15 Mean ICU length of admission was reported^{6-9,11,12,16-19,21} and ranged from 5 days¹⁸ to 17 days.¹² A measure of patient severity of illness/mortality risk was reported in 10 of the studies^{6,8-10,12,14,17-19,21} using a variety of instruments including the Acute Physiologic and Chronic Health Evaluation (APACHE) II, APACHE III, Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiologic Score (SAPS II),²² and All Patients Refined Diagnosis Related Group (APR-DRG). The APACHE II was the most common tool used to measure illness severity (6 studies^{8-10,12,18,21}), with mean scores across these studies ranging from 9.5²¹ (indicating an 8% mortality risk) to 22⁹ (indicating a 40% mortality risk).²³ The American Society of Anesthesiologist’s risk classification was used in 1 study to determine surgical risk, but no mean score for the study sample was reported¹³ (see Table 2).

PI characteristics in studies. PU occurrence rates across the study populations varied from 9.4%¹⁶ to 39.3%.⁶ When stratified by stage, 5 studies identified Stage 2 PI,^{9,10,13,18,21} 4 identified Stage 1,^6,9,11,12 1 identified Stage 3,¹⁵ and 1⁸identified deep tissue injury (DTI) as most common. In 6 studies,^{7,14,16,17,19,20}, the most common stage of PU was not recorded. With regard to PU location, 7 of the 9 studies that used this descriptor identified the sacrococcygeal region as the most common anatomical site.^{7-10,12,18,19} In 1 study,²¹ the ear, scapula, and heels were documented as the most common sites for PU development; in another,⁶the heel was the most common location. With regard to the application of PU prevention strategies, 7 studies^{6,8,11,12,18,19,21} reported the presence of or consideration for PU prevention strategies as part of the design and implementation of the study (see Table 2).

Risk factors. Numerous potential PU risk factors were examined in the studies in this review. Table 3 highlights the significant predictors found in each study according to its multivariate analysis in addition to risk factors found to be significant in univariate analysis, those found to be nonsignificant, and other risk factors considered in the study design.

Overall, 43 risk factors were found to be significant predictors across the studies in this review and were grouped into 6 broad categories as previously described; 7 were found significant in multivariate analysis in 3 or more studies (see Table 4). These risk factors included age, ICU length of admission, diabetes mellitus, cardiovascular disease, hypotension, prolonged mechanical ventilation, and vasopressor agents.

Demographic/patient characteristics. Age was the most frequently reported predictor and found to be significant in 6 studies.^6,9,11,18-20 However, the mean age of patients in these 6 studies ranged from 55 to 69 years, representing middle-aged to younger elder adults. When the mean age of patients who developed a PU across these 6 studies was examined, ages ranged between 60 years and 73 years. In multivariate analysis, 1 prospective cohort study⁹ of 370 cardiopulmonary ICU patients found age >42.5 years to be a significant predictor of PU development. In a prospective 2-phase study of 369 surgical ICU patients, Slowikowski and Funk²⁰ found age ≥70 years to be a significant predictor. Advancing age has long been considered a risk factor for PU development, as earlier studies^24,25 in the ICU population noted.

Length of stay. Length of stay was the second most common predictor across these 16 studies and was found to be significant in 5 studies.^6,9,11,17,18 In a prospective cohort study of 84 ICU patients in Saudi Arabia, Tayyib et al⁶ reported the average length of stay for patients who developed a PU was 13.3 ± 8.3 days as compared to the PU-free group with 9.1 ± 6.6 days. In multivariate analysis, length of stay was found to be a significant predictor for patients with any stage of PI (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.01-3.30; P = .045) as well as for patients with Stage 2 through Stage 4 PI (OR 1.2, 95% CI 1.08-1.39).⁶ Campanili et al⁹ found an ICU admission of >9.5 days was a significant predictor of PU development. Patients with a PU were found to have a mean length of stay of 14 days as compared to patients who remained PU-free at 4.5 days (P <.001). A prospective study of 160 ICU patients in Brazil by Cremasco et al¹⁷ also found length of stay to be predictive for patients who developed PU (OR 1.12, 95% CI 1.04-1.20; P = .002), with a mean number of ICU days of 23.9 days as compared to those that remained PU-free at 9.4 days (P <.001). Similarly, a retrospective study of 347 medical/surgical ICU patients by Cox¹⁸ found length of stay to be significant in multivariate analysis for all stages of PI (OR 1.033, 95% CI 1.003-1.064; P = .03) and for Stage 2 or greater PIs (OR 1.008, 95% CI 1.004.-1.012; P <.001) and reported a mean length of stay of 281 hours (12 days) in patients that developed a PU compared to 81 hours (3 days) for patients who remained PU-free (P <.01). In their prospective study of 352 medical/surgical ICU patients, Nassaji et al¹¹ also reported ICU length of stay as a significant predictor (OR 1.19, 95% CI 1.13-1.25; P <.001).

Comorbidities. Significant comorbidities found across these studies included diabetes mellitus, cardiovascular disease, renal disease/failure, pulmonary disease, trauma, and anemia. Of these, diabetes mellitus^11,15,20 and cardiovascular disease^13,15,18 were each found to be significant in multiple studies. These 2 comorbidities are known to be strongly associated with PU development across patient populations.³

Diabetes mellitus was identified as a significant predictor in 3 studies.^11,15,20 Slowikowski and Funk²⁰ found a history of diabetes was a significant predictor of PU development (OR 1.93, 95% CI 1.11-1.35; P = .019), as did Nassaji et al.¹¹ The latter study found PU development was more than 5 times more likely in patients with a history of diabetes (OR 5.58, 95% CI 1.83-18.7; P = .003). In a retrospective study of 610 critical care patients, Serra et al¹⁵ found both diabetes and congestive heart failure to be significant predictors, (OR 2.25, 95% CI not reported. P = .047; OR 2.25, 95% CI: not reported; P = .0047, respectively [in women]). Results of a retrospective, observational study by O’Brien et al¹³ showed a preoperative history of congestive heart failure to be predictive of ICU PU development (OR 1.78, 95% CI 1.27-2.49; P = .001), and a history of cardiovascular disease was found to be predictive of PU development in a retrospective, correlational study¹⁸ among medical-surgical ICU patients (OR 2.9, 95% CI 1.3-6.4; P = .007). One (1) retrospective study⁸ of 306 cardiovascular and medical surgical ICU patients found cardiovascular disease protective of PU development (OR 0.035, 95% CI 0.002-0.764; P = .03), which may have been a reflection of the sampling methodology.

Intrinsic factors. Hypotension is defined by the Society for Critical Care Medicine Sepsis 3 guidelines²⁶ as a systolic blood pressure <90 mm Hg, mean arterial pressure (MAP) <60 mm Hg or 70 mm Hg, or a drop in systolic blood pressure >40 mm Hg. Hypotension denotes that perfusion is impaired.²⁷ Blood is shunted from the periphery in an ongoing effort to preserve vital organ function, affecting tissue tolerance as capillaries close at lower tissue interface pressures.²⁸ Hypotension was found to be a significant predictor of PUs in 3 studies.^7,8,16 In their retrospective, 345 ICU-patient study, Bly et al⁷ reported a systolic blood pressure <90 mm Hg was predictive of PU development (OR 3.5, 95% CI 1.24-9.91: P <.05), and results of the retrospective cohort study by Wilczewski et al¹⁶ reported prolonged periods of MAP <70 mm Hg as the only predictor associated with PU development in a sample of 95 spinal cord injured patients in a surgical ICU. Cox and Roche⁸ found longer mean hours of MAP <60 mm Hg while on vasopressor agents to be predictive of PU development (OR 1.096, 95% CI 1.020-1.178; P = .01). Cox¹⁸ found MAP <60 mm Hg was significant in univariate analysis but not in multivariate analysis.

Iatrogenic/care factors. Prolonged mechanical ventilation was found to be a significant predictor in 3 studies.^8,10,19 Cox and Roche⁸ found patients who required mechanical ventilation for >72 hours were 23 times more likely to develop a PU (OR 23.604, 95% CI 6.4-86.6; P <.001), and in a prospective study of 216 ventilated patients in 2 medical/surgical ICUs, Apostolopulou et al¹⁰ reported mechanical ventilation for >20 days was a significant predictor of PU development (OR 7.225, 95% CI 2.46-21.201; P <.001). In their prospective cohort study of 299 ventilated medical/surgical ICU patients, Manzano et al¹⁹ found the time on mechanical ventilation before PU development was an independent risk factor (OR 1.042, 95% CI 1.005-1.080; P =.024), with PU risk increasing by 4.2% for each day on mechanical ventilation. O’Brien et al¹³ identified the presence of an endotracheal or tracheostomy airway in an ICU patient before the surgical procedure was a significant predictor of postoperative PU development (OR 1.663, 95% CI 3.63-7.67; P <.001).

Vasopressor agents. Vasopressors are potent vasoconstricting agents used to raise MAP in patients with profound hypotension unresponsive to fluid resuscitation²⁹; administration commonly is confined to critically ill patients in the ICU setting. Common agents include norepinephrine, epinephrine, phenylephrine, vasopressin, and dopamine. In this review, 4 studies^7,8,14,18 found vasopressor agents to be significant predictors of PU development. Bly et al⁷ found patients receiving more than 1 vasopressor (type not specified) were 3.3 times more likely to develop a PI (OR 3.71; 95% CI 1.65-6.62; P <.05). Cox and Roche⁸ found vasopressin administration to be independently associated with PU development (OR 4.816, 95% CI 1.66-13.92; P = .004). Vasopressin is usually a second-line agent used to manage shock states refractory to a single vasopressor agent. Cox and Roche⁸ postulate the addition of a second vasopressor agent (usually vasopressin) was considered the tipping point for PU risk. The retrospective cohort study by Tschannen et al¹⁴ reported patients who received vasopressor agents (type not specified) were 33 times more likely to develop a PU (OR 1.33, 95% CI 1.03-1.73; P = .03). Cox¹⁸ found norepinephrine to be an independent predictor of Stage 2 or greater PUs (Stage 3, Stage 4, DTI, unstageable). Apostolopoulou et al¹⁰ found vasopressor agents to be significant in univariate analysis only; however, in this study the variable inotropic agents (medications primarily indicated to improve cardiac contractility) was used. Although 4 studies^9,13,16,21 did not find significant associations between these agents and PU development, in most of these studies the vasopressor agents under investigation were not stated and as such the ability to draw meaningful conclusions was impaired. Additionally, changes in treatment protocols such as the SEPSIS 3 guidelines²⁶ have recently modified the hierarchy of vasopressor agent selection, potentially compromising knowledge of their effect on PU development.

Pressure ulcer risk assessment scales. The Braden Scale is the most well-known PU risk assessment scale and is used across the care continuum, including ICUs. The Braden Scale measures PU risk on 6 subscales (sensory perception, activity, mobility, moisture, friction/shear, and nutrition). Cumulative scores range from 6 to 23, with lower scores indicating greater PU risk. Used mostly abroad, the Jackson-Cubbin Scale³⁰ is a tool designed for use in ICUs and measures risk based on 12 risk factors (age, weight, past medical history, general skin condition, mental condition, mobility, hemodynamics, respirations, oxygen requirements, nutrition, incontinent, hygiene). Cumulative scores range from 9 to 48, with lower scores indicating greater risk.

The total Braden Scale score was found to be a significant predictor in 2 studies.^14,20 Tschannen et al¹⁴ found that a lower Braden score on admission was a significant risk factor in multivariate analysis (OR 0.89, 95% CI 0.86-0.93; P <.001); Slowikowski and Funk²⁰ also cited the total Braden Scale score (time of measurement not specified) as an independent risk factor (OR 1.30, 95% CI 1.15-1.47; P <.001). In the study by Cox¹⁸ that measured the total Braden score and the individual subscale scores on admission to the ICU, the total Braden score was found to be significant in univariate analysis only (r = -0.276, P ≤.01), and the subscales friction/shear and mobility were independent predictors of PU development (OR 5.715, 95% CI 1.423-22.95; P = .01; and OR 0.439, 95% CI 0.21-0.95; P = .04, respectively). In other studies that included the Braden Scale score in data analysis, 1 found it to be significant in univariate analysis only,⁸ while another found no relationship between the Braden Scale score and PU development.⁹

In the 1 study that employed the Jackson-Cubbin Scale to measure PU risk, Apostolopoulou et al¹⁰ found a Jackson-Cubbin score ≤29 to be a significant predictor of PU development (OR 0.015, 95% CI 0.005-0.050; P <.001). A comparative review³¹ of PU risk assessment scales found the Jackson-Cubbin superior to the Braden Scale in the ICU population. A systematic review and meta-analysis³² of the predictive validity of PU risk assessment scales used in the critical care population concluded the Braden scale was the best PU risk assessment scale for this population due to a lack of large studies using alternative PU risk assessment scales including the Jackson-Cubbin Scale. To date, no critical care-specific PU risk assessment scale has been validated in multiple empirical investigations using larger sample sizes in the critical care population. As such, a need for a PU risk assessment tool in this population persists.

Severity of illness. Severity of illness/mortality risk measures were reported in 10 of the studies in this review.^{6,8-10,12,14,17-19,21} Scales used to measure severity of illness included the APACHE II,^{8-10,12,18,21} APACHE III,¹⁹ SOFA,¹⁹ and SAPS II.¹⁷ In addition, APR-DRG¹⁴ and ASA Risk Classification^13,33 were used as indicators of severity of illness; these are not tools specific to the ICU population. Of these scales, 4 were found in individual studies to be significant predictors of PU development.^13,14,17,19 Cremasco et al¹⁷ found the SAPS II to be a significant predictor of PU (OR 1.058, 95% CI 1.004-1.114; P =.035); using the SOFA scale. Manzano et al¹⁹ found the fourth day cardiovascular SOFA score and the first day respiratory SOFA scores to be predictive (OR 1.33 95% CI 1.066-1.664; P = .12; and OR 1.56, 95% CI 1.026-2.360; P = .37, respectively). The APACHE III score also was measured in this study and found to be nonsignificant in univariate analysis. The ASA risk classification was used in a study of intraoperative risk factors in 2695 critical care patients; higher anesthesia risk classes of 4 or 5 as compared to lower risk classes of 1, 2, or 3 were found to be predictive of PU development (OR1.63, 95% CI 1.19-2.23; P = .003).¹³ Tschannen et al¹⁴ measured risk for mortality using the APR-DRG and found patients in the highest mortality risk categories were 11 times more likely to develop a PU (OR 11.15, 95% CI 7.1-17.5; P <.001). Higher APACHE II scores were found to be significantly associated to PU development in univariate analysis in 4 studies,^8,12,18,21 while in 2 studies^9,10 no relationship between PUs and the APACHE II score emerged. The use of multiple severity of illness/mortality indices across these studies makes it difficult to determine if any of these tools offers some insight into the relationship between severity of illness measures and PI risk. Although validated tools to measure severity of illness and mortality risk may help describe the burden of illness experienced in the ICU population, these may not translate to valid indicators of PI risk.

PU characteristics. In 6 studies, PU stage was not reported^{7,16,17,19-21} and in 7 studies PU location was not reported.^11,13-17,20 Of the studies that reported PU stage, Stage 2 was the most common,^{9,10,13,18,21} with the sacrococcygeal region cited as the most common location in 6 studies,^7-9,11,18,19which is consistent with the literature.³⁴

Interestingly, only 1 study⁸ (conducted in the United States) reported DTI as the most common stage. This finding may reflect the difference in staging classification utilized in the United States and abroad. In the 2009 NPUAP/European Pressure Ulcer Advisory Panel (EPUAP) International Pressure Ulcer guidelines,³⁵ the categories termed DTI (now termed DTPI) and unstageable PU were only recognized in the United States. DTPI begins at the muscle-bone interface and occurs as a result of tissue deformation due to a short period of intense pressure and/or as a result of tissue ischemia due to prolonged periods of immobility.^36,37 Critical illness coupled with prolonged immobility may render a patient vulnerable to the effects of pressure; thus, it would be logical this population would be at higher risk for more severe PIs. In fact, in a large United States prevalence study,³⁴ critical care patients had a higher prevalence of severe PUs (Stage 3, Stage 4, DTPI, or unstageable) as compared to the general hospital population.

Discussion

The 7 PU risk factors found to be significant across multiple studies included age, length of ICU admission, diabetes mellitus, cardiovascular disease, hypotension, mechanical ventilation, and vasopressor agents. An attribute shared by these risk factors is that they could be considered nonmodifiable. Patient-related factors such as age, comorbidities (diabetes, cardiovascular disease), and hypotension are intrinsically driven, and iatrogenic factors such as mechanical ventilation and vasopressors are lifesaving measures that cannot be terminated in an effort to avert PI risk, potentially diminishing the ability to prevent PI.

Age. According to the NPUAP,³ age may be a confounding variable that has the potential to influence mobility level, perfusion/oxygenation status, nutritional intake, and skin moisture level. In the pathogenesis of PI, these factors may mediate tissue tolerance and can affect the overall architecture of the skin. In the critically ill population, the overall burden of illness and complex care requirements may need to be considered an equally tenable confounding factor influencing tissue tolerance, subsequently escalating PI risk. Thus, in this population, all adults and not just older or elderly adults should be considered vulnerable to the potential for PI.

Length of stay. In the United States, mean ICU length of stay is estimated to be 3.8 days but may vary based on both the patient and ICU attributes.¹ It is logical to infer that the longer a patient remains in the ICU, the greater the probability that PI can occur. Prolonged ICU admission may act as a proxy for overall illness burden. Longer ICU length of stay connotes that a patient’s condition requires a higher level of care to manage the critical nature of his/her illness and prolonged recovery. Additionally, because longer length of stay is also a factor of time, the odds of developing a PI may increase with the passage of time.

When evaluating length of ICU admission as a risk factor, it is equally important to evaluate the time to PI development in determining PI risk. In the studies that reported this finding,^{6,7,9,12,15,17-19} the mean times ranged from 3 days⁹ to 14 days¹⁹; the majority of the studies noted the first week of ICU admission was the most vulnerable timeframe. This finding is consistent with previous studies in the ICU population.^38-40 The first week of a critical illness may be the time period in which the patient may be hemodynamically labile and physiologically unstable, so care priorities are focused on life preservation. This is the time that heightened PI prevention should be implemented within the context of the patient’s critical illness. Conversely, this time period may be ripe for the development of the unavoidable PIs due to the overall condition of the patient.

Diabetes and cardiovascular disease. Pathophysiologically, diabetes mellitus is associated with microvascular complications leading to capillary damage resulting from oxidative stress and poor perfusion. Macrovascular changes associated with diabetes are known to lead to peripheral arterial disease, coronary artery disease, and stroke.⁴¹ The prevalence of coronary artery disease increases with the longevity of a diabetes diagnosis, and the incidence of congestive heart failure is also higher in persons with diabetes.⁴¹ For persons with cardiovascular disease without concomitant diabetes, obstruction of vessels with atherosclerotic plaques impairs tissue perfusion and can lead to major ischemic events.⁴¹ In the setting of a critical illness, the sequelae of either comorbidity can complicate recovery and impair tissue perfusion and oxygenation; these comorbidities are worthy of consideration when establishing PI risk.

Hypotension. Hemodynamic instability is 1 of the primary clinical presentations of patients admitted to the ICU setting. In 3^7,8,16 of the 4 studies that measured hypotension, it was found to be a significant predictor and in 1 study it was found to be significant in univariate analysis.¹⁸ In previous ICU research^39,42 hypotension was not found to be related to PU development in this population or was found to be related in univariate analysis only.^43,44 However, the multivariate results from this review of more recent studies suggest prolonged hypotension should be strongly considered as an intrinsic PI risk factor in the ICU population.

Mechanical ventilation. According to the Society of Critical Care Medicine,¹ respiratory failure requiring ventilator support is the most common reason that requires admission to the ICU in the United States. Mechanical ventilation is indicated when the patient’s spontaneous ventilation is inadequate to sustain life; physiologic indications include respiratory or mechanical insufficiency and ineffective gas exchange, which can impair tissue perfusion and tissue oxygenation.⁴⁵ Prolonged mechanical ventilation as a PI risk factor also may reflect a patient’s overall severity of illness as well as be considered a proxy for immobility. Although progressive mobility in ventilated patients advocated by the American Association of Critical Care Nurses⁴⁶ is implemented in the ICU setting, this intervention could be either contraindicated or cautioned in many mechanically ventilated ICU patients. Additionally, mechanically ventilated patients require continuous head elevation when receiving this modality, predisposing the patient to greater shear forces, a major contributor to PI development, especially deeper injuries that originate at the fascial level overlying a bony prominence. When exposed to shear, blood vessels angulate and stretch and when combined with friction caused by head elevation, shear can cause thrombosis and compromise blood flow to the sacrococcygeal area.²⁸

Vasopressor agents. As potent vasoconstrictors, vasopressor agents are used to increase MAP in critically ill patients with impaired tissue and organ perfusion.²⁹ The pharmacodynamics of these agents suggest these medications can contribute to altered tissue tolerance, thus contributing to PI development. In this review, 4 studies^7,8,14,18 found vasopressor agents to be significant in multivariate analysis, with 2 specific agents (norepinephrine, vasopressin) identified in 2 studies.^8,18 Vasopressin is commonly administered as a second line agent; Cox and Roche⁸ suggest the addition of a second vasopressor agent may be the time period during which PI risk escalates in critically ill patients. Although evidence supporting vasopressor agents as a PI risk factor in critical care is strengthening, further empirical investigation is warranted into the role of specific agents in addition to the duration and dose administered of these agents.

Clinical implications: unavoidable PI. Although evidenced-based PU prevention programs have been successfully implemented and have been shown through ICU quality improvement initiatives to impact PU rates,^47-50 there are patients — specifically, critically ill patients — for whom PI occurrence may at times be unavoidable. However, the determination that a PI was unavoidable cannot be made without consideration for PI prevention strategies. In this review, 7 studies^{6,8,11,12,18,19,21} reported PU prevention strategies were in place when the study was conducted and in 2 studies, infrequent repositioning was found to be a significant predictor of PU development.^6,21 In order to validate that PI was beyond the control of care providers, it is important for future investigations to consider PI prevention interventions in the study design.

The ability to label a PI “unavoidable” creates a clinical paradox for caregivers as unavoidable pressure injury currently is not recognized in the hospitalized patient; regulatory and quality indicators at this time give credence to the notion that all PIs are preventable. For example, in 2007 the Centers for Medicare and Medicaid Services⁵¹ deemed the occurrence of Stage 3 and Stage 4 hospital-acquired PUs as “never events,” restricting reimbursement to facilities for care necessary to treat these conditions. Moreover, the National Database of Nursing Quality Indicators⁵² includes hospital-acquired PUs as nurse-sensitive quality indicators, linking PU occurrence to the quality of care delivered by nurses. Litigation exposure is an ever-present threat to caregivers; more than 17 000 lawsuits related to PUs are filed annually, second only to wrongful death and more common than patient falls.⁵³ Based on the current health care climate, it is a research imperative to develop the clinical criterion to validate the unavoidable PI in the hospitalized patient, especially in the critically ill population, in an effort to assist bedside caregivers in more accurate distinction of this clinical phenomenon.

The future of the Braden Scale in critical care. Formalized PI risk assessment of the ICU patient continues to be a facet of prevention that needs to be modified in the critical care population. Although the Braden Scale remains the most common tool used in critical care and most settings across the United States, questions remain regarding its clinical utility in the critical care population and its ability to discriminate true risk. In the studies in this review that considered formalized PI risk assessment as either a descriptive variable or as part of the data analysis, all patients were found to be at moderate to high risk for PI. Although the total Braden scale score was found predictive in 2 studies^14,20 and in 2 of the subscales (mobility and friction/shear) in 1 study,¹⁸ it is noteworthy that none of these elements was found to be predictive in multiple studies in this review. The need for the development and testing of a critical care PI risk tool to accurately detect PI risk persists to provide caregivers a potential edge in the application of evidence-based prevention strategies.

Limitations

The author recognizes this review has limitations. First, differences in methodologic approaches and risk factors chosen for inclusion and analysis create a degree of difficulty in interpreting and synthesizing these results. Secondly, differences in prevention strategies across the study sites cannot be controlled; thus, for some of these studies it was unclear whether PU prevention strategies were in place at the time of the study.

Conclusion

PI development in critically ill patients remains a multifactorial phenomenon for which true risk is both pervasive and elusive. This review identified 7 risk factors (age, prolonged ICU admission, diabetes mellitus, cardiac disease, hypotension, vasopressor use, and prolonged mechanical ventilation) as significant predictors in 3 or more studies, with the majority of these factors nonmodifiable and potential contributors to unavoidable PIs. Advancing the science regarding the pathogenesis and physiologic mechanisms that accelerate PI development is imperative in any effort to better understand unavoidable PI. The need for large multisite studies and studies using large datasets capable of validating risk factors unique to the critical care population remains. Enhanced PI risk quantification for this population will aid caregivers in earlier and more targeted risk detection, which has the potential to impact the care delivered to this complex and vulnerable patient population.

References

1. Society for Critical Care Medicine. Critical Care Statistics. Available at: www.sccm.org/Communications/Pages/CriticalCareStats.aspx. Accessed November 8, 2016.

2. Barrett ML, Smith MW, Elixhauser A, Honigman LS, Pines JM. Utilization of Intensive Care Services, 2011. Healthcare Cost and Utilization Project. 2014. Available at: http://hcup-us.ahrq.gov/reports/statbriefs/sb185-Hospital-Intensive-Care.... Accessed November 8, 2016.

3. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Haesler E, ed. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (ed). Osborne Park, Australia: Cambridge Media;2014.

4. Bergstrom N, Braden B, Laguzza A, Holman V. The Braden scale for predicting pressure sore risk. Nurs Res. 1987;36(4):205–210.

5. Edsberg LE, Langemo D, Baharestani MM, Posthauer ME, Goldberg M. Unavoidable pressure injury: state of the science and consensus outcome. J Wound Ostomy Continence Nurs. 2014;41(4):313–334.

6. Tayyib N, Coyer F, Lewis P. Saudi Arabian adult intensive care unit pressure ulcer incidence and risk factors: a prospective cohort study. Int Wound J. 2016;13(5):912–919.

7. Bly D, Schallom M, Sona C, Klinkenberg D. A model of pressure, oxygenation, and perfusion risk factors for pressure ulcers in the intensive care unit. Am J Crit Care. 2016;25(2):156–164.

8. Cox J, Roche S. Vasopressors and development of pressure ulcers in adult critical care patients. Am J Crit Care. 2015;24(6):501–510.

9. Campanili T, Santos V, Strazzieri-Pulido KC, Thomaz Pde B, Nogueria PC. Incidence of pressure ulcers in cardiopulmonary intensive care unit patients. Rev Esc Enferm USP. 2015;49:7–14.

10. Apostolopoulou E, Tselebis A, Terzis K, Kamarinou E, Lambropoulous I, Kalliakmanis A. Pressure ulcer incidence and risk factors in ventilated intensive care patients. Health Science J. 2014;8(3):333–342.

11. Nassaji M, Askari Z, Ghorbani R. Cigarette smoking and risk of pressure ulcers in adult intensive care unit patients. Int J Nurs Prac. 2014;20(4):418–423.

12. Ülker Efteli E, Yapucu Günes U. A prospective, descriptive study of risk factors related to pressure ulcer development among patients in intensive care units. Ostomy Wound Manage. 2013;59(7):22–27.

13. O’Brien D, Shanks A, Talsma A, Brenner P, Ramachandran S. Intraoperative risk factors associated with postoperative pressure ulcers in critically ill patients: a retrospective observational study. Crit Care Med. 2013;42(1):40–47.

14. Tschannen D, Bates O, Talsma A, Guo Y. Patient-specific and surgical characteristics in the development of pressure ulcers. Am J Crit Care. 2012;21(2):116–125.

15. Serra R, Caroleo S, Buffone G, et al. Low serum albumin level as an independent risk factor for the onset of pressure ulcers in intensive care unit patients. Int Wound J. 2014;11(5):550–553.

16. Wilczweski P, Grimm D, Gianakis A, Gill B, Sarver W, McNett M. Risk factors associated with pressure ulcer development in critically ill traumatic spinal cord injury patients. J Trauma Nurs. 2012;19(1):5–10.

17. Cremasco M, Wenzel F, Zanei S, Whitaker I. Pressure ulcers in the intensive care unit: the relationship between nursing workload, illness severity, and pressure ulcer risk. J Clin Nurs. 2013;22(15-16):2183–2191.

18. Cox J. Predictors of pressure ulcers in adult critical care patients. Am J Crit Care. 2011;20(5):364–374.

19. Manzano F, Navarro M, Roldan D, et al. Pressure ulcer incidence and risk factors in ventilated intensive care patients. J Crit Care. 2010;25(3):469–476.

20. Slowikowski G, Funk M. Factors associated with pressure ulcers in patients in a surgical intensive care unit. J Wound Ostomy Continence Nurs. 2010;37(6):619–626.

21. Kaitani T, Tokunaga K Matsui N, Sanada H. Risk factors related to the development of pressure ulcers in the critical care setting. J Clin Nurs. 2010;19(3-4):414–421.

22. Kelly M, Manaker S, Finlay G (eds). Predictive Scoring Systems in the Intensive Care Unit. October 2016. Available at: www.uptodate.com/contents/predictive-scoring-systems-in-the-intensive-ca.... Accessed: November 10, 2016.

23. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985;13(10):818–829.

24. Frankel H, Sperry J, Kaplan L. Risk factors for pressure ulcer development in a best practice surgical intensive care unit. Am Surg. 2007;73(12):1215–1217.

25. Eachempati S, Hydo L, Barie P. Factors influencing the development of decubitus ulcers in critically ill surgical patients. Crit Care Med. 2001;29(9):1678–1682.

26. Society for Critical Care Medicine-Sepsis Definitions Task Force, The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); 2016. Available at: file:///C:/Users/jillcox/AppData/Local/Temp/Quality-Sepsis-Definitions-SCCM-ESICM-Joint-Session-Critical-Care-Congress.pdf. Accessed on October 13, 2016.

27. Stephens R, Halder S, Weiner C. Hypotension and shock. In: Parrillo JE, Ayres SM (eds). Piccini & Nilsson: The Osler Medical Handbook, 2nd ed. Philadelphia, PA: Saunders-Elsevier;2006:239–252.

28. Pieper B. Pressure ulcers: impact, etiology and classification. In: Bryant R, Nix D (eds). Acute and Chronic Wounds: Current Management Concepts, 5th ed. St. Louis, MO: Elsevier;2016.

29. Manaker S. Use of vasopressors and inotropes. 2016. Available at: www.uptodate.com/contents/use-of-vasopressors-and-inoyropes.

Accessed October 31, 2016.

30. Jackson C. The revised Jackson-Cubbin pressure area risk calculator. Int Crit Care Nurs. 1999;15(3):169–175.

31. Kim E, Lee S, Lee E, Eom M. Comparison of the predictive validity among pressure ulcer risk assessment scales for surgical ICU patients. Aus J Adv Nurs. 2009;26(4):87–94.

32. Garcia-Fernandez P, Pancorbo-Hildago PL, Soldevilla Agreda JJ, Agreda J, Rodriquez Torres M. Risk assessment scales for pressure ulcers in intensive care units: a systematic review with meta-analysis. EWMA J. 2013;13(2):7–13.

33. ASA physical status classification system. Available at: www.asahq.org/resources/clinical-information/asa-physical-status-classif.... Accessed November 10, 2016.

34. VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 International pressure ulcer prevalence survey and a 3 year acute care, unit-specific analysis. Ostomy Wound Manage. 2009;55(11):39-45.

35. European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers. Washington, DC: National Pressure Ulcer Advisory Panel:2009.

36. Black JM, Brindle CT, Honaker JS. Differential diagnosis of suspected deep tissue injury. Int Wound J. 2016;13(4):531–539.

37. Oomens CW, Bader D, Loerakke S, Baaijens F. Pressure induced deep tissue injury explained. Ann Biomed Eng. 2015;43(2):297–305.

38. Carlson EV, Kemp MG, Shott, S. Predicting the risk of pressure ulcers in critically ill patients. Am J Crit Care. 1999;8(4):262–269.

39. Compton F, Hoffmann F, Hortig T, et al. Pressure ulcer predictors in ICU patients: nursing skin assessment versus objective parameters. J Wound Care. 2008;17(10):417–424.

40. Fife C, Otto G, Capsuto E, et al. Incidence of pressure ulcers in a neurologic intensive care unit. Crit Care Med. 2001:29(2):273–290.

41. Brashers V, Jones R, Huether S. Alterations in hormonal regulation. In: Huether S, McCance K (eds). Understanding Pathophysiology, 6th ed. St Louis, MO: Elsevier;2017.

42. Pender L, Frazier S. The relationship between dermal ulcers, oxygenation and perfusion in mechanically ventilated patients. Intensive Crit Care Nurs. 2005;21(1): 29–38.

43. Senturan L, Karabacak U, Ozdilek S. The relationship among pressure ulcers, oxygenation and perfusion in mechanically ventilated patients in an intensive care unit. J Wound Ostomy Continence Nurs.

Potential Conflicts of Interest: None disclosed

Dr. Cox is an Associate Clinical Professor, Rutgers School of Nursing, Newark, NJ; and an advanced practice nurse/CWOCN, Englewood Hospital and Medical Center, Englewood, NJ. Please address correspondence to: Jill Cox, PhD, RN, APN-C, CWOCN, 350 Engle Street, Englewood, NJ 07631; email: jillcox@sn.rutgers.edu; jill.cox@ehmchealth.org

Section:

Volume 63 - Issue 12 - December 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(12):22–28

Glenda Motta, RN, MPH; and Catherine T. Milne, APRN, MSN, CWOCN-AP

Topics:

skilled nursing facility

evaluation study

incontinence pads

Dermatitis

pressure injury

Abstract

Due to the high prevalence of incontinence among skilled nursing facility (SNF) residents, incontinence-associated dermatitis (IAD) is a common occurrence. In addition, facility staff may mistakenly identify IAD as a pressure injury. A prospective, descriptive, multicenter study was conducted in 3 Connecticut facilities to evaluate the effect of substituting a disposable, high-fluid capacity underpad for nonpermeable disposable and reusable containment products on the rate of IADs.

Residents with and without IAD but with high IAD risk scores who were bed- or chairbound or ambulatory and used disposable nonpermeable briefs and underpads or reusable, laundered containment products when in bed longer than 2 hours were randomly enrolled and observed for a 4-week period. Facility staff were trained on the importance of differentiating between IAD and pressure injury; they substituted the study product (a disposable, high-fluid capacity underpad) for all previously used containment products. Patient risk for IAD and skin condition were assessed using the Perineal Assessment Tool (PAT) and the Skin Condition Assessment Tool (SAT), respectively, at 5 time points: baseline, week 1, week 2, week 3, and week 4. The PAT is a 4-item instrument based conceptually on the 4 determinants in perineal skin breakdown; subscales are rated from 1 (least risk) to 3 (most risk), with a total score range of 4 to 12. The SAT is used to evaluate IAD specifically, generating a cumulative severity score ranging from 0 to 3 on area of skin affected, degree of redness, and depth of erosion. Final data analysis was conducted on 40 residents: 25 had IAD present at enrollment and 15 were deemed high risk for developing IAD. Mean SAT scores in the 25 participants with IAD decreased with significance at week 1 (P = .0016), week 2 (P = .0023), week 3 (P = .0005), and week 4 (P<.0001). Baseline IAD severity scores averaged 3.3 ± 1.7. Overall IAD average severity scores in this group decreased from baseline mean of 3.3 ± 1.7 to 0.7 ± 1.4 at week 4 (P<.001). The 15 participants with intact, nondamaged skin at enrollment did not develop IAD from baseline to week 4, and PAT score risk levels decreased from high (7 or greater) to low (6 or less) as a result of a specific reduction in the duration of irritant exposure category for 11 (73%) of this group of participants by week 4. PAT risk level scores for both IAD and non-IAD participants at baseline averaged 8.1 ± 1.4; after 4 weeks, they averaged 7.0 ± 1.5). Although change was not significant, results suggest the use of a disposable, high-fluid capacity underpad improved SAT scores over time. IAD rates increased in each facility, but pressure injury incidence rates decreased for the study duration. Replacing a nonpermeable, reusable containment product with a disposable, high-fluid capacity underpad when SNF residents are in bed longer than 2 hours may impact the severity of IAD and reduce its incidence. The inverse impact reported on IAD and pressure injury incidence rates 1 month after training suggest study educational efforts had a short-lasting effect. Future research is indicated to determine the most effective method to improve nurses’ ability to identify and distinguish IAD from pressure injury in the SNF setting.

According to a systematic review,¹ prevalence rates of urinary incontinence among nursing home residents range from 43% to 77% (median 58%); for women, the rate ranges from 60% to 78% and for men from 45% to 72%.² An economical analysis³ showed the time from nursing facility admission to occurrence of incontinence-associated dermatitis (IAD) ranged from 6 to 42 days, with the median of 13 days.

Recent discussion on IAD and implications for research points to the need for clinical evidence on its differentiation from pressure injury.⁴ Accurate differential classification of IAD versus Stage 1 or Stage 2 pressure injury is challenging for both expert and nonspecialty nurses. According to a 2010 consensus panel,⁵ IAD is frequently misclassified despite the fact that ischemia is not the cause. In the skilled nursing facility (SNF) setting, this may lead to incorrect high pressure injury prevalence or incidence rates and resultant federal and/or state survey deficiencies. The Centers for Medicare and Medicaid Services⁶ publishes these findings for public review, and poor quality outcomes such as these impact Medicare reimbursement.

A cross-sectional study⁷ and a retrospective cohort study⁸ have shown that using absorbent products such as pads and briefs is the most common urine collection method in nursing homes; they are used by 56.1% to 67.6% of residents with urinary incontinence. Reports in the literature indicate that switching to moisture-wicking underpads results in a decrease in moisture-associated skin issues; for example, findings from a quality improvement study⁹ noted disposable pads helped maintain dry skin, thus preventing moisture-associated skin dermatitis (MASD) as well as pressure injuries in hospitalized patients. Using a cluster randomization method in a randomized clinical trial, Francis et al¹⁰ compared standard moderately absorptive reusable underpads to disposable high-absorbant underpads in hospitalized patients. Although no statistical differences were noted in IAD rates, hospital-acquired pressure injuries were lower (P = .02).

No studies have been published that compared high-absorbant underpads to briefs or nonpermeable containment products in the long-term care setting with bedbound residents. The primary purpose of this multicenter, prospective study was to evaluate if substituting standardly used products with a disposable high-fluid capacity underpad (Wings™ Quilted Moisture Vapor Permeable Underpad; Cardinal Health, Mansfield, MA) would affect incidence and severity of IAD. Specifically, the study pad replaced products such as single-use disposable briefs and standard nonvapor, permeable, moderately absorptive underpads usually used for bedbound, chairbound, or ambulatory SNF residents who were not toileted at night or when they were confined to bed longer than 2 hours.

Methods

Participants. This prospective, descriptive, multicenter, study was conducted in 3 Connecticut SNFs. SNF residents presenting with IAD and those without but at risk for IAD were enrolled. A complete list of inclusion/exclusion criteria is shown in Table 1. Enrolled participants were assessed weekly for 4 weeks. This timeframe was chosen to allow data collection at 5 points: baseline, week 1, week 2, week 3, and week 4. Data from residents who dropped out or were unable to complete the study due to hospitalization or death were excluded from analysis.

Consent. An independent Institutional Review Board (Allentown IRB Regulatory and Technical Associates, Old Lyme, CT) reviewed and approved the study protocol. Residents who agreed to participate and provided written informed consent were enrolled. Residents unable to understand or provide written consent were enrolled after their designated legal representative agreed to the study procedures and provided written consent for participation.

Procedure. Following approval of the study protocol, the principal investigator educated facility staff on participant selection, clinical procedures, and documentation requirements. In addition, the investigator conducted training on the importance of differentiating between IAD and pressure injury. At study initiation, the investigator utilized didactic method and visuals (pictures) comparing and contrasting the 2 clinical entities. All licensed nurses (RNs and LPNs) on all 3 shifts in each facility received training. Staff then referred male and female residents who met inclusion/exclusion criteria (see Table 1) to the investigator. After obtaining consent and before enrollment, the investigator assessed each potential participant for eligibility and determined if IAD was present. Following enrollment, the investigator performed assessments at baseline and weekly for 4 weeks, taking photographs for comparison purposes.

Facility staff placed each participant on the study pad when time in bed was expected to be longer than 2 hours and then conducted wetness checks every 2 hours; this benchmark was chosen to coincide the wetness checks and subsequent incontinence care with pressure injury prevention care activities at the participating facilities such as routine turning and repositioning. If any amount of wetness was felt on the study pad, staff changed it and provided routine incontinence skin care per facility protocol, including cleansing using a pH balanced liquid soap, moisturizing using a lotion, and applying a zinc-based moisture barrier. Particular skin care products differed among facilities, but they remained unchanged before, during, and after the study.

In addition, staff followed the usual turning and repositioning plan established for each participant. While providing incontinence care over the 4-week period, facility staff observed the skin for any new occurrences of IAD or other types of damage. Any changes were reported to the investigator within 24 hours.

Staff recorded the type and number of study products used daily on each participant on a pen-and-paper Product Placement Report form kept at the participant’s bedside and totaled use on a weekly basis. Facilities provided an itemization of containment products that constituted “usual care” for each participating resident. In 2 facilities, usual care consisted of a brief changed every 2 hours during the night and 2 disposable pads. In the third facility, briefs were used for men and women deemed as “heavy wetters” (defined as requiring linen change in addition to a change of brief). Otherwise, reusable cloth pads were the norm.

Tools and data collection. The principal investigator utilized a remote data capture system to complete electronic Case Report Forms. All data were managed in a secure database that provided content control and auditability, ensured content security, and complied with all applicable regulatory guidelines. Identifiable participant information was not recorded in the database. A unique subject identification number was allocated to each participant that also indicated enrolling site.

IAD risk was based on contributing factors as itemized in the Perineal Assessment Tool (PAT), a 4-item instrument based conceptually on the 4 determinants noted in perineal skin breakdown: intensity per type (eg, solid stool, liquid stool, urine) and duration of irritant, perineal skin condition, and contributing factors such as Clostridium difficile infection, poor nutrition, or tube feeding. Subscales are rated from 1 (least risk) to 3 (most risk), with a total score range of 4 to 12. Persons with scores 7 or above are considered high risk and scores <6 are considered low risk for perineal breakdown. Interrater reliability of the PAT was acceptable with a calculated value of the Pearson product-moment correlation r = .970, 95%, confidence interval = .923–.988, and P = <.0001.¹¹

On enrollment, the investigator recorded participant demographic data, including gender, age, race, ethnicity, height, weight, and body mass index. The baseline skin assessment included known history of IAD (type, location, duration, and moisture frequency). Skin was assessed using the IAD Skin Condition Assessment Tool (SAT), an instrument that generates a cumulative severity score based on area of skin affected, degree of redness, and depth of erosion.¹² The total SAT score ranges from 0 (no IAD) to 10 (severe IAD). The tool contains 3 domains: area of skin breakdown (score 0-3); skin redness (score 0-3); and erosion (score 0-4). Although reliability and validity have not been established, it was selected and deemed appropriate for use in the SNF setting owing to its use in a randomized, controlled, long-term care incontinence study.¹³

Facility staff manually reported product usage data and results of wetness checks using the Product Placement Form. The investigator verified congruence between recorded data and pad counts (pads were kept at each participant’s bedside) and reviewed the medical record to determine congruence between data recorded on the Product Placement Report form and documentation of staff performance of wetness checks and incontinence care.

For each facility, the investigator collected IAD and pressure injury prevalence rates for the 1-month period before study initiation, the time of the study duration, and at 1-month following study completion. IAD and pressure injuries were reported daily to the infection control nurse who reviewed the medical records and confirmed the documentation with a visual inspection of the patient. Weekly and monthly incidence for each unit and the entire facility were compiled and presented at quality and medical staff meetings. Incidence rates then were calculated and reported at monthly quality meetings. All facilities participating in the study calculated the number of residents (in percentage) with both pressure and IAD on a daily basis to reflect “real-time” incidence.

Data analysis. Staff entered data into the participant’s medical record. The investigator transferred the data onto Case Report Forms that then were sent electronically to a centralized secure database for analysis.

Descriptive statistics were used to summarize demographic and clinical characteristics of the enrolled participants. Number of available observations (n), mean, standard deviation (SD), median, and minimum and maximum values were assessed, along with the frequency and percentage of participants assigned to either IAD present or IAD risk category.

The PAT and IAD Skin Condition Assessment Tool scores were tabulated at baseline and week 4. Because this was not a controlled, randomized comparison study, a formal sample size calculation based on statistical need was not performed. Data from the 3 facilities were aggregated for analysis because too few residents participated to evaluate outcomes per facility.

IAD-positive participants, regardless of severity at baseline, were analyzed using the McNemar chi-squared test for paired or dependent data. Data were assessed for each participant with IAD and IAD diagnosis change between baseline and post-procedure timepoints, which identified concordant pairs (no change in IAD diagnosis between baseline and post-procedure) and discordant pairs (change in diagnosis or severity between baseline and post-procedure). Discordant pairs could be in both direction (IAD=YES at baseline to IAD=NO post-procedural, or IAD=No at baseline then YES=post-procedure). The McNemar test then was calculated using these discordant and concordant pairs. Because pressure injury was not a variable studied, it was not analyzed. However, the investigator reviewed the weekly infection control data to see who had IAD.

Results

A total of 43 residents met inclusion criteria, provided consent, and were enrolled. Three (3) dropped out voluntarily after the baseline visit and were excluded from analysis. The remaining 40 enrolled residents completed study requirements and qualified for evaluation (12 from facility 1, 17 from facility 2, and 11 from facility 3), including 31 women (78%). Participant mean age was 83 (range 62–98) years. Ambulatory status at baseline was 2 bedbound, 6 mostly bedbound but occasionally able to move to a chair, and 32 wheelchair-dependent patients. At the time of enrollment, 25 participants presented with IAD; 15 had intact skin but were determined to be at risk of developing IAD; 36 had a reported known history of IAD. Of those, the proportion of participants with scores indicating a change from IAD-positive to IAD-negative between baseline and post procedures (6 IAD positive post-procedure and 19 IAD-negative post procedure) was significant for all time points: from 16 (62.5%) IAD-positive at baseline to 9 (37.5%) at week 1 (P = .0016); 8 (35.0%) from week 1 to week 2 (P = .0023); 7 (32.5%) from week 2 to week 3 (P = .005); and 4 (15.4%) at week 4 (P<.0001) (see Figure 1). The overall reduction in IAD severity from a mean score of 3.3 ± 1.7 at baseline to a mean score of 0.7 ± 1.4 at week 4 also was significant (P<.001). The mean PAT score (ie, risk for perineal skin breakdown) for these 25 participants decreased from 8.7 at baseline to 7.5 at week 4 (see Figure 2). The 15 participants without IAD at enrollment maintained intact, nondamaged skin at all data collection time points from baseline to week 4. PAT score risk levels decreased from high (7 or greater) to low (6 or less) as a result of a specific reduction in the duration of irritant exposure category in these participants at week 4 (see Figure 2).

Impact on IAD rates. Facility IAD rates began to increase after the investigator completed staff training on the importance of differentiating between IAD and pressure injury. As a serendipitous finding, investigators noticed (as did the infection control nurse) the IAD and pressure injury rates reversed. IAD rates continued to increase in each facility for the study duration as follows: facility 1 from 0% to 4.5%; facility 2 from 0.05% to 3.4%; and facility 3 from 0.0% to 0.3%. Conversely, reported pressure injury incidence rates increased in all 3 facilities for the 1-month post study follow-up period: facility 1 from 1.2% to 3.8%; facility 2 from 1.2% to 1.5%; and facility 3 from 0.6% to 0.9%, while IAD rates decreased in facility 1 from 4.5% to 2.3%; in facility 2 from 3.4% to 2.9%; and in facility 3 from 0.3% to 0.0%.

Discussion

The study focused on evaluating the clinical impact of a disposable, high-fluid capacity underpad on IAD rates in SNFs used for residents with incontinence who were in bed longer than 2 hours. The analysis revealed significant differences in the reduction of IAD in the 25 participants enrolled with IAD. In addition, the 15 participants with intact skin who were identified to be at risk of IAD maintained intact, nondamaged skin between baseline and week 4.

Based on the authors’ observations, absorbent products are widely used in SNFs for containing urine and feces; bed- and chairbound nursing facility residents wear diaper-type briefs. Some residents who are ambulatory during the day and not toileted during the night also wear briefs when confined to bed. Improper application of these products, using an incorrect size, or not changing a brief in the recommended timeframe may result in MASD.¹⁴ It has been reported in a multicenter prospective surveillance study¹⁵ (N = 118) and a randomized trial¹⁶ (N = 68) that absorbent products can further increase the risk of skin problems, inflammation, and infections, especially if used inappropriately.

Based on the authors’ clinical experience, many hospitalized patients with incontinence who are bed- and/or chairbound typically do not wear diaper-type briefs. Increasingly, hospital staff use disposable underpads with high fluid capacity designed to wick moisture away from the skin.^10,17 In the authors’ experience, relatively little attention is paid to the problems associated with using these and other nonpermeable containment products while SNF residents are in bed longer than 2 hours.

The International Organization for Standardization (ISO) document¹⁸Urine-absorbing aide – General guidelines on evaluation describes factors that should be considered when evaluating adult incontinence absorbing aids. This document stresses that no research has identified a single product proven suitable for every user. ISO clinical researchers¹⁹ have concluded that, due to the considerable variability in individual user preference, patient-centered management of incontinence may best be achieved by allowing users to choose combinations of designs for different circumstances (eg, nighttime versus daytime usage). The current findings suggest a high-fluid capacity absorbent pad used by SNF residents who are in bed more than 2 hours may be a helpful component of an individualized incontinence management program.

During the study, facility-reported IAD rates increased in each facility while pressure injury incidence rates decreased. The inverse was true 1 month post study: pressure injury incidence rates increased while IAD rates decreased. The authors believe this was a result of the staff education on distinguishing between IAD and pressure injury provided by the investigator before and during the study. The investigator noted that the participating facilities did not believe IAD was a problem among residents until educated on the subject. The inverse findings noted in the 1 month follow-up period suggest ongoing education is essential to reinforce the differentiation between IAD and pressure injury.

Gray et al²⁰ observed that IAD is frequently misclassified as a pressure ulcer. Trevellini and Smith¹⁷ describes a performance improvement project initiated in a 750+ bed acute care facility ICU to empower the staff nurse to identify and classify skin integrity issues according to etiology and implement evidence-based nursing strategies to prevent IAD, fungal rash, and pressure injury. In this study, 100 wound care nurses were asked to review 9 unique wound photos and determine whether the primary etiologic factor was pressure, moisture, IAD, or skin tear. The analysis revealed that the agreement between the 100 respondents for the 9 photos was only 17% better than chance alone.

A randomized controlled trial²¹ with a convenience sample of more than 1200 Belgian, Dutch, British, and Portuguese nurses asked participants to classify photos of pressure injuries and IAD; in the post test, the percentage of correct assessments of IAD was significantly higher in the education group (70.7%) versus 35.6% in the control group (P<.001).

The current study supports other research findings that generalist nurses are not well versed in determining etiology of buttock wounds.²² Previous studies did not examine interventional results over a period of time. In this study, educational efforts had a short-lasting effect. Future research is indicated to determine the most effective method to improve nurses’ ability to identify and distinguish IAD from pressure injury. Last year, penalties imposed on Medicare and Medicaid certified nursing homes (for all deficiencies combined) ranged from $1000 to more than $354 000.⁶ Therefore, it is critical that IAD is not erroneously documented as a pressure injury.

A feasibility study conducted by researchers in the UK²³concluded IAD instruments are too time-consuming and linguistically complex for use in routine clinical practice in nursing homes. These findings suggest that a simple rating tool combined with photographs to illustrate the different severity categories may be suitable for daily monitoring of skin health in nursing home residents, at least to address some of the issues noted in the current study.

Limitations

Because this was not a randomized controlled study, findings cannot be applied to the general population of SNF residents who are incontinent. The study protocol may have resulted in more frequent wetness checks, turning, and repositioning than before study initiation. Also, the education that focused on differentiating between IAD and pressure injury may have impacted the reported IAD and pressure injury incidence rates.

No validated tool to reliably detect the presence of IAD and measure its severity has been deemed superior in the clinical setting. Clinical tools that provide objective measurement of IAD severity are limited, as are validated skin health tools for determining intervention outcomes in trials such as this, tempering the current outcomes.

All participants were provided a pad made by a single manufacturer. Therefore, the influence of pads from different manufacturers on IAD or pressure injury prevalence or incidence rates was not addressed. In addition, pad change frequency varied for each participant. Thus, no cause and effect can be attributed to a single product. Each SNF resident should have an individualized plan of care to manage incontinence that is based on a number of factors.

Implications for Practice and Research

Although wound, ostomy, continence nurses may be involved in policy regarding the use of incontinence products in the SNF setting, very little evidence is available to support these decisions. Studies such as this, although limited, may be of assistance when developing clinical practice pathways for the use of incontinence containment products or configuring a simple rating tool to assist with identification of IAD and recommending appropriate interventions. The current findings also reinforce the need for education regarding the prevalence of IAD in SNFs and its differentiation from pressure injury. These results support previous conclusions that a simple, valid, and reliable rating tool suitable for routine clinical practice by nurses and other caregivers in nursing homes, is needed.

Conclusion

Using a disposable, high-fluid capacity underpad as replacement for nonvapor permeable containment products for SNF residents in bed longer than 2 hours may impact the severity of IAD when present and reduce its incidence. The current findings support recommendations that studies comparing the effect of various pad types on skin health in older adults are needed to help reduce the incidence of IAD.^14,24,25 Because pad function depends in part on the available brand, it is probable that differences in design and composition may affect skin differently.

The inverse impact reported on IAD and pressure injury incidence rates suggests that education focused on differentiating between these conditions would be valuable in the SNF setting. This may lead not only to improved quality of care but also to more accurate federal and/or state survey findings. n

References

1. Offermans MP, Du Moulin ME, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288–294.

2. Landefeld CS, Bowers BJ, Feld AD et al. National Institutes of Health state-of-the-science conference statement: prevention of fecal and urinary incontinence in adults. Ann Intern Med. 2008;148(6):449–458.

3. Bliss DZ, Zeher C, Savik K, Thayer D, Smith G. An economical evaluation of four skin damage prevention regimens in nursing home residents with incontinence: economics of skin damage prevention. Ostomy Wound Manage. 2006;52(12):46–55.

4. Gray M, McNichol L, Nix D. Incontinence-associated dermatitis progress, promises, and ongoing challenges. J Wound Ostomy Continence Nurs. 2016;43(2):188–192.

5. Doughty D, Junkin J, Kurtz P, et al. Incontinence-associated dermatitis: consensus statements, evidenced-based guidelines for prevention and treatment and current challenges. J Wound Ostomy Continence Nurs. 2012; 39(3):303–315.

6. Centers for Medicare and Medicaid Services. Nursing Home Compare. Available at: https://data.Medicare.gov/data/Nursing-Home-Compare. Accessed July 28, 2016.

7. Yoshida M, Wada Y, Takahashi W, Inadome A, Ueda S. Control of urination in elderly bedridden patients. Nishinihon J Urol. 1996;58(5):490–495.

8. Rogers MA, Mody L, Kaufman kSR, Fries BE, McMahon LF Jr, Saint S. Use of urinary collection devices in skilled nursing facilities in five states. J Am Geriatr Soc. 2008;56(5):854–861.

9. Wound, Ostomy, Continence Nurses Society. WOC nurse utilizes skin care champion program to decrease pressure ulcer rates. Wound, Ostomy, Continence Nurses Society. Available at: http://c.ymcdn.com/sites/www.wocn.org/resource/resmgr/Publications/WOC_N.... Accessed July 25, 2016.

10. Francis K, Pang SM, Cohen B, Salter H, Homel P. Disposable versus reusablea absorbent underpads for prevention of hospital-acquired incontinence-associated dermatitis and pressure injuries. J Wound Ostomy Continence Nurs. 2017;44(4):374–379.

11. Nix DH. Validity and reliability of the Perineal Assessment Tool. Ostomy Wound Manage. 2002;48(2):43–49.

12. Gray M, Bliss DZ, Doughty DB, Ermer-Seltun J, Kennedy-Evans KL, Palmer MH. Incontinence-associated dermatitis: a consensus. J Wound Ostomy Continence Nurs. 2007;34(1):45–54.

13. Beeckman D, Verhaeghe, S’ Defloor T, Schoonhoven L, Vanderwee K. A 3-in-1 perineal care washcloth impregnated with dimethicone 3% versus water and pH-neutral soap to prevent and treat incontinence-associated dermatitis: a randomized, controlled clinical trial. J Wound Ostomy Continence Nurs. 2011;38(6) 627–634.

14. Shigeta Y, Nakagami G, Sanada H, Konya C, Sugama J. Factors influencing intact skin in women with incontinence using absorbent products: results of a cross-sectional, comparative study. Ostomy Wound Manage. 2010;56(12):26–33.

15. Omli R, Skotnes LH, Romild U, Bakke A, Mykletun A, Kuhry E. Pad per day usage, urinary incontinence and urinary tract infections in nursing home residents. Age Ageing. 2010;39(5):549–554.

16. Rao S, Bhatt J, Houghton C, Macfarlane P. An improved urine collection pad method: a randomized clinical trial. Arch Dis Child. 2004;89(8):773–775.

17. Trevellini C, Smith J. MICU skin integrity rounds: empowering the staff nurse and improving patient outcomes. J Wound Ostomy Continence Nurs. 2009;36(3S):S29.

18. International Standards Organization. ISO 15621. Urine Absorbing Aids—General Guidelines for Tests. Geneva, Switzerland: International Standards Organization;2011.

19. Fader M, Cottenden AM, Getliffe K. Absorbent products for moderate-heavy urinary and/or faecal incontinence in women and men. Cochrane Database Syst Rev. 2008(4):CD007408.

20. Gray M, Beeckman D, Bliss D, et al. Incontinence-associated dermatitis. a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012;39(1):61–74.

21. Beeckman D, Schooven L, Fletcher J, et al. Pressure ulcers and incontinence-associated dermatitis: effectiveness of the Pressure Ulcer Classification Education Yool on classification by nurses. Qual Saf Health Care. 2010;19(5):e3. doi: 10.1136/qshc.2008.028415. Epub 2010 Jul 29.

22. Mahoney M, Rozenboom B, Doughty D, Smith H. Issues related to accurate classification of buttocks wounds. J Wound Ostomy Continence Nurs. 2011;38(6):635–642.

23. Clarke-O’Neill S, Farbrot A, Eidrup ML, Lagerstedt Eidrup ML, Cottenden A, Fader M. Is it feasible to use incontinence-associated dermatitis assessment tools in routine clinical practice in the long-term care setting? J Wound Ostomy Continence Nurs. 2015;42(4):379–388.

24. Palese A, Regattin L, Venuti F, et al. Incontinence pad use in patients admitted to medical wards: an Italian multicentre prospective cohort study. J Wound Ostomy Continence Nurs. 2007;44(6):649–654.

25. Bliss DZ, Bland P, Wiltzen K, et al. Absorbent briefs containing curly fiber lower (acidify) skin pH reducing risk for incontinence associated skin damage (IASD). Poster session presented at: WOCN Society and CAET Joint Conference. June 4–8, 2016. Montreal, Quebec, Canada.

Potential Conflicts of Interest: GM Associates received a research grant from Medtronic (Minneapolis, MN) to conduct the study.

Ms. Motta is a reimbursement and clinical consultant as President and CEO, GM Associates, Inc, Loveland, CO. Ms. Milne is an Advanced Practice Wound, Ostomy, Continence Nurse, Connecticut Clinical Nursing Associates, Bristol, CT. Please address correspondence to: Glenda Motta, RN, MPH, 845 Crabapple Drive, Loveland, CO 80538; email: gmassoc@aol.com.

Section:

Volume 63 - Issue 12 - December 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(12):29–37

Maria Reinwalds, MSc, RN; Andrea Blixter, MSc, RN; and Eva Carlsson, PhD, ET, RN

Topics:

qualitative evaluation

Ileostomy

revision surgery

rectal cancer

Fecal Incontinence

anterior resection syndrome

Abstract

Standard surgical treatment for patients operated for rectal cancer is abdominoperineal excision of the tumor resulting in a permanent colostomy or an anterior resection, often with construction of a temporary loop ileostomy. Both options impact bowel function. Living with a permanent colostomy has been studied in depth, but knowledge is limited about patients’ experiences living with a resected rectum after stoma reversal and how it affects daily life. A qualitative study was conducted to describe the first 4 to 6 weeks after reversal of a temporary loop ileostomy due to rectal cancer.

Patients from 1 university hospital and 1 county hospital in Sweden were recruited by telephone and were eligible to participate in the study if they: 1) had been operated for rectal cancer with an anterior resection and a temporary loop ileostomy that had been reversed; 2) were >18 years of age, fully oriented, and understood the Swedish language; and 3) had a postoperative course without complications. Interviews were conducted between December 2013 and June 2015 either at the hospital or at the participants’ homes. Participants were asked to narrate their experiences since stoma reversal. Probing open-ended questions were used to stimulate narration and clarify and enhance understanding. The interviews were recorded, transcribed verbatim, and analyzed using thematic content analysis. The 16 participants included 9 women and 7 men (median age 67 years). Three (3) main themes emerged: Life being controlled by the altered bowel function, with the subthemes loss of control over bowel function, uncertainty regarding bowel function, and being limited in social life; Striving to regain control over the bowel, with the subthemes using ability and knowledge, social support, and being grateful and hopeful; and A desire to be normal, with subthemes getting rid of the stoma and restoration of body image. Patients experienced severe bowel function problems, including increased bowel movement frequency and inability to anticipate or trust bowel function after stoma reversal. Outwardly, patients experienced a significant improvement in body image but continued to struggle with suboptimal bowel function. Patients needed reassurance that their bowel symptoms were normal. Participants strove to regain control over bowel function using various strategies, including what they had learned about diet and medication before stoma reversal and by trying to defy the restrictions of their new normal. They felt they were fighting to regain bowel control without help from health care professionals. In order to cope with altered bowel function, they needed the support of family and friends. The results suggest that, following stoma reversal, patients need information about available treatments to address their symptoms and require regular follow-up visits to evaluate and address functional results.

In Europe, approximately 140 000 persons are diagnosed with rectal cancer (RC) each year¹; the annual number in Sweden is slightly more than 2000 persons.² The treatment for RC is surgical removal of the tumor, sometimes complemented with radiotherapy and/or chemotherapy.¹ RC surgery (rectum resection with a permanent or temporary fecal stoma) affects bowel function.

A prospective study³ among 57 patients (median age 66 years) surveyed preoperatively and at 1, 3, and 6 months postoperatively reported patients’ main concerns were the cancer diagnosis and the uncertain nature of the disease, worries about becoming a burden to or being dependent on others, and what their new life would entail. Focus group interviews⁴ with 7 patients with a temporary stoma (2 women, participant age range 40–75 years) concluded that in cases involving a temporary stoma, the closure of the stoma was an important event. Most patients felt hopeful about a future without a stoma and few worried about not being able to resume life as it was before the cancer surgery. The perceptions of patients living with a permanent colostomy and patient experiences in the early period after ostomy creation have been studied in depth, but knowledge is limited regarding patients’ early experience of living with a resected rectum after stoma reversal and how it affects daily life.

Background

Since the early 20th century, the standard treatment for RC has been surgery with removal of the rectum and anal sphincter, abdominoperineal excision (APE), and construction of a permanent stoma. According to a Cochrane review,⁵ as surgical technique has evolved, patients are increasingly undergoing sphincter-preserving surgery. The primary surgical choice whenever feasible is anterior resection (AR), with removal of the major part of the rectum and construction of an anastomosis between the colon and the small remaining part of the rectum or the anal canal.¹ Leaving the anal sphincter and lowest part of the rectum makes it possible to keep bowel continuity or to restore it later.⁵ A Swedish randomized multicenter trial⁶ (N = 234 patients, median age 68 years) assessed the rate of symptomatic anastomotic leakage in patients operated on with low AR for RC. Patients randomized to a diverting loop ileostomy or loop transverse colostomy (n = 116) had leakage in 10.3% of cases; the rate was 28% in persons without stoma (n = 118). Therefore, the recommendation for patients operated on with a low AR was to construct a diverting stoma to reduce the risk of anastomotic leakage. The stoma, usually a temporary loop ileostomy, is reversed later.⁶

The main reason for sphincter-preserving surgery becoming the gold standard for RC treatment has been the assumption that quality of life (QoL) was poorer for people with a permanent stoma than for people who underwent sphincter-preserving surgery.⁵ According to a qualitative, descriptive study⁷ in which 9 patients (age range 44–67 years) were interviewed 6 to 12 weeks after stoma surgery and a literature review⁸ including 11 studies (N = 248 patients), living with a stoma means losing control over bowel function and having to cope with a changed body image, altered self, and changes in daily life. The loss of bodily control can affect the patient’s ability to maintain a sense of adulthood (ie, they are dependent in ways contradictory to adulthood and adult relations).⁸Knowing the stoma is only temporary can make patients feel their usual life is on hold and that it will resume once the stoma is reversed, negatively impacting how they adapt to life with a stoma.⁴ A British prospective, longitudinal interview study⁹ with 16 participants (age range 51–87 years) that aimed to illuminate the recovery process following curative surgery for colorectal cancer found bowel function was a particular concern after colorectal surgery. The loss of continence and fear of stoma leakage could cause patients to view the temporary stoma as a short-lived surgical complication separate from their self — that is, patients who exhibited concern regarding the possibility of the stoma bag leaking tended to view their temporary stomas as a surgical complication of the physical body, unrelated to self and thus less problematic to the psyche.

Studies have tried to compare QoL in patients with and without a stoma due to RC treatment using demographic and treatment characteristics.^5,10 Questionnaires used in the studies included the European Organization of Research and Treatment of Cancer Quality of Life-C30, the Hospital Anxiety and Depression Scale, and the Illness Cognition Questionnaire, all of which have been validated. In particular, a Dutch questionnaire study¹⁰ found no significant differences in health-related QoL between people with (n = 62, mean age 68.6) and without a stoma (n = 60, mean age 67.9). A Cochrane review⁵ challenged the assumption that patients operated on with an APE and a permanent stoma had poorer QoL than patients operated on with an AR. The review⁵ included 35 nonrandomized studies with a total of 5127 participants. The studies did not support the assumption that QoL in people after AR is superior to that of people after APE/Hartmann’s surgery. The authors concluded that larger, better designed and executed prospective studies are needed to answer this question.

A descriptive review¹¹ including 21 studies (N = 875 patients) reported that up to 90% of all patients operated on with sphincter-preserving surgery will subsequently suffer from altered bowel function, termed anterior resection syndrome (ARS). This syndrome includes a wide range of symptoms from increased bowel frequency to fecal incontinence (FI), which has been reported to occur up to 15 years post AR.¹¹ Results of a qualitative, indepth interview study involving 7 patients (age range 60–78 years) by Desnoo and Faithfull¹² found patients treated for RC with an AR and a temporary loop ileostomy frequently experienced a change of bowel habits 7 to 20 months after stoma reversal. A literature review¹³ (N = 9 articles) examining QoL outcomes following stoma reversal after RC treatment noted the possibility of permanent difficulties after stoma reversal that can significantly affect patient QoL if left untreated. The patients survived the initial cancer treatment and the stoma was gone, but they were left with side effects or long-term symptoms from the bowel¹²— symptoms that in many cases they did not expect.¹³

Patients with RC not only deal with issues of daily living, but they also have to face the fact that the body is changing. In her doctoral thesis, Lindwall¹⁴ described the inability to trust your body can cause feelings of uncertainty and vulnerability. The treatment for RC may endanger both body image and body ideal and can lead to chronic problems.¹² Restoring bodily control by relearning how the body works and being able to trust the body again was important in order for patients to recover after surgical treatment for colorectal cancer.⁹

Length of hospital stay for a patient undergoing surgical closure of a temporary loop ileostomy is often <48 hours; at hospital discharge, the patient has not always caught up emotionally after surgery and he/she remains uncertain as to how the bowel works. Research is limited regarding how patients experience the early period after stoma reversal. The authors propose greater knowledge of patients’ experiences would be useful in helping health care professionals determine the need for counseling and education (both preoperatively and during the early recovery period) as well as to organize the best follow-up for these patients. Therefore, the purpose of this study was to describe the patient experience during the first 4 to 6 weeks after reversal of a temporary loop ileostomy due to RC.

Methods

Design. This research effort is part of a larger study (ANTILOOP) on early (present study) and late experiences following stoma reversal after RC surgery. To describe the patients’ experiences, an explorative qualitative design based on narrative interviews¹⁵ was chosen and subject to qualitative content analysis.

Participants. Patients who had undergone reversal of a temporary loop ileostomy treated at 1 public county hospital and 1 public university hospital in Sweden were invited to participate in the study. Inclusion criteria stipulated participants had undergone surgery for RC with an AR and received a temporary loop ileostomy; were >18 years of age; fully oriented to time, person, and place and able to understand the Swedish language; and had a postoperative course without complications. Participants were recruited by telephone; their names were provided by the surgical coordinator of each surgical unit.

According to the routine care plan, patients operated for RC with an AR and a loop ileostomy have 1 follow-up consultation with a surgeon 4 to 6 weeks after stoma reversal and once a year for 3 years for RC surveillance. Patients with a temporary loop ileostomy are followed-up postoperatively by an enterostomal therapist (ET) on the ward and at the outpatient clinic according to the following schedule: 10 to 14 days post discharge, 6 weeks, 3 months, 6 months, and 1 year post surgery. After stoma reversal, no regular follow-up by an ET or specialist nurse is provided.

Data collection. Interviews were conducted by the first and second author between December 2013 and June 2015 at the hospital where they had been treated or at the participants’ homes according to their wishes. The participants were asked to narrate their experiences since stoma reversal. The opening question was: Please describe your experiences at home in the initial period following your stoma reversal. Probing open-ended questions were used to stimulate further narration and to clarify and enhance understanding; for example, What or how do you mean? Can you tell me a little bit more? and How did you cope with that? The interviews were recorded and transcribed verbatim and consisted of extensive and rich narratives.

Ethical considerations. At the time of the interviews, participants received written information and signed an informed consent form. The study was conducted according to the ethical principles outlined in the Declaration of Helsinki.¹⁶ The study was approved by the Regional Ethical Review Board (D. Nr: 688-14).

Data analysis. The transcribed interviews were subject to qualitative content analysis as described by Graneheim and Lundman.¹⁷ The interviews were read several times to gain a sense of the whole. The text then was divided into meaning units that were condensed to shorten the text without losing relevant content. The meaning units were given a code. The codes were compared according to similarities and differences and sorted into 8 subthemes. Subthemes then were grouped, resulting in 3 themes. The themes expressed the latent content of the codes and condensed meanings in the interview texts. The analysis was primarily conducted by the first and second author, and the third author had a validating role throughout the analysis process.

Rigor. The validity and trustworthiness of qualitative research can be described using 4 components: credibility, transferability, dependability, and confirmability.¹⁸ The present study aimed to achieve these attributes by presenting the opening-question, detailed description of the context of the study, the recruiting process, and the analytic process and by illustrating the participants’ experiences using quotations. The chosen method was congruent with the aim of the study, and the data analysis was characterized by a critical and open dialogue among the authors. The presented findings were considered the most trustworthy interpretation of the text by all authors.

Results

Participants. All 16 invited patients (9 women, 7 men, median age 67 [range 33–81] years), 12 from the university hospital and 4 from the county hospital, agreed to participate. Initially, the study involved 5 consecutive patients and after a slight break in the study 11 more participants also were consecutively included. They were contacted at the hospital before discharge or by telephone after hospital discharge. Nine (9) interviews were conducted by the first author, and 7 interviews were conducted by the second author. Time from stoma reversal to the interview ranged from 4 to 6 weeks. The participants’ demographics and clinical history are shown in Table 1.

Interview analyses: Life being controlled by the altered bowel function. The analysis of the interviews resulted in 3 themes and 8 subthemes (see Table 2). All participants described major concerns regarding altered bowel function. Loss of control over bowel function and uncertainty regarding how the bowel worked limited their social lives, which led to their entire lives being controlled by the altered bowel function.

Loss of control of bowel function. All participants reported an increase in defecation frequency compared to before the primary cancer surgery. It was not unusual to have to go to the toilet 20 times a day. This led to sores and wounds in the perineal area and caused pain, which sometimes prevented the patient from sitting down. Several patients also suffered from painful defecation.

Before the stoma reversal, participants received information that their bowel function would alter, but none described being prepared for this reality. Reactions of shock and surprise were frequently expressed by most of the participants. Constant feelings of rectal urgency were common and were described by 1 patient as constantly having a knife in your back, forcing you to go to the toilet. Fractioned defecation was described by all participants, causing prolonged time on the toilet.

No, but it’s a bit like, you can go to the loo and you think you’re done, you wash your hands and leave and say no, I have to go to the loo! And you keep on like that! And it’s really bothersome! I go to the loo several times, like five times in a row.— Participant 4

Several participants also suffered from frequent bowel movements at night, causing disturbed sleep and tiredness during the day. The participants reported an inability to hold bowel movements and feelings of incomplete bowel evacuations. Almost all participants experienced episodes of FI. The total loss of control over bowel function was compared to having bad stomach flu.

Before in the old days, when you could regulate your defecation a bit, wait for a bit, sit and wait, and so on. Can’t do that now! It’s uncontrollable, and I have to manage it in my daily life. — Participant 7

Uncertainty regarding bowel function. Participants were greatly troubled by their inability to predict how the bowel would behave. Bowel function varied on a daily basis with no systematic pattern. The bowel behaved differently than it did before cancer surgery and could no longer be trusted (the participants word choice). Function varied from obstructed defecation to daily episodes of fecal leakage. Not knowing how the bowel worked, loss of control regarding bowel function, and prior episodes of FI created feelings of uncertainty and anxiety.

So it’s like you don’t really dare to trust the system…so it’s…yes it’s clear that…it isn’t any fun to poo your pants. That’s the worst thing about it, I feel.— Participant 3

Not feeling comfortable with oneself and one’s body also was experienced. This also caused uncertainty, and the patients put a lot of effort and energy into getting to know their new bodies and trying to find some logic to the unpredictable bowel.

Being limited in social life. Altered bowel function and the need for frequent toilet visits restricted social life. Frequent urgency and the inability to hold bowel movements made almost constant access to a toilet necessary. Participants also described the need to shower after each toilet visit in order to feel fresh and clean. This, along with feelings of embarrassment about having to use the toilet with abnormal frequency within a short period of time, caused many of the participants to stay home instead of participating in social activities. Some had not left home at all during their first weeks because they did not dare leave the toilet. This made managing daily chores difficult and made patients dependent on other people. Participants expressed how they were unable to use public transportation, go see a movie, go for walks in the woods, or go to the gym.

My social life has been severely affected! I say no to all social events. — Participant 5

Striving to regain control over the bowel. Participants used different strategies to cope with the difficulties that arose due to their altered bowel function and focused on finding a way back to themselves and regaining control over the body. The participants coped by using their ability and knowledge, support from family and friends, and by being grateful and hopeful.

Using ability and knowledge. Most of the participants coped by using previous experience and knowledge in life and, in particular, their time with the stoma. Many tried to control bowel function by making dietary changes. Diets that had proven effective during earlier illness or operations and dietary advice from the time with their stoma were resumed, with questionable results. Foods such as onion or coffee were avoided by some of the participants. A common strategy was to totally refrain from eating, if something special was planned.

If something special’s going on then it’s better not to eat. I daren’t eat in that case because it feels safer to just completely refrain. — Participant 15

When participants tried to tell health care professionals about their problems, they were told to be patient. This response caused patients to assume the symptoms were untreatable and turn to other sources (eg, the internet) for advice on coping with their situation. Great insecurity prevailed about whether other patients also commonly experienced bowel symptoms. A lack of information from health care professionals caused the participants to distrust any information they did receive until it was proven accurate. Although they tried to the best of their ability to cope with the situation, none of the participants knew how to manage their altered bowel function satisfactorily. They expressed the thought that concrete tips and advice from health care professionals, mostly regarding dietary advice and bowel regulating drugs, would have been appreciated. Several participants used antidiarrheals that were prescribed while they had a stoma. One patient stated it was a turning point when he started to use antidiarrheals. The use of these drugs allowed him to leave the home.

Some tips on how to eat, or that I could have taken that loperamide could have helped me from the start when I had diarrhea at the hospital. So perhaps I wouldn’t have had those worst 2 weeks there anyway. That would have been [appreciated]!— Participant 3

Planning their lives around bowel function was common to all participants. They were forced to constantly keep track of public restrooms and only dared to visit places with access to a toilet. To reduce the risk of fecal leakage outside the home, toilet visits were made before they left the house in order to try to empty the bowel. Another way to cope with potential leakage was to use incontinence pads or carry a change of clothes.

You have to think about this all the time, about having access to a toilet. Because you don’t know like when and what time anything will happen.— Participant 2

In striving to regain control over the body, 1 strategy was to challenge oneself. This strategy was most commonly seen among the younger (33- to 42-year-old) patients. They chose not to accept limitations due to altered bowel function but instead tried to force the body into obedience. One way was to ignore feelings of urgency, hoping that they would pass without an episode of FI. Another way was to defy the fear of leakage by going for short walks close to home with the toilet only minutes away.

I don’t really accept this thing with sitting on the loo for 5 hours every day! It doesn’t work for me, I can’t have a life like that!... I take more of an attitude that my body has to adjust to what I think is right…”— Participant 4

Social support. All the participants found it important to have support from family and friends in order to cope with their altered bowel function. This included practical support, such as help with grocery shopping and doing daily chores such as cleaning the house and mowing the lawn. It also included emotional support (eg, having someone to share the difficulties in life, making them easier to bear). Because talking about bowel habits in public was considered taboo, it was even more important to have someone close to talk to.

My wife, of course… We know each other inside out and then, when you live together with the problems that one or the other has, and we’re very close, so we live with this together…this is what I need… she helps and supports me all the way…— Participant 7

A lack of support from health care professionals made support from family and friends indispensable. One participant said she could not share her own worries and difficulties with her family because they were sick and fragile and talking about her problems made them even sicker. This made her situation harder to bear and she felt all alone and abandoned.

I think you can get quite lonely after leaving the hospital…When I was released, I went out through a door and then I was completely alone. I was completely abandoned! I should have had much, much more support than I did… No one can manage by themselves! They can’t…— Participant 10

Being grateful and hopeful. Despite great difficulties with their bowel symptoms, the participants expressed how grateful they were to have gotten rid of the stoma. They endured their altered bowel function because they felt having a stoma was worse. Only 1 patient said she sometimes regretted having the stoma reversed, but she also expressed gratitude that the stoma was gone. Most patients considered altered bowel function a fair price to pay as they were now cured of cancer.

Oh God, I’ve been through cancer surgery – what should I expect? I’ve been lucky! I think I’ve got a little handicap and I’ll have to live with that…I’ve been given a second chance in life. And I’m going to take good care of it!—Participant 11

The participants dealt with the rough with the smooth aspects of life and were grateful to be alive.

Yes, I’m still thankful. That’s how I think in order to handle the situation…there’s so much else when you look and listen and see that is so much worse… like the opposite to life… — Participant 8

All the participants hoped their bowel function would improve. None thought their symptoms would last for more than 1 year. They chose to be patient and positive about the future.

A desire to be normal. Participants stated they had high expectations of getting rid of the stoma and being physically restored. However, the high expectations were as yet unfulfilled due to the symptoms of altered bowel function.

Yes, first I thought I would be ecstatic to get rid of the stoma, but I never was! But that was because this was so much trouble instead…— Participant 13

Getting rid of the stoma. The participants viewed the stoma as a barrier to being able to freely choose clothes and recreational activities. They felt it limited them; for example, while they had the stoma they refrained from swimming, exercise, and other activities that involved public changes of clothes. Many chose not to tell people they had a stoma because it was considered not normal. Living with a stoma meant not having control over bowel function, which forced many of the participants to be preoccupied with access to toilets. Life with a stoma was difficult for most of the participants, and they had been looking forward to the day when it would be reversed. Receiving the date for stoma reversal surgery felt like winning the lottery.

It was such a relief to get rid of that bag! …It’s so nice now to be able to bend, yes, the difference is like night and day.— Participant 12

Instead of having to cope with the stoma, patients were forced to use incontinence products, ointments, and nursery bags that are used for infants. This was perceived as returning to infancy.

I thought it would be completely different. That I’d be able to wear those small briefs again…that it would be like before, but it never is… — Participant 10

Restoration of body image. The participants had a strong desire to regain bowel continuity and have a normal bodily appearance. Many saw the stoma as a constant reminder of their cancer and the reversal as the end of a period of illness and the start of something new.

I feel healthier, more whole. The disease doesn’t constantly remind me of it. The bag reminded me about what I’d gone through. And I’m so damned happy not to have that because now I don’t often think about what I’ve gone through during the day anymore. That’s so nice. That means I’ve moved on a bit.— Participant 3

At the time of the interviews (4 to 6 weeks post stoma reversal), all the participants expressed relief that the stoma was gone, including gratitude that their bodies looked normal again. Only 1 participant said that if the symptoms persisted, he would consider having the stoma back.

Discussion

The findings of the study show that 4 to 6 weeks after reversal of a temporary loop ileostomy due to RC treatment, patients were grateful the stoma was gone. After the stoma reversal, participants envisioned their bodies would be restored and they expected life to return to normal. However, all participants experienced severe symptoms due to altered bowel function ranging from rectal urgency and frequent bowel movements to episodes of fecal leakage. Life was controlled by altered bowel function, something few patients were prepared for. In striving to regain control over bowel function, participants coped by using their ability and knowledge, support from family and friends, and gratitude that they were alive and hopeful about the future.

Participants reported bowel symptoms that were so severe they controlled their entire life. A large part of both the day and night revolved around their bowel function. Losing control over bowel function had physical (pain and sores) and emotional (sleep disturbance and distress) effects. The symptoms experienced included everything from evacuatory dysfunction to rectal urgency and FI and were consistent with the description of ARS by Bryant et al.¹¹

The bowel symptoms reported in the present study varied from day to day with no obvious pattern. This, along with the inability to control bowel function and episodes of fecal leakage, caused feelings of uncertainty and distress; uncertainty over bowel function and the inability to trust the bowel led to a restricted social life. This is consistent with the findings in a British qualitative study¹⁹ with a phenomenological approach. Data were collected using indepth semistructured interviews that explored the lived experiences of 8 patients (median age 64 years) suffering from ARS after RC treatment during the same time period as the current study. Similar findings also are described in 2 studies of patients who, for various reasons, experienced FI, where the loss of control over bowel function was characterized by insecurity and led to limitations in everyday life.^20,21 The first study was conducted according to the grounded theory approach and aimed to elucidate the life situation and psychosocial processes of 9 women suffering from postnatal FI and how they coped with their situation.²⁰ In the second study, indepth interviews conducted among 5 women living with FI identified and described the lived experiences of people living with FI and how it affected daily life.²¹

Before stoma reversal, all participants in the present study were told that after the reversal their bowel function would be different from how it was before their cancer surgery. Nevertheless, none were prepared for the actual result. Participants expressed feelings of shock and wanted to know if anyone else was experiencing the same symptoms. Not knowing if they were alone in the symptoms caused even more uncertainty. According to Mishel’s uncertainty in illness theory,²² an individual’s perception of uncertainty is influenced by many factors, including the nature of the symptom. If the symptoms do not follow any pattern or if they are unexpected, the uncertainty may increase. Using a prospective, nonexperimental correlation design, Galloway and Graydon²³ interviewed 40 patients (age range 43–89 years) who had undergone colon cancer surgery. Using the Mishel Uncertainty in Illness Scale,²⁴ the authors found a relationship among distress symptoms, uncertainty, and the need for information. Patients who indicated more uncertainty needed more information regarding their treatment, possible complications, and everyday life. In other qualitative research,¹² patients who had undergone resection for RC found sharing experiences and sensible matters with others in the same situation was helpful.

All participants strove to handle the difficulties that had arisen from altered bowel function and tried to regain control by using different coping strategies. According to Benner and Wrubel’s nursing theory,²⁵ the choice of coping strategies a person uses is influenced by the person’s background, understanding, knowledge, and situation in life. The participants in the present study coped mostly by using the experiences, ability, and knowledge they had developed while living with the stoma. This included making dietary changes or the use of medications. In their descriptive cross-sectional study, Santos et al²⁶ conducted interviews to compare and evaluate the use of coping strategies and QoL in patients with temporary (n = 42) and permanent (n = 72) stomas. They reported differences in coping strategies for patients with a temporary stoma compared to patients with a permanent stoma. The most common coping strategies for patients living with a temporary stoma was the use of escape-avoidance and denial. This proved to be ineffective, because the person did not respond to or manage his/her new situation. Patients with a permanent stoma mainly used coping strategies focused on problem-solving and acceptance of the situation, thus increasing QoL. According to Danielsen et al,⁴ patients with a temporary stoma felt like life was “taking a break” because they knew the situation was not permanent. Similar strategies were seen in the present study — many participants had chosen to refrain from different activities while the temporary stoma was in place, thinking they could resume these activities once the stoma was gone. After the stoma reversal, coping strategies more focused on problem-solving were employed.

A few participants who shared their bowel symptoms with health care professionals were told to be patient. Lacking support and help, these patients expressed frustration at having to cope with their bowel symptoms on their own. Similar findings also were reported by patients suffering from ARS who stated they could not cope with the unpredictable bowel themselves and needed help.¹⁹ Nevertheless, most of the participants in the present study chose not to seek help from health care professionals. Ohlsson-Nevo et al²⁷ conducted semistructured interviews with persons treated for colorectal cancer (n = 13) and their partners (n = 13) aiming to describe their experiences the first year after surgery. The authors found patients did not always choose to share their physical problems with a health care provider or service for a number of reasons: patients expected the problems to pass of their own accord and they had their own theory about the cause and solution of the problem. Similar perceptions prevailed among the participants in the present study; they thought their bowel symptoms were transient and would not last more than a year, and they had different theories as to why the bowel behaved differently. Although they struggled with their symptoms, all participants also expressed gratitude that the stoma was gone. Perhaps the fear of having the stoma recreated gave them an incentive to endure their bowel symptoms. The participants expressed gratitude to be alive. The altered bowel function was perceived as a fair price to pay for life, so they chose to take the good days with the bad days. This view also has been expressed by other survivors of RC.¹²

One coping strategy to regain control over the body was to challenge oneself, a strategy found among the younger patients. They chose to try to force the body into obedience by putting themselves in situations without direct access to a toilet. Fear of failure was always present, but younger participants sometimes had the nerve to fail while older participants refrained from the challenge. The younger participants stated that even though they were grateful to be alive, they would not want to live with their bowel symptoms for the rest of their lives. Although the study sample is small, this practice indicates that people from different generations have different attitudes. Clinicians should consider this in the light of higher demands made on younger people, such as societal demands to return to work and family responsibilities.

All participants expressed high expectations of getting rid of the stoma. For the most part, this was due to the perception that, without the stoma, the body would behave normally again. Patients with stomas experience a change in body image.^5,8 After the stoma reversal, current study participants experienced altered bowel function. Although the stoma was gone, the body did not behave as it did before the cancer surgery. A fight to regain normality persisted. Desnoo and Faithfull¹² described how, after reversal of a temporary stoma due to RC treatment, patients suffered from a change of body image and body ideal due to their altered bowel function. According to his theory, Price²⁸ found loss of bodily control, as with FI, is highly associated with old age or infancy, subsequently strongly affecting body image among these patients. In the present study, several participants associated the loss of control over bowel function and the need to wear incontinence pads with returning to infancy. Feeling their loss of adulthood also has been described by patients living with a stoma.⁸ Following surgical treatment for colorectal cancer, patients were required to listen to their bodies to understand and discover its responses to surgery if they wanted to restore a sense of control.⁹ This involved finding patterns to make sense and establish meaning of a particular symptom; it was also important to be able to rely on family and friends for practical and emotional support.⁹ In the present study, participants had not yet found any pattern to their bowel symptoms. Outwardly, their bodies had been restored to presurgical appearance, but inwardly, their bowel function had not. In order to cope with the altered bowel function, it was important for patients to receive both practical and emotional support from family and friends.

Many participants chose not to tell the health care professionals about their bothersome symptoms, making it important for clinicians to follow-up the patients in terms of functional results. A validated instrument, the Low Anterior Resection Syndrome score (LARS score), has been developed for classification of low ARS aimed at the symptoms of bowel dysfunction.²⁹This could be used in the follow-up of these patients at an out-patient clinic led by specialist nurses.

Limitations

Limitations of this study include the exclusion of patients who did not speak Swedish and that the majority of the participants were recruited from the university hospitals because the county hospital performed fewer surgeries. However, a strength of the present study is that all of the participants were eager to tell their stories and that inclusion criteria allowed all patients who had undergone AR and stoma reversal regardless of symptoms to participate. This is in contrast to a study by Taylor and Bradshaw¹⁹ that only included patients reporting changes in bowel function after surgery.

Conclusion

The results of this qualitative study showed that severe bowel function symptoms were experienced in the early period (4 to 6 weeks) after stoma reversal. Many questions arose after discharge from the hospital, and patients needed reassurance that the bowel symptoms they were experiencing were normal. All participants strove to regain control over bowel function using various strategies. They were resourceful and demonstrated potential and viability despite having to prevail without help or support from health care professionals. These study findings reveal the need for patients to be followed-up regularly after stoma reversal. It is a human right, guided by ethical principles, to alleviate suffering and restore health, and to receive information and knowledge about exciting remedies and treatments.³⁰ This information and knowledge should be provided verbally before discharge and written information needs to be developed.

Acknowledgments

The authors express sincere thanks to the patients who took part in the study.

References

1. Zampiano MG, Labianca R, Beretta GD, et al. Rectal cancer. Crit Rev Oncol Hematol. 2009;70(2):160–182.

2. The National Board of Health and Welfare. Statistical Database, Cancer Statistics. Available at: www.socialstyrelsen.se/statistics/statisticaldatabase/cancer Accessed October, 18, 2016.

3. Carlsson E, Berndtsson I, Hallén AM, Lindholm E, Persson E. Concerns and quality of life before surgery and during the recovery period in patients with rectal cancer and an ostomy. J Wound Ostomy Continence Nurs. 2010;37(6):654–661.

4. Danielsen A, Soerensen E, Burcharth K, Rosenberg J. Impact of temporary stoma on patients everyday lives: feelings of uncertainty while waiting for closure of the stoma. J Clin Nurs. 2013;22(9-10):1343–1352.

5. Pachler J, Wille-Jørgensen P. Quality of life after rectal resection for cancer, with or without permanent colostomy (review). Cochrane Database Syst Rev. 2012;12:CD004323.pub.4. doi:10.1002/14651858.

6. Mattiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer. Ann Surg. 2007;246(2):207–214.

7. Persson E, Hellström AL. Experiences of Swedish men and women 6 to 12 weeks after ostomy surgery. J Wound Ostomy Continence Nurs. 2002;29(2):103-108.

8. Thorpe G, McArthur M, Richardson B. Bodily change following faecal stoma formation: qualitative interpretive synthesis. J Adv Nurs. 2009;65(9):1778–1789.

9. Taylor C, Richardson A, Cowley S. Restoring embodied control following surgical treatment for colorectal cancer: a longitudinal qualitative study. Int J Nurs Stud. 2010;47(8):946–956.

10. Bossema ER, Seuntiëns MWM, Marijnen CAM, Baas-Thijssen MCM, van de Velde CJH, Stiggelbout AM. The relation between illness cognitions and quality of life in people with and without a stoma following rectal cancer treatment. Psychooncology. 2011;20(4):428–434.

11. Bryant CLC, Lunniss PJ, Knowles CH, Thaha MA, Chan CLH. Anterior resection syndrome. Lancet Oncol. 2012;13(9):e403–e408.

12. Desnoo L, Faithfull S. A qualitative study of anterior resection syndrome: the experiences of cancer survivors who have undergone resection surgery. Eur J Cancer Care. 2006;15(3):244–251.

13. Taylor C, Morgan L. Quality of life following reversal of temporary stoma after rectal cancer treatment. Eur J Oncol Nurs. 2011;15(1):59–66.

14. Lindwall L. The Body as a Carrier of Health and Suffering. Vasa, Finland; Åbo Akademi University;2004.

15. Mishler E. Research Interviewing – Context and Narrative. Cambridge, MA: Harvard University Press;1986.

16. World Medical Association. Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Patients. Available at: www.wma.net/en/30publications/10policies/b3/index.html. Accessed October, 22, 2016.

17. Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurs Educ Today. 2004;24(2):105–112.

18. Lincoln Y, Guba EG. Naturalistic Inquiry. Beverly Hills, CA: Sage;1985.

19. Taylor C, Bradshaw E. Tied to the toilet: lived experiences of altered bowel function (anterior resection syndrome) after temporary stoma reversal. J Wound Ostomy Continence Nurs. 2013;40(4):415–421.

20. Rasmussen JL, Ringsberg KC. Being involved in an everlasting fight – a life with postnatal faecal incontinence. A qualitative study. Scand J Caring Sci. 2010;24(1):108–115.

21. Olsson F, Berterö C. Living with faecal incontinence: trying to control the daily life that is out of control. J Clin Nurs. 2014;24(1-2):141–150.

22. Mishel MH. Reconceptualization of the uncertainty in illness theory. J Nurs Sch. 1990;22(4):256–262.

23. Galloway SC, Graydon JE. Uncertainty, symptom distress, and information needs after surgery for cancer of the colon. Cancer Nurs. 1996;19(2):112–117.

24. Mishel MH. The measurement of uncertainty in illness. Nurs Res. 1981;30(5):258-263.

25. Benner PE, Wrubel J. The Primacy of Caring: Stress and Coping in Health and Illness. Menlo Park, CA: Addison-Wesley Publishing Co;1989.

26. de Gouveia Santos V, Chaves E, Kimura M. Quality of life and coping of persons with temporary and permanent stomas. J Wound Ostomy Continence Nursing. 2006;33(5):503–509.

27. Ohlsson-Nevo E, Andershed B, Nilsson U, Anderzén-Carlsson A. Life is back to normal and yet not — partners´ and patient´s experiences of life of the first year after colorectal cancer surgery. J Clin Nurs. 2012;21(3-4):555–563.

28. Price B. Assessing altered body image. J Psychiatr Mental Health Nurs. 1995;2(3):169-175.

29. Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior tresection for rectal cancer. Ann Surg. 2012;255(5):922–928.

30. International Council of Nursing. The ICN Code of Ethics for Nurses. Available at: www.icn.ch/images/stories/documents/about/icncode_english.pdf. Accessed December, 13, 2016.

Potential Conflicts of Interest: The study was conducted with grants from the Local Research and Development Board for Gothenburg and Södra Bohuslän, Sweden.

Ms. Reinwalds is a nurse practitioner, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital/Östra, Gothenburg, Sweden. Ms. Blixter is a head nurse, Department of Surgery, Angered Hospital, Gothenburg Sweden; and during data collection worked as a registered nurse, Kungälv Hospital, Kungälv, Sweden. Dr. Carlsson is an enterostomal therapist, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital/ Östra; and a senior lecturer, Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Please address correspondence to: Maria Reinwalds, MSc, RN, Department of Surgery/Colorectal Unit, Sahlgrenska University Hospital/Östra, SE-416 85 Gothenburg, Sweden; email: maria.reinwalds@vgregion.se.

Section:

Volume 63 - Issue 12 - December 2017 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2017;63(12):38–47

Leo M. Nherera, MSc; Marco Romanelli, MD: Paul Trueman, MA; and Valentina Dini, MD

Topics:

wound healing

porcine small intestine submucosa

Extracellular Matrix

chronic wounds

Burns

Abstract

Small intestine submucosa (SIS) has been extensively evaluated in preclinical models and developed into commercially produced medical technologies intended for use in several different indications. The SIS extracellular matrix cellular and/or tissue-based product is a commercially available, porcine-derived SIS dressing. The purpose of this review was to consider the role of the SIS dressing in the management of chronic wounds and burns.

Using a variety of search terms from the literature to describe the SIS dressing, the following databases were searched: PubMed, York Centre for Reviews and Dissemination database, National Health Service Economic Evaluation database, Health Technology Assessment database, and the Cochrane Library. The search identified 78 studies of which 21 met the inclusion/exclusion criteria. Of those, 14 involved chronic wounds, 3 described the management of burn wounds, and 4 were economic evaluations. The wide variety of comparative treatments and outcomes studied precluded the use of meta-analysis techniques. Study results show SIS dressings may improve outcomes in chronic wounds and cost less than several alternative biological wound treatments. Studies to examine their efficacy in burn wound management are warranted.

A wound survey conducted by Vowden et al¹ in 2 local health authorities in the United Kingdom found wounds of various causes in all types of health care settings from acute care facilities to long-term institutions contribute substantially to the costs of hospitalization and nursing time. Similarly, Posnett et al² considered the cost and impact of chronic wounds on patients and health care systems in the UK and also reviewed evidence on prevalence and costs of chronic wounds in the European Union³; the authors concluded chronic wounds are a hidden but significant health care burden. In the European Union alone, 1.5 to 2.0 million individuals receive regular wound care from a health care professional at any one time.³ In addition to their economic burden, wounds also cause substantial pain and distress to patients. A systematic review⁴ that included 37 studies examining the impact of leg ulcers on quality of life noted patients were concerned about pain. A prospective study⁵ that included 10 patients living with wounds and a cross-sectional study⁶ among 73 patients found wounds had a negative impact on quality of life and that appropriate services should be designed to take into account patients’ needs. Furthermore, with an aging population and increasing rates of chronic conditions such as diabetes and obesity, the incidence of wounds is expected to increase. In light of these factors, there is a continual need to improve the efficiency of wound care services and to consider the role of technologies that accelerate wound resolution and, consequently, optimize patient outcomes.² However, the desire to use promising, novel technologies needs to be counterbalanced against the need to make the best use of scarce budgets.

The majority of chronic wounds are comprised of venous leg ulcers (VLUs), pressure ulcers (PUs), and diabetic foot ulcers (DFUs). VLUs account for 40% to 70% of chronic lower extremity wounds.⁶ A review of the evidence and costs of diabetes ulceration⁷ noted DFUs are a common complication in diabetes and the largest contributor of morbidity in diabetic neuropathy. PUs are a frequent and predominantly age-related occurrence for bedridden patients in hospitals and institutions; severe ulcers (those that extend beyond the skin into muscle, tendon, and bone) pose a particularly high risk of infection and mortality.² EUCOMED⁸ recently underscored the burden of wounds by reiterating that between 25% and 50% of acute hospital beds are occupied by patients with either acute or chronic wounds.³ A prospective observational study in Spain⁹ found wounds are a large contributor to the incidence of nosocomial infections and other complications related to hospitalization among hospitalized elderly patients.

Burn injuries also pose a significant challenge to wound care providers. Extensive and/or deep burns have been shown in a meta-analysis¹⁰ of observational and randomized controlled trials to be more difficult to manage, often requiring lengthy hospitalization and complex treatments; these complex burns also are associated with a significant risk of complication that can result in a protracted healing process. According to the Expert Working Group International Best Practice Guidelines on management of noncomplex burns,¹¹ a decline in the severity and incidence of burn injuries in Europe during the last 2 decades is attributed to enhanced public awareness and prevention strategies that facilitated management of many burns outside of specialist burn units. However, a cross-sectional cohort study¹² of burn patients presenting for formal treatment at 2 UK city hospitals over a 10-year period identified a relatively high proportion of burn victims (up to 11%) are admitted to specialist burn units. In addition, the study revealed that over this same time frame, there was a total incidence of 4577 cases of second-degree and third-degree burn presentations and improvements in predicted mortality. A retrospective review¹³ of patients with thermal injuries admitted to a single center in a German hospital considered treatment of burns in 2 different decades (1991–2000 [911 patients] and 2001-2010 [695 patients]); it concluded the severity of burns has declined, probably due to the effectiveness of prevention campaigns.

According to in vivo, in vitro, and clinical studies,^14,15 porcine small intestine submucosa (SIS) extracellular matrix contains critical components considered key in supporting granulation and epithelialization in dermal wounds and providing a scaffold for tissue repair such as collagen, proteoglycans, and growth factors. SIS is commercially available in biological dressings designed to mimic the human cutaneous natural extracellular matrix and initially received regulatory clearance in August 1997; it is currently available for sale in the United States, Canada, Mexico, Europe, and Australia.^16,17 SIS is indicated for the management of acute and chronic and partial-thickness and full-thickness wounds; multiple variants are available, comprising 1, 2, and 3 layers for various indications. The product is supplied in a freeze-dried, sterile form, has a shelf life of 24 months, and is currently available in 4 sizes ranging from 10.5 cm² to 140 cm².

Since the first SIS dressings became commercially available, a growing body of evidence has been established on their clinical value in the treatment of chronic wounds; this includes a systematic review¹⁸ that examined dressings, including growth factors, used in VLUs; a nonsystematic review¹⁹ that assessed a variety of SIS extracellular matrix technology in hard-to-heal wounds; and a Health Technology Assessment (HTA) report²⁰ that assessed all skin substitutes used in chronic wounds. These studies concluded that in patients with chronic wounds for whom standard treatment has been unsuccessful, the use of adjunctive therapies, such as SIS and other growth factors, may improve outcomes in the long term.

More recently, clinical evidence from observational studies and case series^21-23 has begun to emerge on the applicability of SIS dressings to burns. Similar in all other ways, SIS specifically for burns is produced as 2 layers to maximize infection control and minimize fluid loss, potential complications specific to burns.

No reviews have been published of either the clinical and economic evidence showing SIS can maximize infection control and minimize fluid loss or on potential complications specific to burns that have been treated with SIS dressings. Given the scarcity of health care resources, it is important that clinical outcomes are considered along with evidence on the economic value of new technologies. Thus, the purpose of this nonsystematic review was to consider the role of an advanced cellular and/or tissue-based product (CTP) — specifically, porcine SIS (OASIS^™ Extracellular Matrix; HealthPoint, Ltd, Fort Worth, TX) — in the management of chronic wounds and burns.

Although individual studies have been reported, no concerted attempt has been made to collate all the published clinical and cost-effectiveness evidence on porcine SIS in the management of wounds.

Methods

This review is based on a nonsystematic, top-level keyword search in PubMed, University of York Centre for Reviews and Dissemination (CRD) databases (ie, National Health Service Economic Evaluation Database and HTA) and the Cochrane Library up to July 2016; an update search was run in April 2017. The search was not limited by date. Search terms were determined by index: the search terms used in PubMed were OASIS® WOUND matrix or OASIS® WOUND healing, porcine small intestine submucosa (SIS), and extracellular matrix; OASIS was used for the CRD database; and OASIS® wound matrix was used for the Cochrane Library. In addition, the reference lists of identified systematic reviews or published HTA reports were hand-searched for references. All studies reporting clinical and cost-effectiveness evidence in chronic wounds and burns were included in the review. The intervention had to be SIS compared to standard care, which could be any of the advanced wound care dressings. Laboratory and animal studies were excluded. One author assessed the abstracts and full texts of studies identified from the search following a discussion of the inclusion criteria. Data on the population (ie, all patients with chronic wounds or burns treated with SIS) and its comparators, authors, and year of publication, outcomes such as healing, length of hospital stay, epithelialization, and costs were abstracted and are presented in Table 1.

Results

Search results. The search identified 78 studies, 21 of which addressed SIS in wound management and were included in the nonsystematic review (see Table 1). The 21 comprised 6 randomized controlled trials (RCTs)^16,17,24-27 and 8 observational studies in chronic wounds.^28-35 Three (3) studies involved burns^21-23 and 4 were economic evaluations^36-39 that compared SIS to conventional dressings as well as newer medical devices. The observational study by Martinson and Martinson²⁹ also reported on economic endpoints.

Clinical evidence on SIS dressings in chronic wounds: clinical and patient outcomes. Wound closure is typically the preferred endpoint in trials of treatments for chronic wounds²⁰; it is measured as the rate of or time to complete wound closure, defined as full epithelialization with no drainage.^16,17,25 In the studies reviewed, SIS as an adjunct to compression therapy dressings achieved statistically significant (P≤.05) enhanced rates of healing compared with compression therapy alone (55% versus 34%, respectively),¹⁶ moist gauze (80% and 65%, respectively),¹⁷ and hyaluronic dressings (82.6% versus 46.3%, respectively)²⁵ in VLUs and compared with becaplermin wound gel (Regranex^◊; Smith & Nephew, Fort Worth, TX), 49% versus 28%, respectively,²⁶ in DFUs. However, no difference was observed by Landsman²⁴ for SIS dressings compared with living skin equivalent (LSE; Dermagraft^®; Organogenesis, Canton, MA) in DFUs. A recent RCT²⁷ in patients with DFUs found a statistically significant difference in wound closure between SIS and standard care as selected by the study investigator, including silver dressings, hydrogel, wet-to-dry wound dressings, or triple antibiotic dressings (54% versus 32%, P = .021). A retrospective study²⁹ using claims data from the Centers for Medicare and Medicaid Services (CMS) Standard Analytical Files (SAF) between January 2011 and December 2014 from DFU patients (13 193 skin substitute treatment episodes) also found SIS was less expensive than its comparators and more wounds were healed at 90 days.

Other reported outcomes observed for SIS in chronic wounds relative to other active treatment modalities observed in RCTs and observational studies included fewer dressing changes in VLUs and DFUs,^16,17,25 fewer re-hospitalizations in VLUs,¹⁶ and improved pain and comfort per Visual Analog Scale scores for VLUs.²⁵ SIS has been observed to be well tolerated and easy to apply,³¹ facilitate grafting,^28,30 and improve quality of life.³¹

Cost effectiveness evidence in chronic wounds. Five (5) published studies compared the cost effectiveness of SIS dressings with active treatments or best supportive care in chronic wounds: 2 involved patients with VLUs^36,37 and 3 considered patients with DFUs.^29,38,39 Martinson and Martinson²⁹ conducted a retrospective database analysis using data from the CMS SAF collected between 2011 and 2014 in patients with DFUs that analyzed 13 193 skin substitute treatment episodes comparing human skin equivalent (HSE) (Apligraf^®; Organogenesis) (4926, 37.3%), LSE (5530, 41.9%), SIS (2458, 18.6%), and MatriStem^® Urinary Bladder Matrix (UBM; ACell Inc, Columbia, MD) (279, 2.1%). The authors found that on average the mean application was 5.5 times per episode of DFU and the percentage of wounds that healed at 90 days was 63% for SIS, 62% for UBM, and 58% each for HSE and LSE. Mean cost (standard deviation) per episode was estimated to be $1901 ± $5394 for SIS, $1435 ± $3160 for UBM, $5364 ± $6966 for HSE, and $14 424 ± $15 074 for LSE. Using SIS resulted in higher healing rates and was a less-expensive option compared to HSE and LSE and is therefore considered a dominant strategy.

Hankin et al³⁶ considered the number needed to treat (NNT) to achieve 1 additional treatment success (defined as wound closure) in patients with VLUs treated with SIS, HSE, or an advanced sterile wound matrix (Talymed^® Marine Polymer Technologies, Inc, Danvers, MA) compared to standard care (compression therapy). Costs of treatment then were considered to determine the cost of an additional successfully treated patient. NNT point estimates of clinical efficacy were 2 for the advanced sterile wound matrix (95% CI; 2-8), 5 for SIS (CI; 3-39), and 6 for HSE (95% CI; 3-24). Incremental costs per additional successfully treated patient were $1600 for the advanced sterile wound matrix, $3150 for SIS, and $29 952 for HSE. On this basis, SIS dressings appear to offer a more cost-effective solution than other advanced biologic dressings.

Carter et al³⁷ developed a Markov model to estimate the cost effectiveness of 3 topically applied CTPs used as adjunct therapies to best supportive care in the management of VLUs. CTPs evaluated in the study included SIS dressings, HSE, and LSE over the course of 1 year. The outcomes of interest were the number of ulcer-free weeks and expected costs of therapies from a payer’s perspective. Results demonstrated SIS dressings were the most cost-effective CTP when used in the management of VLUs as an adjunct to standard care. When compared to best supportive care, the estimated incremental cost effectiveness ratio of SIS was $86/ulcer-free day.

Guest et al³⁸ estimated the cost effectiveness from a Medicare perspective of using trilayer porcine SIS as an adjunct to standard care compared with standard care alone in managing DFUs in the US using a 6-state Markov model utilizing 2016 prices. The model costs were calculated over a 12-month period; clinical data were obtained from a published RCT by Cazzell et al.²⁷ The model results showed patients treated with SIS in addition to standard care had better clinical outcomes — specifically, it was estimated that patients treated with SIS had a 42% increase in the number of ulcer-free months, a 32% increase in the probability of healing, a 3% decrease in the probability of developing complicated ulcers, and a 1% decrease in the probability of undergoing an amputation compared to those treated with standard care alone. The total health care cost per patient of using SIS over 12 months was estimated to be $13 858 compared to $13 962 standard care alone, saving the health system $105 per patient. These findings were consistent in a sensitivity analysis where cost and clinical inputs were varied.

Gilligan et al³⁹ developed a 2-state Markov model based on a published RCT to estimate the cost effectiveness for SIS dressings relative to human fibroblast-derived dermal substitute (HFDS) on wound closure for the treatment of DFUs. A 12-week time horizon of weekly cycle length was employed. Clinical outcomes did not differ between the interventions. HFDS incurred substantially higher cumulative costs per DFU ($3889, £2524) compared to SIS dressings ($2522, £1634) (see Table 1). The authors concluded health care providers should consider SIS dressings as a cost-saving alternative to HFDS.

SIS dressings in burns: clinical and patient outcomes. A single-center observational study by Cuenca-Pardo,²¹ a prospective study,²² and a case series²³ reported the clinical outcomes of treatment with SIS dressings, with facilitating reepithelialization as the key outcome measure. In the study by Cuenca-Pardo and Peralta-Conde,²¹ wounds of 14 patients undergoing tangential excisions for facial burns were covered with SIS. Mean days to complete epithelialization in both second-degree and superficial burns was 8.8 ± 2.4 (range 7–14) days. The rate of epithelialization was 20% to 40% by the third week, and small lesions healed without grafts (see Table 1).

A prospective study by Salgado et al²² of 5 patients with mid-thickness to partial-thickness burns reported that, compared to patients treated with a silver cellulose hydrofiber dressing (AgH; Aquacel^® Ag; ConvaTec, Reading, Berkshire, UK) covered with sterile gauze, patients treated with SIS dressings had a higher epithelial maturation index (ie, progress of the epithelialization process and ranges between -2 and 8) (6.2 ± 0.84 versus 3.2 ± 3.28; P = .029). The study also reported that patients treated with SIS dressings had better orientation and differentiation of epithelial cells, as well as an appropriate basal lamina structure, collagen deposition, and higher transforming growth factor–β3 expression (7.4 ± 8.1 versus 2.1 ± 2.6; P = .055) than tissues treated with AgH dressings. Furthermore, SIS dressings were not integrated in healed tissues, and after 3 months of treatment significantly (P = .025) less scarring was noted than with AgH dressing.

Finally, Cinat²³ reported on 2 cases of partial-thickness burns that had not healed after 14 and 33 days of standard care (Adaptic Touch^™; Acelity, San Antonio, TX), Allevyn^◊ (Smith & Nephew), Hypafix^™ (BSN Medical, Hamburg, Germany), Coban^™ (3M, St Paul, MN), and a hydrogel that then were treated with SIS dressings. The SIS-treated burns showed complete closure within 10 days for 1 case and 35 days with the other. Furthermore, closure was sustained at follow-up (4.5 and 7 months, respectively, for the 2 cases), with continued positive functional and cosmetic outcome, leading to avoidance of surgery.

Cost effectiveness in burns. No studies reported the cost effectiveness of SIS dressings in the management of burns, which reflects the low volume and quality of evidence on the use of these dressings in this indication.

Discussion

Wounds and burns, especially those that are persistent and complex, present a significant burden in all health care settings. Given the scale of this burden, the efficacy and cost-effectiveness of treatment approaches must be considered.

This review assembled the published clinical experience with porcine-derived SIS dressings in chronic wounds and burns evaluated using RCT and observational studies. Compared with other standard care modalities, the available evidence indicates SIS dressings offer enhanced clinical outcomes across multiple clinical goals, including complete wound closure, when compared with a number of alternative treatment options. Three (3) RCTs^16,17,25 reported statistically significant accelerated healing and wound closure in VLU wounds in favor of SIS compared to standard care and other active skin substitutes, 2 studies^26,27 found significant results in favor of SIS in DFU wounds, and 1 did not show any difference on healing outcome.²¹

The studies also report positive outcomes for SIS dressings on other patient outcomes. For example, data on patient-centered endpoints reported in key clinical SIS dressing studies compared with other skin substitutes demonstrate SIS dressings are less painful to remove, more comfortable to wear, easier to use, and easier to store.^21,26,36-38 Furthermore, cost modeling studies suggest the use of SIS as an adjunct to standard care was either cost saving (ie, resulted in fewer costs overall and better clinical outcomes) or cost effective when compared to standard of care alone in chronic wounds.^29,36-38 However, a need remains for further evidence on the value of SIS relative to standard dressings and other advanced treatment modalities that are used more widely in chronic wound care practice, such as negative pressure.

Although limited, evidence on SIS dressings used in the management of partial-thickness to full-thickness burns suggests these dressings may offer a safe, effective, and comfortable option for burn patients who may be candidates for grafting but seek an alternative to surgery.²³ Initial observational studies^21,22 and case series²³ suggest SIS dressings have the potential to improve burn wound outcomes, but these study results should be considered exploratory and studies examining the dressing’s efficacy and cost effectiveness are needed.

Limitations

This review was limited and not systematic, which may have biased the results. In addition, studies identified did not permit a meta-analysis to be conducted because they included different comparators including gauze, compression therapy, becaplermin wound gel, HSE, LSE, and hyaluronic acid biomaterial.

Conclusion

The results of this literature review show SIS dressings may improve outcomes in chronic wounds. Although evidence is limited, the dressings also show promise in burn management. In addition, the studies reviewed showed SIS dressing costs are lower than those of several alternative biological wound treatments. The current evidence suggests SIS dressings are safe and effective. Additional efficacy studies, especially in burn wound management, are warranted.

References

1. Vowden K, Vowden P, Posnett J. The resource costs of wound care in Bradford and Airedale primary care trust in the UK. J Wound Care. 2009;18(3):93–100.

2. Posnett DN, Franks PJ. The costs of skin breakdown and ulceration in the UK. In: Pownall M (ed). Skin Breakdown: The Silent Epidemic. Hull, UK: The Smith & Nephew Foundation;2007:6–12.

3. Posnett J, Gottrup F, Lundgren H, Saal G. The resource impact of wounds on health-care providers in Europe. J Wound Care. 2009;18(4):154–161.

4. Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs. 2004;13(3):341–354.

5. Neil JA, Munjas BA. Living with a chronic wound: the voices of sufferers. Ostomy Wound Manage. 2000;46(5):28–38.

6. Phillips T, Stanton B, Provan A, Lew R. A study of the impact of leg ulcers on quality of life: financial, social, and psychologic implications. J Am Acad Dermato. 1994;31(1):49–53.

7. Ward JD. The cost of diabetic foot problems. Pharmacoeconomics. 1995;8(suppl 1):55–57.

8. EUCOMED. The Burden of Wounds on EU Healthcare Systems. 2014. Available at: www.medtecheurope.org/sites/default/files/resource_items/files/290902009.... Accessed July 7, 2016.

9. Vilella A, Prat A, Bare ML, Bayas JM, Asenjo MA, Salleras L. Risk of nosocomial infection in elderly patients admitted to a university hospital in Spain. Med Clin (Barc). 1993;100(4):128–131.

10. Nherera LM, Trueman P, Roberts CD, Berg L. Silver delivery approaches in the management of partial thickness burns: a systematic review and indirect treatment comparison. Wound Repair Regen. 2017;25(4):707–721.

11. Expert Working Group. International Best Practice Guidelines: Effective Skin and Wound Management of Noncomplex Burns. Wounds International. 2014. Available at: www.woundsinternational.com/media/issues/943/files/content_11308.pdf. Accessed July 7, 2016.

12. Jackson PC, Hardwicke J, Bamford A, et al. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014;259(5):979–984.

13. Theodorou P, Xu W, Weinand C, et al. Incidence and treatment of burns: a twenty-year experience from a single center in Germany. Burns. 2013;39(1):49–54.

14. Badylak SF, Lantz GC, Coffey A, Geddes LA. Small intestinal submucosa as a large diameter vascular graft in the dog. J Surg Res. 1989;47:74–80.

15. Demling RH, Niezgoda JA, Haraway GD, Mostow EN. Small intestinal submucosa wound matrix and full-thickness venous ulcers: preliminary results. Wounds. 2004;16(1):18-22.

16. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D, OASIS Venous Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005;41(5):837–843.

17. Romanelli M, Dini V, Bertone MS. Randomized comparison of OASIS wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. Adv Skin Wound Care. 2010;23(1):34–38.

18. O’Donnell TF Jr, Lau J. A systematic review of randomized controlled trials of wound dressings for chronic venous ulcer. J Vasc Surg. 2006;44(5):1118–1125.

19. Chang J, DeLillo N Jr, Khan M, Nacinovich MR. Review of small intestine submucosa extracellular matrix technology in multiple difficult-to-treat wound types. Wounds. 2013;25(5):113–120.

20. Snyder DL, Sullivan N, Schoelles KM. Skin Substitutes for Treating Chronic Wounds Technology Assessment Report; ECRI Institute EPC December 18, 2012. Available at: www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf. Accessed July 7, 2016.

21. Cuenca-Pardo J, Peralta-Conde D. Quemaduras en cara tratadas con escision temprana y cubiertas con matriz acelular. Cirugía Plástica. 2011;21(1):11–19.

22. Salgado RM, Bravo L, García M, Melchor JM, Krötzsch E. Histomorphometric analysis of early epithelization and dermal changes in mid–partial-thickness burn wounds in humans treated with porcine small intestinal submucosa and silver-containing hydrofiber. J Burn Care Res. 2014;35(5):e330–e337.

23. Cinat M, HealthPoint. Oasis Burn Matrix Case Study. Poster presented at: 29th Annual JAB Maui Symposium. February 2007. Maui, HI.

24. Landsman A, Roukis TS, DeFronzo DJ, Agnew P, Petranto RD, Surprenant M. Living cells or collagen matrix: which is more beneficial in the treatment of diabetic foot ulcers? Wounds. 2008;20(5):111–116.

25. Romanelli M, Dini V, Bertone M, Barbanera S, Brilli C. OASIS wound matrix versus Hyaloskin in the treatment of difficult-to-heal wounds of mixed arterial/venous aetiology. Int Wound J. 2007;4(1):3–7.

26. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care. 2005;18(5 Pt 1):258–266.

27. Cazzells M, Lange DL, Dickerson JE, Slade HB. The management of diabetic foot ulcers with porcine small intestine submucosa tri-layer matrix: a randomized controlled trial. Adv Wound Care. 2015;4(12):711–718.

28. Barendse-Hofmann MG, van Doorn LP, Oskam J, Steenvoorde P. Extracellular matrix prevents split-skin grafting in selected cases. J Wound Care. 2007;16(10):455–458.

29. Martinson M, Martinson N. A comparative analysis of skin substitutes used in the management of diabetic foot ulcers. J Wound Care. 2016;25(10 suppl):S8–S17.

30. Rando T. Use of a biological extracellular matrix wound therapy to heal complex, chronic wounds. J Wound Care. 2009;18(2):70–74.

31. Carson SN, Travis E, Overall K, Lee-Jahshan S. Using becaplermin gel with collagen products to potentiate healing in chronic leg wounds. Wounds. 2003;15(10):339–345.

32. Brown-Etris M, Cutshall WD, Hiles MC. A new biomaterial derived from small intestine submucosa and developed into a wound matrix device. Wounds. 2002;14(4):150–166.

33. Hampton S. Oasis: a dressing for the future. Nurse2Nurse. 2002;2(7):40–41.

34. Olivares-Escutia J, Delbouis-Molina AL, Fernandez-Mezo JN, Escalante-Magana JR, Lopez- Ramos M, Sandoval-Chavez R, Chavez-Flor LF. Tratamiento de heridas con ulceración crónica, mediante submucosa de intestino delgado. Informe de 20 casos. Acta Orthopédica Mexicana. 2002;16(3):125–130.

35. Lown I, Kurt T, Tran H, et al. Does bilayered extracellular matrix technology hasten wound healing in venous stasis ulcers? A retrospective study. Wounds. 2005;17(2):27–31.

36. Hankin CS, Knispel J, Lopes M, Bronstone A, Maus E. Clinical and cost efficacy of advanced wound care matrices for venous ulcers. J Manage Care Pharm. 2012;18(5):375–384.

37. Carter MW, Waycaster C, Schaum K, Gilligan AM. Cost-effectiveness of three adjunct cellular/tissue-derived products used in the management of chronic venous leg ulcers. Value Health. 2014;17(8):801–813.

38. Guest JF, Weidlich D, Singh H, et al. Cost-effectiveness of using adjunctive porcine small intestine submucosa tri-layer matrix compared with standard care in managing diabetic foot ulcers in the US. J Wound Care. 2017;26(suppl 1):S12–S24.

39. Gilligan AM, Waycaster CR, Landsman AL. Wound closure in patients with DFU: a cost-effectiveness analysis of two cellular/tissue-derived products. J Wound Care. 2015;24(3):149–156.

Potential Conflicts of Interest: Mr. Nherera and Mr. Trueman are employees of Smith & Nephew, Hull, UK, which distributes the small intestine submucosa dressing.

Section:

Volume 64 - Issue 1 - January 2018 ISSN 1943-2720

Issue Number:

Index:

Ostomy Wound Management 2018;64(1):12-17

Janice M. Beitz, PhD, RN, CS, CNOR, CWOCN-AP, CRNP, ANEF, FAAN

Topics:

review literature

Obesity

quality of care

attitude of health personnel

outcome and process assessment

Abstract

Comprehensive care of bariatric patients is challenging. Although structural knowledge exists about safe care given correct equipment and supplies, care processes also must be humane. The literature suggests morbidly obese patients may fear the health system because of past negative experiences. The purpose of this literature review was to examine quality issues in the care of bariatric patients in light of Donabedian’s structure-process-outcomes model, emphasizing process components.

Using the Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, and PsycINFO; the criteria English language and years 2005 to 2017; and the search terms morbid obesity, obesity, bariatric, attitudes, health professionals, health clinicians, and patient care yielded 150 articles. Of those, 35 were pertinent to the review. A subsequent search using the terms Donabedian, care, and quality in MEDLINE and CINAHL resulted in 68 and 36 citations, respectively; 4 were used. When the searches were combined, no articles were identified. Findings show care providers generally understand structure aspects (knowledge or what to do) but need increased understanding of optimal care interventions (process issues or how to perform an intervention), including physical and psychological aspects. Organizations have a responsibility to ensure appropriate equipment and supportive services are available to achieve desired outcomes. Structure components will not overcome barriers or prevent complications if uncaring attitudes (processes) interfere with interpersonal interactions. Implications for clinical practice include requisite reflection on personal belief systems and empathetic understanding of precursors to morbid obesity development. Research needs to analyze what process issues are hampering quality care delivery and how to eradicate deficiencies. Health professionals can promote optimal bariatric patient outcomes by developing necessary insight and clinical wisdom. Obesity is a worldwide epidemic and those affected deserve improved care now.

American football coach Vince Lombardi is widely attributed to have said, “Winning isn’t everything: it’s the only thing.” (Actually, these words first were spoken by University of California at Los Angeles football coach Henry Russell “Red” Sanders).¹ The assertion regarding the importance of winning has been touted as a basic tenet of American sports. Although many people do not agree with this perspective, they do support the idea of positive attitudes in attaining athletic excellence. A similar process occurs in health care.

For bariatric patients, attitudes of health care providers can be “everything” for promoting or decimating quality in patient care delivery. Care of bariatric or morbidly obese patients can be exceptionally challenging due to a variety of factors. Knowledge is not enough to overcome these challenges and ensure quality care outcomes when poor attitudes interfere with care delivery.

A pioneer in examining medical care quality, Avedis Donabedian, MD, developed a model of structure-process-outcomes and scrutinized barriers to quality care in each component.^2-5 Process issues appear to be assuming greater importance in a variety of care situations. For example, in a recent research study6 regarding predictors of satisfaction with elderly care, researchers analyzed results from a national survey of 95 000 elderly people in Sweden concerning their satisfaction with care. Using Donabedian’s model for analysis, their findings identified that quality in elder care was primarily determined by factors pertaining to process — that is, “how caregivers behave towards the older person.”⁶

In a published description of a lawsuit outcome,⁷ a morbidly obese patient alleged substandard postoperative care due to perceived discrimination by nurses due to her excessive weight. The patient believed they failed to move and reposition her, resulting in pressure injuries. The patient instituted litigation against the nurses and ultimately lost, but the legal action revealed gaps in care processes.

Donabedian’s model^2-4 revealed challenges in process issues in a cancer care stem cell transplantation program where patients experienced multiple transitions of care. Incorporating this model, a performance improvement project⁸ at a cancer care treatment center in the western United States demonstrated gaps in process issues (eg, patient education, lack of coordination). Once these gaps were addressed, patient satisfaction with care increased.

The purpose of this literature review was to examine quality issues in the care of bariatric patients in light of Donabedian’s structure-process-outcomes model, emphasizing process components.

Morbid Obesity: More Than an Issue of Weight

Obesity and morbid obesity are distinguished as body mass index (BMI) of 30 and >40, respectively.⁹ A descriptive, phenomenological study¹⁰ revealed morbid obesity is a major risk factor for multiple comorbidities and premature mortality. Developing this condition has negative consequences for psychological health and often is linked to lower quality of life, depression, smoking, drinking problems, and poverty. Two (2) comparative, descriptive correlational design studies examined psychological and psychosocial aspects in morbidly obese patients seeking bariatric surgery. One¹¹ (1) involved 50 morbidly obese patients (11 men and 39 women) versus 25 normal weight patients, and another¹² included 149 extremely obese women (Class III or >40 BMI) versus 90 women with Class I (30 to 34.99 BMI) or Class II (35 to 39.99 BMI) obesity.⁹ Both studies found obese and morbidly obese persons reported more psychiatric and stress issues related to their physical status. Notably, the degree of psychopathology was related to BMI, with greater psychological aberrations as weight increased.

Morbid obesity and obesity are challenging in terms of the long-term health and activities of daily living of affected individuals and their caregivers. Morbid obesity and obesity will increasingly impact the American health care system’s resources related to care of comorbidities.^9,13 In 2008, annual medical costs of obesity in the US were $147 billion.13 Currently, 37.5% of adults in the US are obese.¹³ A state review¹³ in New Hampshire found a 2.5% prevalence of morbid obesity in 2007.

Perceptions of obese persons are influenced by cultural considerations. In a cross-sectional study¹⁴ conducted among 586 persons with BMI >30, researchers surveyed participants for perceived threats to health and found morbidly obese people may view themselves as “normal” depending on the standards of ideal body size inherent in their culture.

Several reviews of the literature^15,16 support that morbid obesity is a multifaceted condition that is considered a chronic disease. The disorder involves gender, lifestyle, dietary habits, genetics, ethnic factors, and sleep deprivation/apnea. The authors of a literature review¹⁷ of evidence-based strategies to treat adult obesity call the American culture an “obesogenic” environment (ie, an environment that comprises factors that support being obese¹⁸). Obesogenic environments are not conducive to walking, physical activity, and healthy food access; they promote weight gain and do not promote weight loss within the home or workplace. Some aspects involve the built environment (buildings and spaces created), and some are functions of people’s communities (eg, lack of safety).

Drug therapy involving antipsychotics, antidepressants, diabetic drugs, seizure control drugs, and steroids (glucocorticoids) is associated with substantial weight gain.¹⁵ A case study¹⁹ involving a morbidly obese woman described how patients can become morbidly obese in ways that are entirely out of their control despite health provider perceptions to the contrary whereby they blame the patient.

Conceptual Framework

Donabedian’s model^2-4 proposes that health care or medical care quality can be examined in 3 domains: structure, process, and outcomes. The model suggests that all 3 domains are important and that they may have to be viewed collectively to monitor quality over time. Some authors⁸ suggest the framework is useful as a road map for discussing and evaluating the dynamics associated with planning and implementing care across care setting transitions. The model can identify gaps in care and promote standardization.

In the model, structure is defined as the relatively stable characteristics of the providers of care and their facilities, including organizational elements, personnel elements, and program operations (money, budgetary processes). This component includes factors such as facility type, resources (eg, beds), qualified professionals including specialists (eg, nurses, wound specialists, physical therapists), and special medical/technical equipment (eg, dressings, binders, lifts, and moving devices).

Process involves the delivery of care — that is, providing and receiving care — in terms of both providers and recipients. Providers implement care; patients seek care and (hopefully) adhere to treatment recommendations. Process also involves technical and interpersonal aspects of care. Activities can include patient education, preventive therapies, ongoing assessment, and motivation/collaboration activities and the patients’ response to them.

Outcomes are the changes resulting from health care, including patient health status, patient knowledge, and patient satisfaction. Outcomes also can include staff and system outcomes and are considered the ultimate validation of the effectiveness and quality of health care. A visual of the model applied to bariatric care is displayed in Table 1.

Donabedian also described 7 attributes (pillars)20 of quality health care (see Table 2). One (1) critical characteristic is acceptability, wherein patients and families have care adapted to their wishes. Even in 1990, Donabedian stressed that patients are vitally concerned about how practitioners and everyone else they encounter when seeking and receiving care behave toward them.²⁰

Methods

A comprehensive review of the literature was conducted using the databases Cumulative Index of Nursing and Allied Health Literature (CINAHL), MEDLINE, and PsycINFO. Delimiting characteristics were publications between 2005 to 2017 and English language articles. Search terms included morbid obesity, obesity, bariatric, attitudes, health professionals, health clinicians, and patient care. A second search in MEDLINE and CINAHL for 2005 to 2017 used the terms Donabedian, care, and quality. Bariatric or morbid obesity or obesity then were added to these previous terms by combining the searches, and closely linked articles were included for analysis (eg, safe patient handling and mobility and the Donabedian model).21

Findings/Discussion

The initial search identified 150 articles. Selected pertinent articles (ie, the 35 that clearly addressed the topic) were utilized. The second search of MEDLINE and CINAHL identified an additional 68 and 36 articles, respectively. A total of 39 ultimately were used. Adding bariatric and obesity and morbid obesity to the combination yielded no additional articles.

Multiple reviews^16,17,22-24 have been written about the challenges of care for the morbidly obese that address structure issues in Donabedian’s quality model. These include knowledge about factors such as increased risk for pressure ulcers, skin infections, venous insufficiency, lymphedema, and surgical site infections.²² Interventions for optimal treatment and prevention of skin disorders such as skin fold management, good perigenital care, and exquisite attention to cleanliness are well known.²² Although a recent literature review²⁴ suggested a strong need to develop an evidence-based approach to skin care in bariatric patients, 6 identified articles in the systematic review had common themes of clinical recommendations: 1) using materials to separate skin folds, 2) carefully drying deep skin folds, 3) inspecting the skin regularly, 4) avoiding excessive use of powders, 5) promoting clean perigenital areas and, very importantly, 6) seeking the patient’s views and expertise on care approaches. Consequently, knowledge (structure) is available to improve bariatric care.

Knowledge about the challenges of critical care for morbidly obese patients has been well described. Berrios23 uses a mnemonic to note the multisystem issues associated with bariatric care: A = airway; B = breathing; B = backs; B = bias; C = circulation; D = decubitus ulcers; D = drugs; D = diagnostics; D = diet; D = durable medical equipment. Morbid obesity affects the pulmonary system and capacity to breathe, alters drug metabolism and efficacy, and may interfere with diagnostic testing. Berrios suggests failure to understand the ABCDs of bariatric care can lead to catastrophic outcomes for both patients and care providers.²³

The need for the availability of appropriate bariatric equipment and beds and effective bariatric movement equipment has been well identified; such equipment represents primarily structure components.19,23 Health systems and facilities that accept payment for the care of bariatric patients have a moral and ethical obligation to provide safety through appropriately sized equipment that has been designed and tested for persons who are in higher weight ranges. These facilities also have a corporate duty to have bariatric gowns, blood pressure cuffs, and other supplies (eg, bariatric beds and lifts) that fit the patient correctly; otherwise, the patient may feel uncomfortable or perceive a hostile environment.²³ Patients, nurses, and other caregivers need to recognize hazards by being familiar with weight and size and equipment restrictions of, for example, commodes and stretchers.

Process issues involve interpersonal interactions between health professionals and patients. An important aspect of quality bariatric care is understanding the psychology of chronic illness. Chronic illnesses are known to affect self-efficacy — that is, a person’s belief in his/her capacity to perform behaviors necessary to produce a desired outcome.²⁵ Morbidly obese persons may long for weight loss and improved health but believe it cannot happen. A recent explorative, longitudinal study²⁶ in Norway showed the importance of paid work status on self-efficacy in morbidly obese people. Persons who were not able to work had significantly less self-efficacy. Health professionals should stop and think about what the person’s health state is doing to their employment status.

In an article on the experiences of an obese patient, Brass²⁷ described her life as an obese and then morbidly obese person and offered a plea for health professionals to truly understand. To provide real help, obese persons need providers to understand the complexities of obesity and its psychological and emotional components, not add to the daily burdens of obese people through negative interactions.

Base-Smith²⁸ conducted a phenomenological study of the lived experience of morbidly obese people. She found morbidly obese individuals endure stereotyping, prejudice, and discrimination and suggested health care providers’ conveyance of these attitudes culminates in substandard care delivery.

In a published personal narrative about obesity, Kwambai²⁹ discussed stigma and how it affects care; she offered a plea for health professionals to change attitudes. She noted, “The association between obesity and chronic medical conditions like heart disease and diabetes has only given (health care) people more ammunition to voice judgment… People don’t look at me with sympathy… They look at me with disgust and hatred.”²⁹

In a personal narrative on morbid obesity, Moore³⁰ offered another insight when she reminded health professionals, “I’m your patient, not a problem.” She raised the issue that she doesn’t fit in health care settings (eg, doctor’s offices, stretchers, or too flimsy chairs) and that she is set apart unwillingly from others. In many instances, she has come to view health care as unsafe. She poignantly reminded health providers, “I am a person, not a problem for people to solve, not a disease, nor a moral failing.”

Attitudes. Process issues such as negative attitudes about morbidly obese persons can be addressed and altered. A major approach to altering one’s attitude is developing self-awareness. Envisioning oneself as facing the daily grind of living hampered by gross overweight or morbid obesity may assist with a sense of empathy. According to a recent enthnography,31 awareness that the morbidly obese person encounters fat stigma may assist with a development of mutual presence, wherein patient and care providers address the weight situation openly, honestly, and respectfully.

Another approach to altering attitudes is empathizing about bariatric disease. Research supports that genetic factors may limit weight loss and maintenance even in persons who have undergone bariatric surgery.16 Despite best efforts, some persons cannot lose weight nor maintain weight loss. Health care clinicians have the opportunity to ask respectful questions and learn about the patient’s care history.

Research also supports that obese and morbidly obese people have difficulty describing their emotions. Caregivers may recognize that they can work to promote emotional health by making patients feel safe to speak.32 It also is helpful to ponder the effect of having bariatric patients who are afraid of care providers (they may view the health system negatively) and that their fears are not entirely unreasonable.

Related to this emotional blockade is the role obesity/morbid obesity may play in managing past abuse or adverse childhood events (ACEs). Epidemiological reviews33 conducted at the Permanente Health System in California suggest obesity may have played a protective role physically, socially, and sexually in persons experiencing abuse in childhood. A review of research outcomes at a weight loss program at Permanente System³⁴ suggested, “No one becomes fat out of joy.” Researchers submit that obesity is not the core problem; the problem is deeper psychodynamic issues. Health providers need to ponder the possible protective benefits34,35 and ask about life experiences. The literature^33,34 suggests ACE survivors benefit from sharing their past experiences and that it is not traumatic as some have feared.

Practical care advice.

Lifting. Research proposes that patient care safety literature for bariatric patients has specific suggestions. For example, according to federal and professional guidelines,36,37 health care providers generally should not lift more than 35 lb. In the case of morbid obesity, teamwork has to be written into patient assignments to promote better care processes. Single-care provider assignments can be altered to multiple personnel assignments to avoid having an assigned caregiver always having to search for assistance.

Humor. Humor also can help with altering care processes. Appropriate humor that incorporates humanity and nonjudgment can work very well and is frequently valued by bariatric patients.19 Health care providers have a chance to demonstrate their caring talents and have their finest hour in dealing with obese and morbidly obese persons.

Human touch. Because bariatric patients may encounter negativity and avoidance due to their excess weight, caregivers need to consider the power of therapeutic touch. It is worth thinking about how much human contact the patient experiences, especially if the care milieu is chronic in nature. When was the last time the patient received a “dose” of hugs? “Low tech” does not mean low effect. Human contact may help morbidly obese patients feel safe, accepted, and welcome in the health care setting.

Clinicians’ attitudes can be everything in promoting success or engineering failure. By learning about and reflecting on both structural and processual components of care, clinicians can promote best available outcomes for bariatric patients.

What needs to be studied. Implications for future research pervade the need for improved quality in bariatric care. What components play a critical role in promoting or hindering quality care delivery in specific organizations? How can health facilities prepare for the increasing numbers of morbidly obese patients? How can health professionals gain insight into personal biases and the lived experiences of morbidly obese persons? What outcomes are organizations aiming for in terms of patients, staff, and system functioning for bariatric patients?

Donabedian’s model of structure-process-outcomes for patient care quality was beneficial in surveying the literature on bariatric care. Structural issues (knowledge, evidence) are not as problematic as process components (interpersonal interactions, implementing care). To achieve outcomes of safe, effective care of bariatric patients who are satisfied with their care quality, process care challenges need greater scrutiny, including research initiatives. Are staff prepared to identify biases, acknowledge hazards in care implementation, and reflect on risk for morbid obesity development? Do staff know how to interact therapeutically? Are protocols established to promote these outcomes? Are they even being measured? Given the enlarging prevalence of obesity and morbid obesity across the world, these questions need to be addressed.

Conclusion

Obesity is a worldwide disease epidemic that is debilitating and ultimately fatal. The purpose of this literature review was to examine care challenges and barriers to safe effective care of bariatric patients in light of Donabedian’s model of patient care quality assessment. Findings suggested that structure issues (knowledge, expertise) are not as deficient as process issues (interpersonal interactions, biases, hazardous care approaches). Despite well-established structure components and clinical knowledge, obese and severely obese persons may avoid the health care system and its clinicians because of embarrassment, fear for their safety, and resentment regarding how they are treated. Research is needed on how best to influence the process aspects for bariatric patients. Health care providers can change perceptions (and sometimes reality) by understanding structure and process issues inherent in bariatric care and promote positive outcomes for obese patients, involved staff and caregivers, and health systems.

References

1. Winning isn’t everything; it’s the only thing. Wikipedia. 2017. Available at: https://en.wikipedia.org. Accessed April 30, 2017.

2. Donabedian A. The quality of medical care. Science. 1978;200(4344):856–864.

3. Donabedian A. Evaluating the quality of medical care. Milbank Q. 2005;83(4):692–729.

4. Donabedian A. The Definition of Quality and Approaches to Its Assessment: Explorations in Quality Assessment and Monitoring. Vol 1. Ann Arbor, MI: Health Administration Press;1980.

5. Glickman SW, Baggett KA, Krubert CG, Peterson ED, Schulman KA. Promoting quality: the health care organization from a management perspective. Int J Qual Health Care. 2007;19(6):341–348.

6. Kajonius PJ, Kazemi A. Structure and process quality as predictors of satisfaction with elderly care. Health So Care Community. 2016;24(6):699–707.

7. Tammelleo AD. MA. Morbidly obese patient alleged discrimination: jury verdict for nurse affirmed on appeal. Nurs Law Regan Rep. 2011;51(10):3.

8. Thomson B, Gorospe G, Cooke L, Giesie P, Johnson S. Transitions of care: a hematopoietic stem cell transplantation nursing education project across the trajectory. Clin Oncol Nurs. 2015;19(4):E74–E79.

9. World Health Organization. Obesity and Overweight. Available at: www.who.int/mediacenter/factsheets. Accessed April 23, 2017.

10. Jensen JF, Petersen MH, Larsen TB, Jorgensen DG, Gronbaek HN, Midtgaard J. Young adult women’s experiences of body image after bariatric surgery: a descriptive phenomenological study. J Adv Nurs. 2014;70(5):1138–1149.

11. Abiles V, Rodriguez-Ruiz S, Abiles J, et al. Psychological characteristics of morbidly obese candidates for bariatric surgery. Obes Surg. 2010;20(2):161–167.

12. Wadden TA, Butryn ML, Sarwer DB, et al. Comparison of psychosocial status in treatment-seeking women with class III vs. class I-II obesity. Obesity. 2006;14(suppl 2):90S–98S.

13. Centers for Disease Control and Prevention. Adult Obesity Facts 2012. Available at: www.cdc.gov/obesity/data/adult.html. Accessed April 23, 2017.

14. Oksel E, Gunduzoglu N, Topcu S. The perception of obese persons: cross cultural considerations. Holis Nurs Pract. 2015;29(4):225–231.

15. Bray GA. Obesity in adults: etiology and natural history. UptoDate. 2017; Available at: www.uptodate.com. Accessed April 24, 2017.

16. O’Connell J. Management of obesity: lessons learned from a multidisciplinary team. EDN. 2012;9(1):26–29.

17. Laddu D, Dow C, Hingle M, Thomson C, Going S. A review of evidence-based strategies to treat obesity in adults. Nutr Clin Pract. 2011;26(5):512–525.

18. Powell P, Spears K, Rebori M. What is obesogenic environment? University of Nevada Cooperative Extension. Fact Sheet-10-11. Available at: www.unce.unr.edu/publications/files/hn/2010/fs1011.pdf. Accessed December 8, 2017.

19. Beitz J. Clinician challenges in providing health care for a morbidly obese family member: a bariatric case study. Ostomy Wound Manage. 2015;61(1):42–46.

20. Donabedian A. The seven pillars of quality. Arch Pathol Lab Med.1990;114(11):1115–1118.

21. Hursh A, Salsbury S, Lenhart B, Doran S, Zadvinskis KM. Using personalize care boards for communicating safe patient handling and mobility status in acute care. Lessons learned using the Donabedian model. Am J SPHM. 2013;3(4):124–131.

22. Beitz J. Providing quality skin and wound care for the bariatric patient: an overview of clinical challenges. Ostomy Wound Manage. 2014;60(1):12–21.

23. Berrios LA. The ABCDs of managing morbidly obese patients in intensive care units. Crit Care Nurs. 2016;36(5):17–26.

24. Cowdell F, Radley K. What do we know about skin-hygiene care for patients with bariatric needs? Implications for nursing practice. J Adv Nurs. 2014;70(3):543–552.

25. Bandura A. Self-efficacy: The Exercise of Control. New York, NY: Macmillan;1997.

26. Bonsaksen T, Fagermoen MS, Lerdal A. Trajectories of self-efficacy in persons with chronic illness: an explorative longitudinal study. Psychol Health. 2014;29(3):350–364.

27. Brass CR. Experiences of an obese patient. Narrative Inquiry Bioethics. 2014;4(2):88–91.

28. Base-Smith V. What is the lived experience of being morbidly obese and its implications for health care providers? Dissertation Abstracts International: Section B: The Sciences and Engineering. 2006;67(1-B):506. UMI Order Number: AA13206386.

29. Kwambai K. Obesity treatment: one sized docs not fit all. Narrative Inquiry Bioethics. 2014;4(2):104–107.

30. Moore L. I’m your patient, not a problem. Narrative Inquiry Bioethics. 2014;4(2):110–112.

31. Hales C, de Vries K, Coombs M. Managing social awkwardness when caring for morbidly obese patients in intensive care: a focused ethnography. Int J Nurs Stud. 2016;58:82–89.

32. Zijlstra H, Van Middendorp H, Devaere L, Larsen JK, Van Ramshort B, Geenen R. Emotion processing and regulation in women with morbid obesity who apply for bariatric surgery. Psychol Health. 2012;27(12):1375–1387.

33. Felitti VJ, Anda R, Nordenberg D, et al. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998;14(4):245–256.

34. Felitti VJ, Jakstis K, Pepper V, Ray A. Obesity: problem, solution, or both? Perm J. 2010;14(1):24–30.

35. Anda RF, Felitti VJ, Bremner JD, et al. The enduring effects of abuse and related adverse experiences in childhood. Eur Arch Psychiatry Clin Neurosci. 2006;256(3):174–186.

36. Occupational Safety and Health Administration. Safe Patient Handling Programs: Effectiveness and Cost Savings. Available at: https//osha.gov/dsg/hospital/documents/3.5_SPH_effectivenss_508.pdf. Accessed May 5, 2017.

37. Waters T. When is it safe to manually lift a patient? Am J Nurs. 2007;107(8):53–58.

38. Fabbruzzo-Cota C, Frecea M, Kozell K, et al. A clinical nurse specialist-led interprofessional quality improvement project to reduce hospital-acquired pressure ulcers. Clin Nurs Spec. 2016;30(2):110–116.

39. Qu H, Shewchuk RM, Chen Y, Richards JS. Evaluating the quality of acute rehabilitation care for patients with spinal cord injury: an extended Donabedian model. Qual Manage Health Care. 2010;19(1):47–61.

Potential Conflicts of Interest: none disclosed

Dr. Beitz is a Professor of Nursing, WOCNEP Director, School of Nursing-Camden, Rutgers University, Camden, NJ. Please address correspondence to: Janice M. Beitz, PhD, RN, CS, CNOR, CWOCN-AP, CRNP, ANEF, FAAN, WOCNEP Director, School of Nursing-Camden, Rutgers University, 530 Federal Street, Camden, NJ 08102; email: Janice.beitz@camden.rutgers.edu.

Section: