Outcome measurement instruments for erythema associated with incontinence-associated dermatitis: Systematic review.

AIM: To: (a) examine which outcome measurement instruments for erythema associated with incontinence-associated dermatitis (IAD) with supporting evidence about measurement properties are available; (b) evaluate the methodological quality of the studies and the quality of the measurement properties; and (c) identify eligible instruments to measure erythema in incontinence-associated dermatitis research. DESIGN: Systematic review. DATA SOURCES: MEDLINE, EMBASE, CINAHL and CENTRAL were systematically searched until July 2018 (update December 2018). Additional input was gathered from 151 incontinence-associated dermatitis experts. Cited and citing references of included studies were screened. REVIEW METHODS: The COSMIN Risk of Bias checklist was applied to evaluate the methodological quality of the studies. Reported measurement properties were rated against criteria for good measurement properties. RESULTS: Fourteen studies, describing 10 measurement instruments, were included. In five instruments, erythema was captured as a separate concept, two studies provided empirical evidence about the measurement properties. The most studied measurement properties were reliability (9 studies), measurement error (4 studies) and criterion validity (4 studies). In one study, internal consistency was examined. CONCLUSION: No instrument measuring exclusively erythema associated with incontinence-associated dermatitis exists. There is no single composite incontinence-associated dermatitis measurement instrument that outperforms others. Development or adaption of an instrument to measure erythema associated with incontinence-associated dermatitis is one option to solve this challenge. IMPACT: The evidence about measurement properties of instruments measuring erythema associated with incontinence-associated dermatitis has not been summarized to date. The lack of an instrument should trigger activities to measure this domain accurately in future clinical trials.

Knowledge of nurses and nursing assistants about pressure ulcer prevention: A survey in 16 Belgian hospitals using the PUKAT 2.0 tool.

BACKGROUND: Pressure ulcers have a high impact on patients and their families. Profound and up-to-date knowledge among nurses is important given the effect on attitudes and preventative behaviour. To gain insight into educational needs and priorities, regular knowledge assessments are needed. OBJECTIVE: To gain insight into the knowledge of nurses and nursing assistants about pressure ulcer prevention. DESIGN: Cross-sectional multicentre study. METHODS: 474 nurses and nursing assistants recruited at 29 wards in 16 hospitals completed individually the PUKAT 2.0, a valid and reliable questionnaire to measure nurses knowledge about pressure ulcer prevention. Data were collected between February 2016 and December 2017. Independent sample t-tests, one-way analyses of variance and Kruskal-wallis tests were performed to analyse the results. RESULTS: The mean total score was 50.7%. The lowest scores were found in the themes knowledge about prevention (42.7%), aetiology (45.6%) and prevention for specific patient groups (46.6%). Higher educational level (H = 40.43, p < 0.001) and attending additional training about pressure ulcers or wound care in general (t = 2.93, p = 0.004) resulted in significant higher total knowledge scores. CONCLUSION: The results of this study highlight an important knowledge deficit about pressure ulcer prevention. The PUKAT 2.0 knowledge assessment tool made it possible to differentiate between a variety of cognitive process levels. This allowed to identify knowledge gaps and focus areas for continuing professional education. Education curricula for nurses and associated healthcare professionals are to be screened thoroughly and the identified knowledge gaps should be covered. Besides, multifaceted strategies are needed to improve clinical practice.

Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection.

OBJECTIVE: The objective of this study was to compare two different rating scales within one Delphi study for defining consensus in core outcome set development and to explore the influence of consensus criteria on the outcome selection. STUDY DESIGN AND SETTING: Randomized controlled parallel group trial with 1:1 allocation within the first Delphi round of the Core Outcome Set in the Incontinence-Associated Dermatitis project. Outcomes were rated on a three-point or nine-point Likert scale. Decisions about which outcomes to retain were determined by commonly used consensus criteria (i.e., [combinations of] proportions with restricted ranges, central tendency within a specific range, and decrease in variance). RESULTS: Fifty-seven participants (group 1 = 28, group 2 = 29) rated 58 outcomes. The use of the nine-point scale resulted in almost twice as many outcomes being rated as "critical" compared with the three-point scale (24 vs. 13). Stricter criteria and combining criteria led to less outcomes being identified as "critical". CONCLUSION: The format of rating scales in Delphi studies for core outcome set development and the definition of the consensus criteria influence outcome selection. The use of the nine-point scale might be recommended to inform the consensus process for a subsequent rating or face-to-face meeting. The three-point scale might be preferred when determining final consensus.

PROTECT - Trial: A cluster RCT to study the effectiveness of a repositioning aid and tailored repositioning to increase repositioning compliance.

AIM: To study the effectiveness of tailored repositioning and a turning and repositioning system on: (a) nurses' compliance to repositioning frequencies; (b) body posture of patients after repositioning; (c) incidence of pressure ulcers and incontinence-associated dermatitis; (d) nurses' and patients' preferences, comfort and acceptability; and (e) budget impact. BACKGROUND: Patient-tailored systematic repositioning is key in pressure ulcer prevention. To date, a clinical decision-making tool is lacking and compliance to pressure ulcer prevention guidelines is low. Research concerning commercially available turning and repositioning systems is lacking. DESIGN: Multicentre, cluster, three-arm, randomized, controlled pragmatic trial. METHODS: Two hundred and twenty-seven patients at risk of pressure ulcer development were recruited at 29 wards in 16 hospitals between February 2016 and December 2017. Wards were randomly assigned to two experimental groups and one control group. RESULTS: Nurses' compliance to repositioning frequencies increased significantly in the experimental groups when patients were cared for in bed (94.6% vs. 69% and 84.9% vs. 71.4%). Applying the turning and repositioning system was associated with significantly more correctly positioned patients (30-45° tilted side-lying position) (69.6% vs. 34.6%). Few pressure ulcers and incontinence-associated dermatitis incidents occurred. Both patients and nurses were positive about the intervention. Higher labour costs related to repositioning in bed were found in the control group. CONCLUSION: This was the first study investigating the effect of tailored repositioning and the use of a repositioning aid to increase nurses' compliance to repositioning. The results were in favour of the interventions yet demonstrating the importance of follow-up and education. TRIAL REGISTRATION: This study is registered at https://clinicaltrials.gov/NCT02690753;NCT02690753.

Core outcome domains in incontinence-associated dermatitis research.

AIM: To report the development of a core set of outcome domains for clinical research involving adults with incontinence-associated dermatitis or at risk, independently from any geographical location or skin colour. BACKGROUND: The management of incontinence-associated dermatitis is important in caring for incontinent patients. The lack of comparability of clinical trial outcomes is a major challenge in the field of evidence-based incontinence-associated dermatitis prevention and treatment. Core outcome sets may therefore be helpful to improve the value of clinical incontinence-associated dermatitis research. DESIGN: Systematic literature review, patient interviews and consensus study using Delphi procedure. METHODS: A list of outcome domains was generated through a systematic literature review (no date restrictions-April 2016), consultation of an international steering committee and three patient interviews. The project team reviewed and refined the outcome domains prior to starting a three-round Delphi procedure conducted between April-September 2017. The panellists, including healthcare providers, researchers and industry were invited to rate the importance of the outcome domains. RESULTS: We extracted 1,852 outcomes from 244 articles. Experts proposed 56 and patients 32 outcome domains. After refinement, 57 panellists from 17 countries rated a list of 58 outcome domains. The final list of outcome domains includes erythema, erosion, maceration, IAD-related pain and patient satisfaction. CONCLUSION: Erythema, erosion, maceration, incontinence-associated dermatitis -related pain and patient satisfaction are the most important outcome domains to be measured in incontinence-associated dermatitis trials. Based on this international consensus on what to measure, the question of how to measure these domains now requires consideration. Registration: This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET Initiative) database and is part of the Cochrane Skin Group-Core Outcomes Set Initiative (CSG-COUSIN).

CONSIDER - Core Outcome Set in IAD Research: study protocol for establishing a core set of outcomes and measurements in incontinence-associated dermatitis research.

AIM: This study protocol describes the methodology for the development of a core set of outcomes and a core set of measurements for incontinence-associated dermatitis. BACKGROUND: Incontinence is a widespread disorder with an important impact on quality of life. One of the most common complications is incontinence-associated dermatitis, resulting from chemical and physical irritation of the skin barrier, triggering inflammation and skin damage. Managing incontinence-associated dermatitis is an important challenge for nurses. Several interventions have been assessed in clinical trials, but heterogeneity in study outcomes complicates the comparability and standardization. To overcome this challenge, the development of a core outcome set, a minimum set of outcomes and measurements to be assessed in clinical research, is needed. DESIGN: A project team, International Steering Committee and panelists will be involved to guide the development of the core outcome set. The framework of the Harmonizing Outcomes Measures for Eczema roadmap endorsed by Cochrane Skin Group Core Outcomes Set Initiative, is used to inform the project design. METHODS: A systematic literature review, interviews to integrate the patients' perspective and a consensus study with healthcare researchers and providers using the Delphi procedure will be performed. The project was approved by the Ethics review Committee (April 2016). DISCUSSION: This is the first project that will identify a core outcome set of outcomes and measurements for incontinence-associated dermatitis research. A core outcome set will reduce possible reporting bias, allow results comparisons and statistical pooling across trials and strengthen evidence-based practice and decision-making. REGISTRATION: This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and is part of the Cochrane Skin Group Core Outcomes Set Initiative (CSG-COUSIN).

PROTECT - trial: a multicentre prospective pragmatic RCT and health economic analysis of the effect of tailored repositioning to prevent pressure ulcers - study protocol.

AIM: The aims of this trial were as follows: (1) to compare the (cost-) effectiveness of a turning and repositioning system and an algorithm for a tailored repositioning vs. usual care to improve reposition frequency in patients at risk; and (2) to compare the (cost-) effectiveness of standardized incontinence care vs. usual care. BACKGROUND: Pressure ulcers are a serious and common problem for hospitalized patients. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for health care. International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. Interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. There is a lack of rigorous research addressing the effectiveness of a turning and repositioning system and it is unclear how to tailor the frequency and posture to specific patient needs. DESIGN: Multicentre, cluster, three-arm, randomized, controlled pragmatic trial and a cost-effectiveness analysis. The ward is the unit of randomization. METHODS: Tailored repositioning, the use of a device to facilitate patient repositioning and an optimal procedure for incontinence care will be combined. Participating wards will be intensive care units, geriatric and rehabilitation wards. A sample size calculation was performed (80% power, α = 0·05). This study is approved by the Ethics Committee (February 2016). DISCUSSION: Data collection is currently ongoing. The results are expected to be obtained in March 2017.

Independent risk factors for the development of skin erosion due to incontinence (incontinence-associated dermatitis category 2) in nursing home residents: results from a multivariate binary regression analysis.

The aim of this study was to identify characteristics independently associated with a higher risk of developing skin damage because of incontinence [incontinence-associated dermatitis (IAD) category 2] in nursing home residents. As part of a larger randomised controlled trial, IAD incidence was monitored for 1 month in a sample of 381 incontinent residents using a validated IAD Severity Categorisation Tool. Data on demographical, physical, functional and psychological characteristics were collected. The overall IAD incidence (category 1-2) was 30·0%, and 6% of the participants developed skin damage (IAD category 2). Residents who developed IAD category 2 were less mobile [odds ratio (OR) 2·72, 95% confidence interval (CI) 1·06-6·94], had more friction and shear issues (OR 2·54; 95% CI 1·02-6·33) and had more erythema due to incontinence (OR 3·02; 95% CI 1·04-8·73) before IAD category 2 occurrence. Care providers should give full attention to risk factors to both detect residents at risk for IAD development and to start prevention in time.

Interventions for preventing and treating incontinence-associated dermatitis in adults.

BACKGROUND: Incontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and procedures are the same for both prevention and treatment of IAD. OBJECTIVES: The objective of this review was to assess the effectiveness of various products and procedures to preventand treat incontinence-associated dermatitis in adults. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 September 2016). Additionally we searched other electronic databases: CENTRAL(2015, Issue 4), MEDLINE (January 1946 to May Week 3 2015), MEDLINE In-Process (inception to 26 May 2015), CINAHL(December 1981 to 28 May 2015), Web of Science (WoS; inception to 28 May 2015) and handsearched conference proceedings (to June 2015) and the reference lists of relevant articles, and contacted authors and experts in the field. SELECTION CRITERIA: We selected randomised controlled trials (RCTs) and quasi-RCTs, performed in any healthcare setting, with included participants over 18 years of age, with or without IAD. We included trials comparing the (cost) effectiveness of topical skin care products such as skin cleansers, moisturisers, and skin protectants of different compositions and skin care procedures aiming to prevent and treat IAD. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles, abstracts and full-texts, extracted data, and assessed the risk of bias of the included trials. MAIN RESULTS: We included 13 trials with 1295 participants in a qualitative synthesis. Participants were incontinent for urine, stool, or both, and were residents in a nursing home or were hospitalised.Eleven trials had a small sample size and short follow-up periods. .The overall risk of bias in the included studies was high. The data were not suitable for meta-analysis due to heterogeneity in participant population, skin care products, skin care procedures, outcomes, and measurement tools.Nine trials compared different topical skin care products, including a combination of products. Two trials tested a structured skin care procedure. One trial compared topical skin care products alongside frequencies of application. One trial compared frequencies of application of topical skin care products.We found evidence in two trials, being of low and moderate quality, that soap and water performed poorly in the prevention and treatment of IAD (primary outcomes of this review). The first trial indicated that the use of a skin cleanser might be more effective than the use of soap and water (risk ratio (RR) 0.39, 95% confidence interval (CI) 0.17 to 0.87; low quality evidence). The second trial indicated that a structured skin care procedure, being a washcloth with cleansing, moisturising, and protecting properties, might be more effective than soap and water (RR 0.31, 95% CI 0.12 to 0.79; moderate quality evidence). Findings from the other trials, all being of low to very low quality, suggest that applying a leave-on product (moisturiser, skin protectant, or a combination) might be more effective than not applying a leave-on product. No trial reported on the third primary outcome 'number of participants not satisfied with treatment' or on adverse effects. AUTHORS' CONCLUSIONS: Little evidence, of very low to moderate quality, exists on the effects of interventions for preventing and treating IAD in adults. Soap and water performed poorly in the prevention and treatment of IAD. Application of leave-on products (moisturisers, skin protectants, or a combination) and avoiding soap seems to be more effective than withholding these products. The performance of leave-on products depends on the combination of ingredients, the overall formulation and the usage (e.g. amount applied). High quality confirmatory trials using standardised, and comparable prevention and treatment regimens in different settings/regions are required. Furthermore, to increase the comparability of trial results, we recommend the development of a core outcome set, including validated measurement tools. The evidence in this review is current up to 28 September 2016.