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.
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.
Systematic literature review, patient interviews and consensus study using Delphi procedure.
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.
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.
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.
Karen Van den Bussche
Dorien De Meyer
Ann Marie Dunk
Nele Van Damme
Ann Van Hecke
- COS for clinical trials or clinical research
- Delphi process
- Systematic review
The work will be organized and conducted by the IAD International Research Group. This is an international collaboration between researchers and practitioners with various professional backgrounds. The group includes experts with a background in nursing (n=9), physics (n=1), and dermatology (n=1). Extensive clinical expertise (nursing and medical) is combined with expertise in the field of research methods (laboratory, clinical research, qualitative research, and mixed methods), incontinence, and materials science/bioengineering. This diversity in the experts’ backgrounds and expertise will embed IAD research within a broad perspective.
In a first step integrative and systematic reviews will be screened to obtain a comprehensive collection of reported outcomes. The ongoing systematic Cochrane Review with the title “Prevention and treatment of incontinence- associated dermatitis (IAD) in adults” will be a major information source for that purpose. Based on iterative qualitative analyses outcome categories will be inductively developed (e.g. patient perspective, caregiver perspective, biophysical, clinical) and all reported outcomes classified.
Next the empirical evidence supporting the validity, applicability, and usefulness will be reviewed and synthesized.
Based on these literature analyses, a Delphi study will be conducted. Specifically the guidance for the developing COS within Delphi methods according to Sinha et al. (2011) will be followed: (1) clinicians and patients will be involved, (2) open questions will be asked at the beginning, (3) measures to minimize attrition will be established.
After consensus on a COS for IAD, results of the previous literature analysis will be used to look for potential instruments that meet the COS. In case that there is a need for further methodological development necessary projects will be set up.