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Core outcome domains in incontinence-associated dermatitis research

  • Van den Bussche, Karen
  • Kottner, Jan
  • Beele, Hilde
  • De Meyer, Dorien
  • Dunk, Ann Marie
  • Ersser, Steven
  • Lange, Toni
  • Petrovic, Mirko
  • Schoonhoven, Lisette
  • Smet, Steven
  • Van Damme, Nele
  • Verhaeghe, Sofie
  • Van Hecke, Ann
  • Beeckman, Dimitri
Publication Date
Jan 01, 2018
Ghent University Institutional Archive
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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 restrictionsApril 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 GroupCore Outcomes Set Initiative (CSG-COUSIN).

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