1. Core outcome domains in incontinence-associated dermatitis research
- Author
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Ann Marie Dunk, Mirko Petrovic, Dimitri Beeckman, Lisette Schoonhoven, Karen Van den Bussche, Steven J. Ersser, Jan Kottner, Sofie Verhaeghe, Hilde Beele, Nele Van Damme, Toni Lange, Steven Smet, Ann Van Hecke, and Dorien De Meyer
- Subjects
medicine.medical_specialty ,Delphi Technique ,Pain ,Dermatitis ,Outcome (game theory) ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,All institutes and research themes of the Radboud University Medical Center ,Cost of Illness ,medicine ,Humans ,030212 general & internal medicine ,General Nursing ,computer.programming_language ,Clinical Trials as Topic ,business.industry ,Pruritus ,Prognosis ,Project team ,Clinical trial ,Clinical research ,Systematic review ,Urinary Incontinence ,Caregivers ,Patient Satisfaction ,Family medicine ,Quality of Life ,Outcomes research ,business ,computer ,Delphi - Abstract
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).
- Published
- 2018