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Core outcome domains in incontinence‐associated dermatitis research
Author(s) -
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 year - 2018
Publication title -
journal of advanced nursing
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.948
H-Index - 155
eISSN - 1365-2648
pISSN - 0309-2402
DOI - 10.1111/jan.13562
Subject(s) - delphi method , medicine , outcome (game theory) , patient reported outcome , clinical trial , medline , systematic review , physical therapy , family medicine , quality of life (healthcare) , nursing , statistics , mathematics , mathematical economics , political science , law
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 ).