Karen Van den Bussche1, Jan Kottner1,2, Hilde Beele3, Dorien De Meyer1, Ann Marie Dunk4, Steven Ersser5, Toni Lange6, Mirko Petrovic7, Lisette Schoonhoven8,9, Steven Smet10, Nele Van Damme1, Sofie Verhaeghe11, Ann Van Hecke11,12, Dimitri Beeckman1,13. 1. Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health, Ghent University, Ghent, Belgium. 2. Clinical Research Center for Hair and Skin Science, Department of Dermatology, Charité-Universtitätsmedizin, Berlin, Germany. 3. Department of Dermatology, Ghent University Hospital, Ghent, Belgium. 4. Tissue Viability Unit, Canberra Hospital, ACT Health, Canberra, ACT, Australia. 5. Department of Health Sciences, University of York, York, UK. 6. Center for Evidence-Based Healthcare, Medizinsche Fakultät Carl Gustav Carus TU Dresden, Dresden, Germany. 7. Department of Geriatrics, Ghent University Hospital, Ghent, Belgium. 8. Faculty of Health Sciences, University of Southampton, Southampton, UK. 9. Radboud University Medical Center, Scientific Institute for Quality of Healthcare, Nijmegen, The Netherlands. 10. Wound Care Center, Ghent University Hospital, Ghent, Belgium. 11. Department of Public Health, University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium. 12. Nursing Department, Ghent University Hospital, Ghent, Belgium. 13. School of Nursing & Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland.
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 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).
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 incontinentpatients. 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).
Authors: Monira El Genedy-Kalyoncu; Alexandra Fastner; Bettina Völzer; Kathrin Raeder; Konrad Neumann; Nils Axel Lahmann; Jan Kottner Journal: BMJ Open Date: 2022-09-29 Impact factor: 3.006