CONSIDER - Core Outcome Set in IAD Research: study protocol for establishing a core set of outcomes and measurements in incontinence-associated dermatitis research.
OBJECTIVE
This study protocol describes the methodology for the development of a core set of outcomes and a core set of measurements for incontinence-associated dermatitis.


BACKGROUND
Incontinence is a widespread disorder with an important impact on quality of life. One of the most common complications is incontinence-associated dermatitis, resulting from chemical and physical irritation of the skin barrier, triggering inflammation and skin damage. Managing incontinence-associated dermatitis is an important challenge for nurses. Several interventions have been assessed in clinical trials, but heterogeneity in study outcomes complicates the comparability and standardization. To overcome this challenge, the development of a core outcome set, a minimum set of outcomes and measurements to be assessed in clinical research, is needed.


METHODS
A project team, International Steering Committee and panelists will be involved to guide the development of the core outcome set. The framework of the Harmonizing Outcomes Measures for Eczema roadmap endorsed by Cochrane Skin Group Core Outcomes Set Initiative, is used to inform the project design.


METHODS
A systematic literature review, interviews to integrate the patients' perspective and a consensus study with healthcare researchers and providers using the Delphi procedure will be performed. The project was approved by the Ethics review Committee (April 2016).


CONCLUSIONS
This is the first project that will identify a core outcome set of outcomes and measurements for incontinence-associated dermatitis research. A core outcome set will reduce possible reporting bias, allow results comparisons and statistical pooling across trials and strengthen evidence-based practice and decision-making.


BACKGROUND
This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and is part of the Cochrane Skin Group Core Outcomes Set Initiative (CSG-COUSIN).
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Karen
http://orcid.org/0000-0001-5308-8729
K
Van den Bussche
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Dorien
http://orcid.org/0000-0002-9893-6231
D
De Meyer
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Nele
N
Van Damme
Clinical Research Center for Hair of Skin Science, Charité-Universitätsmedizin, Berlin, Germany.
Jan
J
Kottner
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Dimitri
http://orcid.org/0000-0003-3080-8716
D
Beeckman
D003872:Dermatitis / Q000209:etiology* / Q000503:physiopathology; D006801:Humans; D017063:Outcome Assessment, Health Care; D014549:Urinary Incontinence / Q000150:complications*
clinical nursing research; core outcome set; domains; incontinence-associated dermatitis; measurement instruments; nursing; outcome assessment; outcomes; outcomes research