A Cochrane Review on Incontinence- Associated Dermatitis (IAD) for Making the Case for Core Outcome Sets (COS) in Clinical Trials in Wound Care

Prof. Dimitri Beeckman, RN, PhD
University Centre for Nursing and Midwifery, Ghent University, Belgium 



ABSTRACT 


Incontinence is a widespread disorder with an important impact on quality of life. One of the most common complications is incontinence-associated dermatitis (IAD), resulting from chemical and physical irritation of the skin barrier, triggering inflammation and skin damage. Managing IAD is an important challenge for healthcare professionals. 


There are few validated methods for assessing IAD improvement, possibly due to the multiplicity of outcomes collected. Selective outcome reporting bias, defined as results-based selection of outcomes for publication, is a problem in many clinical trials and affects the conclusions of a significant proportion of systematic reviews.


Specific organizations have been formed to address outcome reporting bias. The Core Outcome Measures in Effectiveness Trials Initiative (COMET) brings together researchers interested in developing a standardized set of core outcomes in various health-related fields. A core outcome set (COS) is defined as an agreed minimum set of outcomes that is recommended to be measured and reported in all clinical trials of a given condition or disease. The implementation of a COS may reduce the risk of selective outcome reporting and allow for more important outcomes to be assessed.


The aim of this lecture is to present an international COS that is relevant to clinical trials of IAD (Van de Bussche et al. 2016) based on the systematic synthesis of peer-reviewed research evidence (Beeckman et al. 2016); preferences from relevant stakeholder groups, including patients, clinicians, regulators; and structured consensus processes involving all relevant perspectives.


References


Van den Bussche K, De Meyer D, Van Damme N, Kottner J, Beeckman D. CONSIDER - Core Outcome Set in IAD Research: study protocol for establishing a core set of outcomes and measurements in incontinence-associated dermatitis research. J Adv Nurs. 2016 Sep 28. doi: 10.1111/jan.13165. 


Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11:CD011627.