Cochrane reviews and dermatological trials outcome concordance: why Core Outcome Sets could make trial results more usable

Schmitt, Jochen; Lange, Toni; Kottner, Jan; Prinsen, Cecilia A C; Weberschock, Tobias; Hahnel, Elisabeth; Apfelbacher, Christian; Brandstetter, Susanne; Dreher, Andreas; Stevens, Giles; Burden-Teh, Esther; Rogers, Natasha; Spuls, Phyllis; Grainge, Matthew J; Williams, Hywel C; Jacobi, Lena; Cochrane Skin Core Outcome Set Initiative (CS-COUSIN)

Abstract

Evidence-based healthcare requires that relevant outcomes for patients are included in clinical trials which investigating treatment effects allowing subsequent systematic reviews to summarize all relevant evidence to guide clinical practice. Currently, no gold standard of outcome choice for dermatology trials and reviews exists. We systematically assessed the concordance between efficacy outcomes a random sample of 10 Cochrane Skin systematic reviews, 220 dermatology trials included. Reviews did not include 742 (68%) of the 1,086 trial outcomes. Of the 60 outcomes the reviews sought, 17 (28%) of these were not reported in any trial whilst 12 were assessed in less than 50% of trials. For 11/23 (48%) primary review outcomes meta-analysis was impossible, because trial outcomes were absent or unclear. This small overlap of review/trial outcomes could suggest that trials are not measuring the outcomes perceived to be the most important by patients, clinicians, systematic reviewers and trialists. The lack of standardized outcome measures, poor reporting of outcomes in trials and low concordance of outcomes between reviews and primary studies could be improved by the development and implementation of Core Outcome Sets (COS). These are an agreed minimum set of key outcomes, for specified conditions, to be reported in all trials.

Citation

Schmitt, J., Lange, T., Kottner, J., Prinsen, C. A. C., Weberschock, T., Hahnel, E., …Cochrane Skin Core Outcome Set Initiative (CS-COUSIN). (2019). Cochrane reviews and dermatological trials outcome concordance: why Core Outcome Sets could make trial results more usable. Journal of Investigative Dermatology, 139(5), 1045-1053. https://doi.org/10.1016/j.jid.2018.11.019

• Journal Article Type: Article
• Acceptance Date: Nov 5, 2018
• Online Publication Date: Dec 5, 2018
• Publication Date: 2019-05
• Deposit Date: Nov 15, 2018
• Publicly Available Date: Dec 6, 2019
• Journal: Journal of Investigative Dermatology
• Print ISSN: 0022-202X
• Electronic ISSN: 1523-1747
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 139
• Issue: 5
• Pages: 1045-1053
• DOI: https://doi.org/10.1016/j.jid.2018.11.019
• Keywords: Cell Biology; Biochemistry; Molecular Biology; Dermatology
• Public URL: https://nottingham-repository.worktribe.com/output/1269193
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S0022202X18329117
• Additional Information: This article is maintained by: Elsevier; Article Title: Cochrane Reviews and Dermatological Trials Outcome Concordance: Why Core Outcome Sets Could Make Trial Results More Usable; Journal Title: Journal of Investigative Dermatology; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.jid.2018.11.019; Content Type: article; Copyright: © 2018 The Authors. Published by Elsevier, Inc. on behalf of the Society for Investigative Dermatology.