Development of core outcome sets in hidradenitis suppurativa:a systematic review of outcome measure instruments to inform the process


Journal: Br. J. Dermatol. 2016 Feb;

Author(s): Ingram JR, Hadjieconomou S, Piguet V

BACKGROUND: The recent hidradenitis suppurativa (HS) Cochrane review identified outcome measure heterogeneity as an important issue to address when designing future HS trials.

OBJECTIVES: To follow the Harmonising Outcome Measures for Eczema (HOME) roadmap, by performing a systematic review of HS outcome measure instruments to inform the development of a HS core outcome set.

METHODS: We performed a systematic review to identify validation evidence for outcome measure instruments used in HS randomised controlled trials (RCTs), and assessed the methodological quality of all HS outcome measure validity studies using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist.

RESULTS: The 12 RCTs included in the HS Cochrane review utilised a total of 30 outcome measure instruments, including 16 physician reported instruments, 11 patient reported instruments and three composite measures containing elements of both. Twenty-seven (90%) of the instruments lacked any validation data. Two further instruments have been developed and partially validated recently. Of the seven studies meeting our systematic review inclusion criteria, six were of ‘fair’ or ‘poor’ methodological quality, in part because most of the studies were not primarily designed for instrument validation. The HiSCR instrument is supported by good quality validation data but there are gaps including assessment of internal consistency, inter-rater reliability and minimal clinically important difference, and convergent validity fell below the acceptable range for some comparisons.

CONCLUSIONS: Multiple, usually unvalidated outcome measure instruments have been used in HS RCTs. Where validation evidence is available there are issues of low methodological quality or incomplete validity assessment and so no instruments can be fully recommended currently. This article is protected by copyright. All rights reserved.

Dermatology Journal and/or Publisher

Journal Name: The British journal of dermatology
Journal Abbreviation: Br. J. Dermatol.
Journal Volume: , Issue:
Journal Date Published: 2016-02-12

National Center for Biotechnology Information

PMI ID: 26873867
Created: 2016-02-13

Abstract Source: National Center for Biotechnology Information, U.S. National Library of Medicine Abstract Query for “Hidradenitis suppurativa”


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