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

Ingram, John R. ORCID: https://orcid.org/0000-0002-5257-1142, Hadjieconomou, Sofia and Piguet, Vincent 2016. Development of core outcome sets in hidradenitis suppurativa:a systematic review of outcome measure instruments to inform the process. British Journal of Dermatology 175 (2) , pp. 263-272. 10.1111/bjd.14475

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Abstract

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.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine Postgraduate Medical and Dental Education
Subjects:	R Medicine > RL Dermatology
Publisher:	Wiley-Blackwell
ISSN:	0007-0963
Date of First Compliant Deposit:	30 March 2016
Date of Acceptance:	2 February 2016
Last Modified:	11 May 2023 09:28
URI:	https://orca.cardiff.ac.uk/id/eprint/87397

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