Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study

Matthew J. Page, Hsiaomin Huang, Arianne Verhagen, Rachelle Buchbinder, Joel Gagnier

Research output: Contribution to journalArticle (Academic Journal)

15 Citations (Scopus)
238 Downloads (Pure)

Abstract

Objective
To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders.
Methods
We performed an online modified Delphi study with an international, multidisciplinary and multi-stakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core.
Results
In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: ‘pain’, ‘physical functioning’, ‘global assessment of treatment success’ and ‘health-related quality of life’. Two additional domains, ‘sleep functioning’ and ‘psychological functioning’, met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that ‘number of deaths’ was not a core domain, but insufficient agreement on whether or not several other domains, including ‘range of motion’ and ‘muscle strength’, were core domains.
Conclusion
Based upon international consensus from patients, clinicians and researchers, ‘pain’, ‘physical functioning’, ‘global assessment of treatment success’ and ‘health-related quality of life’ were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration.
Original languageEnglish
Article numbere000380
Number of pages9
JournalRMD Open
Volume2
Issue number2
Early online date21 Dec 2016
DOIs
Publication statusPublished - Dec 2016

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    Blazeby, J. M.

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