A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group

Abstract

Objective.The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders.Methods.In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps.Results.There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated.Conclusion.Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

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

“…The finding that nearly all Delphi participants rated ‘pain’ and ‘physical functioning’ as core domains is consistent with what has been measured in published shoulder trials (these were measured in 90% and 71% of trials, respectively 18. However, the high ratings of ‘global assessment of treatment success’ and ‘health-related quality of life’ contrasts with published literature, where both domains were measured in only 15% of trials 18.…”

“…However, the high ratings of ‘global assessment of treatment success’ and ‘health-related quality of life’ contrasts with published literature, where both domains were measured in only 15% of trials 18. The infrequent measurement of these domains may have occurred because of unfamiliarity with appropriate measurement instruments or assumptions that ‘pain’ and ‘physical functioning’ are the only PROMs that matter.…”

“…One author (HH) made a list of corresponding authors of all shoulder trials indexed in PubMed from 2006 to 2015 (identified from our previous literature review) 18. Three authors (RB, JJG and APV) nominated other researchers with expertise in shoulder disorders not identified from PubMed, and clinicians from different disciplines who have clinical experience in managing people with shoulder disorders.…”

“…We refined the initial list of 32 potential core domains identified from our previous literature review,18 through discussion and debate, by considering if there were any important domains missing and if certain domains were too broad or should be aggregated. This resulted in 41 domains being generated for inclusion in round one (table 1; definitions in online supplementary file 1, table S1).…”

“…10 We recently completed a review of outcome domains and measurement instruments reported in 409 randomised trials of interventions for shoulder disorders published between 1954 and 2015 18. We identified 32 domains across these trials.…”