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

Background: The OMERACT Shoulder Core Outcome Set Special Interest Group was established to develop a core outcome set for clinical trials of shoulder disorders.

Methods: In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomised 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 core outcome set. Findings were discussed at a stakeholder pre-meeting 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 pre-meeting and OMERACT 2016 Special Interest Group meeting respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set comprising an inner core of four domains: pain, physical function/activity, global perceived effect and adverse events including death. A middle core comprised three domains: emotional wellbeing, 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) Explore whether participation (recreation and work) should be in the inner core; 2) Conduct a third Delphi round to finalise definitions and wording of domains and reach final endorsement for the domains; and 3) determine which instruments fulfil OMERACT criteria to measuring each domain.