The OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders

Objective: To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the OMERACT Filter 2.1 Core Domain Set process.

Methods: At OMERACT 2018, the Outcome Measures in Rheumatology (OMERACT) Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and an international Delphi involving patients, clinicians and researchers, as well as a new systematic review of qualitative studies on the experiences of people withbshoulder disorders. After discussions in break-out groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants.

Results: The qualitative review (N=8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction was also identified but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes four ‘mandatory’ trial domains: pain, function, patient global - shoulder and adverse events including death; and four ‘important but optional’ domains: participation (recreation/work), sleep, emotional wellbeing and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set.

Conclusion: OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.