• J Rheumatol · Dec 2017

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

    • Rachelle Buchbinder, Matthew J Page, Hsiaomin Huang, Arianne P Verhagen, Dorcas Beaton, Christian Kopkow, Mario Lenza, Nitin B Jain, Bethan Richards, Pamela Richards, Marieke Voshaar, Danielle van der Windt, Joel J Gagnier, and Shoulder Core Outcome Set Special Interest Group.
    • Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; School of Public Health and Preventive Medicine, Monash University, Melbourne; Department of Rheumatology, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; School of Social and Community Medicine, University of Bristol, Bristol; Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, UK; Department of Orthopedic Surgery, and Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Department of General Practice, Erasmus Medical Centre University, Rotterdam; Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands; St. Michael's Hospital, Musculoskeletal Health and Outcomes Research, The Li Ka Shing Knowledge Institute, composed of the Keenan Research Center and the Li Ka Shing International Healthcare Education Center of St. Michael's Hospital; Institute for Work and Health, Toronto, Ontario, Canada; University Hospital Carl Gustav Carus Dresden, Center for Evidence-Based Healthcare, Dresden, Germany; Hospital Israelita Albert Einstein, Sao Paulo, Brazil. rachelle.buchbinder@monash.edu.
    • J Rheumatol. 2017 Dec 1; 44 (12): 1880-1883.

    ObjectiveThe 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.MethodsIn 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.ResultsThere 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.ConclusionOur 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.

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