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The OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders
Sofia Ramiro1,2, Matthew J Page3,4, Samuel L Whittle3,4
1From the Department of Rheumatology, Leiden University Medical Center, Leiden; Zuyderland Medical Center, Heerlen; Department of Psychology, Health and Technology, University of Twente, Enschede; Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands; School of Public Health and Preventive Medicine, Monash University; Monash Department of Physiotherapy, School of Primary and Allied Health Care, Monash University; Monash Department of Clinical Epidemiology, Cabrini Institute; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Department of Rheumatology, The Queen Elizabeth Hospital and the University of Adelaide; Adelaide Medical School, The University of Adelaide, Adelaide; University of Technology; Royal Prince Alfred Hospital, Camperdown NSW; University of Sydney, Sydney, Australia; Department of Orthopaedic Surgery, University of Michigan; Department of Epidemiology, School of Public Health, Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan; Departments of Physical Medicine and Rehabilitation, Orthopaedics, and Epidemiology (Medicine), Vanderbilt University Medical Center, Nashville, Tennessee, USA; Institute for Work & Health; University of Toronto, Toronto; Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; University of Bristol, Bristol; Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Keele; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals UK National Health Service (NHS) Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Department of Applied Health Sciences, Hochschule für Gesundheit Bochum (University of Applied Sciences), Bochum, Germany; Hospital Israelita Albert Einstein, São Paulo, Brazil; Department of Physiotherapy, OsloMet - Oslo Metropolitan University, Oslo, Norway. sofiaramiro@gmail.com.
Objective:
To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process.
Methods:
At OMERACT 2018, the 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 international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout 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 4 "mandatory" trial domains: pain, function, patient global - shoulder, and adverse events including death; and 4 "important but optional" domains: participation (recreation/work), sleep, emotional well-being, 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.
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