TY - JOUR
T1 - The OMERACT core domain set for clinical trials of shoulder disorders
AU - Ramiro, Sofia
AU - Page, Matthew J.
AU - Whittle, Samuel L.
AU - Huang, Hsiaomin
AU - Verhagen, Arianne P.
AU - Beaton, Dorcas E.
AU - Richards, Pamela
AU - Voshaar, Marieke
AU - Shea, Beverley
AU - Van Der Windt, Danielle A.
AU - Kopkow, Christian
AU - Lenza, Mario
AU - Jain, Nitin B.
AU - Richards, Bethan
AU - Hill, Catherine
AU - Gill, Tiffany K.
AU - Koes, Bart
AU - Foster, Nadine E.
AU - Conaghan, Philip G.
AU - Smith, Toby
AU - Malliaras, Peter
AU - Roe, Yngve
AU - Gagnier, Joel J.
AU - Buchbinder, Rachelle
N1 - Funding Information:
RB is supported by an Australian National Health and Medical Research Council Senior Principal Research Fellowship. NEF is an NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). TS and PGC are supported by the NIHR Biomedical Research Centre, Oxford and the NIHR Leeds Biomedical Research Centre, respectively. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR, or the UK Department of Health. S. Ramiro, MD, MSc, PhD, Department of Rheumatology, Leiden University Medical Center, and Zuyderland Medical Center, Heerlen; M.J. Page, PhD, School of Public Health and Preventive Medicine, Monash University; S.L. Whittle, MBBS(Hons), MClinEpi, FRACP, Department of Rheumatology, The Queen Elizabeth Hospital and the University of Adelaide; H. Huang, MPH, Department of Orthopaedic Surgery, University of Michigan; A.P. Verhagen, MSc, PhD, University of Technology; D.E. Beaton, BScOT, PhD, Institute for Work & Health,
Publisher Copyright:
The Journal of Rheumatology Copyright © 2019. All rights reserved.
PY - 2019/8/1
Y1 - 2019/8/1
N2 - 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.
AB - 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.
KW - Core outcome set
KW - OMERACT
KW - Outcome measurement
KW - Shoulder
KW - Trials
KW - n/a OA procedure
UR - http://www.scopus.com/inward/record.url?scp=85070227022&partnerID=8YFLogxK
U2 - 10.3899/jrheum.181070
DO - 10.3899/jrheum.181070
M3 - Article
C2 - 30709947
AN - SCOPUS:85070227022
VL - 46
SP - 969
EP - 975
JO - Journal of rheumatology
JF - Journal of rheumatology
SN - 0315-162X
IS - 8
ER -