TY - JOUR
T1 - A preliminary core domain set for clinical trials of shoulder disorders
T2 - A report from the OMERACT 2016 shoulder core outcome set special interest group
AU - Shoulder Core Outcome Set Special Interest Group
AU - Buchbinder, Rachelle
AU - Page, Matthew J.
AU - Huang, Hsiaomin
AU - Verhagen, Arianne P.
AU - Beaton, Dorcas
AU - Kopkow, Christian
AU - Lenza, Mario
AU - Jain, Nitin B.
AU - Richards, Bethan
AU - Richards, Pamela
AU - Voshaar, Marieke
AU - Van Der Windt, Danielle
AU - Gagnier, Joel J.
N1 - Publisher Copyright:
Copyright © 2017. All rights reserved.
PY - 2017/12/1
Y1 - 2017/12/1
N2 - Objective. The 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. Methods. In 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. Results. There 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. Conclusion. Our 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.
AB - Objective. The 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. Methods. In 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. Results. There 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. Conclusion. Our 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.
KW - Core outcome set
KW - Outcome measurement
KW - Shoulder
KW - Trials
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U2 - 10.3899/jrheum.161123
DO - 10.3899/jrheum.161123
M3 - Article
C2 - 28089972
AN - SCOPUS:85034443711
SN - 0315-162X
VL - 44
SP - 1880
EP - 1883
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 12
ER -