The OMERACT core domain set for clinical trials of shoulder disorders

<p>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.</p> <p>Methods At OMERACT 2018, the OMERACT Shoulder Working Gr...

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Main Authors: Ramiro, S, Page, M, Whittle, S, Huang, H, Verhagen, A, Beaton, D, Richards, P, Scholte-Voshaar, M, Shea, B, Van Der Windt, D, Kopkow, C, Lenza, M, Jain, N, Richards, B, Hill, C, Gill, T, Koes, B, Foster, N, Conaghan, P, Smith, T, Malliaras, P, Roe, Y, Gagnier, J, Buchbinder, R
Format: Journal article
Language:English
Published: Journal of Rheumatology 2019
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author Ramiro, S
Page, M
Whittle, S
Huang, H
Verhagen, A
Beaton, D
Richards, P
Scholte-Voshaar, M
Shea, B
Van Der Windt, D
Kopkow, C
Lenza, M
Jain, N
Richards, B
Hill, C
Gill, T
Koes, B
Foster, N
Conaghan, P
Smith, T
Malliaras, P
Roe, Y
Gagnier, J
Buchbinder, R
author_facet Ramiro, S
Page, M
Whittle, S
Huang, H
Verhagen, A
Beaton, D
Richards, P
Scholte-Voshaar, M
Shea, B
Van Der Windt, D
Kopkow, C
Lenza, M
Jain, N
Richards, B
Hill, C
Gill, T
Koes, B
Foster, N
Conaghan, P
Smith, T
Malliaras, P
Roe, Y
Gagnier, J
Buchbinder, R
author_sort Ramiro, S
collection OXFORD
description <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p>
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spelling oxford-uuid:4e2f0744-1423-4462-a904-7148d8e727a92022-03-26T15:59:53ZThe OMERACT core domain set for clinical trials of shoulder disordersJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:4e2f0744-1423-4462-a904-7148d8e727a9EnglishSymplectic Elements at OxfordJournal of Rheumatology2019Ramiro, SPage, MWhittle, SHuang, HVerhagen, ABeaton, DRichards, PScholte-Voshaar, MShea, BVan Der Windt, DKopkow, CLenza, MJain, NRichards, BHill, CGill, TKoes, BFoster, NConaghan, PSmith, TMalliaras, PRoe, YGagnier, JBuchbinder, R<p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p>
spellingShingle Ramiro, S
Page, M
Whittle, S
Huang, H
Verhagen, A
Beaton, D
Richards, P
Scholte-Voshaar, M
Shea, B
Van Der Windt, D
Kopkow, C
Lenza, M
Jain, N
Richards, B
Hill, C
Gill, T
Koes, B
Foster, N
Conaghan, P
Smith, T
Malliaras, P
Roe, Y
Gagnier, J
Buchbinder, R
The OMERACT core domain set for clinical trials of shoulder disorders
title The OMERACT core domain set for clinical trials of shoulder disorders
title_full The OMERACT core domain set for clinical trials of shoulder disorders
title_fullStr The OMERACT core domain set for clinical trials of shoulder disorders
title_full_unstemmed The OMERACT core domain set for clinical trials of shoulder disorders
title_short The OMERACT core domain set for clinical trials of shoulder disorders
title_sort omeract core domain set for clinical trials of shoulder disorders
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