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, Shoulder Core Outcome Set Special Interest Group

Research output: Contribution to journalArticleOtherpeer-review

18 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1880-1883
Number of pages4
JournalJournal of Rheumatology
Volume44
Issue number12
DOIs
Publication statusPublished - 1 Dec 2017

Keywords

  • Core outcome set
  • Outcome measurement
  • Shoulder
  • Trials

Cite this

Buchbinder, Rachelle ; Page, Matthew J. ; Huang, Hsiaomin ; Verhagen, Arianne P. ; Beaton, Dorcas ; Kopkow, Christian ; Lenza, Mario ; Jain, Nitin B. ; Richards, Bethan ; Richards, Pamela ; Voshaar, Marieke ; Van Der Windt, Danielle ; Gagnier, Joel J. ; Shoulder Core Outcome Set Special Interest Group. / A preliminary core domain set for clinical trials of shoulder disorders : A report from the OMERACT 2016 shoulder core outcome set special interest group. In: Journal of Rheumatology. 2017 ; Vol. 44, No. 12. pp. 1880-1883.
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abstract = "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.",
keywords = "Core outcome set, Outcome measurement, Shoulder, Trials",
author = "Rachelle Buchbinder and Page, {Matthew J.} and Hsiaomin Huang and Verhagen, {Arianne P.} and Dorcas Beaton and Christian Kopkow and Mario Lenza and Jain, {Nitin B.} and Bethan Richards and Pamela Richards and Marieke Voshaar and {Van Der Windt}, Danielle and Gagnier, {Joel J.} and {Shoulder Core Outcome Set Special Interest Group}",
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Buchbinder, R, Page, MJ, Huang, H, Verhagen, AP, Beaton, D, Kopkow, C, Lenza, M, Jain, NB, Richards, B, Richards, P, Voshaar, M, Van Der Windt, D, Gagnier, JJ & Shoulder Core Outcome Set Special Interest Group 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', Journal of Rheumatology, vol. 44, no. 12, pp. 1880-1883. https://doi.org/10.3899/jrheum.161123

A preliminary core domain set for clinical trials of shoulder disorders : A report from the OMERACT 2016 shoulder core outcome set special interest group. / Buchbinder, Rachelle; Page, Matthew J.; Huang, Hsiaomin; Verhagen, Arianne P.; Beaton, Dorcas; Kopkow, Christian; Lenza, Mario; Jain, Nitin B.; Richards, Bethan; Richards, Pamela; Voshaar, Marieke; Van Der Windt, Danielle; Gagnier, Joel J.; Shoulder Core Outcome Set Special Interest Group.

In: Journal of Rheumatology, Vol. 44, No. 12, 01.12.2017, p. 1880-1883.

Research output: Contribution to journalArticleOtherpeer-review

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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.

AU - Shoulder Core Outcome Set Special Interest Group

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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.

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