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, 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

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, 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

Permalink

Publication Type:: Journal Article
Citation:: Journal of Rheumatology, 2017, 44 (12), pp. 1880 - 1883
Issue Date:: 2017-12-01

Open Access

Copyright Clearance Process

Recently Added
In Progress
Open Access

This item is open access.

Adobe PDF

Download Accepted Manuscript VersionAdobe PDF (509.19 kB)

View on publisher's site

View statistics

Full metadata record

Field	Value	Language
dc.contributor.author	Buchbinder, R	en_US
dc.contributor.author	Page, MJ	en_US
dc.contributor.author	Huang, H	en_US
dc.contributor.author	Verhagen, AP https://orcid.org/0000-0002-6195-0128	en_US
dc.contributor.author	Beaton, D	en_US
dc.contributor.author	Kopkow, C	en_US
dc.contributor.author	Lenza, M	en_US
dc.contributor.author	Jain, NB	en_US
dc.contributor.author	Richards, B	en_US
dc.contributor.author	Richards, P	en_US
dc.contributor.author	Voshaar, M	en_US
dc.contributor.author	Van Der Windt, D	en_US
dc.contributor.author	Gagnier, JJ	en_US
dc.date.available	2020-05-25T19:11:48Z
dc.date.issued	2017-12-01	en_US
dc.identifier.citation	Journal of Rheumatology, 2017, 44 (12), pp. 1880 - 1883	en_US
dc.identifier.issn	0315-162X	en_US
dc.identifier.uri	http://hdl.handle.net/10453/126112
dc.description.abstract	Copyright © 2017. All rights reserved. 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.	en_US
dc.relation.ispartof	Journal of Rheumatology	en_US
dc.relation.isbasedon	10.3899/jrheum.161123	en_US
dc.subject.classification	Arthritis & Rheumatology	en_US
dc.subject.mesh	Shoulder	en_US
dc.subject.mesh	Shoulder Joint	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Joint Diseases	en_US
dc.subject.mesh	Consensus	en_US
dc.subject.mesh	Rheumatology	en_US
dc.subject.mesh	Delphi Technique	en_US
dc.subject.mesh	Outcome Assessment (Health Care)	en_US
dc.subject.mesh	Outcome Assessment, Health Care	en_US
dc.title	A preliminary core domain set for clinical trials of shoulder disorders: A report from the OMERACT 2016 shoulder core outcome set special interest group	en_US
dc.type	Journal Article
utslib.citation.volume	12	en_US
utslib.citation.volume	44	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1107 Immunology	en_US
utslib.for	1117 Public Health and Health Services	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Graduate School of Health
utslib.copyright.status	open_access
pubs.issue	12	en_US
pubs.publication-status	Published	en_US
pubs.volume	44	en_US

Abstract:

Copyright © 2017. All rights reserved. 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.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/126112