Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study.

Page, MJ; Huang, H; Verhagen, AP; Buchbinder, R; Gagnier, JJ

Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study.

Page, MJ Huang, H Verhagen, AP Buchbinder, R Gagnier, JJ

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Publisher:: BMJ
Publication Type:: Journal Article
Citation:: RMD Open, 2016, 2, (2), pp. e000380
Issue Date:: 2016

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Field	Value	Language
dc.contributor.author	Page, MJ
dc.contributor.author	Huang, H
dc.contributor.author	Verhagen, AP
dc.contributor.author	Buchbinder, R
dc.contributor.author	Gagnier, JJ
dc.date.accessioned	2022-04-18T23:32:24Z
dc.date.available	2016-11-28
dc.date.available	2022-04-18T23:32:24Z
dc.date.issued	2016
dc.identifier.citation	RMD Open, 2016, 2, (2), pp. e000380
dc.identifier.issn	2056-5933
dc.identifier.issn	2056-5933
dc.identifier.uri	http://hdl.handle.net/10453/156358
dc.description.abstract	OBJECTIVE: To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders. METHODS: We performed an online modified Delphi study with an international, multidisciplinary and multistakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core. RESULTS: In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life'. Two additional domains, 'sleep functioning' and 'psychological functioning', met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that 'number of deaths' was not a core domain, but insufficient agreement on whether or not several other domains, including 'range of motion' and 'muscle strength', were core domains. CONCLUSIONS: Based on international consensus from patients, clinicians and researchers, 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life' were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration.
dc.format	Electronic-eCollection
dc.language	eng
dc.publisher	BMJ
dc.relation.ispartof	RMD Open
dc.relation.isbasedon	10.1136/rmdopen-2016-000380
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences
dc.title	Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study.
dc.type	Journal Article
utslib.citation.volume	2
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health/GSH.Physiotherapy
utslib.copyright.status	open_access	*
dc.date.updated	2022-04-18T23:32:20Z
pubs.issue	2
pubs.publication-status	Published online
pubs.volume	2
utslib.citation.issue	2

Abstract:

OBJECTIVE: To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders. METHODS: We performed an online modified Delphi study with an international, multidisciplinary and multistakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core. RESULTS: In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life'. Two additional domains, 'sleep functioning' and 'psychological functioning', met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that 'number of deaths' was not a core domain, but insufficient agreement on whether or not several other domains, including 'range of motion' and 'muscle strength', were core domains. CONCLUSIONS: Based on international consensus from patients, clinicians and researchers, 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life' were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration.

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http://hdl.handle.net/10453/156358