Core Outcome Set-STAndardised Protocol items: the COS-STAP statement

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dc.contributor.authorKirkham, Jamie J.
dc.contributor.authorGorst, Sarah
dc.contributor.authorAltman, Douglas G.
dc.contributor.authorBlazeby, Jane M.
dc.contributor.authorClarke, Mike
dc.contributor.authorTunis, Sean
dc.contributor.authorWilliamson, Paula R.
dc.contributor.authorCOS-STAP group
dc.contributor.authorAldcroft, Adrian
dc.contributor.authorBagley, Heather
dc.contributor.authorConnolly, Bronwen
dc.contributor.authorCaballero-Fonseca, F.
dc.contributor.authorLi, Tianjing
dc.contributor.authorMatvienko-Sikar, Karen
dc.contributor.authorThomas, Victoria
dc.contributor.funderMedical Research Councilen
dc.date.accessioned2019-11-26T05:21:16Z
dc.date.available2019-11-26T05:21:16Z
dc.date.issued2019-02-11
dc.description.abstractBackground: Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to users of their research. The uptake of a COS by COS users will depend in part on the transparency and robustness of the methods used in the COS development study, which would be increased by the use of a standardised protocol. This article describes the development of the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for the content of a COS development study protocol. Methods: The COS-STAP Statement was developed following the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included an initial item generation stage, a two-round Delphi survey involving more than 150 participants representing three stakeholder groups (COS developers, journal editors and patient and public involvement researchers interested in COS development), followed by a consensus meeting with eight voting participants. Results: The COS-STAP Statement consists of a checklist of 13 items considered essential documentation in a protocol, outlining the scope of the COS, stakeholder involvement, COS development plans and consensus processes. Conclusions: Journal editors and peer reviewers can use the guidance to assess the completeness of a COS development study protocol submitted for publication. By providing guidance for key content, the COS-STAP Statement will enhance the drafting of high-quality protocols and determine how the COS development study will be carried out.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid116en
dc.identifier.citationKirkham, J.J., Gorst, S., Altman, D.G., Blazeby, J.M., Clarke, M., Tunis, S. and Williamson, P.R. and the COS-STAP group (2019) ‘Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement’. Trials, 20(1), 116. (7pp) doi: 10.1186/s13063-019-3230-xen
dc.identifier.doi10.1186/s13063-019-3230-xen
dc.identifier.eissn1745-6215
dc.identifier.endpage7en
dc.identifier.issued1en
dc.identifier.journaltitleTrialsen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/9224
dc.identifier.volume20en
dc.language.isoenen
dc.publisherBioMed Central Ltden
dc.relation.projectinfo:eu-repo/grantAgreement/RCUK/MRC/MR/K025635/1/GB/MRC North West Hub for Trials Methodology Research/en
dc.relation.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3230-x
dc.rights© The Author(s) 2019. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectCore outcome seten
dc.subjectGuidelineen
dc.subjectProtocolen
dc.titleCore Outcome Set-STAndardised Protocol items: the COS-STAP statementen
dc.typeArticle (peer-reviewed)en
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