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Guideline
. 2019 Feb 11;20(1):116.
doi: 10.1186/s13063-019-3230-x.

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

Jamie J Kirkham  1 , Sarah Gorst  1 , Douglas G Altman  2 , Jane M Blazeby  3 , Mike Clarke  4 , Sean Tunis  5 , Paula R Williamson  6 ; COS-STAP Group
Collaborators, Affiliations
Guideline

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

Jamie J Kirkham et al. Trials. .

Abstract

Background: 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.

Keywords: Core outcome set; Guideline; Protocol.

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Conflict of interest statement

Authors’ information

Full details provided on page 1.

Ethics approval and consent to participate

The University of Liverpool Ethics Committee was consulted and granted ethical approval for both the Delphi survey (Reference 2232) and the consensus meeting (Reference 3271). Informed consent was assumed if a participant responded to the Delphi survey or agreed to attend the consensus meeting.

Consent for publication

Not applicable.

Competing interests

DGA, JMB, MC, ST and PRW are members of the COMET Management Group. SG and JJK declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

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