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

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...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine Vol. 20; no. 1; pp. 116 - 7
Main Authors: Kirkham, Jamie J., Gorst, Sarah, Altman, Douglas G., Blazeby, Jane M., Clarke, Mike, Tunis, Sean, Williamson, Paula R.
Format: Journal Article
Language:English
Published: London BioMed Central 11.02.2019
BioMed Central Ltd
Springer Nature B.V
BMC
Subjects:
Analysis
Biomedicine
Checklist - standards
Consensus
Core outcome set
Delphi Technique
Editors
Endpoint Determination - standards
Guideline
Health Sciences
Humans
Medical research
Medicine
Medicine & Public Health
Outcome and process assessment (Medical care)
Practice guidelines (Medicine)
Project management
Protocol
Research Design - standards
Stakeholder Participation
Stakeholders
Statistics for Life Sciences
United Kingdom > UK
United States > US
Protocol
Guideline
Core outcome set
ISSN:1745-6215, 1745-6215
Online Access:Get full text
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Summary: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.
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ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-019-3230-x