Core Outcome Set-STAndards for Reporting: The COS-STAR Statement.

Background
Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent.

Methods and Findings
In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas.

Conclusions
With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users.

Contributors

Jamie J. Kirkham,
Sarah Gorst,
Douglas G. Altman,
Jane M. Blazeby,
Mike Clarke,
Declan Devane,
Elizabeth Gargon,
David Moher,
Jochen Schmitt,
Peter Tugwell,
Sean Tunis,
Paula R. Williamson

Publication

Journal: PLoS Med
Volume: 13
Issue: 10
Pages: -
Year: 2016
DOI: https://doi.org/10.1371/journal.pmed.1002148

Further Study Information

Current Stage: Completed
Date:
Funding source(s): MRCNetworkof Hubsfor TrialsMethodology Research(MR/L004933/1-R55)


Health Area

Disease Category: Other

Disease Name: N/A

Target Population

Age Range: Unknown

Sex:

Nature of Intervention:

Stakeholders Involved

- Guideline developers
- Journal editors
- Methodologists
- Other
- Researchers
- Trialists

Study Type

- COS methods research

Method(s)

- Consensus meeting
- Delphi process

An international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting.

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