Core Outcome Set–STAndards for Reporting

The COS-STAR Statement

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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article numbere1002148
JournalPLoS Medicine
Volume13
Issue number10
DOIs
StatePublished - Oct 1 2016
Externally publishedYes

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Health care
Outcome Assessment (Health Care)
Health
Guidelines
Checklist
Patient Advocacy
Manuscripts
Health Services
Delivery of Health Care

ASJC Scopus subject areas

  • Biotechnology
  • Biochemistry
  • Molecular Biology
  • Cell Biology

Cite this

Kirkham, J. J., Gorst, S., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., ... Williamson, P. R. (2016). Core Outcome Set–STAndards for Reporting: The COS-STAR Statement. PLoS Medicine, 13(10), [e1002148]. https://doi.org/10.1371/journal.pmed.1002148

Core Outcome Set–STAndards for Reporting : The COS-STAR Statement. / Kirkham, Jamie J.; Gorst, Sarah; Altman, Douglas G.; Blazeby, Jane M.; Clarke, Mike; Devane, Declan; Gargon, Elizabeth; Moher, David; Schmitt, Jochen; Tugwell, Peter; Tunis, Sean; Williamson, Paula R.

In: PLoS Medicine, Vol. 13, No. 10, e1002148, 01.10.2016.

Research output: Contribution to journalArticle

Kirkham, JJ, Gorst, S, Altman, DG, Blazeby, JM, Clarke, M, Devane, D, Gargon, E, Moher, D, Schmitt, J, Tugwell, P, Tunis, S & Williamson, PR 2016, 'Core Outcome Set–STAndards for Reporting: The COS-STAR Statement', PLoS Medicine, vol. 13, no. 10, e1002148. https://doi.org/10.1371/journal.pmed.1002148
Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D et al. Core Outcome Set–STAndards for Reporting: The COS-STAR Statement. PLoS Medicine. 2016 Oct 1;13(10). e1002148. https://doi.org/10.1371/journal.pmed.1002148
Kirkham, Jamie J. ; Gorst, Sarah ; Altman, Douglas G. ; Blazeby, Jane M. ; Clarke, Mike ; Devane, Declan ; Gargon, Elizabeth ; Moher, David ; Schmitt, Jochen ; Tugwell, Peter ; Tunis, Sean ; Williamson, Paula R. / Core Outcome Set–STAndards for Reporting : The COS-STAR Statement. In: PLoS Medicine. 2016 ; Vol. 13, No. 10.
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