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Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review

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  • Elizabeth Gargon
  • Binu Gurung
  • Nancy Medley
  • Doug G Altman
  • Jane M Blazeby
  • Mike Clarke
  • Paula R Williamson

Abstract

Background: A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies. Methods: We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition. Results: A total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n = 164; 83%) and Europe (n = 150; 76%). Conclusions: This systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.

Suggested Citation

  • Elizabeth Gargon & Binu Gurung & Nancy Medley & Doug G Altman & Jane M Blazeby & Mike Clarke & Paula R Williamson, 2014. "Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review," PLOS ONE, Public Library of Science, vol. 9(6), pages 1-12, June.
    • Handle: RePEc:plo:pone00:0099111
    DOI: 10.1371/journal.pone.0099111
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    References listed on IDEAS

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    1. Kerry Dwan & Douglas G Altman & Juan A Arnaiz & Jill Bloom & An-Wen Chan & Eugenia Cronin & Evelyne Decullier & Philippa J Easterbrook & Erik Von Elm & Carrol Gamble & Davina Ghersi & John P A Ioannid, 2008. "Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias," PLOS ONE, Public Library of Science, vol. 3(8), pages 1-31, August.
    2. David Moher & Alessandro Liberati & Jennifer Tetzlaff & Douglas G Altman & The PRISMA Group, 2009. "Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement," PLOS Medicine, Public Library of Science, vol. 6(7), pages 1-6, July.
    3. David Moher & Kenneth F Schulz & Iveta Simera & Douglas G Altman, 2010. "Guidance for Developers of Health Research Reporting Guidelines," PLOS Medicine, Public Library of Science, vol. 7(2), pages 1-9, February.
    4. Ian Sinha & Leanne Jones & Rosalind L Smyth & Paula R Williamson, 2008. "A Systematic Review of Studies That Aim to Determine Which Outcomes to Measure in Clinical Trials in Children," PLOS Medicine, Public Library of Science, vol. 5(4), pages 1-10, April.
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    Cited by:

    1. Nicola L Harman & Iain A Bruce & Jamie J Kirkham & Stephanie Tierney & Peter Callery & Kevin O'Brien & Alex M D Bennett & Raouf Chorbachi & Per N Hall & Anne Harding-Bell & Victoria H Parfect & Nichol, 2015. "The Importance of Integration of Stakeholder Views in Core Outcome Set Development: Otitis Media with Effusion in Children with Cleft Palate," PLOS ONE, Public Library of Science, vol. 10(6), pages 1-22, June.
    2. Sarah L Gorst & Elizabeth Gargon & Mike Clarke & Jane M Blazeby & Douglas G Altman & Paula R Williamson, 2016. "Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey," PLOS ONE, Public Library of Science, vol. 11(1), pages 1-12, January.
    3. Sarah L Gorst & Elizabeth Gargon & Mike Clarke & Valerie Smith & Paula R Williamson, 2016. "Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps," PLOS ONE, Public Library of Science, vol. 11(12), pages 1-14, December.

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