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How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Authors
  • Prinsen, Cecilia A. C.1
  • Vohra, Sunita2, 3, 4
  • Rose, Michael R.5
  • Boers, Maarten1, 6
  • Tugwell, Peter7
  • Clarke, Mike8
  • Williamson, Paula R.9
  • Terwee, Caroline B.1
  • 1 VU University Medical Center, Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, De Boelelaan 1089a, 1081 HV, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 2 University of Alberta, Department of Pediatrics, Faculty of Medicine and Dentistry, Edmonton, AB, Canada , Edmonton (Canada)
  • 3 University of Alberta, School of Public Health, Edmonton, AB, Canada , Edmonton (Canada)
  • 4 University of Alberta, Women’s and Children’s Health Research Institute, Edmonton, AB, Canada , Edmonton (Canada)
  • 5 King’s College Hospital, Department of Neurology, London, UK , London (United Kingdom)
  • 6 Amsterdam Rheumatology & Immunology Center, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 7 University of Ottawa, Department of Medicine, Ottawa, ON, Canada , Ottawa (Canada)
  • 8 Queen’s University Belfast, Northern Ireland Network for Trials Methodology Research, Institute of Clinical Sciences, Royal Hospitals, Belfast, UK , Belfast (United Kingdom)
  • 9 University of Liverpool, Department of Biostatistics, Liverpool, UK , Liverpool (United Kingdom)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Sep 13, 2016
Volume
17
Issue
1
Identifiers
DOI: 10.1186/s13063-016-1555-2
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundIn cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population.MethodsInformed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed.ResultsOf the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %).ConclusionsThis study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes.

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