How to select outcome measurement instruments for outcomes included in a “Core Outcome Set”–a practical guideline
Open accessAbstract
BACKGROUND: In 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. METHODS: Informed 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. RESULTS: Of 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 %). CONCLUSIONS: This 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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The measurement tool for certain outcomes, particularly some PROMs, remains undefined due to the lack of agreed-upon measurement instruments in the literature.
“Third, although outcome constructs were selected, the measurement tool for certain outcomes, particularly some PROMs, remains undefined due to the lack of agreed‐upon measurement instruments in the literature (Powers 3rd et al. 2017; Prinsen et al. 2016).”
From 1st Global Consensus for Clinical Guidelines: Identifying a Core Outcome Set for Implant Dentistry in Edentulous Maxilla Rehabilitation (2026) · cites this paper as Prinsen et al. 2016
Content validity is considered by clinimetric and psychometric experts as the first measurement property to consider when selecting an instrument.
“Content validity is considered by clinimetric and psychometric experts as the first measurement property to consider when selecting an instrument [7,25].”
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- Authors
- Prinsen, C. A. C., Vohra, S., Rose, M. R., Boers, M., Tugwell, P., Clarke, M., Williamson, P. R., & Terwee, C. B.
- Affiliations
- Amsterdam Public Health (NL)
- University of Alberta (CA)
- King's College Hospital (GB)
- University of Ottawa (CA)
- Queen's University Belfast (GB)
- University of Liverpool (GB)
- Corresponding author
- Prinsen, Cecilia A. C.
- ORCID
- Venue
- Trials
- Published
- 2016-09-13
- Volume
- 17
- Issue
- 1
- Pages
- 449-449
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC5020549
- OpenAlex
- W2519102334
- Cited by
- 1,106
- References
- 20
- Citations by year
- 2026: 94 · 2025: 121 · 2024: 173 · 2023: 111 · 2022: 163 · 2021: 151 · 2020: 115 · 2019: 69 · 2018: 61 · 2017: 44 · 2016: 3
- FWCI
- 168.71
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Seventh Framework Programme (BE) (FP7/2007-2013; 305081)
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Social Sciences › Education › Health Education and Validation
- Keywords
- outcome measurement instruments, core outcome set, COSMIN, comets, instrument selection, measurement properties, feasibility, clinical trials, consensus-based guidelines, Delphi consensus
- MeSH terms
- Delphi Technique, Humans, Outcome Assessment, Health Care, Practice Guidelines as Topic
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