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Trials

, 17:449

First Online: 13 September 2016Received: 01 September 2015Accepted: 09 July 2016DOI: 10.1186-s13063-016-1555-2

Cite this article as: Prinsen, C.A.C., Vohra, S., Rose, M.R. et al. Trials 2016 17: 449. doi:10.1186-s13063-016-1555-2

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.

KeywordsCOMET Core Outcome Set COSMIN Delphi study Guideline Instrument selection Outcomes research Outcome measurement instrument AbbreviationsCOMETCore Outcome Measures in Effectiveness Trials Initiative

COSCore Outcome Set

COSMINCOnsensus-based Standards for the selection of health Measurement INstruments

OMERACTOutcome Measures in Rheumatology

OMIOutcome Measurement Instrument

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1555-2 contains supplementary material, which is available to authorized users.





Author: Cecilia A. C. Prinsen - Sunita Vohra - Michael R. Rose - Maarten Boers - Peter Tugwell - Mike Clarke - Paula R. William

Source: https://link.springer.com/



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