COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement ins

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(2020) 20:293

RESEARCH ARTICLE

Open Access

COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study L. B. Mokkink1* , M. Boers1,2, C. P. M. van der Vleuten3, L. M. Bouter1,4, J. Alonso5, D. L. Patrick6, H. C. W. de Vet1 and C. B. Terwee1

Abstract Background: Scores on an outcome measurement instrument depend on the type and settings of the instrument used, how instructions are given to patients, how professionals administer and score the instrument, etc. The impact of all these sources of variation on scores can be assessed in studies on reliability and measurement error, if properly designed and analyzed. The aim of this study was to develop standards to assess the quality of studies on reliability and measurement error of clinician-reported outcome measurement instruments, performance-based outcome measurement instrument, and laboratory values. Methods: We conducted a 3-round Delphi study involving 52 panelists. Results: Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. Consensus was reached on components of outcome measurement instruments, i.e. the potential sources of variation. Next, we reached consensus on standards on design requirements (n = 5), standards on preferred statistical methods for reliability (n = 3) and measurement error (n = 2), and their ratings on a fourpoint scale. There was one term for a component and one rating of one standard on which no consensus was reached, and therefore required a decision by the steering committee. Conclusion: We developed a tool that enables researchers with and without thorough knowledge on measurement properties to assess the quality of a study on reliability and measurement error of outcome measurement instruments. Keywords: Risk of Bias, Delphi study, Quality assessment, Reliability, Measurement error, Outcome measurement instruments, COSMIN

* Correspondence: [email protected] 1 Department of Epidemiology and Data Science, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation