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 Mokkink, M Boers, C P M van der Vleuten, L M Bouter, J Alonso, D L Patrick, H C W de Vet, C B Terwee

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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 four-point 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.

Original languageEnglish
Article number293
Pages (from-to)1-13
Number of pages13
JournalBMC Medical Research Methodology
Volume20
Issue number1
DOIs
Publication statusPublished - 3 Dec 2020

Funding

This Delphi study was funded by ZonMw (The Netherlands Organisation for Health Research and Development) (grant number 916.176.098). This work is part of the research programme Veni (received by LM) with project number 91617098, funded by ZonMw (The Netherlands Organisation for Health Research and Development). The funding body has no role in the study design, the collection, analysis, and interpretation of data or in the writing of this manuscript. We are very grateful to all the panelists of this study, who provided us with many helpful and critical comments and arguments (in alphabetical order): M.A. D?Agostino, Dorcas Beaton, Sophie van Belle, Sandra Beurskens, Kristie Bjornson, Jan Boehnke, Patrick Bossuyt, Don Bushnell, Stefan Cano, Saskia le Cessie, Alessandro Chiarotto, Mike Clark, Jon Deeks, Iris Eekhout, Jim Farnsworth II, Oke Gerke, Sabine Goldhahn, Robert M. Gow, Philip Griffiths, Cristian Gugiu, Jean-Benoit Hardouin, D?sir?e van der Heijde, I-Chan Huang, Ellen Janssen, Brian Jolly, Lars Konge, Jan Kottner, Brittany Lapin, Hanneke van der Lee, Mariska Leeflang, Nancy Mayo, Sue Mallett, Joy C. MacDermid, Geert Molenberghs, Holger Muehlan, Koen Neijenhuijs, Raymond Ostelo, Laura Quinn, Dennis Revicki, Jussi Repo, Johannes B. Reitsma, Anne W. Rutjes, Mohsen Sadatsafavi, David Streiner, Matthew Stephenson, Berend Terluin, Zyphanie Tyack, Werner Vach, Gemma Vilagut Saiz, Marc K. Walton, Matthijs Warrens, Daniel Yee Tak Fong. I am grateful to Charlotte Teunissen, Femke Rutters, Sandra Amor and Erik Nutma all working at the Amsterdam UMC, location VUmc, for their time to teach me about laboratory and imaging tests. We would like to thank Ilse Jansma for her help to develop the search strings for PubMed, and EMBASE. This Delphi study was funded by ZonMw (The Netherlands Organisation for Health Research and Development) (grant number 916.176.098).

FundersFunder number
Charlotte Teunissen
Dorcas Beaton
EMBASE
ZonMw916.176.098

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