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. 2018 May;27(5):1171-1179.
doi: 10.1007/s11136-017-1765-4. Epub 2017 Dec 19.

COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures

L B Mokkink  1 , H C W de Vet  2 , C A C Prinsen  2 , D L Patrick  3 , J Alonso  4 , L M Bouter  2   5 , C B Terwee  2
Affiliations

COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures

L B Mokkink et al. Qual Life Res. 2018 May.

Abstract

Purpose: The original COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to assess the methodological quality of single studies on measurement properties of Patient-Reported Outcome Measures (PROMs). Now it is our aim to adapt the COSMIN checklist and its four-point rating system into a version exclusively for use in systematic reviews of PROMs, aiming to assess risk of bias of studies on measurement properties.

Methods: For each standard (i.e., a design requirement or preferred statistical method), it was discussed within the COSMIN steering committee if and how it should be adapted. The adapted checklist was pilot-tested to strengthen content validity in a systematic review on the quality of PROMs for patients with hand osteoarthritis.

Results: Most important changes were the reordering of the measurement properties to be assessed in a systematic review of PROMs; the deletion of standards that concerned reporting issues and standards that not necessarily lead to biased results; the integration of standards on general requirements for studies on item response theory with standards for specific measurement properties; the recommendation to the review team to specify hypotheses for construct validity and responsiveness in advance, and subsequently the removal of the standards about formulating hypotheses; and the change in the labels of the four-point rating system.

Conclusions: The COSMIN Risk of Bias checklist was developed exclusively for use in systematic reviews of PROMs to distinguish this application from other purposes of assessing the methodological quality of studies on measurement properties, such as guidance for designing or reporting a study on the measurement properties.

Keywords: Measurement properties; Outcome measurement instruments; Quality assessment; Risk of bias; Systematic review.

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Conflict of interest statement

Conflict of interest

All authors, with the exception of CAC Prinsen, are the developers of the original COSMIN checklist.

Ethical approval

This article does not contain any studies with human participants performed by any of the authors.

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