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

L B Mokkink,J Alonso,D L Patrick,L M Bouter,H C W De Vet,C A C Prinsen,C B Terwee

doi:10.1007/s11136-017-1765-4

Abstract

PurposeThe 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.MethodsFor 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.ResultsMost 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.ConclusionsThe 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.

Highlights

Research performed with Patient-Reported Outcome Measures (PROMs) of poor or unknown quality constitutes a waste of resources and is unethical [1]
Content validity is considered to be the most important measurement property because first of all it should be clear that the items of the PROM are relevant, comprehensive, and comprehensible with respect to the construct of interest and target population [3]
Internal structure refers to how the different items in a PROM are related, which is important to know for deciding how items might be combined into scales or subscales

Summary

Introduction

Research performed with Patient-Reported Outcome Measures (PROMs) of poor or unknown quality constitutes a waste of resources and is unethical [1]. This practice is widespread [2]. Selecting the best PROM for the outcome of interest (i.e., to be used in an evaluative application) in a methodologically sound way requires (1) high-quality studies on the measurement properties of relevant PROMs in the target population and (2) a high-quality systematic review of studies on measurement properties in which all information is gathered and evaluated in a systematic and transparent way. In a systematic review of PROMs, the methodological quality of included studies and the quality of the PROMs (i.e., its measurement properties) should be assessed separately. Assessing the methodological quality of studies is important, because the quality of the study determines the trustworthiness of the results (i.e., risk of bias)

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