Use one of our checklists for assessing the methodological quality of a study and improve the design and reporting of your study.
The methodological quality of studies on measurement properties can be assessed for different purposes, for example, as guidance for designing or reporting your study on measurement properties, to determine the risk of bias in single studies included in a systematic review of outcome measurement instruments or by reviewers or journal editors to appraise the methodological quality of articles or grant applications of studies on measurement properties.
Therefore, we have developed the COSMIN Risk of Bias checklist, and we are currently developing a COSMIN Study Design checklist and a COSMIN Reporting checklist for these different purposes as the standards included in each checklist will be slightly different. For example, when designing a study, it might be useful to have a standard on the preferred sample size, and when reporting a study on measurement properties, it is useful to have a standard on reporting missing data.
The COSMIN Study Design checklist is developed for use when designing studies on measurement properties of PROMs. It can be used by researchers and clinicians or other professionals who are designing a study on measurement properties, or by e.g. scientific committees and medical ethical committees who are appraising protocols of studies on measurement properties, or scientific journals that will publish study protocols of studies on measurement properties.
The COSMIN Risk of Bias checklist (Mokkink, et al. 2018) substitutes the original COSMIN checklist (Mokkink, et al. 2010). The COSMIN Risk of Bias checklist was exclusively developed for assessing the methodological quality of single studies included in systematic reviews of PROMs. The purpose of assessing the methodological quality of a study in a systematic review is to screen for risk of bias in the included studies. The term ‘risk of bias’ is in compliance with the Cochrane methodology for systematic reviews of interventions and diagnostic test accuracy studies (Interventions and diagnostic test accuracy studies: Cochrane Handbook for Systematic Reviews of Interventions, 2011). It refers to whether you can trust results based on the methodological quality of the study.
The checklist contains standards referring to design requirements and preferred statistical methods of studies on measurement properties. For each measurement property a COSMIN Risk of Bias box was developed containing all standards needed to assess the quality of a study on that specific measurement property. Both preferred statistical methods based on Classical test Theory (CTT) and Item Response Theory (IRT) or Rasch analyses are included in the standards. The COSMIN Risk of Bias checklist contains ten boxes with standards for PROM development and for the nine measurement properties.
More tools to help you using the COSMIN Risk of Bias checklist in systematic reviews on outcome measurement instruments can be found here.
At the moment we are working on the development of standards for assessing the methodological quality of single studies on measurement properties of other types of outcome measurement instruments (i.e. clinician-reported outcome measures and performance-based outcome measures).
3 COSMIN Reporting checklist
In collaboration with the University of Michigan, we are developing reporting guidelines for studies on measurement properties of PROMs. More information will be announced upon publication of our study results.
Original COSMIN checklist
We do not recommend to use the original version of the COSMIN checklist (Mokkink, et. al. 2010) in your ongoing studies anymore, but instead, use the new COSMIN Risk of Bias checklist, or the Study Design checklist.