Checklists for Assessing Study Qualities

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 several COSMIN checklist, tools and guidelines 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.

  1. COSMIN Risk of Bias checklist for PROMs
  2. COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments
  3. COSMIN Study Design checklist
  4. COSMIN Reporting checklist (PCORI reference:  1606-35556, ongoing research).

1 COSMIN Risk of Bias checklist for PROMs

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.

We developed user manuals for helping you applying the Risk of Bias checklist is a systematic review on PROMs.

More tools to help you using the COSMIN Risk of Bias checklist in systematic reviews on outcome measurement instruments, and translated versions of the tools, can be found here.

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

The COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error can be used to assess the quality of such studies of any type on measurement instrument, which are typically more complex as PROMs, as equipment and professionals are involved in the measurement (Mokkink, et al. 2020). This COSMIN Risk of Bias tool was developed for assessing the methodological quality of single studies, for example, included in systematic reviews. 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 tool consists of two parts. In Part A the goal is to understand how the results of the study under review can inform us about the quality of the outcome measurement instruments. Part B can be used to assess the quality of the study, and contains standards referring to design requirements and preferred statistical methods of studies on measurement properties.

This user manual can help you applying the Risk of Bias tool, e.g. in a systematic review on outcome measurement instruments.

3 COSMIN Study Design checklist

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.

4  COSMIN Reporting Guideline for studies on measurement properties

In collaboration with the University of Michigan, we developed the COSMIN Reporting Guideline for the reporting of studies on
measurement properties of PROMs. This reporting guideline can improve and direct the reporting of studies investigating any measurement properties of PROMs. Improving the reporting of these studies increases their transparency and therefore makes obvious their risk of bias as well as their import to scientifc knowledge. This allows accurate methodological assessment of these papers, reliable application of their fndings (e.g., to clinical research) and also allows researchers to build on or improve future investigations in the area.

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.