COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures
Open accessAbstract
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.
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The study had a robust design following the latest COSMIN guidelines.
“The strength that enhanced the clinical significance of this study was its robust design following the latest COSMIN guidelines [17].”
From Validation of the Tinnitus Acceptance Questionnaire: Japanese Version (2022) · cites this paper as [17]
The Background describes COSMIN standards for assessing methodological quality, but distinguishes the COSMIN Study Design checklist from the Risk of Bias checklist addressed in this paper. The paper therefore supports the reference to COSMIN guidance, but not the implication that this particular checklist provides guidelines for designing the citing study. The citing authors’ judgment that their design was robust is their own, not a finding attributed to this source. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe sample size was set at 120 because it met the COSMIN guideline criteria for 'very good' (7 times the number of items and at least 100).
“The sample size of this study was set at 120 because this number met the COSMIN guideline criteria for “very good” (7 times the number of items and at least 100) [17].”
From Validation of the Tinnitus Acceptance Questionnaire: Japanese Version (2022) · cites this paper as [17]
The Results section (‘Adaptations of individual standards’; page unavailable) discusses sample-size requirements and says a study can be rated ‘very good’ even below the suggested sizes when justified. Our copy does not state the claimed rule of seven times the number of items and at least 100, or establish that 120 meets it for the citing study. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe study was based on classical test theory according to the COSMIN study design checklist.
“This study was based on classical test theory according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) study design checklist, which is recommended when designing studies to evaluate the measurement properties of existing patient-reported outcome measures [17].”
From Validation of the Tinnitus Acceptance Questionnaire: Japanese Version (2022) · cites this paper as [17]
The Background (page not available) identifies the COSMIN Study Design checklist as a version intended to guide studies of PROM measurement properties. Our copy does not say that the checklist requires or recommends classical test theory, so it does not support that part of the attributed claim. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThis was the first study that developed and tested the validity and reliability of a Japanese version of the TAQ in accordance with the latest COSMIN guidelines.
“To the best of our knowledge, this was the first study that developed and tested the validity and reliability of a Japanese version of the TAQ in accordance with the latest COSMIN guidelines [17].”
From Validation of the Tinnitus Acceptance Questionnaire: Japanese Version (2022) · cites this paper as [17]
The target number of respondents for the retest sample was >50.
“The target number of respondents for the retest sample was >50 [17].”
From Validation of the Tinnitus Acceptance Questionnaire: Japanese Version (2022) · cites this paper as [17]
The Results section (‘Adaptations of individual standards’; page unavailable) discusses sample-size requirements and says the single-study sample-size standard was removed from the Reliability box. Our copy does not give a >50 threshold or a target number of respondents for a retest sample (searched: ‘50,’ ‘retest sample,’ and ‘test-retest reliability’). (LLM, conf=0.74)
Experimental — accuracy not yet measured
Risk of bias was assessed with the COSMIN checklist.
“The risk of bias of the studies on the other measurement properties was also assessed with the COSMIN risk of bias checklist [23].”
From Evidence on the measurement properties of health-related quality of life instruments is largely missing in patients with low back pain: A systematic review (2018) · cites this paper as [23]
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- Authors
- Mokkink, L. B., de Vet, H. C. W., Prinsen, C. A. C., Patrick, D. L., Alonso, J., Bouter, L. M., & Terwee, C. B.
- Affiliations
- Amsterdam Public Health (NL)
- University of Washington (US)
- Municipal Institute for Medical Research (ES)
- Corresponding author
- Mokkink, L. B.
- Venue
- Quality of Life Research
- Published
- 2017-12-19
- Volume
- 27
- Issue
- 5
- Pages
- 1171-1179
- ISSN
- 0962-9343 (ISSN-L)
- 1573-2649
- PMC
- PMC5891552
- OpenAlex
- W2779791612
- Cited by
- 2,479
- References
- 17
- Citations by year
- 2026: 302 · 2025: 341 · 2024: 441 · 2023: 346 · 2022: 353 · 2021: 321 · 2020: 238 · 2019: 105 · 2018: 27 · 2017: 2
- FWCI
- 25.16
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Quality of Life Research (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
- VU Research Portal (publishedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, cc-by)
- Repositori digital de la UPF (Universitat Pompeu Fabra) (submittedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Education › Health Education and Validation
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- COSMIN, risk of bias, patient-reported outcome measures, measurement properties, systematic review methodology, checklist adaptation, item response theory, construct validity, responsiveness, hand osteoarthritis, methodological quality assessment
- MeSH terms
- Patient Reported Outcome Measures, Health Status, Humans, Quality of Life, Bias, Databases, Factual, Consensus, Checklist
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