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COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study
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Abstract
Background: Scores on an outcome measurement instrument depend on the type and settings of the instrument used, how instructions are given to patients, how professionals administer and score the instrument, etc. The impact of all these sources of variation on scores can be assessed in studies on reliability and measurement error, if properly designed and analyzed. The aim of this study was to develop standards to assess the quality of studies on reliability and measurement error of clinician-reported outcome measurement instruments, performance-based outcome measurement instrument, and laboratory values. Methods: We conducted a 3-round Delphi study involving 52 panelists. Results: Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. Consensus was reached on components of outcome measurement instruments, i.e. the potential sources of variation. Next, we reached consensus on standards on design requirements ( n = 5), standards on preferred statistical methods for reliability ( n = 3) and measurement error ( n = 2), and their ratings on a four-point scale. There was one term for a component and one rating of one standard on which no consensus was reached, and therefore required a decision by the steering committee. Conclusion: We developed a tool that enables researchers with and without thorough knowledge on measurement properties to assess the quality of a study on reliability and measurement error of outcome measurement instruments.
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“For the risk-of-bias analysis, two researchers (L.I.P. and an epidemiologist and midwife in training, C.A.N.) independently evaluated the included studies using the standardized COSMIN risk-of-bias tool 16 .”
Dragomir, A., Buzatu, A. R., Marin, R. C., Moleriu, R. D., Muntean, C., Piroș, T., Crintea, I. N., Alexa, A. A., Marcu, A., & Dinuți, M. (2026) · Diagnostics · doi:10.3390/diagnostics16162574 · Cited by 1
“For internal consistency, N = 308 exceeds by a wide margin the sample of 100 required for a very good rating under COSMIN [31].”
Budgett, J., Demnitz‐King, H., Sommerlad, A., Kupeli, N., Vickerstaff, V., & Cooper, C. (2026) · Age and Ageing · doi:10.1093/ageing/afag260 · Cited by 1
“COSMIN-based frameworks anticipate modest associations when instruments assess related, non-identical constructs [ 10].”
Luo, J., Zhong, J., Li, H., Zhang, S., Zhang, L., Hou, J., Ke, J., Li, H., Liu, F., & Chen, X. (2022) · BMC Gastroenterology · doi:10.1186/s12876-022-02503-7 · Cited by 1
“The SEM of the RFIPC was 7.10.”
MethodInfluentialLopes, N. V. D. A., Sá, J., do Nascimento, L. F. E., Mendes, L. D. A., Bruno, S., Torres‐Castro, R., Fregonezi, G., & Resqueti, V. (2022) · PLoS ONE · doi:10.1371/journal.pone.0275646 · Cited by 1
“Next, results of every single study on a measurement property will be rated against updated criteria for good measurement properties as sufficient (+), insufficient (-), or indeterminate (?) [26].”
BackgroundMethodCross-cultural adaptation and validation of the Neck Bournemouth Questionnaire into Urdu language
Farooq, M. N., Naz, S., Mughal, A. S., Sohail, S., & Anis, M. (2023) · Physiotherapy Theory and Practice · doi:10.1080/09593985.2023.2206477 · Cited by 1
“…of measurement (SEM), which are calculated using the formulas SEM × 1.96 × √2 (De Vet, Terwee, Knol, and Bouter, 2006; Terwee et al., 2007) and standard deviation × √ (1 – ICC) (De Vet, Terwee, Knol, and Bouter, 2006), respectively, were used to determine measurement error (Mokkink et al., 2020).”
InfluentialTranslation and validation of the Urdu version of the neck pain and disability scale
Farooq, M. N., Naz, S., Kousar, A., & Gul, A. (2023) · Disability and Rehabilitation · doi:10.1080/09638288.2023.2213901 · Cited by 1
“The smallest detectable change (SDC) and the standard error of measurement (SEM), which are calculated using the formulas SEM × 1.96 × √2 [45,46] and SD × √ (1–ICC) [46], respectively, were used to determine measurement error [42].”
MethodInfluentialLafitte, R., Diaine, F., Dai, S., Carré, O., Dupierrix, E., Jolly, C., Piscicelli, C., & Pérennou, D. A. (2023) · Journal of Neuroscience Methods · doi:10.1016/j.jneumeth.2023.109900 · Cited by 1
Birinci, T., Altun, S., Ziroğlu, N., & Mutlu, E. K. (2023) · Evaluation & the Health Professions · doi:10.1177/01632787231183089 · Cited by 1
“MDC 95 was calculated as the SEM multiplied by 1.96 multiplied by the square root of 2 (Mokkink et al., 2020).”
MethodInfluentialKristensen, L. Q., van Tulder, M. W., Rosenbæk, F., Muren, M. A., Kristensen, H. K., Mokkink, L. B., & Oestergaard, L. G. (2023) · Scandinavian Journal of Occupational Therapy · doi:10.1080/11038128.2023.2258161 · Cited by 1
Self-citationValidity, reliability and responsiveness of a goniometer watch to measure pure forearm rotation
Harte, D., Nevill, A. M., Ramsey, L., & Martin, S. (2023) · Hand Therapy · doi:10.1177/17589983231211813 · Cited by 1
Wilfling, D., Mohler, R. A., Berg, A., Dörner, J., Bartmann, N., Klatt, T., Meyer, G., Halek, M., Köpke, S., & Dichter, M. (2024) · BMC Geriatrics · doi:10.1186/s12877-023-04528-3 · Cited by 1
“This methodical approach was based on the COSMIN standards for test theory studies [23].”
MethodLamezon, A. C., Cavon, B. L., & Valderramas, S. (2024) · Revista Brasileira de Geriatria e Gerontologia · doi:10.1590/1981-22562024027.230189.en · Cited by 1
“Systematic reviews of outcome measurement instruments are important tools for selecting the most appropriate instrument for the construct of interest and providing an overview of quality through measurement properties 16-20 .”
BackgroundMethodGaleoto, G., Viglianisi, K. M., Berardi, A., Sellitto, G., Ruotolo, I., Simeon, R., & Carlizza, A. (2024) · Medicina · doi:10.3390/medicina60040664 · Cited by 3
“According to the “Consensus-based standards for the selection of health measurement instruments” (COSMIN) guidelines and consistent with previous studies of the MSK-HQ [16], a minimum sample size of 30 subjects was considered adequate for this study.”
MethodScarfò, E., Ranucci, M., Berardi, A., Simeon, R., & Galeoto, G. (2024) · Children · doi:10.3390/children11050555 · Cited by 1
“The scale’s reliability and validity were evaluated using the “Consensus-Based Standards for the Selection of Health Status Measurement Instruments” (COSMIN) [24] checklist.”
Methodel Hadouchi, M., Kiers, H., Boerstra, B. A., Berends, R., Schreuder, E., Veenhof, C., & van Dieën, J. H. (2024) · Physical Therapy Reviews · doi:10.1080/10833196.2024.2376439 · Cited by 1
“…Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines [13] and adhered to the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) [14] and the COSMIN methodology for systematic reviews of Patient-Reported Outcome Measures (PROMs) [15–17].”
Monroy-Vite, N., Fresán, A., Olvera, C. P. L., & López, N. M. (2024) · Mexican Law Review · doi:10.22201/iij.24485306e.2024.1.19199 · Cited by 1
Identification of unmet palliative care needs of nursing home residents: A scoping review protocol
Crowley, P., Saab, M. M., Cornally, N., Ronan, I., Tabirca, S., & Murphy, D. (2024) · PLoS ONE · doi:10.1371/journal.pone.0306980 · Cited by 1
“It was found that of the four tools reviewed, only one screening tool met the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria which are used for assessing the methodological quality of tools [26].”
MethodRaats, J., Feys, P., Gysemberg, G., Ferdinand, S., Levin, M. F., & Lamers, I. (2024) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2024.105806 · Cited by 1
Lessa, E. A., Silva, C. F. E., Matos, L. R. R. D. S., & Trombini-Souza, F. (2024) · Revista Brasileira de Geriatria e Gerontologia · doi:10.1590/1981-22562024027.230252.pt · Cited by 1
Cross-Cultural Adaptation and Validation of the Listening Inventory for Education-Revised in Italian
Nicastri, M., D’Alessandro, H. D., Anderson, K. L., Ciferri, M., Cavalcanti, L., Greco, A., Giallini, I., Portanova, G., & Mancini, P. (2024) · Audiology Research · doi:10.3390/audiolres14050069 · Cited by 1
“The reliability and validity procedures were in accordance with the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) check-list [44].”
Errebo, M., Oxfeldt, M., Tegner, H., & Christensen, J. (2024) · Scandinavian Journal of Pain · doi:10.1515/sjpain-2024-0032 · Cited by 1
Introduction and Systematic Review of the Good Nursing Care Scale
Mattila, T., Stolt, M., Katajisto, J., & Leino‐Kilpi, H. (2024) · Journal of Clinical Nursing · doi:10.1111/jocn.17486 · Cited by 1
Loo, C. Y., Fenwick, E., Man, R. E. K., Lamoureux, E. L., & Tan, A. C. S. (2024) · Clinical and Experimental Ophthalmology · doi:10.1111/ceo.14466 · Cited by 1
“16,17 Recently, the COSMIN checklist has also been used to assess PCOMs.”
Nkhata, L. A., Human, A., Louw, Q. A., & Brink, Y. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-089929 · Cited by 2
Gonçalves, G. V., Calixtre, L. B., Fialho, H. R. F., Jales, M. T. M., Kamonseki, D. H., & Barbosa, G. M. (2025) · Journal of Bodywork and Movement Therapies · doi:10.1016/j.jbmt.2025.02.008 · Cited by 1
The Complexity of the Neonatal Pain Construct: A Commentary on Glenzel et al. (2023)
Breton-Piette, A., Gélinas, C., & Aita, M. (2025) · Pain Management Nursing · doi:10.1016/j.pmn.2025.02.007 · Cited by 1
Al-Ebrahim, S. Q., Hafidh, K., Harrison, J., Chen, T. F., O’Donnell, L. K., AlHusseini, A., Alzubaidi, H., & Mohammed, M. A. (2025) · Research in Social and Administrative Pharmacy · doi:10.1016/j.sapharm.2025.04.001 · Cited by 1
Instruments to Assess Disease-Specific Quality of Life in Dogs: A Scoping Review
Rhein, F. F., Klee, R., Albrecht, B., & Krämer, S. (2025) · Animals · doi:10.3390/ani15121780 · Cited by 1
“…on developing disease-specific QoL [10], the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) risk of bias checklist, and COSMIN guidelines for systematic reviews of patient-reported outcome measures [17–20] that were adapted to veterinary medicine.”
Edger-Lacoursière, Z., Calva, V., Germain, N., Malo-Leclerc, I., Marois-Pagé, E., Schneider, G., Shashoua, D., Tremblay, C., Vaillancourt, A., Packham, T., et al. (2025) · Journal of Hand Therapy · doi:10.1016/j.jht.2025.04.008 · Cited by 1
Gyombolai, Z., Zimonyi-Bakó, A. V., Kubik, A. Z., Arndt, B., Sztruhár, I. J., Mayer, R., Simon, A., Molnár, G., & Kovács, É. (2025) · Scientific Reports · doi:10.1038/s41598-025-09453-6 · Cited by 1
“The psychometric properties (validity and reliability) of the HU-DEMMI were assessed following the quality criteria published by Terwee et al. 31 and using the COSMIN recommendations 34–36 .”
Alves, L. D. S., Vella, S. P., Figueiredo, E. A. B., Chiarotto, A., Maher, C. G., Coombs, D., & Machado, G. C. (2025) · The American Journal of Emergency Medicine · doi:10.1016/j.ajem.2025.09.014 · Cited by 1
Metadata
- Authors
- Mokkink, L. B., Boers, M., van der Vleuten, C. P. M., Bouter, L. M., Alonso, J., Patrick, D. L., de Vet, H. C. W., & Terwee, C. B.
- Affiliations
- Amsterdam Public Health (NL)
- Universitat Pompeu Fabra (ES)
- University of Washington (US)
- Corresponding author
- Mokkink, L. B.
- Venue
- BMC Medical Research Methodology
- Published
- 2020-12
- Volume
- 20
- Issue
- 1
- Pages
- 293-293
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC7712525
- OpenAlex
- W3107903990
- Cited by
- 588
- References
- 31
- Citations by year
- 2026: 106 · 2025: 121 · 2024: 149 · 2023: 101 · 2022: 72 · 2021: 37 · 2020: 2
- FWCI
- 32.32
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Research Methodology (publishedVersion, cc-by)
- Research Square (acceptedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, cc-by)
- VU Research Portal (publishedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
- Repositori digital de la UPF (Universitat Pompeu Fabra) (submittedVersion, cc-by)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Nederlandse Organisatie voor Wetenschappelijk Onderzoek (91617098)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Reliability and Agreement in Measurement
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- COSMIN, risk of bias, reliability statistics, measurement error, outcome measurement instruments, clinician-reported outcomes, performance-based outcome measures, laboratory parameters, study quality assessment, Delphi consensus, measurement properties
- MeSH terms
- Delphi Technique, Humans, Reproducibility of Results, Bias, Consensus
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