The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study

Lidwine B Mokkink, Caroline B Terwee, Donald L Patrick, Jordi Alonso, Paul W Stratford, Dirk L Knol, Lex M Bouter, Henrica C W de Vet, Lidwine B Mokkink, Caroline B Terwee, Donald L Patrick, Jordi Alonso, Paul W Stratford, Dirk L Knol, Lex M Bouter, Henrica C W de Vet

Abstract

Background: Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist.

Methods: A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated 'agree' or 'strongly agree'.

Results: Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed.

Conclusions: The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.

Figures

Fig. 1
Fig. 1
COSMIN taxonomy of relationships of measurement properties
Fig. 2
Fig. 2
The 4-step procedure to complete the COSMIN checklist

References

    1. Committee for Medicinal Products for Human Use (CHMP). (2005). Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products, EMEA, London, 2005. Available at: . Accessed November 10, 2008.
    1. US Department of Health and Human Services FDA Center for Drug Evaluation and Research. US Department of Health and Human Services FDA Center for Biologics Evaluation and Research. US Department of Health and Human Services FDA Center for Devices and Radiological Health Guidance for industry: patient-reported outcome measures: Use in medical product development to support labeling claims: Draft guidance. Health and Quality of Life Outcomes. 2006;4:79. doi: 10.1186/1477-7525-4-79.
    1. Marshall M, Lockwood A, Bradley C, Adams C, Joy C, Fenton M. Unpublished rating scales: A major source of bias in randomised controlled trials of treatments for schizophrenia. British Journal of Psychiatry. 2000;176:249–252. doi: 10.1192/bjp.176.3.249.
    1. Lohr KN, Aaronson NK, Alonso J, Burnam MA, Patrick DL, Perrin EB, et al. Evaluating quality-of-life and health status instruments: Development of scientific review criteria. Clinical Therapeutics. 1996;18:979–992. doi: 10.1016/S0149-2918(96)80054-3.
    1. Nunnally JC. Psychometric theory. New York, London: McGraw-Hill; 1978.
    1. Terwee CB, Bot SD, De Boer MR, Van der Windt DA, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. Journal of Clinical Epidemiology. 2007;60:34–42. doi: 10.1016/j.jclinepi.2006.03.012.
    1. Valderas JM, Ferrer M, Mendivil J, Garin O, Rajmil L, Herdman M, et al. Development of EMPRO: A tool for the standardized assessment of patient-reported outcome measures. Value in Health. 2008;11:700–708. doi: 10.1111/j.1524-4733.2007.00309.x.
    1. Kirshner B, Guyatt GH. A methodological framework for assessing health indexes. Journal of Chronic Diseases. 1985;38:27–36. doi: 10.1016/0021-9681(85)90005-0.
    1. Mokkink LB, Terwee CB, Stratford PW, Alonso J, Patrick DL, Riphagen I, et al. Evaluation of the methodological quality of systematic reviews of health status measurement instruments. Quality of Life Research. 2009;18:313–333. doi: 10.1007/s11136-009-9451-9.
    1. Evers S, Goossens M, De Vet H, Van Tulder M, Ament A. Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria. International Journal of Technology Assessment in Health Care. 2005;21:240–245.
    1. Verhagen AP, De Vet HCW, De Bie RA, Kessels AG, Boers M, Bouter LM, et al. The Delphi list: A criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. Journal of Clinical Epidemiology. 1998;51:1235–1241. doi: 10.1016/S0895-4356(98)00131-0.
    1. Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., Bouter, L.M., De Vet H. C. W. International consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes: results of the COSMIN study. Journal of Clinical Epidemiology (accepted for publication).
    1. Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L. et al. (2009). The COSMIN checklist manual. . Accessed September 2009.
    1. Pfennings LE, Van der Ploeg HM, Cohen L, Polman CH. A comparison of responsiveness indices in multiple sclerosis patients. Quality of Life Research. 1999;8:481–489. doi: 10.1023/A:1008971904852.
    1. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307–310.
    1. De Vet HCW, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. Journal Clinical Epidemiology. 2006;59:1033–1039. doi: 10.1016/j.jclinepi.2005.10.015.
    1. Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, et al. Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments. BioMed Central Medical Research Methodology. 2006;6:2. doi: 10.1186/1471-2288-6-2.
    1. De Boer MR, Moll AC, De Vet HCW, Terwee CB, Volker-Dieben HJ, Van Rens GH. Psychometric properties of vision-related quality of life questionnaires: A systematic review. Ophthalmic and Physiological Optics. 2004;24:257–273. doi: 10.1111/j.1475-1313.2004.00187.x.
    1. Veenhof C, Bijlsma JW, Van den Ende CH, Van Dijk GM, Pisters MF, Dekker J. Psychometric evaluation of osteoarthritis questionnaires: A systematic review of the literature. Arthritis and Rheumatism. 2006;55:480–492. doi: 10.1002/art.22001.
    1. Powell C. The Delphi technique: Myths and realities. Journal of Advanced Nursing. 2003;41:376–382. doi: 10.1046/j.1365-2648.2003.02537.x.
    1. Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., et al. (2010). The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: A clarification on its content. BMC Medical Research Methodology.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner