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The online version of this article (https://doi.org/10.1007/s11136-018-1829-0) contains supplementary material, which is available to authorized users.
Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM’s content validity and grading the quality of the evidence in systematic reviews of PROMs.
An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales (‘strongly disagree’ to ‘strongly agree’), and provided arguments for their ratings.
Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM.
The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.
Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., Bouter, L. M., & de Vet, H. C. (2010). The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. Journal of Clinical Epidemiology, 63(7), 737–745. CrossRefPubMed
Messick, S. (1980). Test validity and the ethics of assessment. American Psychologist, 35, 1012–1027. CrossRef
Streiner, D. L., & Norman, G. R. (2008). Health measurement scales. A practical guide to their development and use. New York: Oxford University Press. CrossRef
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1-eliciting concepts for a new PRO instrument. Value Health, 14(8), 967–977. CrossRefPubMed
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: Part 2-assessing respondent understanding. Value Health, 14(8), 978–988. CrossRefPubMed
American Educational Research Association, American Psychological Association, National Council on Measurement in Education. (2014). Standards for educational & psychological testing. Washington, DC.
U.S.Department of Health and Human ServicesFood and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). (2009). Guidance for industry patient-reported outcome measures: Use in medical product development to support labeling claims. Rockville, MD.
European Medicines Agency. (2005). Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) Measures in the evaluation of medicinal products London.
Cortina, J. M. (1993). What is coefficient alpha? An examination of theory and applications. Journal of Applied Psychology, 78, 98–104. CrossRef
de Leeuw, E. D., Hox, J. J., & Dillman, D. A. (2008). International handbook of survey methodology. New York: Psychology Press.
Prinsen, C. A., Mokkink, L. B., Bouter, L. M., Alonso, J., Patrick, D. L., De Vet, H. C. W., & Terwee, C. B. (2017). COSMIN guideline for systematic reviews of outcome measurement instruments. Quality of Life Research, Jan 23 [Epub ahead of print].
Olshansky, E., Lakes, K. D., Vaughan, J., Gravem, D., Rich, J. K., David, M., Nguyen, H., & Cooper, D. (2012). Enhancing the construct and content validity of rating scales for clinical research: Using qualitative methods to develop a rating scale to assess parental perceptions of their role in promoting infant exercise. The International Journal of Education Psychological Assessment, 10(1), 36–50.
de Vet, H. C. W., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). Measurement in medicine. Cambridge: Cambridge University Press. CrossRef
Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., Bouter, L. M., & de Vet, H. C. (2010). The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: An international Delphi study. Quality of Life Research, 19(4), 539–549. CrossRefPubMedPubMedCentral
Reeve, B. B., Wyrwich, K. W., Wu, A. W., Velikova, G., Terwee, C. B., Snyder, C. F., Schwartz, C., Revicki, D. A., Moinpour, C. M., McLeod, L. D., Lyons, J. C., Lenderking, W. R., Hinds, P. S., Hays, R. D., Greenhalgh, J., Gershon, R., Feeny, D., Fayers, P. M., Cella, D., Brundage, M., Ahmed, S., Aaronson, N. K., & Butt, Z. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22(8), 1889–1905. CrossRefPubMed
PROMIS® Instrument Development and Validation Scientific Standards Version 2.0 (2013). Retrieved 29 March 2017, from http://www.healthmeasures.net/explore-measurement-systems/promis/measure-development-research/119-measure-development-research.
COSMIN database of systematic reviews of outcome measurement instruments. Retrieved 24 Feb 2015, from http://database.cosmin.nl/.
Mokkink, L. B., de Vet, H. C. W., Prinsen, C. A. C., Patrick, D. L., Alonso, J., Bouter, L. M., & Terwee, C. B. (2018). COSMIN risk of bias checklist for assessing the methodological quality of studies on the measurement properties of Patient-Reported Outcome Measures. Quality of Life Research, Dec 19 [Epub ahead of print].
Guyatt, G., Oxman, A. D., Akl, E. A., Kunz, R., Vist, G., Brozek, J., Norris, S., Falck-Ytter, Y., Glasziou, P., DeBeer, H., Jaeschke, R., Rind, D., Meerpohl, J., Dahm, P., & Schunemann, H. J. (2011). GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology, 64(4), 383–394. CrossRefPubMed
Schunemann, H. J., Brozek, J., Guyatt, G. H., & Oxman, A. D. (2013). GRADE Handbook. http://gdt.guidelinedevelopment.org/app/handbook/handbook.html#h.9rdbelsnu4iy.
Rothman, M., Burke, L., Erickson, P., Leidy, N. K., Patrick, D. L., & Petrie, C. D. (2009). Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO task force report. Value Health, 12(8), 1075–1083. CrossRefPubMed
Mokkink, L. B., Terwee, C. B., Knol, D. L., Stratford, P. W., Alonso, J., Patrick, D. L., Bouter, L. M., & de Vet, H. C. (2010). The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: A clarification of its content. BMC Medical Research Methodology, 10, 22. CrossRefPubMedPubMedCentral
Zumbo, B. D., & Chan, E. K. H. (2014). Validity and validation in social, behavioral, and Health Sciences. New York: Springer International Publishing. CrossRef
- COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study
C. B. Terwee
C. A. C. Prinsen
M. J. Westerman
D. L. Patrick
L. M. Bouter
H. C. W. de Vet
L. B. Mokkink
- Springer International Publishing