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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
Open accessAbstract
The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.
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“Patient involvement is seen as essential to ensure the content validity of the questionnaire.12, 13, 14, 15”
From Patient involvement in the development of patient‐reported outcome measures: a scoping review (2017) · cites this paper as [14]
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“and whether the questionnaire captures these outcomes in a comprehensible and understandable manner.12, 13, 14, 15”
From Patient involvement in the development of patient‐reported outcome measures: a scoping review (2017) · cites this paper as [14]
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“several researchers stressed the importance of this approach as the necessary starting point for developing measurement tools to be used in quantitative research in order to ensure content validity [8-12].”
From Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients’ experience (2014) · cites this paper as [11]
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Terwee, C. B., Prinsen, C. A. C., Chiarotto, A., Westerman, M. J., Patrick, D. L., Alonso, J., Bouter, L. M., de Vet, H. C. W., & Mokkink, L. B. (2018) · Quality of Life Research · doi:10.1007/s11136-018-1829-0 · Cited by 2,348
Self-citationPatrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011) · Value in Health · doi:10.1016/j.jval.2011.06.013 · Cited by 1,135
Self-citationde Souza, J. A., Yap, B. J., Wroblewski, K., Blinder, V. S., Araújo, F. S., Hlubocky, F. J., Nicholas, L. H., O’Connor, J. M., Brockstein, B., Ratain, M. J., et al. (2016) · Cancer · doi:10.1002/cncr.30369 · Cited by 932
The development of a financial toxicity patient‐reported outcome in cancer: The COST measure
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Cappelleri, J. C., Lundy, J. J., & Hays, R. D. (2014) · Clinical Therapeutics · doi:10.1016/j.clinthera.2014.04.006 · Cited by 605
Metadata
- Authors
- Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L.
- Affiliations
- University of Washington (US)
- United States Food and Drug Administration (US)
- Brown University (US)
- Uppsala University (SE)
- Corresponding author
- Patrick, Donald L.
- Venue
- Value in Health
- Publisher
- Elsevier BV
- Published
- 2011-12
- Volume
- 14
- Issue
- 8
- Pages
- 967-977
- ISSN
- 1098-3015 (ISSN-L)
- OpenAlex
- W2128536774
- Cited by
- 1,095
- References
- 47
- Citations by year
- 2026: 87 · 2025: 96 · 2024: 113 · 2023: 89 · 2022: 91 · 2021: 119 · 2020: 98 · 2019: 78 · 2018: 74 · 2017: 63 · 2016: 59 · 2015: 43 · 2014: 37 · 2013: 32 · 2012: 13
- FWCI
- 67.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Value in Health (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Nursing › Research and Theory › Health Education and Validation
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- content validity, patient-reported outcomes, item generation, cognitive interviewing, regulatory submissions, patient understanding, good scientific practice
- MeSH terms
- Documentation, European Union, Humans, Interviews as Topic, Surveys and Questionnaires, Research Design, United States, United States Food and Drug Administration, Outcome Assessment, Health Care, Focus Groups, Qualitative Research, Validation Studies as Topic
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