Fit for purpose and modern validity theory in clinical outcomes assessment

Author:

Edwards Michael C.ORCID,Slagle Ashley,Rubright Jonathan D.,Wirth R. J.

Publisher

Springer Science and Business Media LLC

Subject

Public Health, Environmental and Occupational Health

Reference29 articles.

1. Thissen, D., & Wainer, H. (2001). Test scoring. Mahwah, NJ: Lawrence Erlbaum Associates.

2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. (2009). Guidance for industry patient-reported outcome measures: Use in medical product development to support labeling claims. Retrieved January 30, 2017, from http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf . Published December 2009

3. FDA-NIH Biomarker Working Group. (2016). BEST (Biomarkers, EndpointS, and other Tools) Resource. Retrieved January 30, 2017, from https://www.ncbi.nlm.nih.gov/books/NBK338448/

4. Patrick, D. L., Burke, L. B., Gwaltney, C. J., Kline Leidy, N., Martin, M. L., Molsen, E., et al. (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 in Health, 14, 967–977.

5. Patrick, D. L., Burke, L. B., Gwaltney, C. J., Kline Leidy, N., Martin, M. L., Molsen, E., et al. (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 in Health, 14, 978–988.

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