The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders

Author:

Cruz Rivera Samantha,McMullan Christel,Jones Laura,Kyte Derek,Slade Anita,Calvert Melanie

Funder

Consejo Nacional de Ciencia y Tecnología

Publisher

Springer Science and Business Media LLC

Subject

Health Information Management,Health Informatics

Reference55 articles.

1. Fayers, P. M., & Machin, D. (2013). Quality of life: the assessment, analysis and interpretation of patient-reported outcomes. Hoboken: Wiley.

2. FDA. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. http:///www.fdagov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf . 2009.

3. Calvert, M. J., & Freemantle, N. (2003). Use of health-related quality of life in prescribing research. Part 1: why evaluate health-related quality of life? J Clin Pharm Ther, 28(6), 513–521. https://doi.org/10.1046/j.0269-4727.2003.00521.x .

4. Black, N. (2013). Patient reported outcome measures could help transform healthcare. BMJ, 346, f167. https://doi.org/10.1136/bmj.f167 .

5. Patrick, D. L., & Deyo, R. A. (1989). Generic and disease-specific measures in assessing health status and quality of life. Med Care, 27, S217–SS32.

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