Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science

Author:

McKenna Stephen P

Publisher

Springer Science and Business Media LLC

Subject

General Medicine

Reference49 articles.

1. World Health Organization: International Classification of Impairments, Disabilities and Handicaps: A Manual of Classification Relating to Consequences of Disease. 1980, Geneva: World Health Organization

2. World Health Organization: International Classification of Functioning, Disability and Health. 2001, Geneva: World Health Organization

3. Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M, PRO Harmonization Group: Incorporating the patient's perspective into drug development and communication: an ad hoc task force report on the patient-reported outcomes (PRO) harmonization group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003, 5: 522-531.

4. Burke LB, Kennedy DL, Miskala PH, Papadopoulos EJ, Trentacosti AM: The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther. 2008, 84: 281-283. 10.1038/clpt.2008.128.

5. EMEA, Committee for Medicinal Products for Human Use (CMHP): Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. Doc Ref EMEA/CHMP/EWP/139391/2004. 2005, London: European Medicines Agency, [ http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf ]

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