Regulatory issues for health-related quality of life - PhRMA Health Outcomes Committee Workshop, 1999

Value in Health

Volumn 5, Issue 1, 2002, Pages 14-25

  Santanello, N C ^a   Baker, E ^b   Cappelleri, J C ^b   Copley Merriman, K ^b   DeMarinis, R ^c   Gagnon, J P ^d   Hsuan, A ^e   Jackson, J ^f   Mahmoud, R ^e   Miller, D ^g   Morgan, M ^h   Osterhaus, J ⁱ   Tilson, H ^g   Willke, R ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b PFIZER INC   (United States)

^c Wyeth Ayerst Research   (United States)

^d SANOFI   (France)

^e JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^f BRISTOL MYERS SQUIBB   (United States)

^g GLAXOSMITHKLINE   (United Kingdom)

^h ELI LILLY AND COMPANY   (United States)

ⁱ Wasatch Health Outcomes   (United States)

Author keywords

Guidance; Outcomes research; Quality of life research; Regulatory

Indexed keywords

DATA ANALYSIS; DRUG LABELING; HUMAN; MEDICAL RESEARCH; OUTCOMES RESEARCH; PRIORITY JOURNAL; PSYCHOLOGICAL ASPECT; QUALITY OF LIFE; REVIEW; SOCIAL ASPECT; VALIDATION PROCESS;

EID: 0036171531     PISSN: 10983015     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1524-4733.2002.51047.x     Document Type: Article

References (23)

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5. Reproducibility and responsiveness of health status measures
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7. Measuring quality of life in clinical trials: A taxonomy and review
8. Measuring health-related quality of life
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10. Dissent. How should health status measures be assessed? Cautionary notes on procrustean frameworks
11. Cross cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines
12. Procedures for comparing samples with multiple endpoints
13. Some statistical methods for multiple endpoints in clinical trials
14. Quality of life: Statistical issues and analysis
15. Analysis of incomplete quality of life data in clinical trials
16. Methods of analysis for longitudinal studies of health-related quality of life
17. Recommendations for evaluating the validity of quality of life claims for labeling and promotion
18. Methodological problems in the retrospective computation of responsiveness to change: The Lesson of Cronbach
19. Determining a minimal important change in a disease-specific quality of life questionnaire
20. Response. A methodologic framework for health status measures: Clarity or oversimplification?
21. Comparisons of the costs and quality of norms for the SF-36