The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the food and drug administration guidance on patient-reported outcomes

Value in Health

Volumn 10, Issue SUPPL. 2, 2007, Pages

  Sloan, Jeff A ^a   Halyard, Michele Y ^b   Frost, Marlene H ^a   Dueck, Amylou C ^a   Teschendorf, Bonnie ^c   Rothman, Margaret L ^d  

^a MAYO CLINIC   (United States)

^b MAYO CLINIC   (United States)

^c AMERICAN CANCER SOCIETY   (United States)

^d JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

FDA guidance; Patient reported outcomes; QOL; Quality of life

Indexed keywords

CLINICAL PRACTICE; CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; MEDICAL RESEARCH; OUTCOMES RESEARCH; PATIENT REPORTED OUTCOMES; PRIORITY JOURNAL;

EID: 36048929764     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1111/j.1524-4733.2007.00267.x     Document Type: Conference Paper

References (20)

1. Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims (DRAFT). US Department of Health and Human Services Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH), February 2006. Available from: http://www.fda.gov/cder/guidance/ 5460dft.htm [Accessed May 18, 2007].
2. Sloan JA, Dueck AC, Erickson PA, et al. Analysis and interpretation of results based on patient-reported outcomes. Value Health 2007 10 (Suppl. 2 S106 15.
3. Weaver TE. Outcome measurement in sleep medicine practice and research. Part 1: assessment of symptoms, subjective and objective daytime sleepiness, health-related quality of life and functional status. Sleep Med Rev 2001 5 : 103 28.
4. Patel KK, Veenstra DL, Patrick DL. A review of selected patient-generated outcome measures and their application in clinical trials. Value Health 2003 6 : 595 603.
5. Acquadro C, Berzon R, Dubois D, et al. 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 31.
6. Hahn EA, Cella D, Dobrez D, et al. The talking touchscreen: a new approach to outcomes assessment in low literacy. Psycho-Oncology 2004 13 : 86 95.
7. Shikiar R, Rentz AM. Satisfaction with medication. an overview of conceptual, methodologic, and regulatory issues. Value Health 2004 7 : 204 15.
8. Revicki DA, Osoba D, Fairclough D, et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000 9 : 887 900.
9. Institute of Medicine. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC : National Research Council of the National Academies, 2005.
10. Frost MH, Bonomi AE, Ferrans CE, et al. Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clin Proc 2002 77 : 488 94.
11. Guyatt GH. Making sense of quality-of-life data. Med Care 2000 38 : II 175-9.
12. Lipscomb J, Gotay CC, Snyder C. Outcomes Assessment in Cancer: Measures, Methods, and Applications. Cambridge, UK : Cambridge University Press, 2005.
13. Rothman ML, Beltran P, Cappelleri JC, et al. Patient-reported outcomes: conceptual issues. Value Health 2007 10 (Suppl. 2 S66 75.
14. Snyder CF, Watson ME, Jackson JD, et al. Patient-reported outcome instrument selection: designing a measurement strategy. Value Health 2007 10 (Suppl. 2 S76 85.
15. Turner RR, Quittner AL, Parasuraman BM, et al. Patient-reported outcomes: instrument development and selection issues. Value Health 2007 10 (Suppl. 2 S86 93.
16. Frost MH, Reeve BB, Liepa AM, et al. What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health 2007 10 (Suppl. 2 S94 105.
17. Revicki DA, Erickson PA, Sloan JA, Dueck AC. Interpreting and reporting results based on patient-reported outcomes. Value Health 2007 10 (Suppl. 2 S116 24.
18. Osoba D, Bezjak A, Brundage M, Pater J. Evaluating health-related quality of life in cancer clinical trials: the National Cancer Institute of Canada Clinical Trials Group experience. Value Health 2007 10 (Suppl. 2 S138 45.
19. Patrick DL, Burke LB, Powers JH, et al. Patient-reported outcomes to support medical product labeling claims. Value Health 2007 10 (Suppl. 2 S125 37.
20. Chauhan CA. Patient-reported observation. Value Health 2007 10 (Suppl. 2 S146 7.