• 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:[Accessed May 18, 2007].
  • 2
    Mayo/FDA Patient-Reported Outcome Meeting. Chantilly, VA, February 2006.
  • 3
    Rothman M, Beltran P, Cappelleri JC, et al. Mayo/FDA Patient-Reported Outcomes Consensus Writing Group. Patient reported outcomes: conceptual issues. Value Health 2007;10(Suppl. 2):S6675.
  • 4
    Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 1999;282:7905.
  • 5
    Jaeschke RJ, Singer J, Guyatt GH. Ascertaining the minimal clinically important difference. Control Clin Trial 1989;10:40715.
  • 6
    Detsky AD, Sackett DL. When was a “negative” clinical trial big enough? How many patients you needed depends on what you found. Arch Intern Med 1985;145:70912.
  • 7
    Naylor CD, Llewellyn-Thomas HA. Can there be a more patient-centered approach to determining clinically important effect sizes for randomized treatment trials? J Clin Epid 1994;47:78795.
  • 8
    Burke L. Acceptable evidence for pharmaceutical advertising and labeling. DIA Workshop on Pharmacoeconomic and Quality of Life Labeling and Marketing Claims, October 2000.
  • 9
    Hahn EA, Cella D, Chassany O, et al. A. guide for clinicians to compare the precision of health-related quality of life data relative to other clinical measures. Mayo Clinic Proc (in press).
  • 10
    Santanello NC, Baker D, Cappelleri JC, et al. Regulatory issues for health-related quality of life—PhRMA Health Outcomes Committee Workshop, 1999. Value Health 2002;5:1425.
  • 11
    Damiano AM, Snyder C, Strausser B, Willian MK. A review of health-related quality-of-life concepts and measures for Parkinson's disease. Qual Life Res 1999;8:23543.
  • 12
    Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 2002;11:193205.
  • 13
    Frost MH, Reeve BB, Liepa AM, et al. Mayo/FDA Patient-Reported Outcomes Consensus Writing Group. What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health 2007;10(Suppl. 2):S94105.
  • 14
    Food and Drug Administration. Advair information. Thomson's Physician Desk Reference, 2006.
  • 15
    Mathias SD, Colwell HH, Miller DP, et al. Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo. Clin Ther 2000;22:12839.
  • 16
    Food and Drug Administration. Enbrel information. Physician Desk Reference (60th ed.) Thomson, 2006.
  • 17
    Caro G, Caro JJ, O'Brien JA, et al. The bother assessment in skin conditions (BASC) scale: Redefining quality of life measures in dermatology. American Academy of Dermatology Annual Meeting 1996.
  • 18
    Food and Drug Administration. Vaniqa information. Thompson's Physician Desk Reference, 2006.
  • 19
    Rosen RC, Riley A, Wagner G, et al. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49:82230.
  • 20
    Food and Drug Administration. Viagra information. Thomson's Physician Desk Reference, 2006.
  • 21
    Turner R, Quittner AL, Parasuraman BM, et al. Mayo/FDA Patient-Reported Outcomes Consensus Writing Group. Patient-reported outcomes: instrument development and selection issues. Value Health 2007;10(Suppl. 2):S8693.
  • 22
    Damiano AM, McGrath MM, Willian MK, et al. Evaluation of a measurement strategy for Parkinson's disease: assessing patient health-related quality of life. Qual Life Res 2000;9:87100.
  • 23
    Gotay CC, Lipscomb J, Snyder CF. Reflections on findings of the cancer outcomes measurement working group: moving to the next phase. J Natl Cancer Inst 2005;97:156874.
  • 24
    Stephenson NL, Herman J. Pain measurement: a comparison using horizontal and vertical visual analogue scales. Appl Nurs Res 2000;13:1578.
  • 25
    Ware JE. SF-36® Health Survey update. Available from:[Accessed March 14, 2007].
  • 26
    Guyatt G. The switch from paper. DIA Workshop on Benefits and Challenges with ePRO: Outcomes and Endpoints as We Emerge from the Long Age of Paper Methods, April 2005.