• 1
    Patrick DL, Burke LB, Powers JH, et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 2007;10(Suppl. 2):S12537.
  • 2
    Rothman ML, Beltran P, Cappelleri JC, et al. Patient-reported outcomes: conceptual issues. Value Health 2007;10(Suppl. 2):S6675.
  • 3
    Center for Drug Evaluation and Research. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville, MD: US Food and Drug Administration, 2006.
  • 4
    Donatti C, Wild D, Hareendran A. The use of conceptual models, conceptual frameworks, and endpoint models to support label claims of treatment benefit using patient reported outcomes. ISPOR Connections 2008;912.
  • 5
    Mathias SD, Gao SK, Miller KL, et al. Impact of chronic Immune Thrombocytopenic Purpura (ITP) on health-related quality of life: a conceptual model starting with the patient perspective. Health Qual Life Outcomes 2008;6:13.
  • 6
    Victorson DE, Anton S, Hamilton A, et al. A conceptual model of the experience of dyspnea and functional limitations in chronic obstructive pulmonary disease. Value Health 2009;12:101825.
  • 7
    American Cancer Society. Cancer Facts & Figures, 2008. Atlanta, GA: ACS, 2008.
  • 8
    Thompson I, Thrasher JB, Aus G, et al. Guideline for the management of clinically localized prostate cancer: 2007 update. J Urol 2007;177:210631.
  • 9
    Shelley M, Harrison C, Coles B, et al. Chemotherapy for hormone-refractory prostate cancer. Cochrane Database Syst Reviews 2006;(4):CD005247.
  • 10
    Petrylak DP. The treatment of hormone-refractory prostate cancer: docetaxel and beyond. Rev Urol 2006;8(Suppl. 2):S4855.
  • 11
    Tannock IF, De Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:150212.
  • 12
    Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:151320.
  • 13
    Winquist E, Waldron T, Berry S, et al. Non-hormonal systemic therapy in men with hormone-refractory prostate cancer and metastases: a systematic review from the Cancer Care Ontario Program in Evidence-based Care's Genitourinary Cancer Disease Site Group. BMC Cancer 2006;6:112.
  • 14
    Yuen KY, Shelley M, Sze WM, et al. Bisphosphonates for advanced prostate cancer. Cochrane Database Syst Reviews 2006;(4):CD006250.
  • 15
    Cella D, Petrylak DP, Fishman M, et al. Role of quality of life in men with metastatic hormone-refractory prostate cancer: how does atrasentan influence quality of life? Eur Urol 2006;49:7819.
  • 16
    Dawson NA. Epothilones in prostate cancer: review of clinical experience. Ann Oncol 2007;18(Suppl. 5):227.
  • 17
    Berry DL, Moinpour CM, Jiang CS, et al. Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. J Clin Oncol 2006;24:282835.
  • 18
    Moinpour CM, Donaldson GW, Redman MW. Do general dimensions of quality of life add clinical value to symptom data? J Natl Cancer Inst Monogr 2007;37:318.
  • 19
    Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods 2006;18:5982.
  • 20
    Lepore SJ, Helgeson VS, Eton DT, Schulz R. Improving quality of life in men with prostate cancer: a randomized controlled trial of group education interventions. Health Psychology 2003;22:44352.
  • 21
    Tannock IF, Osoba D, Stockler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14:175664.
  • 22
    Stockler MR, Osoba D, Goodwin P, et al. Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. J Clin Epidemiol 1998;51:13745.
  • 23
    Basch E, Iasonos A, Barz A, et al. Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy. J Clin Oncol 2007;25:537480.
  • 24
    Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol 2007;25:51217.
  • 25
    Ferrans CE, Zerwic JJ, Wilbur JE, Larson JL. Conceptual model of health-related quality of life. J Nurs Scholarsh 2005;37:33642.
  • 26
    Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA 1995;273:5965.