Journal of Clinical Epidemiology
Volume 51, Issue 2 , Pages 137-145 , February 1998

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

  • Martin R. Stockler

      Affiliations

    • Ontario Cancer Institute/Princess Margaret Hospital, Toronto, Ontario, Canada
    • University of Sydney, NSW Australia
    • Royal Prince Alfred Hospital, Sydney NSW Australia
  • ,
  • David Osoba

      Affiliations

    • British Columbia Cancer Agency, Vancouver, British Columbia, Canada
  • ,
  • Pamela Goodwin

      Affiliations

    • University of Toronto, Toronto, Ontario, Canada
    • Mt. Sinai Hospital, Toronto, Ontario, Canada
  • ,
  • Paul Corey

      Affiliations

    • University of Toronto, Toronto, Ontario, Canada
  • ,
  • Ian F. Tannock

      Affiliations

    • Ontario Cancer Institute/Princess Margaret Hospital, Toronto, Ontario, Canada
    • University of Toronto, Toronto, Ontario, Canada
    • Corresponding Author InformationIan F. Tannock, Department of Medicine, Ontario Cancer Institute/Princess Margaret Hospital, 610 University Ave., Toronto, Ontario, Canada M5G 2M9

,Accepted 21 October 1997.

References 

  1. Kirshner B, Guyatt GH. A methodologic framework for assessing health indices. J Chronic Dis. 1985;38:27–36
  2. Feinstein AR. Clinimetrics. New Haven, CT: Yale University Press; 1987;
  3. 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;14:1756–1764
  4. Tannock I, Gospodarowicz M, Meakin W, et al.  Treatment of metastatic prostate cancer with low dose prednisone (Evaluation of pain and quality of life as pragmatic indices of response). J Clin Oncol. 1989;7:590–597
  5. Melzack R. The McGill pain questionnaire (Major properties and scoring methods). Pain. 1975;1:277–299
  6. Melzack R. The short form McGill Pain Questionnaire. Pain. 1987;30:191–197
  7. Aaronson NK, Ahmedzai S, Bergman B, et al.  The European Organisation for Research and Treatment of Cancer QLQ-C30 (A quality of life instrument for use in international clinical trials in oncology). J Natl Cancer Inst. 1993;85:365–376
  8. Aaronson NK, Bullinger M, Ahmedzai S. A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results Cancer Res. 1988;111:231–249
  9. Sprangers MAG, Cull A, Bjordal K, Groenvold M. The European Organization for Research and Treatment of Cancer approach to quality of life assessment (Guidelines for developing questionnaire modules). Quality Life Res. 1993;2:287–295Aaranoson NK for the EORTC Study Group on Quality of Life
  10. Lehmann EL. Non-Parametrics (Statistical Methods Based on Ranks). San Fransisco, CA: Holden-Day; 1975;
  11. Armitage P, Berry G. Statistical Methods in Medical Research. 2. Oxford: Blackwell Scientific Publications; 1987;419
  12. Effron B, Tibshirani RJ. An Introduction to the Bootstrap. New York: Chapman and Hall; 1993;
  13. Moore MJ, Osoba D, Murphy K, et al.  The use of palliative endpoints to evaluate the effects of mitoxantrone and low dose prednisone in patients with hormonally resistant prostate cancer. J Clin Oncol. 1994;12:689–694
  14. Stockler M. Validation of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) as an outcome measure for clinical trials in advanced hormone-resistant prostate cancer; assessment of convergent, discriminative, and predictive validity with baseline data from a randomised trial. (thesis) Toronto, ON: University of Toronto; 1996.
  15. Ringdal GI, Ringdal K. Testing the EORTC quality of life questionnaire on cancer patients with heterogeneous diagnoses. Qual Life Res. 1993;2:129–140
  16. Niezogoda HE, Pater JL. A validation study of the domains of the core EORTC quality of life questionnaire. Qual Life Res. 1993;2:319–325
  17. Osoba D, Zee B, Pater J, et al.  Psychometric properties and responsiveness of the EORTC quality of life questionnaire (QLQ-C30) in patients with breast, ovarian, and lung cancer. Qual Life Res. 1994;3:353–364
  18. Hjermstad MJ, Fossa SD, Bjordal K, Kaasa S. Test/retest study of the European Organisation for Research and Treatment of Cancer core quality of life questionnaire. J Clin Oncol. 1995;13:1249–1254
  19. Osoba D, Pater JL, Zee B, et al.  Effective anti-emetic therapy improves quality of life (QOL) after moderately emetogenic chemotherapy (MEC). Qual Life Res. 1995;4:467;Abstract
  20. Zubrod CG, Schneiderman M, Frei E, et al.  Appraisal of methods for the study of chemotherapy of cancer in man (comparative therapeutic trial of nitrogen mustard and triethylene thiophosphoramide). J Chron Dis. 1960;11:7–33
  21. Osoba D, Aaronson NK, Muller M, et al.  Effect of neurological dysfunction on health-related quality of life in patients with high-grade glioma. J Neurooncol. 1997;34:263–278
  22. Osoba D, Rodrigues G, Myles J, Pater J. Significance of changes in health-related quality of life (QOL) scores in women receiving chemotherapy for recurrent or metastatic breast cancer. Qual Life Res. 1995;4:467;Abstract
  23. Bombardier C, Raboud J, Auranofin Cooperating Group . A comparison of health-related quality of life measures for rheaumatoid arthritis research. Controlled Clin Trials. 1991;12:243S–256S
  24. Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989;27:S178–S189
  25. Beaton DE, Hogg-Johnson S, Bombardier C. Evaluating changes in health status (Reliability and responsiveness of five generic health status measures in the soft tissue injuries). J Clin Epidemiol. 1997;50:79–93
  26. Gliklich RE, Hilinski JM. Longitudinal sensitivity of generic and specific health measures in chronic sinusitis. Qual Life Res. 1995;4:27–32
  27. Katz JN, Larson MG, Phillips CB, Fossel AH, Liang MH. Comparative measurement sensitivity of short and longer health status instruments. Med Care. 1992;30:917–925
  28. Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care. 1990;28:632–642
  29. Guyatt GH, Deyo RA, Charlson M, Levine MN, Mitchell A. Responsiveness and validity in health status measurement (a clarification). J Clin Epidemiol. 1989;42:403–408
  30. Hays RD, Hadorn D. Responsiveness to change (an aspect of validity, not a separate dimension). Qual Life Res. 1992;1:73–75

PII: S0895-4356(97)00269-2

Journal of Clinical Epidemiology
Volume 51, Issue 2 , Pages 137-145 , February 1998