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Methodological Issues in the Analysis of Quality of Life Data in Clinical Trials: Illustrations from the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial

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Statistical Methods for Quality of Life Studies

Abstract

We present two Quality of Life (QOL) endpoints collected in conjunction with the recently completed Breast Cancer Prevention Trial (BCPT) performed by the National Surgical Adjuvant Breast and Bowel Project. The analyses of these endpoints (depression and hot flashes) indicate the importance of randomization and give some insight about the impact of missing data in a large randomized trial.

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References

  • Anelli, T.F., Anelli, A., Tran, K.N., Lebwohl, D.E. and Borgen, P.I. (1994). Tamoxifen administration is associated with a high rate of treatment-limiting symptoms in male breast cancer patients. Cancer 74, 74–77.

    Article  PubMed  CAS  Google Scholar 

  • Bernhard, J., Cella, D.F., Coates, A.S., Fallowfield, L., Ganz, P., Moinpour, C.M., Mosconi, P., Osoba, D., Simes, J. and Hürny, C. (1998a). Missing quality of life data in cancer clinical trials: serious problems and challenges. Statistics in Medicine 17, 517–532.

    Article  PubMed  CAS  Google Scholar 

  • Bernhard, J. and Gelber, R.D., eds. (1998b). Workshop on missing data in quality of life research in clinical trials: practical and methodological issues. Statistics in Medicine 17, 511–796.

    Article  Google Scholar 

  • Boyd, J.H., Weissman, M.M., Thompson, W.D. and Myers, J.K. (1982). Screening for depression in a community sample. Archives of General Psychiatry 39, 1195–1200.

    Article  PubMed  CAS  Google Scholar 

  • Cathcart, C.K., Jones, S.E., Pumroy, C.S., Peters, G.N., Knox, S.M. and Cheek, J.H. (1993). Clinical recognition and management of depression in node negative breast cancer patients treated with tamoxifen. Breast Cancer Research and Treatment 27, 277–281.

    Article  PubMed  CAS  Google Scholar 

  • Cella, D.F. and Bonomi, A.E. (1995). Measuring quality of life: 1995 update. Oncology 9 (11-suppl), 47–60.

    PubMed  CAS  Google Scholar 

  • Day, R., Ganz, P.A., Costantino, J.P., Cronin, W.M., Wickerham, D.L. and Fisher, B. (1999), Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-l study. Journal of Clinical Oncology 17, 2659–2669.

    PubMed  CAS  Google Scholar 

  • DeGruttola, V. and Tu, X.M. (1994). Modelling progression of CD4-lymphocyte count and its relationship to survival time. Biometrics 50, 1003–1014.

    Article  CAS  Google Scholar 

  • Fisher, B., Costantino, J.P., Wickerham, D.L., Redmond, C.K., Kavanah, M., Cronin, W.M., Vogel V., Robidoux, A., Dimitrov, N., Atkins, J., Daly, M., Wieand, S., Tan-Chiu, E., Ford, L. and Wolmark, N. (1998). Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-l study. Journal of the National Cancer Institute 90, 1371–1388.

    Article  PubMed  CAS  Google Scholar 

  • Gail, M.H., Costantino, J.P., Bryant, J., Croyle, R., Freedman, L., Helzlsouer, K. and Vogel V. (1999). Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. Journal of the National Cancer Institute 91, 1829–1846.

    Article  PubMed  CAS  Google Scholar 

  • Ganz, P.A. (1994a). Long range effect of clinical trial interventions on quality of life. Cancer 74 (9-suppl), 2620–2624.

    Article  PubMed  CAS  Google Scholar 

  • Ganz, P.A. (1994b). Quality of life measures in cancer chemotherapy: methodology and implications. Pharmacoeconomics 5, 376–388.

    Article  PubMed  CAS  Google Scholar 

  • Ganz, P.A., Day, R., Ware, J.E., Redmond, C. and Fisher, B. (1995). Base-line quality-of-life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. Journal of the National Cancer Institute 87, 1372–1382.

    Article  PubMed  CAS  Google Scholar 

  • Ganz, P.A., Day, R. and Costantino, J. (1998). Compliance with quality of life data collection in the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial. Statistics in Medicine 17, 613–622.

    Article  PubMed  CAS  Google Scholar 

  • Gregoire, A.J., Kumar, R., Everitt, B., Henderson, A.F. and Studd J.W. (1996). Transdermal oestrogen for treatment of severe postnatal depression. Lancet 347, 930–933.

    Article  PubMed  CAS  Google Scholar 

  • Hahn, R. A. (1997). The nocebo phenomenon: concept, evidence, and implications for public health. Preventive Medicine 26, 607–611.

    Article  PubMed  CAS  Google Scholar 

  • Halbreich, U. (1997). Role of estrogen in postmenopausal depression. Neurology 48 (5 Suppl7), S16–19.

    Article  PubMed  CAS  Google Scholar 

  • Little, R.J.A. (1995). Modeling the drop-out mechanism in repeated measures studies. Journal of the American Statistical Association 90, 1112–1121.

    Article  Google Scholar 

  • Love, R.R., Cameron, L., Connell, B.L. and Leventhal H. (1991). Symptoms associated with tamoxifen treatment in postmenopausal women. Archives of Internal Medicine 151, 1842–1847.

    Article  PubMed  CAS  Google Scholar 

  • Lyness, J.M., Noel, T.K., Cox, C., King, D.A., Conwell, Y., Caine, E.D. (1997). Screening for depression in elderly primary care patients: a comparison of the Center for Epidemiologic Studies-Depression Scale and the Geriatric Depression Scale. Archives of Internal Medicine 157, 449–454.

    Article  PubMed  CAS  Google Scholar 

  • Moinpour, C.M., Savage, M.J., Troxel, A., Lovato, L.C., Eisenberger, M., Veith, R.W., Higgins, B., Skeel, R., Yee, M., Blumenstein, B.A., Crawford, E.D. and Meyskens, F.L. Jr. (1998). Quality of life in advanced prostate cancer: results of a randomized therapeutic trial. Journal of the National Cancer Institute 90, 1537–1544.

    Article  PubMed  CAS  Google Scholar 

  • Myers, J.K. and Weissman, M.M. (1980). Use of a self-report symptom scale to detect depression in a community sample. American Journal of Psychiatry 137, 1081–1084.

    PubMed  CAS  Google Scholar 

  • Radloff, L.S. (1977). The CES-D Scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 1, 385–401.

    Article  Google Scholar 

  • Roberts, R.E. and Vernon, S.W. (1983). The Center for Epidemiologic Studies Depression Scale: its use in a community sample. American Journal of Psychiatry 140, 41–46.

    PubMed  CAS  Google Scholar 

  • Schluchter, M.D. (1992). Methods for the analysis of informatively censored longitudinal data. Statistics in Medicine 11, 1861–1870.

    Article  PubMed  CAS  Google Scholar 

  • Shariff, S., Cumming, E., Lees, A., Handman, M. and Cumming, D.C. (1995). Mood disorder in women with early breast cancer taking tamoxifen, an estradiol receptor antagonist: an expected or unexpected Effect? Annals of the New York Academy of Sciences 761, 365–368.

    Article  PubMed  CAS  Google Scholar 

  • Sherbourne, C.D. (1992). Social functioning: sexual problems and measures. In: Stewart, A.L. and Ware, J.E. (eds.). Measuring Functioning and Well-Being: The Medical Outcomes Study Approach, Durham, North Carolina: Duke University Press.

    Google Scholar 

  • Tannock, I.F., Osoba, D., Stockier, M.R., Ernst, D.S., Neville, A.J., Moore, M.J., Armitage, G.R., Wilson, J.J., Venner, P.M., Coppin, C.M. and Murphy, K.C. (1996). Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. Journal of Clinical Oncology 14, 1756–1764.

    PubMed  CAS  Google Scholar 

  • Ten Have, T.R., Kunselman, A.R., Pulkstenis, E.P. and Landis, J.R. (1998). Mixed effects logistic regression models for longitudinal binary response data with informative drop-out. Biometrics 54, 367–383.

    Article  PubMed  Google Scholar 

  • Ten Have, T.R., Miller, M.E., Reboussin, B.A. and James, M.K. (2000). Mixed effects logistic regression models for longitudinal ordinal functional response data with multiple-cause drop-out from the Longitudinal Study of Aging. Biometrics 56, 279–287.

    Article  PubMed  Google Scholar 

  • Ware, J.E., Kosinski, M. and Keller, S.D. (1994). SF-36 Physical and Mental Summary Scales: A User’s Manual. Boston: The Health Institute, New England Medical Center.

    Google Scholar 

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© 2002 Springer Science+Business Media Dordrecht

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Land, S. et al. (2002). Methodological Issues in the Analysis of Quality of Life Data in Clinical Trials: Illustrations from the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial. In: Mesbah, M., Cole, B.F., Lee, ML.T. (eds) Statistical Methods for Quality of Life Studies. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-3625-0_7

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  • DOI: https://doi.org/10.1007/978-1-4757-3625-0_7

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4419-5207-3

  • Online ISBN: 978-1-4757-3625-0

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