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
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.
KeywordsDepressive Symptom National Surgical Adjuvant Breast Naive Model Breast Cancer Prevention Trial Missing Form
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- 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.PubMedGoogle 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.PubMedCrossRefGoogle 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.PubMedCrossRefGoogle 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.PubMedCrossRefGoogle 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.PubMedGoogle 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