Compliance with patient-reported outcomes in multicenter clinical trials: Methodologic and practical approaches

Journal of Clinical Oncology

Volumn 25, Issue 32, 2007, Pages 5113-5120

  Land, Stephanie R ^a   Ritter, Marcie W ^a   Costantino, Joseph P ^a   Julian, Thomas B ^a   Cronin, Walter M ^a   Haile, Sarah R ^a   Wolmark, Norman ^a   Ganz, Patricia A ^a  

^a UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RALOXIFENE; TAMOXIFEN;

ADULT; AGED; BREAST CANCER; CANCER PREVENTION; CLINICAL RESEARCH; CLINICAL TRIAL; COMPLIANCE (PHYSICAL); CONFERENCE PAPER; CONTROLLED STUDY; HEALTH PROGRAM; HUMAN; MULTICENTER STUDY; PATIENT COMPLIANCE; PRIORITY JOURNAL; QUALITY OF LIFE; TREATMENT OUTCOME;

CLINICAL TRIALS AS TOPIC; HUMANS; MULTICENTER STUDIES AS TOPIC; NEOPLASMS; PATIENT SATISFACTION; QUALITY INDICATORS, HEALTH CARE; QUALITY OF LIFE; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME;

EID: 36849090787     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.12.1749     Document Type: Conference Paper

References (31)

1. Bernhard J, Gusset H, Hurny C: Practical issues in quality of life assessment in multicentre trials conducted by the Swiss Group for Clinical Cancer Research. Stat Med 17:633-639, 1998
2. Bernhard J, Cella DF, Coates AS, et al: Missing quality of life data in cancer clinical trials: Serious problems and challenges. Stat Med 17:517-532, 1998
3. Hayden KA, Moinpour CM, Metch B, et al: Pitfalls in quality-of-life assessment: Lessons from a Southwest Oncology Group breast cancer clinical trial. Oncol Nurs Forum 20:1415-1419, 1993
4. Hopwood P, Harvey A, Davies J, et al: Survey of the administration of quality of life (QL) questionnaires in three multicentre randomised trials in cancer: The Medical Research Council Lung Cancer Working Party and the CHART Steering Committee. Eur J Cancer 34:49-57, 1998
5. Kaasa S, Hjermstad MJ, Jordhoy MS, et al: Compliance in quality of life data: A Norwegian experience. Stat Med 17:623-632, 1998
6. Mosconi P, Torri V, Cifani S, et al: The multi-centre assessment of quality of life: The Interdisciplinary Group for Cancer Care Evaluation (GIVIO) experience in Italy. Stat Med 17:577-585, 1998
7. Olschewski M: Compliance with QOL assessment in multi-centre German breast cancer trials. Stat Med 17:571-575, 1998
8. Coates A, Gebski V: Quality of life studies of the Australian New Zealand Breast Cancer Trials Group: Approaches to missing data. Stat Med 17:533-540, 1998
9. Troxel AB, Fairclough DL, Curran D, et al: Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med 17:653-666, 1998
10. Land S, Wieand HS, Day R, et al: 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, Lee M (eds): Statistical Design, Measurement and Analysis of Health Related Quality of Life. Boston, MA, Kluwer Academic Publishers, 2002, pp 71-85
11. Little R, Rubin D: Statistical Analysis With Missing Data. New York, NY, Wiley and Sons, 1987
12. Pauler DK, McCoy S, Moinpour C: Pattern mixture models for longitudinal quality of life studies in advanced stage disease. Stat Med 22:795-809, 2003
13. Fairclough DL: Multiple imputation for nonrandom missing data in longitudinal studies of health-related quality of life, in Mesbah M, Cole BF, Lee M (eds): Statistical Design, Measurement and Analysis of Health Related Quality of Life: Design, Measurements and Analysis. Boston, MA, Kluwer Academic Publishers, 2002, pp 323-337
14. Italian Group for Evaluation of Outcomes in Oncology: Patient compliance with quality of life questionnaires. Tumori 85:92-95, 1999
15. Kopp I, Lorenz W, Rothmund M, et al: Relation between severe illness and non-completion of quality-of-life questionnaires by patients with rectal cancer. J R Soc Med 96:442-448, 2003
16. Walker M, Brown J, Brown K, et al: Practical problems with the collection and interpretation of serial quality of life assessments in patients with malignant glioma. J Neurooncol 63:179-186, 2003
17. Ganz PA, Day R, Costantino J: Compliance with quality of life data collection in the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial. Stat Med 17:613-622, 1998
18. Hahn EA, Webster KA, Cella D, et al: Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: Problems and solutions. Stat Med 17:547-559, 1998
19. Hopwood P, Stephens RJ, Machin D: Approaches to the analysis of quality of life data: Experiences gained from a Medical Research Council Lung Cancer Working Party palliative chemotherapy trial. Qual Life Res 3:339-352, 1994
20. Osoba D, Zee B: Completion rates in health-related quality-of-life assessment: Approach of the National Cancer Institute of Canada Clinical Trials Group. Stat Med 17:603-612, 1998
21. Bernhard J, Gusset H, Hurny C: Quality-of-life assessment in cancer clinical trials: An intervention by itself? Support Care Cancer 3:66-71, 1995
22. Hurny C, Bernhard J, Joss R, et al: Feasibility of quality of life assessment in a randomized phase III trial of small cell lung cancer: A lesson from the real world - The Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol 3:825-831, 1992
23. Young T, Maher J: Collecting quality of life data in EORTC clinical trials: What happens in practice? Psychooncology 8:260-263, 1999
24. Vogel VG, Costantino JP, Wickerham DL, et al: Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 295:2727-2741, 2006
25. Land SR, Wickerham DL, Costantino JP, et al: Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 295:2742-2751, 2006
26. Phillips RA, Faulkner M, Gassman J, et al: Recruitment of African Americans with chronic renal insufficiency into a multicenter clinical trial: The African American Study of Kidney Disease and Hypertension. J Clin Hypertens (Greenwich) 6:430-436, 2004
27. Unson CG, Dunbar N, Curry L, et al: The effects of knowledge, attitudes, and significant others on decisions to enroll in a clinical trial on osteoporosis: Implications for recruitment of older African-American women. J Natl Med Assoc 93:392-401, 2001
28. Gorelick PB, Harris Y, Burnett B, et al: The recruitment triangle: Reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial - An interim report from the African-American Antiplatelet Stroke Prevention Study (AAASPS). J Natl Med Assoc 90:141-145, 1998
29. Gorelick PB, Richardson D, Hudson E, et al: Establishing a community network for recruitment of African Americans into a clinical trial. The African-American Antiplatelet Stroke Prevention Study (AAASPS) experience. J Natl Med Assoc 88:701-704, 1996
30. Fallowfield L: Compliance issues in quality of life assessment: Experiences of two Cancer Research Campaign sponsored groups. Stat Med 17:541-546, 1998
31. Batel-Copel LM, Kornblith AB, Batel PC, et al: Do oncologists have an increasing interest in the quality of life of their patients? A literature review of the last 15 years. Eur J Cancer 33:29-32, 1997