Estimating clinically meaningful changes for the functional assessment of cancer therapy - Prostate: Results from a clinical trial of patients with metastatic hormone-refractory prostate cancer

Value in Health

Volumn 12, Issue 1, 2009, Pages 124-129

  Cella, David ^b,c   Nichol, Michael B ^a   Eton, David ^b,c   Nelson, Joel B ^e   Mulani, Parvez ^d  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b EVANSTON NORTHWESTERN HEALTHCARE   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d ABBOTT LABORATORIES   (United States)

^e UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

Clinically meaningful change; Heath related quality of life; Minimally important difference; Prostate cancer

Indexed keywords

ALKALINE PHOSPHATASE BONE ISOENZYME; ATRASENTAN; HORMONE;

ARTICLE; CANCER SURVIVAL; CANCER THERAPY; CLINICAL TRIAL; CONTROLLED STUDY; HUMAN; KARNOFSKY PERFORMANCE STATUS; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; QUALITY OF LIFE; SCANNING ELECTRON MICROSCOPY; STUDENT T TEST;

AGED; AGED, 80 AND OVER; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG RESISTANCE, NEOPLASM; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PROSTATIC NEOPLASMS; QUALITY OF LIFE; QUESTIONNAIRES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 58849115091     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1111/j.1524-4733.2008.00409.x     Document Type: Article

References (27)

1. Esper P, Hampton JN, Smith DC, et al. Quality-of-life evaluation in patients receiving treatment for advanced prostate cancer. Oncol Nurs Forum 1999 26 : 107 12.
2. Passik SD, Kirsh KL. The importance of quality-of-life endpoints in clinical trials to the practicing oncologist. Hematol Oncol Clin North Am 2000 14 : 877 86.
3. Splinter TA. Chemotherapy in advanced non-small cell lung cancer. Eur J Cancer 1990 26 : 1093 9.
4. Cella D, Eton DT, Fairclough DL, et al. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 2002 55 : 285 95.
5. Federal Drug Administration. Guidance for industry. Patient reported outcome measures: use in medical product development to support labeling claims. Available from: http://www.fda.gov/cder/guidance/5460dft.pdf [Accessed June 16, 2008 JA, Cella D, Hays RD. Clinical significance of patient-reported questionnaire data: another step toward consensus. J Clin Epidemiol 2005 58 : 1217 9.
6. Moore MJ, Osoba D, Murphy K, et al. Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer. J Clin Oncol 1994 12 : 689 94.
7. Halabi S, Small ES, Kantoff PW, et al. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol 2003 21 : 1232 7.
8. Wyrwich KW, Wolinsky FD. Identifying meaningful intra-individual change standards for health-related quality of life measures. J Eval Clin Pract 2000 6 : 39 49.
9. Wyrwich KW, Tierney W, Wolinsky F. Further evidence supporting a SEM-based criterion for identifying meaningful intra-individual changes in health related quality of life. J Clin Epidemiol 1999 52 : 861 73.
10. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989 10 : 407 15.
11. Cella D, Eton DT, Lai JS, et al. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 2002 24 : 547 61.
12. Eton DT, Cella D, Yost KJ, et al. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol 2004 57 : 898 910.
13. Yost KJ, Sorensen MV, Hahn EA, et al. Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument. Value Health 2005 8 : 117 27.
14. Yost KJ, Cella D, Chawla A, et al. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol 2005 58 : 1241 51.
15. Esper P, Mo F, Chodak G, et al. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology 1997 50 : 920 8.
16. Yount S, Cella D, Banik D, et al. Brief assessment of priority symptoms in hormone refractory prostate cancer: the FACT Advanced Prostate Symptom Index (FAPSI). Health Qual Life Outcomes 2003 1 : 69.
17. Mulani PM, Sleep D, Isaacson J, et al. Relationship of bone alkaline phosphatase and quality of life in men with hormone refractory prostate cancer. J Clin Oncol 2004 22 : 4688. 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
18. Sullivan PW, Nelson JB, Mulani PM, et al. Quality of life as a potential predictor for morbidity and mortality in patients with metastatic hormone-refractory prostate cancer. Qual Life Res 2006 15 : 1297 306.
19. Mazumdar M, Glassman JR. Categorizing a prognostic variable: review of methods, code for implementation and applications to decision-making about cancer treatments. Stat Med 2000 19 : 113 32.
20. Cohen J ed.). Statistical Power Analysis for the Behavioral Sciences (revised edition). New York : Academic Press, 1977.
21. Emrich LJ, Priore RL, Murphy GP, Brady MF. Prognostic factors in patients with advanced stage prostate cancer. Cancer Res 1985 45 : 5173 9.
22. Petrylak DP, Scher HI, Li Z, et al. Prognostic factors for survival of patients with bidimensionally measurable metastatic hormone-refractory prostatic cancer treated with single-agent chemotherapy. Cancer 1992 70 : 2870 8.
23. Anastasi A, Urbina S. Psychological Testing (7th ed.). Upper Saddle River, NJ : Prentice Hall, 1997.
24. Nunnally J, Bernstein I. Psychological Methods. New York : McGraw-Hill, 1994.
25. Landis JR, Koch GC. The measurement of observer agreement for categorical data. Biometrics 1977 33 : 159 74.
26. Hays RD, Farivar SS, Liu H. Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD 2005 2 : 63 7.
27. Wyrwich KW. Minimal important difference thresholds and the standard error of measurement: is there a connection. J Biopharm Stat 2004 14 : 97 110.