Other paradigms: Health-related quality of life as a measure in cancer treatment: Its importance and relevance

Cancer Journal

Volumn 15, Issue 5, 2009, Pages 435-440

  Trask, Peter C ^a   Hsu, Ming Ann ^a   McQuellon, Richard ^b  

^a PFIZER INC   (United States)

^b WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

Cancer treatment; Health related quality of life; Minimal important difference; Oncology; Outcomes; Symptoms; Therapeutic benefit

Indexed keywords

CANCER THERAPY; HEALTH PRACTITIONER; HUMAN; MEDICAL DECISION MAKING; MEDICAL INFORMATION; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; REVIEW; TREATMENT OUTCOME; TUMOR VOLUME;

ATTITUDE TO HEALTH; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY OF LIFE; QUESTIONNAIRES; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME;

EID: 70350179462     PISSN: 15289117     EISSN: 1540336X     Source Type: Journal    
DOI: 10.1097/PPO.0b013e3181b9c5b9     Document Type: Review

References (60)

1. Revicki D, Osoba D, Fairclough D, et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res. 2000;9:887-900.
2. Ferrans CE. Definitions and conceptual models of quality of life. In: Lipscomb J, Gotay CC, Snyder C, eds. Outcomes Assessment in Cancer. New York: Cambridge University Press; 2005;14-30.
3. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life: a conceptual model of patient outcomes. JAMA. 1995;273:59-65.
4. Sloan JA, Cella D, Frost M, et al. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc. 2002;77:367-370.
5. Aaronson NK, et al., The European Organization for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncology: an update. S. B., Editor. In: Quality of Life and Pharmacoeconomics in Clinical Trials. 2nd Ed. New York: Raven Press; 1996:179-189.
6. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization 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.
7. Cella D. F.A.C.I.T. Manual. Manual of the functional assessment of chronic illness therapy (FACIT) scales (version 4). Evanston, IL: Center on Outcomes, Research and Education (CORE), Evanston Northwestern Healthcare and Northwestern University; 1997.
8. Johnson JR, Temple R. Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep. 1985;69:1155-1159.
9. Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21: 1404-1411.
10. Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics April 2005. Rockville, MD: USDHHS, FDA; 2005.
11. Watkins Bruner D, Bryan CJ, Aaronson N, et al. Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute sponsored clinical trials networks. J Clin Oncol. 2007;25:5051-5057.
12. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology. J Clin Oncol. 1996;14:671-679.
13. Blazeby JM, Avery K, Sprangers M, et al. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol. 2006;24:3178-3186.
14. McQuellon R, Gavazzi C, Piso P, et al. Quality of life and nutritional assessment in peritoneal surface malignancy (PSM): recommendations for care. J Surg Oncol. 2008;98:300-305.
15. Gondek K, Sagnier PP, Gilchrist K, et al. Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels. J Clin Oncol. 2007;25:5087-5093.
16. Spano JP, Chodkiewicz C, Maurel J, et al. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008;371:2101-2108.
17. Huschka MM, Mandrekar SJ, Schaefer PL, et al. A pooled analysis of quality of life measures and adverse events data in North Central Cancer Treatment Group lung cancer clinical trials. Cancer. 2007;109:787-795.
18. Morton RF, Sloan JA, Grothey A, et al. A comparison of simple single-item measures and the common toxicity criteria in detecting the onset of oxaliplatin- induced peripheral neuropathy in patients with colorectal cancer [abstract]. J Clin Oncol. 2005;23:8087.
19. Osoba D. The clinical value and meaning of health-related quality of life outcomes in oncology. In: Lipscomb J, Gotay CC, Snyder C, eds. Outcomes Assessment in Cancer. New York: Cambridge University Press; 2005:386-405.
20. Cella D, Cappelleri JC, Bushmakin A, et al. Quality of life predicts progression- free survival in patients with metastatic renal cell carcinoma treated with sunitinib versus interferon alfa. J Oncol Pract. 2009;5:66-70.
21. Montazeri A. Health-related quality of life in breast cancer patients: a bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res. 2008;29:1-32.
22. Guyatt G. Insights and limitations from health-related quality-of-life research. J Gen Intern Med. 1997;12:720-721.
23. Mangione CM, Goldman L, Orav EJ, et al. Health-related quality of life after elective surgery: measurement of longitudinal changes. J Gen Intern Med. 1997;12:686-697.
24. Joly F, Vardy J, Pintilie M, et al. Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Ann Oncol. 2007;18:1935-1942.
25. Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life scores. J Clin Oncol. 1998;16:139-144.
26. Brundage M, Osoba D, Bezjak A, et al. Lessons learned in the assessment of health-related quality of life: selected examples from the National Cancer Institute of Canada Clinical trials group. J Clin Oncol. 2007;25:5078-5081.
27. 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;55:285-295.
28. Cella D, Nichol MB, Eton D, et al. 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 Health. In press.
29. 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.
30. 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;58:1241-1251.
31. Guidance for Industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. Draft Guidance. 2006. USDHHS, FDA, Rockville, MD.
32. Bukowski R, Cella D, Gondek K, et al. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007;30:220-227.
33. Bezjak A, Tu D, Seymour L, et al. Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the National Cancer Institute of Canada clinical trials group study BR. 21. J Clin Oncol. 2006; 24:3831-3837.
34. Guyatt GH, Osoba D, Wu AW, et al; the Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371-383.
35. Cella D, Bullinger M, Scott C, et al; the Clinical Significance Consensus Meeting Group. Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc. 2002;77:384-392.
36. Sloan JA, Aaronson N, Cappelleri JC, et al; the Clinical Significance Consensus Meeting Group. Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc. 2002;77:479-487.
37. Frost MH, Bonomi AE, Ferrans CE, et al; the Clinical Significance Consensus Meeting Group. Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clin Proc. 2002; 77:488-494.
38. Sprangers MAG, Moinpour CM, Moynihan TJ, et al; the Clinical Significance Consensus Meeting Group. Assessing meaningful change in quality of life over time: a users' guide for Clinicians. Mayo Clin Proc. 2002;77:561-571.
39. Symonds T, Berzon R, Marquis P, et al; the Clinical Significance Consensus Meeting Group. The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clin Proc. 2002;77:572-583.
40. Moore DH, Blessing JA, McQuellon RP, et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004;22:3113-3119.
41. Fairclough DL, Peterson HF, Cella D, et al. Comparison of several modelbased methods for analysing incomplete quality of life data in cancer clinical trials. Stat Med. 1998;17:781-796.
42. Fairclough DL, Peterson HF, Chang V. Why are missing quality of life data a problem in clinical trials of cancer therapy? Stat Med. 1998;17:667-677.
43. Ganz PA, Schag AC, Lee JJ, et al. Breast conservation versus mastectomy. Is there a difference in psychological adjustment or quality of life in the year after surgery? Cancer. 1992;69:1729-1738.
44. Bar-On D, Lazar A, Amir M. Quantitative assessment of response shift in QOL research. Soc Indic Res. 2000;49:37-49.
45. Visser MR, Oort FJ, Sprangers MA. Methods to detect response shift in quality of life data: a convergent validity study. Qual Life Res. 2005;14:629-639.
46. Halyard MY, Frost MH, Dueck A, et al. Is the use of QOL data really any different than other medical testing? Curr Probl Cancer. 2006;30:261-271.
47. Brucker PS, Yost K, Cashy J, et al. General population and cancer patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Eval Health Prof. 2005;28:192-211.
48. Ganz PA, Goodwin PJ. Quality of life in breast cancer-what have we learned and where do we go from here? In: Lipscomb J, Gotay CC, Snyder C, eds. Outcomes Assessment in Cancer. New York: Cambridge University Press; 2005:93-125.
49. McQuellon RP, Russell GB, Jesse MT, et al. Factors associated with longterm survival following stem cell transplantation (SCT) for non-Hodgkins lymphoma. J Clin Oncol. 2007;25:702s.
50. McQuellon RP, Russell GB, Shen P, et al. Survival and health outcomes after cytoreductive surgery with intraperitoneal hyperthermic chemotherapy for disseminated peritoneal cancer of appendiceal origin. Ann Surg Oncol. 2008;15:125-133.
51. Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45:S3-S11.
52. Fries JF, Bruce B, Cella D. The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes. Clin Exp Rheumatol. 2005;23:S53-S57.
53. Davis K, Cella D. Assessing quality of life in oncology clinical practice: a review of barriers and critical success factors. J Clin Outcomes Manage. 2002;9:327-332.
54. Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977;196:129-136.
55. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995;273:59-65.
56. King MT. The interpretation of scores from the EORTC Quality of Life Questionnaire QLQ-C30. Qual Life Res. 1996;5:555-567.
57. Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002;11:207-221.
58. 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-Biological Response Modifiers (FACT-BRM) instrument. Value Health. 2005;8:117-127.
59. Schwartz AL, Meek PM, Nail LM, et al. Measurement of fatigue. Determining minimally important clinical differences. J Clin Epidemiol. 2002;55:239-244.
60. Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes. 2007;5:70.