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© 2002 American Society for Clinical Oncology
Beyond the Development of Quality-of-Life Instruments: Where Do We Go From Here?Henderson Hospital, Hamilton, Ontario, Canada
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, CA OVER 50 YEARS ago, Karnofsky and Burchenal1 described a simple scale to measure the impact of cancer and its treatment on function in patients with lung cancer receiving nitrogen mustard therapy. In the ensuing years, the number and complexity of anticancer therapies increased dramatically. Such treatments not only caused tumor regression and improved survival but also, in some instances, were associated with significant toxicity. In the early 1980s, in what some might consider a renaissance, clinicians and researchers recognized that there was more to treating a cancer than merely shrinkage of the tumor (response rate) and lengthening of survival.2 The impact of the cancer and associated therapies could have substantial impact on a patient’s physical, emotional, and social functioning (termed quality of life).3,4 The recognition of the importance of quality of life led to much research on measurement of this aspect of cancer treatment.5 A rigorous methodology evolved for the development of many quality-of-life instruments.6,7 The resulting instruments had to be valid (measured what they were supposed to) and reproducible (consistent over time in stable patients). TheJournal of Clinical Oncology led the way in raising the profile of the topic by publishing initial descriptive papers for a number of quality-of-life instruments, including the Functional Living Index-Cancer,8 the Functional Assessment of Cancer Therapy scale,9 and the Breast Cancer Chemotherapy Questionnaire.10 The next stage in the quality-of-life story was the incorporation of quality of life as an outcome measure in cancer clinical trials.11 The belief was that quality of life would be useful in the comparison of treatments where differences in such antitumor outcomes as response or survival were modest but toxicities significant.12 The measurement of quality of life in trials brought with it further methodologic challenges related to compliance with data collection and complex longitudinal analyses when data were not missing at random. For example, patients who become sick or die can no longer complete the quality-of-life assessments.13 In this edition of the Journal, Heffernan et al14 describe the development of an instrument to specifically measure quality of life for patients with hepatobiliary cancer. The instrument combines the well-established Functional Assessment of Cancer Therapy scale-G questionnaire, which assesses generic quality-of-life issues, with a new 18-item disease-specific subscale. The study is an exemplary model of how to develop a quality-of-life instrument. The steps used, including item generation, testing for validity and reliability, and measuring responsiveness were painstakingly carried out and well-described in the article. The question now, however, is what comes next? Will this instrument be used in trials or every day practice? How will it contribute to improved patient care? Despite the availability of a number of quality-of-life instruments, the existence of a journal devoted specifically to quality-of-life research, and the fact that thousands of cancer patients have had their quality of life measured in clinical trials, it is disappointing that there are relatively few examples of formal quality-of-life measurement that have influenced individual patient decision-making or treatment policies. There are certainly some important positive exceptions, such as Tannock et al’s15 study in patients with advanced prostate cancer. However, in that study, pain relief and decreased analgesic use were the primary and secondary end points. There are a number of studies that have been published in the Journal in recent years that show significant changes in specific symptoms or toxicity but no significant changes in quality-of-life measurements.16-18 In all of these instances, the condition-specific measurements seem to perform better than the multidimensional or global quality-of-life instruments in assessing differences in patients. An exception is the trial reported by Moinpour et al,19 in which patients with metastatic prostate cancer were randomly assigned to orchiectomy with flutamide or placebo. The quality-of-life assessment documented fewer symptoms in the placebo, as was expected, and a nonsignificant trend toward better physical functioning in the placebo group. However, an unexpected result was a poorer emotional functioning for the patients receiving flutamide that was statistically significant, which led to speculation about a CNS effect of this antiandrogen. Thus, quality-of-life assessment may sometimes detect unanticipated outcomes. Years ago, the Journal took a lead role in recognizing the importance of quality of life. In addition, this outcome has been very important for the American Society of Clinical Oncology.20 Currently, the National Cancer Institute, through the Cancer Outcomes Measurement Working Group, has a major effort underway to assess the added value of quality-of-life assessment in clinical trials and clinical research. A major publication will be forthcoming that will summarize where we are to date in the assessment of quality of life, what has been accomplished, and what still needs to be done. In everyday practice, clinicians and patients consider issues related to quality of life in their decision-making. How does the measurement of quality of life in groups of patients and the administration of a quality-of-life questionnaire to an individual patient ultimately improve care? This is the challenge for the next decade. We think back to the eloquent 1999 editorial in this Journal by George Browman21 that raised these same questions. The editors have given considerable thought to the issue of "whither goes quality of life measurement." We have a strong feeling that the Journal must move beyond the publication of new instruments and measurement of quality of life in trials. We strongly encourage research on the next step—the translation of quality-of-life measurement into clinical practice to improve patient care—and would be pleased to publish such research. REFERENCES 1. Karnofsky DA, Burchenal JH: The clinical evaluation of chemotherapeutic agents in cancer, in MacLeod CM (ed): Evaluation of Chemotherapeutic Agents. New York, NY, Columbia University Press, 1949, pp 199-205 2. Schag CC, Heinrich RL, Ganz PA: Karnofsky performance status revisited: Reliability, validity, and guidelines. J Clin Oncol 2: 187-193, 1984[Abstract] 3. Aaronson NK: Quality of life: What is it? How should it be measured? Oncology (Huntingt) 2:69-76, 64, 1988 4. Cella DF, Cherin EA: Quality of life during and after cancer treatment. Compr Ther 14: 69-75, 1988 5. Aaronson NK: Quality of life research in cancer clinical trials: A need for common rules and language. Oncology (Huntingt) 4: 59-66, 1990 6. Aaronson NK: Methodologic issues in assessing the quality of life of cancer patients. Cancer 67: 844-850, 1991[CrossRef][Medline] 7. Cella DF, Tulsky DS: Measuring quality of life today: methodological aspects. Oncology (Huntingt) 4: 29-38, 1990[Medline] 8. Schipper H, Clinch J, McMurray A, et al: Measuring the quality of life of cancer patients: The Functional Living Index-Cancer—Development and validation. J Clin Oncol 2: 472-483, 1984[Abstract]
9.
Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 11: 570-579, 1993 10. Levine MN, Guyatt GH, Gent M, et al: Quality of life in stage II breast cancer: An instrument for clinical trials. J Clin Oncol 6: 1798-1810, 1988[Abstract] 11. Nayfield SG, Ganz PA, Moinpour CM, et al: Report from a National Cancer Institute (USA) workshop on quality of life assessment in cancer clinical trials. Qual Life Res 1: 203-210, 1992[CrossRef][Medline] 12. Ganz PA, Figlin RA, Haskell CM, et al: Supportive care versus supportive care and combination chemotherapy in metastatic non-small cell lung cancer: Does chemotherapy make a difference? Cancer 63: 1271-1278, 1989[CrossRef][Medline] 13. 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[CrossRef][Medline]
14.
Heffernan N, Cella D, Webster K, et al: Measuring health-related quality of life in patients with hepatobiliary cancers: The Functional Assessment of Cancer Therapy–Hepatobiliary Questionnaire. J Clin Oncol 20: 2229-2239, 2002
15.
Tannock IF, Osoba D, Stockler MR, et al: Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: A Canadian randomized trial with palliative end points. J Clin Oncol 14: 1756-1764, 1996
16.
Kirkbride P, Bezjak A, Pater J, et al: Dexamethasone for the prophylaxis of radiation-induced emesis: A National Cancer Institute of Canada Clinical Trials Group phase III study. J Clin Oncol 18: 1960-1966, 2000
17.
Day R, Ganz PA, Costantino JP, et al: Health-related quality of life and tamoxifen in breast cancer prevention: A report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Clin Oncol 17: 2659-2669, 1999
18.
Yang JC, Chang AE, Baker AR, et al: Randomized prospective study of the benefit of adjuvant radiation therapy in the treatment of soft tissue sarcomas of the extremity. J Clin Oncol 16: 197-203, 1998
19.
Moinpour CM, Savage MJ, Troxel A, et al: Quality of life in advanced prostate cancer: Results of a randomized therapeutic trial. J Natl Cancer Inst 90: 1537-1544, 1998
20.
American Society of Clinical Oncology: Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol 14: 671-679, 1996
21.
Browman GP: Science, language, intuition, and the many meanings of quality of life. J Clin Oncol 17: 1651, 1999 (editorial)
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Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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