, Volume 1, Issue 6, pp 394–408

Health—Related Quality of Life Assessment and the Pharmaceutical Industry

  • Dennis A. Revicki
  • Margaret Rothman
  • Bryan Luce
Review Article Quality of Life and the Pharmaceutical Industry


Concerns about cost containment in healthcare and interest in the impact of medical treatment on patient health status and well—being have increased the emphasis on health—related quality of life (HRQOL) research. HRQOL assessment as part of the development and evaluation of pharmaceuticals is a reality and is likely to increase over time. HRQOL studies may assist industry in the regulatory approval process, for marketing purposes, and to assist physicians and healthcare managers in making decisions about alternative drug therapies. HRQOL studies provide physicians with complete information about the benefits and risks of drug treatments in terms of patient physical, psychological, and social functioning and well—being. HRQOL measures, especially health utility assessments, can contribute to defining health outcomes in cost—effectiveness analyses. HRQOL studies need to be planned early in the drug development process and careful attention must be made to selecting comparative medical treatments, instrumentation, data collection protocols, length of follow—up, and sample size for these studies. It is important to address issues of investigator and other sources of bias. There is evidence that the pharmaceutical industry is increasing the use of HRQOL outcomes in clinical studies. Healthcare decision—makers, physicians and patients are demanding that industry demonstrate the impact of a new drug on patient HRQOL in addition to safety and efficacy. Clearly, HRQOL represents an important indicator of the benefit of pharmaceuticals.


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  1. Agency for Health Care Policy and Research. The study of patients outcomes associated with pharmaceutical therapy (RFA NS−92–03). Rockville, MD: Agency for Health Care Policy and Research, Center for Medical Effectiveness Research, 1992Google Scholar
  2. Bergner M. Quality of life, health status, and clinical research. Medical Care 27 (Suppl.): S148–S156, 1989PubMedCrossRefGoogle Scholar
  3. Bergner M, Rothman ML. Health status measures: an overview and guide for selection. Annual Review of Public Health 8: 191–210, 1987PubMedCrossRefGoogle Scholar
  4. Bombardier C, Ware J, Russell I, Larson M, Chalmers A, et al. Auranofin therapy and quality of life in patients with rheumatoid arthritis: results of a multicenter trial. American Journal of Medicine 81: 565–578, 1986PubMedCrossRefGoogle Scholar
  5. Brooks RG. Health status and quality oflife measurement: issues and developments. Swedish Institute for Health Economics, Lund, Sweden, 1991Google Scholar
  6. Bush JW, Chen MM, Patrick DL. Health status index in cost—effectiveness: analysis of PKU program. In Berg RL (Eds) Health status indexes, Hospital Research and Educational Trust, Chicago, 1973Google Scholar
  7. Canadian Erythropoietin Study Group. Association between recombinant human erythropoietin and quality of life and exercise capacity of patients receiving haemodialysis. British Medical Journal 300: 573–578, 1990CrossRefGoogle Scholar
  8. Croog SH, Levine S, Sudilovsky A, Baume RM, Clive J. Sexual symptoms in hypertensive patients: a clinical trial of antihypertensive medications. Archives of Internal Medicine 148: 788–794, 1988PubMedCrossRefGoogle Scholar
  9. Croog SH, Levine S, Testa MA, Brown B, Bulpitt CJ, et al. The effects of antihypertensive therapy on the quality of life. New England Journal of Medicine 314: 1657–1664, 1986PubMedCrossRefGoogle Scholar
  10. Croog SH, Sudilovsky A, Levine S, Testa M. Work performance, absenteeism and antihypertensive medications. Journal of Hypertension 5 (1): S47–S54, 1987PubMedCrossRefGoogle Scholar
  11. Deyo RA. Measuring functional outcomes in therapeutic trials for chronic disease. Controlled Clinical Trials 5: 223–240, 1984PubMedCrossRefGoogle Scholar
  12. Edelson J, Weinstein M, Tosteson A, Williams L, Lee T, et al. Long—term cost—effectiveness of various initial monotherapies for mild to moderate hypertension. Journal of the American Medical Association 263: 408–413, 1990CrossRefGoogle Scholar
  13. Erickson P, Kendall EA, Anderson JP, Kaplan RM. Using composite health status measures to assess the nation’s health. Medical Care 27 (Suppl.): S66–S76, 1989PubMedCrossRefGoogle Scholar
  14. Evans R, Rader B, Manninen D and Cooperative Multicenter EPO Clinical trial Group. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. Journal of the American Medical Association 263: 825–830, 1990PubMedCrossRefGoogle Scholar
  15. Fanshel S, Bush J. A health status index and its application to health—services outcomes. Operations Research 18: 1021–1066, 1970CrossRefGoogle Scholar
  16. Frieds JF. Aging, natural death, and the compression of morbidity. New England Journal of Medicine 303: 130–135, 1980CrossRefGoogle Scholar
  17. Freund DA, Dittus RS. Principles of pharmacoeconomic analysis of drug therapy. PharmacoEconomics 1 (1): 20–29, 1992PubMedCrossRefGoogle Scholar
  18. Hatziandreu E, Revicki D, Brown R. A cost—effectiveness study of maintenance treatment for major depression. Battelle Medical Technology Assessment and Policy Research Center, pp. 1–31, Washington DC, 1992Google Scholar
  19. Henderson-James D, Spilker B. An industry perspective. In Spilker B (Ed.) Quality oflife assessments in clinical trials, Raven Press, New York, 1990Google Scholar
  20. Hillman A, Eisenberg J, Pauly M, Bloom B, Glick H, et al. Avoiding bias in the conduct and reporting of cost—effectiveness research supported by pharmaceutical companies. New England Journal of Medicine 324: 1362–1365, 1991PubMedCrossRefGoogle Scholar
  21. Hollandsworth JG. Evaluating the impact of medical treatment on the quality oflife: a 5−year update. Social Science and Medicine 26 (4): 425–434, 1988PubMedCrossRefGoogle Scholar
  22. Jaeschke R, Guyatt GH, Cook D. Quality of life instruments in the evaluation of new drugs. PharmacoEconomics 1 (2): 84–93, 1992PubMedCrossRefGoogle Scholar
  23. Johnson J, Temple R. Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treatment Reports 69: 1155–1157, 1985PubMedGoogle Scholar
  24. Katz S, Ford AB, Moskowitz RW, Jaffee MW. Studies of illness in the aged. The index of ADL: a standardized measure of biological and psychosocial function. Journal of the American Medical Association 185: 914–919, 1963PubMedCrossRefGoogle Scholar
  25. Kupperman M, Luce B, Mc Govern B, Podrid P, Jaffee MW, et al. An analysis of the cost effectiveness of the implantable cardiac defibrillator. Circulation 81: 91–100, 1990CrossRefGoogle Scholar
  26. Levine S, Croog S. What constitutes quality of life? A conceptualization of the dimensions of life quality in healthy populations and patients with cardiovascular disease. In Wenger NK, et al. (Eds) Assessment of quality of life in clinical trials of cardiovascular therapies, pp. 46–58, Le Jacq, New York, 1984Google Scholar
  27. Levine S, Croog S, Sudilovsky A, Testa M. Effects of antihypertensive medications on vitality and wel1—being. Journal of Family Practice 25 (4): 357–363, 1987PubMedGoogle Scholar
  28. Lohr K (Ed.). Advances in health status assessment: conference proceedings. Medical Care 27 (Suppl.): S1–S294, 1989PubMedCrossRefGoogle Scholar
  29. Lohr K (Ed.). Advances in health status assessment: fostering the application of health status measures in clinical settings. Medical Care 30 (Suppl.), MS1–MS293, 1992Google Scholar
  30. Luce B, Weschler J, Underwood C. The use of quality—of—life measures in the private sector. In Mosteller F, Falotico-Taylor J (Eds.) Quality of life and technology assessment, pp. 55–64, Institute of Medicine, National Academy Press, Washington, DC, 1989Google Scholar
  31. McDowell I, Newell C. Measuring health: a guide to rating scales and questionnaires, pp. 1–342, Oxford University Press, New York, 1987Google Scholar
  32. Morris L. A marketing perspective. In Spilker B (Ed.) Quality of life assessments in clinical trials, pp. 171–182, Raven Press, New York, 1990Google Scholar
  33. National Cancer Institute. Quality of life assessment in cancer clinical trials, pp. 1–60, Division of Cancer Prevention and Control, National Cancer Institute, Bethesda, 1991Google Scholar
  34. Nunnally JC. Psychometric theory, pp. 1–701, McGraw-Hill, New York, 1978Google Scholar
  35. Patrick D, Erickson P. Assessing health—related quality of life for clinical decision making. In Walker SR & Rosser RM (Eds) Quality of life: assessment and application, pp. 9–49, MTP Press, Lancaster, England, 1988Google Scholar
  36. Revicki D. Quality of life research and the health care industry. Journal of Research in Pharmaceutical Economics 2 (1): 41–53, 1990Google Scholar
  37. Revicki D. Relationship between health utility and psychometric health status measures. Medical Care 30 (Suppl), MS274–MS282, 1992CrossRefGoogle Scholar
  38. Revicki D, Brown R, Adler M, Corea J. Recombinant human erythropoietin and health—related quality of life of AIDS patients with anaemia, pp. 1–27, Battelle Medical Technology Assessment and Policy Research Center, Washington, DC, 1992Google Scholar
  39. Revicki D, Brown R, Corea J, Adler M. Health—related quality of life associated with recombinant human erythropoietin therapy for predialysis renal disease patients, pp. 1–30, Battelle Medical Technology Assessment and Policy Research Center, Washington, DC, 1991Google Scholar
  40. Sackett DL, Chambers LW, Mc Phearson AS, Goldsmith AS, Mcauley RG. The development and application of indices of health: general methods and a summary of results. American Journal of Public Health 67: 423–427, 1977PubMedCrossRefGoogle Scholar
  41. Shoemaker D, Burke G, Dorr A, Temple R, Friedman M. A regulatory perspective. In Spilker B (Ed.) Quality of life assessments in clinical trials, pp. 193–201, Raven Press, New York, 1990Google Scholar
  42. Spilker B (Ed.). Quality of life assessments in clinical trials, pp.1–470, Raven Press, New York, 1990Google Scholar
  43. Spilker B, Molinek F, Johnston K, Simpson R, Tilson H. Quality of life bibliography and indexes. Medical Care 29 (Suppl.), DS1–DS78, 1990Google Scholar
  44. Sudilovsky A, Croog S, Crook T, Turnbull B, Testa M, et al. Differential effects of antihypertensive medications on cognitive functioning. Psychopharmacology Bulletin 25 (1): 133–138, 1989PubMedGoogle Scholar
  45. Testa M, Hollenberg NK, Anderson RB, Williams GH. Assessment of quality of life by patient and spouse during antihypertensive therapy with atenolol and nifedipine gastrointestinal therapeutic system. American Journal of Hypertension 4: 363–373, 1991PubMedGoogle Scholar
  46. Torrrance G, Feeny D. Utilities and quality—adjusted life years. International Journal of Technology Assessment in Health Care 5: 559–575, 1989CrossRefGoogle Scholar
  47. Ware JE. Methodologic considerations in the selection of health status assessment procedures. In Wenger N, et al. (Eds) Assessment of quality of life in clinical trials of cardiovascular therapies, pp. 87–111, Le Jacq, New York, 1984Google Scholar
  48. Ware JE. The use of health status and quality of life measures in outcomes and effectiveness research, Prepared for the National Agenda Setting Conference on Outcomes and Effectiveness Research, pp. 1–60, Agency for Health Care Policy and Research, Alexandria, VA, April, 1991Google Scholar
  49. Ware JE, Sherbourne CD. A 36−item short—form health survey (SF−36): I. conceptual framework and item selection. Medical Care, in press, 1992Google Scholar
  50. Weinstein MC, Stason WB. Foundations of cost—effectiveness an alysis for health and medical practices. New England Journal of Medicine 296: 716–721, 1977PubMedCrossRefGoogle Scholar
  51. Wenger N, Mattson M, Furberg C, Elinson L (Eds) Assessment of quality of life in clinical trials of cardiovascular therapies, pp. 1–374, Le Jacq, New York, 1984Google Scholar
  52. Williams J, Sanders C, Riddiough M. Cost effectiveness of vaccination against pneumococcal pneumonia. New England Journal of Medicine 303 (10): 553–559, 1980CrossRefGoogle Scholar
  53. Williams G. Quality oflife and its impact on hypertensive patients. American Journal of Medicine 82: 98–105, 1987PubMedCrossRefGoogle Scholar
  54. Williams G, Croog S, Levine S, Testa M, Sudilovsky A. Impact of antihypenensive therapy on quality of life: effect of hydrochlorothiazide. Journal of Hypenension 5 (1): S29–S35, 1987Google Scholar
  55. Wu A, Mathews W, Brysk L, Atkinson J, Grant I, et al. Quality of life in a placebo—controlled trial of zidovudine in patients with AIDS and AIDS—related complex. Journal of Acquired Immune Deficiency Syndrome 3: 683–690, 1990Google Scholar

Copyright information

© Adis International Limited 1992

Authors and Affiliations

  • Dennis A. Revicki
    • 1
  • Margaret Rothman
    • 1
  • Bryan Luce
    • 1
  1. 1.Medical Technology Assessment and Policy Research Center, Battelle Human Affairs, Research CentersUSA

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