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CMAJ : Canadian Medical Association Journal logoLink to CMAJ : Canadian Medical Association Journal
. 1989 Jun 15;140(12):1441–1448.

Measuring quality of life in clinical trials: a taxonomy and review.

G H Guyatt 1, S J Veldhuyzen Van Zanten 1, D H Feeny 1, D L Patrick 1
PMCID: PMC1269981  PMID: 2655856

Abstract

Measurement of quality of life is becoming increasingly relevant to controlled clinical trials. Two basic types of instrument are available: generic instruments, which include health profiles and utility measurements based on the patient's preferences in regard to treatment and outcome; and specific instruments, which focus on problems associated with individual diseases, patient groups or areas of function. The two approaches are not mutually exclusive; each has its strengths and weaknesses and may be suitable under different circumstances. We surveyed 75 randomized trials published in three medical journals in 1986 and categorized them according to the importance of quality of life as a measure of outcome and the extent to which quality of life was actually measured. Although a number of the investigators used quality-of-life instruments in a sophisticated manner, in only 10 of 55 trials in which the measurement had been judged to be crucial or important were instruments with established validity and responsiveness used. We conclude that although accurate measurement of quality of life in randomized trials is now feasible it is still not widely done. Using the framework we have outlined, investigators can choose generic or specific instruments according to the purpose and the focus of their trial.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Bergner M., Bobbitt R. A., Carter W. B., Gilson B. S. The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 1981 Aug;19(8):787–805. doi: 10.1097/00005650-198108000-00001. [DOI] [PubMed] [Google Scholar]
  2. Bergner M. Measurement of health status. Med Care. 1985 May;23(5):696–704. doi: 10.1097/00005650-198505000-00028. [DOI] [PubMed] [Google Scholar]
  3. Croog S. H., Levine S., Testa M. A., Brown B., Bulpitt C. J., Jenkins C. D., Klerman G. L., Williams G. H. The effects of antihypertensive therapy on the quality of life. N Engl J Med. 1986 Jun 26;314(26):1657–1664. doi: 10.1056/NEJM198606263142602. [DOI] [PubMed] [Google Scholar]
  4. Deyo R. A., Diehl A. K., Rosenthal M. How many days of bed rest for acute low back pain? A randomized clinical trial. N Engl J Med. 1986 Oct 23;315(17):1064–1070. doi: 10.1056/NEJM198610233151705. [DOI] [PubMed] [Google Scholar]
  5. Deyo R. A. Measuring functional outcomes in therapeutic trials for chronic disease. Control Clin Trials. 1984 Sep;5(3):223–240. doi: 10.1016/0197-2456(84)90026-6. [DOI] [PubMed] [Google Scholar]
  6. Fletcher A. E., Hunt B. M., Bulpitt C. J. Evaluation of quality of life in clinical trials of cardiovascular disease. J Chronic Dis. 1987;40(6):557–569. doi: 10.1016/0021-9681(87)90014-2. [DOI] [PubMed] [Google Scholar]
  7. Fries J. F., Spitz P., Kraines R. G., Holman H. R. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137–145. doi: 10.1002/art.1780230202. [DOI] [PubMed] [Google Scholar]
  8. Guyatt G. H., Berman L. B., Townsend M., Pugsley S. O., Chambers L. W. A measure of quality of life for clinical trials in chronic lung disease. Thorax. 1987 Oct;42(10):773–778. doi: 10.1136/thx.42.10.773. [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Guyatt G. H., Bombardier C., Tugwell P. X. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986 Apr 15;134(8):889–895. [PMC free article] [PubMed] [Google Scholar]
  10. Guyatt G. H., Townsend M., Berman L. B., Pugsley S. O. Quality of life in patients with chronic airflow limitation. Br J Dis Chest. 1987 Jan;81(1):45–54. doi: 10.1016/0007-0971(87)90107-0. [DOI] [PubMed] [Google Scholar]
  11. Guyatt G. H., Townsend M., Pugsley S. O., Keller J. L., Short H. D., Taylor D. W., Newhouse M. T. Bronchodilators in chronic air-flow limitation. Effects on airway function, exercise capacity, and quality of life. Am Rev Respir Dis. 1987 May;135(5):1069–1074. doi: 10.1164/arrd.1987.135.5.1069. [DOI] [PubMed] [Google Scholar]
  12. Guyatt G., Walter S., Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;40(2):171–178. doi: 10.1016/0021-9681(87)90069-5. [DOI] [PubMed] [Google Scholar]
  13. Hoofnagle J. H., Davis G. L., Pappas S. C., Hanson R. G., Peters M., Avigan M. I., Waggoner J. G., Jones E. A., Seeff L. B. A short course of prednisolone in chronic type B hepatitis. Report of a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1986 Jan;104(1):12–17. doi: 10.7326/0003-4819-104-1-12. [DOI] [PubMed] [Google Scholar]
  14. Hunt S. M., McKenna S. P., McEwen J., Backett E. M., Williams J., Papp E. A quantitative approach to perceived health status: a validation study. J Epidemiol Community Health. 1980 Dec;34(4):281–286. doi: 10.1136/jech.34.4.281. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Kaplan R. M., Bush J. W., Berry C. C. Health status: types of validity and the index of well-being. Health Serv Res. 1976 Winter;11(4):478–507. [PMC free article] [PubMed] [Google Scholar]
  16. Kirshner B., Guyatt G. A methodological framework for assessing health indices. J Chronic Dis. 1985;38(1):27–36. doi: 10.1016/0021-9681(85)90005-0. [DOI] [PubMed] [Google Scholar]
  17. Liang M. H., Larson M. G., Cullen K. E., Schwartz J. A. Comparative measurement efficiency and sensitivity of five health status instruments for arthritis research. Arthritis Rheum. 1985 May;28(5):542–547. doi: 10.1002/art.1780280513. [DOI] [PubMed] [Google Scholar]
  18. Llewellyn-Thomas H., Sutherland H. J., Tibshirani R., Ciampi A., Till J. E., Boyd N. F. The measurement of patients' values in medicine. Med Decis Making. 1982 Winter;2(4):449–462. doi: 10.1177/0272989X8200200407. [DOI] [PubMed] [Google Scholar]
  19. MacKenzie C. R., Charlson M. E., DiGioia D., Kelley K. Can the Sickness Impact Profile measure change? An example of scale assessment. J Chronic Dis. 1986;39(6):429–438. doi: 10.1016/0021-9681(86)90110-4. [DOI] [PubMed] [Google Scholar]
  20. MacKenzie C. R., Charlson M. E. Standards for the use of ordinal scales in clinical trials. Br Med J (Clin Res Ed) 1986 Jan 4;292(6512):40–43. doi: 10.1136/bmj.292.6512.40. [DOI] [PMC free article] [PubMed] [Google Scholar]
  21. Mahler D. A., Weinberg D. H., Wells C. K., Feinstein A. R. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751–758. doi: 10.1378/chest.85.6.751. [DOI] [PubMed] [Google Scholar]
  22. Mayou R., MacMahon D., Sleight P., Florencio M. J. Early rehabilitation after myocardial infarction. Lancet. 1981 Dec 19;2(8260-61):1399–1402. doi: 10.1016/s0140-6736(81)92811-7. [DOI] [PubMed] [Google Scholar]
  23. McCormick J. B., King I. J., Webb P. A., Scribner C. L., Craven R. B., Johnson K. M., Elliott L. H., Belmont-Williams R. Lassa fever. Effective therapy with ribavirin. N Engl J Med. 1986 Jan 2;314(1):20–26. doi: 10.1056/NEJM198601023140104. [DOI] [PubMed] [Google Scholar]
  24. Meenan R. F., Anderson J. J., Kazis L. E., Egger M. J., Altz-Smith M., Samuelson C. O., Jr, Willkens R. F., Solsky M. A., Hayes S. P., Blocka K. L. Outcome assessment in clinical trials. Evidence for the sensitivity of a health status measure. Arthritis Rheum. 1984 Dec;27(12):1344–1352. doi: 10.1002/art.1780271204. [DOI] [PubMed] [Google Scholar]
  25. Mitsuyasu R. T., Champlin R. E., Gale R. P., Ho W. G., Lenarsky C., Winston D., Selch M., Elashoff R., Giorgi J. V., Wells J. Treatment of donor bone marrow with monoclonal anti-T-cell antibody and complement for the prevention of graft-versus-host disease. A prospective, randomized, double-blind trial. Ann Intern Med. 1986 Jul;105(1):20–26. doi: 10.7326/0003-4819-105-1-20. [DOI] [PubMed] [Google Scholar]
  26. Nelson E., Conger B., Douglass R., Gephart D., Kirk J., Page R., Clark A., Johnson K., Stone K., Wasson J. Functional health status levels of primary care patients. JAMA. 1983 Jun 24;249(24):3331–3338. [PubMed] [Google Scholar]
  27. Olsson G., Lubsen J., van Es G. A., Rehnqvist N. Quality of life after myocardial infarction: effect of long term metoprolol on mortality and morbidity. Br Med J (Clin Res Ed) 1986 Jun 7;292(6534):1491–1493. doi: 10.1136/bmj.292.6534.1491. [DOI] [PMC free article] [PubMed] [Google Scholar]
  28. Ott C. R., Sivarajan E. S., Newton K. M., Almes M. J., Bruce R. A., Bergner M., Gilson B. S. A controlled randomized study of early cardiac rehabilitation: the Sickness Impact Profile as an assessment tool. Heart Lung. 1983 Mar;12(2):162–170. [PubMed] [Google Scholar]
  29. Pocock S. J., Hughes M. D., Lee R. J. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med. 1987 Aug 13;317(7):426–432. doi: 10.1056/NEJM198708133170706. [DOI] [PubMed] [Google Scholar]
  30. Prigatano G. P., Wright E. C., Levin D. Quality of life and its predictors in patients with mild hypoxemia and chronic obstructive pulmonary disease. Arch Intern Med. 1984 Aug;144(8):1613–1619. [PubMed] [Google Scholar]
  31. Sackett D. L., Chambers L. W., MacPherson A. S., Goldsmith C. H., Mcauley R. G. The development and application of indices of health: general methods and a summary of results. Am J Public Health. 1977 May;67(5):423–428. doi: 10.2105/ajph.67.5.423. [DOI] [PMC free article] [PubMed] [Google Scholar]
  32. Schipper H., Clinch J., McMurray A., Levitt M. Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation. J Clin Oncol. 1984 May;2(5):472–483. doi: 10.1200/JCO.1984.2.5.472. [DOI] [PubMed] [Google Scholar]
  33. Shepp D. H., Dandliker P. S., Meyers J. D. Treatment of varicella-zoster virus infection in severely immunocompromised patients. A randomized comparison of acyclovir and vidarabine. N Engl J Med. 1986 Jan 23;314(4):208–212. doi: 10.1056/NEJM198601233140404. [DOI] [PubMed] [Google Scholar]
  34. Siegrist J. Impaired quality of life as a risk factor in cardiovascular disease. J Chronic Dis. 1987;40(6):571–578. doi: 10.1016/0021-9681(87)90016-6. [DOI] [PubMed] [Google Scholar]
  35. Spitzer W. O., Dobson A. J., Hall J., Chesterman E., Levi J., Shepherd R., Battista R. N., Catchlove B. R. Measuring the quality of life of cancer patients: a concise QL-index for use by physicians. J Chronic Dis. 1981;34(12):585–597. doi: 10.1016/0021-9681(81)90058-8. [DOI] [PubMed] [Google Scholar]
  36. Spitzer W. O. State of science 1986: quality of life and functional status as target variables for research. J Chronic Dis. 1987;40(6):465–471. doi: 10.1016/0021-9681(87)90002-6. [DOI] [PubMed] [Google Scholar]
  37. Sugarbaker P. H., Barofsky I., Rosenberg S. A., Gianola F. J. Quality of life assessment of patients in extremity sarcoma clinical trials. Surgery. 1982 Jan;91(1):17–23. [PubMed] [Google Scholar]
  38. Sutherland H. J., Dunn V., Boyd N. F. Measurement of values for states of health with linear analog scales. Med Decis Making. 1983;3(4):477–487. doi: 10.1177/0272989X8300300406. [DOI] [PubMed] [Google Scholar]
  39. Toevs C. D., Kaplan R. M., Atkins C. J. The costs and effects of behavioral programs in chronic obstructive pulmonary disease. Med Care. 1984 Dec;22(12):1088–1100. doi: 10.1097/00005650-198412000-00004. [DOI] [PubMed] [Google Scholar]
  40. Torrance G. W. Measurement of health state utilities for economic appraisal. J Health Econ. 1986 Mar;5(1):1–30. doi: 10.1016/0167-6296(86)90020-2. [DOI] [PubMed] [Google Scholar]
  41. Yu V. L., Goetz A., Wagener M., Smith P. B., Rihs J. D., Hanchett J., Zuravleff J. J. Staphylococcus aureus nasal carriage and infection in patients on hemodialysis. Efficacy of antibiotic prophylaxis. N Engl J Med. 1986 Jul 10;315(2):91–96. doi: 10.1056/NEJM198607103150204. [DOI] [PubMed] [Google Scholar]

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