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Review of Available Instruments and Methods for Assessing Quality of Life in Anti-Anginal Trials

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  • Pharmacoeconomics
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Abstract

Collection of patient-centred health status is a method for quantifying patient outcome in the context of clinical trials for the treatment of coronary artery disease (CAD). Traditional clinical trial end-points, such as morbidity and mortality, fail to adequately measure the health-related outcomes of disease states for which death is a rare occurrence. Health-related quality of life (QOL) and functional status surveys allow measurement of the general, and/or disease-specific, health-related limitations experienced by patients. Measures of patient preference, in turn, quantify the effects these health-related limitations have on the overall value patients ascribe to their current health state.

Together, these outcomes measures may provide a more accurate appraisal of the benefit conferred by treatment. Currently, selection of the appropriate outcomes measures and methodological approaches for a clinical trial is complicated by the lack of consensus on a single quality of life measure for use with patients with (CAD). This article outlines the use of QOL measures in anti-anginal trials done to date and summarises the approaches currently available for assessing QOL, including the differences between psychometric and preference-based techniques, and general and disease-specific health measures. In conclusion, a framework is provided for selecting the appropriate instruments and methodology in the context of the clinical trial.

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References

  1. Fries JF, Singh G. The hierarchy of patient outcomes. In: Spilker B, editor. Quality of life and pharamcoeconomics in clinical trials. 2nd ed. Philadelphia (PA): Lipincott-Raven, 1996: 33–40

    Google Scholar 

  2. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989; 27: S217–32

    Article  PubMed  CAS  Google Scholar 

  3. Tsevat J, Weeks JC, Guadagnoli E, et al. Using health-related quality-of-life information: clinical encounters, clinical trials, and health policy. J Gen Intern Med 1994; 9(10): 576–82

    Article  PubMed  CAS  Google Scholar 

  4. Spertus JA, Winder JA, Dewhurst TA, et al. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol 1994; 74: 1240–4

    Article  PubMed  CAS  Google Scholar 

  5. Rogers WJ, Coggin CJ, Gersh BJ, et al. Ten-year follow-up of quality of life in patients randomized to receive medical therapy or coronary artery bypass graft surgery (CASS). Circulation 1990; 82(5): 1647–58

    Article  PubMed  CAS  Google Scholar 

  6. Nissinen A, Wiklund I, Lahti T, et al. Anti-anginal therapy and quality of life: a comparison of the effects of transdermal nitroglycerin and long acting oral nitrates. J Clin Epidemiol 1991; 44(9): 989–97

    Article  PubMed  CAS  Google Scholar 

  7. Dupuy HJ. The psychological well-being (PGWB) index. In: Wenger N, Mattson M, Furberg C, et al., editors. Assessment of quality of life in clinical trials of cardiovascular therapies. New York: Le Jacq, 1984: 170–83

    Google Scholar 

  8. Wilson A, Wiklund I, Lahti T, et al. A summary index for the assessment of quality of life in angina pectoris. J Clin Epidemiol 1991; 44: 981–8

    Article  PubMed  CAS  Google Scholar 

  9. Fletcher A, McLoone P, Bulpitt C. Quality of life on angina therapy: a randomised controlled trial of transdermal glyceryl trinitrate against placebo. Lancet 1988; II: 4–8

    Article  Google Scholar 

  10. Ronnevik PK, Silke B, Ostergaard O. Felodipine in addition to beta-adrenergic blockade for angina pectoris. Eur Heart J 1995; 16: 1535–41

    PubMed  CAS  Google Scholar 

  11. Hinkle LE, Witney LH, Lehman EW, et al. Occupation, education and coronary heart disease. Science 1968; 161: 238–46

    Article  PubMed  Google Scholar 

  12. Rehnqvist N, Hjemdahl P, Billing E, et al. Effects of metoprolol vs verapamil in patients with stable angina pectoris. Eur Heart J 1996; 17: 76–81

    Article  PubMed  CAS  Google Scholar 

  13. Kaplan RM, Anderson JP, Wu AW, et al. The quality of well-being scale: applications in AIDS, cystic fibrosis, and arthritis. Med Care 1989; 27: S27–43

    Article  PubMed  CAS  Google Scholar 

  14. Bergner M, Bobbitt RA, Carter WB, et al. The sickness impact profile: development and final revision of a health status measure. Med Care 1981; 19: 787–805

    Article  PubMed  CAS  Google Scholar 

  15. Read JL, Quinn RJ, Hoefer MA. Measuring overall health: an evaluation of three important approaches. J Chronic Dis 1987; 40(1 Suppl.): S7–21

    Article  Google Scholar 

  16. Deyo RA, Inui TS, Leininger JD, et al. Measuring functional outcomes in chronic disease: a comparison of traditional scales and a self-administered health status questionnaire in patients with rheumatoid arthritis. Med Care 1983; 21: 180–92

    Article  PubMed  CAS  Google Scholar 

  17. DeBruin AF, De Witte LP, Stevens F, et al. Sickness impact profile: the state of the art of a generic functional status measure. Soc Sci Med 1992; 35: 1003–14

    Article  CAS  Google Scholar 

  18. Beaton DE, Bomardier C, Hogg-Johnson S. Choose your tool: a comparison of the psychometric properties of five generic health status instruments in workers with soft tissue injuries. Qual Life Res 1994; 3: 50–6

    Article  Google Scholar 

  19. Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care 1990; 28: 632–42

    Article  PubMed  CAS  Google Scholar 

  20. Hays RD, Sherbourne CD, Mazel RM. The RAND 36-item health survey 1.0. Econ Eval 1993; 2: 217–27

    CAS  Google Scholar 

  21. Ware JE, Sherbourne CD. The MOS36-item short-form health survey (SF-36): conceptual framework and item selection. Med Care 1992; 30: 473–83

    Article  PubMed  Google Scholar 

  22. Rand Health Sciences Program. RAND 36-item health survey 1.0. Santa Monica (CA): Rand Corporation, 1992

    Google Scholar 

  23. Katz JN, Larson MG, Phillips CB, et al. Comparative measurement sensitivity of short and longer health status instruments. Med Care 1992; 30: 917–25

    Article  PubMed  CAS  Google Scholar 

  24. Medical Outcomes Trust. How to score the SF-36 short-form health survey. Boston (MA): The Medical Outcomes Trust, 1992

    Google Scholar 

  25. Ware JE, Snow KK, Kosinski M, et al. SF-36 health survey: manual and interpretation guide. Boston (MA): The Health Institute, New England Medical Center, 1993

    Google Scholar 

  26. Hlatky MA. Patient preferences and clinical guidelines. JAMA 1995; 273(15): 1185–90

    Article  Google Scholar 

  27. Nease RF, Kneeland T, O’Conner GT, et al. Variation in patient utilities for outcomes of the management of chronic stable angina. JAMA 1995; 273(15): 1185–90

    Article  PubMed  Google Scholar 

  28. von Neumann J, Morgenstern O. Theory of games and economic behavior. Princeton (NJ): Princeton University Press, 1947

    Google Scholar 

  29. Weinstein MC, Fineberg HV. Clinical decision analysis. Philadelphia: WB Saunders, 1980

    Google Scholar 

  30. Torrance GW, Feeny DH, Furlong WJ, et al. Multiattribute utility function for a comprehensive health status classification system: Health Utilities Index Mark 2. Med Care 1996; 34(7): 702–22

    Article  PubMed  CAS  Google Scholar 

  31. Keeny RL, Raiffa H. Decisions with multiple objectives: preferences and value tradeoffs. New York (NY): John Wiley, 1976

    Google Scholar 

  32. Gold MR, Siegel JE, Russell LB, editors. Cost-effectiveness in health and medicine. New York (NY): Oxford University Press, 1996

    Google Scholar 

  33. Martin AJ, Lumley TS, Simes RJ. Incorporating trade-offs in quality of life assessment. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott-Raven, 1996: 403–12

    Google Scholar 

  34. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199–208

    Article  Google Scholar 

  35. Kaplan RM, Anderson JP, Ganiats TG. The quality of well-being scale: rationale for a single quality of life index. In: Walker SR, editor. Quality of life assessment: key issues in the 1990’s. Dordrecht, Netherlands: Kluwer Academic Publishers, 1993: 65–94

    Chapter  Google Scholar 

  36. Kaplan RM, Bush JW, Berry CC. Health status: types of validity and the Index of Weil-Being. Health Serv Res 1976; 11: 478–507

    PubMed  CAS  Google Scholar 

  37. Feeny DH, Torrance GW, Furlong WJ. Health utilities index. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials. Philadelphia (PA): Lippincott-Raven, 1996: 239–52

    Google Scholar 

  38. Feeny DH. Multi-attribute health status classification systems. Pharmacoeconomics 1995; 7: 490–502

    Article  PubMed  CAS  Google Scholar 

  39. Patrick DL, Erickson P. Health status and health policy: allocating resources to healthcare. New York: Oxford University Press, 1993

    Google Scholar 

  40. Cohen DJ, Breall JA, Ho KK, et al. Evaluating the potential cost-effectiveness of stenting as a treatment for symptomatic single-vessel coronary disease: use of a decision-analytic model. Circulation 1994; 89(4): 1859–74

    Article  PubMed  CAS  Google Scholar 

  41. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989; 27(3 Suppl.): S217–32

    Article  PubMed  CAS  Google Scholar 

  42. Guyatt GH, Jaeschke R, Feeny DH, et al. Measurements in clinical trials: choosing the right approach. In: Spilker B, editor. Quality of life and pharamcoeconomics in clinical trials. Philadelphia: Lipincott-Raven, 1996; 41–48

    Google Scholar 

  43. Cleary P. Health-related quality of life in persons with AIDS. Med Care 1993; 31(7): 569–80

    Article  PubMed  CAS  Google Scholar 

  44. Cox J, Naylor CD. The Canadian Cardiovascular Society grading scale for angina pectoris: is it time for refinements? Ann Intern Med 1992; 117: 677–83

    PubMed  CAS  Google Scholar 

  45. Goldman L, Hashimoto B, Cook EF, et al. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: advantages of a new specific activity scale. Circulation 1981; 64(6): 1227–34

    Article  PubMed  CAS  Google Scholar 

  46. Hlatky MA, Boineau RE, Higginbotham MB, et al. A brief self-administered questionnaire to determine functional capacity (The Duke Activity Status Index). Am J Cardiol 1989; 64: 651–4

    Article  PubMed  CAS  Google Scholar 

  47. Nelson CL, Herndon JE, Mark DB, et al. Relation of clinical and angiographic factors to functional capacity as measured by the Duke Activity Status Index. Circulation 1991; 68(9): 973–5

    CAS  Google Scholar 

  48. Spertus JA, Winder JA, Dewhurst TA, et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 1995; 25(2): 333–41

    Article  PubMed  CAS  Google Scholar 

  49. Guyatt GH, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis 1987; 40: 171–8

    Article  PubMed  CAS  Google Scholar 

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Correspondence to Brent D. Bliven.

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Bliven, B.D., Green, C.P. & Spertus, J.A. Review of Available Instruments and Methods for Assessing Quality of Life in Anti-Anginal Trials. Drugs & Aging 13, 311–320 (1998). https://doi.org/10.2165/00002512-199813040-00007

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