CNS Drugs

, Volume 1, Issue 6, pp 465–476 | Cite as

Assessing Health-Related Quality of Life Outcomes of Drug Treatments for Psychiatric Disorders

  • Dennis A. Revicki
  • Miranda Murray
Review Article Clinical Concepts


There is increasing interest in evaluating the health outcomes and effectiveness of new pharmaceutical treatments for psychiatric disorders, such as depression, anxiety and schizophrenia. There is also increased emphasis on understanding the affect of treatment on patient quality of life.

Few comprehensive health-related quality of life (HRQL) studies have been performed to examine social, occupational and functional outcomes in patients with chronic schizophrenia. The most widely used scales include the Social Adjustment Scale, the Quality of Life Scale and the Quality of Life Interview. New scales, such as the Quality of Life Index for Mental Health, are under development and there is increasing interest in evaluating more broadly the impact of treatment of patient indices of functioning and well-being in schizophrenia. Research, over the last few years, has focused on understanding the impact of major depression and anxiety and treatment for these disorders on HRQL. Existing generic health status measures, such as those developed for the Medical Outcomes Study, are increasingly incorporated into clinical trials of new antidepressant treatments. Unfortunately, most of these have not reached publication. Several depression-specific measures, such as the SmithKline Beecham Quality of Life scale, Quality of Life Enjoyment and Satisfaction Questionnaire, and the Quality of Life in Depression scale, have been developed and are beginning to be used in clinical studies. However, there is only limited information available about the reliability, validity and responsiveness of most of these new scales.

The selection of HRQL measures and the design of HRQL components for clinical trials needs to be guided by the objectives of the research, the target population, and the potential positive and negative consequences of the pharmacological treatment. Selection of specific instruments is based on the relevance of the measure, the reliability and validity of the scale, and practical considerations. The ability of a HRQL scale to discriminate between persons with different severity of disease, and the responsiveness to change are critical treatment evaluations. Practical characteristics include respondent and investigator burden, and the mode of administration of the scale. In the design of a clinical trial, attention must be focused on identifying appropriate data collection intervals to detect important changes in HRQL, if they should occur, and in addressing logistical and practical issues associated with the administration of HRQL scales.


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  1. 1.
    Revicki DA, Rothman M, Luce B. Health-related quality of life assessments and the pharmaceutical industry. PharmacoEconomics 1992; 1: 394–408PubMedCrossRefGoogle Scholar
  2. 2.
    Revicki DA, Shakespeare A, Borowitz M. Health state preferences in schizophrenia: comparisons of patients, family members and clinicians. Proceedings of the Annual Meeting of the Society for Medical Decision Making; 1993 Oct: Durham, USAGoogle Scholar
  3. 3.
    Awad AG. Quality of life of schizophrenic patients on medications and implications for new drug trials. Hosp Community Psychiatry 1992; 43: 262–5PubMedGoogle Scholar
  4. 4.
    Lehman AF, Burns BJ. Severe mental illness in the community. In: Spilker B, editor. Quality of life assessments in clinical trials. New York: Raven Press, 1990: 357–66Google Scholar
  5. 5.
    Lehman AF. Measures of humanistic outcomes (quality of life) among persons with severe and persistent mental disorders. Baltimore: University of Maryland, Department of Psychiatry, 1993Google Scholar
  6. 6.
    Collins EJ, Hogan TP, Himansu D. Measurement of therapeutic response in schizophrenia. A critical survey. Schizophr Res 1991; 5: 249–53PubMedCrossRefGoogle Scholar
  7. 7.
    Revicki DA, Turner R, Brown R, et al. Reliability and validity of health-related quality of life battery for evaluating outpatient antidepressant treatment. Qual Life Res 1992; 1: 257–66PubMedCrossRefGoogle Scholar
  8. 8.
    Rost K, Smith GR, Burnman MA, et al. Measuring the outcomes of care for mental health problems: the case of depressive disorders, Med Care 1992; 30: MS266–73PubMedCrossRefGoogle Scholar
  9. 9.
    Carpenter WT, Hanlon TE, Heinrichs DW, et al. Continuous versus targeted medication in schizophrenic outpatients: outcome results. Am J Psychiatry 1990; 147: 1138–48PubMedGoogle Scholar
  10. 10.
    Lehman AF, Ward NC, Linn LS. Chronic mental patients: the quality of life issue. Am J Psychiatry 1982; 10: 1271–6Google Scholar
  11. 11.
    Meltzer HY, Burnett S, Bastani B, et al. Effects of six months of clozapine treatment on the quality of life of chronic schizophrenic patients. Hosp Community Psychiatry 1990; 41: 892–7PubMedGoogle Scholar
  12. 12.
    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, Agency for Health Policy and Research, Alexandria, VA, April 1991Google Scholar
  13. 13.
    World Health Organization. World Health Organization Constitution. Basic Documents. Geneva: World Health Organization, 1948Google Scholar
  14. 14.
    Patrick D, Erickson P. Health status and health policy: allocating resources to health care. New York: Oxford University Press, 1993Google Scholar
  15. 15.
    Franklin JL, Simmons J, Solovitz B, et al. Assessing quality of life in the mentally ill: a three-dimensional model. Eval Health Prof 1986; 3: 376–88CrossRefGoogle Scholar
  16. 16.
    May PRA. Schizophrenia: evaluation of treatment methods. In: Freedman AM, Kaplan HI, Sadock BJ, editors. Comprehensive textbook of psychiatry. Baltimore: Williams & Wilkins Co., 1975: 955–82Google Scholar
  17. 17.
    Carpenter WT, Heinrichs DW, Hanlon TE. Methodologic standards for treatment outcome research in schizophrenia. Am J Psychiatry 1981; 138: 465–71PubMedGoogle Scholar
  18. 18.
    Van Putten T, May PRA, Marder SR, et al. Subjective response to antipsychotic drugs. Arch Gen Psychiatry 1981; 38: 187–90PubMedCrossRefGoogle Scholar
  19. 19.
    Hogan TP, Awad AG, Eastwood MR. A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative validity. Psychol Med 1983; 13: 177–83PubMedCrossRefGoogle Scholar
  20. 20.
    Hogan TP, Awad AG. Subjective response to neuroleptic and outcome in schizophrenia: a re-examinations comparing two measure. Psychol Med 1992; 22: 347–52PubMedCrossRefGoogle Scholar
  21. 21.
    Hawk AB, Carpenter WT, Struass JS. Diagnostic criteria and two-year outcome in schizophrenia: a report from the International Pilot Study of Schizophrenia. Arch Gen Psychiatry 1975; 32: 343–7PubMedCrossRefGoogle Scholar
  22. 22.
    Heinrichs DW, Hanlon TE, Carpenter WT. The quality of life scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull 1984; 3: 388–98Google Scholar
  23. 23.
    Meltzer HY. Dimensions of outcome with clozapine. Br J Psychiatry 1992; 160 Suppl. 17: 46–53Google Scholar
  24. 24.
    Lurie N, Moscovice IS, Finch M, et al. Does capitation affect the health of chronically mentally ill? JAMA 1992; 267: 3300–4PubMedCrossRefGoogle Scholar
  25. 25.
    Hogan TP, Awad AG, Eastwood MR. Early subjective response and prediction of outcome to neuroleptic drug therapy in schizophrenia. Can J Psychiatry 1985 30: 246–8PubMedGoogle Scholar
  26. 26.
    Kane RA, Kane RL, Arnold S. Measuring social functioning in mental health studies. Concepts and instruments. DHHS Pub. no. (ADM) 85-1384. Washington, DC: US Government Printing Office, 1985Google Scholar
  27. 27.
    Strauss JS, Carpenter WT. The prediction of outcome in schizophrenia. II. Relationships between predictor and outcome variables: a report from the WHO International Pilot Study of Schizophrenia. Arch Gen Psychiatry 1974; 31: 37–42PubMedCrossRefGoogle Scholar
  28. 28.
    Gaebel W, Pietzcker A. Prospective study of course of illness in schizophrenia: Part II. Prediction of outcome. Schizophrenia Bull; 1987 13: 299–308Google Scholar
  29. 29.
    Schooler N, Hogarty G, Weissman MM. Social Adjustment Scale II (SASII). In: Hargreaves WA, Attkisson CC, Sorenson JE, editors. Resource materials for community health program evaluators. Publ. no. (ADM) 79-328. Washington DC: US Department of Health, Education and Welfare, 1979: 290–330Google Scholar
  30. 30.
    Kreisman D, Blumenthal R, Borenstein M, et al. Family attitudes and patient social adjustment in a longitudinal study of outpatient schizophrenics receiving low-dose neuroleptics: the family’s view. Psychiatry 1988; 51: 3–13PubMedGoogle Scholar
  31. 31.
    Bellack AS, Morrison RL, Nixted JR, et al. An analysis of social competence in schizophrenia. Br J Psychiatry 1990; 156: 809–18PubMedCrossRefGoogle Scholar
  32. 32.
    Hogarty GE, Anderson CM, Reiss DJ, et al. Family psychoeducation, social skills training, and maintenance chemotherapy in the aftercare treatment of schizophrenia. Arch Gen Psychiatry 1986; 43: 633–42PubMedCrossRefGoogle Scholar
  33. 33.
    Hogarty GE, Anderson CM, Reiss DJ, et al. Family psychoeducation, social skills training, and maintenance chemotherapy in the aftercare treatment of schizophrenics II: Two-year effects of a controlled study on relapse and adjustment. Arch Gen Psychiatry 1991; 48: 340–7PubMedCrossRefGoogle Scholar
  34. 34.
    Glazer W, Aaronson HS, Prusoff BA, et al. Assessment of social adjustment in chronic ambulatory schizophrenics. J Nerv Ment Dis 1980: 168: 493–7PubMedCrossRefGoogle Scholar
  35. 35.
    Paykel ES, Klerman GL, DiMascio A, et al. Maintenance anti-depressants, psychotherapy, symptoms and social function. In: Cole J, Friedhoff A, Freedman J, editors. Psychopathology and psychopharmacology. Baltimore: Johns Hopkins Press, 1973: 205–18Google Scholar
  36. 36.
    Weissman MM, Klerman GL, Paykel ES, et al. Treatment effects on the social adjustment of depressed patients. Arch Gen Psychiatry 1974; 30: 771–8PubMedCrossRefGoogle Scholar
  37. 37.
    Weissman MM, Klerman GL, Prusoff BA, et al. Depressed out-patients: results one year after treatment with drugs and/or interpersonal psychotherapy. Arch Gen Psychiatry 1981; 38: 51–5PubMedCrossRefGoogle Scholar
  38. 38.
    Kocsis JH, Frances AJ, Voss C, et al. Imipramine treatment for chronic depression. Arch Gen Psychiatry 1988; 45: 253–7PubMedCrossRefGoogle Scholar
  39. 39.
    Stewart JW, Quitkin FM, McGrath PJ, et al. Social functioning in chronic depression: effect of six weeks of antidepressant treatment. Psychiatry Res 1988; 25: 213–22PubMedCrossRefGoogle Scholar
  40. 40.
    Weissman MM, Prusoff BA, Thompson WD, et al. Social adjustment by self-report in a community sample and in psychiatric outpatients. J Nerv Ment Dis 1978; 166: 317–26PubMedCrossRefGoogle Scholar
  41. 41.
    Weissman MM, Sholomskas D, John J. The assessment of social adjustment: an update. Arch Gen Psychiatry 1981; 38: 1250–8PubMedCrossRefGoogle Scholar
  42. 42.
    Weissman MM, Bothwell S. The assessment of social adjustment by patient self-report. Arch Gen Psychiatry 1976; 33: 1111–5PubMedCrossRefGoogle Scholar
  43. 43.
    Wiersma D, de John A, Kraaijkamp HJM, et al. GSDS-II Manual: The Groningen Social Disabilities Schedule. Groningen, The Netherlands: University of Groningen, Department of Social Psychiatry, 1990Google Scholar
  44. 44.
    Bigelow DA, McFarland BH, Olson MM. Quality of life of community health program clients: validating a measure. Community Ment Health J 1991; 27: 43–55PubMedCrossRefGoogle Scholar
  45. 45.
    Lehman AF. A quality of life interview for the chronically mentally ill. Eval Prog Planning 1988; 11: 51–62CrossRefGoogle Scholar
  46. 46.
    Becker M, Diamond R, Sainfort F. A new patient focused index for measuring quality of life in persons with severe and persistent mental illness. Qual Life Res 1993; 2: 239–51PubMedCrossRefGoogle Scholar
  47. 47.
    Stewart AL, Hays RD, Ware JD. The MOS short-form general health survey: reliability and validity in patients population. Med Care 1988; 26: 724–35PubMedCrossRefGoogle Scholar
  48. 48.
    Simpson CJ, Hyde CE, Faragher EB. The chronically mentally ill in community facilities: a study of quality of life. Br J Psychiatry 1989; 154: 77–82PubMedCrossRefGoogle Scholar
  49. 49.
    Lehman AF, Possidente S, Hawker F. The quality of life of chronic mental patients in a state hospital and community residents. Hosp Community Psychiatry 1986; 37: 901–7PubMedGoogle Scholar
  50. 50.
    Levitt AJ, Hogan TP, Bucosky CM, Quality of life in chronically mentally ill patients in day treatment. Psychol Med 1990; 20: 703–10PubMedCrossRefGoogle Scholar
  51. 51.
    Rosenfield S, Neese-Todd S. Why model programs work: factors predicting the subjective quality of life of the chronically mentally ill. Hosp Community Psychiatry. In pressGoogle Scholar
  52. 52.
    Lehman AF, Possidente S, Hawker F. The quality of life of the chronically mentally ill; gender and decade of life effects. Eval Prog Planning 1992; 15: 7–12CrossRefGoogle Scholar
  53. 53.
    Markowitz JS, Weissman MM, Ouellette R, et al. Quality of life in panic disorder. Arch Gen Psychiatry 1989; 46: 984–2PubMedCrossRefGoogle Scholar
  54. 54.
    George LK, Blazer D, Hughes D, et al. Social support and the outcome of major depression. Br J Psychiatry 1989; 154: 478–85PubMedCrossRefGoogle Scholar
  55. 55.
    Wells KB, Stewart A, Hays RD, et al. The functioning and well-being of depressed patients: results from the medical outcomes study. JAMA 1989; 262: 914–21PubMedCrossRefGoogle Scholar
  56. 56.
    Johnson J, Weissman MM, Klerman GL. Service utilization and social morbidity associated with depressive symptoms in the community. JAMA 1992; 267: 1478–83PubMedCrossRefGoogle Scholar
  57. 57.
    Broadhead WE, Blazer DG, George LK, et al. Depression, disability days, and days lost from work in a prospective epidemiology survey. JAMA 1990; 264: 2524–8PubMedCrossRefGoogle Scholar
  58. 58.
    Weissman MM. Panic disorder: impact on quality of life. J Clin Psychiatry 1991; 52 Suppl. 2: 6S–9SGoogle Scholar
  59. 59.
    Massion AO, Warshaw MG, Keller MB. Quality of life and psychiatric morbidity in panic disorder and generalized anxiety disorder. Am J Psychiatry 1993; 150: 600–7PubMedGoogle Scholar
  60. 60.
    Mesters P, Cosyns P, Dejaiffe G, et al. Assessment of quality of life in the treatment of major depressive disorder with fluoxetine, 20 mg, in ambulatory patients aged over 60 years. Int Clin Psychopharmacol 1993; 8: 337–40PubMedCrossRefGoogle Scholar
  61. 61.
    Stewart A, Ware, J. Measuring functioning and well-being: the Medical Outcomes Study approach. Durham, NC: Duke University Press, 1992Google Scholar
  62. 62.
    Bergner M, Bobbit RA, Carter WB, et al. The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981; 19: 787–805PubMedCrossRefGoogle Scholar
  63. 63.
    McKenna SP, Hunt SM. A new measure of quality of life in depression: testing the reliability and construct validity of the QLDS. Health Policy 1992; 22: 321–30PubMedCrossRefGoogle Scholar
  64. 64.
    Stoker MJ, Dunbar GC, Beaumont G. The SmithKline Beecham ‘quality of life’ scale: a validation and reliability study in patient with affective disorder. Qual Life Res 1992; 1: 385–95PubMedCrossRefGoogle Scholar
  65. 65.
    Endicott J, Nee J, Harrison W, et al. Quality of life enjoyment and satisfaction questionnaire: a new measure. Department of Psychiatry, Columbia University and New York State Psychiatric Institute. Psychopharmacol Bull 1993; 29: 321–6PubMedGoogle Scholar
  66. 66.
    Dupuy JH. The Psychological General Well-Being Index. In: N Wenger, M Mattson, C Furberg, et al., editors. Assessment of quality of life in clinical trials of cardiovascular therapies. New York: Le Jacq, 1984: 170–83Google Scholar
  67. 67.
    Bergner DA, Rothman ML. Health status measures: an overview and guide for selection. Annu Rev Public Health 1987; 8: 191–210PubMedCrossRefGoogle Scholar
  68. 68.
    Nunally J. Psychometric theory. New York: McGraw-Hill, 1978Google Scholar
  69. 69.
    Depression Guideline Panel. Depression in primary care: vol. 2. Treatment of major depression. Clinical practice guidelines, Number 5. Rockville, MD: US Department of Health and Human Services, Public Health Service, Agency for Health Gare Policy and Research. AHCPR Publication No. 93-0551, 1993: 1-175Google Scholar
  70. 70.
    Spilker B, editor. Quality of life assessments in clinical trials. New York: Raven Press, 1990Google Scholar

Copyright information

© Adis International Limited 1994

Authors and Affiliations

  • Dennis A. Revicki
    • 1
  • Miranda Murray
    • 1
  1. 1.Battelle Medical Technology Assessment Program, BattelleCenters for Public Health Research and EvaluationArlingtonUSA

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