PharmacoEconomics

, Volume 24, Issue 8, pp 751–765 | Cite as

A Comparative Review of Health-Related Quality-of-Life Measures for Use in HIV/AIDS Clinical Trials

  • Darren J. Clayson
  • Diane J. Wild
  • Paul Quarterman
  • Isabelle Duprat-Lomon
  • Maria Kubin
  • Stephen Joel Coons
Review Article

Abstract

With the advent of highly active antiretroviral therapy (HAART), HIV-infected patients are living longer and are concerned not only with a treatment’s ability to extend their life but also with the quality of the life they are able to lead. Regulatory authorities are also paying closer attention to the use of health-related quality-of-life (HR-QOL) measures in clinical trials and to the subsequent claims that are made based on the results. This paper reviews existing HR-QOL measures reported in the HIV/AIDS literature since 1990 and identifies those most worthy of consideration for use in future clinical trials.

A comprehensive review following predefined selection criteria was conducted. Generic and HIV-targeted measures were assessed for content and practicality for the clinical trial setting. The generic measures were additionally reviewed for the ability to produce preference-based index scores and for the existence of normative general population data. Three generic and six HIV-targeted measures met these selection criteria and were then assessed more fully in terms of their development (HIV-targeted measures), psychometric properties and appropriateness for use in clinical trials.

It was determined that each of the selected generic measures (i.e. Medical Outcomes Study [MOS] 36-Item Short Form Survey Instrument [SF-36], EQ-5D, Health Utilities Index [HUI]) could serve as a useful adjunct to an HIV-targeted measure in a trial. The Functional Assessment of HIV Infection (FAHI) and MOS-HIV health survey were deemed the two most appropriate HIV-targeted measures. Each of the measures can be self-administered in ≤10 minutes and there was ample evidence of their excellent psychometric properties. However, they would not be optimal in all HIV-infected subgroups (e.g. treatment naive vs advanced; adolescents vs older adults) targeted for clinical trial interventions.

Although there is no one best HR-QOL measure for use in HIV/AIDS clinical trials, based on our review criteria we identified three generic and two HIVtargeted candidate measures. However, these measures have their limitations and it is clear that greater consensus needs to develop regarding more effective and efficient approaches to HR-QOL measurement in HIV/AIDS clinical trials. Along with the increasingly complex HR-QOL measurement task resulting from changes in the HIV-infected population and shifts in the HR-QOL burden associated with HIV infection and its treatment over the past 25 years, it is increasingly important that HR-QOL outcomes become viable endpoints in HIV/AIDS clinical trials.

Notes

Acknowledgements

The review was funded by Bayer Healthcare. I. Duprat-Lomon is an employee of Bayer Pharma and M. Kubin is an employee of Bayer Healthcare, the sponsors of this study. The co-authors from Bayer have no conflicts of interest to declare. At the time this review was conducted, D.J. Clayson was an employee of Oxford Outcomes Ltd.

The authors have no other conflicts of interest to declare.

References

  1. 1.
    Sepkowitz KA. AIDS: the first 20 years. N Engl J Med 2001; 344: 1764–72PubMedCrossRefGoogle Scholar
  2. 2.
    Torres RA, Barr M. Impact of combination therapy for HIV infection on inpatient census. N Engl J Med 1997; 336: 1531–2PubMedCrossRefGoogle Scholar
  3. 3.
    Hirschel B, Francioli P. Progress and problems in the fight against AIDS. N Engl J Med 1998; 338: 906–8PubMedCrossRefGoogle Scholar
  4. 4.
    Fauci AS. The AIDS epidemic: considerations for the 21st century. N Engl J Med 1999; 341: 1046–50PubMedCrossRefGoogle Scholar
  5. 5.
    Walensky RP, Paltiel AD, Losina E, et al. The survival benefits of AIDS treatment in the United States. J Infect Dis 2006; 194: 11–9PubMedCrossRefGoogle Scholar
  6. 6.
    Tsiodras S, Mantzoros C, Hammer S, et al. Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy: a 5-year cohort study. Arch Intern Med 2000; 160: 2050–6PubMedCrossRefGoogle Scholar
  7. 7.
    Martinez E, Garcia-Viejo MA, Blanch J, et al. Lipodystrophy syndrome in patients with HIV infection: quality of life issues. Drug Saf 2001; 24: 157–66PubMedCrossRefGoogle Scholar
  8. 8.
    Blanch J, Rousaud A, Martinez E, et al. Factors associated with severe impact of lipodystrophy on the quality of life of patients infected with HIV-1. Clin Infect Dis 2004; 38: 1464–70PubMedCrossRefGoogle Scholar
  9. 9.
    Kamin DS, Grinspoon SK. Cardiovascular disease in HIV-positive patients. AIDS 2005; 19: 641–52PubMedCrossRefGoogle Scholar
  10. 10.
    Leplege A, Rude N, Ecosse E, et al. Measuring quality of life from the point of view of HIV-positive subjects: the HIV-QL31. Qual Life Res 1997; 6: 585–94PubMedCrossRefGoogle Scholar
  11. 11.
    Hosein SR. Company backs out of immune drug study [online]. Available from URL: http://www.thebody.com/catie/silcaat_ pullout.html [Accessed 2005 Jul 9]Google Scholar
  12. 12.
    Tsasis P. Health-related quality-of-life measurements in HIV/AIDS care. AIDS Patient Care STDs 2000; 14 (8): 427–38PubMedCrossRefGoogle Scholar
  13. 13.
    Coons SJ, Rao S, Keininger DL, et al. A comparative review of generic quality of life instruments. Pharmacoeconomics 2000; 17: 13–35PubMedCrossRefGoogle Scholar
  14. 14.
    Coons SJ. Health outcomes and quality of life. In: DiPiro JT, Talbert RL, Yee GC, et al., editors. Pharmacotherapy: a pathophysiologic approach. 6th ed. New York: McGraw-Hill, 2005: 17–25Google Scholar
  15. 15.
    Chassany O, Sagnier P, Marquis P, et al. Patient-reported outcomes: the example of health-related quality of life. A European guidance document for the integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J 2002; 36: 209–38CrossRefGoogle Scholar
  16. 16.
    Badia X, Podzamczer D, Casado A, et al. Evaluating changes in health status in HIV-infected patients: Medical Outcomes Study-HIV and Multidimensional Quality of Life-HIV quality of life questionnaires. AIDS 2000; 14: 1439–47PubMedCrossRefGoogle Scholar
  17. 17.
    European Medicines Agency. Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. London: European Medicines Agency, 2005 Jul 27 [online]. Available from URL: http://www.emea.eu.int/pdfs/human/ewp/13939104en.pdf [Accessed 2005 Nov 27]Google Scholar
  18. 18.
    Food and Drug Administration. Guidance for industry [draft]. Patient-reported outcome measures: use in medical product development to support labeling claims. [online]. Available from URL: http://www.fda.gov/cder/guidance/5460dft.htm [Accessed 2006 Jun 10]Google Scholar
  19. 19.
    Hays RD. Generic versus disease-targeted instruments. In: Fayers P, Hays R, editors. Assessing quality of life in clinical trials. 2nd ed. Oxford: Oxford University Press, 2005: 3–8Google Scholar
  20. 20.
    Smith MY, Feldman J, Kelly P, et al. Health-related quality of life of HIV-infected women: evidence for the reliability, validity and responsiveness of the Medical Outcomes Study Short-Form 20. Qual Life Res 1996; 5: 47–55PubMedCrossRefGoogle Scholar
  21. 21.
    Wu A, on behalf of the Quality of Life Subcommittee of the ACTG Outcomes Committee. ACTG QOL 601–602 (QOL 601-2) Health Survey Manual. AIDS Clinical Trials Group, 1999 [online]. Available from URL: http://www.fstrf.org/qol/ manualql601-2799.pdf [Accessed 2005 Jul 9]Google Scholar
  22. 22.
    Mrus JM, Williams PL, Tsevat J, et al. Gender differences in health-related quality of life in patients with HIV/AIDS. Qual Life Res 2005; 14: 479–91PubMedCrossRefGoogle Scholar
  23. 23.
    Hays RD, Shapiro MF. An overview of generic health-related quality of life measures for HIV research. Qual Life Res 1992; 1: 91–7PubMedCrossRefGoogle Scholar
  24. 24.
    De Boer JB, Van Dam FSAM, Sprangers MAG, et al. Longitudinal study on the quality of life of symptomatic HIV-infected patients in a trial of zidovudine versus zidovudine and interferon-alpha. AIDS 1993; 7: 947–53PubMedCrossRefGoogle Scholar
  25. 25.
    De Boer JB, Sprangers MAG, Aaronson NK, et al. The feasibility, reliability and validity of the EORTC QLQ-C30 in assessing the quality of life of patients with a symptomatic HIV infection or AIDS (CDC IV). Psychol Health 1994; 9: 65–77CrossRefGoogle Scholar
  26. 26.
    Wu AW, Jacobson DL, Frick KD, et al. Validity and responsiveness of the EuroQol as measure of health-related quality of life in people enrolled in an AIDS clinical trial. Qual Life Res 2002; 11: 273–82PubMedCrossRefGoogle Scholar
  27. 27.
    Delate T, Coons SJ. The use of the EQ-5D and MOS-HIV in a sample of persons with HIV. Clin Infect Dis 2001; 32: e47–52PubMedCrossRefGoogle Scholar
  28. 28.
    Araki SS, Guh DP, Singer J, et al. The impact of AIDS-related events and non-AIDS serious adverse events on health-related quality of life in a multinational trial of antiretroviral therapy. Abstracts of the 26th Annual Meeting of the Society for Medical Decision Making; 2004 Oct 17–20; Atlanta (GA) [online]. Available from URL: http://smdm.confex.com/smdm/2004ga/techprogram/P1493.HTM [Accessed 2005 Jul 9]Google Scholar
  29. 29.
    Joyce V, Araki SS, Sundaram V, et al. Utility-based assessments of quality of life in a randomized trial of antiretroviral therapy in advanced HIV disease. Abstracts of the 26th Annual Meeting of the Society for Medical Decision Making; 2004 Oct 17–20; Atlanta (GA) [online]. Available from URL: http:// smdm.confex.com/smdm/2004ga/techprogram/P1477.HTM [Accessed 2005 Jul 9]Google Scholar
  30. 30.
    Kyriakides TC, Babiker A, Singer J, et al. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patents in whom antiretroviral therapy has failed: rationale and design of the OPTIMA trial. Control Clin Trials 2003; 24: 481–500PubMedCrossRefGoogle Scholar
  31. 31.
    Eriksson LE, Nordstrom G, Berglund T, et al. The health-related quality of life in a Swedish sample of HIV-infected persons. J Adv Nurs 2000; 32: 1213–23PubMedCrossRefGoogle Scholar
  32. 32.
    Cederfj äll C, Langius-Eklöf A, Lidman K, et al. Gender differences in perceived health-related quality of life among persons with HIV infection. AIDS Patient Care STDs 2001; 15: 31–9CrossRefGoogle Scholar
  33. 33.
    Bayoumi AM, Redelmeier DA. Economic methods for measuring the quality of life associated with HIV infection. Qual Life Res 1997; 8: 471–80CrossRefGoogle Scholar
  34. 34.
    Cohen SR, Hassan SA, Lapointe BJ, et al. Quality of life in HIV disease as measured by the McGill Quality of Life Questionnaire. AIDS 1996; 10: 1421–7PubMedCrossRefGoogle Scholar
  35. 35.
    Tramarin A, Campostrini S, Postma MJ, et al. A multicentre study of patient survival, disability, quality of life and cost of care among patients with AIDS in Northern Italy. Pharmacoeconomics 2004; 22: 43–53PubMedCrossRefGoogle Scholar
  36. 36.
    Srisurapanont M, Sombatmai S, Jarusuraisin N. HIV-seropositive results, health-related quality of life, and social support: a 24-week prospective study in Thailand. AIDS Patient Care STDs 2001; 15: 211–5PubMedCrossRefGoogle Scholar
  37. 37.
    Kaplan RM, Patterson TL, Kerner DN, et al. The quality of well-being scale in asymptomatic HIV-infected patients. Qual Life Res 1997; 6: 507–14PubMedCrossRefGoogle Scholar
  38. 38.
    Copfer AE, Ampel NM, Hughes TE, et al. The use of two measures of health-related quality of life in HIV-infected individuals: a cross-sectional comparison. Qual Life Res 1996; 5: 281–6PubMedCrossRefGoogle Scholar
  39. 39.
    Anderson JP, Kaplan RM, Coons SJ, et al. Comparison of the quality of well-being scale and the SF-36 results among two samples of ill adults: AIDS and other illnesses. J Clin Epidemiol 1998; 51: 755–62PubMedCrossRefGoogle Scholar
  40. 40.
    Wu AW, Mathews WC, Brysk LT, et al. Quality of life in a placebo-controlled trial of zidovudine in patients with AIDS and AIDS-related complex. J AIDS 1990; 3: 683–90Google Scholar
  41. 41.
    Hughes TE, Kaplan RM, Coons SJ, et al. Construct validities of the quality of well-being scale and the MOS-HIV-34 health survey for HIV-infected patients. Med Decis Making 1997; 7: 439–46CrossRefGoogle Scholar
  42. 42.
    Gelber RD, Lenderking WR, Cotton DJ, et al. Quality of life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection. Ann Intern Med 1992; 116: 961–6PubMedGoogle Scholar
  43. 43.
    Lenderking WR, Gelber RD, Cotton DJ, et al. Evaluation of the quality of life associated with zidovudine treatment in asymptomatic human immunodeficiency virus infection. N Engl J Med 1994; 330: 738–43PubMedCrossRefGoogle Scholar
  44. 44.
    Revicki DA, Simpson KN, Wu AW, et al. Evaluating the quality of life associated with rifabutin prophylaxis for Mycobacterium avium complex in persons with AIDS: combining Q-TWiST and multiattribute utility techniques. Qual Life Res 1995; 4: 309–18PubMedCrossRefGoogle Scholar
  45. 45.
    Han C, Pulling CC, Telke SE, et al. Assessing the utility of five domains in SF-12 health status questionnaire in an AIDS clinical trial. AIDS 2002; 16: 431–9PubMedCrossRefGoogle Scholar
  46. 46.
    Mannheimer SB, Matts J, Telzak E, et al. Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care 2005; 17: 10–22PubMedCrossRefGoogle Scholar
  47. 47.
    Vidrine DJ, Amick BC, Gritz ER, et al. Functional status and overall quality of life in a multiethnic HIV-positive population. AIDS Patient Care STDs 2003; 17: 187–97PubMedCrossRefGoogle Scholar
  48. 48.
    Delate T, Coons SJ. The discriminative ability of the 12-item short form health survey (SF-12) in a sample of persons infected with HIV. Clin Ther 2000; 22: 1112–20PubMedCrossRefGoogle Scholar
  49. 49.
    Braitstein P, Montessori V, Chan K, et al. Quality of life, depression and fatigue among persons coinfected with HIV and hepatitis C: outcomes from a population-based cohort. AIDS Care 2005; 17: 505–15PubMedCrossRefGoogle Scholar
  50. 50.
    Low-Beer S, Chan K, Wood E, et al. Health related quality of life among persons with HIV after the use of protease inhibitors. Qual Life Res 2000; 9: 941–9PubMedCrossRefGoogle Scholar
  51. 51.
    Wachtel T, Piette J, Mor V, et al. Quality of life in persons with human immunodeficiency virus infection: measurement by the Medical Outcomes Study instrument. Ann Intern Med 1992; 116: 129–37PubMedGoogle Scholar
  52. 52.
    Arpinelli F, Visona G, Bruno R, et al. Health-related quality of life in asymptomatic patients with HIV: evaluation of the SF-36 health survey in Italian patients. Pharmacoeconomics 2000; 18 (1): 63–72PubMedCrossRefGoogle Scholar
  53. 53.
    Tate D, Paul RH, Flanigan TP, et al. The impact of apathy and depression on quality of life in patients infected with HIV. AIDS Patient Care STDs 2003; 17: 115–20PubMedCrossRefGoogle Scholar
  54. 54.
    Bing EG, Hays RD, Jacobson LP, et al. Health-related quality of life among people with HIV disease: results from the Multicenter AIDS Cohort Study. Qual Life Res 2000; 9: 55–63PubMedCrossRefGoogle Scholar
  55. 55.
    Call SA, Klapow JC, Stewart KE, et al. Health-related quality of life and virologic outcomes in an HIV clinic. Qual Life Res 2001; 9: 977–85CrossRefGoogle Scholar
  56. 56.
    Hsiung P-C, Fang C-T, Chang Y-Y, et al. Comparison of WHOQOL-BREF and SF-36 in patients with HIV infection. Qual Life Res 2005; 14: 141–50PubMedCrossRefGoogle Scholar
  57. 57.
    Cunningham WE, Hays RD, Williams KW, et al. Access to medical care and health-related quality of life for low-income persons with symptomatic human immunodeficiency virus. Med Care 1995; 33: 739–54PubMedCrossRefGoogle Scholar
  58. 58.
    Cunningham WE, Hays RD, Ettl MK, et al. The prospective effect of access to medical care on health-related quality-of-life outcomes in patients with symptomatic HIV disease. Med Care 1998; 36: 295–306PubMedCrossRefGoogle Scholar
  59. 59.
    Ragsdale D, Morrow JR. Quality of life as a function of HIV classification. Nurs Res 1990; 39: 355–9PubMedCrossRefGoogle Scholar
  60. 60.
    Chandra PS, Deepthivarma S, Jairam KR, et al. Relationship of psychological morbidity and quality of life to illness-related disclosure among HIV-infected persons. J Psychom Res 2003; 54: 199–203CrossRefGoogle Scholar
  61. 61.
    Lubeck DP, Fries JF. Assessment of quality of life in early stage HIV-infected persons: data from the AIDS Time-oriented Health Outcome Study (ATHOS). Qual Life Res 1997; 6: 494–506PubMedCrossRefGoogle Scholar
  62. 62.
    Cella DF, McCain NL, Peterman AH, et al. Development and validation of the functional assessment of human immunodeficiency virus infection (FAHI) quality of life instrument. Qual Life Res 1996; 5: 450–63PubMedCrossRefGoogle Scholar
  63. 63.
    Peterman AH, Cella D, Mo F, et al. Psychometric validation of the revised Functional Assessment of Human Immunodeficiency virus infection (FAHI) quality of life instrument. Qual Life Res 1997; 6: 572–84PubMedCrossRefGoogle Scholar
  64. 64.
    Abrams DI, Steinhart C, Frascino R. Epoetin alfa therapy for anaemia in HIV-infected patients: impacts on quality of life. Int J STD AIDS 2000; 11: 659–65PubMedCrossRefGoogle Scholar
  65. 65.
    Earthman CP, Reid PM, Harper IT, et al. Body cell mass repletion and improved quality of life in HIV-infected individuals receiving oxandrolone. J Parenter Enteral Nutr 2002; 26 (6): 357–65CrossRefGoogle Scholar
  66. 66.
    Sikkema KJ, Hansen NB, Meade CS, et al. Improvements in health-related quality of life following a group intervention for coping with AIDS-bereavement among HIV-infected men and women. Qual Life Res 2005; 14: 991–1005PubMedCrossRefGoogle Scholar
  67. 67.
    Lenderking WR, Testa MA, Katzenstein D, et al. Measuring quality of life in early HIV disease: the modular approach. Qual Life Res 1997; 6: 515–30PubMedCrossRefGoogle Scholar
  68. 68.
    Holmes WC, Shea JA. Performance of a new, HIV/AIDS-targeted quality of life (HAT-QoL) instrument in asymptomatic seropositive individuals. Qual Life Res 1997; 6: 561–71PubMedCrossRefGoogle Scholar
  69. 69.
    Holmes WC, Shea JA. A new HIV/AIDS-targeted quality of life (HAT-QoL) instrument: development, reliability, and validity. Med Care 1998; 36: 138–54PubMedCrossRefGoogle Scholar
  70. 70.
    Holmes WC, Shea JA. Two approaches to measuring quality of life in HIV/AIDS population: HAT-QoL and MOS-HIV. Qual Life Res 1999; 8: 515–27PubMedCrossRefGoogle Scholar
  71. 71.
    Demmer C. Quality of life and risk perception among predominantly heterosexual, minority individuals with HIV/AIDS. AIDS Patient Care STDs 2001; 15: 481–9PubMedCrossRefGoogle Scholar
  72. 72.
    Hays RD, Spritzer KL, McCaffrey DF, et al. The HIV cost and services utilization study (HCSUS) measures of health-related quality of life. Santa Monica (CA): RAND, 1998: DRU-1897-AHCPRGoogle Scholar
  73. 73.
    Hays RD, Cunningham WE, Sherbourne CD, et al. Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV Cost and Services Utilization Study. Am J Med 2000; 108: 714–22PubMedCrossRefGoogle Scholar
  74. 74.
    Sherbourne CD, Hays RD, Fleishman JA. Impact of psychiatric conditions on health-related quality of life in persons with HIV infection. Am J Psychiatry 2000; 157: 248–54PubMedCrossRefGoogle Scholar
  75. 75.
    Cunningham WE, Crystal S, Bozzette S, et al. The association of health-related quality of life with survival among persons with HIV infection in the United States. J Gen Intern Med 2005; 20: 21–7PubMedCrossRefGoogle Scholar
  76. 76.
    Jia H, Uphold CR, Wu S, et al. Predictors of changes in health-related quality of life among men with HIV infection in the HAART era. AIDS Patient Care STDs 2005; 19: 395–405PubMedCrossRefGoogle Scholar
  77. 77.
    Burgess A, Dayer M, Catalan J, et al. The reliability and validity of two HIV-specific health-related quality-of-life measures: a preliminary analysis. AIDS 1993; 7: 1001–8PubMedCrossRefGoogle Scholar
  78. 78.
    Schag CAC, Ganz PA, Kahn B, et al. Assessing the needs and quality of life of patients with HIV infection: development of the HIV Overview of Problems-Evaluation System (HOPES). Qual Life Res 1992; 1: 397–413PubMedCrossRefGoogle Scholar
  79. 79.
    Ganz PA, Schag CAC, Kahn L, et al. Describing the health-related quality of life impact of HIV infection: findings from a study using the HIV Overview of Problems-Evaluation System (HOPES). Qual Life Res 1993; 2: 109–19PubMedCrossRefGoogle Scholar
  80. 80.
    De Boer JB, Sprangers AG, Aaronson NK, et al. A study of the reliability, validity and responsiveness of the HIV overview of problems evaluation system (HOPES) in assessing the quality of life of patients with AIDS and symptomatic HIV infection. Qual Life Res 1996; 5: 339–47PubMedCrossRefGoogle Scholar
  81. 81.
    O’Leary JF, Ganz PA, Wu AW, et al. Toward a better understanding of health-related quality of life: a comparison of the medical outcomes study HIV health survey (MOS-HIV) and the HIV overview of problems-evaluation system (HOPES). J Acquir Immune Defic Syndr Hum Retrovirol 1998; 17: 433–41PubMedCrossRefGoogle Scholar
  82. 82.
    Sarna L, van Servellen G, Padilla G, et al. Quality of life in women with symptomatic HIV/AIDS. J Adv Nurs 1999; 30: 597–605PubMedCrossRefGoogle Scholar
  83. 83.
    Kemppainen JK. Predictors of quality of life in AIDS patients. J Assoc Nurses AIDS Care 2001; 12 (1): 61–70PubMedCrossRefGoogle Scholar
  84. 84.
    Holzemer WL, Spicer JG, Wilson HS, et al. Validation of the quality of life scale: living with HIV. J Adv Nurs 1998; 28 (3): 622–30PubMedCrossRefGoogle Scholar
  85. 85.
    McDonnell KA, Gielen AC, O’Campo PO, et al. Abuse, HIV status and health-related quality of life among a sample of HIV positive and HIV negative low income women. Qual Life Res 2005; 14: 945–57PubMedCrossRefGoogle Scholar
  86. 86.
    Paton NI, Chapman CAT, Chan S-P, et al. Validation of the Medical Outcomes Study HIV Health Survey as a measure of quality of life in HIV-infected patients in Singapore. Int J STD AIDS 2002; 13: 456–61PubMedCrossRefGoogle Scholar
  87. 87.
    Carretero MD, Burgess AP, Soler P, et al. Reliability and validity of an HIV-specific health-related quality of life measure for use with injecting drug users. AIDS 1996; 10: 1699–705PubMedCrossRefGoogle Scholar
  88. 88.
    Wu AW, Revicki DA, Jacobson D, et al. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Qual Life Res 1997; 6: 481–93PubMedCrossRefGoogle Scholar
  89. 89.
    Fumaz CR, Tuldra A, Ferrer MJ, et al. Quality of life, emotional status, and adherence of HIV-1-infected patients treated with efavirenz versus protease inhibitor-containing regimens. J AIDS 2002; 29: 244–53Google Scholar
  90. 90.
    Scott-Lennox JA, Wu AW, Boyer G, et al. Reliability and validity of French, German, Italian, Dutch, and UK English translations of the medical outcomes study HIV health survey. Med Care 1999; 37: 908–23PubMedCrossRefGoogle Scholar
  91. 91.
    Justice AC, Holmes W, Gifford AL, et al. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol 2001; 54: S77–90PubMedCrossRefGoogle Scholar
  92. 92.
    Smith KW, Avis NE, Mayer KH, et al. Use of the MQoL-HIV with symptomatic HIV-positive patients. Qual Life Res 1997; 6: 555–60PubMedCrossRefGoogle Scholar
  93. 93.
    Osowiecki DM, Cohen RA, Morrow KM, et al. Neurocognitive and psychological contributions to quality of life in HIV-1-infected women. AIDS 2000; 14: 1327–32PubMedCrossRefGoogle Scholar
  94. 94.
    Bozzette SA, Hays RD, Berry S, et al. Derivation and properties of a brief health status assessment instrument for use in HIV disease. J AIDS 1995; 8: 253–65Google Scholar
  95. 95.
    Bozzette SA, Hays RD, Berry S, et al. A perceived health index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care 1994; 32: 716–31PubMedCrossRefGoogle Scholar
  96. 96.
    Bozzette SA, Kanouse DE, Berry S, et al. Health status and function with zidovudine or zalcitabine as initial therapy for AIDS: a randomized controlled trial. JAMA 1995; 273: 295–301PubMedCrossRefGoogle Scholar
  97. 97.
    Campsmith ML, Nakashima AK, Davidson AJ. Self-reported health-related quality of life in persons with HIV infection: results from a multisite interview project. Health Qual Life Outcomes 2003; 1: 12 [online]. Available from URL: http:// www.hqlo.com/content/1/1/12 [Accessed 2005 Jul 9]PubMedCrossRefGoogle Scholar
  98. 98.
    WHOQOL HIV Group. Preliminary development of the World Health Organization’s quality of life HIV instrument (WHOQOL-HIV): analysis of the pilot version. Soc Sci Med 2003; 57: 1259–75CrossRefGoogle Scholar
  99. 99.
    Starace F, Cafaro L, Abrescia N, et al. Quality of life assessment in HIV-positive persons: application and validation of the WHOQOL-HIV, Italian version. AIDS Care 2002; 14: 405–15PubMedCrossRefGoogle Scholar
  100. 100.
    WHOQOL HIV Group. WHOQOL-HIV for quality of life assessment among people living with HIV and AIDS: results from the field test. AIDS Care 2004; 16: 882–9CrossRefGoogle Scholar
  101. 101.
    Stewart AL, Ware JE. Measuring function and well-being: the medical outcome study approach. Durham (NC): Duke University Press, 1991Google Scholar
  102. 102.
    Wu AW, Hay RD, Kelly S, et al. Applications of the medical outcomes study health-related quality of life measures in HIV/AIDS. Qual Life Res 1997; 6: 531–54PubMedCrossRefGoogle Scholar
  103. 103.
    Wu AW, Rubin HR, Mathews WC, et al. A health status questionnaire using 30 items from the Medical Outcomes Study: preliminary validations in persons with early HIV in-fection. Med Care 1991; 29: 786–98PubMedCrossRefGoogle Scholar
  104. 104.
    Coons SJ, Shaw JW. Generic adult health status measures. In: Fayers P, Hays R, editors. Assessing quality of life in clinical trials. 2nd ed. Oxford: Oxford University Press, 2005: 325–38Google Scholar
  105. 105.
    Feeny D. Preference-based measures: utility and quality-adjusted life years. In: Fayers P, Hays R, editors. Assessing quality of life in clinical trials. 2nd ed. Oxford: Oxford University Press, 2005: 405–29Google Scholar
  106. 106.
    Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001; 33 (5): 337–43PubMedCrossRefGoogle Scholar
  107. 107.
    Horsman J, Furlong W, Feeny D, et al. The Health Utilities Index (HUI®): concepts, measurement properties and applications. Health Qual Life Outcomes 2003; 1: 54 [online]. Availa-ble from URL: http://www.hqlo.com/content/1/1/54 [Accessed 2005 Jul 9]PubMedCrossRefGoogle Scholar
  108. 108.
    Ware J, Sherbourne C. The MOS 36-item Short-Form Health Survey: 1. Conceptual framework and item selection. Med Care 1992; 30: 473–83PubMedCrossRefGoogle Scholar
  109. 109.
    Ware JE, Kosinski M, Keller SD. SF-36 physical and mental health summary scales: a user’s manual. Boston (MA): The Health Institute, 1994Google Scholar
  110. 110.
    Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002; 21: 271–92PubMedCrossRefGoogle Scholar
  111. 111.
    Ware JE, Snow KK, Kosinski M, et al. SF-36 health survey: manual and interpretation guide. Boston (MA): The Health Institute, 1993Google Scholar
  112. 112.
    Gandek B, Ware JE. Methods for validating and norming translations of health status questionnaires: the IQOLA project approach. J Clin Epidemiol 1998; 11: 953–9CrossRefGoogle Scholar
  113. 113.
    Carrieri P, Spire B, Duran S, et al. Health-related quality of life after 1 year of highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2003; 32: 38–47PubMedCrossRefGoogle Scholar
  114. 114.
    Saunders DS, Burgoyne RW. Evaluating health-related wellbeing outcomes among outpatient adults with human immunodeficiency virus infection in the HAART era. Int J STD AIDS 2002; 13: 683–90PubMedCrossRefGoogle Scholar
  115. 115.
    Dolan P. Modeling valuations for EuroQol health states. Med Care 1997; 35: 1095–108PubMedCrossRefGoogle Scholar
  116. 116.
    Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 model. Med Care 2005; 43: 203–20PubMedCrossRefGoogle Scholar
  117. 117.
    Kind P. Guidelines for value sets in economic and non-economic studies using EQ-5D. In: Brooks R, Rabin R, de Charro F, editors. The measurement and valuation of health status using the EQ-5D: a European perspective. Dordrecht: Kluwer Academic Publishers, 2003: 29–41CrossRefGoogle Scholar
  118. 118.
    Kind P, Hardman G, Macran S. UK population norms for the EQ-5D. Discussion Paper 172. York: The University of York Centre for Health Economics, 1999 119.Google Scholar
  119. Luo N.
    Johnson JA, Shaw JW, et al. Self-reported health status of the adult US population as assessed by the EQ-5D and Health Utilities Index. Med Care 2005; 43: 1078–186PubMedCrossRefGoogle Scholar
  120. 120.
    Szende A, Williams A, editors. Measuring self-reported population health: an international perspective based on EQ-5D. Rotterdam: EuroQol Group, 2004Google Scholar
  121. 121.
    Stavem K, Froland SS, Hellum KB. Comparison of preference-based utilities of the 15D, EQ-5D and SF-6D in patients with HIV-AIDS. Qual Life Res 2005; 14: 971–80PubMedCrossRefGoogle Scholar
  122. 122.
    Furlong WJ, Feeny DH, Torrance GW, et al. The Health Utilities Index (HUI®) system for assessing health-related quality of life in clinical studies. Ann Med 2001; 33: 375–84PubMedCrossRefGoogle Scholar
  123. 123.
    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 1993; 11: 570–9PubMedGoogle Scholar
  124. 124.
    Jette AM, Davies AR, Cleary PD, et al. The functional status questionnaire: reliability and validity when used in primary care. J Gen Intern Med 1986; 1: 143–9PubMedCrossRefGoogle Scholar
  125. 125.
    Evans SR, Krown SE, Testa MA, et al. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi’s sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol 2002; 20 (15): 3236–41PubMedCrossRefGoogle Scholar
  126. 126.
    Wilson HS, Hutchinson SA, Holzemer WI. Salvaging quality of life in ethnically diverse patients with advanced HIV/AIDS. Qual Health Res 1997; 7 (1): 75–97CrossRefGoogle Scholar
  127. 127.
    Safrin S, Finkelstein DM, Feinberg J, et al. Comparison of three regimens for treatment of mild to moderate Pneumocystis carinii pneumonia in patients with AIDS. Ann Intern Med 1996; 124 (9): 792–802PubMedGoogle Scholar
  128. 128.
    Volberding PA, Lagakos SW, Koch MA, et al. Zidovudine in asymptomatic human immunodeficiency virus infection: a controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimetre. N Engl J Med 1990; 322: 941–9PubMedCrossRefGoogle Scholar
  129. 129.
    Chaisson RE, Benson CA, Dube MP, et al. Clarithromycin therapy for bacteremic Mycobacterium avium complex disease: a randomised, double-blind, dose-ranging study in patients with AIDS. AIDS Clinical Trial Group Protocol 157 Study Team. Ann Intern Med 1994; 121: 905–11PubMedGoogle Scholar
  130. 130.
    The SOCA Research Group. Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed Cytomegalovirus retinitus in patients with AIDS. Arch Ophthalmol 1996; 114 (1): 23–33CrossRefGoogle Scholar
  131. 131.
    Revicki DA, Moyle G, Stellbrink HJ, et al. Quality of life outcomes of combination zalcitabine-zidovudine, saquinavir-zidovudine, and saquinavir-zalcitabine-zidovudine therapy for HIV-infected adults with CD4 cell counts between 50 and 350 per cubic millimetre. AIDS 1999; 13: 851–8PubMedCrossRefGoogle Scholar
  132. 132.
    Cohen C, Revicki DA, Nabulsi A. A randomised trial of the effect of ritonavir in maintaining quality of life in advanced HIV disease. AIDS 1998; 12: 1495–502PubMedCrossRefGoogle Scholar
  133. 133.
    Piketty C, Jayle D, Leplege A, et al. Double-blind placebo-controlled trial of oral dehydroepiandrosterone in patients with advanced HIV disease. Clin Endocrinol 2001; 55: 325–30CrossRefGoogle Scholar
  134. 134.
    Chatterton ML, Scott-Lennox J, Wu AW, et al. Quality of life and treatment satisfaction after the addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens in treatment-experienced patients with HIV infection. Pharmacoeconomics 1999; 15 Suppl. 1: 68–74CrossRefGoogle Scholar
  135. 135.
    Lorenz KA, Shapiro MF, Asch SM, et al. Associations of symptoms and health-related quality of life: findings from a national study of persons with HIV infection. Ann Intern Med 2001; 134: 854–60PubMedGoogle Scholar
  136. 136.
    McDonnell KA, Gielen AC, Wu AW, et al. Measuring health-related quality of life among women with HIV. Qual Life Res 2000; 9: 931–40PubMedCrossRefGoogle Scholar
  137. 137.
    Weissman JS, Cleary PD, Seage GR, et al. The influence of health-related quality of life and social characteristics on hospital use by patients with AIDS in the Boston Health Study. Med Care 1996; 34: 1037–54PubMedCrossRefGoogle Scholar
  138. 138.
    Cleary PD, Fowler FJ, Weissman J, et al. Health-related quality of life in persons with acquired immune deficiency syndrome. Med Care 1993; 31: 569–80PubMedCrossRefGoogle Scholar
  139. 139.
    Cunningham WE, Bozzette SA, Hays RD, et al. Comparison of health-related quality of life in clinical trial and nonclinical trial human immunodeficiency virus-infected cohorts. Med Care 1995; 33: AS15–25PubMedGoogle Scholar
  140. 140.
    Gill CJ, Griffith JL, Jacobson D, et al. Relationship of HIV viral loads, CD4 counts, and HAART use to health-related quality of life. J AIDS 2002; 30: 485–92Google Scholar
  141. 141.
    De Boer JB, Van Dam FSAM, Sprangers MAG. Health-related quality-of-life evaluation in HIV-infected patients. Pharmacoeconomics 1995; 8 (4): 291–304PubMedCrossRefGoogle Scholar
  142. 142.
    Vanhems P, Toma E, Pineault R. Quality of life assessment and HIV infection: a review. Eur J Epidemiol 1996; 12: 221–8PubMedCrossRefGoogle Scholar
  143. 143.
    Franchi D, Wenzel RP. Measuring health-related quality of life among patients infected with human immunodeficiency virus. Clin Infect Dis 1998; 26: 20–6PubMedCrossRefGoogle Scholar
  144. 144.
    Davis EA, Pathak DS. Psychometric evaluation of four HIV disease-specific quality-of-life instruments. Ann Pharmacother 2001; 35: 546–52PubMedCrossRefGoogle Scholar
  145. 145.
    Viswanathan H, Anderson R, Thomas J. Nature and correlates of SF-12 physical and mental quality of life components among low-income HIV adults using an HIV service center. Qual Life Res 2005; 14: 935–44PubMedCrossRefGoogle Scholar
  146. 146.
    Vidrine DJ, Amick BC, Gritz ER, et al. Assessing a conceptual framework of health-related quality of life in a HIV/AIDS population. Qual Life Res 2005; 14: 923–33PubMedCrossRefGoogle Scholar
  147. 147.
    Shahriar J, Delate T, Hays RD, et al. Commentary on using the SF-36 or MOS-HIV in studies of persons with HIV disease. Health Qual Life Outcomes 2003; (11): 25 [online]. Available from URL: http://www.hqlo.com/content/1/1/25 [Accessed 2005 Nov 27]CrossRefGoogle Scholar
  148. 148.
    Brucker PS, Yost K, Cashy J, et al. General population norms for the Functional Assessment of Cancer Therapy: General (FACT-G). Eval Health Prof 2005; 28: 192–211PubMedCrossRefGoogle Scholar
  149. 149.
    Marin A, Casado JL, Aranzabal L, et al. Validation of a specific questionnaire on psychological and social repercussions of the lipodystrophy syndrome in HIV-infected patients. Qual Life Res 2006; 15: 767–75PubMedCrossRefGoogle Scholar
  150. 150.
    Murdaugh C, Moneyham L, Jackson K, et al. Predictors of quality of life in HIV-infected rural women: psychometric test of the chronic illness quality of life ladder. Qual Life Res 2006; 15: 777–89PubMedCrossRefGoogle Scholar
  151. 151.
    Smith KA. Optimal clinical trial designs for immune-based therapies in persistent viral infections. Med Immunol 2002; 1: 4 [online]. Available from URL: http://www.medimmunol.com/content/1/1/4 [Accessed 2006 Feb 2]PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  • Darren J. Clayson
    • 1
  • Diane J. Wild
    • 2
  • Paul Quarterman
    • 2
  • Isabelle Duprat-Lomon
    • 3
  • Maria Kubin
    • 4
  • Stephen Joel Coons
    • 5
  1. 1.PharmaQuest LtdBanbury, OxfordshireUK
  2. 2.Oxford Outcomes LtdCassington, OxfordUK
  3. 3.Bayer PharmaPuteaux CedexFrance
  4. 4.Bayer HealthcareWuppertalGermany
  5. 5.The University of Arizona College of PharmacyTucsonUSA

Personalised recommendations