Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies

Albert W Wu, Kristin A Hanson, Gale Harding, Seema Haider, Margaret Tawadrous, Alexandra Khachatryan, Chris L Pashos, Kit N Simpson, Albert W Wu, Kristin A Hanson, Gale Harding, Seema Haider, Margaret Tawadrous, Alexandra Khachatryan, Chris L Pashos, Kit N Simpson

Abstract

Background: Selection of an appropriate patient-reported outcome (PRO) instrument for a clinical trial requires knowledge of the instrument's responsiveness to detecting treatment effects. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D).

Methods: A systematic review identified clinical trials using the MOS-HIV or EQ-5D to assess outcomes for HIV-infected adults. Data abstracted from each study included study type, treatment regimen(s), PRO results, and effect size (either reported or calculated). Effect size was calculated as the difference between baseline and follow-up mean scores divided by the baseline standard deviation. Magnitude was categorized as small (d=0.20), medium (d=0.50), and large (d=0.80).

Results: Between 2005 and 2010, the MOS-HIV was administered in 12 trials. Significant differences were observed between groups and over time in physical health summary (PHS) and mental health summary (MHS) scores (P<0.05) in subjects switching therapy after experiencing Grade-2 adverse events. Effect sizes were medium (0.55 and 0.49 for PHS and MHS, respectively) among treatment-naïve adults beginning therapy (two studies), but negligible among treatment-experienced adults (0.04 and 0.13 for PHS and MHS, respectively; three studies). The EQ-5D was used in five trials between 2001 and 2010. It was responsive to occurrences of adverse events and opportunistic infections, with small-to-medium effect sizes (range 0.30-0.50) in each of its five dimensions.

Conclusions: A systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and/or over time in treatment-naïve HIV-infected patients. These instruments may be used either individually or together in clinical trials to measure changes in HRQL.

Figures

Figure 1
Figure 1
Sensitivity of EQ-5D VAS to detect change in HRQL with experience of an opportunistic infection.

References

    1. Food and Drug Administration. Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist. 2009;74:65132–65133.
    1. Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ. A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics. 2006;24:751–765. doi: 10.2165/00019053-200624080-00003.
    1. Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID)
    1. Wu AW, Jacobson KL, Frick KD, Clark R, Revicki DA, Freedberg KA, Scott-Lennox J, Feinberg J. Validity and responsiveness of the euroqol as a measure of health-related quality of life in people enrolled in an AIDS clinical trial. Qual Life Res. 2002;11:273–282. doi: 10.1023/A:1015240103565.
    1. Cohen J. A power primer. Psychol Bull. 1992;112:155–159.
    1. Wu AW, Hays RD, Kelly S, Malitz F, Bozzette SA. Applications of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS. Qual Life Res. 1997;6:531–554. doi: 10.1023/A:1018460132567.
    1. Wu AW. MOS-HIV Health Survey Users Manual. Baltimore, Maryland: Johns Hopkins University; 1999.
    1. Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV) Qual Life Res. 1997;6:481–493. doi: 10.1023/A:1018451930750.
    1. Revicki DA, Sorensen S, Wu AW. Reliability and validity of physical and mental health summary scores from the Medical Outcomes Study HIV Health Survey. Med Care. 1998;36:126–137. doi: 10.1097/00005650-199802000-00003.
    1. Rabin R, Oemar M, Oppe M. EQ-5D-3L User Guide: Basic information on how to use the EQ-5D-3L instrument. Version 4.0. Rotterdam, The Netherlands: EuroQol Group; 2011.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Qual Life Res. 2011;20:1727–1736. doi: 10.1007/s11136-011-9903-x.
    1. Chang BH, Boehmer U, Zhao Y, Sommers E. The combined effect of relaxation response and acupuncture on quality of life in patients with HIV: a pilot study. J Altern Complement Med. 2007;13:807–815. doi: 10.1089/acm.2007.7024.
    1. Bucciardini R, Fragola V, Massella M, Polizzi C, Mirra M, Goodall R, Carey D, Hudson F, Zajdenverg R, Floridia M. Initio Trial International Coordinating C. Health-related quality of life outcomes in HIV-infected patients starting different combination regimens in a randomized multinational trial: the INITIO-QoL substudy. AIDS Res Hum Retroviruses. 2007;23:1215–1222. doi: 10.1089/aid.2007.0067.
    1. Huang IC, Wu AW, Finnern HW, Thijs H, Gathe JC, Fairclough DL. Health-related quality of life and tolerability in treatment-experienced HIV-1-infected patients on tipranavir versus comparator regimens. Antivir Ther. 2008;13:15–25.
    1. Lafaurie M, Collin F, Bentata M, Garre M, Leport C, Levy Y, Goujard C, Chene G, Molina JM, Group AS. Switch from zidovudine- to non-zidovudine-containing regimens is associated with modest haematological improvement and no obvious clinical benefit: a substudy of the ANRS 099 ALIZE trial. J Antimicrob Chemother. 2008;62:1122–1129. doi: 10.1093/jac/dkn309.
    1. Sprinz E, Neto AJ, Bargman E, Green SL, Luo MP, Sylte JR, McMillan FI, King KR, Rode RA, Brun SC. Substitution with lopinavir/ritonavir improves patient-reported outcomes including quality of life in patients who were intolerant to their antiretroviral therapy. HIV Clin Trials. 2006;7:291–308. doi: 10.1310/hct0706-291.
    1. Nuesch R, Gayet-Ageron A, Chetchotisakd P, Prasithsirikul W, Kiertiburanakul S, Munsakul W, Raksakulkarn P, Tansuphasawasdikul S, Chautrakarn S, Ruxrungtham K. The impact of combination antiretroviral therapy and its interruption on anxiety, stress, depression and quality of life in Thai patients. Open AIDS J. 2009;3:38–45. doi: 10.2174/1874613600903010038.
    1. Powers AE, Marden SF, McConnell R, Leidy NK, Campbell CM, Soeken KL, Barker C, Davey RT, Dybul MR. Effect of long-cycle structured intermittent versus continuous HAART on quality of life in patients with chronic HIV infection. AIDS. 2006;20:837–845. doi: 10.1097/01.aids.0000218547.39339.13.
    1. Anis AH, Nosyk B, Sun H, Guh DP, Bansback N, Li X, Barnett PG, Joyce V, Swanson KM, Kyriakides TC. Quality of life of patients with advanced HIV/AIDS: measuring the impact of both AIDS-defining events and non-AIDS serious adverse events. J Acquir Immune Defic Syndr. 2009;51:631–639. doi: 10.1097/QAI.0b013e3181a4f00d.
    1. Wu AW, Snyder CF, Huang IC, Skolasky R, McGruder HF, Celano SA, Selnes OA, Andrade AS. A randomized trial of the impact of a programmable medication reminder device on quality of life in patients with AIDS. AIDS Patient Care STDS. 2006;20:773–781. doi: 10.1089/apc.2006.20.773.
    1. Shalit P, True A, Thommes JA, Investigators Q. Quality of life and tolerability after administration of enfuvirtide with a thin-walled needle: QUALITE Study. HIV Clin Trials. 2007;8:24–35. doi: 10.1310/hct0801-24.
    1. Levine AM, Salvato P, Leitz GJ. Champs 2 Study G. Efficacy of epoetin alfa administered every 2 weeks to maintain hemoglobin and quality of life in anemic HIV-infected patients. AIDS Res Hum Retroviruses. 2008;24:131–139. doi: 10.1089/aid.2006.0200.
    1. Stangl AL, Wamai N, Mermin J, Awor AC, Bunnell RE. Trends and predictors of quality of life among HIV-infected adults taking highly active antiretroviral therapy in rural Uganda. AIDS Care. 2007;19:626–636. doi: 10.1080/09540120701203915.
    1. Carr A, Hudson J, Chuah J, Mallal S, Law M, Hoy J, Doong N, French M, Smith D, Cooper DA, Group PS. HIV protease inhibitor substitution in patients with lipodystrophy: a randomized, controlled, open-label, multicentre study. AIDS. 2001;15:1811–1822. doi: 10.1097/00002030-200109280-00010.
    1. Bucciardini R, Massella M, Corpolongo A, Narciso P, Fragola V, Mirra M, Donnini S, Vigano O, Costarelli S, Tozzi V. T20QoL: an observational multicenter cohort study to evaluate the quality of life in HIV-patients treated with enfuvirtide (ENF, T-20) in combination with an optimized background therapy. Biologics. 2008;2:577–581.
    1. Bhargava A, Booysen Fle R. Healthcare infrastructure and emotional support are predictors of CD4 cell counts and quality of life indices of patients on antiretroviral treatment in Free State Province, South Africa. AIDS Care. 2010;22:1–9.

Source: PubMed

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