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

Health and Quality of Life Outcomes

Kit N Simpson¹  Chris L Pashos³  Alexandra Khachatryan⁶  Margaret Tawadrous²  Seema Haider²  Gale Harding⁷  Kristin A Hanson⁴  Albert W Wu⁵ 

[1] Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA;Pfizer Inc, 558 Eastern Point Road, Groton, CT, 06340, USA;United BioSource Corporation, 430 Bedford Street, Suite 300, Lexington Office Park, Lexington, MA, 02420, USA;United BioSource Corporation, 185 Dorval Avenue, Suite 500, Dorval, QC, H9S 5J9, Canada;Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA;Pharmerit, 4350 East West Highway, Suite 430, Bethesda, MD, 20814, USA;United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD, 20814, USA

关键词: NNRTI;    EQ-5D;    MOS-HIV;    Patient-reported outcome (PRO);    HIV;   

Others  :  823885
DOI  :  10.1186/1477-7525-11-42

 received in 2012-07-02, accepted in 2013-03-01,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Wu et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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