接受抗逆转录病毒疗法的 HIV 感染成年人中 MOS-HIV 和 EQ-5D 的反应性。
Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies.
机构信息
Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA.
出版信息
Health Qual Life Outcomes. 2013 Mar 12;11:42. doi: 10.1186/1477-7525-11-42.
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.
背景
为临床试验选择合适的患者报告结局（PRO）工具需要了解该工具检测治疗效果的反应能力。本研究的目的是检查两种用于涉及 HIV 感染成人的临床试验的健康相关生活质量（HRQL）工具的反应能力：针对 HIV 的医疗结局研究 HIV 健康调查（MOS-HIV）和通用测量工具，即 EuroQol-5D（EQ-5D）。
方法
系统评价确定了使用 MOS-HIV 或 EQ-5D 评估 HIV 感染成人结局的临床试验。从每项研究中提取的数据包括研究类型、治疗方案、PRO 结果和效应大小（报告或计算）。效应大小的计算方法为基线和随访平均得分之间的差异除以基线标准差。幅度分为小（d=0.20）、中（d=0.50）和大（d=0.80）。
结果
2005 年至 2010 年间，12 项试验中使用了 MOS-HIV。在经历 2 级不良事件后转换治疗的受试者中，观察到身体健康综合评分（PHS）和心理健康综合评分（MHS）得分在组间和时间上均有显著差异（P<0.05）。开始治疗的治疗初治成人（两项研究）的效应大小为中等（PHS 和 MHS 分别为 0.55 和 0.49），但治疗经验丰富的成人的效应大小可忽略不计（PHS 和 MHS 分别为 0.04 和 0.13；三项研究）。EQ-5D 于 2001 年至 2010 年期间用于五项试验。它对不良事件和机会性感染的发生具有反应性，其五个维度的效应大小均为小至中等（范围为 0.30-0.50）。
结论
PRO 研究结果的系统评价表明，MOS-HIV 和 EQ-5D 均能反应治疗初治 HIV 感染患者组间和/或随时间的变化。这些工具可单独或一起用于临床试验中，以衡量 HRQL 的变化。
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