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两种用于测量自我报告的抗逆转录病毒治疗依从性的工具的随机比较。

A randomized comparison of two instruments for measuring self-reported antiretroviral adherence.

作者信息

Mannheimer S, Thackeray L, Huppler Hullsiek K, Chesney M, Gardner E M, Wu A W, Telzak E E, Lawrence J, Baxter J, Friedland G

机构信息

Division of Infectious Diseases, Columbia University College of Physicians & Surgeons and Harlem Hospital Center, New York, NY, USA.

出版信息

AIDS Care. 2008 Feb;20(2):161-9. doi: 10.1080/09540120701534699.

DOI:10.1080/09540120701534699
PMID:18293124
Abstract

A randomised trial compared two instruments for assessing self-reported adherence to antiretroviral medications: (1) a day-by-day recall instrument that elicited the number of missed doses in each of the prior three days (3-day instrument; n=64) and (2) a general recall instrument that elicited an estimate of proportion of pills taken during the prior seven days (7-day instrument; n=70). Adherence was measured at study visits over 12 months among participants in a clinical trial assessing treatment strategies for individuals with virologic failure and multidrug-resistant HIV. Participants had a median (interquartile range) of 133 (41-264) CD4 cells/ml(3) and a median of 10 major HIV resistance mutations at baseline. Mean adherence levels were 90-98% throughout the study. There was a greater trend in the likelihood of 100% adherence when measured by the 3-day versus the 7-day instrument (odds ratio (OR)=1.45; p=0.06). The likelihood of consistent 100% adherence measured by either instrument decreased over time (p<0.001). Participants reporting 100% adherence at more than half of study visits had better virologic and immunologic outcomes at month-12 compared to those reporting 100% adherence at half or fewer visits (HIV RNA decline of 0.96 versus 0.51 log, respectively, p=0.02; and CD4 cell increase of 51.0 versus 17.8 cells, p=0.04). This study demonstrated the utility of the general 7-day recall adherence self-report instrument as well as the 3-day day-by-day recall adherence self-report instrument for measuring antiretroviral adherence. Self-reported adherence was significantly associated with virologic and immunologic outcomes in this population with advanced drug-resistant HIV disease.

摘要

一项随机试验比较了两种评估自我报告的抗逆转录病毒药物依从性的工具

(1)一种逐日回忆工具,该工具可得出前三天中每天漏服的剂量数(3天工具;n = 64);(2)一种总体回忆工具,该工具可得出前七天服用药丸比例的估计值(7天工具;n = 70)。在一项评估病毒学失败和多重耐药HIV感染者治疗策略的临床试验中,对参与者进行了为期12个月的研究访视,以测量依从性。参与者基线时CD4细胞计数的中位数(四分位间距)为133(41 - 264)个/毫升(3),HIV主要耐药突变的中位数为10个。在整个研究过程中,平均依从水平为90% - 98%。与7天工具相比,用3天工具测量时,达到100%依从性的可能性有更大的趋势(优势比(OR)=1.45;p = 0.06)。两种工具测量得到的持续100%依从性可能性均随时间下降(p <0.001)。与那些报告在一半或更少访视中达到100%依从性的参与者相比,在超过一半的研究访视中报告100%依从性的参与者在第12个月时具有更好的病毒学和免疫学结果(HIV RNA下降分别为0.96对0.51 log,p = 0.02;CD4细胞增加分别为51.0对17.8个细胞,p = 0.04)。本研究证明了总体7天回忆依从性自我报告工具以及3天逐日回忆依从性自我报告工具在测量抗逆转录病毒依从性方面的效用。在这群患有晚期耐药性HIV疾病的人群中,自我报告的依从性与病毒学和免疫学结果显著相关。

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