Eby Jessica, Chapman Jennifer, Marukutira Tafireyi, Anabwani Gabriel, Tshume Ontibile, Lepodisi Omphile, Dipotso Tebo, Mokete Keboletse, Gross Robert, Lowenthal Elizabeth
Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Botswana-Baylor Children's Clinical Centre of Excellence, Gaborone, Botswana.
Pharmacoepidemiol Drug Saf. 2015 Dec;24(12):1313-20. doi: 10.1002/pds.3887. Epub 2015 Oct 12.
The purpose of this study was to determine whether diary-driven adjustment of Medication Event Monitoring System (MEMS) data based on Supporting Information strengthens the relationship between measured antiretroviral medication adherence and plasma HIV viral load (VL).
HIV+ adolescents on antiretroviral treatment were monitored with MEMS for 30 days preceding a VL measurement. The primary outcome was VL ≥ 400 copies/mL. Handwritten diaries were used to comprehensively record deviations from recommended use (bottle opened but dose not taken or bottle not opened and dose taken). Data were adjusted ("cleaned") based on diary events. Data were "capped" at the prescribed number of doses/day. Receiver operator characteristic analysis compared the relationships between (i) raw MEMS data, (ii) diary-cleaned, (iii) capped, or (iv) cleaned and capped MEMS data and VL.
Over 30 days preceding VL measurements, 273 adolescents had 465 diary events. Capping resulted in fewer patients classified as 95% adherent (65.2%) compared with raw data (71.4%), p < 0.001. Adherence was highly associated with VL (OR 1.05, p < 0.001). The area under the receiver operating characteristic curve for continuous adherence compared with VL was 0.89 (95%CI: 0.82-0.95). Neither diary-cleaning, capping, nor cleaning and capping MEMS data significantly altered the association between adherence and VL (p = 0.14, 0.40, and 0.19, respectively).
Medication Event Monitoring System data-cleaning based on diary entries did not affect the adherence-VL relationship.
本研究旨在确定基于辅助信息对药物事件监测系统(MEMS)数据进行以日记为导向的调整是否能加强所测量的抗逆转录病毒药物依从性与血浆HIV病毒载量(VL)之间的关系。
在进行VL测量前30天,使用MEMS对接受抗逆转录病毒治疗的HIV阳性青少年进行监测。主要结局为VL≥400拷贝/mL。使用手写日记全面记录与推荐用药的偏差(药瓶打开但未服药或药瓶未打开但服药)。根据日记事件对数据进行调整(“清理”)。数据按规定的每日剂量数进行“上限设定”。接受者操作特征分析比较了以下各项之间的关系:(i)原始MEMS数据,(ii)经日记清理的数据,(iii)上限设定的数据,或(iv)清理并上限设定的MEMS数据与VL。
在VL测量前的30天里,273名青少年有465次日记事件。与原始数据(71.4%)相比,上限设定导致被归类为依从性达95%的患者减少(65.2%),p<0.001。依从性与VL高度相关(OR 1.05,p<0.001)。与VL相比,连续依从性的接受者操作特征曲线下面积为0.89(95%CI:0.82 - 0.95)。日记清理、上限设定以及清理并上限设定MEMS数据均未显著改变依从性与VL之间的关联(p分别为0.14、0.40和0.19)。
基于日记条目对药物事件监测系统数据进行清理并不影响依从性与VL之间的关系。