Bruxvoort Katia, Festo Charles, Cairns Matthew, Kalolella Admirabilis, Mayaya Frank, Kachur S Patrick, Schellenberg David, Goodman Catherine
Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom; Impact Evaluation Thematic Group, Ifakara Health Institute, Dar es Salaam, Tanzania.
Impact Evaluation Thematic Group, Ifakara Health Institute, Dar es Salaam, Tanzania.
PLoS One. 2015 Jul 27;10(7):e0134275. doi: 10.1371/journal.pone.0134275. eCollection 2015.
Self-report is the most common and feasible method for assessing patient adherence to medication, but can be prone to recall bias and social desirability bias. Most studies assessing adherence to artemisinin-based combination therapies (ACTs) have relied on self-report. In this study, we use a novel customised electronic monitoring device--termed smart blister packs--to examine the validity of self-reported adherence to artemether-lumefantrine (AL) in southern Tanzania.
Smart blister packs were designed to look identical to locally available AL blister packs and to record the date and time each tablet was removed from packaging. Patients obtaining AL at randomly selected health facilities and drug stores were followed up at home three days later and interviewed about each dose of AL taken. Blister packs were requested for pill count and extraction of smart blister pack data.
Data on adherence from both self-report verified by pill count and smart blister packs were available for 696 of 1,204 patients. There was no difference between methods in the proportion of patients assessed to have completed treatment (64% and 67%, respectively). However, the percentage taking the correct number of pills for each dose at the correct times (timely completion) was higher by self-report than smart blister packs (37% vs. 24%; p<0.0001). By smart blister packs, 64% of patients completing treatment did not take the correct number of pills per dose or did not take each dose at the correct time interval.
Smart blister packs resulted in lower estimates of timely completion of AL and may be less prone to recall and social desirability bias. They may be useful when data on patterns of adherence are desirable to evaluate treatment outcomes. Improved methods of collecting self-reported data are needed to minimise bias and maximise comparability between studies.
自我报告是评估患者药物依从性最常见且可行的方法，但可能容易出现回忆偏倚和社会期望偏倚。大多数评估基于青蒿素的联合疗法（ACTs）依从性的研究都依赖自我报告。在本研究中，我们使用一种新型定制电子监测设备——智能泡罩包装——来检验坦桑尼亚南部自我报告的蒿甲醚-本芴醇（AL）依从性的有效性。
智能泡罩包装设计得与当地现有的AL泡罩包装外观相同，并记录每片药从包装中取出的日期和时间。在随机选择的医疗机构和药店获取AL的患者在三天后接受家访，并就服用的每剂AL进行访谈。要求提供泡罩包装以进行药片计数并提取智能泡罩包装数据。
1204名患者中有696名患者提供了通过药片计数验证的自我报告和智能泡罩包装的依从性数据。两种方法评估的完成治疗患者比例没有差异（分别为64%和67%）。然而，自我报告的在正确时间服用正确数量药片（按时完成）的百分比高于智能泡罩包装（37%对24%；p<0.0001）。通过智能泡罩包装，64%完成治疗的患者每剂未服用正确数量的药片或未在正确的时间间隔服用每剂药。
智能泡罩包装导致对AL按时完成率的估计较低，可能不太容易出现回忆和社会期望偏倚。当需要关于依从性模式的数据来评估治疗结果时，它们可能会很有用。需要改进收集自我报告数据的方法，以尽量减少偏倚并最大限度地提高研究之间的可比性。
