Arnet I, Haefeli W E
Department of Internal Medicine, University Hospital, Basel, Switzerland.
Clin Pharmacol Ther. 2000 Jan;67(1):44-7. doi: 10.1067/mcp.2000.103821.
Electronic compliance monitoring has provided new variables to describe drug intake behavior and new strategies to improve compliance. However, as evaluated in this study, the recording of opening events of pill bottles does not necessarily mean drug intake.
In an open 3-week trial with an oral vitamin combination, drug intake was recorded with use of an electronic pill box that contained 25 capsules and that registered each opening of the bottle. Thirty-seven patients were asked to take one capsule every morning for 21 days. Opening and closing events were related to the results of pill counts and patient interviews at the end of the trial.
Drug consumption was 101.8% (663 recorded opening and closing events) in the 31 patients who completed the trial. Pill boxes were opened more than once by 10 patients on at least one monitored day. For seven patients the total number of openings was >25 (range, 26 to 29) and thus exceeded the number of capsules provided. A third interview of these patients revealed real overconsumption in only two patients. Six patients remembered that they had shown the device to relatives or friends or that they had checked to see whether they had closed the pill box well, thus turning a "curiosity event" into a drug intake event.
In short-term studies particularly, such curiosity events may substantially modify the electronic assessment of compliance surrogates. In these trials the combined evaluation of electronic openings, pill counts, and interviews may be a suitable way to reveal such openings without pill intake.
电子依从性监测提供了描述药物服用行为的新变量以及提高依从性的新策略。然而,如本研究评估所示,药瓶开启事件的记录并不一定意味着药物已服用。
在一项为期3周的口服维生素组合开放试验中,使用一个装有25粒胶囊并能记录每次药瓶开启情况的电子药盒来记录药物服用情况。37名患者被要求每天早晨服用一粒胶囊,共服用21天。试验结束时,将药瓶的开启和关闭事件与药丸计数结果及患者访谈情况相关联。
完成试验的31名患者的药物消耗量为101.8%(记录了663次开启和关闭事件)。在至少一个监测日,有10名患者不止一次打开药盒。7名患者的药盒总开启次数>25次(范围为26至29次),因此超过了提供的胶囊数量。对这些患者的第三次访谈显示,只有两名患者实际过量服用。6名患者记得他们曾向亲戚或朋友展示过该装置,或者他们曾检查药盒是否关好,从而将“好奇事件”转变为药物服用事件。
特别是在短期研究中,此类好奇事件可能会显著改变对依从性替代指标的电子评估。在这些试验中,综合评估电子开启记录、药丸计数和访谈可能是一种揭示此类未服药的药盒开启情况的合适方法。