Background

The use of electronic-based devices to measure and to improve adherence of subjects in clinical trials is increasing. AiCure has developed a mobile technology that is claimed to provide visual confirmation of drug ingestion. While there is evidence suggesting that including such self-monitoring device in a study increases adherence, the quality of the data produced by the device may be questionable. Can the mobile technology reliably distinguish whether a subject takes the study drug or not?

Methods

Adherence was calculated based on exposure, self-reporting and self-monitoring for subjects randomized to an anti-depressant. Levels of adherence and agreement between the three approaches were investigated based on calculation of proportions, two-way tables and receiver operating curves.

Results

A total of 214 subjects had measured concentrations of study drug at all three time points (end of weeks 3, 4 and 5), along with adherence data to define proportion of days adherent based on self-reporting and the self-monitoring instrument developed by AiCure. Self-reported adherence proportions were higher than self-monitored adherence proportions, although both were high (>90%). Neither self-reported and self-monitored adherence agreed with exposure-based adherence.

Conclusion

Both self-reported and self-monitored adherence overestimated adherence. Neither the self-reported nor the self-monitored adherence measure reflected subjects’ actual adherence. This prompts for cautiousness when interpreting either of them, and it underlines the need for thorough validation of electronic devices and software that claims to measure adherence. The AiCure instrument may not be able to reliably determine whether the subjects swallow the study medication.

中文翻译：

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自我报告和自我监测的依从性是否是达到相关血浆浓度的良好代理？：来自健康志愿者抗抑郁药研究的经验

背景

在临床试验中，越来越多地使用基于电子的设备来测量和提高受试者的依从性。AiCure 开发了一种移动技术，据称可以提供药物摄入的视觉确认。虽然有证据表明在研究中加入这种自我监测设备会增加依从性，但该设备产生的数据质量可能存在问题。移动技术能否可靠地区分受试者是否服用研究药物？

方法

依从性是根据随机分配到抗抑郁药的受试者的暴露、自我报告和自我监测来计算的。基于比例、双向表和接收者操作曲线的计算，研究了三种方法之间的依从性和一致性水平。

结果

共有 214 名受试者在所有三个时间点（第 3、4 和 5 周结束）测量了研究药物的浓度，以及依从性数据，以根据自我报告和开发的自我监测工具来定义依从天数的比例爱治。自我报告的依从性比例高于自我监测的依从性比例，尽管两者都很高（>90%）。自我报告和自我监测的依从性都与基于暴露的依从性一致。

结论

自我报告和自我监测的依从性都高估了依从性。自我报告和自我监测的依从性测量都没有反映受试者的实际依从性。这提示在解释其中任何一个时要谨慎，并强调需要彻底验证声称可以衡量依从性的电子设备和软件。AiCure 仪器可能无法可靠地确定受试者是否吞下了研究药物。