BACKGROUND Non-adherence to medication is associated with increased risk of relapse in patients with bipolar disorder (BD). OBJECTIVES To (1) validate patient-evaluated adherence to medication measured via smartphones against validated adherence questionnaire; and (2) investigate characteristics for adherence to medication measured via smartphones. METHODS Patients with BD (n=117) evaluated adherence to medication daily for 6-9 months via smartphones. The Medication Adherence Rating Scale (MARS) and the Rogers' Empowerment questionnaires were filled out. The 17-item Hamilton Depression Rating Scale, the Young Mania Rating Scale and the Functional Assessment Short Test were clinically rated. Data were collected multiple times per patient. The present study represents exploratory pooled reanalyses of data collected as part of two randomised controlled trials. FINDINGS During the study 90.50% of the days were evaluated as 'medication taken', 6.91% as 'medication taken with changes' and 2.59% as 'medication not taken'. Adherence to medication measured via smartphones was valid compared with the MARS (B: -0.049, 95% CI -0.095 to -0.003, p=0.033). Younger age and longer illness duration were significant predictors for non-adherence to medication (model concerning age: B: 0.0039, 95% CI 0.00019 to 0.0076, p=0.040). Decreased affective symptoms measured with smartphone-based patient-reported mood and clinical ratings as well as decreased empowerment were associated with non-adherence. CONCLUSIONS Smartphone-based monitoring of adherence to medication was valid compared with validated adherence questionnaire. Younger age and longer illness duration were predictors for non-adherence. Increased empowerment was associated with adherence. CLINICAL IMPLICATIONS Using smartphones for empowerment of adherence using patient-reported measures may be helpful in everyday clinical settings. TRIAL REGISTRATION NUMBER NCT01446406 and NCT02221336.

中文翻译：

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通过智能手机评估双相情感障碍患者服药依从性的有效性和特征：对 MONARCA I 和 II 试验汇总数据的探索性重新分析。

背景技术不坚持服药与双相情感障碍（BD）患者复发风险增加相关。目标 (1) 根据经过验证的依从性调查问卷，验证通过智能手机测量的患者评估的药物依从性；(2) 研究通过智能手机测量的药物依从性特征。方法 BD 患者 (n=117) 通过智能手机评估每天服药的依从性，持续 6-9 个月。填写了药物依从性评定量表（MARS）和罗杰斯赋权问卷。采用17项汉密尔顿抑郁评定量表、青年躁狂评定量表和功能评估短期测试进行临床评定。每个患者的数据被多次收集。本研究对作为两项随机对照试验的一部分收集的数据进行了探索性汇总再分析。结果 在研究期间，90.50% 的天数被评估为“服用药物”，6.91% 的天数被评估为“服用有变化的药物”，2.59% 的天数被评估为“未服用药物”。与 MARS 相比，通过智能手机测量的药物依从性是有效的（B：-0.049，95% CI -0.095 至 -0.003，p=0.033）。年龄较小和病程较长是不坚持服药的显着预测因素（年龄模型：B：0.0039，95% CI 0.00019 至 0.0076，p=0.040）。通过基于智能手机的患者报告的情绪和临床评分来测量情感症状的减少以及授权的减少与不依从性相关。结论 与经过验证的依从性问卷相比，基于智能手机的药物依从性监测是有效的。年龄较小和病程较长是不依从的预测因素。授权的增加与依从性相关。临床意义 使用智能手机通过患者报告的措施增强依从性可能在日常临床环境中有所帮助。试用注册号 NCT01446406 和 NCT02221336。