AIMS To evaluate the efficacy and monitoring capabilities of a breathalyser-based eHealth system for patients with alcohol use disorder (AUD) and to investigate the quality and validity of timeline follow-back (TLFB) as outcome measure in clinical trials and treatment. METHODS Patients (n = 115) were recruited to clinical trials from a 12-step aftercare programme (12S-ABS) and from hospital care with abstinence (HC-ABS) or controlled drinking (HC-CDR) as goal and randomly divided into an eHealth and a control group. The effect of the eHealth system was analysed with TLFB-derived primary outcomes-change in number of abstinent days (AbsDay) and heavy drinking days (HDDs) compared to baseline-and phosphatidyl ethanol (PEth) measurements. Validity and quality of TLFB were evaluated by comparison with breath alcohol content (BrAC) and eHealth digital biomarkers (DBs): Addiction Monitoring Index (AMI) and Maximum Time Between Tests (MTBT). TLFB reports were compared to eHealth data regarding reported abstinence. RESULTS The primary outcome (TLFB) showed no significant difference between eHealth and control groups, but PEth did show a significant difference especially at months 2 and 3. Self-reported daily abstinence suffered from severe quality issues: of the 28-day TLFB reports showing full abstinence eHealth data falsified 34% (BrAC measurements), 39% (MTBT), 54% (AMI) and 68% (BrAC/MTBT/AMI). 12S-ABS and HC-ABS patients showed severe under-reporting. CONCLUSIONS No effect of the eHealth system was measured with TLFB, but a small positive effect was measured with PEth. The eHealth system revealed severe quality problems with TLFB, especially regarding abstinence-should measurement-based eHealth data replace TLFB as outcome measure for AUD?

中文翻译：

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基于呼吸分析仪的eHealth数据表明，戒酒的自我报告是一项针对酒精使用障碍临床试验的较差的衡量指标。

目的评估基于呼吸分析仪的eHealth系统对酒精使用障碍（AUD）患者的疗效和监测能力，并调查时间轴跟踪（TLFB）作为临床试验和治疗中的结局指标的质量和有效性。方法将115例患者从12步护理计划（12S-ABS）和节制（HC-ABS）或控制饮酒（HC-CDR）的医院护理中纳入临床试验，并随机分为一名电子卫生保健和一个对照组。与基线和磷脂酰乙醇（PEth）测量值相比，使用TLFB得出的主要结局变化-禁忌日（AbsDay）和重度饮酒日（HDDs）的变化分析了eHealth系统的效果。通过与呼吸酒精含量（BrAC）和eHealth数字生物标记物（DBs）：成瘾监测指数（AMI）和最大检测间隔时间（MTBT）进行比较，评估了TLFB的有效性和质量。将TLFB报告与有关报告的禁欲的eHealth数据进行比较。结果eHealth与对照组之间的主要结局（TLFB）没有显着差异，但PEth确实表现出显着差异，尤其是在第2和第3个月。自我报告的每日禁欲遭受严重的质量问题：在28天的TLFB报告中完全禁欲的eHealth数据伪造了34％（BrAC测量），39％（MTBT），54％（AMI）和68％（BrAC / MTBT / AMI）。12S-ABS和HC-ABS患者报告严重不足。结论TLFB不能测量eHealth系统的作用，而PEth可以测量出小的积极作用。