Kontigo Care AB, Påvel Snickares Gränd 12, 753 20 Uppsala, Sweden.
Uppsala Clinical Research Center, Dag Hammarskjölds väg 14 B, Uppsala Science Park, 751 83 Uppsala, Sweden.
Alcohol Alcohol. 2020 Apr 16;55(3):237-245. doi: 10.1093/alcalc/agaa004.
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.
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.
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.
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?
评估一种基于呼气酒精测试的电子健康系统在治疗酒精使用障碍（AUD）患者中的疗效和监测能力，并研究时间线回溯（TLFB）作为临床试验和治疗中结局测量的质量和有效性。
将来自 12 步康复项目（12S-ABS）和以戒断（HC-ABS）或控制饮酒（HC-CDR）为目标的住院治疗的患者（n=115）招募到临床试验中，并随机分为电子健康组和对照组。使用 TLFB 衍生的主要结局（与基线相比，戒断天数（AbsDay）和重度饮酒天数（HDDs）的变化）和磷脂酰乙醇（PEth）测量来分析电子健康系统的效果。通过与呼气酒精含量（BrAC）和电子健康数字生物标志物（DBs）：成瘾监测指数（AMI）和最大测试间隔时间（MTBT）进行比较，评估 TLFB 的有效性和质量。TLFB 报告与电子健康数据中报告的戒断情况进行比较。
主要结局（TLFB）在电子健康组和对照组之间没有显著差异，但 PEth 确实在第 2 和第 3 个月有显著差异。自我报告的每日戒断情况存在严重的质量问题：在 28 天 TLFB 报告中显示完全戒断的情况下，电子健康数据伪造了 34%（BrAC 测量值）、39%（MTBT）、54%（AMI）和 68%（BrAC/MTBT/AMI）。12S-ABS 和 HC-ABS 患者的报告严重不足。
TLFB 未测量到电子健康系统的效果，但 PEth 测量到了较小的积极效果。电子健康系统显示 TLFB 存在严重的质量问题，尤其是关于戒断情况——应该用基于测量的电子健康数据替代 TLFB 作为 AUD 的结局测量吗？
