@article{ref1,
title="Breathalyser-based eHealth data suggest that self-reporting of abstinence is a poor outcome measure for alcohol use disorder clinical trials",
journal="Alcohol and alcoholism",
year="2020",
author="Hämäläinen, Markku D. and Zetterström, Andreas and Winkvist, Maria and Söderquist, Marcus and Öhagen, Patrik and Andersson, Karl and Nyberg, Fred",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="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. <br><br>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. <br><br>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. <br><br>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?<br><br>© The Author(s) 2020. Medical Council on Alcohol and Oxford University Press. All rights reserved.<p /> <p>Language: en</p>",
language="en",
issn="0735-0414",
doi="10.1093/alcalc/agaa004",
url="http://dx.doi.org/10.1093/alcalc/agaa004"
}