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Breathalyser-Based eHealth Data Suggest That Self-Reporting of Abstinence Is a Poor Outcome Measure for Alcohol Use Disorder Clinical Trials
Kontigo Care AB, Pavel Snickares Grand 12, S-75320 Uppsala, Sweden..
Kontigo Care AB, Pavel Snickares Grand 12, S-75320 Uppsala, Sweden..
Kontigo Care AB, Pavel Snickares Grand 12, S-75320 Uppsala, Sweden..
Kontigo Care AB, Pavel Snickares Grand 12, S-75320 Uppsala, Sweden..
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2020 (English)In: Alcohol and Alcoholism, ISSN 0735-0414, E-ISSN 1464-3502, Vol. 55, no 3, p. 237-245Article, review/survey (Refereed) Published
Abstract [en]

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?

Place, publisher, year, edition, pages
2020. Vol. 55, no 3, p. 237-245
National Category
Substance Abuse
Identifiers
URN: urn:nbn:se:uu:diva-414257DOI: 10.1093/alcalc/agaa004ISI: 000535877600001PubMedID: 32118260OAI: oai:DiVA.org:uu-414257DiVA, id: diva2:1446476
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Vinnova, 2014-03659Available from: 2020-06-24 Created: 2020-06-24 Last updated: 2020-06-24Bibliographically approved

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Öhagen, PatrikAndersson, KarlNyberg, Fred

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UCR-Uppsala Clinical Research CenterMedical Radiation ScienceDepartment of Pharmaceutical Biosciences
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