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An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework

BACKGROUND: Due to a resurgent debate on the misuse of P values, the Journal of Medical Internet Research is hosting a standing theme issue inviting the reanalysis of (primarily digital health) trial data using a Bayesian framework. This first paper in this series focuses on an electronic screening...

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Autor principal: Bendtsen, Marcus
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938590/
https://www.ncbi.nlm.nih.gov/pubmed/31845903
http://dx.doi.org/10.2196/14420
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author Bendtsen, Marcus
author_facet Bendtsen, Marcus
author_sort Bendtsen, Marcus
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description BACKGROUND: Due to a resurgent debate on the misuse of P values, the Journal of Medical Internet Research is hosting a standing theme issue inviting the reanalysis of (primarily digital health) trial data using a Bayesian framework. This first paper in this series focuses on an electronic screening and brief intervention (eSBI), targeting harmful and hazardous alcohol consumption, which student health care centers across Sweden have routinely administerd to all students during the past decade. The second Alcohol Email Assessment and Feedback Study Dismantling Effectiveness for University Students (AMADEUS-2) trial aimed to assess the effect of the eSBI on alcohol consumption among students who were harmful and hazardous drinkers. A two-arm randomized controlled trial design was employed, randomizing eligible participants to either a waiting list or direct access to an eSBI. Follow-up assessments were conducted 2 months after randomization. Subsequent analysis of the trial followed the conventional null hypothesis approach, and no statistical significance was found between groups at follow-up with respect to the number of standard drinks consumed weekly. However, in an unspecified sensitivity analysis, it was discovered that removing three potential outliers made the difference between the groups significant. OBJECTIVE: The objective of this study is to reperform the primary and sensitivity analysis of the AMADEUS-2 trial using a Bayesian framework and to compare the results with those of the original analysis. METHODS: The same regression models used in the original analysis were employed in this reanalysis (negative binomial regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest. RESULTS: Null hypothesis tests did not identify a statistically significant difference between the intervention and control groups, potentially due to a few extreme data points. The Bayesian analysis indicated a 93.6% probability that there was a difference in grams of alcohol consumed at follow-up between the intervention and control groups and a 71.5% probability that the incidence rate ratio was <0.96. Posterior probabilities increased when excluding three potential outliers, yet such post hoc analyses were not necessary to show the preference toward offering an eSBI to harmful and hazardous drinkers among university students. CONCLUSIONS: The null hypothesis framework relies on point estimates of parameters. P values can therefore swing heavily, depending on a single or few data points alone, casting doubt on the value of the analysis. Bayesian analysis results in a distribution over parameter values and is therefore less sensitive to outliers and extreme values. Results from analyses of trials of interventions where small-to-modest effect sizes are expected can be more robust in a Bayesian framework, making this a potentially better approach for analyzing digital health research data. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 02335307; http://www.isrctn.com/ISRCTN02335307
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spelling pubmed-69385902020-01-13 An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework Bendtsen, Marcus J Med Internet Res Original Paper BACKGROUND: Due to a resurgent debate on the misuse of P values, the Journal of Medical Internet Research is hosting a standing theme issue inviting the reanalysis of (primarily digital health) trial data using a Bayesian framework. This first paper in this series focuses on an electronic screening and brief intervention (eSBI), targeting harmful and hazardous alcohol consumption, which student health care centers across Sweden have routinely administerd to all students during the past decade. The second Alcohol Email Assessment and Feedback Study Dismantling Effectiveness for University Students (AMADEUS-2) trial aimed to assess the effect of the eSBI on alcohol consumption among students who were harmful and hazardous drinkers. A two-arm randomized controlled trial design was employed, randomizing eligible participants to either a waiting list or direct access to an eSBI. Follow-up assessments were conducted 2 months after randomization. Subsequent analysis of the trial followed the conventional null hypothesis approach, and no statistical significance was found between groups at follow-up with respect to the number of standard drinks consumed weekly. However, in an unspecified sensitivity analysis, it was discovered that removing three potential outliers made the difference between the groups significant. OBJECTIVE: The objective of this study is to reperform the primary and sensitivity analysis of the AMADEUS-2 trial using a Bayesian framework and to compare the results with those of the original analysis. METHODS: The same regression models used in the original analysis were employed in this reanalysis (negative binomial regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest. RESULTS: Null hypothesis tests did not identify a statistically significant difference between the intervention and control groups, potentially due to a few extreme data points. The Bayesian analysis indicated a 93.6% probability that there was a difference in grams of alcohol consumed at follow-up between the intervention and control groups and a 71.5% probability that the incidence rate ratio was <0.96. Posterior probabilities increased when excluding three potential outliers, yet such post hoc analyses were not necessary to show the preference toward offering an eSBI to harmful and hazardous drinkers among university students. CONCLUSIONS: The null hypothesis framework relies on point estimates of parameters. P values can therefore swing heavily, depending on a single or few data points alone, casting doubt on the value of the analysis. Bayesian analysis results in a distribution over parameter values and is therefore less sensitive to outliers and extreme values. Results from analyses of trials of interventions where small-to-modest effect sizes are expected can be more robust in a Bayesian framework, making this a potentially better approach for analyzing digital health research data. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 02335307; http://www.isrctn.com/ISRCTN02335307 JMIR Publications 2019-12-17 /pmc/articles/PMC6938590/ /pubmed/31845903 http://dx.doi.org/10.2196/14420 Text en ©Marcus Bendtsen. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 17.12.2019. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Bendtsen, Marcus
An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework
title An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework
title_full An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework
title_fullStr An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework
title_full_unstemmed An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework
title_short An Electronic Screening and Brief Intervention for Hazardous and Harmful Drinking Among Swedish University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework
title_sort electronic screening and brief intervention for hazardous and harmful drinking among swedish university students: reanalysis of findings from a randomized controlled trial using a bayesian framework
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938590/
https://www.ncbi.nlm.nih.gov/pubmed/31845903
http://dx.doi.org/10.2196/14420
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