Mechanisms of change in control group drinking in clinical trials of brief alcohol intervention: Implications for bias toward the null
Abstract
ISSUES: Reductions in control group consumption over time that are possibly related to research design affect the impact of brief alcohol interventions (BAI) in clinical settings. APPROACH: We conducted a systematic review to identify research design factors that may contribute to control group change, strategies to limit these effects and implications for researchers. Studies with control group n > 30 were selected if they published baseline and outcome consumption data, conducted trials in clinical settings in Anglophone countries and did not censor gender or age. KEY FINDINGS: Among 38 studies cited in 20 reviews through October 2009, 16 met criteria (n = 31-370). In 54%, controls received alcohol specific handouts, advice and/or referral. Both the number and depth of assessments were highly variable. The percentage change in consumption ranged from-0.10 to-0.84 (mean-0.32), and effect size from 0.04 to 0.70 (mean 0.37). Published data were insufficient for meta-analysis. IMPLICATIONS: Researchers should consider strategies to reduce the impact of research design factors, such as procedures to enhance sample diversity, blind subjects to study purpose to limit social desirability bias, reduce the number and depth of instruments (assessment reactivity), and finally, analytic techniques to decrease the impact of outliers and regression to the mean. CONCLUSIONS: This review identifies problems with retrospective analysis of predictors of control group change, and underscores the need to design prospective studies to permit identification, quantification and adjustment for potential sources of bias in BAI trials.
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The act of assessing alcohol use in research may by itself reduce drinking, making it hard to distinguish assessment effects from intervention effects.
“There is an additional concern that research assessments of alcohol consumption can themselves lead to decreased drinking28 thus making it difficult to separate the assessment effect from the overall intervention outcomes.”
From A Brief Intervention Reduces Hazardous and Harmful Drinking in Emergency Department Patients (2012) · cites this paper as [28]
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Assessment Reactivity within the Context of a Web-Based Brief Intervention for Alcohol Use
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- Authors
- BERNSTEIN, J. A., BERNSTEIN, E., & HEEREN, T. C.
- Affiliations
- Boston University (US)
- Corresponding author
- BERNSTEIN, JUDITH A.
- Venue
- Drug and Alcohol Review
- Publisher
- Wiley
- Published
- 2010-09
- Volume
- 29
- Issue
- 5
- Pages
- 498-507
- ISSN
- 0959-5236 (ISSN-L)
- 1465-3362
- OpenAlex
- W1590437440
- Cited by
- 68
- References
- 100
- Citations by year
- 2026: 1 · 2025: 1 · 2023: 3 · 2022: 4 · 2021: 2 · 2020: 2 · 2019: 3 · 2018: 2 · 2017: 3 · 2016: 3 · 2015: 4 · 2014: 12 · 2013: 8 · 2012: 10
- FWCI
- 1.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Drug and Alcohol Review (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- brief alcohol intervention, placebo effect, social desirability bias, regression to the mean, clinical trials, sample diversity
- MeSH terms
- Alcohol Drinking, Humans, Psychotherapy, Brief, Research Design, Time Factors, Bias, Treatment Outcome, Controlled Clinical Trials as Topic, Control Groups
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