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Table 1 Statistical methods for outcomes and ancillary analyses

From: Brief motivational therapy versus enhanced usual care for alcohol use disorders in primary care in Chile: study protocol for an exploratory randomized trial

Outcome

Hypothesis

Outcome measure

Methods of analysis

1) Primary

 a) Drinks per drinking day at 6 months

BMT reduced outcome from baseline to 6 months

Drinks per drinking day during the last 90 days in the Timeline Follow Back [continuous]

T test

2) Secondary

 a) Alcohol use pattern at 6 months

Back to a low-risk use or abstinence after the treatment

Presence of a low-risk pattern: less than 100 g of ethanol a week and no binge drinking occasions (i.e., more than three SD in women and 4 in men) during the last 90 days in the Timeline Follow Back [binary]

Chi-squared test

 b) Frequency of heavy drinking at 6 months

Reduction

Number of heavy drinking occasions (i.e., more than three SD in women and more than four in men) during the last 90 days in the Timeline Follow Back [continuous]

T test

 c) Most extended period of abstinence during the last 3 months

Augmentation

Number of days of abstinence within the last 90 days in the Timeline Follow Back [continuous]

T test

 d) Severity of dependency at 6 months

Reduction

Score in the Alcohol DAYS, SEV, and WORST SEV score in the Substance Dependence Severity Scale (last 30 days) [continuous]

T test

 e) Alcohol related negative consequences

Reduction

Total consequences score in the Drinker Inventory of Consequences [continuous]

T test

3) Subgroup analyses

 a) High v/s low severity

Greater effect in low severity.

  

 b) Motivational level

Higher motivation intensifies the treatment effect.

  

 c) Educational level

Higher education intensifies the treatment effect.

  

 d) Male v/s female

Sex interacts with treatment effect.

  

4) Sensitivity analyses

 a) Per-protocol analysis

  

a) T test/chi-squared

 b) Adjustment for baseline variables

  

b) Linear model (multivariate regression)

 c) Missing data imputation

  

c) Multiple imputation (missing-at-random assumption)