Table 2.
Summary of Recommendations for Design and Analysis of Alcohol Treatment Studies.
| Recommendation | Selected Relevant Citations |
|---|---|
| 1. Careful consideration and reporting of exclusion criteria | Altman et al., 2001; Humphreys et al., 2008 |
| 2. Selection of a randomization procedure that reduces imbalances across treatment groups | Hedden et al., 2006; Matts and Lachin, 1988 |
| 3. Consider use of propensity score or instrumental variable methods when group imbalances exist | Berger, 2005b; Leyrat et al., 2013 |
| 4. Use of well-validated self-report measures and either biomarkers or carefully selected collateral informants to validate self-reported consumption | Litten et al., 2010; Miller, 1996; Sobell and Sobell, 1992; Sobell et al., 1997 |
| 5. Careful consideration of the timing of assessments to inform the durability of treatment effects and variation in outcomes over time | Collins and Graham, 2002; Stasiewicz et al., 2013 |
| 6. Investigation of data distributions and the use of either data transformation or alternative analytic techniques when data are non-normal | Atkins et al., 2013; Gueorguieva et al., 2012; Witkiewitz et al., 2010 |
| 7. An intention-to-treat (ITT) analytic approach that takes into account clustering of patients within sites, therapists, and/or groups and that controls for covariate adjustment in the randomization procedure | Del Re et al., 2013; Kahan and Morris, 2013; Moerbeek et al., 2003 |
| 8. An alternative approach to ITT, such as the complier average causal effect model, if there is unequal compliance across groups | Tucker et al., 2012; Ye et al., 2014 |
| 9. Minimizing missing primary outcome data by continuing to assess all individuals (including those who drop out of treatment) and maximum likelihood estimation or multiple imputation to accommodate missing data | Enders, 2010; Hallgren and Witkiewitz, 2014; Witkiewitz et al., 2014 |
| 10. Sensitivity analyses to evaluate the impact of missing data on the treatment effect estimates | Enders, 2011; Jackson et al., 2014 |