Stein 2002.
Methods | RCT. | |
Participants | 187 US AUDIT‐positive active injection drug users. | |
Interventions | MI (n= 95) vs control (assessment only) (n= 92). | |
Outcomes |
Physiological primary: None. Non‐physiological primary: Number of drinking days. Secondary: None. |
|
Notes | BRAINE study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Subjects were assigned to treatments using a randomisation schedule created with permuted blocks of eight assignments." |
Allocation concealment (selection bias) | Unclear risk | "The data manager prepared the randomisation schedule before the first patient enrolled." |
Blinding (performance bias and detection bias) Patients and providers | High risk | No blinding. |
Blinding (performance bias and detection bias) Assessors | Low risk | "At each follow‐up assessment, research assistants were blinded to the treatment condition of the subject." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3% loss to follow‐up at 6 months. Balanced. No reasons provided. ITT performed. Missing data were imputed using a 'worst case scenario' strategy. |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes based on the study hypotheses. |
Other bias | Unclear risk | Only self‐reported outcomes. There were no differences between groups at baseline. |