Saitz 2007.
Methods | RCT. | |
Participants | 341 US medical inpatients who were drinking risky amounts of alcohol. | |
Interventions | Motivational counselling (n= 172) vs usual care (n= 169). | |
Outcomes |
Physiological primary: None. Non‐physiological primary: Drinking risky amounts, heavy drinking episodes, abstinence. Secondary: Readiness to change (Taking Steps Scale on the Stages of Change Readiness and Treatment Eagerness Scale). Data not reported. Received alcohol assistance. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "...permuted block (size 8) randomisation procedure stratified by AUDIT score." |
Allocation concealment (selection bias) | Unclear risk | Used sealed opaque envelopes. It is unclear whether the envelopes were opaque and/or sequentially numbered. |
Blinding (performance bias and detection bias) Patients and providers | High risk | No blinding. |
Blinding (performance bias and detection bias) Assessors | Unclear risk | It is not stated whether the assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 3 months follow‐up, the attrition was 17% in the usual care group and 24% in the brief intervention group. At 12 months, the attrition was 14% in the usual care group and 18% in the brief intervention group. Flow chart with reasons for attrition reported. It appears that ITT was performed ("...analyzed all patients in the groups to which they were randomly assigned.) |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes based on the study hypotheses. |
Other bias | Unclear risk | Baseline imbalances (gender, alcohol‐attributable medical diagnoses, received alcohol assistance, drug use) existed despite randomization. Biological breath tests were conducted at follow‐ups. |