Fleming 2010.
Methods |
Design: RCT Follow‐up: 6, 12 months Attrition: 12 % |
|
Participants |
Mean age (years): 21 Sex: 49% male N participants: 986 Allocation: n = 493 intervention; n = 493 control Setting: college health clinics, higher risk students Country: USA and Canada |
|
Interventions |
Programme type: brief motivational interviewing Set‐up: 2 individual sessions Key components: contracting and goal‐setting, diary cards and take‐home exercises Duration: 15 min each Control: assessment only |
|
Outcomes |
Outcomes: number of drinks last 28 days; number of heavy drinking days; number of drinking days last 28 days; alcohol related problems; urgent health care utilisation; health status measures ‐ depression, smoking, injuries, violence Measures: Timeline Followback; Rutgers Alcohol Problem Index |
|
Funding and Declared Conflicts of Interest | Funded by NIAAA. No information or declarations about potential conflicts of interest | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation achieved using a computer‐generated allocation method |
Allocation concealment (selection bias) | Low risk | No identifiers available to recognise controls |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition 12%. Intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding only occurred in the control condition: One of the goals of the trial was to blind subjects assigned to the control groups to minimise the intervention effect of the research procedures. The subjects randomised into the control group were told the trial focused on a number of health behaviours, including alcohol. The physicians and their staffs were not told which of their patients were randomised into the control group |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blinded to group status |
Unit of Analysis issues | Low risk | Not applicable |