Bernstein 2009.
Methods | Pilot RCT. | |
Participants | 210 patients aged 14‐21 years in an urban, academic paediatric emergency department. USA. | |
Interventions | Brief MI (n = 68) vs assessed control (n=71) vs non assessed control (n = 71). | |
Outcomes |
Physiological primary: None. Non‐physiological primary: Marijuana consumption including a 30‐day self‐report of marijuana use, attempts to quit, cut back, or change conditions of use, and risk factor questions repeated at follow‐up. Secondary: None. Follow‐up was at 12 months. |
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Notes | We do not report data on the non assessed control because baseline data on this group were not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was based on computer‐generated random numbers in blocks of 100 stratified by age group (14‐17 and 18‐21 years)." |
Allocation concealment (selection bias) | Low risk | "A double opaque envelope system enabled blinding of the research assistants who performed the assessment to randomisation status. The first envelope, with randomisation to assessed (Int, AC) or non assessed (NAC) status, was opened immediately after enrolment. A second envelope indicating Int or AC status was not opened until after assessment." |
Blinding (performance bias and detection bias) Patients and providers | High risk | No blinding. |
Blinding (performance bias and detection bias) Assessors | Low risk | "Participants were cautioned not to reveal to the research assistants at the time of follow‐up whether or not they had received any further testing after enrolment" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 30% lost to follow‐up at 3 months in the assessed groups, not balanced between groups. 29% lost to follow‐up at twelve months across all groups, not balanced across groups. Reasons for loss not stated. Not ITT, but worst‐case scenario analysis. |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes based on the stated hypotheses. |
Other bias | High risk | Only self‐reported outcomes. The intervention group used marijuana on more days per month than the AC group at baseline. |