Babor 2006.

Methods	Cluster RCT: brief intervention (two arms delivered by different professionals) versus usual care; 15 practices randomised. Used a pre‐post repeated measures group design. ITT: yes.
Participants	Setting: USA; family or internal medicine clinics in a managed care organisation (MCO) Participants ≥ 18 years were screened with Health Assessment Survey including AUDIT and selected if they scored 8+ (men) or 7+ (women). Number of clinics randomised = 15; number of participants randomised = 50,411, 60% male; mean age followed up at 3 months (n = 1379) = 45.9 years. At baseline: mean drinks per week (defined by AUDIT questions 1 to 2) = 13.8 (men); 8.7 (women).
Interventions	Group P (N = 17,257 randomised, 1151 sampled for follow‐up) received brief intervention (according to their level of drinking ‐ see below for detail) from physician or physician assistant. Group S (N = 15,938 randomised, 1124 sampled for follow‐up) received brief intervention from specialist, i.e. mostly nurses. Group C (N = 17,216 randomised, 1955 sampled for follow‐up) was the control group and received "patient care as usual" (not defined). Within each group treatment allocated by drinking level: Zone I (modified AUDIT 7 to 15 for women and men aged > 65 years; 8 to 15 for men < 65 years) participants received simple advice (3 to 5 minutes) and an information brochure; Zone II (AUDIT 16 to 19) received advice and a more extensive self‐help manual; Zone III (AUDIT > 19) specified advice and referral to specialty care for alcohol assessment and treatment. Advice comprised: feedback of screening scores and any problems or symptoms identified; discussion of the participant’s risk level; connection of drinking risk to actual or potential problems and information about safer drinking limits; commitment to a goal of cutting back or stopping; and presentation of the brochure and encouragement to reach the established goal.
Outcomes	Number of drinks per week; per cent at risk drinkers who had changed drinking at three months; health care utilisation (all days, outpatients visits, inpatient days, emergency department visits, ADM‐related days (mental health). Assessed at 3 and 12 months.
Funding source	This research was supported by grant no. 029620 from the Robert Wood Johnson Foundation.
Declaration of interests	Not reported.
Notes	Cutting Back programme. Payment: the MCOs were reimbursed; participants received no payment. Loss to follow‐up: 81/575 (14%) overall (not reported by arm).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random numbers from table generated by independent statistician (p. 625).
Allocation concealment (selection bias)	Low risk	Allocation by independent statistician – not a member of the team (p. 625).
Blinding of treatment providers	Low risk	Cluster‐randomised trial and all participants from a particular clinic received the same intervention, so therefore risk of contamination between arms was low.
Blinding of participants	High risk	No reported attempt to blind participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Computer‐assisted telephone interview by independent survey organisation – interviewers not aware of the study condition (p. 625).
Incomplete outcome data (attrition bias) All outcomes	High risk	Only reported data from those who completed, not those randomised.
Selective reporting (reporting bias)	High risk	Only primary outcome fully reported.