Rubio 2010.

Methods	Parallel RCT: brief intervention plus health leaflet versus health leaflet. ITT: yes.
Participants	Setting: Spain, primary care clinic. Participants: 18 to 65 years, AUDIT = 8 to 15 or reported binge drinking (men ≥ 5 and women ≥ 4 standard drinks per occasion one or more times in the past month); screened with AUDIT; excluded if alcohol dependent (AUDIT > 15), or refused to take part, or pregnant, or planning to move out of the area within the year, or no telephone, or already participating in an alcohol intervention program, or Axis I psychiatric disorder that prevented participation (according to physician’s judgement). Number randomised = 752; 65% male; mean age of total sample not reported; 88% employed, 4% unemployed, 8% homemaker; 58% high school or less, 38% some college, 4% college degree or more. Baseline data not reported for total sample.
Interventions	BI group (N = 371) received two 10 to 15 minute counselling sessions four weeks apart from the primary care physician using a scripted workbook, which included a review of alcohol‐related health effects, a pie chart displaying the frequency of different types of at‐risk drinkers, a list of methods for cutting down drinking, a treatment contract, and cognitive behavioural exercises. An office nurse contacted the patients two and eight weeks after the initial counselling sessions to reinforce the face‐to‐face sessions. Participants also received the same booklet as the control group. Control group (N = 381) received a booklet on general health issues and were instructed to address any health concerns in their usual manner.
Outcomes	Mean number of binge drinking episodes in the last 30 days, mean number of drinks in previous seven days, mean number of participants binge drinking in last 30 days, mean number of participants reporting excessive drinking in the previous seven days (> 18 drinks per week for men and > 13 for women); all reported separately by gender. Assessed at 12 months.
Funding source	Funding: This research was supported by Grants FCM/03 and FCM/04 (Fundacion Cerebro y Mente) and Instituto de Salud Carlos III, Centro de Investigación en Red de Salud Mental, CIBERSAM.
Declaration of interests	Conflict of Interest: none of the authors have any conflicts of interest associated with the work presented in this manuscript.
Notes	Loss to follow‐up: BI group: 31/371 (8%). Control group: 47/381 (12%).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised by a computer generated allocation method (men and women were randomised separately) (p. 73).
Allocation concealment (selection bias)	Unclear risk	Implementation of sequence not reported.
Blinding of treatment providers	High risk	Not blinded.
Blinding of participants	High risk	Not blinded. Screened by AUDIT.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Conducted by blinded researchers not assigned to the subject’s clinic (p. 73).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up reported with reasons.
Selective reporting (reporting bias)	Low risk	Outcomes specified in methods are reported.