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. 2017 Mar 31;2017(3):CD001007. doi: 10.1002/14651858.CD001007.pub3

Omenn 1988.

Methods Study design: Randomized controlled trial
Country: USA
 Recruitment: Single worksite (13,000 workers, 9 employers)
 Group size: typically 15 ‐ 20
Participants 159 smokers; 66% men, av. age 43, av. cpd 25, with preference for group programme or no preference (Smokers with preference for S‐H were not allocated to group programmes)
 Led by instructors trained in both programmes
Interventions 1. Multiple Component programme. 3 sessions over 3 wks. Didactic format
 2. RP programme. 8 sessions over 8 wks. Interactive format, choice of immediate or phased quit
 3. Minimal Treatment programme. S‐H materials only. ACS 22‐page Quitter's Guide 7‐day plan
Outcomes Abstinence at 12 m (single PPA)
 Validation: saliva cotinine ≤ 35 ng/ml
Notes 1+2 vs 3 in comparison 1.1.2 vs different S‐H. No difference in outcome at 12 m between 2 group programmes. Self‐reported quit rates similar across all 3 conditions but more missing saliva samples in S‐H so validated rates lower
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "nurses at aid stations using randomized assignment lists generated by research centre, within preference for format"
Allocation concealment (selection bias) High risk Mention of lists and not envelopes suggests that concealment unlikely
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Biochemical validation of abstinence
Incomplete outcome data (attrition bias) 
 All outcomes Low risk At least 89% followed up in each arm