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

Nevid 1997.

Methods Study design: Randomized controlled trial
Country: USA
 Recruitment: Community volunteers, via media and healthcare settings
 Group size: 3 ‐ 12, single‐sex groups, same‐sex therapists
Participants 93 Hispanic smokers (excludes 56 people, 35 Gr, 21 S‐H who were randomized but did not attend any session and were not included in further analysis); 48% women, av. age 44, av. cpd 21
 Therapists: bilingual Hispanic psychologists and social workers
Interventions 1. Group therapy. 8 x 2 hrs. Included videos using culturally‐specific components. Motivation, nicotine fading, quitting techniques, RP, 'buddy' support. TQD 5th week
 2. S‐H with 1 group session for motivation and instructions and telephone contact. ALA Freedom from Smoking in 20 days in English & Spanish, also Guia para Dejar de Fumar 
 Both conditions received same maintenance programme; ALA S‐H manual A Lifetime of Freedom from Smoking and 2 telephone calls a month for 6 m
Outcomes Abstinence at 12 m (sustained from post‐treatment). PPA rates also reported
 Validation. Saliva cotinine
Notes Comparison 1.1.2 vs different S‐H. Low take‐up rates. 33% of eligible attended orientation session, only 62% of enrollees attended any further session. Using 12‐m PPA rates would give 3/39 vs 4/54 quit
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "pairwise random assignment ... a random numbers table was used to generate a sequence of odd and even numbers, which was then used as the basis for randomly assigning members of each pair of consecutively enrolled participants within each gender to either [the treatment or control]"
Allocation concealment (selection bias) Unclear risk Seems unlikely from description that schedule was concealed
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Biochemical validation of abstinence
Incomplete outcome data (attrition bias) 
 All outcomes High risk Post‐randomization dropouts are excluded. There was differential attendance