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 |
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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 |