Siddiqi 2013.
Study characteristics | ||
Methods | Design: 3‐group cluster‐randomized controlled trial Setting: Health centers in Pakistan Recruitment: Opportunistic in practice |
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Participants | 1955 patients aged 18 years or older with suspected pulmonary tuberculosis (cough for 3 weeks without any other cause) who also regularly smoked tobacco (≥ 1 cpd), av. age 41, 95% M, av. cpd 16 | |
Interventions |
Intervention 1: Behavioral support sessions (BSS) • Participants received 2 structured sessions delivered by directly‐observed therapy facilitators using an educational flipbook (session 1: 30 minutes; session 2: 10 minutes on the quit day) • Directly‐observed therapy facilitators received a 1‐day training program delivered by the research team • Other healthcare professionals received briefing about BSS Intervention 2: BSS+ • Participants received a free 7‐week course of sustained‐release bupropion in addition to BSS • Physicians received training and written guidance on prescribing bupropion Control: • Participants received usual care and a self‐help leaflet on smoking cessation. No further details on the usual care reported • Directly‐observed therapy facilitators received information on trial procedures only |
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Outcomes | Continuous abstinence at 6m Valiation: Expired CO ≤ 9 ppm |
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Funding Source | International Development and Research Centre, Canada | |
Author's declarations of interest | Unable to access this information through the link provided in the paper | |
Notes | Strategy: Adjunctive counseling + Cost‐free medications + Provider training Level: Patient + Provider Comparison type: Multicomponent vs. standard care; active vs active (isolating effect of cost‐free medications) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Low risk | QUOTE: "...computer generated random‐number lists to generate the allocation sequence" |
Allocation concealment | Unclear risk | No details reported |
Blinding of outcome assessors All outcomes | High risk | Smoking status is self‐report and there was different contact between the control arm and the intervention arms |
Incomplete outcome data All outcomes | Low risk | At participant level, the overall loss to follow‐up was 5.8% (n = 114/1955 survivors); 8.0% (n = 53/659) in the BSS+ group, 3.1% (n = 20/640) in the BSS group, and 6.3% (n = 41/656) in the control group at 6‐month follow‐up |
Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the health centers before randomization |
Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "The 3 groups were generally similar with respect to the baseline characteristics, although mean age, sex, and smoking type differed slightly" |
Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "...adjusting for cluster effect using an intraclass correlation coefficient of 0.036" |