Aung 2019.
Study characteristics | ||
Methods | Design: randomized controlled trial Setting: 7 primary healthcare settings in rural districts where people often grow tobacco in their gardens and consume home‐made hand‐rolled cigarettes, Northern Thailand Recruitment: QUOTE: "Recruitment for the study started simultaneously at seven primary health care units within the mobile non‐communicable diseases clinic network of Maetha district, Lampang province, in June 2012" |
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Participants | 319 people who smoked, aged between 35 and 80 years and have diabetes and/or hypertension; who had never succeeded in quitting smoking; 28.9% female; median age 64 years | |
Interventions | Intervention: Participants received: 1) adjunctive counseling; 2) carbon monoxide testing; 3) NRT gum; 4) a family‐assisted smoking cessation diary Nurses attended 2 pre‐intervention training workshops to deliver the intervention service package Control: participants received brief advice and a reminder to quit by a healthcare worker on subsequent visits to the hospital. Participants were requested to inform the healthcare worker when and if they quit smoking |
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Outcomes | CO‐validated smoking abstinence at 6m (self‐reported rates were also collected at 12m, but are not used in our analysis) Validation: CO |
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Funding Source | Ministry of Education, Japan | |
Author's declarations of interest | Authors declared that they had no competing interests. | |
Notes | Strategy: multicomponent (adjunctive counseling, CO monitoring, cost‐free medications, provider training) Level: patient, Provider Comparison type: multicomponent vs. standard care |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Low risk | QUOTE: "Random sequences are generated by the statistician on the basis of blocks of 24" |
Allocation concealment | Low risk | QUOTE: "The allocated arm for each participant will be provided to the study sites PCUs in opaque, sealed envelopes" |
Blinding of outcome assessors All outcomes | Low risk | Abstinence was biochemically verified |
Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 3.8% (n = 12/319); 1.9% (n = 3/160) in the intervention group and 5.7% (n = 9/159) in the control group were lost to follow‐up at 12 months |