Hennrikus 2002.
Methods | Cluster‐randomised controlled trial Country: USA Setting: 24 Minneapolis‐St Paul worksites; 2 x 3 factorial design, stratified by gender and education |
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Participants | 2402 current smokers (smoked at least 100 cigs in lifetime). Mean age 39, 56.2% women, 62% married/partner | |
Interventions | 1. Group: 13 group sessions over 2 months. 2. Phone: sent printed materials, inc ALA Freedom from Smoking + 3 to 6 telephone counselling sessions 3. Choice: free choice between group or phone programmes. All programmes offered 3 times over 18 months; smokers could join more than once. Half of the sites in each intervention were offered direct incentives for participation and for quitting: Quitters at 1 month won USD 20 and entered lottery for grand prize (USD 500 as 1 prize (5 sites), 2 x USD 250 (6 sites) or 4 x USD 125 (1 site)). Drawn about every 6 months | |
Outcomes | Baseline, 7‐day PPA at 12 months, 24 months Validation: self‐report, countersigned by friend or family member for monthly abstinence. Grand draw prize winners + 24 months random sample of quitters (paid USD 25 for compliance) tested for salivary cotinine | |
Notes | Study was funded by the National Heart, Lung, and Blood Institute. Data extrapolated from percentages | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Four worksites were randomly assigned to each of the 6 experimental conditions". Method not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not all participants had abstinence biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 12 months 14.5% lost, and at 24 months 18.3% lost |
Other bias | High risk | Group dropouts were not followed up; phone dropouts were rung for up to 10 times for each counselling session, and were then left messages or sent letters |