Dent 2009.
Methods |
Country: USA Design: Open‐label, prospective, randomised controlled trial Study objective: To assess the effectiveness on smoking cessation of a face‐to‐face group programme conducted by the pharmacist team compared with a brief standard‐care session delivered by a pharmacist over the telephone Method of analysis: Participant data and testing results were recorded in a Microsoft SQL Server 2000 database. Baseline categorical variables by intervention group were compared using the Chi2 test and the 2‐sample t‐test Clustering adjustments made: Not applicable |
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Participants |
Eligible for study: n = 120 Randomised: n = 101 Completed: Intervention n = 49; Control n = 48 Age: Intervention 56.7; Control 55.0 Gender: Men 93% Inclusion criteria: daily tobacco users for 7 days or more motivated to quit smoking Exclusion criteria: Had recently started NRT |
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Interventions |
Setting: Single outpatient pharmacy department in the Rocky Mountain region of the USA Intervention description: Motivational programme delivered in 3 x 2‐hour sessions in small groups by pharmacists using the transtheoretical model of change and health belief model. Specifically consisted of peer support, goal setting, behavioural strategies and cognitive strategies tailored to individual's current motivation to quit. Follow‐up support was provided as necessary in person or over the phone. NRT and bupropion were offered as appropriate Control description: Participants received 1 timed 5‐ to 10‐minute session over the phone that included all the components of standard care recommended by the Clinical Practice Guidelines and practiced within the VA for brief interventions delivered by healthcare providers, referred to as "The 5 A's". NRT and bupropion were offered as appropriate Duration of Intervention: 3 in‐person sessions (3 hours for session 1, 2 hours for session 2 and 1 hour for session 3) delivered at 2‐week intervals over 5 weeks |
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Outcomes |
Prespecified outcomes: 7‐day, 30‐day and continuous abstinence rates, self‐reported by participants at 6 months following the intervention Follow‐up period: 6 months |
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Notes | Funding: The Prevent Cancer Foundation Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Randomization codes assigned to each participant were computer generated by the study statistician and stratified by sex in blocks of 6.” |
Allocation concealment (selection bias) | Unclear risk | No mention of whether or how allocation was concealed: Quote: “The pharmacist team conducted a baseline assessment over the telephone, then notified participants of their group assignment.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates low and similar between groups (1/51 lost to intervention, 3/51 lost to control) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence biochemically verified using urinary cotinine |
Selective reporting (reporting bias) | Unclear risk | No published protocol available. Outcomes reported in the Methods were reported in analyses |