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. 2019 Oct 31;2019(10):CD003698. doi: 10.1002/14651858.CD003698.pub3

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
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
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
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
Notes Funding: The Prevent Cancer Foundation
Declarations of interest: not reported
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