Dent 2009.
Study characteristics | ||
Methods | Design: Randomized controlled trial Setting: A Veterans Health Administration, community‐based outpatient clinic in the Rocky Mountain region, USA Recruitment: Patients identified through EMR‐generated list. Called by pharmacist and invited to participate |
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Participants | 101 adults who smoked 1 or more cigarettes daily for 7 days, were at least somewhat ready to quit in the next 2 weeks (≥ 4 on a 10‐point motivational scale), were willing and capable of attending 3 scheduled sessions at the clinic, and were interested in participating in the study. av.age 56, 19 cpd, 93% M | |
Interventions | Common components in both groups: all people who smoked were referred to a clinical pharmacist via the electronic computerized patient record system. They were offered their choice of immediate‐release bupropion tablets or nicotine patch at no cost. Intervention: participants who smoked participated in a face‐to‐face 3‐session group program at the clinic, delivered by the pharmacist and pharmacy students. For follow‐up, all participants were instructed to call the clinic for questions or to receive additional support as needed. Control: The pharmacist or pharmacy student used a structured script and delivered 1 timed 5‐ to‐10 minute session to the participants over the telephone that included all the components of standard care recommended by the Clinical Practice Guidelines |
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Outcomes | Continuous abstinence at 6m Validation: Urinary cotinine < 0.3 ug/ml |
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Funding Source | Not reported | |
Author's declarations of interest | Not reported. | |
Notes | Strategy: Adjunctive counseling Level: Patient Comparison type: Single component vs. standard care |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | 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 | Low risk | QUOTE: "Randomisation codes assigned to each participant were computer generated by the study statistician and stratified by sex in blocks of 6" |
Blinding of outcome assessors All outcomes | Low risk | Smoking status was validated by urinary cotinine |
Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 4.0% (n = 4/101); 2.0% (n = 1/50) in the intervention group and 5.9% (3/51) in the control group were lost to follow‐up at 6 months. Therefore, dropout was low and balanced between arms |