Piper 2018.
Study characteristics | ||
Methods | Design: randomized controlled trial Setting: 7 primary care clinics within 2 Wisconsin healthcare systems, USA Recruitment: Mailings to patients identified from electronic health record |
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Participants | 623 people who smoked 57.3% F, av. age 49.7, av. cpd 16.8 | |
Interventions | Common components in both groups: counseling and nicotine patches (duration different between the groups) Intervention: participants received 3 weeks of prequit mini‐lozenges, 26 weeks of nicotine patch + mini‐lozenges, 3 in‐person and 8 phone counseling sessions, and 7 – 11 automated prompts to use medication Control: participants received 10 minutes of in‐person counseling, 8 weeks of nicotine patch, and referral to quitline services |
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Outcomes | PPA at 12m Validation: CO < 6 ppm | |
Funding Source | National Institutes of Health | |
Author's declarations of interest | Authors declared that they had no conflict of interest | |
Notes | Strategy: Adjunctive counseling, cost‐free medications, medication prompts Level: Patient Comparison type: Multicomponent vs. standard care |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Low risk | QUOTE: "Computer‐based randomization used a 1:1 randomization within blocks of six participants, stratified by gender" |
Allocation concealment | Low risk | QUOTE: "Computer‐based randomization used a 1:1 randomization within blocks of six participants, stratified by gender" |
Blinding of outcome assessors All outcomes | Low risk | Smoking status was biochemically validated |
Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 45.1% (n = 281/623); 48.1% (n = 148/308) in the intervention group and 42.2% (n = 133/315) in the control group were lost to follow‐up at 12 months |