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. 2021 Sep 6;2021(9):CD011556. doi: 10.1002/14651858.CD011556.pub2

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
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
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
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