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

Piper 2016.

Study characteristics
Methods Design: Fractional factorial screening experiment
Setting: Primary care clinics in southern Wisconsin, USA
Recruitment: participants were recruited from 11 primary care clinics. During clinic visits, clinical care staff were prompted by electronic health record technology to invite people identified as smoking to participate in the study
Participants 637 participants, 55% F, av. age 45.8, average cpd not reported
Interventions Intervention 1. Pre‐quit nicotine patch
Half the participants were assigned to the active condition and received 14 mg patches for the 3 weeks prior to the TQD, while the other half did not receive prequit patches
Intervention 2. Prequit nicotine gum
Participants in the active condition received 2 mg nicotine gum for the 3 weeks prior to the TQD (≥ 9 pieces of gum/day, 1 piece/1 – 2 hours); the other half did not. Participants who received both Prequit Patch and Gum were told to use at least 5 pieces/day of gum, unless such use produced adverse effects
Intervention 3. Preparation counseling
Participants in the active condition received 3 x 20‐min counseling sessions prior to the TQD, focused on coping skills, reduction, and making practice quit attempts,while the other half of participants did not. The sessions 3 weeks and 1 week before the TQD were in‐person, and the week‐2 session was over the phone
Intervention 4. In‐person counseling
Participants in the intensive condition received 3 x 20‐min face‐to‐face counseling sessions: 1 week pre‐TQD, on the TQD, and at week 1. Sessions focused on skill building and intra‐treatment social support. Participants assigned to the minimal level received 1 x 3‐min in‐person session at Week‐1
Intervention 5. Phone counseling
Participants in the intensive condition received 3 x 15‐min phone sessions (TQD, Days 2 and 10), focused on coping skills, avoiding smoking cues, and intra‐treatment social support. Participants assigned to the minimal condition received 1 x 10‐min session on the TQD. Thus, all participants received someTQD phone counseling
Intervention 6. Extended medication
All participants received combination NRT (nicotine patch + nicotine gum) starting on their TQD. Half were assigned to receive 8 weeks of patches and 8 weeks of nicotine gum. The other half received 16 weeks of patches and 16 weeks of gum
Outcomes 7‐day PPA at 6m
Validation: None
Quit attempts
Funding Source Grants from the National Cancer Institute to the University of Wisconsin Center for Tobacco Research and Intervention and by the Wisconsin Partnership Program. Dr. Collins is also supported by NIH grants
Author's declarations of interest Authors declared that they had no conflict of interest
Notes Strategy: Adjunctive counseling (preparation phase and cessation phase, in person and via telephone), cost‐free medications (pre‐ and post‐quit, gum and patch)
Level: Patient
Comparison types: Active vs. active
Due to the complexity of the intervention components and combinations of intervention components tested, it was impossible to include this study in any of our meta‐analyses. Instead we describe the authors' conclusions narratively, in supplementary table 3.
Risk of bias
Bias Authors' judgement Support for judgement
Sequence Generation Low risk Database that used stratified permuted block randomization
Allocation concealment Unclear risk No details reported
Blinding of outcome assessors
All outcomes High risk Smoking status self‐report. Different contact between trial arms
Incomplete outcome data
All outcomes Low risk The overall loss to follow‐up was 41.3% (n = 263/637); the number lost to follow‐up ranged from 36% to 46% across the 6 factors at 6 months