Skip to main content
. 2021 Sep 6;2021(9):CD011556. doi: 10.1002/14651858.CD011556.pub2

Lindsay 1989.

Study characteristics
Methods Design: 3‐group cluster‐randomized controlled trial
Setting: Primary care practices, Canada
Recruitment: Receptionists identified people who smoked while visiting provider for routine appointment
Participants 83 providers
1942 people who smoked aged > 16 years, 64% smoked at least 20 cpd, av. age not reported, av. cpd not reported
Interventions Intervention 1: Gum only
• Physicians were cued by a project document indicating the participant's agreement to participate. Physicians in this group were instructed to advise the participant to quit smoking
• Participants were advised to use nicotine gum (at their own cost) by their physician
Intervention 2: Gum plus
• Physicians attended a training session on smoking cessation. Flow sheet provided to them to help them deliver intervention. Physicians in this group were instructed to advise the participant to quit smoking
• Participants received self‐help materials and were advised to use nicotine gum (at their own cost) by their physician
Control: usual care. QUOTE: "If it was part of their usual practice to address the smoking issue with patients, this occurred. We gave no instructions to patients about whether they should mention their agreement to participate to their physician, and we had no way of assessing whether this, in fact, occurred"
Outcomes 3m continuous abstinence measured at 12 months
Validation: Salivary cotinine < 0.057 umol/L
Quit attempts
Measures of provider implementation: Ask, Advise, Assist, Assist‐Meds, Assist‐Self‐help, Assist‐Quit Date, Arrange
Funding Source National Institute of Health (USA) and Canadian National Research and Development Program
Author's declarations of interest Not reported
Notes Strategy: Provider training + flow sheet
Level: Provider + Practice
Comparison type: Multi‐component vs. standard care
Risk of bias
Bias Authors' judgement Support for judgement
Sequence Generation Unclear risk No details reported
Allocation concealment Unclear risk No details reported
Blinding of outcome assessors
All outcomes Low risk Smoking abstinence was validated by cotinine
Incomplete outcome data
All outcomes Unclear risk Authors reported that 21.3% (n = 129/606) of participants in the gum‐plus group attended 4 or 5 follow‐up visits and that no data were available for gum‐only group. No further details reported
Recruitment bias (cluster RCTs only) Low risk Participants were affiliated with the practice before randomization. QUOTE: "patients entered the study when they visited their physician for a routine office appointment"
Balanced baseline characteristics? (cluster RCTs only) Low risk QUOTE: "we observed no differences on physician characteristics among experimental groups"; "we observed some difference in motivation levels among groups and the main analyses of outcome adjusted for these differences"
Adjustment for clustering in analysis? (cluster RCTs only) Low risk QUOTE: "treatment effect was assessed using analysis of covariance; the unit of analysis being the practice"