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. 2021 Mar 9;2021(3):CD013522. doi: 10.1002/14651858.CD013522.pub2

Tomioka 2014.

Study characteristics
Methods Study design: longitudinal cohort
Country: Japan
Data collection period: September 2007 ‐ August 2013
Registry ID: N/A (cohort)
Participants Number of participants: N = 277; Number included in meta‐analysis: N = 277
Sample characteristics (at baseline):
Age (mean): 60.9 years (SD 12.2); Sex (% male): 65% (180/277)
Population category: general population; Specific population: smoking cessation clinic attendees
Nicotine dependence: Tobacco Dependence Screener (TDS) 7.7 (SD 1.6); Baseline cigarettes per day: 22.9 (SD 12.4); Motivation to quit: selected by motivation to quit
Interventions Behavioural support for smoking cessation: an educational seminar introduced the programme and explained the following topics ‐ harmful effects of smoking, possible benefits of quitting smoking, how to handle withdrawal symptoms and how to prevent relapses; a leaflet was used to reinforce the information; the programme consisted of 5 sessions ‐ participants returned 2, 4, 8 and 12 weeks after their baseline visit date for follow‐up; at each visit, CO concentration was measured and the attending physician and a nurse with experience in smoking cessation confirmed whether smoking cessation had continued; brief counselling (≤ 15 mins) was provided and the staff praised those who continued with cessation or expressed appreciation of the efforts of those who had continued to smoke and recommended a rechallenge; no psychosocial support was provided
Pharmacological support for smoking cessation: all participants received either transdermal nicotine patches or varenicline following discussion with the attending physician; a pharmacist explained the effect of each drug, its usage and side effects using a leaflet to support the information; a target quit date was set on the day that nicotine patches were applied or on the 8th day after the first dose of varenicline ‐ initial prescriptions were transdermal nicotine patches in 160 participants and varenicline in 117 (6 participants in each group were switched to another medication because of adverse events or participant demand)
Psychotherapeutic or psychoactive support for mental health or mood: did not receive mood management
Outcomes Definition of cessation used: participants were considered to be quitters even if they smoked at 8 weeks but had quit completely between the 8‐week and 12‐week visits ‐ reports of abstinence were subjected to verification by an exhaled CO level of ≤ 10 ppm
Cessation definition used for outcome(s) in this analysis: point‐prevalence abstinence
Measure of biovalidation: expired CO (≤ 10 ppm)
Definition of people who continued to smoke used: those who smoked between the 8‐week and 12‐week visits
Time point(s) at which follow‐up was conducted: 12 weeks
Outcome category: Psychological Quality of Life (QoL)
Outcome measure(s): St George’s Respiratory Questionnaire (SGRQ; mental subscale)
Funding source This research received no specific grant from any funding agency in the public, commercial or not‐for‐profit sectors
Author conflicts of interest None
Notes Outcome data source: Unpublished data