Carolien van Rossem1, Mark Spigt1,2, Wolfgang Viechtbauer3, Annelies E M Lucas1,4, Onno C P van Schayck1, Daniel Kotz1,5. 1. CAPHRI School for Public Health and Primary Care, Department of Family Medicine, Maastricht University, Maastricht, the Netherlands. 2. General Practice Research Unit, Department of Community Medicine, The Arctic University of Norway, Tromsø, Norway. 3. MHeNS School for Mental Health and Neuroscience, Department of Psychiatry and Neuropsychology, Maastricht University, Maastricht, the Netherlands. 4. Eindhoven Corporation of Primary Health Care Centres (SGE), Eindhoven, the Netherlands. 5. Institute of General Practice, Addiction Research and Clinical Epidemiology unit, Medical Faculty of the Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.
Abstract
AIMS: To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. DESIGN: A multi-site (n = 10), two-group, parallel, pragmatic randomized controlled trial. SETTING: A network of primary health-care centres in the Netherlands. PARTICIPANTS: A total of 295 adult daily smokers (meanage = 48 years; mean cigarettes/day = 19). INTERVENTION AND COMPARATOR: Patients were randomized to receive individual counselling by a practice nurse (PN) (n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. MEASUREMENTS: The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. FINDINGS:Abstinence rates in the PN versus GP groups were 32.2% (n = 48) versus 39.0% [n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% (n = 38) versus 28.8% (n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. CONCLUSIONS: Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided.
RCT Entities:
AIMS: To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. DESIGN: A multi-site (n = 10), two-group, parallel, pragmatic randomized controlled trial. SETTING: A network of primary health-care centres in the Netherlands. PARTICIPANTS: A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). INTERVENTION AND COMPARATOR: Patients were randomized to receive individual counselling by a practice nurse (PN) (n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. MEASUREMENTS: The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. FINDINGS: Abstinence rates in the PN versus GP groups were 32.2% (n = 48) versus 39.0% [n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% (n = 38) versus 28.8% (n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. CONCLUSIONS: Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided.
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