Effectiveness and feasibility of smoking counselling: a randomized controlled trial in an Italian emergency department.

BACKGROUND: 5A's counselling is recommended for screening and treating patients with smoking addiction. The emergency department (ED) setting might be a suitable environment for conducting interventions for smoking cessation. The present study aims to determine the feasibility and effectiveness on smoking cessation of 5A's counselling administered to ED patients by nurses. METHODS: Parallel group randomized trial assessing 5A's counselling for smoking cessation vs. usual care at a University Hospital in the North of Italy. The primary end-point was prevalence of tobacco-free patients. The secondary outcomes at 6- and 12-month follow-up were (i) consecutive past 30-day smoking abstinence; (ii) past 7-day 50%, or more, decrease in daily tobacco consumption over baseline; and (iii) number of attempts to quit smoking. RESULTS: A total of 480 patients were randomized to intervention (n = 262) or usual care (n = 218). Intention to treat analysis displayed no differences in primary and secondary outcomes between groups. A slight but not statistically significant enhancement in cessation was recorded in the intervention group [relative risk (RR) = 1.04, 95% confidence interval (CI) = 0.58-1.87] at 6 months, whereas a reversed observation at 12 months (RR = 0.86, 95% CI = 0.50-1.47). Similar results were obtained for the secondary outcomes. Per protocol analysis increased the size of the results. Of the 126 smokers receiving counselling, 18 were visited and treated at the local smoking cessation centre, with 12 of them successfully completing the treatment. CONCLUSION: The results of this study indicate that the ED is not a suited environment for 5A's counselling.

Long-Term Outcomes of Pulmonary Vein Isolation in Patients With Brugada Syndrome and Paroxysmal Atrial Fibrillation.

Background Pharmacological treatment of atrial fibrillation (AF) in the setting of Brugada syndrome (BrS) is challenging. In addition, patients with BrS with an implantable cardioverter-defibrillator (ICD) might experience inappropriate shocks for fast AF. Long-term outcome of pulmonary vein isolation in BrS has not been well established yet, and it is still unclear whether pulmonary vein triggers are the only pathophysiological mechanism of AF in BrS. The aim of the study is to assess the long-term outcomes in patients with BrS undergoing pulmonary vein isolation for paroxysmal AF compared with a matched cohort of patients without BrS. Methods and Results Sixty patients with BrS undergoing pulmonary vein isolation with cryoballoon catheter ablation for paroxysmal AF were matched with 60 patients without BrS, who underwent the same procedure. After a mean follow-up of 58.2±31.7 months, freedom from atrial tachyarrhythmias was achieved in 61.7% in the BrS group and in 78.3% in the non-BrS group (log-rank P=0.047). In particular, freedom from AF was 76.7% in the first group and in 83.3% in the second (P=0.27), while freedom from atrial tachycardia/atrial flutter was 85% and 95% (P=0.057). In the BrS group, 29 patients (48.3%) had an ICD and 8 (27.6%) had a previous ICD-inappropriate shock for fast AF. In the BrS cohort, ICD-inappropriate interventions for AF were significantly reduced after ablation (3.4% versus 27.6%; P=0.01). Conclusions Pulmonary vein isolation in patients with BrS was associated with higher rate of arrhythmic recurrence. Despite this, catheter ablation significantly reduced inappropriate ICD interventions in BrS patients and can be considered a therapeutic strategy to prevent inappropriate device therapies.

Beyond intention-to-treat: The effect of brief counseling for tobacco cessation in secondary analyses of a cluster randomized controlled trial in Swedish dental clinics.

In experimental studies the assigned intervention measures the received intervention if full protocol adherence is achieved, but this is rarely the case in public health. The objective of this study was to estimate the effect of a brief counseling intervention delivered in Swedish dental clinics on tobacco use cessation, taking non-adherence into account. We conducted three secondary analyses. In a per-protocol analysis the experimental counseling delivered as intended was contrasted to usual care (control). In an as-treated analysis individuals were compared according to the counseling components actually received, disregarding randomization. In an instrumental variable analysis the effect of the intervention among those who would always be treated as assigned was estimated. Logistic regression was used to examine the association between tobacco cessation outcomes (seven-day abstinence, three-month abstinence, half-reduction, quit attempts) and the defined exposure to the intervention. Protocol adherence in the intervention group was 73.4%. The per-protocol analysis closely replicated the results of the intention-to-treat analysis, showing a statistically significant effect of the brief counseling on the reduction in tobacco consumption OR = 1.81, 95% CI [1.06, 3.07], but no significant effect for other outcomes. In the as-treated analysis, receiving more counseling components compared with no tobacco counseling increased the likelihood of half-reduction. The instrumental variable yielded biased results. We conclude that despite application problems, conducting per-protocol, as-treated and instrumental variable analyses in randomized trials where experimental conditions are not strictly standardized strengthens and puts in context the inference based on intention-to-treat analysis.