Gender, smoking, and tobacco cessation with pharmacological treatment in a cluster randomized clinical trial.

INTRODUCTION: Whether men find it easier to quit smoking than women is still controversial. Different studies have reported that the efficacy of pharmacological treatments could be different between men and women. This study conducted a secondary analysis of 'Subsidized pharmacological treatment for smoking cessation by the Spanish public health system' (FTFT-AP study) to evaluate the effectiveness of a drug-funded intervention for smoking cessation by gender. METHODS: A pragmatic randomized clinical trial by clusters was used. The population included smokers aged ≥18 years, smoking >10 cigarettes per day, randomly assigned to an intervention group receiving regular practice and financed pharmacological treatment, or to a control group receiving only regular practice. The main outcome was continued abstinence at 12 months, self-reported and validated with CO-oximetry. The percentage, with 95% confidence intervals, of continued abstinence was compared between both groups at 12 months post-intervention, by gender and the pharmacological treatment used. Multilevel logistic regression analysis was performed. RESULTS: A total of 1154 patients from 29 healthcare centers were included. The average age was 46 years (SD=11.78) and 51.7% were men. Overall, the self-reported abstinence at 12 months was 11.1% (62) in women and 15.7% (93) in men (AOR=1.4; 95% CI: 1.0-2.0), and abstinence validated by CO-oximetry was 4.6% (26) and 5.9% (35) in women and men, respectively (OR=1.3; 95% CI: 0.7-2.2). In the group of smokers receiving nicotine replacement treatment, self-reported abstinence was higher in men compared to women (29.5% vs 13.5%, OR=2.7; 95% CI: 1.3-5.8). CONCLUSIONS: The effectiveness of a drug-financed intervention for smoking cessation was greater in men, who also showed better results in self-reported abstinence with nicotine replacement treatment.

A primary healthcare information intervention for communicating cardiovascular risk to patients with poorly controlled hypertension: The Education and Coronary Risk Evaluation (Educore) study-A pragmatic, cluster-randomized trial.

PURPOSE: Uncertainty exists regarding the best way to communicate cardiovascular risk (CVR) to patients, and it is unclear whether the comprehension and perception of CVR varies according to the format used. The aim of the present work was to determine whether a strategy designed for communicating CVR information to patients with poorly controlled high blood pressure (HBP), but with no background of cardiovascular disease, was more effective than usual care in the control of blood pressure (BP) over the course of a year. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial was performed. Consecutive patients aged 40-65 years, all diagnosed with HBP in the last 12 months, and all of whom showed poor control of their condition (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), were recruited at 22 primary healthcare centres. Eleven centres were randomly assigned to the usual care arm, and 11 to the informative intervention arm (Educore arm). At the start of the study, the Educore arm subjects were shown the "low risk SCORE table", along with impacting images and information pamphlets encouraging the maintenance of good cardiovascular health. The main outcome variable measured was the control of HBP; the secondary outcome variables were SCORE table score, total plasma cholesterol concentration, use of tobacco, adherence to prescribed treatment, and quality of life. RESULTS: The study participants were 411 patients (185 in the Educore arm and 226 in the usual care arm). Multilevel logistic regression showed that, at 12 months, the Educore intervention achieved better control of HBP (OR = 1.57; 1.02 to 2.41). No statistically significant differences were seen between the two arms at 12 months with respect to the secondary outcomes. CONCLUSIONS: Compared to usual care, the Educore intervention was associated with better control of HBP after adjusting for age, baseline SBP and plasma cholesterol, at 12 months.

Subsidized pharmacological treatment for smoking cessation by the Spanish public health system: A randomized, pragmatic, clinical trial by clusters.

INTRODUCTION: Research has shown that financing drug therapy increases smoking abstinence rates, although most of these studies have been carried out in the private healthcare setting. The aim of this work is to assess the effect of subsidized pharmacological treatment on smoking cessation rates by the Spanish public healthcare system. METHODS: A pragmatic, randomized, clinical trial was performed by clusters. Randomization unit was the primary healthcare center and the analysis unit was the patient. Smokers consuming ≥10 cigarettes/day were randomly assigned to an intervention group that received financed pharmacological treatment or to a control group that followed usual care. The main outcome was self-reported or CO-confirmed continuous abstinence at 12 months. The main outcome, continuous abstinence rates (%), were compared between groups at 12 months post-intervention. A model was adjusted using mixed-effect logistic regression. RESULTS: A total of 1154 patients were included from 23 healthcare centers. In the intention-to-treat analysis, self-reported abstinence after 12 months in the control and intervention groups, respectively, was 9.6% (37/387) and 15.4% (118/767) (gender-adjusted OR=1.75; 95% CI: 1.1-2.8); for CO-confirmed abstinence the corresponding values were 3.1% (12/387) and 6.4% (49/767) (gender-adjusted OR=1.72; 95% CI: 0.7-4.0). Pharmacological treatment use was 35.1% (136/387) in the control group, and 58.3% (447/767) in the intervention group (adjusted OR=4.25; 95% CI: 1.8-9.9). CONCLUSIONS: Subsidizing pharmacological treatment for smoking cessation increases self-reported or CO-confirmed abstinence rates under realistic conditions in the primary care setting of the Spanish public health system.