Lorenzo Capasso

Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study

Objective To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes), directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both. Design Prospective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up. Data Sources Direct contact and structured questionnaires by phone or via internet. Methods Adults (30–75 years) were included if they were smokers of ≥1 tobacco cigarette/day (tobacco smokers), users of any type of e-cigarettes, inhaling ≥50 puffs weekly (e-smokers), or smokers of both tobacco and e-cigarettes (dual smokers). Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence. Main Outcome Measures Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily. Data Synthesis We used linear and logistic regression, with region as cluster unit. Results Follow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%). All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35–8.02), whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall). Conclusions Adding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction. If e-cigarette safety will be confirmed, however, the use of e-cigarettes alone may facilitate quitters remaining so. Registration Number NCT01785537.

Origin, evolution and paleoepidemiology of brucellosis.

Brucellosis is a worldwide disease. Although it has been eradicated in some countries, it continues to be an important disease in many farming areas. Previous works have described the evolution and diffusion of brucellosis in antiquity through direct analysis of ancient human remains collected by the University Museum of Chieti, Italy, and by using paleopathological and historical data. The earliest published case was reported in a skeletal individual dated to the Middle Bronze Age. However, our research group has diagnosed vertebral brucellosis in the partial skeleton of the late Pliocene Australopithecus africanus, demonstrating that this infectious disease occasionally affected our direct ancestors 2·3-2·5 million years ago. The frequency of brucellosis increased during the Roman period, when the disease would almost certainly have been endemic in Roman society, and during the Middle Ages. Most paleopathological cases involve adult male skeletal individuals, and lumbar vertebrae and sacroiliac joints are most commonly involved.

Phlebitis risk varies by peripheral venous catheter site and increases after 96 hours: a large multi‐centre prospective study

AIMS This multi-centre prospective field study evaluated whether peripheral venous catheter site of insertion influences the risk of catheter-related phlebitis. Potential predictors of phlebitis were also investigated. BACKGROUND Millions of patients worldwide use peripheral venous catheters, which frequently cause local complications including phlebitis, infection and obstruction. Although phlebitis predictors have been broadly investigated, uncertainties remain on the potential effect of cannulation anatomical site, duration and the appropriate time for catheter removal. DESIGN A prospective cohort design was carried out from January-June 2012. METHODS The clinical course of each patient who received a new peripheral venous catheter for any cause in five Italian hospitals was followed by trained nurses until catheter removal. The presence of phlebitis was assessed every 24 hours using the Visual Infusion Phlebitis score. Analyses were based upon multilevel mixed-effects regression. RESULTS The final sample consisted of 1498 patients. The average time for catheters in situ was 65·6 hours and 23·6% of the catheters were in place beyond 96 hours. Overall phlebitis incidence was 15·4%, 94·4% of which were grade 1. The likelihood of phlebitis independently increased with increasing catheter duration, being highest after 96 hours. Compared with patients with catheter placed in the dorsum of the hand (22·8% of the sample), those with the catheter located in the antecubital fossa (34·1%) or forearm were less likely to have a phlebitis of any grade. CONCLUSIONS Antecubital fossa and forearm veins may be preferential sites for peripheral venous cannulation. Our results support Centers for Disease Control and Prevention recommendations to replace catheters in adults no later than 96 hours. A relevant proportion of healthcare personnel did not adhere to such guidelines - more attention to this issue is required.

Depression symptoms and the progression of carotid intima-media thickness: a 5-year follow-up study.

OBJECTIVE Only a few studies have investigated the changes in carotid intima-media thickness (IMT) over time, and uncertainties remain on the underlying mechanisms linking depression and subclinical atherosclerosis. We carried out a prospective cohort study to evaluate whether depression is associated with changes in carotid IMT in subjects with cardiac risk factors but free from coronary heart disease (CHD), and to what extent the atherogenicity of depression can be explained by inflammatory markers and autonomic nervous system dysfunction. METHODS During baseline and follow-up visits: all participants were asked to provide blood samples and compile a structured questionnaire; trained physicians assessed depression symptoms using Beck Depression Inventory (BDI); altered cardiac autonomic tone was measured using time-domain components of heart rate variability in 24 h Holter recordings; measurements of carotid IMT were carried out using B-mode ultrasound image acquisition. Logistic and linear regression analyses were used to adjust for potential confounders and explore potential mediators. RESULTS A total of 381 subjects completed the 5-year follow-up. The mean carotid IMT significantly increased in all subjects but the amount of increase was significantly larger among subjects with depression symptoms: mean IMT increased by 0.16±0.14 mm; 0.31±0.28 mm and 0.61±0.54 mm among the subjects with no, mild and moderate/severe depression, respectively (all p<0.01). The association between moderate/severe depression and IMT increase remained highly significant even after controlling for all the variables considered, however when both IL-6 and CRP were included in multivariate models the regression coefficient decreased by 42.3%. Some of the inflammation markers and autonomic nervous system dysfunction were also independently correlated with carotid IMT increase. CONCLUSION Depression symptoms are independently associated with an accelerated progression of carotid IMT in subjects with CHD risk factors, and inflammation may substantially modulate the association between depression and carotid IMT progression.

Impact of atrial fibrillation termination mode during catheter ablation procedure on maintenance of sinus rhythm

BACKGROUND Catheter ablation is a common and effective procedure for addressing atrial fibrillation (AF) refractory to antiarrhythmic drugs. AF can be terminated in 3 modes: (1) directly into sinus rhythm (SR); (2) evolving into regular atrial tachycardia (AT) and subsequently into SR; and (3) after direct current (DC) cardioversion if AF persists. Scarce data are available on the relationship between clinical outcomes and termination mode after 1 catheter ablation. OBJECTIVE The purpose of this study was to evaluate for the first time the association between 1-year ablation efficacy and termination mode after repeated catheter ablations in patients presenting with persistent or long-standing persistent AF. METHODS This prospective study involved 400 consecutive patients (age 62.7 ± 7.2 years) who underwent catheter ablation for drug-refractory persistent AF (4.6 ± 2.4 months) using a stepwise ablation approach. RESULTS AF was terminated by radiofrequency application directly into SR in 135 patients; passing through AT into SR in 195 patients; and through DC cardioversion in 70 patients. After 1-year follow-up with repeated Holter monitoring, the percentages of SR maintenance were 72.6%, 80.0%, and 28.6%, respectively (P < .001). Compared with the subjects who were converted directly into SR, the adjusted hazard ratios (HRs) of SR maintenance were significantly lower for those who required DC cardioversion (HR = 0.54; P < .001) and higher for those converted through AT (HR = 1.69; P = .027). The latter association was even stronger in the 104 subjects who required a second procedure (HR = 6.25; P = .001). CONCLUSION Termination of AF through AT during catheter ablation was more effective than both DC shock and direct SR in maintaining stable SR 1 year after both the first and the second procedures.

AHRQ prevention quality indicators to assess the quality of primary care of local providers: a pilot study from Italy

Background: Outside the USA, Agency for Healthcare Research and Quality (AHRQ) prevention quality indicators (PQIs) have been used to compare the quality of primary care services only at a national or regional level. However, in several national health systems, primary care is not directly managed by the regions but is in charge of smaller territorial entities. We evaluated whether PQIs might be used to compare the performance of local providers such as Italian local health authorities (LHAs) and health districts. Methods: We analysed the hospital discharge abstracts of 44 LHAs (and 11 health districts) of five Italian regions (including ≈18 million residents) in 2008–10. Age-standardized PQI rates were computed following AHRQ specifications. Potential predictors were investigated using multilevel modelling. Results: We analysed 11 470 722 hospitalizations. The overall rates of preventable hospitalizations (composite PQI 90) were 1012, 889 and 988 (×100 000 inhabitants) in 2008, 2009 and 2010, respectively. Composite PQIs were able to differentiate LHAs and health districts and showed small variation in the performance ranking over years. Conclusion: Although further research is required, our findings support the use of composite PQIs to evaluate the performance of relatively small primary health care providers (50 000–60 000 enrollees) in countries with universal health care coverage. Achieving high precision may be crucial for a structured quality assessment system to align hospitalization rate indicators with measures of other contexts of care (cost, clinical management, satisfaction/experience) that are typically computed at a local level.

E-cigarette regulations in Italy: fluctuating and confusing

The excellent Lancet Series on the cancer wars returned to the term cancer war as outlined by President Nixon in 1971. Cancer treatment with extensive surgery, radiation therapy from deep x-ray machines and toxic multiagent chemotherapy was all given in the hope and belief that more was better and that if we pushed hard enough we would cure more cancers. Douglas Hanahan outlines a vision for correcting the missteps that our so-called war on cancer with “magic bullets” has caused. However, he continues to use similar battlefield and warfare analogies. In developed countries, these analogies have contributed to over-diagnosis and over-treatment of some cancers, particularly prostate cancer. Despite all the very expensive and toxic radical “weapons” used, the mortality rate for prostate cancer in developed countries is still very similar or worse than in countries with much lower incidence. This causes widespread distressing and unnecessary toxicities and suff ering, or “collateral damage”. The misplaced battlefield analogy has led to 40 years of toxic and overly aggressive chemotherapy in incurable solid cancers for which no studies have shown that maximum tolerated doses of chemotherapy achieve longer survival or better quality of life than do minimum effective doses. This approach has led to inappropriate and toxic therapies for many patients with indolent diseases such as follicular low-grade non-Hodgkin lymphomas and chronic lymphocytic leukaemia. It has deprived many patients with advanced cancer from access to early palliative care referral for which there is strong evidence of benefi t. The war analogy has also set a poor example for appropriate use of high-quality evidence for realistic goal-setting and resource allocation. Hasn’t the time come to dispense with the battlefield analogies that have clearly failed us in so many ways, and adopt a new analogy of multidisciplinary treatment teams using collaboration to build lasting and sustaining treatment bridges?

Stepwise ablation approach versus pulmonary vein isolation in patients with paroxysmal atrial fibrillation: Randomized controlled trial

BACKGROUND Pulmonary vein isolation (PVI) is a central procedure for the treatment of paroxysmal atrial fibrillation (PAF). However, in patients with PAF and structural atrial disease, PVI may fail and cause progressive atrial remodeling, often leading to persistent/permanent atrial fibrillation. OBJECTIVE We performed a prospective, single-blind, 2-center randomized controlled trial to compare the efficacy of PVI alone with that of PVI plus stepwise ablation in achieving sinus rhythm and nonatrial arrhythmia inducibility in patients with PAF refractory to antiarrhythmic therapy. METHODS Patients were randomized to perform a first catheter ablation procedure either through PVI alone or through PVI plus substrate modification in stepwise ablation. Data were recorded at 3, 6, and 12 months after both ablation procedures. Patients who experienced atrial fibrillation/atrial tachycardia (AF/AT) recurrence were encouraged to undergo repeat ablation using the technique of the first ablation procedure. RESULTS A total of 150 patients were enrolled (mean age 62.8 ± 8.7 years; 92 (61.3%) men; 104 (69.3%) hypertensive; AF mean duration 10.7 months), with 75 patients in each group. After 12 months of the first procedure, patients who were converted to sinus rhythm using stepwise ablation showed a significantly lower rate of AF/AT recurrence (26.7%) than did those who were treated using PVI alone (46.7%; P < .001). Similar results were observed in the 52 patients who underwent a second catheter ablation procedure. After adjusting for several potential confounders, the hazard ratio of 12-month AF/AT recurrence after the first ablation procedure was 0.53 (95% confidence interval 0.30-0.91) for those treated using stepwise ablation. CONCLUSION In addition to PVI, stepwise ablation achieving sinus rhythm and nonatrial arrhythmia inducibility has relevantly improved the clinical outcome of the PAF control strategy.

Self-reported medication adherence and beliefs among elderly in multi-treatment: a cross-sectional study

AIM To evaluate the association between adherence to treatment and beliefs about medications in multi-treated elderly patients. BACKGROUND A large body of evidence documented the importance of adherence to therapy in predicting clinical outcomes, and the association between adherence and medication beliefs in patients of various ages and with different health conditions. However, so far only a few studies have specifically investigated the associations between medication beliefs and adherence among elderly in polypharmacy. METHODS In this multicenter cross-sectional study we used the MMAS-8 and BMQ Scales to assess medication adherence and beliefs about medications, respectively. RESULTS The final sample consisted of 567 patients. Patients reporting higher levels of necessity or concerns about their medicines showed higher adherence (OR: 1.61, and 2.02, respectively; both p<.001). Accepting patients (high necessity and low concerns) were less likely (OR: 0.24; p<.001) to report adherence than ambivalent ones (high necessity and concerns). CONCLUSIONS Medication adherence is related to high necessity and concern about treatment. In nursing practice it is important to understand the specific barriers to adherence and to engage patients in the implementation of strategies to improve adherence.

Semi-basements used as dwellings: hygienic considerations and analysis of the regulations.

Current housing shortage in Italy is forcing a growing number of individuals to use as living environment spaces that were originally devoted to other purposes. Among such spaces, semi-basements hold a particular relevance because of their specific characteristics and their effects on human health. The authors analyse the relatively scarce legislation about this topic at both national and regional level. The local Building Codes of the ten most populous cities of Italy are reviewed, assessing whether the use of semi-basements as living spaces is allowed and, if so, which restrictions and requirements are imposed. The authors conclude that, on one hand, further research is strongly needed to estimate the amount of exposed population and their health risk, on the other the existing legislation on the topic is often discretionary and deeply unhomogeneous across the country.