To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results. From a 50% random sample of the randomized controlled trials (RCTs) published in journals indexed in PubMed during 2011, we selected the trials with ≥ 100 participants, evaluating the efficacy and safety of drugs, biologics, and medical devices through a head-to-head comparison. We analyzed 319 trials. Overall, 238,386 of the 289,718 randomized subjects (82.3%) were included in the 182 trials funded by companies. Of the 182 industry-sponsored trials, only 23 had two industry sponsors and only three involved truly antagonistic comparisons. Industry-sponsored trials were larger, more commonly registered, used more frequently noninferiority/equivalence designs, had higher citation impact, and were more likely to have "favorable" results (superiority or noninferiority/equivalence for the experimental treatment) than nonindustry-sponsored trials. Industry funding [odds ratio (OR) 2.8; 95% confidence interval (CI): 1.6, 4.7] and noninferiority/equivalence designs (OR 3.2; 95% CI: 1.5, 6.6), but not sample size, were strongly associated with "favorable" findings. Fifty-five of the 57 (96.5%) industry-funded noninferiority/equivalence trials got desirable "favorable" results. The literature of head-to-head RCTs is dominated by the industry. Industry-sponsored comparative assessments systematically yield favorable results for the sponsors, even more so when noninferiority designs are involved.

Starting from a previous experience carried out by the working group “Building and Environmental Hygiene” of the Italian Society of Hygiene and Preventive Medicine (SItI), the aim of the present work is to define new strategic goals for achieving a “Healthy and Salutogenic City”, which will be useful to designers, local governments and public bodies, policy makers, and all professionals working at local health agencies. Ten key points have been formulated: 1. climate change and management of adverse weather events; 2. land consumption, sprawl, and shrinking cities; 3. tactical urbanism and urban resilience; 4. urban comfort, safety, and security perception; 5. strengths and weaknesses of urban green areas and infrastructures; 6. urban solid waste management; 7. housing emergencies in relation to socio-economic and environmental changes; 8. energy aspects and environmental planning at an urban scale; 9. socio-assistance and welfare network at an urban scale: importance of a rational and widespread system; and 10. new forms of living, conscious of coparticipation models and aware of sharing quality objectives. Design strategies, actions, and policies, identified to improve public health and wellbeing, underline that the connection between morphological and functional features of urban context and public health is crucial for contemporary cities and modern societies.

Atrial fibrillation (AF) is the leading rhythm disorder in western countries. A direct relationship between left atrium (LA) enlargement and electromechanical remodelling has been established. A causative link between epicardial fat (EF), visceral adipose tissue deposited around the heart, and AF has been hypothesized. Several reports suggested the association between EF and the presence of AF. The aim of this study was to verify the relationship between AF and EF depot, performing a meta-analysis of observational case series studies. Studies were identified by searching electronic databases by two independent investigators using ‘atrial fibrillation’ and ‘epicardial fat’ as keywords. Comparisons between healthy participants and AF cases were performed using a random effect meta-analysis estimating standardized mean difference among comparison groups. Meta regression was used to address the effect given by potential biological and technical confounders. Through a search result of 502 articles, only 7 were selected to conduct the present study. The comparison between all AF with respect to healthy participants resulted in a 32.0 ml of EF difference (95% confidence interval (CI) = 21.5, 42.5) showing that EF volume is higher in AF cases. A statistical significant difference of EF was observed when comparing both persistent and paroxysmal AF subtypes with respect to healthy participants (EF difference 48.0 ml (95% CI = 25.2, 70.8) and 15.7 ml (95% CI = 10.1, 21.4) for persistent and paroxysmal, respectively). A significant EF difference resulted also when comparing persistent to paroxysmal AF subtypes (29.6 ml (95% CI = 12.7, 46.5)) The present work expands the strength of previously reported association between EF amount and atrial arrhythmia.

Objective To evaluate the extent of non-publication or delayed publication of registered randomized trials on vaccines, and to investigate potential determinants of delay to publication. Design Survey. Data sources Trials registry websites, Scopus, PubMed, Google. Study selection Randomized controlled trials evaluating the safety or the efficacy or immunogenicity of human papillomavirus (HPV), pandemic A/H1N1 2009 influenza, and meningococcal, pneumococcal, and rotavirus vaccines that were registered in ClinicalTrials.gov, Current Controlled Trials, WHO International Clinical Trials Registry Platform, Clinical Study Register, or Indian, Australian-New Zealand, and Chinese trial registries in 2006-12. Electronic databases were searched up to February 2014 to identify published manuscripts containing trial results. These were reviewed and classified as positive, mixed, or negative. We also reviewed the results available in ClinicalTrials.gov. Main outcome measures Publication status of trial results and time from completion to publication in peer reviewed journals. Data synthesis Cox proportional hazards regression was used to evaluate potential predictors of publication delay. Results We analysed 384 trials (85% sponsored by industry). Of 355 trials (404 758 participants) that were completed, 176 (n=151 379) had been published in peer reviewed journals. Another 42 trials (total sample 62 765) remained unpublished but reported results in ClinicalTrials.gov. The proportion of trials published 12, 24, 36, and 48 months after completion was 12%, 29%, 53%, and 73%, respectively. Including results posted in ClinicalTrials.gov, 48 months after study completion results were available for 82% of the trials and 90% of the participants. Delay to publication between non-industry and industry sponsored trials did not differ, but non-industry sponsored trials were 4.42-fold (P=0.008) more likely to report negative or mixed findings. Negative results were reported by only 2% of the published trials. Conclusions Most vaccine trials are published eventually or the results posted in ClinicalTrials.gov, but delays to publication of several years are common. Actions should focus on the timely dissemination of data from vaccine trials to the public.