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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.

The purpose of this systematic review is to analyze and summarize the current knowledge regarding the use of yoga to manage and prevent stress and burnout in healthcare workers. In February 2017, a literature search was conducted using the databases Medline (PubMed) and Scopus. Studies that addressed this topic were included. Eleven articles met the inclusion criteria. Seven studies were clinical trials that analyzed yoga interventions and evaluated effectiveness by gauging stress levels, sleep quality and quality of life. A study on Chinese nurses showed statistical improvement in stress levels following a six-month yoga program (χ2 = 16.449; p < 0.001). A population of medical students showed improvement in self-regulation values after an 11-week yoga program (from 3.49 to 3.58; p = 0.04) and in self-compassion values (from 2.88 to 3.25; p = 0.04). Four of the included articles were observational studies: They described the factors that cause stress in the work environment and highlighted that healthcare workers believe it is possible to benefit from improved physical, emotional and mental health related to yoga activity. According to the literature, yoga appears to be effective in the management of stress in healthcare workers, but it is necessary to implement methodologically relevant studies to attribute significance to such evidence.

Given the rapid development of genetic tests, an assessment of their benefits, risks, and limitations is crucial for public health practice. We performed a systematic review aimed at identifying and comparing the existing evaluation frameworks for genetic tests. We searched PUBMED, SCOPUS, ISI Web of Knowledge, Google Scholar, Google, and gray literature sources for any documents describing such frameworks. We identified 29 evaluation frameworks published between 2000 and 2017, mostly based on the ACCE Framework (n = 13 models), or on the HTA process (n = 6), or both (n = 2). Others refer to the Wilson and Jungner screening criteria (n = 3) or to a mixture of different criteria (n = 5). Due to the widespread use of the ACCE Framework, the most frequently used evaluation criteria are analytic and clinical validity, clinical utility and ethical, legal and social implications. Less attention is given to the context of implementation. An economic dimension is always considered, but not in great detail. Consideration of delivery models, organizational aspects, and consumer viewpoint is often lacking. A deeper analysis of such context-related evaluation dimensions may strengthen a comprehensive evaluation of genetic tests and support the decision-making process.

Background Despite mergers have increasingly affected hospitals in the recent decades, literature on the impact of hospitals mergers on healthcare quality measures (HQM) is still lacking. Our research aimed to systematically review evidence regarding the impact of hospital mergers on HQM focusing especially on process indicators and clinical outcomes. Methods The search was carried out until January 2020 using the Population, Intervention, Comparison and Outcome model, querying electronic databases (MEDLINE, Scopus, Web Of Science) and refining the search with hand search. Studies that assessed HQM of hospitals that have undergone a merger were included. HQMs were analyzed through a narrative synthesis and a strength of the evidence analysis based on the quality of the studies and the consistency of the findings. Results The 16 articles, included in the narrative synthesis, reported inconsistent findings and few statistically significant results. All indicators analyzed showed an insufficient strength of evidence to achieve conclusive results. However, a tendency in the decrease of the number of beds, hospital staff and inpatient admissions and an increase in both mortality and readmission rate for acute myocardial infarction and stroke emerged in our analysis. Conclusions In our study, there is no strong evidence of improvement or worsening of HQM in hospital mergers. Since a limited amount of studies currently exists, additional studies are needed. In the meanwhile, hospital managers involved in mergers should adopt a clear evaluation framework with indicators that help to periodically and systematically assess HQM ascertaining that mergers ensure and primarily do not reduce the quality of care.

Promoting self-care is one of the most promising strategies for managing chronic conditions. This overview aimed to investigate the effectiveness of eHealth interventions at improving self-care in patients with type-2 diabetes mellitus, cardiovascular disease, and chronic obstructive pulmonary disease when compared to standard care. We carried out a review of systematic reviews on PubMed, Scopus, Cochrane, PsychInfo, and CINAHL. AMSTAR-2 was used for quality appraisal. Eight systematic reviews (six with meta-analysis) were included, involving a total of 41,579 participants. eHealth interventions were categorized into three subgroups: (i) reminders via messaging apps, emails, and apps; (ii) telemonitoring and online operator support; (iii) internet and web-based educational programs. Six systematic reviews showed an improvement in self-care measurements through eHealth interventions, which also led to a better quality of life and clinical outcomes (HbA1C, blood pressure, hospitalization, cholesterol, body weight). This overview provided some implications for practice and research: eHealth is effective in increasing self-care in chronic patients; however, it is required to designate the type of eHealth intervention based on the needed outcome (e.g., implementing telemonitoring to increase self-monitoring of blood pressure). In addition, there is a need to standardize self-care measures through increased use of validated assessment tools.

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. 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. Direct contact and structured questionnaires by phone or via internet. 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. Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily. We used linear and logistic regression, with region as cluster unit. 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). 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. NCT01785537.

Background It is well known that, to be effective, vaccination programs require a high and consistent population uptake. Nevertheless, vaccine coverage is often insufficient. University students occupy a unique position within the broader population: they are highly mobile and socially active individuals who serve as influential figures among their peers and younger age groups, making them an ideal target for educational campaigns. Methods This review (CRD42022309724) quantified the vaccination intention rates for routine immunizations in university students and systematically examined the determinants of vaccination acceptance. Cross-sectional studies that analyzed vaccination intention for at least one routine immunization using multivariable logistic regression were included. We used random-effects models to calculate the pooled proportions of vaccination intention. Determinants were categorized into contextual factors (such as socio-demographic, economic and cultural factors), individual/group factors (such as knowledge, awareness, peer opinions, infection risk perceptions) and vaccine-specific issues (such as vaccine effectiveness and vaccination policies). Results Thirty-six articles were included: 29 on the human papilloma virus (HPV) vaccine and seven on the influenza vaccine. The pooled proportion of students intending to get vaccinated was 54% (95% CI: 47–60%) for HPV and 43% (95% CI: 26–61%) for influenza. The strongest positive determinants were individual/group factors, such as higher knowledge and awareness, pro-vaccine peer opinions, positive personal experience with vaccinations, and higher risk perception for HPV infection, and higher risk perception for infection and previous vaccination history for influenza. By contrast, contextual influences played a minor role in both vaccinations, while vaccine-specific concerns, particularly about costs and availability, negatively influenced intention for both vaccines. Conclusions Given the suboptimal rates of vaccination intention towards HPV and influenza vaccine that we found, addressing key determinants, such as awareness of infection risks and perception of vaccination benefits, is essential to increase vaccination acceptance in university students and to achieve high vaccination coverage.

Achieving high levels of vaccination coverage against COVID-19 may be hindered by vaccine hesitancy. We quantified over time the prevalence of COVID-19 vaccine hesitancy among university students, investigated its determinants, and analyzed student attitudes, risk perceptions and compliance with preventive measures. The survey was administered online from 1 March to 30 June 2021. A multivariable logistic regression model was built to identify predictors of hesitancy. Overall, we collected 5369 questionnaires that were grouped into three survey periods (March, April–May, and May–June). The response rate ranged from 81.2% to 76.4%, whereas vaccine hesitancy ranged from 22% to 29%. Multivariable analysis showed that April–May participants had higher odds of hesitancy than March respondents. Other positive predictors were being male, not being a healthcare student, having a lower academic level, and not disclosing a political position. Conversely, higher levels of perceived COVID-19 severity, concern for the emergency, confidence in vaccine safety and effectiveness, and self-reported adherence to mask wearing indoors and outdoors were negatively associated with hesitancy. We found that vaccine hesitancy changed over time and in relation to several factors. Strategies aimed at increasing the students’ awareness and engagement, restoring confidence in health authorities, and limiting disinformation around the vaccines should be devised.

The addictive protection against SARS-CoV-2 reinfection conferred by vaccination, as compared to natural immunity alone, remains to be quantified. We thus carried out a meta-analysis to summarize the existing evidence on the association between SARS-CoV-2 vaccination and the risk of reinfection and disease. We searched MedLine, Scopus and preprint repositories up to July 31, 2022, to retrieve cohort or case-control studies comparing the risk of SARS-CoV-2 reinfection or severe/critical COVID-19 among vaccinated vs. unvaccinated subjects, recovered from a primary episode. Data were combined using a generic inverse-variance approach. Eighteen studies, enrolling 18,132,192 individuals, were included. As compared to the unvaccinated, vaccinated subjects showed a significantly lower likelihood of reinfection (summary Odds Ratio—OR: 0.47; 95% CI: 0.42–0.54). Notably, the results did not change up to 12 months of follow-up, by number of vaccine doses, in studies that adjusted for potential confounders, adopting different reinfection definitions, and with different predominant strains. Once reinfected, vaccinated subjects were also significantly less likely to develop a severe disease (OR: 0.45; 95% CI: 0.38–0.54). Although further studies on the long-term persistence of protection, under the challenge of the new circulating variants, are clearly needed, the present meta-analysis provides solid evidence of a stronger protection of hybrid vs. natural immunity, which may persist during Omicron waves and up to 12 months.

During the SARS-CoV-2 testing program offered through the RT-PCR test by Sapienza University of Rome, we conducted a test-negative case-control study to identify risk factors for acquiring SARS-CoV-2 infection among university students. Each SARS-CoV-2-positive case detected was matched to two controls randomly selected from students who tested negative on the same day. 122 positive students and 244 negative students were enrolled in the study. Multivariable conditional logistic regression models were built. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. A second model was limited to students who had attended campus. Out of 8223 tests for SARS-CoV-2, 173 students tested positive (2.1%), of whom 122 (71.5%) were included in the case-control study. In the first analysis, being a non-Italian student (aOR: 8.93, 95% CI: 2.71-29.41), having received only the primary vaccination course (aOR: 2.94, 95% CI: 1.24-6.96) compared to the booster dose, known exposure to a COVID-19 case or someone with signs/symptoms suggestive of COVID-19 (aOR: 6.51, 95% CI: 3.48-12.18), and visiting discos (aOR: 4.07, 95% CI: 1.52-10.90) in the two weeks before testing increased the likelihood of SARS-CoV-2 infection. Conversely, students attending in-person lectures on campus seemed less likely to become infected (aOR: 0.34, 95% CI: 0.15-0.77). No association was found with other variables. The results of the second model were comparable to the first analysis. This study indicates that if universities adopt strict prevention measures, it is safe for students to attend, even in the case of an infectious disease epidemic.