To reflect on content, trends and quality of scientific publishing on COVID-19. In particular, to report on the systematic screening, quantitative assessment and critical appraisal of the first 10,000 scientific papers published on COVID-19 and to compare how scientific outputs matched identified research priorities and public health needs. A comprehensive research strategy was developed to systematically retrieve on a daily basis all studies published on COVID-19. From included studies we extracted: bibliometric parameters, country of studies' implementation and study design. We assigned papers to 25 a priori defined COVID-19-related topics and we described scientific outputs in relation to countries' academic publishing ranking, as well as COVID-19 burden. 10,000 scientific articles were published on COVID-19 between 20th January and 7th May 2020, accounting for 2.3% of total scientific production over the study period. One third (33%) focused on COVID-19 clinical management, with little adherence to identified research priorities. Over sixty per cent of papers were opinion pieces not reporting original data. Papers were published on 1881 different journals but with half of scientific production included in 8% of journals. The US accounted for one fourth of total scientific production, followed by China (22.2%) and Italy (9%). Never before in the history of academic publishing such a great volume of research focused on a single topic, this being likely to introduce major changes in the way science is produced and communicated, at the risk of bringing it far from its ultimate aim: informing clinical and public health practice and decision making.

The urgency of having rapidly safe and efficient COVID-19 vaccines called for the need to shorten trial phases, reduce sample sizes, and speed-up the approval process by the regulatory Agencies. In light of this, monitoring adverse effects (AEFI) (both immediate and at medium-long term) become of great importance. Aim of this cross-sectional study was to explore the associations between several factors and risk of immediate AEFI. Data come from the electronic dataset developed ad hoc to record demographic data, anamnesis and data related to immunization, set-up in the mass vaccination site in Novegro (Milan). Novegro mass vaccination site was one of the mass vaccinations sites with the highest flow in Lombardy Region, with a maximum capacity of 5,000 vaccinations/day. The center opened in April 2021 and closed the 1st of August 2021. A multivariable logistic regression model was used. Odds ratios adjusted (aOR) for age and sex are presented. Statistical significance was set at p<0.05. Analyses were conducting using STATA. Among the total of 314,671 subjects vaccinated, 0.5% developed an immediate AEFI, on average 17.0 ± 0.43 minutes after the administration. The three most frequent AEFI recorded were vagal response (30%), anxiety reaction (24%) and dizziness (21%). AEFI were more frequently observed among women [aOR= 2.24 (95%CI= 2.00 - 2.50)], and those with at least one previous disease [aOR= 1.47 (95%CI= 1.22-1.76)]. In conclusion, AEFI were less likely to occur for increasing age and after the second dose. Results from this large, complete and representative sample population regarding enrich the interesting scientific debate on potential adverse events following COVID-19 immunization.

After the first cases of COVID-19 detected in Wuhan (China), the virus rapidly spread in the world, so much so that on February 20 the first autochthonous case was officially identified in Italy. However, this person had no apparent history of travel abroad or contact with people tested positive for the virus. For this reason, the aim of this literature review was to reconstruct the epidemiological dynamics of the first wave of SARS-CoV-2 infection in the Lombardy Region. To this end, a systematic review was carried out on PubMed/MEDLINE and EMBASE, and on grey literature. All article assessing incidence, mortality and hospitalizations by Lombardy province and municipality, and the impact of the main containment and organizational measures were considered eligible. In addition, data on general mortality and mortality due to COVID-19, hospital admission, and serological and environmental were also retrieved. From the included studies, it emerged that Lombardy was the first European region in which the virus began to circulate as early as January 2020 (and probably even earlier). Despite the high number of cases and deaths recorded, the reproduction number observed in Lombardy Region was, at the beginning of March 2020, the same (or lower) than in other regions. In conclusion, data of the first epidemic wave in Lombardy, compared to other Italian and foreign regions, highlight the extreme criticality of having had the first autochthonous case (and the first substantial outbreaks) when knowledge was still scarce and individual prevention measures were not widespread.

(1) Background: Patent foramen ovale (PFO) is a congenital abnormality present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. We applied the hospital-based HTA model (AdHopHTA) to conduct a multidimensional assessment of NobleStitch EL, an innovative suture-mediated PFO closure device. We compared it to Amplatzer PFO Occluder (APO) to provide evidence to inform technologies’ governance in hospital settings. (2) Methods: For each AdHopHTA dimension we: systematically retrieved available evidence from the literature applying the PRISMA guidelines and then analyzed original clinical and cost data of a NobleStitch EL device at San Raffaele research hospital in Milan (Italy). The economic dimension was analyzed through activity-based costing and a cost analysis. We conducted semi-structured interviews with selected healthcare professionals to explore the organizational, legal, social, and ethical impact. (3) Results: A single study was included for the NobleStitch EL, with 10 for APO. Both literature data and original data showed comparable safety. Efficacy data analysis found that the PFO closure was at 89% for NobleStitch EL vs. 89–97% for APO. APO has a better impact on the budget and minor process costs. Consulted experts reported that the organizational impact of NobleStitch EL in the short and the long run as null, albeit a better impact under the social and the ethical aspects. (4) Conclusion: We suggest that there is inadequate evidence to conclude the relative efficacy of NobleStitch EL as compared to APO. Nevertheless, this report shows a good safety profile and higher costs for NobleStitch EL, with no organizational or legal impact. Further studies in selected population are recommended.