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Purpose: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct., Methods: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe., Results: A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype., Conclusions: A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe., (© 2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)

Academic freedom is a critical norm of science. Despite the widely postulated importance of academic freedom, the literature attests to a dearth of research on the topic. Specifically, we know little about how academic freedom relates to indicators of societal progress, such as innovation. We address this research gap by empirically assessing the impact of academic freedom on the quantity (patent applications) and quality (patent citations) of innovation output using a comprehensive sample of 157 countries over the 1900-2015 period. We find that improving academic freedom by one standard deviation increases patent applications by 41% and forward citations by 29%. The results are robust across a range of different specifications. Our findings constitute an alarming plea to policymakers: global academic freedom has declined over the past decade for the first time in the last century and our estimates suggest that this decline poses a substantial threat to the innovation output of countries in terms of both quantity and quality., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Audretsch et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Suicidal attempts (SA) represent heterogeneous behaviours ranging in their seriousness from fatal and near-fatal (high-lethality) cases to those that do not require medical attention (low lethality). These considerations stress the need to identify high-risk individuals for high lethality SA in order to target suicide preventive interventions. The present study aims at evaluating the role of sociodemographic and clinical variables and examining personality pathological features in predicting high lethality SA. The sample was composed by 94 patients who were consecutively admitted to the Mood Disorders Unit of the San Raffaele Turro Hospital in Milan. The results of binary logistic regression analyses showed that previous SA and current suicide ideation play a role in predicting serious SA. Considering the DSM-5 personality dysfunctional domains assessed by the Personality Inventory for DSM-5, our logistic regression analyses suggested that high lethality SA was associated with Detachment PID-5 domain. Finally, binary hierarchical regression analysis showed that Detachment domain remained a significant predictor of serious SA over and above the effect of previous SA and suicide ideation. As a whole, our results highlight the importance of a multidimensional approach to develop adequate assessment, effective treatments and prevention of high lethality SA risk., (© 2022 John Wiley & Sons Ltd.)

Purpose: This post-authorisation safety study estimated the risk of anaphylaxis in patients receiving intravenous (IV) iron in Europe, with interest in iron dextran and iron non-dextrans. Studies conducted in the United States have reported risk of anaphylaxis to IV iron ranging from 2.0 to 6.8 per 10 000 first treatments., Methods: Cohort study of IV iron new users, captured mostly through pharmacy ambulatory dispensing, from populations covered by health and administrative data sources in five European countries from 1999 to 2017. Anaphylaxis events were identified through an algorithm that used parenteral penicillin as a positive control., Results: A total of 304 210 patients with a first IV iron treatment (6367 iron dextran), among whom 13-16 anaphylaxis cases were identified and reported as a range to comply with data protection regulations. The pooled unadjusted incidence proportion (IP) ranged from 0.4 (95% confidence interval [CI], 0.2-0.9) to 0.5 (95% CI, 0.3-1.0) per 10 000 first treatments. No events were identified at first dextran treatments. There were 231 294 first penicillin treatments with 30 potential cases of anaphylaxis (IP = 1.2; 95% CI, 0.8-1.7 per 10 000 treatments)., Conclusion: We found an IP of anaphylaxis from 0.4 to 0.5 per 10 000 first IV iron treatments. The study captured only a fraction of IV iron treatments administered in hospitals, where most first treatments are likely to happen. Due to this limitation, the study could not exclude a differential risk of anaphylaxis between iron dextran and iron non-dextrans. The IP of anaphylaxis in users of penicillin was consistent with incidences reported in the literature., (© 2021 Vifor (International) AG. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)

The nature of the relationship between borderline personality disorder (borderline PD), post-traumatic stress disorder (PTSD) and complex PTSD remains controversial. In this study we attempted to investigate the association between traumatic events and borderline PD and the co-occurrence of complex PTSD, PTSD and borderline PD. Finally, we tested the association between complex PTSD and PTSD diagnoses and other DSM-5 Section II personality disorders. In a sample of 416 patients, we administered the International Trauma Questionnaire (ITQ) to evaluate the PTSD/complex PTSD diagnoses and the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) and the Personality Diagnostic Questionnaire- 4+ (PDQ-4+) to assess borderline PD and other PDs. One hundred-twenty-three participants reported experiencing one or more traumatic events. Our findings show that the presence of adverse events does not represent a risk factor for borderline PD assessed using both SCID-5-PD and PDQ4+. A co-occurrence of borderline PD diagnoses and complex PTSD/PTSD diagnoses has not been observed. We found a significant association only between complex PTSD and schizoid personality disorder assessed using PDQ4+. Our findings suggest relevant clinical implications for the development of effective treatment for complex PTSD, PTSD and borderline PD., (Copyright © 2020. Published by Elsevier B.V.)

To evaluate the reliability and convergent validity of the Structured Clinical Interview for DSM-5 Alternative Model for Personality Disorders (SCID-5-AMPD) Module I and Module II, 88 adult psychotherapy participants were administered the Italian translations of the SCID-5-AMPD Module I and Module II, Level of Personality Functioning Scale-Brief Form (LPFS-BF), Level of Personality Functioning Scale-Self Report (LPFS-SF), Personality Inventory for DSM-5 (PID-5), Personality Diagnostic Questionnaire-4+ (PDQ-4+), and Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) relying on a Williams crossover design. SCID-5-AMPD Module I and Module II showed excellent inter-rater reliability. In terms of convergent validity, meaningful associations were observed between SCID-5-AMPD Module I scores and self-report measures of Criterion A; similarly, SCID-5-AMPD Module II trait scores were meaningfully related to PID-5 trait scores. As a whole, our preliminary findings supported the clinical utility of DSM- 5 AMPD.

Crowdfunding has gained traction as a mechanism to raise resources for entrepreneurial and artistic projects, yet there is little systematic evidence on the potential of crowdfunding for scientific research. We first briefly review prior research on crowdfunding and give an overview of dedicated platforms for crowdfunding research. We then analyze data from over 700 campaigns on the largest dedicated platform, Experiment.com. Our descriptive analysis provides insights regarding the creators seeking funding, the projects they are seeking funding for, and the campaigns themselves. We then examine how these characteristics relate to fundraising success. The findings highlight important differences between crowdfunding and traditional funding mechanisms for research, including high use by students and other junior investigators but also relatively small project size. Students and junior investigators are more likely to succeed than senior scientists, and women have higher success rates than men. Conventional signals of quality-including scientists' prior publications-have little relationship with funding success, suggesting that the crowd may apply different decision criteria than traditional funding agencies. Our results highlight significant opportunities for crowdfunding in the context of science while also pointing towards unique challenges. We relate our findings to research on the economics of science and on crowdfunding, and we discuss connections with other emerging mechanisms to involve the public in scientific research., Competing Interests: The authors have declared that no competing interests exist.

Scientific research performed with the involvement of the broader public (the crowd) attracts increasing attention from scientists and policy makers. A key premise is that project organizers may be able to draw on underused human resources to advance research at relatively low cost. Despite a growing number of examples, systematic research on the effort contributions volunteers are willing to make to crowd science projects is lacking. Analyzing data on seven different projects, we quantify the financial value volunteers can bring by comparing their unpaid contributions with counterfactual costs in traditional or online labor markets. The volume of total contributions is substantial, although some projects are much more successful in attracting effort than others. Moreover, contributions received by projects are very uneven across time--a tendency toward declining activity is interrupted by spikes typically resulting from outreach efforts or media attention. Analyzing user-level data, we find that most contributors participate only once and with little effort, leaving a relatively small share of users who return responsible for most of the work. Although top contributor status is earned primarily through higher levels of effort, top contributors also tend to work faster. This speed advantage develops over multiple sessions, suggesting that it reflects learning rather than inherent differences in skills. Our findings inform recent discussions about potential benefits from crowd science, suggest that involving the crowd may be more effective for some kinds of projects than others, provide guidance for project managers, and raise important questions for future research.

Aim: Analyze the results of an early experience in day-case LC (laparoscopic cholecystectomy) in a single laparoscopic unit, in terms of clinical outcome, unexpected admissions, readmissions, patients satisfaction., Materials and Methods: During three years, 200 consecutive patients underwent LC. Emergency procedures (32pts) and patients scheduled for cholecystectomy plus other surgical procedures (21pts) were excluded. Thus, 147 patients underwent elective LC and 43 were scheduled for DSLC (day-surgery laparoscopic cholecystectomy)., Results: Six patients (13,9%) were considered not eligible for a same day discharge and admitted to the inpatients ward for overnight observation. The re-admission rate was 2,3% and 41 patients (95.3%) were completely satisfied., Discussion: Patients satisfaction was complete in 95.3% of cases, related to a correct preoperative information and the reduction in hospital costs amounted approximately to 41%. Despite the evidence of feasibility and safety of the daycase procedure, the Italian cultural background is nowadays inadequate for a clean acceptance of the DSLC. The provision of adequate staff education and training prior to full DSLC introduction is mandatory to the success of this organizational model., Conclusions: LC can be performed safely in an outpatient setting if there's a careful education of patients and the surgical and anesthesiologist team is well-trained. Besides, good results can be achieved considering inclusion criteria. For the admission to be kept to a minimum, postoperative pain and nausea management has to be carefully planned such as discharge criteria evaluated. For selected patients, day-case LC is feasible and safe and can provide a reduction in hospital costs.

Objectives: To compare the differences between LESS and SL among a population of subjects inexperienced of both techniques., Materials and Methods: Participants were randomly assigned to the LESS or SL arm of the course; between the population examined, none had previous laparoscopic experience. The trial consisted in performing three increasingly difficult exercises either with LESS or standard laparoscopy., Results: Time of execution and Objective Structured Assessment of Technical Skills score (OSATS) were recorded. Statistical analysis failed to detect any significant difference between the two arms of the trial. A trend in favor of standard laparoscopy was observed anyway., Discussion: Our study evaluates the technical performance on a surgical simulator in the laboratory setting, with the use of standardized tasks and validated metrics. We believe that a controlled and safe environment aids objective evaluation of LESS compared to SL. Literature on this particular topic is somehow conflicting and heterogeneous. Our trial demonstrated that novices performed LESS tasks without any additional difficulties compared to standard laparoscopy. The aim of such investigation is to support knowledge of this new technology in order to facilitate its use in selected patients and surgical procedures.

Background: Laparoscopic splenectomy is accepted as a safe approach in the surgical treatment of blood disorders worldwide. Compared with the laparotomic technique, it is associated with a lower risk of intraoperative bleeding, less postoperative pain, and faster discharge times. The advent of robotic surgery (RS) has changed the concept of minimally invasive surgery because, in addition to allowing a three-dimensional view, it permits greater freedom of movement and higher levels of accuracy than laparoscopic surgery (LS). The aim of this study was to comparatively evaluate whether RS presents advantages over LS in spleen surgery., Methods: In two Surgical Units with experience in laparoscopic splenectomy, over a 7-year period, two groups of 45 patients underwent LS and RS. The two groups were well matched for demographic characteristics, indications, and spleen size., Results: No statistically significant differences were found regarding intraoperative blood loss, conversion rate to laparotomy, food intake, drain removal, postoperative complications, and median time to discharge. On the contrary, statistically increased differences were observed in median operative time and costs. In both groups, the transfusion and mortality rate was 0%. At the 6-month follow-up no surgical complications were observed., Conclusions: Although RS offers a three-dimensional view, greater freedom of movement, and higher levels of accuracy, it is associated with longer operative times and higher costs. It can consequently be concluded that with the intrinsic limits of the study design used, at the current time, RS does not have any significant advantage over LS in splenectomy.

Aim: Aim of the study is to evaluate correlations between incidental thyroid carcinoma (ITC) and benign thyroid pathologies (BTP), to determine the most represented histotype and to point out the total thyroidectomy's possible advantages in terms of radicality, follow-up management and incidence of complications., Materials and Methods: During 10 years, 739 patients underwent thyroid surgery for BTP. Fine needle biopsy (FNAB) was negative in all cases; 503 total thyroidectomies (TT), 5 subtotal thyroidectomies (ST) and 231 emithyroidectomies (ET) were performed., Results: The specimens pathological examination revealed the presence of a ITC in 82 patients (11.1%); the prevalent histotype was the papillary one with a less than 1cm diameter in almost the totality of cases but with nodes metastasis in the 3.6% of cases. Complications were detected in 117 patients with a morbidity rate of 15.8%., Discussion: In our study the ITC prevalence was of 11.1% similar to literature with a higher incidence in patients affected by multinodular than uninodular goiter. No statistical significant differences were found between euthyroid and toxic pathologies. In our series hyperthyroidism doesn't seem to hold a protective role towards the ITC onset., Conclusions: The ITC incidence is relevant; the prevalent histotype is papillary and nodes metastasis are present even if in a low percentage of cases. Besides, the complications of TT are similar to conservative procedures. The recurrence of goiter and ITC require a second surgical procedure, with a higher risk of complications. So we can claim that the standard surgical treatment of bilateral PBT would be represented by TT.

Background: Laparoscopic cholecystectomy is the "gold standard" in the treatment of symptomatic gallbladder lithiasis. Nevertheless, some pitfalls are associated with the use of the monopolar hook, such as the risk of thermal injuries and biliary complications. By contrast, the ultrasonically activated scalpel, ie, Harmonic (Ethicon Endo Surgery INC - Johnson & Johnson Medical SPA, Somerville, NJ) in laparoscopic cholecystectomies has been increasingly used for dissection of the gallbladder and for division of vessels and the cystic duct, because it reduces the risk of thermal injuries., Methods: During a 2-year period, in a personal series of 95 consecutive patients, the Harmonic scalpel was used as the sole instrument for both division and dissection of the cystic artery and duct. The average length of inpatient stay, procedure duration, and complications were compared with the data of a homogenous control group of patients who were treated using monopolar electrosurgery and clips., Results: Neither major complications nor bile duct injuries were detected in either group, and no statistically significant difference was found between the 2 in terms of the incidence of postoperative complications. However, the mean operative time was significantly shorter in patients treated with the Harmonic scalpel., Conclusion: The Harmonic scalpel is not only a safe and effective instrument but also a reliable substitute for clips because it provides complete hemobiliary stasis. Even if the study revealed no differences with regard to postoperative complications, the Harmonic scalpel represents a viable alternative because of the shorter operation time and cost savings that are inherent in a procedure using it as a single instrument.