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BACKGROUND: Inborn errors of immunity (IEI) are rare diseases, which makes diagnosis a challenge. A better description of the initial presenting manifestations should improve awareness and avoid diagnostic delay. Although increased infection susceptibility is a well-known initial IEI manifestation, less is known about the frequency of other presenting manifestations.OBJECTIVE: We sought to analyze age-related initial presenting manifestations of IEI including different IEI disease cohorts.METHODS: We analyzed data on 16,486 patients of the European Society for Immunodeficiencies Registry. Patients with autoinflammatory diseases were excluded because of the limited number registered.RESULTS: Overall, 68% of patients initially presented with infections only, 9% with immune dysregulation only, and 9% with a combination of both. Syndromic features were the presenting feature in 12%, 4% had laboratory abnormalities only, 1.5% were diagnosed because of family history only, and 0.8% presented with malignancy. Two-third of patients with IEI presented before the age of 6 years, but a quarter of patients developed initial symptoms only as adults. Immune dysregulation was most frequently recognized as an initial IEI manifestation between age 6 and 25 years, with male predominance until age 10 years, shifting to female predominance after age 40 years. Infections were most prevalent as a first manifestation in patients presenting after age 30 years.CONCLUSIONS: An exclusive focus on infection-centered warning signs would have missed around 25% of patients with IEI who initially present with other manifestations.

Summary Background & aims Bioimpedance analysis-derived phase angle (PhA), as marker of body cell mass and cell integrity, might be altered in obesity, a condition which is characterized by alterations in muscle structure and function. The aim of this systematic review was to evaluate whether and to which extent PhA varies in individuals/patients with excess body weight focusing on: a) changes in PhA due to obesity; b) changes in PhA after bariatric interventions or training programs. Methods According to PRISMA criteria, a systematic literature search until February 2021 using PubMed, Embase, Scopus, and Web of Science was performed. Selection criteria included studies on patients with obesity without comorbidities other than metabolic diseases. Results A total of 278 articles were first identified. After removing duplicates and excluding studies that did not fulfil the inclusion criteria, the full text of the remaining 80 potentially relevant studies was examined to finally retrieve 11 cross-sectional and 10 longitudinal studies. Few studies have shown that PhA is lower in individuals/patients with obesity than in controls. The only study on the matter showed a decrease with age after the fourth decade of life. Four out of five studies reported consistently greater mean values in men than in women. In two studies PhA was lower in patients with severe obesity; in addition, Patients with low PhA had higher BMI and PhA was inversely correlated with fat mass. Longitudinal studies showed that PhA markedly decreased after bariatric surgery and slightly increased after training programs. Conclusions Thus, a relatively low number of studies have evaluated PhA in individuals/patients with obesity with sometimes contradictory and preliminary results. PhA might be useful to evaluate muscle quality in individuals/patients with obesity but further studies are needed to more accurately associate this variable with changes in muscle structure and strength, as well as in metabolic functions.

Objective: To evaluate the long-term effectiveness, safety, and tolerability of erenumab in a real-world migraine population, looking for putative predictors of responsiveness. Background: Erenumab proved to be effective, safe, and well tolerated in the prevention of episodic migraine (EM) and chronic migraine (CM) in long-term extension studies of double-blind, placebo-controlled trials in patients with no more than two (EM) or three (CM) prior preventive treatment failures. Methods: A 48-week, multicenter, longitudinal cohort real-life study was conducted at 15headache centers across eight Italian regions between December 20, 2018 and July 31, 2020. We considered all consecutive patients with high-frequency episodic migraine (HFEM) or CM aged 18–65years. Each patient was treated with erenumab 70mg, administered monthly. The dose was switched to 140mg in nonresponders and in responders who had become nonresponders for at least 4weeks. Change in monthly migraine days (MMDs) or monthly headache days (MHDs) at Weeks 45–48 compared with baseline was the primary efficacy endpoint. Secondary endpoints encompassed variation in monthly analgesic intake, achievement of a ≥50%, ≥75%, or 100% reduction in migraine or headache days, and any change in the Visual Analogue Scale (VAS) and Headache Impact Test-6 scores (HIT-6) during the same time interval. Results: A total of 242 patients with migraine received at least one dose of erenumab 70mg and were considered for safety analysis, whereas 221 received a monthly erenumab dose for ≥48weeks and were included in the effectiveness and safety analysis set. All patients had previously been treated unsuccessfully with ≥3migraine-preventive medication classes. From baseline to Weeks 45–48, erenumab treatment reduced MMD by 4.3±5.3(mean±SD) in patients with HFEM, and MHD by 12.8±8.9 (mean±SD) in subjects with CM. VAS and HIT-6scores were decreased by 1.8±1.9 (mean±SD) and 12.3±11 (mean±SD) in HFEM, and by 3.0±2.2 (mean±SD) and 13.1±11.2 (mean±SD) in CM. Median monthly analgesic intake passed from 11.0 (interquartile range [IQR] 10.0–13.0) to 5 (IQR 2.0–8.0) in HFEM and from 20.0 (IQR 15.0–30.0) to 6.0 (IQR 3.8–10.0) in CM. The ≥50% responders were 56.1% (32/57) in HFEM and 75.6% (124/164) in CM; ≥75% responders were 31.6% (18/57) and 44.5% (73/164); and 100% responders were 8.8% (5/57) and 1.2% (2/164), respectively. At Week 48, 83.6% (137/164) of patients with CM had reverted to EM. Erenumab was safe and well tolerated. Responsiveness to erenumab was positively associated with cutaneous allodynia (OR: 5.44, 95% CI: 1.52–19.41; p=0.009) in HFEM. In patients with CM, ≥50% responsiveness was positively associated with male sex (OR: 2.99, 95% CI: 1.03–8.7; p=0.044) and baseline migraine frequency (OR: 1.12, 95% CI: 1.05–1.20; p=0.001) and negatively associated with psychiatric comorbidities (OR: 0.37, 95% CI: 0.15–0.87; p=0.023) and prior treatment failures (OR: 0.77, 95% CI: 0.64–0.92; p=0.004). Conclusions: Long-term (48-week) erenumab treatment provides sustained effectiveness, safety, and tolerability in real-life patients with HFEM or CM with ≥3 prior preventive treatment failures. The dose of 140mg was required in most patients along the study and should be taken into consideration as the starting dose. Allodynia (in HFEM), male sex, and baseline migraine frequency (in CM) might represent positive responsiveness predictors. Conversely, psychiatric comorbidities and multiple prior preventive treatment failures could be negative predictors in patients with CM.

Acute kidney injury (AKI) occurs in 3.2 - 9.6% of hospital admissions and in 2.1 - 22.1% of prevalent intensive care unit patients, worldwide. There is a sexual dimorphism in the AKI evolution with implications of sex hormones, endothelin etc. We provide a mini-review on the gender-related differences in the AKI evolution.

Purpose Two chimeric antigen receptor T-cell (CAR-T) therapies have been approved in the United States (USA) in 2017 and Europe (EU) in 2018: axicabtagene ciloleucel and tisagenlecleucel. They contain the patient’s own T cells, which are extracted, genetically modified, and reinfused. Alongside the good efficacy results, the assessment of safety profile of these new therapies represents a great challenge. Our aim was to analyze the reports of the adverse drug reactions (ADR) after CAR-T administration as occurred in the real clinical setting. Methods We performed a retrospective observational study, collecting all the reports in EU (EudraVigilance, EV) and US (FAERS) databases of ADRs regarding axicabtagene ciloleucel and tisagenlecleucel. Both descriptive and statistical analyses were performed, the latter by using Reporting Odds Ratio (ROR). Results A total number of 1426 reports of suspected ADRs were retrieved in EudraVigilance and FAERS. Patients’ reported age reflected the age range for which the drugs are approved (18–64 years for axicabtagene ciloleucel and patients aged under 25 years for tisagenlecleucel). The most reported event was cytokine release syndrome (CRS), 185 events for tisagenlecleucel and 462 for axicabtagene ciloleucel in FAERS and 137 and 498, respectively, in EudraVigilance. A disproportionality was found comparing axicabtagene ciloleucel with tisagenlecleucel for the above-mentioned event: EV ROR 2.47, 95% CI 2.22–2.74, FAERS 1.89, 1.70–2.10. Conclusion CRS represents the major problem with the administration of CAR-T therapies. Our analysis has not revealed new ADRs; however, it supports the safety profile of CAR-T with new data from real clinical setting.

In patients with coronavirus disease 2019 (COVID-19), the prevalence of pre-existing cardiovascular diseases is elevated. Moreover, various features, also including pro-thrombotic status, further predispose these patients to increased risk of ischemic cardiovascular events. Thus, the identification of optimal antithrombotic strategies in terms of the risk–benefit ratio and outcome improvement in this setting is crucial. However, debated issues on antithrombotic therapies in patients with COVID-19 are multiple and relevant. In this article, we provide ten questions and answers on risk stratification and antiplatelet/anticoagulant treatments in patients at risk of/with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection based on the scientific evidence gathered during the pandemic.

The study of the role of neurotransmitter systems in the pathogenesis of epilepsy is one of the priorities of epileptology. New data on the functions of free neurotransmitter-like amino acid in the central nervous system are of the greatest importance and determine the prospects for the development of novel effective anticonvulsants. It is widely believed in clinical medicine that epilepsy has distinct gender characteristics. The aim of this study was to investigate the gender peculiarities in the content of neurotransmitter amino acids in the brain of Krushinsky-Molodkina (KM) rats, which were used as model organisms for the study of genetically induced audiogenic epilepsy. The content of Asp, Glu, GABA, Gly, and Tau of the medulla oblongata, hippocampus and cerebral cortex were determined using high-performance liquid chromatography (HPLC) in intact KM rats, KM rats exposed to a series of epileptiform seizures, and Wistar rats (control group). Both the Wistar and KM rats had gender distinctions in the distribution of free amino acids among the investigated brain parts. The audiogenic epilepsy was characterized by smoothing gender differences as well as differences between the concentrations of free amino acids in the cortex and medulla oblongata, specific for Wistar rats. The changes observed in male rats after the set of seizures included the increase in GABA concentration and a decrease in the Gly level in all investigated brain parts, as well as the decrease of the Tau content in the cortex and hippocampus. At the same time, the Glu content in cortex increased, while the Asp level decreased. After 6 days of audiogenic stimulations the female KM rats demonstrated the increase in the Glu level in all investigated brain parts, the increase in Gly and Asp levels in hippocampus, and no changes in the GABA content. Thus, after the set of epileptiform seizures the KM rats achieved a new steady state of the studied amino acids pool, which differed in males and females. In this case, gender differences significantly changed after the seizures.Izuchenie roli neĭromediatornykh sistem v patogeneze épilepsii – odno iz prioritetnykh napravleniĭ épileptologii. Novye dannye o funktsiiakh svobodnykh aminokislot-neĭromediatorov v tsentral'noĭ nervnoĭ sisteme imeiut naibol'shuiu znachimost' i opredeliaiut perspektivy sozdaniia novykh éffektivnykh protivosudorozhnykh sredstv. V klinicheskoĭ meditsine uzhe ustoialos' mnenie o tom, chto épilepsiia imeet otchetlivye polovye osobennosti. Odnako na segodniashniĭ den' eshche ne nakopleno dostatochno dannykh, podvodiashchikh pod éto predstavlenie biokhimicheskuiu osnovu. Tsel'iu nastoiashchikh issledovaniĭ bylo izuchenie polovykh otlichiĭ v soderzhanii aminokislot-neĭromediatorov golovnogo mozga u krys linii Krushinskogo-Molodkinoĭ (KM) – modeli vrozhdennoĭ audiogennoĭ épilepsii. Kontsentratsii Asp, Glu, GAMK, Gly i Tau opredeleny metodom vysokoéffektivnoĭ zhidkostnoĭ khromatografii v prodolgovatom mozge, gippokampe i kore bol'shikh polushariĭ. Biokhimicheskiĭ analiz proveden dlia intaktnykh krys KM – zhivotnykh posle serii épileptiformnykh pripadkov – i kontrol'noĭ gruppy linii Vistar. Rezul'taty biokhimicheskogo analiza svidetel'stvuiut o tom, chto nariadu s obshchimi zakonomernostiami raspredeleniia svobodnykh aminokislot-neĭromediatorov v golovnom mozge, ne zavisiashchimi ni ot pola, ni ot predraspolozhennosti k sudorogam, sushchestvuiut otchetlivye polovye razlichiia kak u krys Vistar, tak i u KM. Audiogennaia épilepsiia krys KM kharakterizuetsia sglazhivaniem kak polovykh otlichiĭ, tak i kharakternoĭ dlia linii Vistar raznitsy mezhdu koroĭ i prodolgovatym mozgom v soderzhanii svobodnykh aminokislot. Seriia iz shesti ezhednevnykh audiostimuliatsiĭ vyzyvaet u samtsov i samok KM razlichnye izmeneniia kontsentratsiĭ svobodnykh aminokislot v golovnom mozge. Izmeneniia, nabliudaemye u samtsov posle pripadkov, nosiat obshchemozgovoĭ kharakter i proiavliaiutsia v povyshenii kontsentratsii GAMK i padenii urovnia Gly (vo vsekh otdelakh), snizhenii soderzhaniia Tau (v kore i gippokampe). Pri étom v kore vozrastaet kontsentratsiia Glu i snizhaetsia uroven' Asp. U samok zhe nabliudaetsia povyshenie urovnia Glu (vo vsekh otdelakh), v gippokampe vozrastaiut kontsentratsii Gly i Asp, pri étom soderzhanie GAMK ne izmeniaetsia. Takim obrazom, posle serii épileptiformnykh pripadkov u krys KM ustanavlivaetsia novoe ustoĭchivoe sostoianie pula issleduemykh aminokislot, razlichnoe u samtsov i samok. Pri étom kharakter polovykh otlichiĭ posle perenesennykh pristupov sushchestvenno izmeniaetsia.

Background and ObjectivesSeveral studies have assessed risk factors associated with the severity of COVID-19 outcomes in people with multiple sclerosis (PwMS). The potential role of disease-modifying therapies (DMTs) and demographic and clinical factors on the risk of acquiring SARS-CoV-2 infection has not been evaluated so far. The objective of this study was to assess risk factors of contracting SARS-CoV-2 infection in PwMS by using data collected in the Italian MS Register (IMSR).MethodsA case-control (1:2) study was set up. Cases included PwMS with a confirmed diagnosis of COVID-19, and controls included PwMS without a confirmed diagnosis of COVID-19. Both groups were propensity score–matched by the date of COVID-19 diagnosis, the date of last visit, and the region of residence. No healthy controls were included in this study. COVID-19 risk was estimated by multivariable logistic regression models including demographic and clinical covariates. The impact of DMTs was assessed in 3 independent logistic regression models including one of the following covariates: last administered DMT, previous DMT sequences, or the place where the last treatment was administered.ResultsA total of 779 PwMS with confirmed COVID-19 (cases) were matched to 1,558 PwMS without COVID-19 (controls). In all 3 models, comorbidities, female sex, and a younger age were significantly associated (p < 0.02) with a higher risk of contracting COVID-19. Patients receiving natalizumab as last DMT (OR [95% CI]: 2.38 [1.66–3.42], p < 0.0001) and those who underwent an escalation treatment strategy (1.57 [1.16–2.13], p = 0.003) were at significantly higher COVID-19 risk. Moreover, PwMS receiving their last DMT requiring hospital access (1.65 [1.34–2.04], p < 0.0001) showed a significant higher risk than those taking self-administered DMTs at home.DiscussionThis case-control study embedded in the IMSR showed that PwMS at higher COVID-19 risk are younger, more frequently female individuals, and with comorbidities. Long-lasting escalation approach and last therapies that expose patients to the hospital environment seem to significantly increase the risk of SARS-CoV2 infection in PwMS.Classification of EvidenceThis study provides Class III evidence that among patients with MS, younger age, being female individuals, having more comorbidities, receiving natalizumab, undergoing an escalating treatment strategy, or receiving treatment at a hospital were associated with being infected with COVID-19. Among patients with MS who were infected with COVID-19, a severe course was associated with increasing age and having a progressive form of MS, whereas not being on treatment or receiving an interferon beta agent was protective.

Objectives We aimed to identify clinical, anamnestic, and sociodemographic characteristics associated with a positive swab for SARS-CoV2, and to provide a predictive score to identify at risk population in children aged 2–14 years attending school and tested for clinical symptoms of COVID-19. Design Cross sectional study. Setting Outpatient clinic of the IRCCS Burlo Garofolo, a maternal and child health tertiary care hospital and research centre in Italy. Data collection and analysis Data were collected through a predefined form, filled out by parents, and gathered information on sociodemographic characteristics, and specific symptoms, which were analysed to determine their association with a positive SARS-CoV-2 swab. The regression coefficients of the variables included in the multivariate analysis were further used in the calculation of a predictive score of the positive or negative test. Results Between September 20th and December 23rd 2020, from 1484 children included in the study, 127 (8.6%) tested positive. In the multivariate analysis, the variables retained by the model were the presence of contact with a cohabiting, non-cohabiting or unspecified symptomatic case (respectively OR 37.2, 95% CI 20.1–68.7; 5.1, 95% CI 2.7–9.6; 15.6, 95% CI 7.3–33.2); female sex (OR 1.49, 95% CI 1.0–2.3); age (6–10 years old: OR 3.2, 95% CI 1.7–6.1 p10 years old: OR 4.8, 95% CI 2.7–8.8 p Conclusions The timely identification of SARS-CoV2 cases among children is useful to reduce the dissemination of the disease and its related burden. The predictive score may be adopted in a public health perspective to rapidly identify at risk children.

Neonatal nutritional supplements may improve early growth for infants born small, but effects on long-term growth are unclear and may differ by sex. We assessed the effects of early macronutrient supplements on later growth. We searched databases and clinical trials registers from inception to April 2019. Participant-level data from randomised trials were included if the intention was to increase macronutrient intake to improve growth or development of infants born preterm or small-for-gestational-age. Co-primary outcomes were cognitive impairment and metabolic risk. Supplementation did not alter BMI in childhood (kg/m2: adjusted mean difference (aMD) −0.11[95% CI −0.47, 0.25], p = 0.54; 3 trials, n = 333). Supplementation increased length (cm: aMD 0.37[0.01, 0.72], p = 0.04; 18 trials, n = 2008) and bone mineral content (g: aMD 10.22[0.52, 19.92], p = 0.04; 6 trials, n = 313) in infancy, but not at older ages. There were no differences between supplemented and unsupplemented groups for other outcomes. In subgroup analysis, supplementation increased the height z-score in male toddlers (aMD 0.20[0.02, 0.37], p = 0.03; 10 trials, n = 595) but not in females, and no significant sex interaction was observed (p = 0.21). Macronutrient supplementation for infants born small may not alter BMI in childhood. Supplementation increased growth in infancy, but these effects did not persist in later life. The effects did not differ between boys and girls.

Although vaccines have been evaluated and approved for SARS-CoV-2 infection prevention, there remains a lack of effective treatments to reduce the mortality of COVID-19 patients already infected with SARS-CoV-2. The global data on COVID-19 showed that men have a higher mortality rate than women. We further observed that the proportion of mortality of females increases starting from around the age of 55 significantly. Thus, sex is an essential factor associated with COVID-19 mortality, and sex related genetic factors could be interesting mechanisms and targets for COVID-19 treatment. However, the associated sex factors and signaling pathways remain unclear. Here, we propose to uncover the potential sex associated factors using systematic and integrative network analysis. The unique results indicated that estrogens, e.g., estrone and estriol, (1) interacting with ESR1/2 receptors, (2) can inhibit SARS-CoV-2 caused inflammation and immune response signaling in host cells; and (3) estrogens are associated with the distinct fatality rates between male and female COVID-19 patients. Specifically, a high level of estradiol protects young female COVID-19 patients, and estrogens drop to an extremely low level in females after about 55 years of age causing the increased fatality rate of women. In conclusion, estrogen, interacting with ESR1/2 receptors, is an essential sex factor that protects COVID-19 patients from death by inhibiting inflammation and immune response caused by SARS-CoV-2 infection. Moreover, medications boosting the down-stream signaling of ESR1/ESR2, or inhibiting the inflammation and immune-associated targets on the signaling network can be potentially effective or synergistic combined with other existing drugs for COVID-19 treatment.

Background There is a lack of information regarding the provision of parental leave for surgical careers. This survey study aims to evaluate the experience of maternity/paternity leave and views on work–life balance globally. Methods A 55-item online survey in 24 languages was distributed via social media as per CHERRIES guideline from February to March 2020. It explored parental leave entitlements, attitude towards leave taking, financial impact, time spent with children and compatibility of parenthood with surgical career. Results Of the 1393 (male : female, 514 : 829) respondents from 65 countries, there were 479 medical students, 349 surgical trainees and 513 consultants. Consultants had less than the recommended duration of maternity leave (43.8 versus 29.1 per cent), no paid maternity (8.3 versus 3.2 per cent) or paternity leave (19.3 versus 11.0 per cent) compared with trainees. Females were less likely to have children than males (36.8 versus 45.6 per cent, P = 0.010) and were more often told surgery is incompatible with parenthood (80.2 versus 59.5 per cent, P Conclusion Surgeons across the globe had inadequate parental leave. Significant gender disparity was seen in multiple aspects.

BackgroundSince COVID-19 was declared a pandemic, attempts have been made to monitor trends over time and to compare countries and regions. Insufficient testing for COVID-19 underestimates the incidence and inflates the case-fatality proportion. Given the age- and sex- distribution of morbidity and mortality from COVID-19, the underlying sex- and age-distribution of a population needs to be accounted for. The aim of this paper is to present a method for monitoring trends of COVID-19 using adjusted mortality trend ratios (AMTR).MethodsAge- and sex-mortality distribution of a reference population composed of the first 14,086 fatalities which occurred before the end of March and were reported in Europe by some countries were used to calculate age- and sex-specific mortality rates per 1,000,000 population. These were applied to each country population to calculate the expected deaths. Adjusted Mortality Trend Ratios (AMTRs) with 95% confidence intervals (C.I.) were calculated for selected European countries from 17/03/2020 to 22/06/2020 by dividing observed cumulative mortality, by expected mortality times the crude mortality of the reference population. These estimated the sex- and age-adjusted mortality for COVID-19 per million population in each country.ResultsThe cumulative mortality from COVID-19, the crude mortality rates, and the AMTRs were calculated for each country and compared. United Kingdom, Italy, France and Spain registered the highest mortality in Europe. On 22/06/2020 in Europe the total mortality rate from COVID-19 was 352 per 1,000,000 inhabitants; and it was highest in Belgium (850 per 1,000,000 inhabitants) followed by Spain, UK, Italy, Sweden and France. When accounting for the underlying age and sex structure of each country, Belgium remained the single country experiencing the highest AMTR of 929 per million inhabitants on 22/06/2020; however Ireland – which had a CMR in line with the total European population – emerged as having experienced a much more important impact of COVID-19 mortality with an AMTR of 550/million on 22/06/2020, higher than Sweden and Italy.ConclusionsIn understanding and managing the pandemic of COVID-19, comparable international data is a priority. Our methods allow a fair comparison of mortality in space and over time. The authors urge the WHO, given the absence of age and sex-specific mortality data for direct standardisation, to adopt this method to estimate the comparative mortality from COVID-19 pandemic worldwide.Key messageComparing trends of the COVID-19 pandemic over time and in space is essential to monitor the disease and compare different local policiesUsing the concept of indirect standardisation we propose a method to effectively compare age- and sex-adjusted mortality rates trends interpretable as deaths for COVID-19 per million inhabitantsApplying this methods, interesting features of the infection in Europe emerged; e.g. by 22/06/2020 Belgium is the most severely affected country with an AMTR of 929 per million inhabitants, followed by the UK; Ireland and Sweden rank fourth and fifth most affected country in EuropeThe WHO should consider using this method for monitoring the spread of COVID-19, which only requires recording the total number of death from COVID-19 from each country/region

Medical procreation impairs both the biological and psychological lives of couples. However, male and female attitudes to infertility are different and require a different approach during the IVF journey. Thus, the gender impact assessment (GIA) method was used to analyse original studies present in the literature. We found some gender-related differences and, subsequently, possible outcomes of intervention to improve healthy reproduction management and prevent infertility. In particular, it became apparent that there was the need for an in-depth male infertility assessment and a gender-specific follow-up.

To estimate the prevalence of self-reported tuberculosis TB diagnosed at Peruvian correctional facilities (CFs), and their associated factors.Cross-sectional study based on secondary analysis of the National Census held in all Peruvian CFs in 2016. Outcome was defined as self-reported TB diagnosed by a healthcare professional intra-penitentiary. A descriptive bivariate analysis was carried out, followed by multivariate analysis using Poisson regression in order to calculate the adjusted prevalence ratios (PRa). Additionally, a mixed effects multilevel model adjusted by CFs as clusters was performed.Of 77 086 prison inmates in 66 CFs participated in the original census, of which 69 890 were included. Of these, 1754 self-reported TB diagnosed intra-penitentiary, yielding a prevalence of 2510/100 000 PDL. In the final model, self-reported TB was associated with younger age, male gender, lower educational level, not having a stable partner, having prison readmissions and having relatives in prison. There was also strong association with HIV/AIDS (PRa 2.77; 1.84-4.18), STIs (PRa 2.13; 1.46-3.10), DM (PRa 1.99; 1.59-2.50) and recreational drugs use (PRa 1.41; 1.23-1.61). The mixed model showed significant variance for belonging to different CFs (2.13; 1.02-4.44) and CF overcrowding (3.25; 1.37-7.71).Self-reported TB prevalence found was higher than reported by other lower/lower-middle income countries. Demographic factors, individual clinical features and overcrowding increases the likelihood of self-reported TB.Estimer la prévalence de la tuberculose (TB) auto-déclarée, diagnostiquée dans des établissements pénitentiaires (EP) péruviens et les facteurs associés. MÉTHODES: Etude transversale basée sur une analyse secondaire du recensement national réalisée dans tous les EP péruviens en 2016. Le résultat était défini comme une TB auto-déclarée diagnostiquée par un professionnel de la santé intra-pénitentiaire. Une analyse descriptive à deux variables a été réalisée, suivie d'une analyse à plusieurs variables en utilisant une régression de Poisson afin de calculer les ratios de prévalence ajustés (PRa). En outre, un modèle multiniveau à effets mixtes ajusté selon les EP comme grappes a été réalisé. RÉSULTATS: 77.086 détenus de 66 EP ont participé au recensement initial, dont 69.890 ont été inclus. Parmi ceux-ci, 1.754 cas de TB auto-déclarée ont été diagnostiqués au sein des pénitenciers, soit une prévalence de 2.510/100.000 PDL. Dans le dernier modèle, la TB auto-déclarée était associée à un âge plus jeune, au sexe masculin, à un niveau d’éducation plus faible, à l'absence de partenaire stable, à la réadmission en prison et avoir des parents en prison. Il existait également une forte association avec le VIH/SIDA (PRa: 2,77; 1,84 - 4,18), les IST (PRa: 2,13; 1,46 - 3,10), le diabète (PRa: 1,99; 1,59 - 2,50) et la consommation de drogues à des fins récréatives (PRa: 1,41; 1,23 - 1,61). Le modèle mixte a montré une variance significative pour l'appartenance à différents EP (2,13; 1,02 - 4,44) et au surpeuplement des EP (3,25; 1,37 à 7,71).La prévalence auto-déclarée de la TB était plus élevée que celle rapportée par d'autres pays à revenu inférieur/moyen-inférieur. Les facteurs démographiques, les caractéristiques cliniques individuelles et le surpeuplement augmentent le risque de TB auto-déclarée.

Objective Patients with Cushing’s syndrome (CS) have increased mortality. The aim of this study was to evaluate the causes and time of death in a large cohort of patients with CS and to establish factors associated with increased mortality. Methods In this cohort study, we analyzed 1564 patients included in the European Registry on CS (ERCUSYN); 1045 (67%) had pituitary-dependent CS, 385 (25%) adrenal-dependent CS, 89 (5%) had an ectopic source and 45 (3%) other causes. The median (IQR) overall follow-up time in ERCUSYN was 2.7 (1.2–5.5) years. Results Forty-nine patients had died at the time of the analysis; 23 (47%) with pituitary-dependent CS, 6 (12%) with adrenal-dependent CS, 18 (37%) with ectopic CS and two (4%) with CS due to other causes. Of 42 patients whose cause of death was known, 15 (36%) died due to progression of the underlying disease, 13 (31%) due to infections, 7 (17%) due to cardiovascular or cerebrovascular disease and 2 due to pulmonary embolism. The commonest cause of death in patients with pituitary-dependent CS and adrenal-dependent CS were infectious diseases (n = 8) and progression of the underlying tumor (n = 10) in patients with ectopic CS. Patients who had died were older and more often males, and had more frequently muscle weakness, diabetes mellitus and ectopic CS, compared to survivors. Of 49 deceased patients, 22 (45%) died within 90 days from start of treatment and 5 (10%) before any treatment was given. The commonest cause of deaths in these 27 patients were infections (n = 10; 37%). In a regression analysis, age, ectopic CS and active disease were independently associated with overall death before and within 90 days from the start of treatment. Conclusion Mortality rate was highest in patients with ectopic CS. Infectious diseases were the commonest cause of death soon after diagnosis, emphasizing the need for careful clinical vigilance at that time, especially in patients presenting with concomitant diabetes mellitus.

Background Functional dyspepsia (FD) is one of the most common conditions in clinical practice. In spite of its prevalence, FD is associated with major uncertainties in terms of its definition, underlying pathophysiology, diagnosis, treatment, and prognosis. Methods A Delphi consensus was initiated with 41 experts from 22 European countries who conducted a literature summary and voting process on 87 statements. Quality of evidence was evaluated using the grading of recommendations, assessment, development, and evaluation (GRADE) criteria. Consensus (defined as >80% agreement) was reached for 36 statements. Results The panel agreed with the definition in terms of its cardinal symptoms (early satiation, postprandial fullness, epigastric pain, and epigastric burning), its subdivision into epigastric pain syndrome and postprandial distress syndrome, and the presence of accessory symptoms (upper abdominal bloating, nausea, belching), and overlapping conditions. Also, well accepted are the female predominance of FD, its impact on quality of life and health costs, and acute gastrointestinal infections, and anxiety as risk factors. In terms of pathophysiological mechanisms, the consensus supports a role for impaired gastric accommodation, delayed gastric emptying, hypersensitivity to gastric distention, Helicobacter pylori infection, and altered central processing of signals from the gastroduodenal region. There is consensus that endoscopy is mandatory for establishing a firm diagnosis of FD, but that in primary care, patients without alarm symptoms or risk factors can be managed without endoscopy. There is consensus that H. pylori status should be determined in every patient with dyspeptic symptoms and H. pylori positive patients should receive eradication therapy. Also, proton pump inhibitor therapy is considered an effective therapy for FD, but no other treatment approach reached a consensus. The long‐term prognosis and life expectancy are favorable. Conclusions and Inferences A multinational group of European experts summarized the current state of consensus on the definition, diagnosis and management of FD., Key summary Current knowledge Functional dyspepsia is one of the most common conditions encountered in clinical practice.There is a lack of guidance for clinicians in guiding diagnosis and treatment of this prevalent condition.No treatments are currently approved for the treatment of functional dyspepsia in Europe. What is new here A Delphi panel consisting of 41 experts from 22 European countries established the level of consensus on 87 statements regarding functional dyspepsia.The statements reaching consensus serve to guide clinicians in recognizing, diagnosing and treating FD in clinical practice.Endoscopy is mandatory for establishing a firm diagnosis of functional dyspepsia D, but in primary care patients without alarm symptoms or risk factors can be managed without endoscopy. Helicobacter pylori status should be determined in every patient with dyspeptic symptoms and H. Pylori positive patients should receive eradication therapy.Proton pump inhibitor‐therapy is considered an effective therapy for FD, but no other treatment approach reached consensus support.

BackgroundAcute kidney injury (AKI) is common in coronavirus disease-2019 (COVID-19) and the severity of AKI is linked to adverse outcomes. In this study, we investigated the factors associated with in-hospital outcomes among hospitalized patients with COVID-19 and AKI.MethodsIn this multicenter retrospective observational study, we evaluated the characteristics and in-hospital renal and patient outcomes of 578 patients with confirmed COVID-19 and AKI. Data were collected from 34 hospitals in Turkey from March 11 to June 30, 2020. AKI definition and staging were based on the Kidney Disease Improving Global Outcomes criteria. Patients with end-stage kidney disease or with a kidney transplant were excluded. Renal outcomes were identified only in discharged patients.ResultsThe median age of the patients was 69 years, and 60.9% were males. The most frequent comorbid conditions were hypertension (70.5%), diabetes mellitus (43.8%), and chronic kidney disease (CKD) (37.6%). The proportions of AKI stages 1, 2, and 3 were 54.0%, 24.7%, and 21.3%, respectively. 291 patients (50.3%) were admitted to the intensive care unit. Renal improvement was complete in 81.7% and partial in 17.2% of the patients who were discharged. Renal outcomes were worse in patients with AKI stage 3 or baseline CKD. The overall in-hospital mortality in patients with AKI was 38.9%. In-hospital mortality rate was not different in patients with preexisting non-dialysis CKD compared to patients without CKD (34.4 versus 34.0%, p = 0.924). By multivariate Cox regression analysis, age (hazard ratio [HR] [95% confidence interval (95%CI)]: 1.01 [1.0–1.03], p = 0.035], male gender (HR [95%CI]: 1.47 [1.04–2.09], p = 0.029), diabetes mellitus (HR [95%CI]: 1.51 [1.06–2.17], p = 0.022) and cerebrovascular disease (HR [95%CI]: 1.82 [1.08–3.07], p = 0.023), serum lactate dehydrogenase (greater than two-fold increase) (HR [95%CI]: 1.55 [1.05–2.30], p = 0.027) and AKI stage 2 (HR [95%CI]: 1.98 [1.25–3.14], p = 0.003) and stage 3 (HR [95%CI]: 2.25 [1.44–3.51], p = 0.0001) were independent predictors of in-hospital mortality.ConclusionsAdvanced-stage AKI is associated with extremely high mortality among hospitalized COVID-19 patients. Age, male gender, comorbidities, which are risk factors for mortality in patients with COVID-19 in the general population, are also related to in-hospital mortality in patients with AKI. However, preexisting non-dialysis CKD did not increase in-hospital mortality rate among AKI patients. Renal problems continue in a significant portion of the patients who were discharged.

Vaccination is one of the greatest achievements of public health. Vaccination programs have contributed to the decline in mortality and morbidity of various infectious diseases. This review aims to investigate the impact of sex/gender on the vaccine acceptance, responses, and outcomes. The studies were identified by using PubMed, until 30th June 2020. The search was performed by using the following keywords: SARS-CoV-2, Covid-19, gender, sex, vaccine, adverse reaction. Clinical trials, retrospective and prospective studies were included. Studies written in languages other than English were excluded. Three authors (TC, EB and IA) reviewed all study abstracts. Studies were included if gender differences in response to vaccination trials were reported. All selected studies were qualitatively analyzed. Innate recognition and response to viruses, as well as, adaptive immune responses during viral infections, differ between females and males. Unfortunately, a majority of vaccine trials have focused on healthy people, with ages between 18 to 65 years, excluding the elderly, pregnant women, post-menopausal female and children. In conclusion, it is apparent that the design of vaccines and vaccine strategies should be sex-specific, to reduce adverse reactions in females and increase immunogenicity in males. It should be mandatory to examine sex-related variables in pre-clinical and clinical vaccine trials, such as their crucial role for successful prevention of pandemic Covid-19.

Background There is a worrying lack of epidemiological data on the sex differential in COVID-19 infection and death rates between the regions of Peru. Methods Using cases and death data from the national population-based surveillance system of Peru, we estimated incidence, mortality and fatality, stratified by sex, age and geographic distribution (per 100,000 habitants) from March 16 to November 27, 2020. At the same time, we calculated the risk of COVID-19 death. Results During the study period, 961894 cases and 35913 deaths were reported in Peru. Men had a twofold higher risk of COVID-19 death within the overall population of Peru (odds ratio (OR), 2.11; confidence interval (CI) 95%; 2.06–2.16; pp Conclusions These findings show the higher incidence, mortality and fatality rates among men than among women from Peru. These rates vary widely by region, and men are at greater risk of COVID-19 death. In addition, the mortality and fatality rates increased with age, and were most predominant in men 50 years of age or older.

Background and aims: An increasing proportion of women believe that smoking few cigarettes daily substantially reduces their risk of developing cardiovascular (CV) related disorders. The effect of low intensity smoking is still largely understudied. We investigated the relation among sex, age, cigarette smoking and ST segment elevation myocardial infarction (STEMI) as initial manifestation of CV disease. Methods: We analyzed data of 50,713 acute coronary syndrome patients with no prior manifestation of CV disease from the ISACS-Archives (NCT04008173) registry. We compared the rates of STEMI in current smokers (n = 11,530) versus nonsmokers (n = 39,183). Results: In the young middle age group (

Purpose: The primary objective of this study was to evaluate the prevalence, characteristics and the most frequently used complementary and alternative medicine (CAM) methods among infertile couples. A secondary aim was to assess predictors and patients’ attitude to disclose the usage of CAM. Methods: This study was designed as a cross-sectional survey and conducted on patients admitted to infertility clinics of two hospitals. Results: The overall prevalence of CAM among 324 infertile participants (162 couples) was 25.6 % (n = 83). 48 % of the infertile couples had experience with at least one type of CAM method and the most commonly used CAM was herbal products (84 %). The frequency of CAM tended to be higher among females compared to males (33 % versus 17 %, respectively; p = 0.02). Patients who failed to conceive with previous medical therapies were more inclined to use CAM (p = 0.01). After logistic regression analyses, only gender and previous unsuccessful ART treatment were found to be associated independently with CAM use. Conclusion: CAM use is common among infertile population. CAM users were more likely to be women at any age who had failed to achieve a pregnancy with previous artificial reproductive treatment(s), mainly used herbal products and mostly reluctant to report the use of CAM. © 2021 Elsevier Masson SAS

Background and Aim: The prevalence and clinical significance of extrahepatic autoimmune diseases (EHAIDs) have not been evaluated in a large cohort of primary biliary cholangitis (PBC). Methods: The medical records of 1554 patients with PBC from 20 international centers were retrospectively reviewed. Development of decompensated cirrhosis (ascites, variceal bleeding, and/or hepatic encephalopathy) and hepatocellular carcinoma were considered clinical endpoints. Results: A total of 35 different EHAIDs were diagnosed in 440 (28.3%) patients with PBC. Patients with EHAIDs were more often female (92.5% vs 86.1%, P&nbsp

Resilience is defined as “the capacity of individuals to cope successfully with significant change or adversity”. The challenge posed by the COVID-19 pandemic may potentially represent an overwhelmingly stressful event for patients with chronic diseases. Aim of our study was to investigate the levels of resilience in individuals with inflammatory arthritis living in Emilia Romagna, the third hardest-hit Italian region during the ongoing COVID-19 pandemic. To this purpose, we developed a survey consisting of four different sections assessing demographic characteristics, the 14-item resilience scale (RS14) and questionnaires evaluating depression and anxiety. Consecutive patients with inflammatory arthritis were recruited over a short time frame immediately after the end of national lockdown and compared with control individuals from the general population. One hundred twenty-two patients and 173 controls were included. Levels of resilience, as measured by RS14 score, were significantly higher in patients with inflammatory arthritis (82.6 ± 14.0 vs 79.0 ± 12.8, p = 0.018). After stratification for gender, the difference in RS14 score was maintained in women (p = 0.045), but not in men (p = 0.252). High resilience, defined as having a RS14 score > 90, was significantly more prevalent in patients than in controls (30% vs 16%, p = 0.009). In arthritis patients, no significant differences in RS14 were observed after stratification for specific diagnosis, age, or disease duration and activity. Our findings suggest that patients with inflammatory arthritis may be more resilient than the general population towards unexpected stressful events such as the ongoing COVID-19 pandemic.Key Points• Living with inflammatory arthritis may foster resilience.• After COVID-19, patients with inflammatory arthritis were more resilient than the general population. Electronic supplementary material The online version of this article (10.1007/s10067-020-05411-x) contains supplementary material, which is available to authorized users.

Background The aetiology of Parkinson’s disease (PD) is still very controversial, with a peculiar lack of established risk factors or protective behavior. Methods We carried out a case–control study of 634 idiopathic PD patients admitted from 2011 to 2015 to two hospitals located in central Italy and 532 controls matched by hospital, gender and age (± 5 years). The study questionnaire included questions on host factors, family history, residence, occupation and lifestyle. Odds ratios (ORs) for PD and 95% confidence intervals (CIs) were estimated with logistic regression, adjusting for actual and potential confounders. Results A lower OR was observed in females (0.74; 95%CI:0.58–0.96), while older age classes showed a constantly increased risk for PD (p Conclusions The results from this study confirmed the higher risk of PD in males and in elderly, and the inverse association with smoking habit. The possible etiological role of familial clustering, dietary habit, and some job tasks is suggested.

Despite limited genomic diversity, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has shown a wide range of clinical manifestations in different patient populations. The mechanisms behind these host differences are still unclear. Here, we examined host response gene expression across infection status, viral load, age, and sex among shotgun RNA sequencing profiles of nasopharyngeal (NP) swabs from 430 individuals with PCR-confirmed SARS-CoV-2 and 54 negative controls. SARS-CoV-2 induced a strong antiviral response with up-regulation of antiviral factors such as OAS1-3 and IFIT1-3 and T helper type 1 (Th1) chemokines CXCL9/10/11, as well as a reduction in transcription of ribosomal proteins. SARS-CoV-2 culture in human airway epithelial (HAE) cultures replicated the in vivo antiviral host response 7 days post infection, with no induction of interferon-stimulated genes after 3 days. Patient-matched longitudinal specimens (mean elapsed time = 6.3 days) demonstrated reduction in interferon-induced transcription, recovery of transcription of ribosomal proteins, and initiation of wound healing and humoral immune responses. Expression of interferon-responsive genes, including ACE2, increased as a function of viral load, while transcripts for B cell–specific proteins and neutrophil chemokines were elevated in patients with lower viral load. Older individuals had reduced expression of the Th1 chemokines CXCL9/10/11 and their cognate receptor CXCR3, as well as CD8A and granzyme B, suggesting deficiencies in trafficking and/or function of cytotoxic T cells and natural killer (NK) cells. Relative to females, males had reduced B cell–specific and NK cell–specific transcripts and an increase in inhibitors of nuclear factor kappa-B (NF-κB) signaling, possibly inappropriately throttling antiviral responses. Collectively, our data demonstrate that host responses to SARS-CoV-2 are dependent on viral load and infection time course, with observed differences due to age and sex that may contribute to disease severity., Despite limited genomic diversity, SARS-CoV-2 has shown a wide range of clinical manifestations in different patient populations; the mechanisms behind these host differences are still unclear. This study reveals that SARS-CoV-2 infection induces inflammation by activation of interferon signaling, with differences in host response observed due to sex and age.

A gender-specific drug utilization study was performed in the Campania region, Southern Italy. Data were based on outpatient drug prescriptions collected from administrative databases. The study population included all patients with at least one drug prescription in 2018. Prevalence was used as a measure to estimate the degree of exposure to drugs. A total of 3,899,360 patients were treated with at least one drug (54.2% females). The number of prescriptions was higher in females than males (55.6% vs. 44.4%). Females recorded higher prevalence for the majority of therapeutic groups (ATC II&mdash, anatomical therapeutic chemical), as well as for anti-inflammatory and antirheumatic products drugs (M01) (25.6% vs. 18.7%, risk ratio (RR): 0.73), beta blocking agents (C07) (14.5% vs. 11.6%, RR: 0.80), psychoanaleptics (N06) (7.1% vs. 3.7%, RR: 0.52), and antianemic preparations (B03) (2.8% vs. 6.7%, RR: 0.4). Higher prevalence was identified for males only for drugs used in diabetes (A10) (6.8% vs. 6.2%, RR: 1.1), particularly for biguanides (A10BA). Conversely, treatment duration was longer among males, explaining the higher mean cost per treated patient. This real-world study showed substantial gender differences in terms of medication use and duration of treatment and costs. These results are relevant to promoting and supporting the emerging role of precision and personalized medicine.

BackgroundThe global rate of intensive care unit (ICU) admission during the COVID-19 pandemic varies within countries and is among the main challenges for health care systems worldwide. Conflicting results have been reported about the response to coronavirus infection and COVID-19 outcomes in men and women. Understanding predictors of intensive care unit admission might be of help for future planning and management of the disease.Methods and findingsWe designed a cross-sectional observational multicenter nationwide survey in Italy to understand gender-related clinical predictors of ICU admission in patients with COVID-19. We analyzed information from 2378 charts of Italian patients certified for COVID-19 admitted in 26 hospitals. Three hundred ninety-five patients (16.6%) required ICU admission due to COVID19 infection, more frequently men (74%), with a higher prevalence of comorbidities (1,78±0,06 vs 1,54±0,03 pConclusionsOur study demonstrates that gender is the primary determinant of the disease's severity among COVID-19. Obesity is the condition more often observed among those admitted to ICU within both genders.Trial registrationClinicaltrials.gov: NCT04331574.

Elbuken, Gulsah/0000-0002-0920-6895; Kadioglu, Pinar/0000-0002-8329-140X WOS:000562953800001 PubMed ID: 32154572 Introduction: The outcome of medical treatment in patients with Graves' disease (GD) is generally difficult to predict. In this study, we examined the hypothesis that gender may affect the outcome of treatment with antithyroid drugs (ATDs). Material and methods: This is a retrospective multicentre study including 717 (514 female and 203 male) patients with the first episode of GD treated for at least 12 months. Patients were classified as relapse, poorly controlled (several episodes of hyperthyroidism followed by euthyroidism and rarely hypothyroidism, occurring after titration of ATDs), and remission. Results: During the mean follow-up time of 26.75 +/- 21.25 months (between 1 and 120 months), 269 (37.5%),176 (24.5%), and 272 (37.9%) patients experienced a relapse, a poorly controlled disease, and remained in remission, respectively. During the follow-up time, 223 (43.4%) of the female and only 49 (24%) of the male patients remained in remission. Relapse and poorly controlled disease (non-remitting GD) were more common in male compared to female patients with GD (hazard ratio 1.26, 95% CI: 1.03-133, p - 0.025). Graves' disease in male patients tended to relapse earlier, and male patients tended to have larger goiter sizes at diagnosis as well. The smoking habit was also significantly inure frequent in males compared to female patients with GD. Conclusion: Male patients with GD have a markedly higher frequency of relapse and poorly controlled disease, as compared to female patients. Larger goiter sizes and higher frequency of smoking may contribute to the higher frequency of relapse and poorly controlled disease in male patients.

Aim: To evaluate the epidemiology of male breast cancer (MBC) in Italy and to describe incidence and survival data in relation to age, morphology, year of incidence, geographic area, and possible association with other cancers compared with female BC. Methods: Cases were extracted from 40 Italian Cancer Registries. Standardized incidence rates (SIR), age-specific rates, and 5-year survival were calculated. The association with second tumors was also evaluated. All data were compared with data from female BCs. Results: In the 2000–2014 period, 2175 new cases of MBC were registered, with an SIR of 1.7 × 100,000. The incidence showed a slight upward trend and increased with increasing age. The 5-year survival was 82% in the first two periods (2000–2004, 2005–2009), lower than in females (87%). The most frequent morphology was the ductal carcinoma (84%). Stage at diagnosis was 39.5% stage I, 33.1% stage II, 20.9% in stage III, and 6.4% in stage IV. Concerning receptor status, 96.4% had ER+ and 82.5% PR+; 46.5% had high Ki67 and 14.7% HER2 amplified. The risk of BC increased if the man had already had a previous tumor in any site (excess absolute risk, EAR = 2.7) and especially if he had had prostate cancer (EAR = 5.1). Instead, males with a previous diagnosis of BC had an increased risk of testicular, kidney and lung cancer. Conclusions: MBC requires more attention in terms of diagnosis and treatment as clinicians tend to follow the guidelines that have been developed for female BC management.

Context Signs and symptoms of Cushing’s syndrome (CS) overlap with common diseases, such as the metabolic syndrome, obesity, osteoporosis, and depression. Therefore, it can take years to finally diagnose CS, although early diagnosis is important for prevention of complications. Objective The aim of this study was to assess the time span between first symptoms and diagnosis of CS in different populations to identify factors associated with an early diagnosis. Data Sources A systematic literature search via PubMed was performed to identify studies reporting on time to diagnosis in CS. In addition, unpublished data from patients of our tertiary care center and 4 other centers were included. Study Selection Clinical studies reporting on the time to diagnosis of CS were eligible. Corresponding authors were contacted to obtain additional information relevant to the research question. Data Extraction Data were extracted from the text of the retrieved articles and from additional information provided by authors contacted successfully. From initially 3326 screened studies 44 were included. Data Synthesis Mean time to diagnosis for patients with CS was 34 months (ectopic CS: 14 months; adrenal CS: 30 months; and pituitary CS: 38 months; P < .001). No difference was found for gender, age ( Conclusions Time to diagnosis differs for subtypes of CS but not for gender and age. Time to diagnosis remains to be long and requires to be improved.

Background Four percent of the world’s population suffers from depression, which is a major public health issue. Medical students are at risk, as their depressive symptoms (DS) prevalence is reported to be approximately 27% worldwide. Since few data on Italian medical students exist, this study aimed to estimate their DS prevalence and assess risk and protective factors. Methods The PRIMES was a multicentre cross-sectional study performed in 12 Italian medical schools. Questionnaires were self-reported and included 30 sociodemographic items and the Beck Depression Inventory-II (BDI-II). The primary outcome was the presence of DS (BDI-II score≥14). The main analyses were chi-squared tests and multivariable logistic regressions with a p-value