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This cross-sectional study aimed to assess the association between drugs and alcohol intake and sexual abuse in adolescents, otherwise defined as Drug Facilitated Sexual Assault (DFSA). We considered the survivors who accessed care at the Centre "Soccorso Violenza Sessuale" (SVS – Sexual Violence Relief Centre) in Turin (Italy), between May 2003 and May 2022. We found that 973 patients aged 13–24 among which 228 were victims of DFSA. Epidemiological and anamnestic aspects of the episode of sexual violence were examined, with a specific focus on investigating the alcohol and/or drug intake as reported by the victim, along with the results of the toxicological analysis. the study further accounts for the variations caused by the COVID-19 pandemic on DFSA-related accesses. Our findings show that 23% of adolescents accessing care at SVS were subjected to DFSA. Six out ten adolescents knew their aggressor, at times a partner (10%) oran acquaintance (43%). In 12% of cases violence was perpetrated by a group of people (12%). Almost 90% of young victims described alcohol consumption, while 37% reported drug use at the time of the assault. Alcohol taken alone or in combination with other substances was the most detected drug in our sample throughout the period considered. Given the large use of psychoactive substances among adolescents, it is imperative to implement harm reduction strategies alongside educational activities aimed at fostering awareness about consent. Health personnel should be trained to manage the needs of victims of DFSA clinically and forensically. [ABSTRACT FROM AUTHOR]

The objective of our study was to determine the joint protective effect of a previous SARS-CoV-2 infection and vaccination on the risk of a new infection and hospitalization. Two case–control studies nested in a cohort of COVID-19 patients cared for by the Local Health Unit (LHU) of Vercelli, Italy, were performed, one to estimate the risk of infection and the second to estimate the risk of hospitalization. Each new infection and hospitalization was matched with up to 4 disease-free subjects who were the same age, sex and index date (i.e., controls). Study subjects were followed up from cohort entry date to disease outcome, end of follow-up or emigration. Vaccination was associated with a 36% (OR 0.64; 95%CI 0.62–0.66) and 90% (OR 0.10; 95%CI 0.07–0.14) reduction in the risk of infection and hospitalization, respectively. Prior infection was associated with a 65% (OR 0.35; 95%CI 0.30–0.40) and 90% (OR 0.10; 95%CI 0.07–0.14) reduction in the risk of infection and hospitalization, respectively. Vaccinated and recovered subjects showed a 63% (OR 0.37; 95%CI 0.34–0.14) and 98% (OR 0.02; 95%CI 0–0.13) reduction in the risk of infection and hospitalization, respectively. Vaccination remains an essential public health tool for preventing severe forms of COVID-19. Our study shows that vaccination or previous infection has a strong protective effect against Sars-CoV-2 hospitalization. The protective role against infection appears to be present although with a lower efficacy rate than that presented in the RCTs. [ABSTRACT FROM AUTHOR]

Background: Parkinson's disease (PD) is a chronic, progressive neurodegenerative condition that gradually worsens motor function and leads to postural instability and, eventually, falls. Several factors may influence the frequency of future falls, such as slowness, freezing of gait, loss of balance, and mobility problems, cognitive impairments, and the number of previous falls. The TED bracelet is an advanced technological wearable device able to predict falls. Aims: This principal aim is to investigate the feasibility of a full-scale research project that uses the TED bracelet to identify whether individuals with PD are at risk of falling. Methods: This study will involve a pilot prospective observational study design; the subjects will include 26 patients suffering from mild PD and 26 others with no PD and no gait problems. Data will be collected from the TED bracelet and then compared to a paper-based fall diary. The enrolled participants will have a scheduled outpatient evaluation to collect both clinical and instrumental data as well as biological samples. Discussion: This pilot study could then be implemented in a larger form to further evaluate the effectiveness of the TED device. Finally, it will help further develop gait monitoring systems for people with Parkinson's disease and other neurodegenerative diseases that can affect physical function and mobility, such as dementia and Alzheimer's. Conclusions: Preventing falls and their complications could lead to major advancements in the quality of home care for patients with PD, which would significantly impact the quality of life of both these patients and their caregivers. [ABSTRACT FROM AUTHOR]

Endothelial damage and fibro-proliferative vasculopathy of small vessels are pathological hallmarks of systemic sclerosis (SSc). The consequence is the detachment of resident elements that become circulating endothelial cells (CECs). The aim of our study was to evaluate the potential of CECs as biomarker in SSc. We enrolled 50 patients with limited cutaneous (lcSSc) and diffuse cutaneous (dcSSc) subset of SSc, who underwent clinical evaluation to establish the organ involvement. CECs were measured by flow-cytometry utilizing a polychromatic panel. An evident difference was observed in CEC counts comparing controls to SSc patients (median 10.5 vs. 152 cells/ml, p < 0.0001) and for the first time, between the two subsets of disease (median lcSSc 132 vs. dcSSc 716 CEC/ml, p < 0.0001). A significant correlation was established between CECs and some SSc clinical parameters, such as digital ulcers, skin and pulmonary involvement, presence of Scl-70 antibodies, nailfold videocapillaroscopy patterns and EUSTAR activity index. After 12 months, CECs correlated with clinical worsening of patients, showing that a number higher than 414 CEC/ml is a strong negative prognostic factor (RR 5.70). Our results indicate that CECs are a direct indicator of systemic vascular damage. Therefore, they can be used as a reliable marker of disease severity. [ABSTRACT FROM AUTHOR]

Background and Objective: Conflicting findings from studies evaluating the association between use of antidepressant drugs and mortality have been reported. We tested the hypothesis that better adherence to antidepressant therapy may reduce mortality.Methods: The cohort included 29,845 individuals aged ≥ 65 years from several Italian health units who were newly treated with antidepressant drugs after hospital discharge with a diagnosis for cardiovascular disease during 2008-2010. These individuals were observed from the first prescription until the end of data availability (i.e. 2012-2014, depending on the local database). During this period, information on (1) prescription of antidepressants and other medications and (2) death from any cause (outcome) was recorded. Proportional hazards models were fitted to estimate the association between better adherence to antidepressants (defined as proportion of days covered ≥ 75%) and outcome, by adjusting and stratifying for several covariates.Results: Patients with better adherence to antidepressants had a reduced mortality of 9% (95% CI 3-14). Patients who did not use other medicaments during follow-up had reduced mortality associated with better adherence to antidepressants of 21% (− 1-38), 14% (7-20), 20% (13-26) and 13% (7-19) for no users of antihypertensive agents, lipid-lowering agents, other cardiovascular drugs and antidiabetics, respectively.Conclusions: Better adherence to antidepressants is associated with reduced all-cause mortality, mainly in patients who did not use other pharmacological treatments. Behavioural changes to enhance adherence among the elderly with cardiovascular disease might offer important benefits in reducing their mortality. [ABSTRACT FROM AUTHOR]

Purpose: To assess the effectiveness of an informative intervention on general practitioners aimed at improving patients' adherence to statin therapy. Methods: In the local health unit (LHU) of Bergamo, Lombardy (Italy), each general practitioner received a synthetic scientific document on dyslipidaemia and statins and aggregated data on adherence in 2006 for his/her patients compared to the means in the LHU and in his/her working district. Furthermore, a sample of seven districts received also a table of adherence levels for single patients. Patient's level data were retrieved from the health care utilisation databases of the LHU. Adherence parameters (proportion of patients with only one prescription, medication possession ratio [MPR] and proportion of non-persistent patients) were assessed after 1 year of follow-up. Results: Overall, 5833 and 4788 new statin users were enrolled before and after the intervention, respectively. The percentage of patients with only one prescription decreased from 28.0 to 23.9 % ( p < 0.001). MPR increased from 70.3 to 76.0 % ( p < 0.001), and proportion of patients with MPR ≥80 % increased from 45.4 to 56.4 % ( p < 0.001). The persistence also showed an improvement, both in terms of decreasing proportion of non-persistent (from 51.9 to 41.4 %, p < 0.001) and of increasing duration of continued therapy (from 235 to 264 mean days of persistent therapy, p < 0.001). There were not significant differences between the two types of intervention. Conclusions: This intervention resulted in an overall improvement of the short-term adherence to therapy. This tool can be replicated in other local contexts and with other chronic therapies. [ABSTRACT FROM AUTHOR]

Background and Objective: Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detection, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongside an SRS as an independent system, with the aim of improving signal detection.Methods: A signal detection strategy, focused on a limited set of adverse events deemed important in pharmacovigilance, was performed retrospectively in two data sources-(1) the Exploring and Understanding Adverse Drug Reactions (EU-ADR) database network and (2) the EudraVigilance database-using data between 2000 and 2010. Five events were considered for analysis: (1) acute myocardial infarction (AMI); (2) bullous eruption; (3) hip fracture; (4) acute pancreatitis; and (5) upper gastrointestinal bleeding (UGIB). Potential signals identified in each system were verified using the current published literature. The complementarity of the two systems to detect signals was expressed as the percentage of the unilaterally identified signals out of the total number of confirmed signals. As a proxy for the associated costs, the number of signals that needed to be reviewed to detect one true signal (number needed to detect [NND]) was calculated. The relationship between the background frequency of the events and the capability of each system to detect signals was also investigated.Results: The contribution of each system to signal detection appeared to be correlated with the background incidence of the events, being directly proportional to the incidence in EU-ADR and inversely proportional in EudraVigilance. EudraVigilance was particularly valuable in identifying bullous eruption and acute pancreatitis (71 and 42 % of signals were correctly identified from the total pool of known associations, respectively), while EU-ADR was most useful in identifying hip fractures (60 %). Both systems contributed reasonably well to identification of signals related to UGIB (45 % in EudraVigilance, 40 % in EU-ADR) but only fairly for signals related to AMI (25 % in EU-ADR, 20 % in EudraVigilance). The costs associated with detection of signals were variable across events; however, it was often more costly to detect safety signals in EU-ADR than in EudraVigilance (median NNDs: 7 versus 5).Conclusion: An EHR-based system may have additional value for signal detection, alongside already established systems, especially in the presence of adverse events with a high background incidence. While the SRS appeared to be more cost effective overall, for some events the costs associated with signal detection in the EHR might be justifiable. [ABSTRACT FROM AUTHOR]

Purpose: Osteoporosis is a chronic disease of the bone, whose incidence increases progressively with aging. The main consequences of osteoporosis are fragility fractures, which have considerable medical, social, and economic implications. Adequate treatment of osteoporosis must be considered as a compelling public health intervention. Bisphosphonates (BPs) represent the most significant advance in this field in the past decade, and they are widely used in the treatment of osteoporosis. However, evidence for their effectiveness is limited to secondary prevention, whereas their effect in primary prevention is uncertain and needs further investigation. Methods: Using administrative data collected in the 'Biphosphonates Efficacy-Safety Tradeoff' (BEST) study, a nested case-control study was conducted by including 56,058 participants, aged 55 years who were started on oral BPs from 2003 to 2005. Cases were the 1,710 participants who were hospitalized for osteoporotic fractures until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio of fracture associated with categories of treatment duration. Results: Compared with participants assuming BPs for less than 1 year, those who remained on therapy for at least 2 years had a 21 % (95 % confidence interval (CI) 7 to 33 %) fracture risk reduction. Conclusion: This study provides evidence that BPs, dispensed for primary prevention of osteoporotic fractures, are associated with a reduced risk of osteoporotic fractures after at least 2 years of treatment. [ABSTRACT FROM AUTHOR]

Background: Data mining in spontaneous reporting databases has shown that drug-induced liver injury is infrequently reported in children. Objectives: Our objectives were to (i) identify drugs potentially associated with acute liver injury (ALI) in children and adolescents using electronic healthcare record (EHR) data; and (ii) to evaluate the significance and novelty of these associations. Methods: We identified potential cases of ALI during exposure to any prescribed/dispensed drug for individuals <18 years old from the EU-ADR network, which includes seven databases from three countries, covering the years 1996-2010. Several new methods for signal detection were applied to identify all statistically significant associations between drugs and ALI. A drug was considered statistically significantly associated with ALI, using all other time as a reference category, if the 95 % CI lower band of the relative risk was >1 and in the presence of at least three exposed cases of ALI. Potentially new signals were distinguished from already known associations concerning ALI (whether in adults and/or in the paediatric population) through manual review of published literature and drug product labels. Results: The study population comprised 4,838,146 individuals aged <18 years, who contributed an overall 25,575,132 person-years of follow-up. Within this population, we identified 1,015 potential cases of ALI. Overall, 20 positive drug-ALI associations were detected. The associations between ALI and domperidone, flunisolide and human insulin were considered as potentially new signals. Citalopram and cetirizine have been previously described as hepatotoxic in adults but not in children, while all remaining associations were already known in both adults and children. Conclusions: Data mining of multiple EHR databases for signal detection confirmed known associations between ALI and several drugs, and identified some potentially new signals in children that require further investigation through formal epidemiologic studies. This study shows that EHRs may complement traditional spontaneous reporting systems for signal detection and strengthening. [ABSTRACT FROM AUTHOR]

To evaluate the association between alcohol consumption and endometrial cancer risk, we analyzed data from a hospital-based case–control study, conducted in Italy between 1992 and 2006, on 454 endometrial cancer cases and 908 controls, and performed a meta-analysis updated to October 2009. Compared to never alcohol drinkers, the odds ratio was 1.03 (95% confidence interval, CI, 0.76–1.41) for ≤7, 1.27 (95% CI 0.86–1.87) for 8–14, and 1.19 (95% CI 0.80–1.77) for ≥15 drinks/week, with no trend in risk. No association emerged for wine, beer, and spirit consumption analyzed separately. The meta-analysis included 20 case–control and seven cohort studies, for a total of 13,120 cases. Compared to non/low drinkers, the pooled relative risks for drinkers were 0.90 (95% CI 0.80–1.01) for case–control studies, 1.01 (95% CI 0.90–1.14) for cohort studies, and 0.95 (95% CI 0.88–1.03) overall, with no heterogeneity between study design ( p = 0.156). The overall estimate for heavy versus non/low drinkers was 1.12 (95% CI 0.87–1.45). The results were consistent according to selected study characteristics, including geographic area, definition of alcohol drinkers, and type of controls in case–control studies. Our findings provide evidence that alcohol drinking is not associated with endometrial cancer risk, although a weak positive association for very high drinkers cannot be excluded. [ABSTRACT FROM AUTHOR]

Objective: Fiber intake has been inversely related to stomach cancer risk, although this issue is still controversial.Methods: A case-control study was conducted in Italy between 1997 and 2007, including 230 cases with incident, histologically confirmed stomach cancer, and 547 controls with acute, non-neoplastic diseases. Dietary habits were investigated through a validated food frequency questionnaire.Results: Compared with the lowest quintile of intake, the multivariate odds ratios (ORs, including terms for major recognised confounding factors and total energy intake) for the highest quintile were 0.47 (95% confidence interval (CI): 0.28-0.79) for total fiber, 0.50 (95% CI: 0.30-0.85) for soluble non-cellulose polysaccharides (NCP), 0.39 (95% CI: 0.23-0.66) for total insoluble fiber, 0.54 (95% CI: 0.32-0.91) for insoluble NCP, 0.37 (95% CI: 0.22-0.64) for cellulose, and 0.59 (95% CI: 0.36-0.98) for lignin. With reference to the sources of fiber, an inverse association was found for fiber from vegetable (OR = 0.42, 95% CI: 0.24-0.72), and to a lesser extent from fruit (OR = 0.65, 95% CI: 0.38-1.10), but not for fiber from grain (OR = 1.25, 95% CI: 0.77-2.03).Conclusions: This study found an inverse relationship between stomach cancer risk and various types of fiber, derived, in particular, from vegetables and fruit. [ABSTRACT FROM AUTHOR]

To evaluate diagnostic performance of endorectal magnetic resonance (eMR) for diagnosing local recurrence of prostate cancer (PC) in patients with previous radical prostatectomy (RP) and to assess whether contrast-enhanced (CE)-eMR improved diagnostic accuracy in comparison to unenhanced study. Unenhanced eMR data of 72 male patients (mean of total PSA: 1.23 +/- 1.3 ng/ml) with previous RP were interpreted retrospectively and classified either as normal or suspicious for local recurrence. All eMR examinations were re-evaluated also on CE-eMR 4 months after the first reading. Images were acquired on a 1.5-T system. These data were compared to the standard of reference for local recurrence: prostatectomy bed biopsy results; choline positron emission tomography results; PSA reduction or increase after pelvic radiotherapy; PSA modification during active surveillance. Sensitivity, specificity, predictive positive value, negative predictive value and accuracy were 61.4%, 82.1%, 84.4%, 57.5% and 69.4% for unenhanced eMR and 84.1%, 89.3%, 92.5%, 78.1% and 86.1% for CE-eMR. A statistically significant difference was found between accuracy and sensitivity of the two evaluations (chi(2) = 5.33; p = 0.02 and chi(2) = 9.00; p = 0.0027). EMR had great accuracy for visualizing local recurrence of PC after RP. CE-eMR improved diagnostic performance in comparison with T2-weighted imaging alone. [ABSTRACT FROM AUTHOR]