A European inventory of common electronic health record data elements for clinical trial feasibility

Background: Clinical studies are a necessity for new medications and therapies. Many studies, however, struggle to meet their recruitment numbers in time or have problems in meeting them at all. With increasing numbers of electronic health records (EHRs) in hospitals, huge databanks emerge that could be utilized to support research. The Innovative Medicine Initiative (IMI) funded project ‘Electronic Health Records for Clinical Research’ (EHR4CR) created a standardized and homogenous inventory of data elements to support research by utilizing EHRs. Our aim was to develop a Data Inventory that contains elements required for site feasibility analysis. Methods:The Data Inventory was created in an iterative, consensus driven approach, by a group of up to 30 people consisting of pharmaceutical experts and informatics specialists. An initial list was subsequently expanded by data elements of simplified eligibility criteria from clinical trial protocols. Each element was manually reviewed by pharmaceutical experts and standard definitions were identified and added. To verify their availability, data exports of the source systems at eleven university hospitals throughout Europe were conducted and evaluated. Results: The Data Inventory consists of 75 data elements that, on the one hand are frequently used in clinical studies, and on the other hand are available in European EHR systems. Rankings of data elements were created from the results of the data exports. In addition a sub-list was created with 21 data elements that were separated from the Data Inventory because of their low usage in routine documentation. Conclusion: The data elements in the Data Inventory were identified with the knowledge of domain experts from pharmaceutical companies. Currently, not all information that is frequently used in site feasibility is documented in routine patient care.<br

Sunny holidays before and after melanoma diagnosis are respectively associated with lower breslow thickness and lower relapse rates in Italy

Background: Previous studies have reported an association between sun exposure and improved cutaneous melanoma (CM) survival. We analysed the association of UV exposure with prognostic factors and outcome in a large melanoma cohort. Methods: A questionnaire was given to 289 (42%) CM patients at diagnosis (Group 1) and to 402 CM patients (58%) during follow-up (Group 2). Analyses were carried out to investigate the associations between sun exposure and melanoma prognostic factors and survival. Results: Holidays in the sun two years before CM diagnosis were significantly associated with lower Breslow thickness (p=0.003), after multiple adjustment. Number of weeks of sunny holidays was also significantly and inversely associated with thickness in a dose-dependent manner (p=0.007). However when stratifying by gender this association was found only among women (p=0.0004) the risk of CM recurrence in both sexes was significantly lower in patients (n=271) who had holidays in the sun after diagnosis, after multiple adjustment including education: HR=0.30 (95%CI:0.10-0.87; p=0.03) conclusions: Holidays in the sun were associated with thinner melanomas in women and reduced rates of relapse in both sexes. However, these results do not prove a direct causal effect of sun exposure on survival since other confounding factors, such as vitamin D serum levels and socio-economic status, may play a role. Other factors in sun seeking individuals may also possibly affect these results

Nationwide analysis of open groin hernia repairs in Italy from 2015 to 2020

Introduction: Inguinal hernia repair is one of the most commonly performed operations in general surgery. A total of 130.000 inguinal hernia repairs are performed yearly in Italy, and approximately 20 million inguinal hernias are treated worldwide annually. This report represents the trend analysis in inguinal hernia repair in Italy from a nationwide dataset for the 6-year period from 2015 to 2020. Materials and methods: Based on regional hospital discharge records, all the inguinal hernia repairs performed in public and private hospitals in Italy between 2015 and 2020 were reviewed based on diagnosis and procedure codes. For the aim of this study, data from the AgeNas (The National Agency for Regional Health Services) data source were analyzed. Results: Elective inguinal hernia repairs outnumbered urgent operations over the 6-year study period, ranging from 122,737 operations in 2015 to 65,780 in 2020 as absolute numbers, and from 87.96 to 83.3% of total procedures in 2019 and 2020 respectively, with an annual change ranging from - 66.58%, between 2020 and 2019, to - 2.49%, between 2019 and 2018 (mean = - 18.74%; CI =- 46.7%-9.22%; p &lt; 0.0001). Conclusions: This large-scale review of groin hernia data from a nationwide Italian dataset provides a unique opportunity to obtain a snapshot of open groin hernia repair activity. More specifically, there is a trend to perform more elective than urgent procedures and there is a steady decrease in the amount of open hernia repairs in favor to laparoscopy

Reproductive factors and risk of melanoma : a population-based cohort study

Background The association between reproductive factors and risk of cutaneous melanoma (CM) is unclear. We investigated this issue in the Norwegian Women and Cancer cohort study. Objectives To examine the association between the reproductive factors age at menarche, menstrual cycle length, parity, age at first and last birth, menopausal status, breastfeeding duration and length of ovulatory life, and CM risk, overall and by histological subtypes and anatomical site. Methods We followed 165 712 women aged 30-75 years at inclusion from 1991-2007 to the end of 2015. Multivariable Cox regression was used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Results The mean age at cohort enrolment was 49 years. During a median follow-up of 18 years, 1347 cases of CM were identified. No reproductive factors were clearly associated with CM risk. When stratifying by histological subtype we observed significant heterogeneity (P = 0 center dot 01) in the effect of length of ovulatory life on the risk of superficial spreading melanoma (HR 1 center dot 02, 95% CI 1 center dot 01-1 center dot 04 per year increase) and nodular melanoma (HR 0 center dot 97, 95% CI 0 center dot 94-1 center dot 01 per year increase). When stratifying by anatomical site, menopausal status (HR 0 center dot 54, 95% CI 0 center dot 31-0 center dot 92, postmenopausal vs. premenopausal) and menstrual cycle length (HR 1 center dot 07, 95% CI 1 center dot 01-1 center dot 13, per day increase) were associated with CM of the trunk, and significant heterogeneity between anatomical sites was observed for menopausal status (P = 0 center dot 04). Conclusions In this large population-based Norwegian cohort study, we did not find convincing evidence of an association between reproductive factors and risk of CM.Peer reviewe

The leading “blended” civil medical evacuation operation (MEDEVAC) in unforeseen health emergency. From military use to civil development

Introduction: Medical evacuation has historically been rooted in military contexts. It involves the systematic transfer of sick or injured individuals from the battlefield to designated medical facilities. Medical evacuation has found application in civilian settings: the Ebola outbreak and the COVID-19 pandemic. This paper examines the medical evacuation that occurred during the COVID-19 pandemic in Lombardy, Italy (Operation “MEDEVAC”), where overloaded hospitals required the transfer of patients to other regions and even internationally. Methods: MEDEVAC was implemented by the Regional Emergency and Urgency Agency (AREU). Data from MEDEVAC were analysed using the AREU register, detailing patient characteristics, transfer logistics, and outcomes. Results: From March to April 2020, 121 intensive care patients were transferred via MEDEVAC, primarily by air. 65 % of patients were moved to other Italian regions. The Federal Republic of Germany received 35 % of patients, all transported by air. Outcome and mortality rates among transferred patients were comparable to those within regional intensive care units. One life-threatening event was reported during transport. The return of patient to Lombardy showed a 100 % survival rate. Conclusion: This study emphasises the importance of standardised protocols, improved information exchange systems, and enhanced training for medical personnel involved in medical evacuation. MEDEVAC was found to be feasible and able to cope with demands that were excessive in relation to available resources. This study proposes the development of a shared protocol for air transport of patients and a model for international cooperation among emergency response agencies to optimise future medical evacuation activities in civil context

Italy’s Post-COVID-19 Stroke Network: Has It Returned to Pre-Pandemic Standards?

The COVID-19 pandemic strongly transformed the healthcare system in the Lombardy region (Italy), forcing a rapid reorganization of hospital structures. The emergency medical service (EMS) system and emergency departments (EDs) were among the most affected departments. Several studies have shown a change in the epidemiology of time-dependent pathologies, such as stroke, during the pandemic’s peak. However, there is little scientific evidence regarding the interpandemic phase. The regional register for ED accesses (EUOL) was analyzed, taking into consideration all accesses for stroke and stroke-like syndromes during the years 2019, 2020, and 2021. The analysis shows a significant difference in the average number of diagnoses per month [2092 vs. 1815 vs. 2015, respectively (p < 0.05)] and an increase in the percentage of transports carried out by EMS vehicles to EDs [17% vs. 25% vs. 22%, respectively (p < 0.05)]. The length of stay (LOS) increased for both discharged patients (9.0 vs. 10.1 vs. 11.2 h, respectively; p < 0.005) and hospitalized patients (7.5 vs. 9.7 vs. 10.6 h, respectively; p < 0.005). During the COVID-19 pandemic, the overall number of stroke diagnoses decreased, while the percentage of patients transported to EDs by EMS vehicles increased. Furthermore, an increased processing time in EDs was highlighted

Changing the stroke network during pandemic scenarios does not affect the management of patients with a positive Cincinnati prehospital stroke scale

Introduction Time plays a crucial role in the management of stroke, and changing the prehospital emergency network, altering the HUB and spoke relationship in pandemic scenarios, might have an impact on time to fibrinolysis or thrombectomy. The aim of this study was to evaluate the time-dependent stroke emergency network in Lombardy region (Italy) by comparing 2019 with 2020 and early 2021. Three parameters were investigated: (i) time of arrival of the first vehicle at the scene, (ii) overall duration of missions, and (iii) number of patients transported by emergency vehicles.Methods Data analysis process conducted using the SAS-AREU portal (SAS Institute, USA).Results The number of patients with a positive CPSS was similar among the different pandemic waves. Mission duration increased from a mean time (SD) of 52.9 (16.1) min in 2019 to 64.1 (19.7) in 2020 and 55.0 (16.8) in 2021. Time to first vehicle on scene increased to 15.7 (8.4) min in 2020 and 16.0 (7.0) in 2021 compared to 2019, 13.6 (7.2) (P < 0.05). The number of hospital with available stroke units decreased from 46 in 2019 to 10 during the first pandemic wave.Conclusions The pandemic forced changes in the clinical mission of many hospitals by reducing the number of stroke units. Despite this, the organization of the emergency system allowed to identify strategic hospitals and thus avoid excessive transport time. The result was an adequate time for fibrinolysis/thrombectomy, in agreement with the guidelines. Coordinated management in emergency situations makes it possible to maintain service quality standards, despite the unfavorable scenario

Efficacy of bergamot: From anti-inflammatory and anti-oxidative mechanisms to clinical applications as preventive agent for cardiovascular morbidity, skin diseases, and mood alterations

We summarize the effects of bergamot (extract, juice, essential oil, and polyphenolic fraction) on cardiovascular, bone, inflammatory, skin diseases, mood alteration, anxiety, pain, and stress. This review included a total of 31 studies (20 studies on humans with 1709 subjects and 11 in animals (rats and mice)). In humans, bergamot-derived extract (BE) exerts positive effects on hyperlipidemia with an oral dose from 150 mg to 1000 mg/day of flavonoids administered from 30 to 180 days, demonstrating an effect on body weight and in modulating total cholesterol, triglycerides, LDL, and HDL. Studies in animals confirm promising data on glucose control (500/1000 mg/day of BE with a treatment lasting 30 days) are available in rats. In animals models, bergamot essential oil (BEO, 10 mg/kg or 20 mg/kg daily for 20 weeks) increases bone volume, decreases psoriatic plaques, increases skin collagen content, and promotes hair growth. Bergamot juice (20 mg/kg) is promising in terms of pro-inflammatory cytokine reduction. In humans, aromatherapy (from 15 to 30 min) does not appear to be useful in order to reduce stress, anxiety, and nausea, compared to placebo. Compared to baseline, BE topical application and BEO aromatherapy reduce blood diastolic and systolic pressure and could have a significant effect on improving mental conditions

Application of Environmental Potential Risk Indicator for Pesticides (EPRIP) to evaluate the environmental risks of Alternate Wetting and Drying irrigation for rice in northern Italy

Environmental Potential Risk Indicator for Pesticides (EPRIP) (Reus et al., 2002) was used to estimate the environmental impact of pesticides used in rice production with traditional and water-saving irrigation methods in the main Italian rice district (Lomellina, PV). EPRIP is based upon the Exposure Toxicity Ration (ETR) of the Predicted Environmental Concentration (PEC) (Padovani et al., 2004). A modified version of MED-Rice tool was used in order to evaluate PECs of seven pesticides into groundwater, surface water and paddy sediment. ETR and PEC were estimated at a local scale (field and surroundings), with short-term toxicological parameters (NOEC) and, therefore, reflecting a worst-case scenario, assuming that organisms are subjected to maximum exposure. ETR were then converted into risk points (RPs) accordingly to the following table (Trevisan et al., 2009): Range of ETR RISK POINT &lt;0.01 1 0.01-0.1 2 0.1-1.0 3 1.0-10.0 4 &gt;10.0 5 An experimental platform was set up in the main Italian rice district (Lomellina, PV), during the agricultural seasons 2019 and 2020, to compare different irrigation management options: in particular, wet seeding and traditional flooding (WFL) and wet seeding and alternated wetting and drying (AWD) for the agricultural season 2019 were considered in this paper. Two widely used pesticides (Clomazone, MCPA) were measured in irrigation water (inflow and outflow) and groundwater. Estimated RPs following Trevisan et al. (2009) were compared to measured RPs, based on the analysed Clomazone and MCPA concentrations in water samples collected from the experimental fields. Finally, the overall EPRIP indicator was based on RPs to evaluate the probability of the predicted concentration of contaminants in the environment to overcome a supposed threshold. The results are calculated considering the probability of not exceeding the Risk Point 3 (RP3) by assuming a Poisson cumulative function