EBPH is Back for a Global Audience

We are proud to announce the re-starting of the Journal Epidemiology Biostatistics and Public Health (EBPH), made possible thanks to the Milano University Press (MUP), the new publisher of the journal

Quality Assessment of Healthcare Databases

The assessment of data quality and suitability plays an important role in improving the validity and generalisability of the results of studies based on secondary use of health databases. The availability of more and more updated and valid information on data quality and suitability provides data users and researchers an useful tool to optimize their activities. In this paper, we have summarized and synthesized the main aspects of Data Quality Assessment (DQA) applied in the field of secondary use of healthcare databases, with the aim of drawing attention to the critical aspects having to be considered and developed for improving the correct and effective use of secondary sources. Four developing features are identified: standardizing DQA methods, reporting DQA methods and results, synergy between data managers and data users, role of Institutions. Interdisciplinarity, multi-professionality and connection between government institutions, regulatory bodies, universities and the scientific community will provide the "toolbox" for i) developing standardized and shared DQA methods for health databases, ii) defining the best strategies for disseminating DQA information and results

The new European regulation on personal data protection: significant aspects for data processing for scientific research purposes

On 27 April 2016, after a troubled gestation,, Regulation 2016/6791 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data was finally published. The Regulation is to have a two-year transitional period, meaning it will actually enter into force in the first half of 2018

Legal aspects regarding the use and integration of electronic medical records for epidemiological purposes with focus on the Italian situation

The "Observational Studies" working group of the Italian Association of Medical Statistics and Clinical Epidemiology (SISMEC) has undertaken to study the impact of recent healthcare sector regulations on the legal and organisational aspects of managing all EMR databases with emphasis on Legislative Decree No. 196/2003 (the Italian Personal Data Protection Law). This paper examines six issues relating to theirs legal implications. The first section, “Confidentiality”, provides definitions and the regulatory context for the terms "confidentiality" and "personal data". In the second, “Nature of data held in electronic medical record archives”, we discuss the problem of sensitive data and procedures to make the identification code anonymous. In “Data ownership” we highlight the difference between the data controller and the database controller. The fourth section, “Conditions for processing”, discusses problems associated with using research data from one study in other investigations. In the fifth, “Patient consent”, we address the problems related to patient consent. Finally in “Penalties” we outline the main civil and criminal liability issues applied in case of non-compliance with the provisions of the Personal Data Protection Code. Where possible, we provide suggestions on how to comply with the legal requirements of managing medical record archives in order to make it easier for researchers to remain in compliance with the relevant provisions

Relationship between Burr-Hole position and pneumocephalus in patients operated for chronic subdural hematoma

Objective: Chronic subdural hematoma (CSDH) is one of the most frequent neurosurgical conditions in people aging between 70 and 80 years. The cranial burr-hole (CBH) with surgical cavity irrigation through the burr hole and closed drainage system is the treatment of choice but -post-operative outcome can be influenced by pneumocephalus. In this study, we aimed to explore the relationship between the anterior-posterior (AP) burr-hole position and the volume of post-operative pneumocephalus. Patients and Methods: We identified 153 consecutive patients who underwent BHC for CSDH at our institution. Baseline and post-operative data were retrospectively collected from medical records. The linear regression model was used to estimate the association between the volume of post-operative subdural air collection and burr-hole position along with other baseline patients and hematoma variables. Results: The AP position of the burr-hole was independently associated with the volume of post-operative pneumocephalus: lower volume of subdural air was observed in patients with more anterior cranial burr-hole. Conclusions: In patients operated for CSDH, the cranial burr-hole should be performed anteriorly to grant a lesser amount of subdural post-operative air collection

Socio-economic disparities in the appropriateness of diabetes care in an Italian region: findings of AEQUITAS study

Background: To evaluate socio-economic disparities in diabetes prevalence and care in Marches (a region of central Italy) in 2003-2010 through a cross-sectional study. Methods: The databases of 52 general practitioners were mined for people with diabetes (age ≥20 years). These data were linked with records from other regional administrative databases. Healthcare disparities, specifically potentially preventable hospitalizations (PPH) related to diabetes and its complications, were analysed using participants’ gender, age, and education data and the Italian Deprivation Index. Crude, age-specific and gender-specific diabetes prevalence was estimated for each year of observation. A time-trend analysis was performed. Admissions that might have been prevented according to Agency for Healthcare Research and Quality criteria were used to calculate the PPH rate for each level of social condition indicators. Rate ratios and 95% confidence intervals were estimated with a multiple Poisson regression model. Results: The search found 6,494 participants with diabetes mellitus aged ≥20 years. Disease prevalence ranged from 5.4% (2003) to 7.8% (2010), with a significant 0.31% positive trend. Those aged ≤44 years were at significantly higher risk of PPH than older people. A significant PPH excess was found among people living in socio-economically disadvantaged areas. Education and gender did not significantly affect PPH. Conclusion. People with diabetes seem to use primary care services appropriately irrespective of socio-economic status. Outpatient services are not equally distributed on the regional territory; this may increase disease severity and/or the risk of diabetes complications and affect appropriateness of diabetes care

The city of Yakutsk: a case of study for human brown adipose tissue in extremely cold conditions

The discovery of the presence of functional brown adipose tissue (BAT) also in healthy humans [1-3] has focused the attention of the scientific community on the possibility to expand body BAT content as a therapeutic strategy for the treatment and prevention of obesity and the associated metabolic disorders. Indeed, white-to- brown adipocyte transdifferentiation, leading to “browning” of the adipose organ, has been shown to reduce body weight and improve metabolic parameters in obese and insulin-resistant animal models. BAT from subject exposed daily to extremely cold outdoor temperatures has never been studied through morphological techniques. In this context, an exciting case of study are the citizens of Yakutsk, an East- ern Siberian population exposed to the annual average temperature of -10 °C, that peaks up to -50°C during winter. In autoptic fat biopsies from a 54-year-old patient living in Yakutsk BAT is present in the perirenal and para-aortic fat specimens. Importantly, the mean adipocyte area of the subcutaneous fat from this patient is significantly lower than the mean area of subcutaneous adipocytes obtained from age- and sex-matched Italian patients. Statistical analysis of data obtained from the Territorial Organ of the Federal State Statistics Service of the Republic of Sakha (Yakutia), the Yakut Republican Medical Information and Analytical Center of the Ministry of Health of Yakutia showed a correlation between home heating and type-2 diabetes incidence during the years from 1994 to 2013, a period in which the indoor temperature increased significantly. The nutritional values of food consumed during these years also changed in parallel with the worsening of inhabitants metabolic health conditions. Taken together these data suggest a possible link between the metabolic condi- tions of inhabitants of Yakutia and the living temperature experienced

Expression of Trop2 in bladder cancer is modulated by miR125b: in vivo and in vitro analyses

Human trophoblastic cell surface antigen 2 (Trop-2) is a 40-kDa transmembrane glycoprotein, first identified as a cell surface marker for human trophoblast cells (1). Elevated expression of Trop-2 has been shown in several types of epithelial cancers and correlated with tumour aggressive and poor prognosis (2-3). The first aim of this study was to evaluate the variation of the Trop-2 expression in normal urothelium and urothelial bladder cancer. The immunohistochemical results showed an increase of Trop-2 levels in bladder cancer tissues with the increase of the severity of the pathology. Recent data identified Trop-2 as a target for miR-125b suggesting a pos sible role of miR-125b in the modulation of Trop-2 protein expression (4). The second aim was to verify if Trop-2 could be a target for miR-125b in bladder cells and to evaluate the possible role of miR-125b in the modulation of Trop-2 protein expression in normal bladder as well as in urothelial bladder cancer. In vitro we showed a contribution of miR-125b in deregulation of Trop-2 protein expression in a bladder cell line and we found that the expression of miR-125b was inversely correlated with the expression of Trop-2 protein on a cohort of bladder cancer tissues. We concluded to investigate in a larger population the use of Trop-2 and/or miR-125b as potential diagnostic markers in urothelial bladder cancer

The Silent Epidemic of Diabetic Ketoacidosis at Diagnosis of Type 1 Diabetes in Children and Adolescents in Italy During the COVID-19 Pandemic in 2020

To compare the frequency of diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes in Italy during the COVID-19 pandemic in 2020 with the frequency of DKA during 2017-2019

Temporal trends in diabetic ketoacidosis at diagnosis of paediatric type 1 diabetes between 2006 and 2016: results from 13 countries in three continents

Aims/hypothesis The aim of this work was to evaluate geographical variability and trends in the prevalence of diabetic ketoacidosis (DKA), between 2006 and 2016, at the diagnosis of childhood-onset type 1 diabetes in 13 countries over three continents. Methods An international retrospective study on DKA at diagnosis of diabetes was conducted. Data on age, sex, date of diabetes diagnosis, ethnic minority status and presence of DKA at diabetes onset were obtained from Australia, Austria, Czechia, Denmark, Germany, Italy, Luxembourg, New Zealand, Norway, Slovenia, Sweden, USA and the UK (Wales). Mean prevalence was estimated for the entire period, both overall and by country, adjusted for sex and age group. Temporal trends in annual prevalence of DKA were estimated using logistic regression analysis for each country, before and after adjustment for sex, age group and ethnic minority status. Results During the study period, new-onset type 1 diabetes was diagnosed in 59,000 children (median age [interquartile range], 9.0 years [5.5–11.7]; male sex, 52.9%). The overall adjusted DKA prevalence was 29.9%, with the lowest prevalence in Sweden and Denmark and the highest in Luxembourg and Italy. The adjusted DKA prevalence significantly increased over time in Australia, Germany and the USA while it decreased in Italy. Preschool children, adolescents and children from ethnic minority groups were at highest risk of DKA at diabetes diagnosis in most countries. A significantly higher risk was also found for females in Denmark, Germany and Slovenia. Conclusions/interpretation DKA prevalence at type 1 diabetes diagnosis varied considerably across countries, albeit it was generally high and showed a slight increase between 2006 and 2016. Increased awareness of symptoms to prevent delay in diagnosis is warranted, especially in preschool children, adolescents and children from ethnic minority groups