bluuebunny/crossref_metadata_2025 huggingface dataset:
Improving quality of care for cancer pain: an Italian five-year project
Authors: Greco Maria Teresa , Roberto Anna , Corli Oscar , Apolone Giovanni
Published: April 2023

Background: cancer pain is still undertreated as for inappropriate use of opioids, as for reason related to other factors. To increase knowledge of cancer pain, the “Mario Negri” Institute promote a series of initiatives to improve the quality of care and patients’ outcomes.

Methods: a series of activities were launched including literature review, clinical studies and training schemes.

Results: literature reviews shown a prevalence of undertreatment ranged from 8% to 82% and a raw prevalence of BTcP (Breakthrough Cancer Pain) of 51%. In the outcome research study mean worst pain at baseline was 6.8, and 38.3% received a strong opioids. Prevalence of BTcP was 40.3%, and 33.9% of the patients were not receiving rescue therapy at the study inclusion. About analgesic effectiveness of oral and transdermal opioids (TD), treatments with TD were associated with a lower probability to switch (OR=0.83) and to drop out from the study (OR=0.68).

Conclusions: the initiative, still ongoing, has allowed a) the creation of a unit for the study and evaluation of cancer pain, b) the production of clinical evidence about the epidemiology, quality and effects of cancer pain management in Italy, c) the design and promotion of a Randomized Controlled Trial to evaluate the effectiveness of four major opioids.
Factors associated with self-medication among expatriate high school students: a cross-sectional survey in United Arab Emirates
Authors: Shehnaz Syed Ilyas , Sreedharan Jayadevan , Khan Nelofer , Issa Khaled Jamal , Arifulla Mohamed
Published: April 2023

The study aimed to assess factors associated with self-medication (SM) among expatriate high school students of United Arab Emirates using a validated questionnaire. Most common reasons for self-medication in 324 participating students were: presence of mild illness and previous experiences. High risk practices like altering the dose, discontinuation of medication and self-medication without adult guidance were observed. The likelihood of SM was 4.9 times (95%C.I.: 2.0-12.2) in students not utilizing private healthcare services than those who were utilizing these services. Increased efforts are needed to prevent the risks of self-medication in adolescents through healthcare education for both parents and adolescents.
Factors affecting overweight and obesity among urban adults: a cross-sectional study
Authors: Sen Jaydip , Mondal Nitish , Dutta Sweeta
Published: April 2023

Background: the prevalence of overweight and obesity are increasing at an alarming rate in the developing countries. The present cross-sectional study assesses the prevalence of overweight and obesity along with their associated variables among urban adult individuals belonging to the Bengalee Hindu Caste Population (BHCP).

Methods: the study has been carried out among 600 adult individuals belonging to the BHCP in the age group of 20-60 years and residing in the district of Jalpaiguri, West Bengal, India. Height and weight, along with a number of socio-economic, demographic and lifestyle variables were recorded. International cut off points of the body mass index were used to assess overweight (BMI ≥ 23.00 kg/m2) and obesity (BMI ≥ 25.00 kg/m2). The statistical tests (ANOVA, chi-square and multinomial logistic regression) were done using SPSS (version 15.00).

Results: the prevalence of overweight and obesity were observed to be high among both the male (23.67% and 9.67%) and the female (20.33% and 29.33%) individuals. The sex difference was observed to be significant in case of obesity (p<0.01) and combined overweight-obesity (p<0.01). The multinomial logistic regression indicated that age and monthly income had significant effects on overweight (p<0.05). Sex, age, monthly income, marital status, education and alcohol intake were observed to have significant effects on obesity (p<0.05). Sex, age, monthly income and monthly income and marital status also showed significant effects with combined overweight-obesity (BMI ≥ 23.00 kg/m2) (p<0.05).

Conclusions: the prevalence of overweight and obesity exhibited an increasing trend among urban adults of the BHCP. Sex, age, marital status and monthly income were observed to have more influence on the prevalence of overweight and obesity among them. There appears to be an urgent need for the development of health strategies and intervention programmes for combating the consequences of overweight and obesity.
Surveillance of healthcare acquired infections in hospital and community: a retrospective study in Local Healthcare Organization of Rovigo
Authors: Ronzani Francesca , Scarin Marino , Brusaferro Marco , Intenti Antonia , Marchetto Raffaela , Boldrin Michela , Pierotti Silvia , Marcolongo Adriano
Published: April 2023

Background: antimicrobial resistance is recognized as one of the greatest threats to human health worldwide. Infections caused by multidrug-resistant bacteria are associated with higher incidences of mortality, morbidity, prolonged hospital stay and increase of costs. Surveillance of alert organism/conditions and bacterial resistance to antimicrobials is a systematic and dynamic system of data collection that analyses and monitors trends of bacterial resistance. This study was conducted to detect antimicrobial susceptibility patterns in order to inform treatment choices and generate hospital-wide baseline data.

Methods: the Local Healtcare Oganization of Rovigo has started a program of surveillance on antimicrobial resistance in hospital and community. In this work some results of the surveillance of microorganism isolated and related antimicrobial resistance are reported, collected in the period 2009-2010 in Rovigo and Trecenta Hospitals, Territorial Nursing Homes (TNH) and community from patients’ blood, urine and respiratory samples.

Results: data show a significant difference in the level of antibiotic resistance between the two Hospitals. High rates of extended-spectrum β-lactamase (ESBL)-producing organisms are detected and carbapenems are the only reliable agents for the treatment of many infections in the Hospital of Trecenta and TNH.

Conclusions: because ESBL producing bacteria are emerging pathogens in the community, the rational use of available antibiotics or the appropriate antimicrobial prescribing are imperative. Local surveillance is a powerful tool to detect and monitor hospital and community infections and provides information useful as a guide to medical practice, including therapeutics and disease-control activities.
Challenges in Dental Statistics: Data and Modelling
Authors: Matranga Domenica , Castiglia Paolo , Solinas Giuliana
Published: April 2023

The aim of this work is to present the reflections and proposals derived from the first Workshop of the SISMEC STATDENT working group on statistical methods and applications in dentistry, held in Ancona (Italy) on 28th September 2011. STATDENT began as a forum of comparison and discussion for statisticians working in the field of dental research in order to suggest new and improve existing biostatistical and clinical epidemiological methods. During the meeting, we dealt with very important topics of statistical methodology for the analysis of dental data, covering the analysis of hierarchically structured and over-dispersed data, the issue of calibration and reproducibility, as well as some problems related to survey methodology, such as the design and construction of unbiased statistical indicators and of well conducted clinical trials. This paper gathers some of the methodological topics discussed during the meeting, concerning multilevel and zero-inflated models for the analysis of caries data and methods for the training and calibration of raters in dental epidemiology.
Wilks’ dissimilarity for gene clustering: computational issues
Authors: Di Lascio F. Marta L. , Roverato Alberto
Published: April 2023

Clustering methods are widely used in the analysis of gene expression data for their ability to uncover coordinated expression profiles. One important goal of clustering is to discover co–regulated genes because it has been postulated that co–regulation implies a similar function. In the context of agglomerative hierarchical clustering, we introduced a dissimilarity measure based on the Wilks’ Λ statistic that they called the Wilks’ dissimilarity and showed its usefulness in the identification of transcription modules. In this paper, we discuss the ability of the Wilks’ dissimilarity to identify clusters of co-expressed genes by providing an example where the most commonly used dissimilarity measures fail. Furthermore, we carry out a set of simulations aimed to investigate the use of a sparse canonical correlation technique in the estimation of the Wilks’ dissimilarity and provide guidelines for its use.
The Gini Test for Survival Data in Presence of Small and Unbalanced Groups
Authors: Gigliarano Chiara , Bonetti Marco
Published: April 2023

The aim of this note is to study the performance of the Gini concentration test for survival data in presence of unbalanced and small samples. We compared the performance of the asymptotic test with an alternative permutation distribution test, illustrating by simulation that if groups are very small the latter test should be used. Also, we show how the definition of the length of time considered in the construction of the test statistic can be chosen to improve the performance of the test.
Harmful alcohol habits did not explain the social gradient of sickness absence in Swedish women and men
Authors: Mardby Ann-Charlotte M , Holmgren Kristina EM , Hensing Gunnel KE
Published: April 2023

Background: the aim of this study was to examine the prevalence and socioeconomic distribution of harmful alcohol habits in sick-listed women and men, and whether the social gradient in sickness absence could be explained by the socioeconomic distribution of harmful alcohol habits.

Methods: this cross-sectional questionnaire study included newly sick-listed individuals (n=2 798, 19-64 years, 66% women) from Sweden. The outcome variable, self-reported harmful alcohol habits, was measured with the Alcohol Use Disorder Identification Test. Registered socioeconomic variables (education, income, occupational class) were explanatory variables with age as confounder and selfreported health, symptoms, mental wellbeing, and self-efficacy as mediators. Chi2-tests and logistic regression models were applied.

Results: 9% of sick-listed women and 22% of men had harmful alcohol habits. Women with a low annual income (≤149 000 SEK) had higher odds ratios (OR=2.47; 95% CI=1.43-4.27) of harmful alcohol habits than those with ≥300 000 SEK/year. The significance of low income remained when mediators were introduced into the logistic regression model (OR=2.03, 95% CI=1.13-3.65). In the model including age, income was no longer significant. Men with low income were more likely to have harmful alcohol habits than men with high income (OR=2.59; 95% CI=1.45-4.62). When mediators were included low income remained significant (OR=2.88; 95% CI=1.56-5.31). Income was no longer significant when age was introduced. Education and occupational status were not significant.

Conclusions: harmful alcohol habits were common among sick-listed women and men. The socioeconomic differences in harmful alcohol habits did not explain the social gradient in sickness absence.
The governance of prevention in Italy
Authors: Boccia Antonio , De Vito Corrado , Marzuillo Carolina , Ricciardi Walter , Villari Paolo
Published: April 2023

After the political elections of February 2013, one of the tasks of the Ministry of Health of the new Government will be the development of the new edition – the third – of the National Prevention Plan (NPP), after the NPP 2005-2007 and the NPP 2010-2012. A brainstorming process about the recent experience of the NPP 2010-2012 is important not only to elaborate technical indications for new plan, but also to make some reflections on...
Robert J. Levine: a distinguished problem solver
Authors: Bucci Roberto
Published: April 2023

Robert Levine: a man capable of intelligent and constructive criticism, who could accept with humility the criticisms of others. A man who left a deep mark in the history of research, both inside and outside the United States. Above all, a great problem solver.

A brilliant doctor and refined bioethicist, he was able to deal with the disasters of research on human subjects and to remedy to them. He fought against the application in clinical practice of ethical principles valid only for research, but also against the universalisation of the rules of informed consent, which are applicable only to Western cultures. A researcher who deserves to be known by all, especially by young people.
Countries, national alcohol limits and risk behaviours: results from the TEN D by Night project
Authors: Siliquini Roberta , Bert Fabrizio , Manzoli Lamberto , TEN-D Group
Published: April 2023

Background: this paper re-analysed data from the international cross-sectional TEN-D survey to investigate the association between country or national alcohol limits and risk behaviours.

Methods: data were collected on subjects aged 16-35 years owning a driving license and attending recreational sites during weekend nights in Belgium/Netherlands, Bulgaria, Italy, Poland and Spain. Each participant was administered a: questionnaire, driving simulation, breath alcohol concentration (BAC) and illegal drugs detection tests. Random-effect regression was used to identify independent predictors of 3 outcomes: high BAC (≥0.5 g/L); negative driving behaviours; self-reported illegal drug consumption.

Results: the survey included 4 534 subjects (mean age 23.1±4.2 years; males 68.3%). Alcohol misuse was highest in Poland (65.1%) and Spain (83.7%), which also showed the highest frequency of negative driving behaviours (39.0%) and illegal drugs consumption (55.6%). Multivariate analysis confirmed country as a predictor of all outcomes, whereas no association was found with national alcohol limits.

Conclusions: the absence of association between national alcohol limits and alcohol misuse or negative driving behaviours suggests that cultural factors might be predominant in explaining the differences across countries. Our findings are preliminary and further research is needed.
A systematic review of the cost-effectiveness of lifestyle modification as primary prevention intervention for type 2 diabetes mellitus
Authors: Radl Katrin , Ianuale Carolina , Boccia Stefania
Published: April 2023

Background: diabetes is one of the leading causes of death, and has a huge economic impact on the burden of society. Lifestyle interventions such as diet, physical activity and weight reducing are proven to be effective in the prevention of diabetes. To encourage policy actions, data on the costeffectiveness of such strategies of prevention programmes are needed.

Methods: a systematic review of the literature on the cost-effectiveness of prevention strategies focusing on lifestyle interventions for diabetes type 2 patients. A weighted version of Drummond checklist was used to further assess the quality of the included studies.

Results: six studies met the inclusion criteria and were therefore considered in this paper. Intensive lifestyle intervention to prevent diabetes type 2 is cost-effective in comparison to other interventions. All studies were judged of medium-to-high quality.

Conclusions: policy makers should consider the adoption of a prevention strategy focusing on intensive lifestyle changes because they are proven to be either cost-saving or cost-effective.
Cost effectiveness of aortic valve therapies: a systematic review of the literature
Authors: Battaglia Suzanne , Mazzucco Walter , Ricciardi Walter
Published: April 2023

Background: we performed a systematic review on the cost effectiveness of transcatheter aortic valve implantation (TAVI) to standard aortic valve replacement and medical management in high-risk elderly patients with severe aortic stenosis.

Methods: in accordance with Preferred Reporting Items for Systematic reviews and Meta-Analyses, a systematic review on current literature for cost-effectiveness of TAVI, standard aortic valve replacement, and medical management for elderly patients with high-risk severe aortic stenosis was performed. Incremental cost effectiveness ratio is used to measure effectiveness through life years gained or quality adjusted life years. Drummond checklist was used to further assess the quality of the included studies.

Results: the systematic literature search identified 4 primary publications (derived from 52 citations) that fulfilled the inclusion criteria. Tremendous discrepancy in incremental cost effectiveness ratio is demonstrated with operable patients similar to Cohort A of the PARTNER trial (€ 749 416 and € 39 577). Inoperable patients similar to Cohort B of the PARTNER trial suggest notable differences in favour for transcatheter aortic valve implantation with an increase in quality adjusted life years (0.06 versus 1.6, respectively). With lifetime horizon to transcatheter aortic valve implantation there is a more comparable incremental cost effectiveness ratio in the literature (€ 38 260 and € 37 432). Lowest incremental cost effectiveness ratio witnessed in the technical inoperable group at € 26 482. Lifetime horizon of 10 years with transcatheter aortic valve implantation differ (€ 39 388 versus € 19 947). Overall, a review of the literature suggests TAVI usage in patients for severe aortic stenosis whom are not eligible for surgery. All the studies were overall judged of medium-high quality.

Conclusions: transcatheter aortic valve replacement is more cost effective with a lifetime horizon for the treatment of patients with high-risk aortic stenosis compared with medical management considering those ineligible for standard aortic valve replacement. Further cost effectiveness research is needed in the stratifications of patient risk and patient co-morbidities for those candidates eligible for surgery.
Anti-asthmatics prescriptions in the paediatric population in the Lazio Region of Italy: association with socio-demographic children’s and physician’s characteristics
Authors: Chini Francesco , Orzella Letizia , Pezzotti Patrizio , Nardelli Marco , Guasticchi Gabriella
Published: April 2023

Background Asthma is the most common chronic disease in childhood; inItaly its prevalence is estimated to be 9% in children (0-14 years old).

Objective Estimate the use of anti-asthmatics prescriptions in the paediatric population and to evaluate its association with children’s and physician’s characteristics.

Methods The study was conducted in 728,830 children 1-14 years old residing in the Lazio region,Central Italy. Individual data on AA (ATC R03) prescriptions during 2009 were used. Prevalence was calculated according to children’s gender, age and area of residence.

The association, in terms of rate ratio (RR), between AA prescription with children’s and physicians’ characteristics was estimated by multi level Poisson models.

Results Overall, 404,239 AA prescriptions were given to 178,850 (25%) children with the highest frequency in the 1-2 age group (39%). Boys were more likely to receive a prescription than girls. Beclomethasone was the most prescribed active ingredient (34%), followed by salbutamol (24%); 44% of children ³6 years old had only 1 box prescription in the year, 48.9% of these subjects were treated with inhaled corticosteroids alone.

Children’s gender, age and area of residence were the major determinants in drug prescription while, as far as physicians’ level,  gender and number of patients in charge were associated to a greater probability of getting an AA prescription.

Conclusion Prescription data provide useful information to measure prevalence use and consumption of AA drugs. Variability between age groups as well as differences in doctors’ characteristics suggests that specific strategies to optimise resource use of AA are needed.
The CONSTANCES cohort, an epidemiological research infrastructure. Methods and results of the pilot phase
Authors: Zins Marie , Berkman Lisa F. , Goldberg Marcel
Published: April 2023

Background: prospective cohorts represent an essential design for epidemiological studies and allow for the study of the combined effects of lifestyle, environment, genetic predisposition, and other risk factors on a large variety of disease endpoints. The CONSTANCES cohort is intended to provide public health information and to serve as an epidemiological research infrastructure accessible to the epidemiologic research community. Although designed as a “general-purpose” cohort with very broad coverage, it will particularly focus on occupational and social determinants of health, and on chronic diseases and aging.

Methods: the CON STANC ES cohort is designed as a randomly selected representative sample of French adults aged 18-69 years at inception; 200 000 subjects will be included over a five-year period. At inclusion, the selected subjects are invited to fill a questionnaire and to attend a Health Screening Center (HSC) for a comprehensive health examination: weight, height, blood pressure, electrocardiogram, vision, auditory, spirometry, and biological parameters; for those aged 45 years and older, a specific work-up of functional, physical, and cognitive capacities is performed. A biobank will be set up. The follow-up includes a yearly self-administered questionnaire, and a periodic visit to an HSC. Social and work-related events and health data are collected from the French national retirement, health and death databases. The data include social and demographic characteristics, socioeconomic status, life events, behaviors, and occupational factors. The health data cover a wide spectrum: self-reported health scales, reported prevalent and incident diseases, long-term chronic diseases and hospitalizations, sick-leaves, handicaps, limitations, disabilities and injuries, healthcare utilization and services provided, and causes of death. To take into account non-participation at inclusion and attrition throughout the longitudinal follow-up, a cohort of non-participants was set up and will be followed through the same national databases as participants.

Results: a field-pilot was performed in 2010 in seven HSCs, which included about 3 500 subjects; it showed a satisfactory structure of the sample and a good validity of the collected data.

Conclusions: the constitution of the full eligible sample begun in 2012 and the cohort will be completed by the end of 2017. A public call for ancillary research projects will be launched in 2014.
Perception of pregnant women towards midwives: attitude and practice during child delivery in health institutions in Ogbomoso, South-West, Nigeria
Authors: Oluyemisi Adeyemo F. , Oyadiran Gifty O. , Ijedimma Margaret O. , Akinlabi Bosede O. , Adewale Akinoso J.
Published: April 2023

Background: This study aims to ascertain pregnant women’s perceptions of the attitudes and practice of midwives during labour in a mission teaching hospital and a state hospital in Ogbomoso, Southwest Nigeria, and to determine whether or not a relationship exists between patients’perceptions of midwives practice during delivery and the occurrence of neonatal deaths.

Methods: The survey was conducted by administering the questionnaire adapted from Caring Behaviour Inventory (CBI) to a random sample of five hundred and seventy nine respondent mothers who gave birth in either a Mission teaching hospital or a state hospital in Ogbomoso, Southwest Nigeria. This standardised questionnaire collects demographic data and patient perceptions of nursing attitudes and practice, ranking patients’ responses to a series of statements about the midwives on a four point Likert scale. Data was analysed using Pearson product moment correlation analyses and multiple regression analyses.

Results: Our study revealed that there was a positive response on the attitude and practise of midwives during delivery by the respondents. Secondly, there was a positive impression on the influence of the attitude and practice of midwives during delivery by the respondents.

Conclusions: There was no evidence of a relationship between patients’ perceptions of midwives practice during delivery and the occurrence of neonatal deaths.
Propensity score methodology for confounding control in health care utilization databases
Authors: Patorno Elisabetta , Grotta Alessandra , Bellocco Rino , Schneeweiss Sebastian
Published: April 2023

Propensity score (PS) methodology is a common approach to control for confounding in nonexperimental studies of treatment effects using health care utilization databases. This methodology offers researchers many advantages compared with conventional multivariate models: it directly focuses on the determinants of treatment choice, facilitating the understanding of the clinical decision-making process by the researcher; it allows for graphical comparisons of the distribution of propensity scores and truncation of subjects without overlapping PS indicating a lack of equipoise; it allows transparent assessment of the confounder balance achieved by the PS at baseline; and it offers a straightforward approach to reduce the dimensionality of sometimes large arrays of potential confounders in utilization databases, directly addressing the “curse of dimensionality” in the context of rare events. This article provides an overview of the use of propensity score methodology for pharmacoepidemiologic research with large health care utilization databases, covering recent discussions on covariate selection, the role of automated techniques for addressing unmeasurable confounding via proxies, strategies to maximize clinical equipoise at baseline, and the potential of machine-learning algorithms for optimized propensity score estimation. The appendix discusses the available software packages for PS methodology. Propensity scores are a frequently used and versatile tool for transparent and comprehensive adjustment of confounding in pharmacoepidemiology with large health care databases.
Priority actions of the different Regional Prevention Plans: common features and innovations
Authors: Russo Francesca , Michieletto Federica , Pettenò Annarosa , Postiglione Chiara , Napoletano Giuseppina
Published: April 2023

The National Prevention Plan (NPP) 2010-2012, approved by the Agreement between the Government, the Regions and Autonomous Provinces of Trento and Bolzano on 29 April 2010, called for Regions to adopt, by 31/12/2010, the Regional Prevention Plan (RPP) for implementing the interventions provided by the NPP 2010-2012.

This article has considered and compared the different RPP’s. In an attempt to provide an outlook on the future medical prevention plans over the next few years in Italy, a comparison has been made between the RPP from 19 Regions and the Autonomous Province of Trento. This work has been focused on the actions identified in regional plans as a priority concerning the major common and innovative elements.

The analysis of each RPP revealed a common plan to chronic degenerative diseases, because of the aging of the population in every Region of Italy. Other important common targets are: surveillance systems, vaccination programs and screening programs. Toscana and Liguria, more than other Regions, are engaged in the creation of networks involving various social actors. In some Regions there are projects aimed at eliminating social, economic or gender inequities, such as the project “women’s health” in the Region of Puglia. Toscana and Emilia-Romagna Plans pay attention to environment and pollution issues.

Despite social, environmental and economic differences, the various Regions have common principles, concerning: life style, surveillance, vaccination and the screening for cancer.
A study on feeding practice of under 6 months infants attending the Nutrition Clinic of a tertiary care hospital of West Bengal, India
Authors: Shrivastava Prabha , Saha Indranil , Nandy Saswati
Published: April 2023

Background: while breast feeding is a natural act, it is also a learned behavior. The right technique of feeding in the right position is the key to success of breastfeeding.

Methods: to assess the feeding practice including positioning, attachment and suckling of under 6 months’ infants, a cross-sectional study was undertaken at R. G. Kar Medical College and Hospital, India, among 99 mothers in 2010.

Results: 59.8% mothers completed feeding from one breast before going to the next breast. 77.3% mothers alternated their breasts during subsequent feeds. 41.2% babies were well attached, 47.4% babies were correctly positioned.

Conclusions: there is a need to teach the mothers  the techniques of correct positioning and attachment, especially, in the post natal period before discharge from the hospital after delivery.
Reshaping the agenda of the European Commission for the health systems and policy research in Europe within Horizon 2020
Authors: Walshe Kieran , McKee Martin , Groenewegen Peter , Hansen Johan , Figueras Josep , Boccia Stefania , Ricciardi Walter
Published: April 2023

In 2012 the European Regional Office of WHO published a new health policy strategy, Health 2020, and an accompanying European Action Plan [1, 2], with both documents since being endorsed by the 53 member states. Following consultation with member states, a series of overarching targets have been established in the three areas of Health 2020: i) reducing the burden of disease and risk factors;  ii) enhancing health and well- being; and iii) improving governance and systems for health. The WHO is now working with member state governments to develop ‘Regional’ Health 2020 targets [3, 4].

If Health 2020 is to achieve these goals, the actions that flow from it must be based on the best...
Legal aspects regarding the use and integration of electronic medical records for epidemiological purposes with focus on the Italian situation
Authors: Stendardo Antonietta , Preite Francesca , Gesuita Rosaria , Villani Simona , Zambon Antonella , SISMEC "Observational Studies" working group
Published: April 2023

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.
Clinical use, safety and effectiveness of novel high cost anticancer therapies after marketing approval: a record linkage study
Authors: Negri Eva , Rossi Marta , Bonifazi Martina , Franchi Matteo , Carioli Greta , Zocchetti Carlo , Corrao Giovanni , La Vecchia Carlo
Published: April 2023

Background: major clinical outcomes of anticancer drugs may differ between clinical trials and clinical practice. Administrative databases provide long-term information on safety and effectiveness of these drugs in large unselected populations and in selected subgroups of patients. In addition, these data provide complementary information on topics where evidence from randomized clinical trials is unavailable.

Methods: this project will investigate 17 new targeted high cost drugs in Lombardy oncology practice between 2006 and 2010 using data from electronic healthcare databases. Specific objectives are: 1) to estimate the incidence of serious adverse events in clinical practice and their predictors; 2) to estimate survival and progression free survival and their predictors; 3) to compare major clinical outcomes according to different regimen of therapy. We will build a database by record linkage of several regional health service sources: the File F registry (in which the administration of the 17 drugs is recorded), the Regional hospital discharge forms (SDO ) database, the drug prescription database, the outpatients' services database, and the Registry Office database. Subjects resident in Lombardy who received at least one prescription of these drugs from 2006 to 2010 will be considered. Complications warranting hospitalization will be derived from the patients' SDO s after the first drug administration. Vital status will be obtained from the Registry Office database.

Results: we will provide estimates of the incidence of serious adverse events of novel anticancer therapies, and of overall and disease free survival in clinical practice, overall and in selected subgroups.

Conclusions: these data will contribute to a better effectiveness evaluation, particularly in patients under-represented in clinical trials.
Seroprevalence of and risk factors for Leishmania seropositivity in a sample population of Western Sicily (Italy)
Authors: Amodio Emanuele , Calamusa Giuseppe , Sidoti Enza , Migliazzo Antonella , Vitale Fabrizio , Costantino Claudio , Vitale Francesco
Published: April 2023

Background: Leishmania is a vector-borne parasite responsible for significant morbidity and mortality worldwide. The aim of this study was to assess the prevalence of and risk factors for Leishmania infantum seropositivity in a sample of Sicilian population.Methods: A total of 260 subjects were interviewed using a standardized questionnaire and requested for an venous blood sample.Results: Overall, 36 subjects (13.8%) were seropositive against L. infantum with a statistically significant higher prevalence of positivity in older subjects (p=0.04). After adjustment for age, a higher risk for Leishmania seropositivity was found in subjects who had pets living outdoors and untreated with anti-pests, and in those who were current smokers (adj-OR = 2.95 and adj-OR = 3.11, respectively; p < 0.05).Conclusions: Our data confirm that Leishmania infections among Sicilian citizens can be considered relatively frequent, suggesting that a percentage of Leishmania seropositivity can be probably attributed to exposure to both old and new risk factors.
Sensitivity analysis for direct and indirect effects in the presence of exposure-induced mediator-outcome confounders
Authors: VanderWeele Tyler J , Chiba Yasutaka
Published: April 2023

Questions of mediation are often of interest in reasoning about mechanisms, and methods have been developed to address these questions. However, these methods make strong assumptions about the absence of confounding. Even if exposure is randomized, there may be mediator-outcome confounding variables. Inference about direct and indirect effects is particularly challenging if these mediator-outcome confounders are affected by the exposure because in this case these effects are not identified irrespective of whether data is available on these exposure-induced mediator-outcome confounders. In this paper, we provide a sensitivity analysis technique for natural direct and indirect effects that is applicable even if there are mediator-outcome confounders affected by the exposure. We give techniques for both the difference and risk ratio scales and compare the technique to other possible approaches
Charles Everett Koop: the “Family doctor of America”
Authors: Bucci Roberto , Colamesta Vittoria , La Torre Giuseppe
Published: April 2023

Charles Everett Koop was a great Surgeon General, probably the most influential in the history of the United States of America. He never missed courage in his life and often he had used it to tackle professional and personal tough problems.

In his public activity, he faced controversial health problems of American people as smoking, abortion and the first occurrence of the epidemic Acquired Immune Deficiency Syndrome (AIDS). Koop was a rigorous man. The lodestar that guided Koop in his work, as a public servant was to do the best for health of Americans. In his prestigious and difficult role, he faced the pressing problems of health of millions of people trying to avoid political influence. During his mandate of eight years, Koop increased the influence and authority of his role. His appearance and behaviour were unmistakable: Lincolnesque beard and uniform, conduct hard and pure, exclusively oriented to the health of citizens, over the personal conveniences, political pressure and lobbying. An exemplary man, who for his passion for medicine and his sincere interest in promoting public health, was affectionately considered the "Family Doctor of America".
The relationship between sleep time and self-rated health: an analysis based on Italian survey data
Authors: Citoni Guido
Published: April 2023

Background: a growing and broadly discussed literature has shown that the relationship between sleep duration and health is not linear. Not only are insomnia and insufficient sleep harmful to one’s health, but excessive sleep too is also not beneficial. This study tests the association between selfrated state of health and the duration and pattern of sleep: we discuss the losses and costs in terms of quality of life deriving from excessive sleep time.

Methods: we use an ordered probit specification, applied to the Italian Survey on the Use of Time (sample of Italians aged fifteen and over who keep a diary for a working day).

Results: we show that greater sleep duration is negatively correlated both with self-reported state of health and with self-reported health satisfaction, while respondents’ subjective perceptions of too much and too little sleep are associated with health conditions in the usual u-shaped way.

Conclusions: the negative impact of long sleep on self-reported health is confirmed. However, the effect of short sleep on health conditions is positive, while a measure of decreasing sleep quality - comprising number of interruptions of sleep, insomnia and napping - is correlated to some extent with decreasing health. The public health consequences are still to be explored: the potential gains from sleep restriction are substantial, but little is known about the causal link or the risks. Further research is needed before taking policy decisions.
A quick guide to cancer epidemiology
Authors: Boffetta Paolo , Boccia Stefania , La Vecchia Carlo
Published: April 2023

This short and essential book [1] is addressed essentially to medical and public health students, and to anyone interested in a summary up to date presentation of cancer epidemiology and prevention. It is subdivided into four major sections, that include principles of primary and secondary cancer prevention, the current global burden of neoplasms,...
Allocating the Sample Size in Phase II and III Trials to Optimize Success Probability
Authors: De Martini Daniele
Published: April 2023

Background Clinical trials of phase II and III often fail due to poor experimental planning. Here, the problem of allocating available resources, in terms of sample size, to phase II and phase III is studied with the aim of increasing success rate. The overall success probability (OSP) is accounted for.

Methods Focus is placed on the amount of resources that should be provided to phase II and III trials to attain a good level of OSP, and on how many of these resources should be allocated to phase II to optimize OSP. It is assumed that phase II data are not considered for confirmatory purposes and that are used for planning phase III through sample size estimation. Being $r$ the rate of resources allocated to phase II, $OSP(r)$ is a concave function and there exists an optimal allocation $r_{opt}$ giving $\max\{OSP\}$. If $M_I$ is the sample size giving the desired power to phase III, and $kM_I$ is the whole sample size that can be allocated to the two phases, it is indicated how large $k$ and $r$ should be in order to achieve levels of OSP of practical interest.

Results For example, when 5 doses are evaluated in phase II and 2 parallel phase III confirmatory trials (one-tail type I error $=2.5\%$, power $=90\%$) are considered with 2 groups each, $k=24$ is needed to obtain $OSP\simeq 75\%$, with $r_{opt}\simeq 50\%$. The choice of $k$ depends mainly on how many phase II treatment groups are considered, not on the effect size of the selected dose. When $k$ is large enough, $r_{opt}$ is close to $50\%$. An $r\simeq25\%$, although not best, might give a good OSP and an invitingly small total sample size, provided that $k$ is large enough.

Conclusions To improve the success rate of phase II and phase III trials, the drug development could be looked at in its entirety. Resources larger than those usually employed should be allocated to phase II to increase OSP. Phase II allocation rate may be increased to, at least, 25\%, provided that a sufficient global amount of resources is available.
Does economic crisis affect prevention services? An Italian region as a study case
Authors: De Vito Corrado , Di Marco Marco , Marzuillo Carolina , Matarazzo Azzurra , Massimi Azzurra , Villari Paolo
Published: April 2023

Background: The Latium Region in Italy is currently under pressure from national government to achieve economic consolidation of regional health services and is subject to a formal regional recovery plan.

Methods: Using recognized health indicators together with a government assessment tool, we evaluate the impact of the economic downturn on the health of the Latium Region population.

Results: We find that healthcare spending in the Latium Region needs to become more efficient by improving primary healthcare and by restoring efficiency in hospitals.

Conclusions: Prevention activities should not only be defended in the current financial and economic crisis, but also streamlined and strengthened.
Prevalence and determinants of diabetes mellitus in a representative sample of Italian adults
Authors: Asciutto Rosario , Lugo Alessandra , Gallus Silvano , Roncaglioni Maria Carla , La Vecchia Carlo , Bosetti Cristina
Published: April 2023

Background: Diabetes mellitus is a dramatic epidemic worldwide. This study providea an updated estimate of itsprevalence and determinants among Italian adults.

Methods: Data were derived from a face-to-face survey conducted in 2013 on 2901 individuals (1391 men, 1510 women) aged ≥18 years, representative of the general adult Italian population. Odds ratios (OR) for diabetes versus non diabetes in relation to selected risk factors were derived using multiple logistic regression models.

Results: Overall, 135 out of 2901 adults (4.7%) reported a diagnosis of diabetes, with similar prevalence in men (4.8%) and in women (4.5%). Diabetes increased with age (0.6% at age 18-44, 5.1% at age 45-64, and 11.3% at age ≥65 years; p-trend <0.001) and decreased with increasing level of education (12.8% for low, 7.8% for middle, and 1.4% for high education; p-trend <0.001). Prevalence was higher among obese subjects (10.8%) compared to normal weight subjects (3.1%; OR=2.46; p-trend=0.001), among individuals reporting a physical activity <30 minutes of walk/day (5.6%) compared to those reporting >60 minutes of walk/day (3.8%; OR=1.43), and among ex-smokers (11.6%) compared to never smokers (4.2%; OR=2.51); moreover, it was lower among moderate drinkers (3.1%) than among abstainers (6.1%; OR=0.57; p-trend=0.016). Prevalence of diabetes was 16.1% in individuals with a diagnosis of hypertension (OR=4.66), 15.2% in those with high cholesterol (OR=3.84), and 21.6% among aspirin users (OR=4.46).

Conclusion: Although diabetes prevalence in Italy is still comparatively low, effective clinical and preventive intervention strategies – focused on major risk behaviors – should be implemented to control the diffusion of this condition.
PERANCANGAN KOMPONEN STRUKTUR PENYUSUN BANGUNAN DENGAN PENDEKATAN CIRCULAR ECONOMY DAN KONSEP “EDITABLE MODULAR BUILDING”
Authors: Handali Kevin , Suteja Mekar Sari
Published: April 2023

Tanjung Pasir Village is a village located north of Tangerang, Banten. Residents in this village have a unique habit of the buildings. They are used to building the house gradually in the core areas (bedrooms, kitchen and living room) then adding other rooms over time. This habit has a negative impact on development activities that are not running effectively and efficiently. A lot of material is wasted even though it can still be reused to minimize expenses during construction. By using the Circular Economy principle, namely the use of multifunctional materials, namely reusing existing materials with different functions. This principle works in extending the duration of material use. This design idea was inspired by the formation of LEGO which was created in 1949 and has a consistent shape and connection so that it can still be played today. The design concept is made simple modular which is manageable and sustainable. Application of the principle to this concept occurs in the use of permanent, semi-permanent, variable components and members of constant MEP structures.
Keywords:  Circular Economy; component; lego; recycled material; structure
Abstrak 
Desa Tanjung Pasir merupakan desa yang terletak di utara Tangerang, Banten. Penduduk di desa ini memiliki kebiasaan yang unik pada bangunan-bangunannya. Mereka terbiasa untuk membangun rumah secara bertahap pada area inti (kamar tidur, dapur, dan ruang keluarga) kemudian menambahkan ruang-ruang lain dengan berjalannya waktu. Kebiasaan ini memberikan dampak buruk terhadap kegiatan pembangunan yang berjalan secara tidak efektif dan efisien. Banyak material yang terbuang sia-sia padahal masih dapat dipakai kembali untuk meminimalisir pengeluaran saat pembangunan. Tulisan ini mencoba menggagas prinsip Circular Economy dalam mendesain suatu struktur penyusun bangunan. Konsepnya adalah penggunaan kembali material yang sudah ada agar multifungsi. Prinsip ini bekerja dalam memperpanjang durasi pemakaian material. Ide desain ini terinspirasi dari bentukan LEGO (tahun 1949) yang memiliki bentuk dan sambungan yang konsisten sehingga tetap bisa dimainkan hingga saat ini. Konsep desain dibuat modular sederhana yang dapat diatur dan berkelanjutan (editable modular). Penerapan konsep ini pada penggunaan struktur permanen, semi-permanen, komponen yang dapat diubah serta bagian struktur MEP konstan.