A. Stendardo, F. Preite, R. Gesuita, S. Villani, A. Zambon
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.
{"title":"Legal aspects regarding the use and integration of electronic medical records for epidemiological purposes with focus on the Italian situation","authors":"A. Stendardo, F. Preite, R. Gesuita, S. Villani, A. Zambon","doi":"10.2427/8971","DOIUrl":"https://doi.org/10.2427/8971","url":null,"abstract":"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.","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"76 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88578737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Embargoes - often used by scientific institutions such as medical societies and scientific journals to give access to reporters before material is published - can inspire heated arguments. Some journalists love them, while others say they - along with Ingelfinger Rule, which prohibits pre-publication publicity of results before they appear in a peer-reviewed journal - discourage original reporting [1]. Journals find them helpful in “choreographing” the dance of medical news [2], but some have eschewed them completely [3]. Despite all of this debate,…
{"title":"If you must use embargoes, here’s how to do it right","authors":"I. Oransky","doi":"10.2427/9043","DOIUrl":"https://doi.org/10.2427/9043","url":null,"abstract":"\u0000Embargoes - often used by scientific institutions such as medical societies and scientific journals to give access to reporters before material is published - can inspire heated arguments. Some journalists love them, while others say they - along with Ingelfinger Rule, which prohibits pre-publication publicity of results before they appear in a peer-reviewed journal - discourage original reporting [1]. Journals find them helpful in “choreographing” the dance of medical news [2], but some have eschewed them completely [3]. Despite all of this debate,… \u0000","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"24 21","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72408335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Routinely stored information on healthcare utilisation in everyday clinical practice has proliferated over the past several decades. There is, however, some reluctance on the part of many health professionals to use observational data to support healthcare decisions, especially when data are derived from large databases. Challenges in conducting observational studies based on electronic databases include concern about the adequacy of study design and methods to minimise the effect of both misclassifications (in the absence of direct assessments of exposure and outcome validity) and confounding (in the absence of randomisation). This paper points out issues that may compromise the validity of such studies, and approaches to managing analytic challenges. First, strategies of sampling within a large cohort, as an alternative to analysing the full cohort, will be presented. Second, methods for controlling outcome and exposure misclassifications will be described. Third, several techniques that take into account both measured and unmeasured confounders will also be presented. Fourth, some considerations regarding random uncertainty in the framework of observational studies using healthcare utilisation data will be discussed. Finally, some recommendations for good research practice are listed in this paper. The aim is to provide researchers with a methodological framework, while commenting on the value of new techniques for more advanced users.
{"title":"Building reliable evidence from real-world data: methods, cautiousness and recommendations","authors":"G. Corrao","doi":"10.2427/8981","DOIUrl":"https://doi.org/10.2427/8981","url":null,"abstract":"Routinely stored information on healthcare utilisation in everyday clinical practice has proliferated over the past several decades. There is, however, some reluctance on the part of many health professionals to use observational data to support healthcare decisions, especially when data are derived from large databases. Challenges in conducting observational studies based on electronic databases include concern about the adequacy of study design and methods to minimise the effect of both misclassifications (in the absence of direct assessments of exposure and outcome validity) and confounding (in the absence of randomisation). This paper points out issues that may compromise the validity of such studies, and approaches to managing analytic challenges. First, strategies of sampling within a large cohort, as an alternative to analysing the full cohort, will be presented. Second, methods for controlling outcome and exposure misclassifications will be described. Third, several techniques that take into account both measured and unmeasured confounders will also be presented. Fourth, some considerations regarding random uncertainty in the framework of observational studies using healthcare utilisation data will be discussed. Finally, some recommendations for good research practice are listed in this paper. The aim is to provide researchers with a methodological framework, while commenting on the value of new techniques for more advanced users.","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85142497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Austin Bradford Hill was born on July 8, 1897, third son of Sir Leonard Erskine Hill, a distinguished medical physiologist, Professor of Physiology at The London Hospital. He grew up in an upper class Victorian family. Sir Leonard, who created an ingenious instrument for blood pressure measuring, had a deep influence on his son. In fact, Bradford decided to follow his father example. He attended Chigwell Grammar School, which was established in 1629, but unfortunately, Bradford’s decision to join the Faculty of Medicine coincided with a really big event: First World War. Bradford entered British naval aviation and...
{"title":"Austin Bradford Hill: simply the best","authors":"Roberto Bucci, V. Colamesta, G. Torre","doi":"10.2427/9426","DOIUrl":"https://doi.org/10.2427/9426","url":null,"abstract":"Austin Bradford Hill was born on July 8, 1897, third son of Sir Leonard Erskine Hill, a distinguished medical physiologist, Professor of Physiology at The London Hospital. He grew up in an upper class Victorian family. Sir Leonard, who created an ingenious instrument for blood pressure measuring, had a deep influence on his son. In fact, Bradford decided to follow his father example. He attended Chigwell Grammar School, which was established in 1629, but unfortunately, Bradford’s decision to join the Faculty of Medicine coincided with a really big event: First World War. Bradford entered British naval aviation and...","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89928885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Few weeks after the journal Science published a very unusual investigation by science journalist John Bohannon showing how many open access journals – among those asking for a submission or publication fee – don't really care about quality and accept for publication studies containing obvious and macroscopic mistakes, collecting money...
{"title":"«Trust, but verify»: easier said than done","authors":"F. Turone","doi":"10.2427/9441","DOIUrl":"https://doi.org/10.2427/9441","url":null,"abstract":"Few weeks after the journal Science published a very unusual investigation by science journalist John Bohannon showing how many open access journals – among those asking for a submission or publication fee – don't really care about quality and accept for publication studies containing obvious and macroscopic mistakes, collecting money...","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80118600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In the last decade a substantial number of epidemiological studies suggested that outdoor air pollution and in particular respirable particulate matter (PM10) and fine particulate matter (PM2.5) are associated with an increased risk of lung cancer.The most recent is a multicentre European study...
{"title":"Outdoor air pollution and lung cancer: what now?","authors":"E. Pira, P. Piolatto","doi":"10.2427/9444","DOIUrl":"https://doi.org/10.2427/9444","url":null,"abstract":"In the last decade a substantial number of epidemiological studies suggested that outdoor air pollution and in particular respirable particulate matter (PM10) and fine particulate matter (PM2.5) are associated with an increased risk of lung cancer.The most recent is a multicentre European study...","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74458640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The editors-in-chief, editors, members of the editorial board and publisher of Epidemiology, Biostatistics and Public Health wish to express their sincere gratitude to the referees of the articles considered for the 2013 volume of the Journal. Giuseppe Arbia Fabio Barbone Joana Bastos Stefania Boccia Anna Bossi Silvio Brusaferro Chiara Cadeddu Caterina Caminiti Giovanni Capelli Guido Citoni Gianfranco Damiani Antonio De Belvis Emma De Feo Elisabetta De Vito Chiara de Waure Domitilla Di Thiene Ana Duarte Bruno Federico Monica Ferraroni Alessandra Frustaci Carlotta Galeone Silvano Gallus Maurizio Genuardi Guglielmo Giraldi Maria Rosaria Gualano Carolina Ianuale Farhad Islami Giuseppe La Torre Patrizia Laurenti Laura Lauria Carlo La Vecchia Emanuele Leoncini Alice Mannocci Walter Mazzucco Silvia Miccoli Cristina Montomoli Eva Negri Nicola Nicolotti Caterina Palazzo GianCarlo Paradisi Patrizio Pasqualetti Claudio Pelucchi Brunella Posteraro Delphine Praud Gianluigi Quaranta Luca Sbrogiò Benedetto Simone Giuliana Solinas Maria Lucia Specchia Annamaria Tortorano Fabio Turone Brigid Unim Maria Assunta Veneziano Francesco Vitale Antonella Zambon Alessandro Zanetti.
This paper gathers some contributions concerning survey methodology in dental research, as discussed during the first Workshop of the SISMEC STATDENT working group on statistical methods and applications in dentistry, held in Ancona on the 28th September 2011. The first contribution deals with the European Global Oral Health Indicators Development (EGOHID) Project which proposed a comprehensive and standardized system of epidemiological tools (questionnaires and clinical forms) for national data collection on oral health in Europe. The second contribution regards the design and conduct of trials to evaluate the clinical efficacy and safety of toothbrushes and mouthrinses. Finally, a flexible and effective tool used to trace dental age reference charts tailored to Italian children is presented.
{"title":"Challenges in dental statistics: survey methodology topics","authors":"G. Pizzo, S. Milani, E. Spada, Livia Ottolenghi","doi":"10.2427/9097","DOIUrl":"https://doi.org/10.2427/9097","url":null,"abstract":"\u0000This paper gathers some contributions concerning survey methodology in dental research, as discussed during the first Workshop of the SISMEC STATDENT working group on statistical methods and applications in dentistry, held in Ancona on the 28th September 2011. \u0000The first contribution deals with the European Global Oral Health Indicators Development (EGOHID) Project which proposed a comprehensive and standardized system of epidemiological tools (questionnaires and clinical forms) for national data collection on oral health in Europe. The second contribution regards the design and conduct of trials to evaluate the clinical efficacy and safety of toothbrushes and mouthrinses. Finally, a flexible and effective tool used to trace dental age reference charts tailored to Italian children is presented. \u0000","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88752421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: transplantation of human organs and tissues saves many lives and restores essential functions in combination of high measurable quality indicators. In spite of the fact that organ transplants have saved thousands of lives and greatly improved the quality of life of thousands more, regrettably many people will not benefit from this therapeutic procedure. Methods: this review is based on economic evaluation studies published since 2000 and reviews published since 1987 for kidney, liver, lung, heart, pancreas, and small bowel transplantations that were conducted in 2010. Results: empirical evidence showed that the costs of organ transplantations have generally decreased over time due to improvements in medicine, while survival and quality of life have improved. This indicates that the cost-effectiveness of transplantation has also improved over this period. Conclusions: cost effectiveness studies on organ transplantations could contribute to the efforts of policy makers in maximising societal health benefits by managing society’s scarce resources. The differences between EU country are not only associated with different legal procedures but are also associated with social, organizational and several other factors.
{"title":"A systematic literature review on the policies and economic evaluation of organ transplantations in EU","authors":"G. Tritaki, P. D. Giannantonio, S. Boccia","doi":"10.2427/9470","DOIUrl":"https://doi.org/10.2427/9470","url":null,"abstract":"\u0000Background: transplantation of human organs and tissues saves many lives and restores essential functions in combination of high measurable quality indicators. In spite of the fact that organ transplants have saved thousands of lives and greatly improved the quality of life of thousands more, regrettably many people will not benefit from this therapeutic procedure. \u0000Methods: this review is based on economic evaluation studies published since 2000 and reviews published since 1987 for kidney, liver, lung, heart, pancreas, and small bowel transplantations that were conducted in 2010. \u0000Results: empirical evidence showed that the costs of organ transplantations have generally decreased over time due to improvements in medicine, while survival and quality of life have improved. This indicates that the cost-effectiveness of transplantation has also improved over this period. \u0000Conclusions: cost effectiveness studies on organ transplantations could contribute to the efforts of policy makers in maximising societal health benefits by managing society’s scarce resources. The differences between EU country are not only associated with different legal procedures but are also associated with social, organizational and several other factors. \u0000","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"124 15","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72376624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Siliquini, M. Giacometti, S. Scoffone, Cristina Viglianchino, M. Bo, Veronica Galis
Background: major sporting and cultural events are a sensitive political and social issue. The aim of this study was to perform a critical review of the international literature regarding health impact assessment (HIA) studies of major events to identify all the health indicators available in the literature. Methods: we drew up a review of available literature on HIAs pertaining to major sports and cultural events. The papers obtained were read and then assessed in relation to the inclusion criteria, and the health indicators used were listed and commented upon. Results: we found three published HIA reports. One is a full report, and the other two are a screening report and a rapid HIA report. Through a detailed analysis, it has been possible to develop a set of indicators that can be used for future HIAs on major sporting and cultural events. Conclusions: reports of HIAs for major events that are available online identify several health impacts. In the pre-event phase, negative effects are predominant; in the post-event period, positive impacts prevail. The characteristics of the different stakeholders involved in the events play an important role in the evaluation process.
{"title":"Health impact assessment of major collective events: an overview of the available experiences","authors":"R. Siliquini, M. Giacometti, S. Scoffone, Cristina Viglianchino, M. Bo, Veronica Galis","doi":"10.2427/8902","DOIUrl":"https://doi.org/10.2427/8902","url":null,"abstract":"\u0000Background: major sporting and cultural events are a sensitive political and social issue. The aim of this study was to perform a critical review of the international literature regarding health impact assessment (HIA) studies of major events to identify all the health indicators available in the literature. \u0000Methods: we drew up a review of available literature on HIAs pertaining to major sports and cultural events. The papers obtained were read and then assessed in relation to the inclusion criteria, and the health indicators used were listed and commented upon. \u0000Results: we found three published HIA reports. One is a full report, and the other two are a screening report and a rapid HIA report. Through a detailed analysis, it has been possible to develop a set of indicators that can be used for future HIAs on major sporting and cultural events. \u0000Conclusions: reports of HIAs for major events that are available online identify several health impacts. In the pre-event phase, negative effects are predominant; in the post-event period, positive impacts prevail. The characteristics of the different stakeholders involved in the events play an important role in the evaluation process. \u0000","PeriodicalId":45811,"journal":{"name":"Epidemiology Biostatistics and Public Health","volume":"2012 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82622479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}