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Legal aspects regarding the use and integration of electronic medical records for epidemiological purposes with focus on the Italian situation 关于为流行病学目的使用和整合电子病历的法律问题,重点是意大利的情况
Q3 Nursing Pub Date : 2022-07-06 DOI: 10.2427/8971
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.
意大利医学统计和临床流行病学协会(SISMEC)的"观察研究"工作组已着手研究最近的医疗保健部门条例对管理所有电子病历数据库的法律和组织方面的影响,重点研究第196/2003号法令(意大利个人数据保护法)。本文探讨了与它们的法律含义有关的六个问题。第一部分“保密”提供了术语“保密”和“个人资料”的定义和监管背景。第二章“电子病历档案中保存的数据的性质”,讨论了敏感数据的问题和使识别码匿名的程序。在“数据所有权”中,我们强调了数据控制器和数据库控制器之间的区别。第四部分,“处理条件”,讨论了在其他调查中使用一项研究的研究数据的相关问题。在第五部分“患者同意”中,我们讨论了与患者同意相关的问题。最后,在“处罚”中,我们概述了在不遵守《个人资料保护法》规定的情况下适用的主要民事和刑事责任问题。在可能的情况下,我们就如何遵守医疗档案管理的法律要求提供建议,以使研究人员更容易遵守相关规定。
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引用次数: 1
If you must use embargoes, here’s how to do it right 如果你必须使用禁运,这里有一些正确的做法
Q3 Nursing Pub Date : 2022-07-06 DOI: 10.2427/9043
I. Oransky
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,…
禁运——经常被医学学会和科学期刊等科学机构用来在材料发表前允许记者接触到它们——可能引发激烈的争论。一些记者喜欢它们,而另一些记者则认为它们——连同英格尔芬格规则(Ingelfinger Rule)——阻碍了原创报道[1]。英格尔芬格规则禁止在研究结果出现在同行评议期刊之前进行出版前宣传。期刊发现它们有助于“编排”医学新闻的舞蹈[2],但有些期刊则完全避开它们[3]。尽管有这些争论,……
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引用次数: 1
Building reliable evidence from real-world data: methods, cautiousness and recommendations 从真实世界的数据中建立可靠的证据:方法、谨慎和建议
Q3 Nursing Pub Date : 2022-07-06 DOI: 10.2427/8981
G. Corrao
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.
在过去的几十年里,日常临床实践中关于医疗保健利用的常规存储信息激增。然而,许多卫生专业人员不愿意使用观察数据来支持卫生保健决策,特别是当数据来自大型数据库时。进行基于电子数据库的观察性研究的挑战包括研究设计和方法的充分性,以尽量减少错误分类(缺乏对暴露和结果有效性的直接评估)和混淆(缺乏随机化)的影响。本文指出了可能损害这些研究有效性的问题,以及管理分析挑战的方法。首先,将介绍在一个大队列中抽样的策略,作为分析整个队列的替代方法。其次,将描述控制结果和暴露错误分类的方法。第三,还将介绍几种考虑可测量和不可测量混杂因素的技术。第四,将讨论使用医疗保健利用数据的观察性研究框架中关于随机不确定性的一些考虑。最后,本文提出了一些良好的研究实践建议。其目的是为研究人员提供一个方法框架,同时评论新技术对更高级用户的价值。
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引用次数: 14
Austin Bradford Hill: simply the best 奥斯汀·布拉德福德·希尔:简直是最好的
Q3 Nursing Pub Date : 2022-07-04 DOI: 10.2427/9426
Roberto Bucci, V. Colamesta, G. Torre
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...
奥斯汀·布拉德福德·希尔出生于1897年7月8日,是伦纳德·厄斯金·希尔爵士的第三个儿子,伦纳德·厄斯金·希尔爵士是一位杰出的医学生理学家,伦敦医院的生理学教授。他成长于一个维多利亚时代的上层阶级家庭。伦纳德爵士发明了一种精巧的血压测量仪器,对他的儿子产生了深远的影响。事实上,布拉德福德决定以他父亲为榜样。他就读于1629年建立的Chigwell文法学校,但不幸的是,布拉德福德决定加入医学院的同时,发生了一件大事:第一次世界大战。布拉德福德进入英国海军航空兵…
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引用次数: 1
«Trust, but verify»: easier said than done “信任,但要核实”:说起来容易做起来难
Q3 Nursing Pub Date : 2022-07-04 DOI: 10.2427/9441
F. Turone
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...
几周后,《科学》杂志发表了一篇由科学记者约翰·博汉农(John Bohannon)进行的非常不寻常的调查,调查显示,在那些收取投稿或出版费用的期刊中,有多少开放获取期刊并不真正关心质量,而是接受含有明显和宏观错误的发表研究,收钱……
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引用次数: 0
Outdoor air pollution and lung cancer: what now? 室外空气污染与肺癌:现在怎么办?
Q3 Nursing Pub Date : 2022-07-04 DOI: 10.2427/9444
E. Pira, P. Piolatto
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...
在过去十年中,大量流行病学研究表明,室外空气污染,特别是可吸入颗粒物(PM10)和细颗粒物(PM2.5)与肺癌风险增加有关。最近的一项多中心欧洲研究……
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引用次数: 3
A note of thanks 一封感谢信
Q3 Nursing Pub Date : 2022-07-04 DOI: 10.2427/9443
S. Boccia, C. la Vecchia
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.
《流行病学、生物统计学和公共卫生》杂志的主编、编辑、编委会成员和出版人谨向该杂志2013年卷所审议文章的审稿人表示诚挚的感谢。朱塞佩·阿比亚,法比奥·巴伯恩,乔安娜·巴斯托斯,斯蒂法尼亚·博西亚,安娜·博西,西尔维奥·布鲁萨菲罗·基亚拉,卡迪琳娜·卡米尼,乔瓦尼·卡佩利,吉多·西托尼,吉安弗兰科·达米亚尼,安东尼奥·德·贝尔维斯,艾玛·德·菲奥,伊丽莎白·德·维托,基亚拉·德·瓦尔蒂娜·迪·蒂内,安娜·杜阿尔特,布鲁诺·费德里科,莫妮卡·费拉罗尼,亚历山德拉·弗拉斯塔奇·卡洛塔·加莱奥·席尔瓦·加卢斯·毛里齐奥,吉列尔莫·吉拉尔迪,玛丽亚·罗萨莉亚·瓜拉诺卡罗莱纳·法哈德·伊斯拉姆,朱塞佩·拉托尔·帕特里齐亚·劳伦蒂,劳拉·劳拉·卡洛·卡洛·拉维奇亚,伊曼纽尔·莱昂西尼,爱丽丝·曼诺奇,沃尔特·马祖科,西尔维娅·米科利,克里斯蒂娜·蒙托莫利,伊娃·内格里,尼古拉·尼科洛蒂,卡特琳娜宫,吉安卡洛·帕拉迪西,帕特里齐奥·帕斯夸莱蒂,克劳迪奥·佩鲁奇,布鲁内拉·波斯特罗,德尔菲娜·普劳德,吉安路易吉·夸兰塔·卢卡Sbrogiò贝内代托·西蒙娜·朱利亚娜·索利纳斯玛丽亚·露西亚·斯佩基亚,安娜玛丽亚·托尔托拉诺,法比奥·图罗,布里吉德·尤尼姆,玛丽亚·阿松塔·威尼斯,弗朗西斯科·维塔莱,安东内拉·赞邦,亚历山德罗·萨内蒂。
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引用次数: 0
Challenges in dental statistics: survey methodology topics 牙科统计的挑战:调查方法主题
Q3 Nursing Pub Date : 2022-07-04 DOI: 10.2427/9097
G. Pizzo, S. Milani, E. Spada, Livia Ottolenghi
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.
本文收集了关于牙科研究中调查方法的一些贡献,这些贡献是2011年9月28日在安科纳举行的SISMEC STATDENT牙科统计方法和应用工作组第一次研讨会上讨论的。第一份贡献涉及欧洲全球口腔健康指标发展(EGOHID)项目,该项目提出了一个全面和标准化的流行病学工具系统(问卷调查和临床表格),用于收集欧洲国家口腔健康数据。第二个贡献是设计和进行试验,以评估牙刷和漱口水的临床疗效和安全性。最后,提出了一种灵活有效的工具,用于追踪适合意大利儿童的牙齿年龄参考图表。
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引用次数: 0
A systematic literature review on the policies and economic evaluation of organ transplantations in EU 欧盟器官移植政策与经济评价的系统文献综述
Q3 Nursing Pub Date : 2022-06-30 DOI: 10.2427/9470
G. Tritaki, P. D. Giannantonio, S. Boccia
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.
背景:人体器官和组织的移植可以挽救许多生命,并恢复基本功能,结合高可测量的质量指标。尽管器官移植已经挽救了成千上万人的生命,并极大地提高了成千上万人的生活质量,但令人遗憾的是,许多人不能从这种治疗过程中受益。方法:本综述基于2000年以来发表的经济评价研究和1987年以来发表的关于2010年进行的肾、肝、肺、心脏、胰腺和小肠移植的综述。结果:经验证据表明,随着时间的推移,由于医学的进步,器官移植的成本普遍下降,而生存和生活质量也有所提高。这表明在此期间移植的成本效益也有所提高。结论:器官移植的成本效益研究有助于决策者通过管理社会稀缺资源来实现社会健康效益最大化。欧盟国家之间的差异不仅与不同的法律程序有关,而且与社会、组织和其他几个因素有关。
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引用次数: 1
Health impact assessment of major collective events: an overview of the available experiences 重大集体事件对健康的影响评估:现有经验概述
Q3 Nursing Pub Date : 2022-06-30 DOI: 10.2427/8902
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.
背景:大型体育和文化活动是一个敏感的政治和社会问题。本研究的目的是对有关重大事件的健康影响评估(HIA)研究的国际文献进行批判性审查,以确定文献中可用的所有健康指标。方法:我们对与重大体育和文化活动有关的HIAs的现有文献进行了回顾。对获得的论文进行阅读,然后根据纳入标准进行评估,列出所使用的健康指标并对其进行评论。结果:我们找到了3篇已发表的HIA报告。一个是完整报告,另外两个是筛选报告和快速HIA报告。通过详细的分析,有可能制定出一套指标,可用于今后关于重大体育和文化活动的评价。结论:网上可获得的重大事件的卫生影响评估报告确定了若干健康影响。在事件前阶段,负面影响占主导地位;在事件发生后的时期,积极的影响占上风。参与事件的不同利益相关者的特征在评估过程中起着重要作用。
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引用次数: 1
期刊
Epidemiology Biostatistics and Public Health
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