Druschke Diana, Arnold Katrin, Heinrich Luise, Reichert Jörg, Rüdiger Mario, Schmitt Jochen
Zentrum für Evidenzbasierte Gesundheitsversorgung, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.
Klinik und Poliklinik für Kinder- und Jugendmedizin, Fachbereich Neonatologie und Pädiatrische Intensivmedizin, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.
Gesundheitswesen. 2020 Mar;82(S 02):S108-S116. doi: 10.1055/a-1082-0740. Epub 2020 Mar 19.
The linkage of primary and secondary data is becoming an increasingly popular approach in healthcare research, but involves some challenges for all involved parties, for example due to data protection requirements. The aim of this article is to systematically outline the methods used and experiences made during a cohort study in the field of pediatric health care research (EcoCare-PIn) that involved access to and linkage of three different data sources. Particular focus is placed on the necessary regulatory measures with regard to data access and data linkage as well as on data validation to ensure a correct linkage.
While complying with all relevant data protection requirements, the study realized an individual-level linkage of a) pseudonymized administrative health insurance data from a statutory health insurance on Saxon children born between 2007 and 2013, b) primary data collected via postal questionnaires from parents/caregivers and c) medical data from kindergarten- and school-entry-examinations of Saxon health authorities. The fundamental principle of the concept of data linkage was to strictly separate the sites of data collection and data analysis, which was realized through the involvement of a trust center.
Challenges especially pertained to the extensive regulatory pre-requirements for data access as well as to data protection requirements while performing the study. Technical aspects and data validation also required a considerable share of attention and resources. A number of validation routines were applied to avoid incorrect data linkage and to ensure the high quality of the final dataset. Data validation included both plausibility checks within the primary data and consistency checks of information given in primary and secondary data.
The linkage of primary and secondary data on the individual level offers great opportunities for using the strengths of different data sources synergistically and overcoming some of their limitations. Statutory health insurance data and medical data from kindergarten- and school-entry-examinations of Saxon health authorities are examples of already existing data sources that can complement cost-consuming primary data collections by valuable data sets and open up opportunities for longitudinal analysis.
在医疗保健研究中，将原始数据与二次数据相联系正成为一种越来越流行的方法，但对所有相关方来说都存在一些挑战，例如由于数据保护要求。本文的目的是系统地概述在儿科医疗保健研究领域（EcoCare-PIn）的一项队列研究中所使用的方法和取得的经验，该研究涉及访问和链接三个不同的数据源。特别关注与数据访问和数据链接相关的必要监管措施以及数据验证，以确保正确的链接。
在遵守所有相关数据保护要求的同时，该研究实现了个体层面的链接，即：a）来自法定健康保险的、关于2007年至2013年在萨克森州出生儿童的匿名化行政健康保险数据；b）通过邮政问卷从父母/照顾者那里收集的原始数据；c）来自萨克森州卫生当局幼儿园入学和学校入学检查的医疗数据。数据链接概念的基本原则是严格分离数据收集和数据分析的地点，这通过一个信任中心的参与得以实现。
挑战尤其涉及数据访问的广泛监管前置要求以及研究实施过程中的数据保护要求。技术方面和数据验证也需要相当多的关注和资源。应用了许多验证程序以避免错误的数据链接并确保最终数据集的高质量。数据验证包括原始数据内的合理性检查以及原始数据和二次数据中所提供信息的一致性检查。
在个体层面将原始数据与二次数据相联系，为协同利用不同数据源的优势并克服其一些局限性提供了巨大机会。来自法定健康保险的数据以及来自萨克森州卫生当局幼儿园入学和学校入学检查的医疗数据，是现有数据源的例子，它们可以用有价值的数据集补充耗费成本的原始数据收集，并为纵向分析开辟机会。
