Hospices Civils de Lyon, Groupement Hospitalier Sud, Unité de pharmacie clinique oncologique, Pierre-Bénite, France.
Translational Innovation in Medicine and Complexity - Unité Mixte de Recherche 5525, Université Grenoble Alpes, Grenoble, France.
J Med Internet Res. 2023 May 18;25:e41048. doi: 10.2196/41048.
European national disparities in the integration of data linkage (ie, being able to match patient data between databases) into routine public health activities were recently highlighted. In France, the claims database covers almost the whole population from birth to death, offering a great research potential for data linkage. As the use of a common unique identifier to directly link personal data is often limited, linkage with a set of indirect key identifiers has been developed, which is associated with the linkage quality challenge to minimize errors in linked data.
The aim of this systematic review is to analyze the type and quality of research publications on indirect data linkage on health product use and care trajectories in France.
A comprehensive search for all papers published in PubMed/Medline and Embase databases up to December 31, 2022, involving linked French database focusing on health products use or care trajectories was realized. Only studies based on the use of indirect identifiers were included (ie, without a unique personal identifier available to easily link the databases). A descriptive analysis of data linkage with quality indicators and adherence to the Bohensky framework for evaluating data linkage studies was also realized.
In total, 16 papers were selected. Data linkage was performed at the national level in 7 (43.8%) cases or at the local level in 9 (56.2%) studies. The number of patients included in the different databases and resulting from data linkage varied greatly, respectively, from 713 to 75,000 patients and from 210 to 31,000 linked patients. The diseases studied were mainly chronic diseases and infections. The objectives of the data linkage were multiple: to estimate the risk of adverse drug reactions (ADRs; n=6, 37.5%), to reconstruct the patient's care trajectory (n=5, 31.3%), to describe therapeutic uses (n=2, 12.5%), to evaluate the benefits of treatments (n=2, 12.5%), and to evaluate treatment adherence (n=1, 6.3%). Registries are the most frequently linked databases with French claims data. No studies have looked at linking with a hospital data warehouse, a clinical trial database, or patient self-reported databases. The linkage approach was deterministic in 7 (43.8%) studies, probabilistic in 4 (25.0%) studies, and not specified in 5 (31.3%) studies. The linkage rate was mainly from 80% to 90% (reported in 11/15, 73.3%, studies). Adherence to the Bohensky framework for evaluating data linkage studies showed that the description of the source databases for the linkage was always performed but that the completion rate and accuracy of the variables to be linked were not systematically described.
This review highlights the growing interest in health data linkage in France. Nevertheless, regulatory, technical, and human constraints remain major obstacles to their deployment. The volume, variety, and validity of the data represent a real challenge, and advanced expertise and skills in statistical analysis and artificial intelligence are required to treat these big data.
最近强调了欧洲各国在将数据链接（即能够在数据库之间匹配患者数据）纳入常规公共卫生活动方面存在差异。在法国，索赔数据库涵盖了从出生到死亡的几乎所有人，为数据链接提供了巨大的研究潜力。由于通常限制使用通用唯一标识符直接链接个人数据，因此已开发出使用一组间接关键标识符进行链接的方法，这与最小化链接数据错误的链接质量挑战有关。
本系统评价的目的是分析法国关于健康产品使用和护理轨迹的间接数据链接的研究出版物的类型和质量。
对截至 2022 年 12 月 31 日在 PubMed/Medline 和 Embase 数据库中发表的所有论文进行了全面搜索，涉及到关注健康产品使用或护理轨迹的法国链接数据库。仅包括基于使用间接标识符的研究（即，没有可用的唯一个人标识符来轻松链接数据库）。还对数据链接进行了描述性分析，并使用 Bohensky 框架评估了数据链接研究的质量指标和遵守情况。
共选择了 16 篇论文。7 项（43.8%）在国家层面进行了数据链接，9 项（56.2%）在地方层面进行了数据链接。不同数据库中包含的患者数量和由此产生的链接患者数量差异很大，分别为 713 至 75,000 名患者和 210 至 31,000 名链接患者。研究的疾病主要是慢性病和传染病。数据链接的目标多种多样：估计不良反应（ADR；n=6，37.5%）、重建患者的护理轨迹（n=5，31.3%）、描述治疗用途（n=2，12.5%）、评估治疗益处（n=2，12.5%）和评估治疗依从性（n=1，6.3%）。登记处是与法国索赔数据链接最频繁的数据库。没有研究关注与医院数据仓库、临床试验数据库或患者自我报告数据库的链接。链接方法在 7 项研究中是确定性的（43.8%），在 4 项研究中是概率性的（25.0%），在 5 项研究中没有指定（31.3%）。链接率主要在 80%到 90%之间（15 项研究中的 11 项，73.3%）。对评估数据链接研究的 Bohensky 框架的遵守情况表明，始终对链接的源数据库进行了描述，但没有系统地描述要链接的变量的完成率和准确性。
本综述强调了法国对健康数据链接的兴趣日益浓厚。然而，监管、技术和人力资源方面的限制仍然是其部署的主要障碍。数据的数量、种类和有效性是一个真正的挑战，需要在统计分析和人工智能方面具备先进的专业知识和技能来处理这些大数据。
