Evaluation of an indirect record linkage method in an exemplary study on the risk of cancer and cancer mortality in type 2 diabetes patients treated with different antidiabetics

在关于接受不同糖尿病药物治疗的 2 型糖尿病患者的癌症风险和癌症死亡率的示范性研究中，间接记录关联方法的评估

• 批准号: 316648086
• 负责人: Professorin Dr. Iris Pigeot
• 金额: --
• 依托单位: Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPS GmbH
• 依托单位国家: 德国
• 项目类别: Research data and software (Scientific Library Services and Information Systems)
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2020-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/316648086?language=en
• 关键词: Evaluation; indirect; record; linkage; method

Claims data of statutory health insurance providers are an important resource for epidemiological studies in health services and drug safety research. The benefit of these data stems from the large number of patients and the potential for long follow-up periods offering the opportunity to investigate both very rare adverse drug reactions and adverse drug reactions with long latency times. Important information about diseases such as tumor stage or cause of death are lacking since the data was collected for billing and not primarily for research purposes. Furthermore, the validity of tumor diagnoses in the data is unknown. A linkage of claims data with data from a cancer registry provides the missing information, thereby making an essential contribution to the investigation of the effects of carcinogenic substances. In this research proposal, an exemplary study of cancer risk and cancer mortality in type 2 diabetes patients treated with different antidiabetic therapies serves to evaluate to which extent easier data access can be facilitated using different methods of linking pseudonymized claims data to data from epidemiological cancer registries in Germany. First, an indirect record linkage will be performed using year of birth, sex, community code, and date/quarter of the tumor diagnosis. Second, the results will be evaluated by a well-established and exact, yet elaborate linkage procedure using so-called control numbers. As such a linkage requires a very stringent data protection concept and is very time-consuming, it is not feasible for every research question. Using the exemplary study, the differences in quality between the two linked datasets will be described and assessed. The overall objective of this project is to optimize the linkage procedures of both methods in order to give recommendations for the cost and time-efficient conduct of further studies with specific data protection requirements. Furthermore, recommendations will be given under which circumstances either one of the two linkage procedures will lead to valid findings. The results of the project will be disseminated to researchers using secondary data in Germany.

法定健康保险提供者的索赔数据是健康服务和药物安全研究流行病学研究的重要资源。这些数据的益处来自大量患者以及长期随访期的潜力，这提供了调查非常罕见的不良药物反应和不良药物反应，而延迟时间很长。缺乏有关肿瘤阶段或死因等疾病的重要信息，因为数据是用于计费的，而不是主要用于研究目的。此外，数据中肿瘤诊断的有效性尚不清楚。索赔数据与癌症注册表的数据的联系提供了丢失的信息，从而为研究致癌物质的影响做出了重要贡献。在这项研究建议中，通过不同抗糖尿病疗法治疗的2型糖尿病患者的癌症风险和癌症死亡率的示例性研究可用于评估在哪种程度上，可以使用不同的方法来促进数据访问的程度，该方法可以通过将假名索赔数据与来自德国流行病学癌症注册的数据联系起来的不同方法。首先，将使用出生年份，性别，社区法规以及肿瘤诊断的日期/四分之一进行间接连接。其次，结果将通过使用所谓的控制号码来评估良好，精确但精心设计的链接程序。因此，链接需要一个非常严格的数据保护概念，并且非常耗时，因此对于每个研究问题都是不可行的。使用示例性研究，将描述和评估两个链接数据集之间的质量差异。该项目的总体目的是优化两种方法的链接程序，以便为具有特定数据保护要求的进一步研究的成本和时间效率进行建议。此外，在哪些情况下，两个链接程序之一都将导致有效的发现。该项目的结果将使用德国的二级数据传播给研究人员。