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.

法定医疗保险提供者的索赔数据是卫生服务和药物安全研究中流行病学研究的重要资源。这些数据的好处来自于大量的患者和长期随访期的可能性，从而提供了调查非常罕见的药物不良反应和潜伏期较长的药物不良反应的机会。由于收集这些数据是为了记账，而不是主要为了研究目的，因此缺乏关于疾病的重要信息，如肿瘤分期或死亡原因。此外，数据中肿瘤诊断的有效性尚不清楚。索赔数据与癌症登记数据的联系提供了缺失的信息，从而对调查致癌物质的影响作出了重要贡献。在这项研究提案中，对接受不同抗糖尿病治疗的2型糖尿病患者的癌症风险和癌症死亡率的示范性研究，旨在评估使用将假名索赔数据与德国流行病学癌症登记数据联系起来的不同方法，可以在多大程度上促进更容易的数据获取。首先，将使用出生年份、性别、社区代码和肿瘤诊断日期/季度进行间接记录联系。其次，结果将通过一个建立良好、准确但复杂的链接程序进行评估，该程序使用所谓的控制号。由于这样的联动需要非常严格的数据保护概念，而且非常耗时，并不是对每一个研究问题都可行。使用示例性研究，将描述和评估两个相关联的数据集之间的质量差异。该项目的总体目标是优化这两种方法的联系程序，以便就具有具体数据保护要求的进一步研究的成本和时间效益提出建议。此外，将提出建议，在何种情况下，两种联系程序中的任何一种都将导致有效的调查结果。该项目的结果将使用德国的二次数据传播给研究人员。