Nivel, Netherlands Institute of Health Services Research, P.O Box 1568, 3500 BN, Utrecht, Netherlands.
Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.
BMC Med Res Methodol. 2022 Apr 27;22(1):124. doi: 10.1186/s12874-022-01601-0.
The growing volume of health data provides new opportunities for medical research. By using existing registries, large populations can be studied over a long period of time. Patient-level linkage of registries leads to even more detailed and extended information per patient, but brings challenges regarding responsibilities, privacy and security, and quality of data linkage. In this paper we describe how we dealt with these challenges when creating the Primary Secondary Cancer Care Registry (PSCCR)- Breast Cancer.
The PSCCR - Breast Cancer was created by linking two existing registries containing data on 1) diagnosis, tumour and treatment characteristics of all Dutch breast cancer patients (NCR), and 2) consultations and diagnoses from primary care electronic health records of about 10% of Dutch GP practices (Nivel-PCD). The existing registry governance structures and privacy regulations were incorporated in those of the new registry. Privacy and security risks were reassessed. Data were restricted to females and linked using postal code and date of birth. The breast cancer diagnosis was verified in both registries and for a subsample of 44 patients with the GP as well.
A collaboration agreement was signed in which the organisations retained data responsibility and accountability for 'their' registry. A Trusted Third Party performed the record linkage. Ten percent of the patients with breast cancer could be linked to the primary care registry, as was expected based on the coverage of Nivel-PCD, and finally 7 % could be included. The breast cancer diagnosis was verified by the GP in 42 of the 44 patients.
We developed and validated a procedure for patient-level linkage of health data registries without a unique identifier, while preserving the integrity and privacy of the original registries. The method described may help researchers wishing to link existing health data registries.
日益增长的健康数据量为医学研究提供了新的机会。通过使用现有的注册系统，可以对大量人群进行长时间的研究。患者层面的注册系统链接可以为每个患者提供更详细和扩展的信息，但也带来了责任、隐私和安全以及数据链接质量方面的挑战。本文介绍了在创建初级二级癌症护理注册系统（PSCCR）-乳腺癌时，我们如何应对这些挑战。
PSCCR - 乳腺癌是通过链接两个现有的注册系统创建的，这两个系统包含了 1）所有荷兰乳腺癌患者的诊断、肿瘤和治疗特征（NCR），以及 2）初级保健电子健康记录中约 10％的荷兰全科医生实践的咨询和诊断（Nivel-PCD）。新注册系统采用了现有的注册表治理结构和隐私法规。重新评估了隐私和安全风险。数据仅限于女性，并使用邮政编码和出生日期进行链接。在两个注册系统中都对乳腺癌诊断进行了验证，并对 GP 中的 44 名患者进行了部分验证。
签署了合作协议，其中组织保留了对“其”注册表的数据责任和问责制。一个可信的第三方执行了记录链接。根据 Nivel-PCD 的覆盖范围，预计可以将 10％的乳腺癌患者链接到初级保健注册系统，最终可以将 7％的患者纳入。在 44 名患者中，有 42 名患者的乳腺癌诊断得到了 GP 的验证。
我们开发并验证了一种在没有唯一标识符的情况下对健康数据注册系统进行患者层面链接的程序，同时保持了原始注册表的完整性和隐私性。所描述的方法可能有助于希望链接现有健康数据注册表的研究人员。
