Department of Clinical Sciences - Paediatrics, Lund University, Lund and Malmö, Sweden.
Haemophilia. 2020 Apr;26 Suppl 3:26-28. doi: 10.1111/hae.13920.
Registries will enable cohort studies to be performed, which are usually considered to be the best quality of observational studies. The quality of data of registries can be increased if is it possible to merge results ('crosstalk') between registries. A prerequisite for that is an agreed uniform core set of data to be collected and uniform definitions on the items to be collected. This paper discusses problems and barriers with existing registries and provides recommendations from an EMA workshop (European Medicines Agency), for core common data sets and how to secure the quality of data collected. The PedNet registry including >2200 children with haemophilia is presented as an example of a registry/cohort study.
注册中心将能够开展队列研究，通常认为队列研究是观察性研究中质量最高的一种。如果可以合并（“交流”）注册中心之间的结果，那么注册中心的数据质量可以提高。实现这一目标的前提是能够商定要收集的统一核心数据集和要收集的项目的统一定义。本文讨论了现有注册中心存在的问题和障碍，并提供了来自 EMA 研讨会（欧洲药品管理局）的关于核心通用数据集的建议，以及如何确保所收集数据的质量。PedNet 注册中心包括 2200 多名血友病患儿，它被作为一个注册/队列研究的示例。
