Division of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Clin Exp Rheumatol. 2013 Jul-Aug;31(4 Suppl 78):S28-32. Epub 2013 Oct 3.
Many studies have been conducted concerning discontinuation of biologic disease-modifying anti-rheumatic drugs (DMARD), but mainly in trial settings which result in limited generalisability. Registry studies can complement the current literature of biologic DMARD discontinuation by providing more generalisable information. However, it may be necessary to combine registries to increase power and provide more diverse patient populations. This increased power could provide us information about risk and benefits of discontinuing biologic DMARD in typical clinical practice. However, use of multiple registries is not without challenges. In this review, we discuss the challenges to combining data across multiple registries, focusing on biologic discontinuation as an example. Challenges include: 1) generalizability of each registry; 2) new versus prevalent users designs; 3) outcome definitions; 4) different health care systems; 5) different follow up intervals; and 6) data harmonisation. The first three apply to each registry, and the last three apply to combining multiple registries. This review describes these challenges, corresponding solutions, and potential future opportunities.
许多研究都针对生物疾病修饰抗风湿药物（DMARD）的停药问题进行了探讨，但主要是在临床试验环境下进行的，这导致研究结果的普遍适用性有限。注册研究可以通过提供更具普遍性的信息来补充生物 DMARD 停药的现有文献。然而，为了提高研究的效能并提供更多样化的患者人群，可能需要合并多个注册研究。这种效能的提高可以为我们提供在典型临床实践中停止使用生物 DMARD 的风险和获益信息。然而，使用多个注册研究并非没有挑战。在这篇综述中，我们讨论了合并多个注册研究数据所面临的挑战，重点以生物 DMARD 的停药为例。这些挑战包括：1）每个注册研究的普遍性；2）新患者与既往患者的设计；3）结局定义；4）不同的医疗保健系统；5）不同的随访间隔；以及 6）数据的协调统一。前三个挑战适用于每个注册研究，而后三个挑战适用于合并多个注册研究。本综述描述了这些挑战、相应的解决方案以及潜在的未来机遇。
