Division of Rheumatology, The University of Texas Health Science Center at Houston, Houston, Texas 77030, USA.
Curr Opin Rheumatol. 2013 Jul;25(4):468-76. doi: 10.1097/BOR.0b013e3283620e1d.
To review the optimal criteria and conditions for establishing a clinical registry, as well as detailing their application in a number of ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA) Registries already in existence.
Recent genetic studies and studies of long-term treatment efficacy and side-effects have underscored the need for large numbers of patients, much larger than would be possible from a single center or consortium. An optimal Registry should have its aims established upfront, with appropriate governance and oversight, and inclusion and exclusion criteria for participating collaborators and subject defined. Collaborators contributing subjects to a Registry should use validated instruments for which they have been previously trained. The numerous cross-sectional and longitudinal Registries on AS and axSpA have been recently established that differ widely depending on the referral and selection issues.
The challenge of large-scale examinations of genetics, comorbidities, medication usage, and side-effects in spondyloarthritis underscores the need for combining data from well characterized registries of AS patients which require careful planning. There are currently many such registries available internationally, offering promise for collaborations and data pooling that can answer some of the pressing questions facing rheumatology clinicians and researchers.
回顾建立临床注册的最佳标准和条件，并详细介绍它们在现有的一些强直性脊柱炎（AS）和中轴型脊柱关节炎（axSpA）注册中的应用。
最近的遗传研究和长期治疗效果及副作用的研究强调了需要大量的患者，远远超过单一中心或联盟所能提供的数量。一个理想的注册应该预先确定其目标，并建立适当的治理和监督机制，以及参与合作方和参与者的纳入和排除标准。向注册提供参与者的合作方应使用经过验证的工具，并对其进行了预先培训。最近已经建立了许多关于 AS 和 axSpA 的横断面和纵向注册，这些注册在转诊和选择问题上存在很大差异。
在脊柱关节炎中进行大规模的遗传学、合并症、药物使用和副作用检查的挑战凸显了需要结合具有良好特征的 AS 患者的注册数据，这需要仔细规划。目前国际上有许多这样的注册，为合作和数据共享提供了机会，可以回答风湿病临床医生和研究人员面临的一些紧迫问题。
