Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia.
Department of Surgery, Western Precinct, The University of Melbourne, Parkville, VIC, Australia; Western Health Chronic Disease Alliance, Western Health, St Albans, VIC, Australia.
Contemp Clin Trials. 2022 Aug;119:106843. doi: 10.1016/j.cct.2022.106843. Epub 2022 Jul 2.
Clinical registries have become an important platform for performance measurement, quality improvement, and clinical research including registry-based randomised controlled trials (RRCTs). However, the success of RRCTs is highly dependent on the quality of the registry. The aim of this study was to undertake a scoping review to identify the key characteristics that a registry must possess to be considered of high quality to successfully support the conduct of a RRCT.
A comprehensive search of four databases and grey literature was conducted. A narrative synthesis was conducted with a focus on summarising the characteristics that a high-quality registry must possess to support the conduct of RRCTs, and the mechanisms underpinning the collection of high-quality data.
A total of 50 articles were included. Data accuracy, completeness, population capture, data standardisation, and timeliness were identified as essential data attributes of a high-quality clinical registry. The legal and ethical environment in which a registry operates, the available infrastructure support, and ongoing participation by healthcare providers were identified as impacting the collection of high-quality data.
This review summarises the considerable work undertaken to determine the criteria with which to judge the suitability of a clinical registry to support a RRCT. Moving forward, the certification of individual clinical registries may be one way of identifying registries that can support a RRCT. In the interim, we propose the Registry Attributes Framework which can be used to ascertain the suitability of a registry to support a RRCT. Ultimately, the ideal goal should be to define minimum acceptable standards for a registry's key performance indicators (as depicted in the Framework) that would determine its certification status. New registries planned to support a RRCT should be designed and constructed against agreed standards once these are established.
临床注册已成为衡量绩效、改进质量和进行临床研究（包括基于注册的随机对照试验）的重要平台。然而，RRCT 的成功高度依赖于注册的质量。本研究旨在进行范围综述，以确定一个注册必须具备的关键特征，使其被认为具有高质量，从而成功支持 RRCT 的进行。
全面检索了四个数据库和灰色文献。采用叙述性综合方法，重点总结了高质量注册必须具备的特征，以支持 RRCT 的进行，以及支持高质量数据收集的机制。
共纳入 50 篇文章。数据准确性、完整性、人群捕获、数据标准化和及时性被确定为高质量临床注册的基本数据属性。注册所运营的法律和伦理环境、可用的基础设施支持以及医疗保健提供者的持续参与被确定为影响高质量数据收集的因素。
本综述总结了为确定临床注册支持 RRCT 的适宜性而进行的大量工作。今后，对个别临床注册的认证可能是确定支持 RRCT 的注册的一种方式。在此期间，我们提出了注册属性框架，可用于确定注册支持 RRCT 的适宜性。最终，理想的目标应该是为确定其认证状态的注册的关键绩效指标（如框架所示）定义最低可接受标准。一旦这些标准确立，计划支持 RRCT 的新注册应按照商定的标准进行设计和构建。
