Severn Deanery, Bristol, UK.
Department of Anaesthesia, North Bristol NHS Trust, Bristol, UK.
Anaesthesia. 2021 Aug;76(8):1122-1128. doi: 10.1111/anae.15303. Epub 2020 Nov 17.
Randomised controlled trials are the gold standard in clinical research, but remain rare due to their expense and a perceived lack of 'real-world' applicability. At the same time, there has been an exponential increase in routinely collected data which presents opportunities for audit, quality improvement, adverse event reporting and more efficient clinical research. Registry-based research benefits from reduced cost, large sample size and real-world applicability, with methodological developments, particularly registry-based randomised controlled trials and causal inference techniques, showing promise. Limitations include data quality and validity, the need for data linkage, the restrictions of fixed data fields, regulatory barriers, and privacy and security concerns. However, the principal factor hampering current efforts is a lack of anaesthesia-specific datasets in the UK and the fact that most surgical registries do not collect any anaesthetic data. This presents an opportunity for anaesthetists, through enhanced engagement and collaboration, to influence and improve the design of these datasets and increase the value and volume of data collected. Better datasets, coupled with a growing appreciation of new analysis methodologies, would allow significant progress towards realising the potential of routinely collected data for patient benefit. At the same time, work should begin on the development of a minimum dataset for anaesthesia to underpin new data sharing networks and, ideally, a national registry of anaesthesia.
随机对照试验是临床研究的金标准,但由于其费用高昂和被认为缺乏“真实世界”适用性,仍然很少见。与此同时,常规收集的数据呈指数级增长,为审核、质量改进、不良事件报告和更高效的临床研究提供了机会。基于注册的研究具有成本降低、样本量大和适用于真实世界的优势,方法学的发展,特别是基于注册的随机对照试验和因果推理技术,显示出了前景。局限性包括数据质量和有效性、数据链接的需求、固定数据字段的限制、监管障碍以及隐私和安全问题。然而,目前阻碍工作的主要因素是英国缺乏特定于麻醉的数据集,而且大多数手术登记处没有收集任何麻醉数据。这为麻醉师提供了一个机会,通过加强参与和合作,影响和改进这些数据集的设计,并增加收集的数据的价值和数量。更好的数据集,加上对新分析方法的日益认识,将有助于实现常规收集数据为患者带来益处的潜力。与此同时,应该开始开发一个用于麻醉的最小数据集,以支持新的数据共享网络,并且理想情况下,建立一个全国性的麻醉登记处。