MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, 90 High Holborn, London WC1V 6LJ, UK; Health Data Research, UK; Guys and St Thomas' NHS Foundation Trust, London, UK.
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, 90 High Holborn, London WC1V 6LJ, UK.
Contemp Clin Trials. 2023 May;128:107162. doi: 10.1016/j.cct.2023.107162. Epub 2023 Mar 16.
Routinely-collected healthcare systems data (HSD) are proposed to improve the efficiency of clinical trials. A comparison was undertaken between cardiovascular (CVS) data from a clinical trial database with two HSD resources.
Protocol-defined and clinically reviewed CVS events (heart failure (HF), acute coronary syndrome (ACS), thromboembolic stroke, venous and arterial thromboembolism) were identified within the trial data. Data (using pre-specified codes) was obtained from NHS Hospital Episode Statistics (HES) and National Institute for Cardiovascular Outcomes Research (NICOR) HF and myocardial ischaemia audits for trial participants recruited in England between 2010 and 2018 who had provided consent. The primary comparison was trial data versus HES inpatient (APC) main diagnosis (Box-1). Correlations are presented with descriptive statistics and Venn diagrams. Reasons for non-correlation were explored.
From 1200 eligible participants, 71 protocol-defined clinically reviewed CVS events were recorded in the trial database. 45 resulted in a hospital admission and therefore could have been recorded by either HES APC/ NICOR. Of these, 27/45 (60%) were recorded by HES inpatient (Box-1) with an additional 30 potential events also identified. HF and ACS were potentially recorded in all 3 datasets; trial data recorded 18, HES APC 29 and NICOR 24 events respectively. 12/18 (67%) of the HF/ACS events in the trial dataset were recorded by NICOR.
Concordance between datasets was lower than anticipated and the HSD used could not straightforwardly replace current trial practices, nor directly identify protocol-defined CVS events. Further work is required to improve the quality of HSD and consider event definitions when designing clinical trials incorporating HSD.
常规收集的医疗保健系统数据（HSD）被提议用于提高临床试验的效率。本文对临床试验数据库中的心血管（CVS）数据与两种 HSD 资源进行了比较。
在试验数据中，确定了符合方案定义和临床审查的 CVS 事件（心力衰竭（HF）、急性冠状动脉综合征（ACS）、血栓栓塞性中风、静脉和动脉血栓栓塞）。数据（使用预定义的代码）从英国国家卫生服务医院发病统计（HES）和国家心血管结果研究所（NICOR）HF 和心肌缺血审计中获得，这些数据来自于 2010 年至 2018 年期间在英格兰招募的并提供了同意的试验参与者。主要比较是试验数据与 HES 住院（APC）主要诊断（Box-1）。用描述性统计和 Venn 图表示相关性。探索了不相关的原因。
从 1200 名符合条件的参与者中，在试验数据库中记录了 71 项符合方案定义并经临床审查的 CVS 事件。其中 45 项导致住院治疗，因此可能由 HES APC/NICOR 记录。在这些患者中，27/45（60%）由 HES 住院（Box-1）记录，另外还确定了 30 例潜在事件。HF 和 ACS 均可能在所有 3 个数据集进行记录；试验数据记录了 18 例，HES APC 记录了 29 例，NICOR 记录了 24 例。在试验数据集的 18 例 HF/ACS 事件中，有 12 例（67%）被 NICOR 记录。
数据集之间的一致性低于预期，并且所使用的 HSD 不能简单地替代当前的试验实践，也不能直接识别符合方案定义的 CVS 事件。需要进一步努力提高 HSD 的质量，并在设计纳入 HSD 的临床试验时考虑事件定义。
