Williams Richard, Jenkins David, Bolton Thomas, Heald Adrian, Mizani Mehrdad, Sperrin Matthew, Peek Niels
Division of Informatics, Imaging and Data Science, The University of Manchester, Manchester, UK
NIHR Applied Research Collaboration Greater Manchester, Manchester, UK.
BMJ Open. 2025 Apr 23;15(4):e093080. doi: 10.1136/bmjopen-2024-093080.
To assess the degree to which we can replicate a study between a regional and a national database of electronic health record data in the UK. The original study examined the risk factors associated with hospitalisation following COVID-19 infection in people with diabetes.
A replication of a retrospective cohort study.
Observational electronic health record data from primary and secondary care sources in the UK. The original study used data from a large, urbanised region (Greater Manchester Care Record, Greater Manchester, UK-2.8 m patients). This replication study used a national database covering the whole of England, UK (NHS England's Secure Data Environment service for England, accessed via the BHF Data Science Centre's CVD-COVID-UK/COVID-IMPACT Consortium-54 m patients).
Individuals with a diagnosis of type 1 diabetes or type 2 diabetes prior to a positive COVID-19 test result. The matched controls (3:1) were individuals who had a positive COVID-19 test result, but who did not have a diagnosis of diabetes on the date of their positive COVID-19 test result. Matching was done on age at COVID-19 diagnosis, sex and approximate date of COVID-19 test.
Hospitalisation within 28 days of a positive COVID-19 test.
We found that many of the effect sizes did not show a statistically significant difference, but that some did. Where effect sizes were statistically significant in the regional study, then they remained significant in the national study and the effect size was the same direction and of similar magnitude.
There is some evidence that the findings from studies in smaller regional datasets can be extrapolated to a larger, national setting. However, there were some differences, and therefore replication studies remain an essential part of healthcare research.
评估在英国，我们能够在地区和国家电子健康记录数据库之间复制一项研究的程度。原研究考察了糖尿病患者感染新冠病毒后与住院相关的风险因素。
一项回顾性队列研究的复制研究。
来自英国初级和二级医疗保健机构的观察性电子健康记录数据。原研究使用了来自一个大型城市化地区（大曼彻斯特护理记录，英国大曼彻斯特 - 280万患者）的数据。这项复制研究使用了一个覆盖英国整个英格兰的国家数据库（通过英国心脏基金会数据科学中心的心血管疾病 - 新冠病毒 - 英国/新冠病毒影响联盟访问的英国国民保健制度英格兰的安全数据环境服务 - 5400万患者）。
新冠病毒检测呈阳性之前被诊断为1型糖尿病或2型糖尿病的个体。匹配的对照组（3:1）是新冠病毒检测呈阳性，但在其新冠病毒检测呈阳性之日没有糖尿病诊断的个体。匹配是根据新冠病毒诊断时的年龄、性别和新冠病毒检测的大致日期进行的。
新冠病毒检测呈阳性后28天内的住院情况。
我们发现许多效应量没有显示出统计学上的显著差异，但有些显示出了差异。在地区研究中效应量具有统计学显著性的地方，在国家研究中它们仍然显著，并且效应量方向相同且大小相似。
有一些证据表明，在较小的地区数据集中进行的研究结果可以外推到更大的国家背景中。然而，存在一些差异，因此复制研究仍然是医疗保健研究的重要组成部分。
