Musto Liam, Saratzis Athanasios, Nath Mintu, Katsogridakis Emmanuel, Elsworth Ann, Bujkiewicz Sylwia, Hobson Clark, Lawson Claire, Wallace Susan, Gonzalez-Aguado Maria, Smith Aiden, Hodgson Susan, Yao Guiqing Lily, Miola José, Bown Matthew J
Department of Cardiovascular Sciences, NIHR Leicester Biomedical Research Centre and BHF Centre for Research Excellence, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.
Biostatistics Research Group, Department of Health Sciences, University of Leicester, Leicester, United Kingdom.
PLoS One. 2025 Jul 16;20(7):e0327856. doi: 10.1371/journal.pone.0327856. eCollection 2025.
The NHS abdominal aortic aneurysm (AAA) screening programme (NAAASP) is both clinically and economically effective. One of the main determinants of this effectiveness is disease prevalence. AAA prevalence is decreasing over time, steadily reducing the efficiency of the current NAAASP screening policy. One alternative to whole population screening is targeted screening of high-risk groups. Whether this would detect a clinically and publicly acceptable proportion of disease, and whether it would improve cost-effectiveness are unknown. The aim of this research is to estimate the clinical outcomes and cost-effectiveness of targeted AAA screening.
Rather than conducting an expensive and time-consuming randomized trial to directly test targeted screening, we will undertake in-silico trials of targeted AAA screening. To determine success criteria for in-silico trials, the ethics and issues around the acceptability of targeted screening will first be explored through focus groups and interviews. A qualitative evidence synthesis to identify issues associated with targeted screening will be used to establish themes and topic guides. To perform the in-silico trials, individual men's outcomes from the NAAASP (2013-2024, ≈ 2,500,000 men, ≈ 1% with AAA) will be linked to primary care data from the Clinical Practice Research Datalink (CPRD) (20% overlap of records). Risk factors for AAA will be identified by developing a risk prediction model and used as targeted screening criteria in in-silico trials, with diagnostic accuracy as the primary outcome. A discrete event simulation model will be adopted to extrapolate the trial findings beyond the observed period. We will estimate the clinical and cost-effectiveness of targeted screening compared with the current whole population screening strategy. Data linkage will be undertaken under Health Research Authority Confidentiality Advisory Group (Section 251) approval. Linked data will be effectively anonymised. Participants in the qualitative substudy will provide informed consent for participation.
We expect this project to have a direct and significant impact on NHS, UK and worldwide AAA screening policies. The study findings will be submitted for publication in peer-reviewed journals and presented at scientific meetings.
英国国家医疗服务体系（NHS）的腹主动脉瘤（AAA）筛查项目在临床和经济方面均具有成效。该成效的主要决定因素之一是疾病患病率。随着时间推移，AAA患病率在下降，这使得当前NHS腹主动脉瘤筛查政策的效率稳步降低。全人群筛查的一种替代方案是对高危群体进行针对性筛查。这是否能检测出临床上和公众可接受的疾病比例，以及是否能提高成本效益尚不清楚。本研究的目的是评估针对性AAA筛查的临床结果和成本效益。
我们不会开展昂贵且耗时的随机试验来直接测试针对性筛查，而是将进行针对性AAA筛查的计算机模拟试验。为确定计算机模拟试验的成功标准，首先将通过焦点小组和访谈探讨针对性筛查可接受性的伦理和相关问题。将采用定性证据综合法来识别与针对性筛查相关的问题，以确立主题和主题指南。为进行计算机模拟试验，NHS腹主动脉瘤筛查项目（2013 - 2024年，约250万名男性，约1%患有AAA）中个体男性的结果将与来自临床实践研究数据链（CPRD）的初级保健数据相链接（记录重叠20%）。将通过开发风险预测模型来确定AAA的风险因素，并将其用作计算机模拟试验中的针对性筛查标准，以诊断准确性作为主要结果。将采用离散事件模拟模型将试验结果外推至观察期之外。我们将评估与当前全人群筛查策略相比，针对性筛查的临床和成本效益。数据链接将在健康研究管理局保密咨询小组（第251条）批准下进行。链接的数据将进行有效的匿名处理。定性子研究的参与者将提供知情同意书以参与研究。
我们预计该项目将对英国国家医疗服务体系、英国乃至全球的AAA筛查政策产生直接且重大的影响。研究结果将提交至同行评审期刊发表，并在科学会议上展示。
