Cutteridge Joseph, Barsby Joseph, Hume Samuel, Lemmey Hamish A L, Lee Regent, Bera Katarzyna D
Specialised Foundation School, York and Scarborough Teaching Hospitals NHS Foundation Trust, York, UK.
Department of Health Sciences, Faculty of Sciences, University of York, York, UK.
BJS Open. 2025 Mar 4;9(2). doi: 10.1093/bjsopen/zrae156.
Evidence-based medicine relies on randomized clinical trials, which should represent the patients encountered in clinical practice. Characteristics of patients recruited to randomized clinical trials involving vascular index operations (carotid endarterectomy, abdominal aortic aneurysm repair, infrainguinal bypass and major lower limb amputations) were compared with those recorded in the National Vascular Registry across England and Wales.
MEDLINE, Embase, Web of Science, CENTRAL, clinicaltrials.gov and World Health Organization International Trials Registry Platform (CRD42021247905) were searched for randomized clinical trials involving the index operations. Demographic (age, sex, ethnicity) and clinical (co-morbidities, medications, body mass index, smoking, alcohol, cognition) data were extracted, by operation. Characteristics of operated on patients were extracted from publicly available National Vascular Registry reports (2014-2020). All findings are reported according to PRISMA guidelines. Rayyan.AI, Excel and GraphPad Prism were used for screening and analysis.
A total of 307 randomized clinical trials (66 449 patients) were included and compared with National Vascular Registry data for 119 019 patients. Randomized clinical trial patients were younger across all operations; for carotid endarterectomy, bypass and major lower limb amputation randomized clinical trials, there were differences in female patient representation. Further comparisons were limited by the insufficient baseline data reporting across randomized clinical trials, though reporting improved over decades. National Vascular Registry reports lacked information on patient factors such as patient ethnicity or body mass index.
There are significant differences in demographic and clinical factors between patients recruited to vascular surgery randomized clinical trials and the real-world National Vascular Registry vascular surgery patient population. Minimum reporting standards for baseline data should be defined to allow future randomized clinical trials to represent real-world patient populations and ensure the external validity of their results.
循证医学依赖于随机临床试验，而随机临床试验应反映临床实践中遇到的患者情况。将纳入血管指数手术（颈动脉内膜切除术、腹主动脉瘤修复术、腹股沟下旁路移植术和主要下肢截肢术）的随机临床试验患者的特征与英格兰和威尔士国家血管登记处记录的特征进行了比较。
检索MEDLINE、Embase、科学网、CENTRAL、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台（CRD42021247905），以查找涉及指数手术的随机临床试验。按手术提取人口统计学（年龄、性别、种族）和临床（合并症、用药情况、体重指数、吸烟、饮酒、认知）数据。从公开的国家血管登记处报告（2014 - 2020年）中提取手术患者的特征。所有结果均按照PRISMA指南报告。使用Rayyan.AI、Excel和GraphPad Prism进行筛选和分析。
共纳入307项随机临床试验（66449例患者），并与119019例患者的国家血管登记处数据进行比较。所有手术的随机临床试验患者都更年轻；对于颈动脉内膜切除术、旁路移植术和主要下肢截肢术的随机临床试验，女性患者比例存在差异。尽管几十年来报告情况有所改善，但随机临床试验中基线数据报告不足限制了进一步比较。国家血管登记处报告缺乏患者种族或体重指数等患者因素的信息。
血管外科随机临床试验招募的患者与现实世界国家血管登记处的血管外科患者群体在人口统计学和临床因素方面存在显著差异。应定义基线数据的最低报告标准，以便未来的随机临床试验能够代表现实世界的患者群体，并确保其结果的外部有效性。
