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Published on: March 26, 2018
Quantity of Randomised Controlled Trials Relative to Operative Workload in Major Vascular Surgery: A Systematic
Harri G Jones1, Alex Murigu2, Callum Weston3
1Gwent Vascular Institute, Aneurin Bevan University Health Board, UK.
Objective:
Changes in vascular practice have altered workloads across major procedures. The extent to which level 1 evidence has accrued in proportion to current workload across these categories is uncertain, and trial evidence appears unevenly distributed between procedures. This study aimed to assess the number of randomised controlled trials (RCTs) supporting key vascular surgery procedures and compare them with UK operative workload.
Data Sources:
MEDLINE, Embase, and CENTRAL were searched using Cochrane derived RCT filters.
Review Methods:
A systematic review identified RCTs related to abdominal aortic aneurysm (AAA) repair, carotid endarterectomy, lower limb revascularisation, and major lower limb amputation since 1990. Operative workload was defined as the number of procedures in the 2024 UK National Vascular Registry (NVR) report, adjusted for case ascertainment. Primary outcome was the ratio of RCTs to operative workload for each procedure. Secondary outcomes included citation metrics, funding, and trial type. Sensitivity analyses were performed using the number of RCT recruits.
Results:
Of 744 eligible RCTs, open AAA repair and carotid endarterectomy had the largest number of RCTs, with 8.1/100 and 4.5/100 ascertainment adjusted NVR procedures, respectively, followed by endovascular AAA repair (2.4), open lower limb revascularisation (2.1), endovascular lower limb revascularisation (1.7), and major amputation (0.7). Endovascular lower limb revascularisation trials were largely efficacy dominant (72.4%) with a large proportion being industry funded (39.3%). On sensitivity analysis, carotid endarterectomy and open AAA repair had the largest number of recruits to RCT per ascertainment adjusted NVR procedure, with 10.5 and 6.8, respectively, followed by open lower limb revascularisation (4.3), endovascular AAA repair (3.0), endovascular lower limb revascularisation (2.8), and major amputation (0.7).
Conclusion:
Major amputation and lower limb revascularisation appear underrepresented in research trials compared with carotid endarterectomy and AAA repair, relative to UK operative workload. Future research agendas and funding strategies should consider proportionality when prioritising.
