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Updated: Aug 7, 2025
Synergizing Antegrade Endoscopic with Bridging Vein Harvesting for Improvement of Great Saphenous Vein Graft Quality from the Lower Leg
Published on: November 19, 2019
Recruitment into randomised trials of arteriovenous grafts: A systematic review
David Kingsmore1,2, Richard D White3, Gaspar Mestres4
1Vascular Surgery, Queen Elizabeth University Hospital, Glasgow, UK.
Abstract:
Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.
Insights
Randomized controlled trials (RCTs) in surgery, particularly for arteriovenous grafts (AVGs), face recruitment challenges and often have limitations. Future surgical RCTs require better planning for patient populations and attrition to improve data quality.
Area of Science:
- Vascular Surgery
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- Randomized controlled trials (RCTs) are the gold standard for medical evidence but are infrequent in surgery.
- Surgical RCTs face unique challenges, including treatment variability and recruitment difficulties, leading to high discontinuation rates.
- The role of arteriovenous grafts (AVGs) in vascular access is debated, making high-quality trial data crucial for guidelines.
Approach:
- This review systematically analyzed the planning and recruitment strategies of all published RCTs involving AVGs.
- The study aimed to identify variations and limitations in the design and execution of these trials.
- Data from 31 RCTs conducted over 31 years were evaluated for methodological quality.
Key Points:
- Only 31 RCTs on AVGs have been conducted in the last 31 years.
- The vast majority of these trials exhibited significant limitations that compromise their findings.
- Major challenges include planning for patient populations, trial uptake, and attrition due to comorbidities.
Conclusions:
- There is a critical need for higher quality RCTs and data in the field of vascular access, specifically concerning AVGs.
- Improved study design, accounting for patient recruitment and retention, is essential for future surgical RCTs.
- Enhanced planning is fundamental to generating reliable evidence for clinical decision-making and guideline development.
