Randomized controlled trials: still the backbone of vascular surgery?

Area of Science:

• Vascular Surgery
• Evidence-Based Medicine
• Clinical Practice Guidelines

Background:

• Historically, clinical decisions relied on 'intuitive reasoning' and personal experience.
• Landmark randomized trials in carotid disease revolutionized vascular surgery, establishing evidence-based practice.
• Despite their impact, randomized trials have limitations including cost, recruitment challenges, and external validity issues.

Approach:

• This review examines the evolution from intuitive reasoning to evidence-based medicine in vascular surgery.
• It analyzes the pivotal role of randomized trials in shaping current practice guidelines.
• The discussion highlights the tension between trial data and real-world observational evidence.

Key Points:

• Randomized trials became the gold standard, influencing guidelines for carotid disease, lower limb revascularization, and aortic aneurysms.
• Observational studies, though prone to bias, offer insights into 'real-world' practice.
• Guideline bodies like NICE and AHA heavily prioritize randomized trial evidence.

Conclusions:

• Current guidelines struggle to incorporate high-quality observational data due to the prioritization of historical randomized trial evidence.
• This is particularly evident in the management of asymptomatic carotid disease.
• A shift towards valuing diverse evidence sources is needed for contemporary guidelines.