Randomisation is the cornerstone of clinical trial methodology, yet surgical trials face unique challenges that make it harder to implement than in drug trials.
Why randomise? The fundamental purpose is to eliminate selection bias. Without randomisation, surgeons naturally select patients for procedures they believe will benefit them most. This produces confounded results that cannot reliably guide practice.
What is equipoise? Clinical equipoise exists when there is genuine uncertainty within the expert medical community about which treatment is superior. Note the key word: community. Individual surgeons may have preferences, but if the broader community is uncertain, equipoise exists and a trial is ethical.
The challenge in surgery is that equipoise can be harder to maintain. Surgeons develop expertise with particular techniques and may believe one approach is superior based on their personal results. The Wennberg hypothesis suggests that practice variation itself is evidence of equipoise — if different centres do different things, we clearly do not know the right answer.
Practical tips for discussing randomisation with patients:
1. Be honest about uncertainty. Patients generally understand that doctors do not always know the best treatment.
2. Emphasise that both treatments are established and acceptable.
3. Explain that randomisation ensures fairness — it prevents bias in who gets which treatment.
4. Make clear that they can withdraw at any time without affecting their care.
5. Use the teach-back method: ask the patient to explain in their own words what they understand about the study.
For the FRCS academic viva, be prepared to discuss equipoise in the context of current UK trials and to explain why observational data alone cannot answer certain questions.