Future Directions for Surgical Trial Designs in Trigeminal Neuralgia

Key points: 1. There is no high quality comparative effectiveness research for surgery versus pharmacological management or for different surgical techniques.

2. High quality evidence (randomised controlled trials) is required to inform routine decision making for patients with TN and their consultants.

3. The design and conduct of surgery trials using the standard design has numerous challenges (patient preferences, clinician preferences, clinically meaningful outcome measures, learning curves for surgical techniques, irreversibility of results).

4. The ‘cohort multiple RCT’ design is an innovative alternative design that provides both long term observational data and a facility for quick and efficient conduct of multiple trials. Unlike standard trials, patient information and consent replicate that found in routine healthcare wherever possible.

5. Embedding multiple trials within a cohort of patients with a diagnosis of TN would enable the quick and efficient identification and recruitment of patients to trials of a variety of interventions, and help provide the information that patients and clinicians require.