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
