Understanding the problems with recruitment in surgical randomized trials: A lesson from landmark trials on temporal...

Surgical randomized trials are difficult to accomplish. One major problem is recruitment of a sufficient number of patients to address the clinical problem.

We review the various ways patient recruitment in surgical RCTs can be promoted. We examine two landmark trials on the surgical treatment of temporal lobe epilepsy (TLE), one that was successful, and one which did not attain the target number of participants.

Both designs of the Canadian and American trials of surgery for TLE included a benefit to participants: the Canadian trial gave a chance to have immediate access to investigation and treatment, as compared to a 1 year delay (considered 'standard care' in that center), while the American trial offered free surgical management to both arms. Patients were recruited and treatments randomly allocated prior to knowing for certain whether they were surgical candidates or not. This design choice may have helped circumvent the 'equipoise problem'. The Canadian trial offered participation to drug-resistant patients that were already routinely referred to surgical centers, while the success of the American trial which limited recruitment to the early period of drug resistance was dependent on a change of practice of referring clinicians which did not materialize.

The surgical treatment of drug-resistant temporal lobe epilepsy has been validated using RCT methods. Ways to promote participation in surgical trials should be further investigated.