Surgical trials are difficult to conduct and to complete, especially when they concern treatments already in common use, or when surgery is considered only after medical management has failed [1], [2]. In this article we review ways to improve patient recruitment in surgical RCTs. We also review 2 RCTs on temporal lobe epilepsy to illustrate some of the design elements that can be used to render RCTs more acceptable, the first a Canadian trial conducted between 1996 and 2000 which succeeded, and a second American trial conducted between 2003 and 2009 which did not attain the target number of participants.

In the 1990s, surgery for temporal lobe epilepsy was thought to be highly effective but grossly underused. Wiebe, the lead author of the Canadian trial, thought that lack of robust evidence contributed to the underuse: ‘many clinicians who care for patients with epilepsy are uncertain about the efficacy and safety of costly surgical procedures and still view surgery as a last resort for patients with intractable epilepsy. The absence of robust evidence supporting the safety and efficacy of surgery for epilepsy figures prominently among the possible reasons for this view. There have been no randomized, controlled trials’ [3].

Engel, the lead author of the second RCT, explained: ‘The primary reason RCTs had not been performed previously was lack of the necessary equipoise; it was so obvious to those working in epilepsy surgery centers that surgery is effective, that it was considered unethical to assign candidates to the medical arm of a randomized trial’ [4].

Thus, according to these authors, a lack of evidence from randomized trials contributed to under-referral to surgical centers. In turn, the absence of RCT evidence was explained by ‘lack of the necessary equipoise’: epilepsy surgical teams were so certain of the benefits of surgery that to randomly allocate medical therapy to some patients would be unethical.

This seems like a paradox: to give a patient a 50% chance of medical therapy was considered unacceptable by many epilepsy surgeons, while non-surgical clinicians who did not refer their patients believed that a 100% chance of medical therapy was best until proven otherwise, and thus did not obtain a surgical consultation.

Are randomized trials performed to arbiter a difference of expert opinions? Shouldn’t both parties agree to work together to get the kind of evidence necessary to settle the matter? Who has the burden of the proof [5] ?

Of course, patient preferences regarding management decisions or trial participation are crucial in this story. We first review the various ways patient recruitment in surgical RCTs can be promoted.