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Randomized Trials and Collaborative Research in Epilepsy Surgery: Future Directions

Published online by Cambridge University Press:  02 December 2014

Samuel Wiebe  and
Nathalie Jette
Samuel Wiebe*
Affiliation:
Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada
Nathalie Jette
Affiliation:
Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada
*
Foothills Medical Centre, 1403-29th Street N.W., Calgary, Alberta, T2N 2T9, Canada
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Abstract

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Background:

Although randomized controlled trials (RCTs) are the gold standard for evaluating therapeutic interventions, surgical RCTs are particularly challenging and few have been done in the field of epilepsy surgery. We assess the level of RCT activity in epilepsy surgery and propose feasible alternatives to develop sustainable research initiatives in this area.

Methods:

We undertook a systematic review of the world literature to assess the level of RCT activity in epilepsy surgery. Previous personal experience with RCTs in epilepsy surgery and examples of successful Canadian multicentre research networks were reviewed to propose initiatives for sustainable, valid research in epilepsy surgery.

Results:

We identified 12 RCTs in epilepsy surgery, including 692 patients, of whom 416 were involved in vagus nerve stimulation, 16 in various brain electrostimulation procedures, 180 in comparisons of different surgical techniques, and 80 in a comparison of medical versus surgical therapy. Most studies were of short duration (median = 3 months, range 3-12 months). In the area of resective surgery, only temporal lobe epilepsy has been subjected to any type of RCT comparison. All RCTs have been done within the last 13 years. There were no multicentre Canadian surgical studies.

Conclusion:

The adoption of RCTs in epilepsy surgery has been slow and difficult worldwide. Because of its universal health care system and its well established epilepsy surgery centres, Canada is in a strong position to create a national epilepsy surgery research initiative capable of undertaking high quality, sustainable research in epilepsy surgery.

Résumé:

RÉSUMÉ:Contexte:

Bien que les essais contrôlés randomisés (ECRs) soient l’étalon or pour évaluer l’intervention thérapeutique, les ECRs chirurgicaux posent un défi particulier et peu ont été faits dans le domaine de la chirurgie de l’épilepsie. Nous avons évalué le niveau d’activité ECR en chirurgie de l’épilepsie et nous proposons des alternatives réalisables pour développer des initiatives de recherche viables dans ce domaine.

Méthodes:

Nous avons effectué une revue systématique de la littérature mondiale afin d’évaluer le niveau d’activité ECR en chirurgie de l’épilepsie. Nous avons revu notre expérience personnelle antérieure dans ce domaine et des exemples de recherche multicentrique en réseau au Canada qui ont été couronnées de succès afin de proposer des initiatives viables et valides dans ce domaine.

Résultats:

Nous avons identifié 12 ECRs en chirurgie de l’épilepsie auxquelles 692 patients ont participé, soit 416 patients qui ont participé à des études sur la stimulation du nerf vague, 16 à des études sur l’électrostimulation cérébrale par différentes techniques, 180 à des études de comparaison de différentes techniques chirurgicales et 80 à des études comparant un traitement médical à un traitement chirurgical. La plupart des études étaient de courte durée (médiane de 3 mois, fourchette de 3 à 12 mois). En ce qui concerne la résection chirurgicale, seule la chirurgie pour épilepsie temporale a fait l’objet d’ECRs. Tous les ECRs ont été faits au cours des 13 dernières années. Il n’existe pas d’étude chirurgicale canadienne multicentrique.

Conclusions:

Le recours aux ECRs dans le domaine de la chirurgie de l’épilepsie à travers le monde est un processus lent et difficile. Le Canada est dans une position privilégiée pour créer une initiative de recherche nationale dans ce domaine. Il possède un système universel de soins de santé et des centres de chirurgie de l’épilepsie qui sont bien établis, ce qui permet d’entreprendre une recherche viable, de haute qualité.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 33 , Issue 4 , November 2006 , pp. 365 - 371
Copyright
Copyright © The Canadian Journal of Neurological 2006

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