title: Design considerations for a multicenter randomized controlled trial of early surgery for mesial temporal lobe epilepsy.
abstract: OBJECTIVE
  To describe the trial design for the multicenter Early Randomized Surgical Epilepsy Trial (ERSET). Patients with pharmacoresistant epilepsy are generally referred for surgical treatment an average of two decades after onset of seizures, often too late to avoid irreversible disability. ERSET was designed to assess the safety and efficacy of early surgical intervention compared to continued pharmacotherapy.
  
  
  METHODS
  ERSET is a randomized controlled, parallel group clinical trial with blinded outcome adjudication. Participants are patients with mesial temporal lobe epilepsy (MTLE) older than the age of 12 who have had pharmacoresistant seizures for not >2 years and are determined by detailed evaluation to be surgical candidates prior to randomization. The primary outcome measure is seizure freedom in the second year of a 2-year follow-up period. Health-related quality of life (HRQOL), neurocognitive function, ancillary outcomes, and adverse events were also measured.
  
  
  RESULTS
  Significant methodologic problems addressed by the study design included the following: recruitment of participants early in the course of epilepsy; establishment of operational definitions for "pharmacoresistant" and "early"; and standardization of diagnostic testing, medical treatment, and surgical interventions across multiple centers.
  
  
  CONCLUSIONS
  Rigorous trial designs to assess surgical interventions in epilepsy are necessary to provide evidence to guide treatment. This article is the first of a series; trial results will be reported in subsequent publications.
authors.affiliation: Department of Neurology, UCLA, Los Angeles, California 90095-1769, USA. engel@ucla.edu
authors.forename: Jerome
authors.initials: J
authors.lastname: Engel
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Samuel
authors.initials: S
authors.lastname: Wiebe
authors.forename: John T
authors.initials: JT
authors.lastname: Langfitt
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Erba
authors.forename: Irenita
authors.initials: I
authors.lastname: Gardiner
authors.forename: John
authors.initials: J
authors.lastname: Stern
authors.forename: Sandra
authors.initials: S
authors.lastname: Dewar
authors.forename: Michael R
authors.initials: MR
authors.lastname: Sperling
authors.forename: Margaret
authors.initials: M
authors.lastname: Jacobs
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
mesh_terms: D000293:Adolescent; D000328:Adult; D000654:Amobarbital; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D004292:Dominance, Cerebral; D004311:Double-Blind Method; D004351:Drug Resistance; D004569:Electroencephalography / Q000706:statistics & numerical data; D004833:Epilepsy, Temporal Lobe / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D019635:Neurosurgical Procedures / Q000379:methods*; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D049268:Positron-Emission Tomography; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000654:Amobarbital