Early Surgical Therapy for Drug-Resistant Temporal Lobe Epilepsy: A Randomized Trial
Jerome Engel,Michael P. McDermott,Samuel Wiebe,John T. Langfitt,John M. Stern,Sandra Dewar,Michael R. Sperling,Irenita Gardiner,Giuseppe Erba,Itzhak Fried,Margaret Jacobs,Harry V. Vinters,Scott Mintzer,Karl Kieburtz +13 more
TLDR
Whether surgery soon after failure of 2 antiepileptic drug (AED) trials is superior to continued medical management in controlling seizures and improving quality of life (QOL) is sought and among patients with newly intractable disabling MTLE, resective surgery plus AED treatment resulted in a lower probability of seizures during year 2 of follow-up than continued AEDtreatment alone.Abstract:
Context Despite reported success, surgery for pharmacoresistant seizures is often seen as a last resort. Patients are typically referred for surgery after 20 years of seizures, often too late to avoid significant disability and premature death. Objective We sought to determine whether surgery soon after failure of 2 antiepileptic drug (AED) trials is superior to continued medical management in controlling seizures and improving quality of life (QOL). Design, Setting, and Participants The Early Randomized Surgical Epilepsy Trial (ERSET) is a multicenter, controlled, parallel-group clinical trial performed at 16 US epilepsy surgery centers. The 38 participants (18 men and 20 women; aged ≥12 years) had mesial temporal lobe epilepsy (MTLE) and disabling seizues for no more than 2 consecutive years following adequate trials of 2 brand-name AEDs. Eligibility for anteromesial temporal resection (AMTR) was based on a standardized presurgical evaluation protocol. Participants were randomized to continued AED treatment or AMTR 2003-2007, and observed for 2 years. Planned enrollment was 200, but the trial was halted prematurely due to slow accrual. Intervention Receipt of continued AED treatment (n = 23) or a standardized AMTR plus AED treatment (n = 15). In the medical group, 7 participants underwent AMTR prior to the end of follow-up and 1 participant in the surgical group never received surgery. Main Outcome Measures The primary outcome variable was freedom from disabling seizures during year 2 of follow-up. Secondary outcome variables were health-related QOL (measured primarily by the 2-year change in the Quality of Life in Epilepsy 89 [QOLIE-89] overall T-score), cognitive function, and social adaptation. Results Zero of 23 participants in the medical group and 11 of 15 in the surgical group were seizure free during year 2 of follow-up (odds ratio = ∞; 95% CI, 11.8 to ∞; P Conclusions Among patients with newly intractable disabling MTLE, resective surgery plus AED treatment resulted in a lower probability of seizures during year 2 of follow-up than continued AED treatment alone. Given the premature termination of the trial, the results should be interpreted with appropriate caution. Trial Registration clinicaltrials.gov Identifier: NCT00040326read more
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Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.
Melanie Calvert,Jane M Blazeby,Douglas G. Altman,Dennis A. Revicki,David Moher,Michael Brundage +5 more
TL;DR: In this article, the authors describe the development of the CONSORT PRO extension based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network.
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Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy
Vicenta Salanova,Thomas C. Witt,Robert M. Worth,Thomas R. Henry,Robert E. Gross,Jules M. Nazzaro,Douglas Labar,Michael R. Sperling,Ashwini Sharan,Evan Sandok,Adrian Handforth,John M. Stern,Steve Chung,Jaimie M. Henderson,Jacqueline A. French,Gordon H. Baltuch,William E. Rosenfeld,Paul A. Garcia,Nicholas M. Barbaro,Nathan B. Fountain,W. Jeffrey Elias,Robert R. Goodman,John R. Pollard,Alexander I. Tröster,Christopher P. Irwin,Kristin Lambrecht,Nina M. Graves,Robert S. Fisher +27 more
TL;DR: This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years.
Reporting of Patient-Reported Outcomes in Randomized Trials
Melanie Calvert,Jane M Blazeby,Douglas G. Altman,Dennis A. Revicki,David Moher,Michael Brundage +5 more
TL;DR: The development of the CONSORT PRO extension is described, based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network, to supplement the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes.
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