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Design considerations for a multicenter randomized controlled trial of early surgery for mesial temporal lobe epilepsy

Engel Jr, Jerome ; McDermott, Michael P. ; Wiebe, Samuel ; Langfitt, John T. ; Erba, Giuseppe ; Gardiner, Irenita ; Stern, John ; Dewar, Sandra ; Sperling, Michael R. ; Jacobs, Margaret ; Kieburtz, Karl

Epilepsia (Copenhagen), 2010-10, Vol.51 (10), p.1978-1986 [Periódico revisado por pares]

Oxford, UK: Blackwell Publishing Ltd

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Título:
Design considerations for a multicenter randomized controlled trial of early surgery for mesial temporal lobe epilepsy
Autor: Engel Jr, Jerome ; McDermott, Michael P. ; Wiebe, Samuel ; Langfitt, John T. ; Erba, Giuseppe ; Gardiner, Irenita ; Stern, John ; Dewar, Sandra ; Sperling, Michael R. ; Jacobs, Margaret ; Kieburtz, Karl
Assuntos: Adolescent ; Adult ; Amobarbital ; Anticonvulsants - therapeutic use ; Anticonvulsants. Antiepileptics. Antiparkinson agents ; Biological and medical sciences ; Child ; Dominance, Cerebral ; Double-Blind Method ; Drug Resistance ; Early surgery ; Electroencephalography - statistics & numerical data ; Epilepsy, Temporal Lobe - diagnosis ; Epilepsy, Temporal Lobe - drug therapy ; Epilepsy, Temporal Lobe - surgery ; Female ; Follow-Up Studies ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Humans ; Longitudinal Studies ; Male ; Medical sciences ; Nervous system (semeiology, syndromes) ; Neurology ; Neuropharmacology ; Neurosurgical Procedures - methods ; Outcome Assessment (Health Care) ; Patient Selection ; Pharmacology. Drug treatments ; Positron-Emission Tomography ; Psychiatric Status Rating Scales ; Randomized controlled trial ; Research Design ; Temporal lobe epilepsy ; Treatment Outcome
É parte de: Epilepsia (Copenhagen), 2010-10, Vol.51 (10), p.1978-1986
Notas: See
Appendix
for investigators.
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The original ERSET investigators also included: Susan AxelrodJohn Barry, MDRobert L. Beach, MD, PhDMichel Berg, MDDavid Blum, MDRobert Brook, MD, ScDThomas Browne, MDHenry Buchtel, PhDJames Burchfiel, PhDLeslie Cahan, MDMargaret Calvano, MSRochelle Caplan, MDJames Cloyd, PhDAndrew Cole, MDWilliam Cunningham, MDPeter DiBiaso, MSRobert Fisher, MD, PhDNancy Foldvary, DOJacqueline French, MDItzhak Fried, MD, PhDRobert Goodman, MDRaghuveer Halkar, MDAllen Hauser, MDThomas Henry, MDDaniel Hoch, MD, PhDPatricia Hudgins, MDSteve Karceski, MDElise Kayson, RNFaustino Lopez, MD, PhDGary Mathern, MDMartha Morrell, MDJeffrey Nicholl, MDErasmo Passaro, MDJack Pellock, MDMichael Risinger, MDOren SaghSer, MDSteven Schachter, MDW. Donald Shields, MDAileen Shinaman, JDDennis Spencer, MDKarleen Swarztrauber, MDDavid Treiman, MDPaul Van Ness, MDBarbara Vickrey, MD, MPHHarry Vinters, MDTed Walczak, MDJames Wilmore, MDAllen Wyler, MD
Engel engel@ucla.edu, McDermott mikem@bst.rochester.edu, Wiebe swiebe@ucalgary.ca, Langfitt John_Langfitt@URMC.Rochester.edu, Erba Giuseppe_Erba@urmc.rochester.edu, Gardiner Nita.Gardiner@ctcc.rochester.edu, Stern jstern@ucla.edu, Dewar sdewar@mednet.ucla.edu, Sperling Michael.Sperling@jefferson.edu, Jacobs margaretpj704@verizon.net, Kieburtz Karl.Kieburtz@ctcc.rochester.edu
Descrição: Summary Purpose: 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. Discussion: 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.
Editor: Oxford, UK: Blackwell Publishing Ltd
Idioma: Inglês

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Design considerations for a multicenter randomized controlled trial of early surgery for mesial temporal lobe epilepsy

Engel Jr, Jerome ; McDermott, Michael P. ; Wiebe, Samuel ; Langfitt, John T. ; Erba, Giuseppe ; Gardiner, Irenita ; Stern, John ; Dewar, Sandra ; Sperling, Michael R. ; Jacobs, Margaret ; Kieburtz, Karl

Oxford, UK: Blackwell Publishing Ltd

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