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What Constitutes a Clinically Meaningful Outcome in Pediatric Epilepsy?

What Constitutes a Clinically Meaningful Outcome in Pediatric Epilepsy?

Format

Webcast

Time to Complete

1 hour

Released

January 16, 2019

Expires

January 16, 2020
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Maximum Credits

1.00 / AMA PRA Category 1 Credit(s)TM

Accredited Provider


Jointly provided by Postgraduate Institute for Medicine and Miller Communications

Commercial Supporter

This activity is supported by an independent educational grant from Zogenix, Inc.

Program Description

Change in seizure frequency is a well-established end point for epilepsy treatment efficacy studies and serves as the primary data for regulatory approval of new therapies. Yet, from the perspective of both patients and caregivers, improvements in non-seizure outcomes are also extremely important. There are few validated methods of assessment for non-seizure outcomes for therapeutic trials, however, and the relationships between non-seizure outcomes and seizure burden are incompletely understood. In this activity, expert faculty will discuss implications of considering non-seizure outcomes on trial design and patient selection, as well as how measures such as the clinical global impression of change (CGIC) may be used to define clinically meaningful response for pediatric epilepsy treatment trials

Intended Audience

This activity is intended for physicians engaged in the care of patients with pediatric epilepsy.

Educational Objectives

After completing this activity, participants should be better able to:

  • Summarize ways in which different stakeholders evaluate seizure and non-seizure outcomes in pediatric epilepsy clinical trials
  • Utilize seizure frequency and clinical global impression of change to define clinically meaningful response to treatment

Conflicts of Interest Disclosure Policy

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty

Renée A. Shellhaas, MD, MS
Clinical Associate Professor of Pediatrics Neurology Division
University of Michigan
C.S. Mott Children’s Hospital
Ann Arbor, Michigan

Dr. Shellhaas has nothing to disclose.

Dennis J. Dlugos, MD, MSCE
Professor of Neurology and Pediatrics
Perelman School of Medicine
University of Pennsylvania
Director
Pediatric Epilepsy Program
Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania

Dr. Dlugos discloses the following:
Contracted Research: Pennsylvania Department of Health, The Epilepsy Study Consortium

Joseph E. Sullivan, MD
Associate Professor of Neurology & Pediatrics
University of California, San Francisco (UCSF)
Director
UCSF Pediatric Epilepsy Center of Excellence
Benioff Children’s Hospital
San Francisco, California

Dr. Sullivan discloses the following:
Consulting Fees: Epygenix, Marinus, Stoke, Xenon
Fees for Non-CME/CE Services Received Directly from a Commercial Interest or their Agents (e.g., speakers’ bureaus): Invitae
Contracted Research: Zogenix, Inc

Planners and Managers

The PIM planners and managers have nothing to disclose.

The Miller Medical Communications, LLC, planners and managers have nothing to disclose.

Credit

1.00

Type

AMA PRA Category 1 Credit(s)TM

Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and MedInsights CE Academy.  Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Designation Statement

The Postgraduate Institute for Medicine designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit(s)TM .  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

Media

Internet

Instructions

This activity is offered at no cost to participants. To obtain credit, please proceed with the activity until you have successfully completed this program, and evaluation, and have received a digital copy of your credit certificate. Your online certificate will be saved on myCME within your Profile/CME History, which you can access at any time.

If you have any questions relating to the accreditation of this activity, please contact Postgraduate Institute for Medicine at: inquiries@pimed.com or (303) 799-1930.

SYSTEM REQUIREMENTS

Hardware and Software Requirements
  • A computer with an internet connection
  • Internet Browser: Internet Explorer 7.x or higher, Firefox 4.x or higher, Safari 2.x or higher, or any other W3C standards compliant browser
  • Additional Software: Adobe Flash Player and/or an HTML 5 capable browser maybe required for video or audio playback. PowerPoint or Adobe Acrobat Reader may occasionally be required
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