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Updates to the National Institute of Neurological Disorders and Stroke (NINDS) Multiple Sclerosis (MS) Common Data Element (CDE) Recommendations: 2018 MS Oversight Committee (OC) Review

May 4

Conference Paper

Gay, K.; Edun, I.; Sheikh, M.; Esterlitz, J.; Lublin, F.; Utz, U.; Lungu, C.; Mendoza-Puccini, C.;on behalf

American Academy of Neurology 71st Annual Meeting

Philadelphia, PA


2018 MS Oversight Committee (OC) Review; Common Data Element (CDE); Multiple Sclerosis (MS); National Institute of Neurological Disorders and Stroke (NINDS)

Objective: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) project was established in 2006 to develop data standards for clinical research in neuroscience. The goals of the NINDS CDE project include reducing study start-up time and cost, streamlining data collection, facilitating data sharing, improving data quality and serving as a resource for new clinical investigators. Background: The Multiple Sclerosis (MS) CDEs were developed in 2011 by a subject matter expert Working Group. These recommendations include template case report forms, CDE details and instruments. Recommendations are stratified by Classifications: Core (required), Supplemental-Highly Recommended (strongly encouraged based on study type), Supplemental (commonly collected, but not required), Exploratory (reasonable to fill in gaps, but require further validation). An MS Oversight Committee (OC) was formed in 2013 to review user feedback and updates to the CDEs based on advancements in clinical research. The OC convened most recently in 2018 to review the recommendations. Design/Methods: The MS OC members volunteered to review the existing MS CDE recommendations by subdomain. They focused on the following questions: Is the classification for the element/measure still accurate? Are there any new elements/measures that should be considered as Core or Supplemental – Highly Recommended? For instruments classified as Supplemental–Highly Recommended, can a context (e.g., for MS imaging studies) for use be specified? Results: The MS OC will reconvene to review the recommended updates prior to a public review on the NINDS CDE website. Changes to the MS CDEs will be incorporated and finalized once the OC has arrived at a consensus. Conclusions: NINDS encourages the use of CDEs for all clinical research in neuroscience. To ensure that the CDEs are a dynamic and useful resource, the recommendations are updated periodically based on the current state of science and user input.

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