A Common Language for Clinical Research Studies: NINDS, CDC, ME/CFS and CDEs

Discussion in 'General ME/CFS news' started by MeSci, Apr 14, 2018.

  1. MeSci

    MeSci Senior Member (Voting Rights)

    Cornwall, UK
    Source: Neurology
    Vol 90, #15 Supplement
    Date: April 23, 2018
    URL: http://n.neurology.org/content/90/15_Supplement/P2.016

    [American Academy of Neurology 70th Annual Meeting, Los Angeles]

    A Common Language for Clinical Research Studies: The National Institute of Neurological Disorders and Stroke (NINDS) and Centers for Disease Control and Prevention (CDC) Myalgic
    Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Common Data Elements (CDEs) (P2.016)
    Robin Feldman(1), Katelyn Gay(1), Sherita Ala'i(1), Joy Esterlitz(1), Muniza Sheikh(1), Sarah Tanveer(1), Kristen Joseph(1), Elizabeth Unger(2), Vicky Whittemore(3)

    1 The Emmes Corporation Rockville MD United States
    2 Chronic Viral Diseases Branch, Centers for Disease Control and Prevention Atlanta GA United States
    3 Channels, Synapses and Circuits, National Institute of Neurological Disorders and Stroke Rockville MD United States



    Through a collaboration between the NINDS, National Institutes of Health (NIH), and the CDC, Version 1.0 of CDE recommendations are being developed for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The goals of this project are to increase the efficiency and effectiveness of clinical research studies and treatment, increase data quality, facilitate data sharing and aggregation of information across studies, and help educate new clinical investigators.


    In December 2016, members from the world-wide ME/CFS community were invited to join a CDE development working group (WG) to prepare standard template case report forms (CRFs) and instrument recommendations for clinical research studies. The almost 60 member WG is comprised of patient advocates, clinicians and researchers whose expertise includes a variety of ME/CFS research domains.


    The CDE WG divided into thirteen subgroups: (1) Baseline/Covariate Information; (2) Fatigue; (3) Post-Exertional Malaise; (4) Sleep; (5) Pain; (6) Neurologic; (7) Cognitive; (8) Central Nervous System Imaging; (9) Autonomic; (10) Neuroendocrine; (11) Immune; (12) Quality of Life/Functional Status/CPET/Activity; and (13) Biomarkers. Regular subgroup meetings were held to discuss their purview, review forms and instruments within their domain currently used in ME/CFS research and applicable CDEs from other NINDS CDE disease recommendations.


    Working group end products included a summary of recommendations, templates (CRFs), CDE detail reports, instrument recommendations, and guideline documents. Public Review is scheduled for December 2017 - January 2018 to elicit feedback from the community. The version 1.0 recommendations are expected to be posted to the NINDS CDE website in late February 2018.


    NINDS/CDC encourage the use of CDEs by the clinical research community to expedite study start-up, standardize data collection, and allow for future data sharing. The development of CDEs is an iterative process.

    Updates will be made to these ME/CFS CDEs as research progresses and feedback is received from the community.

    Study Supported by: This material is based upon work supported by NIH contracts HHSN271201200034C and HHSN271201700064C and CDC IAA 16FED1609717.
    Sly Saint, Sean, Hutan and 7 others like this.

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