Coma; Common data elements; Disorders of consciousness; Minimally conscious state; Therapeutic interventions; Vegetative state; Humans; Consciousness; Consciousness Disorders/diagnosis; Consciousness Disorders/therapy; Common Data Elements; Biomedical Research; Consciousness Disorders; Critical Care and Intensive Care Medicine; Neurology (clinical)
Abstract :
[en] [en] BACKGROUND: Over the past 30 years, there have been significant advances in the understanding of the mechanisms associated with loss and recovery of consciousness following severe brain injury. This work has provided a strong grounding for the development of novel restorative therapeutic interventions. Although all interventions are aimed at modulating and thereby restoring brain function, the landscape of existing interventions encompasses a very wide scope of techniques and protocols. Despite vigorous research efforts, few approaches have been assessed with rigorous, high-quality randomized controlled trials. As a growing number of exploratory interventions emerge, it is paramount to develop standardized approaches to reporting results. The successful evaluation of novel interventions depends on implementation of shared nomenclature and infrastructure. To address this gap, the Neurocritical Care Society's Curing Coma Campaign convened nine working groups and charged them with developing common data elements (CDEs). Here, we report the work of the Therapeutic Interventions Working Group.
METHODS: The working group reviewed existing CDEs relevant to therapeutic interventions within the National Institutes of Health National Institute of Neurological Disorders and Stroke database and reviewed the literature for assessing key areas of research in the intervention space. CDEs were then proposed, iteratively discussed and reviewed, classified, and organized in a case report form (CRF).
RESULTS: We developed a unified CRF, including CDEs and key design elements (i.e., methodological or protocol parameters), divided into five sections: (1) patient information, (2) general study information, (3) behavioral interventions, (4) pharmacological interventions, and (5) device interventions.
CONCLUSIONS: The newly created CRF enhances systematization of future work by proposing a portfolio of measures that should be collected in the development and implementation of studies assessing novel interventions intended to increase the level of consciousness or rate of recovery of consciousness in patients with disorders of consciousness.
Disciplines :
Neurology
Author, co-author :
Monti, Martin M ; Department of Psychology, University of California Los Angeles, 6522 Pritzker Hall, Los Angeles, CA, USA. monti@psych.ucla.edu
Beekman, Rachel; Department of Neurology, Yale University School of Medicine, New Haven, CT, USA
Spivak, Norman M; David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Thibaut, Aurore ; Université de Liège - ULiège > GIGA > GIGA Neurosciences - Coma Science Group
Schnakers, Caroline; Casa Colina Hospital and Centers for Healthcare, Pomona, CA, USA
Whyte, John; Moss Rehabilitation Research Institute, Elkins Park, PA, USA
Molteni, Erika; School of Biomedical Engineering and Imaging Sciences, Faculty of Life Sciences and Medicine, School of Life Course Sciences, King's College London, London, UK
Curing Coma Campaign and its Contributing Members
Language :
English
Title :
Common Data Element for Disorders of Consciousness: Recommendations from the Working Group on Therapeutic Interventions.
NIGMS - National Institute of General Medical Sciences Tiny Blue Dot Foundation MRC - Medical Research Council
Funding text :
This work was supported by the Tiny Blue Dot Foundation, the National Institutes of Health National Institute of General Medical Sciences (5R01GM135420), the National Institutes of Health National Institute of General Medical Sciences (5T32GM008042), and Medical Research Council UK (MR/R016372/1).
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