Common Data Element for Disorders of Consciousness: Recommendations from the Working Group on Therapeutic Interventions

Abstract

Abstract Background. Over the past thirty 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. While 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 NIH National Institute of Neurological Disorders and Stroke (NINDS) 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. Results. We developed a unified CRF, including CDEs and key design elements (KDE; i.e., methodological or protocol parameters), divided into five sections: (i) patient information; (ii) general study information; (iii) behavioral interventions; (iv) pharmacological interventions; and (v) device interventions. Conclusion. 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 DoC