The Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Development of Case Report Forms for Global Use

Molly McNett*, Ericka L. Fink, Michelle Schober, Shraddha Mainali, Raimund Helbok, Courtney L. Robertson, Jorge Mejia-Mantilla, Pedro Kurtz, Cássia Righy, Juan D. Roa, Carlos Villamizar-Rosales, Valeria Altamirano, Jennifer A. Frontera, Nelson Maldonado, David Menon, Jose Suarez, Sherry H.Y. Chou

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

Since its original report in January 2020, the coronavirus disease 2019 (COVID-19) due to Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) infection has rapidly become one of the deadliest global pandemics. Early reports indicate possible neurological manifestations associated with COVID-19, with symptoms ranging from mild to severe, highly variable prevalence rates, and uncertainty regarding causal or coincidental occurrence of symptoms. As neurological involvement of any systemic disease is frequently associated with adverse effects on morbidity and mortality, obtaining accurate and consistent global data on the extent to which COVID-19 may impact the nervous system is urgently needed. To address this need, investigators from the Neurocritical Care Society launched the Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID). The GCS-NeuroCOVID consortium rapidly implemented a Tier 1, pragmatic study to establish phenotypes and prevalence of neurological manifestations of COVID-19. A key component of this global collaboration is development and application of common data elements (CDEs) and definitions to facilitate rigorous and systematic data collection across resource settings. Integration of these elements is critical to reduce heterogeneity of data and allow for future high-quality meta-analyses. The GCS-NeuroCOVID consortium specifically designed these elements to be feasible for clinician investigators during a global pandemic when healthcare systems are likely overwhelmed and resources for research may be limited. Elements include pediatric components and translated versions to facilitate collaboration and data capture in Latin America, one of the epicenters of this global outbreak. In this manuscript, we share the specific data elements, definitions, and rationale for the adult and pediatric CDEs for Tier 1 of the GCS-NeuroCOVID consortium, as well as the translated versions adapted for use in Latin America. Global efforts are underway to further harmonize CDEs with other large consortia studying neurological and general aspects of COVID-19 infections. Ultimately, the GCS-NeuroCOVID consortium network provides a critical infrastructure to systematically capture data in current and future unanticipated disasters and disease outbreaks.

Original languageEnglish (US)
Pages (from-to)793-828
Number of pages36
JournalNeurocritical Care
Volume33
Issue number3
DOIs
StatePublished - Dec 2020

Funding

Dr. Chou reports grants from National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), grants from National Institute of Health, grants from University of Pittsburgh Dean’s Faculty Advancement Award during the conduct of the study. Dr. Fink reports grants from the National Institutes of Health during the conduct of the study. Dr. Mainali reports grant support from Center for Clinical and Translational Science at The Ohio State University sponsored by the National Center for Advancing Translational Sciences-Award Number UL1TR002733 outside the submitted work. Dr. Frontera reports grants from NIH/NIA, grants from NIH/NINDS during the conduct of the study. The remaining authors declare no conflict of interest related to this work. GCS-NeuroCOVID Consortium Steering Committee Members: Paul Vespa MD, Javier Provencio MD PhD, Daiwai Olson RN PhD, Claude Hemphill MD, Jose Suarez MD, Chethan Rao MD, and Nerissa Ko MD MS. Pediatric Consortium Coordinators: Pamela Rubin, RN and David Maloney, BS. Department of Critical Care Medicine, UPMC Children?s Hospital of Pittsburgh, Pittsburgh, USA. Pediatric Consortium Neurointensivists: Dennis Simon, MD, Department of Critical Care Medicine, UPMC Children?s Hospital of Pittsburgh, Pittsburgh, PA, USA; Elizabeth Wells, MD, MHS, Division of Neurology, Children?s National Hospital, Washington, D.C., USA; Juan Piantino, MD, Division of Neurology, Oregon Health & Science University; Andrew Geneslaw, MD, Department of Pediatrics, Morgan Stanley Children?s Hospital; Alexis A. Topjian, MD, MSc, Division of Pediatric Critical Care Medicine, Children?s Hospital of Philadelphia; Jose A. Pineda, MD, Division of Pediatric Critical Care Medicine, Children?s Hospital of Los Angeles; and Kristen P. Guilliams, MD, Division of Pediatric Critical Care Medicine, St. Louis Children?s Hospital. Adult Consortium Team: Michal Hammond MD, Valeria Altamirano BS MS, Ali J Smith BS, Carlos Villamizar Rosales MD MS, Nicole Paul BS, Lauren Kaplan BS, Aleksandra S Safonova BS, Charith Ratnayake BS, Adytia D Sharma, Abigail Skeel, Department of Critical Care Medicine, University of Pittsburgh School of Medicine. Neurocritical Care Society, Neurocritical Care Research Central (NCRC), Neurocritical Care Research Network (NCRN).

Keywords

  • COVID-19
  • Case report form
  • Common data element
  • Coronavirus
  • Disease prevalence
  • Neurological manifestations
  • Neurological symptoms
  • SARS-CoV2

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine
  • Clinical Neurology

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