College of Nursing, The Ohio State University, Columbus, OH, USA.
Division of Pediatric Critical Care Medicine and Safar Center for Resuscitation Research, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.
Neurocrit Care. 2020 Dec;33(3):793-828. doi: 10.1007/s12028-020-01100-4. Epub 2020 Sep 18.
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.
自 2020 年 1 月首次报告以来，由严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）引起的 2019 年冠状病毒病（COVID-19）迅速成为全球最致命的大流行之一。早期报告表明 COVID-19 可能存在与神经系统相关的表现，症状从轻度到重度不等，发病率高度变化，以及症状的因果或巧合发生存在不确定性。由于任何系统性疾病的神经系统受累通常与发病率和死亡率的不良影响有关，因此迫切需要获得关于 COVID-19 可能对神经系统产生影响的程度的准确和一致的全球数据。为了满足这一需求，神经危重病学会的研究人员发起了全球 COVID-19 神经功能障碍研究协作组（GCS-NeuroCOVID）。GCS-NeuroCOVID 协作组迅速实施了一项一级实用研究，以确定 COVID-19 神经表现的表型和患病率。这一全球合作的一个关键组成部分是制定和应用通用数据元素（CDE）和定义，以促进在资源环境中进行严格和系统的数据收集。这些元素的整合对于减少数据的异质性和允许未来进行高质量的荟萃分析至关重要。GCS-NeuroCOVID 协作组专门设计了这些元素，以便在全球大流行期间，当医疗保健系统可能不堪重负并且研究资源可能有限时，临床研究人员能够实施。这些元素包括儿科组件和翻译版本，以促进拉丁美洲的合作和数据收集，拉丁美洲是此次全球疫情的中心之一。在本文中，我们分享了 GCS-NeuroCOVID 协作组一级研究的成人和儿科 CDE 的具体数据元素、定义和基本原理，以及为在拉丁美洲使用而改编的翻译版本。目前正在进行全球努力，以进一步协调 CDE 与其他研究 COVID-19 感染的神经和一般方面的大型协作组。最终，GCS-NeuroCOVID 协作组网络为在当前和未来不可预见的灾难和疾病爆发中系统地收集数据提供了关键基础设施。
