Determining the global outcomes of traumatic brain injury in low-, middle- and high- income countries: a prospective, global neurosurgery, multicenter cohort study (Global NeuroSurg 1 Study Protocol)

A. Negida, Zoe E. Teton, Brittany Stedelin, Caleb S Nerison, Hieder Al-Shami, A. Hegazy, Ahmed M. Raslan
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引用次数: 2

Abstract

Globally, traumatic brain injury (TBI) affects 69 million individuals every year. However, there are wide variations in the management of TBI across low-, middle- and high-income countries which reflects on the outcomes of TBI worldwide. This study aims to provide a comprehensive global picture of the surgical and nonsurgical management and outcomes of TBI. The Global NeuroSurg 1 study is a prospective international multicentre cohort study conducted in self-selected registered centers. Any hospital receiving and managing TBI patients is eligible to participate (registration through www.globalneurosurg.org). After obtaining institutional ethical approvals, collaborator teams collect consecutive TBI patient data within any 2 weeks from the 1 June 2019 to the 30 September 2021 with 90 days of follow-up for every patient. Data items include (1) patient demographics, (2) TBI timing, severity and mechanism, (3) clinical status of the patient, (4) radiographic findings, (5) surgical and nonsurgical management and (6) patient survival and Glasgow outcome score. All data are submitted to the secure RedCap system of Oregon Health and Science University, OR. Binary logistic regression analysis will be conducted to evaluate the predictors of 30-day mortality. The odds ratios and the corresponding 95% confidence intervals will be calculated for each variable. Then variables that are independently contributing to the mortality will be selected and examined. Study ethical approvals or ethical approval waivers are obtained from all participating centers. All collected data are kept confidential and will be used only for the purpose of this study.
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确定低、中、高收入国家外伤性脑损伤的全球结局:一项前瞻性、全球神经外科、多中心队列研究(全球神经外科1研究方案)
在全球范围内,创伤性脑损伤每年影响6900万人。然而,低收入、中等收入和高收入国家的TBI管理存在很大差异,这反映了世界范围内TBI的结果。本研究旨在全面了解TBI的手术和非手术治疗及结果。Global NeuroSurg 1研究是一项前瞻性国际多中心队列研究,在自行选择的注册中心进行。任何接收和管理TBI患者的医院都有资格参与(通过www.globalneurosurg.org注册)。在获得机构伦理批准后,合作者团队在2019年6月1日至2021年9月30日的任何两周内收集连续的TBI患者数据,每个患者随访90天。数据项目包括(1)患者人口统计数据,(2)TBI的时间、严重程度和机制,(3)患者的临床状态,(4)放射学检查结果,(5)手术和非手术治疗,以及(6)患者生存率和格拉斯哥结果评分。所有数据都提交给俄勒冈州健康与科学大学的安全RedCap系统。将进行二元逻辑回归分析,以评估30天死亡率的预测因素。将为每个变量计算比值比和相应的95%置信区间。然后,将选择并检查独立导致死亡率的变量。从所有参与中心获得研究伦理批准或伦理批准豁免。所有收集的数据都是保密的,仅用于本研究目的。
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