TITLE: Global NeuroSurg 1 Study: Determining the Global Outcomes of Traumatic Brain Injury in low-, middle-, and high- income countries: A prospective, international cohort study
AUTHORS: Ahmed Negida, Zoe Teton, Hieder Al-Shami, Ahmed Hegazy, Ahmed M. Raslan

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><span style = "font-weight:bold;">Background</span></div><div class = "text-block">Every year, there are about sixty-nine million new cases of Traumatic Brain Injury (TBI) worldwide. However, there are wide variations in the management of TBI across low-, middle-, and high-income countries which affect TBI outcomes worldwide.</div><div class = "text-block"><span style = "font-weight:bold;">Aim</span></div><div class = "text-block">This study aims to provide a comprehensive global picture of the management and outcomes of TBI in high-, middle-, and low-income countries.</div><div class = "text-block"><span style = "font-weight:bold;">Objectives</span></div><div class = "text-block"><span style = "font-style:italic;">Primary objectives</span></div><div class = "text-block"><ul style = "list-style-type:disc;"><li style = "counter-reset:ol0;list-style-type:disc;">To determine the mortality rates after TBI in low-, middle-, and high-income countries.</li><li style = "counter-reset:ol0;list-style-type:disc;">To determine the functional outcomes after TBI in low-, middle-, and high-income countries.</li><li style = "counter-reset:ol0;list-style-type:disc;"><span style = "font-style:italic;">Secondary objectives </span></li><li style = "counter-reset:ol0;list-style-type:disc;">To compare the mortality rates of TBI in HICs vs. LMICs.</li><li style = "counter-reset:ol0;list-style-type:disc;">To compare the functional outcomes of TBI in HICs vs. LMICs.</li><li style = "counter-reset:ol0;list-style-type:disc;">To determine the factors associated with mortality following TBI.</li><li style = "counter-reset:ol0;list-style-type:disc;">To determine the pattern of TBI management in low-, middle-, and high-income countries.</li><li style = "counter-reset:ol0;list-style-type:disc;">To determine TBI associated complications.</li><li style = "counter-reset:ol0;list-style-type:disc;">To form of an international network of neurosurgery researchers to facilitate future research efforts.</li></ul></div><div class = "text-block"><span style = "font-style:italic;">Secondary objectives </span></div><div class = "text-block"><ul style = "list-style-type:disc;"><li style = "counter-reset:ol0;list-style-type:disc;">To compare the mortality rates of TBI in HICs vs. LMICs.</li><li style = "counter-reset:ol0;list-style-type:disc;">To compare the functional outcomes of TBI in HICs vs. LMICs.</li><li style = "counter-reset:ol0;list-style-type:disc;">To determine the factors associated with mortality following TBI.</li><li style = "counter-reset:ol0;list-style-type:disc;">To determine the pattern of TBI management in low-, middle-, and high-income countries.</li><li style = "counter-reset:ol0;list-style-type:disc;">To determine TBI associated complications.</li><li style = "counter-reset:ol0;list-style-type:disc;">To form of an international network of neurosurgery researchers to facilitate future research efforts.</li></ul></div><div class = "text-block"><span style = "font-weight:bold;">Study Design</span></div><div class = "text-block">A multicenter, international, prospective cohort study</div><div class = "text-block"><span style = "font-weight:bold;">Duration</span></div><div class = "text-block"><span>One year (from the 1</span><span style = "vertical-align:super;">st</span><span> of June 2019 to the 31</span><span style = "vertical-align:super;">st</span><span> of May 2020)</span></div><div class = "text-block"><span style = "font-weight:bold;">Follow up</span><span>: 90 days</span></div><div class = "text-block"><span style = "font-weight:bold;">Study Setting</span></div><div class = "text-block">The study will be conducted in self-selected registered centers worldwide. Any hospital receiving and managing TBI patients is eligible to participate in Global NeuroSurg-1; There is no minimum patient number per center; all consecutive cases must be included.</div><div class = "text-block"><span style = "font-weight:bold;">Eligibility Criteria</span></div><div class = "text-block">The study will include TBI patients who meet the following criteria:</div><div class = "text-block">[1] TBI defined as WHO ICD-11 codes from NA07.0 to NA07.9.</div><div class = "text-block">[2] patients with mild, moderate, and severe TBI </div><div class = "text-block">[3] Age ≥18 years old</div><div class = "text-block">[4] both genders</div><div class = "text-block"><span style = "font-weight:bold;">Data Collection Method</span></div><div class = "text-block">We will collect anonymous data on patient demographics, TBI etiology and severity, clinical and surgical management, and the 30-day and 90-day mortality rate. All data will be submitted to the secure Redcap system of the Oregon Clinical & Translational Research Institute, Oregon Health and Science University. </div><div class = "text-block"><span style = "font-weight:bold;">Sample Size</span></div><div class = "text-block">A total sample size of 1153 patients will allow detecting a mortality rate of 25% with a 5% wide 95% confidence interval. The sample size was calculated using R software version 3.4.1 (The R Foundation for Statistical Computing).</div><div class = "text-block"><span style = "font-weight:bold;">Statistical analysis plan</span></div><div class = "text-block"><span>The human development index (HDI) is a composite score of life expectancy, education, and income indices published by the United Nations (</span><a style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;">http://hdr.undp.org/en/statistics</span></a><span>).</span></div><div class = "text-block">Participating centers will be classified into three tertiles according to the HDI rank. We will test the differences between HDI tertiles by using the Pearson chi-square test for categorical variable and Kruskal–Wallis test for continuous variables. Binary logistic regression analysis will be conducted to evaluate the predictors of 30-day mortality. The odds ratios (OR) and the corresponding 95% confidence intervals will be calculated for each variable. First, variables from the univariate analysis with P˂0.05 will be selected for inclusion in the multivariate model. Then variables that are independently contributing to the mortality will be selected and examined. All analyses will be conducted by STATA software (version 15) for windows.</div><div class = "text-block"><span style = "font-weight:bold;">Ethics and dissemination</span></div><div class = "text-block">Study ethical approval will be acquired from all participating centers. All collected data will be kept confidential and will be used only for this study.</div></div>

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