Espiritu Adrian I, Sy Marie Charmaine C, Anlacan Veeda Michelle M, Jamora Roland Dominic G
Department of Neurosciences, College of Medicine and Philippine General Hospital, University of the Philippines Manila, Manila, Philippines
Department of Clinical Epidemiology, College of Medicine, University of the Philippines Manila, Manila, Philippines.
BMJ Open. 2020 Nov 30;10(11):e040944. doi: 10.1136/bmjopen-2020-040944.
The SARS-CoV-2, virus that caused the COVID-19 global pandemic, possesses a neuroinvasive potential. Patients with COVID-19 infection present with neurological signs and symptoms aside from the usual respiratory affectation. Moreover, COVID-19 is associated with several neurological diseases and complications, which may eventually affect clinical outcomes.
The Philippine COVID-19 Outcomes: a Retrospective study Of Neurological manifestations and Associated symptoms (The Philippine CORONA) study investigators will conduct a nationwide, multicentre study involving 37 institutions that aims to determine the neurological manifestations and factors associated with clinical outcomes in COVID-19 infection.
This is a retrospective cohort study (comparative between patients with and without neurological manifestations) via medical chart review involving adult patients with COVID-19 infection. Sample size was determined at 1342 patients. Demographic, clinical and neurological profiles will be obtained and summarised using descriptive statistics. Student's t-test for two independent samples and χ test will be used to determine differences between distributions. HRs and 95% CI will be used as an outcome measure. Kaplan-Meier curves will be constructed to plot the time to onset of mortality (survival), respiratory failure, intensive care unit (ICU) admission, duration of ventilator dependence, length of ICU stay and length of hospital stay. The log-rank test will be employed to compare the Kaplan-Meier curves. Stratified analysis will be performed to identify confounders and effects modifiers. To compute for adjusted HR with 95% CI, crude HR of outcomes will be adjusted according to the prespecified possible confounders. Cox proportional regression models will be used to determine significant factors of outcomes. Testing for goodness of fit will also be done using Hosmer-Lemeshow test. Subgroup analysis will be performed for proven prespecified effect modifiers. The effects of missing data and outliers will also be evaluated in this study.
This protocol was approved by the Single Joint Research Ethics Board of the Philippine Department of Health (SJREB-2020-24) and the institutional review board of the different study sites. The dissemination of results will be conducted through scientific/medical conferences and through journal publication. The lay versions of the results may be provided on request.
NCT04386083.
导致新冠疫情全球大流行的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）具有神经侵袭潜力。新冠病毒感染患者除了出现常见的呼吸道感染症状外，还伴有神经学体征和症状。此外，新冠病毒与多种神经疾病及并发症相关，这可能最终影响临床结局。
菲律宾新冠病毒感染结局：神经学表现及相关症状回顾性研究（菲律宾新冠病毒感染结局研究）的研究者们将开展一项全国性、多中心研究，该研究涉及37个机构，旨在确定新冠病毒感染患者的神经学表现以及与临床结局相关的因素。
这是一项回顾性队列研究（有神经学表现患者与无神经学表现患者之间的对比研究），通过查阅病历对成年新冠病毒感染患者进行研究。样本量确定为1342例患者。将获取人口统计学、临床和神经学资料，并使用描述性统计方法进行总结。采用两独立样本的学生t检验和χ检验来确定分布差异。风险比（HR）和95%置信区间（CI）将用作结局指标。将构建Kaplan-Meier曲线来描绘死亡（生存）、呼吸衰竭、重症监护病房（ICU）入院、呼吸机依赖持续时间、ICU住院时间和住院时间的发病时间。将采用对数秩检验来比较Kaplan-Meier曲线。将进行分层分析以识别混杂因素和效应修饰因素。为计算调整后的HR及95%CI，将根据预先设定的可能混杂因素对结局的粗HR进行调整。将使用Cox比例回归模型来确定结局的显著因素。还将使用Hosmer-Lemeshow检验进行拟合优度检验。将对已证实的预先设定的效应修饰因素进行亚组分析。本研究还将评估缺失数据和异常值的影响。
本方案已获得菲律宾卫生部单一联合研究伦理委员会（SJREB-2020-24）以及不同研究地点的机构审查委员会的批准。研究结果将通过科学/医学会议和期刊发表进行传播。如有要求，可提供结果的通俗版本。
NCT04386083。
