Analysis Resource Core

JH-EPICS分析资源核心摘要 JH-EPICS分析资源核心(ARC)将为以下方面提供统计建模和分析支持 U54提案中的调查人员。此外，ARC将在以下方面提供指导： 关于性别、年龄、种族和民族差异在免疫机制中的交叉性的假设 新冠肺炎。在这两个角色中，ARC将确保U54研究是有效的、透明的和可重复的。 目前的证据表明，新冠肺炎大流行对男性和女性的影响存在差异，包括在 与疾病严重程度和死亡率以及负面社会和经济影响的关系。至关重要的是我们要探索 性和性别如何与其他生物和社会分层相交 适当的治疗和干预。在其统计分析角色中，ARC将制定和 实施统计模型和方法，以比较以下各子组之间的纵向轨迹 约翰霍普金斯大学新冠肺炎注册使用了多项免疫功能指标。我们将支持这三个 对影响基线和时变因素的具体假设进行测试的研究项目 疾病的发展。在其交叉性职能中，核心将向这两个项目提供专家指导，以 测试关于性别(社会结构)、性别(生物结构)、种族、 种族、年龄差异与SARS-CoV-2对人类免疫系统的影响。在协作中 通过U54调查人员，ARC将：1.从实验室实验中获取、管理和管理数据 和来自约翰霍普金斯大学皇冠(新冠肺炎精确医学分析平台)的所有注册 在约翰霍普金斯大学5家医院网络内接受医疗服务的新冠肺炎患者。2.框住 研究人员的科学问题，然后设计实验室和/或临床研究 提供最有力的证据来回答所提出的问题。3.设计并实现统计功能 分析和协作解释结果，以产生有效、透明和可重现的结果 科学发现。通过区分假设生成和假设检验来确保有效性 分析。每个假设检验分析都将有一个预先指定的统计分析计划 处理数据。4.分析性和性别的作用以及性和性别的交集 其他生物学和社会分层因素，如年龄、种族和民族，新冠肺炎免疫 反应和临床结果。这些分析将被纳入研究项目1-3。

JH-EPICS Analysis Resource Core Summary The JH-EPICS Analysis Resource Core (ARC) will provide statistical modeling and analysis support to investigators in this U54 proposal. In addition, the ARC will provide guidance in the framing and testing of hypotheses about the intersectionality of gender, age, racial, and ethnic differences in immune mechanisms in COVID-19. In both roles, the ARC will assure that the U54 research is valid, transparent, and reproducible. Current evidence shows that the COVID-19 pandemic has differential effects on men and women, including in relation to disease severity and mortality and negative social and economic impacts. It is vital that we explore how sex and gender intersect with other biological and social stratifiers if we are to have effective and appropriate therapeutic treatment and interventions. In its statistical analysis role, the ARC will develop and implement statistical models and methods for comparing longitudinal trajectories among subgroups of the Johns Hopkins COVID-19 registry using multiple measures of immune function. We will support the three Research Projects to devise tests of specific hypotheses about baseline and time-varying factors that affect disease progression. In its intersectionality function, the Core will provide expert guidance to both Projects to test hypotheses about the intersectionality of gender (social construct), sex (biological construct), race, ethnicity, and age differences with the effects of SARS-CoV-2 on the human immune system. In collaboration with the U54 investigators, the ARC will: 1. Acquire, manage, and curate data from laboratory experiments and from the Johns Hopkins CROWN (COVID-19 Precision Medicine Analytics Platform) Registry of all COVID-19 patients who receive health services within the Johns Hopkins network of 5 hospitals. 2. Frame the investigators’ scientific questions in statistical terms, then design laboratory and/or clinical studies that produce the strongest possible evidence to answer the questions posed. 3. Design and implement statistical analyses and collaborate on interpretation of results so as to produce valid, transparent, and reproducible scientific findings. Validity will be assured by distinguishing hypothesis generating from hypothesis testing analyses. Each hypothesis testing analysis will have a pre-specified statistical analysis plan in advance of working with the data. 4. Analyze the role of sex and gender and the intersection of sex and gender with other biological and social stratifiers, such as age, race, and ethnicity, on COVID-19 immunologic responses and clinical outcomes. These analyses will be integrated into Research Projects 1-3.