Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II): protocol for an observational study using linked Scottish national data.
Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II): protocol for an observational study using linked Scottish national data.
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DOI：
10.1136/bmjopen-2020-039097
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发表时间：
2020-06-21
期刊：
影响因子：
2.9
通讯作者：
Sheikh, Aziz
中科院分区：
文献类型：
--
作者：
Simpson, Colin R;Robertson, Chris;Sheikh, Aziz
简介：随着2019年12月新型严重急性呼吸系统综合征冠状病毒2型（SARS-CoV-2）的出现以及随后的COVID-19大流行，需要进行人群水平的监测和对现有或新的治疗或预防干预措施的有效性进行快速评估，以确保干预措施针对那些因COVID-19而患严重疾病或死亡的风险最高的人群。我们的目标是重新调整和扩大现有的大流行报告平台，以确定SARS-CoV-2的发病率，任何新的大流行疫苗的吸收和有效性（一旦可用）和现有或新的抗微生物药物和其他疗法所赋予的任何保护作用。前瞻性观察队列将用于每日/每周监测COVID-19的进展情况。19流行病，并评估治疗干预措施在苏格兰各地约540万在全科诊所登记的个人中的有效性。将收集患者级初级保健数据、非工作时间、住院、死亡率和实验室数据的全国关联数据集。主要结局将衡量：（A）实验室确认的SARS-CoV-2感染、发病率和死亡率与人口统计学、社会经济学和临床人群特征之间的关联;（B）COVID-19的医疗负担与人口统计学、社会经济学和临床人群特征之间的关联。次要结果将估计：（A）吸收（仅针对疫苗）;（B）有效性;（C）新的或现有的治疗方法、疫苗和抗微生物剂对SARS-CoV-2感染的安全性。将通过多变量logistic回归模型评估人群特征与主要结局之间的关联。将根据时间依赖性考克斯模型或泊松回归模型评估治疗、疫苗和抗菌剂的有效性。自我控制的研究设计将探讨估计治疗和药物相关的不良事件的风险。伦理和传播：我们获得了国家研究伦理服务委员会，东南苏格兰02批准。研究结果将在国际会议上发表，并发表在同行评审期刊上。
INTRODUCTION: Following the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in December 2019 and the ensuing COVID-19 pandemic, population-level surveillance and rapid assessment of the effectiveness of existing or new therapeutic or preventive interventions are required to ensure that interventions are targeted to those at highest risk of serious illness or death from COVID-19. We aim to repurpose and expand an existing pandemic reporting platform to determine the attack rate of SARS-CoV-2, the uptake and effectiveness of any new pandemic vaccine (once available) and any protective effect conferred by existing or new antimicrobial drugs and other therapies.METHODS AND ANALYSIS: A prospective observational cohort will be used to monitor daily/weekly the progress of the COVID-19 epidemic and to evaluate the effectiveness of therapeutic interventions in approximately 5.4million individuals registered in general practices across Scotland. A national linked dataset of patient-level primary care data, out-of-hours, hospitalisation, mortality and laboratory data will be assembled. The primary outcomes will measure association between: (A) laboratory confirmed SARS-CoV-2 infection, morbidity and mortality, and demographic, socioeconomic and clinical population characteristics; and (B) healthcare burden of COVID-19 and demographic, socioeconomic and clinical population characteristics. The secondary outcomes will estimate: (A) the uptake (for vaccines only); (B) effectiveness; and (C) safety of new or existing therapies, vaccines and antimicrobials against SARS-CoV-2 infection. The association between population characteristics and primary outcomes will be assessed via multivariate logistic regression models. The effectiveness of therapies, vaccines and antimicrobials will be assessed from time-dependent Cox models or Poisson regression models. Self-controlled study designs will be explored to estimate the risk of therapeutic and prophylactic-related adverse events.ETHICS AND DISSEMINATION: We obtained approval from the National Research Ethics Service Committee, Southeast Scotland 02. The study findings will be presented at international conferences and published in peer-reviewed journals.