Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Department II of Internal Medicine, Hematology/Oncology, Goethe University, Frankfurt, Germany.
Eur J Epidemiol. 2022 Aug;37(8):849-870. doi: 10.1007/s10654-022-00896-z. Epub 2022 Jul 29.
The German government initiated the Network University Medicine (NUM) in early 2020 to improve national research activities on the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic. To this end, 36 German Academic Medical Centers started to collaborate on 13 projects, with the largest being the National Pandemic Cohort Network (NAPKON). The NAPKON's goal is creating the most comprehensive Coronavirus Disease 2019 (COVID-19) cohort in Germany. Within NAPKON, adult and pediatric patients are observed in three complementary cohort platforms (Cross-Sectoral, High-Resolution and Population-Based) from the initial infection until up to three years of follow-up. Study procedures comprise comprehensive clinical and imaging diagnostics, quality-of-life assessment, patient-reported outcomes and biosampling. The three cohort platforms build on four infrastructure core units (Interaction, Biosampling, Epidemiology, and Integration) and collaborations with NUM projects. Key components of the data capture, regulatory, and data privacy are based on the German Centre for Cardiovascular Research. By April 01, 2022, 34 university and 40 non-university hospitals have enrolled 5298 patients with local data quality reviews performed on 4727 (89%). 47% were female, the median age was 52 (IQR 36-62-) and 50 pediatric cases were included. 44% of patients were hospitalized, 15% admitted to an intensive care unit, and 12% of patients deceased while enrolled. 8845 visits with biosampling in 4349 patients were conducted by April 03, 2022. In this overview article, we summarize NAPKON's design, relevant milestones including first study population characteristics, and outline the potential of NAPKON for German and international research activities.Trial registration https://clinicaltrials.gov/ct2/show/NCT04768998 . https://clinicaltrials.gov/ct2/show/NCT04747366 . https://clinicaltrials.gov/ct2/show/NCT04679584.
德国政府于 2020 年初启动了网络大学医学（NUM），以提高德国在严重急性呼吸系统综合症冠状病毒 2（SARS-CoV-2）大流行方面的研究活动。为此，36 家德国学术医疗中心开始合作开展 13 个项目，其中最大的项目是国家大流行队列网络（NAPKON）。NAPKON 的目标是在德国建立最大的 2019 年冠状病毒病（COVID-19）队列。在 NAPKON 内，从最初感染到长达三年的随访期间，成人和儿科患者在三个互补的队列平台（跨部门、高分辨率和基于人群）中进行观察。研究程序包括全面的临床和影像学诊断、生活质量评估、患者报告的结果和生物样本采集。三个队列平台建立在四个基础设施核心单元（交互、生物样本、流行病学和整合）和与 NUM 项目的合作之上。数据捕获、监管和数据隐私的关键组成部分基于德国心血管研究中心。截至 2022 年 4 月 1 日，34 家大学医院和 40 家非大学医院共招募了 5298 名患者，其中 4727 名（89%）患者进行了当地数据质量审查。47%为女性，中位年龄为 52（IQR 36-62-），50 例儿科病例。44%的患者住院，15%入住重症监护病房，12%的患者在入组期间死亡。截至 2022 年 4 月 3 日，4349 名患者共进行了 8845 次生物样本采集就诊。在这篇概述文章中，我们总结了 NAPKON 的设计、相关里程碑，包括首批研究人群特征，并概述了 NAPKON 对德国和国际研究活动的潜力。试验注册 https://clinicaltrials.gov/ct2/show/NCT04768998. https://clinicaltrials.gov/ct2/show/NCT04747366. https://clinicaltrials.gov/ct2/show/NCT04679584.
