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长新冠的流行情况、病理生理学、预测和健康相关生活质量:纵向多队列 CORona 随访(CORFU)研究的研究方案。

Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study.

机构信息

Department of Cardiology, Maastricht UMC+, Maastricht, The Netherlands.

Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.

出版信息

BMJ Open. 2022 Nov 29;12(11):e065142. doi: 10.1136/bmjopen-2022-065142.

Abstract

INTRODUCTION

The variety, time patterns and long-term prognosis of persistent COVID-19 symptoms (long COVID-19) in patients who suffered from mild to severe acute COVID-19 are incompletely understood. Cohort studies will be combined to describe the prevalence of long COVID-19 symptoms, and to explore the pathophysiological mechanisms and impact on health-related quality of life. A prediction model for long COVID-19 will be developed and internally validated to guide care in future patients.

METHODS AND ANALYSIS

Data from seven COVID-19 cohorts will be aggregated in the longitudinal multiple cohort CORona Follow Up (CORFU) study. CORFU includes Dutch patients who suffered from COVID-19 at home, were hospitalised without or with intensive care unit treatment, needed inpatient or outpatient rehabilitation and controls who did not suffer from COVID-19. Individual cohort study designs were aligned and follow-up has been synchronised. Cohort participants will be followed up for a maximum of 24 months after acute infection. Next to the clinical characteristics measured in individual cohorts, the CORFU questionnaire on long COVID-19 outcomes and determinants will be administered digitally at 3, 6, 12, 18 and 24 months after the infection. The primary outcome is the prevalence of long COVID-19 symptoms up to 2 years after acute infection. Secondary outcomes are health-related quality of life (eg, EQ-5D), physical functioning, and the prevalence of thromboembolic complications, respiratory complications, cardiovascular diseases and endothelial dysfunction. A prediction model and a patient platform prototype will be developed.

ETHICS AND DISSEMINATION

Approval was obtained from the medical research ethics committee of Maastricht University Medical Center+ and Maastricht University (METC 2021-2990) and local committees of the participating cohorts. The project is supported by ZonMW and EuroQol Research Foundation. Results will be published in open access peer-reviewed scientific journals and presented at (inter)national conferences.

TRIAL REGISTRATION NUMBER

NCT05240742.

摘要

简介

患有轻度至重度急性 COVID-19 的患者中,持续性 COVID-19 症状(长新冠)的种类、时间模式和长期预后尚不完全清楚。本研究将对七个 COVID-19 队列的数据进行汇总,以描述长新冠症状的患病率,并探索其病理生理机制及对健康相关生活质量的影响。此外,我们还将开发并内部验证长新冠预测模型,以指导未来患者的护理。

方法与分析

该研究将纳入在家中感染 COVID-19、无需住院或入住重症监护病房、需要住院或门诊康复以及未感染 COVID-19 的对照患者。该研究将对 COVID-19 队列的参与者进行随访,最长随访时间为急性感染后 24 个月。除了在各个队列中测量的临床特征外,还将在感染后 3、6、12、18 和 24 个月时使用 CORFU 长新冠结局和决定因素问卷进行数字评估。主要结局是急性感染后 2 年内长新冠症状的患病率。次要结局是健康相关生活质量(如 EQ-5D)、身体机能以及血栓栓塞并发症、呼吸系统并发症、心血管疾病和内皮功能障碍的患病率。我们还将开发预测模型和患者平台原型。

伦理与传播

该研究已获得 Maastricht University Medical Center+和 Maastricht University 医学研究伦理委员会(METC 2021-2990)以及参与队列的当地委员会的批准。该项目得到了 ZonMW 和 EuroQol 研究基金会的支持。研究结果将发表在同行评议的开放获取科学期刊上,并在(国际)会议上展示。

试验注册编号

NCT05240742。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f57/9709810/e06bceb386e6/bmjopen-2022-065142f01.jpg

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