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COVID-19 确诊患者住院后功能恢复的纵向队列研究方案。

Functional recovery following hospitalisation of patients diagnosed with COVID-19: a protocol for a longitudinal cohort study.

机构信息

School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

出版信息

BMJ Open. 2021 Dec 13;11(12):e053021. doi: 10.1136/bmjopen-2021-053021.

Abstract

INTRODUCTION

COVID-19 is an international public health crisis with more than 132 million infections worldwide. Beyond acute infection, emerging data indicate patients diagnosed with COVID-19 may experience persistent sequelae similar to survivors of sepsis or acute respiratory syndromes, including mobility limitations and fatigue. However, there is limited evidence on the trajectory of functional recovery in those hospitalised with COVID-19. The primary aim of the Coronavirus Registry Functional Recovery (COREG-FR) study is to understand the trajectory of functional recovery among individuals hospitalised for COVID-19 over the medium (up to 6 months) and longer term (6-12 months) that will guide clinical care and optimal management of serious COVID-19 illness and recovery.

METHODS AND ANALYSIS

COREG-FR is a multicentre longitudinal cohort study. We will enrol a minimum of 211 adults age 18 years and older with COVID-19 from five hospitals. Participants will be followed from admission to hospital as an inpatient, to hospital discharge, and at 3-month, 6-month, 9-month and up to 12-month post-hospital discharge. We will conduct telephone interviews at ward admission and discharge, and telephone interviews plus in-person assessments of physical function and lung function at all remaining follow-ups. Our primary outcome is the Activity Measure for Post-Acute Care mobility scale measured at all time points. We will conduct linear mixed effects regression analyses to explore determinants of functional outcomes after COVID-19 illness. Subgroup analyses based on age (≤65 vs >65 years), frailty status (Clinical Frailty Scale score ≤4 vs >5) and variants of concern will be conducted.

ETHICS AND DISSEMINATION

COREG-FR has been approved by Research Ethics Boards at participating sites. We will disseminate this work through peer-reviewed manuscripts, presentations at national and international meetings and through the established COREG website (www.coregontario.ca). COREG-FR is designed as a data platform for future studies evaluating COVID-19 recovery.

TRIAL REGISTRATION NUMBER

NCT04602260; Pre-results.

摘要

简介

COVID-19 是一场国际公共卫生危机,全球已有超过 1.32 亿例感染病例。除了急性感染,新出现的数据表明,被诊断患有 COVID-19 的患者可能会出现类似于败血症或急性呼吸综合征幸存者的持续后遗症,包括行动能力受限和疲劳。然而,关于 COVID-19 住院患者的功能恢复轨迹,目前证据有限。冠状病毒注册功能恢复(COREG-FR)研究的主要目的是了解 COVID-19 住院患者在中期(最长 6 个月)和长期(6-12 个月)的功能恢复轨迹,以指导临床护理和严重 COVID-19 疾病和康复的最佳管理。

方法和分析

COREG-FR 是一项多中心纵向队列研究。我们将从五家医院招募至少 211 名年龄在 18 岁及以上的 COVID-19 成年患者。参与者将从住院时入院到住院、出院,以及在 3 个月、6 个月、9 个月和最长 12 个月的出院后进行随访。我们将在病房入院和出院时进行电话访谈,并在所有剩余随访时进行电话访谈和身体功能及肺功能的现场评估。我们的主要结局是在所有时间点测量的康复护理后活动量表的移动度。我们将进行线性混合效应回归分析,以探讨 COVID-19 疾病后功能结局的决定因素。将根据年龄(≤65 岁与>65 岁)、虚弱状态(临床虚弱量表评分≤4 与>5)和关注变体进行亚组分析。

伦理和传播

COREG-FR 已获得参与机构的伦理审查委员会的批准。我们将通过同行评议的论文、在国内外会议上的演讲以及通过已建立的 COREG 网站(www.coregontario.ca)来传播这项工作。COREG-FR 旨在成为评估 COVID-19 恢复的未来研究的数据平台。

试验注册号

NCT04602260;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d34/8671848/392674af967c/bmjopen-2021-053021f01.jpg

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