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COVID-19大流行对医护人员身体、行为和心理健康的早期及中期影响:CoPE-HCP研究方案

Early and Mid-Term Implications of the COVID-19 Pandemic on the Physical, Behavioral and Mental Health of Healthcare Professionals: The CoPE-HCP Study Protocol.

作者信息

Khanji Mohammed Y, Maniero Carmela, Ng Sher, Siddiqui Imrana, Gupta Jaya, Crosby Louise, Antoniou Sotiris, Khan Rehan, Kapil Vikas, Gupta Ajay

机构信息

Barts Heart Centre, St. Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom.

Newham University Hospital, Barts Health NHS Trust, London, United Kingdom.

出版信息

Front Psychol. 2021 Feb 2;12:616280. doi: 10.3389/fpsyg.2021.616280. eCollection 2021.

DOI:10.3389/fpsyg.2021.616280
PMID:33603701
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7884763/
Abstract

INTRODUCTION

The COVID-19 pandemic has led to unprecedented strain to healthcare systems worldwide and posed unique challenges to the healthcare professionals (HCPs) and the general public.

OBJECTIVES

The aim of this study is to evaluate the impact of COVID-19 on the mental health, behavioral, and physical wellbeing of HCPs in the early and mid-term periods of the pandemic in comparison to non-HCPs. Thus, facilitating and guiding optimum planning and delivery of support to HCPs.

METHODS AND ANALYSIS

An observational cross-sectional survey and cohort study aiming to enroll over 1050 participants (minimum, 800 HCPs and 250 controls). Study questionnaires will be completed at baseline and after 6-weeks and 4-months. Recruitment initiated July 2020. The study was designed in London, United Kingdom, but open to participants worldwide. Baseline: Questionnaires comprising of validated self-administered screening tools for depression, anxiety, sleep-related issues, wellbeing, and burnout. The questionnaires also explore changes in behavior and physical wellbeing of the participants. In addition, associations of these mental health and behavioral factors with work-related factors and support will be explored. Six-weeks and 4-months follow-up: Follow-up questionnaires will assess change in symptoms of anxiety and depression, sleep disorders, use of alcohol and other substances, behavioral or interpersonal relationship changes. Physical wellbeing will be assessed through the presence of suspected or confirmed COVID-19 infection and absence from work. We will also evaluate the impact of variable provision of personal protection equipment (supply and training), extended working hours, and concern for the wellbeing of family members, anxiety levels, and evidence of burnout.

STATISTICAL CONSIDERATIONS

The study has 80% power to detect a 10% difference of combined depression and/or anxiety symptoms between the groups using two-sided type 1 error at 0.05 at baseline. Assuming that only 50% of these HCPs agree to be a part of a cohort survey, we will have 80% power to detect around 12% difference in the two groups in reported physical symptoms (20% vs. 32.3%), or prevalence of depression and/or anxiety at the end of the study.

ETHICS

The study was approved by the Cambridge East, Research Ethics Committee (20/EE/0166).

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov, NCT04433260.

摘要

引言

新冠疫情给全球医疗系统带来了前所未有的压力,给医护人员和普通公众带来了独特的挑战。

目的

本研究旨在评估新冠疫情早期和中期,与非医护人员相比,新冠疫情对医护人员心理健康、行为和身体健康的影响。从而促进并指导对医护人员的最佳支持规划与提供。

方法与分析

一项观察性横断面调查和队列研究,旨在招募超过1050名参与者(至少800名医护人员和250名对照)。研究问卷将在基线、6周后和4个月后完成。招募工作于2020年7月开始。该研究在英国伦敦设计,但对全球参与者开放。基线:问卷包括经过验证的用于评估抑郁、焦虑、睡眠相关问题、幸福感和职业倦怠的自我管理筛查工具。问卷还将探究参与者行为和身体健康的变化。此外,还将探究这些心理健康和行为因素与工作相关因素及支持之间的关联。6周和4个月随访:随访问卷将评估焦虑和抑郁症状、睡眠障碍、酒精及其他物质使用情况、行为或人际关系变化。身体健康将通过是否疑似或确诊感染新冠病毒以及是否缺勤来评估。我们还将评估个人防护设备(供应和培训)的不同提供情况、延长工作时间以及对家庭成员健康的担忧、焦虑水平和职业倦怠证据的影响。

统计考量

该研究有80%的把握度在基线时使用双侧I型错误率0.05检测两组之间抑郁和/或焦虑症状合并出现时10%的差异。假设这些医护人员中只有50%同意参与队列调查,我们将有80%的把握度在研究结束时检测两组在报告的身体症状(20%对32.3%)或抑郁和/或焦虑患病率方面约12% 的差异。

伦理

该研究已获得剑桥东部研究伦理委员会批准(20/EE/0166)。

试验注册号

ClinicalTrials.gov,NCT04433260。

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