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COVID-19 大流行对有护理或支持需求人群的影响:一项 SARS-CoV-2 登记研究的方案。

Impact of the COVID-19 pandemic on people in need of care or support: protocol for a SARS-CoV-2 registry.

机构信息

Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany

Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany.

出版信息

BMJ Open. 2023 May 16;13(5):e071134. doi: 10.1136/bmjopen-2022-071134.

Abstract

INTRODUCTION

People in need of care or support are severely affected by the COVID-19 pandemic. We lack valid data of long-term assessments. We present a register study to detect the physical and psychosocial impact of the COVID-19 pandemic on people in need of care or support in Bavaria, Germany. To describe the persons' life conditions comprehensively, we assess the perspectives and needs of the respective care teams too. Results will serve as evidence-based source to manage the pandemic and long-term prevention strategies.

METHODS AND ANALYSIS

The 'Bavarian ambulatory COVID-19 Monitor' is a multicentre registry including a purposive sample of up to 1000 patient-participants across three study sites in Bavaria. The study group consists of 600 people in need of care with a positive SARS-CoV-2 PCR test. Control group 1 comprises 200 people in need of care with a negative SARS-CoV-2 PCR test, while control group 2 comprises 200 people with a positive SARS-CoV-2 PCR test but are not in need of care. We assess the clinical course of infection, psychosocial aspects and care needs using validated measures. Follow-up is every 6 months for up to 3 years. Additionally, we assess up to 400 people linked to these patient-participants (caregivers, general practitioners (GPs)) for their health and needs. Main analyses are stratified by level of care I-V (I=minor/V=most severe impairment of independence), inpatient/outpatient care setting, sex and age. We use descriptive and inferential statistics to analyse cross-sectional data and changes over time. In qualitative interviews with 60 stakeholders (people in need of care, caregivers, GPs, politicians), we explore interface problems of different functional logics, of everyday and professional perspectives.

ETHICS AND DISSEMINATION

The Institutional Review Board of the University Hospital LMU Munich (#20-860) and the study sites (Universities of Wurzburg and Erlangen) approved the protocol. We disseminate the results by peer-reviewed publications, international conferences, governmental reports, etc.

摘要

简介

需要护理或支持的人受到 COVID-19 大流行的严重影响。我们缺乏长期评估的有效数据。我们提出了一项登记研究,以检测 COVID-19 大流行对德国巴伐利亚州需要护理或支持的人的身体和心理社会影响。为了全面描述这些人的生活状况,我们还评估了各自护理团队的观点和需求。研究结果将作为管理大流行和长期预防策略的循证来源。

方法与分析

“巴伐利亚门诊 COVID-19 监测”是一项多中心登记研究,包括巴伐利亚三个研究地点的最多 1000 名患者参与者的有目的样本。研究组由 600 名 COVID-19 阳性 PCR 检测结果呈阳性的需要护理的人组成。对照组 1 由 200 名 COVID-19 阴性 PCR 检测结果呈阴性的需要护理的人组成,而对照组 2 由 200 名 COVID-19 阳性但不需要护理的人组成。我们使用经过验证的措施评估感染的临床过程、心理社会方面和护理需求。随访时间最长为 3 年,每 6 个月一次。此外,我们还评估与这些患者参与者相关的最多 400 人(护理人员、全科医生 (GP)) 的健康和需求。主要分析按护理 I-V 级(I=轻度/V=独立性严重受损)、住院/门诊护理环境、性别和年龄分层。我们使用描述性和推断性统计分析横断面数据和随时间的变化。在与 60 名利益相关者(需要护理的人、护理人员、全科医生、政治家)的定性访谈中,我们探讨了不同功能逻辑、日常和专业观点之间的接口问题。

伦理与传播

慕尼黑大学附属医院伦理审查委员会 (#20-860) 和研究地点(维尔茨堡大学和埃尔兰根大学)批准了该方案。我们通过同行评议的出版物、国际会议、政府报告等传播研究结果。

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