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BMJ Open ; 10(9): e040569, 2020 09 29.
Article in English | MEDLINE | ID: covidwho-809101

ABSTRACT

INTRODUCTION: This protocol describes an observational study which set out to assess whether frailty and/or multimorbidity correlates with short-term and medium-term outcomes in patients diagnosed with COVID-19 in a European, multicentre setting. METHODS AND ANALYSIS: Over a 3-month period we aim to recruit a minimum of 500 patients across 10 hospital sites, collecting baseline data including: patient demographics; presence of comorbidities; relevant blood tests on admission; prescription of ACE inhibitors/angiotensin receptor blockers/non-steroidal anti-inflammatory drugs/immunosuppressants; smoking status; Clinical Frailty Score (CFS); length of hospital stay; mortality and readmission. All patients receiving inpatient hospital care >18 years who receive a diagnosis of COVID-19 are eligible for inclusion. Long-term follow-up at 6 and 12 months is planned. This will assess frailty, quality of life and medical complications.Our primary analysis will be short-term and long-term mortality by CFS, adjusted for age (18-64, 65-80 and >80) and gender. We will carry out a secondary analysis of the primary outcome by including additional clinical mediators which are determined statistically important using a likelihood ratio test. All analyses will be presented as crude and adjusted HR and OR with associated 95% CIs and p values. ETHICS AND DISSEMINATION: This study has been registered, reviewed and approved by the following: Health Research Authority (20/HRA1898); Ethics Committee of Hospital Policlinico Modena, Italy (369/2020/OSS/AOUMO); Health and Care Research Permissions Service, Wales; and NHS Research Scotland Permissions Co-ordinating Centre, Scotland. All participating units obtained approval from their local Research and Development department consistent with the guidance from their relevant national organisation.Data will be reported as a whole cohort. This project will be submitted for presentation at a national or international surgical and geriatric conference. Manuscript(s) will be prepared following the close of the project.


Subject(s)
Coronavirus Infections , Frail Elderly , Frailty , Multimorbidity , Pandemics , Pneumonia, Viral , Public Health/methods , Quality of Life , Adult , Aged , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/mortality , Coronavirus Infections/therapy , Correlation of Data , Europe/epidemiology , Female , Frail Elderly/psychology , Frail Elderly/statistics & numerical data , Frailty/diagnosis , Frailty/epidemiology , Geriatric Assessment/methods , Hospitalization/statistics & numerical data , Humans , Male , Multicenter Studies as Topic , Observational Studies as Topic , Pneumonia, Viral/diagnosis , Pneumonia, Viral/mortality , Pneumonia, Viral/therapy , SARS-CoV-2 , Survival Analysis
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