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A study protocol for the COPE study: COVID-19 in Older PEople - the influence of frailty and multimorbidity on survival. A multi-centre, European observational study

Price, Angeline, Barlow-Pay, Fenella, Duffy, Sioban, Pearce, Lyndsay, Vilches-Moraga, Arturo, Moug, Susan, Quinn, Terry, Stechman, Michael, Braude, Philip, Mitchell, Emma, Myint, Phyo Kyaw, Verduri, Alessia, McCarthy, Kathryn, Carter, Ben and Hewitt, Jonathan ORCID: 2020. A study protocol for the COPE study: COVID-19 in Older PEople - the influence of frailty and multimorbidity on survival. A multi-centre, European observational study. BMJ Open 10 (9) , e040569. 10.1136/bmjopen-2020-040569

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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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: BMJ Publishing Group
ISSN: 2044-6055
Date of First Compliant Deposit: 28 September 2020
Date of Acceptance: 11 September 2020
Last Modified: 07 Nov 2022 18:11

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