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

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Title: Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study
Authors: Thomas Lee, Sandeep Singh, Phyo Kyaw Myint, Sheila Jones, Ben Carter, Susan Moug, Terry Quinn, Michael Thomas, Emma Bhatti, Angeline Price, Fenella Barlow-Pay, Siobhan Duffy, Lyndsay Pearce, Arturo Vilches-Moraga, Michael Stechman, Philip Braude, Emma Mitchell, Alessia Verduri, Kathryn McCarthy, Jonathan Hewitt, Charlotte Davey, Kiah Lunstone, Alice Cavenagh, Charlotte Silver, Thomas Telford, Rebecca Simmons, Dolcie Paxton, Francis Rickard, Mark Holloway, James Hesford, Tarik Jichi, Norman Galbraith, Jenny Edwards, Carly Bisset, Ross Alexander, Abigail Ingham, Roxanna Short, Aine McGovern, Jemima Collins, Eilidh Bruce, Alice Einarsson, Enrico Clini, Giovanni Guaraldi, Madeline Garcia, Shefali Sangani, Thomas Kneen, George Kyriakopoulos, Denise Tan
Source: BMJ Open, Vol 10, Iss 9 (2020)
Publisher Information: BMJ Publishing Group, 2020.
Publication Year: 2020
Collection: LCC:Medicine
Subject Terms: Medicine
More Details: 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.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2044-6055
Relation: https://bmjopen.bmj.com/content/10/9/e040569.full; https://doaj.org/toc/2044-6055
DOI: 10.1136/bmjopen-2020-040569
Access URL: https://doaj.org/article/fa9813ffb3f24eedafed8de02fa13f5a
Accession Number: edsdoj.fa9813ffb3f24eedafed8de02fa13f5a
Database: Directory of Open Access Journals
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  Data: 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.
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