TY - JOUR
T1 - Study protocol for the COPE study
T2 - COVID-19 in Older PEople: The influence of frailty and multimorbidity on survival. A multicentre, European observational study
AU - Price, Angeline
AU - Barlow-Pay, Fenella
AU - Duffy, Siobhan
AU - Pearce, Lyndsay
AU - Vilches-Moraga, Arturo
AU - Moug, Susan
AU - Quinn, Terry
AU - Stechman, Michael
AU - Braude, Philip
AU - Mitchell, Emma
AU - Myint, Phyo Kyaw
AU - Verduri, Alessia
AU - McCarthy, Kathryn
AU - Carter, Ben
AU - Hewitt, Jonathan
PY - 2020/9/29
Y1 - 2020/9/29
N2 - 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.
AB - 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.
KW - geriatric medicine
KW - health policy
KW - public health
UR - http://www.scopus.com/inward/record.url?scp=85092374913&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-040569
DO - 10.1136/bmjopen-2020-040569
M3 - Article
C2 - 32994260
AN - SCOPUS:85092374913
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e040569
ER -
