Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study
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 re...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-09-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e040569.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1841554080080592896 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Thomas Lee |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-fa9813ffb3f24eedafed8de02fa13f5a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-fa9813ffb3f24eedafed8de02fa13f5a2025-01-09T03:55:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-040569Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational studyThomas LeeSandeep Singh0Phyo Kyaw Myint1Sheila JonesBen Carter2Susan Moug3Terry Quinn4Michael Thomas5Emma Bhatti6Angeline Price7Fenella Barlow-Pay8Siobhan Duffy9Lyndsay Pearce10Arturo Vilches-Moraga11Michael Stechman12Philip Braude13Emma Mitchell14Alessia Verduri15Kathryn McCarthy16Jonathan Hewitt17Charlotte DaveyKiah LunstoneAlice CavenaghCharlotte SilverThomas TelfordRebecca SimmonsDolcie PaxtonFrancis RickardMark Holloway18James HesfordTarik JichiNorman GalbraithJenny EdwardsCarly BissetRoss AlexanderAbigail InghamRoxanna ShortAine McGovernJemima CollinsEilidh Bruce19Alice EinarssonEnrico Clini20Giovanni Guaraldi21Madeline GarciaShefali SanganiThomas KneenGeorge KyriakopoulosDenise TanCardiology, Cardio-Thoracic Sciences Centre, All India Institute of Medical Sciences, New Delhi, Delhi, IndiaInstitute of Applied Health Sciences, University of Aberdeen, Aberdeen, UKWellcome Trust Clinical Training Fellow, Division of Psychiatry, University College London4 Royal Alexandra Hospital, Paisley, UKSchool of Cardiovascular and Medical Sciences, University of Glasgow College of Medical Veterinary and Life Sciences, Glasgow, UK2 Department of Thoracic Oncology, Thoraxklinik-Heidelberg gGmbH, Heidelberg, Baden-Württemberg, GermanyAnaesthetics, Royal Alexandra Hospital, Paisley, UKAgeing and Complex Medicine, Salford Royal NHS Trust, Salford, UKDepartment of Anaesthetics, Royal Alexandra Hospital, Paisley, Renfrewshire, UKGeneral Surgery, Royal Alexandra Hospital, Paisley, Renfrewshire, UKGeneral Surgery, Salford Royal NHS Foundation Trust, Salford, UKAgeing and Complex Medicine, Salford Royal NHS Trust, Salford, UKGeneral Surgery, University Hospital of Wales, Cardiff, UK3 CLARITY (Collaborative Ageing Research), North Bristol NHS Trust, Westbury on Trym, UKMedicine for Older People, North Bristol NHS Trust, Westbury on Trym, Bristol, UKHospital Policlinico Modena, Modena, Italy3 Neurology, Swedish Medical Center, Englewood, Colorado, USAGeriatric Medicine, Cardiff University, Cardiff, UKHead First (Assessment, Rehabilitation & Case Management) Limited, Hawkhurst, UKAberdeen Royal InfirmaryRespiratory Diseases Unit, University of Modena and Reggio Emilia, Modena, ItalyDepartment of Infectious Diseases, Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena, Modena, ItalyIntroduction 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.https://bmjopen.bmj.com/content/10/9/e040569.full |
| spellingShingle | 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 Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study BMJ Open |
| 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 |
| title_full | Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study |
| title_fullStr | Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study |
| title_full_unstemmed | Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study |
| title_short | Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study |
| title_sort | study protocol for the cope study covid 19 in older people the influence of frailty and multimorbidity on survival a multicentre european observational study |
| url | https://bmjopen.bmj.com/content/10/9/e040569.full |
| work_keys_str_mv | AT thomaslee studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT sandeepsingh studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT phyokyawmyint studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT sheilajones studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT bencarter studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT susanmoug studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT terryquinn studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT michaelthomas studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT emmabhatti studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT angelineprice studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT fenellabarlowpay studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT siobhanduffy studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT lyndsaypearce studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT arturovilchesmoraga studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT michaelstechman studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT philipbraude studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT emmamitchell studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT alessiaverduri studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT kathrynmccarthy studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT jonathanhewitt studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT charlottedavey studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT kiahlunstone studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT alicecavenagh studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT charlottesilver studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT thomastelford studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT rebeccasimmons studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT dolciepaxton studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT francisrickard studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT markholloway studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT jameshesford studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT tarikjichi studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT normangalbraith studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT jennyedwards studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT carlybisset studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT rossalexander studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT abigailingham studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT roxannashort studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT ainemcgovern studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT jemimacollins studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT eilidhbruce studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT aliceeinarsson studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT enricoclini studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT giovanniguaraldi studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT madelinegarcia studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT shefalisangani studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT thomaskneen studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT georgekyriakopoulos studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy AT denisetan studyprotocolforthecopestudycovid19inolderpeopletheinfluenceoffrailtyandmultimorbidityonsurvivalamulticentreeuropeanobservationalstudy |