The impact of the COVID-19 pandemic on the provision, practice, and outcomes of vascular surgery (COVER study)

ISRCTN	ISRCTN80453162
DOI	https://doi.org/10.1186/ISRCTN80453162
IRAS number	282224
Secondary identifying numbers	COVER_01, IRAS 282224

Submission date: 12/04/2020
Registration date: 14/04/2020
Last edited: 10/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
The COVER study is an international study aiming to assess how the COVID-19 coronavirus pandemic has changed the medical care of patients who have artery and vein problems. It consists of three separate projects or "Tiers". The 1st Tier is an internet based survey where doctors and healthcare professionals are asked some questions (every week) about how the care of these patients has changed. The 2nd Tier is a study where each hospital inputs the nature of the surgeries performed every week on an online database. The 3rd Tier is similar to the 2nd Tier; it will collect information on what happens to patients having artery or vein surgery during the pandemic. Finally, we will collect information regarding what happened to these patients for a year.

This study will help healthcare professionals understand how the COVID-19 pandemic has changed the care of patients with artery and vein problems. This is an important question, as patients with such health problems typically have many other health issues and/or are elderly. This makes them it more likely for them to develop COVID-19 related problems and life threatening complications.

Who can participate?
Any patient with a vascular condition.

What does the study involve?
Health professionals at participating centres will complete an online survey regarding vascular surgery that has been carried out.

What are the possible benefits and risks of participating?
None.

Where is the study run from?
University Hospital Coventry and Warwickshire (UK)

When is the study starting and how long is it expected to run for?
April 2020 to April 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Ruth Benson (public), vern.arterial.disease@gmail.com
2. Prof Christopher Imray (scientific), vern.arterial.disease@gmail.com
3. Sandip Nandhra (public), vern.arterial.disease@gmail.com
4. Prof Matt Bown (scientific), mjb42@le.ac.uk
5. Ms Ann Elsworth (public), ame29@le.ac.uk

Study website

Contact information

Miss Ruth Benson
Public

Vascular and Endovascular Research Network (President)
Birmingham
B15 2QU
United Kingdom

ORCID ID	0000-0001-5889-4391
Phone	+44 (0)121 4143344
Email	vern.arterial.disease@gmail.com

Prof Christopher Imray
Scientific

University Hospitals Warwickshire
Department of Vascular Surgery
Coventry
CV22DX
United Kingdom

Phone	+44 (0)247 6964000
Email	vern.arterial.disease@gmail.com

Mr Athanasios Saratzis
Scientific

BHF Cardiovascular Research Facility
Glenfield Hospital
Leicester
LE39QP
United Kingdom

ORCID ID	0000-0002-3399-094X
Phone	+44 (0)121 2524178
Email	vern.arterial.disease@gmail.com

Mr Sandip Nandhra
Public

Vascular and Endovascular Research Network
Newcastle
NE7 7DN
United Kingdom

Phone	+44 (0)191 2336161
Email	vern.arterial.disease@gmail.com

Prof Matt Bown
Scientific

Department of Cardiovascular Sciences
University of Leicester
BHF Cardiovascular Research Centre
Glenfield General Hospital
Leicester
LE2 7LX
United Kingdom

ORCID ID	0000-0002-6180-3611
Phone	+44 (0)116 252 3190
Email	mjb42@le.ac.uk

Ms Ann Elsworth
Public

Office 65
Clinical Sciences Building
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

Phone	+44 (0)116 2502381
Email	ame29@le.ac.uk

Study information

Study design	Observational longitudinal study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Available for download (alongside all documents) at the study website.
Scientific title	The impact of the COVID-19 pandemic on the provision, practice, and outcomes of vascular surgery. An international cohort study (COVER)
Study acronym	COVER
Study hypothesis	The COVID-19 pandemic has already had a significant impact on worldwide healthcare systems. There is an urgent need to quantify the specific impact on the provision of vascular and endovascular surgery and the adjustments made to standard vascular practice in light of the pandemic.
Ethics approval(s)	Approved 02/04/2020, Liverpool Central NHS Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8056; liverpoolcentral.rec@hra.nhs.uk), ref: 20/NW/0196
Condition	Any vascular condition, including: aortic or other type of aneurysmal disease, peripheral arterial disease, venous disease, vascular malformations, trauma, major haemorrhage, access (for renal dialysis), carotid (and cerebrovascular) disease, any other type of pathology treated by vascular surgeons.
Intervention	This project is a three-tiered study designed to fully elucidate the impact of the COVID-19 pandemic on vascular surgery across the world. The aim of Tier 1 is to document how the provision and availability of vascular services evolves over time per unit/region/country. The aim of Tier 2 is to prospectively capture data on all vascular procedures performed during the pandemic and understand the impact on outcomes in the short and medium-term (up to 1 year). The aim of Tier 3 is to document (prospectively) deviations from standards of care/practice during the pandemic in vascular patients. The main objective of the COVER study is to understand and evaluate the impact of the COVID-19 pandemic on global vascular practice and the effect on outcomes for patients presenting/receiving treatment during the pandemic. Population (patients) – All patients with a vascular pathology. Outcome of interest – Tier 1: state of vascular services per centre weekly; Tier 2: procedures performed in each centre; Tier 3: assessment of longer-term outcomes. Time – end of study 12 months after the end of the COVID19 pandemic. The study is formally supported by the Vascular Society of Great Britain and Ireland (VSGBI), the British Society for Endovascular Therapy (BSET), the Rouleaux Club, the NIHR, SingVasc and several national vascular surgery societies in Europe, Asia, Australia, New Zealand, and the Americas.
Intervention type	Other
Primary outcome measure	1. Structure and processes within the vascular service measured using a novel online questionnaire weekly until the end of data collection 2. Document all vascular surgery and interventional procedures performed using an online purpose-built data collection tool (per centre/patient) at baseline, time/date of surgery, date of discharge from hospital, three, six, and twelve months: 2.1. Type of procedure performed 2.2. Time taken from presentation to the surgical team to intervention 2.3. Mode of referral (primary vs. secondary care) 2.4. Site of surgery – hub or spoke hospital 2.5. Imaging modalities used and timings 2.6. Emergency classification i.e. urgent/emergency/elective 2.7. Operative technique(s) and device(s) used 2.8. Mode(s) of anaesthesia (local, regional, general, locoregional, other) 2.9. Whether suspected or confirmed COVID-19 positive (+ve) at time of surgery, COVID-19 +ve after surgery, or COVID-19 negative (-ve) 2.10. Documentation of changes to usual practice for this specific procedure as per surgeon’s standard protocol (type of procedure, type of anaesthetic, post-procedural destination) 3. Management of all referred urgent vascular cases using the online survey, focusing on: 3.1. Chronic Limb Threatening Ischaemia (CLTI): 3.1.1. Decision to discharge/admit/refer to a "hot"/emergency clinic 3.1.2. Decision for endovascular or open surgery first 3.1.3. Decision for best medical therapy or palliation or primary amputation 3.2. Carotid disease: 3.2.1. Number of patients managed with best medical therapy (BMT) 3.2.2. Modifications to the indication and decision for carotid endarterectomy (CEA) 3.2.3. Delays to treatment due to lack of theatre/bed availability 3.3. Abdominal Aortic Aneurysm (AAA) 3.3.1. Increasing use of Endovascular repair (if applicable) 3.3.2. Changes to criteria for intervention 3.3.3. Decisions for palliation, i.e. ‘turn down’ 3.4. Acute Aortic syndrome (AAS) 3.4.1. Decision to manage in non-critical care beds 3.4.2. Changes to imaging protocol at unit level 3.4.3. Decision to defer surgery
Secondary outcome measures	1. Collected after surgery has been performed at three, six, and twelve months using patient records: 1.1. Re-admission 1.2. Re-intervention 1.3. All-cause mortality 1.4. Operation-specific morbidity 1.5. Morbidity 1.6. [If COVID-19 +ve] - respiratory outcome, admission to intensive care unit 2. Condition-specific outcomes at 3, 6 months and 1 year: 2.1. CLTI - limb salvage, amputation free survival, all-cause mortality 2.2. Carotid disease - ipsilateral stroke rate, any stroke rate, all-cause mortality 2.3. AAA - aneurysm-related mortality, all-cause mortality 2.4. AAS - complication rate including ruptures, all-cause mortality
Overall study start date	23/03/2020
Overall study end date	01/04/2022

Eligibility

Participant type(s)	All
Age group	All
Sex	Both
Target number of participants	20 centres, 10 patients from each centre
Participant inclusion criteria	Any patient with a vascular condition
Participant exclusion criteria	Does not meet inclusion criteria
Recruitment start date	09/04/2020
Recruitment end date	01/04/2022

Locations

Countries of recruitment

Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire Saint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo, Democratic Republic
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
England
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See (Vatican City State)
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, North
Korea, South
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia, Federated States of
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Martin (French part)
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten (Dutch part)
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States Minor Outlying Islands
United States of America
Uruguay
Uzbekistan
Vanuatu
Venezuela
Viet Nam
Virgin Islands, British
Virgin Islands, U.S.
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe

Study participating centre

University Hospital Coventry and Warwickshire (lead Research and Development centre)

University Hospital Coventry and Warwickshire, RD&I (FAO Professor Imray)
Coventry
CV2 2DX
United Kingdom

Sponsor information

University Hospitals Coventry and Warwickshire NHS Trust
Hospital/treatment centre

University Hospitals Warwickshire
Department of Research and Development (FAO Professor Imray)
Coventry
CV22DX
England
United Kingdom

Phone	+44 (0)2476964000
Email	R&DSponsorship@uhcw.nhs.uk
Website	http://www.uhcw.nhs.uk/
"ROR"	https://ror.org/025n38288

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/06/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal. This is an international effort led by the Vascular and Endovascular Research Network (VERN). The COVER study follows a collaborative authorship policy. All collaborators, including nurses, students, trainees, doctors, and other healthcare professionals, can be eligible for authorship. You can access the authorship policy here: http://vascular-research.net/authorship-policy/
IPD sharing plan	Not provided at registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	Presented at National Research Collaborative Meeting Conference 2020	08/04/2021	06/12/2021	No	No
Protocol article		30/12/2020	06/12/2021	Yes	No
Results article		01/04/2021	06/12/2021	Yes	No
Results article		01/10/2020	06/12/2021	Yes	No
Results article	Qualitative results of clinician survey	03/12/2021	06/12/2021	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

10/03/2022: A scientific contact and a public contact have been added and the plain English summary updated accordingly.
06/12/2021: Publication references added.
14/04/2020: Trial’s existence confirmed by NHS Health Research Authority