The impact of COVID-19 pandemic on vascular registries and clinical trials

TY - JOUR

T1 - The impact of COVID-19 pandemic on vascular registries and clinical trials

AU - Aziz, Faisal

AU - Behrendt, Christian-Alexander

AU - Sullivan, Kaity

AU - Beck, Adam W

AU - Beiles, C Barry

AU - Boyle, Jon R

AU - Mani, Kevin

AU - Benson, Ruth A

AU - Wohlauer, Max V

AU - Khashram, Manar

AU - Jorgensen, Jens Eldrup

AU - Lemmon, Gary W

N1 - Copyright © 2021 Elsevier Inc. All rights reserved.

PY - 2021/6

Y1 - 2021/6

N2 - Quality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.

AB - Quality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.

KW - Biomedical Research/statistics & numerical data

KW - COVID-19/epidemiology

KW - Clinical Trials as Topic

KW - Humans

KW - Procedures and Techniques Utilization

KW - Quality Improvement

KW - Registries

KW - Vascular Surgical Procedures/statistics & numerical data

U2 - 10.1053/j.semvascsurg.2021.04.001

DO - 10.1053/j.semvascsurg.2021.04.001

M3 - SCORING: Review article

C2 - 34144744

VL - 34

SP - 28

EP - 36

JO - SEMIN VASC SURG

JF - SEMIN VASC SURG

SN - 0895-7967

IS - 2

ER -