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      Moving forward: ensuring quality research in vascular surgery during COVID-19

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          Abstract

          In their article, Valdivia and Chaudhuri discuss the impact of deaths from the coronavirus disease 2019 (COVID-19) on the outcomes of trials and registries, importantly highlighting the negative impact on the accuracy of databases and calling for improved guidelines surrounding mortality reporting. 1 COVID-19 is a double-edged sword: while it has brought new research questions amidst times of uncertainty, it has equally complicated traditional academic pursuits. Although trials and registries should be considered in a case-by-case manner, timely interventions are needed to protect participants’ safety first and foremost. Studies, where possible, should consider halting or delaying the recruitment of new patients, establishing on-site precaution measures, and maximizing follow-ups via telemedicine. 2 , 3 Revision of statistical analyses, data interpretation, and protocols is unavoidable as, similar to patient safety, integrity in research should remain prioritized. This pandemic can, however, also become an opportunity to revisit how clinical research is conducted. Learning from current challenges in accounting for heightened mortality due to COVID-19, trials and registries need to be structured for unexpected events that would significantly influence the number of participants or their outcomes. Future pandemics and global crises are bound to occur and devising pre-specified protocols for patient follow-up, data storage, and human resource management will be crucial in ensuring the consistency of clinical research when resources are redirected towards emergency response. 3 , 4 Furthermore, there is potential for a larger role for citizen-driven science and self-reported outcomes in advancing pandemic-related research and beyond, reducing the burden on clinical providers and scientists whilst still ensuring the advancement of our field. One silver lining of the pandemic for research will be the vast body of literature that is being generated on disease-specific outcomes affected by COVID-19. 5 New international collaboratives like the Vascular Surgery COVID-19 Collaborative (VASCC) and the COvid-19 Vascular sERvice (COVER) are actively collecting information on the consequences of surgery delays and COVID-19 infections in vascular patients. 6 , 7 Only through cooperation, transparency, and solidarity between researchers will we be able to bounce back from the darkness of the COVID-19 era and build resiliency into surgical research to navigate future crises.

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          Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity

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            Conducting Clinical Research During the COVID-19 Pandemic: Investigator and Participant Perspectives

            As the medical landscape changes daily with the coronavirus disease (COVID-19) pandemic, clinical researchers are caught off-guard and are forced to make decisions on research visits in their ongoing clinical trials. Although there is some guidance from local and national organizations, the principal investigator (PI) is ultimately responsible for determining the risk-benefit ratio of conducting, rescheduling, or cancelling each research visit. The PI should take into consideration the ethical principles of research, local/national guidance, the community risk of the pandemic in their locale, staffing strain, and the risk involved to each participant, to ultimately decide on the course of action. While balancing the rights and protection of the human subject, we seldom examine patients’ views and opinions about their scheduled research visit(s). This article discusses the ethical principles of beneficence and autonomy in helping the decision-making process. We discuss ways to weigh-in local and national guidance, staffing strain, and institutional support into the decision-making process and outline potential changes needed for regulatory bodies depending on the decision. Further, we discuss the need to weigh-in the individual risk-benefit ratio for each participant and present a decision tree to navigate this complex process. Finally, we examine participant and caregiver perspectives on their fears, sense of preparedness, and factors that they consider before deciding whether to keep or postpone the research appointments. This entry also provides PIs ways to support their research participants in both scenarios, including provision of psychological support.
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              The Vascular Surgery Covid-19 Collaborative (VASCC)

              Dear Editor, The unprecedented pandemic spread of the novel coronavirus (SARS-CoV-2; Covid-19) has severely impacted the delivery of health care services in the United States and around the world. As of April 9, 2020, there are more than 1.5 million confirmed cases of Covid-19 worldwide and over 16,000 deaths in the United States alone [1,2]. The important public health guidelines of social distancing to help curtail and flatten the curve through mitigation and suppression has resulted in a dramatic reduction of in-person clinic visits, if not halting them completely. Furthermore, in an effort to preserve the very scarce assets of personal protective equipment as well as Intensive Care Unit resources, such as ventilators, medications, and trained personnel, elective vascular surgical cases have decreased significantly. The American College of Surgeons placed recommendations on the management of elective surgical procedures with the use of the Elective Surgery Acuity Scale on March 13, 2020, and specific tiers to triage vascular surgery operations [3, 4]. On March 14, 2020, the Surgeon General urged the widespread halt of hospital elective procedures due to the mounting concerns of the Covid-19 surge. Given these discussions, most vascular surgeons have reduced their practice patterns to emergency vascular surgery and/or very urgent cases. The adage of “time is tissue” remains a paramount concern for the vascular surgery community. On behalf of our patients, we are concerned about the delays of these procedures but clearly understand the public health necessity to restrict the use of valuable equipment and personnel. Despite physical distancing, within several days vascular surgeons organized through social media both locally and internationally to work, understand, and help predict what these unanticipated delays would be on patient outcomes. This led to the inception of the Vascular Surgery Covid-19 Collaborative (VASCC), the combined international effort to help obtain prospective data on the impact of widespread vascular surgical care delays due to a national crisis and pandemic. We currently have over 300 members representing a majority of the states in the United States and over 28 countries worldwide, and we are continuing to grow and amass a data registry in cooperation with the Vascular Low Frequency Disease Consortium (VLFDC). On behalf of the myriad of vascular surgeons involved among multiple practice patterns, we request our vascular surgery community to contribute and assist in this international disaster that affects us all.
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                Author and article information

                Contributors
                Journal
                J Vasc Surg
                J. Vasc. Surg
                Journal of Vascular Surgery
                Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.
                0741-5214
                1097-6809
                15 July 2020
                15 July 2020
                Affiliations
                [1 ]Faculty of Medicine, Universite de Montreal, Montreal, Quebec, Canada
                [2 ]Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada
                [3 ]Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States
                Author notes
                []Corresponding Author Xiya Ma, MD, MSc Faculty of Medicine, Universite de Montreal 2900, boul. Edouard-Montpetit, Montreal, QC, Canada, H3T 1J4 +1 514 243 2941 xiyama.xm@ 123456gmail.com
                Article
                S0741-5214(20)31590-1
                10.1016/j.jvs.2020.07.048
                7362845
                8ad4d5f9-cf50-4b05-944c-38f6d8bef673
                © 2020 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                : 29 June 2020
                : 8 July 2020
                Categories
                Article

                Surgery
                vascular surgery,research,covid-19,coronavirus
                Surgery
                vascular surgery, research, covid-19, coronavirus

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