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: whereas it has brought new research questions in 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 by 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 prespecified 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 toward 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 while 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.
References
- 1.Valdivia A.R., Chaudhuri A. A need for consensus on mortality reporting related to the COVID-19 pandemic in ongoing and future vascular registries and trials. J Vasc Surg. 2020 Jun 24 doi: 10.1016/j.jvs.2020.06.013. [Online ahead of print] [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Fleming T.R., Labriola D., Wittes J. Conducting clinical research during the COVID-19 pandemic: protecting scientific integrity. JAMA. 2020 May 28 doi: 10.1001/jama.2020.9286. [Online ahead of print] [DOI] [PubMed] [Google Scholar]
- 3.Lunt H., Heenan H. Mitigating the impact of disasters and emergencies on clinical trials site conduct: a site perspective following major and minor unforeseen events. Contemp Clin Trials Commun. 2019;16:100487. doi: 10.1016/j.conctc.2019.100487. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Padala P.R., Jendro A.M., Padala K.P. Conducting clinical research during the COVID-19 pandemic: investigator and participant perspectives. JMIR Public Health Surveill. 2020;6:e18887. doi: 10.2196/18887. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.COVIDSurg Collaborative Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study [published correction appears in Lancet 2020 Jun 9] Lancet. 2020;396:27–38. doi: 10.1016/S0140-6736(20)31182-X. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Mouawad N.J., Cuff R.F., Hultgren R., Chuen J., Galeazzi E., Wohlauer M. The Vascular Surgery COVID-19 Collaborative (VASCC) J Vasc Surg. 2020;72:379–380. doi: 10.1016/j.jvs.2020.04.463. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Benson R.A., Vascular and Endovascular Research Network (VERN) Collaborators The COvid-19 Vascular sERvice (COVER) study: an international Vascular and Endovascular Research Network (VERN) collaborative study assessing the provision, practice, and outcomes of vascular surgery during the COVID-19 pandemic. Eur J Vasc Endovasc Surg. 2020;60:156–157. doi: 10.1016/j.ejvs.2020.04.039. [DOI] [PMC free article] [PubMed] [Google Scholar]