key: cord-0779180-irtpxt7w
authors: Valdivia, Andrés Reyes; Chaudhuri, Arindam
title: A need for consensus on mortality reporting related to the COVID-19 pandemic in ongoing and future vascular registries and trials.
date: 2020-06-25
journal: J Vasc Surg
DOI: 10.1016/j.jvs.2020.06.013
sha: b9898b56557444d43fe4863b242f30fd38245db4
doc_id: 779180
cord_uid: irtpxt7w

nan

As the SARS-CoV-2 virus continues to take more lives, quite a few of these 13 will be from the vascular population 3 , typically older and with multiple comorbidities, 14 recognised risk factors for COVID-19-related mortality 4 . Some such patients will be 15 involved in ongoing vascular trials and registries. 16

Presenting "overall mortality rate" is obligatory at registry/trial reporting, 17 particularly specifying the cause of death (COD). There may be some "unknown COD" 18 but these should be a minority, particularly in robust prospective studies. Some 19 "unknown COD" may be attributable to COVID-19, with many dying without COD 20 confirmation. This is related to lack of testing, or high false negative rates, with 21 controversy surrounding the accuracy of oropharyngeal versus nasopharyngeal swabs 5 22 particularly for late testing 6 . 23

The issues arising from COVID-19-related deaths are two-fold: firstly, to do 24 with accurate capture of COD (reporting issues), and secondly, the influence of increased deaths on the completeness of data in ongoing studies (outcome issues). This 1 is a research concern 7, 8 , with calls to extend trial durations 9 , and may necessitate post-2 hoc/retrospective power calculations to reassess statistical validity of studies. 3

We therefore hypothesize four possible scenarios related to mortality reporting: 4

(1) patients with accurate categorization of COVID-19 related COD; (2) patients with 5 prior confirmed COVID-19 infection who recover but die later with unknown COD (3) 6 patients dying from an unknown cause during the pandemic, where COD is uncertain 7 and finally (4) accurate capture of non-COVID-19-related COD. Options 1 and 4 are 8 qualitatively most desirable in terms of data capture. 9

Global clinical uncertainty 10 has implications for registries that report on 10 mortality. This concern pertains to both ongoing and to future study design, as we 11 cannot predict patterns of disease chronicity or repetitiveness. This may lead to similar 12 outcomes as indicated: (1) Accurate COD capture (2) 

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