Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Nov;48(11):e1038-e1044.
doi: 10.1097/CCM.0000000000004572.

Guiding Principles for the Conduct of Observational Critical Care Research for Coronavirus Disease 2019 Pandemics and Beyond: The Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study Registry

Allan J Walkey  1 , R Christopher Sheldrick  2 , Rahul Kashyap  3 , Vishakha K Kumar  4 , Karen Boman  4 , Scott Bolesta  5 , Fernando G Zampieri  6 , Vikas Bansal  3 , Michael O Harhay  7 , Ognjen Gajic  8
Affiliations

Guiding Principles for the Conduct of Observational Critical Care Research for Coronavirus Disease 2019 Pandemics and Beyond: The Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study Registry

Allan J Walkey et al. Crit Care Med. 2020 Nov.

Abstract

Objectives: Use of observational data to inform the response and care of patients during a pandemic faces unique challenges.

Design: The Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study COVID 2019 Registry Core data and research methodology team convened over virtual meetings throughout March to June 2020 to determine best practice goals for development of a pandemic disease registry to support rapid data collection and analysis.

Setting: International, multi-center registry of hospitalized patients.

Patients: None.

Interventions: None.

Measurements and main results: Large-scale observational data collection requires: 1) quality assurance and harmonization across many sites; 2) a transparent process for selecting from among many potential research questions; 3) the use of best practices in design of descriptive, predictive, and inferential studies; (4) innovative approaches to characterize random error in the setting of constantly updated data; (5) rapid peer-review and reporting; and (6) transitions from a focus on discovery to implementation. Herein, we describe the guiding principles to best practices and suggestions for innovations to study design and reporting within the coronavirus disease 2019 Viral Infection and Respiratory Illness Universal Study pandemic registry.

Conclusions: Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study coronavirus disease 2019 registry sought to develop and implement prespecified best practices combined with grassroots efforts from clinical sites worldwide in order to develop clinically useful knowledge in response to a pandemic.

PubMed Disclaimer

Conflict of interest statement

Dr. Walkey receives funding from the National Institutes of Health/National Heart, Lung and Blood Institute (NIH/NHLBI) grants R01HL151607, R01HL139751, R01HL136660, Agency of Healthcare Research and Quality R01HS026485, Boston Biomedical Innovation Center/NIH/NHLBI 5U54HL119145-07, and royalties from UptoDate. Dr. Harhay receives funding from NIH/NHLBI grant R00 HL141678. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Figures

Figure 1.
Figure 1.
Flow diagram of data entry and presentation for Viral Infection and Respiratory Illness Universal Study. COVID-19 = coronavirus disease 2019, CRF = case report form, ID = identification, IRB = institutional review board, REDCap = Research Electronic Data Capture.
Figure 2.
Figure 2.
Pathways for rapid and rigorous generation and dissemination of knowledge in a pandemic setting.
Figure 3.
Figure 3.
Schema of study proposal review and dissemination pathways.
See this image and copyright information in PMC

References

    1. Rome BN, Avorn J. Drug evaluation during the Covid-19 pandemic. N Engl J Med. 2020; 382:2282–2284 - PubMed
    1. Rowland C. FDA authorizes widespread use of unproven drugs to treat coronavirus, saying possible benefit outweighs risk. Washington Post. 2020. Available at: https://www.washingtonpost.com/business/2020/03/30/coronavirus-drugs-hyd.... Accessed July 13, 2020
    1. Mehra MR, Desai SS, Ruschitzka F, et al. Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: A multinational registry analysis. Lancet. 2020. May 22. [online ahead of print] - PMC - PubMed
    1. 2020. . Available at: https://www.recoverytrial.net/. Accessed July 13, 2020.
    1. REMAP-CAP. 2020. . Available at: https://www.remapcap.org/. Accessed July 13, 2020