Lessons From a Rapid Project Management Exercise in the Time of Pandemic: Methodology for a Global COVID-19 VIRUS Registry Database

Janice R Turek, Vikas Bansal, Aysun Tekin, Shuchita Singh, Neha Deo, Mayank Sharma, Marija Bogojevic, Shahraz Qamar, Romil Singh, Vishakha Kumar, Rahul Kashyap, Janice R Turek, Vikas Bansal, Aysun Tekin, Shuchita Singh, Neha Deo, Mayank Sharma, Marija Bogojevic, Shahraz Qamar, Romil Singh, Vishakha Kumar, Rahul Kashyap

Abstract

Background: The rapid emergence of the COVID-19 pandemic globally collapsed health care organizations worldwide. Incomplete knowledge of best practices, progression of disease, and its impact could result in fallible care. Data on symptoms and advancement of the SARS-CoV-2 virus leading to critical care admission have not been captured or communicated well between international organizations experiencing the same impact from the virus. This led to the expedited need for establishing international communication and data collection on the critical care patients admitted with COVID-19.

Objective: Developing a global registry to collect patient data in the critical care setting was imperative with the goal of analyzing and ameliorating outcomes.

Methods: A prospective, observational global registry database was put together to record extensive deidentified clinical information for patients hospitalized with COVID-19.

Results: Project management was crucial for prompt implementation of the registry for synchronization, improving efficiency, increasing innovation, and fostering global collaboration for valuable data collection. The Society of Critical Care Medicine Discovery VIRUS (Viral Infection and Respiratory Illness Universal Study): COVID-19 Registry would compile data for crucial longitudinal outcomes for disease, treatment, and research. The agile project management approach expedited establishing the registry in 15 days and submission of institutional review board agreement for 250 participating sites. There has been enrollment of sites every month with a total of 306 sites from 28 countries and 64,114 patients enrolled (as of June 7, 2021).

Conclusions: This protocol addresses project management lessons in a time of crises which can be a precept for rapid project management for a large-scale health care data registry. We aim to discuss the approach and methodology for establishing the registry, the challenges faced, and the factors contributing to successful outcomes.

Trial registration: ClinicalTrials.gov NCT04323787; https://ichgcp.net/clinical-trials-registry/NCT04323787.

Keywords: COVID-19; critical care; global; program management; registry.

Conflict of interest statement

Conflicts of Interest: RK is receiving grants from the Betty and Moore Foundation and Jensen & Jensen, LLC for supporting this registry. Neither of them has any role in writing, reviewing, or influencing this manuscript. Other coauthors have no conflict of interest.

©Janice R Turek, Vikas Bansal, Aysun Tekin, Shuchita Singh, Neha Deo, Mayank Sharma, Marija Bogojevic, Shahraz Qamar, Romil Singh, Vishakha Kumar, Rahul Kashyap. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.03.2022.

Figures

Figure 1
Figure 1
VIRUS Global Pandemic Registry Team Organizations. AJW: Allan J Walkey. AT: Aysun Tekin. BU: Boston University. CM: Colleen McNamara. CS: Christopher R Sheldrick. GM: Gregory Martin. JT: Janice Turek. KB: Karen Boman. KG: Katja Gist. LR: Lynn Retford. MB: Marija Bogojevic. MC: Mayo Clinic. MG: Michael Garcia. MR: Mary Reidy. MS: Mayank Sharma. ND: Neha Deo. OG: Ognjen Gajic. PS: Phillip Schulte. RK: Rahul Kashyap. SHS: Smith Heavner. SJ: Shelsey Johnson. ST: Sandeep Tripathi. UB: Utpal Bhalala. VB: Vikas Bansal. VK: Vishakha Kumar.
Figure 2
Figure 2
Workflow of the VIRUS: COVID-19 International registry. DAG: data access group, PI: program investigator, PM: program manager.
Figure 3
Figure 3
The one-year (April 2020-April 2021) trend of patient enrollment in VIRUS Registry.
Figure 4
Figure 4
Active sites for the VIRUS: COVID-19 registry with the executive regional Leads.

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