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

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://clinicaltrials.gov/ct2/show/NCT04323787

Biomarker-Concordant Steroid Administration in Severe Coronavirus Disease-2019

“…24 Incidental laboratory test positivity for severe acute respiratory syndrome coronavirus 2 during admission for an unrelated reason is also outside the scope of the Registry. 22…”

“…There is no patient contact at the time of study inclusion, and the decision to enroll is made solely by the local research collaborators. 22 Patients who have previously been enrolled and those who have not provided research authorization are not eligible. 24 Incidental laboratory test positivity for severe acute respiratory syndrome coronavirus 2 during admission for an unrelated reason is also outside the scope of the Registry.…”

“…During the weekly study meetings, the inconsistencies were shared with the participating sites, and institution-based training sessions were provided to improve data quality. 22 Due to the increased workloads of the local teams because of the pandemic conditions, data missingness was a significant issue, particularly for daily data variables such as medications, including corticosteroids, and laboratory test results, including CRP levels. At the time data for this study was downloaded (December 2021), the Registry had 71 466 patients enrolled.…”

“…The VIRUS Registry was launched as a global database in March 2020 with the goal of creating a platform for determining the safety and observational effectiveness of interventions in COVID-19 patients; and collecting, analyzing, and displaying data in near real-time. [21][22][23] All COVID-19-related admissions to participating hospitals are eligible for the VIRUS Registry. Local teams determine COVID-19-related admissions based on the eligibility criteria of severe acute respiratory syndrome coronavirus 2 test positivity within 21 days of admission or high clinical suspicion for COVID-19 by clinical providers in the absence of reliable laboratory testing resources.…”

The impact of violence on healthcare workers' mental health in conflict based settings amidst COVID‐19 pandemic, and potential interventions: A narrative review

“…The effect on HCWs mental well being is not well studied and its impact on patient clinical care is even less studied. The need of the hour to develop and sustain near real time clinical registries [54][55][56][57] to capture harmonized clinical data from hospitals, HCWs and patients.…”