An Electronic Data Capture Tool for Data Collection During Public Health Emergencies: Development and Usability Study.

BACKGROUND: The Discovery Critical Care Research Network Program for Resilience and Emergency Preparedness (Discovery PREP) partnered with a third-party technology vendor to design and implement an electronic data capture tool that addressed multisite data collection challenges during public health emergencies (PHE) in the United States. The basis of the work was to design an electronic data capture tool and to prospectively gather data on usability from bedside clinicians during national health system stress queries and influenza observational studies. OBJECTIVE: The aim of this paper is to describe the lessons learned in the design and implementation of a novel electronic data capture tool with the goal of significantly increasing the nation's capability to manage real-time data collection and analysis during PHE. METHODS: A multiyear and multiphase design approach was taken to create an electronic data capture tool, which was used to pilot rapid data capture during a simulated PHE. Following the pilot, the study team retrospectively assessed the feasibility of automating the data captured by the electronic data capture tool directly from the electronic health record. In addition to user feedback during semistructured interviews, the System Usability Scale (SUS) questionnaire was used as a basis to evaluate the usability and performance of the electronic data capture tool. RESULTS: Participants included Discovery PREP physicians, their local administrators, and data collectors from tertiary-level academic medical centers at 5 different institutions. User feedback indicated that the designed system had an intuitive user interface and could be used to automate study communication tasks making for more efficient management of multisite studies. SUS questionnaire results classified the system as highly usable (SUS score 82.5/100). Automation of 17 (61%) of the 28 variables in the influenza observational study was deemed feasible during the exploration of automated versus manual data abstraction. The creation and use of the Project Meridian electronic data capture tool identified 6 key design requirements for multisite data collection, including the need for the following: (1) scalability irrespective of the type of participant; (2) a common data set across sites; (3) automated back end administrative capability (eg, reminders and a self-service status board); (4) multimedia communication pathways (eg, email and SMS text messaging); (5) interoperability and integration with local site information technology infrastructure; and (6) natural language processing to extract nondiscrete data elements. CONCLUSIONS: The use of the electronic data capture tool in multiple multisite Discovery PREP clinical studies proved the feasibility of using the novel, cloud-based platform in practice. The lessons learned from this effort can be used to inform the improvement of ongoing global multisite data collection efforts during the COVID-19 pandemic and transform current manual data abstraction approaches into reliable, real time, and automated information exchange. Future research is needed to expand the ability to perform automated multisite data extraction during a PHE and beyond.

ICU Resource Limitations During Peak Seasonal Influenza: Results of a 2018 National Feasibility Study.

OBJECTIVES: Demonstrate the feasibility of weekly data collection and analysis of public health emergency (PHE) data. Assess fluctuations in, and challenges of, resource matching and potential effect on patient care for influenza in ICUs. DESIGN: Multicenter prospective noninterventional study testing effectiveness of leveraging the Discovery Critical Care Research Network Program for Resilience and Emergency Preparedness (Discovery-PREP) in performing PHE research. A 20-question internet survey was developed to prospectively assess ICU influenza-related resource stress. An informatics tool was designed to track responses; data were analyzed within 24 hours of weekly survey completion by the team biostatistician for timely reporting. PARTICIPANTS: Critical care and Emergency Medicine Discovery-PREP network investigators self-selected to participate in the voluntary query. SETTING: ICUs of 13 hospitals throughout the United States, 12 academic, and one community. INTERVENTIONS: ICU physicians were electronically surveyed weekly over 17 weeks during the influenza season (January 2018-April 2018). Responses were collected for 48 hours after each email query. MEASUREMENTS AND MAIN RESULTS: The average weekly response among the sites was 79% (range, 65-100%). Significant stress, defined as alterations in ICU staffing and/or resource allocation, occurred in up to 41% of sites during the national peak of influenza activity. These alterations included changes in staffing, not accepting external patient transfers, and canceling elective surgery. During this same period, up to 17% of the sites indicated that these changes might not have been sufficient to prevent potentially avoidable patient harm. CONCLUSIONS: This novel approach to querying ICU operational stress indicated that almost half of participating sites experienced critical care resource limitations during peak influenza season and required process and/or staffing changes to better balance resources with patient care demands. This weekly national reporting infrastructure could be adapted and expanded to better inform providers, hospital emergency management teams, and government leaders during PHEs.

Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment.

OBJECTIVE: We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitted securely to the Food and Drug Administration's (FDA's) blockchain through a secure data broker (SDB). MATERIALS AND METHODS: This assessment was divided into four sections: an institutional EHR readiness assessment, legal consultation, institutional review board application submission, and a test of healthcare data transmission over a blockchain infrastructure. RESULTS: All participating institutions reported the ability to electronically extract data from EHRs for research. Formal legal agreements were deemed unnecessary to the project but would be needed in future tests of real patient data exchange. Data transmission to the FDA blockchain met the success criteria of data connection from within the four institutions' firewalls, externally to the FDA blockchain via a SDB. DISCUSSION: The readiness survey indicated advanced analytic capability in hospital institutions and highlighted inconsistency in Fast Healthcare Interoperability Resources format utilitzation across institutions, despite requirements of the 21st Century Cures Act. Further testing across more institutions and annual exercises leveraging the application of data exchange over a blockchain infrastructure are recommended actions for determining the feasibility of this approach during a public health emergency and broaden the understanding of technical requirements for multisite data extraction. CONCLUSION: The FDA's RAPID (Real-Time Application for Portable Interactive Devices) program, in collaboration with Discovery, the Critical Care Research Network's PREP (Program for Resilience and Emergency Preparedness), identified the technical and legal challenges and requirements for rapid data exchange to a government entity using the FDA blockchain infrastructure.