Electronic Data Management for Vaccine Trials in Low Resource Settings: Upgrades, Scalability, and Impact of ODK

Abstract

Background: ODK provides software and standards that are popular solutions for off-grid electronic data collection and has substantial code overlap and interoperability with a number of related software products including CommCare, Enketo, Ona, SurveyCTO, and KoBoToolbox. These tools provide open-source options for off-grid use in public health data collection, management, analysis, and reporting. During the 2018-2020 Ebola epidemic in the North Kivu and Ituri regions of Democratic Republic of Congo, we used these tools to support the DRC Ministère de la Santé RDC and World Health Organization in their efforts to administer an experimental vaccine (VSV-Zebov-GP) as part of their strategy to control the transmission of infection. Method: New functions were developed to facilitate the use of ODK, Enketo and R in large scale data collection, aggregation, monitoring, and near-real-time analysis during clinical research in health emergencies. We present enhancements to ODK that include a built-in audit-trail, a framework and companion app for biometric registration of ISO/IEC 19794-2 fingerprint templates, enhanced performance features, better scalability for studies featuring millions of data form submissions, increased options for parallelization of research projects, and pipelines for automated management and analysis of data. We also developed novel encryption protocols for enhanced web-form security in Enketo. Results: Against the backdrop of a complex and challenging epidemic response, our enhanced platform of open tools was used to collect and manage data from more than 280,000 eligible study participants who received VSV-Zebov-GP under informed consent. These data were used to determine whether the VSV-Zebov-GP was safe and effective and to guide daily field operations. Conclusions: We present open-source developments that make electronic data management during clinical research and health emergencies more viable and robust. These developments will also enhance and expand the functionality of a diverse range of data collection platforms that are based on the ODK software and standards.

Keywords: Ebola; electronic data collection; low and middle income countries; open source software; open-data-kit.

Figure 1

Data capture points within the Ebola Vaccination implementation. Individual CRFs captured information at differing points within the programme. Unique participant IDs were recorded at each point to allow downstream data-linkage.

Figure 2

System design of the LSHTM Emergency and Epidemic Data Kit. Devices in the field are used to carry out data collection (enumeration) activities on browsers or an Android App. Those using Android have the option to register ISO/IEC 19794-2 fingerprint templates as part of the data collection. Encrypted records are submitted to one of many parallel web accessible ODK Aggregate server front-ends. All servers lead to a single PostgreSQL database and backup system. All backups contain only encrypted, non-human-readable form data. An Ubuntu virtual machine is scheduled to perform archiving (data pull, decrypt and export activities, including optionally analysis of fingerprint templates) and triggers analysis (data tidying, analysis, and report generation) using R, R markdown and other open-source analytics tools. Outputs are securely copied or emailed to a workstation for end-user interactions. Areas highlighted in red show where data are stored or transferred in encrypted formats and are non-human readable.

Figure 3

Fully customizable automated data flows. The time-based scheduler cron calls ODK Briefcase to perform data archiving and parsing of data from individual forms to aggregated tables of data in comma separated variable (CSV) format. Cron calls to R control R markdown documents that perform statistical, geospatial and demographic analysis, along with data manipulation to create line lists, audit documentation, interactive monitoring dashboards (based on open tools such as Flexdashboard, LeafletJS, etc), interactive maps and other outputs that are shared to workstations of partners in the field, senior academic team, and internal/external monitors.