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.

Highlights

  • ODK [1] provides open-source, community developed software and standards that have found broad utility in public health research [2, 3], epidemiology [4], disease mapping [5], and anthropological [6] studies in low-and-middle-income countries (LMICs)

  • In this paper we report on the technical approach taken to rapidly implement these changes and build an appropriate software suite to support the vaccine programme roll-out in response to Ebola

  • In order to make it possible to handle millions of case report forms (CRFs) submissions to the Epidemic Data Kit (EDK) system without impacting significantly on time taken for pull and export operations, we introduced two performance related features to Briefcase, including “smart append” and “resume from last” controls

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Summary

Introduction

ODK [1] provides open-source, community developed software and standards that have found broad utility in public health research [2, 3], epidemiology [4], disease mapping [5], and anthropological [6] studies in low-and-middle-income countries (LMICs). The core ODK tools are some of the most widely used EDC tools in the world, with over 400,000 active users each month and more than one million app instals to date They form the basis of the ODK ecosystem [9], which underpins the function of many other electronic data tools including Ona [10], KoBoToolbox [11], SurveyCTO [12], CommCare [13], and Enketo [14]. 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

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