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Electronic Data Management for Vaccine Trials in Low Resource Settings: Upgrades, Scalability, and Impact of ODK.
Marks, Michael; Lal, Sham; Brindle, Hannah; Gsell, Pierre-Stéphane; MacGregor, Matthew; Stott, Callum; van de Rijdt, Martijn; Almazor, Guillermo Gutiérrez; Golia, Suman; Watson, Conall; Diallo, Abdourahamane; Toure, Alhassane; Houlihan, Catherine; Keating, Patrick; Martin, Hélène; Restrepo, Ana-Maria Henao; Anokwa, Yaw; Roberts, Chrissy H.
Afiliación
  • Marks M; London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Lal S; London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Brindle H; London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Gsell PS; World Health Organization, Geneva, Switzerland.
  • MacGregor M; London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Stott C; Nafundi LLC, San Diego, CA, United States.
  • van de Rijdt M; Enketo LLC, Denver, CO, United States.
  • Almazor GG; Nafundi LLC, San Diego, CA, United States.
  • Golia S; London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Watson C; London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Diallo A; World Health Organization, Geneva, Switzerland.
  • Toure A; World Health Organization, Geneva, Switzerland.
  • Houlihan C; London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Keating P; Médecins Sans Frontières UK, London, United Kingdom.
  • Martin H; UK Public Health Rapid Support Team, London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Restrepo AH; Nafundi LLC, San Diego, CA, United States.
  • Anokwa Y; World Health Organization, Geneva, Switzerland.
  • Roberts CH; Enketo LLC, Denver, CO, United States.
Front Public Health ; 9: 665584, 2021.
Article en En | MEDLINE | ID: mdl-34805059
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fiebre Hemorrágica Ebola / Epidemias Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Front Public Health Año: 2021 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fiebre Hemorrágica Ebola / Epidemias Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Front Public Health Año: 2021 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Suiza