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

2021 ◽  
Vol 9 ◽  
Author(s):  
Michael Marks ◽  
Sham Lal ◽  
Hannah Brindle ◽  
Pierre-Stéphane Gsell ◽  
Matthew MacGregor ◽  
...  
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Data Management ◽  
Open Source ◽  
Large Scale ◽  
Democratic Republic Of Congo ◽  
World Health ◽  
Electronic Data ◽  
Diverse Range ◽  
Electronic Data Collection

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.

scholarly journals Electronic Data Management in Public Health and Humanitarian Crises. Upgrades, Scalability and Impact of ODK

2020 ◽  
Author(s):  
Michael Marks ◽  
Sham Lal ◽  
Hannah Brindle ◽  
Pierre-Stéphane Gsell ◽  
Matthew MacGregor ◽  
...  
Keyword(s):  
Public Health ◽  
Data Collection ◽  
Clinical Research ◽  
Data Management ◽  
Open Source ◽  
Large Scale ◽  
World Health ◽  
Electronic Data ◽  
Diverse Range ◽  
Health And Social Care

Abstract BackgroundODK provides software and standards that are popular solutions for off-grid electronic data collection and are the basis of related products like CommCare, Enketo, Ona, SurveyCTO and KoBoToolbox. In combination with the use of statistical analysis software such as R, these tools provide fully open-source options for off-grid use in public health data collection, management, analysis and reporting.ResultsNew 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 open-source 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 parallelisation 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. During the 2018-2020 Ebola epidemic in the North Kivu & Ituri regions of Democratic Republic of Congo, ODK, Enketo and R were leveraged 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. 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 under informed consent. These data were used to determine whether the VSV-Zebov-GP was safe and effective and to guide daily field operations.ConclusionsWe 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 (Ona, KoBoToolbox etc.) that are based on the ODK software and standards.FundingThis research is funded by the Department of Health and Social Care using UK Aid funding and is managed by the NIHR (PR-OD-1017-20001).

scholarly journals Electronic data management for vaccine trials in low resource settings: Upgrades, scalability and impact of ODK

2021 ◽  
Author(s):  
Michael Marks ◽  
Sham Lal ◽  
Hannah Brindle ◽  
Pierre-Stéphane Gsell ◽  
Matthew MacGregor ◽  
...  
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Data Management ◽  
Open Source ◽  
Social Care ◽  
World Health ◽  
Electronic Data ◽  
Diverse Range ◽  
Department Of Health ◽  
Health And Social Care

ABSTRACTBackgroundODK 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. In combination with the use of statistical analysis software such as R, these tools provide fully 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 & Ituri regions of Democratic Republic of Congo, we leveraged ODK and other 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.MethodNew 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 open-source 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.ResultsAgainst 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.ConclusionsWe 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 (Ona, KoBoToolbox etc.) that are based on the ODK software and standards.FundingThis research is funded by the Department of Health and Social Care using UK Aid funding and is managed by the NIHR (PR-OD-1017-20001). The views expressed in this publication are those of the authors and not necessarily those of the Department of Health and Social Care.

scholarly journals EXISTING STRATEGIES FOR ELECTRONIC DATA COLLECTION BY ELDER ABUSE MULTI-DISCIPLINARY TEAMS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S423-S423
Author(s):  
Tony Rosen ◽  
David Burnes ◽  
Darin Kirchin ◽  
Alyssa Elman ◽  
Risa Breckman ◽  
...  
Keyword(s):  
Data Collection ◽  
Social Services ◽  
Large Scale ◽  
Elder Abuse ◽  
The United States ◽  
Third Party ◽  
Snowball Sampling ◽  
Electronic Data ◽  
Data Set ◽  
Electronic Data Collection

Abstract Elder abuse cases often require integrated responses from social services, medicine, civil legal, and criminal justice. Multi-disciplinary teams (MDTs), which meet periodically to discuss and coordinate interventions for complex cases, have developed in many communities. Little is known about how these MDTs collect case-level data. Our objective was to describe existing strategies of case-level electronic data collection conducted by MDTs across the United States as a preliminary step in developing a comprehensive database strategy. To identify MDTs currently collecting data electronically, we used a snowball sampling approach discussing with national leaders. We also sent an e-mail to the National Center for Elder Abuse listserv inviting participation. We identified and reviewed 11 databases from MDTs. Strategies for and comprehensiveness of data collection varied widely. Databases used ranged from a simple spreadsheet to a customized Microsoft Access database to large databases designed and managed by a third-party vendor. Total data fields collected ranged from 12-338. Types of data included intake/baseline case/client information, case tracking/follow-up, and case closure/outcomes. Information tracked by many MDTs, such as type of mistreatment, was not captured in a single standard fashion. Documentation about data entry processes varied from absent to detailed. We concluded that MDTs currently use widely varied strategies to track data electronically and are not capturing data in a standardized fashion. Many MDTs collect only minimal data. Based on this, we have developed recommendations for a minimum data set and optimal data structure. If widely adopted, this would potentially improve ability to conduct large-scale comparative research.

scholarly journals Development of an Electronic Data Collection System to Support a Large-Scale HIV Behavioral Intervention Trial: Protocol for an Electronic Data Collection System (Preprint)

2018 ◽  
Author(s):  
W Scott Comulada ◽  
Wenze Tang ◽  
Dallas Swendeman ◽  
Amy Cooper ◽  
Jeremy Wacksman ◽  
...  
Keyword(s):  
Data Collection ◽  
Data Security ◽  
Text Messaging ◽  
Large Scale ◽  
Text Messages ◽  
Intervention Trial ◽  
Electronic Data ◽  
Electronic Data Collection ◽  
Intervention Delivery ◽  
Study Participants

BACKGROUND Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances for electronic data capture (EDC) systems to be appropriately executed and utilized at full capacity in research settings. Mobile technology allows EDC systems to collect near real-time data from study participants, deliver intervention directly to participants’ mobile devices, monitor staff activity, and facilitate near real-time decision making during study implementation. OBJECTIVE This paper presents the infrastructure of an EDC system designed to support a multisite HIV biobehavioral intervention trial in Los Angeles and New Orleans: the Adolescent Medicine Trials Network “Comprehensive Adolescent Research & Engagement Studies” (ATN CARES). We provide an overview of how multiple EDC functions can be integrated into a single EDC system to support large-scale intervention trials. METHODS The CARES EDC system is designed to monitor and document multiple study functions, including, screening, recruitment, retention, intervention delivery, and outcome assessment. Text messaging (short message service, SMS) and nearly all data collection are supported by the EDC system. The system functions on mobile phones, tablets, and Web browsers. RESULTS ATN CARES is enrolling study participants and collecting baseline and follow-up data through the EDC system. Besides data collection, the EDC system is being used to generate multiple reports that inform recruitment planning, budgeting, intervention quality, and field staff supervision. The system is supporting both incoming and outgoing text messages (SMS) and offers high-level data security. Intervention design details are also influenced by EDC system platform capabilities and constraints. Challenges of using EDC systems are addressed through programming updates and training on how to improve data quality. CONCLUSIONS There are three key considerations in the development of an EDC system for an intervention trial. First, it needs to be decided whether the flexibility provided by the development of a study-specific, in-house EDC system is needed relative to the utilization of an existing commercial platform that requires less in-house programming expertise. Second, a single EDC system may not provide all functionality. ATN CARES is using a main EDC system for data collection, text messaging (SMS) interventions, and case management and a separate Web-based platform to support an online peer support intervention. Decisions need to be made regarding the functionality that is crucial for the EDC system to handle and what functionality can be handled by other systems. Third, data security is a priority but needs to be balanced with the need for flexible intervention delivery. For example, ATN CARES is delivering text messages (SMS) to study participants’ mobile phones. EDC data security protocols should be developed under guidance from security experts and with formative consulting with the target study population as to their perceptions and needs. INTERNATIONAL REGISTERED REPOR PRR1-10.2196/10777

scholarly journals A Novel Electronic Data Collection System for Large-Scale Surveys of Neglected Tropical Diseases

PLoS ONE ◽  
2013 ◽  
Vol 8 (9) ◽  
pp. e74570 ◽  
Author(s):  
Jonathan D. King ◽  
Joy Buolamwini ◽  
Elizabeth A. Cromwell ◽  
Andrew Panfel ◽  
Tesfaye Teferi ◽  
...  
Keyword(s):  
Data Collection ◽  
Large Scale ◽  
Neglected Tropical Diseases ◽  
Tropical Diseases ◽  
Collection System ◽  
Electronic Data ◽  
Data Collection System ◽  
Electronic Data Collection

scholarly journals Using Electronic Data Capture for Cardiovascular Electrophysiology Invasive Procedures: An Important Step Towards Interoperable Clinical Registries

2020 ◽  
Vol 9 (1) ◽  
pp. 48
Author(s):  
Mostafa Shanbehzadeh ◽  
Hadi Kazemi-Arpanahi ◽  
Hassan Bostan ◽  
Raoof Nopour
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Case Reports ◽  
Data Capture ◽  
Developmental Study ◽  
Electronic Data Capture ◽  
Invasive Procedures ◽  
Electronic Data ◽  
Electronic Data Collection ◽  
Clinical Registries

Introduction: The capture and integration of structured data from point of care into clinical registries has been a challenge. However, this effort is very important toward a qualitative patient care and research. Collection, organization and interpretation of clinical data can help to improve evidence-based medicine practices. Worksheets data capture are prevalent, but, not flexible, protected, workflow pleasant, and user friendly and do not support the creation of standardized and interoperable data. The aim of this study was to design and implement an Electronic Data Capture (EDC) instruments to be use in context of cardiovascular invasive procedures.Material and Methods: This descriptive and developmental study conducted in three phases as follows. (1) data standardization according national and international data element templates published by specialized societies; (2) developing of an initial data collection and clinical research workflow (3), establishing of electronic case reports using Research Electronic Data Capture (REDCap) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.Results: Three case report forms was developed that included demographics, medical history, physical examination, laboratory tests, radiology examinations, Electrophysiology (EP) procedures, as well as medications and follow-up information. Data-entry validation criteria have been implementing in electronic data collection instrument to assure validity and precision when data enter in electronic form.Conclusion: This paper describes the process used to create an EDC application. Data collection applications were successfully develop as an a priori step in a clinical research for assisting data collection and management in a case of cardiovascular EP invasive procedures. 

scholarly journals Analysis of erroneous data entries in paper based and electronic data collection

2019 ◽  
Author(s):  
Benedikt Ley ◽  
Komal Raj Rijal ◽  
Jutta Marfurt ◽  
Nabaraj Adhikari ◽  
Megha Banjara ◽  
...  
Keyword(s):  
Data Collection ◽  
Data Entry ◽  
Categorical Variables ◽  
Data Sets ◽  
Continuous Variables ◽  
Electronic Data ◽  
Suitable Alternative ◽  
Electronic Data Collection ◽  
Data Points ◽  
Time Variables

Abstract Objective: Electronic data collection (EDC) has become a suitable alternative to paper based data collection (PBDC) in biomedical research even in resource poor settings. During a survey in Nepal, data were collected using both systems and data entry errors compared between both methods. Collected data were checked for completeness, values outside of realistic ranges, internal logic and date variables for reasonable time frames. Variables were grouped into 5 categories and the number of discordant entries were compared between both systems, overall and per variable category. Results: Data from 52 variables collected from 358 participants were available. Discrepancies between both data sets were found in 12.6% of all entries (2352/18,616). Differences between data points were identified in 18.0% (643/3,580) of continuous variables, 15.8% of time variables (113/716), 13.0% of date variables (140/1,074), 12.0% of text variables (86/716), and 10.9% of categorical variables (1,370/12,530). Overall 64% (1,499/2,352) of all discrepancies were due to data omissions, 76.6% (1,148/1,499) of missing entries were among categorical data. Omissions in PBDC (n=1002) were twice as frequent as in EDC (n=497, p<0.001). Data omissions, specifically among categorical variables were identified as the greatest source of error. If designed accordingly, EDC can address this short fall effectively.

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