Abstract
Objective To share approaches and innovations adopted to deliver a relatively inexpensive clinical data management (CDM) framework within a low-income setting that aims to deliver quality pediatric data useful for supporting research, strengthening the information culture and informing improvement efforts in local clinical practice. Materials and methods The authors implemented a CDM framework to support a Clinical Information Network (CIN) using Research Electronic Data Capture (REDCap), a noncommercial software solution designed for rapid development and deployment of electronic data capture tools. It was used for collection of standardized data from case records of multiple hospitals’ pediatric wards. R, an open-source statistical language, was used for data quality enhancement, analysis, and report generation for the hospitals. Results In the first year of CIN, the authors have developed innovative solutions to support the implementation of a secure, rapid pediatric data collection system spanning 14 hospital sites with stringent data quality checks. Data have been collated on over 37 000 admission episodes, with considerable improvement in clinical documentation of admissions observed. Using meta-programming techniques in R, coupled with branching logic, randomization, data lookup, and Application Programming Interface (API) features offered by REDCap, CDM tasks were configured and automated to ensure quality data was delivered for clinical improvement and research use. Conclusion A low-cost clinically focused but geographically dispersed quality CDM (Clinical Data Management) in a long-term, multi-site, and real world context can be achieved and sustained and challenges can be overcome through thoughtful design and implementation of open-source tools for handling data and supporting research.
Highlights
The Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme’s Health Services Unit has engaged in a number of projects with the Kenyan Ministry of Health (MoH) since 2002 with work spanning evidence synthesis to develop national evidence-based clinical guidelines for pediatric care[1], conducting pragmatic clinical trials, and surveys of the quality of care within hospitals[2] (KEMRI serves the same function as Medical Research Council in the United Kingdom and Center for Disease Control in the United States)
A shared, standard pediatric admission record form developed in Kenya[3] and adopted by the MoH linked to a set of national clinical guidelines that define key symptoms, signs, illness definitions, and treatment strategies for the most common conditions provide the basis for core elements of the clinical process on admission The Clinical Information Network (CIN) focuses on these data, admission treatment, and investigations and discharge status
For initiatives in low-resource settings such as this one, we argue that quality clinical data management (CDM) in a long-term, multi-site, and real-world context can be achieved and sustained, and that challenges can be overcome by working closely with clinical teams and through thoughtful design and implementation of open-source tools for handling data
Summary
The Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme’s Health Services Unit has engaged in a number of projects with the Kenyan Ministry of Health (MoH) since 2002 with work spanning evidence synthesis to develop national evidence-based clinical guidelines for pediatric care[1], conducting pragmatic clinical trials, and surveys of the quality of care within hospitals[2] (KEMRI serves the same function as Medical Research Council in the United Kingdom and Center for Disease Control in the United States) This has helped evolve a unique platform of work focusing on implementing key interventions in Kenyan hospitals to improve the delivery of pediatric care across the country, the most recent of which is the Clinical Information Network (CIN).
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