Data collection and analysis toolkit for maternal and neonatal health research and surveillance during epidemic threats: a pilot testing and mixed-methods evaluation

Standardized outcome reporting is essential to generate timely and comparable evidence during epidemics. The World Health Organization (WHO) developed the Maternal and Neonatal Health during Epidemic Threats Core Outcome Set (MNH-EPI-COS) and a complementary Data Collection and Analysis Toolkit to support its implementation. Before global dissemination, the Toolkit required pilot testing to assess its usability, acceptability, appropriateness, and feasibility across diverse research settings, identify challenges encountered by end users, and inform required improvements and refinements to the Toolkit.

A four-phased mixed-methods evaluation was conducted with five research teams from Brazil, Honduras, India, Rwanda, and the United Kingdom. Teams received training and piloted all Toolkit components using retrospective datasets from previous epidemic contexts. Evaluation methods included structured feedback forms, observation of check-in meetings, and a virtual consultation. Findings informed an iterative process of refinement of the Toolkit components. Data were analysed using descriptive statistics and thematic analysis.

Twenty participants with expertise in epidemiology, clinical research, REDCap administration, and data and management analysis completed the pilot. The REDCap project, R scripts, and supporting materials (reference guide, virtual training session, and videos) were consistently rated as clear, well-structured, and feasible to use. Paper-based case report forms (CRFs) were comprehensive but required refinement, particularly regarding redundancy, and alignment with electronic forms. Teams emphasized the need for multilingual materials, specialized training in R, and strengthened data quality controls to enhance the quality of the evidence generated.

The WHO MNH-EPI-COS Data Collection and Analysis Toolkit demonstrated strong usability, acceptability, appropriateness, and feasibility across diverse settings. The findings informed targeted refinements and support the Toolkit’s readiness for broader implementation to strengthen maternal and neonatal health research and surveillance during epidemics. Future evaluations should include prospective, real-time data collection during active outbreaks to further assess and strengthen the Toolkit’s performance under operational epidemic conditions.