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

15 more authors
  1. 1Institute for Clinical Effectiveness and Health Policy: Instituto de Efectividad Clinica y Sanitaria

Abstract

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 Toolkits 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 Toolkits performance under operational epidemic conditions.

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BibTeX
@misc{pingray2026data,
  title = {{Data collection and analysis toolkit for maternal and neonatal health research and surveillance during epidemic threats: a pilot testing and mixed-methods evaluation}},
  author = {V. Pingray and K. Klein and J. P. Alonso and T. Dey and L. Gibbons and A. Ciganda and J. G. Cecatti and M. L. Costa and C. Silveira and R. T. Souza and J. Alger and J. Garcia-Aguilar and P. Buekens and D. S. Melepurakka and S. Goudar and A. Kavi and C. Kajagar and M. S. Somannavar and L. M. Masirika and P. Ndishimye and J. C. Udahemuka and B. Umutoni and R. M. Sankar and A. Papageorghiou and A. Winsey and M. Belizan and M. Berrueta},
  howpublished = {medRxiv},
  year = {2026},
  month = oct,
  doi = {10.64898/2026.10.20.26366068},
  url = {https://www.medrxiv.org/content/10.64898/2026.10.20.26366068v1},
  note = {CC BY},
}
RIS
TY  - UNPB
TI  - Data collection and analysis toolkit for maternal and neonatal health research and surveillance during epidemic threats: a pilot testing and mixed-methods evaluation
AU  - V. Pingray
AU  - K. Klein
AU  - J. P. Alonso
AU  - T. Dey
AU  - L. Gibbons
AU  - A. Ciganda
AU  - J. G. Cecatti
AU  - M. L. Costa
AU  - C. Silveira
AU  - R. T. Souza
AU  - J. Alger
AU  - J. Garcia-Aguilar
AU  - P. Buekens
AU  - D. S. Melepurakka
AU  - S. Goudar
AU  - A. Kavi
AU  - C. Kajagar
AU  - M. S. Somannavar
AU  - L. M. Masirika
AU  - P. Ndishimye
AU  - J. C. Udahemuka
AU  - B. Umutoni
AU  - R. M. Sankar
AU  - A. Papageorghiou
AU  - A. Winsey
AU  - M. Belizan
AU  - M. Berrueta
PY  - 2026
DA  - 2026/10/20
PB  - medRxiv
DO  - 10.64898/2026.10.20.26366068
UR  - https://www.medrxiv.org/content/10.64898/2026.10.20.26366068v1
AB  - 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 Toolkits 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 Toolkits performance under operational epidemic conditions.
ER  -