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Published on: October 31, 2025
To adopt or adapt an existing COS for neonatal research: qualitative study
Jamlick Karumbi1,2, David Gathara3,4, Paula Williamson5
1Department of Health Data Science, University of Liverpool, Liverpool, UK. karumbij@gmail.com.
Trials
|June 9, 2026
Summary
A new core outcome set (COS) for neonatal care in Kenya was developed, adapting existing guidelines for local needs. This feasible adaptation includes clinical and life-impact outcomes important to Kenyan mothers and healthcare providers.
Area of Science:
- Neonatal health research
- Core outcome sets development
- Global health equity in research
Background:
- Core outcome sets (COS) standardize research outcomes but often reflect high-income country (HIC) priorities.
- Neonatal mortality remains high in low- and middle-income countries (LMICs), necessitating context-specific research standards.
- Kenya lacks a COS for neonatal care, despite high neonatal mortality rates.
Purpose of the Study:
- To develop a contextually appropriate core outcome set (COS) for neonatal care and research in Kenya.
- To assess the feasibility of adapting an existing HIC COS for LMIC settings.
Main Methods:
- Employed a mixed qualitative and consensus-based approach following the COMET handbook.
- Included a rapid review of sub-Saharan African neonatal trials, stakeholder engagement (key informant interviews, focus groups), and a consensus workshop using the nominal group technique.
- Outcomes were included in the final COS if endorsed by ≥70% of consensus meeting participants.
Main Results:
- A 12-outcome Kenya Core Outcome Set (COS) for neonatal care was developed.
- Five outcomes achieved immediate consensus: survival, length of hospital stay, feeding/weight gain/growth, cognitive ability, and visual impairment/retinopathy of prematurity.
- Seven additional outcomes were endorsed, including family impact, financial costs, pain, adverse events, respiratory distress, quality of life, and sepsis; five outcomes were Kenya-specific.
Conclusions:
- Adapting HIC neonatal COS for LMIC contexts is feasible but requires systematic adaptation and consideration of local capacity.
- The Kenya COS integrates clinical and life-impact outcomes, reflecting local stakeholder priorities.
- Successful implementation necessitates phased approaches, investment in training, and strengthened clinician-researcher collaboration.
