ArticleTrials2026
To adopt or adapt an existing COS for neonatal research: qualitative study.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundCore outcome sets (COS) standardise the outcomes reported in clinical trials and research, reducing outcome heterogeneity and enabling evidence synthesis. Most neonatal COS have been developed in high-income country (HIC) contexts and may not reflect the priorities, health system capacities, or disease burden of low- and middle-income countries (LMICs). Kenya's neonatal mortality rate remains high at 21 per 1000 live births, yet no COS exists for neonatal care and research in Kenya or, more broadly, in sub-Saharan Africa. This study aimed to develop a contextually appropriate COS for neonatal care and research in Kenya, and to assess the feasibility of adapting an existing HIC COS for use in an LMIC setting.
methodsA mixed qualitative and consensus-based approach was used, guided by the COMET handbook. The process comprised three phases: a rapid review of outcomes reported in neonatal trials from sub-Saharan Africa compared with an existing HIC COS; qualitative stakeholder engagement through key informant interviews (KIIs) and focus group discussions (FGDs) with healthcare providers, national-level policymakers, and mothers of previously admitted neonates at two Kenyan hospitals representing urban and rural settings; and an in-person consensus workshop using the nominal group technique with 13 multidisciplinary stakeholders. Thematic analysis followed Braun and Clarke's six-phase framework. Outcomes endorsed by ≥ 70% of consensus meeting participants were included in the final COS.
resultsSeventeen stakeholders participated in KIIs, and 15 mothers participated in two FGDs. Sixteen candidate outcomes were presented at the consensus meeting. Five outcomes achieved immediate universal consensus: survival, length of hospital stay, ability to feed/weight gain/growth, cognitive ability, and visual impairment/retinopathy of prematurity (RoP). Following discussion and voting, a further seven outcomes were endorsed: impact on mothers and wider family, financial costs to the mother, pain, adverse events due to medicines, respiratory distress, quality of life, and sepsis/infections. The final COS comprises twelve outcomes. Seven overlapped with the existing HIC COS, though with contextually adapted definitions. Five outcomes are Kenya-specific, reflecting the out-of-pocket payment structure, high comorbidity burden, and family-centred care priorities of the Kenyan health system.
conclusionsAdapting an HIC neonatal COS for use in an LMIC context is feasible, but requires systematic definitional adaptation, engagement with existing local frameworks such as WHO Essential Newborn Care guidelines, and attention to diagnostic capacity constraints. The Kenya COS captures both clinical and life-impact outcomes, reflecting the priorities of diverse stakeholder groups including mothers. Realising its value requires phased implementation sensitive to urban-rural differences in facility capacity, investment in workforce training, and stronger collaboration between clinicians and researchers to ensure outcome measurement serves both care improvement and evidence generation.
trial registrationThis is not a clinical trial. CLINICAL TRIAL NUMBER: not applicable.
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