To adopt or adapt an existing neonatal core outcome set in Kenya: a study protocol.

Karumbi, Jamlick, Gathara, David, Young, Bridget ORCID: 0000-0001-6041-9901 and Williamson, Paula ORCID: 0000-0001-9802-6636
(2023) To adopt or adapt an existing neonatal core outcome set in Kenya: a study protocol. Trials, 24 (1). 806-.

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<h4>Background</h4>Development and use of core outcome set(s) (COS) in research can reduce research wastage by ensuring that a minimum set of outcomes are always reported on. Neonatal morbidity and mortality are a big burden in low- and middle-income countries (LMICs). Research is continuously being undertaken to reduce this burden. Currently, there is no COS for neonatal research in LMICs but there exists one for neonatal research in high-income countries (HICs).<h4>Objectives</h4>To determine outcomes that are useful for neonatal care in Kenya to inform whether an existing COS should be adopted or adapted. To assess the feasibility of a routine data collection system to collect data of the agreed-on COS.<h4>Methods</h4>A review of existing literature on neonatal research in LMICs followed by a qualitative study of key stakeholders in neonatal care. To explore whether to adapt or adopt, in two hospitals, two focus group discussions with 6-8 parents/caregivers will be undertaken (one each in two hospitals). Key informant interviews will also be conducted with 6 health care providers in each of the hospitals. At the policy-making level, we will conduct 10 key informant interviews. Qualitative data will be analyzed thematically. A consensus meeting will be undertaken with key stakeholders, who will be presented with an overview of the COS developed for HICs, key findings from the literature, and the qualitative study to determine context-appropriate COS. The agreed-on outcomes will be counterchecked against the case records in the two hospitals. The feasibility of collecting the outcomes on a routine electronic research database, the Clinical Information Network that collects standardized data at admission and discharge, will be explored. The congruence (or not) of the outcomes will be documented and be used to enrich the discussion and provide a snapshot of the feasibility of the health information system to collect routine data on the COS.<h4>Conclusions</h4>A COS for use in neonatal care in Kenya will help enhance outcome measurements and reporting not just in research but also in routine practice. This will enhance the comparability of interventions in trials and routine settings leading to reduced research wastage and likely improved quality of care. Additionally, the methodology used for this work can be adopted in other settings as a means of adopting or adapting an existing COS.

Item Type: Article
Uncontrolled Keywords: Humans, Treatment Outcome, Hospitalization, Focus Groups, Qualitative Research, Research Design, Delphi Technique, Infant, Newborn, Kenya, Review Literature as Topic, Outcome Assessment, Health Care
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 02 Jan 2024 15:46
Last Modified: 02 Feb 2024 15:59
DOI: 10.1186/s13063-023-07821-z
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