Improving the quality of in-patient neonatal routine data as a pre-requisite for monitoring and improving quality of care at scale: A multi-site retrospective cohort study in Kenyan hospitals

Objectives The objectives of this study were to (1) determine if membership of a clinical information network (CIN) was associated with an improvement in the quality of documentation of in-patient neonatal care provided over time, and (2) characterise accuracy of prescribing for basic treatments provided to neonatal in-patients if data are adequate. Design and Settings This was a retrospective cohort study involving all children aged ≤28 days admitted to New-Born Units (NBUs) between January 2018 and December 2021 in 20 government hospitals with an interquartile range of annual NBU inpatient admissions between 550 and 1640 in Kenya. These hospitals participated in routine audit and feedback processes on quality of documentation and care over the study period. Outcomes The study’s outcomes were the number of patients as a proportion of all eligible patients with (1) complete domain-specific documentation scores, and (2) accurate domain-specific treatment prescription scores at admission. Findings 80060 NBU admissions were eligible for inclusion. Upon joining the CIN, documentation scores in the monitoring (vital signs) , other physical examination and bedside testing , discharge information , and maternal history domains demonstrated a statistically significant month-to-month relative improvement in number of patients with complete documentation of 7.6%, 2.9%, 2.4%, and 2.0% respectively. There was also statistically significant month-to-month improvement in prescribing accuracy after joining the CIN of 2.8% and 1.4% for feeds and fluids but not for Antibiotic prescriptions. Findings suggest that much of the variation observed is due to hospital-level factors. Conclusions It is possible to introduce tools that capture important clinical data at least 80% of the time in routine African hospital settings but analyses of such data will need to account for missingness using appropriate statistical techniques. These data allow trends in performance to be explored and could support better impact evaluation, performance benchmarking, exploration of links between health system inputs and outcomes and scrutiny of variation in quality and outcomes of hospital care. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was primarily supported by a Wellcome Trust Senior Fellowship (#097170) awarded to ME. Additional support was provided by a Wellcome Trust core grant awarded to the KEMRI-Wellcome Trust Research Programme (#092654). The funders had no role in the preparation of this report or the decision to submit for publication. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval was provided by the Kenya Medical Research Institute (KEMRI) Scientific and Ethical Review Committee (SERU #3459) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Not Applicable The datasets generated and/or analysed during the current study are not publicly available due to the primary data being owned by the hospitals and their counties with the Ministry of Health The research staff do have permission to share the data without further written approval from both the KEMRI-Wellcome Trust Data Governance Committee and the Facility, County or Ministry of Health as appropriate to the data request. Requests for access to primary data from qualitative research by people other than the investigators will be submitted to the KEMRI-Wellcome Trust Research Programme data governance committee as a first step through dgc@kemri-wellcome.org, who will advise on the need for additional ethical review by the KEMRI Research Ethics Committee. * A&F : Audit and Feedback CIN : Clinical Information Network CPAP : Continuous Positive Airway Pressure ETAT+ : Emergency Treatment and Triage plus admission KEMRI : Kenya Medical Research Institute KMC : Kangaroo Mother Care KPA : Kenya Paediatric Association LMICs : Low and middle-income countries MoH : Ministry of Health NAR : Neonatal Admission Record NBU : Newborn Unit SERU : KEMRI’s Scientific and Ethics Review Unit SSA : Sub-Saharan Africa WHO : World Health Organization.