Discussion
malaria
MALARIA
In this cluster randomized controlled trial involving 44,306 sick children under 15 years of age in Tanzania, the use of the ePOCT+ digital clinical decision support algorithm (CDSA) package resulted in a close-to three-fold reduction in the likelihood of a sick child receiving an antibiotic prescription compared to children in usual care facilities. Despite substantially fewer antibiotic prescriptions, clinical failure did not increase in intervention facilities. Such findings align with Tanzania’s National Action Plan to reduce antibiotic useThe reduction of antibiotic prescription associated with the ePOCT+ intervention in our study is consistent with our previous research with CDSAs in Tanzania in more controlled research settingsClinical failure was not higher in patients managed in ePOCT+ health facilities, despite a significant reduction in antibiotic prescription in line with other antibiotic stewardship studiesAlthough the present findings are encouraging, it is important to note that nearly 25% of patients were not managed using ePOCT+ in the intervention arm. Lower uptake of the tool could reduce the positive impact of antibiotic stewardship as seen in the lower reduction in antibiotic prescription in the intention-to-treat (ITT) population. It is reasonable to assume that not all health providers use the digital tool to manage all patients, just as health providers do not consult the IMCI paper chartbook every time they see a patient. Indeed CDSAs have been found to improve adherence to IMCI guidelinesOur study possesses several strengths that contribute to its robustness. First, we employed a cluster randomized controlled study design, which was adequately powered to assess noninferiority of clinical failure. Second, the implementation of our intervention encompassed a wide range of epidemiological settings, including both rural and urban areas, with varying levels of malaria transmission and facilities such as dispensaries and health centers. Moreover, our study employed comprehensive patient inclusion criteria that were designed to be inclusive. By incorporating these inclusive criteria, randomly sampling health facilities for inclusion, and observing consistent effects across subgroups at both the health facility and individual levels, our findings can be generalized to a broader population.There are several limitations to our study. First, antibiotic prescription data relied on documentation by the health-care provider, an approach often used in pragmatic trialsIn conclusion, the ePOCT+ electronic clinical decision support algorithm (CDSA) in association with point-of-care tests (CRP, hemoglobin, pulse oximeter) and mentorship support informed by clinical practice data, safely and substantially reduced antibiotic prescription in sick children less than 15 years of age presenting to primary care facilities in Tanzania. Widespread implementation of ePOCT+ could help address the urgent problem of antimicrobial resistance by reducing excessive antibiotic prescription in sick children while maintaining clinical safety.