Statistical Analyses
malaria, acute febrile illness
MALARIA, SECONDARY
Data were collected using offline electronic case report forms on Open Date Kit (ODK) that were later uploaded onto centralized OpenClinica software. Statistical analysis was performed using R version 4.2.1. Descriptive analysis was performed to characterize study participants, and categorical data were reported using numbers and percentages. Cross-tabulation and The primary outcomes were the proportion of patients with acute febrile illness with favorable clinical outcomes at day 7. The proportion of prescribed antibiotics in both arms was calculated, and the test of proportion was performed to determine any significance between the arms. This was achieved by providing point estimates of the proportion of outpatient cases of acute febrile illness with favorable outcomes (with an outcome of alive and asymptomatic) with a 95% confidence interval (CI) and comparison between arms (relative risk [RR] and absolute difference of proportions and 95% CI). Second, the point estimate of the proportion of patients with antibiotic prescriptions for acute febrile illness received on day 0 or until day 7 among all patients within the arm, comparison between the arms (RR and absolute difference of proportions and 95% CI) were estimated. Finally, we evaluated the outcomes by determining whether the patients should have received antibiotics or not based on their diagnosis.The analysis of primary and secondary end points was described as the main analysis in a prespecified statistical analysis plan (SAP). Subgroup analysis by age, sex, and quarter of the year was also prespecified. The SAP prespecified that exploratory analyses would be conducted. No adjustment for multiple comparisons was prespecified in the SAP. Analyses by respiratory vs nonrespiratory and by malaria diagnosis were all exploratory.Only 1512 patients were enrolled instead of the planned optimal sample size of 2766 (ie, 52%). To solve the issue of loss of power to detect the effect due to a small sample size, the precision of the analysis was adjusted from the planned 4% to 6% while maintaining the power of the study at 80% and the significance level at 5%.