Of 196 patients enrolled, 195 completed the study and provided 6869 total temperature measurements. Statistical analyses were performed in R ( ), version 3.0.2. P-values <0.05 were considered statistically significant. We also identified the surface temperature threshold corresponding to the highest sum of sensitivity and specificity. Sensitivities and specificities were calculated for surface temperatures of ≥37.5° C and ≥38.0° C with 95% confidence intervals (CIs) computed using the bootstrap approach. We conducted a receiver-operating characteristic (ROC) analysis, calculating areas under the curve (AUCs) as a measure of the ability of surface temperatures to detect fever defined by internal temperatures. We analyzed the agreement between the internal and surface temperatures with Bland-Altman plots 6 to which we added linear regression lines showing the relationship of temperature differences against mean temperature. We conducted descriptive analyses and generated a scatterplot of surface-internal temperature pairs, calculating Pearson's correlation coefficient for the paired measurements. Among patients with treatment resistance, we determined whether axillary temperatures were sufficient to identify the need for retreatment at any time during the inpatient observation period. If >2 temperature measurements occurred within 5 minutes, only the first 2 qualifying temperatures were included. We included temperature pairs if a surface and an internal temperature (e.g., oral-axillary or rectal-axillary) were recorded within 5 minutes of each other. We defined treatment resistance as fever occurring between 36 hours and 7 days after completion of the IVIG infusion without another likely source 2 and used a threshold of ≥38.0☌ by any route. After discharge, the legal guardian used the same model of thermometer to record temperatures by a single route once daily between 4 and 6 PM for 3 days. During infusions of IVIG and study medication, nurses obtained hourly measurements by the axillary route only. Additional temperatures were measured if clinically indicated. Each patient had 2 thermometers, each designated for a specific route. Nurses measured temperatures using digital thermometers (American Diagnostic Corp, model Adtemp™ II 413) every 6 hours by both surface (axillary) and internal (rectal or oral, based on nurse's assessment of age and developmental level) routes prior to scheduled aspirin doses. We postulated that axillary temperatures would differ significantly from oral and rectal temperatures and lack sensitivity for detecting fever in patients with KD. 1 A Phase III clinical trial of intensification of primary IVIG treatment of acute KD with infliximab 4 provided an opportunity to analyze agreement within a large set of temperature readings concurrently measured by different routes and to inform best practices for temperature routes and thresholds in KD research and clinical practice. 3 The lack of uniformity in fever definition may contribute to differences in treatment failure rates among sites and studies. 1, 2 Previous clinical studies of KD patients have not specified a standard route of temperature measurement. and Japan, the country of highest incidence. Despite the importance of fever in KD, no detailed study of best practice for fever measurement has been performed in this patient population, and approaches vary widely across medical centers and between the U.S. Fever is invariably present in children with acute Kawasaki disease (KD) and is the clinical sign that dictates many interventions, including retreatment after initial therapy with intravenous immunoglobulin (IVIG).
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