METHODS: We compared 2 different consecutive video libraries (40 video per arm) collected at Humanitas Research Hospital with 2 different CADe system brands (CADe A and CADe B). For each video, the number of CADe false activations, the cause and the time spent by the endoscopist to examine the area erroneously highlighted were reported. The FP activations were classified according to the previously developed classification of false positives (the NOISE classification) according to their cause and relevance.
RESULTS: A total of 1021 FP activations were registered across the 40 videos of the Group A (25.5±12.2 FPs per colonoscopy). A comparable number of FPs were identified in the Group B (n=1028, mean:25.7±13.2 FPs per colonoscopy) (p 0.53). Among them, 22.9±9.9 (89.8%, Group A), and 22.1±10.0 (86.0%, Group B) were due to artifacts from bowel wall. Conversely, 2.6±1.9 (10.2%) and 3.5±2.1 (14%) were caused by bowel content (p 0.45). Within the Group A each false activation required 0.2±0.9 seconds, with 1.6±1.0 (6.3%) FPs requiring additional time for endoscopic assessment. Comparable results were reported within the Group B with 0.2±0.8 seconds spent per false activation and 1.8±1.2 FPs per colonoscopy requiring additional inspection.
CONCLUSION: The use of a standardized nomenclature permitted to provide comparable results with either of the 2 recently approved CADe systems.
METHODS: PACKNOW was an open-label, randomized, controlled trial of acetaminophen (500 mg or 1000 mg every 6 hours for 72 hours) vs no acetaminophen in Malaysian patients aged ≥5 years with knowlesi malaria of any severity. The primary end point was change in creatinine at 72 hours. Secondary end points included longitudinal changes in creatinine in patients with severe malaria or acute kidney injury (AKI), stratified by hemolysis.
RESULTS: During 2016-2018, 396 patients (aged 12-96 years) were randomized to acetaminophen (n = 199) or no acetaminophen (n = 197). Overall, creatinine fell by a mean (standard deviation) 14.9% (18.1) in the acetaminophen arm vs 14.6% (16.0) in the control arm (P = .81). In severe disease, creatinine fell by 31.0% (26.5) in the acetaminophen arm vs 20.4% (21.5) in the control arm (P = .12), and in those with hemolysis by 35.8% (26.7) and 19% (16.6), respectively (P = .07). No difference was seen overall in patients with AKI; however, in those with AKI and hemolysis, creatinine fell by 34.5% (20.7) in the acetaminophen arm vs 25.9% (15.8) in the control arm (P = .041). Mixed-effects modeling demonstrated a benefit of acetaminophen at 72 hours (P = .041) and 1 week (P = .002) in patients with severe malaria and with AKI and hemolysis (P = .027 and P = .002, respectively).
CONCLUSIONS: Acetaminophen did not improve creatinine among the entire cohort but may improve renal function in patients with severe knowlesi malaria and in those with AKI and hemolysis.
CLINICAL TRIALS REGISTRATION: NCT03056391.