METHODS/DESIGN: Consensus statements for the use of single use endoscopy and accessories were developed using a modified Delphi process, utilizing an international endoscopist expert panel of 62 experts from 33 nations. The main steps in the process were selecting the consensus group, conducting systematic literature reviews, developing statements, and anonymous voting on the statements until consensus was reached. High-risk patients were defined as those with multi-drug-resistant infections, immunosuppressive medication or chemotherapy, post-transplantation, or with severe neutropenia.
RESULTS: Of the 26 statements that were voted upon through two rounds, 17 statements reached consensus. Category 1: single use accessories (8 statements), related to defining recommendations for the use of single use accessories in all patient populations or high-risk patients. Category 2: clinical indication for single use endoscopes (9 statements), including indications to high-risk patients, protecting the endoscope apparatus and contamination measures in endoscopy units. Category 3: technical factors (4 statements), related to superior performance and technical specifications with the new innovation. Category 4: environmental issues (2 statements), concerning mechanisms that reduce the detrimental burden to the environment. Category 5: financial implications (3 statements), related to healthcare policies, cost neutrality and other financial associations of single use endoscopy.
CONCLUSIONS: This is the first international initiative in determining clinical indications for single use endoscopy and accessories. The study's findings should serve as a framework for future physicians to guide future research and aid the proper evidence-based indications for the implementation of single use endoscopes in clinical practice.
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.