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We propose Artificial Intelligence Prospective Randomized Observer BlindingEvaluation (AI-PROBE) for quantitative clinical performance evaluation ofradiology AI systems within prospective randomized clinical trials. AI-PROBEencompasses a study design and a matching radiology IT infrastructure thatrandomly blinds radiologists for results provided by AI-based image analysis.To demonstrate the applicability of our evaluation framework, we present afirst prospective randomized clinical trial on the effect of Intra-CranialHemorrhage (ICH) detection in emergent care head CT on radiology studyTurn-Around Time (TAT). Here, we acquired 620 non-contrast head CT scans frominpatient and emergency room patients at a large academic hospital. Followingacquisition, scans were automatically analyzed for the presence of ICH usingcommercially available software (Aidoc, Tel Aviv, Israel). Cases identifiedpositive for ICH by AI (ICH-AI+) were flagged in radiologists' readingworklists, where flagging was randomly switched off with probability 50%. TATwas measured as time difference between study completion and first clinicallycommunicated reporting, with time stamps automatically retrieved from variousIT systems. TATs for flagged cases (73+/-143 min) were significantly lower thanTATs for non-flagged (132+/-193 min) cases (p<0.05, one-sided t-test), where105 of 122 ICH-AI+ cases were true positive. Total sensitivity, specificity,and accuracy over all analyzed cases were 95.0%, 96.7%, and 96.4%,respectively. We conclude that automatic identification of ICH reduces TAT forICH in emergent care head CT, which carries the potential for improving timelyclinical management of ICH. Our results suggest that AI-PROBE can contribute tosystematic quantitative evaluation of AI systems in clinical practice usingclinically meaningful quantities, such as TAT or diagnostic accuracy.

A Prospective Randomized Clinical Trial for Measuring Radiology Study  Reporting Time on Artificial Intelligence-Based Detection of Intracranial  Hemorrhage in Emergent Care Head CT