Risk Factors for Nondiagnostic Imaging in a Real-World Deployment of Artificial Intelligence Diabetic Retinal Examinations in an Integrated Health care System: Maximizing Workflow Efficiency Through Predictive Dilation.

In the pivotal clinical trial that led to Food and Drug Administration De Novo "approval" of the first fully autonomous artificial intelligence (AI) diabetic retinal disease diagnostic system, a reflexive dilation protocol was used. Using real-world deployment data before implementation of reflexive dilation, we identified factors associated with nondiagnostic results. These factors allow a novel Retrospective review of patients who were assessed with autonomous AI at Johns Hopkins Medicine (8/2020 to 5/2021). We constructed a multivariable logistic regression model for nondiagnostic results to compare characteristics of patients with and without diagnostic results, using adjusted odds ratio (aOR). Of 241 patients (59% female; median age = 59), 123 (51%) had nondiagnostic results. In multivariable analysis, type 1 diabetes (T1D, aOR = 5.82, 95% confidence interval [CI]: 1.45-23.40, We used factors associated with nondiagnostic results to design a novel, predictive dilation workflow, where patients most likely to benefit from pharmacologic dilation are dilated

Déclaration de conflit d'intérêts

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RMW receives research funding from Dexcom, Inc. and Boehringer Ingelheim, unrelated to this research. MDA reports the following conflicts of interest: Investor, Director, Consultant, and Digital Diagnostics; patents and patent applications assigned to the University of Iowa and Digital Diagnostics that are relevant to the subject matter of this article; Chair Health care AI Coalition, Washington DC; member, American Academy of Ophthalmology (AAO) AI Committee; member, AI Workgroup Digital Medicine Payment Advisory Group (DMPAG). The remaining authors declare no competing financial or nonfinancial interests.