%0 Journal Article
%T Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patient Diagnosis and Outcomes (IDEAL Study)-a protocol for a multicenter, double-blinded randomized controlled trial.
%A Shi Z
%A Hu B
%A Lu M
%A Chen Z
%A Zhang M
%A Yu Y
%A Zhou C
%A Zhong J
%A Wu B
%A Zhang X
%A Wei Y
%A Zhang LJ
%A  
%J Trials
%V 25
%N 1
%D 2024 Jun 4
%M 38835091
%F 2.728
%R 10.1186/s13063-024-08184-9
%X <B>BACKGROUND: </B>This multicenter, double-blinded, randomized controlled trial (RCT) aims to assess the impact of an artificial intelligence (AI)-based model on the efficacy of intracranial aneurysm detection in CT angiography (CTA) and its influence on patients' short-term and long-term outcomes.<BR><B>METHODS: </B>Study design: Prospective, multicenter, double-blinded RCT.<BR><B>METHODS: </B>The model was designed for the automatic detection of intracranial aneurysms from original CTA images.<BR><B>METHODS: </B>Adult inpatients and outpatients who are scheduled for head CTA scanning. Randomization groups: (1) Experimental Group: Head CTA interpreted by radiologists with the assistance of the True-AI-integrated intracranial aneurysm diagnosis strategy (True-AI arm). (2) Control Group: Head CTA interpreted by radiologists with the assistance of the Sham-AI-integrated intracranial aneurysm diagnosis strategy (Sham-AI arm).<BR><B>METHODS: </B>Block randomization, stratified by center, gender, and age group.<BR><B>METHODS: </B>Coprimary outcomes of superiority in patient-level sensitivity and noninferiority in specificity for the True-AI arm to the Sham-AI arm in intracranial aneurysms.<BR><B>RESULTS: </B>Diagnostic performance for other intracranial lesions, detection rates, workload of CTA interpretation, resource utilization, treatment-related clinical events, aneurysm-related events, quality of life, and cost-effectiveness analysis.<BR><B>METHODS: </B>Study participants and participating radiologists will be blinded to the intervention.<BR><B>METHODS: </B>Based on our pilot study, the patient-level sensitivity is assumed to be 0.65 for the Sham-AI arm and 0.75 for the True-AI arm, with specificities of 0.90 and 0.88, respectively. The prevalence of intracranial aneurysms for patients undergoing head CTA in the hospital is approximately 12%. To establish superiority in sensitivity and noninferiority in specificity with a margin of 5% using a one-sided α = 0.025 to ensure that the power of coprimary endpoint testing reached 0.80 and a 5% attrition rate, the sample size was determined to be 6450 in a 1:1 allocation to True-AI or Sham-AI arm.<BR><B>CONCLUSIONS: </B>The study will determine the precise impact of the AI system on the detection performance for intracranial aneurysms in a double-blinded design and following the real-world effects on patients' short-term and long-term outcomes.<BR><B>BACKGROUND: </B>This trial has been registered with the NIH, U.S. National Library of Medicine at ClinicalTrials.gov, ID: NCT06118840 . Registered 11 November 2023.