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.
Trials
; 25(1): 358, 2024 Jun 04.
Article
en En
| MEDLINE
| ID: mdl-38835091
ABSTRACT
BACKGROUND:
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.METHODS:
Studydesign:
Prospective, multicenter, double-blinded RCT. SETTINGS The model was designed for the automatic detection of intracranial aneurysms from original CTA images.PARTICIPANTS:
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). RANDOMIZATION Block randomization, stratified by center, gender, and age group. PRIMARYOUTCOMES:
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. SECONDARYOUTCOMES:
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. BLINDING Study participants and participating radiologists will be blinded to the intervention. SAMPLE SIZE 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 11 allocation to True-AI or Sham-AI arm.DISCUSSION:
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. TRIAL REGISTRATION This trial has been registered with the NIH, U.S. National Library of Medicine at ClinicalTrials.gov, ID NCT06118840 . Registered 11 November 2023.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Inteligencia Artificial
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Aneurisma Intracraneal
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Angiografía por Tomografía Computarizada
Límite:
Adult
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Female
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Humans
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Male
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2024
Tipo del documento:
Article
País de afiliación:
China