A Diagnostic Test on DeepDoc-an AI-based Decision Support System

• Conditions: Stroke; Vertigo; Headache; Meningitis/Encephalitis

• Registration Number: NCT04055766
• Lead Sponsor: Xijing Hospital

Brief Summary

DeepDoc is an AI-based decision support system for the early etiology diagnosis of neurological diseases using clinical data points from patients admitted to hospital within 24 hours.This study aims to evaluate whether the diagnosis of the DeepDoc AI-based decision support system is better than the doctor's initial diagnosis by a multi-center, superiority diagnostic study.

Detailed Description

The doctor completes the admission note within 24 hours after the patient is admitted to the hospital. After informed consent is given to the patient who meet the inclusion criteria, open the DeepDoc to fill in the patient identification information. Then take the picture of the initial diagnosis of the admission note page and upload it to DeepDoc, fill the doctor's initial diagnosis into the DeppDoc. And put the patient's clinical data points into the DeepDoc to get a DeepdDoc diagnosis.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-08-04
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13
• Study Start: 2020-09-01
• Primary Completion: 2020-09-09
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache.
2. Neurological examination results and imaging changes within 24 hours of admission.

Exclusion Criteria

Patients discharged, transferred to the hospital, or died within 24 hours after admission.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of diagnosis by DeepDoc AI-based Decision Support System	24 hours	Accuracy of diagnosis by DeepDoc and compare this result with doctors

Secondary Outcome Measures

Name	Time	Method
Sensitivity of diagnosis by DeepDoc AI-based Decision Support System	24 hours	Sensitivity of diagnosis by DeepDoc and compare this result with doctors
Specificity of diagnosis by DeepDoc AI-based Decision Support System	24 hours	Specificity of diagnosis by DeepDoc and compare this result with doctors