Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice

Completed

• Conditions: Subcutaneous Emphysema; Pneumothorax; Consolidation; Pulmonary Nodule, Solitary; Atelectasis; Cardiomegaly; Pleural Effusion

• Registration Number: NCT05963945
• Lead Sponsor: Carebot s.r.o.

Brief Summary

The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists.

Detailed Description

In the period between October 18th, 2022, and November 17th, 2022, anonymized chest X-ray images of patients were collected at the Radiodiagnostic Department of the Havířov Hospital, p.o. The collection process involved utilizing the CloudPACS imaging and archiving system provided by OR-CZ spol. s r.o.

The collected X-ray images were subjected to the proposed DLAD (Carebot AI CXR) for analysis. Subsequently, the DLAD's performance was compared with the standard clinical practice, where radiologists assessed the CXR images in the simulated hospital setting with access to standard viewing tools (e.g., pan, zoom, WW/WL) and were given an unlimited amount of time to complete the review. Each radiologist determined the presence or absence of 7 indicated radiological findings, including atelectasis (ATE), consolidation (CON), pleural effusion (EFF), pulmonary lesion (LES), subcutaneous emphysema (SCE), cardiomegaly (CMG), and pneumothorax (PNO).

Study Timeline

• Study Start: 2022-10-18
• Primary Completion: 2022-11-17
• Study Completion: 2023-03-21
• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 956

Inclusion Criteria

• Hospital patients > 18 years who were referred for chest radiography October 18th, 2022, and November 17th, 2022 at the Radiodiagnostic Department of the Havířov Hospital, p.o.

Exclusion Criteria

• Patients < 18 years
• Chest X-ray images in lateral positions
• Duplicated chest X-ray images

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance test	March 2023	The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists. The performance test includes sensitivity and specificity, positive and negative likelihood ratio, and positive and negative predictive value. The aforementioned parameters are statistically compared using confidence intervals (CI) and p-Values. The comparison procedure consists of two steps: a global hypothesis test is conducted to determine whether there are significant differences between DLAD and radiologists. If the global hypothesis test yields a significant result, individual hypothesis tests are performed. Additionally, multiple comparison methods, such as McNemar with continuity correction for Se and Sp, Holm method for LRs, and weighted generalized score statistics for PVs, are applied to control the overall error rate. All tests are performed as two-tailed tests at the 5% significance level.

Trial Locations

Locations (1)

Nemocnice Havířov, p. o.; 🇨🇿 Havířov, Czechia