Defining, Evaluating, and Sharing Methodologies for Quality Control in Diagnostic Imaging

NCT05770024 | Unknown

• 1 other identifier: 10/20
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to validate a radiological quality control (QC) system on the performance of diagnostic imaging. Patient images, previously anonymized by each radiologic diagnostic structures (SDR), will be sent to the QC service, which will blindly submit the images for evaluation external peer review by experts in the field. Through the blinded approach, the information obtained from the QC will allow the SDR to know its own performance analytics, but not those of other SDRs using the service, and to a centralized system to have an anonymized estimate of the quality of performance delivered. Finally, the analyzed data will provide not only a mere count, but will allow to reduce and prevent errors in the appropriateness, execution, reporting and diagnostic content of the examinations

Conditions

Subjects Undergoing Diagnostic Imaging Tests

Outcome Measures

Primary Outcomes (1)

• Definition and implementation of diagnostic image quality control procedures for the purpose of purposes of monitoring the accuracy and appropriateness of the service provided by SDRs

  * Definition of a survey for evaluation of diagnostic procedures; * Definition of a panel of experts; * Optimization of radiological quality control workflow; * Identification of elements for workflow automation; * Definition of feedback strategies for the improvement of procedures diagnostics

  1-36 months

Interventions

imaging tests OTHER

X-ray radiography (RX); computer tomography (CT); magnetic resonance (MR); positron emission tomography (PET); single photon emission computed tomography (SPECT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing diagnostic imaging tests

You may qualify if:

• Diagnostic examinations related to imaging modalities (RX, CT, MR, PET, SPECT...), agreed with SDRs, of body districts on which diagnostic images are available in DICOM format, medical history data and clinical question, report

You may not qualify if:

• Incompleteness of data for the purpose of the review process

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead

Study Sites (1)

IRCCS Synlab SDN

Naples, 80143, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: September 3, 2020
• Primary Completion: January 31, 2024
• Study Completion: September 30, 2024
• Last Updated: March 25, 2024

Record last verified: 2023-03

Locations

IT (1)