The Ethical eAdjudication® environment supports the independent review and adjudication of image-based endpoints through direct integration with any DICOM Viewer / Repository.
DICOM (Digital Imaging and Communications in Medicine) AS THE MEDICAL IMAGES STANDARD (1)DICOM is the international standard for medical images and related information (ISO 12052). It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use. DICOM is implemented in almost every radiology, cardiology imaging, and radiotherapy device (X-ray, CT, MRI, ultrasound, etc.), and increasingly in devices in other medical domains such as ophthalmology and dentistry. With tens of thousands of imaging devices in use, DICOM is one of the most widely deployed healthcare messaging standards in the world.
There are literally billions of DICOM images currently in use for clinical care. Since its first publication in 1993, DICOM has revolutionized the practice of radiology, allowing the replacement of X-ray film with a fully digital workflow. Much as the Internet has become the platform for new consumer information applications, DICOM has enabled advanced medical imaging applications that have “changed the face of clinical medicine”. From the emergency department to cardiac stress testing, to breast cancer detection, DICOM is the standard that makes medical imaging work — for doctors and for patients.
CENTRAL READING AND ADJUDICATION OF ENDPOINTS BASED ON IMAGES
When a clinical trial relies on image-based endpoints and the assessment of these images could be subject to local bias factors "a centralized image interpretation process, fully blinded, may greatly enhance the credibility of image assessment and better ensure consistency of image assessments"(2).
In addition, the assessment of a potential endpoint based on images, frequently also requires the consultation of other medical records that reside in separate non-imaging databases. In these cases, the software platform managing the endpoint adjudication and collecting the reviewers' judgement must be able to directly display the medical images by integrating a DICOM viewer.
INTEGRATION OF A DICOM VIEWER WITH ETHICAL eADJUDICATION ®
Ethical eAdjudication® allows DICOM images reading by connecting its event repository with virtually any DICOM medical image application available on the market. Consequently, the study designer and the reviewers do not have to use a predefined DICOM tool but can choose the DICOM tool/database that they consider more appropriate for the study goals and use it in the standard environment chosen for managing the Adjudication studies. DICOM images can be either uploaded in eAdjudication® as part of a case package (image list or batch import) or accessed via a hyperlink pointing to the external database record (real-time integration).
THE DICOM GRID ® CLOUD MEDICAL EXCHANGE
As an example, we describe below a reviewer’s interaction with images stored in the DICOM GRID(3) web platform for Medical Image Exchange.
The images collected and stored in the DICOM GRID facilities are visualized without leaving the eAdjudication® repository and the Adjudication Forms. They are presented to the Reviewers in the DICOM GRID viewer and can be assessed as part of the procedures and workflows implemented for any other non-image study.
Figure 1 above shows a typical adjudication form in the eAdjudication® platform. The information is grouped in four sections: Key Variables, Documents, Images and Trends. Each of these sections is populated manually or automatically (for details see this blog post) with items from different external databases.
In the images section of this example there are two links: “Image Set 1” and “Image Set 2” that are automatically added or edited depending on their status in the external DICOM GRID platform, e.g. new uploads, updates, etc. A Reviewer can easily access the images stored in the DICOM viewer by simply clicking the links without leaving the Assessment Form. If they possess a workstation with a large enough screen they can display the viewer and the Adjudication questionnaire side by side.
The system manages internally all other aspects of the DICOM integration: Authentication, attribution of the image sets to the correct event, storage, images & metadata update, audit trail, etc. Once trained on the eAdjudication® software, reviewers will follow the same procedures for all studies whether these involve medical images or not.
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(1) from Wikipedia
(2) FDA - Clinical trial Imaging Endpoint Process Standards - Guidance Draft 1 March 2015
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