Earlier this year, a team from the Division of Imaging, Diagnostics, and Software Reliability at the FDA's Center for Devices and Radiological Health published a laboratory pilot study showing that the choice of color scale and display device hardware affected the visual assessment of functional images. The researchers are currently evaluating the extent of this effect in the clinical setting, using the open-source software application to help size the study and analyze data, said presenter Dr. Silvina Zabala-Travers. An international multisite study is now underway, with clinicians as readers for several functional imaging modalities.
"The goal of my RSNA oral presentation is to introduce attendees to a simple, freely available, open-source software tool developed by my colleagues from the FDA for reader study sizing and analysis, and to share the simple steps I followed to get from my pilot data to an appropriate number of readers and cases to include in my follow-up clinical studies," Zabala-Travers told AuntMinnie.com.
Get all the details at the Wednesday afternoon session.
