How does PI-RADS v2.1 impact patient classification? A head-to-head comparison between PI-RADS v2.0 and v2.1.

ABSTRACT

BACKGROUND: PI-RADS classification has recently been updated, with the magnitude of changes implemented currently unknown. PURPOSE: To quantify the categorization shifts between PI-RADS v2.0 and v2.1. MATERIAL AND METHODS: Retrospective review of 535 consecutive diagnostic magnetic resonance imaging (MRI) studies performed over 18 months, assigning to each case a PI-RADS category in the peripheral zone (PZ), the transition zone (TZ), and the whole gland using both PI-RADS v2.0 and v2.1. Significance of changes in category assignments and of differences in the number of positive or negative MRIs were evaluated using the McNemar test. RESULTS: Comparing v2.0 to v2.1 for the whole gland, 11.2% of PI-RADS 2 categories shifted to PI-RADS 1 (6.9% in the PZ, 56.8% in the TZ), 16.1% of PI-RADS 3 categories shifted to PI-RADS 2 (15.0% in the PZ, 20.0% in the TZ), and 2.1% of PI-RADS 2 categories shifted to PI-RADS 3 (0.3% in the PZ, 1.9% in the TZ). The proportion of PI-RADS 1 significantly increased from 0.6% to 7.3%, PI-RADS 2 significantly decreased from 60.0% to 53.8%, and PI-RADS 3 non-significantly decreased from 11.6% to 11.0%. The total number of positive exams (PI-RADS 3-5) did not change significantly (39.4% versus 38.8%). CONCLUSION: The most prominent change between v2.0 and v2.1 was observed in the TZ with the downgrading of typical benign prostatic hyperplasia nodules from category 2 into category 1. Overall, there were no significant changes in the number of positive and negative MRI results, with an expected low influence in clinical management.