Can structured integration of BI-RADS criteria by a clinical decision rule reduce the number of unnecessary biopsies in BI-RADS 4 lesions? A systematic review and meta-analysis

Abstract Aim This systematic review and meta-analysis investigate the added value of structured integration of Breast Imaging Reporting and Data System (BI-RADS) criteria using the Kaiser score (KS) to avoid unnecessary biopsies in BI-RADS 4 lesions. Material and methods A systematic review and meta-analysis were conducted using predefined criteria. Eligible articles, published in English until May 2024, dealt with KS in the context of BI-RADS 4 MRI. Two reviewers extracted study characteristics, including true positives (TP), false positives (FP), true negatives (TN), and false negatives (FN). Sensitivity, specificity, negative likelihood ratio, and positive likelihood ratio were calculated using bivariate random effects. Fagan nomograms identified the maximum pre-test probability at which post-test probabilities of a negative MRI aligned with the 2% malignancy rate benchmark for downgrading BI-RADS 4 to BI-RADS 3. I ² statistics and meta-regression explored sources of heterogeneity. p -values < 0.05 were considered significant. Results Seven studies with 1877 lesions (833 malignant, 1044 benign) were included. The average breast cancer prevalence was 47.3%. Pooled sensitivity was 94.3% (95%-CI 88.9%–97.1%), and pooled specificity was 68.1% (95%-CI 56.6%–77.7%) using a random effects model. Overall, 52/833 cases were FNs (6.2%). Fagan nomograms showed that KS could rule out breast cancer in BI-RADS 4 lesions at a pre-test probability of 20.3% for all lesions, 25.4% for masses, and 15.2% for non-mass lesions. Conclusions In MRI-assessed BI-RADS 4 lesions, applying structured BI-RADS criteria with the KS reduces unnecessary biopsies by 70% with a 6.2% FN rate. Breast cancer can be ruled out up to pre-test probabilities of 20.3%. Key Points Question What, if any, value is added by structured integration of BI-RADS criteria using the Kaiser Score (KS) to avoid unnecessary biopsies in BI-RADS 4 lesions? Findings The structured integration of BI-RADS criteria using the Kaiser Score (KS) reduces unnecessary biopsies in BI-RADS 4 lesions by 70%. Clinical relevance The structured approach offered by the Kaiser Score (KS) avoids unnecessary recalls, potentially reducing patient anxiety, lessening the burden on medical personnel, and the need for further imaging and biopsies due to more objective and thus efficient clinical decision-making in evaluating BI-RADS 4 lesions.