Chau Hung Lee1, Balamurugan Vellayappan2, Cher Heng Tan1,3. 1. Department of Radiology, Tan Tock Seng Hospital, Singapore, Singapore. 2. Department of Radiation Oncology, National University Cancer Institute, National University Health System, Singapore, Singapore. 3. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.
Abstract
OBJECTIVES: To perform a systematic review and meta-analysis comparing diagnostic performance and inter reader agreement between PI-RADS v. 2.1 and PI-RADS v. 2 in the detection of clinically significant prostate cancer (csPCa). METHODS: A systematic review was performed, searching the major biomedical databases (Medline, Embase, Scopus), using the keywords "PIRADS 2.1" or "PI RADS 2.1" or "PI-RADS 2.1". Studies reporting on head-to-head diagnostic comparison between PI-RADS v. 2.1 and v. 2 were included. Pooled sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were compared between PI-RADS v. 2.1 and v. 2. Summary receiver operator characteristic graphs were plotted. Analysis was performed for whole gland, and pre-planned subgroup analysis was performed by tumour location (whole gland vs transition zone (TZ)), high b-value DWI (b-value ≥1400 s/mm2), and reader experience (<5 years vs ≥5 years with prostate MRI interpretation). Inter-reader agreement and pooled rates of csPCa for PI-RADS 1-3 lesions were compared between PI-RADS v. 2.1 and v. 2. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool v. 2 (QUADAS-2). RESULTS: Eight studies (1836 patients, 1921 lesions) were included. Pooled specificity for PI-RADS v. 2.1 was significantly lower than PI-RADS v. 2 for whole gland (0.62 vs 0.66, p = 0.02). Pooled sensitivities, PPVs and NPVs were not significantly different (p = 0.17, 0.31, 0.41). Pooled specificity for PI-RADS v. 2.1 was significantly lower than PI-RADS v. 2 for TZ only (0.67 vs 0.72, p = 0.01). Pooled sensitivities, PPVs and NPVs were not significantly different (p = 0.06, 0.36, 0.17). Amongst studies utilising diffusion-weighted imaging with highest b-value of ≥1400 s/mm2, pooled sensitivities, specificities, PPVs and NPVs were not significantly different (p = 0.52, 0.4, 0.5, 0.47). There were no significant differences in pooled sensitivities, specificities, PPVs and NPVs between PI-RADS v. 2.1 and PI-RADS v. 2 for less-experienced readers (p = 0.65, 0.37, 0.65, 0.81) and for more experienced readers (p = 0.57, 0.90, 0.91, 0.65). For PI-RADS v. 2.1 alone, there were no significant differences in pooled sensitivity, specificity, PPV and NPV between less and more experienced readers (p = 0.38, 0.70, 1, 0.48). Inter-reader agreement was moderate to substantial for both PI-RADS v. 2.1 and v. 2. There were no significant differences between pooled csPCa rates between PI-RADS v. 2.1 and v. 2 for PI-RADS 1-2 lesions (6.6% vs 7.3%, p = 0.53), or PI-RADS 3 lesions (24.1% vs 26.8%, p = 0.28). CONCLUSIONS: Diagnostic performance and inter-reader agreement for PI-RADS v. 2.1 is comparable to PI-RADS v. 2, however the significantly lower specificity of PI-RADS v. 2.1 may result in increased number of unnecessary biopsies. ADVANCES IN KNOWLEDGE: 1. Compared to PI-RADS v. 2, PI-RADS v. 2.1 has a non-significantly higher sensitivity but a significantly lower specificity for detection of clinically significant prostate cancer.2. PI-RADS v. 2.1 could potentially result in considerable increase in number of negative targeted biopsy rates for PI-RADS 3 lesions, which could have been potentially avoided.
OBJECTIVES: To perform a systematic review and meta-analysis comparing diagnostic performance and inter reader agreement between PI-RADS v. 2.1 and PI-RADS v. 2 in the detection of clinically significant prostate cancer (csPCa). METHODS: A systematic review was performed, searching the major biomedical databases (Medline, Embase, Scopus), using the keywords "PIRADS 2.1" or "PI RADS 2.1" or "PI-RADS 2.1". Studies reporting on head-to-head diagnostic comparison between PI-RADS v. 2.1 and v. 2 were included. Pooled sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were compared between PI-RADS v. 2.1 and v. 2. Summary receiver operator characteristic graphs were plotted. Analysis was performed for whole gland, and pre-planned subgroup analysis was performed by tumour location (whole gland vs transition zone (TZ)), high b-value DWI (b-value ≥1400 s/mm2), and reader experience (<5 years vs ≥5 years with prostate MRI interpretation). Inter-reader agreement and pooled rates of csPCa for PI-RADS 1-3 lesions were compared between PI-RADS v. 2.1 and v. 2. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool v. 2 (QUADAS-2). RESULTS: Eight studies (1836 patients, 1921 lesions) were included. Pooled specificity for PI-RADS v. 2.1 was significantly lower than PI-RADS v. 2 for whole gland (0.62 vs 0.66, p = 0.02). Pooled sensitivities, PPVs and NPVs were not significantly different (p = 0.17, 0.31, 0.41). Pooled specificity for PI-RADS v. 2.1 was significantly lower than PI-RADS v. 2 for TZ only (0.67 vs 0.72, p = 0.01). Pooled sensitivities, PPVs and NPVs were not significantly different (p = 0.06, 0.36, 0.17). Amongst studies utilising diffusion-weighted imaging with highest b-value of ≥1400 s/mm2, pooled sensitivities, specificities, PPVs and NPVs were not significantly different (p = 0.52, 0.4, 0.5, 0.47). There were no significant differences in pooled sensitivities, specificities, PPVs and NPVs between PI-RADS v. 2.1 and PI-RADS v. 2 for less-experienced readers (p = 0.65, 0.37, 0.65, 0.81) and for more experienced readers (p = 0.57, 0.90, 0.91, 0.65). For PI-RADS v. 2.1 alone, there were no significant differences in pooled sensitivity, specificity, PPV and NPV between less and more experienced readers (p = 0.38, 0.70, 1, 0.48). Inter-reader agreement was moderate to substantial for both PI-RADS v. 2.1 and v. 2. There were no significant differences between pooled csPCa rates between PI-RADS v. 2.1 and v. 2 for PI-RADS 1-2 lesions (6.6% vs 7.3%, p = 0.53), or PI-RADS 3 lesions (24.1% vs 26.8%, p = 0.28). CONCLUSIONS: Diagnostic performance and inter-reader agreement for PI-RADS v. 2.1 is comparable to PI-RADS v. 2, however the significantly lower specificity of PI-RADS v. 2.1 may result in increased number of unnecessary biopsies. ADVANCES IN KNOWLEDGE: 1. Compared to PI-RADS v. 2, PI-RADS v. 2.1 has a non-significantly higher sensitivity but a significantly lower specificity for detection of clinically significant prostate cancer.2. PI-RADS v. 2.1 could potentially result in considerable increase in number of negative targeted biopsy rates for PI-RADS 3 lesions, which could have been potentially avoided.
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