A multifaceted approach to quality in the MRI-directed biopsy pathway for prostate cancer diagnosis
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EDITORIAL
A multifaceted approach to quality in the MRI-directed biopsy pathway for prostate cancer diagnosis Anwar R. Padhani 1
&
Ivo G. Schoots 2,3 & Baris Turkbey 4 & Gianluca Giannarini 5 & Jelle O. Barentsz 6
Received: 22 October 2020 / Accepted: 16 November 2020 # European Society of Radiology 2020
Key Points • Identify, assure, and measure major sources of variability affecting the MRI-directed biopsy pathway for prostate cancer diagnosis. • Develop strategies to control and minimize variations that impair pathway effectiveness including the performance of main players and team working. • Assure end-to-end quality of the diagnostic chain with robust multidisciplinary team working.
For a urological outpatient population where the prevalence of clinically significant prostate cancer (csPCa) is approximately 20–40% [1], MRI brings the advantages of biopsy avoidance in 37% of men with MRI-negative scans (range, 17–56%) [2–8], and reduced detection of clinically insignificant PCa by 9% [1]. These advantages minimize the harms of unnecessary biopsies, over-diagnoses, and over-treatments [9]. These benefits are related to the consistent high negative predictive value (NPV) and sensitivity of MRI for PCa detection [10, 11] that enable the reliable “ruling-out” of csPCa without needing biopsies [7, 12]. A recent meta-analysis of 36 studies including more than 5000 biopsy-naïve men had an NPV of 91% (95% CI 88–96%), meaning that 1 in 10 men with International Society of Uropathology (ISUP) Gleason Grade (GG) ≥ 2 remained undiagnosed [10]. We must remember that most of the prospective level 1 evidence studies used for guideline development were performed in high-volume expert centers [2, 5, 6]. However, “real-world” studies show similar NPVs, despite heterogeneities in disease prevalence, MRI scanners, and expertise of radiologists, urologists, and pathologists [1, 3, 8, 10, 11]. These concordant data reenforced the guideline recommendations to use MRI-
negative results for avoiding prostate biopsies, with appropriate clinical caveats and safety-nets protocols [13–15]. The consistent and high NPV is related to fewer confounding factors, mostly related to disease prevalence rates and radiological factors. The latter being image quality, image read-outs, and data processing. Because radiologists have direct control of MRI, they can point to multiple advances including technologies that improve the speed and consistencies of MRI acquisitions, uniform image interpretation criteria [16], certification efforts [17], quality checks scores [18], and recent advances in automated gland contouring and suspicion lesion heat-maps using deep learning techniques [19]. Unfortunately, the “rule-in” ability of MRI is less consistent, with large variances in positive predictive values (PPV) with false-positive rates as high as 50% [20]. This unreliability is seen in the high proportion of PI-RADS 3–4 category patients who have biopsies that are negative for csPCa. On the other hand, patients with PI-RADS 5 category scores have hig
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