Synopsis
In this talk, a
literature review will be shown of PI-RADS v2. The role of experience and
training will be discussed. To ensure optimal quality, certification and
quality criteria will be provided. Finally, the role of an expertise network
will be emphasized.
It will be concluded,
that it has been shown that PI-RADSv2 is an adequate ‘‘language’’ for assessing
the risk of the presence of clinically significant PCa. The sensitivity is
significantly better than that of PI-RADSv1. Nonetheless, there is large
heterogeneity that could be reduced by an improved PI-RADSv3 and by training
and certification of radiologists. Equally important, however, is the training
of urologists and other involved physicians in being able to communicate in the
same ‘‘language’’.
Introduction
Multiparametric
magnetic resonance imaging (mpMRI) is now a well-established tool to improve
the diagnosis of prostate cancer (PCa). Several meta-analyses show that the use
of mpMRI and mpMRI-targeted biopsy in men with a suspicion of PCa yields higher
detection of clinically significant PCa than the current standard using
systematic transrectal ultrasound-guided biopsy (TRUS-GB) and reduces the
detection of indolent PCa [1,2]. Further support for these concepts has come
from the results of the PROMIS project, a large multi-institutional trial in
the UK [3]. Therefore, when used as a triage test, mpMRI could be an important
contributor in causing a shift in the current paradigm of overdiagnosis and overtreatment
of PCa.
However, as pointed
out in this issue of European Urology by Woo and coworkers [4], there is
significant variability in published results. For example, there is a highly
variable negative predictive value for the exclusion of clinically significant
PCa, ranging from 63% to 98% [5]. Among the possible explanations for these
variable results are differences in patient populations, reference standards,
image acquisition techniques, image quality, interpretation criteria, reader
experience, and inter-reader variability.
Considering the high
disease frequency and the growing importance of prostate mpMRI, the entire PCa
health care community, including radiologists, urologists, (radiation)
oncologists, and pathologists, must speak the same ‘‘language’’ and have access
to reliable high-quality mpMRI exams. To harmonize practices, in 2012 the
European Society of Urogenital Radiology (ESUR) published guidelines, including
a scoring system, called Prostate Imaging Reporting and Data System (PI-RADS)
version 1 [6].
On the basis of
additional experience and rapid progress in the field, PI-RADS version 2 was
developed by the ESUR, the American College of Radiology (ACR), and the
International Working group of the AdMeTEch foundation, and was published in
2016 [7]. PI-RADSv2 was designed to promote global standardization and diminish
variation in the acquisition, interpretation, and reporting of prostate mpMRI
examinations. It was intended to be a ‘‘living’’ document that would need to be
tested and validated for specific clinical applications. The expectation was
that it would continue to evolve as clinical experience and scientific data
accrued.
In the excellent
systematic review and diagnostic meta-analysis by Woo et al [4], PI-RADSv2 had
high pooled sensitivity of 89% and specificity of 73%. In the studies in which
head-to-head comparison was possible, the sensitivity of PI-RADSv2 was
significantly better than PI-RADSv1 (95% vs 88%) with equal specificity (73% vs
75%), thus supporting the use of PI-RADSv2. On the basis of their findings, the
authors propose some areas for improvement in PI-RADS. This adds to the growing
literature based on experience and research that has highlighted the strengths
of PI-RADSv2 and areas that need refinement, improvement, or additions. Some of
these include clarification of PI-RADS assessment category (1-5) cutoff values
for different clinical scenarios for detecting PCa (eg, diagnosis in biopsy-naıve
men vs men with previous negative biopsy/biopsies or men on active
surveillance), decreasing inter-observer variability, update the system
according to new technical developments, use for surveillance, and
incorporation of PI-RADS with other relevant information (such as PSA and
family history) into nomograms to improve diagnosis and management. Efforts are
already underway to incorporate these and other improvements into PI-RADS v3.Experience & Training
Despite the
heterogeneous level of experience of the radiologists (4–22 yr) who
participated in the 21 studies included in the review and meta-analysis, Woo et
al did not perform a meta-regression analysis or subgroup analysis of the
quality of the reader/reading. This is an important issue, and it may be a
major contributor to differences in results from the studies analyzed. The
inappropriate and unreliable use of PI-RADSv2 by users who have not had
sufficient training or experience may not only result in suboptimal and
variable results for research but may also be compromising clinical care [8].
Puech et al [9] proposed
three levels of competence in reading prostate MRI:
(1) Level I: the
reader can select the appropriate modality and is able to review images and use
the results. At this level, the technique is not performed.
(2) Level II: the
reader follows an initial training course with practical experience on
interpreting prostate MRI, but with a cover of double reading.
(3) Level III: the
reader can independently report prostate MRI under all circumstances without
double reading.
Of course, several
factors influence the learning curve: the dedication and quality of the
individual radiologist, the quality of the initial course, the availability of
histopathologic and urologic feedback during multidisciplinary meetings, and
the learning process during consensus or double readings. Many radiologists may
achieve the equivalent of level III competence by completing a recent
accredited training program. However, for others who received their training
where prostate mpMRI is not routinely performed or who completed their training
before prostate mpMRI was a substantial component of a training program, level
III competence will be more challenging.Certification & Quality Criteria
Several authors have
advocated for additional training and certification (credentialing) for
radiologists who supervise and interpret prostate mpMRI [10].
To improve the current
diagnostic pathway for PCa, many lessons can be learned from mammography
screening, for which dedicated courses and certification (credentialing) of
individual readers are used. Several measures that could be considered to
secure high quality for individual reporting of prostate mpMRI include:
- Make initial
continuing medical education courses and yearly hands-on courses mandatory for
prostate MRI readers.
- Perform a minimum
number of procedures per year.
- Define an upper
limit for equivocal diagnoses (PI-RADS 3), depending on the indications and
patient population. Define a lower limit for PI-RADS 4 and 5 cases that should yield
clinically significant PCa.
- Required
participation in multidisciplinary meetings to compare PI-RADS findings with
histopathology.
- Transparency of
institutional clinical outcome data.
Expert panels of the
ESUR and ACR should take the lead to further define these criteria to secure
high-quality (reading of) prostate MRI and allow further implementation by the
urology community.Prostate Expertise Network
A prerequisite for
further development and evolution of high-quality (reading of) prostate MRI is
concentration of specific knowledge on this topic. By means of a worldwide
network of prostate MRI expert centers—which are sharing their knowledge—the
technique can be constantly updated and improved. Internet connectivity of
centers with expertise may allow ‘‘double reading’’ of difficult cases, with
subsequent better outcomes and diagnoses. Of course, this could be beneficial
not only for men with (a suspicion of) PCa but also for fast implementation of
newly validated techniques and the development of a large scientific database.Conclusions
It has been shown that
PI-RADSv2 is an adequate ‘‘language’’ for assessing the risk of the presence of
clinically significant PCa. The sensitivity is significantly better than that
of PI-RADSv1. Nonetheless, there is large heterogeneity that could be reduced
by an improved PI-RADSv3 and by training and certification of radiologists.
Equally important, however, is the training of urologists and other involved
physicians in being able to communicate in the same ‘‘language’’.
Conflicts of interest:
The authors have nothing to disclose.Acknowledgements
No acknowledgement found.References
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