Prostate Cancer Diagnostic Pathway Research Articles

PT162 - Multiparametric ultrasound for the diagnosis of prostate cancer: Greyscale, shearwave elastography and contrast-enhanced imaging in comparison with radical prostatectomy specimens

Introduction & Objectives: The diagnostic pathway for prostate cancer (PCa) is advancing towards an imaging-driven approach. The introduction of new ultrasound (US) modalities, such as quantitative contrast-enhanced US (CEUS), shear wave elastography (SWE) and the combination of different US modalities shows promise but a structured comparison with gold standard radical prostatectomy (RP) specimens is still lacking. The primary objective of this study is to determine the diagnostic performance of greyscale US (GS), SWE, CEUS and their combination, multiparametric US (mpUS) for the detection and localization of clinically significant (cs)PCa by comparison with corresponding RP histopathology.

100 - Use of the PHI assay as a first line triaging test in an image-guided prostate cancer diagnostic pathway. The PHI in Refining MRI (PRIM) study

100 - Use of the PHI assay as a first line triaging test in an image-guided prostate cancer diagnostic pathway. The PHI in Refining MRI (PRIM) study

The added value of systematic biopsy in men with suspicion of prostate cancer undergoing multiparametric MRI-targeted biopsy

PurposeIncorporation of multiparametric magnetic resonance imaging (mpMRI) and targeted biopsy (TBx) in the diagnostic pathway for prostate cancer (CaP) is rapidly becoming common practice. In men with a prebiopsy positive mpMRI a TBx only approach, thereby omitting transrectal ultrasound-guided systematic biopsy (SBx), has been postulated. In this study we evaluated the additional clinical relevance of SBx in men with a positive prebiopsy mpMRI (Prostate Imaging Reporting and Data System [PI-RADS] ≥ 3) undergoing TBx for CaP detection, Gleason grading and CaP localization. Material and methodsProspective data of 255 consecutive men with a prebiopsy positive mpMRI (PI-RADS ≥ 3) undergoing 12-core SBx and subsequent MRI-transrectal ultrasound fusion TBx in 2 institutions between 2015 and 2018 was obtained. The detection rate for significant CaP (Gleason score [GS] ≥ 3 + 4) for TBx and SBx were compared. The rate of potentially missed significant CaP by a TBx only approach was determined and GS concordance and CaP localization by TBx and SBx was evaluated. ResultsTBx yielded significant CaP in 113 men (44%) while SBx yielded significant CaP in 110 men (43%) (P = 0.856). Insignificant CaP was found in 21 men (8%) by TBx, while SBx detected 34 men (13%) with insignificant CaP (P = 0.035). A TBx only approach, omitting SBx, would have missed significant CaP in 13 of the 126 men (10%) with significant CaP on biopsy. Ten of the 118 men (8%), both positive on TBx and SBx, were upgraded in GS by SBx while 11 men (9%) had higher maximum tumor core involvement on SBx. Nineteen of the 97 men (20%) with significant CaP in both TBx and SBx were diagnosed with unilateral significant CaP on mpMRI and TBx while SBx demonstrated bilateral significant CaP. ConclusionsIn men with a prebiopsy positive mpMRI, TBx detects high-GS CaP while reducing insignificant CaP detection as compared to SBx. SBx and TBx as stand-alone missed significant CaP in 13% and 10% of the men with significant CaP on biopsy, respectively. A combination of SBx and TBx remains necessary for the most accurate assessment of detection, grading, tumor core involvement, and localization of CaP.

Multiparametric ultrasound: evaluation of greyscale, shear wave elastography and contrast-enhanced ultrasound for prostate cancer detection and localization in correlation to radical prostatectomy specimens

BackgroundThe diagnostic pathway for prostate cancer (PCa) is advancing towards an imaging-driven approach. Multiparametric magnetic resonance imaging, although increasingly used, has not shown sufficient accuracy to replace biopsy for now. The introduction of new ultrasound (US) modalities, such as quantitative contrast-enhanced US (CEUS) and shear wave elastography (SWE), shows promise but is not evidenced by sufficient high quality studies, especially for the combination of different US modalities. The primary objective of this study is to determine the individual and complementary diagnostic performance of greyscale US (GS), SWE, CEUS and their combination, multiparametric ultrasound (mpUS), for the detection and localization of PCa by comparison with corresponding histopathology.Methods/designIn this prospective clinical trial, US imaging consisting of GS, SWE and CEUS with quantitative mapping on 3 prostate imaging planes (base, mid and apex) will be performed in 50 patients with biopsy-proven PCa before planned radical prostatectomy using a clinical ultrasound scanner. All US imaging will be evaluated by US readers, scoring the four quadrants of each imaging plane for the likelihood of significant PCa based on a 1 to 5 Likert Scale. Following resection, PCa tumour foci will be identified, graded and attributed to the imaging-derived quadrants in each prostate plane for all prostatectomy specimens. Primary outcome measure will be the sensitivity, specificity, negative predictive value and positive predictive value of each US modality and mpUS to detect and localize significant PCa evaluated for different Likert Scale thresholds using receiver operating characteristics curve analyses.DiscussionIn the evaluation of new PCa imaging modalities, a structured comparison with gold standard radical prostatectomy specimens is essential as first step. This trial is the first to combine the most promising ultrasound modalities into mpUS. It complies with the IDEAL stage 2b recommendations and will be an important step towards the evaluation of mpUS as a possible option for accurate detection and localization of PCa.Trial registrationThe study protocol for multiparametric ultrasound was prospectively registered on Clinicaltrials.gov on 14 March 2017 with the registry name ‘Multiparametric Ultrasound-Study for the Detection of Prostate Cancer’ and trial registration number NCT03091231

Comparison of the Diagnostic Accuracy of Micro-ultrasound and Magnetic Resonance Imaging/Ultrasound Fusion Targeted Biopsies for the Diagnosis of Clinically Significant Prostate Cancer

Multiparametric magnetic resonance imaging (mpMRI) and MRI/ultrasound (US) fusion targeted biopsies are an increasingly popular alternative to randomized biopsies, but adoption of this technique has been limited owing to its additional costs and complexity. High-resolution micro-ultrasound (micro-US) is a real-time US-based imaging modality that allows real-time targeted prostate biopsies using the Prostate Risk Identification Using Micro-Ultrasound risk identification protocol. We compared the diagnostic accuracy of micro-US targeted biopsies (index test) and MRI/US fusion targeted biopsies (reference standard test) in detecting clinically significant prostate cancer (csPC), defined as Gleason ≥7 disease, in a prospectively collected cohort of 104 patients with suspected PC defined according to prostate-specific antigen, digital rectal examination, and the presence of at least one Prostate Imaging-Reporting and Data System ≥3 lesion at mpMRI. PC was diagnosed in 56 patients (54%) and csPC in 35 (34%). Micro-US sensitivity for csPC detection was 94%, with 33/35 csPC cases correctly identified. The negative predictive value was 90%, while the positive predictive value was 40% and the specificity was 28%. Of the 61 targeted zones concordant between micro-US and mpMRI, 24 were csPC. Discordant targeted lesions led to csPC discovery by micro-US in three cases and mpMRI in four cases. Both techniques missed one case for which csPC was diagnosed by systematic biopsies only. Patient summaryAccording to the results of our preliminary trial, micro-ultrasound may provide additional information regarding the presence or absence of clinically significant prostate cancer (PC) in patients with suspected PC. Further studies are warranted to investigate how this new imaging modality can best be leveraged within the PC diagnostic pathway.

Prostate cancer diagnostic pathway: Is a one-stop cognitive MRI targeted biopsy service a realistic goal in everyday practice? A pilot cohort in a tertiary referral centre in the UK

ObjectivesTo evaluate the feasibility of a novel multiparametric MRI (mpMRI) and cognitive fusion transperineal targeted biopsy (MRTB) led prostate cancer (PCa) diagnostic service with regard to cancer detection and reducing...

MRI in prostate cancer diagnosis: do we need to add standard sampling? A review of the last 5 years.

In recent years, evidence has accrued to support the introduction of multiparametric magnetic resonance imaging (mpMRI) in the prostate cancer diagnostic pathway. The exact role of mpMRI in different settings is not widely agreed. In this review, we look at the use of MRI in three groups of men: biopsy naive men, those with a previous negative biopsy and those with a previous positive biopsy suitable for active surveillance. An electronic MEDLINE/PubMed search up to 24th January 2018 was performed, using the search terms (prostate cancer OR prostate adenocarcinoma) AND (MRI OR magnetic resonance) AND (biopsy naive OR active surveillance OR prior negative biopsy OR no prior biopsy). Only those studies which reported detection rates of standard biopsy and MRI-targeted biopsy, where all men had both an MRI and standard biopsy were included. In total 34 articles were included (14 biopsy naive, 10 prior negative biopsy, and 10 prior positive biopsy). MRI-targeted biopsy consistently resulted in greater detection of clinically significant prostate cancer, and a lower detection of clinically insignificant prostate cancer, across all three patient populations. This effect was most prominent in men with at least one previous negative biopsy, and least prominent in men on active surveillance. In the presence of a negative mpMRI detection of csPCa found at systematic biopsy ranged from 0 to 20%. MRI-targeted biopsy is more efficient than standard biopsy in detecting clinically significant disease in men with a positive MRI, and results in less detection of clinically insignificant cancer. In men with a negative MRI, a significant minority of men will have clinically significant cancer detected on systematic biopsy.

V12-10 EVALUATING THE DIAGNOSTIC ROLE OF IN-BORE MAGNETIC RESONANCE IMAGING GUIDED PROSTATE BIOPSY

You have accessJournal of UrologyImaging Based Techniques & Uroradiology1 Apr 2018V12-10 EVALUATING THE DIAGNOSTIC ROLE OF IN-BORE MAGNETIC RESONANCE IMAGING GUIDED PROSTATE BIOPSY Tiffany Cherry, Diarmaid Moran, Paul Simkin, Richard Dowling, Stefan Heinze, and Homayoun Zargar Tiffany CherryTiffany Cherry More articles by this author , Diarmaid MoranDiarmaid Moran More articles by this author , Paul SimkinPaul Simkin More articles by this author , Richard DowlingRichard Dowling More articles by this author , Stefan HeinzeStefan Heinze More articles by this author , and Homayoun ZargarHomayoun Zargar More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.3018AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES With the increasing role of magnetic resonance imaging (MRI) in prostate cancer diagnosis, in-bore MRI (IB-MRI) guided biopsy has become a feasible method of sampling suspicious lesions with real-time guidance. This may allow a focus on otherwise under-sampled areas while also reducing the diagnosis of clinically insignificant cancers. We aim to report the diagnostic role that IB-MRI guided biopsies have played in our initial cohort. METHODS All patients intended for IB-MRI guided prostate biopsy at our institution are included. Retrospectively recorded data includes indication, previous biopsy results, PIRADS score of targeted lesion, histological results and complications. We also assessed the impact on clinical management. RESULTS 31 patients with identified lesions attempted to undergo IB-MRI guided biopsy. A median number of 5 cores were taken (range 3-11). 19 patients had previously undergone a prostate biopsy (14 transperineal, 5 TRUS), 9 of whom were on active surveillance. Outcomes are summarised in Table 1 with results categorised according to the PIRADS score of the targeted lesion. Any grade of prostate cancer was considered a positive result. Two significant complications occurred (urinary sepsis and rectal bleeding), and 2 intended biopsies did not proceed (1 patient intolerability, 1 target lesion no longer seen). See Table 1: Summary of MRI guided biopsy resultsOf the 10 patients with no previous biopsy, 5 were offered radical therapy for clinically significant prostate cancer (Gleason grade greater than or equal to 7) and 1 was placed onto active surveillance for Gleason 6 disease. Excluding biopsy naïve patients, undergoing an IB-MRI changed the preferred clinical management in 10 out of 19 patients, 9 of whom have chosen to undergo definitive therapy. CONCLUSIONS IB-MRI guided biopsy appears to offer a reliable and acceptable method to accurately target identified lesions. Overall in our cohort, this method led to definitive therapy being offered to 52% of those patients biopsied. Its ongoing role in the prostate cancer diagnostic pathway should continue to be evaluated. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1239-e1240 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Tiffany Cherry More articles by this author Diarmaid Moran More articles by this author Paul Simkin More articles by this author Richard Dowling More articles by this author Stefan Heinze More articles by this author Homayoun Zargar More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

An update on prostate biopsy in the era of magnetic resonance imaging.

Prostate cancer (PCa) is a singular disease owing to absence of imaging technique able to detect suspicious glandular area at higher risk of disease. Nowadays, magnetic resonance imaging (MRI) has been used as a way to detect PCa and simplify targeting prostate biopsy (PB). The aim of this study is to review the most recent data regarding standard BP and MRI-guided PB. A comprehensive systematic MEDLINE search was performed in December 2017 for English-language reports by using the following terms: "prostate biopsy," "multiparametric magnetic resonance imaging," "prostate cancer," "transrectal and transperineal ultrasound," "target biopsy." Previous published reviews and recent published original articles were preferred in order to meet our study scope. Retrieved studies of greater interest were reported in two main sections: standard PB and MRI-guided BP. Thus, the main items regarding PB were analyzed. Briefly, clinical suspicious of PCa is based on prostate specific antigen level and digital rectal examination findings although a PCa risk assessment through a nomogram risk calculator is nowadays advised. Ten-eighteen biopsy cores, depending on prostate volume, and peripheral sampling seem the suitable scheme for initial biopsy while a saturation template (>20 cores including transitional prostate area) is widely used in case of repeat PB. Performing a local anesthesia is now the standard of care with several available techniques. No difference exists in term of PCa detection rate between transperienal and transrectal approaches however the last one is mostly used. The use of MRI-guided biopsy seems to be a promising imaging technique able to identify an index lesion at higher suspicious of PCa. In particular, MRI shows a higher accuracy than standard PB in the detection of clinically significant PCa. No general consensus exists on which MRI-guided biopsy should be used with three different ways currently available to take biopsy core. However, the initial MRI cognitive PB has been replaced by fusion MRI technique to guide biopsy with reproducible results. Absence of standardization founded in initial MRI studies has been recently revised by introduction of common criteria to assess PCa presence on MRI. PB is the cornerstone in diagnosis and management of PCa. Although ultrasound transrectal and transperineal PB are still considered as the standard, emerging data confirm the role of MRI-guided biopsy, particularly in patients with a previous negative biopsy. However, MRI costs and the moderate inter-reader reproducibility of the exam are still significant concerns requiring further studies to define the right role of MRI in the PCa diagnostic pathway.

Multiparametric MRI fusion-guided biopsy for the diagnosis of prostate cancer.

To discuss the timing, benefits, limitations and current controversies of multiparametric magnet resonance imaging (mpMRI) combined with fusion-guided biopsy and consider how additional incorporation of multivariable risk stratification might further improve prostate cancer diagnosis. MpMRI has been proven advantageous over standard practice for biopsy-naïve men and men with previous biopsy in large prospective studies providing level 1b evidence. Upfront multivariable risk stratification followed by or combined with mpMRI further improves diagnostic accuracy. Regarding active surveillance, mpMRI in combination with fusion biopsy can support initial candidate selection and may help to monitor disease progression. mpMRI and fusion biopsy, however, do not spare failure and conflicting data exists to what extend (systematic) biopsies can be omitted. Integration of mpMRI into the diagnostic pathway for prostate cancer is beneficial; yet more prospective and randomized data is needed to establish reliable procedure standards after mpMRI acquisition.

Diagnostic Accuracy of Multiparametric Magnetic Resonance Imaging and Fusion Guided Targeted Biopsy Evaluated by Transperineal Template Saturation Prostate Biopsy for the Detection and Characterization of Prostate Cancer

We evaluated the diagnostic accuracy of multiparametric magnetic resonance imaging and multiparametric magnetic resonance imaging/transrectal ultrasound fusion guided targeted biopsy against that of transperineal template saturation prostate biopsy to detect prostate cancer. We retrospectively analyzed the records of 415 men who consecutively presented for prostate biopsy between November 2014 and September 2016 at our tertiary care center. Multiparametric magnetic resonance imaging was performed using a 3 Tesla device without an endorectal coil, followed by transperineal template saturation prostate biopsy with the BiopSee® fusion system. Additional fusion guided targeted biopsy was done in men with a suspicious lesion on multiparametric magnetic resonance imaging, defined as Likert score 3 to 5. Any Gleason pattern 4 or greater was defined as clinically significant prostate cancer. The detection rates of multiparametric magnetic resonance imaging and fusion guided targeted biopsy were compared with the detection rate of transperineal template saturation prostate biopsy using the McNemar test. We obtained a median of 40 (range 30 to 55) and 3 (range 2 to 4) transperineal template saturation prostate biopsy and fusion guided targeted biopsy cores, respectively. Of the 124 patients (29.9%) without a suspicious lesion on multiparametric magnetic resonance imaging 32 (25.8%) were found to have clinically significant prostate cancer on transperineal template saturation prostate biopsy. Of the 291 patients (70.1%) with a Likert score of 3 to 5 clinically significant prostate cancer was detected in 129 (44.3%) by multiparametric magnetic resonance imaging fusion guided targeted biopsy, in 176 (60.5%) by transperineal template saturation prostate biopsy and in 187 (64.3%) by the combined approach. Overall 58 cases (19.9%) of clinically significant prostate cancer would have been missed if fusion guided targeted biopsy had been performed exclusively. The sensitivity of multiparametric magnetic resonance imaging and fusion guided targeted biopsy for clinically significant prostate cancer was 84.6% and 56.7% with a negative likelihood ratio of 0.35 and 0.46, respectively. Multiparametric magnetic resonance imaging alone should not be performed as a triage test due to a substantial number of false-negative cases with clinically significant prostate cancer. Systematic biopsy outperformed fusion guided targeted biopsy. Therefore, it will remain crucial in the diagnostic pathway of prostate cancer.

Diagnostic accuracy of mpMRI and fusion-guided targeted biopsy evaluated by transperineal template saturation prostate biopsy for the detection and characterization of prostate cancer

PURPOSE To evaluate the diagnostic accuracy of mpMRI and mpMRI / transrectal ultrasound (TRUS) fusion-guided targeted biopsy (FTB) against transperineal template saturation prostate biopsy (TTSPB) for the detection of prostate cancer (PCa). PATIENTS AND METHODS Retrospective analysis of 415 men consecutively presenting for prostate biopsy between 11/2014 and 9/2016 at our tertiary care centre. MpMRI (3-Tesla, without endorectal coil) was performed followed by TTSPB with the BiopSee® fusion system. Additional FTB was carried out in men with a suspicious lesion on mpMRI (Likert score 3-5). Any Gleason pattern 4 was defined as clinically significant PCa (csPCa). Detection rates of mpMRI and FTB were compared with the detection rate of TTSPB using the McNemar test. RESULTS The median numbers of TTSPB and FTB cores taken were 40 (range 30-55) and three (2-4), respectively. Among 124 patients (29.9%) without suspicious lesion on mpMRI, 32 (25.8%) were found to have csPCa on TTSPB. Among 291 patients (70.1%) with a Likert score 3-5 on mpMRI, FTB detected 129 (44.3%), TTSPB 176 (60.5%) and the combined approach 187 patients (64.3%) with a csPCa. Overall, 58 cases (19.9%) of csPCa would have been missed if FTB was performed exclusively. Sensitivities of mpMRI and FTB for csPCa were 84.6% and 56.7%, with a negative likelihood ratio of 0.35 and 0.46, respectively. CONCLUSIONS MpMRI alone should not be used as a triage test due to a substantial number of false-negative cases with csPCa. Systematic biopsy outperformed FTB and will therefore remain crucial in the diagnostic pathway of PCa.

Multiparametric MRI and MRI/TRUS Fusion Guided Biopsy for the Diagnosis of Prostate Cancer.

Purpose of this chapter To demonstrate the timing, benefits, limitations and current controversies of multiparametric magnet resonance imaging (mpMRI) combined with fusion guided biopsy and consider how additional incorporation of multivariable risk stratification might further improve prostate cancer (PC) diagnosis. Recent findings MpMRI has been shown to add important information to the diagnostic pathway for prostate cancer. Fusion biopsy has also shown advantages in comparison to standard practice for biopsy-naïve men and men with previous biopsy in large prospective studies providing level 1b evidence. Adding upfront multivariable risk stratification followed by or combined with mpMRI diagnostic accuracy can further be improved. Regarding active surveillance (AS), mpMRI in combination with fusion biopsy can support initial candidate selection and may help to monitor disease progression. However, mpMRI and fusion biopsy are not without failure and conflicting data exists to what extend (systematic) biopsies can be omitted. Summary The integration of mpMRI into the diagnostic pathway for PC can add important information for further decision making, yet more prospective and randomized data is needed to establish reliable procedure standards after mpMRI acquisition.

The management of rectal bleeding following transrectal prostate biopsy: A review of the current literature.

Since the advent of prostate-specific antigen (PSA)-based testing, transrectal ultrasound (TRUS)-guided prostate biopsy has become a standard part of the diagnostic pathway for prostate cancer (PCa). Rectal bleeding is one of the common side effects of this transrectal route. While rectal bleeding is usually mild and self-limiting, it can be life-threatening. In this article, we examine rectal bleeding post-TRUS-guided prostate biopsy and explore the literature to evaluate techniques and strategies aimed at preventing and managing this common and important complication. A PubMed literature search was carried out using the keywords "transrectal-prostate-biopsy-bleed." A search of the bibliography of reviewed studies was also conducted. Additionally, papers in non-PubMed-listed journals of which the authors were aware were appraised. Numerous modifiable risk factors for this bleeding complication exist, particularly anticoagulants/antiplatelets and the number of core biopsies taken. Successfully described corrective measures for such rectal bleeding include tamponade (digital/packs/catheter/tampon/condom), endoscopic sclerotherapy/banding/clipping, radiological embolization, and surgical intervention. We advocate early consultation with the colorectal/gastroenterology and interventional radiology services and a progressive, stepwise approach to the management of post-biopsy rectal bleeding, starting with resuscitation and conservative tamponade measures, moving to endoscopic hemostasis ± radiological embolization ± transanal surgical methods. Given the infrequent but serious nature of major rectal bleeding after TRUS biopsy, we recommend the establishment of centralized databases or registries forthwith to prospectively capture such data. To the best of our knowledge, this is the first comprehensive look specifically at the management of post-TRUS biopsy rectal bleeding.

The Missing Link in the Diagnostic Pathway of Prostate Cancer.

Prostate cancer is one of the most common cancers in the Western world. It is among the leading causes of cancer related death. While its incidence and survival increased significantly during the last few decades in Denmark, the mortality rate did not change for patients younger than 80year old. Development of new techniques, such as multiparametric MRI, helps to increase the accuracy of diagnosis. However, a missing link in the diagnostic pathway may result in mistreatment if an acinar adenocarcinoma of prostate is transformed into a neuroendocrine phenotype such as small cell carcinoma.

Focal therapy as primary treatment for localized prostate cancer: definition, needs and future.

Focal therapy (FT) may offer a promising treatment option in the field of low to intermediate risk localized prostate cancer. The aim of this concept is to combine minimal morbidity with cancer control as well as maintain the possibility of retreatment. Recent advances in MRI and targeted biopsy has improved the diagnostic pathway of prostate cancer and increased the interest in FT. However, before implementation of FT in routine clinical practice, several challenges are still to overcome including patient selection, treatment planning, post-therapy monitoring and definition of oncologic outcome surrogates. In this article, relevant questions regarding the key steps of FT are critically discussed and the main available energy modalities are analyzed taking into account their advantages and unmet needs.

Scoring systems used for the interpretation and reporting of multiparametric MRI for prostate cancer detection, localization, and characterization: could standardization lead to improved utilization of imaging within the diagnostic pathway?

Multiparametric magnetic resonance imaging (mpMRI) is increasingly being used earlier in the prostate cancer diagnostic pathway in order to detect and localize disease. Its results can be used to help decide on the indication, type, and localization of a prostate biopsy for cancer diagnosis. In addition, mpMRI has the potential to contribute information on the characterization, or aggressiveness, of detected cancers including tumor progression over time. There is considerable variation in the way results of different MRI sequences are reported. We conducted a review of scoring systems that have been used in the detection and characterization of prostate cancer. This revealed that existing scoring and reporting systems differ in purpose, scale, and range. We evaluate these differences in this review. This first step in collating all methods of scoring and reporting mpMRI will ultimately lead to consensus approaches to develop a standardized reporting scheme that can be widely adopted and validated to ensure comparability of research outputs and optimal clinical practice.