Ostomy continence devices: a systematic review of the literature and meta-analysis.

AIM: Colostomy complication rates range widely from 10% to 70%. The psychological burden on patients, leading to lifestyle changes and decreased quality of life (QoL), is one of the largest factors. The aim of this work was to assess the history and efficacy of ostomy continence devices in improving continence and QoL. METHOD: In this PRISMA-compliant systematic review and meta-analysis, we searched PubMed, Scopus, Google Scholar and clinicaltrials.gov for studies on continence devices for all ostomies up to April 2023. Primary outcomes were continence and improvement in QoL. Secondary outcomes were leakage, patient's device preference and complications. Risk of Bias 2 and the revised tool to assess risk of bias in non-randomized studies of interventions (ROBINS-1) were used to assess risk of bias. Certainty of evidence was graded using GRADE. RESULTS: Twenty-two studies assessed devices from 1978 to 2022. The two main types identified were ball-valve devices and plug systems. Conseal and Vitala were the two main devices with significant evidence allowing for pooled analyses. Conseal, the only currently marketed device, had a pooled rate of continence of 67.4%, QoL improvement was 74.9%, patient preference over a traditional appliance was 69.1%, leakage was 10.1% and complications was 13.7%. Since 2011, five studies have investigated experimental devices on both human and animal models. CONCLUSION: Ostomy continence has been a long-standing goal without a consistently reliable solution. We propose that selective and short-term usage of continence devices may lead to improved continence and QoL in ostomy patients. Further research is needed to develop a reliable daily device for ostomy continence. Future investigation should include the needs of ileostomates.

Disparities in Access to Radiation Therapy by Race and Ethnicity in the United States With Focus on American Indian/Alaska Native People.

OBJECTIVES: Striking disparities in access to radiation therapy (RT) exist, especially among racial and ethnic-minority patients. We analyzed census block group data to evaluate differences in travel distance to RT as a function of race and ethnicity, socioeconomic status, and rurality. METHODS: The Directory of Radiotherapy Centers provided the addresses of facilities containing linear accelerators for RT. We classified block groups as majority (≥ 50%) American Indian/Alaska Native (AI/AN), black, white, Asian, no single racial majority, or Hispanic regardless of race. We used the Area Deprivation Index to classify deprivation and Rural-Urban Commuting Area codes to classify rurality. Generalized linear mixed models tested associations between these factors and distance to nearest RT facility. RESULTS: Median distance to nearest RT facility was 72 miles in AI/AN-majority block groups, but 4 to 7 miles in block groups with non-AI/AN majorities. Multivariable models estimated that travel distances in AI/AN-majority block groups were 39 to 41 miles longer than in areas with non-AI/AN majorities. Travel distance was 1.3 miles longer in the more deprived areas versus less deprived areas and 16 to 32 miles longer in micropolitan, small town, and rural areas versus metropolitan areas. CONCLUSIONS: Cancer patients in block groups with AI/AN-majority populations, nonmetropolitan location, and low socioeconomic status experience substantial travel disparities in access to RT. Future research with more granular community- and individual-level data should explore the many other known barriers to access to cancer care and their relationship to the barriers posed by distance to RT care.

Emergency Medicine/Critical Care Medicine (EM/CCM) Trainees' Performance on Standardized Critical Care Medicine Examinations: A Ten-Year Review.

BACKGROUND: Emergency Medicine/Critical Care Medicine (EM/CCM) trainees may obtain board certification through Internal Medicine (American Board of Internal Medicine [ABIM]), Surgery (American Board of Surgery [ABS]), and Anesthesiology (American Board of Anesthesiology [ABA]). However, EM/CCM trainees experience challenges, including: 1) additional training requirements and 2) an unwillingness to accept EM graduates by many programs. OBJECTIVES: We sought to: 1) compare EM/CCM knowledge acquisition to medicine (Internal Medicine [IM]/CCM), surgery (surgical critical care [SCC]), and anesthesiology (anesthesiology critical care medicine [ACCM]) Fellows at the local and national level using the Multidisciplinary Critical Care Knowledge Assessment Program (MCCKAP) in-service examination as an objective measure; and 2) compare American Board of Medical Specialties (ABMS) pass rates for EM/CCM. METHODS: Single-center retrospective analysis comparing scores obtained by EM/CCM on the MCCKAP examination with SCC and ACCM over a 10-year period. Scores are presented as means with standard deviations. We performed similar analysis on ABMS examination pass rates. RESULTS: There were 117 MCCKAP scores (37 EM/CCM; 80 SCC and ACCM) evaluated. EM/CCM mean score 562.4 (SD 67.4); SCC and ACCM mean score 505.3, (SD 87.5) at the institutional level (p < 0.001). Similarly, EM/CCM scored higher than the national mean (562.4, SD 67.4 vs. 500 SD 100, p < 0.001). Nationally, ABIM-CCM board certification rate was 91.2% for 137 EM/CCM, compared with 93.2% for IM/CCM (p = 0.22); 28 EM/CCM have obtained ABA-CCM board certification with rates similar to ACCM (90.4 vs. 89.3%; p = 0.85). CONCLUSIONS: EM/CCM Fellows demonstrate successful knowledge acquisition both locally and at a national level. EM/CCM achieve ABMS pass rates similar to other CCM trainees. The current arbitrary additional training requirements placed on EM/CCM should be removed.

Interreader Variability of Prostate Imaging Reporting and Data System Version 2 in Detecting and Assessing Prostate Cancer Lesions at Prostate MRI.

OBJECTIVE. The purpose of this study was to evaluate agreement among radiologists in detecting and assessing prostate cancer at multiparametric MRI using Prostate Imaging Reporting and Data System version 2 (PI-RADSv2). MATERIALS AND METHODS. Treatment-naïve patients underwent 3-T multipara-metric MRI between April 2012 and June 2015. Among the 163 patients evaluated, 110 underwent prostatectomy after MRI and 53 had normal MRI findings and transrectal ultrasound-guided biopsy results. Nine radiologists participated (three each with high, intermediate, and low levels of experience). Readers interpreted images of 58 patients on average (range, 56-60) using PI-RADSv2. Prostatectomy specimens registered to MRI were ground truth. Interob-server agreement was evaluated with the index of specific agreement for lesion detection and kappa and proportion of agreement for PI-RADS category assignment. RESULTS. The radiologists detected 336 lesions. Sensitivity for index lesions was 80.9% (95% CI, 75.1-85.9%), comparable across reader experience (p = 0.392). Patient-level specificity was experience dependent; highly experienced readers had 84.0% specificity versus 55.2% for all others (p < 0.001). Interobserver agreement was excellent for detecting index lesions (index of specific agreement, 0.871; 95% CI, 0.798-0.923). Agreement on PI-RADSv2 category assignment of index lesions was moderate (κ = 0.419; 95% CI, 0.238-0.595). For individual category assignments, proportion of agreement was slight for PI-RADS category 3 (0.208; 95% CI, 0.086-0.284) but substantial for PI-RADS category 4 (0.674; 95% CI, 0.540-0.776). However, proportion of agreement for T2-weighted PI-RADS 4 in the transition zone was 0.250 (95% CI, 0.108-0.372). Proportion of agreement for category assignment of index lesions on dynamic contrast-enhanced MR images was 0.822 (95% CI, 0.728-0.903), on T2-weighted MR images was 0.515 (95% CI, 0.430-0623), and on DW images was 0.586 (95% CI, 0.495-0.682). Proportion of agreement for dominant lesion was excellent (0.828; 95% CI, 0.742-0.913). CONCLUSION. Radiologists across experience levels had excellent agreement for detecting index lesions and moderate agreement for category assignment of lesions using PI-RADS. Future iterations of PI-RADS should clarify PI-RADS 3 and PI-RADS 4 in the transition zone.

What Are We Missing? False-Negative Cancers at Multiparametric MR Imaging of the Prostate.

Purpose To characterize clinically important prostate cancers missed at multiparametric (MP) magnetic resonance (MR) imaging. Materials and Methods The local institutional review board approved this HIPAA-compliant retrospective single-center study, which included 100 consecutive patients who had undergone MP MR imaging and subsequent radical prostatectomy. A genitourinary pathologist blinded to MP MR findings outlined prostate cancers on whole-mount pathology slices. Two readers correlated mapped lesions with reports of prospectively read MP MR images. Readers were blinded to histopathology results during prospective reading. At histopathologic examination, 80 clinically unimportant lesions (<5 mm; Gleason score, 3+3) were excluded. The same two readers, who were not blinded to histopathologic findings, retrospectively reviewed cancers missed at MP MR imaging and assigned a Prostate Imaging Reporting and Data System (PI-RADS) version 2 score to better understand false-negative lesion characteristics. Descriptive statistics were used to define patient characteristics, including age, prostate-specific antigen (PSA) level, PSA density, race, digital rectal examination results, and biopsy results before MR imaging. Student t test was used to determine any demographic differences between patients with false-negative MP MR imaging findings and those with correct prospective identification of all lesions. Results Of the 162 lesions, 136 (84%) were correctly identified with MP MR imaging. Size of eight lesions was underestimated. Among the 26 (16%) lesions missed at MP MR imaging, Gleason score was 3+4 in 17 (65%), 4+3 in one (4%), 4+4 in seven (27%), and 4+5 in one (4%). Retrospective PI-RADS version 2 scores were assigned (PI-RADS 1, n = 8; PI-RADS 2, n = 7; PI-RADS 3, n = 6; and PI-RADS 4, n = 5). On a per-patient basis, MP MR imaging depicted clinically important prostate cancer in 99 of 100 patients. At least one clinically important tumor was missed in 26 (26%) patients, and lesion size was underestimated in eight (8%). Conclusion Clinically important lesions can be missed or their size can be underestimated at MP MR imaging. Of missed lesions, 58% were not seen or were characterized as benign findings at second-look analysis. Recognition of the limitations of MP MR imaging is important, and new approaches to reduce this false-negative rate are needed. © RSNA, 2017 Online supplemental material is available for this article.

All over the map: An interobserver agreement study of tumor location based on the PI-RADSv2 sector map.

BACKGROUND: Prostate imaging reporting and data system version 2 (PI-RADSv2) recommends a sector map for reporting findings of prostate cancer mulitparametric MRI (mpMRI). Anecdotally, radiologists may demonstrate inconsistent reproducibility with this map. PURPOSE: To evaluate interobserver agreement in defining prostate tumor location on mpMRI using the PI-RADSv2 sector map. STUDY TYPE: Retrospective. POPULATION: Thirty consecutive patients who underwent mpMRI between October, 2013 and March, 2015 and who subsequently underwent prostatectomy with whole-mount processing. FIELD STRENGTH: 3T mpMRI with T2 W, diffusion-weighted imaging (DWI) (apparent diffusion coefficient [ADC] and b-2000), dynamic contrast-enhanced (DCE). ASSESSMENT: Six radiologists (two high, two intermediate, and two low experience) from six institutions participated. Readers were blinded to lesion location and detected up to four lesions as per PI-RADSv2 guidelines. Readers marked the long-axis of lesions, saved screen-shots of each lesion, and then marked the lesion location on the PI-RADSv2 sector map. Whole-mount prostatectomy specimens registered to the MRI served as ground truth. Index lesions were defined as the highest grade lesion or largest lesion if grades were equivalent. STATISTICAL TEST: Agreement was calculated for the exact, overlap, and proportion of agreement. RESULTS: Readers detected an average of 1.9 lesions per patient (range 1.6-2.3). 96.3% (335/348) of all lesions for all readers were scored PI-RADS ≥3. Readers defined a median of 2 (range 1-18) sectors per lesion. Agreement for detecting index lesions by screen shots was 83.7% (76.1%-89.9%) vs. 71.0% (63.1-78.3%) overlap agreement on the PI-RADS sector map (P < 0.001). Exact agreement for defining sectors of detected index lesions was only 21.2% (95% confidence interval [CI]: 14.4-27.7%) and rose to 49.0% (42.4-55.3%) when overlap was considered. Agreement on defining the same level of disease (ie, apex, mid, base) was 61.4% (95% CI 50.2-71.8%). DATA CONCLUSION: Readers are highly likely to detect the same index lesion on mpMRI, but exhibit poor reproducibility when attempting to define tumor location on the PI-RADSv2 sector map. The poor agreement of the PI-RADSv2 sector map raises concerns its utility in clinical practice. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 2 J. MAGN. RESON. IMAGING 2018;48:482-490.

Computer-aided diagnosis prior to conventional interpretation of prostate mpMRI: an international multi-reader study.

OBJECTIVES: To evaluate if computer-aided diagnosis (CAD) prior to prostate multi-parametric MRI (mpMRI) can improve sensitivity and agreement between radiologists. METHODS: Nine radiologists (three each high, intermediate, low experience) from eight institutions participated. A total of 163 patients with 3-T mpMRI from 4/2012 to 6/2015 were included: 110 cancer patients with prostatectomy after mpMRI, 53 patients with no lesions on mpMRI and negative TRUS-guided biopsy. Readers were blinded to all outcomes and detected lesions per PI-RADSv2 on mpMRI. After 5 weeks, readers re-evaluated patients using CAD to detect lesions. Prostatectomy specimens registered to MRI were ground truth with index lesions defined on pathology. Sensitivity, specificity and agreement were calculated per patient, lesion level and zone-peripheral (PZ) and transition (TZ). RESULTS: Index lesion sensitivity was 78.2% for mpMRI alone and 86.3% for CAD-assisted mpMRI (p = 0.013). Sensitivity was comparable for TZ lesions (78.7% vs 78.1%; p = 0.929); CAD improved PZ lesion sensitivity (84% vs 94%; p = 0.003). Improved sensitivity came from lesions scored PI-RADS < 3 as index lesion sensitivity was comparable at PI-RADS ≥ 3 (77.6% vs 78.1%; p = 0.859). Per patient specificity was 57.1% for CAD and 70.4% for mpMRI (p = 0.003). CAD improved agreement between all readers (56.9% vs 71.8%; p < 0.001). CONCLUSIONS: CAD-assisted mpMRI improved sensitivity and agreement, but decreased specificity, between radiologists of varying experience. KEY POINTS: • Computer-aided diagnosis (CAD) assists clinicians in detecting prostate cancer on MRI. • CAD assistance improves agreement between radiologists in detecting prostate cancer lesions. • However, this CAD system induces more false positives, particularly for less-experienced clinicians and in the transition zone. • CAD assists radiologists in detecting cancer missed on MRI, suggesting a path for improved diagnostic confidence.

Can Apparent Diffusion Coefficient Values Assist PI-RADS Version 2 DWI Scoring? A Correlation Study Using the PI-RADSv2 and International Society of Urological Pathology Systems.

OBJECTIVE: The purposes of this study were to assess correlation of apparent diffusion coefficient (ADC) and normalized ADC (ratio of tumor to nontumor tissue) with the Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) and updated International Society of Urological Pathology (ISUP) categories and to determine how to optimally use ADC metrics for objective assistance in categorizing lesions within PI-RADSv2 guidelines. MATERIALS AND METHODS: In this retrospective study, 100 patients (median age, 62 years; range, 44-75 years; prostate-specific antigen level, 7.18 ng/mL; range, 1.70-84.56 ng/mL) underwent 3-T multiparametric MRI of the prostate with an endorectal coil. Mean ADC was extracted from ROIs based on subsequent prostatectomy specimens. Histopathologic analysis revealed 172 lesions (113 peripheral, 59 transition zone). Two radiologists blinded to histopathologic outcome assigned PI-RADSv2 categories. Kendall tau was used to correlate ADC metrics with PI-RADSv2 and ISUP categories. ROC curves were used to assess the utility of ADC metrics in differentiating each reader's PI-RADSv2 DWI category 4 or 5 assessment in the whole prostate and by zone. RESULTS: ADC metrics negatively correlated with ISUP category in the whole prostate (ADC, τ = -0.21, p = 0.0002; normalized ADC, τ = -0.21, p = 0.0001). Moderate negative correlation was found in expert PI-RADSv2 DWI categories (ADC, τ = -0.34; normalized ADC, τ = -0.31; each p < 0.0001) maintained across zones. In the whole prostate, AUCs of ADC and normalized ADC were 87% and 82% for predicting expert PI-RADSv2 DWI category 4 or 5. A derived optimal cutoff ADC less than 1061 and normalized ADC less than 0.65 achieved positive predictive values of 83% and 84% for correct classification of PI-RADSv2 DWI category 4 or 5 by an expert reader. Consistent relations and predictive values were found by an independent novice reader. CONCLUSION: ADC and normalized ADC inversely correlate with PI-RADSv2 and ISUP categories and can serve as quantitative metrics to assist with assigning PI-RADSv2 DWI category 4 or 5.

Validation of the Dominant Sequence Paradigm and Role of Dynamic Contrast-enhanced Imaging in PI-RADS Version 2.

Purpose To validate the dominant pulse sequence paradigm and limited role of dynamic contrast material-enhanced magnetic resonance (MR) imaging in the Prostate Imaging Reporting and Data System (PI-RADS) version 2 for prostate multiparametric MR imaging by using data from a multireader study. Materials and Methods This HIPAA-compliant retrospective interpretation of prospectively acquired data was approved by the local ethics committee. Patients were treatment-naïve with endorectal coil 3-T multiparametric MR imaging. A total of 163 patients were evaluated, 110 with prostatectomy after multiparametric MR imaging and 53 with negative multiparametric MR imaging and systematic biopsy findings. Nine radiologists participated in this study and interpreted images in 58 patients, on average (range, 56-60 patients). Lesions were detected with PI-RADS version 2 and were compared with whole-mount prostatectomy findings. Probability of cancer detection for overall, T2-weighted, and diffusion-weighted (DW) imaging PI-RADS scores was calculated in the peripheral zone (PZ) and transition zone (TZ) by using generalized estimating equations. To determine dominant pulse sequence and benefit of dynamic contrast-enhanced (DCE) imaging, odds ratios (ORs) were calculated as the ratio of odds of cancer of two consecutive scores by logistic regression. Results A total of 654 lesions (420 in the PZ) were detected. The probability of cancer detection for PI-RADS category 2, 3, 4, and 5 lesions was 15.7%, 33.1%, 70.5%, and 90.7%, respectively. DW imaging outperformed T2-weighted imaging in the PZ (OR, 3.49 vs 2.45; P = .008). T2-weighted imaging performed better but did not clearly outperform DW imaging in the TZ (OR, 4.79 vs 3.77; P = .494). Lesions classified as PI-RADS category 3 at DW MR imaging and as positive at DCE imaging in the PZ showed a higher probability of cancer detection than did DCE-negative PI-RADS category 3 lesions (67.8% vs 40.0%, P = .02). The addition of DCE imaging to DW imaging in the PZ was beneficial (OR, 2.0; P = .027), with an increase in the probability of cancer detection of 15.7%, 16.0%, and 9.2% for PI-RADS category 2, 3, and 4 lesions, respectively. Conclusion DW imaging outperforms T2-weighted imaging in the PZ; T2-weighted imaging did not show a significant difference when compared with DW imaging in the TZ by PI-RADS version 2 criteria. The addition of DCE imaging to DW imaging scores in the PZ yields meaningful improvements in probability of cancer detection. © RSNA, 2017 An earlier incorrect version of this article appeared online. This article was corrected on July 27, 2017. Online supplemental material is available for this article.

PI-RADSv2: How we do it.

Much criticism has been leveled at screening for prostate cancer using prostate-specific antigen (PSA) testing, yet there is no suitable replacement to improve the detection of clinically significant cancer (CSC). Prostate multiparametric magnetic resonance imaging (mpMRI) combined with mpMRI-guided biopsies is one possible solution, as it reduces detection of low-grade disease and increases detection of CSC. However, mpMRI is critically limited by lack of standardization across institutions and low interobserver agreement. The Prostate Imaging Reporting and Diagnostic System version 2 (PI-RADSv2) aims to address these concerns. We discuss the clinical and technical considerations for implementing PI-RADSv2, how we have adapted to PI-RADSv2, and review current research. While PI-RADSv2 represents a major step forward for standardizing prostate mpMRI, it does not provide a level of standardization that is routine with clinical blood tests and reader reproducibility remains an issue. Future research should seek to further improve quality assurance of mpMRI building on the important contributions of PI-RADSv2. LEVEL OF EVIDENCE: 5 Technical Efficacy: Stage 2 J. MAGN. RESON. IMAGING 2017;46:11-23.

Accuracy and agreement of PIRADSv2 for prostate cancer mpMRI: A multireader study.

PURPOSE: Multiparametric MRI (mpMRI) improves the detection of clinically significant prostate cancer, but is limited by interobserver variation. The second version of theProstate Imaging Reporting and Data System (PIRADSv2) was recently proposed as a standard for interpreting mpMRI. To assess the performance and interobserver agreement of PIRADSv2 we performed a multi-reader study with five radiologists of varying experience. MATERIALS AND METHODS: Five radiologists (n = 2 prostate dedicated, n = 3 general body) blinded to clinicopathologic results detected and scored lesions on prostate mpMRI using PIRADSv2. The endorectal coil 3 Tesla MRI included T2W, diffusion-weighted imaging (apparent diffusion coefficient, b2000), and dynamic contrast enhancement. Thirty-four consecutive patients were included. Results were correlated with radical prostatectomy whole-mount histopathology produced with patient-specific three-dimensional molds. An index lesion was defined on pathology as the lesion with highest Gleason score or largest volume if equivalent grades. Average sensitivity and positive predictive values (PPVs) for all lesions and index lesions were determined using generalized estimating equations. Interobserver agreement was evaluated using index of specific agreement. RESULTS: Average sensitivity was 91% for detecting index lesions and 63% for all lesions across all readers. PPV was 85% for PIRADS ≥ 3 and 90% for PIRADS ≥ 4. Specialists performed better only for PIRADS ≥ 4 with sensitivity 90% versus 79% (P = 0.01) for index lesions. Index of specific agreement among readers was 93% for the detection of index lesions, 74% for the detection of all lesions, and 85% for scoring index lesions, and 58% for scoring all lesions. CONCLUSION: By using PIRADSv2, general body radiologists and prostate specialists can detect high-grade index prostate cancer lesions with high sensitivity and agreement. LEVEL OF EVIDENCE: 1 J. Magn. Reson. Imaging 2017;45:579-585.

Prospective Evaluation of the Prostate Imaging Reporting and Data System Version 2 for Prostate Cancer Detection.

PURPOSE: Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) was developed to standardize the interpretation and reporting of multiparametric prostate magnetic resonance imaging and provide guidelines for biopsy of multiparametric magnetic resonance imaging findings. We prospectively evaluated the cancer detection rate at each overall PI-RADSv2 score. MATERIALS AND METHODS: This prospective study included 62 consecutive patients with 116 lesions who underwent multiparametric prostate magnetic resonance imaging at 3T with PI-RADSv2 evaluation and subsequent targeted magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and concurrent 12-core systematic prostate biopsy between May and September 2015. Median patient age and prostate specific antigen values were 65.5 years (range 50.3 to 76.6) and 7.10 ng/ml (range 0.47 to 863.0), respectively. Mean lesion size was 12.7 mm overall. Lesion based cancer detection rates for all tumors and for Gleason 3+4 or greater tumors at each PI-RADSv2 score were calculated. Univariate analysis was performed to assess differences in the cancer detection rate among PI-RADSv2 scores. RESULTS: A total of 116 lesions in 62 patients were evaluated prospectively (0 PI-RADS 1, 18 PI-RADS 2, 19 PI-RADS 3, 47 PI-RADS 4, 32 PI-RADS 5), and the patients underwent magnetic resonance/transrectal ultrasound fusion guided biopsy and systematic biopsy. Histopathology revealed 55 of 116 (47.4%) cancers (17 Gleason 3+3, 16 Gleason 3+4, 6 Gleason 4+3, 12 Gleason 4+4, 3 Gleason 4+5 and 1 Gleason 5+4). Based on targeted biopsy on a per lesion basis, the overall cancer detection rates of PI-RADS 2, 3, 4 and 5 scores for all tumors was 22.2%, 15.8%, 29.8% and 78.1%, respectively. The cancer detection rate of PI-RADS 2, 3, 4 and 5 scores for Gleason 3+4 or greater tumors was 5.6%, 0%, 21.3% and 75%, respectively. Differences in the cancer detection rate between overall PI-RADS 4 and 5 scores were significant (p <0.001 for Gleason greater than 3+3 and Gleason 3+4 or greater cancers). CONCLUSIONS: A PI-RADS score of 5 had the highest prospective cancer detection rate (78%). A PI-RADS score of 4 had only a 30% cancer detection rate, which is lower than expected. Surprisingly, no or few significant cancers were detected at a PI-RADS score of 3 (16%). These early prospective data suggest that current criteria result in a high false-positive rate that lowers the cancer detection rate. Therefore, stricter criteria may be needed in the future to decrease false-positives and increase the cancer detection rate for PI-RADS scores of 3, 4 and 5.

Does Abstinence From Ejaculation Before Prostate MRI Improve Evaluation of the Seminal Vesicles?

OBJECTIVE: The purpose of the present study is to determine whether abstinence from ejaculation before undergoing multiparametric prostate MRI increases seminal vesicle (SV) volume and therefore improves diagnostic interpretation of the SVs. MATERIALS AND METHODS: This retrospective study included 238 patients who underwent 3-T MRI of the prostate over a 4-month period. Patients were requested to complete a questionnaire that asked how long it had been since their last ejaculation (i.e., < 3 days vs ≥ 3 days). Forty-two patients (mean patient age, 62.0 years) indicated that it had been less than 3 days since their last ejaculation and were designated as group 1, whereas the remainder indicated an interval of 3 days or more since their last ejaculation. A group of 42 age-matched subjects (mean patient age, 62.1 years) were randomly selected from the remaining 196 patients and were designated as group 2. SV volumes were measured manually. Two radiologists who were blinded to group assignment and patient characteristics scored the right and left SVs separately to determine diagnostic interpretability, which was scored on a 3-point scale as follows: a score of 1 denoted that the SVs were not dilated and the score was nondiagnostic, a score of 2 indicated that the SVs were not dilated but the score was diagnostic, and a score of 3 denoted that the SVs were dilated and the score was diagnostic. Volume differences and interpretability scores were analyzed using a t test. Interobserver agreement was analyzed using the Cohen kappa statistic. A separate analysis was performed to evaluate differences in diagnostic interpretability for patients 60 years and younger versus patients older than 60 years, by use of the chi-square test and relative risk ratio analysis. RESULTS: The right, left, and total SV volumes for group 1 were 3.1 mL, 2.9 mL, and 6.0 mL, respectively, whereas those for group 2 were 4.7 mL, 4.1 mL, and 8.8 mL, respectively (p = 0.011). The mean interpretability scores for group 1 and group 2 were 2.0 and 2.5, respectively. For group 1, reader 1 and reader 2 assigned a nondiagnostic score for 10 and 13 patients, respectively, whereas for group 2, they assigned a nondiagnostic score for two and five patients, respectively (p = 0.01, for reader 1; and p = 0.03, for reader 2). For men in group 1 who were older than 60 years, reader 1 and reader 2 gave a nondiagnostic score for nine and 11 patients, respectively; whereas for men in group 2 who were older than 60 years, the readers gave a nondiagnostic score for two and five patients, respectively (p = 0.01, for reader 1; and p = 0.05, for reader 2). CONCLUSION: For men older than 60 years, abstinence from ejaculation for 3 or more days before undergoing MRI examination resulted in larger SV volumes and lower rates of nondiagnostic evaluation and therefore might improve evaluation of SV invasion on multi-parametric MRI. The difference is less striking in men 60 years and younger.

Predicted Inferior Outcomes for Lung SBRT With Treatment Planning Systems That Fail Independent Phantom-Based Audits.

PURPOSE: More than 15% of radiation therapy clinics fail external audits with anthropomorphic phantoms conducted by Imaging and Radiation Oncology Core-Houston (IROC-H) while passing other industry-standard quality assurance (QA) tests. We seek to evaluate the predicted effect of such failed plans on outcomes for patients treated with stereotactic body radiation therapy (SBRT) for lung tumors. METHODS AND MATERIALS: We conducted a retrospective study of 55 patients treated with SBRT for lung tumors with a prescription biologically equivalent dose (BED)10 ≥100 Gy using a treatment planning system (TPS) that passed IROC-H phantom audits. Sample linear accelerator beam models with introduced errors were commissioned by varying the multileaf collimator leaf-tip offset parameter (ie, dosimetric leaf gap) over the range ±1.0 mm relative to the validated model. These models mimic TPS that pass internal QA measures but fail IROC-H tests. Patient plans were recalculated on sample beam models. The predicted tumor control probability (TCP) and normal tissue complication probability (NTCP) were calculated based on published dose-response models. RESULTS: A leaf-tip offset value of -1.0 mm decreased the fraction of plans receiving a planning treatment volume of BED10 ≥100 Gy from 95% to 27%. This translated to a significant decrease in 2-year TCP of 4.8% (95% CI: 2.0%-5.5%) with a decrease in TCP up to 21%. Conversely, a leaf-tip offset of +1.0 mm resulted in 36% of patients exceeding previously met organs at risk (OAR) constraints, including 2 instances of spinal cord and brachial plexus overdoses and a small increase in chest wall NTCP of 0.7%, (95% CI: 0.5%-0.8%). CONCLUSIONS: Simulated treatment plans with modest MLC leaf offsets result in lung SBRT plans that significantly underdose tumor or exceed OAR constraints. These dosimetric endpoints translate to significant detriments in TCP. These simulated plans mimic planning systems that pass internal QA measures but fail independent phantom-based tests, underscoring the need for enhanced quality assurance including external audits of TPS.

Performance of multiparametric prostate magnetic resonance imaging validated by targeted and systematic transperineal biopsies.

Objective: To measure the performance of multiparametric (mp) magnetic resonance imaging (MRI) to identify intraprostatic tumour deposits using a systematic and targeted MR-guided transperineal prostate biopsy technique. Materials and Methods: Patients underwent a combined systematic and targeted MR-guided transperineal biopsy procedure in the dorsal lithotomy position under general anaesthesia. Systematic biopsies were spaced 10 mm or less apart and additional biopsies targeted any Prostate Imaging-Reporting and Data System (PI-RADS) 3, 4 or 5 lesions identified on mpMRI. Cancer detection rates were calculated on a per patient and per lesion basis. Results: A total of 125 patients underwent the biopsy procedure. The positive predictive value (PPV) of mpMRI per patient was 59% for any cancer and 49% for Gleason score (GS) ≥ 7 cancer. The negative predictive value (NPV) of mpMRI per patient was 67% for any cancer and 88% for GS ≥ 7 cancer. On a per lesion basis, the PPV of PI-RADS 3 lesions for any and GS ≥ 7 cancer was 24% and 10%. For PI-RADS 4 lesions it was 42% and 32%. For PI-RADS 5 lesions, it was 76% and 70%. MpMRI failed to identify GS ≥ 7 cancer found on systematic biopsy in 22% of patients. Conclusion: Based on a combination of systematic and targeted transperineal prostate biopsies, mpMRI showed a high NPV and low PPV for GS ≥ 7 cancer on a per patient basis. The PPV of mpMRI on a per lesion basis increased with increasing PI-RADS score. However, there were a significant number of both false positive as well as false negative (mpMRI invisible) areas within the prostate that contained GS ≥ 7 cancer. Therefore, pathologic confirmation using both targeted and systematic mapping biopsy is necessary to accurately identify all intraprostatic tumour deposits.

Radiation therapy for low- and high-risk perineural invasion in head and neck cutaneous squamous cell carcinoma: Clinical outcomes and patterns of failure.

BACKGROUND: Perineural invasion (PNI) in head and neck squamous cell carcinoma (HNSCC) portends poor prognosis. Extent of treatment of nerve pathways with varying degrees of PNI and patterns of failure following elective neural radiotherapy (RT) remain unclear. METHODS: Retrospective review of HNSCC patients with high-risk (clinical/gross, large-nerve, extensive) or low-risk (microscopic/focal) PNI who underwent curative-intent treatment from 2010 to 2021. RESULTS: Forty-four patients (mean follow-up 22 months; 59% high-risk, 41% low-risk PNI) were included. Recurrence following definitive treatment occurred in 31% high-risk and 17% low-risk PNI patients. Among high-risk patients, 69% underwent surgery with post-operative RT and 46% underwent elective neural RT. Local control (83% low-risk vs. 75% high-risk), disease-free, and overall survival did not differ between groups. CONCLUSIONS: High local control rates were achieved in high-risk PNI patients treated with adjuvant or primary RT, including treatment of both involved and uninvolved, communicating cranial nerves, with few failures in electively treated regions.

Disparities in Access to Radiation Therapy Facilities Among American Indians/Alaska Natives and Hispanics in Washington State.

PURPOSE: Racial and ethnic minorities in the state of Washington experience higher cancer mortality relative to whites. We sought to characterize differences in travel distance to radiation therapy (RT) facilities in Washington by race and ethnicity with a special focus on non-Hispanic American Indians and Alaska Natives as a contributor to limited access and cancer disparities. METHODS AND MATERIALS: Geocoded mortality data from Washington Department of Health (2011-2018) were used to identify decedents with mortality related to all-causes, all cancers, and cancers likely requiring access to RT. This was determined from optimal RT usage estimates by diagnosis. RT facility locations were ascertained from the Directory of Radiation Therapy Centers and confirmed. Distance from decedents' address listed on death certificates to nearest RT facility was calculated. Generalized mixed models were used for statistical analysis. RESULTS: We identified 418,754 deaths; 109,134 were cancer-related, 60,973 likely required RT. Among decedents with cancers likely requiring RT, non-Hispanic American Indians and Alaska Natives decedents would have had to travel 1.16 times (95% confidence interval [CI], 1.09-1.24) farther from their residences to reach the nearest treatment facility compared with non-Hispanic whites. This association existed in metro counties but was more pronounced in nonmetro counties (1.39 times farther; 95% CI, 1.22-1.58). In addition, Hispanics would have had to travel 1.11 times farther (95% CI, 1.06-1.16) to reach the nearest facility compared with non-Hispanic whites, primarily due to differences in urban counties. Decedents in nonmetro counties lived on average 35 miles (SD = 29) from RT centers and non-Hispanic American Indians and Alaska Natives in nonmetro counties 53 miles (SD = 38). Compared with non-Hispanic white decedents, those who were non-Hispanic black, non-Hispanic Asian, and non-Hispanic Native Hawaiian decedents lived closer to RT facilities. CONCLUSIONS: We observed significant disparities in access to RT facilities in Washington, specifically for non-Hispanic American Indians and Alaska Natives and rural decedents. The findings call for initiatives to improve access to critical cancer treatment services for these underserved populations with known disparities in cancer deaths.

A Prospective Study of a Resorbable Intravesical Fiducial Marker for Bladder Cancer Radiation Therapy.

Purpose: We conducted a prospective pilot study to evaluate safety and feasibility of TraceIT, a resorbable radiopaque hydrogel, to improve image guidance for bladder cancer radiation therapy (RT). Methods and Materials: Patients with muscle invasive bladder cancer receiving definitive RT were eligible. TraceIT was injected intravesically around the tumor bed during maximal transurethral resection of bladder tumor. The primary endpoint was the difference between radiation treatment planning margin on daily cone beam computed tomography based on alignment to TraceIT versus standard-of-care pelvic bone anatomy. The Van Herk margin formula was used to determine the optimal planning target volume margin. TraceIT visibility, recurrence rates, and survival were estimated by Kaplan-Meier method. Toxicity was measured by Common Terminology Criteria for Adverse Events version 4.03. Results: The trial was fully accrued and 15 patients were analyzed. TraceIT was injected in 4 sites/patient (range, 4-6). Overall, 94% (95% confidence interval [CI], 90%-98%) of injection sites were radiographically visible at RT initiation versus 71% (95% CI, 62%-81%) at RT completion. The median duration of radiographic visibility for injection sites was 106 days (95% CI, 104-113). Most patients were treated with a standard split-course approach with initial pelvic radiation fields, then midcourse repeat transurethral resection of bladder tumor followed by bladder tumor bed boost fields, and 14/15 received concurrent chemotherapy. Alignment to fiducials could allow for reduced planning target volume margins (0.67 vs 1.56 cm) for the initial phase of RT, but not for the boost (1.01 vs 0.96 cm). This allowed for improved target coverage (D95% 80%-83% to 91%-94%) for 2 patients retrospectively planned with both volumetric-modulated arc therapy and 3-dimensional conformal RT. At median follow-up of 22 months, no acute or late complications attributable to TraceIT placement occurred. No patients required salvage cystectomy. Conclusions: TraceIT intravesical fiducial placement is safe and feasible and may facilitate tumor bed delineation and targeting in patients undergoing RT for localized muscle invasive bladder cancer. Improved image guided treatment may facilitate strategies to improve local control and minimize toxicity.

Carbon Monoxide Poisoning.

Carbon monoxide is a colorless, odorless, highly toxic gas primarily produced through the incomplete combustion of organic material. Carbon monoxide binds to hemoglobin and other heme molecules, causing tissue hypoxia and oxidative stress. Symptoms of carbon monoxide poisoning can vary from a mild headache to critical illness, which can make diagnosis difficult. When there is concern for possible carbon monoxide poisoning, the diagnosis can be made via blood co-oximetry. The primary treatment for patients with carbon monoxide poisoning is supplemental oxygen, usually delivered via a nonrebreather mask. Hyperbaric oxygen can also be used, but the exact indications are controversial.

Comparisons of 3-Dimensional Conformal and Intensity-Modulated Neutron Therapy for Head and Neck Cancers.

PURPOSE: Neutron therapy is a high linear energy transfer modality that is useful for the treatment of radioresistant head and neck (H&N) cancers. It has been limited to 3-dimensioanal conformal-based fast-neutron therapy (3DCNT), but recent technical advances have enabled the clinical implementation of intensity-modulated neutron therapy (IMNT). This study evaluated the comparative dosimetry of IMNT and 3DCNT plans for the treatment of H&N cancers. MATERIALS AND METHODS: Seven H&N IMNT plans were retrospectively created for patients previously treated with 3DCNT at the University of Washington (Seattle). A custom RayStation model with neutron-specific scattering kernels was used for inverse planning. Organ-at-risk (OAR) objectives from the original 3DCNT plan were initially used and were then systematically reduced to investigate the feasibility of improving a therapeutic ratio, defined as the ratio of the mean tumor to OAR dose. The IMNT and 3DCNT plan quality was evaluated using the therapeutic ratio, isodose contours, and dose volume histograms. RESULTS: When compared with the 3DCNT plans, IMNT reduces the OAR dose for the equivalent tumor coverage. Moreover, IMNT is most advantageous for OARs in close spatial proximity to the target. For the 7 patients with H&N cancers examined, the therapeutic ratio for IMNT increased by an average of 56% when compared with the 3DCNT. The maximum OAR dose was reduced by an average of 20.5% and 20.7% for the spinal cord and temporal lobe, respectively. The mean dose to the larynx decreased by an average of 80%. CONCLUSION: The IMNT significantly decreases the OAR doses compared with 3DCNT and provides comparable tumor coverage. Improvements in the therapeutic ratio with IMNT are especially significant for dose-limiting OARs near tumor targets. Moreover, IMNT provides superior sparing of healthy tissues and creates significant new opportunities to improve the care of patients with H&N cancers treated with neutron therapy.