Objectives
To determine whether modified transperineal template prostate‐mapping (TTPM) biopsy protocols, altering the template or the biopsy density, have sensitivity and negative predictive value ...(NPV) equal to full 5‐mm TTPM.
Patients and Methods
Retrospective analysis of an institutional registry including treatment‐naïve men undergoing 5‐mm TTPM biopsy analysed in a 20‐zone fashion. The value of three modified strategies was assessed by comparing the information provided by selected zones against full 5‐mm TTPM. Strategy 1, did not consider the findings of anterior areas; strategies 2 and 3 simulated a reduced biopsy density by excluding intervening zones. A bootstrapping technique was used to calculate reliable estimates of sensitivity and NPV of these three strategies for the detection of clinically significant disease (maximum cancer core length ≥4 mm and/or Gleason score ≥3 + 4).
Results
In all, 391 men with a median (interquartile range, IQR) age of 62 (58–67) years were included. The median (IQR) PSA level and PSA density were 6.9 (4.8–10) ng/mL and 0.17 (IQR 0.12–0.25) ng/mL/mL, respectively. A median (IQR) of 6 (2–9) cores out of 48 (33–63) taken per man were positive for prostate cancer. No cancer was detected in 67 men (17%), whilst low‐, intermediate‐ and high‐risk disease was identified in 78 (20%), 80 (21%), and 166 (42%), respectively. Strategy 1, 2 and 3 had sensitivities of 78% 95% confidence interval (CI) 73–84%, 85% (95% CI 80–90%) and 84% (95% CI 79–89%), respectively. The NPVs of the three strategies were 73% (95% CI 67–80%), 80% (95% CI 74–86%) and 79% (95% CI 72–84%), respectively.
Conclusion
Altering the template or decreasing sampling density has a substantial negative impact on the ability of TTPM biopsy to exclude clinically significant disease. This should be considered when modified TTPM biopsy strategies are used to select men for tissue‐preserving approaches, and when modified TTPM are used to validate new diagnostic tests.
Objective
To determine the additional diagnostic value of diffusion‐weighted imaging (DWI) and dynamic contrast‐enhanced imaging (DCE) in men requiring a repeat biopsy within the PICTURE study.
...Patients and Methods
PICTURE was a paired‐cohort confirmatory study in which 249 men who required further risk stratification after a previous non‐magnetic resonance imaging (MRI)‐guided transrectal ultrasonography‐guided biopsy underwent a 3‐Tesla (3T) multiparametic (mp)MRI consisting of T2‐weighted imaging (T2W), DWI and DCE, followed by transperineal template prostate mapping biopsy. Each mpMRI was reported using a LIKERT score in a sequential blinded manner to generate scores for T2W, T2W+DWI and T2W+DWI+DCE. Area under the receiver‐operating characteristic curve (AUROC) analysis was performed to compare the diagnostic accuracy of each combination. The threshold for a positive mpMRI was set at a LIKERT score ≥3. Clinically significant prostate cancer was analysed across a range of definitions including UCL/Ahmed definition 1 (primary definition), UCL/Ahmed definition 2, any Gleason ≥3 + 4 and any Gleason ≥4 + 3.
Results
Of 249 men, sequential MRI reporting was available for 246. There was a higher rate of equivocal lesions (44.6%) using T2W alone compared to the addition of DWI (23.9%) and DCE (19.8%). Using the primary definition of clinically significant disease, there was no significant difference in the overall accuracy between T2W, with an AUROC of 0.74 (95% confidence interval CI 0.68–0.80), T2W+DWI at 0.76 (95% CI 0.71–0.82), and T2W+DWI+DCE, with an AUROC of 0.77 (95% CI 0.71–0.82; P = 0.55). The AUROC values remained comparable using other definitions of clinically significant disease including UCL/Ahmed definition 2 (P = 0.79), Gleason ≥3 + 4 (P = 0.53) and Gleason ≥4 + 3 (P = 0.53).
Conclusions
Using 3T MRI, a high level of diagnostic accuracy can be achieved using T2W as a single parameter in men with a prior biopsy; however, such a strategy can lead to a higher rate of equivocal lesions.
Objectives
To develop and validate a surgical performance indicator based on severe urinary complications that require an intervention within 2 years of radical prostatectomy (RP), identified in ...hospital administrative data.
Patients and Methods
Men who underwent RP between 2008 and 2012 in England were identified using hospital administrative data. A transparent coding framework based on procedure codes was developed to identify severe urinary complications which were grouped into ‘stricture’, ‘incontinence’ and ‘other’. Their validity as a performance indicator was assessed by evaluating the consistency with diagnosis codes and association with patient and surgical characteristics. Kaplan–Meier methods were used to assess time to first occurrence and multivariable logistic regression was used to estimate adjusted odds ratios (ORs) for patient and surgical characteristics.
Results
A total of 17 299 men were included, of whom 2695 (15.6%) experienced at least one severe urinary complication within 2 years. High proportions of men with a complication had relevant diagnosis codes: 86% for strictures and 93% for incontinence. Urinary complications were more common in men from poorer socio‐economic backgrounds (OR comparing lowest with highest quintile: 1.45; 95% confidence interval CI 1.26–1.67) and in those with prolonged length of hospital stay (OR 1.54, 95% CI 1.40–1.69), and were less common in men who underwent robot‐assisted surgery (OR 0.65, 95% CI 0.58–0.74).
Conclusion
These results show that severe urinary complications identified in administrative data provide a medium‐term performance indicator after RP. They can be used for research assessing outcomes of treatment methods and for service evaluation comparing performance of prostate cancer surgery providers.
Introduction
Diagnosing prostate cancer routinely involves tissue biopsy and increasingly image guided biopsy using multiparametric MRI (mpMRI). Excess tissue after diagnosis can be used for research ...to improve the diagnostic pathway and the vertical assembly of prostate needle biopsy cores into tissue microarrays (TMAs) allows the parallel immunohistochemical (IHC) validation of cancer biomarkers in routine diagnostic specimens. However, tissue within a biopsy core is often heterogeneous and cancer is not uniformly present, resulting in needle biopsy TMAs that suffer from highly variable cancer detection rates that complicate parallel biomarker validation.
Materials and Methods
The prostate cores with the highest tumor burden (in terms of Gleason score and/or maximum cancer core length) were obtained from 249 patients in the PICTURE trial who underwent transperineal template prostate mapping (TPM) biopsy at 5 mm intervals preceded by mpMRI. From each core, 2 mm segments containing tumor or benign tissue (as assessed on H&E pathology) were selected, excised and embedded vertically into a new TMA block. TMA sections were then IHC‐stained for the routinely used prostate cancer biomarkers PSA, PSMA, AMACR, p63, and MSMB and assessed using the h‐score method. H‐scores in patient matched malignant and benign tissue were correlated with the Gleason grade of the original core and the MRI Likert score for the sampled prostate area.
Results
A total of 2240 TMA cores were stained and IHC h‐scores were assigned to 1790. There was a statistically significant difference in h‐scores between patient matched malignant and adjacent benign tissue that is independent of Likert score. There was no association between the h‐scores and Gleason grade or Likert score within each of the benign or malignant groups.
Conclusion
The construction of highly selective TMAs from prostate needle biopsy cores is possible. IHC data obtained through this method are highly reliable and can be correlated with imaging. IHC expression patterns for PSA, PSMA, AMACR, p63, and MSMB are distinct in malignant and adjacent benign tissue but did not correlate with mpMRI Likert score.
Objectives Outcomes of liver transplantations from donation after circulatory death (DCD) donors may be inferior to those achieved with donation after brain death (DBD) donors. The impact of using ...DCD donors is likely to depend on specific national practices. We compared risk-adjusted graft loss and recipient mortality after transplantation of DCD and DBD livers in the UK. Design Prospective cohort study. Multivariable Cox regression and propensity score matching were used to estimate risk-adjusted HR. Setting 7 liver transplant centres in the National Health Service (NHS) hospitals in England and Scotland. Participants Adults who received a first elective liver transplant between January 2005 and December 2010 who were identified in the UK Liver Transplant Audit. Interventions Transplantation of DCD and DBD livers. Outcomes Graft loss and recipient mortality. Results In total, 2572 liver transplants were identified with 352 (14%) from DCD donors. 3-year graft loss (95% CI) was higher with DCD livers (27.3%, 21.8% to 33.9%) than with DBD livers (18.2%, 16.4% to 20.2%). After adjustment with regression, HR for graft loss was 2.3 (1.7 to 3.0). Similarly, 3-year mortality was higher with DCD livers (19.4%, 14.5% to 25.6%) than with DBD livers (14.1%, 12.5% to 16.0%) with an adjusted HR of 2.0 (1.4 to 2.8). Propensity score matching gave similar results. Centre-specific adjusted HRs for graft loss and recipient mortality seemed to differ among transplant centres, although statistical evidence is weak (p value for interaction 0.08 and 0.24, respectively). Conclusions Graft loss and recipient mortality were about twice as high with DCD livers as with DBD livers in the UK. Outcomes after DCD liver transplantation may vary between centres. These results should inform policies for the use of DCD livers.
Abstract
Background
The nipple-areola complex (NAC) is important aesthetically and functionally for both sexes. Methods for positioning the NAC in males are less well established in the literature ...compared to females but are just as important.
Objectives
This study aims to determine the normal parameters for the male NAC, to review literature, and to present a reliable method for preoperative placement.
Methods
Normal male patients, with no prior chest wall conditions, were prospectively recruited to participate. General demographics and chest wall dimensions were recorded—sternal notch to nipple (SNND), internipple (IND), anterior axillary folds distances (AFD), NAC, and chest circumference were measured. Comparisons were made using t test and ANOVA.
Results
One hundred and fifty-eight patients were recruited (age range, 18-90 years); mostly (86.7%) with normal or overweight BMI. The IND averaged 249.4 mm, the SNND averaged 204.2 mm, and the AFD averaged 383.8 mm. Areola diameter averaged 26.6 mm and for the nipple, 6.9 mm. The IND:AFD ratio was 0.65. There was no statistical difference in the IND:AFD ratio, SNND, or NAC parameters comparing different ethnic groups. The SNND increased with greater BMI (P ≤ 0.001). Using these data, we suggest ideal NAC dimensions and devised a simple method for positioning of the NAC on the male chest wall.
Conclusions
This is the largest study, with the widest range in age and BMI, to date on this topic. Although fewer men than women undergo surgery to the breast, there is a growing awareness for enhancing the appearance of the male chest wall.
Level of Evidence: 4
Background
Ventilator-associated pneumonia is associated with significant morbidity, mortality and healthcare costs. Most of the cost data that are available relate to general intensive care patients ...in privately remunerated institutions. This study assessed the cost of managing ventilator-associated pneumonia in a cardiac intensive care unit in the National Health Service in the United Kingdom.
Methods
Propensity-matched study of prospectively collected data from the cardiac surgical database between April 2011 and December 2014 in all patients undergoing cardiac surgery (n = 3416). Patients who were diagnosed as developing ventilator-associated pneumonia, as per the surveillance definition for ventilator-associated pneumonia (n = 338), were propensity score matched with those who did not (n = 338). Costs of treating post-op cardiac surgery patients in intensive care and cost difference if ventilator-associated pneumonia occurred based on Healthcare Resource Group categories were assessed. Secondary outcomes included differences in morbidity, mortality and cardiac intensive care unit and in-hospital length of stay.
Results
There were no significant differences in the pre-operative characteristics or procedures between the groups. Ventilator-associated pneumonia developed in 10% of post-cardiac surgery patients. Post-operatively, the ventilator-associated pneumonia group required longer ventilation (p < 0.01), more respiratory support, longer cardiac intensive care unit (8 vs 3, p < 0.001) and in-hospital stay (16 vs 9) days. The overall cost for post-operative recovery after cardiac surgery for ventilator-associated pneumonia patients was £15,124 compared to £6295 for non-ventilator-associated pneumonia (p < 0.01). The additional cost of treating patients with ventilator-associated pneumonia was £8829.
Conclusion
Ventilator-associated pneumonia was associated with significant morbidity to the patients, generating significant costs. This cost was nearer to the lower end for the cost for general intensive care unit patients in privately reimbursed systems.
Objective To evaluate the minimum disease burden of prostate cancer at which multiparametric magnetic resonance imaging (MRI) optimally performs. Methods Between 2006 and 2008, 64 men underwent ...multiparametric MRI imaging (index test) followed by template prostate mapping biopsy (reference test). Three radiologists independently reported each quadrant of every prostate on a scale of 1 to 5: highly likely benign, likely benign, equivocal, likely malignant, highly likely malignant (≥3 or ≥4 was considered positive). There were 256 prostate sectors; bootstrapping adjustment was used to account for nonindependence. The target condition indicating cancer on biopsies was varied by changing the maximum cancer core length (MCCL) and total cancer core length (TCCL) within each sector from 1 mm to 10 mm. The sensitivity, specificity, and positive (PPVs) and negative predictive values (PPVs) were calculated for each MCCL and TCCL. Gleason ≤3+3 and Gleason ≥3+4 cancers were analyzed separately. Results Mean age was 62 years (range, 40-76 years), and mean prostate-specific antigen level was 8.2 μg/L (range, 2.1-43 μg/L). Fifty percent of quadrants (127 of 256) had prostate cancer, of which 65% (83 of 127) were Gleason ≤3+3. For Gleason ≤3+3, multiparametric MRI had an NPV of ≥95% at an MCCL of ≥5 mm and at a TCCL of ≥7 mm (MRI score ≥3). For Gleason ≥3+4, an NPV of ≥95% was seen at an MCCL of ≥5 mm (MRI score ≥3) and TCCL ≥6 mm. Conclusion Multiparametric MRI may allow areas of the prostate which test negative to avoid biopsy. Whether multiparametric MRI can be used as a “triage” test before the first biopsy requires results from ongoing prospective validating cohort studies.
To prospectively compare the diagnostic performance and time efficiency of both second and concurrent computer-aided detection (CAD) reading paradigms for retrospectively obtained computed ...tomographic (CT) colonography data sets by using consensus reading (three radiologists) of colonoscopic findings as a reference standard.
Ethical permission, HIPAA compliance (for U.S. institutions), and patient consent were obtained from all institutions for use of CT colonography data sets in this study. Ten radiologists each read 25 CT colonography data sets (12 men, 13 women; mean age, 61 years) containing 69 polyps (28 were 1-5 mm, 41 were >or=6 mm) by using workstations integrated with CAD software. Reading was randomized to either "second read" CAD (applied only after initial unassisted assessment) or "concurrent read" CAD (applied at the start of assessment). Data sets were reread 6 weeks later by using the opposing paradigm. Polyp sensitivity and reading times were compared by using multilevel logistic and linear regression, respectively. Receiver operating characteristic (ROC) curves were generated.
Compared with the unassisted read, odds of improved polyp (>or=6 mm) detection were 1.5 (95% confidence interval CI: 1.0, 2.2) and 1.3 (95% CI: 0.9, 1.9) by using CAD as second and concurrent reader, respectively. Detection odds by using CAD concurrently were 0.87 (95% CI: 0.59, 1.3) and 0.76 (95% CI: 0.57, 1.01) those of second read CAD, excluding and including polyps 1-5 mm, respectively. The concurrent read took 2.9 minutes (95% CI: -3.8, -1.9) less than did second read. The mean areas under the ROC curve (95% CI) for the unassisted read, second read CAD, and concurrent read CAD were 0.83 (95% CI: 0.78, 0.87), 0.86 (95% CI: 0.82, 0.90), and 0.88 (95% CI: 0.83, 0.92), respectively.
CAD is more time efficient when used concurrently than when used as a second reader, with similar sensitivity for polyps 6 mm or larger. However, use of second read CAD maximizes sensitivity, particularly for smaller lesions.
Men with negative prostate biopsies or those diagnosed with low-risk or low-volume intermediate-risk prostate cancers often require a second prostate biopsy prior to a treatment decision. Prostate ...HistoScanning (PHS) is an ultrasound imaging test that might inform prostate biopsy in such men.
PICTURE was a prospective, paired-cohort validating trial to assess the diagnostic accuracy of imaging in men requiring a further biopsy (clinicaltrials.gov, NCT01492270) (11 January 2012-29 January 2014). We enrolled 330 men who had undergone a prior TRUS biopsy but where diagnostic uncertainty remained. All eligible men underwent PHS and transperineal template prostate mapping (TTPM) biopsy (reference standard). Men were blinded to the imaging results until after undergoing TTPM biopsies. We primarily assessed the ability of PHS to rule out clinically significant prostate (negative predictive value NPV and sensitivity) for a target histological condition of Gleason ≥4+3 and/or a cancer core length (MCCL) ≥6 mm. We also assessed the role of visually estimated PHS-targeted biopsies.
Of the 330 men enrolled, 249 underwent both PHS and TTPM biopsy. Mean (SD) age was 62 (7) years, median (IQR) PSA 6.8 (4.98-9.50) ng/ml, median (IQR) number of previous biopsies 1 (1-2) and mean (SD) gland size 37 (15.5) ml. One hundred and forty six (59%) had no clinically significant cancer. PHS classified 174 (70%) as suspicious. Sensitivity was 70.3% (95% CI 59.8-79.5) and NPV 41.3% (95% CI 27.0-56.8). Specificity and positive predictive value (PPV) were 14.7% (95% CI 9.1-22.0) and 36.8% (95% CI 29.6-44.4), respectively. In all, 213/220 had PHS suspicious areas targeted with targeting sensitivity 13.6% (95% CI 7.3-22.6), specificity 97.6% (95% CI 93.1-99.5), NPV 61.6% (95% CI 54.5-68.4) and PPV 80.0% (95% CI 51.9-95.7).
PHS is not a useful test in men seeking risk stratification following initial prostate biopsy.
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