The knowledge and practices of urologists in the United States (US) about standardization of PSA assays.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 207-207
Author(s):  
A. Gupta ◽  
S. F. Shariat ◽  
J. A. Eastham ◽  
P. T. Scardino ◽  
A. J. Vickers ◽  
...  

207 Background: PSA assays can be calibrated to either the WHO or the Hybritech standard. Studies of PSA-based prostate cancer screening have used Hybritech-standardized assays and prostate cancer risk calculators are based on these studies. Testing of patient samples with a WHO calibrated assay gives values that are 22% lower than from those with Hybritech-calibrated assays. Up to 60% of the labs in the US use WHO calibrated assays. We evaluated whether US urologists are aware of the different calibrators and the differences in PSA values. Methods: A random sample of 1,742 US urologists were invited by email to participate in a web-based survey of their knowledge and practices regarding PSA assay standardization. No mention was made of assays or calibration in the invitation. 419 responses were received. Results: Many (56%) US urologists thought that different standards may lead to clinically relevant differences in PSA values. Although 62% reported awareness of the two PSA calibrators, 67% did not know the difference between the two. Only 17% correctly reported the difference between the two standards. Nationally almost 60% of the labs use WHO standardized assays, but in this survey only 5% of the urologists thought that the hospital where they practice used a WHO standardized assay. The rest reported either not knowing the standard (46%) or use of the Hybritech standard (49%). The majority of urologists did not look at the reference range (64%) or for the PSA standard (74%) in the lab reports. Only 25% reported considering the PSA-calibration in their clinical decisions about prostate biopsy, but only a third of them correctly knew the difference between the calibrators. Conclusions: Many US urologists are unaware of the difference caused by WHO versus Hybritech based PSA-assay calibration. Although 60% of clinical laboratories use WHO-calibrated assays, only 5% of urologists are aware of this use in their practice, and a majority of urologists could not correctly explain the difference between the different calibrators. A greater awareness is needed amongst US urologists about the different PSA calibrators, the calibrator in use at their practice, and means to account for different calibrators in clinical decision making. [Table: see text]

2018 ◽  
Vol 31 (4) ◽  
pp. 205-217 ◽  
Author(s):  
Stefano Villa ◽  
Joseph D Restuccia ◽  
Eugenio Anessi-Pessina ◽  
Marco Giovanni Rizzo ◽  
Alan B Cohen

Italian and American hospitals, in two different periods, have been urged by external circumstances to extensively redesign their quality improvement strategies. This paper, through the use of a survey administered to chief quality officers in both countries, aims to identify commonalities and differences between the two systems and to understand which approaches are effective in improving quality of care. In both countries chief quality officers report quality improvement has become a strategic priority, clinical governance approaches, and tools—such as disease-specific quality improvement projects and clinical pathways—are commonly used, and there is widespread awareness that clinical decision making must be supported by protocols and guidelines. Furthermore, the study clearly outlines the critical importance of adopting a system-wide approach to quality improvement. To this extent Italy seems lagging behind compared to US in fact: (i) responsibilities for different dimensions of quality are spread across different organizational units; (ii) quality improvement strategies do not typically involve administrative staff; and (iii) quality performance measures are not disseminated widely within the organization but are reported primarily to top management. On the other hand, in Italy chief quality officers perceive that the typical hospital organizational structure, which is based on clinical directories, allows better coordination between clinical specialties than in the United States. In both countries, the results of the study show that it is not the single methodology/model that makes the difference but how the different quality improvement strategies and tools interact to each other and how they are coherently embedded with the overall organizational strategy.


2017 ◽  
pp. 1-9 ◽  
Author(s):  
Mark C. Markowski ◽  
John L. Silberstein ◽  
James R. Eshleman ◽  
Mario A. Eisenberger ◽  
Jun Luo ◽  
...  

Purpose A splice variant of the androgen receptor, AR-V7, confers resistance to AR-targeted therapies (ATTs) but not taxane chemotherapies in patients with metastatic castration-resistant prostate cancer. Since August 2015, a clinical-grade assay to detect AR-V7 messenger RNA expression in circulating tumors cells (CTCs) has been available to providers through a Clinical Laboratory Improvement Amendments–certified laboratory at Johns Hopkins University. Methods We contacted ordering providers of the first 150 consecutive tests by using a questionnaire-based survey to determine how the results of AR-V7 testing were used to influence clinical practice. Results In all, 142 (95%) of 150 questionnaires were completed by 38 providers from 29 sites across the United States and Canada. AR-V7 test results were reported either as CTC– (28%), CTC+/AR-V7– (30%), or CTC+/AR-V7+ (42%). Prevalence of AR-V7 detection increased with prior exposure to ATTs (abiraterone and enzalutamide naïve, 22%; after abiraterone or enzalutamide, 35%; after abiraterone and enzalutamide, 43%). Overall, management was affected by AR-V7 testing in 53% of the patients and even more often with CTC+/AR-V7+ results. AR-V7+ patients were commonly switched from ATT to taxane chemotherapy (43%) or were offered a clinical trial (43%); management remained unchanged in only 14% of these patients. Overall, patients who had a change in management on the basis of AR-V7 testing were significantly more likely to achieve a physician-reported 50% decline in prostate-specific antigen response on next-line therapy than those who did not change treatment (54% v 31%; P = .015). Conclusion Providers used AR-V7 testing to influence clinical decision making more often than not. Physicians reported that men with AR-V7+ results had the most treatment changes, and such men were preferentially managed with taxane therapy or offered a clinical trial, which may have improved outcomes.


2021 ◽  
Vol 8 ◽  
Author(s):  
Enchong Zhang ◽  
Fujisawa Shiori ◽  
Mo Zhang ◽  
Peng Wang ◽  
Jieqian He ◽  
...  

Prostate cancer (PCa) is the most common malignancy among men worldwide. However, its complex heterogeneity makes treatment challenging. In this study, we aimed to identify PCa subtypes and a gene signature associated with PCa prognosis. In particular, nine PCa-related pathways were evaluated in patients with PCa by a single-sample gene set enrichment analysis (ssGSEA) and an unsupervised clustering analysis (i.e., consensus clustering). We identified three subtypes with differences in prognosis (Risk_H, Risk_M, and Risk_L). Differences in the proliferation status, frequencies of known subtypes, tumor purity, immune cell composition, and genomic and transcriptomic profiles among the three subtypes were explored based on The Cancer Genome Atlas database. Our results clearly revealed that the Risk_H subtype was associated with the worst prognosis. By a weighted correlation network analysis of genes related to the Risk_H subtype and least absolute shrinkage and selection operator, we developed a 12-gene risk-predicting model. We further validated its accuracy using three public datasets. Effective drugs for high-risk patients identified using the model were predicted. The novel PCa subtypes and prognostic model developed in this study may improve clinical decision-making.


2021 ◽  
pp. 104063872110576
Author(s):  
Vanessa J. Oakes ◽  
S. Michelle Todd ◽  
Amanda A. Carbonello ◽  
Pawel Michalak ◽  
Kevin K. Lahmers

Theileria orientalis Ikeda is a newly identified agent of bovine infectious anemia in the United States. Although T. orientalis Ikeda is transmitted by ticks other than the tick that transmits Anaplasma marginale—a bacterial etiology of bovine infectious anemia—the geographic distributions of these 2 infectious organisms overlap, with coinfection reported in some cattle. Only anaplasmosis has an approved effective treatment in the United States. To provide rapid diagnostic information for producers with anemic animals, we developed a duplex real-time PCR (rtPCR) for A. marginale and T. orientalis. With a cutoff of 38 cycles, the duplex assay has a sensitivity of 97.0% and a specificity of 100% for A. marginale; with a cutoff of 45 cycles, the duplex assay has a sensitivity and a specificity of 100% for T. orientalis, compared to existing tests. In addition to providing a tool for improved clinical decision-making for veterinarians and producers, our rtPCR facilitates the study of coinfection of cattle in Virginia. Of 1,359 blood samples analyzed, 174 were positive for T. orientalis, 125 were positive for A. marginale, and 12 samples were positive for both T. orientalis and A. marginale. Hence, coinfection by these 2 agents of bovine infectious anemia does occur within Virginia. It is likely that this pattern of infection will be seen in other regions where T. orientalis and A. marginale infections are endemic, despite the difference in tick vectors.


2021 ◽  
Author(s):  
Vanessa J. Oakes ◽  
S. Michelle Todd ◽  
Amanda A. Carbonello ◽  
Pawel Michalak ◽  
Kevin K. Lahmers

AbstractTheileria orientalis ikeda is a newly identified agent of bovine infectious anemia in the United States. Although it is transmitted by separate tick hosts than Anaplasma marginale – a bacterial etiology of bovine infectious anemia –the geographic distributions of these two infectious organisms overlap, with co-infection reported in some cattle. Only anaplasmosis has approved effective treatment in the United States. To provide rapid diagnostic information for producers with anemic animals, we developed a duplex qPCR for A. marginale and T. orientalis. With a cut-off of 38 cycles, the duplex assay has a sensitivity of 96.97% and a specificity of 100% for A. marginale; with a cut-off of 45 cycles, the duplex assay has a sensitivity and a specificity of 100% for T. orientalis. In addition to providing a tool for improved clinical decision-making for veterinarians and producers, this qPCR facilitates the study of co-infection rate of cattle in Virginia. Of 1,359 blood samples analyzed, 174 were positive for the presence of T. orientalis, 125 were positive for the presence of A. marginale, and 12 samples were positive for both T. orientalis and A. marginale. This indicated that co-infection of both of these etiologies of bovine infectious anemia does occur within the state of Virginia. It is likely that this pattern of infection will be seen in regions where T. orientalis and A. marginale are endemic, despite the difference in tick vectors.


Author(s):  
Irene Casanova-Salas ◽  
Alejandro Athie ◽  
Paul C. Boutros ◽  
Marzia Del Re ◽  
David T. Miyamoto ◽  
...  

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Kempny ◽  
K Dimopoulos ◽  
A E Fraisse ◽  
G P Diller ◽  
L C Price ◽  
...  

Abstract Background Pulmonary vascular resistance (PVR) is an essential parameter assessed during cardiac catheterization. It is used to confirm pulmonary vascular disease, to assess response to targeted pulmonary hypertension (PH) therapy and to determine the possibility of surgery, such as closure of intra-cardiac shunt or transplantation. While PVR is believed to mainly reflect the properties of the pulmonary vasculature, it is also related to blood viscosity (BV). Objectives We aimed to assess the relationship between measured (mPVR) and viscosity-corrected PVR (cPVR) and its impact on clinical decision-making. Methods We assessed consecutive PH patients undergoing cardiac catheterization. BV was assessed using the Hutton method. Results We included 465 patients (56.6% female, median age 63y). The difference between mPVR and cPVR was highest in patients with abnormal Hb levels (anemic patients: 5.6 [3.4–8.0] vs 7.8Wood Units (WU) [5.1–11.9], P<0.001; patients with raised Hb: 10.8 [6.9–15.4] vs. 7.6WU [4.6–10.8], P<0.001, respectively). Overall, 33.3% patients had a clinically significant (>2.0WU) difference between mPVR and cPVR, and this was more pronounced in those with anemia (52.9%) or raised Hb (77.6%). In patients in the upper quartile for this difference, mPVR and cPVR differed by 4.0WU [3.4–5.2]. Adjustment of PVR required Conclusions We report, herewith, a clinically significant difference between mPVR and cPVR in a third of contemporary patients assessed for PH. This difference is most pronounced in patients with anemia, in whom mPVR significantly underestimates PVR, whereas in most patients with raised Hb, mPVR overestimates it. Our data suggest that routine adjustment for BV is necessary.


2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Victoria Hale ◽  
Maren Weischer ◽  
Jong Y. Park

Although the causes of prostate cancer are largely unknown, previous studies support the role of genetic factors in the development of prostate cancer.CHEK2plays a critical role in DNA replication by responding to double-stranded breaks. In this review, we provide an overview of the current knowledge of the role of a genetic variant, 1100delC, ofCHEK2on prostate cancer risk and discuss the implication for potential translation of this knowledge into clinical practice. Currently, twelve articles that discussedCHEK2∗1100delC and its association with prostate cancer were identified. Of the twelve prostate cancer studies, five studies had independent data to draw conclusive evidence from. The pooled results of OR and 95% CI were 1.98 (1.23–3.18) for unselected cases and 3.39 (1.78–6.47) for familial cases, indicating thatCHEK2∗1100delC mutation is associated with increased risk of prostate cancer. Screening for CHEK2∗1100delC should be considered in men with a familial history of prostate cancer.


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