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Sensitivity, which denotes the proportion of subjects correctly given a positive assignment out of all subjects who are actually positive for the outcome, indicates how well a test can classify subjects who truly have the outcome of interest. Specificity, which denotes the proportion of subjects correctly given a negative assignment out of all subjects who are actually negative for the outcome, indicates how well a test can classify subjects who truly do not have the outcome of interest. Positive predictive value reflects the proportion of subjects with a positive test result who truly have the outcome of interest. Negative predictive value reflects the proportion of subjects with a negative test result who truly do not have the outcome of interest. Sensitivity and specificity are inversely related, wherein one increases as the other decreases, but are generally considered stable for a given test, whereas positive and negative predictive values do inherently vary with pre-test probability (e.g., changes in population disease prevalence). This article will further detail the concepts of sensitivity, specificity, and predictive values using a recent real-world example from the medical literature.

Blinding mitigates several sources of bias which, if left unchecked, can quantitively affect study outcomes. Blinding remains under-utilized, particularly in non-pharmaceutical clinical trials, but is often highly feasible through simple measures. Although blinding is generally viewed as an effective method by which to eliminate bias, blinding does also pose some inherent limitations, and it behooves clinicians and researchers to be aware of such caveats. This article will review general principles for blinding in clinical trials, including examples of useful blinding techniques for both pharmaceutical and non-pharmaceutical trials, while also highlighting the limitations and potential consequences of blinding. Appropriate reporting on blinding in trial protocols and manuscripts, as well as future directions for blinding research, will also be discussed.

PurposeTo summarize contemporary and emerging strategies for the diagnosis and management of metastatic hormone sensitive prostate cancer (mHSPC), focusing on diagnostic testing and therapeutics.MethodsLiterature review using PUBMED-Medline databases as well as clinicaltrials.gov to include reported or ongoing clinical trials on treatment for mHSPC. We prioritized the findings from phase III randomized clinical trials, systematic reviews, meta-analyses and clinical practice guidelines.ResultsThere have been significant changes to the diagnosis and staging evaluation of mHSPC with the integration of increasingly accurate positron emission tomography (PET) imaging tracers that exceed the performance of conventional computerized tomography (CT) and bone scan. Germline multigene testing is recommended for the evaluation of patients newly diagnosed with mHSPC given the prevalence of actionable alterations that may create candidacy for specific therapies. Although androgen deprivation therapy (ADT) remains the backbone of treatment for mHSPC, approaches to first-line treatment include the integration of multiple agents including androgen receptor synthesis inhibitors (ARSI; abiraterone) Androgen Receptor antagonists (enzalutamide, darolutamide, apalautamide), and docetaxel chemotherapy. The combination of ADT, ARSI, and docetaxel chemotherapy has recently been evaluated in a randomized trial and was associated with significantly improved overall survival including in patients with a high burden of disease. The role of local treatment to the prostate with radiation has been evaluated in randomized trials with additional studies underway evaluating the role of cytoreductive radical prostatectomy.ConclusionThe staging and initial management of patients with mHSPC has undergone significant advances in the last decade with advancements in the diagnosis, treatment and sequencing of therapies.

Background: Primary small cell carcinoma of the kidney (PSCCK) is exceedingly rare and data on disease characteristics and outcomes are sparse. This study examines a nationally-representative cancer registry to better characterize PSCCK. Methods: We queried the National Cancer Database to identify patients with histology-confirmed PSCCK from 2004 to 2015. Adjusted Cox proportional hazards regression and Kaplan–Meier analyses were employed to assess predictors of mortality and estimate median survival time, respectively. Results: A total of 110 patients were included (47:53% female:male, 77% ≥60 years of age, 86% Caucasian). Significant predictors of mortality included female sex, age 60–69 years, treatment at an Integrated Network Cancer Program, stage cM1, and lack of surgical and chemoradiotherapy treatment. Independent protective factors were high socioeconomic status and treatment at an Academic Research Program. The estimated median overall survival time was 9.31 (95% CI 7.28–10.98) months for all patients. No differences in estimated survival time were observed across individual treatment modalities among those patients who underwent treatment (p = 0.214). Conclusions: PSCCK is an aggressive malignancy with a median survival time of less than one year. Future studies that correlate clinical tumor staging with specific treatment modalities are needed to optimize and individualize management.

Purposeof ReviewThe use of genomic testing for prostate cancer continues to grow; however, utilization remains institutionally dependent. Herein, we review current tissue-based markers and comment on current use with active surveillance and prostate MRI.Recent FindingsWhile data continues to emerge, several studies have shown a role for genomic testing for treatment selection. Novel testing options include ConfirmMDx, ProMark, Prolaris, and Decipher, which have shown utility in select patients.SummaryThe current body of literature on this specific topic remains very limited; prospective trials with long-term follow-up are needed to improve our understanding on how these genomic tests fit when combined with our current clinical tools. As the literature matures, it is likely that newer risk calculators that combine our classic clinical variables with genomic and imaging data will be developed to bring about standard protocols for prostate cancer decision-making.

Evidence-based medicine is predicated on the integration of best available research evidence with clinical expertise and patient values to inform care. In medical research, several distinct measures are commonly used to describe the associations between variables, and a sound understanding of these pervasive measures is foundational in the clinician’s ability to interpret, synthesize, and apply available evidence from the medical literature. Accordingly, this article aims to provide an educational tutorial/topic primer on some of the most ubiquitous measures of association and risk quantification in medical research, including odds ratios, relative risk, absolute risk, and number needed to treat, using several real-world examples from the medical literature.

Radiation therapy (RT) in the management of pelvic cancers remains a clinical challenge to urologists given the sequelae of urethral stricture disease secondary to fibrosis and vascular insults. The objective of this review is to understand the physiology of radiation-induced stricture disease and to educate urologists in clinical practice regarding future prospective options clinicians have to deal with this condition. The management of post-radiation urethral stricture consists of conservative, endoscopic, and primary reconstructive options. Endoscopic approaches remain an option, but with limited long-term success. Despite concerns with graft take, reconstructive options such as urethroplasties in this population with buccal grafts have shown long-term success rates ranging from 70 to 100%. Robotic reconstruction is augmenting previous options with faster recovery times. Radiation-induced stricture disease is challenging with multiple interventions available, but with successful outcomes demonstrated in various cohorts including urethroplasties with buccal grafts and robotic reconstruction.

BackgroundThe relationship between frailty and nocturnal voiding is poorly understood.AimTo characterize the association between frailty, as defined by a frailty index (FI) based upon the Canadian Study of Health and Aging (CSHA) criteria, and nocturia, defined by measures of nocturnal urine production.MethodsReal-world retrospective analysis of voiding diaries from elderly males with lower urinary tract symptoms (LUTS) at an outpatient urology clinic. Males ≥ 65 years with ≥ 2 nocturnal voids were included. A modified FI was calculated from the LUTS database, which captured 39 variables from the original CSHA FI. Patients were divided into 3 groups by modified FI: low (≤ 0.077) (n = 59), intermediate (> 0.077 and < 0.179) (n = 58), and high (≥ 0.179) (n = 41). Diary parameters were compared using the Kruskal–Wallis test and pairwise comparisons with the Wilcoxon rank-sum test and Bonferroni adjustment.ResultsThe high frailty group was characterized by higher nocturnal urine volume (NUV), maximum voided volume (MVV), nocturnal maximum voided volume (NMVV), and nocturnal urine production (NUP). The presence of comorbid diabetes mellitus did not explain this effect.ConclusionElderly males seeking treatment for LUTS with a high frailty burden are disproportionately affected by excess nocturnal urine production. Future research on the mechanistic relationship between urine production and functional impairment is warranted.

Purpose We aimed to determine the potential relationship between atherosclerotic cardiovascular disease (ASCVD) score, which equates to 10-year risk of atherosclerotic cardiovascular events, and functional bladder capacity (FBC) among men in the outpatient urology setting. Methods We secondarily analyzed voiding diaries from men aged 40 to 79 years with nocturia. Patients with a history of cardiovascular disease or who had nocturnal polyuria were excluded. Patients were stratified by whether they met the high-risk ASCVD threshold (≥ 20%) following current cardiology consensus guidelines and assessed for the presence of small FBC (24-h maximum voided volume ≤ 200 ml). Logistic regression analyses were employed to explore associations between small FBC and ASCVD. Results Eighty-four men (median ASCVD score 18.4 [IQR 12.8–26.9] %, age 66 [61–71] years, body mass index [BMI] 29.4 [26.4–32.7] kg/m 2 ) were included, of whom 36 (42.9%) were high-risk and 48 (57.1%) fell below the high-risk threshold. High-risk patients were more likely to have small FBC (23 [63.9%] vs. 14 [29.2%], p  = 0.002). ASCVD risk predicted small FBC on univariate analysis ( p  = 0.002). No such effect was observed with age ( p  = 0.116), BMI ( p  = 0.523), or benign prostatic obstruction ( p  = 0.180). The association between ASCVD risk and small FBC persisted on multivariate analysis after controlling for BMI and benign prostatic obstruction ( p  = 0.002). No significant predictors of small FBC were observed when age, a major determinant of ASCVD risk and independent correlate of small FBC, was substituted for ASCVD score ( p  = 0.108). Conclusions Small FBC is related to a higher predicted cardiovascular event rate in men with nocturia.

In the original publication of the article, the author’s name Jeffrey P. Weiss was misspelled as “Jeffry P. Weiss”.