Examining transitions of care among nursing home residents with and without antipsychotic medication use.

OBJECTIVES: This study examines the association between antipsychotic (AP) medication use and care transitions in the nursing home (NH) population. METHODS: This cross-sectional study used data from a 5% random sample of Medicare beneficiaries between 2011 and 2015. Propensity score adjusted negative binomial regression was performed and conditional probabilities of having a first transition from the NH to specific locations were calculated. RESULTS: Among 150,284 eligible beneficiaries, the majority were female (67%), white (84%), and >75 years old (63%). Controlling for resident characteristics, the odds of having any transition was 5% lower among those with AP use [IRR (95% confidence interval (CI))=0.95(0.94-0.96)] relative to those with no AP use. Residents with AP use had higher proportions of transitions to hospital (22.7% vs. 19.5%, p < 0.01), emergency department (19.6% vs. 10.7%, p < 0.01), and different NH (1.5% vs. 0.4%, p < 0.01), and lower proportions of transition to non-healthcare locations compared to those without AP use. CONCLUSIONS: Findings demonstrate that residents with AP use had higher probabilities of transitions to more costly care settings such as the emergency department and hospital compared to those without AP use. Future longitudinal studies will help to inform clinical interventions aimed at improving the quality of care for this population.

Artificial intelligence CAD tools in trauma imaging: a scoping review from the American Society of Emergency Radiology (ASER) AI/ML Expert Panel.

BACKGROUND: AI/ML CAD tools can potentially improve outcomes in the high-stakes, high-volume model of trauma radiology. No prior scoping review has been undertaken to comprehensively assess tools in this subspecialty. PURPOSE: To map the evolution and current state of trauma radiology CAD tools along key dimensions of technology readiness. METHODS: Following a search of databases, abstract screening, and full-text document review, CAD tool maturity was charted using elements of data curation, performance validation, outcomes research, explainability, user acceptance, and funding patterns. Descriptive statistics were used to illustrate key trends. RESULTS: A total of 4052 records were screened, and 233 full-text articles were selected for content analysis. Twenty-one papers described FDA-approved commercial tools, and 212 reported algorithm prototypes. Works ranged from foundational research to multi-reader multi-case trials with heterogeneous external data. Scalable convolutional neural network-based implementations increased steeply after 2016 and were used in all commercial products; however, options for explainability were narrow. Of FDA-approved tools, 9/10 performed detection tasks. Dataset sizes ranged from < 100 to > 500,000 patients, and commercialization coincided with public dataset availability. Cross-sectional torso datasets were uniformly small. Data curation methods with ground truth labeling by independent readers were uncommon. No papers assessed user acceptance, and no method included human-computer interaction. The USA and China had the highest research output and frequency of research funding. CONCLUSIONS: Trauma imaging CAD tools are likely to improve patient care but are currently in an early stage of maturity, with few FDA-approved products for a limited number of uses. The scarcity of high-quality annotated data remains a major barrier.

Prostate Specific Antigen Testing after Radical Prostatectomy-Can We Stop at 20 Years?

PURPOSE: We examined the clinical features and outcomes associated with delayed biochemical recurrence after radical prostatectomy, specifically among men with more than 20 years of followup. MATERIALS AND METHODS: A total of 16,720 men underwent radical prostatectomy and 2,699 experienced biochemical recurrence. We determined predictors of delayed biochemical recurrence as well as metastasis-free and cancer specific survival rates for recurrence at various time points after radical prostatectomy. We performed subset analysis of the 732 men with 20 or more years of recurrence-free followup. Cumulative incidence curves for metastasis and prostate cancer death were calculated and stratified by biochemical recurrence time points. RESULTS: Predictors of delayed biochemical recurrence included elevated prostate specific antigen at radical prostatectomy, higher clinical and pathological stage, and positive surgical margins. Delayed biochemical recurrence was associated with favorable cumulative incidence curves for metastasis and prostate cancer death compared to early biochemical recurrence. Among the 732 men with undetectable prostate specific antigen at 20 years biochemical recurrence developed in 17 (2.3%), metastatic disease developed in a single patient and none died of prostate cancer. The actuarial probability of biochemical recurrence among men with undetectable prostate specific antigen at 20 years increased with adverse pathological features. CONCLUSIONS: Men with delayed biochemical recurrence have favorable clinical features and improved survival. Men with undetectable prostate specific antigen 20 years after radical prostatectomy had a low rate of recurrence and no deaths from prostate cancer. This suggests that 20 years is a reasonable time to discontinue prostate specific antigen testing.

The Impact of Downgrading from Biopsy Gleason 7 to Prostatectomy Gleason 6 on Biochemical Recurrence and Prostate Cancer Specific Mortality.

PURPOSE: Gleason score is one of the most important prognostic indicators for prostate cancer. Downgrading from biopsy Gleason score 7 to radical prostatectomy Gleason score 6 occurs commonly and yet to our knowledge the impact on survival outcomes is unknown. We examined biochemical recurrence and prostate cancer specific mortality risk in a large cohort evaluated by a single group of expert urological pathologists. MATERIALS AND METHODS: Of 23,918 men who underwent radical prostatectomy at our institution between 1984 and 2014, 10,236 with biopsy and radical prostatectomy Gleason score 6 or 7 without upgrading were included in analysis. The cohort was divided into 3 groups, including group 1-biopsy and radical prostatectomy Gleason score 6 in 6,923 patients (67.6%), group 2-Gleason score 7 downgraded to radical prostatectomy Gleason score 6 in 648 (6.3%) and group 3-biopsy and radical prostatectomy Gleason score 7 in 2,665 (26.0%). Biochemical recurrence and prostate cancer specific mortality risks were compared using Cox regression and competing risk analyses adjusting for clinicopathological variables. RESULTS: At a median followup of 5 years (range 1 to 29), 992 men experienced biochemical recurrence and 95 had died of prostate cancer. Biochemical recurrence-free survival in downgraded cases (group 2) was better than in group 3 cases, which had Gleason score 7 on biopsy and radical prostatectomy (p <0.001), but worse than group 1 cases, which had Gleason score 6 on biopsy and radical prostatectomy (p <0.001). Downgrading was independently associated with biochemical recurrence (adjusted HR 1.87, p <0.0001) but not with prostate cancer specific mortality (adjusted HR 1.65, p = 0.636). CONCLUSIONS: Downgrading from biopsy Gleason score 7 to radical prostatectomy Gleason score 6 was an independent predictor of biochemical recurrence but not prostate cancer specific mortality, likely due to the presence of minor amounts of Gleason pattern 4.

Prediction of pathological stage based on clinical stage, serum prostate-specific antigen, and biopsy Gleason score: Partin Tables in the contemporary era.

OBJECTIVE: To update the Partin Tables for prediction of pathological stage in the contemporary setting and examine trends in patients treated with radical prostatectomy (RP) over the past three decades. PATIENTS AND METHODS: From January 2010 to October 2015, 4459 men meeting inclusion criteria underwent RP and pelvic lymphadenectomy for histologically confirmed prostate cancer at the Johns Hopkins Hospital. Preoperative clinical stage, serum prostate-specific antigen (PSA) level, and biopsy Gleason score (i.e. prognostic Grade Group) were used in a polychotomous logistic regression model to predict the probability of pathological outcomes categorised as: organ-confined (OC), extraprostatic extension (EPE), seminal vesicle involvement (SV+), or lymph node involvement (LN+). Preoperative characteristics and pathological findings in men treated with RP since 1983 were collected and clinical-pathological trends were described. RESULTS: The median (range) age at surgery was 60 (34-77) years and the median (range) PSA level was 4.9 (0.1-125.0) ng/mL. The observed probabilities of pathological outcomes were: OC disease in 74%, EPE in 20%, SV+ in 4%, and LN+ in 2%. The probability of EPE increased substantially when biopsy Gleason score increased from 6 (Grade Group 1, GG1) to 3 + 4 (GG2), with smaller increases for higher grades. The probability of LN+ was substantially higher for biopsy Gleason score 9-10 (GG5) as compared to lower Gleason scores. Area under the receiver operating characteristic curves for binary logistic models predicting EPE, SV+, and LN+ vs OC were 0.724, 0.856, and 0.918, respectively. The proportion of men treated with biopsy Gleason score ≤6 cancer (GG1) was 47%, representing a substantial decrease from 63% in the previous cohort and 77% in 2000-2005. The proportion of men with OC cancer has remained similar during that time, equalling 73-74% overall. The proportions of men with SV+ (4.1% from 3.4%) and LN+ (2.3% from 1.4%) increased relative to the preceding era for the first time since the Partin Tables were introduced in 1993. CONCLUSIONS: The Partin Tables remain a straightforward and accurate approach for projecting pathological outcomes based on readily available clinical data. Acknowledging these data are derived from a tertiary care referral centre, the proportion of men with OC disease has remained stable since 2000, despite a substantial decline in the proportion of men with biopsy Gleason score 6 (GG1). This is consistent with the notion that many men with Gleason score 6 (GG1) disease were over treated in previous eras.

Blood Transfusion is Associated with Increased Perioperative Morbidity and Adverse Oncologic Outcomes in Bladder Cancer Patients Receiving Neoadjuvant Chemotherapy and Radical Cystectomy.

PURPOSE: Perioperative blood transfusion (PBT) has been inconsistently associated with adverse outcomes. Bladder cancer patients are unique as they frequently undergo neoadjuvant chemotherapy (NAC) with resulting immunosuppression, which may be exacerbated by transfusion-related immunomodulation. We examined the effect of leukoreduced PBT on oncologic outcomes and perioperative morbidity in radical cystectomy (RC) patients who received NAC, quantifying exposure with a novel dose-index variable. METHODS: The Johns Hopkins Radical Cystectomy database was queried for patients who had undergone NAC followed by RC from 2010 to 2013. Overall, 119 patients had available PBT and survival data. A multivariable Cox model evaluated risk factors, including pathologic stage, Charlson Comorbidity Index, age, race, year of surgery, surgical margin status, PBT, and preoperative hemoglobin for bladder cancer-specific survival (CSS) and overall survival (OS). Logistic regression models determined factors that were independently associated with perioperative morbidity. RESULTS: Median follow-up was 7.8 months (range 0.2-41.8), and during follow-up there were 25 deaths and 21 cancer deaths. PBT significantly predicted OS (hazard ratio [HR] 1.26, 95 % confidence interval [CI] 1.07-1.49; p = 0.005), CSS (HR 1.32, 95 % CI 1.11-1.57; p = 0.002), and morbidity (odds ratio [OR] 1.67, 95 % CI 1.26-2.21; p = 0.004) in univariate analyses. In multivariable models, PBT was significantly associated with morbidity (OR 1.77, 95 % CI 1.30-2.39; p = 0.0002), but not OS or CSS. Intraoperative transfusion was associated with decreased OS and CSS, and increased morbidity, whereas postoperative transfusion was only associated with increased morbidity. CONCLUSIONS: Intraoperative blood transfusion was associated with increased perioperative morbidity and worsened OS and CSS in patients undergoing RC who had NAC. Although PBT may be life-saving in certain patients, a restrictive transfusion strategy may improve outcomes.

Is clinical stage T2c prostate cancer an intermediate- or high-risk disease?

BACKGROUND: Clinical stage T2c (cT2c) is an indeterminate factor in prostate cancer (PC) risk stratification. According to the D'Amico grouping and American Urological Association guidelines, cT2c is a high risk, whereas the National Comprehensive Cancer Network and the European Urological Association classify cT2c as an intermediate risk. This study assessed whether cT2c tumors without other high-risk factors (clinical stage T2c, not otherwise specified [cT2c-NOS]) behaved as an intermediate or high risk through an analysis of biochemical recurrence (BCR) after radical prostatectomy. METHODS: Two thousand seven hundred fifty-nine men from the Shared Equal Access Regional Cancer Hospital (SEARCH) Database and 12,900 men from Johns Hopkins Hospital (JHH) from 1988-2011 and 1982-2012, respectively, were analyzed. Patients were grouped into low-risk (prostate-specific antigen [PSA] < 10 ng/mL, Gleason sum ≤ 6, and cT1-T2a), intermediate-risk (PSA = 10-20 ng/mL, Gleason sum = 7, or cT2b), and high-risk PC categories (PSA > 20 ng/mL, Gleason sum = 8-10, or cT3). Men with cT2c tumors who were not otherwise at high risk (ie, PSA< 20 ng/mL and Gleason sum < 8) were placed into a separate category termed cT2c-NOS. Associations between cT2c-NOS and intermediate- and high-risk patients and BCR were tested with the log-rank test and Cox proportional analysis models. RESULTS: Ninety-nine men (4%) from SEARCH and 202 men (2%) from JHH had tumors classified as cT2c-NOS. The cT2c-NOS patients had a BCR risk similar to that of the intermediate-risk patients (SEARCH, P = .27; JHH, P = .23) but a significantly lower BCR risk in comparison with the high-risk patients (SEARCH, P < .001; JHH, P < .001). When they were specifically compared with intermediate- and high-risk patients, after adjustments for year and center, cT2c-NOS patients had outcomes comparable to those of intermediate-risk patients (SEARCH, P = .53; JHH, P = .54) but significantly better than those of high-risk patients (SEARCH, P = .003; JHH, P < .001). CONCLUSIONS: Patients with cT2c disease without other high-risk features had outcomes similar to the outcomes of patients with intermediate-risk PC and significantly better than the outcomes of patients with high-risk PC. These findings suggest that men with cT2c disease should be considered to be at intermediate risk.

Indications for intervention during active surveillance of prostate cancer: a comparison of the Johns Hopkins and Prostate Cancer Research International Active Surveillance (PRIAS) protocols.

OBJECTIVE: To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics. PATIENTS AND METHODS: Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention. RESULTS: Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone reclassification on the JHH protocol and thus would not have undergone definitive intervention. CONCLUSIONS: There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.

Prostate specific antigen velocity risk count predicts biopsy reclassification for men with very low risk prostate cancer.

PURPOSE: Prostate specific antigen velocity is an unreliable predictor of adverse pathology findings in patients on active surveillance for low risk prostate cancer. However, to our knowledge a new concept called prostate specific antigen velocity risk count, recently validated in a screening cohort, has not been investigated in an active surveillance cohort. MATERIALS AND METHODS: We evaluated a cohort of men from 1995 to 2012 with prostate cancer on active surveillance. They had stage T1c disease, prostate specific antigen density less than 0.15 ng/ml, Gleason score 6 or less, 2 or fewer biopsy cores and 50% or less involvement of any core with cancer. The men were observed by semiannual prostate specific antigen measurements, digital rectal examinations and an annual surveillance biopsy. Treatment was recommended for biopsy reclassification. Patients with 30 months or greater of followup and 3 serial prostate specific antigen velocity measurements were used in primary analysis by logistic regression, Cox proportional hazards, Kaplan-Meier analysis and performance parameters, including the AUC of the ROC curve. RESULTS: Primary analysis included 275 of 668 men who met very low risk inclusion criteria, of whom 83 (30.2%) were reclassified at a median of 57.1 months. Reclassification risk increased with risk count, that is a risk count of 3 (HR 4.63, 95% CI 1.54-13.87) and 2 (HR 3.73, 95% CI 1.75-7.97) compared to zero. Results were similar for Gleason score reclassification (HR 7.45, 95% CI 1.60-34.71 and 3.96, 95% CI 1.35-11.62, respectively). On secondary analysis the negative predictive value (risk count 1 or less) was 91.5% for reclassification in the next year. Adding the prostate specific antigen velocity risk count improved the AUC in a model including baseline prostate specific antigen density (0.7423 vs 0.6818, p = 0.025) and it outperformed the addition of overall prostate specific antigen velocity (0.7423 vs 0.6960, p = 0.037). CONCLUSIONS: Prostate specific antigen velocity risk count may be useful for monitoring patients on active surveillance and decreasing the frequency of biopsies needed in the long term.

Obesity and long-term survival after radical prostatectomy.

PURPOSE: Obesity is a modifiable risk factor associated with worse outcomes for many cancers, yet implications for prostate cancer are not well understood. Notably the impact of body mass index on long-term survival after treatment is unclear. We performed a retrospective cohort study on a large series of men who underwent radical prostatectomy to assess the impact of obesity on long-term biochemical recurrence-free survival, prostate cancer specific survival and overall survival. MATERIALS AND METHODS: Between 1982 and 2012, 11,152 men underwent radical prostatectomy at a single tertiary referral center. Patients were stratified according to body mass index as normal weight (body mass index less than 25 kg/m(2)), overweight (body mass index 25 to less than 30 kg/m(2)), mild obesity (body mass index 30 to less than 35 kg/m(2)) and moderate/severe obesity (body mass index 35 kg/m(2) or greater), comprising 27.6%, 56.0%, 14.1% and 2.3% of the cohort, respectively. Covariates included age, preoperative prostate specific antigen, surgery year, Gleason score, pathological stage, surgical margin and race. Predictors of biochemical recurrence-free survival, prostate cancer specific survival and overall survival were identified using Cox proportional hazard models. RESULTS: Median followup was 5 years (range 1 to 27). Actuarial 20-year biochemical recurrence-free survival for mild and moderate/severe obesity was 65% and 51%, respectively, compared to 76% for normal weight men (p ≤0.001). In a multivariate model obesity was a significant predictor of biochemical recurrence-free survival (mild HR 1.30, p = 0.002; moderate/severe HR 1.45, p = 0.028) and overall survival (mild HR 1.41, p = 0.003; moderate/severe HR 1.81, p = 0.033). However, only mild obesity was significantly associated with prostate cancer specific survival (HR 1.51, p = 0.040), whereas moderate/severe obesity was not (HR 1.58, p = 0.356). CONCLUSIONS: Obese men have higher rates of biochemical recurrence than normal weight patients during long-term followup. Obesity at the time of surgery independently predicts overall survival and biochemical recurrence-free survival but not prostate cancer specific survival.

Allogeneic versus autologous blood transfusion and survival after radical prostatectomy.

BACKGROUND: Potential adverse effects of blood transfusion (BT) remain controversial, especially for clinical outcomes after curative cancer surgery. Some postulate that immune modulation after allogeneic BT predisposes to recurrence and death, but autologous superiority is not established. This study assessed whether BT is associated with long-term prostate cancer recurrence and survival with a large single-institutional radical prostatectomy (RP) database. STUDY DESIGN AND METHODS: Between 1994 and 2012, a total of 11,680 patients had RP with available outcome and transfusion data. A total of 7443 (64%) had complete covariate data. Clinical variables associated with biochemical recurrence-free survival (BRFS), cancer-specific survival (CSS), and overall survival (OS) were identified with Cox proportional hazards models for three groups: no BT (reference, 27.7%, n = 2061), autologous BT only (68.8%, n = 5124), and any allogeneic BT (with or without autologous, 3.5%, n = 258). RESULTS: Median (range) follow-up was 6 (1-18) years. Kaplan-Meier analysis showed significantly decreased OS (but not BRFS or PCSS) in the allogeneic group versus autologous and no BT groups (p = 0.006). With univariate analysis, any allogeneic BT had a hazard ratio (HR) of 2.29 (range, 1.52-3.46; p < 0.0001) for OS, whereas autologous BT was not significant (HR, 1.04 [range, 0.82-1.32], p = 0.752). In multivariable models, neither autologous nor allogeneic BT was independently associated with BRFS, CSS, or OS, and a dose response was not observed for allogeneic units and BRFS. CONCLUSION: Although allogeneic but not autologous BT was associated with decreased long-term OS, after adjustment for confounding clinical variables, BT was not independently associated with OS, BRFS, or CSS regardless of transfusion type. Notably, no association was observed between allogeneic BT and cancer recurrence. Observed differences in OS may reflect confounding.

Sustained IL-6 and sTNF-αR1 levels after hip fracture predict 5-year mortality: A prospective cohort study from the Baltimore Hip Studies.

BACKGROUND: Persistent inflammation is associated with adverse health outcomes, but its impact on mortality has not been investigated previously among hip fracture patients. This article aims to investigate the influence of changes in levels of cytokines in the 2 months after a hip fracture repair on 5-year mortality. METHODS: This is a prospective cohort study from the Baltimore Hip Studies (BHS) with 191 community-dwelling older men and women (≥65 years) who had recently undergone surgical repair of an acute hip fracture, with recruitment from May 2006 to June 2011. Plasma interleukin-6 (IL-6), soluble tumor necrosis factor alpha receptor1 (sTNFα-R1), and interleukin-1 receptor agonist (IL-1RA) were obtained within 22 days of admission and at 2 months. All-cause mortality over 5 years was determined. Logistic regression analysis tested the associations between the cytokines' trajectories and mortality over 5 years, adjusted for covariates (age, sex, education, body mass index, lower extremity physical activities of daily living, and Charlson comorbidity index). RESULTS: High levels of IL-6 and sTNFα-R1 at baseline with small or no decline at 2 months were associated with higher odds of 5-year mortality compared with those with lower levels at baseline and greater decline at 2 months after adjustment for age, and other potential confounders (OR = 4.71, p = 0.01 for IL-6; OR = 15.03, p = 0.002 for sTNFα-R1). Similar results that failed to reach significance were found for IL-1RA (OR = 2.40, p = 0.18). Those with higher levels of cytokines at baseline with greater decline did not have significantly greater mortality than the reference group, those with lower levels at baseline and greater decline. CONCLUSION: Persistent elevation of plasma IL-6 and sTNFα-R1 levels within the first 2 months after hospital admission in patients with hip fracture is associated with higher 5-year mortality. These patients may benefit from enhanced care and earlier intensive interventions to reduce the risk of death.

Pathological and oncologic outcomes for men with positive lymph nodes at radical prostatectomy: The Johns Hopkins Hospital 30-year experience.

BACKGROUND: We report the 30-year institutional experience of radical prostatectomy (RP) for men with clinically localized prostate cancer (PC) found to have lymph node (LN) metastases at surgery. METHODS: The Johns Hopkins RP Database (1982-2011) was queried for 505 (2.5%) men with node-positive (N1) PC. Survival analysis was completed using the Kaplan-Meier method and proportional hazard regression models. RESULTS: The proportion of men with N1PC was 8.3%, 3.5%, and 1.4% in the pre- (1982-1990), early- (1991-2000), and contemporary-PSA eras (2001-2011), respectively. A trend toward decreasing PSA, less palpable disease but more advanced Gleason sum was noted in the most contemporary era. Median total and positive nodes were 13.2 (1-41) and 1.7 (1-12), respectively. Of 135 patients with a unilateral tumor, 80 (59.3%), 28 (20.7%), and 15 (11.1%) had ipsilateral, contralateral, and bilateral positive LN. 15-year biochemical-recurrence free, metastases-free and cancer-specific survival was 7.1%, 41.5%, and 57.5%, respectively. Predictors of biochemical-recurrence, metastases and death from PC in multivariate analysis included Gleason sum at RP, the number and percent of positive LN; notably total number of LN dissected did not predict outcome. CONCLUSIONS: In this highly-selected RP cohort, men found to have N1PC disease at RP can experience a durable long-term metastases-free and cancer-specific survival. Predictors of survival include Gleason sum, number, and percentage of positive LN. While total number of LN dissected was not predictive, approximately 30% of men with N1PC will have positive LN contralateral to the primary prostatic lesion highlighting the importance of a thorough, bilateral pelvic LN dissection.

Nightly vs on-demand sildenafil for penile rehabilitation after minimally invasive nerve-sparing radical prostatectomy: results of a randomized double-blind trial with placebo.

OBJECTIVES: To clarify the role of phosphodiesterase type 5 (PDE5) inhibitors in post-prostatectomy penile rehabilitation (PPPR). To compare nightly and on-demand use of PDE5 inhibitors after nerve-sparing minimally invasive radical prostatectomy (RP). PATIENTS AND METHODS: We conducted a single-institution, double-blind, randomized controlled trial of nightly vs on-demand 50-mg sildenafil citrate after nerve-sparing minimally invasive RP. A total of 100 preoperatively potent men, aged <65 years, with scores on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) ≥26, underwent nerve-sparing surgery. The patients were randomized to either nightly sildenafil and on-demand placebo (nightly sildenafil group), or on-demand sildenafil and nightly placebo (on-demand sildenafil group; maximum on-demand dose six tablets/month) for 12 months. Patients then underwent a 1-month washout period. Validated measures of erectile function (IIEF-EF score and the Expanded Prostate Cancer Index Composite [EPIC]) were compared between treatment groups over the entire 13-month time course, using multivariable mixed linear regression models. RESULTS: The treatment groups were well matched preoperatively (mean age 54.3 vs 54.6 years, baseline IIEF-EF score 29.4 vs 29.3, for the nightly vs the on-demand sildenafil groups, respectively). No significant differences were found in erectile function between treatments (nightly vs on-demand sildenafil) at any single timepoint after RP, after adjusting for potential confounding factors. When evaluated over all timepoints simultaneously, no significant effects of treatment group (nightly vs on-demand sildenafil) were found on recovery of potency, as assessed by absolute IIEF-EF scores (P = 0.765), on percentage of men returning to an IIEF-EF score >21 (P = 0.830), or on IIEF-EF score recovery to a percentage of baseline value (P = 0.778). When evaluated over all timepoints simultaneously, no significant effects of treatment group were found on secondary endpoints such as assessment of potency (including EPIC item 59 response 'erections firm enough for intercourse'), attempted intercourse frequency or confidence. CONCLUSIONS: Erectile recovery up to 1 year after RP does not differ between previously potent men who use sildenafil nightly compared to on-demand. This trial does not support chronic nightly sildenafil as being any better than on-demand sildenafil for use in penile rehabilitation after nerve-sparing minimally invasive RP.

Outcomes after endoscopic local excision of early-stage gastric adenocarcinoma in the United States.

BACKGROUND AND OBJECTIVES: Local excision (LE) for early-stage gastric cancer has expanded in the United States over recent years, however, national outcomes are unknown. The objective of the study was to evaluate national survival outcomes following LE for early-stage gastric cancer. METHODS: Patients with resectable gastric adenocarcinoma between 2010 and 2016 were identified from the National Cancer Database then classified by LE curability into eCuraA (high) and eCuraC (low) according to Japanese Gastric Cancer Association guidelines. Demographics, clinical/provider descriptors, and perioperative/survival outcomes were extracted. Propensity-weighted cox proportional hazards regression assessed factors associated with overall survival. RESULTS: Patients were stratified into eCuraA (N = 1167) and eCuraC (N = 13,905) subgroups. Postoperative 30-day mortality (0% vs 2.8%, p < 0.001) and readmission (2.3% vs 7.8%, p = 0.005) favored LE. Local excision was not associated with survival on propensity-weighted analyses. However, among eCuraC patients, LE was associated with higher likelihood of positive margins (27.1% vs 7.0%, p < 0.001), which was the strongest predictor of poor survival (HR 2.0, p < 0.001). CONCLUSIONS: Although early morbidity is low, oncologic outcomes following LE are compromised for eCuraC patients. These findings support careful patient selection and treatment centralization in the early adoption phase of LE for gastric cancer.

Associations between living alone, social interactions, and physical performance differ by sex: Results from the Baltimore Hip Studies.

BACKGROUND: There is mixed evidence on whether living arrangements and social interactions are associated with poorer health outcomes after hip fracture repair. Distinct social profiles among male and female older adults may explain some of the differences. However, prior studies did not evaluate these differences by sex. This article aims to assess if the associations between living alone, social interaction, and physical performance differ by sex among hip fracture survivors. METHODS: This prospective cohort study is part of the Baltimore Hip Studies seventh cohort, with 168 male and 171 female hip fracture patients assessed at baseline (≤22 days after hospitalization) and at 2, 6, and 12 months post admission. Living arrangements and interaction with children or siblings and others in the past 2 weeks were collected at all visits. Physical performance was measured in the follow-up visits with the Short Physical Performance Battery (SPPB). Linear mixed models tested associations of living alone and social interaction with SPPB over time adjusted for age, education, comorbidities, physical functioning pre-fracture, cognitive function, self-rated health, and time. RESULTS: For men only, living alone was associated with worse performance (0.7 points lower SPPB scores, p = 0.05). Higher social interaction was associated with 0.8 and 1.2 point higher SPPB scores for men and women, respectively (p < 0.05). Visiting with friends was significantly associated with better function among males, while visiting with children or siblings was associated with worse SPPB among females. CONCLUSIONS: Living arrangements and types of social interaction are differentially associated with physical function for older men and women. Screening for social isolation/integration and including interventions that promote social interaction and participation should be considered in healthcare programs for hip fracture survivors.

Treatment decision-making for localized prostate cancer: what younger men choose and why.

BACKGROUND AND OBJECTIVE: The literature lacks knowledge about information preferences and decision-making in young prostate cancer patients. This study provides insight into information sources consulted and factors dictating treatment decision-making in young prostate cancer patients. METHODS: Subjects were identified from pathology consult service of a National Center of Excellence. Questionnaires were mailed to 986 men, under 50 years of age, diagnosed with Gleason score 6 prostate cancer between 2001 and 2005. RESULTS: Four hundred ninety-three men responded. The most common primary therapies were surgery 397 (81.4%), radiation 52 (10.7%), and active surveillance (AS) 26 (5.3%). Participants with at least some college education (P = 0.003) or annual income >$100,000 (P = 0.003) were more likely to consult three or more doctors. Amongst all treatments, "doctor's recommendation" was the most influential information source, although relatively less important in the AS group. Internet was the second most frequent information source. Participants with higher education (P = 0.0003) and higher income (P = 0.002) considered sexual function more important while making a treatment choice. Only 2% of the men preferred a passive role in the decision-making. Informed decision-making was preferred more by patients who chose radiation and AS while shared decision-making was preferred more by surgery patients (P < 0.05). The majority (89%) of the respondents did not regret their decision. No difference in satisfaction levels was found between different treatment modalities. CONCLUSIONS: This study provides insight into information sources consulted, such as the greater internet use, and various factors dictating treatment decision-making in young prostate cancer patients. There was an overall very high satisfaction rate regardless of the therapy chosen.

The impact of anatomical radical retropubic prostatectomy on cancer control: the 30-year anniversary.

PURPOSE: Radical prostatectomy has decreased prostate cancer specific mortality in men with clinically localized prostate cancer. We report oncological outcomes of the longest running series of nerve sparing radical retropubic prostatectomy on the 30th anniversary of the inaugural operation. MATERIALS AND METHODS: A total of 4,478 men underwent anatomical radical retropubic prostatectomy, as performed by a single surgeon (PCW), at the Johns Hopkins Medical Institutions from 1982 to 2011, without neoadjuvant or adjuvant therapy. During a median followup of 10 years (range 1 to 29), we examined progression-free, metastasis-free and cancer specific survival. RESULTS: The overall 25-year progression-free, metastasis-free and cancer specific survival rates were 68%, 84% and 86%, respectively, although there were significant differences in treatment outcomes between men treated in the pre-PSA and PSA eras. In each era, there were significant differences in progression-free, metastasis-free and cancer specific survival by D'Amico risk groups. In multivariable models considering prostatectomy features, pathological stage and grade were significantly associated with the risk of metastatic progression and disease specific mortality. CONCLUSIONS: Excellent prostate cancer specific survival was demonstrated up to 30 years after surgery. Clinical risk categories and pathological tumor features were significant predictors of long-term disease specific outcomes, supporting their ongoing use in risk stratification and management decisions. Anatomical radical retropubic prostatectomy continues to represent the gold standard in the surgical management of clinically localized prostate cancer to which alternate treatment options should be compared.

Association of [-2]proPSA with biopsy reclassification during active surveillance for prostate cancer.

PURPOSE: Previous studies have suggested an association between [-2]proPSA expression and prostate cancer detection. Less is known about the usefulness of this marker in following patients with prostate cancer on active surveillance. Thus, we examined the relationship between [-2]proPSA and biopsy results in men enrolled in an active surveillance program. MATERIALS AND METHODS: In 167 men from our institutional active surveillance program we used Cox proportional hazards models to examine the relationship between [-2]proPSA and annual surveillance biopsy results. The outcome of interest was biopsy reclassification (Gleason score 7 or greater, more than 2 positive biopsy cores or more than 50% involvement of any core with cancer). We also examined the association of biopsy results with total prostate specific antigen, %fPSA, [-2]proPSA/%fPSA and the Beckman Coulter Prostate Health Index phi ([-2]proPSA/free prostate specific antigen) × (total prostate specific antigen)(½)). RESULTS: While on active surveillance (median time from diagnosis 4.3 years), 63 (37.7%) men demonstrated biopsy reclassification based on the previously mentioned criteria, including 28 (16.7%) of whom had reclassification based on Gleason score upgrading (Gleason score 7 or greater). Baseline and longitudinal %fPSA, %[-2]proPSA, [-2]proPSA/%fPSA and phi measurements were significantly associated with biopsy reclassification, and %[-2]proPSA and phi provided the greatest predictive accuracy for high grade cancer. CONCLUSIONS: In men on active surveillance, measures based on [-2]proPSA such as phi appear to provide improved prediction of biopsy reclassification during followup. Additional validation is warranted to determine whether clinically useful thresholds can be defined, and to better characterize the role of %[-2]proPSA and phi in conjunction with other markers in monitoring patients enrolled in active surveillance.

Comparison of outcomes between pure laparoscopic vs robot-assisted laparoscopic radical prostatectomy: a study of comparative effectiveness based upon validated quality of life outcomes.

OBJECTIVE: To compare perioperative, oncological and functional outcomes of laparoscopic radical prostatectomy (LRP) and robot-assisted laparoscopic radical prostatectomy (RALP) with emphasis on health-related quality of life (HRQOL) data as few studies exist. PATIENTS AND METHODS: Patients underwent RALP or LRP by a single, fellowship trained surgeon with a standard clinical care pathway. HRQOL data using the Expanded Prostate Cancer Index Composite (EPIC) were collected at 0, 3, 6 and 12 months after 175 consecutive LRP and 174 RALP procedures. Urinary and sexual function outcomes were compared using two methods: (1) EPIC summary/subscale analyses described as percent return to baseline function and (2) traditional single-question analysis. RESULTS: The two groups were statistically similar with respect to demographics, clinical stage, perioperative outcomes, stage-specific surgical margin rates, and baseline urinary and sexual function scores. There was no statistical difference in postoperative urinary function between RALP and LRP using EPIC or single-question analyses at 3, 6 and 12 months. EPIC questionnaire data showed a greater return to baseline sexual function over time (mixed model analysis) in RALP than in LRP patients who had a bilateral nerve sparing procedure (Sexual Summary Score, P= 0.005; Sexual Function and Bother Subscales, P= 0.007). Using EPIC, RALP patients receiving a bilateral nerve sparing procedure showed improved percent return to baseline potency at 3 and 6 months (P < 0.025) compared with LRP patients, but had similar outcomes at 12 months (73.7% vs 66.2%, P= 0.3). Single-question analysis suggested improved potency after RALP compared with LRP, with a greater percentage of RALP patients reporting successful sexual intercourse in the past 4 weeks (87.5% vs 66.7% at 12 months, P= 0.06). CONCLUSIONS: When comparing surgical techniques, RALP and LRP groups showed statistically similar postoperative urinary function outcomes. RALP patients had an earlier return of sexual function when compared with LRP patients after a bilateral nerve sparing procedure.