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1.  The Patient Protection and Affordable Care Act: The Impact on Urologic Cancer Care 
Urologic oncology  2012;31(7):980-984.
In March 2010, the Patient Protection and Affordable Care Act as well as its amendments were signed into law. This sweeping legislation was aimed at controlling spiraling healthcare costs and redressing significant disparities in healthcare access and quality. Cancer diagnoses and their treatments constitute a large component of rising healthcare expenditures and, not surprisingly, the legislation will have a significant influence on cancer care in the United States. Because genitourinary malignancies represent an impressive 25% of all cancer diagnoses per year, this legislation could have a profound impact on urologic oncology. To this end, we will present key components of this landmark legislation, including the proposed expansion to Medicaid coverage, the projected role of Accountable Care Organizations, the expected creation of quality reporting systems, the formation of an independent Patient-Centered Outcomes Research Institute, and enhanced regulation on physician-owned practices. We will specifically address the anticipated effect of these changes on urological cancer care. Briefly, the legal ramifications and current barriers to the statutes will be examined.
doi:10.1016/j.urolonc.2012.01.007
PMCID: PMC3773249  PMID: 22819697
Patient Protection and Affordable Care Act; Health Care Education and Reform Act; Urologic Oncology; ACA; ACO; PCORI
2.  Trends in the use of evidence-based therapy for resectable gastric cancer 
Journal of surgical oncology  2014;110(3):285-290.
Background and Objectives
Two pivotal randomized controlled trials (RCTs), the Intergroup (INT-0116) and Medical Research Council Adjuvant Gastric Infusional Chemotherapy (MAGIC) trials, demonstrated a survival benefit of multimodality therapy in patients with resectable gastric cancer. The purpose of this study was to determine utilization rates of these treatment regimens in the U.S. and to identify factors associated with receipt of evidence-based care.
Methods
We performed a retrospective cohort study of patients with Stage IB-Stage IV (M0) gastric adenocarcinoma who underwent resection from 1991–2009 using the linked SEER-Medicare database.
Results
Only 19.1% of patients received post-operative chemoradiation therapy (CRT), and 1.9% received peri-operative chemotherapy; most patients underwent surgery alone (60.9%). Patients with more advanced stage, younger age, and fewer comorbidities were more likely to receive evidence-based care. We found no association between National Cancer Institute (NCI) designation and delivery of multimodality therapy. However, patients who underwent medical oncology consultation were much more likely to receive evidence-based treatment (OR 3.10, 95% CI 2.35–4.09).
Conclusions
Rates of peri-operative chemotherapy and post-operative CRT in patients with resected gastric cancer remain remarkably low, despite high-quality RCT evidence demonstrating their benefit. Furthermore, NCI designation does not appear to be associated with administration of evidence-based treatment.
doi:10.1002/jso.23635
PMCID: PMC4260801  PMID: 24891231
stomach neoplasms; chemotherapy; adjuvant; chemoradiotherapy; adjuvant; epidemiology
3.  Impact of prostate cancer on sexual relationships: a longitudinal perspective on intimate partners’ experiences 
The journal of sexual medicine  2013;10(12):10.1111/jsm.12295.
Introduction
In this prospective study of localized prostate cancer patients and their partners, we analyzed how partner issues evolve over time, focusing on satisfaction with care, influence of cancer treatment and its impact on relationship with patient, cancer worry, and personal activities.
Aims
Our study aims were twofold: 1) to determine whether the impact of treatment on patients and partners moderate over time and (2) if receiving surgery (i.e., radical prostatectomy) influences partner issues more than other treatments.
Methods
Patients newly diagnosed with localized prostate cancer and their female partners were recruited from 3 states to complete surveys by mail at 3 time points over 12 months.
Main Outcome Measures
The four primary outcomes assessed in the partner analysis included satisfaction with treatment, cancer worry, and the influence of cancer and its treatment on their relationship (both general relationship and sexual relationship).
Results
This analysis included 88 patient-partner pairs. At 6 months, partners reported that cancer had a negative impact on their sexual relationship (39% - somewhat negative and 12% - very negative). At 12 months, this proportion increased substantially (42% – somewhat negative and 29% - very negative). Partners were significantly more likely to report that their sexual relationship was worse when the patient reported having surgery (p=0.0045, OR=9.8025, 95% CI 2.076–46.296). A minority of partners reported significant negative impacts in other areas involving their personal activities (16% at 6 months and 25% at 12 months) or work life (6% at 6 months, which increased to 12% at 12 months).
Conclusion
From partners’ perspectives, prostate cancer therapy has negative impact on sexual relationships, and appears to worsen over time.
doi:10.1111/jsm.12295
PMCID: PMC3855071  PMID: 24118980
prostate cancer; partner; sexual function
4.  Effect of Age, Tumor Risk, and Comorbidity on Competing Risks for Survival in a U.S. Population–Based Cohort of Men With Prostate Cancer 
Annals of internal medicine  2013;158(10):709-717.
Background
Accurate estimation of life expectancy is essential to offering appropriate care to men with early-stage prostate cancer, but mortality risks associated with comorbidity are poorly defined.
Objective
To determine the effect of age, comorbidity, and tumor risk on other-cause and prostate cancer–specific mortality in men with early-stage disease.
Design
Prospective cohort study.
Setting
A nationally representative, population-based cohort.
Patients
3183 men with nonmetastatic prostate cancer at diagnosis.
Measurements
Baseline self-reported comorbidity (scored as a count of 12 major comorbid conditions), tumor characteristics, initial treatment, and overall and disease-specific mortality through 14 years of follow-up. Survival analyses that accounted for competing risks were performed.
Results
Fourteen-year cumulative other-cause mortality rates were 24%, 33%, 46%, and 57% for men with 0, 1, 2, and 3 or more comorbid conditions, respectively. For men diagnosed at age 65 years, subhazard ratios for other-cause mortality among those with 1, 2, or 3 or more comorbid conditions (vs. none) were 1.2 (95% CI, 1.0 to 1.4), 1.7 (CI, 1.4 to 2.0), and 2.4 (CI, 2.0 to 2.8), respectively. Among men with 3 or more comorbid conditions, 10-year other-cause mortality rates were 26%, 40%, and 71% for those aged 60 years or younger, 61 to 74 years, and 75 years or older at diagnosis, respectively. Prostate cancer–specific mortality was minimal in patients with low-risk (3%) and intermediate-risk (7%) disease but appreciable in those with high-risk disease (18%) and did not vary by number of comorbid conditions (10% to 11% in all groups).
Limitation
Comorbid conditions were self-reported.
Conclusion
Older men with multiple major comorbid conditions are at high risk for other-cause mortality within 10 years of diagnosis and should consider this information when deciding between conservative management and aggressive treatment for low- or intermediate-risk prostate cancer.
Primary Funding Source
National Cancer Institute.
doi:10.7326/0003-4819-158-10-201305210-00005
PMCID: PMC3760479  PMID: 23689764
5.  Mortality After Radical Prostatectomy or External Beam Radiotherapy for Localized Prostate Cancer 
Background
No randomized trials have compared survival outcomes for men with localized prostate cancer (PC) being treated with radical prostatectomy (RP) or external beam radiotherapy (EBRT). The goal of the study, therefore, was to estimate the association of RP (compared with EBRT) with overall and PC mortality.
Methods
We analyzed an observational cohort from the population-based Prostate Cancer Outcomes Study, which included men aged 55 to 74 years diagnosed with localized PC between October 1994 and October 1995 who underwent either RP (n = 1164) or EBRT (n = 491) within 1 year of diagnosis. Patients were followed until death or study end (December 31, 2010). Overall and disease-specific mortality were assessed with multivariable survival analysis, with propensity scores to adjust for potential treatment selection confounders (demographics, comorbidities, and tumor characteristics). All statistical tests were two-sided.
Results
After 15 years of follow-up, there were 568 deaths, including 104 from PC. RP was associated with statistically significant advantages for overall (hazard ratio [HR] = 0.60, 95% confidence interval [CI] = 0.53 to 0.70, P <.0001.) and disease-specific mortality (HR = 0.35, 95% CI = 0.26 to 0.49, P <.0001.). Mortality benefits for RP were also observed within treatment propensity quintiles, when subjects were pair-matched on propensity scores, and in subgroup analyses based on age, tumor characteristics, and comorbidity.
Conclusions
Population-based observational data on men diagnosed with localized PC in the mid-1990s suggest a mortality benefit associated with RP vs EBRT. Possible explanations include residual selection bias or a true survival advantage. Results might be less applicable for men facing treatment decisions today.
doi:10.1093/jnci/djt059
PMCID: PMC3653822  PMID: 23615689
6.  Epidemiology of Vocal Fold Paralyses After Total Thyroidectomy for Well-Differentiated Thyroid Cancer in Medicare Population 
Objectives
Population-level incidence of vocal fold paralysis after thyroidectomy for well-differentiated thyroid carcinoma (WDTC) is not known. This study aimed to measure longitudinal incidence of post-operative vocal fold paralyses and need for directed interventions in the Medicare population undergoing total thyroidectomy for WDTC.
Study Design
Retrospective Cohort Study
Setting
United States Population
Subjects
Medicare Beneficiaries
Methods
SEER-Medicare data (1991 – 2009) were used to identify beneficiaries who underwent total thyroidectomy for WDTC. Incident vocal fold paralyses and directed interventions were identified. Multivariate analyses were used to determine factors associated with odds of developing these surgical complications.
Results
Of 5,670 total thyroidectomies for WDTC, 9.5% were complicated by vocal fold paralysis [8.2% unilateral vocal fold paralysis (UVFP); 1.3% bilateral vocal fold paralysis (BVFP)]. Rate of paralyses decreased 5% annually from 1991 to 2009 (OR 0.95, 95% CI 0.93 – 0.97; p<0.001). Overall, 22% of patients with vocal fold paralysis required surgical intervention (UVFP 21%, BVFP 28%). Multivariate logistic regression revealed odds of post-thyroidectomy paralysis increased with each additional year of age, with non-Caucasian race, particular histologic types, advanced stage, and in particular registry regions.
Conclusions
Annual rates of post-thyroidectomy vocal fold paralyses are decreasing among Medicare beneficiaries with WDTC. High incidence in this aged population is likely due to a preponderance of temporary paralyses, which is supported by the need for directed intervention in less than a quarter of affected patients. Further population-based studies are needed to refine the population incidence and risk factors for paralyses in the aging population.
doi:10.1177/0194599814521381
PMCID: PMC4229384  PMID: 24482349
vocal fold paralysis; unilateral vocal fold paralysis; bilateral vocal fold paralysis; thyroid cancer; thyroidectomy; epidemiology; incidence; Medicare
7.  Assessment of Patient Experience with Unilateral Vocal Fold Immobility: A Preliminary Study 
Objective
Systematically moving toward patient-centered care for unilateral vocal fold immobility (UVFI) requires comprehensive understanding of the variability of actual patient experiences. This rigorous qualitative study assesses UVFI-related disability and proposes a preliminary taxonomy of UVFI patient experience.
Study Design
1) Semi-structured interviews, 2) taxonomy development
Methods
Consecutive UVFI patients presenting July - September 2012 prospectively underwent open-ended interviews investigating how UVFI affected their quality of life (QOL) and had caused disability. Comments reported by >20% were synthesized into axes based on content similarity. Variables were arranged into a preliminary taxonomy of UVFI patient experience, which was evaluated for four attributes of face validity.
Results
The majority of 39 patients had “extensive” baseline voice use (56%) and an iatrogenic etiology (62%). Taxonomy of patient experience included 3 main axes of symptomatic classification: 1) voice, 2) swallowing, and 3) breathing - all with intrinsic (physical, emotional) and extrinsic (social) sub-axes that describe major impacts on QOL. Voice complaints were 100% penetrant, while breathing and swallowing symptoms afflicted 76% and 66% of interviewees. Of affected patients, solid and liquid dysphagia was experienced by 70% and 63%. Of dyspneic patients, shortness of breath existed with talking (97%) and exercise (72%). Persistent throat congestion (76%), weakened cough (62%), globus (62%), and dysfunctional valsalva (41%) were frequent.
Conclusion
Patient experience with UVFI has been incompletely characterized. This qualitative assessment and preliminary taxonomy highlight several related patient experiences not well documented in the literature or incorporated into currently available metrics.
doi:10.1016/j.jvoice.2014.01.006
PMCID: PMC4226757  PMID: 24739444
unilateral vocal fold immobility; unilateral vocal fold/cord paralysis; quality of life; patient experience; dysphonia; dysphagia; dyspnea; classification; taxonomy; patient-centered care
9.  Efficacy of Intermittent Androgen Deprivation Therapy vs Conventional Continuous Androgen Deprivation Therapy for Advanced Prostate Cancer: A Meta-analysis 
Urology  2013;82(2):327-333.
OBJECTIVE
To compare the efficacy of intermittent androgen deprivation therapy (IADT) vs continuous androgen deprivation therapy (CADT) for the treatment of advanced prostate cancer; we performed a meta-analysis of randomized controlled trials (RCTs), assessing the risks of disease progression, all-cause, and disease-specific mortality.
MATERIALS AND METHODS
We conducted a systematic search of several bibliographic systems to identify all RCTs of IADT in men with newly diagnosed metastatic or biochemical only prostate cancer. We abstracted outcome data, study characteristics, and participant demographics. We performed heterogeneity tests and calculated the summarized risk differences (RD) and risk ratios at 95% confidence intervals (CI), using inverse variance methods in random-effects approaches.
RESULTS
We identified 8 RCTs (N = 4664) comparing mortality between IADT and CADT. For all men combined, we observed small but nonsignificant differences in all-cause mortality (RD = 0.02, 95% CI = −0.02, 0.06), disease-specific mortality (RD = 0.04, 95% CI = −0.01, 0.08), and disease progression (RD = −0.03, 95% CI = −0.09, 0.04). Among the prespecified subgroup with histologically confirmed, newly diagnosed metastatic disease, we found no difference in overall survival (RD = 0.00, 95% CI = −0.09, 0.09).
CONCLUSION
We found no difference in overall survival, but a small increased risk in disease-specific survival for men treated with IADT relative to CADT was observed. IADT could be considered as an alternative to CADT because of better quality of life outcome. Patients should be informed of the possible risks and benefits of both therapies. More research confirming the benefits of IADT vs CADT is needed to inform treatment decisions.
doi:10.1016/j.urology.2013.01.078
PMCID: PMC4154705  PMID: 23896094
10.  The relationship between perioperative blood transfusion and overall mortality in patients undergoing radical cystectomy for bladder cancer 
Urologic oncology  2011;31(6):871-877.
Objectives
The relationship between perioperative blood transfusion (PBT) and oncologic outcomes is controversial. In patients undergoing surgery for colon cancer and several other solid malignancies, PBT has been associated with an increased risk of mortality. Yet, the urologic literature has a paucity of data addressing this topic. We sought to evaluate whether PBT affects overall survival following radical cystectomy (RC) for patients with bladder cancer.
Methods
The medical records of 777 consecutive patients undergoing RC for urothelial carcinoma of the bladder were reviewed. PBT was defined as transfusion of red blood cells during RC or within the postoperative hospitalization. The primary outcome was overall survival. Clinical and pathologic variables were compared using chi-squared tests, and Cox multivariate survival analyses were performed.
Results
A total of 323 patients (41.6%) underwent PBT. In the univariate analysis, PBT was associated with increased overall mortality (HR 1.40, 95%CI 1.11–1.78). Additionally, an independent association was demonstrated in a nontransformed logistic regression model(HR, 95%CI 1.01–1.36) but not in a model utilizing restricted cubic splines(HR 1.03, 95%CI 0.77–1.38). The c-index was 0.78 for the first model and 0.79 for the second.
Conclusions
In a traditional multivariate model, mirroring those that have been applied to this question in the general surgery literature, we demonstrated an association between PBT and overall mortality after RC. However, this relationship is not observed in a second statistical model. Given the complex nature of adequately controlling for confounding factors in studies of PBT, prospective study will be necessary to fully elucidate the independent risks associated with PBT.
doi:10.1016/j.urolonc.2011.07.012
PMCID: PMC3253245  PMID: 21906965
Bladder Cancer; Cystectomy; Transfusion; Blood
11.  Early Detection of Prostate Cancer: AUA Guideline 
The Journal of urology  2013;190(2):419-426.
Purpose
The guideline purpose is to provide the urologist with a framework for the early detection of prostate cancer in asymptomatic average risk men.
Materials and Methods
A systematic review was conducted and summarized evidence derived from over 300 studies that addressed the predefined outcomes of interest (prostate cancer incidence/mortality, quality of life, diagnostic accuracy and harms of testing). In addition to the quality of evidence, the panel considered values and preferences expressed in a clinical setting (patient-physician dyad) rather than having a public health perspective. Guideline statements were organized by age group in years (age <40; 40 to 54; 55 to 69; >70).
Results
With the exception of prostate-specific antigen (PSA)-based prostate cancer screening, there was minimal evidence to assess the outcomes of interest for other tests. The quality of evidence for the benefits of screening was moderate, and evidence for harm was high for men age 55 to 69 years. For men outside this age range, evidence was lacking for benefit, but the harms of screening, including over diagnosis and over treatment, remained. Modeled data suggested that a screening interval of two years or more may be preferred to reduce the harms of screening.
Conclusions
The Panel recommended shared decision-making for men age 55 to 69 years considering PSA-based screening, a target age group for whom benefits may outweigh harms. Outside this age range, PSA-based screening as a routine could not be recommended based on the available evidence. The entire guideline is available at www.AUAnet.org/education/guidelines/prostate-cancer-detection.cfm
doi:10.1016/j.juro.2013.04.119
PMCID: PMC4020420  PMID: 23659877
prostate cancer; prostate specific antigen; screening; early detection
12.  Factors Influencing Patients’ Acceptance and Adherence to Active Surveillance 
Clinical decision making in localized prostate cancer is a complicated, multidimensional process in which men often consider their own personal preferences, the advice of their healthcare providers, the opinions of their family and friends, and outside information sources. They synthesize all of this within the framework of their own unique socioeconomic situation, their social support network, and their preconceived impressions of their health and the health-care system. This is particularly germane when considering factors that influence a patient’s acceptance of and adherence to active surveillance (AS). We propose a conceptual framework based on a previously described systematic–heuristic theoretical model of decision making in this setting. We identify a number of factors that patients systematically prioritize when considering AS. These include desire for cancer control or cure, age at diagnosis, and concern regarding side effects of treatment. The way patients value these factors and effectively decide on treatment is influenced by more heuristic factors, including physician recommendation, opinion of friends and family members, and overall decision uncertainty. These heuristic factors also play an important role in adherence when a patient elects AS. Finally, some of the factors, particularly the heuristic ones, are potentially modifiable and may serve as targets for future interventions to increase acceptance of and adherence to AS.
doi:10.1093/jncimonographs/lgs024
PMCID: PMC3540870  PMID: 23271775
13.  Optimization of Initial Prostate Biopsy in Clinical Practice: Sampling, Labeling, and Specimen Processing 
The Journal of urology  2013;189(6):2039-2046.
Purpose
An optimal prostate biopsy in clinical practice is based on a balance between adequate detection of clinically significant prostate cancers (sensitivity), assuredness regarding the accuracy of negative sampling (negative predictive value [NPV]), limited detection of clinically insignificant cancers, and good concordance with whole-gland surgical pathology results to allow accurate risk stratification and disease localization for treatment selection. Inherent within this optimization is variation of the core number, location, labeling, and processing for pathologic evaluation. To date, there is no consensus in this regard. The purpose of this review is 3-fold: 1. To define the optimal number and location of biopsy cores during primary prostate biopsy among men with suspected prostate cancer, 2. To define the optimal method of labeling prostate biopsy cores for pathologic processing that will provide relevant and necessary clinical information for all potential clinical scenarios, and 3. To determine the maximal number of prostate biopsy cores allowable within a specimen jar that would not preclude accurate histologic evaluation of the tissue.
Materials and Methods
A bibliographic search covering the period up to July, 2012 was conducted using PubMed®. This search yielded approximately 550 articles. Articles were reviewed and categorized based on which of the three objectives of this review was addressed. Data was extracted, analyzed, and summarized. Recommendations based on this literature review and our clinical experience is provided.
Results
The use of 10–12-core extended-sampling protocols increases cancer detection rates (CDRs) compared to traditional sextant sampling methods and reduces the likelihood that patients will require a repeat biopsy by increasing NPV, ultimately allowing more accurate risk stratification without increasing the likelihood of detecting insignificant cancers. As the number of cores increases above 12 cores, the increase in diagnostic yield becomes marginal. Only limited evidence supports the use of initial biopsy schemes involving more than 12 cores or saturation. Apical and laterally directed sampling of the peripheral zone increases CDR, reduces the need for repeat biopsies, and predicts pathological features on prostatectomy while transition-zone biopsies do not. There is little data to suggest that knowing the exact site of an individual positive biopsy core provides meaningful clinical information. However, determining laterality of cancer on biopsy may be helpful for both predicting sites of extracapsular extension and therapeutic planning. Placement of multiple biopsy cores in a single container (>2) appears to compromise pathologic evaluation, which can reduce CDR and increase the likelihood of equivocal diagnoses.
Conclusions
A 12-core systematic biopsy that incorporates apical and far-lateral cores in the template distribution allows maximal cancer detection, avoidance of a repeat biopsy, and adequate information for both identifying men who need therapy and planning that therapy while minimizing the detection of occult, indolent prostate cancers. This literature review does not provide compelling evidence that individual site-specific labeling of cores benefits clinical decision-making regarding the management of prostate cancer. Based upon the available literature, we recommend packaging no more than two cores in each jar to avoid reduction of CDR through inadequate tissue sampling.
doi:10.1016/j.juro.2013.02.072
PMCID: PMC3925148  PMID: 23485507
14.  Patterns and Predictors of Urodynamics Use in the United States 
The Journal of urology  2012;189(5):1791-1796.
Purpose
Due to the paucity of data on urodynamics on the national level, we assessed the use of urodynamics in a large sample of individuals in the United States and identified predictors of increased complexity of urodynamic procedures.
Materials and Methods
Using administrative health care claims for adults enrolled in private insurance plans in the United States from 2002 to 2007, we identified those who underwent cystometrogram and abstracted relevant demographic and clinical data. We used logistic regression to identify predictors of higher urodynamic complexity over basic cystometrogram, specifically cystometrogram plus pressure flow study and videourodynamics.
Results
We identified 16,574 urodynamic studies, of which 23% were cystometrograms, 71% were cystometrograms plus pressure flow studies and 6% were videourodynamics. Stress incontinence was the most common clinical condition for all studies (33.7%), cystometrogram (30.8%), cystometrogram plus pressure flow study (35.4%) and videourodynamics (24.4%). Urologists performed 59.8% of all urodynamics and gynecologists performed 35.5%. Providers with 14 or more urodynamic studies during the study period performed 75% of all urodynamics and were more likely to perform cystometrogram plus pressure flow study and videourodynamics. On regression analysis the most consistent predictors of cystometrogram plus pressure flow study and/or videourodynamics over cystometrogram were specialty (urologist) and the number of urodynamic tests performed by the provider.
Conclusions
Most urodynamics in this series consisted of cystometrogram plus pressure flow study with stress incontinence the most common diagnosis. However, regardless of diagnosis, urologists and providers who performed more urodynamics were more likely to perform pressure flow study and/or videourodynamics in addition to cystometrogram. Further research is needed to determine whether these differences reflect gaps in the consistency or appropriateness of using urodynamics.
doi:10.1016/j.juro.2012.11.066
PMCID: PMC3984034  PMID: 23159270
urinary bladder; neurogenic; urinary incontinence; urodynamics; physician’s practice patterns; diagnosis
15.  Immediate Effects of the Initial FDA Notification on the Use of Surgical Mesh for Pelvic Organ Prolapse Surgery in Medicare Beneficiaries 
Neurourology and urodynamics  2012;32(4):330-335.
Aims
Prompted by increased reports of complications with the use of mesh for pelvic organ prolapse (POP) surgery, the FDA issued an initial public health notification (PHN) in 2008. We proposed to determine if the numbers of POP cases augmented with surgical mesh performed in U.S. Medicare beneficiaries changed relative to this PHN.
Methods
Using administrative healthcare claims for beneficiaries enrolled in the U.S. Medicare program from 2008 to 2009, we identified women who underwent POP surgery with and without surgical mesh by procedural and diagnosis coding. In addition to comparing cases with and without mesh, we also calculated rates (number of cases per 100,000 female beneficiaries) and compared these relative to the timing of the PHN.
Results
We identified 104,185 POP procedures, of which 27,839 (26.7%) included mesh material and 76,346 (73.3%) did not. Between the last three quarters of 2008 and the first three of 2009, the rates of mesh cases increased (40.3–42.1, P < 0.001) and those without mesh decreased (115.5–111.4, P < 0.001). Inpatient procedures decreased and outpatient procedures increased for both those with and without mesh augmentation. For inpatient procedures, the relative use of biologic graft and synthetic mesh material did not vary over the study period.
Conclusions
A substantial number of Medicare beneficiaries underwent mesh POP procedures in 2008–2009. However, despite the PHN cautioning about potential mesh complications, the numbers of mesh cases continued to rise in the immediate period after the PHN.
doi:10.1002/nau.22318
PMCID: PMC3962985  PMID: 23001605
pelvic organ prolapse; surgical mesh; U.S. Food and Drug Administration; U.S. Medicare program
16.  Obesity, Physical Activity and Lower Urinary Tract Symptoms: Results from the Southern Community Cohort Study 
The Journal of Urology  2011;186(6):2316-2322.
Purpose
Obesity and physical activity (PA) have been posited as modifiable risk factors to delay lower urinary tract symptom (LUTS) progression. This purpose of this study was to determine the independent associations between PA and obesity with LUTS at follow-up among white and African American men.
Materials and Methods
Male participants aged 40–79 were identified from the Southern Community Cohort Study, a prospective cohort based in the southeastern U.S. Baseline data collection included a validated PA questionnaire, height and weight, health history, and other information. We excluded participants with a history of or medication use for benign prostatic hyperplasia or prostate cancer. Participants (n=7318, 60% African American) completed the International Prostate Symptom Score (IPSS) approximately 5 years after baseline. An IPSS score greater than 8 or 20 were classified as having moderate or severe LUTS, respectively, at follow-up. Multivariable logistic regression was used to assess the relationships between obesity, PA and LUTS.
Results
Moderate to severe LUTS severity at follow-up was significantly associated with a BMI of 35 or more (OR=1.38, 95%CI: 1.17–1.63). Similarly, the lowest categories of PA were associated with severe LUTS onset in men with a normal BMI (OR=1.38, 95%CI: 1.05–1.82). These associations were independent of race.
Conclusions
Severe obesity is associated with increased risk of LUTS at follow-up, while physical inactivity may permit LUTS progression among normal weight men, regardless of race. These variables should be considered in future research into modifiable risk factors for LUTS.
doi:10.1016/j.juro.2011.07.067
PMCID: PMC3327364  PMID: 22014824
Benign prostatic hyperplasia; lower urinary tract symptoms; obesity; physical activity; race
17.  Factors associated with satisfaction with prostate cancer care: results from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) 
BJU international  2012;111(2):213-220.
Objectives
To evaluate the impact of demographic, clinical, treatment and patient-reported parameters on satisfaction with prostate cancer care.
Despite the significant worldwide impact of prostate cancer, few data are available specifically addressing satisfaction with treatment-related care.
Patients and methods
CaPSURE comprises participants from 40 US sites who were monitored during and after their treatment course.
Participants who were diagnosed with clinically localized prostate cancer after 1999 underwent radical prostatectomy, radiation therapy or primary androgen deprivation, and those who also completed the satisfaction questionnaire within 2 years of treatment were included in the present study.
Satisfaction was measured using a validated instrument that assesses contact with providers, confidence in providers, communication skills, humanness and overall satisfaction.
Multivariable linear regression analysis were performed to evaluate the independent
relationships between demographic, clinical, treatment and patient-reported parameters
and satisfaction.
Results
Of the 3056 participants, 1927 (63%) were treated with radical prostatectomy, 843 (28%) were treated with radiation therapy and 286 (9%) were treated with primary androgen deprivation.
Multivariable analysis showed that multiple patient-reported factors were independently associated with satisfaction, whereas clinical, demographic and treatment parameters were not.
Baseline health-related quality of life, measured by the 36-item short-form health survey, baseline fear of cancer recurrence (all P < 0.01) and declines in the sexual (P = 0.03), urinary (P < 0.01) and bowel (P = 0.02) function domains of the University of California Los Angeles Prostate Cancer Index were all independently associated with satisfaction.
Patient-reported outcomes were more strongly associated with satisfaction in the low-risk subgroup.
Conclusions
Patient-reported factors such as health-related quality of life and fear of cancer recurrence are independently associated with satisfaction with care
Pretreatment parameters should be used to identify populations at-risk for dissatisfaction to allow for intervention and/or incorporation into treatment decision-making
doi:10.1111/j.1464-410X.2012.11423.x
PMCID: PMC3540193  PMID: 22928860
prostate cancer; quality of care; quality of life; satisfaction
18.  Predictors of Intravesical Therapy Use in Non-Muscle Invasive Bladder Cancer: Results from the Surveillance, Epidemiology, And End-Results Program’s 2003 Patterns of Care Project 
The Journal of Urology  2008;180(2):520-524.
Introduction
In response to variations in cancer care, organizations have developed clinical guidelines. In the case of non-muscle invasive bladder cancer (also known as superficial bladder cancer), two similar sets of guidelines were released in the late 1990’s that provide care recommendations. The purpose of this study was to examine patterns of intravesical therapy utilization in non-muscle invasive bladder cancer in 2003, to determine if disparities in the quality of cancer care remained.
Methods
Data from the Surveillance, Epidemiology, and End-Results (SEER) Program’s 2003 bladder cancer patterns of care project were used. Subjects newly diagnosed with non-muscle invasive bladder cancer in 2003 were included. Clinical and sociodemographic data were obtained from the SEER program and detailed medical record review. Statistical analyses were performed to identify independent predictors of intravesical therapy use in the entire cohort and in a subset of high-risk patients.
Results
685 patients were included in the study. 216 (31.5%) patients received intravesical therapy. In addition to higher tumor stage and grade, intravesical therapy use was independently associated with race/ethnicity and geographic region. In the subset of 350 high-risk patients, 42% received intravesical therapy. Stage, grade, race/ethnicity and geographic region were independently associated with intravesical therapy use in this sub-cohort.
Conclusions
These data suggest there is underutilization of intravesical therapy, even in patients with high-risk non-muscle invasive bladder cancer, and disparities in the quality of care exist. Barriers to utilization of this cancer treatment must be identified, particularly in higher-risk individuals, and providers must become more aware of existing clinical guidelines.
doi:10.1016/j.juro.2008.04.016
PMCID: PMC3327445  PMID: 18550088
non-muscle invasive bladder cancer; intravesical therapy; disparities; quality of care; clinical guidelines
19.  The prostate cancer conundrum revisited: Treatment changes and prostate cancer mortality declines 
Cancer  2012;118(23):5955-5963.
Background
Prostate cancer mortality rates in the US declined by over 40% between 1991 and 2005. The impact of changes in primary treatment and adjuvant and neoadjuvant hormonal therapy on this decline is unknown.
Methods
Application of three independently developed models of prostate cancer natural history and disease detection under common assumptions about treatment patterns, treatment efficacy, and survival in the population. Primary treatment patterns are from the Surveillance, Epidemiology and End Results registry and hormonal therapy frequencies are from the CaPSURE database; treatment efficacies are based on estimates from randomized trials and comparative effectiveness studies of treatment alternatives. The models project prostate cancer mortality without PSA screening and in the presence and absence of treatment benefit. Impact of primary treatment is expressed as a fraction of the difference between observed mortality and projected mortality in the absence of treatment benefit.
Results
The three models project that changes in treatment explain 22–33% of the mortality decline by 2005. These contributions are accounted for mostly by surgery and radiation therapy, which increased in frequency until the 1990s; hormonal therapies contributed little to the mortality decline by 2005. Assuming that treatment benefit is less for older men, changes in treatment explain only 16–23% of the mortality decline by 2005.
Conclusions
Changes in primary treatment explain a minority of the observed decline in prostate cancer mortality. The remainder of the decline is likely due to other interventions, such as PSA screening and advances in the treatment of recurrent and progressive disease.
doi:10.1002/cncr.27594
PMCID: PMC3424303  PMID: 22605665
Computer simulation; mortality; prostatectomy; prostatic neoplasms; radiotherapy; surveillance
20.  Racial Variation in the Quality of Surgical Care for Prostate Cancer 
The Journal of urology  2012;188(4):1279-1285.
Purpose
Difference in the quality of care may contribute to the less optimal prostate cancer treatment outcomes among Blacks compared with Whites. Our objective was to determine whether a racial quality of care gap exists in surgical care for prostate cancer, as evidenced by racial variation in the utilization of high-volume surgeons and facilities, and in certain outcome measures of care quality.
Materials and Methods
We performed cross-sectional and cohort analyses of administrative data from the Healthcare Cost and Utilization Project's all-payer State Inpatient Databases, encompassing all non-Federal hospitals in Florida, Maryland and New York State (1996-2007). Included were men 18 or older with a diagnosis of prostate cancer who underwent radical prostatectomy. We compared use of surgeons and/or hospitals in the top quartile of annual volume for this procedure, inpatient blood transfusion, complications, mortality and length of stay (LOS) between Black and White patients.
Results
Among 105,972 cases, 81,112 (76.5%) were White, 14,006 (13.2%) were Black, 6,999 (6.6%) were Hispanic and 3,855 (3.6%) were All Other. In mixed effects multivariate models, Blacks had markedly lower use of high-volume hospitals (Odds Ratio [OR] = 0.73, 95% Confidence interval [0.70, 0.76]), and surgeons (0.67 [0.64, 0.70]) compared to Whites. Blacks also had a higher odds of receiving a blood transfusion (1.08 [1.01, 1.14]), of longer LOS (1.07 [1.06, 1.07]) and of inpatient mortality (1.73 [1.02, 2.92]).
Conclusions
Using an all-payer dataset, we identified concerning potential quality of care gaps between Blacks and Whites undergoing radical prostatectomy for prostate cancer.
doi:10.1016/j.juro.2012.06.037
PMCID: PMC3770766  PMID: 22902011
Health disparities; quality of care; prostate cancer; surgery
21.  Long-Term Functional Outcomes after Treatment for Localized Prostate Cancer 
The New England journal of medicine  2013;368(5):436-445.
Background
The purpose of this analysis was to compare long-term urinary, bowel, and sexual function after radical prostatectomy or external-beam radiation therapy.
Methods
The Prostate Cancer Outcomes Study (PCOS) enrolled 3533 men in whom prostate cancer had been diagnosed in 1994 or 1995. The current cohort comprised 1655 men in whom localized prostate cancer had been diagnosed between the ages of 55 and 74 years and who had undergone either surgery (1164 men) or radiotherapy (491 men). Functional status was assessed at baseline and at 2, 5, and 15 years after diagnosis. We used multivariable propensity scoring to compare functional outcomes according to treatment.
Results
Patients undergoing prostatectomy were more likely to have urinary incontinence than were those undergoing radiotherapy at 2 years (odds ratio, 6.22; 95% confidence interval [CI], 1.92 to 20.29) and 5 years (odds ratio, 5.10; 95% CI, 2.29 to 11.36). However, no significant between-group difference in the odds of urinary incontinence was noted at 15 years. Similarly, although patients undergoing prostatectomy were more likely to have erectile dysfunction at 2 years (odds ratio, 3.46; 95% CI, 1.93 to 6.17) and 5 years (odds ratio, 1.96; 95% CI, 1.05 to 3.63), no significant between-group difference was noted at 15 years. Patients undergoing prostatectomy were less likely to have bowel urgency at 2 years (odds ratio, 0.39; 95% CI, 0.22 to 0.68) and 5 years (odds ratio, 0.47; 95% CI, 0.26 to 0.84), again with no significant between-group difference in the odds of bowel urgency at 15 years.
Conclusions
At 15 years, no significant relative differences in disease-specific functional outcomes were observed among men undergoing prostatectomy or radiotherapy. Nonetheless, men treated for localized prostate cancer commonly had declines in all functional domains during 15 years of follow-up. (Funded by the National Cancer Institute.)
doi:10.1056/NEJMoa1209978
PMCID: PMC3742365  PMID: 23363497
22.  Salvage Robotic-Assisted Laparoscopic Radical Prostatectomy: A Single Institution, Five-Year Experience 
The Journal of urology  2012;189(2):507-513.
Purpose
Salvage robotic-assisted laparoscopic prostatectomy (sRALP) is a treatment option for certain patients with recurrent prostate cancer (CaP) after primary therapy. Data regarding patient selection, complication rates, and cancer outcomes are scarce. Here, we report the largest, single-institution series to date of sRALP.
Methods
We reviewed our database of 4,234 patients who have undergone robotic-assisted laparoscopic prostatectomy at Vanderbilt University and identified 34 men who had surgery after failure of prior definitive ablative therapy. Each patient had biopsy-proven recurrent CaP and no evidence of metastases. The primary outcome measure was biochemical failure (BCF).
Results
The median time from primary therapy to sRALP was 48.5 months with a median PSA prior to sRALP of 3.86 ng/mL. Most patients had Gleason scores ≤ 7 on pre-sRALP biopsy, although 12 patients (35%) had ≥ Gleason 8 disease. After a median follow-up of 16 months, 18% had BCF. The positive margin rate was 26%, of which 33% had BCF following surgery. On univariable analysis, there was a significant association between PSA doubling time and BCF (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.60-0.99; p=0.049) as well as between Gleason score at original diagnosis and BCF (HR 3.49, 95% CI 1.18-10.3; p=0.023). There were two Clavien II-III complications: a pulmonary embolism and a rectal laceration. Post-operatively, 39% had excellent continence.
Conclusions
sRALP is safe, with many outcomes favorable to open, salvage radical prostatectomy series. Advantages include superior visualization of the posterior prostatic plane, modest blood loss, low complication rates, and short length of stay.
doi:10.1016/j.juro.2012.09.057
PMCID: PMC3698478  PMID: 23000849
Prostate Cancer; Salvage Therapy; Robotics; Prostatectomy; Outcomes Assessment
23.  Complementary and Alternative Medicine use, Patient Reported Outcomes, and Treatment Satisfaction among Men with Localized Prostate Cancer 
Urology  2012;79(5):1034-1041.
Objectives
We sought to evaluate the association between complementary and alternative medicine (CAM) use, satisfaction with treatment, and patient-reported outcomes following treatment.
Methods
The Prostate CAncer Therapy Selection Study (PCATS) prospectively surveyed patients newly diagnosed with localized prostate cancer about their treatment decision making process and outcomes. The PCATS study recruited patients in three geographic areas through hospital-based urology clinics and community urology practices.
Results
More than 700 patients completed the baseline and follow-up surveys. More than 50% of respondents reported using CAM, 39% if prayer was excluded as a type of CAM. In multivariate analysis, factors related to communication with the treating physician, but not CAM use, were associated with treatment satisfaction. The likelihood of stability or improvement in urinary, bowel, and sexual function at 6 months was related to the choice of primary therapy, but unrelated to CAM use.
Conclusions
In this prospective observational study, CAM use was highly prevalent but unrelated to treatment satisfaction or changes in functional status. The impact of CAM on these endpoints remains to be established in comparative effectiveness studies.
doi:10.1016/j.urology.2012.01.023
PMCID: PMC3489914  PMID: 22546381
prostate cancer; complementary and alternative medicine; urinary function; sexual function; bowel function; treatment satisfaction
24.  Sexual Dysfunction and Symptom Impact in Men with Long-Standing Type 1 Diabetes in the DCCT/EDIC Cohort 
The journal of sexual medicine  2009;6(7):1969-1978.
Introduction
Male sexual dysfunction is a common complication of diabetes (DM), but the relative impact of erectile dysfunction (ED), orgasmic dysfunction (OD), and/or decreased libido (DL) on global sexual bother has not been assessed.
Aim
To assess the relationship between ED, OD, and DL and overall sexual satisfaction in men with type 1 DM, and determine which form of dysfunction causes the most bother.
Methods
The study cohort consisted of 713 men with type 1 DM who completed the Diabetes Control and Complication Trial and then participated in the follow-up Epidemiology of Diabetes Interventions and Complications Study. In year 10 of EDIC, 583 (83%) completed a validated instrument assessing ED, OD, and DL and the bother these conditions cause. Statistical tests determined the concordance of function and bother in each domain, and the impact of each domain on overall sexual satisfaction.
Main Outcome Measures
Patient-reported outcomes using responses to individual items of the International Index of Erectile Function (IIEF).
Results
ED was present in 34%, OD in 20%, and DL in 55%. When correlated with overall sexual satisfaction, ED had the highest weighted kappa (0.84, 95% confidence interval [CI] = 0.80–0.87), while OD (0.57, 95% CI = 0.51–0.63) and DL (0.55, 95%CI = 0.48–0.62) were considerably lower. Furthermore, the single item assessing confidence in getting and keeping an erection had the strongest correlation with overall sexual bother as well as specific erectile bother.
Conclusions
ED, OD, and DL are highly prevalent in men with long-standing type I diabetes. All three sexual dysfunctions cause bother in men with DM, but ED causes more general sexual bother and likely has a greater overall impact on quality of life. Our data underscore the importance of asking men with DM about their sexual function and point to the need for further research to investigate disorders of orgasm and desire.
doi:10.1111/j.1743-6109.2009.01292.x
PMCID: PMC2861494  PMID: 19453899
Male Sexual Dysfunction; Diabetes; Erectile Dysfunction; Questionnaire
25.  Association Between Socioeconomic Status (SES) and Lower Urinary Tract Symptom (LUTS) Severity Among Black and White Men 
Journal of General Internal Medicine  2011;26(11):1305-1310.
ABSTRACT
BACKGROUND
A higher prevalence of moderate or severe lower urinary tract symptoms (LUTS) has been reported among African Americans, but the separate effects of race and socioeconomic status (SES) on LUTS severity are unclear.
OBJECTIVE
We investigated the roles of education, income, marital status, and source of health insurance on LUTS reporting among black and white U.S. men.
DESIGN
A prospective cohort within the Southern Community Cohort Study
MAIN MEASURES
The International Prostate Symptom Score (IPSS) was completed during follow-up by 2488 white men and 4188 black men. Multivariable linear and logistic regression methods were used to compare IPSS scores and LUTS severity by race and SES after adjusting for age, duration of follow-up, benign prostatic hyperplasia (BPH) treatment, source of recruitment, smoking status, BMI, mode of follow-up ascertainment, and prior diagnosis of hypertension, diabetes, or hypercholesterolemia.
KEY RESULTS
Overall IPSS scores and the prevalence of moderate/severe LUTS were not significantly associated with race. Instead, higher IPSS scores were significantly associated (p < 0.05) with a lower income, marital status, and source of insurance. Education was also marginally associated with IPSS scores (p = 0.06) among black men. Furthermore, moderate/severe LUTS onset was significantly associated with a household income less than $15,000/year (OR = 1.56 (1.23, 1.96)) and having private health insurance (OR = 0.79 (0.67, 0.93)).
CONCLUSIONS
Social or behavioral factors related to SES affect LUTS reporting, and suggests a potential affect on BPH diagnosis.
doi:10.1007/s11606-011-1776-8
PMCID: PMC3208454  PMID: 21720905
benign prostatic hyperplasia; lower urinary tract symptoms; race; socio-economic status

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