An Empiric Evaluation of the Effect of Variation in Intensity of Followup for Surgically Treated Renal Neoplasms on Cancer Specific Survival.

PURPOSE: Followup protocols after the surgical management of renal cell carcinoma lack clear evidence linking the intensity of imaging surveillance to improved outcomes. In this context we characterized the relationship between surveillance imaging intensity and cancer specific survival. MATERIALS AND METHODS: Using SEER-Medicare data we identified 7,603 men with renal cell carcinoma treated surgically between 2004 and 2009. Multivariable negative binomial regression analysis was performed to assess the relationship between patient level characteristics and the variation in imaging intensity. We modeled the association between kidney cancer specific mortality and imaging intensity using Fine and Gray proportional subdistribution hazards regression with other cause death treated as a competing risk for 2 separate followup periods (15 and 36 months). RESULTS: More than 40% of patients in the short interval cohort and more than 50% in the intermediate interval group underwent no chest imaging during the evaluated survivorship period. More than 30% of patients in both followup periods had no abdominal imaging tests performed. Overall, followup imaging did not appear to confer an improvement in disease specific survival compared to undergoing no imaging in the 2 survivorship periods. CONCLUSIONS: There remains considerable variation in the posttreatment surveillance regimen for patients with renal cell carcinoma in the United States. More importantly, this study raises important questions regarding the link between posttreatment surveillance imaging and survival.

Perioperative complications of conduit urinary diversion with concomitant cystectomy for benign indications: A population-based analysis.

AIMS: Beyond single-institution case series, limited data are available to describe risks of performing a concurrent cystectomy at the time of urinary diversion for benign end-stage lower urinary tract dysfunction. Using a population-representative sample, this study aimed to analyze factors associated with perioperative complications in patients undergoing urinary diversion with or without cystectomy. METHODS: A representative sample of patients undergoing urinary diversion for benign indications was identified from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample from 1998 to 2011. Perioperative complications of urinary diversion with and without concomitant cystectomy were identified and coded using the International Classification of Diseases, version 9. Multivariate logistic regression models identified hospital and patient-level characteristics associated with complications of concomitant cystectomy with urinary diversion. RESULTS: There were 15,717 records for urinary diversion identified, of which 31.8% demonstrated perioperative complications: urinary diversion with concurrent cystectomy (35.0%) and urinary diversion without concomitant cystectomy (30.6%). Comparing the two groups, a concomitant cystectomy at the time of urinary diversion was significantly associated with a complication (OR = 1.23, 95%CI: 1.03-1.48). Comorbid conditions of obesity, pulmonary circulation disease, drug abuse, weight loss, and electrolyte disorders were positively associated with a complication, while private insurance and southern geographic region were negatively associated. CONCLUSIONS: A concomitant cystectomy with urinary diversion for refractory lower urinary tract dysfunction elevates risk in this population-representative sample, particularly in those with certain comorbid conditions. This analysis provides critical information for preoperative patient counseling.

Urinary retention and catheter use among U.S. female Medicare beneficiaries: Prevalence and risk factors.

AIMS: To identify the prevalence of and risk factors for urinary retention and catheterization among female Medicare beneficiaries. METHODS: We identified women with a diagnosis of urinary retention in a 5% sample of Medicare claims in 2012. Women were categorized into three groups based on the occurrence and duration of urinary catheterization within a 1 year period: 1) no catheterization; 2) short-term catheterization (ie, one or more catheterizations in less than 30 days); and 3) chronic catheterization (catheterizations in multiple 30 day periods within 1 year). We then identified a group of age-matched controls without catheterization or a diagnosis of urinary retention in 2012. Clinical and demographic data were collected for each patient, and risk factors for retention and catheterization were compared across groups. We assessed factors associated with urinary retention using multivariable logistic regression. RESULTS: We estimated the rate of retention to be 1532 per 100 000 U.S. female Medicare beneficiaries in 2012, with rates of short term and chronic catheterization estimated to be 160 and 108 per 100 000 women, respectively. Prior diagnoses of neurologic condition, urinary tract infection, and pelvic organ prolapse were positively associated with retention and catheterization in multivariable analyses. CONCLUSIONS: We estimated the prevalence of urinary retention diagnoses among female Medicare beneficiaries to be 1532 per 100 000 women. Retention and catheterization were significantly associated with comorbid disease, with the strongest associations identified with a concomitant diagnosis of neurologic condition, UTI, and POP.

Increasing use of observation among men at low risk for prostate cancer mortality.

PURPOSE: There are growing concerns regarding the overtreatment of localized prostate cancer. It is also relatively unknown whether there has been increased uptake of observational strategies for disease management. We assessed the temporal trend in observation of clinically localized prostate cancer, particularly in men with low risk disease, who were young and healthy enough to undergo treatment. MATERIALS AND METHODS: We performed a retrospective cohort study using the SEER-Medicare database in 66,499 men with localized prostate cancer between 2004 and 2009. The main study outcome was observation within 1 year after diagnosis. We performed multivariable analysis to develop a predictive model of observation adjusting for diagnosis year, age, risk and comorbidity. RESULTS: Observation was performed in 12,007 men (18%) with a slight increase with time from 17% to 20%. However, there was marked increase in observation from 18% in 2004 to 29% in 2009 in men with low risk disease. Men 66 to 69 years old with low risk disease and no comorbidities had twice the odds of undergoing observation in 2009 vs 2004 (OR 2.12, 95% CI 1.73-2.59). Age, risk group, comorbidity and race were independent predictors of observation (each p <0.001), in addition to diagnosis year. CONCLUSIONS: We identified increasing use of observation for low risk prostate cancer between 2004 and 2009 even in men young and healthy enough for treatment. This suggests growing acceptance of surveillance in this group of patients.

Gender, race, and variation in the evaluation of microscopic hematuria among Medicare beneficiaries.

BACKGROUND: Female gender and black race are associated with delayed diagnosis and inferior survival in patients with bladder cancer. OBJECTIVE: We aimed to determine the association between gender, race, and evaluation of microscopic hematuria (an early sign of bladder cancer). DESIGN AND PARTICIPANTS: This was a cohort study using a 5 % random sample of fee-for-service Medicare beneficiaries diagnosed with incident hematuria (International Classification of Diseases, Ninth Revision [ICD-9] code 599.7x) between January 2009 and June 2010 in a primary care setting. Beneficiaries with pre-existing explanatory diagnoses or genitourinary procedures were excluded. MAIN MEASURES: The main endpoint was completeness of the hematuria evaluation in the 180 days after diagnosis. Evaluations were categorized as complete, incomplete, or absent based on receipt of relevant diagnostic procedures and imaging studies. KEY RESULTS: In all, 9,211 beneficiaries met the study criteria. Hematuria evaluations were complete in 14 %, incomplete in 21 %, and absent in 65 % of subjects. Compared to males, females were less likely to have a procedure (26 vs. 12 %), imaging (41 vs. 30 %), and a complete evaluation (22 vs. 10 %) (p < 0.001 for each comparison). Receipt of a complete evaluation did not differ by race. Controlling for baseline characteristics, a complete evaluation was less likely in white women (OR, 0.40 [95 % CI, 0.35-0.46]) and black women (OR, 0.46 [95 % CI, 0.29-0.70]) compared to white men; no difference was found between black and white men. CONCLUSIONS: Women are less likely than men to undergo a complete and timely hematuria evaluation, a finding likely relevant to women's more advanced stage at bladder cancer diagnosis. System-level process improvement between providers of urologic and primary care in the evaluation of hematuria may benefit women harboring malignancy.

Trends in urodynamics in U.S. female medicare beneficiaries, 2000-2010.

AIMS: To document variations and temporal trends in the use of urodynamics (UDS) in female U.S. Medicare beneficiaries. METHODS: Using a 5% sample of U.S. Medicare utilization records, we identified female beneficiaries who had undergone UDS studies between 2000 and 2010 by the presence of Common Procedural Terminology codes for cystometrogram in claims from the Carrier file. We abstracted data for each patient on age, race, residence, ICD9 diagnoses, dates of service, and provider specialty. We calculated rates per 100,000 beneficiaries with data available from the enrollment files (i.e., Denominator files) and reported the numbers and rates per 100,000 by year. RESULTS: During this period, 1.4 million female U.S. Medicare beneficiaries underwent UDS, of which 6% were videourodynamics. Seventy four percent of UDS were associated with a diagnosis of any urinary incontinence, with 50% specific for stress incontinence. The annual rates of UDS increased by 29%, from 422 in 2000 to 543 in 2010 per 100,000. Similar increases were seen across age groups, geographic regions and racial/ethnic groups. The rate of UDS performed by gynecologists increased by 144% over the study period, while that of urologists decreased by 3%. In 2010, gynecologists performed 35% and urologists 58% of all UDS. CONCLUSIONS: The use of UDS in the female Medicare program increased substantially between 2000 and 2010, with some variation across demographics and marked variation across provider specialty.

Trends in the use of evidence-based therapy for resectable gastric cancer.

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 United States and to identify factors associated with receipt of evidence-based care. METHODS: We performed a retrospective cohort study of patients with Stage IB-IV (M0) gastric adenocarcinoma who underwent resection from 1991 to 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.

Centralization of radical prostatectomy in the United States.

PURPOSE: Radical prostatectomy is a common treatment for organ confined prostate cancer and its use is increasing. We examined how the increased volume is being distributed and what hospital characteristics are associated with increasing volume. MATERIALS AND METHODS: We identified all men age 40 to less than 80 years who underwent radical prostatectomy for prostate cancer from 2000 to 2008 in the NIS (Nationwide Inpatient Sample) (586,429). Ownership of a surgical robot was determined using the 2007 AHA (American Hospital Association) Annual Survey. The association between hospital radical prostatectomy volume and hospital characteristics, including ownership of a robot, was explored using multivariate linear regression. RESULTS: From 2000 to 2008 there was a 74% increase in the number of radical prostatectomies performed (p = 0.05) along with a 19% decrease in the number of hospitals performing radical prostatectomy (p <0.001), resulting in an increase in annual hospital radical prostatectomy volume (p = 0.009). Several hospital variables were associated with greater radical prostatectomy volume including teaching status, urban location, large bed size and ownership of a robot in 2007. On multivariate analysis the year, teaching status, large bed size, urban location and presence of a robot were associated with higher hospital radical prostatectomy volume. CONCLUSIONS: Use of radical prostatectomy increased significantly between 2000 and 2008, most notably after 2005. The increase in radical prostatectomy resulted in centralization to select hospitals, particularly those in the top radical prostatectomy volume quartile and those investing in robotic technology. Our findings support the hypothesis that hospitals with the greatest volume increases are specialty centers already performing a high volume of radical prostatectomy procedures.

Immediate effects of the initial FDA notification on the use of surgical mesh for pelvic organ prolapse surgery in medicare beneficiaries.

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.

Volume outcomes of cystectomy--is it the surgeon or the setting?

PURPOSE: Hospital volume and surgeon volume are each associated with outcomes after complex oncological surgery. However, the interplay between hospital and surgeon volume, and their impact on these outcomes has not been well characterized. We studied the relationship between surgeon and hospital volume, and overall mortality after radical cystectomy. MATERIALS AND METHODS: The SEER (Surveillance, Epidemiology and End Results)-Medicare linked database was used to identify 7,127 patients with urothelial carcinoma of the bladder who underwent radical cystectomy from 1992 to 2006. Hospital volume and surgeon volume were expressed by tertile. The primary outcome measure was overall survival. Covariates included age, Charlson comorbidity index, stage, grade, node count, node density, number of positive nodes, urinary diversion and year of surgery. Multivariate analyses using generalized linear multilevel models were used to determine the independent association between hospital and surgeon volume and survival. RESULTS: When hospital volume or surgeon volume was included in the multivariate model, a significant volume-survival relationship was observed for each. However, when both were in the model, hospital volume attenuated the impact of surgeon volume on mortality while the significant hospital volume-mortality relationship persisted (HR 1.18, 95% CI 1.08-1.30, p <0.01). In addition, the adjusted 3-year probability of survival was significantly correlated with hospital volume in each distinct surgeon volume stratum while survival was not correlated with surgeon volume in each hospital volume stratum. CONCLUSIONS: After adjustment for patient and disease characteristics, the relationship between surgeon volume and survival after radical cystectomy is accounted for by hospital volume. In contrast, hospital volume remained an independent predictor of survival, suggesting that structure and process characteristics of high volume hospitals drive long-term outcomes after radical cystectomy.

Cardiac rehabilitation and readmissions after heart transplantation.

BACKGROUND: Exercise-based cardiac rehabilitation (CR) is under-utilized. CR is indicated after heart transplantation, but there are no data regarding CR participation in transplant recipients. We characterized current CR utilization among heart transplant recipients in the United States and the association of CR with 1-year readmissions using the 2013-2014 Medicare files. METHODS: The study population included Medicare beneficiaries enrolled due to disability (patients on the transplant list are eligible for disability benefits under Medicare regulations) or age ≥65 years. We identified heart transplant patients by diagnosis codes and cumulative CR sessions occurring within 1 year after the transplant hospitalization. RESULTS: There were 2,531 heart transplant patients in the USA in 2013, of whom 595 (24%) received Medicare coverage and were included in the study. CR utilization was low, with 326 patients (55%) participating in CR programs. The Midwest had the highest proportion of transplant recipients initiating CR (68%, p = 0.001). Patients initiating CR attended a mean of 26.7 (standard deviation 13.3) sessions, less than the generally prescribed program of 36 sessions. Transplant recipients age 35 to 49 years were less likely to initiate CR (odds ratio [OR] 0.39, 95% confidence interval [CI] 0.23 to 0.66, p < 0.001) and attended 8.2 fewer sessions (95% CI 3.5 to 12.9, p < 0.001) than patients age ≥65 years. CR participation was associated with a 29% lower 1-year readmission risk (95% CI 13% to 42%, p = 0.001). CONCLUSIONS: Only half of cardiac transplant recipients participate in CR, and those who do have a lower 1-year readmission risk. These data invite further study on barriers to CR in this population.

Temporal Trends in Conduit Urinary Diversion With Concomitant Cystectomy for Benign Indications: A Population-based Analysis.

OBJECTIVE: To describe national trends in cystectomy at the time of urinary diversion for benign indications. Multiple practice patterns exist regarding the necessity for concomitant cystectomy with urinary diversion for benign end-stage lower urinary tract dysfunction. Beyond single-institution reports, limited data are available to describe how concurrent cystectomy is employed on a national level. MATERIALS AND METHODS: A representative sample of patients undergoing urinary diversion for benign indications with or without concurrent cystectomy was identified from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample from 1998 to 2011. Using multivariate logistic regression models, we identified hospital- and patient-level characteristics associated with concomitant cystectomy with urinary diversion. RESULTS: There was an increase in the proportion of concomitant cystectomy at the time of urinary diversion from 20% to 35% (P < .001) between 1998 and 2011. The increase in simultaneous cystectomy over time occurred at teaching hospitals (vs community hospitals), in older patients, in male patients, in the Medicare population (vs private insurance and Medicaid), and in those with certain diagnoses. CONCLUSION: There has been an overall increase in the use of cystectomy at the time of urinary diversion for benign indications on a national level, although the indications driving this clinical decision appear inconsistent.

Epidemiology of vocal fold paralyses after total thyroidectomy for well-differentiated thyroid cancer in a Medicare population.

OBJECTIVES: The 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 postoperative vocal fold paralyses and need for directed interventions in the Medicare population undergoing total thyroidectomy for WDTC. STUDY DESIGN: Retrospective cohort study. SETTING: US population. SUBJECTS AND METHODS: Subjects were Medicare beneficiaries. 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 5670 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 (odds ratio 0.95; 95% confidence interval, 0.93-0.97; P < .001). Overall, 22% of patients with vocal fold paralysis required surgical intervention (UVFP 21%, BVFP 28%). Multivariate logistic regression revealed that the odds of postthyroidectomy paralysis increased with each additional year of age, with non-Caucasian race, with particular histologic types, with advanced stage, and in particular registry regions. CONCLUSION: Annual rates of postthyroidectomy 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.

Trends in the multimodality treatment of resectable colorectal liver metastases: an underutilized strategy.

OBJECTIVE: Advances in multimodality therapy have led to increased survival for patients with metastatic colorectal cancer, but the impact on patients undergoing resection for colorectal liver metastases is unclear. The purpose of this study was to evaluate patterns of treatment for resectable colorectal liver metastases in the USA over the last two decades. METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare database, 1,926 patients who underwent hepatic resection for colorectal liver metastasis between 1991 and 2007 were included and divided into two cohorts: period 1 (1991-2000) and period 2 (2001-2007). Demographic data, treatment patterns, and outcomes of the two periods were compared by univariate methods. Multivariable regression models were constructed to predict the use of perioperative chemotherapy, postoperative complications, and 90-day mortality following liver resection. RESULTS: The overall use of perioperative chemotherapy was 33 % and did not differ between periods, but shifted from postoperative to preoperative over time. By multivariable analysis, older age, black race, stage III primary cancer, and metachronous disease were predictive of lesser likelihood of chemotherapy use. The use of preoperative chemotherapy was not associated with any increase in perioperative morbidity or mortality. CONCLUSIONS: Despite increased survival and widespread recommendations for the use of multimodality therapy, the overall resection rate and use of perioperative chemotherapy for resectable colorectal liver metastases remain underutilized and have not increased over time. Efforts to investigate barriers to the widespread use of multimodality therapy for these patients are warranted.

Lymph node yield at radical cystectomy predicts mortality in node-negative and not node-positive patients.

OBJECTIVE: To better define the relationship between lymph node count and survival in patients undergoing radical cystectomy for bladder cancer by identifying and controlling for key confounding variables in a large population-based cohort. Considerable controversy remains regarding the correlation between node count and survival, and most prior analyses have not accounted for both patient and provider factors. METHODS: The Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database was used to identify patients with urothelial bladder carcinoma who underwent radical cystectomy from 1992 to 2006. Patients were divided into 2 cohorts based on the presence or absence of nodal metastases, and we performed Cox regression analyses to evaluate the association between node count and survival. Covariates included age, Charlson comorbidity index, stage, grade, lymph node density, number of positive nodes, urinary diversion, chemotherapy, year of surgery, transfusion, and surgeon volume. RESULTS: The cohort consisted of 2391 node-negative and 779 node-positive patients. In node-negative patients, individuals with low node counts had significantly worse overall survival (OS) and disease-specific survival (DSS) compared to the highest node count tertile. In node-positive patients, node count was not an independent predictor of OS or DSS. CONCLUSION: Lymph node count at radical cystectomy is associated with both OS and DSS in patients without nodal metastases. However, in patients with node-positive disease, node count is not an independent predictor of survival suggesting that it is likely a proxy for other patient and provider factors in these individuals.