The monetary costs of pediatric upper urinary tract stone disease: Analysis in a contemporary United States cohort.

INTRODUCTION: The prevalence of upper urinary tract stone disease (USD) in the United States is rising among both adults and children. Studies on the contemporary economic burden of USD management in the pediatric population are lacking. OBJECTIVE: To comprehensively analyze the economic impact of USD in a contemporary United States pediatric cohort, and to evaluate drivers of cost. STUDY DESIGN: A retrospective cohort study of pediatric patients (aged 0-17), diagnosed with USD between 2011 and 2018 were identified from PearlDiver-Mariner, an all-payer claims database containing diagnostic, treatment and prescription data provided in all treatment settings. Relevant International Classification of Disease (ICD-9 and ICD-10) and Current Procedural Terminology (CPT) codes were used for identification, and only patients with claims recorded for at least one year before and after entry of a diagnosis code for USD were selected (N = 10,045). Patients were stratified into those undergoing operative vs. non-operative management and for each patient, total 1-year healthcare costs following USD diagnosis, including same day and non-same day encounters, were analyzed. Factors associated with increased spending, as well as economic trends were analyzed. RESULTS: Overall, 8498 (85%) patients were managed non-operatively, while 1547 (15%) underwent a total of 1880 procedural interventions. Total overall cost was $117.1 million, while median annual expenditure was $15.8 million. Proportion of spending for outpatient, inpatient and prescription services was 52%, 32% and 16%, respectively (Table). Outpatient management accounted for 67% of overall spending. The proportion of patients managed non-operatively increased significantly over time, in parallel with spending for non-operative care. Comorbidity burden, treatment year and geographic region were among predictors of costs. DISCUSSION: Our study is the first to report actual insurance reimbursements for pediatric USD management using actual reimbursement data, examined across all treatment settings. We found that majority of the costs were for outpatient services and for non-operative management, with a rising tendency toward non-operative management over time. Regional variation in expenditures was evident. Specific reasons underlying these observed patterns could not directly be discerned from our dataset, but merit further investigation. CONCLUSION: Non-operative and outpatient management for pediatric USD are increasingly common, resulting in parallel shifts in spending. Notably, 52% of overall spending was for outpatient care. These insights into the contemporary economic burden of pediatric USD could provide value in shaping future healthcare policy.

Contemporary Assessment of the Economic Burden of Upper Urinary Tract Stone Disease in the United States: Analysis of One-Year Health Care Costs, 2011-2018.

Background: The U.S. health care landscape has witnessed numerous changes since implementation of the Affordable Care Act coupled with rising prevalence of upper urinary tract stone disease (SD). Data on the economic burden of SD during this period are lacking, providing the objective of our study. Materials and Methods: Adults diagnosed as having SD from 2011 to 2018 were identified from PearlDiver Mariner, a national all-payer database reporting reimbursements and prescription costs for all health care encounters. Patients undergoing operative and nonoperative care were identified. Time trends in annual expenditures were evaluated. Multivariable analysis evaluated determinants of spending. Results: A total of $10 billion were spent on SD management between 2011 and 2018 (median overall annual expenditure = $1.4 billion) among 786,756 patients. Inpatient, prescription, and outpatient costs accounted for 34.7%, 20.7%, and 44.6% of expenditures, respectively. Seventy-eight percent of patients were managed nonoperatively (total cost = $6.9 billion). The average overall cost per encounter was $13,587 ($17,102 for surgical vs $11,174 for nonsurgical care). Expenditures on inpatient care decreased significantly over time, while expenditures on prescriptions and outpatient care increased significantly. On multivariable analysis, a higher Charlson Comorbidity Index (CCI) was associated with higher spending, while associations for age, insurance, and region varied by treatment modality. Conclusions: The economic burden of SD management is substantial, dominated by expenditure on nonoperative management and outpatient care. Expenditures for prescription and outpatient care are rising, with the only consistent predictor of higher spending being CCI. Spending variation according to demographic, clinical, and geographic factors was evident.

Identifying and treating ROBO1-ve /DOCK1+ve prostate cancer: An aggressive cancer subtype prevalent in African American patients.

BACKGROUND: There is a need to develop novel therapies which could be beneficial to patients with prostate cancer (CaP) including those who are predisposed to poor outcome, such as African-Americans. This study investigates the role of ROBO1-pathway in predicting outcome and race-based disparity in patients with CaP. METHODS AND RESULTS: Aided by RNA sequencing-based DECIPHER-testing and immunohistochemical (IHC) analysis of tumors we show that ROBO1 is lost during the progressive stages of CaP, a prevalent feature in African-Americans. We show that the loss of ROBO1 predicts high-risk of recurrence, metastasis and poor outcome of androgen-deprivation therapy in radical prostatectomy-treated patients. These data identified an aggressive ROBO1deficient /DOCK1+ve sub-class of CaP. Combined genetic and IHC data showed that ROBO1 loss is accompanied by DOCK1/Rac1 elevation in grade-III/IV primary-tumors and Mets. We observed that the hypermethylation of ROBO1-promoter contributes to loss of expression that is highly prevalent in African-Americans. Because of limitations in restoring ROBO1 function, we asked if targeting the DOCK1 could be an ideal strategy to inhibit progression or treat ROBO1deficient metastatic-CaP. We tested the pharmacological efficacy of CPYPP, a selective inhibitor of DOCK1 under in vitro and in vivo conditions. Using ROBO1-ve and ROBO1+ve CaP models, we determined the median effective concentration of CPYPP for growth. DOCK1-inhibitor treatment significantly decreased the (a) Rac1-GTP/ß-catenin activity, (b) transmigration of ROBO1deficient cells across endothelial lining, and (c) metastatic spread of ROBO1deficient cells through the vasculature of transgenicfl Zebrafish model. CONCLUSION: We suggest that ROBO1 status forms as predictive biomarker of outcome in high-risk populations such as African-Americans and DOCK1-targeting therapy has a clinical potential for treating metastatic-CaP.

Evidence-based Assessment of Current and Emerging Bladder-sparing Therapies for Non-muscle-invasive Bladder Cancer After Bacillus Calmette-Guerin Therapy: A Systematic Review and Meta-analysis.

CONTEXT: Currently, there is no standard of care for patients with non-muscle-invasive bladder cancer (NMIBC) who recur despite bacillus Calmette-Guerin (BCG) therapy. Although radical cystectomy is recommended, many patients decline to undergo or are ineligible to receive it. Multiple agents are being investigated for use in this patient population. OBJECTIVE: To systematically synthesize and describe the efficacy and safety of current and emerging treatments for NMIBC patients after treatment with BCG. EVIDENCE ACQUISITION: A systematic literature search of MEDLINE, Embase, and the Cochrane Controlled Register of Trials (period limited to January 2007-June 2019) was performed. Abstracts and presentations from major conference proceedings were also reviewed. Randomized controlled trials were assessed using the Cochrane risk of bias tool. Data for single-arm trials were pooled using a random-effect meta-analysis with the proportions approach. Trials were grouped based on the minimum number of prior BCG courses required before enrollment and further stratified based on the proportion of patients with carcinoma in situ (CIS). EVIDENCE SYNTHESIS: Thirty publications were identified with data from 23 trials for meta-analysis, of which 17 were single arm. Efficacy and safety outcomes varied widely across studies. Heterogeneity across trials was reduced in subgroup analyses. The pooled 12-mo response rates were 24% (95% confidence interval [CI]: 16-32%) for trials with two or more prior BCG courses and 36% (95% CI: 25-47%) for those with one or more prior BCG courses. In a subgroup analysis, inclusion of ≥50% of patients with CIS was associated with a lower response. CONCLUSIONS: The variability in efficacy and safety outcomes highlights the need for consistent endpoint reporting and patient population definitions. With promising emerging treatments currently in development, efficacious and safe therapeutic options are urgently needed for this difficult-to-treat patient population. PATIENT SUMMARY: We examined the efficacy and safety outcomes of treatments for non-muscle-invasive bladder cancer after bacillus Calmette-Guerin therapy. Outcomes varied across studies and patient populations, but emerging treatments currently in development show promising efficacy.

A Cost-effectiveness Analysis of Systemic Therapy for Metastatic Hormone-sensitive Prostate Cancer.

BACKGROUND: Following the recent publication of results from randomized trials that have demonstrated a survival benefit for the addition of docetaxel or abiraterone acetate to androgen deprivation therapy (ADT) in the treatment of metastatic prostate cancer, it is important to assess whether the benefits of treatment with these agents outweigh their costs. OBJECTIVE: To perform a cost-effectiveness analysis of immediate docetaxel or abiraterone acetate treatment in addition to ADT in men with metastatic hormone-sensitive prostate cancer (PC). DESIGN, SETTING, AND PARTICIPANTS: We developed a state-transition model to simulate the natural progression of metastatic PC. Model parameters were derived from the published literature and through calibration to observed epidemiological data. Following diagnosis, a hypothetical cohort of men with metastatic hormone-sensitive PC could be treated with docetaxel+ADT, abiraterone+ADT, or ADT alone. Once disease progresses to castration-resistant PC, treatment with one of the approved therapies in this setting was initiated. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The outcomes measured were quality-adjusted life years (QALYs) and costs from a US private payer, health sector perspective. RESULTS AND LIMITATIONS: Compared to treatment with ADT alone, docetaxel and abiraterone resulted in a discounted quality-adjusted survival gain of 3.6 and 22.0mo, respectively. Using standard cost-effectiveness metrics, treatment with docetaxel and ADT provides high value for money (ie, is cost effective) with an incremental cost-effectiveness ratio (ICER) of $34723, compared to an ICER of $295212 for abiraterone. The monthly cost of abiraterone would have to be less than $3114 for it to be cost effective. CONCLUSIONS: Docetaxel+ADT is likely the most cost-effective treatment option for men with metastatic hormone-sensitive PC. Although potentially more effective than docetaxel, the costs of abiraterone would have to be considerably lower to match the cost effectiveness of docetaxel+ADT. PATIENT SUMMARY: This study evaluated the balance of costs and benefits for treatment of metastatic hormone-sensitive prostate cancer with docetaxel plus androgen deprivation therapy (ADT), abiraterone plus ADT, or ADT alone. We found that treatment with docetaxel plus ADT likely represents the most cost-effective option in this setting.

Cost-effectiveness Analysis of Active Surveillance Strategies for Men with Low-risk Prostate Cancer.

BACKGROUND: Active surveillance (AS) has become the recommended management strategy for men with low-risk prostate cancer. However, there is considerable uncertainty about the optimal follow-up schedule in terms of the tests to perform and their frequency. OBJECTIVE: To assess the costs and benefits of different AS follow-up strategies compared to watchful waiting (WW) or immediate treatment. DESIGN, SETTING, AND PARTICIPANTS: A state-transition Markov model was developed to simulate the natural history (ie, no testing or intervention) of prostate cancer for a hypothetical cohort of 50-yr-old men newly diagnosed with low-risk prostate cancer. Following diagnosis, men were hypothetically managed with immediate treatment, watchful waiting, or one of several AS strategies. AS follow-up was performed either with transrectal ultrasound-guided biopsy or magnetic resonance imaging (MRI) which was scheduled annually, biennially, every 3yrs, according to the PRIAS protocol (yrs 1, 4, 7, and 10, and then every 5yr) or every 5yr. Diagnosis of higher-grade or -stage disease while on AS resulted in curative treatment. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We measured discounted quality-adjusted life years (QALYs), discounted lifetime medical costs (2017 US$), and incremental cost-effectiveness ratios (ICERs). RESULTS AND LIMITATIONS: Compared to WW, MRI-based surveillance performed every 5yr improved quality-adjusted survival by 4.47 quality-adjusted months and represented high-value health care at the Medicare reimbursement rate using standard cost-effectiveness metrics. Biopsy-based strategies were less effective and less costly than the corresponding MRI-based strategies for each testing interval. MRI-based surveillance at more frequent intervals had ICERs greater than $800000 per QALY and would not be considered cost-effective according to standard metrics. Our results were sensitive to the diagnostic accuracy and costs of both biopsy modes in detecting clinically significant cancer. CONCLUSIONS: Incorporation of MRI into surveillance protocols at Medicare reimbursement rates and decreasing the intensity of repeat testing may be cost-effective options for men opting for conservative management of low-risk prostate cancer. PATIENT SUMMARY: Our study modeled outcomes for men with low-risk prostate cancer undergoing watchful waiting, immediate treatment, or active surveillance with different follow-up schedules. We found that conservative management of low-risk disease optimizes health outcomes and costs. Furthermore, we showed that decreasing the intensity of active surveillance follow-up and incorporating magnetic resonance imaging (MRI) into surveillance protocols can be cost-effective, depending on the MRI costs.

Potential patient harms from misinterpretation of publically reported surgical outcomes.

OBJECTIVE: To determine how the general public interprets surgical complication rates presented from a publicly available online surgical-rating website. SUBJECTS AND METHODS: An in-person electronic survey was administered at the local State Fair to a convenience sample. Participants were presented with a representative output from an online surgeon-rating website and were asked to choose from three statistically equivalent surgeons for a hypothetical medical decision. We then suggested that their insurance company would only cover one surgeon and probed their willingness to pay to switch surgeons for a small chance of lowering the risk of a complication (0.7%, 95% confidence interval [CI] -8.1% to 9.5%, P = 0.9). We quantified the characteristics of those willing to switch, the degree of misinterpretation, and the subsequent potential patient harms. RESULTS: There were 343 completed responses. When presented with a hypothetical healthcare decision, most participants (n = 209, 61%) said they were willing to pay out-of-pocket expenses to switch to a statistically equivalent surgeon. Those who were willing to pay to switch surgeons were more likely to be older (odds ratio [OR] 1.02, 95% CI 1.01-1.03), poorer (OR 1.81, 95% CI 1.07-3.11), previously had cancer (OR 5.9, 95% CI 1.9-25), and misinterpreted the data (OR 3.03, 95% CI 1.87-4.96). Those who were willing to pay out-of-pocket expenses were more inaccurate in their estimation of surgeon complication rates (mean estimate 34.0% vs 8.9%, P < 0.001, correct rate = 3.6%), and on average were willing to pay $6 494 (95% CI 4 108-8 880). CONCLUSION: Understanding of a publicly reported surgical-complication website is often prone to misinterpretation by the general population and may lead to patient harm from a financial aspect.

Incorporating Biomarkers into the Primary Prostate Biopsy Setting: A Cost-Effectiveness Analysis.

PURPOSE: We performed a cost-effectiveness analysis using the PHI (Prostate Health Index), 4Kscore®, SelectMDx™ and the EPI (ExoDx™ Prostate [IntelliScore]) in men with elevated prostate specific antigen to determine the need for biopsy. MATERIALS AND METHODS: We developed a decision analytical model in men with elevated prostate specific antigen (3 ng/ml or greater) in which 1 biomarker test was used to determine which hypothetical individuals required biopsy. In the current standard of care strategy all individuals underwent biopsy. Model parameters were derived from a comprehensive review of the literature. Costs were calculated from a health sector perspective and converted into 2017 United States dollars. RESULTS: The cost and QALYs (quality adjusted life-years) of the current standard of care, which was transrectal ultrasound guided biopsy, was $3,863 and 18.085, respectively. Applying any of the 3 biomarkers improved quality adjusted survival compared to the current standard of care. The cost of SelectMDx, the PHI and the EPI was lower than performing prostate biopsy in all patients. However, the PHI was more costly and less effective than the SelectMDx strategy. The EPI provided the highest QALY with an incremental cost-effectiveness ratio of $58,404 per QALY. The use of biomarkers could reduce the number of unnecessary biopsies by 24% to 34% compared to the current standard of care. CONCLUSIONS: Applying biomarkers in men with elevated prostate specific antigen to determine the need for biopsy improved quality adjusted survival by decreasing the number of biopsies performed and the treatment of indolent disease. Using SelectMDx or the EPI following elevated prostate specific antigen but before proceeding to biopsy is a cost-effective strategy in this setting.

Racial Disparities in Surgical Outcomes Among Males Following Major Urologic Cancer Surgery.

INTRODUCTION: Disparities in healthcare outcomes between races have been extensively described; however, studies fail to characterize the contribution of differences in distribution of covariates between groups and the impact of discrimination. This study aims to characterize the degree to which clinicodemographic factors and unmeasured confounders are contributing to any observed disparities between non-Hispanic white and black males on surgical outcomes after major urologic cancer surgery. METHODS: Non-Hispanic white and black males undergoing radical cystectomy, nephrectomy, or prostatectomy for cancer in the American College of Surgeons National Surgical Quality Improvement Program database from 2007 to 2016 were included in this analysis. The outcome of interest was Clavien III-V complications. Analysis was conducted in 2017 using the Peters-Belson method to compare the disparity in outcomes while adjusting for 13 important demographic and clinical characteristics. RESULTS: Of the 15,693 cases included with complete data, 13.0% (n=2,040) were black. There was a significantly increased rate of unadjusted Clavien III and V complications between white versus black males for radical cystectomy (21.9% vs 10.1%, p=0.005); nephrectomy (6.4% vs 3.9%, p=0.028); and radical prostatectomy (2.3% vs 1.6%, p=0.046). Adjusting for differences in age, BMI, American Society of Anesthesiologists score, functional status, smoking history, and comorbidities including diabetes, chronic obstructive pulmonary disease, heart failure, renal failure, bleeding disorder, steroid use, unintentional weight loss, and hypertension between the groups could not explain the disparity in complications after radical cystectomy; the unexplained discrepancy was an absolute excess of 11.8% (p=0.01) in black males. There was an unexplained excess of complications in black males undergoing radical prostatectomy and nephrectomy but neither reached statistical significance. CONCLUSIONS: Black males undergoing radical cystectomy for cancer experienced higher complication rates than white males. Unexplained differences between the black and white males significantly contributed to the disparity in outcomes, which suggests that unmeasured factors, such as the quality of surgical or perioperative care, are playing a considerable role in the observed inequality. SUPPLEMENT INFORMATION: This article is part of a supplement entitled African American Men's Health: Research, Practice, and Policy Implications, which is sponsored by the National Institutes of Health.

What Gay and Bisexual Men Treated for Prostate Cancer Want in a Sexual Rehabilitation Program: Results of the Restore Needs Assessment.

Introduction: While erectile dysfunction and urinary incontinence are well-documented effects of prostate cancer treatment, the impact of sexual concerns on the lives of gay and bisexual men treated for prostate cancer has not been well researched. Specifically there are no known studies investigating what gay and bisexual men want in sexual recovery treatment. Methods: To conduct this needs assessment, we recruited 193 gay and bisexual men with prostate cancer from the largest online cancer support group in North America. As part of a wider study of sexual functioning, participants completed a 32-item needs assessment and a qualitative question assessing their needs. Results: There was high interest in a sexual recovery program across race/ethnicity and by treatment type. The most preferred formats were a self-directed online curriculum and participation in a support group specific to gay and bisexual men with prostate cancer. A variety of formats, language and contents were deemed appropriate and important by most participants. Frank explicit language and content were preferred. Three themes emerged in the qualitative analysis. Conclusions: Gay and bisexual men treated for prostate cancer want a recovery curriculum that explicitly addresses the sexual challenges they face before, during and after treatment. While differences were identified across race and treatment type, they were relatively few and minor in magnitude, suggesting that a single online curriculum could advance rehabilitation for this population.

The example of CaPSURE: lessons learned from a national disease registry.

INTRODUCTION: Although randomized controlled trials (RCTs) remain the gold standard for determining evidence-based clinical practices, large disease registries that enroll large numbers of patients have become paramount as a relatively cost-effective additional tool. METHODS: We highlight the advantages of disease registries focusing on the example of prostate cancer and the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE™) registry. RESULTS: CaPSURE collects approximately 1,000 clinical and patient-reported variables, in over 13,000 men that are enrolled. Thus far, CaPSURE has yielded over 130 peer-reviewed publications, with several others in press, in key areas of risk migration, practice patterns, outcome prediction, and quality of life outcomes. CONCLUSIONS: Disease registries, like CaPSURE complement RCTs and CaPSURE, have provided a means to better understand many aspects of prostate cancer epidemiology, practice patterns, oncologic and HRQOL outcomes, and costs of care across populations. Specialized observational disease registries such as CaPSURE provide insight and have broad implications for disease management and policy.

Effect of postcystectomy infectious complications on cost, length of stay, and mortality.

OBJECTIVES: To analyze the effect of infectious complications after cystectomy using the Nationwide Inpatient Samples of the Healthcare Cost and Utilization Project. The economic and clinical effects of infectious complications after radical cystectomy have not been analyzed. METHODS: All 6686 patients undergoing radical cystectomy for bladder cancer were identified from the nationwide inpatient samples from 2000 to 2004. Septicemia, bacterial infections, and mycosis were categorized using the Clinical Classification Software. We then analyzed the effect of septicemia on in-hospital mortality, length of stay, and total hospital charges. RESULTS: Of the 6686 patients, 241 (3.6%) were diagnosed with septicemia after cystectomy. The overall, in-hospital mortality rate was 16.67% (n = 33). Septicemia was a significant predictor of in-hospital mortality (P < .001). The mean hospital charge for patients with septicemia was nearly 3 times the amount for the control patients ($161,277 vs $58,560, P < .001). The length of stay was 3 times longer for patients with septicemia than for controls (29 vs 10 days, P < .001). The hospital charges for bacterial infections (n = 161) and mycotic infections (n = 154) were significantly greater than their matched control population ($107,734 and vs $60,716 and $102,541 vs $67,016, respectively, P < .001 for both). CONCLUSIONS: The development of septicemia after cystectomy predicts for patient mortality. Septicemia, bacterial infections, and mycotic infections contribute to large increases in the length of stay and total hospital charges.

Bladder and upper tract urothelial cancer.

PURPOSE: While there are data available indicating the incidence and prevalence of bladder and upper tract urothelial cancer, population level data on resource use, costs and patterns of care for these cancers are limited. We quantified the economic impact of caring for patients with bladder and upper tract urothelial cancer, and determined the primary drivers for such costs in the population in the United States. MATERIALS AND METHODS: The analytical methods used to generate these results have been described previously. RESULTS: An increasing proportion of patients with bladder and upper tract urothelial cancer were being treated in the outpatient setting. Most care was provided by urologists and visit frequency was directly related to disease stage. Only a small proportion of patients potentially eligible for chemotherapy, ie those with advanced disease, sought specialized care from oncologists. Office based diagnostic tests such as cytology were not commonly done, although a substantial number of patients with bladder cancer underwent cystoscopy. The use of excretory urography in these patients was decreasing, while the use of computerized tomography was increasing. Ileal conduits were the most frequently performed type of urinary diversion following cystectomy. The cystectomy rate remained unchanged for a decade. Intravesical therapy was done infrequently in patients with bladder cancer. Annual costs for treating bladder and upper urinary tract cancers were $1 billion and $64 million, respectively, in 2000. These costs represented a $164 million increase over 1994 levels, which outpaced inflation. CONCLUSIONS: The costs of treating bladder cancer increased steadily during a 6-year period despite a decrease in inpatient care. Coupled with a lack of substantial change in transurethral resection and cystectomy rates, this suggests that the primary cost drivers are increased outpatient testing, eg computerized tomography and cystoscopy, and an increase in the number of diagnosed cases. Greater focus on selective use of testing modalities, preventive care such as smoking cessation and earlier identification of patients at risk may help curtail further expenditure with regard to managing bladder and upper urinary tract cancers.

Influence of post-cystectomy complications on cost and subsequent outcome.

PURPOSE: Of commonly performed urological cancer procedures radical cystectomy is associated with the highest morbidity and mortality. The impact of each individual type of complication or a combination of them on various outcome measures, such as mortality, charges and length of stay, is unclear. We quantified the impact of specific post-cystectomy complications and combinations thereof in terms of mortality, charges and length of stay. MATERIALS AND METHODS: All 6,577 patients undergoing radical cystectomy for bladder cancer were identified from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project (1998 to 2002). The prevalence of different International Classification of Diseases, 9th Revision, Clinical Modification coded complications following cystectomy were determined. Outcome variables of interest were in-hospital mortality, total charges and length of stay. The association between types of complications and measured outcomes were examined using univariate and multivariate regression models. The cumulative impact of multiple complications and various combinations of complications on outcomes was also examined. RESULTS: The overall complication rate was 28.4% in 1,869 cases and the mortality rate was 2.6%. Median total charges was 41,905 dollars and median length of stay was 9 days. Overall 20.7% of patients had 1, 6.1% had 2, 1.2% had 3 and 0.42% had greater than 3 complications. At least 1 complication almost doubled the odds of mortality and increased median total charges and length of stay by 15,000 dollars and 4 days, respectively. We defined expected levels of increase in the various outcome measures with increasing numbers of complications. The combination of postoperative infection and respiratory complication had the greatest impact on mortality, while the combination of wound and urinary tract infection had the greatest impact on length of stay and total charges. CONCLUSIONS: Although most patients undergoing cystectomy are older and have multiple comorbidities, the postoperative complications with the most significant impact were those directly related to surgery (primary complications). Secondary complications (cardiac, respiratory, vascular, etc) appear to have less of an impact on most common outcome measures. Hence, the greatest gains can be achieved by limiting primary complications. These data could be used to develop benchmarks of expected levels of primary and secondary complications after cystectomy.

Characteristics of patients and predictors of in-hospital mortality after hospitalization for head and neck cancers.

BACKGROUND: The objectives of this study were to describe the characteristics of patients who were hospitalized for head and neck cancer (HNC) during the years 2000 through 2003 and to identify predictors of in-hospital mortality. METHODS: The Nationwide Inpatient Sample for the years 2000 through 2003 was used. All patients who had a primary diagnosis of any of the HNCs were included in the study. Univariate and multivariate logistic regression analyses were used to identify patient and hospital characteristics that were associated with in-hospital mortality. RESULTS: In total, 24,803 patients were hospitalized for HNCs. The average age of patients was 62 years, the mean length of stay in the hospital was 7.89 days, and the in-hospital mortality rate was 5.18%. Patients who had comorbid conditions and complications and patients who were grouped under the self-pay/no charge/others category had greater odds of in-hospital mortality compared with patients who were covered by private insurance (P<.02). Patients who were treated in large-bed, urban, or teaching hospitals had lower odds of in-hospital mortality compared with patients who were treated in small or medium-bed, rural, or nonteaching hospitals, respectively (P<.03). CONCLUSIONS: Patients with comorbid conditions and complications and patients without adequate insurance coverage had greater odds of in-hospital mortality. One reason for this may be inadequate access to care because of the absence of insurance or underinsurance. Further studies controlling for disease stage will be required to determine whether insurance status and patient-related factors can influence outcomes from HNC in individual patients independent of their disease stage.

Impact of malpractice caps on use and outcomes of radical cystectomy for bladder cancer: data from the surveillance, epidemiology, and end results program.

PURPOSE: The impact of malpractice awards on insurance premiums and health care delivery generates much concern. To our knowledge no data exist regarding the impact of caps, or upper limits, on awards for noneconomic damages (also termed pain and suffering) on health care delivery patterns or outcomes. We investigated the effect of caps on the use of and outcomes following aggressive surgical treatment (radical cystectomy) in patients with bladder cancer. MATERIALS AND METHODS: We performed a retrospective cohort study of patients with bladder cancer who underwent radical cystectomy, identified from the Surveillance, Epidemiology, and End Results (SEER) Program database. Cystectomy rates and post-cystectomy disease specific survival were compared between SEER regions with and without a cap, while controlling for other variables. RESULTS: A significantly greater proportion of patients with stages III and IV bladder cancer underwent cystectomy in SEER regions with a cap. Cap status was a significant predictor of survival from bladder cancer. CONCLUSIONS: Radical cystectomy for bladder cancer is performed more often even for advanced bladder cancer in geographic regions with a cap with a positive impact on survival. The institution of caps may have beneficial effects on patterns of health care beyond that of merely decreasing insurance premium costs.