Relief of Urinary Symptom Burden after Primary Prostate Cancer Treatment.

PURPOSE: Harms of prostate cancer treatment on urinary health related quality of life have been thoroughly studied. In this study we evaluated not only the harms but also the potential benefits of prostate cancer treatment in relieving the pretreatment urinary symptom burden. MATERIALS AND METHODS: In American (1,021) and Spanish (539) multicenter prospective cohorts of men with localized prostate cancer we evaluated the effects of radical prostatectomy, external radiotherapy or brachytherapy in relieving pretreatment urinary symptoms and in inducing urinary symptoms de novo, measured by changes in urinary medication use and patient reported urinary bother. RESULTS: Urinary symptom burden improved in 23% and worsened in 28% of subjects after prostate cancer treatment in the American cohort. Urinary medication use rates before treatment and 2 years after treatment were 15% and 6% with radical prostatectomy, 22% and 26% with external radiotherapy, and 19% and 46% with brachytherapy, respectively. Pretreatment urinary medication use (OR 1.4, 95% CI 1.0-2.0, p = 0.04) and pretreatment moderate lower urinary tract symptoms (OR 2.8, 95% CI 2.2-3.6) predicted prostate cancer treatment associated relief of baseline urinary symptom burden. Subjects with pretreatment lower urinary tract symptoms who underwent radical prostatectomy experienced the greatest relief of pretreatment symptoms (OR 4.3, 95% CI 3.0-6.1), despite the development of deleterious de novo urinary incontinence in some men. The magnitude of pretreatment urinary symptom burden and beneficial effect of cancer treatment on those symptoms were verified in the Spanish cohort. CONCLUSIONS: Men with pretreatment lower urinary tract symptoms may experience benefit rather than harm in overall urinary outcome from primary prostate cancer treatment. Practitioners should consider the full spectrum of urinary symptom burden evident before prostate cancer treatment in treatment decisions.

Adverse health outcomes associated with surgical management of the small renal mass.

PURPOSE: Partial and radical nephrectomy are treatments for the small renal mass. Partial nephrectomy is considered the gold standard as it may protect against renal dysfunction compared to radical nephrectomy. However, both treatments may cause adverse health outcomes. MATERIALS AND METHODS: A matched cohort study was performed using the SEER (Surveillance, Epidemiology and End Results)-Medicare data set. Individuals treated with partial or radical nephrectomy for 4 cm or smaller nonmetastatic renal cell carcinoma were compared to 2 control groups (nonmuscle invasive bladder cancer and noncancer). A greedy algorithm matched surgical groups to controls. Medicare claims were examined for renal, cardiovascular and secondary cancer events. RESULTS: Patients who underwent partial nephrectomy (1,471) and radical nephrectomy (4,299) were matched to controls. The time to event model demonstrated an increased risk of renal events for both treatments. Compared to the bladder cancer control and noncancer control groups, radical nephrectomy hazard ratios for renal events were 2.415 (p <0.0001) and 6.211 (p <0.0001), respectively, while partial nephrectomy hazard ratios were 1.513 (p <0.0001) and 4.926 (p <0.0001), respectively. Secondary cancers were increased for partial nephrectomy and radical nephrectomy compared to both control groups (p <0.0001). Cardiovascular events were increased for both treatments compared to noncancer controls (p <0.0001), but not compared to bladder cancer controls. CONCLUSIONS: Partial nephrectomy and radical nephrectomy may lead to adverse health outcomes. Compared to controls, partial nephrectomy and radical nephrectomy are associated with worsened renal outcomes. The increase in secondary cancers and cardiovascular events with both treatments is notable, and requires further investigation. Further research should investigate if active surveillance of the appropriately selected small renal mass limits adverse health outcomes.

Overall survival advantage with partial nephrectomy: a bias of observational data?

BACKGROUND: Partial nephrectomy (PN) and radical nephrectomy (RN) are standard treatments for a small renal mass. Retrospective studies suggest an overall survival (OS) advantage, however a randomized phase 3 trial suggests otherwise. The effects of both surgical modalities on OS were evaluated compared with controls. METHODS: A matched cohort study was performed using the Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset. Individuals treated with PN or RN for localized renal cell carcinoma (RCC) measuring ≤4 cm were compared with 2 control groups (non-muscle-invasive bladder cancer (BCC) and noncancer controls (NCC). Using a greedy algorithm, RCC groups were matched with controls by demographics and comorbidities. OS for surgical groups and controls were compared. The cause of death was evaluated for cancer groups when differences in OS were noted. RESULTS: Patients undergoing PN and RN were matched with controls. All cancer groups had >95% 10-year cancer-specific survival (CSS). Median OS was similar between RN (9.05 years) and BCC (8.67 years; P = .067) and NCC (8.77 years; P = .49). Median OS was improved for PN (10.45 years) compared with BCC (8.75 years; P<.001) and NCC controls (8.76 years; P<.001). A multivariate Cox hazards model demonstrated that PN improved OS compared with NCC (hazard ratio, 1.257; P<.001) and BCC (hazard ratio, 1.364; P<.001). CONCLUSIONS: RN patients had similar OS compared with controls, suggesting that this treatment modality does not compromise survival. Patients undergoing PN had improved OS compared with controls, suggesting possible selection bias. The apparent survival advantage conferred by PN in SEER-Medicare case series is likely the result of selection bias involving unmeasured confounders.

Patterns and predictors of urodynamics use in the United States.

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.

Medicare payments for outpatient urological surgery by location of care.

PURPOSE: The cost implications associated with offloading outpatient surgery from hospitals to ambulatory surgery centers and the physician office remain poorly defined. Therefore, we determined whether payments for outpatient surgery vary by location of care. MATERIALS AND METHODS: Using national Medicare claims from 1998 to 2006, we identified elderly patients who underwent 1 of 22 common outpatient urological procedures. For each procedure we measured all relevant payments (in United States dollars) made during the 30-day claims window that encompassed the procedure date. We then categorized payment types (hospital, physician and outpatient facility). Finally, we used multivariable regression to compare price standardized payments across hospitals, ambulatory surgery centers and the physician office. RESULTS: Average total payments for outpatient surgery episodes varied widely from $200 for urethral dilation in the physician office to $5,688 for hospital based shock wave lithotripsy. For all but 2 procedure groups, ambulatory surgery centers and physician offices were associated with lower overall episode payments than hospitals. For instance, average total payments for urodynamic procedures performed at ambulatory surgery centers were less than a third of those done at hospitals (p <0.001). Compared to hospitals, office based prostate biopsies were nearly 75% less costly (p <0.001). Outpatient facility payments were the biggest driver of these differences. CONCLUSIONS: These data support policies that encourage the provision of outpatient surgery in less resource intensive settings.

Surgical quality among Medicare beneficiaries undergoing outpatient urological surgery.

PURPOSE: The cost efficiency gains achieved from moving procedures to ambulatory surgery centers and offices may be mitigated if the quality of surgical care at these facilities is not comparable to that at the hospital. Motivated by this, we assessed short-term morbidity and mortality for patients by location of care. MATERIALS AND METHODS: Using a national sample of Medicare claims (1998 to 2006), we identified elderly beneficiaries who underwent one of 22 common outpatient urological procedures. After determining the facility type where each procedure was performed, we measured 30-day mortality, unexpected admissions and postoperative complications. Finally, we fit multivariable logistic regression models to evaluate the association between occurrence of an adverse event and the ambulatory setting where surgical care was delivered. RESULTS: During the study period, there was a substantial increase in the frequency of nonhospital based outpatient surgery. Compared to ambulatory surgery centers and offices, hospitals treated more women (p <0.001). Those patients also tended to be less healthy (p <0.001). While patients experienced fewer postoperative complications following surgery at an ambulatory surgery center, procedures performed outside the hospital were associated with a higher likelihood of a same day admission (ambulatory surgery centers OR 6.96, 95% CI 4.44-10.90 and offices OR 3.64, 95% CI 2.48-5.36). However, notably with case mix adjustment the probability of any adverse event was exceedingly low across all ambulatory settings. CONCLUSIONS: These data indicate that small but measurable variation in surgical quality exists by location of care delivery.

Quality of pathological reporting for renal cell cancer: implications for systemic therapy, prognostication and surveillance.

OBJECTIVE: • To evaluate whether current nephrectomy pathology reports are sufficient to allow clinicians to use prognostic nomograms, tailor surveillance, enroll patients into adjuvant trials and select systemic therapy for renal cell carcinoma (RCC). PATIENTS AND METHODS: • Nephrectomy pathology reports were obtained from the LA County Tumor Registry. Key reporting elements identified by the College of American Pathology (CAP) and utilized in RCC prognostic models were abstracted. Hospital type was coded as community, teaching or cancer centre. • Reporting quality was assessed across hospital type and year. RESULTS: • A total of 317 of 344 sampled reports (92.2%) met the inclusion criteria. Tumour size and margin status were commonly reported. Some 90.2% and 84.2% of reports provided data on histology and Fuhrman grade. Tumour classification was omitted in 27.8%. • Microvascular invasion and necrosis were infrequently reported (44.5% and 25.6%, respectively). Only 59.9% of reports met CAP guidelines for tumour classification, margin, size, histology and grade. • Two prognostic nomograms (Stage, Size, Grade and Necrosis system and Kattan) could rarely be utilized (15.8% and 12.3%, respectively), whereas the UCLA Integrated Staging System could be used frequently (65.6%). There were discrepancies satisfying CAP guidelines between community, teaching and cancer centre hospitals, with 54.7%, 70.5% and 75% of reports meeting CAP criteria (P= 0.0102). CONCLUSIONS: • Current RCC pathology reporting fails to satisfy CAP guidelines, does not permit the use of prognostic systems, and may hinder enrollment into adjuvant trials and the selection of systemic therapy. Important reporting discrepancies exist between hospital types, with cancer centres performing best. • Quality improvement initiatives to encourage consistent, comprehensive and clinically relevant pathology reports would improve the quality of RCC patient care.

Readmission and Prolapse Recurrence After Abdominal and Vaginal Apical Suspensions in Older Women.

OBJECTIVE: Our objective was to evaluate 30-day readmission, 12-month prolapse recurrence, and complications after apical surgeries in older women. METHODS: A retrospective cohort study was conducted using 2002-2011 Medicare data in women 65 years or older who underwent abdominal sacrocolpopexy with synthetic mesh, vaginal uterosacral, or sacrospinous colpopexy with 12 months follow-up. Vaginal mesh procedures were excluded. The primary outcome was 30-day inpatient readmission. Secondary outcomes were complications and prolapse recurrence, defined as either reoperation or pessary insertion. We used Pearson χ, Fisher exact tests, and analyses of variance to examine difference between surgical treatment groups. Odds ratios (ORs) utilizing Charlson Comorbidity Index, age, race, and procedure type were calculated to assess the differences in the outcomes probability. RESULTS: Of 3,015 women, 863 underwent abdominal sacrocolpopexy, 510-uterosacral and 1,642-sacrospinous ligament suspensions. The 30-day readmission was 7.4% (95% confidence interval [CI] 5.7-9.2%; OR 2.4, 95% CI 1.7-3.5, P<.01) after abdominal sacrocolpopexy and 4.5% (95% CI 2.7-6.3%; OR 1.3, 95% CI 0.8-2.1, P=.3) after uterosacral compared with 3.5% (95% CI 2.6-4.4% P<.01) after sacrospinous ligament suspensions. Prolapse recurrence did not differ between the groups (8.2%, 95% CI 6.4-10.1%; 10.6%, 95% CI 7.9-13.3%; and 9.9%, 95% CI 8.4-11.3%, P=.3, respectively). Women had 30-day gastrointestinal complications (6.1%, 95% CI 4.5-7.7%; 1.2%, 95% CI 0.2-2.1%; and 1.1%, 95% CI 0.6-1.6%, P<.01), surgical site infections (5.9%, 95% CI 4.3-7.5%; 3.1%, 95% CI 1.6-4.7%; and 3.7%, 95% CI 2.8-4.6%, P=.01), genitourinary complications (10.9%, 95% CI 8.8-13%; 17.7%, 95% CI 14.3-21%; and 13.6%, 95% CI 12-15.3%, P<.01), and medical complications (7.4%, 95% CI 5.7-9.2%; 7.8%, 95% CI 5.5-10.2%; and 4.4%, 95% CI 3.4-5.4%, P<.01; all after abdominal sacrocolpopexy, uterosacral, and sacrospinous ligament suspensions, respectively). CONCLUSION: Vaginal apical suspensions compared with abdominal sacrocolpopexy with synthetic mesh are associated with lower rates of postoperative 30-day readmission without an increase in prolapse recurrence among older women.

Neoadjuvant androgen deprivation therapy leads to immediate impairment of vitality/hormonal and sexual quality of life: results of a multicenter prospective study.

OBJECTIVE: To evaluate the immediate effects of neoadjuvant androgen deprivation therapy (NADT) on health-related quality of life (HRQOL) among patients undergoing radiation therapy (RT) for newly diagnosed prostate cancer. METHODS: The Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium is a prospective multi-institutional study. HRQOL is measured with the Expanded Prostate Cancer Index Composite-26 questionnaire. Differences in patient-reported HRQOL were observed between pretreatment and 2 months after NADT start (and before definitive RT) with significant differences evaluated by paired t test. RESULTS: From among 450 patients who completed the Expanded Prostate Cancer Index Composite-26 before and 2 months after NADT start, 71 received NADT before proceeding with definitive RT. Patients receiving NADT experienced significant impairment in vitality/hormonal (P <.0001) and sexual (P <.0001) HRQOL after NADT initiation. The mean ± standard deviation vitality/hormonal score fell from an average of 94.1 ± 9.7 before NADT to 78.7 ± 16.3 two months after NADT initiation; and sexual HRQOL fell from a mean of 51.7 ± 31.1 pretreatment to 32.3 ± 26.1 after NADT initiation. Both these HRQOL domain changes exceeded the thresholds for clinical significance. Patients receiving NADT also experienced a significant impairment in urinary continence (P = .024), although this difference did not meet the criteria for clinical significance. CONCLUSION: In this analysis, patients receiving NADT experience significant impairment in sexual and vitality/hormonal HRQOL even before starting definitive RT. The significant effect of this therapy on HRQOL needs to be considered before initiating NADT in men where there is no clear evidence of clinical benefit.