Patient reported treatment burden and attitudes towards in-home intravesical therapy among patients with bladder cancer.

PURPOSE: To quantify patient reported treatment burden while receiving intravesical therapy for bladder cancer and to survey patient perspectives on in-home intravesical therapy. MATERIALS AND METHODS: We conducted a cross-sectional survey of the Bladder Cancer Advocacy Network Patient Survey Network. Survey questions were developed by investigators, then iteratively revised by clinician and patient advocates. Eligible participants had to have received at least 1 dose of intravesical therapy delivered in an ambulatory setting. RESULTS: Two hundred thirty-three patients responded to the survey with median age of 70 years (range 33-88 years). Two-thirds of respondents (66%, 151/232) had received greater than 12 bladder instillations. A travel time of >30 minutes to an intravesical treatment facility was reported by 55% (126/231) of respondents. Fifty-six percent (128/232) brought caregivers to their appointments, and 36% (82/230) missed work to receive treatment. Sixty-one respondents (26%) felt the process of receiving bladder instillations adversely affected their ability to perform regular daily activities. Among those surveyed, 72% (168/232) reported openness to receiving in-home intravesical instillations and 54% (122/228) answered that in-home instillations would make the treatment process less disruptive to their lives. CONCLUSIONS: Bladder cancer patients reported considerable travel distances, time requirements, and need for caregiver support when receiving intravesical therapy. Nearly three-quarters of survey respondents reported openness to receiving intravesical instillations in their home, with many identifying potential benefits for home over clinic-based therapy.

Diagnosis, workup, and risk stratification of upper tract urothelial carcinoma.

Upper tract urothelial carcinoma (UTUC) is a relatively rare disease that presents unique challenges to urologists from both a diagnostic and management standpoint. UTUC is a clinically heterogenous disease with a varied natural history, and given its location in the upper urinary tract, treatment has the potential to cause or worsen chronic kidney disease. Therefore, physicians caring for patients with UTUC must be facile with multiple diagnostic and therapeutic strategies in order to provide optimal patient care. We present an overview of the epidemiology, histology, risk factors, and contemporary approach to the diagnosis, laboratory evaluation, imaging, and risk stratification for patients with UTUC. Computerized tomographic urography, thorough endoscopic evaluation, and biopsy (endoscopically or percutaneously) remain the standard of care for the diagnosis and staging of patients with suspected UTUC. Preoperative nomograms are vital to select patients more optimally for preoperative systemic chemotherapy and facilitate clinical trial enrollment. A thorough understanding of the various diagnostic challenges, imaging/pathologic limitations, biomarkers, and risk stratification tools will allow us as a field to develop new modalities to improve our diagnostic capabilities and reduce the risk of under diagnosis and over treatment for our patients.

Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials.

BACKGROUND/AIMS: There has been growing interest in better understanding the potential of observational research methods in medical product evaluation and regulatory decision-making. Previously, we used linked claims and electronic health record data to emulate two ongoing randomized controlled trials, characterizing the populations and results of each randomized controlled trial prior to publication of its results. Here, our objective was to compare the populations and results from the emulated trials with those of the now-published randomized controlled trials. METHODS: This study compared participants' demographic and clinical characteristics and study results between the emulated trials, which used structured data from OptumLabs Data Warehouse, and the published PRONOUNCE and GRADE trials. First, we examined the feasibility of implementing the baseline participant characteristics included in the published PRONOUNCE and GRADE trials' using real-world data and classified each variable as ascertainable, partially ascertainable, or not ascertainable. Second, we compared the emulated trials and published randomized controlled trials for baseline patient characteristics (concordance determined using standardized mean differences <0.20) and results of the primary and secondary endpoints (concordance determined by direction of effect estimates and statistical significance). RESULTS: The PRONOUNCE trial enrolled 544 participants, and the emulated trial included 2226 propensity score-matched participants. In the PRONOUNCE trial publication, one of the 32 baseline participant characteristics was listed as an exclusion criterion on ClinicalTrials.gov but was ultimately not used. Among the remaining 31 characteristics, 9 (29.0%) were ascertainable, 11 (35.5%) were partially ascertainable, and 10 (32.2%) were not ascertainable using structured data from OptumLabs. For one additional variable, the PRONOUNCE trial did not provide sufficient detail to allow its ascertainment. Of the nine variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 6 (66.7%). The primary endpoint of time from randomization to the first major adverse cardiovascular event and secondary endpoints of nonfatal myocardial infarction and stroke were concordant between the emulated trial and published randomized controlled trial. The GRADE trial enrolled 5047 participants, and the emulated trial included 7540 participants. In the GRADE trial publication, 8 of 34 (23.5%) baseline participant characteristics were ascertainable, 14 (41.2%) were partially ascertainable, and 11 (32.4%) were not ascertainable using structured data from OptumLabs. For one variable, the GRADE trial did not provide sufficient detail to allow for ascertainment. Of the eight variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 4 (50.0%). The primary endpoint of time to hemoglobin A1c ≥7.0% was mostly concordant between the emulated trial and the published randomized controlled trial. CONCLUSION: Despite challenges, observational methods and real-world data can be leveraged in certain important situations for a more timely evaluation of drug effectiveness and safety in more diverse and representative patient populations.

Oncological outcomes of visibly complete transurethral resection prior to neoadjuvant chemotherapy for bladder cancer

ABSTRACT Purpose: To evaluate the potential oncologic benefit of a visibly complete transurethral resection of a bladder tumor (TURBT) prior to neoadjuvant chemotherapy (NAC) and radical cystectomy (RC). Materials and Methods: We identified patients who received NAC and RC between 2011-2021. Records were reviewed to assess TURBT completeness. The primary outcome was pathologic downstaging (<ypT2N0), with complete pathologic response (ypT0N0) and survival as secondary endpoints. Logistic regression and Cox proportional hazards models were utilized. Results: We identified 153 patients, including 116 (76%) with a complete TURBT. Sixty-four (42%) achieved <ypT2N0 and 43 (28%) achieved ypT0N0. When comparing those with and without a complete TURBT, there was no significant difference in the proportion with <ypT2N0 (43% vs 38%, P=0.57) or ypT0N0 (28% vs 27%, P=0.87). After median follow-up of 3.6 years (IQR 1.5-5.1), 86 patients died, 37 died from bladder cancer, and 61 had recurrence. We did not observe a statistically significant association of complete TURBT with cancer-specific or recurrence-free survival (p≥0.20), although the hazard of death from any cause was significantly higher among those with incomplete TURBT even after adjusting for ECOG and pathologic T stage, HR 1.77 (95% CI 1.04-3.00, P=.034). Conclusions: A visibly complete TURBT was not associated with pathologic downstaging, cancer-specific or recurrence-free survival following NAC and RC. These data do not support the need for repeat TURBT to achieve a visibly complete resection if NAC and RC are planned.

Surgical Site Infections in Open and Laparoscopic Operations in Rooms With Open-floor Drainage Systems.

INTRODUCTION: Surgical site infections are common postoperative complications. Some operating rooms have open-floor drainage systems for fluid disposal during endourologic cases, although nonendoscopy cases are not always allowed in these rooms. We hypothesized that operating rooms with open-floor drainage systems would not materially affect risk of surgical site infections for patients undergoing open and laparoscopic procedures. METHODS: Patients who had surgical site infections from 2016 through 2020 were identified from data of the National Surgical Quality Improvement Program. Patients without surgical incisions, with open wounds, and with surgical site infections at surgery were excluded. The primary outcome was surgical site infection occurrence within 30 days of surgery. Multilevel multivariable logistic regression was used to estimate the observed-to-expected surgical site infection ratio for each operating room (2 with and 23 without open-floor drainage systems). RESULTS: We identified 8,419 surgical cases, of which 802 (9.5%) were performed in operating rooms with open-floor drainage systems; 166 patients (2.0%) had surgical site infections. Of the surgical site infections, 7 (4.2%) occurred in operating rooms with open-floor drainage systems. Surgical specialty, American Society of Anesthesiologists physical status, higher case acuity, dyspnea, immunosuppression, longer surgical duration, and wound classification were associated with surgical site infections (P < .05 for all). The observed-to-expected ratios of surgical site infections occurring in the 2 operating rooms with open-floor drainage systems were 0.85 and 1.15. The odds ratio of surgical site infections for urologic cases performed in room with vs without open-floor drainage systems was 1.30 (P = .65). CONCLUSIONS: Urology operating room designs often include open-floor drainage systems for water-based cases. These drainage systems were not associated with an increased risk of surgical site infections.

Features associated with travel distance for radical cystectomy in Florida: Implications for access to care.

INTRODUCTION: Characteristics associated with travel distance for radical cystectomy (RC) remain incompletely defined but are needed to inform efforts to bridge gaps in care. Therefore, we assessed features associated with travel distance for RC in a statewide dataset. METHODS: We identified RC patients in the Florida Inpatient Discharge dataset from 2013 to 2019. Travel distance was estimated using zip code centroids. The primary outcome was travel >50 miles for RC. Secondary outcomes included inpatient mortality, nonhome discharge, and inpatient complications. U.S. County Health Rankings were included as model covariates. Mixed effects logistic regression models accounting for clustering within hospitals were utilized. RESULTS: We identified 4,209 patients, of whom 2,284 (54%) traveled <25 miles, 654 (16%) traveled 25 to 50 miles, and 1271 (30%) traveled >50 miles. Patients who traveled >50 miles primarily lived in central and southwest Florida. Following multivariable adjustment, patients traveling >50 miles were less likely to be Hispanic/Latino (odds ratio [OR] 0.35, 95% CI: 0.23-0.51), and more likely to reside in a county with the lowest health behavior (OR 6.48, 95% CI: 3.81-11.2) and lowest socioeconomic (OR 7.63, 95% CI: 5.30-11.1) rankings compared to those traveling <25 miles (all P < 0.01). Travel distance >50 miles was associated with treatment at a high-volume center and significantly lower risks of inpatient mortality, nonhome discharge, and postoperative complications (all P < 0.02). CONCLUSION: These data identify characteristics of patients and communities in the state of Florida with potentially impaired access to RC care and can be used to guide outreach efforts designed to improve access to care.

Oncological outcomes of visibly complete transurethral resection prior to neoadjuvant chemotherapy for bladder cancer.

PURPOSE: To evaluate the potential oncologic benefit of a visibly complete transurethral resection of a bladder tumor (TURBT) prior to neoadjuvant chemotherapy (NAC) and radical cystectomy (RC). MATERIALS AND METHODS: We identified patients who received NAC and RC between 2011-2021. Records were reviewed to assess TURBT completeness. The primary outcome was pathologic downstaging (

Characterization of Gender Differences in H-index Within Urological Subspecialties.

PURPOSE: Previous work in urology has shown that men have higher h-indices than women. However, the degree to which h-indices vary by gender within urological subspecialties has not been well defined. Herein, we assess gender differences in h-index among different subspecialties. MATERIALS AND METHODS: Demographics were recorded for academic urologists using residency program websites as of July 2021. Scopus was queried to identify h-indices. Gender differences in h-index were estimated from a linear mixed-effects regression model with fixed effects for gender, urological subspecialty, MD/PhD status, years since first publication, interactions of subspecialty with years since first publication, and interactions of subspecialty with gender and random effects for AUA section and institution nested within AUA section. The Holm method was used to adjust for multiplicity (7 hypothesis tests). RESULTS: Of 1,694 academic urologists from 137 institutions, 308 were women (18%). Median years since first publication was 20 for men (IQR 13, 29) and 13 for women (IQR 8, 17). Among all academic urologists, the median h-index was 8 points higher for men (15 [IQR 7, 27]) vs women (7 [IQR 5, 12]). There was no significant gender difference in h-index for any of the subspecialties after adjusting for urologist experience and after applying the Holm method for multiplicity correction. CONCLUSIONS: We were unable to demonstrate a gender difference in h-index after adjusting for urologist experience for any urological subspecialties. Future study is warranted as women become more senior members of the urological workforce.

Analysis of Transurethral Resection of Bladder Tumor Efficiency Utilizing Nonprocedural Operating Room Times.

OBJECTIVE: To analyze the contribution of nonprocedural operating room (OR) times to transurethral resection of bladder tumor (TURBT) operative efficiency. METHODS: Over a 24-month period, all nonprocedural OR times from TURBT surgeries performed at a single institution were prospectively collected. Nonprocedural times included: in-room to anesthesia release time, anesthesia release to cut time, and close to wheels out time. Procedural OR time was cut to close time. We also analyzed the impact of time of day on TURBT efficiency (morning vs afternoon). Comparisons between groups were made using the Wilcoxon rank sum test for continuous variables. RESULTS: We identified 777 consecutive TURBT procedures from 2019 to 2020. The median total OR time was 63 minutes (interquartile range: 50-81 minutes). The nonprocedural time occupied a median of 49.4% of the total operating time (interquartile range: 38.9%-60.4%). Median anesthesia release to cut time was slower when 1 TURBT was performed a day compared to 2 or more (13 minutes vs 12 minutes, P = .04). Median close to wheels out time was faster when there was 1 TURBT in a day (7 minutes vs 8 minutes, P = .02). Median in-room to anesthesia release time was faster in the morning than it was in the afternoon (10 minutes vs 11 minutes, P = .02). CONCLUSION: Nonprocedural times made up roughly half of the total TURBT operating time and should be considered in OR efficiency analyses. TURBT OR efficiency may be related to the number of TURBTs performed in a day as well as the time of day of TURBT start.

Conversion to Disposable Cystoscopes Decreased Post-procedure Encounters and Infections Compared to Reusable Cystoscopes.

INTRODUCTION: We evaluated for differences in post-procedure 30-day encounters or infections following office cystoscopy using disposable vs reusable cystoscopes. METHODS: Cystoscopies performed from June to September 2020 and from February to May 2021 in our outpatient practice were retrospectively reviewed. The 2020 cystoscopies were performed with reusable cystoscopes, and the 2021 cystoscopies were performed with disposable cystoscopes. The primary outcome was the number of post-procedural 30-day encounters defined as phone calls, patient portal messages, emergency department visits, hospitalizations, or clinic appointments related to post-procedural complications such as dysuria, hematuria, or fever. Culture-proven urinary tract infection within 30 days of cystoscopy was evaluated as a secondary outcome. RESULTS: We identified 1,000 cystoscopies, including 494 with disposable cystoscopes and 506 with reusable cystoscopes. Demographics were similar between groups. The most common indication for cystoscopy in both groups was suspicion of bladder cancer (disposable: 153 [30.2%] and reusable: 143 [28.9%]). Reusable cystoscopes were associated with a higher number of 30-day encounters (35 [7.1%] vs 11 [2.2%], P < .001), urine cultures (73 [14.8%] vs 3 [0.6%], P = .005), and hospitalizations attributable to cystoscopy (1 [0.2%] vs 0 [0%], P < .001) than the disposable scope group. Positive urine cultures were also significantly more likely after cystoscopy with a reusable cystoscope (17 [3.4%] vs 1 [0.2%], P < .001). CONCLUSIONS: Disposable cystoscopes were associated with a lower number of post-procedure encounters and positive urine cultures compared to reusable cystoscopes.

Disparities in access to high-volume centers and in hospital discharge status following radical cystectomy in Florida.

INTRODUCTION: Centralization of radical cystectomy (RC) improves outcomes but may unintentionally exacerbate existing disparities in care. Our objective was to assess disparities in access to high-volume RC centers and in postoperative recovery. METHODS: We identified RC patients in the Florida Inpatient Data File from 2013 to 2019. Hospital annual cystectomy volume was categorized as low, medium, or high using data-derived 75th and 90th quantiles: <5, 5 to 13, and >13 RC/year. Outcomes included inpatient mortality, non-home discharge, in-hospital complications, length of stay (LOS) and surgery in a low-volume hospital. Mixed-effects regression models accounting for clustering within centers were utilized. RESULTS: Among 4,396 patients treated at 105 centers, RC at a high-volume center was associated with lower odds of mortality, non-home discharge, shorter length of stay and fewer complications (all P ≤ 0.001). Characteristics associated with receiving care in a low-volume hospital included Black race (OR 1.67, 95% CI 1.14-2.39), Hispanic/Latino ethnicity (OR 1.74, 95% CI 1.32-2.00), and residing in northeast (OR 2.11, 95% CI 1.58-2.80) or west Florida (OR 1.34, 95% CI 1.05-1.71). Black patients had increased odds of non-home discharge (OR 1.91, 95% CI 1.27-2.86) and longer LOS (IRR 1.17, 95% CI 1.08-1.27), but no difference in the rate or number of postoperative complications (P > 0.2). CONCLUSION: In Florida, we observed racial and geographic disparities in likelihood of undergoing RC at a high-volume hospital, and that Black patients experienced longer LOS and lower odds of home discharge despite similar rates of complications. Efforts to increase access to high-value RC care for these vulnerable populations are needed.

International Multi-institutional Characterization of the Perioperative Morbidity of Metastasectomy for Renal Cell Carcinoma.

BACKGROUND: Surgical resection of metastatic renal cell carcinoma (mRCC) has been associated with better cancer-specific survival; however, high-quality data on its perioperative morbidity are lacking. Existing population-based data are severely limited by reliance on billing claims to identify outcomes, which may overestimate events owing to a lack of code specificity. OBJECTIVE: To study 30-d complications after metastasectomy for mRCC. DESIGN, SETTING, AND PARTICIPANTS: The study involved a retrospective cohort of patients who underwent metastasectomy for mRCC between 2005 and 2020 at two high-volume centers. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used generalized estimating equations for a binary response to evaluate associations of features with 30-d complications classified according to Clavien-Dindo grade. RESULTS AND LIMITATIONS: A total of 740 metastasectomies in 522 patients were identified, including 543 performed in the Mayo Clinic and 197 in UZ Leuven. Among the 740 metastasectomies, 193 (26%, 95% confidence interval [CI] 23-29%) had a 30-d complication and 62 (8%, 95% CI 7-11%) had a major (Clavien-Dindo III-V) complication, including eight (1%) perioperative deaths. Age, body mass index, American Society of Anesthesiologists score, metastasectomy concurrent with nephrectomy, multiple sites of metastasis, pancreatic resection, and metastasis size were significantly associated with postoperative complications (all p < 0.05). Age, multiple sites of metastasis, and pancreatic resection were significantly associated with major (Clavien-Dindo III-V) complications (all p < 0.05). Limitations include the retrospective design and surgical selection bias. CONCLUSIONS: In this multi-institutional series, fewer than 10% of metastasectomies for mRCC resulted in a major complication within 30 d of surgery, which is considerably lower than previously observed in population-based data. Favorable perioperative outcomes can be achieved with metastasectomy at high-volume centers in well-selected patients. PATIENT SUMMARY: In this study we found that fewer than 10% of patients who underwent surgical removal of one or more sites of metastatic kidney cancer experienced a major complication within 30 days of surgery.

Intraoperative Blood Transfusion Is Associated With Increased Risk of Venous Thromboembolism After Radical Cystectomy.

PURPOSE: Our objective was to examine whether perioperative blood transfusion is associated with venous thromboembolism following radical cystectomy adjusting for both patient- and disease-related factors. MATERIALS AND METHODS: Patients who underwent radical cystectomy for bladder cancer from 1980-2020 were identified in the Mayo Clinic cystectomy registry. Blood transfusion during the initial postoperative hospitalization was analyzed as a 3-tiered variable: no transfusion, postoperative transfusion alone, or intraoperative with or without postoperative transfusion. The primary outcome was venous thromboembolism within 90 days of radical cystectomy. Associations between clinicopathological variables and 90-day venous thromboembolism were assessed using multivariable logistic regression, with transfusion analyzed as both a categorical and a continuous variable. RESULTS: A total of 3,755 radical cystectomy patients were identified, of whom 162 (4.3%) experienced a venous thromboembolism within 90 days of radical cystectomy. Overall, 2,112 patients (56%) received a median of 1 (IQR: 0-3) unit of blood transfusion, including 811 (38%) with intraoperative transfusion only, 572 (27%) with postoperative transfusion only, and 729 (35%) with intraoperative and postoperative transfusion. On multivariable analysis, intraoperative with or without postoperative blood transfusion was associated with a significantly increased risk of venous thromboembolism (adjusted OR 1.73, 95% CI 1.17-2.56, P = .002). Moreover, when analyzed as a continuous variable, each unit of blood transfused intraoperatively was associated with 7% higher odds of venous thromboembolism (adjusted OR 1.07, 95% CI 1.01-1.13, P = .03). CONCLUSIONS: Intraoperative blood transfusion was significantly associated with venous thromboembolism within 90 days of radical cystectomy. To ensure optimal perioperative outcomes, continued effort to limit blood transfusion in radical cystectomy patients is warranted.