83 results on '"Krupski TL"'
Search Results
2. Determinants of treatment regret in low-income, uninsured men with prostate cancer.
- Author
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Hu JC, Kwan L, Krupski TL, Anger JT, Maliski SL, Connor S, and Litwin MS
- Published
- 2008
3. Impact of SPY Fluorescence Angiography on Incidence of Ureteroenteric Stricture After Urinary Diversion.
- Author
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Yeaman C, Ignozzi G, Kazeem A, Isharwal S, Krupski TL, and Culp SH
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- Aged, Female, Humans, Male, Middle Aged, Anastomosis, Surgical adverse effects, Constriction, Pathologic epidemiology, Constriction, Pathologic etiology, Cystectomy adverse effects, Incidence, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications diagnostic imaging, Prospective Studies, Ureter surgery, Ureter diagnostic imaging, Ureteral Obstruction etiology, Ureteral Obstruction epidemiology, Ureteral Obstruction surgery, Fluorescein Angiography methods, Urinary Diversion adverse effects
- Abstract
Purpose: Ureteroenteric strictures (UESs) are a common and morbid complication of radical cystectomy and urinary diversions. UES occurs in 4% to 25% of all patients undergoing urinary diversion, and anastomotic ischemia is implicated in stricture formation. SPY fluorescence angiography is a technology that can be employed during open surgery that allows for evaluation of ureteral perfusion., Materials and Methods: We performed a prospective single-institution study of intraoperative use of SPY for ureteral assessment with a primary outcome of UES incidence compared with a cohort of historic controls prior to the use of SPY during urinary diversion at our institution. Chart abstraction was conducted to determine the presence of confirmed stricture in these patients, defined as endoscopic diagnosis or definitive imaging findings. Statistical analysis was performed using χ
2 test for UES incidence. Demographic characteristics were analyzed with Wilcoxon rank sum test and χ2 test., Results: A total of 332 patients underwent urinary diversion during the study period. UES occurred in 31 of 277 patients (11.1%) in the control group compared with 1 of 55 patients (1.8%) enrolled in the SPY arm ( P = .03). The per-ureter UES rate was 6.7% (33/582) in the control group compared with 0.9% (1/107) in the SPY group. Median follow-up in the SPY group was 17.5 months and 58.6 months in the control group. Median Charlson Comorbidity Index was 5 in the SPY group and 4 in the control group. There were no other significant demographic differences between the study groups., Conclusions: SPY fluorescent angiography can be used during open urinary diversion to ensure perfusion to ureteroenteric anastomosis. Our single-institution study demonstrates a decreased incidence of UES when ureteral perfusion assessment is performed., Clinical Trial Registration No.: NCT05022199.- Published
- 2024
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4. Patient Satisfaction with a Novel Tele-Cystoscopy Model: Expanding Access to Bladder Cancer Surveillance for Rural Patients.
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Kazeem AO, Hasken W, Sims T, Culp SH, Krupski TL, and Lobo JM
- Abstract
Background: Tele-cystoscopy involves trained advanced practice providers performing cystoscopy with real-time interpretation by an urologist. The goal of this externally validated care model is to expand the availability of cystoscopy to underserved rural areas. Herein we report on population demographics and describe the socioeconomic benefits of tele-cystoscopy for bladder cancer surveillance., Methods: Using an IRB-approved protocol, patients were consented for dual, sequential cystoscopy wherein they experienced a standard-of-care cystoscopy along with tele-cystoscopy. Patients completed a questionnaire that contained both subjective and objective health and socioeconomic-related questions as well as a satisfaction survey. Patients were also probed about factors associated with transportation to their cystoscopy appointments including gasoline costs, travel time, and time off work. Using the Distressed Community Index, patients were ascribed an economic resource category ranging from prosperous to distressed., Results: In total, 48 patients with a mean age of 55 completed surveys after completing dual cystoscopies. Thirteen patients (27%) were uninsured and 10 patients (20%) had Medicaid as primary insurance. The tele-cystoscopy clinic saved patients an average of 235 miles and 434 min of travel time. In total, 82% of patients resided in a distressed community indicating fewer economic resources. Satisfaction results showed a mean score of 31.38 (out of 32)., Conclusions: Patients were satisfied with tele-cystoscopy, noting increased access to health care and fewer disruptions impacting bladder cancer surveillance. Tele-cystoscopy may be a viable option to expand access and improve adherence to guidelines for bladder cancer surveillance, particularly benefiting patients in rural areas and those of lower socioeconomic status., (© The Author(s) 2024. Published by Mary Ann Liebert, Inc.)
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- 2024
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5. Cost-Effectiveness Analysis of the Clear Cell Likelihood Score Against Renal Mass Biopsy for Evaluating Small Renal Masses.
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Chen KY, Lange MJ, Qiu JX, Lambert D, Mithqal A, Krupski TL, Schenkman NS, and Lobo JM
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- Humans, Biopsy economics, Biopsy methods, Cost-Effectiveness Analysis, Decision Support Techniques, Kidney pathology, Kidney diagnostic imaging, Multiparametric Magnetic Resonance Imaging economics, Neoplasm Grading, Carcinoma, Renal Cell economics, Carcinoma, Renal Cell pathology, Carcinoma, Renal Cell diagnosis, Kidney Neoplasms pathology, Kidney Neoplasms economics, Kidney Neoplasms diagnosis
- Abstract
Objective: To examine the cost-effectiveness of the clear cell likelihood score compared to renal mass biopsy (RMB) alone., Methods: The clear cell likelihood score, a new grading system based on multiparametric magnetic resonance imaging, has been proposed as a possible alternative to percutaneous RMB for identifying clear cell renal carcinoma in small renal masses and expediting treatment of high-risk patients. A decision analysis model was developed to compare a RMB strategy where all patients undergo biopsy and a clear cell likelihood score strategy where only patients that received an indeterminant score of 3 undergo biopsy. Effectiveness was assigned 1 for correct diagnoses and 0 for incorrect or indeterminant diagnoses. Costs were obtained from institutional fees and Medicare reimbursement rates. Probabilities were derived from literature estimates from radiologists trained in the clear cell likelihood score., Results: In the base case model, the clear cell likelihood score was both more effective (0.77 vs 0.70) and less expensive than RMB ($1629 vs $1966). Sensitivity analysis found that the nondiagnostic rate of RMB and the sensitivity of the clear cell likelihood score had the greatest impact on the model. In threshold analyses, the clear cell likelihood score was the preferred strategy when its sensitivity was greater than 62.7% and when an MRI cost less than $5332., Conclusion: The clear cell likelihood score is a more cost-effective option than RMB alone for evaluating small renal masses for clear cell renal carcinoma., Competing Interests: Declaration of Competing Interest All authors declare no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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6. Microwave ablation of the T1a small renal mass: expanding beyond 3 cm.
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Qiu J, Ballantyne C, Yeaman C, Lange M, Morgan J, Mershon JP, Richie I, DeNovio A, Clements MB, Krupski TL, Schenkman N, and Lobo JM
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- Humans, Retrospective Studies, Microwaves therapeutic use, Treatment Outcome, Recurrence, Kidney Neoplasms diagnostic imaging, Kidney Neoplasms surgery, Carcinoma, Renal Cell pathology, Catheter Ablation methods, Renal Insufficiency, Chronic
- Abstract
Purpose: To compare the oncological and renal function outcomes for patients receiving microwave ablation (MWA) in tumors < 3 and 3-4 cm., Methods: Retrospective analysis of a prospectively maintained database identified patients with < 3 or 3-4 cm renal cancers undergoing MWA. Radiographic follow-up occurred at approximately 6 months post-procedure and annually thereafter. Serum creatinine and estimated glomerular filtration rate (eGFR) were calculated before and 6-months post-MWA. Local recurrence-free survival (LRFS) was estimated using the Kaplan-Meier method. Tumor size was evaluated as a prognostic factor using Cox proportional-hazards regression. Predictors for change in eGFR and chronic kidney disease (CKD) stage were modeled using linear and ordinal logistic regression., Results: A total of 126 patients fit the inclusion criteria. Overall recurrences were 2/62 (3.2%) and 6/64 (9.4%) for < 3 versus 3-4 cm. Both recurrences in the < 3 cm group were local, 4/6 in the 3-4 cm group were local and 2/6 were metastatic without local progression. For < 3 versus 3-4 cm, cumulative LRFS at 36 months was 94.6% versus 91.4%. Tumor size was not a significant prognostic factor for LRFS. Renal function did not change significantly after MWA. Patient comorbidities and RENAL nephrometry score significantly affected change in CKD., Conclusion: With comparable oncological outcomes, complication rates, and renal function preservation, MWA is a promising management strategy for renal masses of 3-4 cm in select patients. Our findings suggest that current AUA guidelines, which recommend thermal ablation for tumors < 3 cm, may need review to include T1a tumors for MWA, regardless of size., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2023
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7. Air Outlining the Renal System.
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Isharwal S, Gupta S, Tandon YK, and Krupski TL
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- Humans, Kidney diagnostic imaging, Air
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- 2023
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8. India Ink Tattooing of Ureteroenteric Anastomoses.
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Tuong MNE, Prillaman GE, Culp SH, Nelson M, Krupski TL, and Isharwal S
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- Humans, Middle Aged, Cystectomy, Pilot Projects, Anastomosis, Surgical methods, Retrospective Studies, Ureter diagnostic imaging, Ureter surgery, Ureter pathology, Tattooing, Urinary Bladder Neoplasms
- Abstract
While upper tract access through the insensate conduit following urinary diversion takes less time and incurs fewer costs than percutaneous kidney access does for the treatment of ureter and kidney pathology, endoscopic ureteroenteric anastomoses (UEA) identification can be difficult. We injected India Ink into the bowel mucosa near the UEA during ileal conduit diversion (IC) to determine the safety and feasibility of ink tattooing. Patients undergoing IC were prospectively randomized to receive ink or normal saline (NS) injections. The injections were placed 1 cm from UEA in a triangular configuration, and loopogram exams and looposcopy were performed to identify reflux (UR), UEA, the tattooing site and strictures in 10 and 11 patients randomized with respect to ink and NS injections, respectively. Ink patients were older (72 vs. 61 years old, p = 0.04) and had a higher Charlson Comorbidity Index (5 vs. 2, p = 0.01). Looposcopy was performed in three ink and four NS patients. Visualization of UEA was achieved in 100% of the ink and 75% of the NS patients ( p = 0.26). The ink ureteroenteric anastomotic stricture (UEAS) rate was higher ( N = 3 vs. N = 1) and six patients vs. one patients underwent surgery, respectively, for UEAS ( p = 0.31). The study was halted early due to safety concerns. Our pilot study demonstrates that ink can be well visualized following injection near UEA during IC. However, the ink cohort had more UEAS than previously cited in the literature and our prior institutional UEAS rate of 6%. While this study sample is small, the higher incidence of UEAS after ink injection led us to question the utility and safety of ink injection following IC.
- Published
- 2023
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9. Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial.
- Author
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Venkatramani V, Reis IM, Gonzalgo ML, Castle EP, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, and Parekh DJ
- Subjects
- Adult, Aged, Aged, 80 and over, Cohort Studies, Female, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Patient Satisfaction, Treatment Outcome, United States, Activities of Daily Living, Cystectomy methods, Recovery of Function, Robotic Surgical Procedures methods, Urinary Bladder Neoplasms surgery
- Abstract
Importance: No data exist on time to recovery of patient-reported and performance-related measures of functional independence after radical cystectomy (open or robotic)., Objective: To determine recovery of functional independence after radical cystectomy and whether robot-assisted radical cystectomy (RARC) is associated with any advantage over open procedures., Design, Setting, and Participants: Data for this secondary analysis from the RAZOR (Randomized Open vs Robotic Cystectomy) trial were used. RAZOR was a phase 3 multicenter noninferiority trial across 15 academic medical centers in the US from July 1, 2011, to November 18, 2014, with a median follow-up of 2 years. Participants included the per-protocol population (n = 302). Data were analyzed from February 1, 2017, to May 1, 2021., Interventions: Robot-assisted radical cystectomy or open radical cystectomy (ORC)., Main Outcomes and Measures: Patient-reported (activities of daily living [ADL] and independent ADL [iADL]) and performance-related (hand grip strength [HGS] and Timed Up & Go walking test [TUGWT]) measures of independence were assessed. Patterns of postoperative recovery for the entire cohort and comparisons between RARC and ORC were performed. Exploratory analyses to assess measures of independence across diversion type and to determine whether baseline impairments were associated with 90-day complications or 1-year mortality were performed., Findings: Of the 302 patients included in the analysis (254 men [84.1%]; mean [SD] age at consent, 68.0 [9.7] years), 150 underwent RARC and 152 underwent ORC. Baseline characteristics were similar in both groups. For the entire cohort, ADL, iADL, and TUGWT recovered to baseline by 3 postoperative months, whereas HGS recovered by 6 months. There was no difference between RARC and ORC for ADL, iADL, TUGWT, or HGS scores at any time. Activities of daily living recovered 1 month after RARC (mean estimated score, 7.7 [95% CI, 7.3-8.0]) vs 3 months after ORC (mean estimated score, 7.5 [95% CI, 7.2-7.8]). Hand grip strength recovered by 3 months after RARC (mean estimated HGS, 29.0 [95% CI, 26.3-31.7] kg) vs 6 months after ORC (mean estimated HGS, 31.2 [95% CI, 28.8-34.2] kg). In the RARC group, 32 of 90 patients (35.6%) showed a recovery in HGS at 3 months vs 32 of 88 (36.4%) in the ORC group (P = .91), indicating a rejection of the primary study hypothesis for HGS. Independent ADL and TUGWT recovered in 3 months for both approaches. Hand grip strength showed earlier recovery in patients undergoing continent urinary diversion (mean HGS at 3 months, 31.3 [95% CI, 27.7-34.8] vs 33.9 [95% CI, 30.5-37.3] at baseline; P = .09) than noncontinent urinary diversion (mean HGS at 6 months, 27.4 [95% CI, 24.9-30.0] vs 29.5 [95% CI, 27.2-31.9] kg at baseline; P = .02), with no differences in other parameters. Baseline impairments in any parameter were not associated with 90-day complications or 1-year mortality., Conclusions and Relevance: The results of this secondary analysis suggest that patients require 3 to 6 months to recover baseline levels after radical cystectomy irrespective of surgical approach. These data will be invaluable in patient counseling and preparation. Hand grip strength and ADL tended to recover to baseline earlier after RARC; however, there was no difference in the percentage of patients recovering when compared with ORC. Further study is needed to assess the clinical significance of these findings., Trial Registration: ClinicalTrials.gov Identifier: NCT01157676.
- Published
- 2022
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10. Impact of radiation on the incidence and management of ureteroenteric strictures: a contemporary single center analysis.
- Author
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Yeaman CT, Winkelman A, Maciolek K, Tuong M, Nelson P, Morris C, Culp S, Isharwal S, and Krupski TL
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- Aged, Constriction, Pathologic epidemiology, Constriction, Pathologic etiology, Databases, Factual, Female, Humans, Incidence, Male, Middle Aged, Nephrostomy, Percutaneous, Postoperative Complications etiology, Prospective Studies, Risk Factors, Ureteral Obstruction epidemiology, Postoperative Complications epidemiology, Radiotherapy adverse effects, Ureter radiation effects, Ureteral Obstruction etiology, Urinary Diversion adverse effects
- Abstract
Background: Ureteroenteric stricture incidence has been reported as high as 20% after urinary diversion. Many patients have undergone prior radiotherapy for prostate, urothelial, colorectal, or gynecologic malignancy. We sought to evaluate the differences between ureteroenteric stricture occurrence between patients who had radiation prior to urinary diversion and those who did not., Methods: An IRB-approved cystectomy database was utilized to identify ureteroenteric strictures among 215 patients who underwent urinary diversion at a single academic center between 2016 and 2020. Chart abstraction was conducted to determine the presence of confirmed stricture in these patients, defined as endoscopic diagnosis or definitive imaging findings. Strictures due to malignant ureteral recurrence were excluded (3 patients). Statistical analysis was performed using chi squared test, t-test, and Wilcoxon Rank-Sum Test, logistic regression, and Kaplan-Meier analysis of stricture by cancer type., Results: 65 patients had radiation prior to urinary diversion; 150 patients did not have a history of radiation therapy. Benign ureteroenteric stricture rate was 5.3% (8/150) in the non-radiated cohort and 23% (15/65) in the radiated cohort (p = < 0.001). Initial management of stricture was percutaneous nephrostomy (PCN) in 78% (18/23) and the remaining 22% (5/23) were managed with primary retrograde ureteral stent placement. Long term management included ureteral reimplantation in 30.4% (7/23)., Conclusions: Our study demonstrates a significant increase in rate of ureteroenteric strictures in radiated patients as compared to non-radiated patients. The insult of radiation on the ureteral microvascular supply is likely implicated in the cause of these strictures. Further study is needed to optimize surgical approach such as utilization of fluorescence angiography for open and robotic approaches., (© 2021. The Author(s).)
- Published
- 2021
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11. Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial.
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Berry DL, Hong F, Blonquist TM, Halpenny B, Xiong N, Filson CP, Master VA, Sanda MG, Chang P, Chien GW, Jones RA, Krupski TL, Wolpin S, Wilson L, Hayes JH, Trinh QD, and Sokoloff M
- Subjects
- Combined Modality Therapy, Delivery of Health Care, Follow-Up Studies, Humans, Long Term Adverse Effects etiology, Male, Prognosis, Surveys and Questionnaires, Choice Behavior, Decision Making physiology, Decision Support Techniques, Emotions physiology, Long Term Adverse Effects pathology, Prostatic Neoplasms psychology, Prostatic Neoplasms therapy
- Abstract
Introduction: Men diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted the secondary outcome of post-treatment decision regret., Methods: Participants were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care prior to a final treatment decision. Symptoms were measured just before randomization and 6 months later; decision regret was measured at 6 months along with records review to ascertain treatment choices. Regression modeling explored associations between baseline variables including race and D`Amico risk, study group, and 6-month variables regret, choice, and symptoms., Results: At 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered the regret scale. Regret was not significantly different between participants randomized to the P3P intervention compared to the control group (P = 0.360). In univariate analyses, we found that Black men, men with hormonal symptoms, and men with bowel symptoms reported significantly higher decision regret (all P < 0.01). Significant interactions were detected between race and study group (intervention vs. usual care) in the multivariable model; use of the Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (P = 0.037). Interactions between regret, symptoms and treatment revealed that (1) men choosing definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others; and (2) men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others., Conclusion: The Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer., Trial Registration: NCT01844999., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
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12. Urologic Complications Requiring Intervention Following High-dose Pelvic Radiation for Cervical Cancer.
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Beller HL, Rapp DE, Zillioux J, Abdalla B, Duska LR, Showalter TN, Krupski TL, Cisu T, Congleton JY, and Schenkman NS
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- Carcinoma radiotherapy, Cystitis etiology, Cystoscopy, Female, Humans, Middle Aged, Nephrostomy, Percutaneous, Radiotherapy Dosage, Retrospective Studies, Stents, Ureteral Obstruction etiology, Radiation Injuries complications, Uterine Cervical Neoplasms radiotherapy
- Abstract
Objective: To identify the incidence of radiation-induced urologic complication requiring procedural intervention following high-dose radiotherapy for cervical carcinoma, and to identify predictors of complication occurrence., Materials and Methods: We performed a retrospective chart review of cervical cancer patients undergoing radiotherapy with primary focus on procedural complications (Clavien-Dindo ≥ III). Clinical data were collected including radiation dose, procedure performed, timing of complication, and need for additional procedures. Univariate and multivariate logistic regression modeling was performed to assess predictive value of demographic and clinical variables., Results: A total of 126 patients with FIGO stage 1A2-4B cervical cancer were included in study analysis, with 18 patients experiencing procedural complication (14.3%). A total of 22 complications were identified, representing an average of 1.2 complications per patient with complication. The most common complications were ureteral stricture and radiation cystitis. The most common nononcologic procedures performed in the treatment of these complications were ureteral stenting, percutaneous nephrostomy tube placement, and cystoscopy. Notably, a total of 259 procedures were performed in the treatment of urologic complications, representing 14.4 procedures per patient and 24.6 procedures per patient with ureteral stricture. Logistic regression demonstrated active smoking at the time of diagnosis to be a predictor of procedural complication., Conclusion: Radiotherapy in the treatment of cervical cancer is associated with a high rate of urologic procedural complication. These complications often require numerous procedures and long-term management given their complexity. These findings suggest a need for awareness and plans for multidisciplinary management of urologic complications in this patient population., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
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13. Optimizing Telemedicine Technologic Infrastructure with Animal Models: A Case in Telecystoscopy.
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Beller HL, Corey T, Horton BJ, Lobo JM, Schenkman NS, Sims T, Jones RA, and Krupski TL
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- Animals, Cystoscopes, Cystoscopy, Models, Anatomic, Swine, Telemedicine, Urology
- Abstract
Background: Rapid evolution of telemedicine technology requires procedures in telemedicine to adapt frequently. An example in urology, telecystoscopy, allows certified advanced practice providers to perform cystoscopy, endoscopic examination of the bladder, in rural areas with real-time interpretation and guidance by an off-site urologist. We have previously shown the technological infrastructure for optimized video quality. Introduction: Newer models of cystoscope and coder/decoder (codec) are available with anticipation that components used in our original model will become unavailable. Our objective is to assess the diagnostic ability of two cystoscopes (Storz, Wolf) with old (SX20) and new (DX70) codecs. Materials and Methods: A single urologist performed flexible cystoscopy on an ex vivo porcine bladder. Combinations of cystoscope (Storz vs. Wolf), codec (SX20 vs. DX70), and internet transmission speed were used to create eight distinct recordings. Deidentified videos were reviewed by expert urologist reviewers via electronic survey with questions on video quality and diagnostic ability. A logistic regression model was used to assess the ability to make a diagnosis. Results: Eight transmitted cystoscopy videos were reviewed by 16 urologists. Despite new technology, the Storz cystoscope combined with the SX20 codec (the original combination) provides the best diagnostic capacity. Discussion: Technical infrastructure must be routinely validated to assess the component impact on overall quality because newer is not always better. Should the SX20 become obsolete, ex vivo animal models are safe, inexpensive anatomic models for testing. Conclusions: As technology continues to evolve, procedures in telemedicine must critically scrutinize the impact of new technologic components to uphold quality.
- Published
- 2021
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14. Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial.
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Wages NA, Sanders JC, Smith A, Wood S, Anscher MS, Varhegyi N, Krupski TL, Harris TJ, and Showalter TN
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- Follow-Up Studies, Gastrointestinal Tract radiation effects, Health Expenditures, Humans, Lymphatic Metastasis, Male, Middle Aged, Outcome Assessment, Health Care, Prostatectomy, Prostatic Neoplasms economics, Prostatic Neoplasms surgery, Radiation Dose Hypofractionation, Radiation Injuries pathology, Radiation Injuries prevention & control, Radiotherapy, Adjuvant, Salvage Therapy, Urogenital System radiation effects, Prostatic Neoplasms radiotherapy, Quality of Life
- Abstract
Purpose: The phase 1 portion of this multicenter, phase 1/2 study of hypofractionated (HypoFx) prostate bed radiation therapy (RT) as salvage or adjuvant therapy aimed to identify the shortest dose-fractionation schedule with acceptable toxicity. The phase 2 portion aimed to assess the health-related quality of life (QoL) of using this HypoFx regimen., Methods and Materials: Eligibility included standard adjuvant or salvage prostate bed RT indications. Patients were assigned to receive 1 of 3 daily RT schedules: 56.6 Gy in 20 Fx, 50.4 Gy in 15 Fx, or 42.6 Gy in 10 Fx. Regional nodal irradiation and androgen deprivation therapy were not allowed. Participants were followed for 2 years after treatment with outcome measures based on prostate-specific antigen levels, toxicity assessments (Common Terminology Criteria for Adverse Events, v4.0), QoL measures (the Expanded Prostate Cancer Index Composite [EPIC] and EuroQol EQ-5D instruments), and out-of-pocket costs., Results: There were 32 evaluable participants, and median follow-up was 3.53 years. The shortest dose-fractionation schedule with acceptable toxicity was determined to be 42.6 Gy in 10 Fx, with most patients (23) treated with this schedule. Grade 3 genitourinary (GU) and gastrointestinal (GI) toxicities occurred in 3 patients and 1 patient, respectively. There was 1 grade 4 sepsis event. Higher dose to the hottest 25% of the rectum was associated with increased risk of grade 2+ GI toxicity; no dosimetric factors were found to predict for GU toxicity. There was a significant decrease in the mean bowel, but not bladder, QoL score at 1 year compared with baseline. Prostate-specific antigen failure occurred in 34.3% of participants, using a definition of nadir plus 2 ng/mL. Metastases were more likely to occur in regional lymph nodes (5 of 7) than in bones (2 of 7). The mean out-of-pocket cost for patients during treatment was $223.90., Conclusions: We identified 42.6 Gy in 10 fractions as the shortest dose-fractionation schedule with acceptable toxicity in this phase 1/2 study. There was a higher than expected rate of grade 2 to 3 GU and GI toxicity and a decreased EPIC bowel QoL domain with this regimen. Future studies are needed to explore alternative adjuvant/salvage HypoFx RT schedules after radical prostatectomy., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
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15. Tele-Urology During COVID-19: Rapid Implementation of Remote Video Visits.
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Beller HL, Rapp DE, Noona SW, Winkelman AJ, Zillioux JM, Smith RP, Sims T, Corbett ST, Krupski TL, Greene KL, and Schenkman NS
- Abstract
Introduction: COVID-19 has brought unprecedented challenges to the delivery of urological care. Following rapid implementation of remote video visits at our tertiary academic medical center serving a large rural population we describe and assess our experience with planned video visits and ongoing scheduling efforts., Methods: Patients scheduled for video visits between April 14 and April 27, 2020 were included. Prospective and retrospective data were collected on patient and clinical characteristics as well as telemedicine outcomes. Multivariable logistic regression was performed to evaluate factors influencing video visit success. Concurrently scheduling data were collected from a separate cohort regarding patient access to technology and willingness to participate in video visits., Results: A total of 209 patients were included with an overall video visit success rate of 67%. Of video visits that failed (69) reasons included no-show (35%), inability to connect to the telemedicine platform (23%) and lack of Internet access (10%). Nearly half of failed video visits (46.4%) were completed as phone visits. After adjustment for patient demographics commercial insurance was significantly associated with video visit success. In assessment of scheduling outcomes 179 patients were contacted to offer video visits. Of these patients 6.7% reported not having Internet access. Of those with Internet access 87% agreed to proceed with a video visit in lieu of visiting in person., Conclusions: Our experience indicates that rapid implementation of video telemedicine is feasible and highly accepted by patients. Efforts focused on standardized pre-visit patient education may further optimize successful telemedicine visits.
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- 2020
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16. Blinded Comparison of Clarity, Proficiency and Diagnostic Capability of Tele-Cystoscopy Compared to Traditional Cystoscopy: A Pilot Study.
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Lobo JM, Horton B, Jones RA, Tyson T, Hill-Collins P, Sims T, Rueb JJ, Corey T, Rheuban K, Battle P, Beller H, Schenkman N, Culp S, and Krupski TL
- Subjects
- Female, Humans, Male, Pilot Projects, Predictive Value of Tests, Retrospective Studies, Video Recording, Cystoscopy methods, Telemedicine
- Abstract
Purpose: In order to expand the availability of cystoscopy to underserved areas we have proposed using advanced practice providers to perform cystoscopy with real-time interpretation by the urologist on a telemedicine platform, termed "tele-cystoscopy." The purpose of this study is to have blinded external reviewers retrospectively compare multisite, prospectively collected video data from tele-cystoscopy with the video of traditional cystoscopy in terms of video clarity, practitioner proficiency and diagnostic capability., Materials and Methods: Each patient underwent tele-cystoscopy by a trained advanced practice provider and traditional cystoscopy with an onsite urologist. Prospectively collected tele-cystoscopy transmitted video, tele-cystoscopy onsite video and traditional cystoscopy video were de-identified and blinded to external reviewers. Each video was evaluated and rated twice by independent reviewers and diagnostic agreement was quantified., Results: Six tele-cystoscopy encounters were reviewed for a total of 36 assessments. Video clarity, defined by speed of transmission and image resolution, was better for onsite compared to transmitted tele-cystoscopy. Practitioner proficiency for thoroughness of inspection was rated at 92% for tele-cystoscopy and 100% for traditional cystoscopy. Confidence in identification of an abnormality was equivalent. Four of 6 videos had 100% agreement between reviewers for next action taken, indicating high diagnostic agreement. Additionally, provider performing cystoscopy and location did not statistically influence the ability to make a diagnosis or action taken., Conclusions: This model has excellent completeness of examination, equivalent ability to identify abnormalities and external validation of action taken. This pilot study demonstrates that tele-cystoscopy may expand access to bladder cancer surveillance.
- Published
- 2020
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17. Provider Scheduling to Maximize Patient Access.
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Lobo JM, Erdogan SA, Berg BP, Kang H, Clements MB, Culp SH, and Krupski TL
- Abstract
Introduction: We describe and demonstrate an efficient method for assigning clinic days to urology providers in academic and large urology group practices given their numerous scheduling constraints including evaluation and management visits, office or operating room procedures/surgeries, teaching, trainee mentorship, committee work and outreach activities., Methods: We propose an integer programming model for scheduling providers for clinic shifts in order to maximize patient access to appointments considering the aforementioned scheduling constraints. We present results for a case study with an academic urology clinic and lessons learned from implementing the model generated schedule., Results: The integer programming model produced a feasible schedule that was implemented after pairwise and 3-way switches among attending providers to account for preferences. The optimized schedule had reduced variability in the number of providers scheduled per shift (standard deviation 1.409 vs 0.999, p=0.01). While other confounding factors are possible we noted a significant increase in the number of encounters after implementing changes from the model (1,370 vs 1,196 encounters, p=0.011)., Conclusions: Optimization models offer an efficient and transferable method of generating a clinic template for providers that takes into account other clinical and academic responsibilities, and can increase the number of appointments for patients. Optimization of schedules may be performed periodically to address changes in providers or provider constraints.
- Published
- 2020
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18. Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy.
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Becerra MF, Venkatramani V, Reis IM, Soodana-Prakash N, Punnen S, Gonzalgo ML, Raolji S, Castle EP, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, and Parekh DJ
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Cystectomy methods, Quality of Life, Robotic Surgical Procedures, Urinary Bladder Neoplasms surgery
- Abstract
Purpose: We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer., Materials and Methods: Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey (SF-8) at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life., Results: Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-Vanderbilt Cystectomy Index subscale or composite score (p >0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6 months compared to baseline (p <0.05). Continent diversion (versus noncontinent) was associated with worse FACT-bladder-cystectomy score at 3 (p <0.01) but not at 6 months, and the SF-8 physical component was better in continent-diversion patients at 6 months (p=0.019)., Conclusions: Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling.
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- 2020
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19. Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial.
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Mills JT, Rapp DE, Shaw NM, Hougen HY, Agard HE, Case RM Jr, McMurry TL, Schenkman NS, and Krupski TL
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- Device Removal, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Urinary Catheters, Patient Discharge, Urinary Retention epidemiology, Urinary Tract Infections epidemiology, Urination
- Abstract
Purpose: We sought to determine the effect of active versus passive voiding trials on time to hospital discharge and rates of urinary tract infection (UTI) and urinary retention (UR)., Methods: We performed a prospective, randomized trial comparing active (AVT) versus passive (PVT) void trials of inpatients requiring urethral catheter removal. Of 329 eligible patients, 274 were randomized to AVT (bladder filled with saline before catheter removal) or PVT (spontaneous bladder filling after catheter removal). Primary outcome was time to hospital discharge. Secondary outcomes were UTI (NSQIP criteria) and UR (requiring repeat catheterization) within 2 weeks of void trial., Results: The median time to void was 18 (5-115) versus 236 (136-360) min in the AVT and PVT groups, respectively (p < 0.0001). However, no difference was seen in comparison of the median time to hospital discharge between AVT [28.4 (13.6-69.3) h] and PVT [30.0 (10.4-75.6) h] cohorts, respectively (p = 0.93). Six (4.8%) and 13 (12.9%) patients developed UTI in the AVT and PVT groups, respectively (p = 0.03). Eleven (8.8%) and 12 (11.9%) patients developed UR in the AVT and PVT groups, respectively (p = 0.36)., Conclusion: Our study comparing AVT versus PVT demonstrated no difference in time to discharge despite a 3.6 h reduction in time to void associated with AVT. AVT was associated with a 63% reduction in UTI, with no difference seen in UR rates across cohorts. Given the reduction in UTI and technical advantages, our data suggest that AVT should be considered as a recommended technique for void trial protocol., Trial Registration: NCT02886143 (clinicaltrials.gov).
- Published
- 2020
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20. Predictors of Recurrence, and Progression-Free and Overall Survival following Open versus Robotic Radical Cystectomy: Analysis from the RAZOR Trial with a 3-Year Followup.
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Venkatramani V, Reis IM, Castle EP, Gonzalgo ML, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Kibel AS, Pruthi RS, Montgomery JS, Weight CJ, Sharp DS, Chang SS, Cookson MS, Gupta GN, Gorbonos A, Uchio EM, Skinner E, Soodana-Prakash N, Becerra MF, Swain S, Kendrick K, Smith JA Jr, Thompson IM, and Parekh DJ
- Subjects
- Aged, Disease Progression, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Survival Rate, United States, Urinary Bladder Neoplasms mortality, Cystectomy methods, Robotic Surgical Procedures methods, Urinary Bladder Neoplasms surgery
- Abstract
Purpose: The RAZOR (Randomized Open versus Robotic Cystectomy) trial revealed noninferior 2-year progression-free survival for robotic radical cystectomy. This update was performed with extended followup for 3 years to determine potential differences between the approaches. We also report 3-year overall survival and sought to identify factors predicting recurrence, and progression-free and overall survival., Materials and Methods: We analyzed the per protocol population of 302 patients from the RAZOR study. Cumulative recurrence was estimated using nonbladder cancer death as the competing risk event and the Gray test was applied to assess significance in differences. Progression-free survival and overall survival were estimated by the Kaplan-Meier method and compared with the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis., Results: Estimated progression-free survival at 36 months was 68.4% (95% CI 60.1-75.3) and 65.4% (95% CI 56.8-72.7) in the robotic and open groups, respectively (p=0.600). At 36 months overall survival was 73.9% (95% CI 65.5-80.5) and 68.5% (95% CI 59.8-75.7) in the robotic and open groups, respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Patient age greater than 70 years, poor performance status and major complications were significant predictors of 36-month progression-free survival. Stage and positive margins were significant predictors of recurrence, and progression-free and overall survival. Surgical approach was not a significant predictor of any outcome., Conclusions: This analysis showed no difference in recurrence, 3-year progression-free survival or 3-year overall survival for robotic vs open radical cystectomy. It provides important prospective data on the oncologic efficacy of robotic radical cystectomy and high level data for patient counseling.
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- 2020
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21. Does renal mass biopsy influence multidisciplinary treatment recommendations?
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Lobo JM, Clements MB, Bitner DP, Mikula MD, Noona SW, Sultan MI, Cathro HP, Lambert DL, Schenkman NS, and Krupski TL
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- Adenoma, Oxyphilic diagnosis, Adenoma, Oxyphilic therapy, Aged, Angiomyolipoma diagnosis, Angiomyolipoma therapy, Biopsy, Large-Core Needle, Carcinoma, Renal Cell diagnosis, Carcinoma, Renal Cell therapy, Decision Making, Shared, Female, Humans, Image-Guided Biopsy, Kidney Neoplasms diagnosis, Kidney Neoplasms therapy, Male, Middle Aged, Nephrons, Organ Sparing Treatments, Patient Care Team, Ablation Techniques, Adenoma, Oxyphilic pathology, Angiomyolipoma pathology, Carcinoma, Renal Cell pathology, Clinical Decision-Making, Kidney Neoplasms pathology, Nephrectomy, Watchful Waiting
- Abstract
Purpose: To examine how a multidisciplinary team approach incorporating renal mass biopsy (RMB) into decision making changes the management strategy. Methods: A multidisciplinary team comprised of a radiology proceduralist, a pathologist and urologists convened monthly for renal mass conference with a structured presentation of patient demographics, co-mborbidities, tumor pathology, laboratory and radiographic features. Biopsy protocol was standardized to an 18-gauge core needle biopsy using a sheathed apparatus under renal ultrasound guidance. Biopsy diagnostic rate, and concordance with nephrectomy specimens were summarized. Descriptive statistics were used to evaluate influence of RMB on management decisions. Results: A total of 83 patients with a ≤4 cm mass were discussed, and 66% of patients underwent RMB. Of those, 87% were diagnostic with 9% of core biopsies showing benign pathology. Active surveillance (AS) was recommended for 34% of patients with biopsy data as compared to 64% of those without biopsy. Ablation was recommended for 38% of the biopsy cohort compared to 7% without biopsy. Partial nephrectomy rates were similar for both cohorts, approximately 17% and 22%, respectively. Our complication rate was 1.5%, with only 1 Clavien-Dindo Grade 2 complication. Histology was concordant in 93% of patients that ultimately underwent partial nephrectomy after biopsy. Conclusions: Over half of our SRM patients underwent a RMB that provided a diagnosis in 85% of cases. RMB aided in shared decision making by providing insight into the biology of renal masses, which helps to guide multidisciplinary management and consideration of nephron sparing options.
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- 2020
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22. Prostate Cancer Characteristics in the US Preventive Services Task Force Grade D Era: A Single-Center Study and Meta-Analysis.
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Clements MB, Abdalla B, Culp SH, Costabile RA, and Krupski TL
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- Humans, Male, Practice Guidelines as Topic, Preventive Health Services, Prostatic Neoplasms diagnosis, United States, Early Detection of Cancer methods, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms prevention & control
- Abstract
Background: In May 2012, the US Preventive Services Task Force assigned prostate-specific antigen-based screening a grade D recommendation, advising against screening at any age. Our objective was to compare prostate cancer characteristics pre- and post-recommendation with an adjusted analysis of our data and a pooled analysis including other primary data sources., Methods: We identified all incident prostate cancer diagnoses at our institution from 2007 to 2016. Multivariable log binomial regression was used to determine the relative risk (RR) of metastasis at diagnosis, ≥Gleason Group 4, and high D'Amico risk disease pre- versus post-recommendation. The meta-analysis included primary data studies evaluating these outcomes., Results: At our institution, 287 (44.6%) and 224 (48.8%) patients were diagnosed in the pre- and post-cohorts. The RR of metastatic disease at diagnosis did not differ between groups (p = 0.224), nor did the risk of high D'Amico category disease (p = 0.089). The risk of ≥Gleason Group 4 was 1.58 times higher post-recommendation (p = 0.007). The pooled risk of ≥Gleason Group 4 disease was 1.5 (p < 0.001) post-recommendation and was 1.29 (p = 0.006) for high D'Amico risk disease., Conclusions: While the number of metastatic cases did not differ after the recommendation, the risk of high-grade cancers increased at both a local and aggregated level., (© 2020 S. Karger AG, Basel.)
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- 2020
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23. Assigning value to preparation for prostate cancer decision making: a willingness to pay analysis.
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Wilson LS, Blonquist TM, Hong F, Halpenny B, Wolpin S, Chang P, Filson CP, Master VA, Sanda MG, Chien GW, Jones RA, Krupski TL, and Berry DL
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- Aged, Humans, Male, Middle Aged, Decision Making, Decision Support Techniques, Patient Acceptance of Health Care, Patient Education as Topic, Prostatic Neoplasms economics
- Abstract
Background: The Personal Patient Profile-Prostate (P3P) is a web-based decision support system for men newly diagnosed with localized prostate cancer that has demonstrated efficacy in reducing decisional conflict. Our objective was to estimate willingness-to-pay (WTP) for men's decisional preparation activities., Methods: In a multicenter, randomized trial of P3P, usual care group participants received typical preparation for decision making plus referral to publicly-available, educational websites. Intervention group participants received the same, plus online P3P educational media specific to the user's personal preferences and values, and a communication coaching component tailored to race\ethnicity, age and language. WTP data were collected one week after physician consultation. An iterative bidding direct contingent valuation survey format was used, randomly assigning participants to high or low starting values (SV). Tobit models were used to explore associations between SV-adjusted WTP and age, education, marital and work-status, insurance, decision-control preference and decision-making stage., Results: Of 392 participants enrolled, 141 P3P and 107 usual care (UC) provided a WTP value. Men were willing to pay a median $25 (IQR $10-100) for P3P in addition to usual care preparation materials. In the final multivariable tobit regression model, SV, marital status, stage of decision making and income were significantly associated with WTP for P3P. Decision control preference was considered marginally significant (p = 0.11). Men were WTP a median $30 (IQR $10-$200) for usual care material alone. In the final multivariable model, SV, education, and stage of decision making were significantly associated with WTP in usual care., Conclusion: WTP was similar for UC and for the addition of P3P to UC decision preparation. The WTP values were associated with demographic and preference variables. Findings can help focus decision support on future patients who would benefit most: those without strong support systems, at earlier stages of decision making, and open to a shared-decision style., Trial Registration: NCT NCT01844999 . Registered May 3, 2013.
- Published
- 2019
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24. Ileal perforation in the setting of atezolizumab immunotherapy for advanced bladder cancer.
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Zillioux J, DiLizia M, Schaheen B, Rustin R, and Krupski TL
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- Aged, Antibodies, Monoclonal, Humanized, Carcinoma, Transitional Cell secondary, Enterocolitis complications, Humans, Male, Urinary Bladder Neoplasms pathology, Antibodies, Monoclonal adverse effects, Antineoplastic Agents, Immunological adverse effects, Carcinoma, Transitional Cell drug therapy, Enterocolitis chemically induced, Ileal Diseases etiology, Intestinal Perforation etiology, Urinary Bladder Neoplasms drug therapy
- Abstract
Atezolizumab is a promising immunotherapy for advanced urothelial carcinoma. Like other immune checkpoint inhibitors, it can produce rare immune-related adverse events (IRAEs). Here we present the recent case of a patient with metastatic bladder cancer who developed diarrhea and abdominal pain months after beginning atezolizumab therapy. He presented to our institution with an ileal perforation secondary to atezolizumab-induced enterocolitis. After surgical repair, the patient's condition improved, and he was discharged. We discuss the management of atezolizumab-induced enterocolitis, including the importance of early recognition and intervention to prevent more devastating complications.
- Published
- 2018
25. Case report of renal cell carcinoma metastasis to the spermatic cord and groin presenting as a bleeding groin mass.
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Farhi J, Clements M, and Krupski TL
- Published
- 2018
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26. Robotic-Assisted Surgery for Upper Tract Urothelial Carcinoma: A Comparative Survival Analysis.
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Clements MB, Krupski TL, and Culp SH
- Subjects
- Aged, Aged, 80 and over, Carcinoma, Transitional Cell secondary, Female, Hospital Charges, Humans, Kaplan-Meier Estimate, Kidney Neoplasms pathology, Length of Stay, Lymphatic Metastasis, Male, Patient Readmission, Proportional Hazards Models, SEER Program, Survival Rate, Ureteral Neoplasms pathology, Carcinoma, Transitional Cell surgery, Kidney Neoplasms surgery, Laparoscopy economics, Robotic Surgical Procedures economics, Ureteral Neoplasms surgery, Urinary Bladder Neoplasms secondary
- Abstract
Background: We performed a comparative survival analysis of patients undergoing robotic-assisted versus laparoscopic or open surgery for upper tract urothelial carcinoma (UTUC)., Materials and Methods: Patients diagnosed with non-metastatic UTUC undergoing removal of the kidney and/or ureter were identified using Medicare-linked Surveillance, Epidemiology, and End Results Program data (2004-2013). Patients aged 65-85 years were categorized based on surgical approach (open, laparoscopic, or robotic-assisted). Kaplan-Meier methods were used to determine survival (overall and cancer-specific) and intravesical recurrence rates, the former using a propensity score-weighted model. Independent predictors of survival were determined using multivariable Cox proportional hazards regression analysis., Results: We identified a total of 3801 patients meeting the final inclusion criteria: open (n = 1862), laparoscopic (n = 1624), and robotic (n = 315). Robotic surgery was associated with the shortest length of hospital stay (p < 0.001) but highest in-hospital charges (p < 0.001), with no difference in readmission rates (p = 0.964). No difference was found in overall or cancer-specific survival in the robotic cohort when compared with open or laparoscopic surgery. In addition, no difference in the rate of intravesical recurrence was noted in robotic-assisted laparoscopy compared with the other groups. The sole predictor of improved survival was extent of lymphadenectomy, which was highest in the robotic cohort., Conclusions: Using a large, population-based cancer database, there was no survival difference when a robotic-assisted approach was utilized in patients undergoing surgery for UTUC. These findings are important with the increased use of robotic surgery in the management of UTUC.
- Published
- 2018
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27. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial.
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Parekh DJ, Reis IM, Castle EP, Gonzalgo ML, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Kibel AS, Shemanski L, Pruthi RS, Montgomery JS, Weight CJ, Sharp DS, Chang SS, Cookson MS, Gupta GN, Gorbonos A, Uchio EM, Skinner E, Venkatramani V, Soodana-Prakash N, Kendrick K, Smith JA Jr, and Thompson IM
- Subjects
- Adult, Aged, Aged, 80 and over, Cystectomy adverse effects, Female, Humans, Male, Middle Aged, Postoperative Complications epidemiology, Random Allocation, Robotic Surgical Procedures adverse effects, Single-Blind Method, Cystectomy methods, Disease Progression, Progression-Free Survival, Robotic Surgical Procedures methods, Urinary Bladder Neoplasms surgery
- Abstract
Background: Radical cystectomy is the surgical standard for invasive bladder cancer. Robot-assisted cystectomy has been proposed to provide similar oncological outcomes with lower morbidity. We aimed to compare progression-free survival in patients with bladder cancer treated with open cystectomy and robot-assisted cystectomy., Methods: The RAZOR study is a randomised, open-label, non-inferiority, phase 3 trial done in 15 medical centres in the USA. Eligible participants (aged ≥18 years) had biopsy-proven clinical stage T1-T4, N0-N1, M0 bladder cancer or refractory carcinoma in situ. Individuals who had previously had open abdominal or pelvic surgery, or who had any pre-existing health conditions that would preclude safe initiation or maintenance of pneumoperitoneum were excluded. Patients were centrally assigned (1:1) via a web-based system, with block randomisation by institution, stratified by type of urinary diversion, clinical T stage, and Eastern Cooperative Oncology Group performance status, to receive robot-assisted radical cystectomy or open radical cystectomy with extracorporeal urinary diversion. Treatment allocation was only masked from pathologists. The primary endpoint was 2-year progression-free survival, with non-inferiority established if the lower bound of the one-sided 97·5% CI for the treatment difference (robotic cystectomy minus open cystectomy) was greater than -15 percentage points. The primary analysis was done in the per-protocol population. Safety was assessed in the same population. This trial is registered with ClinicalTrials.gov, number NCT01157676., Findings: Between July 1, 2011, and Nov 18, 2014, 350 participants were randomly assigned to treatment. The intended treatment was robotic cystectomy in 176 patients and open cystectomy in 174 patients. 17 (10%) of 176 patients in the robotic cystectomy group did not have surgery and nine (5%) patients had a different surgery to that they were assigned. 21 (12%) of 174 patients in the open cystectomy group did not have surgery and one (1%) patient had robotic cystectomy instead of open cystectomy. Thus, 302 patients (150 in the robotic cystectomy group and 152 in the open cystectomy group) were included in the per-protocol analysis set. 2-year progression-free survival was 72·3% (95% CI 64·3 to 78·8) in the robotic cystectomy group and 71·6% (95% CI 63·6 to 78·2) in the open cystectomy group (difference 0·7%, 95% CI -9·6% to 10·9%; p
non-inferiority =0·001), indicating non-inferiority of robotic cystectomy. Adverse events occurred in 101 (67%) of 150 patients in the robotic cystectomy group and 105 (69%) of 152 patients in the open cystectomy group. The most common adverse events were urinary tract infection (53 [35%] in the robotic cystectomy group vs 39 [26%] in the open cystectomy group) and postoperative ileus (33 [22%] in the robotic cystectomy group vs 31 [20%] in the open cystectomy group)., Interpretation: In patients with bladder cancer, robotic cystectomy was non-inferior to open cystectomy for 2-year progression-free survival. Increased adoption of robotic surgery in clinical practice should lead to future randomised trials to assess the true value of this surgical approach in patients with other cancer types., Funding: National Institutes of Health National Cancer Institute., (Copyright © 2018 Elsevier Ltd. All rights reserved.)- Published
- 2018
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28. Creation of a Novel Digital Rectal Examination Evaluation Instrument to Teach and Assess Prostate Examination Proficiency.
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Clements MB, Schmidt KM, Canfield SE, Gilbert SM, Khandelwal SR, Koontz BF, Lallas CD, Liauw S, Nguyen PL, Showalter TN, Trabulsi EJ, Cathro HP, Schenkman NS, and Krupski TL
- Subjects
- Clinical Competence, Delphi Technique, Efficiency, Equipment Design, Female, Humans, Male, Regression Analysis, Reproducibility of Results, Digital Rectal Examination instrumentation, Education, Medical, Graduate methods, Proctoscopy instrumentation, Prostatic Diseases diagnosis, Urology education
- Abstract
Objective: To create a validated tool to measure digital rectal examination proficiency and aid with teaching of the examination., Design: The Digital Rectal Examination Clinical Tool was created using a modified Delphi method with 5 urologists and 5 radiation oncologists. The instrument was then validated in a population of preclinical medical students examining male urological teaching associates, and clinical trainees (third- and fourth-year medical students and urology resident physicians) examining prospectively enrolled subjects. Trainees completed paired examinations with an attending urologist, and responses were scored with reference to the attending responses., Setting: The instrument was validated at the University of Virginia in the urology clinic, endoscopic operating room, and main operating room settings., Participants: We tested the instrument on consenting subjects consisting of male urologic teaching associates (n = 12), clinic patients (n = 4), and operating room patients (n = 64). The participants were undergraduate (n = 302) and graduate (n = 9) medical trainees., Results: In preclerkship trainees, improved scores in subjects without abnormal compared to those with abnormal findings demonstrated validity. In clinical trainees, scores on the Digital Rectal Examination Clinical Tool increased by 2% for each additional year of training, demonstrating construct validity., Conclusions: We used an expert panel to create a novel instrument for measuring digital rectal examination proficiency and validated it with preclinical and clinical trainee cohorts at our institution., (Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
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29. Decision Support with the Personal Patient Profile-Prostate: A Multicenter Randomized Trial.
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Berry DL, Hong F, Blonquist TM, Halpenny B, Filson CP, Master VA, Sanda MG, Chang P, Chien GW, Jones RA, Krupski TL, Wolpin S, Wilson L, Hayes JH, Trinh QD, Sokoloff M, and Somayaji P
- Subjects
- Adult, Aged, Algorithms, Biopsy, Demography, Humans, Male, Middle Aged, Prostatic Neoplasms pathology, Surveys and Questionnaires, United States, Decision Support Techniques, Internet, Prostatic Neoplasms therapy
- Abstract
Purpose: We evaluated the efficacy of the web based P3P (Personal Patient Profile-Prostate) decision aid vs usual care with regard to decisional conflict in men with localized prostate cancer., Materials and Methods: A randomized (1:1), controlled, parallel group, nonblinded trial was performed in 4 regions of the United States. Eligible men had clinically localized prostate cancer and an upcoming consultation, and they spoke and read English or Spanish. Participants answered questionnaires to report decision making stage, personal characteristics, concerns and preferences plus baseline symptoms and decisional conflict. A randomization algorithm allocated participants to receive tailored education and communication coaching, generic teaching sheets and external websites plus a 1-page summary to clinicians (intervention) or the links plus materials provided in clinic (usual care). Conflict outcomes and the number of consultations were measured at 1 month. Univariate and multivariable models were used to analyze outcomes., Results: A total of 392 men were randomized, including 198 to intervention and 194 to usual care, of whom 152 and 153, respectively, returned 1-month outcomes. The mean ± SD 1-month decisional conflict scale (score range 0 to 100) was 10.9 ± 16.7 for intervention and 9.9 ± 18.0 for usual care. The multivariable model revealed significantly reduced conflict in the intervention group (-5.00, 95% CI -9.40--0.59). Other predictors of conflict included income, marital or partner status, decision status, number of consultations, clinical site and D'Amico risk classification., Conclusions: In this multicenter trial the decision aid significantly reduced decisional conflict. Other variables impacted conflict and modified the effect of the decision aid, notably risk classification, consultations and resources. P3P is an effective adjunct for shared decision making in men with localized prostate cancer., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
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30. Does Robotic Surgical Simulator Performance Correlate With Surgical Skill?
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Mills JT, Hougen HY, Bitner D, Krupski TL, and Schenkman NS
- Subjects
- Cohort Studies, Computer Simulation, Female, Hospitals, University, Humans, Male, Task Performance and Analysis, Video Recording, Virginia, Clinical Competence, Education, Medical, Continuing methods, Medical Staff, Hospital education, Operating Rooms, Robotic Surgical Procedures education, Simulation Training methods
- Abstract
Objective: To assess the relationship between robotic surgical simulation performance and the real-life surgical skill of attending surgeons. We hypothesized that simulation performance would not correlate with real-life robotic surgical skill in attending surgeons., Design: In 2013, Birkmeyer et al. demonstrated an association between laparoscopic surgical performance as determined by expert review of video clips and surgical outcomes. Using that model of expert review, we studied the relationship between robotic simulator performance and real-life surgical skill. Ten attending robotic surgeons performed 4 tasks on the da Vinci Skills Simulator (Camera Targeting 1, Ring Walk 3, Suture Sponge 3, and Energy Dissection 3). Two video clips of a robotic-assisted operation were then recorded for each surgeon. Three expert robotic surgeons reviewed the recordings and rated surgical technique using the Global Evaluative Assessment of Robotic Skills., Setting: University of Virginia; Charlottesville, VA; tertiary hospital PARTICIPANTS: All attending surgeons who perform robotic-assisted surgery at our institution were enrolled and completed the study., Results: The surgeons had a median of 7.25 years of robotic surgical experience with a median of 91 cases (ranging: 20-346 cases) in the last 4 years. Median scores for each simulator task were 87.5%, 39.0%, 77.5%, and 81.5%. Using Pearson's correlation, scores for each of the individual tasks correlated poorly with expert review of intraoperative performance. There was also no correlation (r = -0.0304) between overall simulation score (mean: 70.7 ± 9.6%) and expert video ratings (mean: 3.66 ± 0.32 points)., Conclusions: There was no correlation between attending surgeons' simulator performance and expert ratings of intraoperative videos based on the Global Evaluative Assessment of Robotic Skills scale. Although novice surgeons may put considerable effort into training on robotic simulators, performance on a simulator may not correlate with attending robotic surgical performance. Development of simulation exercises that guide novice surgeons toward expert performance is needed., (Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2017
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31. Intravesical rAd-IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study.
- Author
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Shore ND, Boorjian SA, Canter DJ, Ogan K, Karsh LI, Downs TM, Gomella LG, Kamat AM, Lotan Y, Svatek RS, Bivalacqua TJ, Grubb RL 3rd, Krupski TL, Lerner SP, Woods ME, Inman BA, Milowsky MI, Boyd A, Treasure FP, Gregory G, Sawutz DG, Yla-Herttuala S, Parker NR, and Dinney CPN
- Subjects
- Adenoviridae genetics, Administration, Intravesical, Aged, Aged, 80 and over, BCG Vaccine administration & dosage, Cholic Acids chemistry, Disaccharides chemistry, Drug Resistance, Neoplasm, Fatigue etiology, Female, Genetic Therapy adverse effects, Genetic Vectors administration & dosage, Genetic Vectors genetics, Humans, Interferon alpha-2, Interferon-alpha chemistry, Interferon-alpha genetics, Male, Middle Aged, Neoplasm Grading, Neoplasm Invasiveness, Neoplasm Recurrence, Local, Recombinant Fusion Proteins chemistry, Recombinant Fusion Proteins genetics, Recombinant Fusion Proteins metabolism, Recombinant Proteins chemistry, Recombinant Proteins genetics, Recombinant Proteins metabolism, Treatment Outcome, Urinary Bladder Neoplasms genetics, Urinary Bladder Neoplasms pathology, Urination Disorders etiology, Genetic Therapy methods, Interferon-alpha metabolism, Urinary Bladder Neoplasms therapy
- Abstract
Purpose Many patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC. Methods In this open-label, multicenter (n = 13), parallel-arm, phase II study ( ClinicalTrials.gov identifier: NCT01687244), 43 patients with HG BCG-refractory or relapsed NMIBC received intravesical rAd-IFNα/Syn3 (randomly assigned 1:1 to 1 × 10
11 viral particles (vp)/mL or 3 × 1011 vp/mL). Patients who responded at months 3, 6, and 9 were retreated at months 4, 7, and 10. The primary end point was 12-month HG recurrence-free survival (RFS). All patients who received at least one dose were included in efficacy and safety analyses. Results Forty patients received rAd-IFNα/Syn3 (1 × 1011 vp/mL, n = 21; 3 × 1011 vp/mL, n = 19) between November 5, 2012, and April 8, 2015. Fourteen patients (35.0%; 90% CI, 22.6% to 49.2%) remained free of HG recurrence 12 months after initial treatment. Comparable 12-month HG RFS was noted for both doses. Of these 14 patients, two experienced recurrence at 21 and 28 months, respectively, after treatment initiation, and one died as a result of an upper tract tumor at 17 months without a recurrence. rAd-IFNα/Syn3 was well tolerated; no grade four or five adverse events (AEs) occurred, and no patient discontinued treatment because of an adverse event. The most frequently reported drug-related AEs were micturition urgency (n = 16; 40%), dysuria (n = 16; 40%), fatigue (n = 13; 32.5%), pollakiuria (n = 11; 28%), and hematuria and nocturia (n = 10 each; 25%). Conclusion rAd-IFNα/Syn3 was well tolerated. It demonstrated promising efficacy for patients with HG NMIBC after BCG therapy who were unable or unwilling to undergo radical cystectomy.- Published
- 2017
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32. Patient positioning during minimally invasive surgery: what is current best practice?
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Zillioux JM and Krupski TL
- Abstract
Introduction: Positioning injuries are a known surgical complication and can result in significant patient morbidity. Studies have shown a small but significant number of neurovascular injuries associated with minimally invasive surgery, due to both patient and case-specific factors. We sought to review the available literature in regards to pathophysiological and practical recommendations., Methods: A literature search was conducted and categorized by level of evidence, with emphasis on prospective studies. The result comprised 14 studies, which were summarized and analyzed with respect to our study objectives., Results: While incidence of positioning injury has been identified in up to one-third of prospective populations, its true prevalence after surgery is likely 2%-5%. The mechanism is thought to be intraneural disruption from stretching or pressure, which results in decreased perfusion. On a larger scale, this vascular compromise can lead to ischemia and rhabdomyolysis. Prevention hinges on addressing patient modifiable factors such as body mass index, judicious positioning with appropriate devices, and intraoperative team awareness consisting of recurrent extremity checks and time management., Conclusion: The risk for positioning injuries is underappreciated. Surgeons who perform minimally invasive surgery should discuss the potential for these complications with their patients, and operative teams should take steps to minimize risk factors., Competing Interests: Disclosure Dr Krupski is a subinvestigator for studies/trials under the National Cancer Institute, American Cancer Society, FKD, and Argos. The authors report no conflicts of interest in this work.
- Published
- 2017
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33. Management of Ureteroenteric Stricture: Predictive Modeling to Compare Cost.
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Shaw NM, Lobo JM, Zee R, and Krupski TL
- Subjects
- Constriction, Pathologic economics, Cystectomy economics, Health Care Costs, Humans, Monte Carlo Method, Nephrostomy, Percutaneous economics, Radiology, Interventional economics, Stents economics, Treatment Outcome, Urinary Bladder surgery, Urinary Diversion economics, Urology economics, Constriction, Pathologic surgery, Cystectomy methods, Nephrostomy, Percutaneous methods, Urinary Diversion methods
- Abstract
Background: Ureteroenteric stricture occurs in as many as 15% of patients after cystectomy with urinary diversion. First-line management is typically percutaneous nephrostomy (PCN) drainage. We sought to compare costs of a urologic approach of retrograde stenting through flexible endoscopy and an interventional radiology (IR) approach of PCN and antegrade stenting using predictive modeling. The purpose of this study is to inform best practice for initial stricture management based on existing literature regardless of the benign stricture rate following radical cystectomy. Our hypothesis is that initial management by a urologist may be superior to IR management., Materials and Methods: The primary outcome measure was cost based on 2015 Medicare reimbursement rates by Current Procedural Technology codes with a secondary endpoint of number of procedures a patient undergoes. We developed a simulation model to replicate the experience of stricture patients. The model describes three arms: urologic management with retrograde stent placement, sequential management by IR, and single-stage IR management. We simulated 10,000 patients through the model with the percentage of patients pursuing each treatment arm and success rates chosen based on a review of relevant literature and clinic experience., Results: The average cost of urologic management is $703.23 compared with the average cost of $838.09 for patients using radiologic management. Within radiologic management, the average cost is $862.98 for sequential IR management and $639.44 for single-stage IR management. Patients would undergo an average of 2.53 procedures for those patients initially sent to urology and 2.91 procedures for those sent to radiology. For sequential IR, the average is 3.02 procedures, and for single-stage IR, it is 2.03 procedures. From a cost perspective, the success rate at which retrograde stent placement becomes worth attempting is 35%. If radiologic management is attempted initially, sequential IR management represents a cost-conscious option that limits the total number of procedures., Conclusion: The disparity in cost between IR and urologic management of ureteral stricture provides a rationale for rural practices that may not have immediate access to IR to manage the patient.
- Published
- 2016
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34. Optimizing and validating the technical infrastructure of a novel tele-cystoscopy system.
- Author
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Hougen HY, Lobo JM, Corey T, Jones R, Rheuban K, Schenkman NS, and Krupski TL
- Subjects
- Cost-Benefit Analysis, Crowdsourcing, Humans, Rural Health Services organization & administration, Telemedicine instrumentation, Telemedicine methods, Urinary Bladder Neoplasms surgery, Videoconferencing instrumentation, Videoconferencing organization & administration, Videoconferencing standards, Cystoscopy methods, Telemedicine organization & administration
- Abstract
Introduction: Bladder cancer is the most costly malignancy to manage per capita due to the technical nature and intensity of follow-up. There are few urologists in rural areas, often necessitating that patients travel hours to receive follow-up care multiple times per year. We plan to train registered nurses and allied health professionals to perform cystoscopies which are monitored and interpreted in real-time by board-certified urologists. The key is to ensure optimal picture resolution to guarantee this technology is not inferior to traditional cystoscopy. Our objective was to develop the technical infrastructure needed for a tele-cystoscopy system through assessment of the transmitted video quality using expert reviewers and crowd-sourcing., Methods: All combinations of the tele-cystoscopy system were systematically tested using a single Thiel cadaver. The videos were reviewed by expert urologists and general reviewers using a crowd-sourcing website. The video quality responses were assessed to determine concordance between each set of reviewers, and to determine the optimal equipment that should be selected for the tele-cystoscopy system., Results: Of eight equipment combinations, only two were of high enough quality to be appropriate for medical use. We found there to be strong concordance of responses between the expert and crowd-sourced responses. The trade-offs between cost and tele-cystoscopy system component quality were compared with efficiency frontiers to elucidate the optimal system., Discussion: We created and tested the feasibility of a tele-cystoscopy system that was deemed suitable for medical diagnosis by a group of experts. We further validated tele-cystoscopy video quality using both experts and recently validated crowd-sourcing., (© The Author(s) 2015.)
- Published
- 2016
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35. Comparison of Renal Cell Carcinoma Surveillance Guidelines: Competing Trade-Offs.
- Author
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Lobo JM, Nelson M, Nandanan N, and Krupski TL
- Subjects
- Carcinoma, Renal Cell economics, Cost-Benefit Analysis, Early Detection of Cancer adverse effects, Early Detection of Cancer economics, Health Care Costs statistics & numerical data, Humans, Kidney pathology, Kidney Neoplasms economics, Models, Theoretical, Neoplasm Recurrence, Local diagnosis, Neoplasm Recurrence, Local economics, Practice Guidelines as Topic, Radiation Exposure statistics & numerical data, Risk Assessment, Sensitivity and Specificity, United States, Carcinoma, Renal Cell diagnosis, Early Detection of Cancer methods, Kidney Neoplasms diagnosis
- Abstract
Purpose: We estimated the differences in intensity, cost, radiation exposure and cancer control of published surveillance guidelines screening for secondary renal cell carcinoma in patients treated with partial nephrectomy., Materials and Methods: We developed a Monte Carlo simulation model to contrast the existing guidelines in terms of cost, radiation exposure and cancer control. Model inputs were extrapolated from the existing literature. Surveillance guidelines were analyzed from the AUA, CUA, EAU and NCCN®. Risk stratification among patients treated with partial nephrectomy was based on tumor characteristics., Results: Expected costs during the 5 years after partial nephrectomy were $587 (CUA), $1,076 (AUA), $1,705 (EAU) and $1,768 (NCCN) for low risk patients, and $903 (CUA), $2,525 (EAU) and $3,904 (AUA and NCCN) for high risk patients. Radiation exposure ranged from 31.41 mSv (CUA) to 104.34 mSv (NCCN) for low risk patients and 46.88 mSv (CUA) to 231.61 mSv (AUA and NCCN) for high risk patients. The EAU and CUA guidelines led to the diagnosis of the highest percentage of low risk patients (more than 95%) while all guidelines diagnosed more than 92% of high risk patients with recurrence., Conclusions: Renal cell carcinoma surveillance guidelines differ greatly in terms of intensity, cost and radiation exposure. It is important for clinicians to adopt standardized surveillance strategies that limit unnecessary cost and radiation exposure without compromising cancer control., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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36. Patient positioning and prevention of injuries in patients undergoing laparoscopic and robot-assisted urologic procedures.
- Author
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Sukhu T and Krupski TL
- Subjects
- Humans, Laparoscopy methods, Peripheral Nervous System Diseases prevention & control, Robotics methods, Compartment Syndromes prevention & control, Optic Neuropathy, Ischemic prevention & control, Patient Positioning methods, Peripheral Nerve Injuries prevention & control, Rhabdomyolysis prevention & control, Urologic Surgical Procedures methods
- Abstract
Positioning injuries in the perioperative period are one of the inherent risks of surgery, but particularly in robot-assisted urologic surgery, and can result in often unrecognized morbidity. Injuries such as upper or lower extremity peripheral neuropathies occur via neural mechanisms and injuries such as compartment syndrome, rhabdomyolysis, ischemic optic neuropathy, and acute arterial occlusion occur via vascular mechanisms. The risk of injury may be exacerbated by operative and patient-related risk factors. Patient-related risk factors include ASA class and BMI, while surgery-related risk factors include physical orientation of the patient and operative length. These injuries can be prevented or reduced by joint effort of the surgeon, anesthesiologist, and operating room staff.
- Published
- 2014
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37. Alvimopan: A cost-effective tool to decrease cystectomy length of stay.
- Author
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Manger JP, Nelson M, Blanchard S, Helo S, Conaway M, and Krupski TL
- Abstract
Introduction: We sought to evaluate the cost effectiveness of perioperative use of alvimopan in cystectomy and urinary diversion. A recent randomized controlled trial demonstrated the efficacy of alvimopan in reducing postoperative ileus and length of stay in cystectomy; however, a major limitation was the exclusion of epidural analgesia., Materials and Methods: Eighty-six cystectomy and urinary diversion procedures performed by seven surgeons were analyzed between January 2008 and April 2012. The first 50 patients did not receive alvimopan perioperatively, while the subsequent 36 received a single dose of 12 mg preoperatively and then 12 mg every 12 hours for 15 doses or until discharge., Results: The groups were equal with respect to age, gender, indication, surgeon, and type of diversion. Patients who received alvimopan experienced a shorter length of stay (LOS) versus those in who did not receive alvimopan (10.5 vs. 8.6 days, p = 0.005, 95% CI 0.6-3.3). Readmission for ileus was low in both alvimopan and control groups (0% and 4.4%, respectively). Costs were significantly lower in the alvimopan group than the control groups (2012 USD 32,443 vs. 40,604 p <0.001). This difference stood up to multivariate analysis with a $7,062 difference in hospital stay., Conclusions: Use of alvimopan in the routine perioperative care of our cystectomy and urinary diversion patients has decreased LOS by 1.9 days. Additionally, institution of routine perioperative alvimopan has reduced costs by $7,062 per admission (20% reduction). This demonstrates a real world application of alvimopan at a moderate volume center.
- Published
- 2014
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38. Lower urinary tract symptom improvement after radical prostatectomy correlates with degree of prostatic inflammation.
- Author
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Burris MB, Cathro HP, Kowalik CG, Jensen D, Culp SH, Steers WD, and Krupski TL
- Subjects
- Aged, Humans, Male, Middle Aged, Prostatitis diagnosis, Remission Induction, Retrospective Studies, Severity of Illness Index, Lower Urinary Tract Symptoms complications, Lower Urinary Tract Symptoms surgery, Prostatectomy, Prostatitis complications, Prostatitis surgery
- Abstract
Objective: To determine if prostatic inflammation at the time of radical prostatectomy (RP) was associated with the International Prostate Symptom Score (IPSS)., Methods: We performed a proof of principle analytic case control study of patients who underwent RP between January 2005 and August 2008 for lower urinary tract symptoms (LUTS). We reviewed pathology slides of those who had a change of 4 points or greater, as measured by the IPSS and correlated inflammation with change in IPSS. Multivariate linear regression analyses were performed to determine the association of IPSS with degree of inflammation based on the number of inflammatory cells., Results: Of 249 patients, 136 had complete data and 47 (18.8%) underwent pathologic review. The median change in IPSS for the study cohort was -7.0 points compared to +1.0 point for the control cohort. On univariate analysis, the average improvement in IPSS in patients with severe inflammation was (r = -6.02, 95% confidence interval [CI] -11.0 to -1.1, P = .018) after RP. On multivariate analysis, adjusting for age, body mass index (BMI), year of surgery, history of prostatitis, Gleason score, prostate-specific antigen (PSA), prostate weight, and nerve sparing status, only patients with severe prostatic inflammation had significant improvement in their IPSS (r = -5.93, 95% CI -10.81 to -1.04, P = .004)., Conclusion: Prostatic inflammation measured in prostatectomy specimens is associated with worse baseline IPSS than matched cohorts. Specifically, severe inflammation is an independent predictor of IPSS improvement at 1 year after RP., (Copyright © 2014 Elsevier Inc. All rights reserved.)
- Published
- 2014
- Full Text
- View/download PDF
39. Positioning injuries associated with robotic assisted urological surgery.
- Author
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Mills JT, Burris MB, Warburton DJ, Conaway MR, Schenkman NS, and Krupski TL
- Subjects
- Chi-Square Distribution, Female, Humans, Iatrogenic Disease, Logistic Models, Male, Retrospective Studies, Risk Factors, Treatment Outcome, Patient Positioning, Robotics, Urogenital Surgical Procedures adverse effects, Urologic Diseases surgery
- Abstract
Purpose: Nerve injury associated with patient positioning during surgery is well documented. With the development of robotic surgery, surgeons are faced with new surgical positioning, requiring attention to ensure patient safety. Published reports that address positioning injury during robotic surgery are sparse and none address the overall incidence. In this study we determine the incidence of positioning injury during robotic assisted urological surgery, identify risk factors and describe the time to resolution of the neurological injury., Materials and Methods: We reviewed all adult urological cases at our institution that used the da Vinci® Si and da Vinci Standard® Surgical System from January 2010 to December 2011. We characterized risk factors into the 4 domains of positioning, operative, patient specific and anesthesia related. Within these 4 categories we collected data on 13 specific aspects of patient care to determine their association with positioning injury., Results: Of 334 operations 22 positioning injuries (6.6%) were documented. Of these injuries 13 (59.1%) resolved within 1 month, 4 (18.2%) resolved between 1 and 6 months, and 5 (22.7%) persisted beyond 6 months. We found operative time (p <0.0001), in-room time (p <0.0001) and ASA (American Society of Anesthesiologists) class (p = 0.0033) were significantly associated with injury., Conclusions: Positioning injuries are under recognized in robotic assisted urological surgery and may persist beyond 6 months. Consideration must be given to counseling patients about the risks of positioning injuries, especially for long operations. Patients with multiple medical comorbidities (ASA class 4) are particularly at risk for these injuries., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2013
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40. Adolescent pelvic pain: interstitial cystitis.
- Author
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Hammett J, Krupski TL, and Corbett ST
- Subjects
- Adolescent, Algorithms, Combined Modality Therapy, Cystitis, Interstitial diagnosis, Cystoscopy, Female, Glucocorticoids administration & dosage, Humans, Pelvic Pain drug therapy, Prednisone administration & dosage, Cystitis, Interstitial complications, Cystitis, Interstitial therapy, Pelvic Pain etiology
- Abstract
Interstitial cystitis (IC) is a syndrome characterized by urinary urgency and frequency, dysuria, nocturia, and suprapubic pain. Patients are often difficult to treat due to the phenotypic heterogeneity of the disease and the limited efficacy of the treatment options. Treatment regimens must be individualized and tailored through a process of trial and error. There is a paucity of information regarding the treatment of adolescent IC. Here we report a case of a 13-year-old girl with IC who required multiple management strategies prior to obtaining symptomatic relief. We outline our treatment protocols based on the American Urologic Association IC treatment algorithm., (Copyright © 2013 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2013
- Full Text
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41. Patterns of care for renal surgery: Underutilization of nephron-sparing procedures.
- Author
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Hammett J, Ko J, Byrd N, Crispen PL, and Krupski TL
- Abstract
Background: Nephron-sparing procedures are well-described, provide similar oncologic outcomes to nephrectomy, and potentially decrease morbidity as compared to nephrectomy., Methods: We analyzed academic and community health system data from Virginia and Kentucky to evaluate the utilization and cost of nephron-sparing procedures. Primary International Classification of Disease (ICD-9) diagnosis and procedure codes were employed to target subjects of interest., Results: In total, we analyzed 3809 subjects from Virginia and 3163 subjects from Kentucky between 2004 and 2009 who underwent treatment of a malignant renal mass. There has been a 6.1% and 14.8% decrease in nephrectomy utilization in Virginia and Kentucky, respectively, since 2004. In 2009, 71.4% and 68.8% of all procedures for the treatment of renal masses were radical nephrectomies. The proportion of nephron-sparing procedures has increased in academic (20%) and community (15%) health systems since 2004. The difference in cost between nephrectomy, partial nephrectomy and ablative therapy in Virginia and Kentucky hospitals was negligible (p > 0.05)., Conclusions: Nephron-sparing procedures have been increasingly employed over the last 6 years, but are still underutilized. There does not appear to be a significant cost difference in the treatment of renal masses with nephrectomy, partial nephrectomy or ablative therapies.
- Published
- 2013
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42. Factors associated with satisfaction with prostate cancer care.
- Author
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Krupski TL
- Subjects
- Humans, Male, Fear psychology, Patient Satisfaction, Prostatectomy psychology, Prostatic Neoplasms therapy
- Published
- 2013
- Full Text
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43. Role of denosumab in prostate cancer.
- Author
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Helo S, Manger JP, and Krupski TL
- Subjects
- Animals, Antibodies, Monoclonal pharmacology, Antibodies, Monoclonal, Humanized pharmacology, Antineoplastic Agents pharmacology, Bone and Bones drug effects, Bone and Bones metabolism, Clinical Trials as Topic, Denosumab, Gene Expression Regulation, Neoplastic, Humans, Male, Osteoprotegerin genetics, Osteoprotegerin metabolism, Prostatic Neoplasms genetics, Prostatic Neoplasms metabolism, RANK Ligand antagonists & inhibitors, RANK Ligand genetics, RANK Ligand metabolism, Receptor Activator of Nuclear Factor-kappa B genetics, Receptor Activator of Nuclear Factor-kappa B metabolism, Tumor Burden drug effects, Tumor Burden genetics, Tumor Microenvironment genetics, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Agents therapeutic use, Prostatic Neoplasms drug therapy
- Abstract
Prostate cancer is known to have a tissue tropism for bone. This tissue tropism coupled with the experience with androgen deprivation therapy (ADT) over the past decade has led to heightened awareness of bone complications. Osteopenia and subsequent skeletal-related events (SREs) are one of the more concerning repercussions of ADT along with cardiovascular sequelae. To combat this decrease in bone mineral density, several agents have been developed for bone protection. The largest experience is with bisphosphonates (BPs), but recently (2011) head to head trials have established the role of monoclonal antibodies, particularly in patients with prostate cancer bone metastasis. For patients initiating ADT, monthly denosumab increased bone mineral density, the time for occurrence of any bone metastasis and time for symptomatic bone metastasis. Denosumab is a fully human monoclonal antibody of the IgG(2) subtype that selectively binds and neutralizes receptor activator NF kappa B ligand (RANKL), inhibiting osteoclastogenesis and bone turnover. In vitro binding assays have shown high-affinity binding of denosumab and osteoprotegerin to both soluble and membrane-bound forms of human RANKL. As clinicians may be less familiar with this newer agent, we compiled this review to summarize denosumab's current clinical indications for bone stabilization and mechanism of reduction in tumor burden.
- Published
- 2012
- Full Text
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44. Denosumab: Delay of bone metastasis in men with nonmetastatic castrate-resistant prostate cancer.
- Author
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Manger JP and Krupski TL
- Published
- 2012
- Full Text
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45. Construct validity in a high-fidelity prostate exam simulator.
- Author
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Kowalik CG, Gerling GJ, Lee AJ, Carson WC, Harper J, Moskaluk CA, and Krupski TL
- Subjects
- Adenocarcinoma pathology, Adult, Aged, Education, Medical, Continuing methods, Elastic Modulus, Female, Humans, Limit of Detection, Male, Middle Aged, Prostate pathology, Prostatic Neoplasms pathology, Tumor Burden, Adenocarcinoma diagnosis, Digital Rectal Examination, Models, Anatomic, Prostatic Neoplasms diagnosis
- Abstract
Background: All health care practitioners should be facile in the digital rectal exam (DRE) as it provides prostate, rectal and neurological information. The purpose of this study was first to justify our hypothesis that tissue elasticity is indicative of carcinomatous changes. Second, we employed urological surgeons to evaluate our prostate simulator in three ways: (1) authenticate that the elasticity of the simulated prostates accurately represents the range of normal prostate stiffness, (2) determine the range of nodule size reasonably palpable by DRE and (3) discern what degree of elasticity difference within the same prostate suggests malignancy., Methods: Institutional Review Board-approved materials characterization, human-subjects experiments, histopathology and chart abstraction of clinical history were performed. Material characterization of 21 ex-vivo prostatectomy specimens was evaluated using a custom-built, portable spherical indentation device while a novel prostate simulator was employed to measure human-subject perception of prostatic state., Results: From the materials characterization, the measurements of the 21 gross prostates and 40 cross-sections yielded 306 data points. Within the same prostate, cancer was always stiffer. Of the seven cases with an abnormal DRE, the DRE accurately identified adenocarcinoma in 85%. From the human-subjects experiments, the simulated prostates evaluated by urologists ranged in stiffness from 8.9 to 91 kPa, mimicking the range found on ex vivo analysis of 4.6-236.7 kPa. The urological surgeons determined the upper limit of stiffness palpated as realistic for a healthy prostate was 59.63 kPa while the lower limit of stiffness was 27.1 kPa. Nodule size less than 7.5 mm was felt to be too small to reasonably palpate., Conclusions: We found it is not the absolute elasticity of the nodule, but rather the relationship of the nodule with the background prostate elasticity that constitutes the critical tactile feedback. Prostate simulator training may lead to greater familiarity with pertinent diagnostic cues and diagnosis of prostate cancer.
- Published
- 2012
- Full Text
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46. Pretreatment expectations of patients undergoing robotic assisted laparoscopic or open retropubic radical prostatectomy.
- Author
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Schroeck FR, Krupski TL, Stewart SB, Bañez LL, Gerber L, Albala DM, and Moul JW
- Subjects
- Aged, Biopsy, Humans, Male, Middle Aged, Multivariate Analysis, Neoplasm Staging, Prostate-Specific Antigen blood, Prostatectomy instrumentation, Quality of Life, Recovery of Function, Surveys and Questionnaires, Laparoscopy methods, Patient Satisfaction, Prostatectomy methods, Prostatic Neoplasms surgery, Robotics
- Abstract
Purpose: We previously found that patients undergoing robotic assisted laparoscopic radical prostatectomy vs radical retropubic prostatectomy had a higher likelihood of not being satisfied, independent of side effect profile. We hypothesized that differential preoperative expectations might contribute to this finding. In the current study we compared expectations of patients undergoing robotic assisted laparoscopic radical prostatectomy vs radical retropubic prostatectomy., Materials and Methods: A questionnaire on expectations regarding recovery was administered to 171 patients electing to undergo robotic assisted laparoscopic radical prostatectomy or radical retropubic prostatectomy from 2008 to 2010. We prospectively collected data on patient expectations before surgery. Differences between patients undergoing robotic assisted laparoscopic radical prostatectomy vs radical retropubic prostatectomy were assessed with adjusted proportional odds models., Results: Patients who underwent robotic assisted laparoscopic radical prostatectomy (97) did not differ significantly from those treated with radical retropubic prostatectomy (74) in age, race, income, time between survey and surgery, and prostate specific antigen (p ≥0.4). Patients who underwent radical retropubic prostatectomy had significantly higher clinical stage and Gleason grade disease (p ≤0.007). After adjusting for socioeconomic factors, clinical stage and grade on multivariate analysis, patients who underwent robotic assisted laparoscopic radical prostatectomy expected a significantly shorter length of stay (OR 0.07, p <0.001) and earlier return to physical activity (OR 0.36, p = 0.005). The choice of robotic assisted laparoscopic radical prostatectomy (OR 0.41, p = 0.012), younger age (OR 0.49, p = 0.001) and higher preoperative International Index of Erectile Function-5-item version score (OR 0.60, p = 0.017) were independently associated with the expectation of earlier return of erections but not of continence on multivariate analysis., Conclusions: The body of evidence surrounding robotic assisted laparoscopic radical prostatectomy supports shorter hospitalization but there is no conclusive evidence that the robotic approach results in earlier return to physical activity or improved disease specific outcomes. Nonetheless we found that patients who underwent robotic assisted laparoscopic radical prostatectomy had higher expectations regarding these outcomes, particularly that of erectile function recovery, than did their radical retropubic prostatectomy counterparts., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2012
- Full Text
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47. Achieving realistic postoperative expectations in the prostatectomy population--is it possible?
- Author
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Krupski TL
- Subjects
- Directive Counseling, Humans, Male, Treatment Outcome, Patient Satisfaction, Prostatectomy
- Published
- 2011
- Full Text
- View/download PDF
48. Practice variation in the surgical management of urinary lithiasis.
- Author
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Scales CD Jr, Krupski TL, Curtis LH, Matlaga B, Lotan Y, Pearle MS, Saigal C, and Preminger GM
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Urolithiasis surgery, Lithotripsy, Practice Patterns, Physicians', Ureteroscopy, Urolithiasis therapy
- Abstract
Purpose: Shock wave lithotripsy and ureteroscopy are highly effective treatments for urinary lithiasis. While stone size and location are primary determinants of therapy, little is known about other factors associated with treatment. We identified patient, provider and practice setting characteristics associated with the selection of ureteroscopy or shock wave lithotripsy., Materials and Methods: We used the Medicare 5% sample to identify beneficiaries with an incident stone encounter from 1997 to 2007. Within this group we identified beneficiaries undergoing shock wave lithotripsy or ureteroscopy for the management of urinary calculi. Multivariable regression models identified factors associated with the use of ureteroscopy., Results: The cohort comprised 9,358 beneficiaries who underwent an initial procedure. Shock wave lithotripsy was used in 5,208 (56%) beneficiaries while ureteroscopy was used in 4,150 (44%). Female patients were less likely than males to undergo ureteroscopy (OR 0.844, p = 0.006). Providers who more recently completed residency training used ureteroscopy more often (p = 0.023). Provider and facility volume were associated with initial procedure selection. The odds of a second procedure following initial shock wave lithotripsy were 1.54 times those of ureteroscopy (p <0.001)., Conclusions: Nonclinical factors are associated with the use of ureteroscopy or shock wave lithotripsy for initial stone management, which may reflect provider and/or patient preferences or experience. Further investigation is required to understand the impact of these outcomes on quality and cost of care., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2011
- Full Text
- View/download PDF
49. Bladder augmentation versus urinary diversion in patients with spina bifida in the United States.
- Author
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Wiener JS, Antonelli J, Shea AM, Curtis LH, Schulman KA, Krupski TL, and Scales CD Jr
- Subjects
- Adolescent, Adult, Child, Child, Preschool, Female, Humans, Infant, Male, Middle Aged, Spinal Dysraphism complications, United States, Urinary Bladder, Neurogenic etiology, Urologic Surgical Procedures methods, Urologic Surgical Procedures statistics & numerical data, Young Adult, Urinary Bladder surgery, Urinary Bladder, Neurogenic surgery, Urinary Diversion statistics & numerical data
- Abstract
Purpose: Augmentation cystoplasty has replaced urinary diversion as the cornerstone of surgical management of refractory neurogenic bladder in patients with spina bifida. Other than single institution series little is known about practice patterns of bladder augmentation vs diversion. Therefore, we characterized the use of bladder augmentation and urinary diversion in patients with spina bifida in a nationally representative, all payer, all ages data set., Materials and Methods: Discharge estimates were derived from the Nationwide Inpatient Sample. All patients who underwent bladder augmentation or ileal conduit diversion between 1998 and 2005 with a diagnosis consistent with spina bifida were included in the study., Results: Bladder augmentation was performed in an estimated 3,403 patients and ileal loop diversion in 772 with spina bifida between 1998 and 2005. Patients fell into 2 clinically distinct populations. Those patients undergoing bladder augmentation tended to be younger (mean age 16 vs 36 years, p <0.001) and male (52% of bladder augmentations vs 43% of urinary diversions, p = 0.02), and to have private insurance (46% vs 29%, p <0.001) compared to those undergoing urinary diversion. Furthermore, patients undergoing urinary diversion required more health care resources, with significantly longer hospital stays, higher total charges and more use of home health care after discharge home., Conclusions: Augmentation cystoplasty is widely used in the surgical management of neurogenic bladder in patients with spina bifida, although ileal loop diversion is still performed in a substantial proportion with clinically distinct characteristics., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2011
- Full Text
- View/download PDF
50. Material characterization of ex vivo prostate tissue via spherical indentation in the clinic.
- Author
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Carson WC, Gerling GJ, Krupski TL, Kowalik CG, Harper JC, and Moskaluk CA
- Subjects
- Biomechanical Phenomena, Digital Rectal Examination, Humans, Male, Neoplasm Staging, Prostatic Neoplasms diagnosis, Prostatic Neoplasms pathology, Elastic Modulus, Hardness Tests instrumentation, Prostate cytology, Prostate pathology
- Abstract
Background: The mechanical characterization of prostate tissue has not received much attention and is often disconnected from the clinic, where samples are readily attained., Methods: We developed a spherical indenter for the clinic to generate force-displacement data from ex vivo prostate tissue. Indentation velocity, depth, and sphere diameter, and four means of estimating elastic modulus (EM) were validated. EM was then estimated for 26 prostate specimens obtained via prostatectomy and 6 samples obtained from autopsy. Prostatectomy prostates were evaluated clinically upon digital rectal exam and pathologically post-extirpation., Findings: Whole-mount measurements yielded median EM of 43.2 kPa (SD=59.8 kPa). Once sliced into cross-sections, median EM for stage T2 and T3 glands were 30.9 and 71.0 kPa, respectively, but not significantly different. Furthermore, we compared within-organ EM difference for prostates with (median=46.5 kPa, SD=22.2 kPa) and without (median=31.0 kPa, SD=63.1 kPa) palpable abnormalities., Interpretation: This work finds that diseased prostate tissue is stiffer than normal tissue, stiffness increases with disease severity, and large variability exists between samples, even though disease differences within a prostate are detectable. A further study of late-stage cancers would help to strengthen the findings presented in this work., (Copyright © 2010 IPEM. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2011
- Full Text
- View/download PDF
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