Time-Driven Activity-based Costing and Outcomes of Same-Day Discharge vs Inpatient Robotic Partial and Radical Nephrectomy.

OBJECTIVE: To assess the outcomes, total healthcare utilization, and cost savings for same-day discharge (SDD) vs inpatient robotic-assisted partial nephrectomy (RAPN) and robotic-assisted radical nephrectomy (RARN). METHODS: We compared 146 RAPNs and 65 RARNs consecutively performed as SDD (RAPN=21, RARN=9) vs inpatient (RAPN=125, RARN=56) from April 2015 to May 2023 at two academic medical centers. We collected baseline demographics, perioperative characteristics, and 30-day complications. We applied the Time-Driven Activity-Based Costing analysis to compare total costs of RAPN and PARN throughout the cycle of care, including inpatient vs SDD. RESULTS: Baseline demographics and comorbidities were similar between patients undergoing inpatient vs SDD RAPN and RARN. One Clavien-Dindo grade II complication (3.3%) requiring readmission due to wound infection for antibiotics occurred after SDD RAPN; no complications occurred after SDD RARN. Two unscheduled office or emergency department visits (6.7%) occurred after SDD RAPN for surgical-site infection and urinary retention. SDD vs inpatient RAPN and RARN demonstrated a $3091 (18%) and $4003 (25%) overall cost reduction, respectively. CONCLUSION: SDD RAPN and RARN result in cost savings of 18%-25% without a difference in complications, and thereby improves value-based care for appropriately selected patients.

Decreased Opioid Use and Equivalent Pain Score Outcomes After Robotic Urologic Surgery Using a Simplified Opioid Minimization Protocol: A Safety-Net Hospital Experience.

INTRODUCTION: We aimed to implement a simplified opioid minimization (OM) protocol after robotic urologic surgery in a safety-net hospital to decrease opioid consumption without compromising patient-reported pain or satisfaction. METHODS: Robotic urologic surgery was performed in 103 consecutive patients at a safety-net hospital. An opioid control (OC) cohort was established from January to May 2021, and the OM protocol was implemented from June to October 2021. On postoperative day (POD) 2 and POD7, a validated survey was used to assess pain and satisfaction. Opioid dispensation records were queried from the Prescription Monitoring Program. Outcomes were compared by univariate methods. RESULTS: There were no demographic differences between the OM (n = 45) and OC (n = 35) cohorts. Total opioids received within 30 days of surgery decreased by 68% in the OM vs OC cohort (median [IQR] 32.5 [7.5-65] vs 100 [30-173] morphine milligram equivalents, P < .001). The median amount of opioids prescribed at discharge for the OM cohort was 0 (IQR:0-0) vs 75 morphine milligram equivalents (IQR:0-112.5) for the OC cohort (P < .001). Pain severity did not differ between cohorts on POD2 (median [IQR]: OM=3/10 [2-5], OC=3.5/10 [2-6]; P = .5) or POD7 (median [IQR]: OM=2/10 [0-3], OC=1/10 [0-3]; P = .8), and POD7 satisfaction with pain management remained high for both cohorts (P = .8). CONCLUSIONS: Our simplified OM protocol decreased total opioid use after robotic urologic surgery by 68% without compromising pain or satisfaction.

Impaired robotic surgical visualization: archaic issues in a modern operating room.

While robotic-assisted surgery (RAS) has been revolutionizing surgical procedures, it has various areas needing improvement, specifically in the visualization sector. Suboptimal vision due to lens occlusions has been a topic of concern in laparoscopic surgery but has not received much attention in robotic surgery. This study is one of the first to explore and quantify the degree of disruption encountered due to poor robotic visualization at a major academic center. In case observations across 28 RAS procedures in various specialties, any lens occlusions or "debris" events that appeared on the monitor displays and clinicians' reactions, the cause, and the location across the monitor for these events were recorded. Data were then assessed for any trends using analysis as described below. From around 44.33 h of RAS observation time, 163 debris events were recorded. 52.53% of case observation time was spent under a compromised visual field. In a subset of 15 cases, about 2.24% of the average observation time was spent cleaning the lens. Additionally, cautery was found to be the primary cause of lens occlusions and little variation was found within the spread of the debris across the monitor display. This study illustrates that in 6 (21.43%) of the cases, 90% of the observation time was spent under compromised visualization while only 2 (7.14%) of the cases had no debris or cleaning events. Additionally, we observed that cleaning the lens can be troublesome during the procedure, interrupting the operating room flow.

Same-Day Discharge vs Inpatient Robotic-Assisted Radical Prostatectomy: Complications, Time-Driven Activity-Based Costing, and Patient Satisfaction.

PURPOSE: Historically, robotic-assisted radical prostatectomy is accompanied by an inpatient hospital admission. The COVID-19 pandemic necessitated a transition to same-day discharge robotic-assisted radical prostatectomy in some centers to free up critically needed inpatient beds. This study aims to compare complications, total health care costs, and patient satisfaction for same-day discharge vs inpatient robotic-assisted radical prostatectomy. MATERIALS AND METHODS: We compared 392 consecutive robotic-assisted radical prostatectomies performed as same-day discharge (n = 206) vs inpatient (n = 186) from February 2020 to November 2022 at 2 academic medical centers. We utilized propensity score analysis to assess the impact of same-day discharge vs inpatient robotic-assisted radical prostatectomy on 30-day complications (primary outcome). Time-driven activity-based costing analysis was applied to compare total costs of robotic-assisted radical prostatectomy care, and we administered a validated Patient Satisfaction Outcome Questionnaire to compare satisfaction scores. RESULTS: Inpatient robotic-assisted radical prostatectomy patients were more likely to be older, self-reported Black race or Hispanic ethnicity, and have higher American Society of Anesthesiologists classification. Complication rates were nonsignificantly lower for same-day discharge vs inpatient robotic-assisted radical prostatectomy (OR 0.87, 95% CI 0.35 to 2.21; P = .8). Same-day discharge vs inpatient robotic-assisted radical prostatectomy demonstrated a $2106 (19%) overall cost reduction. Median satisfaction survey scores were similar, and a clinically significant difference can be excluded. CONCLUSIONS: Same-day discharge robotic-assisted radical prostatectomy is cost-effective and should be the preferred approach in appropriately selected patients.

Association between RCT methodology and disease indication with mineralocorticoid-related toxicity for patients receiving abiraterone acetate for advanced prostate cancer: A meta-analysis of RCTs.

INTRODUCTION: While abiraterone acetate (AA) has demonstrated survival benefit in advanced prostate cancer (APC), meaningful cardiotoxicity is observed. It is unclear whether the magnitude differs based on disease indication and concurrent steroid administration. METHODS: We performed a systematic review and meta-analysis of phase II/III RCTs of AA in APC published as of August 11, 2020. Primary outcomes examined were all- and high-grade (grade ≥ 3) hypokalemia and fluid retention, and secondary outcomes included hypertension and cardiac events. We performed random effects meta-analysis comparing intervention (AA + steroid) and control (placebo ± steroid), stratified by treatment indication and whether patients received steroids. RESULTS: Among 2,739 abstracts, we included 6 relevant studies encompassing 5901 patients. Hypokalemia and fluid retention were observed more frequently among patients receiving AA (odds ratio [OR] 3.10 [95% CI 1.69-5.67] and 1.41 [95% CI 1.19-1.66]). This was modified by whether patients in the control received steroids: trials where control patients did not demonstrated a larger association between AA and hypokalemia (OR 6.88 [95% CI 1.48-2.36] versus OR 1.86 [95% CI 4.97-9.54], P < .0001) and hypertension (OR 2.53 [95% CI 1.91-3.36] vs. OR 1.55 [95% CI 1.17-2.04], P = .1) than those where steroids were administered. We observed heterogeneity due to indication: there were greater effects on hypokalemia (P < 0001), hypertension (P = .03), and cardiac disorders (P = .01) among patients treated for mHSPC than mCRPC. CONCLUSIONS: The magnitude of cardiotoxicity with AA differs based on trial design and disease indication. These data are valuable in treatment decisions and highlight utilization of appropriate data for counseling.

Robotic Versus Open Cystectomy for Bladder Cancer: Synthesizing the Data from Current Systematic Reviews and Meta-Analyses.

This is a summary of existing systematic reviews comparing robotic assisted radical cystectomy (RARC) with open radical cystectomy (ORC). Our aim was to compare operative approaches with respect to perioperative, postoperative, oncologic, and health-related quality of life (QOL) outcomes. We performed a systematic review of MEDLINE, Medline-in-Process and Medline Epubs Ahead of Print, and the Cochrane Library on 22 February 2022. We included reviews of adult patients with bladder cancer undergoing RARC or ORC for muscle invasive or high-risk non-muscle invasive bladder cancer. Nonrandomized studies were excluded to minimize confounding and selection bias. The GRADE approach was used to determine the confidence in estimates. We assessed the quality of identified systematic reviews using AMSTAR 2 checklist. Six well-conducted, systematic reviews and meta-analyses were included. RARC was consistently associated with lower estimated blood loss (EBL) and transfusion rates, and longer operative time. There was inconsistent evidence for the impact of RARC on hospital length of stay (LOS). There was no significant difference in overall complication rate or major complication rate, or oncologic outcomes between groups. Comparison of QOL outcomes between studies was limited by statistical and methodological heterogeneity. RARC is associated with improvement in EBL and transfusion risk. There does not appear to be differences in oncologic outcomes or complications between approaches. Prospective studies are needed to assess the impact of diversion type, technique, and recovery pathways on patient outcomes and to assess the impact of operative approach on cost and patient-reported QOL.

Biodynamic prediction of neoadjuvant chemotherapy response: Results from a prospective multicenter study of predictive accuracy among muscle-invasive bladder cancer patients.

BACKGROUND: Biodynamic signatures (temporal patterns of microscopic motion within a 3-dimensional tumor explant) offer phenomic biomarkers that are highly predictive for therapeutic response. OBJECTIVE: By utilizing motility contrast tomography, which provides a simple, fast assessment of motion patterns in living tissue, we evaluated the predictive accuracy of a biodynamic drug response classifier in muscle-invasive bladder cancer (MIBC) patients undergoing neoadjuvant chemotherapy (NAC). DESIGN, SETTING, AND PARTICIPANTS: One hundred five consecutive bladder cancer patients suspected of having MIBC were screened in a multi-institutional prospective observational study (NCT03739177) from July 2018 to June 2020, of whom, 30 completed NAC and radical cystectomy. INTERVENTION(S): Biodynamic signatures from treatment-naïve fresh bladder tumor specimens obtained after transurethral resection were measured in living tumor fragments challenged by standard-of-care cytotoxins. Patients received gemcitabine and cisplatin or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin per institutional guidelines and were followed through radical cystectomy. OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS: A 4-level classifier was developed to predict pathologic complete response (pCR) vs. incomplete response utilizing a one-left-out cross-validation protocol to minimize over-fitting. Area under the curve evaluated predictive utility. RESULTS: Thirty percent (9 of 30) achieved pCR. Utilizing the 4-level classifier, biodynamically "favored" (scoring ≥ 3) and "strongly favored" (scoring 4) regimens accurately predicted pCR at rates of 66.7% (4 of 6 patients) and 100% (4 of 4 patients), respectively. Biodynamically "favored" scores predicted pCR with 88% sensitivity and 95% negative predictive value, P < 0.0001. Only 5.0% (1 of 20 patients) achieved pCR from regimens scoring 1 or 2, indicating poor to no response from NAC. Area under the receiver operating curve was 96% (95% Confidence Interval: 79%-99%, P < 0.0001). Future direction involves validating this model prospectively. PRINCIPAL CONCLUSIONS: Biodynamic scoring accurately predicts response in MIBC patients receiving NAC and holds promise to substantially improve the scope of appropriate management intervention.

Association between Treatment for Localized Prostate Cancer and Mental Health Outcomes.

PURPOSE: We aimed to compare patient-reported mental health outcomes for men undergoing treatment for localized prostate cancer longitudinally over 5 years. MATERIALS AND METHODS: We conducted a prospective population-based analysis using the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study. Patient-reported depressive symptoms (Centers for Epidemiologic Studies Depression [CES-D]) and domains of the Medical Outcomes Study 36-item Short Form survey evaluating emotional well-being and energy/fatigue were assessed through 5 years after treatment with surgery, radiotherapy (with or without androgen deprivation therapy) and active surveillance. Regression models were adjusted for outcome-specific baseline function, demographic and clinicopathological characteristics, and treatment approach. RESULTS: A total of 2,742 men (median [quartiles] age 64 [59-70]) met inclusion criteria. Baseline depressive symptoms, as measured by the CES-D, were low (median 4, quartiles 1-8) without differences between groups. We found no effect of treatment modality on depressive symptoms (p=0.78), though older age, poorer health, being unmarried and baseline CES-D score were associated with declines in mental health. There was no clinically meaningful association between treatment modality and scores for either emotional well-being (p=0.81) or energy/fatigue (p=0.054). CONCLUSIONS: This prospective, population-based cohort study of men with localized prostate cancer showed no clinically important differences in mental health outcomes including depressive symptoms, emotional well-being, and energy/fatigue according to the treatment received (surgery, radiotherapy, or surveillance). However, we identified a number of characteristics associated with worse mental health outcomes including: older age, poorer health, being unmarried, and baseline CES-D score which may allow for early identification of patients most at risk of these outcomes following treatment.

Association between prior nephrectomy and efficacy of immune checkpoint inhibitor therapy in metastatic renal cell carcinoma - A systematic review and meta-analysis.

BACKGROUND: Immune checkpoint-inhibitor (ICI)-based therapy is the standard of care for first-line treatment of metastatic renal cell carcinoma (mRCC). It is unclear whether prior removal of the primary tumor influences the efficacy of these treatments. We performed a systematic review and meta-analysis of studies of first-line ICI in mRCC to determine whether the efficacy of ICI-therapy, compared to sunitinib, is altered based on receipt of prior nephrectomy. METHODS: We systematically reviewed studies indexed in MEDLINE (PubMed), Embase, and Scopus and conference abstracts from relevant medical societies as of August 2020 to identify randomized clinical trials assessing first-line immunotherapy-based regimes in mRCC. Studies were included if overall survival (OS) and progression-free survival (PFS) outcomes were reported with data stratified by nephrectomy status. We pooled hazard ratios (HRs) stratified by nephrectomy status and performed random effects meta-analysis to assess the null hypothesis of no difference in the survival advantage of immunotherapy-based regimes based on nephrectomy status, while accounting for study level correlations. RESULTS: Among 6 randomized clinical trials involving 5,121 patients, 3,968 (77%) had undergone prior nephrectomy. We found an overall survival benefit for immunotherapy-based regimes, compared to sunitinib, among both patients who had undergone nephrectomy (HR 0.75, 95% CI 0.63 -0.88) and those who had not (HR 0.74, 95% CI 0.59 -0.92), without evidence of difference based on nephrectomy history (P = 0.70; I2 = 36%). Results assessing PFS were similar (P = 0.45, I2 = 0%). CONCLUSIONS: These clinical data suggest that prior nephrectomy does not affect the efficacy of ICI-based regimens in mRCC relative to sunitinib.

Association Between Surgical Volume and Survival Among Patients With Variant Histologies of Bladder Cancer.

OBJECTIVE: To examine the relationship between hospital volume and the management of bladder cancer variant histology. Variant histologies of bladder cancer are rare which limits the ability for providers to develop expertise however there is a clear hospital and/or surgeon-volume relationship for management of rare or complex surgical and/or medical diseases. METHODS: We queried the National Cancer Database from 2004-2016 for all cases of bladder cancer, identifying cases of variant histology. Our primary outcome was overall survival while secondary outcomes included identifying treatment patterns. Hospitals were stratified into those that managed ≤2, >2-4, >4-6, and ≥6 cases per year of variant histology. RESULTS: We identified 23,284 patients with bladder cancer of variant histology who were treated at 1301 hospitals. Few institutions had high volume experience with this disease: 18.5% (n = 241) treated >2 patients annually and 5.7% (n = 76) treated >4 cases annually. Hospital volume positively correlated with utilization of early radical cystectomy (RC) in non-muscle invasive disease and neoadjuvant chemotherapy in muscle-invasive disease. On multivariable analysis, increased hospital volume was associated with improved survival. After stratifying by sub-type, hospital volume continued to be associated with improved survival for squamous, small cell, and sarcomatoid cancers. CONCLUSION: Management of variant histology urothelial carcinoma at high-volume centers is associated with improved overall survival. The mechanisms of this are multifactorial, and future research should focus on improvement opportunities for low-volume hospitals, centralization of care, and/or increased access to care at high-volume centers.

Out-of-pocket costs for commercially insured patients with localized prostate cancer.

PURPOSE: Financial toxicity is an underappreciated component of cancer survivorship. Treatment-specific out-of-pocket costs for patients undergoing localized prostate cancer treatment have not, to date, been described and may influence patient's decision making. METHODS: We performed a retrospective cohort study among commercially-insured patients in the United States with incident prostate cancer from 2013 to 2018. We captured out-of-pocket and total costs in the year following diagnosis and compared these between patients receiving radical prostatectomy, radiotherapy, and no local treatment using propensity-score weighting adjusting for patient demographics and pre-diagnosis health utilization costs. RESULTS: Among 30,360 included men [median age 59 years, 83% Charlson score 0], 15,854 underwent surgery, 5,265 radiotherapy, and 9,241 no local therapy in the year following diagnosis. In the 6-months preceding diagnosis, median overall and out-of-pocket health care costs were $2022 (interquartile range $3778) and $466 (interquartile range $781), respectively. Following propensity-score weighting, out-of-pocket costs were significantly lower for patients who received no active treatment (adjusted cost $1746, 95% confidence interval [CI] $1704-1788), followed by those who underwent surgery ($2983, 95% CI $2832-3142, P < 0.001), and those who underwent radiation ($3139, 95% CI $2939-3353, P < 0.001) in the 6-months following diagnosis. Similar patterns were seen with out-of-pocket costs 6 to 12 months following index, with overall costs, and with costs attributable to inpatient, outpatient medical, and outpatient pharmacy services. CONCLUSIONS: Among commercially insured men with incident prostate cancer, active treatment with surgery or radiotherapy was associated with significantly higher out-of-pocket costs versus those who received no treatment, with little difference observed between treatment approaches.

Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study.

BACKGROUND: Ensuring representative data accrual in clinical trials is important to safeguard the generalizability of results and to minimize disparities in care. This study's goal was to evaluate differences in gender representation in trials leading to US Food and Drug Administration (FDA) cancer drug approvals. METHODS: An observational study was conducted from January 2014 to April 2019 using PubMed and the National Institutes of Health trials registry for primary trial reports. The National Cancer Institute's Surveillance, Epidemiology, and End Results program and US Census were consulted for national cancer incidence. The outcome was an enrollment incidence disparity (EID), which was calculated as the difference between male and female trial enrollment and national incidence, with positive values representing male overrepresentation. RESULTS: There were 149 clinical trials with 59,988 participants-60.3% and 39.7% were male and female, respectively-leading to 127 oncology drug approvals. The US incidence rates were 55.4% for men versus 44.6% for women. Gender representation varied by specific tumor type. Most notably, women were underrepresented in thyroid cancer (EID, +27.4%), whereas men were underrepresented in soft tissue cancer (EID, -26.1%). Overall, women were underrepresented when compared with expected incidence (EID, +4.9%; 42% of trials). CONCLUSIONS: For many specific tumor types, women are underrepresented in clinical trials leading to FDA oncology drug approvals. It is critical to better align clinical trial cohort demographics and the populations to which these data will be extrapolated. LAY SUMMARY: This study assesses whether gender disparities exist in clinical trials leading to US Food and Drug Administration (FDA) cancer drug approvals. From January 2014 to April 2019, 149 clinical trials leading to FDA oncology drug approvals showed 60.3% and 39.7% of the enrollees were male and female, respectively. Gender representation varied by specific tumor when compared with the expected incidence rate of cancer in the United States, although women were more often underrepresented. Increased efforts are needed with regard to ensuring equitable representation in oncology clinical trials.