Association between Operative Time and Short-Term Radical Cystectomy Complications.

INTRODUCTION: The aim of this study was to examine the relationship between duration of surgical intervention and postoperative complications in radical cystectomy (RC). We hypothesized that the complication rate increases with longer operative time. METHODS: We analyzed the National Surgical Quality Improvement Program database 2011-2017 to identify all patients who underwent RC. Clinicodemographic characteristics, operative time, and perioperative complications using the Clavien-Dindo Classification (CDC) were abstracted. We fit a generalized linear model with linear splines for operative time to analyze if the relationship between operative time and probability of complication changed over time. RESULTS: A total of 10,520 RC patients were identified with a mean operative time of 5.5 h (standard deviation 2.03). In 55% and 18.2%, any complication and major complications (CDC ≥3) occurred within 30 days postoperatively, respectively. The spline regression model for any complication showed an almost linear relationship between the complication rate and operative time, ranging from 55% at 2.5 h to 82% at 10 h. For major complications, the model revealed the inflection point (knot) at 4.5 h, which corresponds to the lowest complication rate with 15%. Operative times at the extremes of the distribution had higher complication rates: 17.5% if <2.5 h and 28% if >10 h. DISCUSSION/CONCLUSION: Operative time of RC is associated with postoperative complications. Though many factors impact the duration of surgery, surgeries that lasted between 4 and 5 h had trend toward the lowest complication rates. Attention to factors impacting operative time may allow surgeons to identify strategies for optimizing surgical care and reducing complications after RC.

Immune checkpoint inhibitor monotherapy is associated with less cardiac toxicity than combination therapy.

BACKGROUND: Treatment options for many cancers include immune checkpoint inhibitor (ICI) monotherapy and combination therapy with impressive clinical benefit across cancers. We sought to define the comparative cardiac risks of ICI combination and monotherapy. METHODS: We used VigiBase, the World Health Organization pharmacovigilance database, to identify cardiac ADRs (cADRs), such as carditis, heart failure, arrhythmia, myocardial infarction, and valvular dysfunction, related to ICI therapy. To explore possible relationships, we used the reporting odds ratio (ROR) as a proxy of relative risk. A lower bound of a 95% confidence interval of ROR &gt; 1 reflects a disproportionality signal that more ADRs are observed than expected due to chance. RESULTS: We found 2278 cADR for ICI monotherapy and 353 for ICI combination therapy. Combination therapy was associated with significantly higher odds of carditis (ROR 6.9, 95% CI: 5.6-8.3) versus ICI monotherapy (ROR 5.0, 95% CI: 4.6-5.4). Carditis in ICI combination therapy was fatal in 23.4% of reported ADRs, compared to 15.8% for ICI monotherapy (P = 0.058). CONCLUSIONS: Using validated pharmacovigilance methodology, we found increased odds of carditis for all ICI therapies, with the highest odds for combination therapy. Given the substantial risk of severe ADR and death, clinicians should consider these findings when prescribing checkpoint inhibitors.

Are work relative value units correlated with operative duration of common surgical procedures?

OBJECTIVES: Work relative value units (wRVUs) quantify physician workload. In theory, higher wRVU assignments for procedures recognize an increase in complexity and time required to complete the procedure. The fairness of wRVU assignment is debated across specialties, with some surgeons arguing that reimbursement may be unfairly low for longer, more complex cases. For this reason, we sought to assess the correlation of wRVUs with operative time in commonly performed surgeries. STUDY DESIGN: We analyzed the National Surgical Quality Improvement Program database, selecting the 15 most performed surgical procedures across specialties in a 90-day global period, using Current Procedural Terminology codes. METHODS: Calculation and comparison of mean operative time and mean wRVUs were performed for each of the 15 procedures. Cases with missing values for wRVUs or operative time and cases with an operative time of less than 15 minutes were excluded. The Spearman correlation coefficient was calculated to evaluate the strength of correlation between operative duration and wRVUs. RESULTS: A total of 1,994,394 patients met criteria for analysis. The lowest mean wRVU was 7.78 (95% CI, 7.77-7.78) for inguinal hernia repair; the highest was 43.50 (95% CI, 43.37-43.60) for pancreatectomy. The shortest mean operative time was 51.0 (95% CI, 50.8-51.1) minutes for appendectomy; the longest was for pancreatectomy at 324.6 (95% CI, 323.2-326.0) minutes. The Spearman correlation coefficient was 0.81. CONCLUSIONS: In our analysis, we found a strong correlation between operative duration and wRVU assignment. Thus, the reimbursement of physicians depending on wRVUs is fair for the most commonly performed surgical procedures across specialties.

Nephrotoxicity of immune checkpoint inhibitor therapy: a pharmacovigilance study.

BACKGROUND: Immune checkpoint inhibitor (ICI) therapy has demonstrated impressive clinical benefits across cancers. However, adverse drug reactions (ADRs) occur in every organ system, often due to autoimmune syndromes. We sought to investigate the association between ICI therapy and nephrotoxicity using a pharmacovigilance database, hypothesizing that inflammatory nephrotoxic syndromes would be reported more frequently in association with ICIs. METHODS: We analyzed VigiBase, the World Health Organization pharmacovigilance database, to identify renal ADRs (rADRs), such as nephritis, nephropathy and vascular disorders, reported in association with ICI therapy. We performed a disproportionality analysis to explore if rADRs were reported at a different rate with one of the ICI drugs compared with rADRs in the entire database, using an empirical Bayes estimator as a significance screen and defining the effect size with a reporting odds ratio (ROR). RESULTS: We found 2341 rADR for all examined ICI drugs, with a disproportionality signal solely for nephritis [ROR = 3.67, 95% confidence interval (CI) 3.34-4.04]. Examining the different drugs separately, pembrolizumab, nivolumab and ipilimumab + nivolumab combination therapy had significantly higher reporting odds of nephritis than the other ICI drugs (ROR = 4.54, 95% CI 3.81-5.4; ROR = 3.94, 95% CI 3.40-4.56; ROR 3.59, 95% CI 2.71-4.76, respectively). CONCLUSIONS: Using a pharmacovigilance method, we found increased odds of nephritis when examining rADRs associated with ICI therapy. Pembrolizumab, nivolumab and a combination of ipilimumab + nivolumab showed the highest odds. Clinicians should consider these findings and be aware of the increased risk of nephritis, especially in patients treated with pembrolizumab, when administering ICI therapy.

Defining Factors Associated with High-quality Surgery Following Radical Cystectomy: Analysis of the British Association of Urological Surgeons Cystectomy Audit.

BACKGROUND: Radical cystectomy (RC) is associated with high morbidity. OBJECTIVE: To evaluate healthcare and surgical factors associated with high-quality RC surgery. DESIGN SETTING AND PARTICIPANTS: Patients within the prospective British Association of Urological Surgeons (BAUS) registry between 2014 and 2017 were included in this study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: High-quality surgery was defined using pathological (absence of positive surgical margins and a minimum of a level I lymph node dissection template with a minimum yield of ten or more lymph nodes), recovery (length of stay ≤10 d), and technical (intraoperative blood loss <500 ml for open and <300 ml for minimally invasive RC) variables. A multilevel hierarchical mixed-effect logistic regression model was utilised to determine the factors associated with the receipt of high-quality surgery and index admission mortality. RESULTS AND LIMITATIONS: A total of 4654 patients with a median age of 70.0 yr underwent RC by 152 surgeons at 78 UK hospitals. The median surgeon and hospital operating volumes were 23.0 and 47.0 cases, respectively. A total of 914 patients (19.6%) received high-quality surgery. The minimum annual surgeon volume and hospital volume of ≥20 RCs/surgeon/yr and ≥68 RCs/hospital/yr, respectively, were the thresholds determined to achieve better rates of high-quality RC. The mixed-effect logistic regression model found that recent surgery (odds ratio [OR]: 1.22, 95% confidence interval [CI]: 1.11-1.34, p < 0.001), laparoscopic/robotic RC (OR: 1.85, 95% CI: 1.45-2.37, p < 0.001), and higher annual surgeon operating volume (23.1-33.0 cases [OR: 1.54, 95% CI: 1.16-2.05, p = 0.003]; ≥33.1 cases [OR: 1.64, 95% CI: 1.18-2.29, p = 0.003]) were independently associated with high-quality surgery. High-quality surgery was an independent predictor of lower index admission mortality (OR: 0.38, 95% CI: 0.16-0.87, p = 0.021). CONCLUSIONS: We report that annual surgeon operating volume and use of minimally invasive RC were predictors of high-quality surgery. Patients receiving high-quality surgery were independently associated with lower index admission mortality. Our results support the role of centralisation of complex oncology and implementation of a quality assurance programme to improve the delivery of care. PATIENT SUMMARY: In this registry study of patients treated with surgical excision of the urinary bladder for bladder cancer, we report that patients treated by a surgeon with a higher annual operative volume and a minimally invasive approach were associated with the receipt of high-quality surgery. Patients treated with high-quality surgery were more likely to be discharged alive following surgery.

Association of the hospital readmission reduction program with readmission and mortality outcomes after coronary artery bypass graft surgery.

The Affordable Care Act established the Hospital Readmissions Reduction Program (HRRP) to reduce payments to hospitals with excessive readmissions in an effort to link payment to the quality of hospital care. Prior studies demonstrating an association of HRRP implementation with increased mortality after heart failure discharges have prompted concern for potential unintended adverse consequences of the HRRP. We examined the impact of these policies on coronary artery bypass graft (CABG) surgery outcomes using the Nationwide Readmissions Database and found that, in line with previously observed readmission trends for CABG, readmission rates continued to decline in the era of the HRRP, but that this did not come at the expense of increased mortality. These results suggest that inclusion of surgical procedures, such as CABG in the HRRP might be an effective cost-reducing measure that does not adversely affect quality of hospital care.

Cardiovascular toxicities associated with abiraterone compared to enzalutamide-A pharmacovigilance study.

BACKGROUND: Androgen deprivation therapy (ADT) is standard-of-care for advanced prostate cancer. Studies have generally found increased cardiovascular risks associated with ADT, but the comparative risk of newer agents is under-characterized. We defined the cardiac risks of abiraterone and enzalutamide, using gonadotropic releasing hormone (GnRH) agonists to establish baseline ADT risk. METHODS: We used VigiBase, the World Health Organization pharmacovigilance database, to identify cardiac adverse drug reactions (ADRs) in a cohort taking GnRH agonists, abiraterone, or enzalutamide therapy for prostate cancer, comparing them to all other patients. To examine the relationship, we used an empirical Bayes estimator to screen for significance, then calculated the reporting odds ratio (ROR), a surrogate measure of association. A lower bound of a 95% confidence interval (CI) of ROR > 1 reflects a disproportionality signal that more ADRs are observed than expected due to chance. FINDINGS: We identified 2,433 cardiac ADRs, with higher odds for abiraterone compared to all other VigiBase drugs for overall cardiac events (ROR 1•59, 95% CI 1•48-1•71), myocardial infarction (1•35, 1•16-1•58), arrythmia (2•04, 1•82-2•30), and heart failure (3•02, 2•60-3•51), but found no signal for enzalutamide. Patients on GnRH agonists also had increased risk of cardiac events (ROR 1•21, 95% CI 1•12-1•30), myocardial infarction (1•80, 1•61-2•03) and heart failure (2•06, 1•76-2•41). INTERPRETATION: We found higher reported odds of cardiac events for abiraterone but not enzalutamide. Our data may suggest that patients with significant cardiac comorbidities may be better-suited for therapy with enzalutamide over abiraterone. FUNDING: None.

Risk of Immune-related Adverse Events in Melanoma Patients With Preexisting Autoimmune Disease Treated With Immune Checkpoint Inhibitors: A Population-based Study Using SEER-Medicare Data.

OBJECTIVE: The objective of this study was to examine the risk of immune-related adverse events (irAEs) in patients with a preexisting autoimmune disease (pAID) presenting with a cutaneous melanoma receiving an immune checkpoint inhibitor (ICI) therapy. METHODS: Data from the Surveillance, Epidemiology, and End Results cancer registries and linked Medicare claims between January 2010 and December 2015 was used to identify patients diagnosed with cutaneous melanoma who had pAID or received ICI or both. Patients were then stratified into 3 groups: ICI+pAID, non-ICI+pAID, and ICI+non-pAID. Inverse probability of treatment weighted Cox proportional hazards regression models were fitted to assess the risk of cardiac, pulmonary, endocrine, and neurological irAE. RESULTS: In total, 3704 individuals were included in the analysis. The majority of patients consisted of non-ICI+pAID patients (N=2706/73.1%), while 106 (2.9%) patients and 892 (24.1%) were classified as ICI+pAID and ICI+non-pAID, respectively. The risk of irAE was higher in the ICI+pAID group compared with the non-ICI+pAID and ICI+non-pAID, respectively (non-ICI: cardiac: hazard ratio [HR]=3.59, 95% confidence interval [CI]: 2.83-4.55; pulmonary: HR=3.94, 95% CI: 3.23-4.81; endocrine: HR=1.72, 95% CI: 1.53-1.93; neurological: HR=3.88, 95% CI: 2.30-6.57/non-pAID: cardiac: HR=3.83, 95% CI: 3.39-4.32; pulmonary: HR=2.08, 95% CI: 1.87-2.32; endocrine: HR=1.23, 95% CI: 1.14-1.32; neurological: HR=3.77, 95% CI: 2.75-5.18). CONCLUSIONS: Patients with a pAID face a significantly higher risk of irAEs. Further research examining the clinical impact of these events on the patients' oncological outcome and quality of life is urgently needed given our findings of significantly worse rates of adverse events.

Effect of Medicaid Expansion on Receipt of Definitive Treatment and Time to Treatment Initiation by Racial and Ethnic Minorities and at Minority-Serving Hospitals: A Patient-Level and Facility-Level Analysis of Breast, Colon, Lung, and Prostate Cancer.

PURPOSE: We sought to investigate the association between Medicaid expansion under the Affordable Care Act and access to stage-appropriate definitive treatment for breast, colon, non-small-cell lung, and prostate cancer for underserved racial and ethnic minorities and at minority-serving hospitals (MSHs). METHODS: We conducted a retrospective, difference-in-differences study including minority patients with nonmetastatic breast, colon, non-small-cell lung, and prostate cancer and patients treated at MSHs between the age of 40 and 64, with tumors at stages eligible for definitive treatment from the National Cancer Database. We not only defined non-Hispanic Black and Hispanic cancer patients as racial and ethnic minorities but also report findings for non-Hispanic Black cancer patients separately. We examined the effect of Medicaid expansion on receipt of stage-appropriate definitive therapy, time to treatment initiation (TTI) within 30 days of diagnosis, and TTI within 90 days of diagnosis. RESULTS: Receipt of definitive treatment for minorities in expansion states did not change compared with minority patients in nonexpansion states. The proportion of racial and ethnic minorities in expansion states receiving treatment within 30 days increased (difference-in-differences: +3.62%; 95% CI, 1.63 to 5.61; P < .001) compared with minority patients in nonexpansion states; there was no change for TTI within 90 days. Analysis focused on Black cancer patients yielded similar results. In analyses stratified by MSH status, there was no change in receipt of definitive therapy, TTI within 30 days, and TTI within 90 days when comparing MSHs in expansion states with MSHs in nonexpansion states. CONCLUSION: In our cohort of cancer patients with treatment-eligible disease, we found no significant association between Medicaid expansion and changes in receipt of definitive treatment for breast, prostate, lung, and colon cancer for racial and ethnic minorities and at MSHs. Medicaid expansion was associated with improved TTI at the patient level for racial and ethnic minorities, but not at the facility level for MSHs. Targeted interventions addressing the needs of MSHs are still needed to continue mitigating national facility-level disparities in cancer outcomes.

Racial differences in the treatment and outcomes for prostate cancer in Massachusetts.

BACKGROUND: Massachusetts is a northeastern state with universally mandated health insurance since 2006. Although Black men have generally worse prostate cancer outcomes, emerging data suggest that they may experience equivalent outcomes within a fully insured system. In this setting, the authors analyzed treatments and outcomes of non-Hispanic White and Black men in Massachusetts. METHODS: White and Black men who were 20 years old or older and had been diagnosed with localized intermediate- or high-risk nonmetastatic prostate cancer in 2004-2015 were identified in the Massachusetts Cancer Registry. Adjusted logistic regression models were used to assess predictors of definitive therapy. Adjusted and unadjusted survival models compared cancer-specific mortality. Interaction terms were then used to assess whether the effect of race varied between counties. RESULTS: A total of 20,856 men were identified. Of these, 19,287 (92.5%) were White. There were significant county-level differences in the odds of receiving definitive therapy and survival. Survival was worse for those with high-risk cancer (adjusted hazard ratio [HR], 1.50; 95% CI, 1.4-1.60) and those with public insurance (adjusted HR for Medicaid, 1.69; 95% CI, 1.38-2.07; adjusted HR for Medicare, 1.2; 95% CI, 1.14-1.35). Black men were less likely to receive definitive therapy (adjusted odds ratio, 0.78; 95% CI, 0.74-0.83) but had a 17% lower cancer-specific mortality (adjusted HR, 0.83; 95% CI, 0.7-0.99). CONCLUSIONS: Despite lower odds of definitive treatment, Black men experience decreased cancer-specific mortality in comparison with White men in Massachusetts. These data support the growing body of research showing that Black men may achieve outcomes equivalent to or even better than those of White men within the context of a well-insured population. LAY SUMMARY: There is a growing body of evidence showing that the excess risk of death among Black men with prostate cancer may be caused by disparities in access to care, with few or no disparities seen in universally insured health systems such as the Veterans Affairs and US Military Health System. Therefore, the authors sought to assess racial disparities in prostate cancer in Massachusetts, which was the earliest US state to mandate universal insurance coverage (in 2006). Despite lower odds of definitive treatment, Black men with prostate cancer experience reduced cancer-specific mortality in comparison with White men in Massachusetts. These data support the growing body of research showing that Black men may achieve outcomes equivalent to or even better than those of White men within the context of a well-insured population.

Is the current referral trend a threat to the Military Health System? Perioperative outcomes and costs after colorectal surgery in the Military Health System versus civilian facilities.

BACKGROUND: TRICARE military beneficiaries are increasingly referred for major surgeries to civilian hospitals under "purchased care." This loss of volume may have a negative impact on the readiness of surgeons working in the "direct-care" setting at military treatment facilities and has important implications under the volume-quality paradigm. The objective of this study is to assess the impact of care source (direct versus purchased) and surgical volume on perioperative outcomes and costs of colorectal surgeries. METHODS: We examined TRICARE claims and medical records for 18- to 64-year-old patients undergoing major colorectal surgery from 2006 to 2015. We used a retrospective, weighted estimating equations analysis to assess differences in 30-day outcomes (mortality, readmissions, and major or minor complications) and costs (index and total including 30-day postsurgery) for colorectal surgery patients between purchased and direct care. RESULTS: We included 20,317 patients, with 24.8% undergoing direct-care surgery. Mean length of stay was 7.6 vs 7.7 days for direct and purchased care, respectively (P = .24). Adjusted 30-day odds between care settings revealed that although hospital readmissions (odds ratio 1.40) were significantly higher in direct care, overall complications (odds ratio 1.05) were similar between the 2 settings. However, mean total costs between direct and purchased care differed ($55,833 vs $30,513, respectively). Within direct care, mean total costs ($50,341; 95% confidence interval $41,509-$59,173) were lower at very high-volume facilities compared to other facilities ($54,869; 95% confidence interval $47,822-$61,916). CONCLUSION: Direct care was associated with higher odds of readmissions, similar overall complications, and higher costs. Contrary to common assumptions regarding volume and quality, higher volume in the direct-care setting was not associated with fewer complications.

Sex-specific Differences in the Quality of Treatment of Muscle-invasive Bladder Cancer Do Not Explain the Overall Survival Discrepancy.

BACKGROUND: While bladder cancer is less common among women, female sex is associated with worse oncological outcomes. OBJECTIVE: To evaluate sex-specific differences in initial presentation and treatment patterns of muscle-invasive bladder cancer. DESIGN, SETTING, AND PARTICIPANTS: A retrospective study using the National Cancer Database to identify individuals diagnosed with muscle-invasive bladder cancer (cT2-T4aN0M0) between 2004 and 2013. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable logistic regression and negative binomial regression with Bonferroni correction were used to investigate seven treatment measures: care at a high-volume facility, receipt of definitive therapy, delayed treatment, receipt of neoadjuvant or adjuvant chemotherapy, receipt of pelvic lymph node dissection, and number of lymph nodes removed. The secondary outcome was overall survival. RESULTS AND LIMITATIONS: We identified 27525 patients, 27.4% of whom were females. Females were diagnosed significantly more often with nonurothelial carcinoma (15.1% vs 9.9%, p<0.001), with squamous carcinoma being the most prevalent variant (46.9%). After Bonferroni correction, there was no difference in six out of seven treatment quality measures. Females were significantly less likely to experience delayed treatment (odds ratio 0.89, 95% confidence interval [CI] 0.84-0.93, p<0.001). Females had significantly worse overall survival compared with males (hazard ratio 1.04, 95% CI 1.00-1.07, p=0.030). Limitations arise from the retrospective design of the study. CONCLUSIONS: Despite little difference in treatment quality measures, female sex is associated with worse overall survival among individuals with muscle-invasive bladder cancer. Our findings suggest that differences in treatment patterns are unlikely to explain the differences in overall survival. Future initiatives should focus on root causes for gender-specific differences in pathological staging and features at diagnosis. PATIENT SUMMARY: In this study, we did not find differences in the treatment of bladder cancer between men and women that could readily explain why women diagnosed with this disease are more likely to die.

Access denied: The relationship between patient insurance status and access to high-volume hospitals.

BACKGROUND: Underinsured patients face significant barriers in accessing high-quality care. Evidence of whether access to high-volume surgical care is mediated by disparities in health insurance coverage remains wanting. METHODS: The authors used the National Cancer Data Base to identify all adult patients who had a confirmed diagnosis of breast, prostate, lung, or colorectal cancer during 2004 through 2016. The odds of receiving surgical care at a high-volume hospital were estimated according to the type of insurance using multivariable logistic regression analyses for each malignancy. Then, the interactions between study period and insurance status were assessed. RESULTS: In total, 1,279,738 patients were included in the study. Of these, patients with breast cancer who were insured by Medicare (odds ratio [OR], 0.75; P < .001), Medicaid (OR, 0.55; P < .001), or uninsured (OR, 0.50; P < .001); patients with prostate cancer who were insured by Medicare (OR, 0.87; P = .003), Medicaid (OR, 0.58; P = .001), or uninsured (OR, 0.36; P < .001); and patients with lung cancer who were insured by Medicare (OR, 0.84; P = .020), Medicaid (OR, 0.74; P = .001), or uninsured (OR, 0.48; P < .001) were less likely to receive surgical care at high-volume hospitals compared with patients who had private insurance. For patients with colorectal cancer, the effect of insurance differed by study period, and improved since 2011. For those on Medicaid, the odds of receiving care at a high-volume hospital were 0.51 during 2004 through 2007 and 0.99 during 2014 through 2016 (P for interaction = .001); for uninsured patients, the odds were 0.45 during 2004 through 2007 and 1.19 during 2014 through 2016 (P for interaction < .001) compared with patients who had private insurance. CONCLUSIONS: Uninsured, Medicare-insured, and Medicaid-insured patients are less likely to receive surgical care at high-volume hospitals. For uninsured and Medicaid-insured patients with colorectal cancer, the odds of receiving care at high-volume hospitals have improved since implementation of the Patient Protection and Affordable Care Act of 2010.

Where Is the Value in Ambulatory Versus Inpatient Surgery?

OBJECTIVE: The aim of this study was to estimate the effect of index surgical care setting on perioperative costs and readmission rates across 4 common elective general surgery procedures. SUMMARY BACKGROUND DATA: Facility fees seem to be a driving force behind rising US healthcare costs, and inpatient-based fees are significantly higher than those associated with ambulatory services. Little is known about factors influencing where patients undergo elective surgery. METHODS: All-payer claims data from the 2014 New York and Florida Healthcare Cost and Utilization Project were used to identify 73,724 individuals undergoing an index hernia repair, primary total or partial thyroidectomy, laparoscopic cholecystectomy, or laparoscopic appendectomy in either the inpatient or ambulatory care setting. Inverse probability of treatment weighting-adjusted gamma generalized linear and logistic regression was employed to compare costs and 30-day readmission between inpatient and ambulatory-based surgery, respectively. RESULTS: Approximately 87% of index surgical cases were performed in the ambulatory setting. Adjusted mean index surgical costs were significantly lower among ambulatory versus inpatient cases for all 4 procedures (P < 0.001 for all). Adjusted odds of experiencing a 30-day readmission after thyroidectomy [odds ratio (OR) 0.70, 95% confidence interval (CI), 0.53-0.93; P = 0.03], hernia repair (OR 0.28, 95% CI, 0.20-0.40; P < 0.001), and laparoscopic cholecystectomy (OR 0.37, 95% CI, 0.32-0.43; P < 0.001) were lower in the ambulatory versus inpatient setting. Readmission rates among ambulatory versus inpatient-based laparoscopic appendectomy were comparable (OR 0.63, 95% CI, 0.31-1.26; P = 0.19). CONCLUSIONS: Ambulatory surgery offers significant costs savings and generally superior 30-day outcomes relative to inpatient-based care for appropriately selected patients across 4 common elective general surgery procedures.

Trends in Surgical Volume in the Military Health System-A Potential Threat to Mission Readiness.

INTRODUCTION: The Military Health System (MHS) is tasked with a dual mission both to provide medical services for covered patients and to ensure that its active duty medical personnel maintain readiness for deployment. Knowledge, skills, and attitudes (KSA) is a metric evaluating the transferrable skills incorporated into a given surgery or medical procedure that are most relevant for surgeons deployed to a theatre of war. Procedures carrying a high KSA value are those utilizing skills with high relevance for maintaining deployment readiness. Given ongoing concerns regarding surgical volumes at MTFs and the potential adverse impact on military surgeon mission readiness were high-value surgeries to be lost to the civilian sector, we evaluated trends in the setting of high-value surgeries for beneficiaries within the MHS. METHODS: We retrospectively analyzed inpatient admissions data from MTFs and TRICARE claims data from civilian hospitals, 2005-2019, to identify TRICARE-covered patients covered under "purchased care" (referred to civilian facilities) or receiving "direct care" (undergoing treatment at MTFs) and undergoing seven high-value/high-KSA surgeries: colectomy, pancreatectomy, hepatectomy, open carotid endarterectomy, abdominal aortic aneurysm (AAA) repair, esophagectomy, and coronary artery bypass grafting (CABG). Overall and procedure-specific counts were captured, MTFs were categorized into quartiles by volume, and independence between trends was tested with a Cochran-Armitage test, hypothesizing that the proportion of cases referred for purchased care was increasing. RESULTS: We captured 292,411 cases, including 7,653 pancreatectomies, 4,177 hepatectomies, 3,815 esophagectomies, 112,684 colectomies, 92,161 CABGs, 26,893 AAA repairs, and 45,028 carotid endarterectomies. The majority of cases included were referred for purchased care (90.3%), with the proportion of cases referred increasing over the study period (P < .01). By procedure, all cases except AAA repairs were increasingly referred for treatment over the study period (all P < .01, except esophagectomy P = .04). On examining volume, we found that even the highest-volume-quartile MTFs performed a median of less than one esophagectomy, hepatectomy, or pancreatectomy per month. The only included procedure performed once a month or more at the majority of MTFs was CABG. CONCLUSION: On examining volume and referral trends for high-value surgeries within the MHS, we found low surgical volumes at the vast majority of included MTFs and an increasing proportion of cases referred to civilian hospitals over the last 15 years. Our findings illustrate missed opportunities for maintaining the mission readiness of military surgical personnel. Prioritizing the recapture of lost surgical volume may improve the surgical teams' mission readiness.

The impact of smoking on radical cystectomy complications increases in elderly patients.

BACKGROUND: Smoking, the most common risk factor for bladder cancer (BC), is associated with increased complications after radical cystectomy (RC), poorer oncologic outcomes, and higher mortality. The authors hypothesized that the effect of smoking on the probability of major complications increases with increasing age among patients who undergo RC. METHODS: The authors analyzed the American College of Surgeons National Surgical Quality Improvement Program database (2011-2017), identified all patients undergoing RC using Current Procedural Terminology codes, and formed two groups according to smoking status (active smoker and nonsmoker [included former and never-smokers]). Patient characteristics and 30-day postoperative complications using the Clavien-Dindo Classification (CDC) were assessed. A multivariable logistic regression model was constructed that included age, sex, race, body mass index, operative time, comorbidities, chemotherapy status, and type of diversion with major complications (CDC ≥III) as the outcome variable, and explored the interaction between age and smoking status. RESULTS: A total of 10,528 patients underwent RC, including 22.8% who were active smokers. The authors identified an interaction between age and smoking status (P = .045). Older patients were found to experience a stronger smoking effect than younger patients with regard to the probability of major complications. The risk of a major complication was the same for 50-year-old nonsmokers and smokers, but it increased from 17.8% to 21.7% for 70-year-old nonsmokers and smokers, respectively (P < .001). CONCLUSIONS: Up to 20% of patients who undergo RC are active smokers, and these individuals have an increased risk of major complications. The effect of smoking is stronger with increasing age; the difference with regard to complications for smokers versus nonsmokers was found to increase substantially, wherein older smokers are at an especially high risk of complications.

Investigation of Suicidality and Psychological Adverse Events in Patients Treated With Finasteride.

Importance: There is ongoing controversy about the adverse events of finasteride, a drug used in the management of alopecia and benign prostatic hyperplasia (BPH). In 2012, reports started emerging on men who had used finasteride and either attempted or completed suicide. Objective: To investigate the association of suicidality (ideation, attempt, and completed suicide) and psychological adverse events (depression and anxiety) with finasteride use. Design, Setting, and Participants: This pharmacovigilance case-noncase study used disproportionality analysis (case-noncase design) to detect signals of adverse reaction of interest reported with finasteride in VigiBase, the World Health Organization's global database of individual case safety reports. To explore the strength of association, the reporting odds ratio (ROR), a surrogate measure of association used in disproportionality analysis, was used. Extensive sensitivity analyses included stratifying by indication (BPH and alopecia) and age (≤45 and >45 years); comparing finasteride signals with those of drugs with different mechanisms but used for similar indications (minoxidil for alopecia and tamsulosin hydrochloride for BPH); comparing finasteride with a drug with a similar mechanism of action and adverse event profile (dutasteride); and comparing reports of suicidality before and after 2012. Data were obtained in June 2019 and analyzed from January 25 to February 28, 2020. Exposures: Reported finasteride use. Main Outcomes and Measures: Suicidality and psychological adverse events. Results: VigiBase contained 356 reports of suicidality and 2926 reports of psychological adverse events (total of 3282 adverse events of interest) in finasteride users (3206 male [98.9%]; 615 of 868 [70.9%] with data available aged 18-44 years). A significant disproportionality signal for suicidality (ROR, 1.63; 95% CI, 1.47-1.81) and psychological adverse events (ROR, 4.33; 95% CI, 4.17-4.49) in finasteride was identified. In sensitivity analyses, younger patients (ROR, 3.47; 95% CI, 2.90-4.15) and those with alopecia (ROR, 2.06; 95% CI, 1.81-2.34) had significant disproportionality signals for increased suicidality; such signals were not detected in older patients with BPH. Sensitivity analyses also showed that the reports of these adverse events significantly increased after 2012 (ROR, 2.13; 95% CI, 1.91-2.39). Conclusions and Relevance: In this pharmacovigilance case-noncase study, significant RORs of suicidality and psychological adverse events were associated with finasteride use in patients younger than 45 years who used finasteride for alopecia. The sensitivity analyses suggest that these disproportional signals of adverse events may be due to stimulated reporting and/or younger patients being more vulnerable to finasteride's adverse effects.

Recovery from minimally invasive vs. open surgery in kidney cancer patients: Opioid use and workplace absenteeism.

PURPOSE: Does surgical approach (minimally invasive vs. open) and type (radical vs. partial nephrectomy) affects opioid use and workplace absenteeism. MATERIALS AND METHODS: Retrospective multivariable regression analysis of 2,646 opioid-naïve patients between 18 and 64 undergoing radical or partial nephrectomy via either a minimally invasive vs. open approach for kidney cancer in the United States between 2012 and 2017 drawn from the IBM Watson Health Database was performed. Outcomes included: (1) opioid use in opioid-naïve patients as measured by opioid prescriptions in the post-operative setting at early, intermediate and prolonged time periods and (2) workplace absenteeism after surgery. RESULTS: Patients undergoing minimally invasive surgery had a lower odds of opioid use in the early and intermediate post-operative periods (early: odds ratio [OR], 0.77; 95% confidence interval [CI], 0.62-0.97; p=0.02, intermediate: OR, 0.60; 95% CI, 0.48-0.75; p<0.01), but not in the prolonged setting (prolonged: OR, 1.00; 95% CI, 0.75-1.34; p=0.98) and had earlier return to work (minimally invasive vs. open: -10.53 days; 95% CI, -17.79 to -3.26; p<0.01). Controlling for approach, patient undergoing partial nephrectomy had lower rates of opioid use across all time periods examined and returned to work earlier than patients undergoing radical nephrectomy (partial vs. radical: -14.41 days; 95% CI, -21.22 to -7.60; p<0.01). CONCLUSIONS: Patients undergoing various forms of surgery for kidney cancer had lower rates of peri-operative opioid use, fewer days of workplace absenteeism, but no difference in long-term rates of opioid use in patients undergoing minimally invasive as compared to open surgery.

Health care spending in prostate cancer: An assessment of characteristics and health care utilization of high resource-patients.

BACKGROUND: Prostate cancer ranks among the top 5 cancers in contribution to national expenditures. Previous reports have identified that 5% of the population accounts for 50% of the nation's annual health care spending. To date, the assessment of the top 5% resource-patients among men diagnosed with prostate cancer (PCa) has never been performed. We investigate the determinants and health care utilization of high resource-patients diagnosed with PCa using a population-based cohort using the Surveillance, Epidemiology, and End Results Medicare-linked database. METHODS: Men aged ≥66-year-old with a primary diagnosis of PCa in 2009 were identified. High resource spenders were defined as the top 5% of the sum of the total cost incurred for all services rendered per beneficiary. The spending in each group and predictors of being a high resource-patient were assessed. RESULTS: The top 5% resource-patients consisted of 646 men who spent a total of $62,474,504, comprising 26% of the total cost incurred for all 12,875 men who were diagnosed with PCa in 2009. Of the top 5% resource-patients, the average amount spent per patient was $96,710 vs. $14,664 among the bottom 95% resource-patients. In adjusted analyses, older (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.00-1.03), Charlson Comorbidity Index ≥2 (OR: 3.78, 95% CI: 3.10-4.60) men, and advanced disease (metastasis OR: 2.29, 95% CI: 1.68-3.11) were predictors of being a top 5% resource-patient. Of these patients, 210 men died within 1 year of PCa diagnosis (32.5%) vs. 606 men of the bottom 95% resource-patients (5.0%, P < 0.001). CONCLUSION: Five percent of men diagnosed with PCa bore 26% of the total cost incurred for all men diagnosed with the disease in 2009. Multimorbidity and advanced disease stage represent the primary drivers of being a high-resource PCa patient. Multidisciplinary care and shared decision-making is encouraged for such patients to better manage cost and quality of care.