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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.

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 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.

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.

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.

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.

To characterize pulmonary toxicities associated with the use of novel immune checkpoint inhibitors Adverse event reports from immune checkpoint inhibitors targeting PD-1/L1 and CTLA-4 were captured from the W.H.O pharmacovigilance database (VigiBase) up until Dec. 31st 2019 and were analyzed to evaluate for measures of association between the use of immune checkpoint inhibitors and pulmonary toxicities. Disproportionality analysis using both frequentist and Bayesian approaches were used to detect signals between pulmonary immune-related adverse events and the use of these agents. A total of 9202 adverse pulmonary immune checkpoint inhibitor-related events were captured up until 2019. Adverse pulmonary events were compromised of 1305 airway, 18 alveolar, 5491 interstitial, 898 pleural, 560 vascular and 939 non-specific pulmonary events. We found a common association between all immune checkpoint inhibitors studied and pneumonitis, interstitial lung disease, pulmonary embolism and respiratory failure. We also noted other associations between immune checkpoint inhibitors, however not as uniformly across agents. Most of these immune-related adverse drug reactions were noted to be severe and accounted for a significant source of mortality in the reported cases. Immune checkpoint inhibitors are associated with a spectrum of inflammatory pulmonary toxicities. The breadth of pulmonary complications and prevalence may be underappreciated with the use of these agents.

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.

Introduction and Objectives: Budgetary constraints and novel minimally invasive surgical approaches have resulted in surgical care being increasingly provided at ambulatory centers rather than traditional inpatient settings. Despite increasing use of ambulatory-based procedure for bladder outlet obstruction (BOO) procedures, little is known about the effect of care setting on perioperative outcomes and costs. We sought to compare 30-day readmissions rates and costs of BOO procedure performed in the ambulatory vs inpatient setting. Methods: Using Florida and New York all-payer data from the 2014 Healthcare Cost and Utilization Project State Databases, we identified patients who underwent transurethral resection, thermotherapy, or laser/photovaporization for BOO. Patient demographics, regional data, 30-day readmissions rates, and costs (from converted charges) associated with the index procedure and revisits were analyzed. Predictors of 30-day revisits were also identified by fitting a multivariate logistic regression model with facility-level clustering. Results: Of the 15,094 patients identified, 1444 (9.6%) had a 30-day revisit at a median cost of $4263.43. The 30-day readmission rate for inpatient cases was significantly higher than that of surgeries performed in the ambulatory setting (12.0% vs 8.1%, p

Introduction:We sought to identify predictors of index surgical care setting and to determine if care setting influences risk adjusted perioperative costs and/or 30-day revisits following e...

Compared to low-volume hospitals, high-volume hospitals are associated with lower rates of perioperative morbidity and mortality. However, access to high-volume hospitals is unequal. We investigated racial and socioeconomic disparities among patients undergoing surgery for genitourinary malignancies at high-volume hospitals.We queried the National Cancer Database from 2004-2015 to identify patients who underwent radical prostatectomy, radical cystectomy, and nephrectomy for nonmetastatic prostate cancer, muscle-invasive urothelial bladder cancer, and kidney cancer, respectively. Hospitals were ranked based on their annual volume for the given procedure. The endpoint of our study was receipt of treatment at a high-volume hospital. Multivariable logistic regression models were used to identify predictors of treatment at a high-volume hospital.Our final cohort consisted of 397,242 prostate cancer patients, 39,480 bladder cancer patients, and 292,095 kidney cancer patients. For prostate and bladder cancer, Black race was associated with lower odds of treatment at a high-volume hospital (Odds Ratio [OR] 0.83, 95% confidence interval [CI] 0.79-0.87 and 0.71, 95%CI 0.58-0.87; reference: White). Higher education level and private insurance status were associated with greater odds of treatment across all 3 procedures (strongest effect for prostate cancer; higher education level: OR 1.63 [1.58-1.68]; private insurance 1.86 [1.77-1.97]). Moreover, an interaction was found between race and study period for all cancers examined (P0.001). Subgroup analyses revealed that Black patients were more likely to undergo radical prostatectomy at high-volume hospitals in 2013-2015 (OR 0.98, 95%CI 0.94-1.02) compared to 2004-2006 (OR 0.83, 95%CI 0.79-0.87).Across all procedures, patients with lower education status and lack of insurance were less likely to be treated at high-volume hospitals. For prostate cancer and bladder cancer, Black race was a negative predictor of treatment at high-volume hospitals. Further studies are needed to understand the root causes for this inequity.

BACKGROUND Venous thromboembolism (VTE) is a significant source of postoperative morbidity and mortality in patients undergoing common oncologic procedures. We sought to estimate the effect of surgical approach on the risk of developing a VTE. METHODS IBM Watson Health Marketscan Database was used to conduct this retrospective study. In total, 12 938 patients who underwent either a radical prostatectomy, partial colectomy, or hysterectomy via a minimally invasive or open approach. We used a propensity-weighted logistic regression analysis to assess the independent effect of surgical approach on VTE. The primary outcome of interest was the 90-day rate of VTE after surgery. RESULTS Patients undergoing minimally invasive surgery across all three surgical procedures were noted to have a lower odds of developing a VTE: (radical prostatectomy, odds ratio [OR]: 0.667, 95% confidence interval [CI]: 0.500-0.891; P = .006 |partial colectomy: OR, 0.620, 95% CI: 0.477-0.805; P

INTRODUCTION AND OBJECTIVE:To examine the relationship between duration of surgical intervention and postoperative complications in radical cystectomy. We hypothesized that the complication rate in...

INTRODUCTION AND OBJECTIVE:Massachusetts (MA) is a northeastern state with universally mandated health insurance since 2006. Although Black men have generally worse prostate cancer outcomes, emergi...

INTRODUCTION AND OBJECTIVE:Radical cystectomy (RC) can be a challenging procedure associated with a high morbidity. We evaluated healthcare and surgical factors associated with high-quality RC surg...

Evidence for androgen deprivation therapy (ADT) and risk of dementia is both limited and mixed. We aimed to assess the association between ADT and risk of dementia among men with localized and locally advanced prostate cancer (PCa). We conducted a retrospective cohort study using SEER-Medicare-linked data among 100,414 men aged ≥ 66 years and diagnosed with localized and locally advanced PCa (cT1–cT4) between 1992 and 2009. We excluded men with a history of stroke, dementia, or use of psychiatric services. Men were followed until death or administrative end of follow-up at 36 months. Inverse-probability weighted Fine-Gray models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for Alzheimer’s, all-cause dementia, and use of psychiatric services by duration of pharmacologic ADT (0, 1–6, and ≥ 7 months). Among 100,414 men with PCa (median age 73 [IQR: 69–77] years; 84% white, 10% black), 38% (n = 37,911) received ADT within 6 months of diagnosis. Receipt of any pharmacologic ADT was associated with a 17% higher risk of all-cause dementia (HR 1.17, 95% CI 1.07–1.27), 23% higher risk of Alzheimer’s (HR 1.23, 95% CI 1.11–1.37), and 10% higher risk of psychiatric services use, though the confidence interval included the null (HR 1.10, 95% CI 1.00–1.22). Longer duration of ADT (≥7 months) was associated with a 25% higher risk of all-cause dementia, 34% higher risk of Alzheimer’s, and 9% higher risk of psychiatric services, compared with no ADT. Our study supports an association between pharmacologic ADT and higher risk of all-cause dementia, Alzheimer’s, and use of psychiatric services among men with localized and locally advanced PCa.

Background The introduction of immune checkpoint inhibitors has led to a survival benefit in patients with advanced melanoma; however data on the adoption of immunotherapy in the community are scarce. Methods Using the National Cancer Database, we identified 4725 patients aged ≥20 diagnosed with metastatic melanoma in the United States between 2011 and 2015. Multinomial regression was used to identify factors associated with the receipt of treatment at a low vs. high immunotherapy prescribing hospital, defined as the bottom and top quintile of hospitals according to their proportion of treating metastatic melanoma patients with immunotherapy. Results We identified 246 unique hospitals treating patients with metastatic melanoma. Between 2011 and 2015, the proportion of hospitals treating at least 20% of melanoma patients with immunotherapy within 90 days of diagnosis increased from 14.5 to 37.7%. The mean proportion of patients receiving immunotherapy was 7.8% (95% Confidence Interval [CI] 7.47–8.08) and 50.9% (95%-CI 47.6–54.3) in low and high prescribing hospitals, respectively. Predictors of receiving care in a low prescribing hospital included underinsurance (no insurance: relative risk ratio [RRR] 2.44, 95%-CI 1.28–4.67, p = 0.007; Medicaid: RRR 2.10, 95%-CI 1.12–3.92, p = 0.020), care in urban areas (RRR 2.58, 95%-CI 1.34–4.96, p = 0.005) and care at non-academic facilities (RRR 5.18, 95%CI 1.69–15.88, p = 0.004). Conclusion While the use of immunotherapy for metastatic melanoma has increased over time, adoption varies widely across hospitals. Underinsured patients were more likely to receive treatment at low immunotherapy prescribing hospitals. The variation suggests inequity in access to these potentially life-saving drugs.

BACKGROUND Health insurance is a key mediator of health care disparities. Outcomes in bladder cancer, one of the costliest diseases to treat, may be especially sensitive to a patient's insurance status. METHODS The Surveillance, Epidemiology, and End Results registry and the National Cancer Data Base were used to identify individuals younger than 65 years who were diagnosed with bladder cancer from 2007 to 2014. The associations between the insurance status (privately insured, insured by Medicaid, or uninsured) and the following outcomes were evaluated: diagnosis with advanced disease, cancer-specific survival, delay in treatment longer than 90 days, treatment in a high-volume hospital, and receipt of neoadjuvant chemotherapy (NAC). RESULTS Compared with those with private insurance, uninsured and Medicaid-insured individuals were nearly twice as likely to receive a diagnosis of muscle-invasive bladder cancer (odds ratio [OR] for uninsured individuals, 1.90; 95% confidence interval [CI], 1.70-2.12; OR for Medicaid-insured individuals, 2.03; 95% CI, 1.87-2.20). They were also more likely to die of bladder cancer (adjusted hazard ratio [AHR] for uninsured individuals, 1.49; 95% CI, 1.31-1.71; AHR for Medicaid-insured individuals, 1.61; 95% CI, 1.46-1.79). Delays in treatment longer than 90 days were more likely for uninsured (OR, 1.36; 95% CI, 1.12-1.65) and Medicaid-insured individuals (OR, 1.22; 95% CI, 1.03-1.44) in comparison with the privately insured. Uninsured patients had lower odds of treatment at a high-volume facility, and Medicaid-insured patients had lower odds of receiving NAC (P

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

A previous study comparing external beam radiation therapy with/without brachytherapy (EBRT±BT) and radical prostatectomy (RP) for high-risk localized prostate cancer (PCa) did not find a difference in overall survival (OS) between the treatments. However, this study was limited by short follow-up and assessment of OS in patients of divergent age and comorbidities. We therefore compared OS of EBRT+BT versus RP in comparatively young (≤65yr) and healthy men (Charlson Comorbidity Index=0) with high-risk localized PCa in the National Cancer Database. Inverse probability of treatment weighting (IPTW) adjustment was used to balance baseline characteristics. Median follow-up was 92mo (interquartile range 78-108). Using IPTW-adjusted Cox regression analysis, EBRT+BT was associated with a higher risk of all-cause mortality compared with RP (hazard ratio=1.22, 95% confidence interval 1.05-1.43). In young and healthy men presenting with high-risk localized PCa, RP showed statistically significant OS benefit compared with EBRT+BT. PATIENT SUMMARY: In an analysis restricted to young and healthy men presenting with high-risk localized prostate cancer, initial radical prostatectomy is associated with an overall survival benefit compared with external beam radiation therapy plus brachytherapy.

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.

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, Take Home Message In this UK registry study of bladder cancer patients treated with radical cystectomy, 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.

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

ImportanceThere 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.ObjectiveTo investigate the association of suicidality (ideation, attempt, and completed suicide) and psychological adverse events (depression and anxiety) with finasteride use.Design, Setting, and ParticipantsThis 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.ExposuresReported finasteride use.Main Outcomes and MeasuresSuicidality and psychological adverse events.ResultsVigiBase 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 RelevanceIn 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.

Background The rise in deaths attributed to opioid drugs has become a major public health problem in the United States and in the world. Minimally invasive surgery (MIS) is associated with a faster postoperative recovery and our aim was to investigate if the use of MIS was associated with lower odds of prolonged opioid prescriptions after major procedures. Methods Retrospective study using the IBM Watson Health Marketscan® Commerical Claims and Encounters Database investigating opioid-naïve cancer patients aged 18–64 who underwent open versus MIS radical prostatectomy (RP), partial colectomy (PC) or hysterectomy (HYS) from 2012 to 2017. Propensity weighted logistic regression analyses were used to estimate the independent effect of surgical approach on prolonged opioid prescriptions, defined as prescriptions within 91–180 days of surgery. Results Overall, 6838 patients underwent RP (MIS 85.5%), 4480 patients underwent PC (MIS 61.6%) and 1620 patients underwent HYS (MIS 41.8%). Approximately 70–80% of all patients had perioperative opioid prescriptions. In the weighted model, patients undergoing MIS were significantly less likely to have prolonged opioid prescriptions in all three surgery types (Odds Ratio [OR] 0.737, 95% Confidence Interval [CI] 0.595–0.914, p = 0.006; OR 0.728, 95% CI 0.600–0.882, p = 0.001; OR 0.655, 95% CI 0.466–0.920, p = 0.015, respectively). Conclusion The use of the MIS was associated with lower odds of prolonged opioid prescription in all procedures examined. While additional studies such as clinical trials are needed for further confirmation, our findings need to be considered for patient counseling as postoperative differences between approaches do exist.

Background Despite randomized data demonstrating better overall survival favoring radical nephrectomy, partial nephrectomy continues to be the treatment of choice for low-stage renal cell carcinoma. Methods We utilized the National Cancer Database to identify patients younger than 50 years diagnosed with low-stage renal cell carcinoma (cT1) treated with radical nephrectomy or partial nephrectomy (2004–2007). Inverse probability of treatment weighting adjustment was performed for all preoperative factors to account for confounding factors. Kaplan-Meier curves and Cox proportional hazards regression analyses were used to compare overall survival of patients in the two treatment arms. Sensitivity analysis was performed to explore the interaction of type of surgery and clinical stage on overall survival. Results Among the 3009 patients (median age = 44 years [interquartile range (IQR) = 40–47 years]), 2454 patients (81.6%) were treated with radical nephrectomy and 555 patients (18.4%) with partial nephrectomy. The median follow-up was 108.6 months (IQR = 80.2–124.3 months) during which 297 patients (12.1%) in the radical nephrectomy arm and 58 patients (10.5%) in the partial nephrectomy arm died. Following inverse probability of treatment weighting adjustment, there was no difference in overall survival between patients treated with partial nephrectomy and radical nephrectomy (hazard ratio = 0.83, 95% confidence interval = 0.63 to 1.10, P = .196). There were no statistically significant interactions between type of surgery and clinical stage on treatment outcome. Conclusions There was no difference in long-term overall survival between radical and partial nephrectomy in young and healthy patients. This patient cohort may have sufficient renal reserve over their lifetime, and preserving nephrons by partial nephrectomy may be unnecessary.

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.

Key Points Question How do race-based disparities in prostate cancer outcomes differ geographically within the US? Findings In this cohort study of 229 771 men in 17 geographic registries within the Surveillance, Epidemiology, and End Results database, black men had a higher risk of mortality overall compared with white men. The greatest race-based survival difference was seen in men with low-risk prostate cancer in the Atlanta, Georgia, registry, where mortality risk among black men was increased more than 5-fold. Meaning These findings suggest that race-based survival differences in prostate cancer vary regionally, which may allow for targeted interventions to mitigate these disparities., This cohort study examines differences in prostate cancer mortality in white vs black men stratified by geographic region., Importance While racial disparities in prostate cancer mortality are well documented, it is not well known how these disparities vary geographically within the US. Objective To characterize geographic variation in prostate cancer–specific mortality differences between black and white men. Design, Setting, and Participants This cohort study included data from 17 geographic registries within the Surveillance, Epidemiology, and End Results (SEER) database from January 1, 2007, to December 31, 2014. Inclusion criteria were men 18 years and older with biopsy-confirmed prostate cancer. Men missing data on key variables (ie, cancer stage, Gleason grade group, prostate-specific antigen level, and survival follow-up data) were excluded. Analysis was performed from September 5 to December 25, 2018. Exposure Patient SEER-designated race (ie, black, white, or other). Main Outcomes and Measures Fine and Gray competing-risks regression analyses were used to evaluate the difference in prostate-cancer specific mortality between black and white men. A stratified analysis by Gleason grade group was performed stratified as grade group 1 and grade groups 2 through 5. Results The final cohort consisted of 229 771 men, including 178 204 white men (77.6%), 35 006 black men (15.2%), and 16 561 men of other or unknown race (7.2%). Mean (SD) age at diagnosis was 64.9 (8.8) years. There were 4773 prostate cancer deaths among white men and 1250 prostate cancer deaths among black men. Compared with white men, black men had a higher risk of mortality overall (adjusted hazard ratio [AHR], 1.39 [95% CI, 1.30-1.48]). In the stratified analysis, there were 4 registries in which black men had worse prostate cancer-specific survival in both Gleason grade group 1 (Atlanta, Georgia: AHR, 5.49 [95% CI, 2.03-14.87]; Greater Georgia: AHR, 1.88 [95% CI, 1.10-3.22]; Louisiana: AHR, 1.80 [95% CI, 1.06-3.07]; New Jersey: AHR, 2.60 [95% CI, 1.53-4.40]) and Gleason grade groups 2 through 5 (Atlanta: AHR, 1.88 [95% CI, 1.46-2.45]; Greater Georgia: AHR, 1.29 [95% CI, 1.07-1.56]; Louisiana: AHR, 1.28 [95% CI, 1.07-1.54]; New Jersey: AHR, 1.52 [95% CI, 1.24-1.87]), although the magnitude of survival difference was lower than for Gleason grade group 1 in each of these registries. The greatest race-based survival difference for men with Gleason grade group 1 disease was in the Atlanta registry. Conclusions and Relevance These findings suggest that population-level differences in prostate cancer survival among black and white men were associated with a small set of geographic areas and with low-risk prostate cancer. Targeted interventions in these areas may help to mitigate prostate cancer care disparities at the national level.

INTRODUCTION AND OBJECTIVE:Recognizing the burden posed by unplanned hospital readmissions, the Affordable Care Act established the Hospital Readmission Reduction Program (HRRP) in 2013, whereby ho...

INTRODUCTION AND OBJECTIVE:Immune checkpoint inhibitors (ICIs) demonstrate impressive clinical benefit across a variety of cancers. NCCN guidelines for several cancers including renal cell carcinom...

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 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.

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.

With improvements in early detection and treatment, a growing proportion of the population now lives with a personal history of a cancer. Although many cancer survivors are in excellent health, the underlying risk factors and side effects of cancer treatment increase the risk of medical complications and secondary malignancies.The 2013 National Health Interview Survey was utilized to assess the association between personal history of cancer and receipt of U.S. Preventive Services Task Force-recommended services, comprising three cancer screening tests (mammography, colonoscopy, and Pap smear) and six general medical preventive care services (aspirin for prevention of cardiovascular disease; blood pressure, cholesterol, and diabetes screening; diet/activity counseling; and tobacco use counseling). For each preventive service, patients with a history that would preclude that test were excluded. One to three matching of cancer survivors to controls was performed using propensity scores generated from patient-level demographic variables. Conditional logistic regression models were employed to compare odds of screening between matched cohorts of cancer survivors and controls. The years of analysis were 2015 and 2017.A total of 2,639 cancer patients and 31,885 controls were extracted from the merged 2013 National Health Interview Survey. In the propensity score-matched cohorts of eligible adults, only one of the three cancer screening tests, colorectal, was more common in cancer survivors (OR=1.52, 95% CI=1.32, 1.75, p0.001), whereas breast and cervical cancer screening were not more common in survivors. By contrast, all of the medical screening tests, with the exception of diabetes screening, were more common among cancer survivors.The association between receipt of recommended preventive medical care and personal history of cancer varied, depending on the preventive service in question, but in the majority of preventive services assessed, cancer survivors had more frequent screening compared with non-cancer survivors.

The impact of variant histologies on overall survival (OS), as well as their influence on the response to neoadjuvant and adjuvant chemotherapy (AC) is well studied in patients diagnosed with bladder cancer. However, little is known about tumors with variant histologies of the upper urinary tract. The objective of this study was to assess the survival of the predominant variant histologies of tumors of the renal pelvis (RPT) after surgical intervention, and to examine the influence of AC on the OS of the different variant histologies. We identified 21,318 patients with RPT undergoing surgical intervention using the National Cancer Database for the period 2004–2015. We employed multivariable Cox proportional hazards regression models and Kaplan–Meier curves to evaluate the OS according to variant histology. Separate multivariable Cox regression models were used to assess the specific effect of AC on OS of the histological subgroups. The majority of patients were diagnosed with pure urothelial carcinoma (PUC) (96.1%). Overall, 826 patients were diagnosed with variant histologies (adenocarcinoma N = 298, squamous cell carcinoma N = 291, sarcomatoid N = 137, others N = 100). Compared to PUC, adenocarcinomas showed longer OS (HR 0.76, 95% confidence interval (CI) 0.62–0.94, p = 0.01), while sarcomatoid tumors had shorter OS (HR 1.59, 95% CI 1.12–2.26, p = 0.011). A subgroup analysis of patients undergoing AC showed a survival benefit in patients with PUC (HR 0.81, 95% CI 0.73–0.9, p

Early surgical resection remains the recommended treatment option for most small renal mass (≤4 cm). We examined the long-term overall survival (OS) of patients managed with delayed and immediate nephrectomy of cT1a renal cancer.We utilized the National Cancer Database (2005-2010) to identify 14,677 patients (immediate nephrectomy: 14,050 patients vs. late nephrectomy: 627 patients) aged70 years with Charlson Comorbidity Index 0 and cT1aN0M0 renal cell carcinoma. Immediate nephrectomy and late nephrectomy were defined as nephrectomy performed30 days and180 days from diagnosis, respectively. Inverse probability of treatment weighting-adjusted Kaplan-Meier curves and Cox proportional hazards regression analyses were used to compare OS of patients in the 2 treatment arms. Influence of patient age and Charlson Comorbidity Index on treatment effect was tested by interactions. Sensitivity analysis was performed to explore the outcome of delaying nephrectomy for12 months.Median patient age was 55 years with a median follow-up of 82.5 months. Inverse probability of treatment weighting-adjusted Kaplan-Meier curves suggest no significant difference between treatment arms (immediate nephrectomy [30 days] vs. delayed nephrectomy [180 days]) (Hazard ratio 0.96; 95% confidence interval 0.73-1.26; P = 0.77). This outcome was consistent between all patients regardless of age (P = 0.48). Sensitivity analysis reports no difference in OS even if nephrectomy was delayed by12 months (P = 0.60).We report that delayed and immediate nephrectomy for cT1a renal cell carcinoma confers comparable long-term OS. These findings suggest that a period of observation of between 6 and 12 months is safe to allow identification of renal masses, which will benefit from surgical resection.

While bladder cancer is less common among women, female sex is associated with worse oncological outcomes.To evaluate sex-specific differences in initial presentation and treatment patterns of muscle-invasive bladder cancer.A retrospective study using the National Cancer Database to identify individuals diagnosed with muscle-invasive bladder cancer (cT2-T4aN0M0) between 2004 and 2013.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.We identified 27525 patients, 27.4% of whom were females. Females were diagnosed significantly more often with nonurothelial carcinoma (15.1% vs 9.9%, p0.001), 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, p0.001). 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.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.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.

INTRODUCTION AND OBJECTIVES:Current recommendations suggest that nephrectomy or thermal ablation is a recommended treatment option for small renal mass (≤4 cm). This study examined long-term overal...

INTRODUCTION AND OBJECTIVES:Medicaid expansion is a key provision by which the Affordable Care Act seeks to improve access to health insurance. However, there is concern over the quality and cost o...

INTRODUCTION AND OBJECTIVES:There is limited epidemiological evidence for the association between androgen deprivation therapy (ADT) and the risk of incident dementia, yet several studies show no s...

INTRODUCTION AND OBJECTIVES:Medicaid expansion is a key provision by which the Affordable Care Act seeks to improve access to health insurance. However, there is concern over the quality and cost o...

Introduction We evaluated patient, hospital, and cancer-specific factors associated with positive surgical margin (PSM) variability after radical prostatectomy in pT2 prostate cancer in the United States. Patients and Methods A total of 45,426 men from 1152 hospitals with pT2 prostate cancer and known margin status after radical prostatectomy were identified using the National Cancer Database (2010-2015). Data on patient, cancer, hospital factors, and surgical approach were extracted. A mixed effects logistic regression model was computed to examine factors associated with PSM and partial R2 values to assess the relative contributions of patient, cancer, and hospital variables to PSM status. Results Median PSM rate of 8.5% (interquartile range, 5.2%-13.0%). Robotic (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.83-0.99) and laparoscopic (OR, 0.74; 95% CI, 0.64-0.90) surgical approach, academic institution (OR, 0.87; 95% CI, 0.76-1.00) and high hospital surgical volume (>297 cases [OR], 0.83; 95% CI, 0.70-0.99) were independently associated with a lower PSM. Black men (OR, 1.13; 95% CI, 1.01-1.26) and adverse cancer-specific features (prostate-specific antigen [PSA], 10-20; PSA >20; cT3 stage; Gleason 7, 8, 9-10; all P > .01) were independently associated with a higher PSM. Patient-specific, hospital-specific, and cancer-specific factors had a contribution of 2.3%, 3.9%, and 15.2%, respectively, to the variation in PSM. Facility had a contribution of 23.7% to the variation in PSM. Conclusion Cancer-specific factors account for 15.2% of PSM variation with the remaining 84.8% of PSM variation due to patient, hospital, and other factors not accounted within the model. Noncancer-specific factors represent addressable factors that are important for policy-makers in efforts to improve patient outcome.

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, Graphical Abstract