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Hepatocellular carcinoma (HCC) is a major complication of chronic hepatitis C virus (HCV) infection. Among haemophilic (H) men, HCV is the leading cause of liver disease. Direct-acting antiviral agents (DAA) reduce HCV viral load, but impact on HCC is unknown.This was a retrospective study of adult H and nonhaemophilic (NH) male discharges, with and without HCC, identified by ICD-10 codes in the National Inpatient Sample (NIS) database, 2016-2018, with DAA availability. Analyses included discharge-level weights to reflect national estimates. Categorical variables were assessed by Rao-Scott chi-square and continuous variables by weighted simple linear regression. HCC correlates were determined by weighted multivariable logistic regression.Among 7,674,969 adult male discharges, 3730 H (.04%) were identified in 2016-2018, of whom 10.06% had HCV and 1.07% had HCC, significantly higher than NH (1.22% and .27%, respectively) all P .001. Annual HCC rates were similar during the 3-year period (2016-2018) in H and NH. Among H, HCC is associated with older age and higher rates of HCV, HBV, NASH, end-stage liver disease, and Charlson comorbidity (CCI), each P .001. Among HCC, H were younger and more likely HIV+, each P .001, but less likely alcoholic (P = .018) or hyperlipidaemic (P = .008) compared to NH. In multivariable regression, risk factors for HCC among H included NASH (OR 21.6), HCV (OR 3.96), CCI (OR1.54), all P .001, while HIV and hyperlipidaemia were protective.From 2016 to 2018, HCC rates did not change significantly in haemophilia discharges. NASH, HCV, and CCI are significant risks for HCC in haemophilia during the DAA-era.

ImportancePatients with urologic diseases often experience financial toxicity, defined as high levels of financial burden and concern, after receiving care. The Price Transparency Final Rule, which requires hospitals to disclose both the commercial and cash prices for at least 300 services, was implemented to facilitate price shopping, decrease price dispersion, and lower health care costs.ObjectiveTo evaluate compliance with the Price Transparency Final Rule and to quantify variations in the price of urologic procedures among academic hospitals and by insurance class.Design, Setting, and ParticipantsThis was a cross-sectional study that determined the prices of 5 common urologic procedures among academic medical centers and by insurance class. Prices were obtained from the Turquoise Health Database on March 24, 2022. Academic hospitals were identified from the Association of American Medical Colleges website. The 5 most common urologic procedures were cystourethroscopy, prostate biopsy, laparoscopic radical prostatectomy, transurethral resection of the prostate, and ureteroscopy with laser lithotripsy. Using the corresponding Current Procedural Terminology codes, the Turquoise Health Database was queried to identify the cash price, Medicare price, Medicaid price, and commercial insurance price for these procedures.ExposuresThe Price Transparency Final Rule, which went into effect January 1, 2021.Main Outcomes and MeasuresVariability in procedure price among academic medical centers and by insurance class (Medicare, Medicaid, commercial, and cash price).ResultsOf 153 hospitals, only 20 (13%) listed a commercial price for all 5 procedures. The commercial price was reported most often for cystourethroscopy (86 hospitals [56%]) and least often for laparoscopic radical prostatectomy (45 hospitals [29%]). The cash price was lower than the Medicare, Medicaid, and commercial price at 24 hospitals (16%). Prices varied substantially across hospitals for all 5 procedures. There were significant variations in the prices of cystoscopy (χ23 = 85.9; P = .001), prostate biopsy (χ23 = 64.6; P = .001), prostatectomy (χ23 = 24.4; P = .001), transurethral resection of the prostate (χ23 = 51.3; P = .001), and ureteroscopy with laser lithotripsy (χ23 = 63.0; P = .001) by insurance type.Conclusions and RelevanceThese findings suggest that, more than 1 year after the implementation of the Price Transparency Final Rule, there are still large variations in the prices of urologic procedures among academic hospitals and by insurance class. Currently, in certain situations, health care costs could be reduced if patients paid out of pocket. The Centers for Medicare & Medicaid Services may improve price transparency by better enforcing penalties for noncompliance, increasing penalties, and ensuring that hospitals report prices in a way that is easy for patients to access and understand.

For assessing human leukocyte antigen compatibility in deceased donor kidney transplantation, virtual crossmatch is used as an alternative to physical crossmatch and has potential to reduce cold ischemia time. The 2014 United States kidney allocation system prioritized highly sensitized candidates but led to increased shipping of kidneys. Using data from the Scientific Registry of Transplant Recipients, we evaluated changes in virtual crossmatch use with the new allocation policy and the impact of virtual crossmatch use on cold ischemia time and transplant outcomes. This was a retrospective cohort study of adult deceased donor kidney recipients in the United States (2011-2018) transplanted with either 9,632 virtual or 71,839 physical crossmatches. Before allocation change, only 9% of transplants were performed relying on a virtual crossmatch. After the 2014 allocation change, this increased by 2.4%/year so that 18% transplants in 2018 were performed with just a virtual crossmatch. There was significant variation in virtual crossmatch use among transplant regions (range 0.7-36%) and higher use was noted among large volume centers. Compared to physical crossmatches, virtual crossmatches were significantly associated with shorter cold ischemia times (mean 15.0 vs 16.5 hours) and similar death-censored graft loss and mortality (both hazard ratios HR 0.99) at a median follow-up of 2.9 years. Thus, our results show that virtual crossmatch is an attractive strategy for shortening cold ischemia time without negatively impacting transplant outcomes. Hence, strategies to optimize use and reduce practice variation may allow for maximizing benefits from virtual crossmatch.

Rationale & Objective: In patients with chronic kidney disease (CKD), self-rated health (“In general, how do you rate your health?”) is associated with mortality. The association of self-rated health with functional status is unknown. We evaluated the association of limitations in activities of daily living (ADLs) with self-rated health and clinical correlates in a cohort of patients with CKD stages 1-5. Study Design: Prospective cohort study. Setting & Participants: Patients with CKD at a nephrology outpatient clinic in western Pennsylvania. Outcome: Patients participated in a survey assessing their self-rated health (5-point Likert scale) and physical (ambulation, dressing, shopping) and cognitive (executive and memory) ADLs. Adjusted analysis was performed using logistic regression models. Analytical Approach: Logistic regression was conducted to examine the adjusted association of 3 dependent variables (sum of total, physical, and cognitive ADL limitations) with self-rated health (independent variable of interest). Results: The survey was completed by 1,268 participants (mean age, 60 years; 49% females, and 74% CKD stages 3-5), of which 41% reported poor-to-fair health. Overall, 35.9% had at least 1 physical ADL limitation, 22.1% had at least 1 cognitive ADL limitation, and 12.5% had at least 3 ADL limitations. Ambulation was the most frequently reported limitation and was more common in patients reporting poor-to-fair self-rated health compared with those with good-to-excellent self-rated health (58.1% vs 17.4%, P < 0.001). In our fully adjusted model, poor-to-fair self-rated health was strongly associated with limitations in at least 3 ADLs (total ADL) [OR 8.29 (95% CI, 5.23-13.12)]. There was no significant association of eGFR with ADL limitations. Limitations: Selection bias due to optional survey completion, residual confounding, and use of abbreviated (as opposed to full) ADL questionnaires. Conclusions: Poor-to-fair self-rated health is strongly associated with physical ADL limitations in patients with CKD. Future studies should evaluate whether self-rated health questions may be useful for identifying patients who can benefit from additional evaluation and treatment of functional limitations to improve patient-centered outcomes.

BackgroundDiabetes self-management education and support (DSMES) programs have struggled to deliver sustainable, effective support for adults with diabetes (AWDs) to improve self-management behaviors, achieve glycemic goals, and reduce risk for complications. One largely untapped resource for this support is AWDs’ social networks. Fifty to 75% of AWDs have an unpaid family member or friend (“support person”) who provides ongoing help with diabetes management. However, DSMES interventions to date lack structured and effective approaches to directly engage support persons in AWDs’ diabetes management.MethodsThis parallel arm randomized trial is designed to determine the effectiveness of Family Support for Health Action (FAM-ACT), a novel community health worker (CHW)-delivered program focused on educating and supporting patients with type 2 diabetes (T2D) and their support persons (SPs), relative to an established, CHW-delivered, individual patient-focused DSMES and care management (I-DSMES) intervention. Both interventions were developed using a community-based participatory research (CBPR) approach.The study will be conducted in partnership with an urban Federally Qualified Health Center (FQHC) serving a low-income, Latino/a community, with target enrollment of 268 dyads consisting of an FQHC patient with T2D with high HbA1c and an SP. Patient-SP dyads will be randomized to receive FAM-ACT or I-DSMES over 6 months.The primary outcome is change in patient HbA1c from baseline to 6 months. Secondary patient outcomes include 12-month change in HbA1c, changes in patient blood pressure, diabetes self-management behaviors, diabetes distress, patient activation, diabetes self-efficacy, and perceptions of and satisfaction with SP support for diabetes. Secondary SP outcomes include self-efficacy for helping the patient with diabetes management and SP distress about the patient’s diabetes. We also will assess the effect of the COVID-19 pandemic on patient’s ability to manage diabetes.DiscussionThis study will inform scalable, evidence-based approaches that leverage family support to help AWDs improve and sustain self-management strategies that underpin optimal management of multiple diabetes complication risk factors. The protocol is designed for and evaluated with a low-income and predominantly Latino/a community, which may increase applicability to other similar communities. The COVID-19 pandemic presented several challenges to study protocol and intervention delivery; modifications made to address these challenges are described.Trial registrationClinicalTrials.gov NCT03812614. Registered on 18 January 2019.

Home blood pressure monitoring (HBPM) can improve hypertension management. Digital tools to facilitate routinized HBPM and patient self-care are underutilized and lack evidence of effectiveness. MyBP provides video-based education and automated text messaging to support continuous BP self-monitoring with recurring feedback. In this pragmatic trial, we sought to generate preliminary evidence of feasibility and efficacy in community-dwelling adults ≥55 y/o with hypertension recruited from primary care offices. Enrollees were provided a standard automatic BP cuff and randomized 2:1 to MyBP vs treatment-as-usual (control). Engagement with MyBP was defined as the proportion of BP reading prompts for which a reading was submitted, tracked over successive 2-week monitoring periods. Preliminary measures of efficacy included BP readings from phone-supervised home measurements and a self-efficacy questionnaire. Sixty-two participants (40 women, 33 Blacks, mean age 66, mean office BP 164/91) were randomized to MyBP (n = 41) or a control group (n = 21). Median follow-up was 22.9 (SD = 6.7) weeks. In the MyBP group, median engagement with HBPM was 82.7% (Q1 = 52.5, Q3 = 89.6) and sustained over time. The decline in systolic [12 mm Hg (SD = 17)] and diastolic BP [5 mm Hg (SD = 7)] did not differ between the two treatment groups. However, participants with higher baseline systolic BP assigned to MyBP had a greater decline compared to controls [interaction effect estimate −0.56 (−0.96, −0.17)]. Overall hypertension self-efficacy improved in the MyBP group. In conclusion, trial results show that older hypertensive adults with substantial minority representation had sustained engagement with this digital self-monitoring program and may benefit clinically.

BACKGROUND Medicare requires that hospitals report on their adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). OBJECTIVE To evaluate the effect of SEP-1 on treatment patterns and patient outcomes. DESIGN Longitudinal study of hospitals using repeated cross-sectional cohorts of patients. SETTING 11 hospitals within an integrated health system. PATIENTS 54 225 encounters between January 2013 and December 2017 for adults with sepsis who were hospitalized through the emergency department. INTERVENTION Onset of the SEP-1 reporting requirement in October 2015. MEASUREMENTS Changes in SEP-1-targeted processes, including antibiotic administration, lactate measurement, and fluid administration at 3 hours from sepsis onset; repeated lactate and vasopressor administration for hypotension within 6 hours of sepsis onset; and sepsis outcomes, including risk-adjusted intensive care unit (ICU) admission, in-hospital mortality, and home discharge among survivors. RESULTS Two years after its implementation, SEP-1 was associated with variable changes in process measures, with the greatest effect being an increase in lactate measurement within 3 hours of sepsis onset (absolute increase, 23.7 percentage points [95% CI, 20.7 to 26.7 percentage points]; P < 0.001). There were small increases in antibiotic administration (absolute increase, 4.7 percentage points [CI, 1.9 to 7.6 percentage points]; P = 0.001) and fluid administration of 30 mL/kg of body weight within 3 hours of sepsis onset (absolute increase, 3.4 percentage points [CI, 1.5 to 5.2 percentage points]; P < 0.001). There was no change in vasopressor administration. There was a small increase in ICU admissions (absolute increase, 2.0 percentage points [CI, 0 to 4.0 percentage points]; P = 0.055) and no changes in mortality (absolute change, 0.1 percentage points [CI, -0.9 to 1.1 percentage points]; P = 0.87) or discharge to home. LIMITATION Data are from a single health system. CONCLUSION Implementation of the SEP-1 mandatory reporting program was associated with variable changes in process measures, without improvements in clinical outcomes. Revising the measure may optimize its future effect. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

BACKGROUND: The Surprise Question (SQ; “Would you be surprised if this patient died in the next 12 months?”) is a validated prognostication tool for mortality and hospitalization among patients with advanced CKD. Barriers in clinical workflows have slowed SQ implementation in practice. OBJECTIVES: The aims of this study were: (1) to evaluate implementation outcomes after the use of electronic health record (EHR) decision support to automate the collection of the SQ; and (2) to assess the prognostic utility of the SQ for mortality and hospitalization/emergency room (ER) visits. METHODS: We developed and implemented a best practice alert (BPA) in the EHR to identify nephrology outpatients ≥60 years of age with an eGFR

Introduction The COVID-19 pandemic has required significant restructuring of healthcare with conservation of resources and maintaining social distancing standards. With these new initiatives, it is conceivable that the diagnosis of cancer care may be delayed. We aimed to evaluate differences in patient populations being evaluated for cancer before and during the COVID-19 pandemic. Methods and Materials We performed a retrospective review of our electronic medical record and examined patient characteristics of those presenting for a possible new cancer diagnosis to our urologic oncology clinic. Data was analyzed using logistic and linear regression models. Results During the 3-month period before the COVID-19 pandemic began, 585 new patients were seen in one urologic oncology practice. The following 3-month period, during the COVID-19 pandemic, 362 patients were seen, corresponding to a 38% decline. Visits per week increased to pre-COVID-19 levels for kidney and bladder cancer as the county entered the green phase. Prostate cancer visits per week remained below pre-COVID-19 levels in the green phase. When the 2 populations pre-COVID-19 and COVID-19 were compared, there were no notable differences on regression analysis. Conclusion The COVID-19 pandemic decreased the total volume of new patient referrals for possible genitourinary cancer diagnoses. The impact this will have on cancer survival remains to be determined.

INTRODUCTION Obesity alters the pharmacokinetic (PK) properties of drugs making it difficult to determine the appropriate dose when administering weight-based medications. Alternative descriptors of body weight, such as lean body mass (LBM) and ideal body weight (IBW), are sometimes used in these situations. METHODS We performed a single-centre, randomized, controlled, open-label, 3 × 3 crossover trial to determine whether recombinant factor VIII (rFVIII) dosing based on LBM and IBW achieves a targeted FVIII recovery with better precision than based on total body weight (TBW) in overweight and obese, adult males with haemophilia A. Participants were randomized to 1 of 6 possible FVIII concentrate dosing sequence scenarios (TBW, LBM and IBW). Recombinant FVIII was administered on 3 separate weeks following a washout period of at least 72 hours. RESULTS A total of 19 participants were randomized and completed the study. FVIII recovery was lower at 30 minutes post-rFVIII infusion in LBM vs TBW and IBW vs TBW-based dosing, mean difference -0.38 (95% CI: -0.56, -0.20) and -0.28 (95% CI: -0.47, -0.10) IU/dL per IU/kg, respectively. In LBM vs TBW and IBW vs TBW-based dosing, there was a non-significant increase in the proportion of participants with a targeted FVIII recovery of 2.00 ± 0.20 IU/dl per IU/kg, OR = 1.93 (95% CI: 0.44, 8.55) and OR = 3.65 (0.80, 16.72), respectively. DISCUSSION Based on our study's findings, overweight and obese patients with haemophilia A may benefit from an individualized PK analysis using LBM and IBW to determine the most accurate, and potentially cost-effective, method of achieving targeted FVIII recovery.

ImportanceDisruptions in cancer surgery during the COVID-19 pandemic led to widespread deferrals and cancellations, creating a surgical backlog that presents a challenge for health care institutions moving into the recovery phase of the pandemic.ObjectiveTo describe patterns in surgical volume and postoperative length of stay for major urologic cancer surgery during the COVID-19 pandemic.Design, Setting, and ParticipantsThis cohort study identified 24 001 patients 18 years or older from the Pennsylvania Health Care Cost Containment Council database with kidney cancer, prostate cancer, or bladder cancer who received a radical nephrectomy, partial nephrectomy, radical prostatectomy, or radical cystectomy between the first quarter (Q1) of 2016 and Q2 of 2021. Postoperative length of stay and adjusted surgical volumes were compared before and during the COVID-19 pandemic.Main Outcomes and MeasuresThe primary outcome was adjusted surgical volume for radical and partial nephrectomy, radical prostatectomy, and radical cystectomy during the COVID-19 pandemic. The secondary outcome was postoperative length of stay.ResultsA total of 24 001 patients (mean [SD] age, 63.1 [9.4] years; 3522 women [15%], 19 845 White patients [83%], 17 896 living in urban areas [75%]) received major urologic cancer surgery between Q1 of 2016 and Q2 of 2021. Of these, 4896 radical nephrectomy, 3508 partial nephrectomy, 13 327 radical prostatectomy, and 2270 radical cystectomy surgical procedures were performed. There were no statistically significant differences in patient age, sex, race, ethnicity, insurance status, urban or rural status, or Elixhauser Comorbidity Index scores between patients who received surgery before and patients who received surgery during the pandemic. For partial nephrectomy, a baseline of 168 surgeries per quarter decreased to 137 surgeries per quarter in Q2 and Q3 of 2020. For radical prostatectomy, a baseline of 644 surgeries per quarter decreased to 527 surgeries per quarter in Q2 and Q3 of 2020. However, the likelihood of receiving radical nephrectomy (odds ratio [OR], 1.00; 95% CI, 0.78-1.28), partial nephrectomy (OR, 0.99; 95% CI, 0.77-1.27), radical prostatectomy (OR, 0.85; 95% CI, 0.22-3.22), or radical cystectomy (OR, 0.69; 95% CI, 0.31-1.53) was unchanged. Length of stay for partial nephrectomy decreased from baseline by a mean of 0.7 days (95% CI, −1.2 to −0.2 days) during the pandemic.Conclusions and RelevanceThis cohort study suggests that partial nephrectomy and radical prostatectomy surgical volume decreased during the peak waves of COVID-19, as did postoperative length of stay for partial nephrectomy.

To examine overall trends in opioid prescribing after ureteroscopy and compared opioid use between private and academic practice settings. We also analyzed the potential for spillover effect from an unrelated opioid-reduction initiative for major oncologic surgery.We conducted a retrospective chart review of all ureteroscopies performed within our system at four distinct time points from 2016-2019. We recorded the type and number of opioid pills prescribed and calculated oral morphine equivalents. Analysis included comparison between community and academic hospitals as well as pre- and post-initiative.555 patients undergoing ureteroscopy and 29 attending surgeons were included in the analysis. The median prescription size per ureteroscopy decreased throughout the study period in both the private and academic settings. From 2016-2017, median oral morphine equivalents (OMEs) decreased from 60 to 0 in the private setting and remained at 0 for the duration of the study period. Opioid reduction in the academic setting lagged behind private practitioners but median OMEs did steadily decrease to 0 in 2019. No significant spillover effect was observed.Since 2016, opioid prescribing following ureteroscopy has decreased in both the private and academic practice settings. Notably, private practice urologists achieved a median of 0 opioids 2 years prior to academic urologists. These data suggest that, in some circumstances, academic institutions may have been slower to respond to the opioid epidemic.

Background To determine the relationship between adipose tissue and skeletal muscle measurements on computed tomography (CT) and overall survival and major postoperative complications in patients with soft-tissue sarcoma (STS). Methods The retrospective study included 137 STS patients (75 men, 62 women; mean age, 53 years, SD 17.7; mean BMI, 28.5, SD 6.6) who had abdominal CT exams. On a single CT image, at the L4 pedicle level, measurements of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and skeletal muscle area and attenuation were obtained using clinical PACS and specialized segmentation software. Clinical information was recorded, including STS characteristics (size, depth, grade, stage, and site), overall survival, and postoperative complications. The relationships between CT metrics and survival were analyzed using Cox proportional hazard models and those between CT metrics and postoperative complications using logistic regression models. Results There were 33 deaths and 41 major postoperative complications. Measured on clinical PACS, the psoas area (P=0.003), psoas index (P=0.006), psoas attenuation (P=0.011), and total muscle attenuation (P=0.023) were associated with overall survival. Using specialized software, psoas attenuation was also associated with overall survival (P=0.018). Adipose tissue metrics were not associated with survival or postoperative complications. Conclusions In STS patients, CT-derived muscle size and attenuation are associated with overall survival. These prognostic biomarkers can be obtained using specialized segmentation software or routine clinical PACS.

Background Multiparametric magnetic resonance imaging (mpMRI) may improve prostate cancer risk stratification and decrease the need for repeat biopsies in men on prostate cancer active surveillance (AS). However, the impact of mpMRI on AS-related healthcare spending has not been established. Objective To characterize the impact of mpMRI on AS-related Medicare expenditures. Design, setting, and participants Using Surveillance, Epidemiology, and End Results (SEER)-Medicare files, we identified men ≥66 yr old with localized prostate cancer diagnosed during 2008–2013. Outcome measures and statistical analysis With a validated algorithm, we classified men into AS with and without mpMRI groups. We then determined Medicare spending on AS in each group using inflation-adjusted, price-standardized Medicare payments for AS-related procedures (ie, prostate-specific antigen [PSA] tests, prostate biopsies, biopsy complications, and mpMRI). Multivariable median regression compared Medicare spending on AS for men who received mpMRI and those who did not. Results and limitations We identified 9081 men on AS with a median follow-up of 45 mo (interquartile range 29–64 mo). Thirteen percent (N = 1225) received mpMRI. On multivariable median regression, receipt of mpMRI was associated with an additional $447 (95% confidence interval $409–487) in Medicare spending per year. We observed greater frequency of AS-related procedures and higher spending for identical procedures (eg, PSA or prostate biopsy) in the mpMRI group than in the non-mpMRI group (all p Conclusions Among Medicare beneficiaries on AS, mpMRI is associated with additional annual Medicare spending. Future studies are needed to determine optimal use of mpMRI during AS to maximize value. Patient summary Prostate magnetic resonance imaging (MRI) helps physicians determine which prostate cancers are aggressive and which can be monitored safely. We studied whether using MRI during prostate cancer monitoring (also called active surveillance) resulted in increased healthcare spending. There was a modest increase in spending, but this may be worthwhile if the use of MRI allows physicians to monitor prostate cancer more accurately.

In March 2020, regulatory and payment changes allowed "brick and mortar" pediatric practices to offer practice-based telemedicine for the first time, joining direct-to-consumer (DTC) telemedicine vendors in the ability to offer visits for common acute pediatric concerns via telemedicine. We sought to characterize the relative contribution of practice-based telemedicine versus commercial DTC telemedicine models in provision of children's telemedicine from 2018 through 2021.Using January 2018 to September 2021 data from Optum's de-identified Clinformatics® Data Mart Database, we identified telemedicine visits by children ≤17, excluding preventive visits and visits to specialists, emergency departments, and urgent care. Among included visits, we defined "telemedicine-only" providers as those with ≥80% of visits via telemedicine and practice-based telemedicine providers as those with ≤50% of visits via telemedicine. We then described the telemedicine visit volume and diagnoses for these categories overall and per 1000 children per month.From January 2018 to February 2020, telemedicine-only providers accounted for 57,815 telemedicine visits (90.8%), while practice-based telemedicine accounted for 4192 telemedicine visits (6.6%). From March 2020 to September 2021, telemedicine-only providers accounted for 38,282 telemedicine visits (6.1%), while practice-based telemedicine accounted for 555,125 telemedicine visits (88.2%). Per month, telemedicine visits to practice-based telemedicine providers increased from pre-pandemic to pandemic periods (0.1 vs 12.9 visits per 1000 children/month), while telemedicine visits to telemedicine-only providers occurred at a similar rate from pre-pandemic to pandemic periods (0.92 vs 0.96 visits per 1000 children/month).We observed a large increase in telemedicine visits during the pandemic, with the growth in visits exclusively occurring among visits to practice-based telemedicine providers as opposed to telemedicine-only providers.

Regionalization of complex surgical care results in increasing need for patients to travel for complex oncologic procedures such as cystectomy in bladder cancer. We examined the association between travel distance to a cystectomy center, readmission, and survival.Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified bladder cancer patients undergoing radical cystectomy during 2004-2011. Patients were grouped into quartiles of distance to cystectomy center in miles (6 [close], 6-16.9 [moderately close], 17-47.9 [moderately far], ≥ 48 [far]). Multivariable logistic regression, accounting for clustering within hospitals, was used to assess the association between travel distance and readmission. A secondary analysis examined the association between travel distance and survival using multivariable proportional hazard regression.Among 4556 patients who underwent cystectomy, 1857 (41%) were readmitted, and 1251 (67%) of readmissions were to the index hospital. With increasing travel distance there was no significant difference in the overall rate of 90-day readmission. However, the farther a patient traveled, the lower the odds of being readmitted to the index hospital (adjusted odds ratio [95% confidence interval] as follows: moderately close, 0.43 miles [0.29-0.63]; moderately far, 0.14 miles [0.10-0.19]; and far, 0.07 [0.05-0.11]). Increasing travel distance was associated with improved survival.With greater distance traveled to a cystectomy center, rates of readmission to nonindex centers increased. Survival differences may be explained by the impact of travel burden on processes of care and case mix. Future efforts should focus on improving care coordination between index and nonindex hospitals and ensuring equitable access to cystectomy and other critical cancer services.

INTRODUCTION AND OBJECTIVE:An important consequence of the COVID-19 pandemic was a precipitous decline in elective outpatient encounters such as cancer screening. It is particularly important to ex...

INTRODUCTION AND OBJECTIVE:Radical cystectomy is associated with one of the highest readmission rates of any surgery, hovering around 25%. Readmissions occur both at the hospital at which patients ...

OBJECTIVES: To evaluate the impact of centralized surgical and nonsurgical care (i.e., radiation and chemotherapy) on travel distances and survival outcomes for patients with advanced bladder cancer. Bladder cancer is a disease with high mortality for which treatment access is paramount and survival is superior in patients receiving surgery at high-volume centers. METHODS: Using SEER-Medicare, we identified patients 66 years or older diagnosed with bladder cancer between 2004–2013. We categorized patients as treated with either surgical (i.e., radical cystectomy) or nonsurgical (i.e., radiation or chemotherapy) care. We fit a linear probability model to generate the predicted proportion of patients treated at the top quintile of volume over time and assessed travel distance, 1-year all-cause mortality, and 1-year bladder cancer-specific mortality over time. RESULTS: A total of 6,756 and 10,383 patients underwent surgical and nonsurgical care, respectively. The percentage of patients treated at high-volume centers increased over the study period for both surgical care (53% to 62%) and nonsurgical care (47% to 55%), (both p

To examine the relationship between treatment and subsequent functional status among prostate cancer patients.Using Surveillance, Epidemiology, and End Results-Medicare Health Outcomes Survey data, we identified men 65 years or older diagnosed with prostate cancer between 1998 and 2009 (follow-up through 2010) who were treated with conservative management, surgery, or radiation. Our primary outcome was functional status as measured by activities of daily living. Secondary outcomes included physical component summary and mental component summary scores, which are both calculated from the Short Form 36 (SF-36) and the Veterans RAND 12-item health survey (VR-12) questionnaires. We included patients who completed 2 surveys and performed propensity score analyses to match patients 1:5 with noncancer controls. We used generalized linear mixed effects models, accounting for clustering due to insurance plan.We identified 408 patients of whom 143 (35%) underwent conservative management, 59 (14%) underwent surgery, and 206 (51%) underwent radiation. Among conservative management and radiation patients, changes in functional status mirrored that of their noncancer controls (all P.05). Among surgery patients, changes in activities of daily living scores were not significant, but physical component summary (mean difference = 4.5, P.001) and mental component summary (mean difference = 3.3, P = .01) scores declined slightly more than for their noncancer peers.Surgery patients had a slight decline in their general functional status whereas conservative management and radiation patients had no differences in functional status compared with their noncancer peers. Although the functional status of surgery patients declined more than that of their noncancer peers, this difference may not be clinically significant.

OBJECTIVE: To characterize the use of multiparametric magnetic resonance imaging (mpMRI) in male Medicare beneficiaries electing active surveillance for prostate cancer. Multi-parametric resonance imaging (mpMRI) has emerged as a tool that may improve risk-stratification and decrease repeated biopsies in men electing active surveillance. However, the extent to which mpMRI has been implemented in active surveillance has not been established. METHODS: Using Surveillance, Epidemiology, and End Results (SEER) registry data linked to Medicare claims data, we identified men with localized prostate cancer diagnosed between 2008–2013 and managed with active surveillance. We classified men into two treatment groups: active surveillance without mpMRI and active surveillance with mpMRI. We then fit a multivariable logistic regression models to examine changing mpMRI utilization over time, and factors associated with the receipt of mpMRI. RESULTS: We identified 9,467 men on active surveillance. Of these, 8,178 (86%) did not receive mpMRI and 1,289 (14%) received mpMRI. The likelihood of receiving mpMRI over the entire study period increased by 3.7% (p=0.004). On multivariable logistic regression, patients who were younger, white, had lower comorbidity burden, lived in the northeast and west, had higher incomes and lived in more urban areas had greater odds of receiving mpMRI (all p

Objectives To describe the rate and determinants of palliative care use amongst Medicare beneficiaries with bladder cancer and encourage a national dialogue on improving coordinated urological, oncological, and palliative care in patients with genitourinary malignancies. Patients and methods Using Surveillance, Epidemiology, and End Results-Medicare data, we identified patients diagnosed with muscle-invasive bladder cancer (MIBC) between 2008 and 2013. Our primary outcome was receipt of palliative care, defined as the presence of a claim submitted by a Hospice and Palliative Medicine subspecialist. We examined determinants of palliative care use using logistic regression analysis. Results Over the study period, 7303 patients were diagnosed with MIBC and 262 (3.6%) received palliative care. Of 2185 patients with advanced bladder cancer, defined as either T4, N+ , or M+ disease, 90 (4.1%) received palliative care. Most patients that received palliative care (>80%, >210/262) did so within 24 months of diagnosis. On multivariable analysis, patients receiving palliative care were more likely to be younger, female, have greater comorbidity, live in the central USA, and have undergone radical cystectomy as opposed to a bladder-sparing approach. The adjusted probability of receiving palliative care did not significantly change over time. Conclusions Palliative care provides a host of benefits for patients with cancer, including improved spirituality, decrease in disease-specific symptoms, and better functional status. However, despite strong evidence for incorporating palliative care into standard oncological care, use in patients with bladder cancer is low at 4%. This study provides a conservative baseline estimate of current palliative care use and should serve as a foundation to further investigate physician-, patient-, and system-level barriers to this care.

Objective To determine the rate and determinants of neoadjuvant chemotherapy noncompletion in patients with muscle-invasive bladder cancer. Methods Using Surveillance, Epidemiology, and End Results-Medicare data, we identified all patients who underwent cystectomy between 2008-2013 and received chemotherapy within 6 months. Of these, 594 patients received neoadjuvant chemotherapy, defined as the presence of a claim for chemotherapy within the 180 days preceding cystectomy. Our primary outcome was noncompletion of neoadjuvant chemotherapy. We determined regimen-specific cut points for noncompletion based on clinical trials and national guidelines. Results Over the study period, 174 of 594 patients (29%) did not complete neoadjuvant chemotherapy. Noncompleters and completers received a median interquartile range of 4.4 (3.0-8.0) and 10.0 (7.7-11.2) weeks of chemotherapy, respectively. A total of 391 (66%) patients received a cisplatin-based regimen and 203 (34%) patients received an alternative regimen, with 27% and 33% not completing chemotherapy, respectively. After adjusting for covariates, age and geographic region were independently associated with failing to complete chemotherapy. Conclusion Nearly 30% of patients who received neoadjuvant chemotherapy did not complete their regimen. Advanced age and nonclinical factors, such as practice patterns in certain geographic regions, may influence a patient's likelihood of successfully completing chemotherapy.

The randomised controlled trial (RCT) is a powerful approach for testing the effectiveness of various clinical interventions. Cardiology often benefits from large RCTs, which may be used to inform practice decisions ranging from primary prevention to advanced cardiac disease and/or acute cardiac care. RCTs in cardiology often need to be quite large to test for meaningful effects on clinical outcomes, because effect sizes are typically modest and clinical outcomes may take several years to occur after treatment initiation. However, a variety of small clinical trials are also carried out in the biomedical research enterprise; these are often difficult to design and interpret, because the objectives and needs of small clinical trials are quite variable. Some are pilot trials that may be used to refine processes or as part of the planning in advance of a larger trial designed to test therapeutic efficacy. Some are first-in-human or proof-of-concept studies that, also, will eventually be followed by one or more larger trials to test therapeutic efficacy. Some are intended to be stand-alone trials that are small for other reasons. In this paper, we explore some key issues related to design and interpretation of small clinical trials in cardiology. We broadly classify small trials into 4 types: 1) pilot trials, 2) early-stage or proof-of-concept trials, 3) rare diseases or difficult-to-recruit populations, and 4) underpowered trials. For each, we describe the appropriate objectives, analysis, and interpretation.

Objectives To quantify the proportion of patients receiving high-intensity end-of-life care, identify associated risk factors, and assess how receipt of palliative care impact end-of-life care; as the delivery of such care, and how it relates to palliative care, has not been reported in bladder cancer Subjects and Methods We conducted a retrospective cohort study of patients with bladder cancer who died within 1 year of diagnosis using Surveillance, Epidemiology, and End Results linked Medicare data. The primary outcome was a composite measure of high-intensity end-of-life care (>1 hospital admission, >1 ED visit, or ≥1 ICU admission within the last month of life; receipt of chemotherapy within the last 2 weeks of life; or acute care in-hospital death). Secondary outcomes included the use of such care over time and any association with the use of palliative care. A generalized linear mixed model assessed for independent determinants. Results Overall, 45% of patients received high-intensity end-of-life care. This proportion decreased over time. Patients receiving high-intensity care had higher rates of comorbidities, advanced bladder cancer, and nonbladder cancer cause of death. These patients more often received palliative care but, compared to those not receiving high-intensity care, this occurred farther removed from bladder cancer diagnosis and closer to death. Conclusions Nearly half of Medicare beneficiaries with bladder cancer who die within 1 year of diagnosis receive high-intensity care at the end of life. Palliative care was seldom used and only very near the time of death.

Introduction: Hypertension is uncontrolled in 50% of diagnosed adults in the US, and especially in older adults. Home blood pressure monitoring (HBPM) can improve hypertension management by providing clinicians with up-to-date information on BP control and by improving patients’ adherence to prescribed medications and other healthy behaviors. MyBP is a patient-facing HBPM aide that provides video-based education and supports BP self-monitoring with recurring feedback using proactive, bidirectional, automated text messages. Summary reports are routed to primary care providers. Hypothesis: In this proof-of-concept, pragmatic clinical trial, we tested the hypothesis that MyBP will improve hypertension self-efficacy and lower BP in older adults. Methods: Community-dwelling adults ≥55 y/o with uncontrolled hypertension were recruited from primary care offices. Enrollees were provided a standard automatic BP cuff and randomized 2:1 to MyBP vs treatment-as-usual (control). Engagement with MyBP was defined as the proportion of BP reading prompts for which a reading was submitted, tracked over successive 2-week monitoring periods. Study BP data were acquired independently of MyBP from all participants by single-blind, phone-supervised home BP measurements. Results: Participants (N=62; 40 women, 33 Blacks, 38 without a college degree, mean age 66, mean office BP 164/91, mean # BP medications 2.6) were randomized to MyBP (41) vs. control (n=21). In the MyBP group, engagement with HBPM averaged over 80%, without notable attrition over the 5-month study period. Regression analyses revealed an interaction between baseline systolic BP and group assignment on change in systolic BP [interaction effect estimate -0.59 (-1.00, -0.19)], such that patients who had a higher baseline systolic BP and were assigned to MyBP showed a greater decline in systolic BP when compared to control patients. Hypertension self-efficacy also improved in the intervention group compared to controls [estimate 0.556 (0.104,1.008)]. Conclusions: In this pragmatic, pilot clinical trial, older adults with hypertension used a novel mHealth technology at high levels, reported improved hypertension self-efficacy, and experienced a decline in BP if home BP was elevated at baseline.

Key Points Question Are states that chose not to expand Medicaid under the Patient Protection and Affordable Care Act associated with reduced emergency access to acute care hospitals? Findings In this cross-sectional study of acute care hospital availability in all 50 US states and the District of Columbia, states that did not expand Medicaid experienced worsened emergency access to acute care hospitals compared with states that expanded Medicaid. Meaning This study found reduced emergency access to acute care hospitals in states that did not expand Medicare, which could negatively impact the quality of care for time-sensitive conditions such as acute myocardial infarction, stroke, sepsis, and trauma., This cross-sectional study uses hospital-level Medicaid and geospatial data to analyze the association of state expansion of Medicaid under the Patient Protection and Affordable Care Act with emergency access to acute care hospitals., Importance State decisions not to expand Medicaid under the Patient Protection and Affordable Care Act could reduce emergency access to acute care hospitals. Objective To determine the relationship between state Medicaid expansion and emergency access to acute care hospitals in the United States. Design, Setting, and Participants This cross-sectional study linked hospital-level data from the Centers for Medicare & Medicaid Services from 2007 to 2017 to US Census data for all 50 US states and the District of Columbia. Geospatial analyses and difference-in-differences regression models were used to compare temporal changes in the size of the population without 30-minute access to acute care hospitals between 32 states that expanded Medicaid with the population without access in 19 that did not, before and after expansion. Analyses focused on the total population and those with low incomes; secondary analyses examined emergency access to safety-net hospitals. Exposures State-level Medicaid expansion. Main Outcomes and Measures Population without emergency access to an acute care hospital, defined as living outside a 30-minute drive of any hospital. Results States that did not expand Medicaid experienced an increase in the population without access to hospitals overall (without expansion: 6.76% to 6.79% [0.03%]; vs with expansion: 5.65% to 5.35% [–0.30%]; difference-in-differences, 0.33%; 95% CI, 0.33%-0.34%; P

Background The coronavirus disease 2019 (COVID-19) may have a negative effect on the mental and social health of patients with ESKD on chronic in-center hemodialysis (HD), who have a high burden of psychologic symptoms at baseline and unavoidable treatment-related COVID exposures. The goal of our study was to assess the effect of the COVID-19 pandemic on the psychosocial health of patients on chronic in-center HD. Methods Participants enrolled in the ongoing Technology Assisted Collaborative Care (TĀCcare) trial in Western Pennsylvania and New Mexico were approached for participation in a phone survey in May 2020. Data on the pandemic’s effects on participants’ physical and mental health, symptoms (such as anxiety, mood, loneliness, sleep, and stress), and food and housing security were collected. Results Surveys were completed by 49 participants (mean age 56 years; 53% men, 18% Black, 20% American Indian, and 22% Hispanic). Almost 80% of participants reported being moderately to extremely worried about the pandemic’s effects on their mental/emotional health and interpersonal relationships. More than 85% of the participants were worried about obtaining their dialysis treatments due to infection risk from close contact in the dialysis facility or during transportation. Despite this, 82% of participants reported being not at all/slightly interested in trying home dialysis as an alternative option. Overall, 27% of the participants had clinical levels of depressive symptoms but only 12% had anxiety meeting clinical criteria. About 33% of participants reported poor sleep quality over the last month. Perceived stress was high in about 30% of participants and 85% felt overwhelmed by difficulties with COVID-19, although 41% felt that things were fairly/very often going their way. Conclusions Our study provides preliminary insights into the psychosocial distress caused by the COVID-19 pandemic among a diverse cohort of patients receiving chronic HD who are participating in an ongoing clinical trial.

Clinical trials serve as a critical source of information to guide evidence-based practices in urology. Conversely, trials that are abandoned consume significant resources and results are underreported in the literature.ClinicalTrials.gov was queried for urology trials from 2006 to 2016. Trials were screened by 2 screeners for applicability to urology and disputes were resolved by a third independent reviewer. Overall 1,340 trials met final inclusion criteria (722 successful trials, 618 failed trials). Univariable analysis used Fisher's exact, chi-squared and Wilcoxon rank sum tests. Trial characteristics, including AUA (American Urological Association) section, phase, subspecialty, intervention type, source of funding and randomization were examined for association with failure using multivariable logistic regression.Trial failure is associated with oncology subspecialty (adjusted odds ratio 2.25, 95% CI 1.60-3.18), infertility/andrology subspecialty (AOR 4.99, CI 1.60-17.61), device trials (AOR 1.64, CI 1.00-2.70) and combination funding by industry/government/grants (AOR 3.13, CI 2.21-4.48). Clinical trials in AUA sections were less likely to fail than international and multisectional trials. Among trials that failed, poor accrual was the primary reason for trial failure, comprising 41% of all failures. Other reasons for failure include inadequate budget (9%), sponsor cancellation (7%), poor interim results (7%) and toxicity (3%).Despite their significance, many urological trials fail prematurely due to poor accrual. Complex features inherent to oncology, andrology/infertility, devices and multisectional trials pose significant barriers to success.

INTRODUCTION AND OBJECTIVE:Over the last several years, the surgical care for bladder cancer has become increasingly centralized. We sought to examine trends in overall and bladder-cancer specific ...

Objective Live interactive telemedicine is increasingly covered by state Medicaid programs, but whether telemedicine is improving equity in utilization of subspecialty care is not known. We examined patterns of telemedicine use for outpatient pediatric subspecialty care within the state Medicaid programs. Methods We identified children ≤17 years old in 2014 Medicaid Analysis eXtract data for 12 states. We identified telemedicine-using and telemedicine-nonusing medical and surgical subspecialists. Among children cared for by telemedicine-using subspecialists, we assessed child and subspecialist characteristics associated with any telemedicine visit using logistic regression with subspecialist-level random effects. Among children cared for by telemedicine-using and nonusing subspecialists, we compared visit rates across child characteristics by assessing negative binomial regression interaction terms. Results Of 12,237,770 pediatric Medicaid beneficiaries, 2,051,690 (16.8%) had ≥1 subspecialist visit. Of 42,695 subspecialists identified, 146 (0.3%) had ≥1 telemedicine claim. Among children receiving care from telemedicine-using subspecialists, likelihood of any telemedicine use was increased for rural children (odds ratio [OR] 10.4, 95% confidence interval [CI] 6.3–17.1 compared to large metropolitan referent group) and those >90 miles from the subspecialist (OR 13.4, 95% CI 10.2–17.7 compared to 0–30 mile referent group). Compared to children receiving care from telemedicine-nonusing subspecialists, matched children receiving care from telemedicine-using subspecialists had larger differences in visit rates by distance to care, county rurality, ZIP code median income, and child race/ethnicity (P Conclusions Children in rural communities and at distance to subspecialists had increased likelihood of telemedicine use. Use overall was low, and results indicated that early telemedicine policies and implementation did not close disparities in subspecialty visit rates by child geographic and sociodemographic characteristics.

Surgeons play a pivotal role in combating the opioid crisis that currently grips the United States. Changing surgeon behavior is difficult, and the degree to which behavioral science can steer surgeons toward decreased opioid prescribing is unclear.This was a single-institution, single-arm, pre- and postintervention study examining the prescribing of opioids by urologists for adult patients undergoing prostatectomy or nephrectomy. The primary outcome was the quantity of opioids prescribed in oral morphine equivalents (OMEs) after hospital discharge. The primary exposure was a multipronged behavioral intervention designed to decrease opioid prescribing. The intervention had 3 components: 1) formal education, 2) individual audit feedback, and 3) peer comparison performance feedback. There were 3 phases to the study: a pre-intervention phase, an intervention phase, and a washout phase.Three hundred eighty-two patients underwent prostatectomy, and 306 patients underwent nephrectomy. The median OMEs decreased from 195 to 19 in the prostatectomy patients and from 200 to 0 in the nephrectomy patients (P.05 for both). The median OMEs prescribed did not increase during the washout phase. Prostatectomy patients discharged with opioids had higher levels of anxiety than patients discharged without opioids (P.05). Otherwise, prostatectomy and nephrectomy patients discharged with and without opioids did not differ in their perception of postoperative pain management, activity levels, psychiatric symptoms, or somatic symptoms (P.05 for all).Implementing a multipronged behavioral intervention significantly reduced opioid prescribing for patients undergoing prostatectomy or nephrectomy without compromising patient-reported outcomes.

To investigate the association of female sex with the selected treatment for patients with nonmetastatic muscle-invasive bladder cancer. Sex is a known independent predictor of death from bladder cancer. A potential explanation for this survival disparity is difference in treatment pattern and stage presentation among males and females.Using the surveillance, epidemiology, and end results-medicare data set, we identified 6809 patients initially diagnosed with nonmetastatic muscle-invasive bladder cancer between 2004 and 2014. We fit multivariable logistic regression and Cox models to assess the relationship of sex with treatment modality and survival adjusting for differences in patient characteristics.Of the 6809 patients with nonmetastatic muscle invasive bladder cancer, 2528 (37%) received a radical cystectomy while 4281 (63%) received an alternative bladder sparing intervention. Women were significantly more likely to receive a cystectomy (odds ratios [OR] 1.39; 95% confidence intervals [CI] 1.20-1.61), present at an older age with less comorbidities compared to men (P.001). Women were also found to have worse bladder cancer-specific survival (CSS) than men (hazard ratio [HR] 1.18; 95% CI 1.05-1.32), no difference in overall survival (OS) (female HR 0.93; 0.86-1.01) and lower mortality from other causes (HR 0.78; 95% CI 0.70-0.86). There were no differences in OS and CSS by sex in patients with stage pT4a.Female sex predicted more aggressive treatment with radical cystectomy yet worse cancer-specific survival than males. This sex disparity in CSS reduced the known OS advantage observed in women.