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Background:We sought to determine the incidence of community-onset and hospital-acquired coinfection in patients hospitalized with coronavirus disease 2019 (COVID-19) and to evaluate associated predictors and outcomes.Methods:In this multicenter retrospective cohort study of patients hospitalized for COVID-19 from March 2020 to August 2020 across 38 Michigan hospitals, we assessed prevalence, predictors, and outcomes of community-onset and hospital-acquired coinfections. In-hospital and 60-day mortality, readmission, discharge to long-term care facility (LTCF), and mechanical ventilation duration were assessed for patients with versus without coinfection.Results:Of 2,205 patients with COVID-19, 141 (6.4%) had a coinfection: 3.0% community onset and 3.4% hospital acquired. Of patients without coinfection, 64.9% received antibiotics. Community-onset coinfection predictors included admission from an LTCF (OR, 3.98; 95% CI, 2.34–6.76; P < .001) and admission to intensive care (OR, 4.34; 95% CI, 2.87–6.55; P < .001). Hospital-acquired coinfection predictors included fever (OR, 2.46; 95% CI, 1.15–5.27; P = .02) and advanced respiratory support (OR, 40.72; 95% CI, 13.49–122.93; P < .001). Patients with (vs without) community-onset coinfection had longer mechanical ventilation (OR, 3.31; 95% CI, 1.67–6.56; P = .001) and higher in-hospital mortality (OR, 1.90; 95% CI, 1.06–3.40; P = .03) and 60-day mortality (OR, 1.86; 95% CI, 1.05–3.29; P = .03). Patients with (vs without) hospital-acquired coinfection had higher discharge to LTCF (OR, 8.48; 95% CI, 3.30–21.76; P < .001), in-hospital mortality (OR, 4.17; 95% CI, 2.37–7.33; P ≤ .001), and 60-day mortality (OR, 3.66; 95% CI, 2.11–6.33; P ≤ .001).Conclusion:Despite community-onset and hospital-acquired coinfection being uncommon, most patients hospitalized with COVID-19 received antibiotics. Admission from LTCF and to ICU were associated with increased risk of community-onset coinfection. Future studies should prospectively validate predictors of COVID-19 coinfection to facilitate the reduction of antibiotic use.

Background Antibiotics are commonly prescribed to patients as they leave the hospital. We aimed to create a comprehensive metric to characterize antibiotic overuse after discharge among hospitalized patients treated for pneumonia or urinary tract infection (UTI), and to determine whether overuse varied across hospitals and conditions. Methods In a retrospective cohort study of hospitalized patients treated for pneumonia or UTI in 46 hospitals between 1 July 2017–30 July 2019, we quantified the proportion of patients discharged with antibiotic overuse, defined as unnecessary antibiotic use, excess antibiotic duration, or suboptimal fluoroquinolone use. Using linear regression, we assessed hospital-level associations between antibiotic overuse after discharge in patients treated for pneumonia versus a UTI. Results Of 21 825 patients treated for infection (12 445 with pneumonia; 9380 with a UTI), nearly half (49.1%) had antibiotic overuse after discharge (56.9% with pneumonia; 38.7% with a UTI). For pneumonia, 63.1% of overuse days after discharge were due to excess duration; for UTIs, 43.9% were due to treatment of asymptomatic bacteriuria. The percentage of patients discharged with antibiotic overuse varied 5-fold among hospitals (from 15.9% [95% confidence interval, 8.7%–24.6%] to 80.6% [95% confidence interval, 69.4%–88.1%]) and was strongly correlated between conditions (regression coefficient = 0.85; P < .001). Conclusions Antibiotic overuse after discharge was common and varied widely between hospitals. Antibiotic overuse after discharge was associated between conditions, suggesting that the prescribing culture, physician behavior, or organizational processes contribute to overprescribing at discharge. Multifaceted efforts focusing on all 3 types of overuse and multiple conditions should be considered to improve antibiotic prescribing at discharge., Of 21 825 hospitalized patients with pneumonia or urinary tract infection in 46 hospitals, half (49.1%) had antibiotic overuse after discharge. Overuse varied 5-fold among hospitals (15.9%–80.6%) and was correlated between conditions. To improve prescribing, stewardship should include care transitions.

Although characteristics and in-hospital outcomes for persons with coronavirus disease 2019 (COVID-19) have been well described, less is known about the longer-term outcomes of hospitalized patients Although characteristics and in-hospital outcomes for persons with COVID-19 have been well described, less is known about the longer-term outcomes of hospitalized patients Here, a study that aims to describe the 6-day postdischarge clinical, financial, and mental health outcomes of patients with COVID-19 using an observational cohort study is offered

OBJECTIVES High-sensitivity troponin T (hsTnT) testing was approved in the United States to better facilitate diagnosis of acute coronary syndrome (ACS). Although hsTnT has been widely studied internationally, the impact of hsTnT on discharge diagnoses and health care utilization within the United States is less known. We sought to evaluate the effects of implementing hsTnT on diagnosis patterns and stress testing utilization. STUDY DESIGN We performed a retrospective cohort analysis consisting of patients with suspected ACS undergoing either conventional troponin I (n = 14,631) or hsTnT (n = 7237) testing between January 2016 and February 2019. METHODS Log-binomial regression with interrupted time series modeled diagnosis patterns, and logistic regression with segmented time trends modeled stress testing rates. Observed trends were compared with expected trends using average marginal effect (AME). RESULTS Rates of acute myocardial infarction-related diagnoses were similar in the post-hsTnT period (AME, -0.6%; P = .065). Post hsTnT introduction, patients were more likely to receive a diagnosis of heart failure (2.1%; P

Key Points Question What is the frequency with which patients hospitalized with COVID-19 are treated with venous thromboembolism (VTE) prophylactic- and treatment-dose anticoagulation, and what is the association of anticoagulation with in-hospital and 60-day mortality? Findings In this cohort study of 1351 patients hospitalized with COVID-19 in which 1127 patients received anticoagulation, 34.8% missed 2 or more days of VTE prophylaxis. Use of only prophylactic-dose or treatment-dose anticoagulation was associated with lower in-hospital mortality vs no anticoagulation; however, only prophylactic-dose anticoagulation remained associated with lower mortality at 60 days. Meaning These findings suggest that prophylactic-dose VTE anticoagulation may be optimal therapy for patients hospitalized with COVID-19., This cohort study of patients hospitalized with COVID-19 examines the association of anticoagulation treatment with mortality rates, and assesses differences between prophylactic- and treatment-doses in in-hospital and 60-day mortality., Importance Venous thromboembolism (VTE) is a common complication of COVID-19. It is not well understood how hospitals have managed VTE prevention and the effect of prevention strategies on mortality. Objective To characterize frequency, variation across hospitals, and change over time in VTE prophylaxis and treatment-dose anticoagulation in patients hospitalized for COVID-19, as well as the association of anticoagulation strategies with in-hospital and 60-day mortality. Design, Setting, and Participants This cohort study of adults hospitalized with COVID-19 used a pseudorandom sample from 30 US hospitals in the state of Michigan participating in a collaborative quality initiative. Data analyzed were from patients hospitalized between March 7, 2020, and June 17, 2020. Data were analyzed through March 2021. Exposures Nonadherence to VTE prophylaxis (defined as missing ≥2 days of VTE prophylaxis) and receipt of treatment-dose or prophylactic-dose anticoagulants vs no anticoagulation during hospitalization. Main Outcomes and Measures The effect of nonadherence and anticoagulation strategies on in-hospital and 60-day mortality was assessed using multinomial logit models with inverse probability of treatment weighting. Results Of a total 1351 patients with COVID-19 included (median [IQR] age, 64 [52-75] years; 47.7% women, 48.9% Black patients), only 18 (1.3%) had a confirmed VTE, and 219 (16.2%) received treatment-dose anticoagulation. Use of treatment-dose anticoagulation without imaging ranged from 0% to 29% across hospitals and increased over time (adjusted odds ratio [aOR], 1.46; 95% CI, 1.31-1.61 per week). Of 1127 patients who ever received anticoagulation, 392 (34.8%) missed 2 or more days of prophylaxis. Missed prophylaxis varied from 11% to 61% across hospitals and decreased markedly over time (aOR, 0.89; 95% CI, 0.82-0.97 per week). VTE nonadherence was associated with higher 60-day (adjusted hazard ratio [aHR], 1.31; 95% CI, 1.03-1.67) but not in-hospital mortality (aHR, 0.97; 95% CI, 0.91-1.03). Receiving any dose of anticoagulation (vs no anticoagulation) was associated with lower in-hospital mortality (only prophylactic dose: aHR, 0.36; 95% CI, 0.26-0.52; any treatment dose: aHR, 0.38; 95% CI, 0.25-0.58). However, only the prophylactic dose of anticoagulation remained associated with lower mortality at 60 days (prophylactic dose: aHR, 0.71; 95% CI, 0.51-0.90; treatment dose: aHR, 0.92; 95% CI, 0.63-1.35). Conclusions and Relevance This large, multicenter cohort of patients hospitalized with COVID-19, found evidence of rapid dissemination and implementation of anticoagulation strategies, including use of treatment-dose anticoagulation. As only prophylactic-dose anticoagulation was associated with lower 60-day mortality, prophylactic dosing strategies may be optimal for patients hospitalized with COVID-19.

Background: Nearly half of hospitalized patients with bacteriuria or treated for pneumonia receive unnecessary antibiotics (noninfectious or nonbacterial syndrome such as asymptomatic bacteriuria), excess duration (antibiotics prescribed for longer than necessary), or avoidable fluoroquinolones (safer alternative available) at hospital discharge.1–3 However, whether antibiotic overuse at discharge varies between hospitals or is associated with patient outcomes remains unknown. Methods: From July 2017 to December 2018, trained abstractors at 46 Michigan hospitals collected detailed data on a sample of adult, non–intensive care, hospitalized patients with bacteriuria (positive urine culture with or without symptoms) or treated for community-acquired pneumonia (CAP; includes those with the disease formerly known as healthcare-associated pneumonia [HCAP]). Antibiotic prescriptions at discharge were assessed for antibiotic overuse using a previously described, guideline-based hierarchical algorithm.3 Here, we report the proportion of patients discharged with antibiotic overuse by the hospital. We also assessed hospital-level correlation (using Pearson’s correlation coefficient) between antibiotic overuse at discharge for patients with bacteriuria and patients treated for CAP. Finally, we assessed the association of antibiotic overuse at discharge with patient outcomes (mortality, readmission, emergency department visit, and antibiotic-associated adverse events) at 30 days using logit generalized estimating equations adjusted for patient characteristics and probability of treatment. Results: Of 17,081 patients (7,207 with bacteriuria; 9,874 treated for pneumonia), nearly half (42.2%) had antibiotic overuse at discharge (36.3% bacteriuria and 51.1% pneumonia). The percentage of patients discharged with antibiotic overuse varied 5-fold among hospitals from 14.7% (95% CI, 8.0%–25.3%) to 74.3% (95% CI, 64.2%–83.8%). Hospital rates of antibiotic overuse at discharge were strongly correlated between bacteriuria and CAP (Pearson’s correlation coefficient, 0.76; P ≤ .001) (Fig. 1). In adjusted analyses, antibiotic overuse at discharge was not associated with death, readmission, emergency department visit, or Clostridioides difficile infection. However, each day of overuse was associated with a 5% increase in the odds of patient-reported antibiotic-associated adverse events after discharge (Fig. 2). Conclusions: Antibiotic overuse at discharge was common, varied widely between hospitals, and was associated with patient harm. Furthermore, antibiotic overuse at discharge was strongly correlated between 2 disparate diseases, suggesting that prescribing culture or discharge processes—rather than disease-specific factors—contribute to overprescribing at discharge. Thus, discharge stewardship may be needed to target multiple diseases.Funding: This study was supported by the Society for Healthcare Epidemiology of America and by Blue Cross Blue Shield of Michigan and Blue Care Network.Disclosures: Valerie M. Vaughn reports contracted research for Blue Cross and Blue Shield of Michigan, the Department of VA, the NIH, the SHEA, and the APIC. She also reports receipt of funds from the Gordon and Betty Moore Foundation Speaker’s Bureau, the CDC, the Pew Research Trust, Sepsis Alliance, and the Hospital and Health System Association of Pennsylvania.

Background Antibacterials may be initiated out of concern for bacterial coinfection in coronavirus disease 2019 (COVID-19). We determined prevalence and predictors of empiric antibacterial therapy and community-onset bacterial coinfections in hospitalized patients with COVID-19. Methods A randomly sampled cohort of 1705 patients hospitalized with COVID-19 in 38 Michigan hospitals between 3/13/2020 and 6/18/2020. Data were collected on early (within 2 days of hospitalization) empiric antibacterial therapy and community-onset bacterial coinfections (positive microbiologic test ≤3 days). Poisson generalized estimating equation models were used to assess predictors. Results Of 1705 patients with COVID-19, 56.6% were prescribed early empiric antibacterial therapy; 3.5% (59/1705) had a confirmed community-onset bacterial infection. Across hospitals, early empiric antibacterial use varied from 27% to 84%. Patients were more likely to receive early empiric antibacterial therapy if they were older (adjusted rate ratio [ARR]: 1.04 [1.00–1.08] per 10 years); had a lower body mass index (ARR: 0.99 [0.99–1.00] per kg/m2), more severe illness (eg, severe sepsis; ARR: 1.16 [1.07–1.27]), a lobar infiltrate (ARR: 1.21 [1.04–1.42]); or were admitted to a for-profit hospital (ARR: 1.30 [1.15–1.47]). Over time, COVID-19 test turnaround time (returned ≤1 day in March [54.2%, 461/850] vs April [85.2%, 628/737], P < .001) and empiric antibacterial use (ARR: 0.71 [0.63–0.81] April vs March) decreased. Conclusions The prevalence of confirmed community-onset bacterial coinfections was low. Despite this, half of patients received early empiric antibacterial therapy. Antibacterial use varied widely by hospital. Reducing COVID-19 test turnaround time and supporting stewardship could improve antibacterial use.

Introduction Since sipuleucel-T approval in 2010, the treatment landscape for metastatic castration-resistant prostate cancer (mCRPC) now includes the androgen-receptor signaling pathway inhibitors (ASPIs) abiraterone acetate or enzalutamide. In 2013 and 2014, these oral agents were approved for use in men with metastatic prostate cancer who had minimal to no symptoms. We compared overall survival (OS) in men who received their first mCRPC treatment using the Medicare Fee-for-Service 100% administrative claims research dataset with patient-level linkage to the National Death Index. Methods This retrospective cohort analysis (January 2013 to December 2017) included men who were chemo-naïve at treatment start in 2014 and who had continuous Medicare Parts A, B, and D eligibility during the 3-year observation period. We compared: first-line sipuleucel-T vs. first-line ASPIs and any-line sipuleucel-T vs. any-line ASPIs (without sipuleucel-T). We used a multivariable regression model to help control for potentially confounding factors while assessing survival outcomes. Results The model included 6044 eligible men (average age 75–78 years) with similar disease severity; > 80% were white. Median OS, presented as sipuleucel-T vs. ASPI, was 35.2 vs. 20.7 months (n, 906 vs. 5092; any-line cohort) and 34.9 vs. 21.0 months (n, 647 vs. 4810; first-line cohort). Model outcomes indicated sipuleucel-T was associated with significantly prolonged OS compared with ASPIs: adjusted hazard ratio, 0.59 (95% CI 0.527–0.651) and 0.56 (0.494–0.627) for the any-line and first-line cohorts, respectively. Conclusion This analysis suggests use of sipuleucel-T at any time was associated with improved OS compared with ASPI use alone. Of note, these analyses are intended as descriptive rather than definitive as this dataset contains limited data on key clinical factors. While selection bias is a risk in secondary claims data, this research provides important insight into real-world treatment outcomes. Electronic Supplementary Material The online version of this article (10.1007/s12325-020-01509-5) contains supplementary material, which is available to authorized users.

Background In this study among men who underwent radical prostatectomy (RP), African American men (AAM) were 28% more likely to develop recurrent disease compared with Caucasian men (CM). However, among those who had nonmetastatic, castration-resistant prostate cancer (CRPC), race did not predict metastases or overall survival. Whether race predicts metastases among men who receive androgen-deprivation therapy (ADT) after a biochemical recurrence (BCR) (ie, before CRPC but after BCR) is untested. Methods The authors identified 595 AAM and CM who received ADT for a BCR that developed after RP between 1988 and 2015 in the Shared Equal-Access Regional Cancer Hospital (SEARCH) database. Univariable and multivariable Cox models were used to test the association between race and the time from ADT to metastases. Secondary outcomes included the time to CRPC, all-cause mortality, and prostate cancer-specific mortality. Results During a median follow-up of 66 months after ADT, 62 of 354 CM (18%) and 38 of 241 AAM (16%) developed metastases. AAM were younger at the time they received ADT (63 vs 67 years; P .5). Conclusions Among veterans who received ADT post-BCR after RP, race was not a predictor of metastases or other adverse outcomes. The current findings suggest that research efforts to understand racial differences in prostate cancer biology should focus on early stages of the disease (ie, closer to the time of diagnosis).

Introduction Enzalutamide and abiraterone acetate (plus prednisone) are new hormonal treatments for metastatic castration-resistant prostate cancer (mCRPC). This study compared treatment duration, healthcare resource utilization (HRU), and treatment costs for chemotherapy-naïve mCRPC patients treated with enzalutamide or abiraterone acetate in the USA. Methods Chemotherapy-naïve mCRPC patients initiating treatment with enzalutamide or abiraterone acetate were identified from administrative claims. Continuous enrollment ≥ 6 months before and ≥ 3 months after the index date (initiation date of enzalutamide or abiraterone acetate) was required. Treatment duration, all-cause and prostate cancer-related HRU, and costs were estimated during the post-index period. Multivariable analyses compared HRU and costs between cohorts, adjusting for baseline characteristics. Results Overall, 920 chemotherapy-naïve patients initiated enzalutamide and 2310 initiated abiraterone acetate (median follow-up, 10.7 and 13.5 months, respectively). More enzalutamide-treated patients had corticosteroid-sensitive comorbidities at baseline. Treatment duration was longer with enzalutamide versus abiraterone acetate (median, 10.7 vs. 8.8 months; P = 0.008). Enzalutamide was associated with fewer all-cause inpatient admissions [adjusted incidence rate ratio (95% confidence interval) 0.87 (0.76, 0.99)], days of hospitalization [0.84 (0.70, 1.02)], and outpatient visits [0.94 (0.90, 0.98)], and fewer prostate cancer-related outpatient visits [0.92 (0.87, 0.96)] compared with abiraterone acetate. Enzalutamide was also associated with lower prostate cancer-related inpatient and emergency department costs [adjusted differences, $122 (P = 0.024) and $28 (P = 0.009), respectively]. Conclusion Chemotherapy-naïve mCRPC patients treated with enzalutamide versus abiraterone acetate had longer treatment duration and incurred lower HRU and prostate cancer-related inpatient and emergency department costs. Funding Astellas Pharma Inc. Electronic supplementary material The online version of this article (10.1007/s12325-018-0774-1) contains supplementary material, which is available to authorized users.

Background The current study was performed to describe patient characteristics, treatment patterns, survival, health care resource use (HRU), and costs among older women in the United States with advanced (American Joint Committee on Cancer stage III/IV) triple-negative breast cancer (TNBC) in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Methods Women who were aged ≥66 years at the time of diagnosis and diagnosed with advanced TNBC between January 1, 2007, and January 1, 2011, in the SEER-Medicare database and who were followed for survival through December 31, 2013, were eligible. Patient demographic and clinical characteristics at the time of diagnosis, subsequent treatment patterns, and survival outcomes were analyzed. HRU and costs for the first 3 months after diagnosis, the last 3 months of life, and the time in between are summarized. All analyses were stratified by American Joint Committee on Cancer stage of disease. Results There were 1244 patients newly diagnosed with advanced TNBC; the majority were aged ≥75 years (61% with stage III disease and 57.4% with stage IV disease) and white (>70% of patients in both disease stage groups). The most common treatment approaches were surgery combined with chemotherapy for patients for stage III disease (50.6%) and chemotherapy alone or with radiotherapy for patients with stage IV disease (31.3%). Diverse chemotherapy regimens were administered for each line of therapy; nevertheless, the medications used were consistent with national guidelines. Patients with stage III and stage IV disease were found to have a similar mean number of hospitalizations and outpatient visits, but mean monthly costs were greater for patients with stage IV disease at all 3 time points. The mean cost per patient-month (in 2013 US dollars) was $4810 for patients with stage III disease and $9159 for patients with stage IV disease. Conclusions Among older women with advanced TNBC, significant treatment variations and considerable HRU and costs exist. Further research is needed to find effective treatments with which to reduce the clinical and economic burden of this disease. Cancer 2018;124:2104-14. © 2018 American Cancer Society.

Background Antibiotic therapy has no known benefit against COVID-19, but is often initiated out of concern for concomitant bacterial infection. We sought to determine how common early empiric antibiotic therapy and community-onset bacterial co-infections are in hospitalized patients with COVID-19. Methods In this multi-center cohort study of hospitalized patients with COVID-19 discharged from 32 Michigan hospitals during the COVID-19 Michigan surge, we describe the use of early empiric antibiotic therapy (within the first two days) and prevalence of community-onset bacterial co-infection. Additionally, we assessed patient and hospital predictors of early empiric antibiotic using poison generalized estimating equation models. Results Between 3/10/2020 and 5/10/2020, data were collected on 951 COVID-19 PCR positive patients. Patient characteristics are described in Table 1. Nearly two thirds (62.4%, 593/951) of COVID-19 positive patients were prescribed early empiric antibiotic therapy, most of which (66.2%, 393/593) was directed at community-acquired pathogens. Across hospitals, the proportion of COVID-19 patients prescribed early empiric antibiotics varied from 40% to 90% (Figure 1). On multivariable analysis, patients were more likely to receive early empiric antibiotic therapy if they were older (adjusted rate ratio [ARR]: 1.01 [1.00–1.01] per year), required respiratory support (e.g., low flow oxygen, ARR: 1.16 [1.04–1.29]), had signs of a bacterial infection (e.g., lobar infiltrate, ARR: 1.17 [1.02–1.34]), or were admitted to a for-profit hospital (ARR: 1.27 [1.11–1.45]); patients admitted later were less likely to receive empiric antibiotics (April vs. March, ARR: 0.72 [0.62–0.84], Table 2). Community-onset bacterial co-infections were identified in 4.5% (43/951) of COVID-19 positive patients (2.4% [23/951] positive blood culture; 1.9% [18/951] positive respiratory culture). Conclusion Despite low prevalence of community-onset bacterial co-infections, patients hospitalized with COVID-19 often received early empiric antibiotic therapy. Given the potential harms from unnecessary antibiotic use, including additional personal protective equipment to administer antibiotics, judicious antibiotic use is key in hospitalized patients with COVID-19. Disclosures Tejal N. Gandhi, MD, Blue Cross Blue Shield of Michigan (Grant/Research Support) Scott A. Flanders, MD, Agency for Healthcare Research and Quality (Research Grant or Support)Blue Cross Blue Shield of Michigan (Research Grant or Support)

Essentials How best to quantify thrombosis risk with peripherally inserted central catheters (PICC) is unknown. Data from a registry were used to develop the Michigan Risk Score (MRS) for PICC thrombosis. Five risk factors were associated with PICC thrombosis and used to develop a risk score. MRS was predictive of the risk of PICC thrombosis and can be useful in clinical practice. SummaryBackground Peripherally inserted central catheters (PICCs) are associated with upper extremity deep vein thrombosis (DVT). We developed a score to predict risk of PICC-related thrombosis. Methods Using data from the Michigan Hospital Medicine Safety Consortium, image-confirmed upper-extremity DVT cases were identified. A logistic, mixed-effects model with hospital-specific random intercepts was used to identify factors associated with PICC-DVT. Points were assigned to each predictor, stratifying patients into four classes of risk. Internal validation was performed by bootstrapping with assessment of calibration and discrimination of the model. Results Of 23 010 patients who received PICCs, 475 (2.1%) developed symptomatic PICC-DVT. Risk factors associated with PICC-DVT included: history of DVT; multi-lumen PICC; active cancer; presence of another CVC when the PICC was placed; and white blood cell count greater than 12 000. Four risk classes were created based on thrombosis risk. Thrombosis rates were 0.9% for class I, 1.6% for class II, 2.7% for class III and 4.7% for class IV, with marginal predicted probabilities of 0.9% (0.7, 1.2), 1.5% (1.2, 1.9), 2.6% (2.2, 3.0) and 4.5% (3.7, 5.4) for classes I, II, III, and IV, respectively. The risk classification rule was strongly associated with PICC-DVT, with odds ratios of 1.68 (95% CI, 1.19, 2.37), 2.90 (95% CI, 2.09, 4.01) and 5.20 (95% CI, 3.65, 7.42) for risk classes II, III and IV vs. risk class I, respectively. Conclusion The Michigan PICC-DVT Risk Score offers a novel way to estimate risk of DVT associated with PICCs and can help inform appropriateness of PICC insertion.

Objective: To estimate the healthcare costs and characteristics of docetaxel chemotherapy episodes of care for men with metastatic castration-resistant prostate cancer (mCRPC). Methods: This study used the Medicare 5% sample and MarketScan Commercial (2010–2013) claims data sets to identify men with mCRPC and initial episodes of docetaxel treatment. Docetaxel episodes included docetaxel claim costs from the first claim until 30 days after the last claim, with earlier termination for death, insurance disenrollment, or the end of a 24-month look-forward period from initial docetaxel index date. Docetaxel drug claim costs were adjusted for 2011 generic docetaxel introduction, while other costs were adjusted to 2015 values using the national average annual unit cost increase. Results: This study identified 281 Medicare-insured and 155 commercially insured men, with 325 and 172 docetaxel episodes, respectively. The average number of cycles (unique docetaxel infusion days) per episode was 6.9 for Medicare and 6.3 for commercial cohorts. The average cost per episode was $28,792 for Medicare and $67,958 for commercial cohorts, with docetaxel drug costs contributing $2,588 and $13,169 per episode, respectively. The average cost per episode on docetaxel infusion days was $8,577 (30%) for Medicare and $28,412 (42%) for commercial. Non-docetaxel infusion day costs included $7,074 (25%) for infused or injected drugs for Medicare, $10,838 (16%) for commercial cohorts, and $6,875 (24%) and $9,324 (14%) for inpatient admissions, respectively. Limitations: The applicability is only to the metastatic castration-resistance clinical setting, rather than the metastatic hormone-sensitive setting, and the lack of data on the cost effectiveness of different sequencing strategies of a range of systemic therapies including enzalutamide, abiraterone, radium-223, and taxane chemotherapy. Conclusion: The majority of docetaxel episode costs in Medicare and commercial mCRPC populations were non-docetaxel drug costs. Future research should evaluate the total cost of care in mCPRC.

Background: Clinicians often diagnose bacterial infections such as urinary tract infection (UTI) and pneumonia in patients who are asymptomatic or have nonbacterial causes of their symptoms. Misdiagnosis of infection leads to unnecessary antibiotic use and potentially delays correct diagnoses. Interventions to improve diagnosis often focus on infections separately. However, if misdiagnosis is linked, broader interventions to improve diagnosis may be more effective. Thus, we assessed whether misdiagnosis of UTI and community-acquired pneumonia (CAP) was correlated. Methods: From July 2017 to July 2019, abstractors at 46 Michigan hospitals collected data on a sample of adult, non–intensive care, hospitalized patients with bacteriuria (positive urine culture) or who were treated for presumed CAP (discharge diagnosis plus antibiotics). Patients with concomitant bacterial infections were excluded. Using a previously described method,1,2 patients were assessed for UTI or CAP based on symptoms, signs, and laboratory or radiology findings. Misdiagnosis of UTI was defined as patients with asymptomatic bacteriuria (ASB) treated with antibiotics number of patients with bacteriuria Misdiagnosis of CAP was defined as patients treated for presumed CAP who did not have CAP number of patients treated for presumed CAP. Hospital-level correlation was assessed using Pearson’s correlation coefficient between misdiagnosis of UTI and CAP. For patients with prescriber data (N = 3,293), we also assessed emergency department (ED)-level correlation. Results: Of 11,914 patients with bacteriuria, 31.9% (N = 3,796) had ASB. Of those, 2,973 of 3,796 (78.3%) received antibiotics. Of 14,085 patients treated for CAP, 1,602 (11.4%) did not have CAP. Incidence of misdiagnosis varied by hospital: those with high rates of misdiagnosis of UTI were more likely to have high rates of misdiagnosis of CAP (Pearson’s correlation coefficient, 0.58; P ≤ .001) (Fig. 1). Of 2,137 patients misdiagnosed with UTI, 1,159 (54.2%) had antibiotic treatment started in the ED; of those, 942 (81.3%) remained on antibiotics on day 3 of hospitalization. Of 1,156 patients misdiagnosed with CAP, 871 (75.3%) had antibiotic therapy started in the ED, and 789 of these 871 patients (90.6%) were still on antibiotics on day 3 of hospitalization. Hospitals with high rates of UTI misdiagnosis in the ED were more likely to have high rates of CAP misdiagnosis in the ED (Pearson’s correlation coefficient, 0.33; P ≤ .001). Conclusions: Misdiagnosis of 2 unrelated infections was moderately correlated by hospital and weakly correlated by hospital ED. Potential causes include differences in organizational culture (eg, low tolerance for diagnostic uncertainty, emergency department culture), organizational initiatives (eg, sepsis, stewardship), or coordination between emergency and hospital medicine. Additionally, antibiotics initiated in the ED were typically continued following admission, potentially reflecting diagnosis momentum.Funding: This work was supported by Blue Cross Blue Shield of Michigan and Blue Care Network.Disclosures: Valerie M. Vaughn reports contract research for Blue Cross and Blue Shield of Michigan, the Department of Veterans’ Affairs, the NIH, the SHEA, and the APIC. She also reports fees from the Gordon and Betty Moore Foundation Speaker’s Bureau, the CDC, the Pew Research Trust, Sepsis Alliance, and The Hospital and Health System Association of Pennsylvania.

Background: The majority of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are triggered by nonbacterial causes, yet most patients receive antibiotics. Treatment guided by procalcitonin (PCT), a sensitive biomarker of bacterial infection, safely decreases antibiotic use in many controlled trials. We evaluated PCT implementation for inpatients with AECOPD at a large academic hospital. Methods: All patients admitted for AECOPD during the first 6 months of PCT-guided therapy were eligible for inclusion in this retrospective cohort study. Patients with PCT performed were compared with those without PCT. The primary outcome was antibiotic days of therapy (DOT). Secondary outcomes included 30-day readmission and mortality. Results: Of the 238 AECOPD admissions, 73 (31%) had PCT performed. Procalcitonin-tested patients were more likely to meet systemic inflammatory response syndrome (SIRS) criteria, require intensive care unit (ICU)-level care, and have a longer length of stay (LOS) compared with those without PCT. Even after adjustment for these factors, PCT-tested patients received more inpatient DOT and there was no difference in total DOT. However, a low PCT value (Conclusions: In this real-world analysis of inpatients with AECOPD, PCT-guided therapy was poorly adopted by providers and was not associated with a decrease in total antibiotic DOT. However, a low PCT level was associated with a 25.5% decrease in IV antibiotic DOT, suggesting increased comfort stepping down from IV to PO therapy.

INTRODUCTION AND OBJECTIVES:Clinicians may offer abiraterone plus prednisone (ABI), enzalutamide (ENZA), or sipuleucel-T (SIP-T) to patients with asymptomatic or minimally symptomatic metastatic ca...

Objective: The aim of this analysis was to examine treatment patterns in patients with acute myeloid leukemia (AML) in routine clinical practice in the United States, including factors influencing the choice of front-line treatment intensity and the effect of age and treatment line. Methods: We used data from the Adelphi AML Disease Specific Programme, a real-world, cross-sectional survey conducted in 2015. Physicians completed patient record forms providing patients’ demographic and clinical characteristics. Results: In total, 61 academic, non-academic, and office-based hematologists and hematology/oncology specialists provided data on 457 patients with AML; 284 had ≥20% blasts (World Health Organization-defined AML) and were included in the analysis. In the front-line setting, 60% of patients received high-intensity therapy, most commonly cytarabine plus anthracycline; the most common low-intensity treatments were hypomethylating agents. Primary drivers for selecting high-intensity versus low-intensity treatment were age, performance status, and comorbidities; 67%, 64%, and 61% of physicians stated they would prescribe high-intensity treatment to patients aged p0001). In a selected cohort of relapsed/refractory patients, 69% of patients received high-intensity therapy (78% of patients aged Conclusions: Most patients in this analysis of real-world survey data received well-established, front-line induction therapies. Treatment intensity was determined by age, comorbidities, and performance status, as recommended by guidelines.

Enzalutamide (ENZA) and abiraterone acetate plus prednisone (AA) are approved second-generation hormone therapies for chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). This study compared ENZA with AA in chemotherapy-naïve mCRPC by calculating the number needed to treat (NNT) and associated incremental costs to achieve one additional chemotherapy-naïve patient with mCRPC free of radiographic progression, chemotherapy, or death over a 1-year time horizon.Clinical outcomes were obtained from the PREVAIL and COU-AA-302 trials. Three outcomes were evaluated: radiographic progression-free survival, time to cytotoxic chemotherapy initiation, and overall survival at 1 year. NNT was calculated as the reciprocal of the outcome event rate difference for ENZA compared with AA. The incremental costs to achieve one additional outcome at 1 year were calculated as the difference in cost per treated patient multiplied by the NNT. Per-treated-patient costs were considered from a US payer perspective and included medications, monitoring, adverse events, post-progression treatments, and end-of-life care.Within a 1-year time horizon, the total cost per treated patient for ENZA was $2,666 less than AA. Compared with AA, treating 14 patients with ENZA resulted in one additional patient free of progression or death over 1 year; treating 26 patients with ENZA resulted in one additional patient with chemotherapy delayed over 1 year; and treating 91 patients with ENZA resulted in one additional patient free of death over 1 year. Therefore, ENZA is cost-effective compared with AA for all three outcomes evaluated, and the modeled results suggest ENZA is associated with potentially improved clinical outcomes in delaying chemotherapy initiation and disease progression for chemotherapy-naïve patients. The results are robust in sensitivity analyses, where the effect of changes in key model inputs and assumptions were tested.The results modeled in the present study suggest ENZA is cost-effective compared with AA for treating chemotherapy-naïve patients with mCRPC.

e17588 Background: Clinical trials of sip-T predominately included white men (over 90%). Previously we explored outcomes with sip-T in white and black patients (pts) (Kantoff PW, NEJM 2010; Sartor AO, ASCO 2019, #5035). In this retrospective analysis of data from electronic medical record and practice management systems, we explored the hypothesis that Asian and white pts who receive sip-T for CRPC exhibit similar overall survival. Methods: Data came from > 100 US community urology practices, predominantly large urology group practice associations. White and Asian pts were matched based on 5 criteria: sip-T treatment year; treatment pattern for oral and sip-T; metastatic site (Bone v. Nodal v. Visceral); prostate-specific antigen (PSA) within 10%; and age at treatment. Parameters retrieved include those listed in the table. Overall survival (OS) was analyzed using Kaplan Meier (KM) methodology with Cox Proportional Hazards Modelling used to generate the hazard ratio (HR) with Asians as the reference. Descriptive summary statistics were generated for other parameters. Results: The analysis identified 102 white and 77 Asian pts; treatment ranged from 2012 to 2019 with 60% receiving sip-T after 2016, impacting the ability to examine long-term outcomes. Characteristics of the 2 groups were broadly similar, although more Asians had Gleason scores ≥8 than whites (Table). In the KM analysis, most pts were censored. While the KM survival curves separate around month 25, favoring Asian pts, the difference is not significant (HR, 0.69 [95% CI: 0.4, 1.4]; P = 0.277). Conclusions: These real-world data do not show a significant difference in OS between Asian and white men. Both groups exhibited relatively low median PSAs near 5 ng/mL, an observation correlated with longer OS in previous studies. [Table: see text]

e17591 Background: Sipuleucel-T (sip-T) is a cellular immunotherapy that activates a patient’s own immune system to target prostate cancer cells. Flu vaccine contains inactivated virus that stimulates the immune system to induce a response. Hypothetically, influenza vaccines may impact sip-T effectiveness by affecting the apheresis procedure, ex vivo production of sip-T, and/or CD 54+ upregulation. We explored the effect of receiving the flu vaccine on outcomes in men who received first line treatment with sip-T. Methods: Claims data from the 2013-2017 CMS Fee for Service 100% Medicare Identifiable Database for Parts A, B and D Data were examined. Among men with dates of first sip-T doses in 2014 and 2015 (ie, index dates), we identified whether or not they received flu vaccine 30 days before or after based on healthcare common procedure coding system (HCPCS) codes and National Drug Codes (NDCs). Kaplan-Meier methodology was used to assess survival with Cox proportional hazards regression model used to calculate hazard ratios (HR). Three years of follow-up (F/U) were available for men with 2014 index dates; 2 years were available for men with 2014 and 2015 index dates. Results: Approximately 8% of men received the flu vaccine (102 of 1279 with 2 years of F/U; 50 of 656 with 3 years of F/U). Overall, mean age was 76 years. Most ( > 86%) were white. Receipt of flu vaccine did not impact the overall survival of men who received sip-T (HR [95% CI], 0.93 [0.64, 1.35] at 2 years and 0.90 [0.60, 1.37] at 3 years). The resultant Kaplan-Meier curves overlapped (not shown). Conclusions: Based on these claims analyses, concomitant use of flu vaccine did not appear to impact survival outcomes after sip-T administration in men with mCRPC. These data have practical application for clinicians and patients given limited prospective data evaluating the role of flu vaccination in patients receiving immunotherapy. [Table: see text]

e17589 Background: Black men historically have been underrepresented in clinical trials, contributing to poor understanding of potential race-based differences in prostate cancer care and biology. This retrospective, real world analysis examines survival outcomes in black men who received sip-T or oral agents like abiraterone or enzalutamide for mCRPC. Methods: Using Medicare Fee for Service Identifiable Research data, we identified racially black men with a qualifying prostate cancer diagnosis (ICD-9 185, ICD-10 C-61) and an initial drug claim for treatment (abiraterone acetate, cabazitaxel, docetaxel, enzalutamide, radium-223, or sip-T) in 2014 or 2015. Continuous Part A, B, and D eligibility and no HMO enrollment were required for 24 months or until death per Social Security Death Index. We compared outcomes in black patients who received sip-T at any time vs those who received an oral agent in any line and no sip-T. Survival was estimated using the Kaplan-Meier method (unadjusted) and hazard ratios using Cox proportional hazards regression. Results: Of 14,456 patients identified in 2014 and 2015, 1603 were racially black. Among eligible men, 140 received sip-T and 1266 received an oral agent. At 24 months, 76% of men who received sip-T were still alive compared with 49% of those who received the oral agents (Table). Median OS was not estimable in men who received sip-T but was 23.1 months (95% CI: 21.6, NE) in those who received oral agents (Table). In a univariate model, use of sip-T resulted in a 63% reduction in risk of death compared to never receiving sip-T (HR, 0.37 [95% CI, 0.26, 0.52], P < 0.0001). Conclusions: In this real world analysis of black mCRPC patients, sip-T at any point was associated with longer OS over those receiving the oral agents without ever receiving sip-T. Development of a multivariate model is planned. [Table: see text]

e17590 Background: Because elderly patients may exhibit differences in immune activation, we evaluated outcomes in men receiving first line treatment for mCRPC with sip-T or oral agents (ie, abiraterone acetate or enzalutamide) by age. Methods: Claims data from the 2013-2017 Centers for Medicare and Medicaid Services Fee for Service 100% Medicare Identifiable Database for Parts A, B and D were examined. We evaluated with index dates in 2014 and 3 years of follow-up. Patients were categorized by age (Table) and agent use as per Healthcare Common Procedure Coding System codes and National Drug Codes. First line use of sip-T vs oral agents was examined as was any line use of sip-T vs oral agents (without sip-T). Kaplan-Meier methodology was used to assess survival with Cox proportional hazards regression modelling used to calculate hazard ratios (HR). Results: Mean ages of men receiving sip-T and orals were 76 and 78 years, respectively. Most (84%) were white. Regardless of line of use, the risk of death among men receiving sip-T was lower than the risk in men receiving orals, except in men over 90 years old (Table). Conclusions: Based on these claims data, benefits of sip-T use were evident across all ages except for the men 90+ years old with decreasing differences between agents with increasing age, as would be expected. While the oral agents may be perceived as more convenient, greater survival with sip-T suggests that clinicians should consider use of sip-T therapy for mCRPC, irrespective of age. [Table: see text]

42 Background: Since the mCRPC treatment landscape is evolving, we examined real-world use and outcomes of sipuleucel-T (sip-T) and oral agents (abiraterone acetate and enzalutamide) in men with mCRPC. Methods: Using Medicare FFS Identifiable Research data, we identified mCRPC men with a qualifying prostate cancer diagnosis (ICD-9 185, ICD-10 C-61) and an initial treatment claim (abiraterone, cabazitaxel, docetaxel, enzalutamide, radium 223, sip-T) in 2014. Continuous Part A, B, and D eligibility and no HMO enrollment was required through 2017 or until death. mCRPC index date is the date of a mCRPC therapeutic claim. Using 4 groups (sip-T first line, oral first line, sip-T any line, and oral any line [no sip-T]), survival was estimated using Kaplan-Meier methods (unadjusted). Hazard ratios (HR) were estimated using Cox’s proportional hazards regression modeling. Results: During 2014, 14,482 eligible men had mCRPC drug claims. We studied 6,853 naïve mCRPC men with no treatment claim in the prior 12 months. Over 150 permutations of anti-cancer agents were identified. See table for patient characteristics. Sip-T was used 2+ line in 4.5% of men receiving orals 1st. Median overall survival was longer for men who received sip-T, regardless if used 1st line (35 mo) or in any line (35 mo), compared with oral 1st line use (21 mo) or an oral any time without sip-T (21 mo). Similar survival was seen after adjusting for baseline opioid use. While most received sip-T as 1st line, survival rates were higher in men receiving sip-T in any line (48%) compared to men who never received any sip-T (29%). Conclusions: In this analysis, sip-T use was associated with a 45% reduction in risk of death and 14 mo survival benefit in the Medicare FFS population regardless of when used. Real-world analyses like this provide insight into how to optimize sip-T use to treat prostate cancer.[Table: see text]

Background This analysis estimated the number needed to treat with enzalutamide versus bicalutamide to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer who would obtain clinical benefit regarding progression-free survival, radiographic progression-free survival, or no prostate-specific antigen progression at 1 and 2 years following treatment initiation. Methods Clinical event rates were obtained from the STRIVE (NCT01664923) and TERRAIN (NCT01288911) trials, and the number needed to treat was the inverse of the absolute rate difference between the event rates of enzalutamide and bicalutamide. The 95% Confidence Interval of the number needed to treat was derived from the 95% Confidence Interval of the event rate difference. Results Using STRIVE data (patients with metastatic disease: n = 128 enzalutamide; n = 129 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer with progression-free survival were 2.0 and 2.8, respectively; with radiographic progression-free survival, 2.6 and 3.0, respectively; and without prostate-specific antigen progression, 1.8 and 2.4, respectively. Using TERRAIN data (n = 184 enzalutamide; n = 191 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with progression-free survival were 4.3 and 3.7, respectively; with radiographic progression-free survival, 10.0 and 2.8, respectively; and without prostate-specific antigen progression, 2.1 and 3.2, respectively. Conclusions The combined data from TERRAIN and STRIVE demonstrated that treating chemotherapy-naïve metastatic castration-resistant prostate cancer with enzalutamide leads to more patients without clinical progression at 1 and 2 years than with bicalutamide. Trial registration STRIVE (NCT01664923; registration date: August 10, 2012) and TERRAIN (NCT01288911; registration date: February 1, 2011).

Background:Many experts believe that hospitals with more frequent readmissions provide lower-quality care, but little is known about how the preventability of readmissions might change over the postdischarge time frame. Objective:To determine whether readmissions within 7 days of discharge differ from those between 8 and 30 days after discharge with respect to preventability. Design:Prospective cohort study. Setting:10 academic medical centers in the United States. Patients:822 adults readmitted to a general medicine service. Measurements:For each readmission, 2 site-specific physician adjudicators used a structured survey instrument to determine whether it was preventable and measured other characteristics. Results:Overall, 36.2% of early readmissions versus 23.0% of late readmissions were preventable (median risk difference, 13.0 percentage points [interquartile range, 5.5 to 26.4 percentage points]). Hospitals were identified as better locations for preventing early readmissions (47.2% vs. 25.5%; median risk difference, 22.8 percentage points [interquartile range, 17.9 to 31.8 percentage points]), whereas outpatient clinics (15.2% vs. 6.6%; median risk difference, 10.0 percentage points [interquartile range, 4.6 to 12.2 percentage points]) and home (19.4% vs. 14.0%; median risk difference, 5.6 percentage points [interquartile range, -6.1 to 17.1 percentage points]) were better for preventing late readmissions. Limitation:Physician adjudicators were not blinded to readmission timing, community hospitals were not included in the study, and readmissions to nonstudy hospitals were not included in the results. Conclusion:Early readmissions were more likely to be preventable and amenable to hospital-based interventions. Late readmissions were less likely to be preventable and were more amenable to ambulatory and home-based interventions. Primary Funding Source:Association of American Medical Colleges.

Aim: To validate the total illness burden index for prostate cancer (TIBI-CaP) in castration-resistant prostate cancer (CRPC) patients. Patients & methods: Baseline comorbidity scores collected using the TIBI-CaP were compared with the baseline patient-reported health-related quality of life using the SF-12v2 and FACT-P questionnaires in 302 patients enrolled in the Treatment Registry for Outcomes in CRPC Patients (TRUMPET). Results: Baseline TIBI-CaP scores were negatively correlated with all baseline SF-12v2 domain/composite (p

Background Fluoroquinolones increase the risk of Clostridioides difficile infection and antibiotic resistance, but are frequently used for hospitalized patients with bacteriuria. We assessed patterns and predictors of inappropriate fluoroquinolone (FQ) use among hospitalized patients with asymptomatic bacteriuria (ASB) and cystitis. Methods This is a retrospective cohort study of non-ICU medicine patients with ASB or cystitis (complicated or uncomplicated) from January 2018 to March 2019 at 43 Michigan hospitals. Patients with concomitant infections, bacteremia, or pyelonephritis were excluded. Each day of FQ (ciprofloxacin, levofloxacin) use (inpatient and post discharge) was assessed for appropriateness. FQ use was inappropriate if: (A) ASB, (B) urine culture with an FQ-resistant bacteria, (C) a safer alternative empiric or definitive antibiotic (treatment ≥2 days after urine culture collection) based on disease severity, cultures, allergies, and renal function, or (D) excess duration (>7 days complicated cystitis; >3 days uncomplicated cystitis). Hospitals were also surveyed on existing stewardship (ASP) practices targeting FQ use. ASP practices associated with inappropriate FQ use were evaluated using logistic generalized estimated equation models adjusting for patient factors and hospital clustering. Results Of 4849 included patients with ASB (39.7%) or cystitis (60.3%), 21.9% (n = 1,061) received an FQ and 92.7% (n = 984) received a, FQ inappropriately (Figure 1). Of 5,465 FQ days of therapy (DOT), 90.7% (n = 4,959) were inappropriate. Definitive treatment of complicated cystitis led to the greatest proportion of inappropriate FQ DOTs (50.6%), followed by ASB (36.4%) (Table 1). Hospitals varied (Figure 2), but those with cascade reporting of antibiotic susceptibilities, urinary tract infection (UTI) treatment guideline or an ASP performing prospective audit and feedback on FQ use had lower inappropriate FQ treatment rates (Table 2). Conclusion Hospitalized patients with ASB and cystitis often receive an FQ. Most FQ use is inappropriate due to ASB treatment or FQ use for complicated cystitis despite the option of an alternative antibiotic. Prospective audit and feedback, UTI guidelines, and cascade reporting of antibiotic susceptibilities can be used by ASP to reduce inappropriate FQ use. Disclosures All authors: No reported disclosures.

Background Antibiotics prescribed at hospital discharge account for half of antibiotic use related to hospitalization for urinary tract infection or bacterial pneumonia. It is unclear how much antibiotic use at discharge represents overuse, and thus, could potentially be improved through antibiotic stewardship. Methods From July 2017 to December 2018, trained abstractors at 46 Michigan hospitals collected detailed data on a sample of adult, nonintensive care, hospitalized patients with bacteriuria or treated for community-acquired or healthcare-associated pneumonia (discharge diagnosis of pneumonia plus antibiotic treatment). Antibiotic prescriptions at discharge were assessed for overuse using a guideline-based hierarchical algorithm: evaluating first for unnecessary antibiotics (noninfectious/nonbacterial syndrome), then excess duration (antibiotics needed, but prescribed for longer than necessary), and finally avoidable fluoroquinolones (safer alternative antibiotic available) (Figure 1). For each disease state, descriptive results are shown with comparisons by t- or Fisher’s exact tests. Results Of 17,157 patients (7,283 with bacteriuria; 9,874 treated for pneumonia), 30.1% of patients with bacteriuria had asymptomatic bacteriuria and 11.4% of patients treated for pneumonia did not meet diagnostic criteria for pneumonia. The most common antibiotics prescribed at discharge were fluoroquinolones. Nearly half (43.6%) of patients had antibiotic overuse at discharge (33.8% bacteriuria, 50.9% pneumonia), with a median 4 days of overuse after discharge (Table 1). For bacteriuria, 45.0% of overuse days at discharge were due to unnecessary antibiotics; for pneumonia, 61.2% were due to excess antibiotic duration (Figure 2). Patients with community-acquired pneumonia and those with sepsis on admission had the highest rates of antibiotic overuse at discharge (Table 2). Conclusion In the largest assessment of antibiotics at discharge to-date, antibiotic overuse at discharge was extremely common. Specific targets for discharge stewardship vary by disease state. Notably, interventions may be more effective at reducing fluoroquinolone prescribing at discharge indirectly by stopping treatment for asymptomatic bacteriuria and reducing excess duration in pneumonia. Disclosures All Authors: No reported Disclosures.

Use of peripherally inserted central catheters (PICCs) has grown substantially in recent years. Increasing use has led to the realization that PICCs are associated with important complications, including thrombosis and infection. Moreover, some PICCs may not be placed for clinically valid reasons. Defining appropriate indications for insertion, maintenance, and care of PICCs is thus important for patient safety. An international panel was convened that applied the RAND/UCLA Appropriateness Method to develop criteria for use of PICCs. After systematic reviews of the literature, scenarios related to PICC use, care, and maintenance were developed according to patient population (for example, general hospitalized, critically ill, cancer, kidney disease), indication for insertion (infusion of peripherally compatible infusates vs. vesicants), and duration of use (≤5 days, 6 to 14 days, 15 to 30 days, or ≥31 days). Within each scenario, appropriateness of PICC use was compared with that of other venous access devices. After review of 665 scenarios, 253 (38%) were rated as appropriate, 124 (19%) as neutral/uncertain, and 288 (43%) as inappropriate. For peripherally compatible infusions, PICC use was rated as inappropriate when the proposed duration of use was 5 or fewer days. Midline catheters and ultrasonography-guided peripheral intravenous catheters were preferred to PICCs for use between 6 and 14 days. In critically ill patients, nontunneled central venous catheters were preferred over PICCs when 14 or fewer days of use were likely. In patients with cancer, PICCs were rated as appropriate for irritant or vesicant infusion, regardless of duration. The panel of experts used a validated method to develop appropriate indications for PICC use across patient populations. These criteria can be used to improve care, inform quality improvement efforts, and advance the safety of medical patients.

Background Peripherally inserted central catheters (PICCs) are associated with upper extremity-deep vein thrombosis (DVT). However, patterns, risk factors and treatment associated with this event remain poorly defined. Objective To determine patterns, risk factors and treatment related to PICC-DVT in hospitalized patients. Design, Setting & Patients Between 2012–2013, consecutive cases of ultrasound-confirmed, symptomatic PICC-DVT were identified. For each case, at least two contemporaneous controls were identified and matched by age and gender. Patient- and device-specific data were obtained through electronic-medical records. Using variables selected a priori, multivariable logistic regression models were fit to the outcome of PICC-DVT, comparing cases to controls. Results 909 adult hospitalized patients (268 cases, 641 controls) were included in the study. Indications for PICC placement included long-term intravenous antibiotic therapy (n = 447; 49.1%), in-hospital venous access for blood draws or infusion of medications (n = 342; 44.2%), and total parenteral nutrition (n = 120; 6.7%). Patients with PICC-DVT were more likely to have a history of venous thromboembolism (OR 1.70, 95% CI = 1.02-2.82) or have undergone surgery while the PICC was in situ (OR 2.17, 95%CI = 1.17-4.01 for surgeries longer than two hours). Treatment for PICC-DVT varied and included heparin bridging, low molecular weight heparin only and device removal only; the average duration of treatment also varied across these groups. Compared to 4-Fr PICCs, 5- and 6-Fr PICCs were associated with greater risk of DVT (OR 2.74, 95%CI = 0.75-10.09 and OR 7.40 95%CI = 1.94-28.16, respectively). Patients who received both aspirin and statins were less likely to develop PICC-DVT than those that received neither treatment (OR 0.31, 95%CI = 0.16-0.61). Receipt of pharmacological DVT prophylaxis during hospitalization showed a non-significant trend towards reduction in risk of PICC-DVT (OR = 0.72, 95%CI = 0.48-1.08). Conclusion Several factors appear associated with PICC-DVT. While some of these characteristics may be non-modifiable, future studies that target potentially modifiable variables to prevent this adverse outcome would be welcomed.

BACKGROUND Health care reform efforts and initiatives seek to improve quality and reduce costs by eliminating unnecessary care. However, little is known about overuse and its drivers, especially in hospitals. OBJECTIVE To assess the extent of and factors associated with overuse of testing in U.S. hospitals. DESIGN National survey of practice patterns for 2 common clinical vignettes: preoperative evaluation and syncope. Respondents were randomly selected and randomly provided 1 of 4 versions of each vignette. Each version contained identical clinical information but varied in factors that could change physician behavior. Respondents were asked to identify what they believed most hospitalists at their institution would recommend in each vignette. SETTING Mailed survey conducted from June through October 2011. PARTICIPANTS Physicians practicing adult hospital medicine in the United States. MEASUREMENTS Responses indicating overuse (more testing than recommended by American College of Cardiology/American Heart Association guidelines). RESULTS 68% (1020 of 1500) of hospitalists responded. They reported overuse in 52% to 65% of the preoperative evaluation vignettes and 82% to 85% of the syncope vignettes. Overuse more frequently resulted from a physician's desire to reassure patients or themselves than an incorrect belief that it was clinically indicated (preoperative evaluation, 63% vs. 37%; syncope, 69% vs. 31%; P < 0.001 for each). LIMITATION Survey responses may not represent actual clinical choices. CONCLUSION Physicians reported substantial overuse in 2 common clinical situations in the hospital. Improving provider knowledge of guidelines may help reduce overuse, but despite awareness of the guidelines, physicians often deviate from them to reassure patients or themselves. PRIMARY FUNDING SOURCE Blue Cross Blue Shield of Michigan Foundation, Department of Veterans Affairs Center for Clinical Management Research, University of Michigan Specialist-Hospitalist Allied Research Program, and Ann Arbor Veterans Affairs/University of Michigan Patient Safety Enhancement Program.

Treatment of asymptomatic bacteriuria contributes to antimicrobial overuse in hospitalized patients. Indications for urine culture, treatment, and targets for improvement were evaluated in 153 patients. Drivers of antimicrobial overuse included fever with an alternative source, altered mental status, and leukocytosis, which led 435 excess days of antimicrobial therapy.Infect Control Hosp Epidemiol 2014;00(0): 1–4

Background Treatment of asymptomatic bacteriuria (ASB) is a major driver of inappropriate antibiotic use and an important target for antimicrobial stewardship. We identified patient- and hospital-level factors associated with treatment of ASB and its impact on patient outcomes. Methods In this retrospective cohort study, detailed data were abstracted from the medical record of adult non-ICU patients hospitalized with a positive urine culture (Ucx) between January 2016 and February 2018 at 46 Michigan hospitals. Exclusions included pregnancy, urologic surgery or abnormality, immune-compromise, or concomitant infection. ASB was defined as a positive Ucx without signs or symptoms attributable to a urinary tract infection (UTI). The treatment group received ≥1 antibiotic dose. Patient outcomes included mortality, readmissions, Clostridium difficile infection, and emergency room visits. Patient and hospital factors associated with ASB treatment were evaluated using logistic generalized estimating equation models; patient outcomes were inverse probability of treatment weighted. Results Of 2,733 included patients with ASB, 82.9% (n = 2,266) were treated with antibiotics for a median 7 days (IQR 4,9). Ceftriaxone (71.1%) was the most frequent initial therapy; fluoroquinolones (33.2%) were most common at discharge. In the multivariable model, patient variables associated with ASB treatment included: increased age, dementia, positive urinalysis, incontinence, indwelling urinary catheter, and nonambulatory status (Figure 1). Hospitals varied (Figure 2), but those that required a documented indication for antibiotics in the order or medical record had lower ASB treatment rates (OR = 0.5). There was no difference in patient outcomes for patients treated vs. not treated with antibiotics. Conclusion Antibiotic treatment of ASB, often broad-spectrum, is widespread. Certain patient characteristics (including advanced age, nonambulatory, dementia, and incontinence) and the misinterpretation of test results (including overemphasis of the urinalysis) drive clinicians to treat ASB. Requiring documentation of antibiotic indication may decrease inappropriate treatment. Future interventions may be more effective by incorporating these drivers of ASB treatment. Disclosures All authors: No reported Disclosures.

Importance Treatment of asymptomatic bacteriuria (ASB) with antibiotics is a common factor in inappropriate antibiotic use, but risk factors and outcomes associated with treatment of ASB in hospitalized patients are not well defined. Objective To evaluate factors associated with treatment of ASB among hospitalized patients and the possible association between treatment and clinical outcomes. Design, Setting, and Participants A retrospective cohort study was conducted from January 1, 2016, through February 1, 2018, at 46 hospitals participating in the Michigan Hospital Medicine Safety Consortium. A total of 2733 hospitalized medical patients with ASB, defined as a positive urine culture without any documented signs or symptoms attributable to urinary tract infection, were included in the analysis. Exposures One or more antibiotic dose for treatment of ASB. Main Outcomes and Measures Estimators of antibiotic treatment of ASB. Secondary outcomes included 30-day mortality, 30-day hospital readmission, 30-day emergency department visit, discharge to post–acute care settings,Clostridioides difficileinfection (formerly known asClostridium difficile) at 30 days, and duration of hospitalization after urine testing. Results Of 2733 patients with ASB, 2138 were women (78.2%); median age was 77 years (interquartile range [IQR], 66-86 years). A total of 2259 patients (82.7%) were treated with antibiotics for a median of 7 days (IQR, 4-9 days). Factors associated with ASB treatment included older age (odds ratio [OR], 1.10 per 10-year increase; 95% CI, 1.02-1.18), dementia (OR, 1.57; 95% CI, 1.15-2.13), acutely altered mental status (OR, 1.93; 95% CI, 1.23-3.04), urinary incontinence (OR, 1.81; 95% CI, 1.36-2.41), leukocytosis (white blood cell count >10 000/μL) (OR, 1.55; 95% CI, 1.21-2.00), positive urinalysis (presence of leukocyte esterase or nitrite, or >5 white blood cells per high-power field) (OR, 2.83; 95% CI, 2.05-3.93), and urine culture with a bacterial colony count greater than 100 000 colony-forming units per high-power field (OR, 2.30; 95% CI, 1.83-2.91). Treatment of ASB was associated with longer duration of hospitalization after urine testing (4 vs 3 days; relative risk, 1.37; 95% CI, 1.28-1.47). No other differences in secondary outcomes were identified after propensity weighting. Conclusions and Relevance Hospitalized patients with ASB commonly receive inappropriate antibiotic therapy. Antibiotic treatment did not appear to be associated with improved outcomes; rather, treatment may be associated with longer duration of hospitalization after urine testing. To possibly reduce inappropriate antibiotic use, stewardship efforts should focus on improving urine testing practices and management strategies for elderly patients with altered mental status.

Are the antibiotics that you prescribe at hospital discharge helping your patients or harming them? In this commentary, an expert discusses the optimal antibiotic duration for patients with pneumon...

Background Randomized trials demonstrate no benefit from antibiotic treatment exceeding the shortest effective duration. Objective To examine predictors and outcomes associated with excess duration of antibiotic treatment. Design Retrospective cohort study. Setting 43 hospitals in the Michigan Hospital Medicine Safety Consortium. Patients 6481 general care medical patients with pneumonia. Measurements The primary outcome was the rate of excess antibiotic treatment duration (excess days per 30-day period). Excess days were calculated by subtracting each patient's shortest effective (expected) treatment duration (based on time to clinical stability, pathogen, and pneumonia classification [community-acquired vs. health care-associated]) from the actual duration. Negative binomial generalized estimating equations (GEEs) were used to calculate rate ratios to assess predictors of 30-day rates of excess duration. Patient outcomes, assessed at 30 days via the medical record and telephone calls, were evaluated using logit GEEs that adjusted for patient characteristics and probability of treatment. Results Two thirds (67.8% [4391 of 6481]) of patients received excess antibiotic therapy. Antibiotics prescribed at discharge accounted for 93.2% of excess duration. Patients who had respiratory cultures or nonculture diagnostic testing, had a longer stay, received a high-risk antibiotic in the prior 90 days, had community-acquired pneumonia, or did not have a total antibiotic treatment duration documented at discharge were more likely to receive excess treatment. Excess treatment was not associated with lower rates of any adverse outcomes, including death, readmission, emergency department visit, or Clostridioides difficile infection. Each excess day of treatment was associated with a 5% increase in the odds of antibiotic-associated adverse events reported by patients after discharge. Limitation Retrospective design; not all patients could be contacted to report 30-day outcomes. Conclusion Patients hospitalized with pneumonia often receive excess antibiotic therapy. Excess antibiotic treatment was associated with patient-reported adverse events. Future interventions should focus on whether reducing excess treatment and improving documentation at discharge improves outcomes. Primary funding source Blue Cross Blue Shield of Michigan (BCBSM) and Blue Care Network as part of the BCBSM Value Partnerships program.

Background Existing guidelines, including Choosing Wisely recommendations, endorse avoiding placement of peripherally inserted central catheters (PICCs) in patients with chronic kidney disease (CKD). Objective To describe the frequency of and characteristics associated with PICC use in hospitalized patients with stage 3b or greater CKD (glomerular filtration rate [GFR]

222 Background: AA men often present with more aggressive prostate cancer and are less likely to receive treatment, negatively affecting quality-of-life and overall survival (OS). Sipuleucel-T is an autologous cellular immunotherapy approved for asymptomatic or minimally symptomatic mCRPC. Data from the PROCEED registry showed that OS for AA pts treated with SIP-T was 9.3 mo longer than OS for Caucasian pts. In a prior subgroup analysis of Phase III data, AA pts realized a 30.7-mo difference in OS with SIP-T vs. placebo (PBO). We calculated the NNTB to further interpret the OS benefit in AA pts. Methods: Data were pooled from 3 Phase III mCRPC SIP-T trials (D9901, D9902A, and IMPACT). The absolute risk reduction (ARR) is calculated from Kaplan-Meier estimates at 12-, 24-, and 36-mo for all SIP-T subjects, and an AA cohort, receiving ≥1 infusion. NNTB, the inverse of the ARR, represents the number of pts needed to be treated with SIP-T to prevent 1 additional death compared to PBO. All NNTB values are rounded up. Results: Of the 737 pooled mCRPC pts enrolled, 488 men were randomized to SIP-T (n=33 AA), and 249 to PBO. Baseline clinical characteristics between the SIP-T and PBO groups were well balanced; however, compared to overall SIP-T and PBO, AA SIP-T pts were more likely to have received prior chemotherapy, lower hemoglobin, and better performance status. The NNTB at 12-mo was the same (13) for both the pooled SIP-T and AA treated cohort. At 24-mo, the NNTB values were 10 for pooled and 5 for AA. At 36-mo, an NNTB of 8 (pooled) and 3 (AA) SIP-T treatments prevented 1 additional death (Table). Conclusions: This NNTB analysis shows a favorable survival benefit for AA men treated with SIP-T and all treated SIP-T subjects. NNTB values declined over 3-years, suggesting durability of clinical benefit with SIP-T, and that it may address a known survival disparity in AA with prostate cancer. Studies with larger sample sizes may confirm if AA pts derive a greater OS benefit from SIP-T. Clinical trial information: NCT00065442. [Table: see text]

Objective.To determine relative rates of blood culture contamination for 3 skin antisepsis interventions—10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT), and 2% Chlorhexidine gluconate in 70% isopropyl alcohol (CHG)—when used by dedicated phlebotomy teams to obtain peripheral blood cultures.Design.Randomized crossover trial with hospital floor as the unit of randomization.Setting.Teaching hospital with 885 beds.Patients.All adult patients undergoing peripheral blood culture collection on 3 medical-surgical floors from May 2009 through September 2009.Intervention.Each antisepsis intervention was used for 5 months on each study floor, with random crossover after a 1-month washout period. Phlebotomy teams collected all peripheral blood cultures. Each positive blood culture was adjudicated by physicians blinded to the intervention and scored as a true positive or contaminated blood culture. The primary outcome was the rate of blood culture contamination for each antisepsis agent.Results.In total, 12,904 peripheral blood culture sets were evaluated, of which 735 (5.7%) were positive. There were 98 contaminated cultures, representing 13.3% of all positive cultures. The overall blood culture contamination rate for the study population was 0.76%. Intent-to-treat rates of contaminated blood cultures were not significantly different among the 3 antiseptics (P= .18), yielding 0.58% with PI (95% confidence interval [CI], 0.38%-0.86%), 0.76% with IT (95% CI, 0.52%-1.07%), and 0.93% with CHG (95% CI, 0.67%-1.27%).Conclusion.Choice of antiseptic agent does not impact contamination rates when blood cultures are obtained by a phlebotomy team and should, therefore, be based on costs or preference.Trial Registration.ClinicalTrials.gov identifier: NCT01216761.

OBJECTIVEInappropriate treatment of asymptomatic bacteriuria (ASB) in the hospital setting is common. We sought to evaluate the treatment rate of ASB at the 3 hospitals and assess the impact of a hospitalist-focused improvement intervention.DESIGNProspective, interventional trial.SETTINGTwo community hospitals and a tertiary-care academic center.PATIENTSAdult patients with a positive urine culture admitted to hospitalist services were included in this study. Exclusions included pregnancy, intensive care unit admission, history of a major urinary procedure, and actively being treated for a urinary tract infection (UTI) at the time of admission or >48 hours prior to urine collection.INTERVENTIONSAn educational intervention using a pocket card was implemented at all sites followed by a pharmacist-based intervention at the academic center. Medical records of the first 50 eligible patients at each site were reviewed at baseline and after each intervention for signs and symptoms of UTI, microbiological results, antimicrobials used, and duration of treatment for positive urine cultures. Diagnosis of ASB was determined through adjudication by 2 hospitalists and 2 infectious diseases physicians.RESULTSTreatment rates of ASB decreased (23.5%; P=.001) after the educational intervention. Reductions in treatment rates for ASB differed by site and were greatest in patients without classic signs and symptoms of UTI (34.1%; PPCONCLUSIONSA hospitalist-focused educational intervention significantly reduced ASB treatment rates. The impact varied across sites and by patient characteristics, suggesting that a tailored approach may be useful.Infect Control Hosp Epidemiol 2016;37:1044–1051

Objective The objective of this study was to perform a systematic review and meta-analysis of the effects of statins on mortality following pneumonia. Methods We searched MEDLINE, EMBASE, BIOSIS, Cochrane CENTRAL Register of Controlled Trials, Cambridge Scientific Abstracts, BIOSIS, and Scopus. Studies were included if they involved: participants ≥18 years of age; patients with community-acquired pneumonia; current statin users; and reported overall or adjusted mortality after pneumonia. Results Of 491 citations identified, 13 studies involving 254,950 patients met eligibility criteria. Pooled unadjusted data showed that statin use was associated with lower mortality after pneumonia (odds ratio [OR] 0.62, 95% confidence interval [CI], 0.54-0.71). Pooling of adjusted data also showed reduced mortality after pneumonia (OR 0.66, 95% CI, 0.55-0.79). However, this effect was attenuated in subgroup analysis by confounders and in prospective studies. Conclusions Although statin use is associated with decreased mortality after pneumonia, this effect weakens in important subgroups. Only a randomized controlled study can fully explore the link between statins and pneumonia mortality.

The transition out of the hospital is a vulnerable time for patients, relying heavily on communication and coordination of resources across care settings. Understanding the perspectives of inpatient and outpatient physicians regarding factors contributing to readmission and potential preventive strategies is crucial in designing appropriately targeted readmission prevention efforts. To examine and compare inpatient and outpatient physician opinions regarding reasons for readmission and interventions that might have prevented readmission. Cross-sectional multicenter study. We identified patients readmitted to general medicine services within 30 days of discharge at 12 US academic medical centers, and surveyed the primary care physician (PCP), discharging physician from the index admission, and admitting physician from the readmission regarding their endorsement of pre-specified factors contributing to the readmission and potential preventive strategies. We calculated kappa statistics to gauge agreement between physician dyads (PCP-discharging physician, PCP-admitting physician, and admitting-discharging physician). We evaluated 993 readmission events, which generated responses from 356 PCPs (36 % of readmissions), 675 discharging physicians (68 % of readmissions), and 737 admitting physicians (74 % of readmissions). The most commonly endorsed contributing factors by both PCPs and inpatient physicians related to patient understanding and ability to self-manage. The most commonly endorsed preventive strategies involved providing patients with enhanced post-discharge instructions and/or support. Although PCPs and inpatient physicians endorsed contributing factors and potential preventive strategies with similar frequencies, agreement among the three physicians on the specific factors and/or strategies that applied to individual readmission events was poor (maximum kappa 0.30). Differing opinions among physicians on factors contributing to individual readmissions highlights the importance of communication between inpatient and outpatient providers at discharge to share their different perspectives, and suggests that multi-faceted, broadly applied interventions may be more successful than those that rely on individual providers choosing specific services based on perceived risk factors.

Background Community-acquired pneumonia (CAP) guidelines recommend transition to an oral (PO) β-lactam (BL) regimen or fluoroquinolone (FQ) when patients are clinically stable. Due to collateral damage associated with FQs, stewardship efforts often focus on reducing initial FQ use for CAP therapy. We hypothesized that FQ use remains prevalent in CAP treatment despite initial intravenous (IV) BL therapy, and examined factors associated with switching to a PO BL vs. an FQ and the impact on outcomes. Methods In this retrospective cohort study, data were collected from January 2016 through February 2018 on non-ICU medical patients admitted with CAP at 46 Michigan hospitals. Patients were included if they received IV BL (ceftriaxone or ampicillin-sulbactam) plus macrolide/doxycycline by hospital day 2 and switched to a PO respiratory FQ or BL by therapy day 4. Exclusions included positive culture, concomitant infection, HCAP, unstable on day 4, or severe immune deficiency. Data were analyzed using logistic generalized estimating equation models, accounting for hospital-level clustering; outcomes were adjusted using the inverse probability of treatment weighting by propensity scores. Results. Of 555 included patients, 54.4% were switched to a PO BL vs. 45.6% to an FQ by day 4 of therapy. The groups had similar durations of therapy (8 days), time to clinical stability, prior antibiotics, and COPD, but the BL group was older, with a higher Pneumonia Severity Index, CURB-65, and more cardiovascular (CV) disease (Figure 1). In multivariable analysis, CV disease and higher CURB-65 were more common and diabetes (DM) less common in the PO BL group (Figure 2). Sharing antibiotic use data with providers were associated with less FQ use (83.1% vs. 70.8%, OR 0.51, 95% CI 0.27, 0.97, P = 0.04). On adjusted analysis there were no differences in patient outcomes (Figure 3). Conclusion. Among CAP patients started on an IV BL regimen, nearly half were switched to a PO FQ by therapy day 4, including more patients with DM. Although there were sicker patients in the BL group, there were no differences in outcomes between cohorts. To reduce FQ use, stewardship programs should share antibiotic use data and provide guidance for step-down therapy in clinically stable CAP patients. Disclosures All authors: No reported disclosures.

National guidelines1 recommend objective risk stratification for venous thromboembolism (VTE) in hospitalized medical patients. The Padua Prediction Score risk assessment model2 is recommended to categorize patients as high or low risk. The Michigan Hospital Medicine Safety Consortium (HMS), a statewide quality collaborative aimed at preventing adverse events in hospitalized medical patients, collects detailed data on VTE risk factors, prophylactic treatment, and outcomes. Using data from the HMS,3 we sought to determine whether patients in this cohort were receiving appropriate VTE prophylaxis.

Bicalutamide (BIC), a non-steroidal anti-androgen, is FDA-indicated for use in combination with a luteinizing hormone-releasing hormone (LHRH) analog for treatment of Stage D2 metastatic carcinoma of the prostate. Lack of consensus exists regarding the clinical benefit of BIC use, either alone or combined use of BIC with an LHRH analog or antagonist (combined androgen blockade or CAB), versus treatment with androgen deprivation therapy (ADT) alone.The SEER-Medicare database was used to identify prostate cancer patients aged ≥ 66 years diagnosed between 2007 and 2011 and who filled at least one prescription for BIC. Duration of BIC treatment was assessed in relation to ADT use; either alone (monotherapy), as part of CAB only, and as part of CAB followed by monotherapy. Additionally, we assessed use of BIC during or outside a potential testosterone flare prevention period (initiation within 2 months of an LHRH agonist).A total of 7521 prostate cancer patients who filled a prescription for BIC were identified. Eighteen percent of the cohort used BIC alone, over half the patients (54%) used BIC as part of CAB and 27% used BIC as part of CAB followed by monotherapy. Among men treated with BIC as part of CAB, 58% received BIC only within the potential flare period.Although there is no FDA indication for BIC use as monotherapy, 44% of patients in this study used BIC alone or as part of CAB followed by monotherapy. Further research is necessary to understand the outcomes of BIC utilization in these settings, particularly compared with newer second-generation anti-androgens.Medivation LLC, a Pfizer company, and Astellas, Pharma, Inc.

232 Background: Cost of care is an important component of valuation of novel treatments in oncology. Enzalutamide (ENZA) and abiraterone acetate (ABI) are approved hormonal agents for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This study compared healthcare resource utilization (HRU) and costs for patients treated with ENZA or ABI in the U.S. Methods: Adult mCRPC patients initiating ENZA or ABI before and or after cytotoxic chemotherapy were identified from the Truven MarketScan claims database (2012–2015). The first claim of ENZA or ABI was defined as the index date; continuous enrollment ≥6 months before and ≥3 months after the index date was required. HRU and costs were estimated during the post-index period for both cohorts. Generalized linear models compared HRU and costs between the cohorts and were adjusted for baseline demographic and clinical covariates. Analyses were separately conducted for chemo-naïve and chemo-experienced patients. Results: The study included 3230 chemo-naive patients (ENZA 920; ABI 2310) and 692 chemo-experienced patients (ENZA 262; ABI 430). Among chemo-naive patients, ENZA cohort was older (mean age: 74.5 vs 73.5; p=0.013), with a higher proportion of baseline comorbidities vs ABI cohort. During the post-index period, ENZA cohort had fewer all-cause inpatient admissions (IPA) [adjusted incidence rate ratio (IRR) 0.87; p=0.033], all-cause outpatient visits (OPV) [adjusted IRR 0.94; p=0.004], and PC-related OPV (adjusted IRR 0.92; p

228 Background: Androgen receptor inhibitors enzalutamide (ENZA) and bicalutamide (BIC) are used to treat metastatic castration-resistant prostate cancer (mCRPC). The Phase 2 STRIVE trial included 35% non-metastatic (m0) and 65% metastatic CRPC patients (pts); ENZA reduced the risk of progression or death among pts, with an adverse event profile consistent with previous trials. The objective of this analysis was to compare ENZA with BIC using the number needed to treat (NNT) to achieve one additional pt with m0CRPC, with either a progression-free survival (PFS) event, radiographic PFS (rPFS), or free of prostate-specific antigen (PSA) progression at 1 year and 2 years. Methods: The 1- and 2-year event rates of PFS, rPFS, and progression-free PSA among pts treated with ENZA and BIC were obtained from the STRIVE trial report. The NNT was calculated as the reciprocal of the absolute risk reduction between ENZA and BIC at each time point. This represents the number of pts that need to be treated with ENZA, compared with BIC, to obtain one additional pt free of a clinical progression event. PFS was defined as the time from randomization to investigator-assessed radiographic (bone or soft tissue) progression, PSA progression, or death. The 95% confidence interval (CI) of the NNT was derived based on the 95% CI of the event rate difference. Results: The NNT to achieve one additional pt with PFS at 1 year, comparing ENZA with BIC, was 2.2 (95% CI 1.7, 3.4), suggesting that treating three pts with ENZA instead of BIC would result in one additional pt free of progression or death at the end of 1 year. The NNT to achieve one additional pt with PFS at 2 years was also 2.2 (95% CI 1.5, 3.7). For rPFS, the NNTs comparing ENZA with BIC were 4.7 (95% CI 2.8, 14.6) and 3.0 (95% CI 2.0, 6.1) at 1 and 2 years, respectively. For progression-free PSA, the NNTs were 2.0 (95% CI 1.5, 2.8) and 2.0 (95% CI 1.4, 3.3) at 1 and 2 years, respectively. Conclusions: This analysis supports the superior clinical benefit of ENZA versus BIC in men with m0CRPC. Pts treated with ENZA showed low NNT values across all clinical outcomes and time points. Clinical trial information: NCT01664923.