Financial Toxicity Among Patients With Metastatic Prostate Cancer: A Mixed Methods Approach to Identify Effective Interventions.

INTRODUCTION: Financial toxicity associated with treatments for metastatic prostate cancer remains poorly defined. We sought to understand aspects of financial toxicity not captured in a commonly employed financial toxicity questionnaire and identify potential interventions to help alleviate financial toxicity through a convergent mixed methods approach. METHODS: Patients seen at our institution's advanced prostate cancer clinic were approached for completion of the Comprehensive Score for Financial Toxicity (COST-FACIT) questionnaire (quantitative analysis). A maximal variation purposive sample was chosen to participate in focus group discussions (qualitative analysis). Conventional content analysis was performed using an inductive approach. COST-FACIT scores were compared between patients experiencing high and low financial toxicity using Wilcoxon rank sum test. RESULTS: Three themes were identified through qualitative analysis: (1) workload, (2) coping strategies, and (3) communication. We found alignment with the existing theory of financial capacity across our findings. Two unique aspects of financial toxicity emerged that were not assessed quantitatively and deemed to be significant. Specifically, cost transparency (including health care teams knowledgeable about and willing to discuss costs) and inclusion of informal caregivers in financial toxicity screening and decision-making may guide future interventions aimed at limiting financial toxicity in this population. CONCLUSIONS: Prolonged treatment courses involving multiple lines of treatment with varying costs result in distinct financial toxicity components for patients with metastatic prostate cancer that are not assessed with COST-FACIT. Improving cost transparency, health care team knowledge and engagement, and providing resources to support informal caregivers may have a significant impact on the financial toxicity experienced by these patients.

Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial.

BACKGROUND: Innovative restructuring of cardiac rehabilitation (CR) delivery remains critical to reduce barriers and improve access to diverse populations. Destination Cardiac Rehab is a novel virtual world technology-based CR program delivered through the virtual world platform, Second Life, which previously demonstrated high acceptability as an extension of traditional center-based CR. This study aims to evaluate efficacy and adherence of the virtual world-based CR program compared with center-based CR within a community-informed, implementation science framework. METHODS: Using a noninferiority, hybrid type 1 effectiveness-implementation, randomized controlled trial, 150 patients with an eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. Participants will be randomized 1:1 to either the 12-week Destination Cardiac Rehab or the center-based CR control groups. The primary efficacy outcome is a composite cardiovascular health score based on the American Heart Association Life's Essential 8 at 3 and 6 months. Adherence outcomes include CR session attendance and participation in exercise sessions. A diverse patient/caregiver/stakeholder advisory board was assembled to guide recruitment, implementation, and dissemination plans and to contextualize study findings. The institutional review board-approved randomized controlled trial will enroll and randomize patients to the intervention (or control group) in 3 consecutive waves/year over 3 years. The results will be published at data collection and analyses completion. CONCLUSIONS: The Destination Cardiac Rehab randomized controlled trial tests an innovative and potentially scalable model to enhance CR participation and advance health equity. Our findings will inform the use of effective virtual CR programs to expand equitable access to diverse patient populations. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05897710.

Coping Mechanisms for Financial Toxicity Among Patients With Metastatic Prostate Cancer: A Survey-based Assessment.

PURPOSE: Assessments of financial toxicity among patients with metastatic prostate cancer are lacking. Using patient surveys, we sought to identify coping mechanisms and assess characteristics associated with lower financial toxicity. MATERIALS AND METHODS: Surveys were administered to all patients seen at a single center's Advanced Prostate Cancer Clinic over a 3-month period. Surveys included the COST-FACIT (COmprehensive Score for Financial Toxicity) and coping mechanism questionnaires. Patients with metastatic disease (lymph nodes, bone, visceral) were included for analysis. Coping mechanisms were compared between patients experiencing low (COST-FACIT >24) vs high (COST-FACIT ≤24) financial toxicity using Fisher's exact test. Multivariable linear regression was used to evaluate characteristics associated with lower financial toxicity. RESULTS: Overall, 281 patients met inclusion criteria of which 79 reported high financial toxicity. In multivariable analysis, characteristics associated with lower financial toxicity included older age (estimate: 0.36, 95%CI: 0.21-0.52), applying for patient assistance programs (estimate: 4.42, 95%CI: 1.72-7.11), and an annual income of at least $100,000 (estimate: 7.81, 95%CI: 0.97, 14.66). Patients with high financial toxicity were more likely to decrease spending on basic goods (35% vs 2.5%, P < .001) and leisure activities (59% vs 15%, P > .001), as well as use savings (62% vs 17%, P < .001) to pay for their treatment. CONCLUSIONS: In this cross-sectional study, patients with metastatic prostate cancer and high financial toxicity were more likely to decrease spending on basic goods and leisure activities and use savings to pay for care. Understanding the impact of financial toxicity on patients' lives is crucial to inform shared decision-making and interventions designed to mitigate financial toxicity in this population.

Separating variability in healthcare practice patterns from random error.

Improving the quality of care that patients receive is a major focus of clinical research, particularly in the setting of cardiovascular hospitalization. Quality improvement studies seek to estimate and visualize the degree of variability in dichotomous treatment patterns and outcomes across different providers, whereby naive techniques either over-estimate or under-estimate the actual degree of variation. Various statistical methods have been proposed for similar applications including (1) the Gaussian hierarchical model, (2) the semi-parametric Bayesian hierarchical model with a Dirichlet process prior and (3) the non-parametric empirical Bayes approach of smoothing by roughening. Alternatively, we propose that a recently developed method for density estimation in the presence of measurement error, moment-adjusted imputation, can be adapted for this problem. The methods are compared by an extensive simulation study. In the present context, we find that the Bayesian methods are sensitive to the choice of prior and tuning parameters, whereas moment-adjusted imputation performs well with modest sample size requirements. The alternative approaches are applied to identify disparities in the receipt of early physician follow-up after myocardial infarction across 225 hospitals in the CRUSADE registry.

Association of Kidney Function With 30-Day and 1-Year Poststroke Mortality and Hospital Readmission.

Background and Purpose- Kidney dysfunction is common among patients hospitalized for ischemic stroke. Understanding the association of kidney disease with poststroke outcomes is important to properly adjust for case mix in outcome studies, payment models and risk-standardized hospital readmission rates. Methods- In this cohort study of fee-for-service Medicare patients admitted with ischemic stroke to 1579 Get With The Guidelines-Stroke participating hospitals between 2009 and 2014, adjusted multivariable Cox proportional hazards models were used to determine the independent associations of estimated glomerular filtration rate (eGFR) and dialysis status with 30-day and 1-year postdischarge mortality and rehospitalizations. Results- Of 204 652 patients discharged alive (median age [25th-75th percentile] 80 years [73.0-86.0], 57.6% women, 79.8% white), 48.8% had an eGFR ≥60, 26.5% an eGFR 45 to 59, 16.3% an eGFR 30 to 44, 5.1% an eGFR 15 to 29, 0.6% an eGFR <15 without dialysis, and 2.8% were receiving dialysis. Compared with eGFR ≥60, and after adjusting for relevant variables, eGFR <45 was associated with increased 30-day mortality with the risk highest among those with eGFR <15 without dialysis (hazard ratio [HR], 2.09; 95% CI, 1.66-2.63). An eGFR <60 was associated with increased 1-year poststroke mortality that was highest among patients on dialysis (HR, 2.65; 95% CI, 2.49-2.81). Dialysis was also associated with the highest 30-day and 1-year rehospitalization rates (HR, 2.10; 95% CI, 1.95-2.26 and HR, 2.55; 95% CI, 2.44-2.66, respectively) and 30-day and 1-year composite of mortality and rehospitalization (HR, 2.04; 95% CI, 1.90-2.18 and HR, 2.46; 95% CI, 2.36-2.56, respectively). Conclusions- Within the first year after index hospitalization for ischemic stroke, eGFR and dialysis status on admission are associated with poststroke mortality and hospital readmissions. Kidney function should be included in risk-stratification models for poststroke outcomes.

Relationship between Hospital 30-Day Mortality Rates for Heart Failure and Patterns of Early Inpatient Comfort Care.

BACKGROUND: The Centers for Medicare & Medicaid Services rewards hospitals that have low 30-day riskstandardized mortality rates (RSMR) for heart failure (HF). OBJECTIVE: To describe the use of early comfort care for patients with HF, and whether hospitals that more commonly initiate comfort care have higher 30-day mortality rates. DESIGN: A retrospective, observational study. SETTING: Acute care hospitals in the United States. PATIENTS: A total of 93,920 fee-for-service Medicare beneficiaries admitted with HF from January 2008 to December 2014 to 272 hospitals participating in the Get With The Guidelines-Heart Failure registry. EXPOSURE: Early comfort care (defined as comfort care within 48 hours of hospitalization) rate. MEASUREMENTS: A 30-day RSMR. RESULTS: Hospitals' early comfort care rates were low for patients admitted for HF, with no change over time (2.5% to 2.6%, from 2008 to 2014, P = .56). Rates varied widely (0% to 40%), with 14.3% of hospitals not initiating comfort care for any patients during the first 2 days of hospitalization. Risk-standardized early comfort care rates were not correlated with RSMR (median RSMR = 10.9%, 25th to 75th percentile = 10.1% to 12.0%; Spearman's rank correlation = 0.13; P = .66). CONCLUSIONS: Hospital use of early comfort care for HF varies, has not increased over time, and on average, is not correlated with 30-day RSMR. This suggests that current efforts to lower mortality rates have not had unintended consequences for hospitals that institute early comfort care more commonly than their peers.

Association Between Hospital Volume, Processes of Care, and Outcomes in Patients Admitted With Heart Failure: Insights From Get With The Guidelines-Heart Failure.

BACKGROUND: Hospital volume is frequently used as a structural metric for assessing quality of care, but its utility in patients admitted with acute heart failure (HF) is not well characterized. Accordingly, we sought to determine the relationship between admission volume, process-of-care metrics, and short- and long-term outcomes in patients admitted with acute HF. METHODS: Patients enrolled in the Get With The Guidelines-HF registry with linked Medicare inpatient data at 342 hospitals were assessed. Volume was assessed both as a continuous variable, and quartiles based on the admitting hospital annual HF case volume, as well: 5 to 38 (quartile 1), 39 to 77 (quartile 2), 78 to 122 (quartile 3), 123 to 457 (quartile 4). The main outcome measures were (1) process measures at discharge (achievement of HF achievement, quality, reporting, and composite metrics); (2) 30-day mortality and hospital readmission; and (3) 6-month mortality and hospital readmission. Adjusted logistic and Cox proportional hazards models were used to study these associations with hospital volume. RESULTS: A total of 125 595 patients with HF were included. Patients admitted to high-volume hospitals had a higher burden of comorbidities. On multivariable modeling, lower-volume hospitals were significantly less likely to be adherent to HF process measures than higher-volume hospitals. Higher hospital volume was not associated with a difference in in-hospital (odds ratio, 0.99; 95% confidence interval [CI], 0.94-1.05; P=0.78) or 30-day mortality (hazard ratio, 0.99; 95% CI, 0.97-1.01; P=0.26), or 30-day readmissions (hazard ratio, 0.99; 95% CI, 0.97-1.00; P=0.10). There was a weak association of higher volumes with lower 6-month mortality (hazard ratio, 0.98; 95% CI, 0.97-0.99; P=0.001) and lower 6-month all-cause readmissions (hazard ratio, 0.98; 95%, CI 0.97-1.00; P=0.025). CONCLUSIONS: Our analysis of a large contemporary prospective national quality improvement registry of older patients with HF indicates that hospital volume as a structural metric correlates with process measures, but not with 30-day outcomes, and only marginally with outcomes up to 6 months of follow-up. Hospital profiling should focus on participation in systems of care, adherence to process metrics, and risk-standardized outcomes rather than on hospital volume itself.

Regional Variation in 30-Day Ischemic Stroke Outcomes for Medicare Beneficiaries Treated in Get With The Guidelines-Stroke Hospitals.

BACKGROUND: We explored regional variation in 30-day ischemic stroke mortality and readmission rates and the extent to which regional differences in patients, hospitals, healthcare resources, and a quality of care composite care measure explain the observed variation. METHODS AND RESULTS: This ecological analysis aggregated patient and hospital characteristics from the Get With The Guidelines-Stroke registry (2007-2011), healthcare resource data from the Dartmouth Atlas of Health Care (2006), and Medicare fee-for-service data on 30-day mortality and readmissions (2007-2011) to the hospital referral region (HRR) level. We used linear regression to estimate adjusted HRR-level 30-day outcomes, to identify HRR-level characteristics associated with 30-day outcomes, and to describe which characteristics explained variation in 30-day outcomes. The mean adjusted HRR-level 30-day mortality and readmission rates were 10.3% (SD=1.1%) and 13.1% (SD=1.1%), respectively; a modest, negative correlation (r=-0.17; P=0.003) was found between one another. Demographics explained more variation in readmissions than mortality (25% versus 6%), but after accounting for demographics, comorbidities accounted for more variation in mortality compared with readmission rates (17% versus 7%). The combination of hospital characteristics and healthcare resources explained 11% and 16% of the variance in mortality and readmission rates, beyond patient characteristics. Most of the regional variation in mortality (65%) and readmission (50%) rates remained unexplained. CONCLUSIONS: Thirty-day mortality and readmission rates vary substantially across HRRs and exhibit an inverse relationship. While regional variation in 30-day outcomes were explained by patient and hospital factors differently, much of the regional variation in both outcomes remains unexplained.

Association of measured platelet reactivity with changes in P2Y12 receptor inhibitor therapy and outcomes after myocardial infarction: Insights into routine clinical practice from the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) study.

BACKGROUND: Little is known about the use of platelet function testing to guide choice of P2Y12 receptor inhibitor therapy in routine clinical practice. METHODS: We studied 671 myocardial infarction (MI) patients treated with percutaneous coronary intervention in the TRANSLATE-ACS Registry who had VerifyNow platelet function testing performed while on clopidogrel treatment during their index hospitalization (April 2010-October 2012). RESULTS: High platelet reactivity (>208 platelet reactivity units [PRU]) was present in 261 (38.9%) patients. Clopidogrel was switched in-hospital to prasugrel in 80 (30.7%) patients with high platelet reactivity and 18 (4.4%) patients with therapeutic platelet reactivity (≤208 PRU). Among high platelet reactivity patients, switch to prasugrel was associated with lower major adverse cardiovascular events (death, MI, stroke, or unplanned revascularization) at 1year (10.0% vs 22.7%, P=.02; adjusted odds ratio [OR] 0.39, 95% CI 0.18-0.85, P=.02) and no significant difference in Bleeding Academic Research Consortium type 2 or higher bleeding (23.8% vs 22.1%, P=.77; adjusted OR 0.91, 95% CI 0.48-1.7, P=.77) compared with patients continued on clopidogrel. No significant differences in major adverse cardiovascular event (22.2% vs 12.8%, P=.25; adjusted OR 1.8, 95% CI 0.47-7.3, P=.38) or bleeding (22.2% vs 19.4%, P=.77; adjusted OR 1.3, 95% CI 0.27-6.8, P=.72) were observed among therapeutic platelet reactivity patients between switching and continuation on clopidogrel. CONCLUSIONS: Only one-third of percutaneous coronary intervention-treated MI patients with high on-clopidogrel platelet reactivity were switched to a more potent P2Y12 receptor inhibitor. Intensification of antiplatelet therapy was associated with lower risk of ischemic events at 1year among HPR patients.

Assessment of cardiac allograft systolic function by global longitudinal strain: From donor to recipient.

BACKGROUND: Cardiac allografts are routinely evaluated by left ventricular ejection fraction (LVEF) before and after transplantation. However, myocardial deformation analyses with LV global longitudinal strain (GLS) are more sensitive for detecting impaired LV myocardial systolic performance compared with LVEF. METHODS: We analyzed echocardiograms in 34 heart donor-recipient pairs transplanted at Duke University from 2000 to 2013. Assessments of allograft LV systolic function by LVEF and/or LV GLS were performed on echocardiograms obtained pre-explanation in donors and serially in corresponding recipients. RESULTS: Donors had a median LVEF of 55% (25th, 75th percentile, 54% to 60%). Median donor LV GLS was -14.6% (-13.7 to -17.3%); LV GLS was abnormal (ie, >-16%) in 68% of donors. Post-transplantation, LV GLS was further impaired at 6 weeks (median -11.8%; -11.0 to -13.4%) and 3 months (median -11.4%; -10.3 to -13.9%) before recovering to pretransplant levels in follow-up. Median LVEF remained ≥50% throughout follow-up. We found no association between donor LV GLS and post-transplant outcomes, including all-cause hospitalization and mortality. CONCLUSIONS: GLS demonstrates allograft LV systolic dysfunction in donors and recipients not detected by LVEF. The clinical implications of subclinical allograft dysfunction detected by LV GLS require further study.

Renal Dysfunction Is Associated With Poststroke Discharge Disposition and In-Hospital Mortality: Findings From Get With The Guidelines-Stroke.

BACKGROUND AND PURPOSE: Kidney disease is a frequent comorbidity in patients presenting with acute ischemic stroke. We evaluated whether the estimated glomerular filtration rate (eGFR) on admission is associated with poststroke in-hospital mortality or discharge disposition. METHODS: In this cohort study, data from ischemic stroke patients in Get With The Guidelines-Stroke linked to fee-for-service Medicare data were analyzed. The Modification of Diet in Renal Disease study equation was used to calculate the eGFR (mL/min/1.73 m2). Dialysis was identified by International Classification of Diseases, Ninth Revision codes. Adjusted multivariable Cox proportional hazards models were used to determine the independent associations of eGFR with discharge disposition and in-hospital mortality. Adjusted individual models also examined whether the association of clinical and demographic factors with outcomes varied by eGFR level. RESULTS: Of 232 236 patients, 47.3% had an eGFR ≥60, 26.6% an eGFR 45 to 59, 16.8% an eGFR 30 to 44, 5.6% an eGFR 15 to 29, 0.7% an eGFR<15 without dialysis, and 2.8% were receiving dialysis. Of the total cohort, 11.8% died during the hospitalization or were discharged to hospice, and 38.6% were discharged home. After adjusting for other relevant variables, renal dysfunction was independently associated with an increased risk of in-hospital mortality that was highest among those with eGFR <15 without dialysis (odds ratio, 2.52; 95% confidence interval, 2.07-3.07). An eGFR 15 to 29 (odds ratio, 0.82; 95% confidence interval, 0.78-0.87), eGFR <15 (odds ratio, 0.72; 95% confidence interval, 0.61-0.86), and dialysis (odds ratio, 0.86; 95% confidence interval, 0.79-0.94) remained associated with lower odds of being discharged home. In addition, the associations of several clinical and demographic factors with outcomes varied by eGFR level. CONCLUSIONS: eGFR on admission is an important predictor of poststroke short-term outcomes.

Development and validation of a risk model for in-hospital worsening heart failure from the Acute Decompensated Heart Failure National Registry (ADHERE).

BACKGROUND: A subset of patients hospitalized with acute heart failure experiences in-hospital worsening heart failure, defined as persistent or worsening signs or symptoms requiring an escalation of therapy. METHODS: We analyzed data from the Acute Decompensated Heart Failure National Registry (ADHERE) linked to Medicare claims to develop and validate a risk model for in-hospital worsening heart failure. Our definition of in-hospital worsening heart failure included events such as escalation of medical therapy (eg, inotropic medications) >12hours after admission. We considered candidate risk prediction variables routinely assessed at admission, including age, medical history, biomarkers, and renal function. We used logistic regression with robust standard errors to generate a risk model in a 66% random derivation sample; we validated the model in the remaining 34%. We evaluated the calibration and discrimination of the model in both samples. RESULTS: We evaluated 23,696 patients hospitalized with acute heart failure. Baseline characteristics were well matched in the derivation and validation samples, and the occurrence of in-hospital worsening heart failure was similar in both samples (15.4% and 15.6%, respectively). In the multivariable model, the strongest predictors of in-hospital worsening heart failure were increased troponin and creatinine. The model was well calibrated and had good discrimination in the derivation sample (c statistic, 0.74) and validation sample (c statistic, 0.72). CONCLUSIONS: The ADHERE worsening heart failure risk model is a clinical tool with good discrimination for use in patients hospitalized with acute heart failure to identify those at increased risk for in-hospital worsening heart failure. This tool may be useful to target treatment strategies for patients at high risk for in-hospital worsening heart failure.

Association of Get With The Guidelines-Stroke Program Participation and Clinical Outcomes for Medicare Beneficiaries With Ischemic Stroke.

BACKGROUND AND PURPOSE: Get With The Guidelines (GWTG)-Stroke is a national, hospital-based quality improvement program developed by the American Heart Association. Although studies have suggested improved processes of care in GWTG-Stroke-participating hospitals, it is not known whether this improved care translates into improved clinical outcomes compared with nonparticipating hospitals. METHODS: From all acute care US hospitals caring for Medicare beneficiaries with acute stroke between April 2003 and December 2008, we matched hospitals that joined the GWTG-Stroke program with similar hospitals that did not. Using a difference-in-differences design, we analyzed whether hospital participation in GWTG-Stroke was associated with a greater improvement in clinical outcomes compared with the underlying secular change. RESULTS: The matching algorithm identified 366 GWTG-Stroke-adopting hospitals that cared for 88 584 acute ischemic stroke admissions and 366 non-GWTG-Stroke hospitals that cared for 85 401 acute ischemic stroke admissions. Compared with the Pre period (18-6 months before program implementation), in the Early period (0-6 months after program implementation), GWTG-Stroke hospitals had accelerated increases in discharge to home and reduced mortality at 30 days and 1 year. In the Sustained period (6-18 months after program implementation), the accelerated reduction in mortality at 1 year was sustained, with a trend toward sustained accelerated increase in discharge home. CONCLUSIONS: Hospital adoption of the GWTG-Stroke program was associated with improved functional outcomes at discharge and reduced postdischarge mortality.

Comparative Effectiveness of Implantable Cardioverter Defibrillators for Primary Prevention in Women.

BACKGROUND: Clinical trials of implantable cardioverter defibrillators (ICDs) for primary prevention enrolled a limited number of women. We sought to examine clinical practice data to compare survival rates among women with heart failure with or without a primary prevention ICD. METHODS AND RESULTS: We linked data from 264 US hospitals included in the Get With The Guidelines for Heart Failure registry with data from the Centers for Medicare and Medicaid Services. From these sources, we propensity score matched 430 women with heart failure who received a primary prevention ICD to 430 women who did not; we further adjusted using a Cox proportional hazards model. Median follow-up was 3.4 and 3.0 years. For comparison, we matched 859 men receiving an ICD with 859 who did not; median follow-up was 3.9 versus 2.9 years. In the matched cohorts, an ICD was associated with similarly better survival in women (hazard ratio, 0.78; 95% confidence interval, 0.66-0.92; P=0.003) and men (hazard ratio, 0.76; 95% confidence interval, 0.67-0.87 P<0.001). There was no interaction between sex and presence of an ICD with respect to survival (P=0.79). CONCLUSIONS: Among patients with heart failure with reduced left ventricular ejection fraction, a primary prevention ICD was associated with a significant survival advantage among women and among men. These findings support guideline-directed use of primary prevention ICDs in eligible patients.

Relation of Elevated Heart Rate in Patients With Heart Failure With Reduced Ejection Fraction to One-Year Outcomes and Costs.

There are limited data describing outcomes associated with an elevated heart rate in patients with heart failure with reduced ejection fraction (HFrEF) in routine clinical practice. We identified patients with HFrEF at Duke University Hospital undergoing echocardiograms and heart rate assessments without paced rhythms or atrial fibrillation. Outcomes (all-cause mortality or hospitalization and medical costs per day alive) were assessed using electronic medical records, hospital cost accounting data, and national death records. Patients were stratified by heart rate (<70 and ≥70 beats/min) and compared using generalized linear models specified with gamma error distributions and log links for costs and proportional hazard models for mortality/hospitalization. Of 722 eligible patients, 582 patients (81%) were treated with ß blockers. The median heart rate was 81 beats/min (25th and 75th percentiles 69 to 96) and 527 patients (73%) had a heart rate ≥70 beats/min. After multivariate adjustment, a heart rate ≥70 beats/min was associated with increased 1-year all-cause mortality or hospitalization, hazard ratio 1.37 (95% CI 1.07 to 1.75) and increased medical costs per day alive, cost ratio 2.03 (95% CI 1.53 to 2.69). In conclusion, at a large tertiary care center, despite broad use of ß blockers, a heart rate ≥70 beats/min was observed in 73% of patients with HFrEF and associated with worse 1-year outcomes and increased direct medical costs per day alive.

Work Activities and Compensation of Male and Female Cardiologists.

BACKGROUND: Much remains unknown about experiences, including working activities and pay, of women in cardiology, which is a predominantly male specialty. OBJECTIVES: The goal of this study was to describe the working activities and pay of female cardiologists compared with their male colleagues and to determine whether sex differences in compensation exist after accounting for differences in work activities and other characteristics. METHODS: The personal, job, and practice characteristics of a national sample of practicing cardiologists were described according to sex. We applied the Peters-Belson technique and multivariate regression analysis to evaluate whether gender differences in compensation existed after accounting for differences in other measured characteristics. The study used 2013 data reported by practice administrators to MedAxiom, a subscription-based service provider to cardiology practices. Data regarding cardiologists from 161 U.S. practices were included, and the study sample included 2,679 subjects (229 women and 2,450 men). RESULTS: Women were more likely to be specialized in general/noninvasive cardiology (53.1% vs. 28.2%), and a lower proportion (11.4% vs. 39.3%) reported an interventional subspecialty compared with men. Job characteristics that differed according to sex included the proportion working full-time (79.9% vs. 90.9%; p < 0.001), the mean number of half-days worked (387 vs. 406 days; p = 0.001), and mean work relative value units generated (7,404 vs. 9,497; p < 0.001) for women and men, respectively. Peters-Belson analysis revealed that based on measured job and productivity characteristics, the women in this sample would have been expected to have a mean salary that was $31,749 (95% confidence interval: $16,303 to $48,028) higher than that actually observed. Multivariate analysis confirmed the direction and magnitude of the independent association between sex and salary. CONCLUSIONS: Men and women practicing cardiology in this national sample had different job activities and salaries. Substantial sex-based salary differences existed even after adjusting for measures of personal, job, and practice characteristics.

Quality of Care and Ischemic Stroke Risk After Hospitalization for Transient Ischemic Attack: Findings From Get With The Guidelines-Stroke.

BACKGROUND: Patients with transient ischemic attack (TIA) are at increased risk for ischemic stroke. We derived a prediction rule for 1-year ischemic stroke risk post-TIA, examining estimated risk, receipt of inpatient quality of care measures for TIA, and the presence or absence of stroke at 1 year post discharge. METHODS AND RESULTS: We linked 67 892 TIA Get With The Guidelines-Stroke patients >65 years (2003-2008) to Medicare inpatient claims to obtain longitudinal outcomes. Using Cox proportional hazards modeling in a split sample, we identified baseline demographics and clinical characteristics associated with ischemic stroke admission during the year post-TIA, and developed a Get With The Guidelines Ischemic Stroke after TIA Risk Score; performance was examined in the validation sample. Quality of care was estimated by a global defect-free care measure, and individual performance measures within estimated risk score quintiles. The overall hospital admission rate for ischemic stroke during the year post-TIA was 5.7%. Patients with ischemic stroke were more likely to be older, black, and have higher rates of smoking, previous stroke, diabetes mellitus, previous myocardial infarction, heart failure, and atrial fibrillation. The Risk Score showed moderate discriminative performance (c-statistic=0.606); highest quintile patients were less likely to receive statins, smoking cessation counseling, and defect-free care. Although not associated with 1-year ischemic stroke, DCF was associated with a significantly lower risk of all-cause mortality. CONCLUSIONS: TIA patients with high estimated ischemic stroke risk are less likely to receive defect-free care than low-risk patients. Standardized risk assessment and delivery of optimal inpatient care are needed to reduce this risk-treatment mismatch.

Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review.

Myocardial infarction (MI) is a key endpoint in randomized controlled trials (RCTs), but heterogeneous definitions limit comparisons across RCTs or meta-analyses. The 2000 European Society of Cardiology/American College of Cardiology MI redefinition and the 2007 universal MI definition consensus documents made recommendations to address this issue. In cardiovascular randomized trials, we evaluated the impact of implementation of three key recommendations from these reports-troponin use to define MI; separate reporting of spontaneous and procedure-related MI; and infarct size reporting. We searched ClinicalTrials.gov and MEDLINE databases for cardiovascular RCTs with more than 500 patients in which enrolment began between September 2000 and July 2012 and that listed MI in the primary endpoint. We searched English-language publications with primary results or design papers. Of 3222 studies screened, 96 (3.0%) met our criteria. We extracted enrolment start date, number of patients and MI events, follow-up duration, and coronary revascularization rate. Data extraction quality was assessed by duplicated extractions. Of 96 RCTs, 80 had a primary results publication, comprising 608 091 patients and 43 621 endpoint MIs. Myocardial infarction represented 45.3% (95% confidence interval, 40.2-50.4) of events in the primary composite endpoint. Troponin defined MI in 57% (53/93) of trials with an MI definition available. Of these RCTs, three used troponin only if creatine kinase-MB was unavailable, six used troponin to define peri-procedural MI, seven specified the 99th percentile as the MI decision limit, and three reported spontaneous and procedure-related MI separately. None reported biomarker-based infarct size, but five reported MI as multiples of the assay upper limit of normal. Although MI is a major component of cardiovascular RCT primary endpoints, standardized MI reporting and implementation of consensus document recommendations for MI definition are limited. Developing appropriate strategies for uniform implementation is required.