Patient-Reported Financial Burden Following Stereotactic Body Radiation Therapy for Localized Prostate Cancer.

Introduction and Objectives: In patients with localized prostate cancer, 5-fraction, stereotactic body radiation therapy (SBRT) has been found to offer comparable oncologic outcomes and potential for improved treatment compliance compared to conventional, 40-plus fraction radiation therapy (RT). Recent studies of oncologic patient experiences have highlighted both the impact of therapy-associated financial toxicity (FT) on treatment adherence and health-related quality of life (HRQOL). Methods: A cross-sectional assessment of FT after SBRT was performed using the 12-item COST questionnaire. The total questionnaire score (range 0-44) was used to evaluate the FT grade (0-3), with a higher COST value representing lower grade. The patient zip code was used to approximate the distance from the index hospital. Univariate and multivariate analyses of the average COST score (0-4) are performed. Results: The response rate was 57.5% (332 of 575 consented patients) with 90.7%, 8.2%, and 1.1% experiencing grade 0, 1, and 2 FT, respectively, with no grade 3. Unemployment or disability, non-white race, low income, and concurrent hormonal therapy were associated with a statistically significant worse FT (lower COST value) on univariate and multivariate analyses (p < 0.05). Education level and insurance status significant were evaluated on univariate analysis only. There was a non-statistically significant difference in age, marital status, time since treatment, and distance from the index hospital. Conclusions: SBRT was associated with low FT. However, statistically significant socioeconomic disparities in FT remain despite ultra-hypofractionated treatment.

User preferences for and engagement with text messages to support antihypertensive medication adherence: Findings from a pilot study evaluating an emergency department-based behavioral intervention.

OBJECTIVE: We examined users' preferences for and engagement with text messages delivered as part of an emergency department (ED)-based intervention to improve antihypertensive medication adherence. METHODS: We recruited ED patients with elevated blood pressure for a pilot randomized trial evaluating a medication adherence intervention with text messages. Intervention participants chose text content and frequency, received texts for 45 days, and completed a feedback survey. We defined engagement via responses to texts. We examined participant characteristics associated with text preferences, engagement, and feedback. RESULTS: Participants (N = 101) were 57% female and 46% non-White. Most participants (71%) chose to receive both reminder and informational texts; 94% chose reminder texts once per day and 97% chose informational texts three times per week. Median text message response rate was 56% (IQR 26-80%). Participants who were Black (p < 0.01), had lower income (p = 0.03), or had lower medication adherence (p < 0.01) rated the program as more helpful and wanted additional functionalities for adherence support. CONCLUSIONS AND PRACTICE IMPLICATIONS: While overall engagement was modest, participants at risk of worse health outcomes expressed more value and interest in the program. Findings inform the design of text messaging interventions for antihypertensive medication adherence and support targeting vulnerable patients to reduce health disparities. CLINICAL TRIALS REGISTRATION: NCT02672787.

Epidemiology, pathophysiology and contemporary management of cardiogenic shock - a position statement from the Heart Failure Association of the European Society of Cardiology.

Cardiogenic shock (CS) is a complex multifactorial clinical syndrome with extremely high mortality, developing as a continuum, and progressing from the initial insult (underlying cause) to the subsequent occurrence of organ failure and death. There is a large spectrum of CS presentations resulting from the interaction between an acute cardiac insult and a patient's underlying cardiac and overall medical condition. Phenotyping patients with CS may have clinical impact on management because classification would support initiation of appropriate therapies. CS management should consider appropriate organization of the health care services, and therapies must be given to the appropriately selected patients, in a timely manner, whilst avoiding iatrogenic harm. Although several consensus-driven algorithms have been proposed, CS management remains challenging and substantial investments in research and development have not yielded proof of efficacy and safety for most of the therapies tested, and outcome in this condition remains poor. Future studies should consider the identification of the new pathophysiological targets, and high-quality translational research should facilitate incorporation of more targeted interventions in clinical research protocols, aimed to improve individual patient outcomes. Designing outcome clinical trials in CS remains particularly challenging in this critical and very costly scenario in cardiology, but information from these trials is imperiously needed to better inform the guidelines and clinical practice. The goal of this review is to summarize the current knowledge concerning the definition, epidemiology, underlying causes, pathophysiology and management of CS based on important lessons from clinical trials and registries, with a focus on improving in-hospital management.

Post-discharge prognosis of patients admitted to hospital for heart failure by world region, and national level of income and income disparity (REPORT-HF): a cohort study.

BACKGROUND: Heart failure is a global public health problem, affecting a large number of individuals from low-income and middle-income countries. REPORT-HF is, to our knowledge, the first prospective global registry collecting information on patient characteristics, management, and prognosis of acute heart failure using a single protocol. The aim of this study was to investigate differences in 1-year post-discharge mortality according to region, country income, and income inequality. METHODS: Patients were enrolled during hospitalisation for acute heart failure from 358 centres in 44 countries on six continents. We stratified countries according to a modified WHO regional classification (Latin America, North America, western Europe, eastern Europe, eastern Mediterranean and Africa, southeast Asia, and western Pacific), country income (low, middle, high) and income inequality (according to tertiles of Gini index). Risk factors were identified on the basis of expert opinion and knowledge of the literature. FINDINGS: Of 18 102 patients discharged, 3461 (20%) died within 1 year. Important predictors of 1-year mortality were old age, anaemia, chronic kidney disease, presence of valvular heart disease, left ventricular ejection fraction phenotype (heart failure with reduced ejection fraction [HFrEF] vs preserved ejection fraction [HFpEF]), and being on guideline-directed medical treatment (GDMT) at discharge (p<0·0001 for all). Patients from eastern Europe had the lowest 1-year mortality (16%) and patients from eastern Mediterranean and Africa (22%) and Latin America (22%) the highest. Patients from lower-income countries (ie, ≤US$3955 per capita; hazard ratio 1·58, 95% CI 1·41-1·78), or with greater income inequality (ie, from the highest Gini tertile; 1·25, 1·13-1·38) had a higher 1-year mortality compared with patients from regions with higher income (ie, >$12 235 per capita) or lower income inequality (ie, from the lowest Gini tertile). Compared with patients with HFrEF, patients with HFpEF had a lower 1-year mortality with little variation by income level (pinteraction for HFrEF vs HFpEF <0·0001). INTERPRETATION: Acute heart failure is associated with a high post-discharge mortality, particularly in patients with HFrEF from low-income regions with high income inequality. Regional differences exist in the proportion of eligible patients discharged on GDMT, which was strongly associated with mortality and might reflect lack of access to post-discharge care and prescribing of GDMT. FUNDING: Novartis Pharma.

Bioanalytical Assessment of Plasma Concentrations of Angiotensin-Converting Enzyme II Inhibitors and Angiotensin Receptor Blockers: A Pilot Study Among Patients Hospitalized With Acute Heart Failure.

BACKGROUND: Although angiotensin-converting enzyme II inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) improve chronic heart failure (HF) outcomes, their potential harms and benefits in acute HF (AHF) is less clear. STUDY QUESTION: We explored the relationship between ACEI or ARB plasma concentrations among patients with AHF with in-hospital change in estimated glomerular filtration rate (eGFR). DATA SOURCES AND STUDY DESIGN: From August 2016-June 2017, patients with AHF prescribed an outpatient ACEI or ARB were enrolled before AHF treatment. All patients were given twice their home dose of diuretic intravenously and received clinical care at the discretion of the medical team. Of 61 patients in the parent study, saved plasma from 34 who were prescribed an outpatient ACEI or ARB was included in this substudy. MEASURES AND OUTCOMES: Liquid chromatography-tandem mass spectrometry was performed to assess ACEI or ARB plasma concentrations before AHF treatment. Change in eGFR was computed using the Chronic Kidney Disease Epidemiology Collaboration equation, which adjusts for age, sex, and race; diuretic dose and enrollment eGFR were used to adjust for HF severity. Multiple linear regression adjusting for enrollment eGFR and diuretic dose was performed to examine the relationship between drug concentration (undetectable/low vs. in/above-range) and in-hospital change in eGFR. RESULTS: Of 34 patients with AHF, median age was 63 years (interquartile range, 58-78 years), 19 (55.9%) were women, median eGFR at enrollment was 55.6 mL/min (interquartile range, 35.2-75.3 mL/min), and for 11 (32.4%), no ACEI or ARB was detectable in plasma. Medication concentrations in- or above-reference range were associated with in-hospital decrease in eGFR of 8.3 mL/min (95% confidence interval, 15.3-1.3 mL/min decrease), after adjusting for enrollment eGFR and diuretic treatment. CONCLUSIONS: Bioanalytical assessment of medication levels may be useful to guide in-hospital ACEI and ARB therapy for patients with AHF.

Design and rationale of a randomized trial: Using short stay units instead of routine admission to improve patient centered health outcomes for acute heart failure patients (SSU-AHF).

Nearly 85% of acute heart failure (AHF) patients who present to the emergency department (ED) with acute heart failure are hospitalized. Once hospitalized, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence for existing AHF therapies are poor: No currently used AHF treatment is known to improve long-term outcomes. ED treatment is largely the same today as 40 years ago. Admitting patients who could have avoided hospitalization may contribute to adverse outcomes. Hospitalization is not benign; patients enter a vulnerable phase post-discharge, at increased risk for morbidity and mortality. When hospitalization is able to be shortened or avoid completely, certain risks can be mitigated, including risk of medication errors, in-hospital falls, delirium, nosocomial infections, and other iatrogenic complications. Additionally, patients would prefer to be home, not hospitalized. Furthermore, hospitalization and re-hospitalization for AHF predominantly affects patients of lower socioeconomic status (SES). Avoiding hospitalization in patients who do not require admission may improve outcomes and quality of life, while reducing costs. Short stay unit (SSU: <24 h, also referred to as an 'observation unit') management of AHF may be effective for lower risk patients. However, to date there have only been small studies or retrospective analyses on the SSU management for AHF patients. In addition, SSU management has been considered 'cheating' for hospitals trying to avoid 30-day readmission penalties, as SSUs or observation units do not count as an admission. However, more recent analyses demonstrate differential use of observation status has not led to decreases in re-admission, suggesting this concern may be misplaced. Thus, we propose a robust clinical effectiveness trial to demonstrate the effectiveness of this patient-centered strategy.

A National Study of U.S. Emergency Departments: Racial Disparities in Hospitalizations for Heart Failure.

INTRODUCTION: Racial disparities in heart failure hospitalizations are well documented. The majority of heart failure hospitalizations originate from emergency departments, but emergency department hospitalization patterns for heart failure and the factors that influence hospitalization are poorly understood. This gap in knowledge was examined using a nationally representative sample of emergency department visits for heart failure. METHODS: National Hospital Ambulatory Medicare Care Survey data on 2001-2010 emergency department visits were analyzed in 2015-2017 to examine age-related racial differences in hospitalization patterns for heart failure, using multivariable modified Poisson regression models. RESULTS: More than 12million adult visits for heart failure to U.S. emergency departments occurred from 2001 to 2010, with 23% of visits by blacks. Overall, 71% of visits resulted in hospitalization (57% to floor beds and 14% to intensive care units). Among floor admissions for higher clinical acuity visits, whites were more likely than blacks to be hospitalized. Whites with higher clinical acuity were more likely to be hospitalized than those with lower clinical acuity (71% vs 63%, p=0.005). This expected pattern was not observed in blacks, particularly those aged ≥65years, who were hospitalized in 71% of lower clinical acuity visits, but only 61% of higher acuity visits. Among adults aged ≥65years, there was a significant interaction between clinical acuity Xrace with regard to hospitalization (p=0.037). CONCLUSIONS: These results suggest age and racial disparities in hospitalization rates for emergency department patients with heart failure. The reasons for these disparities in hospitalization are unclear. Further studies on emergency department hospitalization decisions, and the impact of emergency department clinical factors, may help clarify this finding. SUPPLEMENT INFORMATION: This article is part of a supplement entitled African American Men's Health: Research, Practice, and Policy Implications, which is sponsored by the National Institutes of Health.

Systolic Blood Pressure and Biochemical Assessment of Adherence: A Cross-Sectional Analysis in the Emergency Department.

Elevated blood pressure (BP) is common in the emergency department (ED), but the relationship between antihypertensive medication adherence and BP in the ED is unclear. This cross-sectional study tested the hypothesis that higher antihypertensive adherence is associated with lower systolic BP (SBP) in the ED among adults with hypertension who sought ED care at an academic hospital from July 2012 to April 2013. Biochemical assessment of antihypertensive adherence was performed using a mass spectrometry blood assay, and the primary outcome was average ED SBP. Analyses were stratified by number of prescribed antihypertensives (<3, ≥3) and adjusted for age, sex, race, insurance, literacy, numeracy, education, body mass index, and comorbidities. Among 85 patients prescribed ≥3 antihypertensives, mean SBP for adherent patients was 134.4 mm Hg (±26.1 mm Hg), and in adjusted analysis was -20.8 mm Hg (95% confidence interval, -34.2 to -7.4 mm Hg; P=0.003) different from nonadherent patients. Among 176 patients prescribed <3 antihypertensives, mean SBP was 135.5 mm Hg (±20.6 mm Hg) for adherent patients, with no difference by adherence in adjusted analysis (+2.9 mm Hg; 95% confidence interval, -4.7 to 10.5 mm Hg; P=0.45). Antihypertensive nonadherence identified by biochemical assessment was common and associated with higher SBP in the ED among patients who had a primary care provider and health insurance and who were prescribed ≥3 antihypertensives. Biochemical assessment of antihypertensives could help distinguish medication nonadherence from other contributors to elevated BP and identify target populations for intervention.

Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding.

PURPOSE: The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. METHODS AND MATERIALS: In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predict the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. RESULTS: Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r2=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r2=0.94-0.98). Considering all patients, only 0.2% of patients in the test cohort and 0.7% in the validation cohort reported bothersome bleeding and had clinically relevant HRQOL changes missed with EPIC-CP. However, of the 2.6% (n=17) of men with bothersome rectal bleeding in the test cohort, EPIC-CP failed to capture 1 patient (6%) as experiencing meaningful declines in bowel HRQOL. CONCLUSIONS: Modern prostate radiation therapy results in exceptionally low rates of bothersome rectal bleeding, and <1% of patients experience bothersome bleeding and are not captured by EPIC-CP as having meaningful HRQOL declines after radiation therapy. However, in the small subset of patients with bothersome rectal bleeding, the longer EPIC-26 should strongly be considered, given its superior performance in this patient subset.

Epidemiology, pathophysiology, and in-hospital management of pulmonary edema: data from the Romanian Acute Heart Failure Syndromes registry.

AIM: The objective of this study was to evaluate the clinical presentation, inpatient management, and in-hospital outcome of patients hospitalized for acute heart failure syndromes (AHFS) and classified as pulmonary edema (PE). METHODS: The Romanian Acute Heart Failure Syndromes (RO-AHFS) study was a prospective, national, multicenter registry of all consecutive patients admitted with AHFS over a 12-month period. Patients were classified at initial presentation by clinician-investigators into the following clinical profiles: acute decompensated HF, cardiogenic shock, PE, right HF, or hypertensive HF. RESULTS: RO-AHFS enrolled 3224 patients and 28.7% (n = 924) were classified as PE. PE patients were more likely to present with pulmonary congestion, tachypnea, tachycardia, and elevated systolic blood pressure and less likely to have peripheral congestion and body weight increases. Mechanical ventilation was required in 8.8% of PE patients. PE patients received higher doses (i.e. 101.4 ±â€Š27.1 mg) of IV furosemide for a shorter duration (i.e. 69.3 ±â€Š22.3 hours). Vasodilators were given to 73.6% of PE patients. In-hospital all-cause mortality (ACM) in PE patients was 7.4%, and 57% of deaths occurred on day one. Increasing age, concurrent acute coronary syndromes, life-threatening ventricular arrhythmias, elevated BUN, left bundle branch block, inotrope therapy, and requirement for invasive mechanical ventilation were independent risk factors for ACM. CONCLUSIONS: In this national registry, the PE profile was found to be a high-acuity clinical presentation with distinctive treatment patterns and a poor short-term prognosis. Advances in the management of PE may necessitate both the development of novel targeted therapies as well as systems-based strategies to identify high-risk patients early in their course.

Improving cardiovascular clinical trials conduct in the United States: recommendation from clinicians, researchers, sponsors, and regulators.

Advances in medical therapies leading to improved patient outcomes are in large part related to successful conduct of clinical trials that offer critical information regarding the efficacy and safety of novel interventions. The conduct of clinical trials in the United States, however, continues to face increasing challenges with recruitment and retention. These trends are paralleled by an increasing shift toward more multinational trials where most participants are enrolled in countries outside the United States, bringing into question the generalizability of the results to the American population. This manuscript presents the perspectives and recommendations from clinicians, researchers, sponsors, and regulators who attended a meeting facilitated by the Food and Drug Administration to improve upon the current clinical trial trends in the United States.

Cost analysis of strategies to reduce blood culture contamination in the emergency department: sterile collection kits and phlebotomy teams.

OBJECTIVE: Blood culture collection practices that reduce contamination, such as sterile blood culture collection kits and phlebotomy teams, increase up-front costs for collecting cultures but may lead to net savings by eliminating downstream costs associated with contamination. The study objective was to compare overall hospital costs associated with 3 collection strategies: usual care, sterile kits, and phlebotomy teams. DESIGN: Cost analysis. SETTING: This analysis was conducted from the perspective of a hospital leadership team selecting a blood culture collection strategy for an adult emergency department (ED) with 8,000 cultures drawn annually. METHODS: Total hospital costs associated with 3 strategies were compared: (1) usual care, with nurses collecting cultures without a standardized protocol; (2) sterile kits, with nurses using a dedicated sterile collection kit; and (3) phlebotomy teams, with cultures collected by laboratory-based phlebotomists. In the base case, contamination rates associated with usual care, sterile kits, and phlebotomy teams were assumed to be 4.34%, 1.68%, and 1.10%, respectively. Total hospital costs included costs of collecting cultures and hospitalization costs according to culture results (negative, true positive, and contaminated). RESULTS: Compared with usual care, annual net savings using the sterile kit and phlebotomy team strategies were $483,219 and $288,980, respectively. Both strategies remained less costly than usual care across a broad range of sensitivity analyses. CONCLUSIONS: EDs with high blood culture contamination rates should strongly consider evidence-based strategies to reduce contamination. In addition to improving quality, implementing a sterile collection kit or phlebotomy team strategy is likely to result in net cost savings.

Assessment of dyspnea early in acute heart failure: patient characteristics and response differences between likert and visual analog scales.

BACKGROUND: Dyspnea is the most common symptom in acute heart failure (AHF), yet how to best measure it has not been well defined. Prior studies demonstrate differences in dyspnea improvement across various measurement scales, yet these studies typically enroll patients well after the emergency department (ED) phase of management. OBJECTIVES: The aim of this study was to determine predictors of early dyspnea improvement for three different, commonly used dyspnea scales (i.e., five-point absolute Likert scale, 10-cm visual analog scale [VAS], or seven-point relative Likert scale). METHODS: This was a post hoc analysis of URGENT Dyspnea, an observational study of 776 patients in 17 countries enrolled within 1 hour of first physician encounter. Inclusion criteria were broad to reflect real-world clinical practice. Prior literature informed the a priori definition of clinically significant dyspnea improvement. Resampling-based multivariable models were created to determine patient characteristics significantly associated with dyspnea improvement. RESULTS: Of the 524 AHF patients, approximately 40% of patients did not report substantial dyspnea improvement within the first 6 hours. Baseline characteristics were similar between those who did or did not improve, although there were differences in history of heart failure, coronary artery disease, and initial systolic blood pressure. For those who did improve, patient characteristics differed across all three scales, with the exception of baseline dyspnea severity for the VAS and five-point Likert scale (c-index ranged from 0.708 to 0.831 for each scale). CONCLUSIONS: Predictors of early dyspnea improvement differ from scale to scale, with the exception of baseline dyspnea. Attempts to use one scale to capture the entirety of the dyspnea symptom may be insufficient.

The burden of acute heart failure on U.S. emergency departments.

OBJECTIVES: The goal of this study was to examine 2006 to 2010 emergency department (ED) admission rates, hospital procedures, lengths of stay, and costs for acute heart failure (AHF). BACKGROUND: Patients with AHF are often admitted and are associated with high readmissions and cost. METHODS: We utilized Nationwide Emergency Department Sample AHF data from 2006 to 2010 to describe admission proportion, hospital length of stay (LOS), and ED charges as a surrogate for resource utilization. Results were compared across U.S. regions, patient insurance status, and hospital characteristics. RESULTS: There were 958,167 mean yearly ED visits for AHF in the United States. Fifty-one percent of the patients were female, and the median age was 75.1 years (interquartile range [IQR]: 62.5 to 83.7 years). Overall, 83.7% (95% confidence interval: 83.1% to 84.2%) were admitted; the median LOS was 3.4 days (IQR: 1.9 to 5.8 days). Comparing 2006 with 2010, there was a small decrease in median LOS (0.09 days), but the proportion admitted did not change. Odds of admission, adjusting for age, sex, hospital characteristic (academic and safety net status), and insurance (Medicare, Medicaid, private, self-pay/no charge) were highest in the Northeast. Median ED charges were $1,075 (IQR: $679 to $1,665) in 2006 and $1,558 (IQR: $1,018 to $2,335) in 2010. Patients without insurance were more likely to be discharged from the ED, but when admitted, were more likely to receive a major diagnostic or therapeutic procedure. CONCLUSIONS: A very high proportion of ED patients with AHF are admitted nationally, with significant variation in disposition and procedural decisions based on region of the country and type of insurance, even after adjusting for potential confounding.

Moving toward comprehensive acute heart failure risk assessment in the emergency department: the importance of self-care and shared decision making.

Nearly 700,000 emergency department (ED) visits were due to acute heart failure (AHF) in 2009. Most visits result in a hospital admission and account for the largest proportion of a projected $70 billion to be spent on heart failure care by 2030. ED-based risk prediction tools in AHF rarely impact disposition decision making. This is a major factor contributing to the 80% admission rate for ED patients with AHF, which has remained unchanged over the last several years. Self-care behaviors such as symptom monitoring, medication taking, dietary adherence, and exercise have been associated with decreased hospital readmissions, yet self-care remains largely unaddressed in ED patients with AHF and thus represents a significant lost opportunity to improve patient care and decrease ED visits and hospitalizations. Furthermore, shared decision making encourages collaborative interaction between patients, caregivers, and providers to drive a care path based on mutual agreement. The observation that "difficult decisions now will simplify difficult decisions later" has particular relevance to the ED, given this is the venue for many such issues. We hypothesize patients as complex and heterogeneous as ED patients with AHF may need both an objective evaluation of physiologic risk as well as an evaluation of barriers to ideal self-care, along with strategies to overcome these barriers. Combining physician gestalt, physiologic risk prediction instruments, an evaluation of self-care, and an information exchange between patient and provider using shared decision making may provide the critical inertia necessary to discharge patients home after a brief ED evaluation.

Risk stratification in acute heart failure: rationale and design of the STRATIFY and DECIDE studies.

BACKGROUND: A critical challenge for physicians facing patients presenting with signs and symptoms of acute heart failure (AHF) is how and where to best manage them. Currently, most patients evaluated for AHF are admitted to the hospital, yet not all warrant inpatient care. Up to 50% of admissions could be potentially avoided and many admitted patients could be discharged after a short period of observation and treatment. Methods for identifying patients that can be sent home early are lacking. Improving the physician's ability to identify and safely manage low-risk patients is essential to avoiding unnecessary use of hospital beds. METHODS: Two studies (STRATIFY and DECIDE) have been funded by the National Heart Lung and Blood Institute with the goal of developing prediction rules to facilitate early decision making in AHF. Using prospectively gathered evaluation and treatment data from the acute setting (STRATIFY) and early inpatient stay (DECIDE), rules will be generated to predict risk for death and serious complications. Subsequent studies will be designed to test the external validity, utility, generalizability and cost-effectiveness of these prediction rules in different acute care environments representing racially and socioeconomically diverse patient populations. RESULTS: A major innovation is prediction of 5-day as well as 30-day outcomes, overcoming the limitation that 30-day outcomes are highly dependent on unpredictable, post-visit patient and provider behavior. A novel aspect of the proposed project is the use of a comprehensive cardiology review to correctly assign post-treatment outcomes to the acute presentation. CONCLUSIONS: Finally, a rigorous analysis plan has been developed to construct the prediction rules that will maximally extract both the statistical and clinical properties of every data element. Upon completion of this study we will subsequently externally test the prediction rules in a heterogeneous patient cohort.

CyberKnife radiosurgery for inoperable stage IA non-small cell lung cancer: 18F-fluorodeoxyglucose positron emission tomography/computed tomography serial tumor response assessment.

OBJECTIVE: To report serial 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) tumor response following CyberKnife radiosurgery for stage IA non-small cell lung cancer (NSCLC). METHODS: Patients with biopsy-proven inoperable stage IA NSCLC were enrolled into this IRB-approved study. Targeting was based on 3-5 gold fiducial markers implanted in or near tumors. Gross tumor volumes (GTVs) were contoured using lung windows; margins were expanded by 5 mm to establish the planning treatment volumes (PTVs). Doses ranged from 42-60 Gy in 3 equal fractions. 18F-FDG PET/CT was performed prior to and at 3-6-month, 9-15 months and 18-24 months following treatment. The tumor maximum standardized uptake value (SUV(max)) was recorded for each time point. RESULTS: Twenty patients with an average maximum tumor diameter of 2.2 cm were treated over a 3-year period. A mean dose of 51 Gy was delivered to the PTV in 3 to 11 days (mean, 7 days). The 30-Gy isodose contour extended an average of 2 cm from the GTV. At a median follow-up of 43 months, the 2-year Kaplan-Meier overall survival estimate was 90% and the local control estimate was 95%. Mean tumor SUV(max) before treatment was 6.2 (range, 2.0 to 10.7). During early follow-up the mean tumor SUV(max) remained at 2.3 (range, 1.0 to 5.7), despite transient elevations in individual tumor SUV(max) levels attributed to peritumoral radiation-induced pneumonitis visible on CT imaging. At 18-24 months the mean tumor SUV(max) for controlled tumors was 2.0, with a narrow range of values (range, 1.5 to 2.8). A single local failure was confirmed at 24 months in a patient with an elevated tumor SUV(max) of 8.4. CONCLUSION: Local control and survival following CyberKnife radiosurgery for stage IA NSCLC is exceptional. Early transient increases in tumor SUV(max) are likely related to radiation-induced pneumonitis. Tumor SUV(max) values return to background levels at 18-24 months, enhancing 18F-FDG PET/CT detection of local failure. The value of 18F-FDG PET/CT imaging for surveillance following lung SBRT deserves further study.

Cost-effectiveness analysis of ED decision making in patients with non-high-risk heart failure.

BACKGROUND: The ED disposition of patients with non-high-risk acute decompensated heart failure (ADHF) is challenging. To help address this problem, we investigated the cost-effectiveness of different ED disposition strategies. METHODS: We constructed a decision analytic model evaluating the cost-effectiveness of 3 possible ED ADHF disposition strategies in a 60-year-old man: (1) discharge home from the ED; (2) observation unit (OU) admission; (3) inpatient admission. Base case patients had no high-risk features. We used Medicare costs and the national physician fee schedule to capture ED, OU, and hospital costs, including costs of complications and death. All analyses were conducted using Decision Maker software (University of Medicine and Dentistry of New Jersey, Newark, NJ). RESULTS: Compared to ED discharge, OU admission had a reasonable marginal cost-effectiveness ratio ($44 249/quality adjusted life year), whereas hospital admission had an unacceptably high marginal cost-effectiveness ratio ($684 101/quality adjusted life year). Sensitivity analyses demonstrated that as the risk of early (within 5 days) and late (within 30 days) readmission exceeded 36% and 74%, respectively, in those discharged from the ED, OU admission became less costly and more effective than ED discharge. Similarly, an increase in relative risk of both early and late death in those discharged from the ED improves the marginal cost-effectiveness ratio of OU admission. Finally, as postdischarge event rates increase in those discharged from the OU, hospital admission became more cost-effective. CONCLUSION: Observation unit admission for patients with non-high-risk ADHF has a societally acceptable marginal cost-effectiveness ratio compared to ED discharge. However, as ED and OU discharge event rates increase, hospital admission becomes the more cost-effective strategy.