Real-World Comparative Effectiveness and Cost Comparison of Thromboprophylactic Use of Enoxaparin versus Unfractionated Heparin in 376,858 Medically Ill Hospitalized US Patients.

BACKGROUND: Venous thromboembolism (VTE) is a serious complication in medically ill inpatients. Enoxaparin or unfractionated heparin (UFH) thromboprophylaxis has been shown to reduce VTE in clinical trials; however, comparative effectiveness and differences in hospital costs are unknown in US hospital practice. OBJECTIVE: This study compared clinical and economic outcomes between enoxaparin and UFH thromboprophylaxis in medically ill inpatients. METHODS: A retrospective cohort study was conducted using the Premier Healthcare Database between 1 January 2010 and 30 September 2016. Inpatients aged ≥ 18 years with a ≥ 6-day hospital stay for serious medical conditions were included. Two patient groups receiving thromboprophylaxis were identified during hospitalization: one receiving enoxaparin and other receiving UFH. Regression models were constructed to compare VTE events, in-hospital mortality, pulmonary embolism (PE)-related mortality, major bleeding, and total hospital costs during both the index hospitalization and the 90-day readmission period between the two groups. RESULTS: A total of 242,474 and 134,384 inpatients received enoxaparin or UFH for thromboprophylaxis, respectively. Compared with UFH prophylaxis, enoxaparin was significantly associated with 15%, 9%, 33%, and 41% reduced odds of VTE, in-hospital mortality, PE-related mortality, and major bleeding, respectively, during index hospitalization, and 10% and 19% reduced odds of VTE and bleeding, respectively, during the readmission period. Mean total hospital costs were significantly lower in patients receiving enoxaparin prophylaxis than in those given UFH. CONCLUSIONS: Thromboprophylaxis with enoxaparin was associated with significantly reduced in-hospital VTE events, death, and major bleeding and lower hospital costs compared with UFH in hospitalized medically ill patients.

Comparative Effectiveness and Costs of Enoxaparin Monotherapy Versus Unfractionated Heparin Monotherapy in Treating Acute Coronary Syndrome.

BACKGROUND: Enoxaparin and unfractionated heparin (UFH) are guideline-recommended anticoagulants for patients with acute coronary syndrome (ACS), including unstable angina (UA) and myocardial infarction with (STEMI) or without ST-segment elevation (NSTEMI). Prior efficacy and safety evidence are mainly from clinical trials. Economic data are insufficient. This study examined the differences in utilization, effectiveness, safety, and costs in treating ACS between enoxaparin and UFH monotherapy using real-world data. METHODS: Using data from 859 US hospitals, inpatients ≥ 18 years of age with a diagnosis of an initial episode of ACS between 2010 and 2016 were identified. Outcomes included 30-day risk of non-fatal myocardial infarction (MI), recurrent angina, in-hospital mortality, composite ischemic complication (having MI/recurrent angina/death), major bleeding, and costs. Multivariable regression was used to compare outcomes between enoxaparin and UFH monotherapy. RESULTS: Among 1,048,053 eligible patients (UA: 219,259; NSTEMI: 582,134; STEMI: 246,660), the prevalence of enoxaparin monotherapy was 12.0%, 13.9%, and 5.1%, and the prevalence of UFH monotherapy was 45.1%, 43.1% and 59.8%, for UA, NSTEMI, and STEMI patients, respectively. Enoxaparin was associated with a lower risk of ischemic complications and death among NSTEMI, but not in UA or STEMI patients, and with a lower risk of major bleeding in all patients. Cost savings per patient during index admission and 30-day follow-up for enoxaparin over UFH was $2972 for UA, $2475 for NSTEMI, and $3050 for STEMI. CONCLUSIONS: Enoxaparin was associated with a lower risk of ischemic complications (including death), lower costs, and better safety than UFH among NSTEMI patients. Improving upstream selection of anticoagulants in appropriate populations may help optimize clinical outcomes and costs.

A rapid evidence assessment of bleed-related healthcare resource utilization in publications reporting the use of direct oral anticoagulants for non-valvular atrial fibrillation.

Objective: Non-valvular atrial fibrillation (NVAF), a common cardiac arrhythmia, is associated with high morbidity and carries a substantial economic burden. Historically, vitamin K antagonists (VKAs; e.g. warfarin) have been used for therapy of NVAF, but recently several direct oral anticoagulants (DOACs) have been approved for prevention of stroke in patients with NVAF. This review summarizes the real-world evidence (RWE) for healthcare resource utilization (HRU) in patients receiving oral anticoagulants (VKAs and/or DOACs) for therapy of NVAF.Methods: A PRISMA-compliant literature search assessed Medline® and Embase® databases from 1 January 2011 to 4 May 2017, and the National Health Service Economic Evaluation Database from 1 January 2011 to 31 December 2015. Publications were included if they reported observational data from real-world use of one or more anticoagulant therapies. Outcomes of interest included hospitalizations, length of stay (LOS), mortality and costs.Results: Twenty-eight publications were included. Apixaban and dabigatran were associated with fewer bleed-related hospitalizations than warfarin. Bleed-related LOS were generally longer for warfarin than for DOACs. Bleed-related treatment costs were lower for patients receiving apixaban or receiving dabigatran than patients receiving rivaroxaban or receiving warfarin. Bleed-related mortality in patients receiving oral anticoagulation for treatment of NVAF were low across all DOACs and warfarin.Conclusions: The limited available evidence for HRU burden among patients receiving oral anticoagulation for NVAF suggests that DOACs (particularly apixaban and dabigatran) offer some degree of benefit in terms of HRU outcomes, compared with warfarin. Further work is required to understand HRU outcomes in patients receiving DOACs.

The Association of Transfer Rate From Hospitals Without Revascularization Capabilities and Mortality Risk for Older Non-ST-Segment Elevation Myocardial Infarction Patients.

BACKGROUND: Interhospital transfer invasive management patterns and implications for older non-ST-segment elevation myocardial infarction (NSTEMI) patients initially presenting to non-revascularization-capable hospitals have not been explored. HYPOTHESIS: Patients admitted to hospitals with a higher transfer proportion have lower risk of long-term mortality. METHODS: We linked CRUSADE Registry data on 5678 patients age ≥65 years from 65 United States non-revascularization-capable hospitals (2003-2006) with inpatient Medicare longitudinal claims. Hospitals were categorized according to hospital-level patient transfer-out rates, low (≤40%) vs high (>40%). The associations between transfer-out rates and 30-day, 6-month, and 3-year mortality risk were evaluated using Cox proportional hazard models. RESULTS: Hospital-level transfer-out rates varied widely (median, 43%; interquartile range, 31%-54%). Compared with patients from low-transfer-out hospitals (n = 2715), patients from high-transfer-out hospitals (n = 2963) were more likely to be male, less likely to have renal insufficiency and prior heart failure, and had lower long-term CRUSADE mortality risk scores. These patients also more commonly received evidence-based acute medications before transfer and underwent subsequent revascularization after transfer. The adjusted risks of mortality at various time intervals were similar for those from high- vs low-transfer-out hospitals: 30 days (hazard ratio: 0.95, 95% confidence interval: 0.79-1.14), 6 months (0.97, 0.84-1.12), and 3 years (1.01, 0.91-1.11). CONCLUSIONS: Transfer rates for older NSTEMI patients vary widely among non-revascularization-capable hospitals. Despite lower predicted mortality risk and higher rates of post-transfer revascularization, patients from high-transfer-out hospitals had a similar risk for short- and long-term mortality compared with those from low-transfer-out hospitals.

Willingness of Patients to Use Computers for Health Communication and Monitoring Following Myocardial Infarction.

We describe the computer use characteristics of 406 post-myocardial infarction (MI) patients and their willingness to engage online for health communication and monitoring. Most participants were computer users (n = 259; 63.8%) and half (n = 209; 51.5%) read health information online at least monthly. However, most participants did not go online to track health conditions (n = 283; 69.7%), look at medical records (n = 287; 70.7%), or e-mail doctors (n = 351; 86.5%). Most participants would consider using a Web site to e-mail doctors (n = 275; 67.7%), share medical information with doctors (n = 302; 74.4%), send biological data to their doctor (n = 308; 75.9%), look at medical records (n = 321; 79.1%), track health conditions (n = 331; 81.5%), and read about health conditions (n = 332; 81.8%). Sharing health information online with family members (n = 181; 44.6%) or for support groups (n = 223; 54.9%) was not of much interest. Most post-MI participants reported they were interested in communicating with their provider and tracking their health conditions online. Because patients with a history of MI tend to be older and are disproportionately minority, researchers and clinicians must be careful to design interventions that embrace post-MI patients of diverse backgrounds that both improve their access to care and health outcomes.

Perception Versus Actual Performance in Timely Tissue Plasminogen Activation Administration in the Management of Acute Ischemic Stroke.

BACKGROUND: Timely thrombolytic therapy can improve stroke outcomes. Nevertheless, the ability of US hospitals to meet guidelines for intravenous tissue plasminogen activator (tPA) remains suboptimal. What is unclear is whether hospitals accurately perceive their rate of tPA "door-to-needle" (DTN) time within 60 minutes and how DTN rates compare across different hospitals. METHODS AND RESULTS: DTN performance was defined by the percentage of treated patients who received tPA within 60 minutes of arrival. Telephone surveys were obtained from staff at 141 Get With The Guidelines hospitals, representing top, middle, and low DTN performance. Less than one-third (29.1%) of staff accurately identified their DTN performance. Among middle- and low-performing hospitals (n=92), 56 sites (60.9%) overestimated their performance; 42% of middle performers and 85% of low performers overestimated their performance. Sites that overestimated tended to have lower annual volumes of tPA administration (median 8.4 patients [25th to 75th percentile 5.9 to 11.8] versus 10.2 patients [25th to 75th percentile 8.2 to 17.3], P=0.047), smaller percentages of eligible patients receiving tPA (84.7% versus 89.8%, P=0.008), and smaller percentages of DTN ≤60 minutes among treated patients (10.6% versus 16.6%, P=0.002). CONCLUSIONS: Hospitals often overestimate their ability to deliver timely tPA to treated patients. Our findings indicate the need to routinely provide comparative provider performance rates as a key step to improving the quality of acute stroke care.

Association of early physician follow-up and 30-day readmission after non-ST-segment-elevation myocardial infarction among older patients.

BACKGROUND: Hospital readmission rates within 30 days after acute myocardial infarction are a national performance metric. Previous data suggest that early physician follow-up after heart failure hospitalizations can reduce readmissions; whether these results can be extended to acute myocardial infarction is unclear. METHODS AND RESULTS: We analyzed data from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines (CRUSADE) Registry linked with Medicare claims from 2003 to 2006 for 25 872 non-ST-segment-elevation myocardial infarction patients ≥65 years of age discharged home from 228 hospitals with >25 patients and full revascularization capabilities. After adjusting for patient, treatment, and hospital characteristics, we examined the relationship between hospital-level physician follow-up within 7 days of discharge and 30-day all-cause readmission using logistic regression. The median hospital-level percentage of patients receiving early physician follow-up was 23.3% (interquartile range, 17.1%-29.1%). Among 24 165 patients with Medicare fee-for-service eligibility 30 days after discharge, 18.5% of patients were readmitted within 30 days of index hospitalization. Unadjusted and adjusted rates of 30-day readmission did not differ among quartiles of hospital-level early physician follow-up. Similarly, each 5% increase in hospital early follow-up was associated with an insignificant change in risk for readmission (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.02; P=0.60). Sensitivity analyses extended these null findings to 30-day cardiovascular readmissions, high-risk subgroups, and early cardiology follow-up. CONCLUSIONS: Although rates of early physician follow-up after acute myocardial infarction varied among US hospitals, hospitals with higher early follow-up rates did not have lower 30-day readmission rates. Targeting strategies other than early physician follow-up may be necessary to reduce readmissions in this population.

Use of stress testing and diagnostic catheterization after coronary stenting: association of site-level patterns with patient characteristics and outcomes in 247,052 Medicare beneficiaries.

OBJECTIVES: The aim of this study was to determine diagnostic testing patterns after percutaneous coronary intervention (PCI). BACKGROUND: Little is known about patterns of diagnostic testing after PCI in the United States or the relationship of these patterns to clinical outcomes. METHODS: Centers for Medicare and Medicaid Services inpatient and outpatient claims were linked to National Cardiovascular Data Registry CathPCI Registry data from 2005 to 2007. Hospital quartiles of the cumulative incidence of diagnostic testing use within 12 and 24 months after PCI were compared for patient characteristics, repeat revascularization, acute myocardial infarction, and death. RESULTS: A total of 247,052 patients underwent PCI at 656 institutions. Patient and site characteristics were similar across quartiles of testing use. There was a 9% and 20% higher adjusted risk for repeat revascularization in quartiles 3 and 4 (highest testing rate), respectively, compared with quartile 1 (lowest testing rate) (p = 0.020 and p < 0.0001, respectively). The adjusted risk for death or acute myocardial infarction did not differ among quartiles. CONCLUSIONS: Although patient characteristics were largely independent of rates of post-PCI testing, higher testing rates were not associated with lower risk for myocardial infarction or death, but repeat revascularization was significantly higher at these sites. Additional studies should examine whether increased testing is a marker for improved quality of post-PCI care or simply increased health care utilization.

Variability in performance measures for assessment of hypertension control.

BACKGROUND: Definitions of multiple performance measures exist for the assessment of blood pressure control; however, limited data on how these technical variations may affect actual measured performance are available. METHODS: We evaluated patients with hypertension followed routinely by cardiologists at Duke University Health System from 2009 to 2010. Provider hypertension control was compared based on reading at the last clinic visit vs the average blood pressure across all visits. The impact of home blood pressure measurements and patient exclusions endorsed by the American Heart Association, the American College of Cardiology, and the Physician Consortium for Performance Improvement were evaluated using medical record reviews. RESULTS: Among 5,552 hypertensive patients, the rate of blood pressure control based on last clinic visit was 69.1%; however, significant clinic-to-clinic variability was seen in serial clinic blood pressure measurements in individual patients (average 18 mm Hg). As a result, provider performance ratings varied considerably depending on whether a single reading or average blood pressure reading was used. The inclusion of home blood pressure measurements resulted in modestly higher rates of blood pressure control performance (+6% overall). Similarly, excluding patients who met guideline-recommended exclusion criteria increased blood pressure control rates only slightly (+3% overall). In contrast, excluding patients who were on 2 or more antihypertensive medications would have raised blood pressure control rates to 96% overall. CONCLUSION: Depending on definitions used, overall and provider-specific blood pressure control rates can vary considerably. Technical aspects of blood pressure performance measures may affect perceived quality gaps and comparative provider ratings.

Patterns of stress testing and diagnostic catheterization after coronary stenting in 250 350 medicare beneficiaries.

BACKGROUND: Patterns of noninvasive stress test (ST) and invasive coronary angiography (CA) utilization after percutaneous coronary intervention (PCI) are not well described in older populations. METHODS AND RESULTS: We linked National Cardiovascular Data Registry CathPCI Registry data with longitudinal Medicare claims data for 250 350 patients undergoing PCI from 2005 to 2007 and described subsequent testing and outcomes. Between 60 days post-PCI and end of follow-up (median 24 months), 49% (n=122 894) received ST first, 10% (n=25 512) underwent invasive CA first, and 41% (n=101 944) had no testing. Several clinical risk factors at time of index PCI were associated with decreased likelihood of downstream testing (ST or CA, P<0.05 for all), including older age (hazard ratio [HR] 0.784 per 10-year increase), male sex (HR 0.946), heart failure (HR 0.925), diabetes mellitus (HR 0.954), smoking (HR 0.804), and renal failure (HR 0.880). Fifteen percent of patients with ST first proceeded to subsequent CA within 90 days of testing (n=18 472/122 894) [corrected]; of these, 48% (n=8831) underwent revascularization within 90 days, compared with 53% (n=13 316) of CA first patients (P<0.0001). CONCLUSIONS: In this descriptive analysis, ST and invasive CA were common in older patients after PCI. Paradoxically, patients with higher risk features at baseline were less likely to undergo post-PCI testing. The revascularization yield was low on patients referred for ST after PCI, with only 7% [corrected] undergoing revascularization within 90 days.

Patterns and predictors of stress testing modality after percutaneous coronary stenting: data from the NCDR(®).

OBJECTIVES: We evaluated temporal trends and geographic variation in choice of stress testing modality after percutaneous coronary intervention (PCI), as well as associations between modality and procedure use after testing. BACKGROUND: Stress testing is frequently performed post-PCI, but the choices among available modalities (electrocardiography only, nuclear, or echocardiography; pharmacological or exercise stress) and consequences of such choices are not well characterized. METHODS: CathPCI Registry(®) data were linked with identifiable Medicare claims to capture stress testing use between 60 and 365 days post-PCI and procedures within 90 days after testing. Testing rates and modality used were modeled on the basis of patient, procedure, and PCI facility factors, calendar quarter, and Census Divisions using Poisson and logistic regression. Post-test procedure use was assessed using Gray's test. RESULTS: Among 284,971 patients, the overall stress testing rate after PCI was 53.1 per 100 person-years. Testing rates declined from 59.3 in quarter 1 (2006) to 47.1 in quarter 4 (2008), but the relative use of modalities changed little. Among exercise testing recipients, adjusted proportions receiving electrocardiography-only testing varied from 6.8% to 22.8% across Census Divisions; and among exercise testing recipients having an imaging test, the proportion receiving echocardiography (versus nuclear) varied from 9.4% to 34.1%. Post-test procedure use varied among modalities; exercise electrocardiography-only testing was associated with more subsequent stress testing (13.7% vs. 2.9%; p < 0.001), but less catheterization (7.4% vs. 14.1%; p < 0.001) than imaging-based tests. CONCLUSIONS: Modest reductions in stress testing after PCI occurring between 2006 and 2008 cannot be ascribed to trends in use of any single modality. Additional research should assess whether this trend represents better patient selection for testing or administrative policies (e.g., restricted access for patients with legitimate testing needs). Geographic variation in utilization of stress modalities and differences in downstream procedure use among modalities suggest a need to identify optimal use of the different test modalities in individual patients.

Association between physician billing and cardiac stress testing patterns following coronary revascularization.

CONTEXT: The degree to which financial factors may influence use of cardiac stress imaging procedures is unknown. OBJECTIVE: To examine the association of physician billing and nuclear stress and stress echocardiography testing following coronary revascularization. DESIGN, SETTING, AND PATIENTS: Using data from a national health insurance carrier, 17,847 patients were identified between November 1, 2004, and June 30, 2007, who had coronary revascularization and an index cardiac outpatient visit more than 90 days following the procedure. Based on overall billings, physicians were classified as billing for both technical (practice/equipment) and professional (supervision/interpretation) fees, professional fees only, or not billing for either. Logistic regression models were used to evaluate the association between physician billing and use of stress testing, after adjusting for patient and other physician factors. MAIN OUTCOME MEASURES: Incidence of nuclear and echocardiographic stress tests within 30 days of an index cardiac-related outpatient visit. RESULTS: The overall cumulative incidence of nuclear or echocardiography stress testing within 30 days of the index cardiac-related outpatient visit following revascularization was 12.2% (95% CI, 11.8%-12.7%). The cumulative incidence of nuclear stress testing was 12.6% (95% CI, 12.0%-13.2%), 8.8% (95% CI, 7.5%-10.2%), and 5.0% (95% CI, 4.4%-5.7%) among physicians who billed for technical and professional fees, professional fees only, or neither, respectively. For stress echocardiography, the cumulative incidence of testing was 2.8% (95% CI, 2.5%-3.2%), 1.4% (95% CI, 1.0%-1.9%), and 0.4% (95% CI, 0.3%-0.6%) among physicians who billed for the technical and professional fees, professional fees only, or neither, respectively. Adjusted odds ratios (ORs) of nuclear stress testing among patients treated by physicians who billed for technical and professional fees and professional fees only were 2.3 (95% CI, 1.8-2.9) and 1.6 (95% CI, 1.2-2.1), respectively, compared with those patients treated by physicians who did not bill for testing (P < .001). The adjusted OR of stress echocardiography testing among patients treated by physicians billing for both or professional fees only were 12.8 (95% CI, 7.6-21.6) and 7.1 (95% CI, 4.0-12.9), respectively, compared with patients treated by physicians who did not bill for testing (P < .001). CONCLUSION: Nuclear stress testing and stress echocardiography testing following revascularization were more frequent among patients treated by physicians who billed for technical fees, professional fees, or both compared with those treated by physicians who did not bill for these services.

The need for transformative innovation in hypertension management.

Despite multiple available effective therapies for hypertension, many patients with high blood pressure in the United States are not adequately controlled. This inability to effectively manage hypertension can be attributed to patient, provider, and system failures. To create an effective model for hypertension management, current care delivery systems must be reorganized around the following principles: improved patient engagement and patient-provider communication, increased use of nonphysician providers, better performance monitoring and feedback systems, and better aligned reimbursement models. Transformation of care around these principles would lead to marked improvements in cost, quality, and access to care.

Cardiovascular research in India: a perspective.

With cardiovascular disease (CVD) emerging as a major cause of mortality in India, clinical research in CVD is becoming increasingly important. There are several favorable factors that offer robust growth of clinical research infrastructure in India: well-established system of governance, a large investment in medical education infrastructure, growing interest in building capacity in clinical research, the presence of regulatory mechanisms governing clinical research, a large pharmaceutical industry, and a highly developed information technology and data processing infrastructure. However, the lack of trained research manpower, inadequate public spending on health, uneven distribution of health infrastructure, and the large prevalence of pretransitional diseases are major weakness in undertaking high-quality clinical research in CVD. Analysis of the contemporary scenario reveals that there are 3 important opportunities for clinical research in India: the need to identify low cost but cutting edge and context-specific interventions to address the health needs of India's large population, the potential for high-quality research, and the high degree of interest (domestically and internationally) in investing in clinical research education and infrastructure.

Training the next generation of physician-executives: an innovative residency pathway in management and leadership.

The rapidly changing field of medicine demands that future physician-leaders excel not only in clinical medicine but also in the management of complex health care enterprises. However, many physicians have become leaders "by accident," and the active cultivation of future leaders is required. Addressing this need will require multiple approaches, targeting trainees at various stages of their careers, such as degree-granting programs, residency and fellowship training, and career and leadership development programs. Here, the authors describe a first-of-its-kind graduate medical education pathway at Duke Medicine, the Management and Leadership Pathway for Residents (MLPR). This program was developed for residents with both a medical degree and management training. Created in 2009, with its first cohort enrolled in the summer of 2010, the MLPR is intended to help catalyze the emergence of a new generation of physician-leaders. The program will provide physicians-in-training with rigorous clinical exposure along with mentorship and rotational opportunities in management to accelerate the development of critical leadership and management skills in all facets of medicine, including care delivery, research, and education. To achieve this, the MLPR includes 15 to 18 months of project-based rotations under the guidance of senior leaders in many disciplines including finance, patient safety, health system operations, strategy, and others. Developing both clinical and management skill sets during graduate medical education holds the promise of engaging future leaders of health care at an early career stage, keeping more MD-MBA graduates within health care, and creating a bench of talented future physician-executives.

Extent of and reasons for nonuse of implantable cardioverter defibrillator devices in clinical practice among eligible patients with left ventricular systolic dysfunction.

BACKGROUND: Several studies that used claims and registry data have reported that 40% to 80% of patients eligible for an implantable cardioverter defibrillator (ICD) fail to receive one in clinical practice, and the rates are especially high among women and blacks. The extent and documented reasons for nonuse of ICDs among patients with left ventricular systolic dysfunction are unknown. METHODS AND RESULTS: Using hospital claims and clinical data, we identified patients hospitalized with a heart failure diagnosis and left ventricular ejection fraction ≤30% between January 1, 2007, and August 30, 2007, at a tertiary-care center. Using claims data, we determined placement of an ICD or cardiac resynchronization therapy with defibrillation device at any time up to 1 year after hospitalization. Medical records for patients without an ICD were abstracted to determine reasons for nonuse. Patients with an ICD were compared with patients without an ICD and also with patients without an ICD who did not have any contraindication for an ICD as identified through chart abstraction. Of the 542 potentially eligible patients identified, 224 (41%) did not have an ICD. In the initial adjusted analysis, female sex (odds ratio=1.90; 95% CI, 1.28 to 2.81) and increasing age (odds ratio=1.07; 95% CI, 1.04 to 1.11) were associated with a higher likelihood of not having an ICD. After detailed chart review, of the 224 patients without an ICD, 117 (52%) were ineligible for the device and 38 (17%) patients refused the device, resulting in only 69 (13%) patients eligible for an ICD who failed to receive one. In this subsequent adjusted analysis, remaining factors associated with a higher likelihood of not having an ICD were absence of ventricular arrhythmias (odds ratio=4.93; 95% CI, 2.56 to 9.50), noncardiology hospital service (odds ratio=3.73; 95% CI, 1.98 to 7.04), and lack of health insurance (odds ratio=3.10; 95% CI, 1.48 to 6.46). CONCLUSIONS: On the basis of a detailed chart review, the true rate of ICD underuse may be substantially lower than previous estimates. In addition, after accounting for ICD eligibility criteria, patient sex and age disparities in ICD therapy were no longer present.

Leveraging observational registries to inform comparative effectiveness research.

Comparative effectiveness research (CER) has gained increased prominence over the past few years, but significant confusion surrounds the scope and definition of what constitutes CER. In some circles, CER is heralded as a tool to improve care quality and patient outcomes while simultaneously reducing health care costs. However, others contend that CER will lead to poorly designed studies whose results will be misinterpreted to limit the development and approval of new therapies. Leading to this confusion is the fact that CER spans a wide spectrum of clinical research domains that includes randomized, controlled trials; observational data analyses; and cost-effectiveness analyses. Recent federal mandates have injected significant funds for observational CER priorities, earmarked incentives for technology investments, and recommended a centralized collection of certain medical information, setting the stage for CER and observational data to gain further prominence as the foundation of many new investigations. In this review article, we define CER and highlight opportunities, and potential pitfalls, of observational registries to expand evidence through CER.

Trends in quality of care for patients with acute myocardial infarction in the National Registry of Myocardial Infarction from 1990 to 2006.

BACKGROUND: Trends in the use of guideline-based treatment for acute myocardial infarction (AMI) as well as its association with patient outcomes have not been summarized in a large, longitudinal study. Furthermore, it is unknown whether gender-, race-, and age-based care disparities have narrowed over time. METHODS AND RESULTS: Using the National Registry of Myocardial Infarction database, we analyzed 2,515,106 patients with AMI admitted to 2,157 US hospitals between July 1990 and December 2006 to examine trends overall and in select subgroups of guideline-based admission, procedural, and discharge therapy use. The contribution of temporal improvements in acute care therapies to declines in in-hospital mortality was examined using logistic regression analysis. From 1990 to 2006, the use of all acute guideline-recommended therapies administered rose significantly for patients with ST-segment elevation myocardial infarction and patients with non-ST-segment myocardial infarction but remained below 90% for most therapies. Cardiac catheterization and percutaneous coronary intervention use increased in patients with ST-segment elevation myocardial infarction and patients with non-ST-segment myocardial infarction, whereas coronary bypass surgery use declined in both groups. Despite overall care improvements, women, blacks, and patients > or =75 years old were significantly less likely to receive revascularization or discharge lipid-lowering therapy relative to their counterparts. Temporal improvements in acute therapies may account for up to 37% of the annual decline in risk for in-hospital AMI mortality. CONCLUSION: Adherence to American Heart Association/American College of Cardiology practice guidelines has improved care of patients with AMI and is associated with significant reductions in in-hospital mortality rates. However, persistent gaps in overall care as well as care disparities remain and suggest the need for ongoing quality improvement efforts.

The impact of for-profit hospital status on the care and outcomes of patients with non-ST-segment elevation myocardial infarction: results from the CRUSADE Initiative.

OBJECTIVES: We sought to determine whether for-profit status influenced hospitals' care or outcomes among non-ST-segment elevation myocardial infarction (NSTEMI) patients. BACKGROUND: While for-profit hospitals potentially have financial incentives to selectively care for younger, healthier patients, perform highly reimbursed procedures, reduce costs by limiting access to expensive medications, and encourage shorter in-patient length of stay, there are limited data available to investigate these issues objectively. METHODS: Using data from the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the American College of Cardiology/American Heart Association guidelines) Initiative, we investigated whether for-profit status influenced hospitals' patient case mix, care, or outcomes among 145,357 patients with NSTEMI treated between January 1, 2001, and December 31, 2005, at 532 U.S. hospitals. Impact of for-profit status on care and outcomes was analyzed overall and after adjustment for clinical and facility factors using regression modeling. RESULTS: Patients (n = 11,658) treated at 58 for-profit hospitals were of similar age and gender, but were more likely to be nonwhite (black, Asian, Hispanic, and other) and have health maintenance organization/private insurance, diabetes mellitus, congestive heart failure, hypertension, and renal insufficiency compared with 133,699 patients treated at 474 nonprofit hospitals. For-profit hospitals were less likely to use discharge beta-blockers, but all other treatments were similar including the use of interventional procedures (cardiac catheterization and revascularization procedures) compared with nonprofit centers. In-hospital length of stay and mortality were also similar by hospital type. CONCLUSIONS: We found no evidence that for-profit hospitals selectively treat less sick patients, provide less evidence-based care, limit in-hospital stays, or have patients with worse acute outcomes than nonprofit centers.