Hospital participation in clinical trials for patients with acute myocardial infarction: Results from the National Cardiovascular Data Registry.

BACKGROUND: Little is known about the proportion of hospitals in the United States that offer clinical trial enrollment opportunities and how patient outcomes differ between hospitals that do and do not participate in clinical trials. METHODS: In the nationwide Chest Pain-MI registry, we described the proportion of hospitals that enrolled patients with acute myocardial infarction (MI) in clinical trials from 2009 to 2014. Hospital-level adherence to every eligible MI performance measure was compared between hospitals that did and did not enroll patients in clinical trials. Using linked Medicare data, we also compared 1-year major adverse cardiovascular events (MACE: death, MI, heart failure, or stroke) among patients ≥65 years old treated at trial versus nontrial hospitals. RESULTS: Among 766 hospitals, 430 (56.1%) enrolled ≥1 MI patient in a clinical trial during the study period, but the proportion of hospitals enrolling patients in clinical trials declined from 36.8% in 2009 to 26.6% in 2014. Complete adherence to performance measures was delivered to a greater proportion of patients at trial hospitals than nontrial hospitals (72.6% vs 64.9%, P < .001; adjusted OR 1.07, 95% CI 1.03-1.12). One-year MACE rates were also lower for trial hospitals (adjusted HR 0.96, 95% CI 0.93-0.99). CONCLUSIONS: Hospitals are becoming less likely to engage in clinical trials for patients with MI. Patients admitted to hospitals that participated in clinical trials more often received guideline-adherent care and had better long-term outcomes.

Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials.

BACKGROUND: Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of death cannot be determined from available data. The US Food and Drug Administration has indicated that this circumstance should occur only rarely, but its prevalence has not been formally assessed. METHODS: Data from 9 global clinical trials (2009-2017) with long-term follow-up and blinded, centrally adjudicated cause of death were used to calculate the proportion of deaths attributed to cardiovascular, noncardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre-diabetes mellitus, stable atherosclerosis, atrial fibrillation, and acute coronary syndrome), region of patient enrollment, and year of trial manuscript publication. Patient- and trial-level variables associated with undetermined cause of death were identified using a logistic model. RESULTS: Across 127 049 enrolled participants from 9 trials, there were 9259 centrally adjudicated deaths: 5012 (54.1%) attributable to cardiovascular causes, 2800 (30.2%) attributable to noncardiovascular causes, and 1447 (15.6%) attributable to undetermined causes. There was variability in the proportion of deaths ascribed to undetermined causes by trial therapeutic area, region of enrollment, and year of trial manuscript publication. On multivariable analysis, acute coronary syndrome or atrial fibrillation trial (versus atherosclerotic vascular disease or diabetes mellitus/pre-diabetes mellitus), longer time from enrollment to death, more recent trial manuscript publication year, enrollment in North America (versus Western Europe), female sex, and older age were associated with greater likelihood of death of undetermined cause. CONCLUSIONS: In 9 cardiometabolic clinical trials with long-term follow-up, approximately 16% of deaths had undetermined causes. This provides a baseline for quality assessment of clinical trials and informs operational efforts to potentially reduce the frequency of undetermined deaths in future clinical research.

Hospital Variation in Adherence Rates to Secondary Prevention Medications and the Implications on Quality.

BACKGROUND: Medication adherence is important to improve the long-term outcomes after acute myocardial infarction (MI). We hypothesized that there is significant variation among US hospitals in terms of medication adherence after MI, and that patients treated at hospitals with higher medication adherence after MI will have better long-term cardiovascular outcomes. METHODS: We identified 19 704 Medicare patients discharged after acute MI from 347 US hospitals participating in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines) from January 2, 2007, to October 1, 2010. Using linked Medicare Part D prescription filling data, medication adherence was defined as proportion of days covered >80% within 90 days after discharge. Cox proportional hazards modeling was used to compare 2-year major adverse cardiovascular events among hospitals with high, moderate, and low 90-day medication adherence. RESULTS: By 90 days after MI, overall rates of adherence to medications prescribed at discharge were 68% for ß-blockers, 63% for statins, 64% for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and 72% for thienopyridines. Adherence to these medications up to 90 days varied significantly among hospitals: ß-blockers (proportion of days covered >80%; 59% to 75%), statins (55% to 69%), thienopyridines (64% to 77%), and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (57% to 69%). Compared with hospitals in the lowest quartile of 90-day composite medication adherence, hospitals with the highest adherence had lower unadjusted and adjusted 2-year major adverse cardiovascular event risk (27.5% versus 35.3%; adjusted hazard ratio, 0.88; 95% confidence interval, 0.80-0.96). High-adherence hospitals also had lower adjusted rates of death or readmission (hazard ratio, 0.90; 95% confidence interval, 0.85-0.96), whereas there was no difference in mortality after adjustment. CONCLUSIONS: Use of secondary prevention medications after discharge varies significantly among US hospitals and is inversely associated with 2-year outcomes. Hospitals may improve medication adherence after discharge and patient outcomes through better coordination of care between inpatient and outpatient settings.

Comparison of performance on Hospital Compare process measures and patient outcomes between hospitals that do and do not participate in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines.

BACKGROUND: Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (ACTION Registry-GWTG) was designed to measure and improve the treatment and outcomes of patients with acute myocardial infarction (AMI), yet it is unknown whether performance of Medicare Hospital Compare metrics and outcomes differ between hospitals participating versus those not participating in the registry. METHODS: Using 2007 to 2010 Hospital Compare data, we matched participating to nonparticipating hospitals based on teaching status, size, percutaneous coronary intervention capability, and baseline (2007) Hospital Compare AMI process measure performance. We used linear mixed modeling to compare 2010 Hospital Compare process measure adherence, 30-day risk-adjusted mortality, and readmission rates. We repeated these analyses after stratification according to baseline performance level. RESULTS: Compared with nonparticipating hospitals, those participating were larger (median 288 vs 139 beds, P < .0001), more often teaching hospitals (18.8% vs 6.3%, P < .0001), and more likely had interventional catheterization lab capabilities (85.7% vs 34.0%, P < .0001). Among 502 matched pairs of participating and nonparticipating hospitals, we found high levels of process measure adherence in both 2007 and 2010, with minimal differences between them. Rates of 30-day mortality and readmission in 2010 were also similar between both groups. Results were consistent across strata of baseline performance level. CONCLUSIONS: In this observational analysis, there were no significant differences in the performance of Hospital Compare process measures or outcomes between hospitals in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines and other hospitals not in the registry. However, baseline performance on the Hospital Compare process measures was very high in both groups, suggesting the need for new quality improvement foci to further improve patient outcomes.

Persistence with secondary prevention medications after acute myocardial infarction: Insights from the TRANSLATE-ACS study.

BACKGROUND: Persistent use of secondary prevention therapies after acute myocardial infarction (MI) is critical to optimizing long-term outcomes. METHODS: Medication persistence was assessed among 7,955 MI patients in 216 hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome study from 2010 to 2012. Persistence was defined as continuation of aspirin, adenosine diphosphate receptor inhibitors, ß-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and statins from discharge to 6 months post-MI. Multivariable logistic regression modeling was used to determine factors associated with nonpersistence, defined as <80% persistence with all medication classes. RESULTS: Overall, 31% of MI patients stopped taking a least 1 medication by 6 months. The most common reasons cited for medications discontinuation were side effects and physician instruction (57%), whereas financial concerns were cited in 8% overall. After multivariable modeling, black race (odds ratio 1.36, 95% CI 1.15-1.62), older age (odds ratio 1.07, 95% CI 1.02-1.12), atrial fibrillation (odds ratio 1.67, 95% CI 1.33-2.09), dialysis (odds ratio 1.79, 95% CI 1.15-2.78), and depression (odds ratio 1.22, 95% CI 1.02-1.45) were associated with lower likelihood of persistence. Private insurance (odds ratio 0.85, 95% 0.76-0.95), prescription cost assistance (odds ratio 0.63, 95% CI 0.54-0.75), and outpatient follow-up arranged before discharge (odds ratio 0.89, 95% CI 0.80-0.99) were associated with higher persistence. CONCLUSIONS: Nearly one-third of MI patients are no longer persistent with their prescribed medications by 6 months. Patients at high risk for nonpersistence may be identified by clinical and sociodemographic features. These observations underscore key opportunities to optimize longitudinal use of secondary prevention therapies.

Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study.

BACKGROUND: Nonadherence to prescribed evidence-based medications after acute myocardial infarction (MI) can contribute to worse outcomes and higher costs. We sought to better understand the modifiable factors contributing to early nonadherence of evidence-based medications after acute MI. METHODS AND RESULTS: We assessed 7425 acute MI patients treated with percutaneous coronary intervention at 216 US hospitals participating in TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) between April 2010 and May 2012. Using the validated Morisky instrument to assess cardiovascular medication adherence at 6 weeks post MI, we stratified patients into self-reported high (score, 8), moderate (score, 6-7), and low (score, <6) adherence groups. Moderate and low adherence was reported in 25% and 4% of patients, respectively. One third of low adherence patients described missing doses of antiplatelet therapy at least twice a week after percutaneous coronary intervention. Signs of depression and patient-reported financial hardship because of medication expenses were independently associated with a higher likelihood of medication nonadherence. Patients were more likely to be adherent at 6 weeks if they had follow-up appointments made before discharge and had a provider explain potential side effects of their medications. Lower medication adherence may be associated with a higher risk of 3-month death/readmission (adjusted hazard ratio, 1.35; 95% confidence interval, 0.98-1.87) although this did not reach statistical significance. CONCLUSIONS: Even early after MI, a substantial proportion of patients report suboptimal adherence to prescribed medications. Tailored patient education and pre discharge planning may represent actionable opportunities to optimize patient adherence and clinical outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503.

Patient-centered priorities for improving medication management and adherence.

OBJECTIVE: The Centers for Education and Research on Therapeutics convened a workshop to examine the scientific evidence on medication adherence interventions from the patient-centered perspective and to explore the potential of patient-centered medication management to improve chronic disease treatment. METHODS: Patients, providers, researchers, and other stakeholders (N = 28) identified and prioritized ideas for future research and practice. We analyzed stakeholder voting on priorities and reviewed themes in workshop discussions. RESULTS: Ten priority areas emerged. Three areas were highly rated by all stakeholder groups: creating tools and systems to facilitate and evaluate patient-centered medication management plans; developing training on patient-centered prescribing for providers; and increasing patients' knowledge about medication management. However, priorities differed across stakeholder groups. Notably, patients prioritized using peer support to improve medication management while researchers did not. CONCLUSION: Engaging multiple stakeholders in setting a patient-centered research agenda and broadening the scope of adherence interventions to include other aspects of medication management resulted in priorities outside the traditional scope of adherence research. PRACTICE IMPLICATIONS: Workshop participants recognized the potential benefits of patient-centered medication management but also identified many challenges to implementation that require additional research and innovation.

Check it, change it: a community-based, multifaceted intervention to improve blood pressure control.

BACKGROUND: Although home blood pressure (BP) monitoring interventions have shown potential in selected populations, it is unclear whether such strategies can be generalized. We sought to determine whether a multifaceted BP control program that uses a web-based health portal (Heart360), community health coaches, and physician assistant guidance could improve hypertension control in a diverse community setting. METHODS AND RESULTS: Between September 12, 2010, and November 11, 2011 Check It, Change It, a community-based hypertension quality improvement program, enrolled 1756 patients with hypertension from 8 clinics in Durham County, NC. The Check It, Change It community intervention was evaluated using a prepost study design without a concurrent control. Participants were stratified into 3 tiers according to their initial BP: tier 0 (BP <140/90 mm Hg)=51% of population, tier 1 (BP=140/90-159/99 mm Hg)=30% of total, and tier 2 (BP ≥159/99 mm Hg)=19% of total. Overall, median age was 59 years (interquartile range, 49-69), 67% were female, and 76% black. After 6 months, the mean overall systolic BP declined 4.7 mm Hg. Rates of achieving target BP control (<140/90) increased overall from 51% at baseline to 63% by 6 months, and 69% had either reached their BP target or had reduced their baseline systolic BP by 10 mm Hg or more. CONCLUSIONS: A multicomponent-tiered hypertension program was associated with improved BP control in a diverse community-based population.

Patient-centered interventions to improve medication management and adherence: a qualitative review of research findings.

OBJECTIVE: Patient-centered approaches to improving medication adherence hold promise, but evidence of their effectiveness is unclear. This review reports the current state of scientific research around interventions to improve medication management through four patient-centered domains: shared decision-making, methods to enhance effective prescribing, systems for eliciting and acting on patient feedback about medication use and treatment goals, and medication-taking behavior. METHODS: We reviewed literature on interventions that fell into these domains and were published between January 2007 and May 2013. Two reviewers abstracted information and categorized studies by intervention type. RESULTS: We identified 60 studies, of which 40% focused on patient education. Other intervention types included augmented pharmacy services, decision aids, shared decision-making, and clinical review of patient adherence. Medication adherence was an outcome in most (70%) of the studies, although 50% also examined patient-centered outcomes. CONCLUSIONS: We identified a large number of medication management interventions that incorporated patient-centered care and improved patient outcomes. We were unable to determine whether these interventions are more effective than traditional medication adherence interventions. PRACTICE IMPLICATIONS: Additional research is needed to identify effective and feasible approaches to incorporate patient-centeredness into the medication management processes of the current health care system, if appropriate.

Differences in short-term versus long-term outcomes of older black versus white patients with myocardial infarction: findings from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of American College of Cardiology/American Heart Association Guidelines (CRUSADE).

BACKGROUND: Blacks are less likely than whites to receive coronary revascularization and evidence-based therapies after acute myocardial infarction, yet the impact of these differences on long-term outcomes is unknown. METHODS AND RESULTS: We linked Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of American College of Cardiology/American Heart Association Guidelines (CRUSADE) registry data to national Medicare claims, creating a longitudinal record of care and outcomes among 40 500 patients with non-ST-segment-elevation myocardial infarction treated at 446 hospitals to examine mortality and readmission rates (mean follow-up, 2.4 years) among black and white patients. Relative to whites (n=37 384), blacks (n=3116) were more often younger and female; more often had diabetes mellitus and renal failure; and received less aggressive interventions, including cardiac catheterization (60.7% versus 54.0%; P<0.001), percutaneous coronary intervention (32.1% versus 23.8%; P<0.001), and coronary bypass surgery (9.2% versus 5.7%; P<0.001). Although blacks had lower 30-day mortality (9.1% versus 9.9%; adjusted hazard ratio, 0.80; 95% confidence interval, 0.71-0.92), they had higher observed mortality at 1 year (27.9% versus 24.5%; P<0.001), although this was not significant after adjustment on long-term follow-up (hazard ratio, 1.00; 95% confidence interval, 0.94-1.07). Black patients also had higher 30-day (23.6% versus 20.0%; P<0.001) and 1-year (62.0% versus 54.6%; P<0.001) all-cause readmission, but these differences were no longer significant after risk adjustment on 30-day (hazard ratio, 1.02; 95% confidence interval, 0.92-1.13) and long-term (hazard ratio, 1.05; 95% confidence interval, 1.00-1.11) follow-up. CONCLUSIONS: Although older blacks with an acute myocardial infarction had lower initial mortality rates than whites, this early survival advantage did not persist during long-term follow-up. The reasons for this are multifactorial but may include differences in comorbidities and postdischarge care.

Trends in outcomes among older patients with non-ST-segment elevation myocardial infarction.

OBJECTIVES: The objective of this study is to assess trends in evidence-based therapy use and short- and long-term mortality over time among older patients with non-ST-segment elevation myocardial infarction (NSTEMI). BACKGROUND: With the prevalence of national quality improvement efforts, the use of evidence-based therapies has improved over time among patients with NSTEMI, yet it is unclear whether these improvements have been associated with significant change in short- and long-term mortality for older patients. METHODS: We linked detailed clinical data for 28,603 NSTEMI patients aged ≥65 years at 171 hospitals in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines Registry with longitudinal Centers for Medicare & Medicaid claims data and compared trends in annual unadjusted and risk-adjusted inhospital and long-term mortality from 2003 to 2006. RESULTS: The median age of our NSTEMI study population was 77 years, 48% were female, and 87% were white. Overall, inhospital and 1-year mortality rates were 6.0% and 24.5%, respectively. When compared with patients treated in 2003, NSTEMI patients treated in 2006 were more likely to receive guideline-recommended inhospital medications and early invasive treatment. Inhospital mortality decreased significantly over the study period (5.5% vs 7.2% [adjusted odds ratio 0.82, 95% CI 0.67-1.00, P = .045] for 2006 vs 2003), but there was no significant change in 1-year mortality from the index admission (24.0% vs 26.0% [adjusted hazard ratio 0.99, 95% CI 0.90-1.08] for 2006 vs 2003). CONCLUSIONS: Between 2003 and 2006, there was a significant reduction in inhospital mortality that corresponded to an increase in the use of evidence-based NSTEMI care. Nevertheless, long-term outcomes have not changed over time, suggesting a need for improved care transition and longitudinal secondary prevention.

Check it, change it: a community-based intervention to improve blood pressure control.

BACKGROUND: Despite the widespread availability of effective and affordable therapies, hypertension remains this country's most significant modifiable cardiovascular risk factor. Approximately 30% to 50% of individuals with hypertension currently fail to reach guideline-recommended target blood pressure (BP) goals. Although multiple interventions have been proposed to affect better hypertension control, the integration of multiple elements in a community-based program has not been evaluated to date. METHODS AND RESULTS: We created a broadly inclusive community-based initiative to control hypertension called Check It, Change It: The Durham Blood Pressure Challenge (CICI). We enrolled ≈2000 participants with hypertension in 8 ambulatory clinics across Durham County, NC. The CICI program engaged individuals by providing them with tools for self-monitoring and tied this information to their caregivers via a web-based portal (the American Heart Association's Heart360, a remote BP monitoring system). Additionally, the CICI facilitated clinical intervention of high-risk individuals using physician assistants and community health coaches. The primary outcome will be a change in BP during the 6 months postenrollment in the program, which will be compared with concurrent and historical control populations of nonparticipants. CONCLUSIONS: We think that this integrated and tiered approach will lead to improved BP control within 6 months. If successful, the CICI program has the potential to enhance community-level BP control.

Spousal depression, anxiety, and suicide after myocardial infarction.

AIMS: Death of a spouse from acute myocardial infarction (AMI) presents hardship, yet few studies have investigated the psychological consequences of fatal and non-fatal AMI on spouses. METHODS AND RESULTS: Several Danish national registries were linked to identify individuals whose spouses had a fatal or non-fatal AMI. Married patients with fatal or non-fatal AMI (1997-2008) were matched with their counterparts dying or hospitalized with a non-AMI cause; incident use of antidepressants and benzodiazepines, incident depression care, and suicides were compared pre- and post-event using Poisson models. Overall, 16 506 spouses of individuals dying of AMI were matched with 49 518 spouses of individuals dying of a non-AMI cause. Similarly, 44 566 spouses of individuals with a non-fatal AMI were matched with 131 563 spouses of individuals with a non-fatal, non-AMI hospitalization. Those whose spouse died of AMI (compared with a non-AMI cause) had increased antidepressant and benzodiazepine use [peak incidence rate ratio (IRR) 5.7 vs. 3.3, and 46.4 vs. 13.0, respectively; P< 0.001]. Those whose spouse had a non-fatal AMI (compared with a non-AMI hospitalization) had increased risk for antidepressant and benzodiazepine initiation (IRR 1.5 vs. 1.1, and 6.7 vs. 1.3, respectively, P< 0.001). Spouses of fatal AMI patients also had an increased risk of depression and suicide. Male individuals whose spouse had a fatal or non-fatal AMI had a relatively higher increased risk of depression than female individuals. CONCLUSION: Spouses of those who experience AMIs-both fatal and non-fatal-are at elevated risk for psychological consequences; therefore, the care needs of AMI patients and their spouses need to be considered.

Modifiable factors associated with failure to attain low-density lipoprotein cholesterol goal at 6 months after acute myocardial infarction.

BACKGROUND: Although controversial, reducing low-density lipoprotein cholesterol (LDL-C) to target levels remains a common therapeutic goal after acute myocardial infarction (AMI). We sought to illuminate patient and provider characteristics associated with LDL-C goal nonattainment after AMI. METHODS: In an observational registry of 24 US hospitals, we included 366 patients with AMI who had baseline LDL-C levels ≥100 mg/dL and underwent 6-month fasting LDL-C reassessment. Our primary outcome was failure to reach the guideline-recommended LDL-C goal of <100 mg/dL at 6 months post-AMI. RESULTS: One in 3 patients with AMI with initially elevated LDL-C failed to attain LDL-C goal at 6 months. Compared with those who attained LDL-C goal, those who did not were more often discharged without a statin (21% vs 9%, P < .001), despite only 4% having documented contraindications. Patients not achieving LDL-C goal also more frequently discontinued statin use by 6 months (24% vs 6%, P < .001). Multivariable modeling (c index, 0.78) revealed the absence of a statin prescription at discharge and lack of persistence on statin therapy as the strongest independent factors associated with failure to reach LDL-C goal. Additional independent risk factors were patient report of not consistently adhering to prescribed medications, not participating in cardiac rehabilitation, nonwhite race, and lack of insurance. CONCLUSIONS: One-third of patients with AMI with baseline hyperlipidemia do not attain the LDL-C goal of <100 mg/dL at 6 months. Our findings support targeted interventions in the transition of AMI care to promote affordable statin prescription at discharge, medication persistence and adherence, and cardiac rehabilitation participation.

Use of emergency medical service transport among patients with ST-segment-elevation myocardial infarction: findings from the National Cardiovascular Data Registry Acute Coronary Treatment Intervention Outcomes Network Registry-Get With The Guidelines.

BACKGROUND: Activation of emergency medical services (EMS) is critical for the early triage and treatment of patients experiencing ST-segment-elevation myocardial infarction, yet data regarding EMS use and its association with subsequent clinical care are limited. METHODS AND RESULTS: We performed an observational analysis of 37 634 ST-segment-elevation myocardial infarction patients treated at 372 US hospitals participating in the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines between January 2007 and September 2009, and examined independent patient factors associated with EMS transportation versus patient self-transportation. We found that EMS transport was used in only 60% of ST-segment-elevation myocardial infarction patients. Older patients, those living farther from the hospital, and those with hemodynamic compromise were more likely to use EMS transport. In contrast, race, income, and education level did not appear to be associated with the mode of transport. Compared with self-transported patients, EMS-transported patients had significantly shorter delays in both symptom-onset-to-arrival time (median, 89 versus 120 minutes; P<0.0001) and door-to-reperfusion time (median door-to-balloon time, 63 versus 76 minutes; P<0.0001; median door-to-needle time, 23 versus 29 minutes; P<0.0001). CONCLUSIONS: Emergency medical services transportation to the hospital is underused among contemporary ST-segment-elevation myocardial infarction patients. Nevertheless, use of EMS transportation is associated with substantial reductions in ischemic time and treatment delays. Community education efforts are needed to improve the use of emergency transport as part of system-wide strategies to improve ST-segment-elevation myocardial infarction reperfusion care.

In-hospital major bleeding during ST-elevation and non-ST-elevation myocardial infarction care: derivation and validation of a model from the ACTION Registry®-GWTG™.

Bleeding, a common complication of acute myocardial infarction (AMI) treatment, is associated with worse outcomes. A contemporary model for major bleeding associated with AMI treatment can stratify patients at elevated risk for bleeding and is needed to risk-adjust AMI practice and outcomes. Using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database, an in-hospital major bleeding risk model was developed in a population of patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction. The model used only baseline variables and was developed (n = 72,313) and validated (n = 17,960) in patients with AMI (at 251 United States centers from January 2007 to December 2008). The 12 most statistically and clinically significant variables were incorporated into the final regression model. The calibration plots are shown, and the model discrimination is demonstrated in derivation and validation cohorts, as well as across key subgroups. The rate of major bleeding in the overall population was 10.8%. The 12 factors associated with major bleeding in the model were heart rate, baseline hemoglobin, female gender, baseline serum creatinine, age, electrocardiographic changes, heart failure or shock, diabetes, peripheral artery disease, body weight, systolic blood pressure, and home warfarin use. The risk model discriminated well in the derivation (C-statistic = 0.73) and validation (C-statistic = 0.71) cohorts. A risk score for major bleeding corresponded well with observed bleeding: very low risk (3.9%), low risk (7.3%), moderate risk (16.1%), high risk (29.0%), and very high risk (39.8%). In conclusion, the ACTION Registry-GWTG in-hospital major bleeding model stratifies risk for major bleeding using variables at presentation and enables risk-adjusted bleeding outcomes for quality improvement initiatives and clinical decision making.

"Reality surgery"--a research ethics perspective on the live broadcast of surgical procedures.

In recent years, the live broadcasting of medical and surgical procedures has gained worldwide popularity. While the practice has appropriately been met with concerns for patient safety and privacy, many physicians tout the merits of real time viewing as a form of investigation, accelerating the process leading to adoption or abolition of newer techniques or technologies. This view introduces a new series of ethical considerations that need to be addressed. As such, this article considers, from a research ethics perspective, the use of live surgical procedure broadcast for investigative purposes.

Risk adjustment for in-hospital mortality of contemporary patients with acute myocardial infarction: the acute coronary treatment and intervention outcomes network (ACTION) registry-get with the guidelines (GWTG) acute myocardial infarction mortality model and risk score.

BACKGROUND: accurate risk adjustment is needed to guide quality improvement initiatives and research to improve care of patients with acute myocardial infarction (MI). We developed and validated a model to predict the risk of in-hospital mortality for contemporary patients with acute MI treated in routine clinical practice. METHODS: the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry-Get With The Guidelines (GWTG) database of patients with acute MI was used to derive (n = 65,668 from 248 US sites) and validate (n = 16,336) a multivariable logistic regression model to predict the likelihood of in-hospital mortality (4.9% in each cohort). RESULTS: factors with the highest independent significance in terms of mortality prediction included age, baseline serum creatinine, systolic blood pressure, troponin elevation, heart failure and/or cardiogenic shock at presentation, ST-segment changes, heart rate, and prior peripheral arterial disease. The model showed very good discrimination, with c statistics of 0.85 and 0.84 in the derivation and validation cohorts, respectively. The model calibrated well overall and in key patient subgroups including males versus females, age <75 versus ≥ 75 years, diabetes versus no diabetes, and ST-elevation MI versus non-ST-elevation MI. The ACTION Registry-GWTG in-hospital mortality risk score was also developed from the model. Patients with a risk score of ≤ 40 had an observed mortality rate of <4% compared with those with a risk score of 41-50 (12%) and risk scores >50 (34%). CONCLUSION: the ACTION Registry-GWTG™ in-hospital mortality model and risk score represent simple, accurate risk adjustment tools for contemporary patients with acute MI.

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