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1.  Factors associated with longer time to treatment for patients with suspected acute coronary syndromes: a cohort study 
Rapid treatment of acute coronary syndromes (ACS) is important; causes of delay in emergency medical services (EMS) care of ACS are poorly understood.
Methods and results
Analysis of data from the IMMEDIATE randomized controlled trial of EMS treatment of people with symptoms suggesting ACS, using hierarchical multiple regression of elapsed time. Out-of-hospital electrocardiograms were performed on 54,230 adults calling 9-1-1; 871 had presumed ACS, 303 of whom had ST-segment elevation myocardial infarction and underwent percutaneous coronary intervention. Compared to their counterparts, women, participants with diabetes, and participants without prior cardiovascular disease waited longer to call 9-1-1(by 28, p <0.01; 10, p 0.03; and 6 minutes, p 0.02, respectively). EMS arrival to electrocardiogram was longer for women (1.5 minutes, p <0.01), older individuals (1.3 minutes, p <0.01), and those without a primary complaint of chest pain (3.5 minutes, p <0.01). On-scene times were longer for women (2 minutes, p < 0.01) and older individuals (2 minutes, p <0.01). Older individuals and participants presenting on weekends and nights had longer door-to-balloon times (by 10, 14 and 11 minutes respectively, p < 0.01). Women and older individuals had longer total times (medical contact to balloon inflation 16, p 0.01, and 9 minutes, p <0.01, respectively; symptom onset to balloon inflation 31.5 minutes for women, p 0.02).
We found delays throughout ACS care, resulting in substantial differences in total times for women and older individuals. These delays may impact outcomes; a comprehensive approach to reduce delay is needed.
PMCID: PMC3985420  PMID: 24425697
acute coronary syndrome; emergency medical services; women
2.  Out-of-Hospital Administration of Intravenous Glucose-Insulin-Potassium in Patients With Suspected Acute Coronary Syndromes 
JAMA  2012;307(18):1925-1933.
Laboratory studies suggest that in the setting of cardiac ischemia, immediate intravenous glucose-insulin-potassium (GIK) reduces ischemia-related arrhythmias and myocardial injury. Clinical trials have not consistently shown these benefits, possibly due to delayed administration.
To test out-of hospital emergency medical service (EMS) administration of GIK in the first hours of suspected acute coronary syndromes (ACS).
Design, Setting, and Participants
Randomized, placebo-controlled, double-blind effectiveness trial in 13 US cities (36 EMS agencies), from December 2006 through July 31, 2011, in which paramedics, aided by electrocardiograph (ECG)-based decision support, randomized 911 (871 enrolled) patients (mean age, 63.6 years; 71.0% men) with high probability of ACS.
Intravenous GIK solution (n=411) or identical-appearing 5% glucose placebo (n=460) administered by paramedics in the out-of-hospital setting and continued for 12 hours.
Main Outcome Measures
The prespecified primary end point was progression of ACS to myocardial infarction (MI) within 24 hours, as assessed by biomarkers and ECG evidence. Prespecified secondary end points included survival at 30 days and a composite of prehospital or in-hospital cardiac arrest or in-hospital mortality, analyzed by intent-to-treat and by presentation with ST-segment elevation.
There was no significant difference in the rate of progression to MI among patients who received GIK (n=200; 48.7%) vs those who received placebo (n=242; 52.6%) (odds ratio [OR], 0.88; 95% CI, 0.66–1.13; P=.28). Thirty-day mortality was 4.4% with GIK vs 6.1% with placebo (hazard ratio [HR], 0.72; 95% CI, 0.40–1.29; P=.27). The composite of cardiac arrest or in-hospital mortality occurred in 4.4% with GIK vs 8.7% with placebo (OR, 0.48; 95% CI, 0.27–0.85; P=.01). Among patients with ST-segment elevation (163 with GIK and 194 with placebo), progression to MI was 85.3% with GIK vs 88.7% with placebo (OR, 0.74; 95% CI, 0.40–1.38; P=.34); 30-day mortality was 4.9% with GIK vs 7.7% with placebo (HR, 0.63; 95% CI, 0.27–1.49; P=.29). The composite outcome of cardiac arrest or in-hospital mortality was 6.1% with GIK vs 14.4% with placebo (OR, 0.39; 95% CI, 0.18–0.82; P=.01). Serious adverse events occurred in 6.8% (n=28) with GIK vs 8.9% (n=41) with placebo (P=.26).
Among patients with suspected ACS, out-of-hospital administration of intravenous GIK, compared with glucose placebo, did not reduce progression to MI. Compared with placebo, GIK administration was not associated with improvement in 30-day survival but was associated with lower rates of the composite outcome of cardiac arrest or in-hospital mortality.
Trial Registration Identifier: NCT00091507
PMCID: PMC4167391  PMID: 22452807
3.  White Paper on CTSA Consortium Role in Facilitating Comparative Effectiveness Research 
PMCID: PMC4130456  PMID: 20443951
research infrastructure; clinical research; health policy; comparative effectiveness research; clinical and translational science
4.  Emergency Medical Service Predictive Instrument Aided Diagnosis and Treatment of Acute Coronary Syndromes and ST Elevation Myocardial Infarction in the IMMEDIATE Trial 
Achallenge for emergency medical service (EMS) is accurate identification of acute coronary syndromes (ACS) and ST elevation myocardial infarction (STEMI) for immediate treatment and transport. The electrocardiograph-based acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI) and the thrombolytic predictive instrument (TPI) have been shown to improve diagnosis and treatment in emergency departments (EDs), but their use by paramedics in the community has been less studied.
Ambulances in study municipalities were outfitted with electrocardiographs with ACI-TIPI and TPI software. Using a before-after quasi-experimental design, in Phase 1, for seven months, paramedics were provided with the ACI-TIPI/TPI continuous 0–100% predictions automatically printed on electrocardiogram (ECG) text headers to supplement their identification of ACS; in Phase 2, for 11 months, paramedics were told to identify ACS based on an ACI-TIPI cutoff probability of ACS ≥ 75% and/or TPI detection of STEMI. In Phase 3, this cutoff approach was used in seven additional municipalities. Confirmed diagnoses of ACS, acute myocardial infarction (AMI), and STEMI were made by blinded physician review for 100% of patients.
In Phase 1, paramedics identified 107 patients as having ACS; in Phase 2, 104. In Phase 1, 45.8% (49) of patients so-identified had ACS confirmed, which increased to 76.0% (79) in Phase 2 (p < 0.001). Of those with ACS, in Phase 1 59.2% (29) had AMI versus 84.8% (67) with AMI in Phase 2 (p <0.01), and, STEMI was confirmed, respectively, in 40.8% (20), versus 68.4% (54) (p <0.01). In Phase 3, of 226 patients identified by paramedics as having ACS, 74.3% (168) had ACS confirmed, of whom 81.0% (136) had AMI and 65.5% (110) had STEMI.
In a wide range of EMS systems, use of electrocardiographs with ACI-TIPI and TPI decision support using a 75% ACI-TIPI cutoff improves paramedic diagnostic performance for ACS, AMI, and STEMI.
PMCID: PMC4104416  PMID: 21366431
acute coronary syndromes; acute myocardial infarction; electrocardiology; emergency medical service; clinical decision support
5.  Academic General Internal Medicine: A Mission for the Future 
After five decades of growth that has included advances in medical education and health care delivery, value cohesion, and integration of diversity, we propose an overarching mission for academic general internal medicine to lead excellence, change, and innovation in clinical care, education, and research. General internal medicine aims to achieve health care delivery that is comprehensive, technologically advanced and individualized; instills trust within a culture of respect; is efficient in the use of time, people, and resources; is organized and financed to achieve optimal health outcomes; maximizes equity; and continually learns and adapts. This mission of health care transformation has implications for the clinical, educational, and research activities of divisions of general internal medicine over the next several decades.
PMCID: PMC3663942  PMID: 23321931
6.  Study Design for the IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care) Trial: A Double-blind Randomized Controlled Trial of Intravenous Glucose, Insulin, and Potassium (GIK) for Acute Coronary Syndromes in Emergency Medical Services 
American heart journal  2012;163(3):315-322.
Experimental studies suggest that metabolic myocardial support by intravenous (IV) glucose, insulin, and potassium (GIK) reduces ischemia-induced arrhythmias, cardiac arrest, mortality, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), and MI size. However, trials of hospital administration of IV GIK to patients with ST elevation MI (STEMI) have generally not shown favorable effects, possibly due to the GIK intervention taking place many hours after ischemic symptom onset. A trial of GIK used in the very first hours of ischemia has been needed, consistent with the timing of benefit seen in experimental studies.
The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care (IMMEDIATE) Trial tested whether, if given very early, GIK could have the impact seen in experimental studies. Accordingly, distinct from prior trials, IMMEDIATE tested the impact of GIK 1) in patients with acute coronary syndromes (ACS), rather than only AMI or STEMI, and 2) administered in prehospital emergency medical service (EMS) settings, rather than later, in hospitals, following emergency department evaluation.
IMMEDIATE was an EMS-based randomized placebo-controlled clinical effectiveness trial conducted in 13 cities across the US which enrolled 911 participants. Eligible were patients age 30 or older for whom a paramedic performed a 12-lead electrocardiogram (ECG)to evaluate chest pain or other symptoms suggestive of ACS for whom electrocardiograph-based ACI-TIPI (acute cardiac ischemia time-insensitive predictive instrument) indicated a > 75% probability of ACS, and/or the TPI (thrombolytic predictive instrument) indicated presence of a STEMI, or if local criteria for STEMI notification of receiving hospitals were met. Prehospital IV GIK or placebo was started immediately.
Pre-specified were the primary endpoint of progression of ACS to infarction, and as major secondary endpoints, the composite of cardiac arrest or in-hospital mortality; 30-day mortality; and the composite of cardiac arrest, 30-day mortality or hospitalization for heart failure (HF). Analyses were planned on an intent-to-treat basis, on a modified intent-to-treat group who were confirmed in emergency departments to have ACS, and for participants presenting with STEMI.
The IMMEDIATE Trial tested whether GIK, when administered as early as possible in the course of ACS by paramedics using ACI-TIPI and TPI decision support, would reduce progression to AMI, mortality, cardiac arrest, and HF. It also tested whether it would provide clinical and pathophysiological information on GIK’s biological mechanisms.
PMCID: PMC4009621  PMID: 22424000
7.  Gun Violence Is a Health Crisis: Physicians’ Responsibilities 
PMCID: PMC3631057  PMID: 23558774
8.  Preliminary Competencies for Comparative Effectiveness Research 
The Clinical and Translational Science Award (CTSA) Workgroup for Comparative Effectiveness Research (CER) Education, Training, and Workforce Development identified a need to delineate the competencies that practitioners and users of CER for patient centered outcomes research, should acquire. With input from CTSA representatives and collaborators, we began by describing the workforce. We recognize the workforce that conduct CER and the end users who use CER to improve the health of individuals and communities. We generated a preliminary set of competencies and solicited feedback from the CER representatives at each member site of the CTSA consortium. We distinguished applied competencies (i.e., skills needed by individuals who conduct CER) from foundational competencies that are needed by the entire CER workforce, including end users of CER. Key competency categories of relevance to both practitioners and users of CER were: 1) Asking relevant research questions; 2) Recognizing or designing ideal CER studies; 3) Executing or using CER studies; 4) Using appropriate statistical analyses for CER; and 5) Communicating and disseminating CER study results to improve health. While CER is particularly broad concept, we anticipate that these preliminary, relatively generic competencies will be used in tailoring curricula to individual learners from a variety of programmatic perspectives.
PMCID: PMC3533240  PMID: 23253670
9.  Comparative Effectiveness Research in Lung Diseases and Sleep Disorders 
The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed.
PMCID: PMC3265273  PMID: 21965016
randomized controlled trials; observational studies; implementation; study designs; methodology
11.  Random Treatment Assignment Using Mathematical Equipoise for Comparative Effectiveness Trials 
In controlled clinical trials, random assignment of treatment is appropriate only when there is equipoise, i.e., no clear preference among treatment options. However, even when equipoise appears absent because prior trials show, on average, one treatment yields superior outcomes, random assignment still may be appropriate for some patients and circumstances. In such cases, enrollment into trials may be assisted by real-time patient-specific predictions of treatment outcomes, to determine whether there is equipoise to justify randomization.
The Percutaneous Coronary Intervention Thrombolytic Predictive Instrument (PCI-TPI) computes probabilities of 30-day mortality for patients having ST elevation myocardial infarction (STEMI), if treated with thrombolytic therapy, and if treated with PCI. We estimated uncertainty around differences in their respective predicted benefits using the estimated uncertainty of the model coefficients. Using the 2,781-patient PCI-TPI development dataset, we evaluated the distribution of predicted benefits for each patient. For three typical clinical situations, randomization was potentially warranted for 70%, 93%, and 80% of patients.
Predictive models may allow real-time patient-specific determination of whether there is equipoise that justifies trial enrollment for a given patient. This approach may have utility for comparative effectiveness trials and for application of trial results to clinical practice.
PMCID: PMC3076795  PMID: 21348950
13.  Improving Use of Prehospital 12-Lead Electrocardiography for Early Identification and Treatment of Acute Coronary Syndrome and ST-Elevation Myocardial Infarction 
Performance of Prehospital electrocardiograms (PH-ECGs) expedites identification of ST-elevation myocardial infarction (STEMI) and reduces door-to-balloon (D2B) times for patients receiving reperfusion therapy. To fully realize this benefit, emergency medical service (EMS) performance must be measured and used in feedback reporting and quality improvement (QI).
Methods and Results
This quasi-experimental design trial tested an approach to improving EMS PH-ECG using feedback reporting and QI interventions in two cities' EMS agencies and receiving hospitals. All patients ≥ 30 years, calling 9-1-1 with possible acute coronary syndrome (ACS) were included. In total 6,994 patients were included: 1,589 patients in the baseline period without feedback and 5,405 in the intervention period when there were feedback reports and QI interventions. Mean age (SD) was 66 (±17) and women represented 51%. Feedback and QI increased PH-ECG performance for patients with ACS from 76% to 93% (p=<.0001) and for patients with STEMI from 77% to 99% (p= <.0001). Aspirin administration increased from 75% to 82% (p=0.001) but the median total EMS run time remained the same at 22 minutes. The proportion of patients with D2B times of ≤90 minutes increased from 27% to 67% (p=0.006).
Feedback reports and QI improved PH-ECG performance for patients with ACS and STEMI and increased aspirin administration, without prehospital transport delays. Improvements in D2B times were also seen.
PMCID: PMC3103142  PMID: 20484201
electrocardiography; myocardial infarction; reperfusion; computers
15.  Comparative Effectiveness of STEMI Regionalization Strategies 
Primary percutaneous coronary intervention (PCI) is more effective on average than fibrinolytic therapy (FT) in the treatment of ST-segment elevation myocardial infarction (STEMI). Yet most U.S. hospitals are not equipped for PCI and FT is still widely used. This study evaluated the comparative effectiveness of STEMI regionalization strategies to increase the use of PCI against standard emergency transport and care.
We estimated incremental treatment costs and quality-adjusted life expectancies of 2,000 patients with STEMI who received PCI or FT in simulations of emergency care in a regional hospital system. To increase access to PCI across the system, we compared a base case strategy to 12 hospital-based strategies of building new PCI labs or extending the hours of existing labs, and one emergency medical services (EMS)-based strategy of transporting all patients with STEMI to existing PCI-capable hospitals. The base case resulted in 609 (569, 647) patients getting PCI. Hospital-based strategies increased the number of patients receiving PCI, the costs of care, and quality-adjusted life years (QALYs) saved, and were cost effective under a variety of conditions. An EMS-based strategy of transporting every patient to an existing PCI facility was less costly and more effective than all hospital expansion options.
Our results suggest that new construction and staffing of PCI labs may not be warranted if an EMS strategy is both available and feasible.
PMCID: PMC2967250  PMID: 20664025
cost-benefit analysis; fibrinolysis; Percutaneous coronary intervention; ST-segment elevation myocardial infarction; thrombolysis
16.  Elapsed Time in Emergency Medical Services for Patients with Cardiac Complaints: Are Some Patients at Greater Risk for Delay? 
In patients with a major cardiac event, the first priority is to minimize time to treatment. For many patients, first contact with the health system is through emergency medical services (EMS). We set out to identify patient and neighborhood-level factors that were associated with time in EMS.
A retrospective cohort study was conducted in ten municipalities in Dallas County, Texas from January 1 through December 31, 2004. The dataset included 5,887 calls with a primary complaint that was cardiac in nature. The region was served by 29 hospitals and 98 EMS depots. Multivariate models included measures of distance traveled, time of day, day of week, patient and neighborhood characteristics. The main outcomes were elapsed time in EMS (continuous; in minutes) and delay in EMS (dichotomous; > 15 minutes beyond median time).
We found positive associations between patient characteristics and both average time and serious delay in EMS care. Variation in average time was not large enough to be clinically meaningful. Approximately 11% (n = 647) of patients were delayed 15 minutes or more. Being non-white was associated with delays, but few patients were affected. Women were more likely to be seriously delayed (adjusted odds ratio 1.52; 95% confidence interval: 1.32, 1.74), and this association did not change after adjusting for other characteristics, including neighborhood socio-economic composition.
Compared to otherwise similar men, women have 50% greater odds of being delayed in the EMS setting. The determinants of serious delay should be a special focus of EMS studies where time to treatment is a priority.
PMCID: PMC2801899  PMID: 20031807
Patients; population; women; emergency medical services; cardiac care
18.  Is Primary Angioplasty for Some as Good as Primary Angioplasty for All? 
To investigate whether proper patient selection might allow most of the benefits of population-wide primary coronary angioplasty to be captured in a subgroup of high-risk patients.
Despite growing evidence that angioplasty yields better outcomes, thrombolytic therapy remains the most common form of reperfusion therapy in acute myocardial infarction (AMI) because of limited capacity for primary coronary angioplasty at most hospitals.
We used a validated logistic regression model, based on individual patient characteristics, to estimate the distribution of mortality risk in a community-based sample of 1,058 patients who received reperfusion therapy for AMI. To estimate the benefits across different baseline risks, we examined the results of 10 randomized controlled trials using meta-regression techniques.
Assuming a constant relative risk reduction, 68% of all mortality benefits in our community-based patient sample could be captured by treating only those patients in the highest quartile of mortality risk and 87% of the benefit could be captured by treating those in the highest half. Moreover, meta-regression of the results from the 10 clinical trials suggests that patients with a mortality risk of less than 2% may be unlikely to receive any mortality benefit. With this risk–benefit relationship, treatment of only the 39% of patients with the highest risk would yield equivalent mortality outcomes to population-wide angioplasty.
Most of the incremental benefits of primary angioplasty can be achieved by treating high-risk patients. For these patients, thrombolytic therapy may be difficult to justify if nearby primary angioplasty is available. For most patients, however, thrombolytic therapy appears to be an effective alternative.
PMCID: PMC1495133  PMID: 12472924
thrombolytic therapy; primary percutaneous transluminal coronary angioplasty; risk stratification; acute myocardial infarction; meta-regression
19.  Patient Protection and Risk Selection 
Individual physicians who are paid prospectively, as in capitated health plans, might tend to encourage patients to avoid or to join these plans according to the patient's health status. Though insurance risk selection has been well documented among organizations paid on a prospective basis, such physician-level risk selection has not been studied.
To assess physician reports of risk selection in capitated health plans and explore potentially related factors.
National mailed survey of primary care physicians in 1997–1998, oversampling physicians in areas with more capitated health plans.
The response rate was 63% (787 of 1,252 eligible recipients). Overall, 44% of physicians reported encouraging patients either to join or to avoid capitated health plans according to the patients' health status: 40% encouraged more complex and ill patients to avoid capitated plans and 23% encouraged healthier patients to join capitated plans. In multivariable models, physicians with negative perceptions of capitated plan quality, with more negative experiences in capitated plans, and those who knew at each patient encounter how they were being compensated had higher odds of encouraging sicker patients to avoid capitated plans (odds ratios, 2.0, 2.2, and 2.0; all confidence intervals >1).
Many primary care physicians report encouraging patients to join or avoid capitated plans according to the patient's health status. Although these physicians' recommendations might be associated primarily with concerns about quality, they can have the effect of insulating certain health plans from covering sicker and more expensive patients.
PMCID: PMC1494997  PMID: 11903774
20.  The Future of Capitation 
Capitation-based reimbursement significantly influences the practice of medicine. As physicians, we need to assure that payment models do not jeopardize the care we provide when we accept higher levels of personal financial risk. In this paper, we review the literature relevant to capitation, consider the interaction of financial incentives with physician and medical risk, and conclude that primary care physicians need to work to assure that capitated systems incorporate checks and balances which protect both patients and providers. We offer the following proposals for individuals and groups considering capitated contracts: (1) reimbursement for primary care physicians should recognize both individual patient encounters and the administrative work of patient care management; (2) reimbursement for subspecialists should recognize both access to subspecialty knowledge and expertise as well as patient care encounters, but in some situations, subspecialists may provide the majority of care to individual patients and will be reimbursed as primary care providers; (3) groups of physicians should accept financial risk for patient care only if they have the tools and resources to manage the care; (4) physicians sharing risk for patient care should meet regularly to discuss care and resource management; and (5) physicians must disclose the financial relationships they have with health plans and medical care organizations, and engage patients and communities in discussions about resource allocation. As a payment model, capitation offers opportunities for primary care physicians to influence the future of health care by improving the management of resources at a local level.
PMCID: PMC1495203  PMID: 11318926
capitation; physician reimbursement; physician organization; physician financial risk; universal health care access
21.  Presentations of Acute Myocardial Infarction in Men and Women 
To assess the influence of gender on the likelihood of acute myocardial infarction (AMI) among emergency department (ED) patients with symptoms suggestive of acute cardiac ischemia, and to determine whether any specific presenting signs or symptoms are associated more strongly with AMI in women than in men.
Analysis of cohort data from a prospective clinical trial.
Emergency departments of 10 hospitals of varying sizes and types in the United States.
Patients 30 years of age or older (n = 10,525) who presented to the ED with chest pain or other symptoms suggestive of acute cardiac ischemia.
The prevalence of AMI was determined for men and women, and a multivariable logistic regression model predicting AMI was developed to adjust for patients’ demographic and clinical characteristics. AMI was almost twice as common in men as in women (10% vs 6%). Controlling for demographics, presenting signs and symptoms, electrocardiogram features, and hospital, male gender was a significant predictor of AMI (odds ratio [OR] 1.7; 95% confidence interval [CI] 1.4 , 2.0). The gender effect was eliminated, however, among patients with ST-segment elevations on electrocardiogram (OR 1.1; 95% CI 0.7, 1.7) and among patients with signs of congestive heart failure (CHF) (OR 1.1; 95% CI 0.8, 1.5). Signs of CHF were associated with AMI among women (OR 1.9; 95% CI 1.4, 2.6) but not men (OR 1.0; 95% CI 0.8, 1.3). Among patients who presented to EDs with chest pain or other symptoms suggestive of acute cardiac ischemia, AMI was more likely in men than in women. Among women with ST-segment elevation or signs of CHF, however, AMI likelihood was similar to that in men with these characteristics.
PMCID: PMC1497064  PMID: 9051556
emergency department (ED); presentation; acute myocardial infarction (AMI); gender; congestive heart failure (CHF)

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