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.
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.
randomized controlled trials; observational studies; implementation; study designs; methodology
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.
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.
electrocardiography; myocardial infarction; reperfusion; computers
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.
METHODS AND RESULTS
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.
cost-benefit analysis; fibrinolysis; Percutaneous coronary intervention; ST-segment elevation myocardial infarction; thrombolysis
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.
Patients; population; women; emergency medical services; cardiac care
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.
thrombolytic therapy; primary percutaneous transluminal coronary angioplasty; risk stratification; acute myocardial infarction; meta-regression
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.
DESIGN AND PARTICIPANTS
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.
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.
capitation; physician reimbursement; physician organization; physician financial risk; universal health care access
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.
MEASUREMENTS AND MAIN Results
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.
emergency department (ED); presentation; acute myocardial infarction (AMI); gender; congestive heart failure (CHF)