American heart journal
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American heart journal · Jun 2013
ReviewThe role of the emergency department in acute heart failure clinical trials--enriching patient identification and enrollment.
Nearly 800,000 of the 1 million patients hospitalized with acute heart failure (AHF) every year are initially treated by emergency physicians. Signs and symptoms are typically most severe at initial presentation, but with timely diagnostic and therapeutic management, rapid improvement can be achieved. As a direct result, emergency physicians set the tone for initial AHF management. ⋯ Moreover, because the traditional approach to AHF clinical trials has relied on cardiology-based research teams to identify patients up to 24 hours after ED presentation, patients admitted to noncardiology services are often missed, and those who are captured tend to be enrolled long after initial therapy has improved acute symptoms. This has resulted in low-enrollment heart failure clinical trials, which has been approximated at 0.41 patients per site per month. We describe the landscape of initial ED management, explain how this may confound clinical trial results, and provide a multidimensional template for successful ED/cardiology collaboration aimed at improving patient enrollment and the conduct of AHF clinical trials in the United States.
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American heart journal · Jun 2013
ReviewRescuing clinical trials in the United States and beyond: a call for action.
Numerous challenges-financial, regulatory, and cultural-are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as well as the broader clinical trial enterprise. To promote consensus around the solutions needed to address the adverse trends in clinical research, the Duke Clinical Research Institute convenedstakeholders from academia, industry, and government. article summarizes the proceedings of this meeting and addresses: (1) adverse trends in the United States and multinational clinical trials, (2) the key issues that underlie these adverse trends, and (3) potential solutions to these problems.
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In recent years, international clinical trials have increasingly included large numbers of patients and research sites from developing countries. In South America particularly, enrollment in randomized clinical trials has increased substantially. Despite this significant growth of late, there has been little systematic assessment of the role of this region in cardiovascular clinical trials. ⋯ Labor costs also tend to be lower than those in high-income countries. On the other hand, clinical research in this region of the world faces limitations posed by a relatively small clinical trials network with limited operations expertise, as well as prolonged regulatory approval timelines, diversity in health care systems, limited training opportunities in clinical research, and a low patient level of education. Thus, there are many opportunities to improve the conduct of clinical research in South America, but strategies and systems must be developed to overcome barriers in this economically growing region and to establish a robust infrastructure for clinical trials, including high-quality investigator networks.
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American heart journal · Jun 2013
Comparative StudyEvaluating early repeat emergency department use in patients with atrial fibrillation: a population-based analysis.
Emergency department (ED) use by patients with atrial fibrillation is high and will accelerate with the aging of the population. In patients with atrial fibrillation who are discharged from the ED, we aimed to describe their subsequent outpatient care, return ED visits, and management strategies associated with early return. ⋯ Among older patients with atrial fibrillation discharged from an ED in the province of Ontario, 9% make 1 or more repeat visits within 14 days. Reductions in repeat emergency visits by low-risk patients are associated with timely specialist follow-up care.
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American heart journal · Jun 2013
Comparative StudyGender differences in clinical outcomes among diabetic patients hospitalized for cardiovascular disease.
The risk of incident cardiovascular disease (CVD) has been shown to be greater among diabetic women than men, but gender differences in clinical outcomes among diabetic patients hospitalized with CVD are not established. We aimed to determine if hemoglobin A1c (HbA1c) was associated with 30-day and 1-year CVD rehospitalization and total mortality among diabetic patients hospitalized for CVD, overall and by gender. ⋯ Risk of 30-day CVD rehospitalization was 8.5-fold higher among diabetic women hospitalized for CVD with HbA1c ≥7% vs <7%; no association was observed among men. A trend for increased 30-day/1-year mortality risk with HbA1c <6% deserves further study.