Clinical trials, informed consent, & emergency medicine: A systematic literature review

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^

Ambulatory care adverse events and preventable adverse events leading to a hospital admission.

BACKGROUND: Most healthcare in the US is delivered in the ambulatory care setting, but the epidemiology of errors and adverse events in ambulatory care is understudied. METHODS: Using the population-based data from the Colorado and Utah Medical Practices Study, we identified adverse events that occurred in an ambulatory care setting and led to hospital admission. Proportions with 95% CIs are reported. RESULTS: We reviewed 14,700-hospital discharge records and found 587 adverse events of which 70 were ambulatory care adverse events (AAEs) and 31 were ambulatory care preventable adverse events (APAEs). When weighted to the general population, there were 2608 AAEs and 1296 (44.3%) APAEs in Colorado and Utah, USA, in 1992. APAEs occurred most commonly in physicians' offices (43.1%, range 46.8-27.8), the emergency department (32.3%, 46.1-18.5) and at home (13.1%, 23.1-3.1). APAEs in day surgery were less common (7.1%, 13.6-0.6) but caused the greatest harm to patients. The types of APAEs were broadly distributed among missed or delayed diagnoses (36%, 50.2-21.8), surgery (24.1%, 36.7-11.5), non-surgical procedures (14.6%, 25.0-4.2), medication (13.1%, 23.1-3.1) and therapeutic events (12.3%, 22.0-2.6). Overall, 10% of the APAEs resulted in serious permanent injury or death. The proportion of APAEs that resulted in death was 31.8% for general internal medicine, 22.5% for family practice and 16.7% for emergency medicine. CONCLUSION: An estimated 75,000 hospitalisations per year are due to preventable adverse events that occur in outpatient settings in the US, resulting in 4839 serious permanent injuries and 2587 deaths.

Master of Education in Teaching Program with an Emphasis in the Health Sciences

Introduction: Concerns about the quality of physician education have changed current medical education practices. Learners must demonstrate competency in core areas, rather than solely participating in educational activities. Academic medical institutions are challenged with identifying leaders to direct curricular and evaluation reforms. An innovative partnership between the University of Houston College of Education and Baylor College of Medicine, the University of Texas Medical School at Houston, and the University of Texas Dental Branch at Houston offers a Masters of Education in Teaching degree with an emphasis in Health Sciences. Courses encompass fundamental areas including curriculum, instruction, technology, measurement, research design and statistics. [See PDF for complete abstract]