Type of Thesis
Dr. William Byrnes
Dr. David Sherwood
Dr. Tarek Sammakia
The use of invasive procedures in research settings is essential to enhance and advance our understanding of biological and physiological mechanisms of disease and medical procedures, thus building the foundation for evidence-based medicine. However, such procedures pose a risk to subjects. The benefits gained from performing a procedure must present a greater gain to society than the risks presented to human subjects. When risks of invasive procedures are realized, they are categorized as adverse events. This study analyzes the risk-to-benefit ratio of invasive procedures performed at the Clinical Translational Research Center (CTRC) at CU Boulder, by quantifying the rate and risk of adverse events from 2003-2015. I further compared these rates to other clinical and research settings.
The rate of adverse events from 2003-2015 was 1 adverse event per 62 procedures. The percentage of adverse events at the CTRC (1.59%) is similar to published research settings and lower than clinical settings. The greatest rate of adverse events over multiple years occurred during GXT protocols, 1 adverse event per 13.51 procedures. However, the symptoms and severity associated with these adverse events were reasonable and largely controllable. The symptoms of GXT adverse events were most commonly abnormal EKGs (ST depressions, hypertension, ventricular ectopy). These symptoms may indicate underlying pathologies in the subject volunteers, but may also be benign. There was no difference between the count of adverse events and sex (50% males, 50% females) and the rate of adverse events between years. The percent of adverse events was highest for elderly people (Age =58-81 years old) for total adverse events (older age group = 50.54%) and GXT (older age group = 69.3%). Further research, including the sex and age of subjects for the total number of procedures performed, is required to determine the absolute risk of adverse events between age groups and sex in this setting.
To better assess the cause of an adverse event, a section on negligence should be added to the adverse event reporting form. The risks quantified in this paper may improve informed consent forms at the CTRC, by making the risks of a procedure more precise. Ultimately, the potential benefits of progressing evidence-based medicine by continuing invasive procedures at the CTRC outweigh the accompanied risk incurred by healthy subjects.
Whitcomb, Mackenzie, "Retrospective Analysis of Reported Adverse Events Occurring at the Clinical Translational Research Center at the University of Colorado Boulder" (2017). Undergraduate Honors Theses. 1471.
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