RESUMO
This descriptive case study covers the development of a survey to assess research subject satisfaction among those participating in clinical research studies at an academic medical center (AMC). The purpose was twofold: to gauge the effectiveness of the survey, as well as to determine the level of satisfaction of the research participants. The authors developed and implemented an electronic research participant satisfaction survey. It was created to provide research teams at the authors' AMC with a common instrument to capture research participant experiences in order to improve upon the quality of research operations. The instrument captured participant responses in a standardized format. Ultimately, the results are to serve as a means to improve the research experience of participants for single studies, studies conducted within a division or department of the AMC, or across the entire research enterprise at the institution. For ease of use, the survey was created within an electronic data capture system known as REDCap, which is used by a consortium of more than 1,800 institutional partners as a tool from the Clinical and Translational Science Awards (CTSA) program of the National Institutes of Health (NIH). Participants in the survey described in this article were more than 18 years of age and participating in an institutional review board (IRB)-approved study. Results showed that the vast majority of participants surveyed had a positive experience engaging in research at the authors' AMC. Further, the tool was found to be effective in making that determination. The authors hope to expand the use of the survey as a means to increase research satisfaction and quality at their university.
RESUMO
BACKGROUND: The renin-angiotensin system is well recognized as a mediator of pathophysiological events in atherosclerosis. The benefits of renin inhibition in atherosclerosis, especially when used in combination with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs) are currently not known. We hypothesized that treatment with the renin inhibitor aliskiren in patients with established cardiovascular disease will prevent the progression of atherosclerosis as determined by high-resolution magnetic resonance imaging (MRI) measurements of arterial wall volume in the thoracic and abdominal aortas of high-risk patients with preexisting cardiovascular disease. METHODS AND RESULTS: This was a single-center, randomized, double-blind, placebo-controlled trial in patients with established cardiovascular disease. After a 2-week single-blind placebo phase, patients were randomized to receive either placebo (n=37, mean ± SD age 64.5 ± 8.9 years, 3 women) or 150 mg of aliskiren (n=34, mean ± SD age 63.9 ± 11.5 years, 9 women). Treatment dose was escalated to 300 mg at 2 weeks and maintained during the remainder of the study. Patients underwent dark-blood, 3-dimensional MRI assessment of atherosclerotic plaque in the thoracic and abdominal segments at baseline and on study completion or termination (up to 36 weeks of drug or matching placebo). Aliskiren use resulted in significant progression of aortic wall volume (normalized total wall volume 5.31 ± 6.57 vs 0.15 ± 4.39 mm(3), P=0.03, and percentage wall volume 3.37 ± 2.96% vs 0.97 ± 2.02%, P=0.04) compared with placebo. In a subgroup analysis of subjects receiving ACEI/ARB therapy, atherosclerosis progression was observed only in the aliskiren group, not in the placebo group. CONCLUSIONS: MRI quantification of atheroma plaque burden demonstrated that aliskiren use in patients with preexisting cardiovascular disease resulted in an unexpected increase in aortic atherosclerosis compared with placebo. Although preliminary, these results may have implications for the use of renin inhibition as a therapeutic strategy in patients with cardiovascular disease, especially in those receiving ACEI/ARB therapy. CLINICAL TRIAL REGISTRATION: URL: http://ClinicalTrials.gov Unique identifier: NCT01417104.
