Comparative Effectiveness Studies
The DCRI is a leader in innovative health services research that improves the quality, value, and outcomes of patient-centered care. Our faculty members conduct accelerated practical studies about the outcomes, comparative clinical effectiveness, safety, and appropriateness of health care items and services.
Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA)
- Available research evidence suggests that atrial fibrillation (AF) has substantial adverse effects on quality of life and significantly increases costs of care. Recognizing this reality, the large multi-center international clinical trial called CABANA, was designed to assess the economics and quality of life consequences of two very different AF therapies: (1) percutaneous left atrial catheter ablation versus (2) rate or rhythm control drug therapy. Patient functional, emotional, economic, and employment status is conducted via questionnaires and telephone interviews. Analysis will compare cost and quality of life outcomes for the two treatment arms according to intention-to-treat and the incremental cost effectiveness ratio. The DCRI is serving as the Data and Statistical Coordinating Center for this trial.
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
- The recent introduction of catheter-based endovascular technology has led to the development and testing of minimally-invasive procedures to treat abdominal aortic aneurysms (AAAs) and prevent rupture, with the potential to reduce morbidity and mortality rates, shorten hospital stay, and provide a satisfactory treatment outcome. The PIVOTAL study is a randomized, prospective, multi-center study whose purpose is to compare endovascular repair versus surveillance in subjects with smaller AAA. The study will be conducted at 50 US sites and a total of 1680 patients are to be enrolled. All patients randomized in the US are to be enrolled in the economic assessment study, which aims to: (1) compare medical resource use patters and associated medical costs for the endovascular repair arm versus the surveillance arm by intention-to-treat; (2) to compare utilities as measured by the EuroQol Health Utility Index for the endovascular repair arm versus the surveillance arm by intention-to-treat; and (3) to perform a cost effectiveness analysis of an endovascular repair versus a surveillance treatment strategy. The DCRI will serve as the Health Economic Coordinating Center for study.
Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)
- Clinicians currently have limited information available to them regarding the functionality of cardiac diagnostic tests. As a result, the wrong diagnostic tests are often overly utilized, and the correct diagnostic tests are often underutilized. Furthermore, patients frequently do not receive the optimal diagnostic test for their condition, leading to missed diagnoses, as well as misdiagnoses. PROMISE is a 10,000 patient trial designed to compare different cardiac diagnostic tests in real-world settings, in order to learn how these tests impact patient outcomes. These evaluations will help to define care and shape health policy for the millions of people referred for cardiac diagnostic testing each year. The PROMISE trial is part of the work of the DCRI imaging program and is being funded by four grants from the National Heart, Lung, and Blood Institute.