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ARRA Investments in Biomedical Imaging and Bioengineering: Comparative Effectiveness Research

Public Health Burden
The rapid increase in the use of advanced imaging techniques for screening, diagnosis, guiding treatment and monitoring progress has had a wide and profound impact on the practice of medicine. Advances in bioengineering and imaging address major problems including liver disease and cirrhosis which results in 40,000 deaths and $1 billion in health care expenditures annually; abdominal aortic aneurysms which affect 5-7% of Americans over the age of 60; and the approximately 168,000 prostatectomies performed each year. Furthermore, informatics tools may improve the more than 30 million advanced diagnostic imaging procedures performed every year in the U.S. which are believed to be of low utility, exposing patients to unnecessary radiation and over-diagnosis.

Comparative Effectiveness Studies
Comparative effectiveness studies compare the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions. Such studies can provide information on the relative strengths and weaknesses of various medical interventions and help clinicians and patients make treatment decisions. ARRA funds will be used for several studies of the use of advanced imaging techniques and bioengineered devices. For example:
  • One project will compare the diagnostic accuracies of quantitative imaging and blood markers with liver biopsy in human subjects. A systematic analysis of non-invasive measurements using magnetic resonance and ultrasound elastography, direct and indirect serum marker panels and liver biopsy will be carried out on a representative patient population to determine the clinical effectiveness of these advanced imaging techniques.1
  • Another project will compare the effectiveness of the FDA-approved abdominal aortic endografts to resist displacement by hemodynamic forces in a wide range of aneurysm geometries and hemodynamic states. This study will develop computational techniques for quantifying forces of the endografts based on patient-specific placement and physiological conditions to estimate the likelihood of failure for each of the five FDA-approved devices. The quantification of risk of failure for each device may lead to better selection based on patient characteristics and reduce the burden of long-term surveillance and death. 2
  • One project will compare clinical as well as patient-reported outcomes between robotic and standard invasive prostatectomy. The project will characterize outcomes that are influenced by practitioner variability and assess the overall effectiveness of open, laparoscopic, and robotic techniques. Identifying factors which improve quality and consistency may reduce adverse outcomes from prostatectomy surgery.3
Accelerating the Adoption of Comparative Effectiveness Research Findings
The goal of comparative effectiveness research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs about which interventions are most effective for individual patients under specific circumstances. To accelerate the adoption of evidence-based findings into practice, ARRA funds are supporting the development of dissemination projects, such as the following:
  • One project aims to implement a robust, comprehensive decision support system at a large community hospital incorporating imaging-related comparative effectiveness findings. This system will inform both patients and providers of evidence-based findings and the appropriateness of ordered procedures. A decision support module for spine imaging will be developed as part of this work because of the low utility of many imaging procedures in this area. Assessment of the effectiveness of this new system will involve collecting and analyzing metrics of both patient and provider satisfaction. 4
  • Another project will translate a clinical decision support system from one IT infrastructure to another large teaching hospital in a different state with a different IT infrastructure and clinical workflow. Evidence-based decision support modules will be developed for imaging of suspected pulmonary embolisms, low back pain and hepatocellular carcinoma. In addition, a novel peer-to-peer consulting system will be incorporated to support physician queries not addressed by the decision support system. The adoption and meaningful use of the system will be monitored and the impact of disseminating the evidence-based guidelines assessed.5

  1. RC1EB010393-02 – Comparative Effectiveness of Advanced Diagnostic Imaging for Hepatic Fibrosis – Talwalkar, Jayant (MN)
  2. RC1EB011443-02 – Resistance to Aortic Endograft Migration: Comparative Effectiveness of FDA Approved Devices – Zarins, Christopher (CA)
  3. RC1EB011001-02 – Effectiveness of Robotic Compared to Standard Prostatectomy for Prostate Cancer – Sanda, Martin (MA)
  4. UC4EB012948-01 – Implementation and Evaluation of Imaging Decision Support Incorporating CER – Gazelle, Scott (MA)
  5. UC4EB012952-01 – Impact of decision support and accountability tools on adoption of evidence – Khorasani, Ramin (MA)

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