Society of Interventional Radiology

Saturday, February 21, 2015

Fueling new era of IR big data

By James B. Spies, M.D., MPH, FSIR 
SIR 2014–15 President

Health care is moving toward a value-based care model, one in which analytics have become a primary focus of health systems. Internal benchmarking typically used to evaluate performance is not enough to meet government mandates, ensure reimbursement and avoid financial penalties. We recognize that we need IR big data—huge pools of information that reveal major trends and ensure high-quality effective outcomes and patient safety.

SIR’s actions with comparative analytics, bringing together data from patients and providers in real time, will help turn IR big data into IR big action. We need to answer questions that have broad implications for patient care and fuel the future with data-driven discoveries. SIR has entered this new era by collaborating with our colleagues in other specialties, the government and industry—and by developing new mechanisms for broad-based studies.

In 2010, the U.S. Food and Drug Administration (FDA) raised concerns about the safety of vena cava filters, calling on medical specialists to help evaluate potential significant health risks for patients. SIR allied with the Society for Vascular Surgery to form the IVC Filter Study Group Foundation, which initiated PRESERVE, the first industry-supported, large-scale, multispecialty prospective clinical research trial to evaluate the use of filters and related follow-up treatment in the United States. This study intends to enroll 2,100 patients at approximately 60 centers, answering questions about the current indications of filter placement, retrieval, safety (fracture, migration, perforation) and efficacy.

This isn’t the first time that SIR has developed a large-scale study in collaboration with others. The FIBROID Registry, initiated with input from the Agency for Healthcare Research and Quality (AHRQ) and FDA, was the largest, multicenter, prospective voluntary registry on any treatment for benign uterine fibroids. Supported by industry, the study enrolled 3,100 patients and provided both short-term safety and long-term efficacy outcomes. Equally important, the registry demonstrated the ability of SIR members to work together in a large study to answer an important public health question.

FDA is developing a number of initiatives to support broad-scale collection of safety data and more robustly identify problems with products once in clinical practice. SIR volunteers meet regularly with FDA representatives, participating in essential information exchange. We often present clinical aspects of new treatments or procedures with new technology being applied to help FDA reviewers understand the context of management of the clinical condition. Additionally, SIR engages in an FDA network of experts, a group of outside clinicians, scientists and engineers who provide the Center for Devices and Radiological Health (CDRH) staff with rapid access to our expertise.

SIR and SIR Foundation remain committed to quality improvement and mechanisms to assess performance in interventional radiology. We are collaborating with the American College of Radiology and an IT solutions provider to develop and design an IR Registry for maintenance of certification (MOC) and Physician Quality Reporting System (PQRS) reporting. With the developing SIR registry efforts based on structured reporting, we have the opportunity to get input from FDA staff and others on important questions that might be answered by this type of quality improvement effort.

Interventional radiologists pioneered minimally invasive medicine, and we are continuing to carry that charge. Our efforts will result in better monitoring of patient outcomes and earlier identification of problems with devices that we use in our treatments. We have never stopped defining the future of medicine and adapting to the evolving health care environment. We are proud that SIR’s concerted actions reflect our new brand, and we will continue to harness image-guided therapies to develop breakthrough treatments, change medical practice and improve the standard of care.

I look forward to discussing these and our other efforts with you at this year’s Annual Scientific Meeting.

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