Clinical registries are organized systems that store standardized data on a specific population defined by a disease, condition, or procedure. Information from clinical data registries can be used to evaluate specific outcomes and compare the effectiveness of different treatments. Furthermore, they are utilized to improve quality of care and patient safety.
The Clinical Research and Registries Division strongly encourages registry endeavors for the purposes of advancing scientific knowledge and developing innovative therapies that lead to improved patient care in IR. Previous registry stakeholders include government agencies, industry manufacturers, and other professional societies.
SIR Foundation is involved in the development of various registries. SIR members have led and supported the following registries:
Global Interventional Oncology - Clinical Outcomes Registry (IO-CORE)
In December 2018, SIR Foundation held a Research Consensus Panel (RCP) on Musculoskeletal Interventional Oncology Interventions, which was led by Matthew R. Callstrom, MD, PhD. After this RCP, a joint meeting by SIR Foundation and Society of Interventional Oncology (SIO) was convened to develop plans for IO-CORE, an international registry to collect prospective clinical evidence in IO. It will involve subject matter experts in each major disease domain for development of subregistries under IO-CORE. In November 2019, SIR Foundation and SIO officially launched IO-CORE. The first IO-CORE Foundation Board meeting was in December 2019, and the board is currently developing the protocol and establishing the infrastructure.
Board of Directors
President: Michael C. Soulen, MD, FSIR, FCIRSE
Vice President: Suresh Vedantham, MD, FSIR
SIO Representative: Stephen Solomon, MD, FSIR
SIR Representative: James B. Spies, MD, MPH, FSIR
Treasurer: Jena Eberly Stack, M Ed, PMP
Secretary: Carolyn Strain, MA, MS
Talosix Sacroplasty Registry
SIR Foundation is collaborating with Talosix in a registry to evaluate the effectiveness of sacroplasty procedure. There is limited research on sacroplasty, and it is not commonly completed due to lack of reimbursement. The registry's goal is to collect data from 252 procedures across 7-10 sites. As of October 2020, 9 sites have collected data from 58 procedures.
- Advanced Pain Management and Spine Specialists
- Beam Interventional
- Clinical Investigations
- Colorado Spine Institute
- Consulting Orthopaedic Associates
- Dr. James Webb & Associates
- Medical College of Wisconsin
- Reading Hospital
- VIRA of Central Georgia
SIR Foundation is recruiting additional sites to participate in the sacroplasty registry. Sites that complete 1-2 sacroplasty procedures are encouraged to participate. Talosix will work with interested sites to complete the appropriate paperwork and training. For additional information, please contact the coordinator of research and grants.
Registry Assessment of Peripheral Interventional Devices (RAPID)
RAPID is an MDEpiNet project that focuses on registry development for peripheral arterial intervention. Standard data elements related to the care and treatment of patients with peripheral artery disease are being developed to create a structured dataset that supports pre‐ and post‐market assessment, quality improvement, and safety surveillance of peripheral interventional devices. SIR members have been involved in the initial stages, and they have attended previous planning meetings. SIR continues to participate as an important stakeholder.
Talosix Vertebral Compression Fracture (VCF) Registry
SIR Foundation collaborated with Talosix to support interventional radiologists participation in the existing VCF Registry. Noridian Healthcare Solutions (NHS) issued a local coverage decision (LCD) requiring outcomes data for vertebral augmentation procedures. By working directly with NHS, Talosix provided a standardized approach to submit information to meet these outcomes requirements and comply with the requirements of the LCD. SIR Foundation covered the cost of participation of a limited number of sites to ensure adequate data collection for coverage purposes, as well as to ensure high-quality data submission that will result in improved patient care. As of April 2018, the registry reached its enrollment goal, and it is closed to enrollment. Douglas P. Beall, MD, the lead investigator, is working on manuscripts related to the data. The data has been presented at the following:
- Beall DP. The US Vertebral Augmentation Registry: Findings from the World's Largest Registry of Vertebroplasty and Kyphoplasty. European Percutaneous Spine Intervention and Vertebroplasty Workshop. Paris, France. February 1, 2019.
- Beall DP. Data From the Vertebral Augmentation Registry. European Percutaneous Spine Intervention and Vertebroplasty Workshop. Paris, France. February 1, 2019.
- Beall DP. The Findings from the United States Registry of Vertebral Augmentation. 6th Annual MAMMI Meeting. Cagliari, Sardinia, Italy. February 7, 2019.
- Beall DP, Shonnard NH, Norwitz J, Wagoner D, Khor S. Registry Outcomes of Cement Augmentation for Osteoporotic Vertebral Compression Fractures. Society of Interventional Radiology, Austin, TX, May 23 – 28, 2019.
- Anderson PA, Beall DP, Shonnard NH, Berven SH, Norwitz J, Wagoner D. Registry Outcomes of Cement Augmentation for Osteoporotic Vertebral Compression Fractures. Lumbar Spine Research Society, Chicago, IL, April 4 – 5, 2019.