The FDA's new post-market surveillance vision highlights the importance of national registries and linkages with electronic health records (EHRs), administrative claims data, and with the Patient-Centered Outcomes Research Institute's (PCORI) Clinical Data Research Networks (CDRN) to create national basis for post- market surveillance. Orthopedic and vascular implants are particularly important to study. Osteoarthritis and vascular disease are common, progressively debilitating diseases with a high prevalence in older Americans. During the past 20 years, device-based hip and knee surgeries became the main treatment options for advanced disease, leading to the use of orthopedic and vascular devices in millions of Americans annually. Major evidence gaps in device performance exist, however, prompting international surveillance efforts jointly by the FDA and the Weill Cornell Medical College. These include International Consortium of Orthopedic Registries (ICOR) and International Consortium of Vascular Registries (ICVR) that are established as distributed research and surveillance networks focusing on questions related to understanding device safety, and effectiveness. While these consortia provide enormous value, each needs to strengthen their own national systems. For Americans, devices used internationally are often not similar to those used in the U.S., creating a critical knowledge gap about device benefits and risks. Moreover, U.S. registries are not always efficient; virtually none capitalize on automated processes for data capture, storage, and export. Taking advantage of growing national investments in EHRs to automate existing registry processes could result in costs savings, gains in efficiency, and quality improvement. In this proposal, we will capitalize on a novel partnership within the FDA's Medical Device Epidemiology Network (MDEpiNet) to build national infrastructure. We will link registries with Medicare, commercial, and state discharge billing claims, and CDRN data to develop an innovative infrastructure enabling post-market surveillance for orthopedic and vascular devices. In addition, through the use of EHRs data, we will showcase pilots for automation in registry creation and provide tools to stakeholders for successful creation of efficient registries. Finally, we will develop, implement, and distribute new methodological approaches that address key data issues emerging from the large linked databases. While the networks are separate, centralized knowledge sharing will support cross-specialty and technology learning. Hence, we have several aims: 1) Develop a national device surveillance network for orthopedic devices, 2) Develop a national device surveillance network for vascular devices, 3) Pilot an approach to create efficient registries using EHRs using fully automated processes, 4) Develop and implement novel methodology to address challenges emerging from creation of registries. Through this initiative, we leverage national investments in variety of data assets to create innovative, scalable models for post-market surveillance system that are sustainable and dynamic.

Public Health Relevance

We capitalize on a novel partnership within the FDA's Medical Device Epidemiology Network to build national surveillance infrastructure for orthopaedic and vascular devices by leveraging registries, claims, electronic health record (EHRs) and patient reported data. We also showcase efficient registry development using EHRs and advance the methodologies for device evaluation. Through this initiative, we leverage national investments in variety of data assets to create innovative, scalable models for post-market surveillance system that are sustainable and dynamic

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01FD005478-02S1
Application #
9461287
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Program Officer
Eloff, Benjamin
Project Start
2015-09-15
Project End
2020-08-31
Budget Start
2016-09-01
Budget End
2017-08-31
Support Year
2
Fiscal Year
2017
Total Cost
$1,300,000
Indirect Cost
Name
Weill Medical College of Cornell University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
060217502
City
New York
State
NY
Country
United States
Zip Code
10065
Ramkumar, Niveditta; Suckow, Bjoern D; Brown, Jeremiah R et al. (2018) Sex-Based Assessment of Patient Presentation, Lesion Characteristics, and Treatment Modalities in Patients Undergoing Peripheral Vascular Intervention. Circ Cardiovasc Interv 11:e005749
DeMartino, Randall R; Huang, Ying; Mandrekar, Jay et al. (2018) External validation of a 5-year survival prediction model after elective abdominal aortic aneurysm repair. J Vasc Surg 67:151-156.e3
Deery, Sarah E; Ergul, Emel A; Schermerhorn, Marc L et al. (2018) Aneurysm sac expansion is independently associated with late mortality in patients treated with endovascular aneurysm repair. J Vasc Surg 67:157-164
Charalel, Resmi A; Durack, Jeremy C; Mao, Jialin et al. (2018) Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals: Epidemiology and Recent Trends. Med Care 56:260-265
Golan, Ron; Bernstein, Adrien N; Gu, Xiangmei et al. (2018) Increased resource use in men with metastatic prostate cancer does not result in improved survival or quality of care at the end of life. Cancer 124:2212-2219
Chughtai, Bilal; Thomas, Dominique; Sun, Tianyi et al. (2018) Failures of Sacral Neuromodulation for Incontinence. JAMA Surg 153:493-494
Golan, Ron; Bernstein, Adrien; Sedrakyan, Art et al. (2018) Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies. J Urol 199:1488-1493
Behrendt, Christian-Alexander; Bertges, Daniel; Eldrup, Nikolaj et al. (2018) International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection. Eur J Vasc Endovasc Surg 56:217-237
Columbo, Jesse A; Kang, Ravinder; Hoel, Andrew W et al. (2018) A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review. J Vasc Surg :
Suckow, Bjoern D; Goodney, Philip P; Columbo, Jesse A et al. (2018) National trends in open surgical, endovascular, and branched-fenestrated endovascular aortic aneurysm repair in Medicare patients. J Vasc Surg 67:1690-1697.e1

Showing the most recent 10 out of 37 publications