The Predictive Analytics and Comparative Effectiveness (PACE) Center at Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies, led by Dr. David Kent, has been awarded two research grants by the Patient-Centered Outcomes Research Institute (PCORI). These two grants will fund the efforts of a Data Consortium with researchers from South Korea, France, Denmark, Switzerland and the United States who are investigating the effects of closure devices versus standard medical treatment for patients with Patent Foramen Ovale (PFO) and Cryptogenic stroke (CS).
One of these grants supported a PFO Data Consortium Meeting in Los Angeles, CA in February 2020. Ultimately, the PFO Data Consortium will conduct an Individual Patient Data Meta-Analysis (IPD-MA) using data from the 6 participating clinical trials studying PFO closure.
The research team states that, “IPD-MA are generally considered to be at the very top of the evidence hierarchy, yet remain rarely performed, largely because of the logistical challenges in organizing these efforts. In our experience, opportunities for feasible and clinically important IPD-MA are rare. Our prior 3 trial IPD-MA has been cited approximately 50 times per year since its publication 3 years ago, and has been broadly influential in guidelines both in the US and in Europe. Both the American Stroke Association and the American Neurological Association are revising guidelines over the next years based on new trials. There is a need for an updated patient-centered analysis. This analysis will also engage with the major thought leaders in the area of stroke prevention in PFO, so we anticipate broad scientific and clinical impact. We view this as an excellent opportunity for “proof-of-concept” for predictive HTE, but we also view the impact as being broader than this.”
This project is led by Dr. David Kent, director of the PACE Center, Professor of Medicine, Neurology, and Clinical and Translational Science, and Director of the Clinical and Translational Science Program at the Tufts Graduate School of Biomedical Sciences, and Dr. David Thaler, Neurologist-in-Chief and Chairman and Professor of Neurology at the Tufts University School of Medicine.
