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Information about ongoing health services research and public health projects


The Systematic, Collaborative, PFO (patent foramen ovale) Closure Evaluation (SCOPE)
Investigator (PI): Kent, David
Performing Organization (PO): (Current): Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Predictive Analytics and Comparative Effectiveness (PACE) Center / (617) 636-7405
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2022
Record Source/Award ID: PCORI/RS-SCOPE-2019-001
Funding: Total Award Amount: $499,970
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: The Patient-Centered Outcomes Research Institute (PCORI) is commissioning an independent participant data meta-analysis to evaluate the benefits and harms of patent foramen ovale closure after cryptogenic stroke, which is a subtype of stroke that constitutes approximately 30 percent of all ischemic strokes. Investigators will (1) perform a meta-analysis (pooled analysis) of individual patient data from six randomized clinical trials comparing patent foramen ovale closure with percutaneous devices plus medical therapy versus medical therapy alone and (2) examine factors that influence which therapy is best for whom. This work is an applied example of methods that researchers use for patient-centered outcomes research previously funded by PCORI at the Tufts Predictive Analytics Resource Center.
MeSH Terms:
  • Cardiac Catheterization
  • Cerebral Ischemia /complications
  • /*surgery
  • Humans
  • Meta-Analysis as Topic
  • Outcome Assessment (Health Care)
  • Patent Foramen Ovale /complications
  • /*surgery
  • Patient-Centered Care
  • Randomized Controlled Trials as Topic
  • Stroke /complications
  • /*surgery
Country: United States
State: Massachusetts
Zip Code: 02111
UI: 20202813
Project Status: Ongoing