Project Summary

Background and Objectives: This meeting will facilitate the collaboration of investigators with relevant trial data, with the ultimate aim of conducting a high-quality and rigorous individual patient data meta-analysis (IPD MA) utilizing the six component databases of patients with patent foramen ovale (PFO) and cryptogenic stroke (CS). The overarching aim of the meeting will be to develop a final analytic plan that will be publicly disseminated via the International Prospective Register of Systematic Reviews (PROSPERO) database of prospectively registered systematic review protocols related to healthcare.

Activities: The PFO DATA Consortium will meet face-to-face to refine the provisional SCOPE analytic plan after incorporating critical input from discussions with the PFO DATA Consortium and review data harmonization issues for critical data elements and determine if there is a need to obtain additional primary data.

Outcomes and Outputs: This convening will provide a finalized analysis plan to be posted on PROSPERO, a finalized data governance plan and an authorship plan for the main papers of the SCOPE project.

Project Information

David M. Kent, MD, MS
Tufts Medical Center
$50,000

Key Dates

12 months
July 2020
2019

Study Registration Information

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Last updated: November 23, 2021