YODA Project

Summary of the Yale University Open Data Access Project's Review of Proposals Received to Systematically Review and Meta-analyze Clinical Data on Bone Morphogenetic Protein 2 (rhBMP-2) Safety and Efficacy

Application Review Committee:

·    Michael Bracken, MPH, PhD (YODA project consultant in epidemiology)

·    Ezekiel Emanuel, MD, PhD (Chair, YODA project steering committee)

·    Jacqueline Grady, MS (YODA project core faculty)

·    Cary Gross, MD (YODA project core faculty)

·    Beth Hodshon, JD, MPH, RN (YODA project core faculty)

·    Harlan Krumholz, MD, SM (YODA project core faculty)

·    Richard Lehman, MD (YODA project core faculty)

·    Haiqun Lin, MD, PhD (YODA project consultant in biostatistics)

·    Jennifer Mattera, DrPH, MPH (YODA project core faculty)

·    Joseph Ross, MD, MHS (YODA project core faculty)


Each application was reviewed for the following primary criteria, (see Formal Review Criteria table below):

·    Technical soundness of the research proposal

·    Experience and expertise of the principal investigator and the project team

·    The institutional environment and adequacy of resources to support the project

·    Management of conflicts of interest and privacy issues

·    Management and budget

These evaluation criteria were informed by those used by the Agency for Healthcare Research and Quality.

Reviewers independently evaluated each proposal and assigned a summary score. Applications were ranked based on the cumulative summary scores. Reviewers engaged in rigorous discussion concerning the strengths and weaknesses of each application and ultimately identified the two best applications.

Key Criteria for Application Review	SCORE (1-5)
Research Proposal Systematic Review Search strategy Plan for data extraction Assessment of study quality Meta-analysis (including methods for managing individual patient level data) Assessing the appropriateness of quantitative meta-analysis Statistical approach Integrating summary-level and individual-level data
Investigators Experience conducting systematic reviews Relevant publication track record Funding track record (i.e. for similar work) Incorporating appropriate clinical input
Environment Adequate institutional infrastructure and resources Addresses institutional conflicts of interest
Conflict of Interest/Ethical Statement/Privacy and Confidentiality Addresses of potential conflicts of interest Stated approach to managing conflicts Appropriate plan for protecting data	Pass Fail
Management and Budget Understanding scope of project Appropriate timeline and delineation of responsibilities Appropriate budget and justification	Pass Fail
SUMMARY SCORE (Research Proposal 40%, Investigators 40% and Environment 20%)

Note: A score of 1 signifies highest quality, while a score of 5 signifies lowest quality.