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Final Report

We performed a methodologic study to demonstrate the feasibility of an academic-Clinical Data Abstraction Center (CDAC) partnership to verify hospitalization study outcomes using clinical records. The specific aims of this proposal were as follows:

1. Demonstrate the feasibility of obtaining approval and waiver of HIPAA authorization from an academic institutional review board to permit verification of outcomes without patient consent via an academic-CDAC partnership.
2. Demonstrate the feasibility of obtaining Data Use Agreements from CMS that permit validation of hospitalization outcomes, without patient consent, using an academic-CDAC partnership;
3. Demonstrate the feasibility of a CDAC obtaining, for research purposes, hospital records corresponding to CMS data likely to be used by researchers for studies of comparative effectiveness;
4. Identify barriers to the proposed model, strategies to overcome or avoid them, and potential improvements to the model;
5. Measure the positive predictive value of a specific outcome that might be employed in studies of comparative effectiveness.