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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

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Outline of Study

This slide set is based on a comparative effectiveness review (CER) titled, Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, that was developed by the Stanford-UCSF Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) and is available online at effectivehealthcare.ahrq.gov (Contract No. 290-02-0017). CERs represent comprehensive systematic reviews of the literature and usually compare two or more types of treatments, such as different drugs, for the same disease. The methods used to develop this CER followed version 1.0 of the Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews published by AHRQ (draft available at: http://effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf). The talk will cover the current evidence on the effectiveness and safety of using recombinant activated coagulation factor VII (rFVIIa) for in-hospital clinical indications beyond those approved by the U.S. Food and Drug Administration (FDA). We will briefly discuss the comparative effectiveness review process, including the specific questions addressed in this CER and the results from this research. Finally, the benefits and harms of rFVIIa are presented in such a way as to promote evidence-based decisionmaking.