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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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The CER Development Process (1)

The comparative effectiveness review (CER) topic, Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Uses vs. Usual Care in the Hospital Setting, was nominated in a public process. The nominated topic was reviewed and selected based on need, importance, and feasibility. Sufficient research into the current literature by experts in the field and stakeholders determined that a CER on the off-label usage trends and benefits and harms for select patient populations was needed and would not duplicate existing work. Based on this research, key clinical questions that the report would address were developed and made available for public comment. The Agency for Healthcare Research and Quality (AHRQ) then commissioned the Stanford-UCSF Evidence-Based Practice Center to prepare the CER with input from a Technical Expert Panel. This advisory panel was comprised of experts in different specialties, including anesthesiology, pediatric hematology/oncology, transplantation, pathology, hematology, pharmacology, trauma surgery, and drug risk management. The panel identified important issues, reviewed proposed methods, defined parameters for the review of evidence, and helped develop the draft report.