Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
The CER Development Process (2)
Utilization data for rFVIIa was taken from the Perspective Comparative Database of Premier, Inc., in Charlotte, NC (2000–2008). A comprehensive systematic review of the literature was conducted from 10 electronic databases, grey literature, trial registries, and reference lists. Studies on the spectrum of rFVIIa off-label use, effectiveness of rFVIIa for the five AHRQ-selected indications, and studies on the potential harms for the five indications were included. All methods used in the review 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 draft CER was prepared and published online and was subject to public comment and peer review. Once finalized, the complete report was published on the Effective Health Care Program Web site (available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=450).
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | methods | peer review | research process
- Agency for Healthcare Research and Quality. Methods reference guide for effectiveness and comparative effectiveness reviews, Version 1.0. Rockville, MD: Agency for Health Care Research and Quality; Draft Posted October 2007. Available at: http://www.effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf.
- Yank V, Tuohy CV, Logan AC, et al. Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, Comparative Effectiveness Review 21 (Prepared by Stanford–UCSF Evidence-based Practice Center under Contract No. 290-02-0017). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC030-EF.
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