The Resource Comparative effectiveness of in-hospital use of recombinant factor VIIa for off-label indications vs. usual care, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Stanford-UCSF Evidence-based Practice Center ; investigators, Veronica Yank, M.D., C. Vaughan Tuohy, B.S., Aaron C. Logan, M.D., Ph.D., Dena M. Bravata, M.D., M.S., Kristan Staudenmayer, M.D., Robin Eisenhut, B.A., Vandana Sundaram, M.P.H., Donal McMahon, M.Sc., Ph.D., Christopher D. Stave, M.L.S., James L. Zehnder, M.D., Ingram Olkin, Ph.D., Kathryn M. McDonald, M.M., Douglas K. Owens, M.D., M.S., and Randall S. Stafford, M.D., Ph.D

Comparative effectiveness of in-hospital use of recombinant factor VIIa for off-label indications vs. usual care, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Stanford-UCSF Evidence-based Practice Center ; investigators, Veronica Yank, M.D., C. Vaughan Tuohy, B.S., Aaron C. Logan, M.D., Ph.D., Dena M. Bravata, M.D., M.S., Kristan Staudenmayer, M.D., Robin Eisenhut, B.A., Vandana Sundaram, M.P.H., Donal McMahon, M.Sc., Ph.D., Christopher D. Stave, M.L.S., James L. Zehnder, M.D., Ingram Olkin, Ph.D., Kathryn M. McDonald, M.M., Douglas K. Owens, M.D., M.S., and Randall S. Stafford, M.D., Ph.D

Label
Comparative effectiveness of in-hospital use of recombinant factor VIIa for off-label indications vs. usual care
Title
Comparative effectiveness of in-hospital use of recombinant factor VIIa for off-label indications vs. usual care
Statement of responsibility
prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Stanford-UCSF Evidence-based Practice Center ; investigators, Veronica Yank, M.D., C. Vaughan Tuohy, B.S., Aaron C. Logan, M.D., Ph.D., Dena M. Bravata, M.D., M.S., Kristan Staudenmayer, M.D., Robin Eisenhut, B.A., Vandana Sundaram, M.P.H., Donal McMahon, M.Sc., Ph.D., Christopher D. Stave, M.L.S., James L. Zehnder, M.D., Ingram Olkin, Ph.D., Kathryn M. McDonald, M.M., Douglas K. Owens, M.D., M.S., and Randall S. Stafford, M.D., Ph.D
Creator
Contributor
Author
Issuing body
Subject
Genre
Language
eng
Summary
This report evaluates the level of evidence currently available to support the effectiveness and safety of using recombinant activated coagulation factor VII (rFVIIa) for clinical indications not approved by the U.S. Food and Drug Administration (FDA). rFVIIa is approved for a variety of uses in hemophilia patients who have developed antibody inhibitors that compromise the use of standard factor replacement. Use of this costly biologic product has expanded beyond these hemophilia-related indications to encompass a range of off-label uses, most of which are in-hospital uses. These uses differ substantially from the drug's FDA approved label. The purpose of this report is two-fold: (1) To document the full range of clinical indications for which rFVIIa is being used and the types of studies available to evaluate these uses and (2) To provide a comparative effectiveness review of rFVIIa vs. usual care for several in-hospital clinical indications: intracranial hemorrhage, massive bleeding secondary to trauma, and the selected surgical procedures of cardiac surgery, liver transplantation, and prostatectomy
Member of
Cataloging source
NLM
http://library.link/vocab/creatorName
Yank, Veronica
Funding information
Conducted by the Stanford-UCSF Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ)
Government publication
federal national government publication
Illustrations
illustrations
Index
no index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
NLM call number
QY 410
http://library.link/vocab/relatedWorkOrContributorName
  • Tuohy, C. Vaughan
  • Logan, Aaron C.
  • Bravata, Dena M.
  • Staudenmayer, Kristan
  • Eisenhut, Robin
  • Sundaram, Vandana
  • McMahon, Donal
  • Stave, Christopher D.
  • Zehnder, James L.
  • Olkin, Ingram
  • McDonald, Kathryn M.
  • Owens, Douglas K.
  • Stafford, Randall S.
  • United States
  • Stanford-UCSF Evidence-based Practice Center
  • Effective Health Care Program (U.S.)
Series statement
  • Comparative effectiveness review
  • AHRQ publication
Series volume
  • number 21
  • no. 10-EHC030-EF
http://library.link/vocab/subjectName
  • Factor VIIa
  • Comparative Effectiveness Research
  • Evidence-Based Medicine
  • Inpatients
  • Off-Label Use
  • Recombinant Proteins
http://bibfra.me/vocab/relation/supportingbody
RzTDSdffmEM
Label
Comparative effectiveness of in-hospital use of recombinant factor VIIa for off-label indications vs. usual care, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Stanford-UCSF Evidence-based Practice Center ; investigators, Veronica Yank, M.D., C. Vaughan Tuohy, B.S., Aaron C. Logan, M.D., Ph.D., Dena M. Bravata, M.D., M.S., Kristan Staudenmayer, M.D., Robin Eisenhut, B.A., Vandana Sundaram, M.P.H., Donal McMahon, M.Sc., Ph.D., Christopher D. Stave, M.L.S., James L. Zehnder, M.D., Ingram Olkin, Ph.D., Kathryn M. McDonald, M.M., Douglas K. Owens, M.D., M.S., and Randall S. Stafford, M.D., Ph.D
Instantiates
Publication
Note
"May 2010."
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Control code
814440665
Extent
1 online resource (331 pages)
Form of item
online
Media category
computer
Media MARC source
rdamedia.
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)814440665
Label
Comparative effectiveness of in-hospital use of recombinant factor VIIa for off-label indications vs. usual care, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Stanford-UCSF Evidence-based Practice Center ; investigators, Veronica Yank, M.D., C. Vaughan Tuohy, B.S., Aaron C. Logan, M.D., Ph.D., Dena M. Bravata, M.D., M.S., Kristan Staudenmayer, M.D., Robin Eisenhut, B.A., Vandana Sundaram, M.P.H., Donal McMahon, M.Sc., Ph.D., Christopher D. Stave, M.L.S., James L. Zehnder, M.D., Ingram Olkin, Ph.D., Kathryn M. McDonald, M.M., Douglas K. Owens, M.D., M.S., and Randall S. Stafford, M.D., Ph.D
Publication
Note
"May 2010."
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Control code
814440665
Extent
1 online resource (331 pages)
Form of item
online
Media category
computer
Media MARC source
rdamedia.
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)814440665

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