The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the food and drug administration guidance on patient-reported outcomes

Jeff A Sloan, Michele Y. Halyard, Marlene H. Frost, Amylou Dueck, Bonnie Teschendorf, Margaret L. Rothman

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Patient-reported outcomes (PROs) have become increasingly prevalent in clinical research and practice. On February 2, 2006, the Food and Drug Administration (FDA) released a draft guidance document with respect to incorporating PROs into clinical research endeavors which include FDA involvement. Researchers at the Mayo Clinic worked with FDA personnel and experts from academia, industry, clinical research, and clinical practice to facilitate discussion, dissemination, and operationalization of the FDA guidance document. This article introduces a manuscript series that resulted from this collective effort. Basic terms are definedand a précis of each article in the manuscript series is given. The ultimate conclusion to be drawn from this series is that, while the goals of assessing and analyzing PRO elements of clinical practice and research are challenging, there now exists a scientific foundation that makes achieving these goals feasible and the results credible. This is vitally important because after all, at the heart of all healthcare endeavors is the patient.

Original languageEnglish (US)
JournalValue in Health
Volume10
Issue numberSUPPL. 2
DOIs
StatePublished - Nov 2007

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Patient Reported Outcome Measures
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Keywords

  • FDA guidance
  • Patient-reported outcomes
  • QOL
  • Quality of life

ASJC Scopus subject areas

  • Nursing(all)
  • Health(social science)
  • Health Professions(all)

Cite this

The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the food and drug administration guidance on patient-reported outcomes. / Sloan, Jeff A; Halyard, Michele Y.; Frost, Marlene H.; Dueck, Amylou; Teschendorf, Bonnie; Rothman, Margaret L.

In: Value in Health, Vol. 10, No. SUPPL. 2, 11.2007.

Research output: Contribution to journalArticle

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