The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the Food and Drug Administration guidance on patient-reported outcomes.
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 On February 2, 2006, the Food and Drug Administration (FDA) released a draft guidance document with respect to incorporating PROs into clinical research endeavors which include FDA involvement.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 defined and 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.
Sloan
Jeff A
JA
Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA. jsloan@mayo.edu
Halyard
Michele Y
MY
Frost
Marlene H
MH
Dueck
Amylou C
AC
Teschendorf
Bonnie
B
Rothman
Margaret L
ML
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003625:Data Collection / Q000379:methods* / Q000706:statistics & numerical data; D017408:Guidelines as Topic; D006801:Humans; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011356:Product Labeling / Q000592:standards* / Q000706:statistics & numerical data; D011594:Psychometrics; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration