Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group
Por:
Morillon M.B., Christensen R., Singh J.A., Dalbeth N., Saag K., Taylor W.J., Neogi T., Kennedy M.A., Pedersen B.M., McCarthy G.M., Shea B., Diaz-Torne C., Tedeschi S.K., Grainger R., Abhishek A., Gaffo A., Nielsen S.M., Noerup A., Simon L.S., Lassere M., Tugwell P., Stamp L.K., Gout Working Group F.T.O.
Publicada:
1 ene 2021
Resumen:
Serum urate (SU) is the most common primary efficacy outcome in trials of urate-lowering therapies for gout. Despite this, it is not formally considered a validated surrogate outcome. In this paper we will outline the definitions of biomarkers and surrogate outcome measures, respectively as well as the available frameworks and challenges in the assessment of the validity of serum urate as a surrogate in gout (i.e. a reasonable replacement for gout symptoms). © 2021 Elsevier Inc.
Filiaciones:
Morillon M.B.:
Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark
Department of Medicine, Odense University Hospital, Svendborg, Denmark
Christensen R.:
Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark
Singh J.A.:
Birmingham Veterans Affairs (VA) Medical Center, University of Alabama at Birmingham, Birmingham, AL, United States
Dalbeth N.:
University of Auckland, New Zealand
Saag K.:
Birmingham Veterans Affairs (VA) Medical Center, University of Alabama, Birmingham, AL, United States
Taylor W.J.:
University of Otago, Wellington, New Zealand
Neogi T.:
Rheumatology, Medicine, Boston Medical Center
Kennedy M.A.:
OMERACT Patient Research Partner, Christchurch, New Zealand
Pedersen B.M.:
OMERACT Patient Research Partner, Aarhus, Denmark
McCarthy G.M.:
Division of Rheumatology, Mater Misericordiae University Hospital, Dublin, Ireland
Shea B.:
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada
Diaz-Torne C.:
Rheumatology Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona., Barcelona
Tedeschi S.K.:
Brigham and Women's Hospital, Division of Rheumatology, Inflammation and Immunity, Boston, United States
Grainger R.:
Rehabilitation Teaching and Research Unit, Department of Medicine, University of Otago Wellington, Wellington, New Zealand
Abhishek A.:
Academic Rheumatology, University of Nottingham, Nottingham, United Kingdom
Gaffo A.:
Birmingham Veterans Affairs (VA) Medical Center, University of Alabama at Birmingham, Birmingham, AL, United States
Nielsen S.M.:
Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark
Noerup A.:
Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark
Simon L.S.:
SDG LLC, Cambridge, MA, United States
Lassere M.:
Department of Rheumatology, St George Hospital, University of NSW, Sydney, Australia
Tugwell P.:
Department of Medicine, University of Ottawa, Ottawa, ON, Canada
Stamp L.K.:
Department of Medicine, University of Otago, Christchurch, New Zealand
Gout Working Group F.T.O.:
Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Open Access
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