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How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure

The evaluation and use of patient reported outcome (PRO) measures requires detailed understanding of the meaning of the outcome of interest. The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials. One section o...

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Detalhes bibliográficos
Main Authors: Brożek, Jan L, Guyatt, Gordon H, Schünemann, Holger J
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2006
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC1599713/
https://ncbi.nlm.nih.gov/pubmed/17005037
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1477-7525-4-69
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