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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 The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials.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...
| Autores principales: | , , |
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| Formato: | Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2006
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1599713/ https://www.ncbi.nlm.nih.gov/pubmed/17005037 http://dx.doi.org/10.1186/1477-7525-4-69 |