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 The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials.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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Main Authors: Brożek, Jan L, Guyatt, Gordon H, Schünemann, Holger J
Format: Online
Language:English
Published: BioMed Central 2006
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1599713/
id pubmed-1599713
recordtype oai_dc
spelling pubmed-15997132006-10-12 How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure Brożek, Jan L Guyatt, Gordon H Schünemann, Holger J Commentary 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 The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials.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 of the guidance document specifically deals with advice about the use of the minimal important difference (MID) that we redefined as the smallest difference in score in the outcome of interest that informed patients or informed proxies perceive as important. The advice, however, is short, indeed much too short. We believe that expanding the section and making it more specific will benefit all stakeholders: patients, clinicians, other clinical decision makers, those designing trials and making claims, payers and the FDA. BioMed Central 2006-09-27 /pmc/articles/PMC1599713/ /pubmed/17005037 http://dx.doi.org/10.1186/1477-7525-4-69 Text en Copyright © 2006 Brożek et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
repository_type Open Access Journal
institution_category Foreign Institution
institution US National Center for Biotechnology Information
building NCBI PubMed
collection Online Access
language English
format Online
author Brożek, Jan L
Guyatt, Gordon H
Schünemann, Holger J
spellingShingle Brożek, Jan L
Guyatt, Gordon H
Schünemann, Holger J
How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure
author_facet Brożek, Jan L
Guyatt, Gordon H
Schünemann, Holger J
author_sort Brożek, Jan L
title How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure
title_short How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure
title_full How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure
title_fullStr How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure
title_full_unstemmed How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure
title_sort how a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure
description 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 of the guidance document specifically deals with advice about the use of the minimal important difference (MID) that we redefined as the smallest difference in score in the outcome of interest that informed patients or informed proxies perceive as important. The advice, however, is short, indeed much too short. We believe that expanding the section and making it more specific will benefit all stakeholders: patients, clinicians, other clinical decision makers, those designing trials and making claims, payers and the FDA.
publisher BioMed Central
publishDate 2006
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1599713/
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