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 The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials.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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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 The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials.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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1611389813454274560 |