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Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study

Objective To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity. Design Cohort study. Setting Six major general medical journals. Participants Randomised clinical trials published in 2005 and 2006 that used a surrogate...

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Detalles Bibliográficos
Autores principales: la Cour, Jeppe Lerche, Brok, Jesper, Gøtzsche, Peter C
Formato: Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923691/
https://www.ncbi.nlm.nih.gov/pubmed/20719823
http://dx.doi.org/10.1136/bmj.c3653
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author la Cour, Jeppe Lerche
Brok, Jesper
Gøtzsche, Peter C
author_facet la Cour, Jeppe Lerche
Brok, Jesper
Gøtzsche, Peter C
author_sort la Cour, Jeppe Lerche
collection PubMed
description Objective To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity. Design Cohort study. Setting Six major general medical journals. Participants Randomised clinical trials published in 2005 and 2006 that used a surrogate as a primary outcome. Results Of 626 published randomised clinical trials, 109 (17%) used a surrogate as a primary outcome. Of these trials, 62 (57%, 95% confidence interval 47% to 67%) clearly reported that the primary outcome was a surrogate. Only 38 (35%, 26% to 45%) also discussed the validity of the surrogate. Conclusion Only about one third of authors of randomised clinical trials that used a surrogate as a primary outcome reported adequately on the surrogate. Better reporting is needed.
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spelling pubmed-29236912010-08-19 Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study la Cour, Jeppe Lerche Brok, Jesper Gøtzsche, Peter C BMJ Research Objective To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity. Design Cohort study. Setting Six major general medical journals. Participants Randomised clinical trials published in 2005 and 2006 that used a surrogate as a primary outcome. Results Of 626 published randomised clinical trials, 109 (17%) used a surrogate as a primary outcome. Of these trials, 62 (57%, 95% confidence interval 47% to 67%) clearly reported that the primary outcome was a surrogate. Only 38 (35%, 26% to 45%) also discussed the validity of the surrogate. Conclusion Only about one third of authors of randomised clinical trials that used a surrogate as a primary outcome reported adequately on the surrogate. Better reporting is needed. BMJ Publishing Group Ltd. 2010-08-18 /pmc/articles/PMC2923691/ /pubmed/20719823 http://dx.doi.org/10.1136/bmj.c3653 Text en © la Cour et al 2010 This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
spellingShingle Research
la Cour, Jeppe Lerche
Brok, Jesper
Gøtzsche, Peter C
Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
title Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
title_full Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
title_fullStr Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
title_full_unstemmed Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
title_short Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
title_sort inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923691/
https://www.ncbi.nlm.nih.gov/pubmed/20719823
http://dx.doi.org/10.1136/bmj.c3653
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