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The COMET Handbook: version 1.0

The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public...

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Autores principales: Williamson, Paula R., Altman, Douglas G., Bagley, Heather, Barnes, Karen L., Blazeby, Jane M., Brookes, Sara T., Clarke, Mike, Gargon, Elizabeth, Gorst, Sarah, Harman, Nicola, Kirkham, Jamie J., McNair, Angus, Prinsen, Cecilia A. C., Schmitt, Jochen, Terwee, Caroline B., Young, Bridget
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5499094/
https://www.ncbi.nlm.nih.gov/pubmed/28681707
http://dx.doi.org/10.1186/s13063-017-1978-4
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author Williamson, Paula R.
Altman, Douglas G.
Bagley, Heather
Barnes, Karen L.
Blazeby, Jane M.
Brookes, Sara T.
Clarke, Mike
Gargon, Elizabeth
Gorst, Sarah
Harman, Nicola
Kirkham, Jamie J.
McNair, Angus
Prinsen, Cecilia A. C.
Schmitt, Jochen
Terwee, Caroline B.
Young, Bridget
author_facet Williamson, Paula R.
Altman, Douglas G.
Bagley, Heather
Barnes, Karen L.
Blazeby, Jane M.
Brookes, Sara T.
Clarke, Mike
Gargon, Elizabeth
Gorst, Sarah
Harman, Nicola
Kirkham, Jamie J.
McNair, Angus
Prinsen, Cecilia A. C.
Schmitt, Jochen
Terwee, Caroline B.
Young, Bridget
author_sort Williamson, Paula R.
collection PubMed
description The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1978-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-54990942017-07-10 The COMET Handbook: version 1.0 Williamson, Paula R. Altman, Douglas G. Bagley, Heather Barnes, Karen L. Blazeby, Jane M. Brookes, Sara T. Clarke, Mike Gargon, Elizabeth Gorst, Sarah Harman, Nicola Kirkham, Jamie J. McNair, Angus Prinsen, Cecilia A. C. Schmitt, Jochen Terwee, Caroline B. Young, Bridget Trials Review The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1978-4) contains supplementary material, which is available to authorized users. BioMed Central 2017-06-20 /pmc/articles/PMC5499094/ /pubmed/28681707 http://dx.doi.org/10.1186/s13063-017-1978-4 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Review
Williamson, Paula R.
Altman, Douglas G.
Bagley, Heather
Barnes, Karen L.
Blazeby, Jane M.
Brookes, Sara T.
Clarke, Mike
Gargon, Elizabeth
Gorst, Sarah
Harman, Nicola
Kirkham, Jamie J.
McNair, Angus
Prinsen, Cecilia A. C.
Schmitt, Jochen
Terwee, Caroline B.
Young, Bridget
The COMET Handbook: version 1.0
title The COMET Handbook: version 1.0
title_full The COMET Handbook: version 1.0
title_fullStr The COMET Handbook: version 1.0
title_full_unstemmed The COMET Handbook: version 1.0
title_short The COMET Handbook: version 1.0
title_sort comet handbook: version 1.0
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5499094/
https://www.ncbi.nlm.nih.gov/pubmed/28681707
http://dx.doi.org/10.1186/s13063-017-1978-4
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