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Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is a...

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Autores principales: Matvienko-Sikar, Karen, Avery, Kerry, Blazeby, Jane, Hughes, Karen, Jacobsen, Pamela, Kirkham, Jamie, Kottner, Jan, Mellor, Katie, Saldanha, Ian, Smith, Valerie, Terwee, Caroline B., Williamson, Paula R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919602/
https://www.ncbi.nlm.nih.gov/pubmed/33693308
http://dx.doi.org/10.12688/hrbopenres.13109.2
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author Matvienko-Sikar, Karen
Avery, Kerry
Blazeby, Jane
Hughes, Karen
Jacobsen, Pamela
Kirkham, Jamie
Kottner, Jan
Mellor, Katie
Saldanha, Ian
Smith, Valerie
Terwee, Caroline B.
Williamson, Paula R.
author_facet Matvienko-Sikar, Karen
Avery, Kerry
Blazeby, Jane
Hughes, Karen
Jacobsen, Pamela
Kirkham, Jamie
Kottner, Jan
Mellor, Katie
Saldanha, Ian
Smith, Valerie
Terwee, Caroline B.
Williamson, Paula R.
author_sort Matvienko-Sikar, Karen
collection PubMed
description Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area.  Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.
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spelling pubmed-79196022021-03-09 Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol Matvienko-Sikar, Karen Avery, Kerry Blazeby, Jane Hughes, Karen Jacobsen, Pamela Kirkham, Jamie Kottner, Jan Mellor, Katie Saldanha, Ian Smith, Valerie Terwee, Caroline B. Williamson, Paula R. HRB Open Res Study Protocol Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area.  Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials. F1000 Research Limited 2021-01-25 /pmc/articles/PMC7919602/ /pubmed/33693308 http://dx.doi.org/10.12688/hrbopenres.13109.2 Text en Copyright: © 2021 Matvienko-Sikar K et al. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Matvienko-Sikar, Karen
Avery, Kerry
Blazeby, Jane
Hughes, Karen
Jacobsen, Pamela
Kirkham, Jamie
Kottner, Jan
Mellor, Katie
Saldanha, Ian
Smith, Valerie
Terwee, Caroline B.
Williamson, Paula R.
Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol
title Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol
title_full Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol
title_fullStr Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol
title_full_unstemmed Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol
title_short Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol
title_sort uptake of core outcome sets by clinical trialists publishing in major medical journals: protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919602/
https://www.ncbi.nlm.nih.gov/pubmed/33693308
http://dx.doi.org/10.12688/hrbopenres.13109.2
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