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A survey of knowledge, perceptions and use of core outcome sets among clinical trialists

BACKGROUND: Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minim...

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Autores principales: Bellucci, Chiara, Hughes, Karen, Toomey, Elaine, Williamson, Paula R., Matvienko-Sikar, Karen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8684586/
https://www.ncbi.nlm.nih.gov/pubmed/34924001
http://dx.doi.org/10.1186/s13063-021-05891-5
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author Bellucci, Chiara
Hughes, Karen
Toomey, Elaine
Williamson, Paula R.
Matvienko-Sikar, Karen
author_facet Bellucci, Chiara
Hughes, Karen
Toomey, Elaine
Williamson, Paula R.
Matvienko-Sikar, Karen
author_sort Bellucci, Chiara
collection PubMed
description BACKGROUND: Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists’ knowledge, perceptions and experiences of COS. METHODS: An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists’ familiarity with and understanding of COS, along with experiences of COS use and development. RESULTS: Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%). CONCLUSIONS: Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05891-5.
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spelling pubmed-86845862021-12-20 A survey of knowledge, perceptions and use of core outcome sets among clinical trialists Bellucci, Chiara Hughes, Karen Toomey, Elaine Williamson, Paula R. Matvienko-Sikar, Karen Trials Research BACKGROUND: Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists’ knowledge, perceptions and experiences of COS. METHODS: An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists’ familiarity with and understanding of COS, along with experiences of COS use and development. RESULTS: Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%). CONCLUSIONS: Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05891-5. BioMed Central 2021-12-19 /pmc/articles/PMC8684586/ /pubmed/34924001 http://dx.doi.org/10.1186/s13063-021-05891-5 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Bellucci, Chiara
Hughes, Karen
Toomey, Elaine
Williamson, Paula R.
Matvienko-Sikar, Karen
A survey of knowledge, perceptions and use of core outcome sets among clinical trialists
title A survey of knowledge, perceptions and use of core outcome sets among clinical trialists
title_full A survey of knowledge, perceptions and use of core outcome sets among clinical trialists
title_fullStr A survey of knowledge, perceptions and use of core outcome sets among clinical trialists
title_full_unstemmed A survey of knowledge, perceptions and use of core outcome sets among clinical trialists
title_short A survey of knowledge, perceptions and use of core outcome sets among clinical trialists
title_sort survey of knowledge, perceptions and use of core outcome sets among clinical trialists
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8684586/
https://www.ncbi.nlm.nih.gov/pubmed/34924001
http://dx.doi.org/10.1186/s13063-021-05891-5
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