Further considerations for placebo controls in surgical trials

The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now...

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Autores principales: Campbell, Marion K., Beard, David J., Blazeby, Jane M., Cousins, Sian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10257825/
https://www.ncbi.nlm.nih.gov/pubmed/37301819
http://dx.doi.org/10.1186/s13063-023-07417-7
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author Campbell, Marion K.
Beard, David J.
Blazeby, Jane M.
Cousins, Sian
author_facet Campbell, Marion K.
Beard, David J.
Blazeby, Jane M.
Cousins, Sian
author_sort Campbell, Marion K.
collection PubMed
description The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making.
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spelling pubmed-102578252023-06-12 Further considerations for placebo controls in surgical trials Campbell, Marion K. Beard, David J. Blazeby, Jane M. Cousins, Sian Trials Commentary The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making. BioMed Central 2023-06-10 /pmc/articles/PMC10257825/ /pubmed/37301819 http://dx.doi.org/10.1186/s13063-023-07417-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This 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 Commentary
Campbell, Marion K.
Beard, David J.
Blazeby, Jane M.
Cousins, Sian
Further considerations for placebo controls in surgical trials
title Further considerations for placebo controls in surgical trials
title_full Further considerations for placebo controls in surgical trials
title_fullStr Further considerations for placebo controls in surgical trials
title_full_unstemmed Further considerations for placebo controls in surgical trials
title_short Further considerations for placebo controls in surgical trials
title_sort further considerations for placebo controls in surgical trials
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10257825/
https://www.ncbi.nlm.nih.gov/pubmed/37301819
http://dx.doi.org/10.1186/s13063-023-07417-7
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