Further considerations for placebo controls in surgical trials

Marion K Campbell; David J Beard; Jane M Blazeby; Sian Cousins; ASPIRE group

doi:10.1186/s13063-023-07417-7

Further considerations for placebo controls in surgical trials

Marion K Campbell, David J Beard, Jane M Blazeby, Sian Cousins^* (Corresponding Author), ASPIRE group

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Article number	391
Number of pages	6
Journal	Trials
Volume	24
Issue number	1
Early online date	10 Jun 2023
DOIs	https://doi.org/10.1186/s13063-023-07417-7
Publication status	Published - 10 Jun 2023

Bibliographical note

Acknowledgements
The authors wish to thank those who attended the ASPIRE expert-consensus workshop in Oxford in 2018 (1), and the dissemination event held the day prior to the workshop in June 2022, including Shyama Chadha, Katie Gordon, Richard Emsley, Catherine Blewett, Rachel Kelly, Peter Hutchinson, Gemma Ainsworth, Alaa Adil Ibrahim Fadl Elseed, Andrew You, Catriona McDaid, Gavin Murphy, Harneet Mankoo, Mark Smith, Prashant Patel and Rob Langley. The authors also wish to thank Katy Chalmers for note-taking at the workshop.

The ASPIRE group includes co-authors: Ahmed Ahmed, Imperial College London, UK; Rasha Al-Lamee, Imperial College London, UK; David Anderson, University of Sydney, Australia; Natalie Blencowe, University of Bristol, UK; Jonathan Cook, University of Oxford, UK; Brian H Cuthbertson, Sunnybrook Health Sciences Centre, Canada; Manuela Ferreira, University of Sydney, Australia; Matt Gardiner, University of Oxford, UK; Katie Gillies, University of Aberdeen, UK; José Miola, University of Leeds, UK; John Norrie, University of Edinburgh, UK; Tom Pinkney, University of Birmingham, UK; Jonathan Pugh, University of Oxford, UK; Maroeska Rovers, Radboud University Medical Centre, Netherlands; Deborah Stocken, University of Leeds, UK; Matt Westmore, Health Research Authority, UK.

Funding
This study was funded by the National Institute for Health and Care Research Bristol Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The study funders had no role in the design of the study, data collection, data analysis, interpretation of data, writing of the report or the decision to submit the article for publication.

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Cite this

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abstract = "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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note = "Acknowledgements The authors wish to thank those who attended the ASPIRE expert-consensus workshop in Oxford in 2018 (1), and the dissemination event held the day prior to the workshop in June 2022, including Shyama Chadha, Katie Gordon, Richard Emsley, Catherine Blewett, Rachel Kelly, Peter Hutchinson, Gemma Ainsworth, Alaa Adil Ibrahim Fadl Elseed, Andrew You, Catriona McDaid, Gavin Murphy, Harneet Mankoo, Mark Smith, Prashant Patel and Rob Langley. The authors also wish to thank Katy Chalmers for note-taking at the workshop. The ASPIRE group includes co-authors: Ahmed Ahmed, Imperial College London, UK; Rasha Al-Lamee, Imperial College London, UK; David Anderson, University of Sydney, Australia; Natalie Blencowe, University of Bristol, UK; Jonathan Cook, University of Oxford, UK; Brian H Cuthbertson, Sunnybrook Health Sciences Centre, Canada; Manuela Ferreira, University of Sydney, Australia; Matt Gardiner, University of Oxford, UK; Katie Gillies, University of Aberdeen, UK; Jos{\'e} Miola, University of Leeds, UK; John Norrie, University of Edinburgh, UK; Tom Pinkney, University of Birmingham, UK; Jonathan Pugh, University of Oxford, UK; Maroeska Rovers, Radboud University Medical Centre, Netherlands; Deborah Stocken, University of Leeds, UK; Matt Westmore, Health Research Authority, UK. Funding This study was funded by the National Institute for Health and Care Research Bristol Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The study funders had no role in the design of the study, data collection, data analysis, interpretation of data, writing of the report or the decision to submit the article for publication.",

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Further considerations for placebo controls in surgical trials

Abstract

Bibliographical note

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