Further considerations for placebo controls in surgical trials

<p>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...

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Bibliographic Details
Main Authors: Campbell, MK, Beard, DJ, Blazeby, JM, Cousins, S
Other Authors: The ASPIRE Group
Format: Journal article
Language:English
Published: Springer 2023
Description
Summary:<p>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.</p>