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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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Detalles Bibliográficos
Autores principales: Campbell, Marion K., Beard, David J., Blazeby, Jane M., Cousins, Sian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
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
Descripción
Sumario: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.