Further considerations for placebo controls in surgical trials
Marion K. Campbell,
David J. Beard,
Jane M. Blazeby,
Sian Cousins,
the ASPIRE group
Affiliations
Marion K. Campbell
Royal College of Surgeons of England (RCSEng) Aberdeen Surgical Trials Centre; Health Services Research Unit, Health Sciences Building, University of Aberdeen
David J. Beard
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences; RCSEng Surgical Intervention Trials Unit; National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre, University of Oxford
Jane M. Blazeby
NIHR Bristol Biomedical Research Centre; RCSEng Bristol Surgical Trials Centre, Bristol Centre for Surgical Research, Population Health Sciences, University of Bristol
Sian Cousins
NIHR Bristol Biomedical Research Centre; RCSEng Bristol Surgical Trials Centre, Bristol Centre for Surgical Research, Population Health Sciences, University of Bristol
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.
