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Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)

Beard, David J. ; Campbell, Marion K. ; Blazeby, Jane M. ; Carr, Andrew J. ; Weijer, Charles ; Cuthbertson, Brian H. ; Buchbinder, Rachelle ; Pinkney, Thomas ; Bishop, Felicity L. and Pugh, Jonathan , et al. (2020) In The Lancet 395(10226). p.828-838
Abstract

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such... (More)

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
The Lancet
volume
395
issue
10226
pages
11 pages
publisher
Elsevier
external identifiers
  • scopus:85080927253
ISSN
0140-6736
DOI
10.1016/S0140-6736(19)33137-X
language
English
LU publication?
yes
id
fb591ce7-28e8-4399-bf42-63aaf971d5a3
date added to LUP
2020-03-17 13:30:36
date last changed
2023-03-15 17:48:27
@article{fb591ce7-28e8-4399-bf42-63aaf971d5a3,
  abstract     = {{<p>Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.</p>}},
  author       = {{Beard, David J. and Campbell, Marion K. and Blazeby, Jane M. and Carr, Andrew J. and Weijer, Charles and Cuthbertson, Brian H. and Buchbinder, Rachelle and Pinkney, Thomas and Bishop, Felicity L. and Pugh, Jonathan and Cousins, Sian and Harris, Ian A. and Lohmander, L. Stefan and Blencowe, Natalie and Gillies, Katie and Probst, Pascal and Brennan, Carol and Cook, Andrew and Farrar-Hockley, Dair and Savulescu, Julian and Huxtable, Richard and Rangan, Amar and Tracey, Irene and Brocklehurst, Peter and Ferreira, Manuela L. and Nicholl, Jon and Reeves, Barnaby C. and Hamdy, Freddie and Rowley, Samuel CS and Cook, Jonathan A.}},
  issn         = {{0140-6736}},
  language     = {{eng}},
  number       = {{10226}},
  pages        = {{828--838}},
  publisher    = {{Elsevier}},
  series       = {{The Lancet}},
  title        = {{Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)}},
  url          = {{http://dx.doi.org/10.1016/S0140-6736(19)33137-X}},
  doi          = {{10.1016/S0140-6736(19)33137-X}},
  volume       = {{395}},
  year         = {{2020}},
}