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

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)
Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)
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.
Guidelines as Topic, Humans, Placebos, Randomized Controlled Trials as Topic/ethics, Research Design, Surgical Procedures, Operative
0140-6736
828-838
Beard, David J.
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Campbell, Marion K
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Blazeby, Jane M
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Carr, Andrew J
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Weijer, Charles
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Cuthbertson, Brian H
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Buchbinder, Rachelle
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Pinkney, Thomas
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Bishop, Felicity L
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Pugh, Jonathan
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Cousins, Sian
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Harris, Ian A
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Lohmander, L Stefan
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Blencowe, Natalie
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Gillies, Katie
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Probst, Pascal
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Brennan, Carol
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Cook, Andrew
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Farrar-Hockley, Dair
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Savulescu, Julian
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Huxtable, Richard
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Rangan, Amar
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Tracey, Irene
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Brocklehurst, Peter
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Ferreira, Manuela L
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Nicholl, Jon
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Reeves, Barnaby C
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Hamdy, Freddie
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Rowley, Samuel Cs
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Cook, Jonathan A
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Beard, David J.
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Campbell, Marion K
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Blazeby, Jane M
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Carr, Andrew J
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Weijer, Charles
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Cuthbertson, Brian H
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Buchbinder, Rachelle
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Pinkney, Thomas
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Bishop, Felicity L
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Pugh, Jonathan
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Cousins, Sian
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Harris, Ian A
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Lohmander, L Stefan
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Blencowe, Natalie
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Gillies, Katie
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Probst, Pascal
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Brennan, Carol
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Cook, Andrew
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Farrar-Hockley, Dair
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Savulescu, Julian
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Huxtable, Richard
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Rangan, Amar
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Tracey, Irene
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Brocklehurst, Peter
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Ferreira, Manuela L
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Nicholl, Jon
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Reeves, Barnaby C
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Hamdy, Freddie
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Rowley, Samuel Cs
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Cook, Jonathan A
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Beard, David J., Campbell, Marion K, Blazeby, Jane M, Carr, Andrew J, Weijer, Charles, Cuthbertson, Brian H, Buchbinder, Rachelle, Pinkney, Thomas, Bishop, Felicity L, Pugh, Jonathan, Cousins, Sian, Harris, Ian A, Lohmander, L Stefan, Blencowe, Natalie, Gillies, Katie, Probst, Pascal, Brennan, Carol, Cook, Andrew, Farrar-Hockley, Dair, Savulescu, Julian, Huxtable, Richard, Rangan, Amar, Tracey, Irene, Brocklehurst, Peter, Ferreira, Manuela L, Nicholl, Jon, Reeves, Barnaby C, Hamdy, Freddie, Rowley, Samuel Cs and Cook, Jonathan A (2020) Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines). Lancet (London, England), 395 (10226), 828-838. (doi:10.1016/S0140-6736(19)33137-X).

Record type: Review

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 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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More information

Published date: 7 March 2020
Keywords: Guidelines as Topic, Humans, Placebos, Randomized Controlled Trials as Topic/ethics, Research Design, Surgical Procedures, Operative

Identifiers

Local EPrints ID: 448510
URI: http://eprints.soton.ac.uk/id/eprint/448510
ISSN: 0140-6736
PURE UUID: 077e54c1-1132-41b6-8539-5aa9c5f8cc82
ORCID for Felicity L Bishop: ORCID iD orcid.org/0000-0002-8737-6662

Catalogue record

Date deposited: 23 Apr 2021 16:33
Last modified: 13 Dec 2021 02:51

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Contributors

Author: David J. Beard
Author: Marion K Campbell
Author: Jane M Blazeby
Author: Andrew J Carr
Author: Charles Weijer
Author: Brian H Cuthbertson
Author: Rachelle Buchbinder
Author: Thomas Pinkney
Author: Jonathan Pugh
Author: Sian Cousins
Author: Ian A Harris
Author: L Stefan Lohmander
Author: Natalie Blencowe
Author: Katie Gillies
Author: Pascal Probst
Author: Carol Brennan
Author: Andrew Cook
Author: Dair Farrar-Hockley
Author: Julian Savulescu
Author: Richard Huxtable
Author: Amar Rangan
Author: Irene Tracey
Author: Peter Brocklehurst
Author: Manuela L Ferreira
Author: Jon Nicholl
Author: Barnaby C Reeves
Author: Freddie Hamdy
Author: Samuel Cs Rowley
Author: Jonathan A Cook

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