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Considerations and methods for placebo controls in surgical trials: state of the art review and ASPIRE guidance

Considerations and methods for placebo controls in surgical trials: state of the art review and ASPIRE guidance
Considerations and methods for placebo controls in surgical trials: state of the art review and ASPIRE guidance
Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this paper is to provide a summary of current knowledge on placebo controls in surgical trials.

A placebo control is a complex type of comparison group and, although powerful, presents many challenges in a surgical setting. This review outlines what a placebo- surgical control entails and our understanding of the placebo phenomenon in the context of surgery. It considers when placebo-surgical controls are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo-surgical control should be designed, how to identify and mitigate risk for participants in placebo surgical trials, how such trials should be conducted and interpreted.

Use of placebo control is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos may be most appropriate where there is poor evidence on the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly due to the placebo effect. Feasibility work is recommended to optimise RCT design and conduct. This review forms an outline for best practice and provides guidance, in the form of the ASPIRE (Applying Surgical Placebo in Randomised Evaluations) checklist, for those considering the use of a placebo-control in a surgical randomised controlled trial.
trial, control, placebo, surgery, evaluation, ethics, efficacy
0140-6736
Beard, David
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Campbell, Marion
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Blazeby, Jane M.
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Carr, Andrew
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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
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Pugh, Jonathan
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Cousins, Sian
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Harris, Ian
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Lomander, L Stephan
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Blencowe, Natalie S.
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Gilles, 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 C.
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Rowley, Samuel
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Cook, Jonathan
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Beard, David
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Campbell, Marion
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Blazeby, Jane M.
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Carr, Andrew
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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
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Pugh, Jonathan
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Cousins, Sian
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Harris, Ian
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Lomander, L Stephan
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Blencowe, Natalie S.
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Gilles, 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 C.
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Rowley, Samuel
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Cook, Jonathan
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Beard, David, Campbell, Marion, Blazeby, Jane M., Carr, Andrew, Weijer, Charles, Cuthbertson, Brian H., Buchbinder, Rachelle, Pinkney, Thomas, Bishop, Felicity, Pugh, Jonathan, Cousins, Sian, Harris, Ian, Lomander, L Stephan, Blencowe, Natalie S., Gilles, 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 C., Rowley, Samuel and Cook, Jonathan (2020) Considerations and methods for placebo controls in surgical trials: state of the art review and ASPIRE guidance. The Lancet. (doi:10.1016/S0140-6736(19)33137-X).

Record type: Article

Abstract

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this paper is to provide a summary of current knowledge on placebo controls in surgical trials.

A placebo control is a complex type of comparison group and, although powerful, presents many challenges in a surgical setting. This review outlines what a placebo- surgical control entails and our understanding of the placebo phenomenon in the context of surgery. It considers when placebo-surgical controls are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo-surgical control should be designed, how to identify and mitigate risk for participants in placebo surgical trials, how such trials should be conducted and interpreted.

Use of placebo control is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos may be most appropriate where there is poor evidence on the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly due to the placebo effect. Feasibility work is recommended to optimise RCT design and conduct. This review forms an outline for best practice and provides guidance, in the form of the ASPIRE (Applying Surgical Placebo in Randomised Evaluations) checklist, for those considering the use of a placebo-control in a surgical randomised controlled trial.

Text
Considerations and Methods for Placebo Controls in Surgical Trials: State of the Art Review and ASPIRE Guidance - Accepted Manuscript
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More information

Accepted/In Press date: 6 December 2019
e-pub ahead of print date: 5 March 2020
Keywords: trial, control, placebo, surgery, evaluation, ethics, efficacy

Identifiers

Local EPrints ID: 436530
URI: http://eprints.soton.ac.uk/id/eprint/436530
ISSN: 0140-6736
PURE UUID: 2bed3400-6e37-4054-b450-30aa6ed9ec1d
ORCID for Felicity Bishop: ORCID iD orcid.org/0000-0002-8737-6662
ORCID for Andrew Cook: ORCID iD orcid.org/0000-0002-6680-439X

Catalogue record

Date deposited: 12 Dec 2019 17:30
Last modified: 28 Apr 2022 06:10

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Contributors

Author: David Beard
Author: Marion Campbell
Author: Jane M. Blazeby
Author: Andrew Carr
Author: Charles Weijer
Author: Brian H. Cuthbertson
Author: Rachelle Buchbinder
Author: Thomas Pinkney
Author: Felicity Bishop ORCID iD
Author: Jonathan Pugh
Author: Sian Cousins
Author: Ian Harris
Author: L Stephan Lomander
Author: Natalie S. Blencowe
Author: Katie Gilles
Author: Pascal Probst
Author: Carol Brennan
Author: Andrew Cook ORCID iD
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 C. Hamdy
Author: Samuel Rowley
Author: Jonathan Cook

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