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

Forskningsoutput: TidskriftsbidragÖversiktsartikel

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.

Detaljer

Författare
  • David J. Beard
  • Marion K. Campbell
  • Jane M. Blazeby
  • Andrew J. Carr
  • Charles Weijer
  • Brian H. Cuthbertson
  • Rachelle Buchbinder
  • Thomas Pinkney
  • Felicity L. Bishop
  • Jonathan Pugh
  • Sian Cousins
  • Ian A. Harris
  • Natalie Blencowe
  • Katie Gillies
  • Pascal Probst
  • Carol Brennan
  • Andrew Cook
  • Dair Farrar-Hockley
  • Julian Savulescu
  • Richard Huxtable
  • Amar Rangan
  • Irene Tracey
  • Peter Brocklehurst
  • Manuela L. Ferreira
  • Jon Nicholl
  • Barnaby C. Reeves
  • Freddie Hamdy
  • Samuel CS Rowley
  • Jonathan A. Cook
Enheter & grupper
Externa organisationer
  • University of Oxford
  • University of Bristol
  • University College West
  • University of Toronto
  • Monash University
  • University of Birmingham
  • University of Southampton
  • University of New South Wales
  • Heidelberg University
  • University Hospital Southampton
  • University of York
  • University of Sydney
  • University of Sheffield
  • MRC Human Nutrition Research
  • University of Aberdeen
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Övrig annan teknik
Originalspråkengelska
Sidor (från-till)828-838
Antal sidor11
TidskriftThe Lancet
Volym395
Utgåva nummer10226
StatusPublished - 2020
PublikationskategoriForskning
Peer review utfördJa