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Considerations and ...
Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)
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- Beard, David J. (author)
- University of Oxford
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- Campbell, Marion K. (author)
- University of Aberdeen
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- Blazeby, Jane M. (author)
- University of Bristol
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- Carr, Andrew J. (author)
- University of Oxford
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- Weijer, Charles (author)
- University College West
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- Cuthbertson, Brian H. (author)
- University of Toronto
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- Buchbinder, Rachelle (author)
- Monash University
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- Pinkney, Thomas (author)
- University of Birmingham
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- Bishop, Felicity L. (author)
- University of Southampton
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- Pugh, Jonathan (author)
- University of Oxford
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- Cousins, Sian (author)
- University of Bristol
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- Harris, Ian A. (author)
- University of New South Wales
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- Lohmander, L. Stefan (author)
- Lund University,Lunds universitet,Ortopedi, Lund,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Orthopaedics (Lund),Section III,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Blencowe, Natalie (author)
- University of Bristol
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- Gillies, Katie (author)
- University of Aberdeen
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- Probst, Pascal (author)
- Heidelberg University
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Brennan, Carol (author)
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- Cook, Andrew (author)
- University of Southampton,University Hospital Southampton
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Farrar-Hockley, Dair (author)
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- Savulescu, Julian (author)
- University of Oxford
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- Huxtable, Richard (author)
- University of Bristol
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- Rangan, Amar (author)
- University of York
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- Tracey, Irene (author)
- University of Oxford
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- Brocklehurst, Peter (author)
- University of Birmingham
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- Ferreira, Manuela L. (author)
- University of Sydney
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- Nicholl, Jon (author)
- University of Sheffield
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- Reeves, Barnaby C. (author)
- University of Bristol
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- Hamdy, Freddie (author)
- University of Oxford
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- Rowley, Samuel CS (author)
- MRC Human Nutrition Research
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- Cook, Jonathan A. (author)
- University of Oxford
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(creator_code:org_t)
- 2020
- 2020
- English 11 s.
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In: The Lancet. - 0140-6736. ; 395:10226, s. 828-838
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http://dx.doi.org/10...
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Abstract
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- 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.
Subject headings
- TEKNIK OCH TEKNOLOGIER -- Annan teknik -- Övrig annan teknik (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Other Engineering and Technologies -- Other Engineering and Technologies not elsewhere specified (hsv//eng)
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The Lancet
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Beard, David J.
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Campbell, Marion ...
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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, Bri ...
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show more...
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Buchbinder, Rach ...
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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 A.
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Lohmander, L. St ...
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Blencowe, Natali ...
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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, ...
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Savulescu, Julia ...
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Huxtable, Richar ...
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Rangan, Amar
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Tracey, Irene
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Brocklehurst, Pe ...
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Ferreira, Manuel ...
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Nicholl, Jon
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Reeves, Barnaby ...
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Hamdy, Freddie
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Rowley, Samuel C ...
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Cook, Jonathan A ...
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- ENGINEERING AND TECHNOLOGY
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The Lancet
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Lund University