Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)
Open accessAbstract
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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Surgical placebo interventions require additional ethical and methodological considerations.
“Surgical placebo interventions require additional ethical and methodological considerations, as detailed by the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines.162”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [162]
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Self-citationBias in Hand Surgical Randomized Controlled Trials: Systematic Review and Meta-Epidemiological Study
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Self-citationEthics of gene and cell therapy development for neurologic disorders
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Self-citationFake news and fake research: Why meta‐research matters more than ever
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Should digital health trials be placebo controlled?
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Self-citationSurgery for pineal cysts with symptoms in the absence of hydrocephalus: a prospective cohort study
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Ethical Questions of Surgical Trials
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Is there a reason to challenge our current practice in children’s forearm fractures?
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Surgical interventions for treating hallux valgus and bunions
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Letter about a Published Paper
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Innovating in the field of weight loss
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- Authors
- Beard, D. J., Campbell, M. K., Blazeby, J. M., Carr, A. J., Weijer, C., Cuthbertson, B. H., Buchbinder, R., Pinkney, T., Bishop, F. L., Pugh, J., Cousins, S., Harris, I. A., Lohmander, L. S., Blencowe, N., Gillies, K., Probst, P., Brennan, C., Cook, A., Farrar-Hockley, D., Savulescu, J., Huxtable, R., Rangan, A., Tracey, I., Brocklehurst, P., Ferreira, M. L., Nicholl, J., Reeves, B. C., Hamdy, F., Rowley, S. C., & Cook, J. A.
- Affiliations
- University of Oxford (GB)
- University of Aberdeen (GB)
- University of Bristol (GB)
- Western University (CA)
- Sunnybrook Health Science Centre (CA)
- Monash University (AU)
- Queen Elizabeth Hospital Birmingham (GB)
- University of Southampton (GB)
- UNSW Sydney (AU)
- Heidelberg University (DE)
- National Health Service (GB)
- University of York (GB)
- John Radcliffe Hospital (GB)
- University of Birmingham (GB)
- The University of Sydney (AU)
- University of Sheffield (GB)
- Medical Research Council (GB)
- Corresponding author
- Beard, David J
- ORCID
- 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
- Blencowe, Natalie
- Gillies, Katie
- Probst, Pascal
- 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
- Cook, Jonathan A
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2020-03
- Volume
- 395
- Issue
- 10226
- Pages
- 828-838
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W3009043580
- Cited by
- 96
- References
- 54
- Citations by year
- 2026: 9 · 2025: 15 · 2024: 14 · 2023: 17 · 2022: 14 · 2021: 19 · 2020: 8
- FWCI
- 2.36
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Bristol Research (University of Bristol) (acceptedVersion, cc-by-nc-nd)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- ePrints Soton (University of Southampton) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Funders
- University Hospitals Bristol NHS Foundation Trust (BRC-1215-20011)
- Cancer Research UK (25352)
- National Institute for Health and Care Research (1215-20011, NF-SI-0611-10216, NIHR200268, BRC-1215-20011)
- Department of Health and Social Care
- University of Oxford
- University of Bristol (BRC‐1215‐20011)
- Oxford Health NHS Foundation Trust
- Medical Research Council (MR/K025643/1, MC_PC_17155)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- placebo comparison, surgical trials, randomized controlled trials, trial ethics, risk mitigation, placebo effect, risk of bias, trial design, surgical treatment
- MeSH terms
- Humans, Placebos, Research Design, Surgical Procedures, Operative, Randomized Controlled Trials as Topic, Guidelines as Topic
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