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  • Beard, David J.University of Oxford (author)

Placebo comparator group selection and use in surgical trials : The aspire project including expert workshop

  • Article/chapterEnglish2021

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  • 2021

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  • LIBRIS-ID:oai:lup.lub.lu.se:285d31cc-78e3-43d6-ba15-3e1358e3c458
  • https://lup.lub.lu.se/record/285d31cc-78e3-43d6-ba15-3e1358e3c458URI
  • https://doi.org/10.3310/HTA25530DOI

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  • Language:English
  • Summary in:English

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  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • Background: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics 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 carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics 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 a high risk of bias, particularly because of the placebo effect. Conclusions: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space.

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  • Campbell, Marion K.University of Aberdeen (author)
  • Blazeby, Jane M.University of Bristol (author)
  • Carr, Andrew J.University of Oxford (author)
  • Weijer, CharlesUniversity of Western Ontario (author)
  • Cuthbertson, Brian H.University of Toronto (author)
  • Buchbinder, RachelleMonash University (author)
  • Pinkney, ThomasUniversity of Birmingham (author)
  • Bishop, Felicity L.University of Southampton (author)
  • Pugh, JonathanUniversity of Oxford (author)
  • Cousins, SianUniversity of Bristol (author)
  • Harris, IanUniversity of New South Wales (author)
  • Lohmander, L. StefanLund University,Lunds universitet,Lund OsteoArthritis Division - Nedbrytning av ledbrosk: en biologisk process som leder till artros,Forskargrupper vid Lunds universitet,Lund OsteoArthritis Division - Molecular marker research group,Lund University Research Groups(Swepub:lu)ort-slo (author)
  • Blencowe, NatalieUniversity of Bristol (author)
  • Gillies, KatieUniversity of Aberdeen (author)
  • Probst, PascalHeidelberg University (author)
  • Brennan, Carol (author)
  • Cook, AndrewUniversity of Southampton (author)
  • Farrar-Hockley, Dair (author)
  • Savulescu, JulianUniversity of Oxford (author)
  • Huxtable, RichardUniversity of Bristol (author)
  • Rangan, AmarUniversity of Oxford,University of York (author)
  • Tracey, IreneUniversity of Oxford (author)
  • Brocklehurst, PeterUniversity of Birmingham (author)
  • Ferreira, Manuela L.University of Sydney (author)
  • Nicholl, JonUniversity of Sheffield (author)
  • Reeves, Barnaby C.University of Bristol (author)
  • Hamdy, FreddieUniversity of Oxford (author)
  • Rowley, Samuel C.S.British Medical Research Council (MRC) (author)
  • Lee, NaomiThe Lancet (author)
  • Cook, Jonathan A.University of Oxford (author)
  • University of OxfordUniversity of Aberdeen (creator_code:org_t)

Related titles

  • In:Health Technology Assessment25:531366-5278

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