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How do US orthopaedic surgeons view placebo-controlled surgical trials? A pilot online survey study
  1. Michael H Bernstein1,2,3,
  2. Maayan N Rosenfield1,
  3. Charlotte Blease4,
  4. Molly Magill1,
  5. Richard M Terek5,
  6. Julian Savulescu6,7,8,
  7. Francesca L Beaudoin9,
  8. Josiah D Rich3,9,10,
  9. Karolina Wartolowska11
  1. 1School of Public Health, Brown University, Center for Alcohol & Addiction Studies, Providence, Rhode Island, USA
  2. 2Warren Alpert Medical School of Brown University, Department of Diagnostic Imaging, Providence, Rhode Island, USA
  3. 3Rhode Island Hospital, Providence, Rhode Island, USA
  4. 4General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
  5. 5Department of Orthopaedics, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA
  6. 6Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
  7. 7Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
  8. 8Melbourne Law School, Carlton, Victoria, Australia
  9. 9Department of Epidemiology, School of Public Health, Brown University, Providence, Rhode Island, USA
  10. 10The Miriam Hospital, Providence, Rhode Island, USA
  11. 11Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK
  1. Correspondence to Dr Michael H Bernstein, Warren Alpert Medical School of Brown University, Department of Diagnostic Imaging, Providence, RI 02912, USA; michael_bernstein{at}brown.edu

Abstract

Randomised placebo-controlled trials (RPCTs) are the gold standard for evaluating novel treatments. However, this design is rarely used in the context of orthopaedic interventions where participants are assigned to a real or placebo surgery. The present study examines attitudes towards RPCTs for orthopaedic surgery among 687 orthopaedic surgeons across the USA. When presented with a vignette describing an RPCT for orthopaedic surgery, 52.3% of participants viewed it as ‘completely’ or ‘mostly’ unethical. Participants were also asked to rank-order the value of five different types of evidence supporting the efficacy of a surgery, ranging from RPCT to an anecdotal report. Responses regarding RPCTs were polarised with 26.4% viewing it as the least valuable (even less valuable than an anecdote) and 35.7 .% viewing it as the most valuable. Where equipoise exists, if we want to subject orthopaedic surgeries to the highest standard of evidence (RPCTs) before they are implemented in clinical practice, it will be necessary to educate physicians on the value and ethics of placebo surgery control conditions. Otherwise, invasive procedures may be performed without any benefits beyond possible placebo effects.

  • pain management

https://doi.org/10.1136/jme-2022-108221

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    Footnotes

    • Twitter @mh_bernstein, @crblease, @KAWartolowska

    • Contributors Manuscript writing: MHB, CB, JS, KW. Survey design: MHB, MNR, MM, CB, RMT, FLB, JDR, KW. Statistical analysis: MHB, KW. Interpretation of results: MHB, MNR, CB, RMT, KW. Acquisition of funding: MHB, MM, FLB, JDR. Manuscript edits: MM, RMT, JDR.

    • Funding MHB was supported by K01DA048087 awarded by the National Institute on Drug Abuse. CB was supported by the John F. Keane & Family Visiting Scholar grant. JDR was supported by P20 GM125507 awarded by the National Institute of General Medical Sciences from which MHB and FLB have received funding. JS, through his involvement with the Murdoch Children’s Research Institute, received funding through from the Victorian State Government through the Operational Infrastructure Support (OIS) Program.

    • Competing interests JS is a Partner Investigator on an Australian Research Council grant LP190100841 which involves industry partnership from Illumina. He does not personally receive any funds from Illumina. JS is a Bioethics Committee consultant for Bayer.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Author note The authors thank Dr. John Kelley for his thoughtful feedback.

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