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
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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.