How do US orthopaedic surgeons view placebo-controlled surgical trials? A pilot online survey study.

Autor:	Bernstein MH; School of Public Health, Brown University, Center for Alcohol & Addiction Studies, Providence, Rhode Island, USA michael_bernstein@brown.edu.; Warren Alpert Medical School of Brown University, Department of Diagnostic Imaging, Providence, Rhode Island, USA.; Rhode Island Hospital, Providence, Rhode Island, USA., Rosenfield MN; School of Public Health, Brown University, Center for Alcohol & Addiction Studies, Providence, Rhode Island, USA., Blease C; General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA., Magill M; School of Public Health, Brown University, Center for Alcohol & Addiction Studies, Providence, Rhode Island, USA., Terek RM; Department of Orthopaedics, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA., Savulescu J; Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.; Melbourne Law School, Carlton, Victoria, Australia., Beaudoin FL; Department of Epidemiology, School of Public Health, Brown University, Providence, Rhode Island, USA., Rich JD; Rhode Island Hospital, Providence, Rhode Island, USA.; Department of Epidemiology, School of Public Health, Brown University, Providence, Rhode Island, USA.; The Miriam Hospital, Providence, Rhode Island, USA., Wartolowska K; Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Jazyk:	angličtina
Zdroj:	Journal of medical ethics [J Med Ethics] 2024 Aug 21; Vol. 50 (9), pp. 643-646. Date of Electronic Publication: 2024 Aug 21.
DOI:	10.1136/jme-2022-108221
Abstrakt:	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. Competing Interests: 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. (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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