美国骨科医生如何看待安慰剂对照手术试验?一项试点在线调查研究。

IF 3.3 2区 哲学 Q1 ETHICS
Michael H Bernstein, Maayan N Rosenfield, Charlotte Blease, Molly Magill, Richard M Terek, Julian Savulescu, Francesca L Beaudoin, Josiah D Rich, Karolina Wartolowska
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引用次数: 0

摘要

随机安慰剂对照试验(RPCT)是评估新型疗法的黄金标准。然而,在骨科干预中,这种设计很少被使用,因为参与者被分配到真实或安慰剂手术中。本研究调查了美国 687 名骨科外科医生对骨科手术 RPCT 的态度。当研究者看到一个描述骨科手术 RPCT 的小故事时,52.3% 的参与者认为它 "完全 "或 "大部分 "不道德。参与者还被要求对支持手术疗效的五种不同类型的证据(从RPCT到传闻报告)的价值进行排序。对RPCT的回答呈现两极分化,26.4%的人认为其价值最低(甚至低于轶事报告),35.7%的人认为其价值最高。在两极分化的情况下,如果我们希望骨科手术在临床实践中实施前接受最高标准的证据(RPCTs)检验,就有必要对医生进行安慰剂手术对照条件的价值和道德教育。否则,除了可能的安慰剂效应外,侵入性手术可能会在没有任何益处的情况下进行。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
How do US orthopaedic surgeons view placebo-controlled surgical trials? A pilot online survey study.

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.

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来源期刊
Journal of Medical Ethics
Journal of Medical Ethics 医学-医学:伦理
CiteScore
7.80
自引率
9.80%
发文量
164
审稿时长
4-8 weeks
期刊介绍: Journal of Medical Ethics is a leading international journal that reflects the whole field of medical ethics. The journal seeks to promote ethical reflection and conduct in scientific research and medical practice. It features articles on various ethical aspects of health care relevant to health care professionals, members of clinical ethics committees, medical ethics professionals, researchers and bioscientists, policy makers and patients. Subscribers to the Journal of Medical Ethics also receive Medical Humanities journal at no extra cost. JME is the official journal of the Institute of Medical Ethics.
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