On the ethical requirement to inform patients about potential treatment benefits.
On the ethical requirement to inform patients about potential treatment benefits.
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关于告知患者潜在治疗益处的道德要求。
DOI：
10.1136/bmj.p1233
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Howick J
中科院分区：
文献类型：
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作者：
Howick J
Davis和他的同事发现，处方药的好处通常没有很好地传达给患者1；临床试验中也出现了类似的问题。如果不提及潜在的好处，可能会导致患者产生不合理的负面预期，并体验到可以避免的“nocebo”效应。3相反的情况也可能是正确的：在没有可靠证据的情况下，患者可能高估了潜在的好处，这一现象被称为治疗乐观主义。4 5在非劣势试验中，问题更令人担忧，因为患者可能会错误地认为正在研究新的干预措施，以评估与现有治疗相比的改善效果，而研究的主要目的是排除被认为“临床可接受”的一定程度的劣质疗效。5更糟糕的是，关于潜在治疗益处的信息呈现方式的不一致可能会破坏伦理委员会关于如何以及是否与患者分享此类信息的决定。欧盟或英国的立法并不要求在临床实践中共享关于治疗益处的信息。1相比之下，《赫尔辛基宣言》规定，在研究研究中，“每个潜在的研究对象都必须充分了解……预期的好处和潜在的风险。6关于试验参与者的类似声明可以在英国7和欧盟8的法规中找到。如果需要在临床试验环境中指定潜在的益处(在尚未确定益处的情况下)，也应该在已确定治疗益处的实践环境中要求这样做。
Davis and colleagues found that the benefits of prescription drugs are often poorly communicated to patients 1; a similar problem arises in clinical trials. 2 Failure to mention potential benefits can cause patients to develop unreasonably negative expectations and experience avoidable “nocebo” effects. 3 The opposite can also be true: without being provided with sound evidence, patients can overestimate potential benefits, a phenomenon known as therapeutic optimism. 4 5 In non-inferiority trials, the problem is more concerning, because patients can mistakenly assume that the new intervention is being studied to evaluate improved efficacy over established treatments, when the primary study aim is to rule out a degree of inferior efficacy deemed “clinically acceptable.” 5 Worse, inconsistency in the way that information about potential treatment benefits is presented can undermine ethics committees’ decisions regarding how and whether to share such information with patients.Sharing information about treatment benefits in clinical practice is not required by EU or UK legislation. 1 By contrast, the Declaration of Helsinki states that, in research studies,“each potential subject must be adequately informed of... the anticipated benefits and potential risks.” 6 Similar statements about trial participants can be found in UK 7 and EU 8 regulations. If specifying potential benefits in a clinical trial setting (where the benefits have not been established) is required, it should also be required in the practice setting where (hopefully) treatment benefits have been established.