On the ethical requirement to inform patients about potential treatment benefits

Davis and colleagues found that the benefits of prescription drugs are often poorly communicated to patients1; 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.45 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…
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