When physicians inform patients about the likely outcome of a recommended treatment, most will review evidence from clinical trials that evaluated that treatment and describe the likely benefits and toxicities, as reported in the trials. The probabilities of beneficial outcome and of toxicity written in consent forms approved by institutional review boards likewise are based on findings of pivotal clinical trials. However, patients treated in everyday practice tend to be older and more frail, to have poorer function and performance status, and to have more comorbidities and less social support than those selected to participate in clinical trials. Here, we review substantial evidence showing that outcomes observed for patients selected to participate in clinical trials (efficacy) differ from outcomes when the same drug or intervention is used in real-world circumstances (effectiveness).^1,2 This efficacy-effectiveness gap (EEG) translates to inferior outcomes (eg, disease response or survival) and greater toxicity when treatments are applied in a real-world clinical situation.

中文翻译：

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告知患者预期的结果：疗效-效果差距。

当医生告知患者推荐治疗的可能结果时，大多数人都会从临床试验中回顾评估该治疗的证据，并描述试验中可能产生的益处和毒性。由机构审查委员会批准的同意书中写明的有益结果和毒性的可能性同样基于关键临床试验的结果。然而，与参加临床试验的患者相比，在日常实践中接受治疗的患者往往年龄更大，体弱多病，功能和表现状态较差，合并症和社会支持较少。这里，^1,2当在现实世界中的临床情况下进行治疗时，这种功效-效果差距（EEG）会导致较差的结果（例如，疾病反应或生存）和更大的毒性。