临床试验中的治疗保真度。

IF 2.1 Q1 REHABILITATION
Archives of physiotherapy Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI:10.33393/aop.2024.3128
Chad E Cook, Bryan O'Halloran, Steve Karas, Mareli Klopper, Jodi L Young
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引用次数: 0

摘要

在临床试验中,治疗忠实度(TF)历来是指临床医生按照设计试验的研究人员的意图实施干预或治疗的程度。治疗忠实度的最新定义包括干预措施的适当设计,其实施方式已知对治疗有益。这需要仔细关注三个关键要素:(1) 遵循方案和剂量,(2) 交付质量,以及 (3) 参与者的依从性。在本观点中,我们描述了临床试验中缺乏 TF 的几个案例,并给出了改善这些试验中遇到的不足的机会。我们认为,除了质量、偏倚风险和证据的确定性之外,TF 也应被视为临床试验真实性的一个基本要素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Treatment fidelity in clinical trials.

In the context of clinical trials, treatment fidelity (TF) has traditionally referred to the extent to which an intervention or treatment is implemented by the clinicians as intended by the researchers who designed the trial. Updated definitions of TF have included an appropriate design of the intervention that was performed in a way that is known to be therapeutically beneficial. This requires careful attention to three key components: (1) protocol and dosage adherence, (2) quality of delivery, and (3) participant adherence. In this viewpoint, we describe several cases in which TF was lacking in clinical trials and give opportunities to improve the deficits encountered in those trials. We feel that along with quality, risk of bias, and certainty of evidence, TF should be considered an essential element of the veracity of clinical trial.

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来源期刊
CiteScore
3.60
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