Cook Chad E, O'Halloran Bryan, Karas Steve, Klopper Mareli, Young Jodi L
Department of Orthopaedics, Duke University School of Medicine, Duke University, Durham, North Carolina - USA.
Department of Population Health Sciences, Duke University, Durham, North Carolina - USA.
Arch Physiother. 2024 Sep 16;14:65-69. doi: 10.33393/aop.2024.3128. eCollection 2024 Jan-Dec.
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.
在临床试验的背景下，治疗依从性（TF）传统上指的是临床医生按照设计试验的研究人员的预期实施干预或治疗的程度。TF的最新定义包括以已知具有治疗益处的方式进行的干预的适当设计。这需要仔细关注三个关键要素：（1）方案和剂量依从性，（2）实施质量，以及（3）参与者依从性。在本文观点中，我们描述了一些临床试验中缺乏TF的案例，并提供了改善这些试验中遇到的不足的机会。我们认为，与质量、偏倚风险和证据确定性一样，TF应被视为临床试验真实性的一个基本要素。
