Treatment fidelity in clinical trials

被引：0

作者：

Cook, Chad E. ^{[1
,2
,3
]}

O'Halloran, Bryan ^{[4
]}

Karas, Steve ^{[5
]}

Klopper, Mareli ^{[6
]}

Young, Jodi L. ^{[7
]}

机构：

[1] Duke Univ, Sch Med, Dept Orthopaed, Durham, NC 27708 USA

[2] Duke Univ, Dept Populat Hlth Sci, Durham, NC 27708 USA

[3] Duke Univ, Duke Clin Res Inst, Durham, NC 27708 USA

[4] Med Univ South Carolina, Div Phys Therapy, Charleston, SC USA

[5] Chatham Univ, Dept Phys Therapy, Pittsburgh, PA USA

[6] Graceland Univ, Dept Phys Therapy, Independence, MO USA

[7] Bellin Coll, Dept Phys Therapy, Green Bay, WI USA

来源：

ARCHIVES OF PHYSIOTHERAPY | 2024年 / 14卷 / 01期

关键词：

Clinical trials; Fidelity; Quality; Treatment;

D O I：

10.33393/aop.2024.3128

中图分类号：

R49 [康复医学];

学科分类号：

100215 ;

摘要：

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.

引用

页码：65 / 69

页数：5

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