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2 型糖尿病随机对照试验中注意力对照组设计和使用的变化:系统评价。

Variations in the Design and Use of Attention Control Groups in Type 2 Diabetes Randomized Controlled Trials: a Systematic Review.

机构信息

Section of General Internal Medicine, Center for Chronic Disease Research and Policy, University of Chicago, 5841 S. Maryland Ave. MC 2007B, Chicago, IL, 60637, USA.

Department of Medicine, University of Chicago, 900 E. 57th St. #8144, Chicago, IL, 60637, USA.

出版信息

Curr Diab Rep. 2023 Sep;23(9):217-229. doi: 10.1007/s11892-023-01514-2. Epub 2023 Jun 9.

Abstract

PURPOSE OF REVIEW

In type 2 diabetes (T2D) research, the phrase "attention control group" (ACGs) has been used with varying descriptions. We aimed to systematically review the variations in the design and use of ACGs for T2D studies.

RECENT FINDINGS

Twenty studies utilizing ACGs were included in the final evaluation. Control group activities had the potential to influence the primary outcome of the study in 13 of the 20 articles. Prevention of contamination across groups was not mentioned in 45% of the articles. Eighty-five percent of articles met or somewhat met the criteria for having comparable activities between the ACG and intervention arms. Wide variations in descriptions and the lack of standardization have led to an inaccurate use of the phrase "ACGs" when describing the control arm of trials, indicating a need for future research with focus on the adoption of uniform guidelines for use of ACGs in T2D RCTs.

摘要

目的综述

在 2 型糖尿病(T2D)研究中,“对照治疗组”(ACG)这一术语有多种描述方式。我们旨在对 T2D 研究中 ACG 的设计和应用的差异进行系统综述。

最近发现

最终评估纳入了 20 项使用 ACG 的研究。在 20 篇文章中的 13 篇中,对照组的活动有可能影响研究的主要结果。有 45%的文章未提及两组间是否存在污染的预防。85%的文章符合或部分符合 ACG 与干预组之间的活动具有可比性的标准。描述方式的广泛差异以及缺乏标准化导致在描述试验的对照臂时对“ACG”一词的不准确使用,表明未来需要研究采用统一的指南来规范 T2D 的 RCT 中 ACG 的使用。

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