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ACURATE:针刺试验中虚假对照报告指南。

ACURATE: A guide for reporting sham controls in trials using acupuncture.

作者信息

Lee Ye-Seul, Kim Song-Yi, Lee Hyangsook, Chae Younbyoung, Lee Myeong Soo

机构信息

Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.

Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University, Seongnam, Republic of Korea.

出版信息

J Evid Based Med. 2023 Mar;16(1):82-90. doi: 10.1111/jebm.12524. Epub 2023 Mar 23.

DOI:10.1111/jebm.12524
PMID:36959765
Abstract

OBJECTIVE

To promote better reporting quality regarding sham acupuncture in clinical trials for a precise appraisal of the adequacy of the sham acupuncture procedure.

METHODS

A three-stage online Delphi survey was conducted to a group of experts. Items with higher than 80% consensus from the initial checklist were selected as the final candidates. Further discussion among the working group was convened to preclude potential redundancy among the items.

RESULTS

A total of 23 experts out of 35 (66%) responded to the Delphi process. The final checklist consists of 23 items in six categories: type of sham acupuncture, details of sham acupuncture manipulation, location of sham acupuncture, treatment regimen, practitioner, and protocol and settings.

CONCLUSION

This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT) and to be used along with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when sham acupuncture needles are used in the study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist reporting sham acupuncture procedures and the related components.

摘要

目的

提高临床试验中假针灸报告质量,以便准确评估假针灸程序的充分性。

方法

对一组专家进行了三阶段在线德尔菲调查。从初始清单中选择共识率高于80%的项目作为最终候选项目。召集工作组进行进一步讨论,以排除项目之间可能的冗余。

结果

35名专家中有23名(66%)对德尔菲过程做出了回应。最终清单包括六类23项:假针灸类型、假针灸操作细节、假针灸部位、治疗方案、从业者以及方案和设置。

结论

本文提出了针灸对照试验和实验报告指南(ACURATE)清单,它是试验报告统一标准(CONSORT)的扩展,当研究中使用假针灸针时,应与针灸临床试验报告标准(STRICTA)一起使用。该清单侧重于清晰描述假针刺程序,以提高可重复性并实现准确评估。我们鼓励研究人员在涉及假针灸的试验和综述中使用ACURATE,以协助报告假针灸程序及相关组成部分。

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