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2001 年 STRICTA 推荐报告针灸研究的建议:对改进对照临床试验设计的影响的综述。

The 2001 STRICTA recommendations for reporting acupuncture research: a review with implications for improving controlled clinical trial design.

机构信息

Department of Physical Medicine and Rehabilitation, Mayo Clinic, Jacksonville, FL 32224, USA.

出版信息

J Altern Complement Med. 2009 Feb;15(2):147-51. doi: 10.1089/acm.2008.0141.

Abstract

BACKGROUND

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in 1996 by researchers and journal editors to improve the quality of reporting of biomedical research by providing a standardized format for researchers to present information on randomized controlled clinical trials (RCTs). This improved data reporting allows readers to independently assess the quality and conclusions of these studies, and has been widely incorporated in contemporary research reports. In 2001, a supplemental set of criteria that specifically address the reporting of design and implementation issues for RCTs involving the use of acupuncture was introduced, termed the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations.The CONSORT guidelines are stated to be part of a broader effort to improve the quality of research, as they can be used by researchers to optimize the design of future trials. Similarly, the STRICTA recommendations outline research reporting standards that are and should be considered when designing controlled clinical trials that involve the use of acupuncture. The CONSORT and STRICTA recommendations thus not only serve to improve research reporting, but also serve to provide guidance for optimizing the designs of future clinical trials.

OBJECTIVES

This paper presents a review of the STRICTA recommendations for reporting the results of controlled trials utilizing acupuncture, discusses their potential limitations, and offers suggestions for additions/enhancements to those standards based on research issued subsequent to the issuance of the STRICTA recommendations in 2001.

摘要

背景

《CONSORT 声明》是由研究人员和期刊编辑于 1996 年制定的,旨在通过为研究人员提供一种标准化的格式来报告随机对照临床试验(RCT)的信息,从而提高生物医学研究报告的质量。这种改进的数据报告允许读者独立评估这些研究的质量和结论,并已广泛纳入当代研究报告中。2001 年,引入了一套补充标准,专门针对涉及针灸的 RCT 的设计和实施问题进行报告,称为 STRICTA(针灸临床试验报告标准)建议。《CONSORT 声明》被认为是提高研究质量的更广泛努力的一部分,因为它们可以被研究人员用来优化未来试验的设计。同样,STRICTA 建议概述了研究报告标准,在设计涉及针灸的对照临床试验时,这些标准是并且应该被考虑。因此,CONSORT 和 STRICTA 建议不仅有助于改进研究报告,还有助于为优化未来临床试验的设计提供指导。

目的

本文回顾了 STRICTA 建议用于报告针灸对照试验的结果,讨论了它们的潜在局限性,并根据 2001 年 STRICTA 建议发布后发布的研究提出了对这些标准的补充/增强建议。

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