随机试验危害报告指南:Harms 2022声明解读  

Guideline for the reporting of harms in randomized trials:interpretation of Harms 2022

作　　者：李斌艳 王丽琼 段炎珊[1,2] 王宇 屠建锋 石广霞 刘存志 LI Binyan;WANG Liqiong;DUAN Yanshan;WANG Yu;TU Jianfeng;SHI Guangxia;LIU Cunzhi(College of Acupuncture-Moxibustion and Tuina Beijing University of Chinese Medicine,Beijing 100029,P.R.China;International Acupuncture and Moxibustion Innovation Institute,Beijing 100029,P.R.China)

机构地区：[1]北京中医药大学针灸推拿学院,北京100029 [2]北京中医药大学国际针灸创新研究院,北京100029

出　　处：《中国循证医学杂志》2024年第3期339-347,共9页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:82004223)。

摘　　要：一项具有临床应用价值的干预措施必须是有效且安全的,因此评价干预措施时,需综合权衡其益害比,只有益处大于危害的干预措施才有应用价值。评价某种干预措施的益害关系,应在临床试验中同时报告益处和危害的证据。为了提高临床试验中危害的报告质量,CONSORT工作组曾在2001版的CONSORT声明中增加了1项有关危害的条目,之后又于2004年发布了针对危害报告的扩展版,但该扩展版并未得到广泛应用,目前危害的报告仍不充分。为了改善这一情况,CONSORT工作组对《更好地报告随机试验中的危害:CONSORT声明扩展版》进行了更新,发布了《CONSORT危害2022声明、解释与说明:随机试验危害报告指南的更新版》(Harms 2022)。本文对Harms 2022更新情况进行介绍和解读,旨在帮助研究人员更好地理解与应用该声明,以期为提高临床研究中危害的报告质量提供帮助。An intervention with clinical application must be effective and safe,therefore,when evaluating interventions,the benefit-harm ratio should be considered,and only those interventions with more benefits than harms have application value.To evaluate the benefits and harms of an intervention evidence of both benefits and harms should be reported in clinical trials.To promote better reporting of harms in randomized controlled trials,the CONSORT group had added an entry on harms in the 2001 version of the CONSORT statement,and then in 2004,the CONSORT group developed the CONSORT Harms extension;however,it has not been consistently applied and needs to be updated,the reporting of harms is still inadequate.The CONSORT group has updated《Better reporting of harms in randomized trial:an extension of the CCONSORT statement.》,published《CONSORT Harms 2022 statement,explanation,and elaboration:updated guideline for the reporting of harms in randomized trials》.This article presents and explains the Harms 2022,with the aim of helping researchers better understand and use the statement,with a view to improving the reporting quality of harms in clinical trials.

关 键 词：危害 报告规范 解读 CONSORT 随机对照试验 

分 类 号：R-03[医药卫生]