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临床试验摘要报告质量亟待提高:采用 CONSORT 对四本中医中药领域的中文顶级期刊进行评估。

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine.

机构信息

Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

出版信息

Trials. 2010 Jul 8;11:75. doi: 10.1186/1745-6215-11-75.

DOI:10.1186/1745-6215-11-75
PMID:20615225
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2911423/
Abstract

BACKGROUND

Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication.

METHOD

Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts).

RESULTS

We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual checklist item.

CONCLUSION

The reporting quality of abstracts of RCTs published in these four TCM journals needs to be improved. Since none of the four journals adopted CONSORT for Abstracts, we hope that the introduction and adoption of CONSORT for Abstracts by TCM journals will lead to an improvement in reporting quality.

摘要

背景

由于语言限制,期刊文章的摘要可能是非中文国家的人了解中医药临床试验的唯一途径。然而,对于这些试验摘要的报告质量知之甚少。我们的研究旨在评估 4 种中医领域主要期刊发表的随机对照试验(RCT)摘要的报告质量,并确定同一摘要出版物的中、英文版本在报告方面的任何差异。

方法

两位研究者手工检索了《中国中西医结合杂志》、《中国结合医学杂志》、《中国中药杂志》和《中国针灸杂志》2006 年至 2007 年发表的所有 RCT 摘要。两位研究者根据改良后的 CONSORT 对所有合格摘要的中、英文版本进行了独立评估,CONSORT 用于报告期刊和会议摘要中的随机试验(CONSORT for abstracts)。

结果

我们共确定了 345 项中医药 RCT,均有中英文摘要。超过一半的中文摘要报告了试验参与者的详细信息(68%;234/345)、对照组干预(52%;179/345)、随机分组的参与者人数(73%;253/345)以及在解释试验结果时的获益情况(55%;190/345)。方法学质量或试验设计和试验结果的关键特征的报告较差;仅有 2%(7/345)包含了试验设计的详细信息,3%(11/345)定义了主要结局,5%(17/345)描述了随机序列生成的方法,只有 4%(13/345)报告了分析的参与者人数。没有摘要提供关于分配隐藏和试验注册的详细信息。报告(同一摘要的中、英文版本之间)的一致性百分比在各检查表项目中从 84%到 100%不等。

结论

这些中医期刊发表的 RCT 摘要的报告质量有待提高。由于这 4 种期刊均未采用 CONSORT for Abstracts,我们希望 CONSORT for Abstracts 在中医期刊中的引入和采用将提高报告质量。

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CONSORT for reporting randomised trials in journal and conference abstracts.用于在期刊和会议摘要中报告随机试验的CONSORT声明。
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CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration.《CONSORT 声明:期刊和会议摘要中随机对照试验报告的解释与详述》
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