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关键护理期刊中临床试验注册和报告指南遵循情况的要求:对期刊作者指南的元流行病学研究。

Requirements for trial registration and adherence to reporting guidelines in critical care journals: a meta-epidemiological study of journals' instructions for authors.

机构信息

Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.

出版信息

Int J Evid Based Healthc. 2018 Mar;16(1):55-65. doi: 10.1097/XEB.0000000000000120.

Abstract

BACKGROUND

The purpose of this study was to investigate the policies of critical care journals with regard to guideline adoption and clinical trial registration to understand the extent to which journals use these mechanisms to improve reporting practices.

METHODS

The current study's sample comprised 37 critical care journals cataloged in the Expanded Science Citation Index of the 2015 Journal Citation Reports and Google Scholar Metrics h5-index critical care subcategory. A web-based data abstraction was performed to identify which journals required, recommended, or made no mention of 17 different reporting guidelines. We also extracted whether journals required or recommended trial registration. Authors were blinded to one another's ratings until completion of the data validation. Cross tabulations and descriptive statistics were calculated by using STATA 13.

RESULTS

Of the 37 critical care journals, 15 (15/37, 40.5%) did not mention a single guideline within their instructions for authors, whereas the remaining 22 (22/37, 59.5%) mentioned one or more guidelines. The Quality of Reporting of Meta-analyses statement and Standards for Reporting Qualitative Research were not mentioned by any journals, whereas the International Committee of Medical Journal Editors Uniform Requirements for Manuscripts (26/37, 70.3%) and Consolidated Standards of Reporting Trials statement (17/37, 45.9%) were mentioned most often. Of the 37 critical care journals, 21 (21/37, 56.8%) did not mention trial or review registration, but the remaining 16 (16/37, 43.2%) mentioned at least one of the two. Trial registration through ClinicalTrials.gov was mentioned by six (6/37, 16.2%) journals, whereas the WHO registry was mentioned by five (5/37, 13.5%). Sixteen (16/37, 43.2%) journals mentioned trial registration through a registry platform.

CONCLUSION

Nearly half of the journals in our sample did not mention a reporting guideline, and only a small percentage of journals required the registration of clinical trials as a condition for publication. Implementing these two mechanisms may limit bias, and their adoption should be considered by journal editors in critical care.

TRIAL REGISTRATION

UMIN000024081.

摘要

背景

本研究旨在调查重症监护期刊在采纳指南和临床试验注册方面的政策,以了解期刊在多大程度上利用这些机制来改善报告实践。

方法

本研究的样本包括 2015 年期刊引文报告扩展科学引文索引和 Google Scholar Metrics h5 指数重症监护子类别中列出的 37 种重症监护期刊。通过网络数据提取,确定哪些期刊需要、推荐或未提及 17 种不同的报告指南。我们还提取了期刊是否需要或推荐试验注册。作者在完成数据验证之前相互之间对评分保持盲态。使用 STATA 13 进行交叉表和描述性统计分析。

结果

在 37 种重症监护期刊中,有 15 种(15/37,40.5%)在其作者指南中未提及任何单一指南,而其余 22 种(22/37,59.5%)则提及了一种或多种指南。《报告荟萃分析的质量声明》和《报告定性研究的标准》没有被任何期刊提及,而《国际医学期刊编辑委员会统一要求》(26/37,70.3%)和《临床试验报告标准声明》(17/37,45.9%)被提及的频率最高。在 37 种重症监护期刊中,有 21 种(21/37,56.8%)未提及试验或综述注册,但其余 16 种(16/37,43.2%)至少提及了其中一种。有 6 种(6/37,16.2%)期刊提到了通过 ClinicalTrials.gov 进行试验注册,有 5 种(5/37,13.5%)期刊提到了世卫组织注册。有 16 种(16/37,43.2%)期刊提到了通过注册平台进行试验注册。

结论

我们样本中的近一半期刊没有提及报告指南,只有一小部分期刊要求临床试验注册作为发表的条件。实施这两种机制可以限制偏倚,重症监护期刊的编辑应考虑采用这两种机制。

试验注册

UMIN000024081。

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