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[中文医学研究论文中ARRIVE指南的依从性调查]

[Survey of Compliance With ARRIVE Guidelines in Medical Research Papers in Chinese].

作者信息

He Xueling, Jiang Tian, He Lin, Bie Mingjiang

机构信息

《()》 ( 610041) Editorial Office of Journal of Sichuan University (Medical Sciences), Chengdu 610041, China.

出版信息

Sichuan Da Xue Xue Bao Yi Xue Ban. 2025 Mar 20;56(2):364-370. doi: 10.12182/20250360506.

Abstract

OBJECTIVE

To evaluate the current status of compliance with animal experiment reporting guidelines in medical research papers published in Chinese and to enhance the transparency of medical research reporting.

METHODS

Using a predefined literature search strategy, we conducted searches in the (CNKI) database for literature published in 2019 and 2022 in journals indexed in published by Peking University Library. We focused on 22 pieces of key information required in the ARRIVE Guidelines 2.0. These pieces of information concerned 6 items of the ARRIVE Essential 10 Items, including study design, sample size, randomization, statistical methods, and experimental animals, and 3 items of the ARRIVE Recommended Set, including abstract, ethical statement, and declaration of interests. We conducted statistical analysis of the reporting rates of the key information in the research publications included in the study.

RESULTS

A total of 4818 research papers were included in the analysis, and none comprehensively reported all 22 pieces of information investigated in the study. Most of the research papers published in 2019 and 2022 reported information on the control groups, with the reporting rate for the respective years being 99.8% (2461/2467) and 99.7% (2343/2351). Although the sample size reporting rates were 79.2% (1954/2467) for research papers published in 2019 and 77.2% (1815/2351) for those published in 2022, none described the method and rationale of sample size calculation. The reporting rates of randomisation and blinding methods were approximately 20% and 1%, respectively. The reporting of statistical methods increased slightly from 91.8% in 2019 to 96.0% in 2022. The reporting of information on the experimental animals showed mixed trends for 2019 and 2022, including the provenance of animals (93.8% vs. 93.7%, > 0.05), strains and substrains (99.1% vs. 99.2%, = 0.514), sex (94.1% vs. 92.7%, = 0.044), age (58.1% vs. 70.6%, < 0.001), weight (84.4% vs. 81.9%, = 0.020), and health status (66.0% vs. 75.5%, < 0.001). Research papers published in both 2019 and 2022 had relatively low rates of reporting animal ethics review (15.8% vs. 38.9%) and animal ethics principles adhered to (9.8% vs. 21.3%), declaration of interests (2.3% vs. 10.6%), and accurate summaries of animal-related information in the abstracts (9.16% vs. 8.13%). In particular, the reporting rate of the animal ethics statement and the declaration of interests increased significantly high in 2022 compared to that in 2019 ( < 0.001).

CONCLUSIONS

Since ARRIVE Guidelines 2.0 was released, transparency in the reporting of most of the ARRIVE checklist items of interest in this study has improved significantly. However, the reporting of randomization, blinding, ethical statement, and declaration of interests still need further improvement and should be prioritized for future efforts.

摘要

目的

评估发表于中文的医学研究论文中动物实验报告指南的遵循现状,提高医学研究报告的透明度。

方法

采用预先设定的文献检索策略,在《中国知网》(CNKI)数据库中检索2019年和2022年发表于北京大学图书馆出版的《中文核心期刊要目总览》收录期刊的文献。我们聚焦于《ARRIVE指南2.0》要求的22条关键信息。这些信息涉及《ARRIVE必备10项》中的6项,包括研究设计、样本量、随机化、统计方法和实验动物,以及《ARRIVE推荐项目集》中的3项,包括摘要、伦理声明和利益声明。我们对纳入研究的科研出版物中关键信息的报告率进行了统计分析。

结果

共纳入4818篇研究论文进行分析,无一全面报告了本研究中调查的所有22条信息。2019年和2022年发表的大多数研究论文报告了对照组的信息,各年份的报告率分别为99.8%(2461/2467)和99.7%(2343/2351)。尽管2019年发表的研究论文样本量报告率为79.2%(1954/2467),2022年发表的为77.2%(1815/2351),但均未描述样本量计算的方法和依据。随机化和盲法的报告率分别约为20%和1%。统计方法的报告率从2019年的91.8%略有上升至2022年的96.0%。2019年和2022年实验动物信息的报告呈现出不同趋势,包括动物来源(93.8%对93.7%,P>0.05)、品系和亚品系(99.1%对99.2%,P = 0.514)、性别(94.1%对92.7%,P = 0.044)、年龄(58.1%对70.6%,P<0.001)、体重(84.4%对81.9%,P = 0.020)和健康状况(66.0%对75.5%,P<0.001)。2019年和2022年发表的研究论文动物伦理审查报告率(15.8%对38.9%)和遵循的动物伦理原则报告率(9.8%对21.3%)、利益声明报告率(2.3%对10.6%)以及摘要中动物相关信息的准确总结报告率(9.16%对8.13%)均相对较低。特别是,与2019年相比,2022年动物伦理声明和利益声明的报告率显著升高(P<0.001)。

结论

自《ARRIVE指南2.0》发布以来,本研究中大多数感兴趣的ARRIVE清单项目的报告透明度有了显著提高。然而,随机化、盲法、伦理声明和利益声明的报告仍需进一步改进,应作为未来工作的重点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f176/12207042/2f0a245aedfb/scdxxbyxb-56-2-364-1.jpg

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