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中文医学论文中动物实验ARRIVE指南报告规范调查

Survey of Compliance With ARRIVE Guidelines in Medical Research Papers in Chinese

  • 摘要:
    目的 调查国内医学论文中涉及动物实验报告的规范现状,以提升医学科研论文的报告透明度。
    方法 本研究以中国知网数据库(CNKI)中北大核心收录期刊为数据来源,采用预先确定的文献检索策略,筛选2019年和2022年发表的文献。对纳入文献中涉及《动物研究:体内实验报告》(Animal research:reporting of in vivo experiments, ARRIVE)指南关键10条中的6个项目(研究设计、样本量、随机化、盲法、统计方法和实验动物资料)以及推荐11条中的3个项目(摘要、伦理声明和利益冲突声明)共计22条主要信息的报告率进行统计分析。
    结果 共纳入文献共4818篇,未发现任何一篇文献全面报告了本研究所调查的22条相关信息。2019年和2022年发表的绝大多数论文均报告了对照组,报告率分别为99.8%(2461/2467)和99.7%(2343/2351),样本量的报告率分别为79.2%(1954/2467)和77.2%(1815/2351),所有论文均未报告样本量的计算方法和依据,随机化方法报告率约为20%,盲法报告率约为1%;2022年对统计学方法的报告(96.4%)比2019年略有增加(91.8%);2019年和2022年对动物来源(93.8% vs. 93.7%,P>0.05)、品种/品系(99.1% vs. 99.2%,P=0.514)、性别(94.1% vs. 92.7%,P=0.044)、年龄(58.1% vs. 70.6%,P<0.001)、体质量(84.4% vs. 81.9%, P=0.020)、健康证明(66.0% vs. 75.5%,P<0.001)等实验动物资料信息的报告程度存在不同的差异。2019年和2022年文献报告动物伦理审查(15.8% vs. 38.9%)或描述遵守的动物伦理原则(9.8% vs. 21.3%)、利益冲突声明(2.3% vs. 10.6%)、摘要中准确报告动物相关信息(9.16% vs. 8.13%)程度均较低。其中,与2019年相比较,2022年动物伦理和利益冲突声明报告程度增加(P<0.001)。
    结论 虽然自ARRIVE 2.0发布以来,大多数项目清单报告透明度明显改善。然而,随机化方法、盲法、动物伦理以及利益冲突的报告程度仍需进一步提升,这些是未来的重点努力方向。

     

    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 China National Knowledge Infrastructure (CNKI) database for literature published in 2019 and 2022 in journals indexed in A Guide to the Core Journals of China 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%, P > 0.05), strains and substrains (99.1% vs. 99.2%, P = 0.514), sex (94.1% vs. 92.7%, P = 0.044), age (58.1% vs. 70.6%, P < 0.001), weight (84.4% vs. 81.9%, P = 0.020), and health status (66.0% vs. 75.5%, P < 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 (P < 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.

     

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