There is no reliable evidence that providing authors with customized article templates including items from reporting guidelines improves completeness of reporting: the GoodReports randomized trial (GRReaT).

IF 3.4 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES BMC Medical Research Methodology Pub Date : 2025-03-14 DOI:10.1186/s12874-025-02518-0
Caroline Struthers, James Harwood, Jennifer Anne de Beyer, Patricia Logullo, Gary S Collins
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Abstract

Background: Although medical journals endorse reporting guidelines, authors often struggle to find and use the right one for their study type and topic. The UK EQUATOR Centre developed the GoodReports website to direct authors to appropriate guidance. Pilot data suggested that authors did not improve their manuscripts when advised to use a particular reporting guideline by GoodReports.org at journal submission stage. User feedback suggested the checklist format of most reporting guidelines does not encourage use during manuscript writing. We tested whether providing customized reporting guidance within writing templates for use throughout the writing process resulted in clearer and more complete reporting than only giving advice on which reporting guideline to use.

Design and methods: GRReaT was a two-group parallel 1:1 randomized trial with a target sample size of 206. Participants were lead authors at an early stage of writing up a health-related study. Eligible study designs were cohort, cross-sectional, or case-control study, randomized trial, and systematic review. After randomization, the intervention group received an article template including items from the appropriate reporting guideline and links to explanations and examples. The control group received a reporting guideline recommendation and general advice on reporting. Participants sent their completed manuscripts to the GRReaT team before submitting for publication, for completeness of each item in the title, methods, and results section of the corresponding reporting guideline. The primary outcome was reporting completeness against the corresponding reporting guideline. Participants were not blinded to allocation. Assessors were blind to group allocation. As a recruitment incentive, all participants received a feedback report identifying missing or inadequately reported items in these three sections.

Results: Between 9 June 2021 and 30 June 2023, we randomized 130 participants, 65 to the intervention and 65 to the control group. We present findings from the assessment of reporting completeness for the 37 completed manuscripts we received, 18 in the intervention group and 19 in the control group. The mean (standard deviation) proportion of completely reported items from the title, methods, and results sections of the manuscripts (primary outcome) was 0.57 (0.18) in the intervention group and 0.50 (0.17) in the control group. The mean difference between the two groups was 0.069 (95% CI -0.046 to 0.184; p = 0.231). In the sensitivity analysis, when partially reported items were counted as completely reported, the mean (standard deviation) proportion of completely reported items was 0.75 (0.15) in the intervention group and 0.71 (0.11) in the control group. The mean difference between the two groups was 0.036 (95% CI -0.127 to 0.055; p = 0.423).

Conclusion: As the dropout rate was higher than expected, we did not reach the recruitment target, and the difference between groups was not statistically significant. We therefore found no evidence that providing authors with customized article templates including items from reporting guidelines, increases reporting completeness. We discuss the challenges faced when conducting the trial and suggest how future research testing innovative ways of improving reporting could be designed to improve recruitment and reduce dropouts.

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没有可靠的证据表明,为作者提供定制的文章模板,包括报告指南中的项目,可以提高报告的完整性:GoodReports随机试验(great)。
背景:尽管医学期刊认可报告指南,但作者往往难以找到并使用适合其研究类型和主题的报告指南。英国赤道中心开发了“好报告”网站,为作者提供适当的指导。试点数据表明,当建议作者在期刊提交阶段使用GoodReports.org的特定报告指南时,作者并没有改进他们的论文。用户反馈表明,大多数报告指南的核对表格式不鼓励在撰写手稿时使用。我们测试了在写作模板中提供自定义的报告指导,以便在整个写作过程中使用,是否比仅仅给出使用哪个报告指导的建议更清晰、更完整。设计和方法:great是一项两组平行1:1随机试验,目标样本量为206。参与者在撰写健康相关研究的早期阶段都是主要作者。符合条件的研究设计为队列研究、横断面研究或病例对照研究、随机试验和系统评价。随机化后,干预组收到一篇文章模板,其中包括相应报告指南中的项目以及解释和示例的链接。对照组收到报告准则建议和关于报告的一般意见。参与者在提交发表之前将他们完成的手稿发送给great团队,以确保相应报告指南的标题、方法和结果部分中的每一项的完整性。主要结果是根据相应的报告准则报告的完整性。参与者并没有对分配视而不见。评估人员对分组分配一无所知。作为一项招聘激励措施,所有参与者都收到了一份反馈报告,指出这三个部分中缺少或报告不充分的项目。结果:在2021年6月9日至2023年6月30日期间,我们随机选择了130名参与者,其中65名为干预组,65名为对照组。我们对收到的37份已完成的手稿进行报告完整性评估,其中干预组18份,对照组19份。论文标题、方法和结果部分(主要结局)完全报告项目的平均(标准差)比例在干预组为0.57(0.18),对照组为0.50(0.17)。两组间的平均差异为0.069 (95% CI -0.046 ~ 0.184;p = 0.231)。在敏感性分析中,当部分报告项目计入完全报告项目时,完全报告项目的平均(标准差)比例在干预组为0.75(0.15),在对照组为0.71(0.11)。两组间的平均差异为0.036 (95% CI -0.127 ~ 0.055;p = 0.423)。结论:由于辍学率高于预期,我们没有达到招聘目标,组间差异无统计学意义。因此,我们没有发现证据表明,为作者提供定制的文章模板(包括报告指南中的项目)可以提高报告的完整性。我们讨论了进行试验时面临的挑战,并建议如何设计未来的研究,测试改进报告的创新方法,以改善招聘和减少退学。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Medical Research Methodology
BMC Medical Research Methodology 医学-卫生保健
CiteScore
6.50
自引率
2.50%
发文量
298
审稿时长
3-8 weeks
期刊介绍: BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.
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