Department of Gastroenterology and Hepatology, University Hospital of Split, Split, Croatia.
Department of Pharmacy, University of Split School of Medicine, Split, Croatia.
BMJ Open. 2022 Mar 30;12(3):e054978. doi: 10.1136/bmjopen-2021-054978.
OBJECTIVE: To determine abstracts' adherence to the Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) statement and to explore the factors associated with reporting quality. DESIGN: An observational study. SETTING: Abstracts of randomised controlled trials published between 2010 and 2019, found searching the MEDLINE database. PARTICIPANTS: A total of 451 abstracts of the clinical trials infections were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Abstracts' reporting quality was determined by assessing their adherence to 17-item CONSORT-A checklist, with overall score being calculated as the sum of items that were adequately reported for each abstract. Additional factors that might influence the reporting quality of the abstracts were analysed, with univariate and multivariate linear regression used to determine how those factors influenced the overall reporting quality. RESULTS: Included abstracts had an overall median quality score of 8/17 (IQR 7-9). Large proportions of abstracts adequately reported interventions, participants, objectives, numbers randomised and conclusions (97.1, 99.3, 89.1. 94.7 and 98.4% of abstracts, respectively). Trial design, randomisation, blinding and funding were severely under-reported with only 8.0, 2.7, 11.0 and 2.0% of abstracts reporting each item. Overall quality scores for abstracts were higher in association with CONSORT-A endorsement (B=5.698; 95% CI 1.781 to 9.615), pharmacological interventions (B=4.063; 95% CI 0.224 to 7.902), multicentre settings (B=5.057; 95% CI 2.370 to 7.743), higher numbers of participants (B=3.607; 95% CI 1.272 to 5.942), hospital settings (B=4.827; 95% CI 1.753 to 7.901) and longer abstracts (B=3.878; 95% CI 0.787 to 6.969 for abstracts with 251-300 words and B=7.404; 95% CI 3.930 to 10.878 for abstracts with more than 300 words). CONCLUSIONS: The overall reporting quality of abstracts was inadequate. The endorsement of CONSORT-A guidelines by more journals might improve the standards of reporting.
目的:确定摘要是否符合临床试验摘要的 CONSORT-A 声明,并探讨与报告质量相关的因素。
设计:观察性研究。
设置:通过搜索 MEDLINE 数据库,检索 2010 年至 2019 年期间发表的随机对照试验的摘要。
参与者:共纳入 451 项感染性临床试验摘要。
主要和次要结果:通过评估摘要对 17 项 CONSORT-A 清单的报告质量,以每个摘要中充分报告的项目总和计算总体评分。分析可能影响摘要报告质量的其他因素,采用单变量和多变量线性回归确定这些因素如何影响总体报告质量。
结果:纳入的摘要总体中位数质量评分为 8/17(IQR 7-9)。大多数摘要充分报告了干预措施、参与者、目标、随机分组数量和结论(分别为 97.1%、99.3%、89.1%、94.7%和 98.4%)。试验设计、随机化、盲法和资金的报告严重不足,只有 8.0%、2.7%、11.0%和 2.0%的摘要报告了每个项目。与 CONSORT-A 认可(B=5.698;95%CI 1.781 至 9.615)、药理学干预(B=4.063;95%CI 0.224 至 7.902)、多中心设置(B=5.057;95%CI 2.370 至 7.743)、更多的参与者(B=3.607;95%CI 1.272 至 5.942)、医院设置(B=4.827;95%CI 1.753 至 7.901)和更长的摘要(B=3.878;95%CI 251-300 词的摘要为 0.787 至 6.969,B=7.404;95%CI 3.930 至 10.878 用于超过 300 个单词的摘要)相关。
结论:摘要的总体报告质量不足。更多期刊对 CONSORT-A 指南的认可可能会提高报告标准。
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