Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.
Griffith University Faculty of Health, Gold Coast, Queensland, Australia.
BMJ Open. 2021 Jul 20;11(7):e045406. doi: 10.1136/bmjopen-2020-045406.
Transparent reporting of trials is necessary to assess their internal and external validity. Currently, little is known about the quality of reporting in antibiotics trials. Our study investigates the reporting of adverse events, conflicts of interest and funding information in trials of penicillins, cephalosporins and macrolides.
A secondary analysis of trials included in a convenience sample of three systematic reviews.
All randomised controlled trials included in the systematic reviews were included, although duplicates were removed. Eligible trials compared the specified antibiotics to placebo, for any indication. Author pairs independently extracted the data on reporting of adverse events from parent reviews, and data on funding and conflict of interest information from the trial reports. We calculated the overall proportion of trials reporting adverse events, conflict of interest information and funding information, and their proportion before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) 2001 Statement.
We included 432 trials. Overall, 62% of trials reported adverse events of any kind, although reporting of deaths or antibiotic resistance was less frequent (20% and 37%, respectively). Conflict-of-interest information was provided in 26% of the trials, and funding information was provided in 66% of the trials. There was no significant difference in reporting of adverse events before and after the publication of CONSORT 2001 Statement (62% vs 62%, p=0.92). Conflict of interest statements were provided more frequently (2% vs 55%, p<0.001) and conflict was present more often (0% vs 14%, p<0.001). There was no difference in the provision of the information about trial funding before (62%) and after (70%) CONSORT 2001 publication.
Information about adverse events, conflict of interest and funding, remains under-reported in trials of antibiotics.
透明报告试验结果对于评估其内部和外部有效性是必要的。目前，人们对抗生素试验报告的质量知之甚少。我们的研究调查了青霉素、头孢菌素和大环内酯类抗生素试验中不良事件、利益冲突和资金信息的报告情况。
对纳入三项系统评价的便利样本中的试验进行二次分析。
所有纳入系统评价的随机对照试验均被纳入，尽管已去除重复试验。合格的试验将指定的抗生素与安慰剂进行比较，用于任何适应证。作者对来自主要综述的不良事件报告数据和来自试验报告的资金和利益冲突信息进行了独立提取。我们计算了报告不良事件、利益冲突信息和资金信息的试验的总体比例，以及 CONSORT 2001 声明发表前后的比例。
我们纳入了 432 项试验。总体而言，有 62%的试验报告了任何类型的不良事件，但报告死亡或抗生素耐药性的比例较低（分别为 20%和 37%）。26%的试验提供了利益冲突信息，66%的试验提供了资金信息。CONSORT 2001 声明发表前后不良事件报告没有显著差异（62%与 62%，p=0.92）。利益冲突声明的提供频率更高（2%与 55%，p<0.001），利益冲突的存在更为常见（0%与 14%，p<0.001）。CONSORT 2001 声明发表前后，试验资金信息的提供没有差异（分别为 62%和 70%）。
抗生素试验中，不良事件、利益冲突和资金信息的报告仍然不足。
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