Maggi Cátia Bauer, Griebeler Isabel Heinzmann, Dal Pizzol Tatiane da Silva
Post-Graduation Program in Epidemiology, School of Medicine, Federal University of Rio Grande do Sul, Porto Alegre/RS, Brazil.
Post-Graduation Program in Pharmaceutical Services, Federal University of Rio Grande do Sul, Porto Alegre/RS, Brazil.
Int J Risk Saf Med. 2014;26(1):9-22. doi: 10.3233/JRS-140609.
The impact of the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 2004 and aimed to improve the quality of the safety information presented in clinical trials, remains uncertain.
To assess the incorporation of the CONSORT statement extension's recommendations in randomised clinical trials (RCTs) evaluating drug therapies published in high-impact medical journals.
Using Medline, 122 RCTs published in 2009 were selected from BMJ, JAMA, Lancet, and NEJM. A structured form was used to identify the harms information reported in the RCTs, following the recommendations of the CONSORT statement extension.
The most frequently met CONSORT recommendation was the mention of harms in the title or abstract of the paper (72.1% of the papers analysed); the least-met recommendation was the reporting of how the harms information was collected (10.7%). The studies that focused on harms presented better information on safety, but only 10.8% met all recommendations in the CONSORT statement.
The adverse event information was insufficient for the RCTs published in four high-impact medical journals five years after the publication of the extension of the CONSORT statement.
2004年发布的《试验报告的统一标准》（CONSORT）声明扩展版旨在提高临床试验中所呈现的安全性信息的质量，但其影响仍不明确。
评估CONSORT声明扩展版的建议在评估药物治疗的高影响力医学期刊上发表的随机临床试验（RCT）中的纳入情况。
利用Medline从《英国医学杂志》（BMJ）、《美国医学会杂志》（JAMA）、《柳叶刀》（Lancet）和《新英格兰医学杂志》（NEJM）中选取2009年发表的122项RCT。按照CONSORT声明扩展版的建议，使用结构化表格来识别RCT中报告的危害信息。
最常满足的CONSORT建议是在论文标题或摘要中提及危害（72.1%的分析论文）；最不常满足的建议是报告危害信息的收集方式（10.7%）。关注危害的研究呈现出更好的安全性信息，但只有10.8%的研究满足CONSORT声明中的所有建议。
在CONSORT声明扩展版发布五年后，在四家高影响力医学期刊上发表的RCT的不良事件信息不足。
