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美国风湿病学会2005年年会摘要中随机临床试验的报告质量

Quality of reporting of randomized clinical trials in abstracts of the 2005 annual meeting of the American College of Rheumatology.

作者信息

Hill Catherine L, Buchbinder Rachelle, Osborne Richard

机构信息

The Queen Elizabeth Hospital, Woodville, South Australia.

出版信息

J Rheumatol. 2007 Dec;34(12):2476-80. Epub 2007 Nov 1.

Abstract

OBJECTIVE

To determine the quality of abstracts reporting randomized clinical trials (RCT) at the 2005 Annual Scientific Meeting of the American College of Rheumatology.

METHODS

All 2005 abstracts including late-breaking abstracts were assessed. An abstract was deemed to be reporting an RCT if it indicated that participants were randomized in the title or body of the abstract. RCT were excluded if they included only pharmacokinetic data. The CONSORT checklist was applied and relevant data extracted. We defined manufacturer support as acknowledgment of industry support or industry employee as co-author.

RESULTS

Of 2146 abstracts, 143 (6.7%) reported RCT. Of these, 78.3% were drug trials, and 63.6% indicated manufacturer support. Only 30.8% of abstracts used "randomized" in the title, 44.1% did not explicitly state whether blinding was undertaken, and only 7.0% clearly stated who was blinded. Thirty percent of studies did not give an explicit definition of eligibility criteria of participants. While 84.6% explicitly described the experimental intervention, only 37.1% explicitly described the comparator intervention. Only 21% explicitly stated that an intention to treat analysis was performed. Baseline demographic and clinical characteristics were reported in 48.3%. While most abstracts reported summary results for each treatment group, only 35.7% reported effect size with its precision.

CONCLUSION

The quality of reporting is suboptimal in many RCT abstracts. Abstracts reporting RCT would benefit from a structured approach that ensures more detailed reporting of eligibility criteria, active and comparator interventions, flow of participants, and adequate summary and precision of results.

摘要

目的

确定在2005年美国风湿病学会年度科学会议上报告随机临床试验(RCT)的摘要质量。

方法

对2005年所有摘要(包括新公布的摘要)进行评估。如果摘要的标题或正文表明参与者是随机分组的,则该摘要被视为报告了一项RCT。仅包含药代动力学数据的RCT被排除。应用CONSORT清单并提取相关数据。我们将制造商支持定义为对行业支持的认可或行业员工作为共同作者。

结果

在2146篇摘要中,143篇(6.7%)报告了RCT。其中,78.3%是药物试验,63.6%表明有制造商支持。只有30.8%的摘要在标题中使用了“随机”一词,44.1%未明确说明是否进行了盲法,只有7.0%清楚地说明了谁被盲法。30%的研究未对参与者的纳入标准给出明确界定。虽然84.6%明确描述了实验性干预措施,但只有37.1%明确描述了对照干预措施。只有21%明确指出进行了意向性分析。48.3%的摘要报告了基线人口统计学和临床特征。虽然大多数摘要报告了每个治疗组的总结结果,但只有35.7%报告了效应大小及其精确性。

结论

许多RCT摘要的报告质量欠佳。报告RCT的摘要将受益于一种结构化方法,该方法可确保更详细地报告纳入标准、活性和对照干预措施、参与者流程以及结果的充分总结和精确性。

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