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在对快速发展的技术进行系统评价时,不仅应考虑随机对照试验,还应考虑病例系列研究。

Not only randomized controlled trials, but also case series should be considered in systematic reviews of rapidly developing technologies.

机构信息

Centre for Reviews and Dissemination, University of York, UK.

出版信息

J Clin Epidemiol. 2009 Dec;62(12):1253-1260.e4. doi: 10.1016/j.jclinepi.2008.12.010. Epub 2009 Apr 5.

Abstract

OBJECTIVE

Case series can influence clinical practice but are often omitted from systematic reviews. We evaluated the contribution of case series to a systematic review of radiofrequency catheter ablation (RFCA) for treatment of atrial fibrillation (AF).

STUDY DESIGN AND SETTING

Analysis of the results of a systematic review based on a search of 25 electronic databases and Internet sources.

RESULTS

We included eight controlled trials and 53 case series. Case series provided most patients longest follow-up and data on adverse events and complications. Rates of freedom from arrhythmia were comparable between case series, RFCA arms of controlled trials, and a survey of RFCA centers.

CONCLUSION

In the case of RFCA for AF, the case series make a useful contribution to the systematic review. Inclusion of case series can increase the evidence base and strengthen the credibility of a review of an emerging health technology. These advantages must be balanced against the risk of bias associated with the lack of a control group, potential publication bias, overrepresentation of results from specialist centers, and overlap of patients across series. Specification in the review protocol of inclusion criteria for outcomes and quality criteria is recommended to make optimum use of case series.

摘要

目的

病例系列研究可能会影响临床实践,但往往会从系统评价中被忽略。我们评估了病例系列研究对射频导管消融(RFCA)治疗心房颤动(AF)的系统评价的贡献。

研究设计与设置

对基于 25 个电子数据库和互联网资源搜索的系统评价结果进行分析。

结果

我们纳入了 8 项对照试验和 53 项病例系列研究。病例系列研究为系统评价提供了最长的随访时间以及不良事件和并发症的数据。病例系列、对照试验的 RFCA 组以及 RFCA 中心调查的心律失常无复发率之间具有可比性。

结论

在 AF 的 RFCA 治疗中,病例系列研究为系统评价做出了有益的贡献。纳入病例系列研究可以增加证据基础,并增强对新兴医疗技术的审查的可信度。必须权衡病例系列研究缺乏对照组、潜在的发表偏倚、来自专业中心的结果过度代表以及各系列之间患者重叠的风险。建议在审查方案中规定结果和质量标准的纳入标准,以最大限度地利用病例系列研究。

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