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生殖医学中检验准确性研究的报告质量:诊断准确性报告标准(STARD)倡议的影响

Quality of reporting of test accuracy studies in reproductive medicine: impact of the Standards for Reporting of Diagnostic Accuracy (STARD) initiative.

作者信息

Coppus Sjors F P J, van der Veen Fulco, Bossuyt Patrick M M, Mol Ben W J

机构信息

Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, the Netherlands.

出版信息

Fertil Steril. 2006 Nov;86(5):1321-9. doi: 10.1016/j.fertnstert.2006.03.050. Epub 2006 Sep 14.

DOI:10.1016/j.fertnstert.2006.03.050
PMID:16978620
Abstract

OBJECTIVE

To evaluate the extent to which test accuracy studies published in two leading reproductive medicine journals in the years 1999 and 2004 adhered to the Standards for Reporting of Diagnostic Accuracy (STARD) initiative parameters, and to explore whether the introduction of the STARD statement has led to an improved quality of reporting.

DESIGN

Structured literature search. Articles that reported on the diagnostic performance of a test in comparison with a reference standard were eligible for inclusion. For each article we scored how well the 25 items of the STARD checklist were reported. These items deal with the study question, study participants, study design, test methods, reference standard, statistical methods, reporting of results, and conclusions. We calculated the total number of reported STARD items per article, summary scores for each STARD item, and the average number of reported STARD items per publication year.

SETTING

Not applicable.

PATIENT(S): Not applicable.

INTERVENTION(S): Not applicable.

MAIN OUTCOME MEASURE(S): Quality of reporting.

RESULT(S): We found 24 studies reporting on test accuracy in reproductive medicine in 1999 and 27 studies in 2004. The mean number of reported STARD items for articles published in 1999 was 12.1 +/- 3.3 (range 6.5-20) and 12.4 +/- 3.2 (range 7-17.5) in 2004, after publication of the STARD statement. Overall, less than half of the studies reported adequately on 50% or more of the STARD items. The reporting of individual items showed a wide variation. There was no significant improvement in mean number of reported items for the articles published after the introduction of the STARD statement.

CONCLUSION(S): Authors of test accuracy studies in the two leading fertility journals poorly report the design, conduct, methodology, and statistical analysis of their study. Strict adherence to the STARD guidelines should be encouraged.

摘要

目的

评估1999年和2004年发表在两份主要生殖医学期刊上的测试准确性研究在多大程度上符合《诊断准确性报告标准》(STARD)倡议参数,并探讨STARD声明的引入是否提高了报告质量。

设计

结构化文献检索。与参考标准相比报告测试诊断性能的文章符合纳入条件。对于每篇文章,我们对STARD清单的25项内容的报告情况进行评分。这些项目涉及研究问题、研究参与者、研究设计、测试方法、参考标准、统计方法、结果报告和结论。我们计算了每篇文章报告的STARD项目总数、每个STARD项目的汇总分数以及每年发表文章报告的STARD项目平均数量。

设置

不适用。

患者

不适用。

干预措施

不适用。

主要观察指标

报告质量。

结果

我们发现1999年有24项关于生殖医学测试准确性的研究,2004年有27项。STARD声明发表后,1999年发表文章报告的STARD项目平均数量为12.1±3.3(范围6.5 - 20),2004年为12.4±3.2(范围7 - 17.5)。总体而言,不到一半的研究对50%或更多的STARD项目进行了充分报告。各个项目的报告情况差异很大。引入STARD声明后发表文章的报告项目平均数量没有显著改善。

结论

两份主要生育期刊上测试准确性研究的作者对其研究的设计、实施、方法和统计分析报告不佳。应鼓励严格遵守STARD指南。

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