Publication and Reporting of Test Accuracy Studies Registered in ClinicalTrials.gov
Publication and Reporting of Test Accuracy Studies Registered in ClinicalTrials.gov
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DOI：
10.1373/clinchem.2013.218149
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发表时间：
2014-04-01
影响因子：
9.3
通讯作者：
Hooft, Lotty
中科院分区：
文献类型：
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作者：
Korevaar, Daniel A.;Ochodo, Eleanor A.;Hooft, Lotty
背景：未发表和选择性报告是生物医学文献中公认的问题，但其在诊断测试领域的程度尚不清楚。我们的目的是识别注册测试准确性研究中未发表以及注册记录与出版物之间的差异。方法：我们确定了根据临床试验中注册的参考标准评估测试准确性的研究。政府于 2006 年 1 月至 2010 年 12 月期间进行了研究。如果研究的完成日期设定在 2011 年 10 月之前，我们将其纳入其中，距离出版至少有 18 个月的时间。我们检索了 PubMed、EMBASE 和 Web of Science，并联系研究人员以获取出版物。结果：我们纳入了 418 项研究，其中 224 项 (54%) 已于 2013 年中期发表。在我们分析之前至少 30 个月完成的研究中，45% 在完成后 30 个月内发表。在研究完成后注册的研究中发表率较高（76%），而在研究状态未知（而非已完成）的研究中发表率较低（36%）。在我们排除这两个类别后，研究持续时间是与发表显着相关的唯一特征，持续长达 1 年的研究 (39%) 的比率低于 13-24 个月 (62%) 或更长 (67%) 的研究 (P = 0.01)。在完成前已注册的 153 项已发表的研究中，有 49 项 (32%) 显示注册和出版之间在纳入标准 (n = 19)、测试/阈值 (n = 9) 和结果 (n = 32) 方面存在差异。结论：在测试准确性研究中，未发表和选择性报告的情况很普遍。应在研究人员和期刊编辑中进一步推广他们的注册。 (C) 2013年美国临床化学协会
BACKGROUND: Failure to publish and selective reporting are recognized problems in the biomedical literature, but their extent in the field of diagnostic testing is unknown. We aimed to identify nonpublication and discrepancies between registered records and publications among registered test accuracy studies.METHODS: We identified studies evaluating a test's accuracy against a reference standard that were registered in ClinicalTrials. gov between January 2006 and December 2010. We included studies if their completion date was set before October 2011, allowing at least 18 months until publication. We searched PubMed, EMBASE, and Web of Science and contacted investigators for publications.RESULTS: We included 418 studies, of which 224 (54%) had been published by mid-2013. Among studies that had been completed at least 30 months before our analyses, 45% were published within 30 months after their completion. Publication rates were high in studies registered after study completion (76%) and low for studies with an unknown (rather than completed) study status (36%). After we excluded these 2 categories, study duration was the only characteristic significantly associated with publication, with lower rates in studies lasting up to 1 year (39%) compared to studies of 13-24 months (62%) or longer (67%) (P = 0.01). In the 153 published studies that had been registered before completion, 49 (32%) showed discrepancies between the registry and publication regarding inclusion criteria (n = 19), test/ threshold (n = 9), and outcomes (n = 32).CONCLUSIONS: Failure to publish and selective reporting are prevalent in test accuracy studies. Their registration should be further promoted among researchers and journal editors. (C) 2013 American Association for Clinical Chemistry