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迈向完整、准确的诊断准确性研究报告:STARD倡议。诊断准确性报告标准。

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy.

作者信息

Bossuyt Patrick M, Reitsma Johannes B, Bruns David E, Gatsonis Constantine A, Glasziou Paul P, Irwig Les M, Lijmer Jeroen G, Moher David, Rennie Drummond, de Vet Henrica C W

机构信息

Department of Clinical Epidemiology and Biostatistics, Academic Medical Center--University of Amsterdam, 1100 DE Amsterdam, The Netherlands.

出版信息

Clin Chem. 2003 Jan;49(1):1-6. doi: 10.1373/49.1.1.

DOI:10.1373/49.1.1
PMID:12507953
Abstract

BACKGROUND

To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.

OBJECTIVE

To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability.

METHODS

The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.

RESULTS

The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both.

CONCLUSIONS

Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

摘要

背景

为了理解诊断准确性研究的结果,读者必须了解此类研究的设计、实施、分析和结果。只有作者完全透明,才能实现这一目标。

目的

提高诊断准确性研究报告的准确性和完整性,使读者能够评估研究中存在偏倚的可能性,并评估其可推广性。

方法

诊断准确性报告标准(STARD)指导委员会检索文献,以确定关于诊断研究的适当实施和报告的出版物,并将潜在项目提取到一个广泛的列表中。研究人员、编辑和专业组织成员在为期两天的共识会议上缩短了该列表,目的是为诊断准确性研究制定一份清单和一个通用流程图。

结果

对已发表的诊断研究指南的检索产生了33份先前发表的清单,我们从中提取了一份包含75个潜在项目的列表。共识会议利用可得的偏倚证据将该列表缩短至25项。一个原型流程图提供了有关患者招募方法、测试执行顺序以及接受评估测试的患者数量、参考标准或两者的信息。

结论

研究评估取决于完整准确的报告。如果医学期刊采用该清单和流程图,诊断准确性研究报告的质量应会提高,这将有利于临床医生、研究人员、审稿人、期刊和公众。

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