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在Cochrane诊断试验准确性评价中定义临床路径。

Defining the clinical pathway in cochrane diagnostic test accuracy reviews.

作者信息

Gopalakrishna G, Langendam Miranda W, Scholten Rob J P M, Bossuyt Patrick M M, Leeflang Mariska M G

机构信息

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, P.O Box 22660, 1100, Amsterdam, DD, The Netherlands.

Cochrane Netherlands, Julius Center - UMC Utrecht Huispostnummer Str. 6.131 Postbus 85500, 3508, Utrecht, GA, The Netherlands.

出版信息

BMC Med Res Methodol. 2016 Nov 10;16(1):153. doi: 10.1186/s12874-016-0252-x.

Abstract

BACKGROUND

The value of a medical test depends on the context in which it might be used. Ideally, questions, results and conclusions of a diagnostic test accuracy (DTA) systematic review should be presented in light of this context. There is increasing acceptance of the value for knowing the impact a test can have on downstream consequences such as costs, implications for further testing and treatment options however there is currently no explicit guidance on how to address this. Authors of a Cochrane diagnostic review have recently been asked to include the clinical pathway in which a test maybe used. We aimed to evaluate how authors were developing their clinical pathways in the light of this.

METHODS

We searched the Cochrane Database of Systematic Reviews for all published DTA reviews. We included only those reviews that included a clinical pathway. We developed a checklist, based on the guidance in the Cochrane Handbook for DTA review authors. To this, we added a number of additional descriptors. We checked if the included pathways fulfilled these descriptors as defined by our checklist.

RESULTS

We found 47 reviews, of which 33 (73 %) contained aspects pertaining to a clinical pathway. The 33 reviews addressed the clinical pathway differently, both in content and format. Of these, 21 provided a textual description and 12 include visual and textual descriptions. There was considerable variation in how comprehensively review authors adhered to our checklist. Eighteen reviews (51 %) linked the index test results to downstream clinical management actions and patient consequences, but only eight went on to differentially report on the consequences for false negative results and nine on the consequences for false positive results.

CONCLUSION

There is substantial variation in the clinical pathway descriptions in Cochrane systematic reviews of test accuracy. Most reviews do not link misclassifications (i.e. false negatives and false positive) to downstream patient consequences. Review authors could benefit from more explicit guidance on how to create such pathways, which in turn can help guide them in their evidence selection and appraisal of the evidence in the context of downstream consequences of testing.

摘要

背景

医学检验的价值取决于其可能的使用背景。理想情况下,诊断试验准确性(DTA)系统评价的问题、结果和结论应根据这一背景来呈现。了解一项检验对下游结果(如成本、进一步检查和治疗选择的影响)的价值越来越受到认可,然而目前对于如何处理这一问题尚无明确指导。Cochrane诊断评价的作者最近被要求纳入检验可能使用的临床路径。我们旨在评估作者如何据此制定他们的临床路径。

方法

我们在Cochrane系统评价数据库中搜索了所有已发表的DTA评价。我们仅纳入那些包含临床路径的评价。我们根据Cochrane DTA评价作者手册中的指导制定了一份清单。在此基础上,我们又添加了一些额外的描述符。我们检查纳入的路径是否符合我们清单所定义的这些描述符。

结果

我们找到了47项评价,其中33项(73%)包含与临床路径相关的内容。这33项评价在内容和形式上对临床路径的处理方式各不相同。其中,21项提供了文字描述,12项同时包括视觉和文字描述。评价作者在遵循我们清单的全面程度上存在很大差异。18项评价(51%)将索引检验结果与下游临床管理行动和患者后果联系起来,但只有8项进一步分别报告了假阴性结果的后果,9项报告了假阳性结果的后果。

结论

Cochrane检验准确性系统评价中的临床路径描述存在很大差异。大多数评价没有将错误分类(即假阴性和假阳性)与下游患者后果联系起来。评价作者可能会从关于如何创建此类路径的更明确指导中受益,这反过来可以帮助他们在检验下游后果的背景下进行证据选择和证据评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a3d1/5103389/16727320ea94/12874_2016_252_Fig1_HTML.jpg

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