A systematic review of the processes used to link clinical trial registrations to their published results.
A systematic review of the processes used to link clinical trial registrations to their published results.
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DOI：
10.1186/s13643-017-0518-3
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发表时间：
2017-07-03
影响因子：
3.7
通讯作者：
Dunn AG
中科院分区：
文献类型：
--
作者：
Bashir R;Bourgeois FT;Dunn AG
测量试验登记和报告的完整性和一致性的研究依赖于将登记与书目数据库联系起来。在这篇系统综述中，我们量化了用于识别这些联系的过程。检索PubMed和Embase数据库，从成立到2016年5月，检索将试验注册与书目数据库联系起来的研究。当注册标识符在书目数据库或出版物中可用时，用于建立这些链接的过程被分类为自动，当链接需要推断或联系试验研究者时，则分类为手动。在可用的情况下提取每个进程标识的链接数。使用线性回归来确定通过自动过程获得的链接的比例是否随着时间的推移而增加。在43项检查注册条目队列的研究中，有24项使用自动和手动流程来查找文章；3 .只自动；11只手动（5只未指定）。12项研究报告了手动和自动过程的结果，并显示中位数为23%（范围从13%到42%）包含文章的自动链接，而17%（范围从5%到42%）的注册表条目需要手动过程来查找文章。没有证据表明带有自动链接的注册表条目的比例有所增加（r2 = 0.02, p = 0.36）。在39项研究中，有21项研究使用了自动和手动流程；9 .只自动；2只手动（7只未指定）。16项研究报告了自动和手动过程的数量，并表明49%（范围从8%到97%）的文章有自动链接到注册表条目，10%（范围从0%到28%）的文章需要手动过程来查找注册表条目。没有证据表明具有自动链接到注册表条目的文章比例增加（r2 = 0.01, p = 0.73）。将试验登记册与其相应出版物联系起来仍然需要大量的人工程序。我们没有发现自动联动的使用随着时间的推移而增加。需要进一步调查，以便为确保出版物与试验注册适当联系起来的方法提供信息，从而能够有效地监测试验报告。本文的在线版本（doi:10.1186/s13643-017-0518-3）包含补充材料，可供授权用户使用。
Studies measuring the completeness and consistency of trial registration and reporting rely on linking registries with bibliographic databases. In this systematic review, we quantified the processes used to identify these links. PubMed and Embase databases were searched from inception to May 2016 for studies linking trial registries with bibliographic databases. The processes used to establish these links were categorised as automatic when the registration identifier was available in the bibliographic database or publication, or manual when linkage required inference or contacting of trial investigators. The number of links identified by each process was extracted where available. Linear regression was used to determine whether the proportions of links available via automatic processes had increased over time. In 43 studies that examined cohorts of registry entries, 24 used automatic and manual processes to find articles; 3 only automatic; and 11 only manual (5 did not specify). Twelve studies reported results for both manual and automatic processes and showed that a median of 23% (range from 13 to 42%) included automatic links to articles, while 17% (range from 5 to 42%) of registry entries required manual processes to find articles. There was no evidence that the proportion of registry entries with automatic links had increased (R 2 = 0.02, p = 0.36). In 39 studies that examined cohorts of articles, 21 used automatic and manual processes; 9 only automatic; and 2 only manual (7 did not specify). Sixteen studies reported numbers for automatic and manual processes and indicated that a median of 49% (range from 8 to 97%) of articles had automatic links to registry entries, and 10% (range from 0 to 28%) required manual processes to find registry entries. There was no evidence that the proportion of articles with automatic links to registry entries had increased (R 2 = 0.01, p = 0.73). The linkage of trial registries to their corresponding publications continues to require extensive manual processes. We did not find that the use of automatic linkage has increased over time. Further investigation is needed to inform approaches that will ensure publications are properly linked to trial registrations, thus enabling efficient monitoring of trial reporting. The online version of this article (doi:10.1186/s13643-017-0518-3) contains supplementary material, which is available to authorized users.