Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features.

Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features.
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梯级楔形群集随机对照试验设计:报告质量和设计功能的评论。

DOI:
10.1186/s13063-017-1783-0
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发表时间:
2017-01-21
期刊:
影响因子:
2.5
通讯作者:
Mander AP
Mander AP
中科院分区:
医学4区
文献类型:
--
作者:
Grayling MJ;Wason JM;Mander AP

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阶梯楔形 (SW) 聚类随机对照试验 (CRCT) 设计的使用频率越来越高。然而,关于 SW-CRCT 报告质量的已发表研究有限。我们通过文献综述来解决这个问题。检索了 Medline、Ovid、Web of Knowledge、Cochrane Library、PsycINFO、ISRCTN 注册中心和 ClinicalTrials.gov,以确定截至 2015 年 2 月采用 SW-CRCT 设计的研究。对于每项纳入的已完成研究,根据 CRCT 的 CONSORT 扩展,根据一系列标准提取信息,以评估报告质量。我们的综述总共纳入了 123 项研究,其中 39 项是完成的试验报告。 SW-CRCT 的报告标准在质量上各不相同。报告每项标准的试验百分比低至 15.4%,中位数为 66.7%。 SW-CRCT 的报告质量还有很大的改进空间。这与 CRCT 的最新发现是一致的。 SW-CRCT 的 CONSORT 扩展是为了标准化 SW-CRCT 的报告。本文的在线版本 (doi:10.1186/s13063-017-1783-0) 包含补充材料,可供授权用户使用。
The stepped wedge (SW) cluster randomized controlled trial (CRCT) design is being used with increasing frequency. However, there is limited published research on the quality of reporting of SW-CRCTs. We address this issue by conducting a literature review. Medline, Ovid, Web of Knowledge, the Cochrane Library, PsycINFO, the ISRCTN registry, and ClinicalTrials.gov were searched to identify investigations employing the SW-CRCT design up to February 2015. For each included completed study, information was extracted on a selection of criteria, based on the CONSORT extension to CRCTs, to assess the quality of reporting. A total of 123 studies were included in our review, of which 39 were completed trial reports. The standard of reporting of SW-CRCTs varied in quality. The percentage of trials reporting each criterion varied to as low as 15.4%, with a median of 66.7%. There is much room for improvement in the quality of reporting of SW-CRCTs. This is consistent with recent findings for CRCTs. A CONSORT extension for SW-CRCTs is warranted to standardize the reporting of SW-CRCTs. The online version of this article (doi:10.1186/s13063-017-1783-0) contains supplementary material, which is available to authorized users.