Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study
Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study
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DOI：
10.1136/bmjopen-2020-038283
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发表时间：
2020-08-01
期刊：
影响因子：
2.9
通讯作者：
Adie, Sam
中科院分区：
文献类型：
--
作者：
Tan, Zet Wei;Tan, Aidan Christopher;Adie, Sam
目的确定标准方案项目：干预性试验建议（SPIRIT）声明（2013）前后已发表的随机对照试验（RCT）方案的报告质量，以及与作者、试验或期刊因素的任何关联。设计方法学研究。使用优化的检索策略对数据源MEDLINE、Embase和CENTRAL进行电子检索。资格标准为活体人类随机对照试验编写的方案，全文发表在同行评审期刊上，并以英语发表。主要结果主要结果是在SPIRIT声明之前和之后发表的RCT方案中充分报告的检查表项目的总体比例。结果检索到300份RCT方案; 150份来自SPIRIT声明之前的时间段（2012年7月9日至2012年12月28日），150份来自SPIRIT声明之后的近期时间段（2019年1月25日至2019年3月20日）。在SPIRIT声明之前，RCT方案中充分报告了47.9%（95% CI，46.5%至49.3%）的检查表项目，在SPIRIT声明之后，报告率为56.7%（95% CI，54.9%至58.5%）。这代表8.8%（95% CI，6.6%至11.1%; p
Objectives To determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors. Design Methodological study. Data sources MEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies. Eligibility criteria Protocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language. Main outcome Primary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement. Results 300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p