Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Meta-Research Centre, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Trials. 2022 Jul 27;23(1):601. doi: 10.1186/s13063-022-06516-1.
To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.
We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components of the 33 SPIRIT items). We descriptively analysed the adherence to SPIRIT guidelines as proportion of adequately reported items (median and interquartile range [IQR]) and stratified the results by year of approval and sponsor.
The proportion of reported SPIRIT items increased from a median of 64.9% (IQR, 57.6-69.2%) in 2012 to a median of 72.5% (IQR, 65.3-78.3%) in 2016. Industry-sponsored RCTs reported more SPIRIT items in 2012 (median 67.4%; IQR, 64.1-69.4%) compared to non-industry-sponsored trials (median 59.8%; IQR, 46.5-67.7%). This gap between industry- and non-industry-sponsored trials increased in 2016 (industry-sponsored: median 75.6%; IQR, 71.2-79.0% vs non-industry-sponsored: median 65.3%; IQR, 51.6-76.3%).
The adherence to SPIRIT guidelines has improved in the UK from 2012 to 2016 but remains on a modest level, especially for non-industry-sponsored RCTs.
评估在《干预性试验标准议定书项目建议》（SPIRIT）指南发表前后，英国研究伦理委员会批准的随机对照试验（RCT）方案报告质量。
我们获得了英国 2012 年（n=103）和 2016 年（n=108）获得伦理批准的 RCT 研究方案。从中，我们评估了对 33 项 SPIRIT 条目（即 33 项 SPIRIT 条目的 64 个组成部分）的遵守情况。我们以充分报告项目的比例（中位数和四分位距 [IQR]）对 SPIRIT 指南的遵守情况进行描述性分析，并按批准年份和赞助商对结果进行分层。
报告的 SPIRIT 项目比例从 2012 年的中位数 64.9%（IQR，57.6-69.2%）增加到 2016 年的中位数 72.5%（IQR，65.3-78.3%）。2012 年，工业赞助商的 RCT 报告了更多的 SPIRIT 项目（中位数 67.4%；IQR，64.1-69.4%），而非工业赞助商的 RCT 报告了较少的 SPIRIT 项目（中位数 59.8%；IQR，46.5-67.7%）。这种工业和非工业赞助商之间的差距在 2016 年进一步扩大（工业赞助商：中位数 75.6%；IQR，71.2-79.0%；非工业赞助商：中位数 65.3%；IQR，51.6-76.3%）。
从 2012 年到 2016 年，英国对 SPIRIT 指南的遵守程度有所提高，但仍处于中等水平，特别是对于非工业赞助商的 RCT。
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