Department of Pediatrics, Kalawati Saran Children's Hospital, Lady Hardinge Medical College, Bangla Sahib Road, New Delhi 110001, India.
Department of Pediatrics, Kalawati Saran Children's Hospital, Lady Hardinge Medical College, Bangla Sahib Road, New Delhi 110001, India.
J Clin Epidemiol. 2016 Mar;71:11-7. doi: 10.1016/j.jclinepi.2015.10.013. Epub 2015 Oct 31.
To assess and compare the immediate and long-term change in reporting quality of randomized controlled trial (RCT) abstracts published in Pediatrics, The Journal of Pediatrics, and JAMA Pediatrics before and after the publication of Consolidated Standards of Reporting Trial (CONSORT)-abstract statement.
Study had "Interrupted time-series" design. Eligible RCT abstracts were retrieved by PubMed search in two study periods from January 2003 to December 2007 (pre-CONSORT) and January 2010 to December 2014 (post-CONSORT). These abstracts were matched with the CONSORT checklist for abstracts. The primary outcome measure was CONSORT-abstract score defined as number of CONSORT items correctly reported divided by 18 and expressed as percentage. The mean percentage scores were used to compare reporting quality between pre- and post-CONSORT using segmented linear regression.
A total of 424 RCT abstracts in pre-CONSORT and 467 in post-CONSORT were analyzed. A significant change in slope of regression line between two time periods (0.151 [confidence interval CI, 0.004-0.298], P = 0.044) was observed. Intercepts did not show a significant difference (-2.39 [CI, 4.93-0.157], P = 0.065).
The overall reporting quality of RCT abstracts in the high-impact pediatrics journals was suboptimal (<50%); however, it improved when assessed over a 5-year period, implying slow but gradual adoption of guideline.
评估并比较《儿科学》、《儿科学杂志》和《美国医学会儿科学》发表的随机对照试验（RCT）摘要在发布 CONSORT 摘要报告标准前后的即时和长期报告质量变化。
本研究采用“间断时间序列”设计。在两个研究期间，通过 PubMed 搜索，从 2003 年 1 月至 2007 年 12 月（CONSORT 前）和 2010 年 1 月至 2014 年 12 月（CONSORT 后），检索合格的 RCT 摘要。这些摘要与 CONSORT 摘要核对表相匹配。主要观察指标是 CONSORT 摘要评分，定义为正确报告的 CONSORT 项目数除以 18，并用百分比表示。使用分段线性回归比较 CONSORT 前后的报告质量，使用平均百分比评分进行比较。
共分析了 CONSORT 前的 424 篇 RCT 摘要和 CONSORT 后的 467 篇 RCT 摘要。观察到两个时期之间回归线斜率的变化有统计学意义（0.151 [置信区间 CI，0.004-0.298]，P = 0.044）。截距没有显著差异（-2.39 [CI，4.93-0.157]，P = 0.065）。
高影响力儿科期刊中 RCT 摘要的总体报告质量较差（<50%）；然而，在 5 年期间评估时，报告质量有所提高，表明指南的采用速度缓慢但逐渐。
