Department of Pediatrics, Children's Hospital of Philadelphia and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA.
Pediatrics. 2011 Sep;128(3):e639-44. doi: 10.1542/peds.2011-0377. Epub 2011 Aug 22.
To perform a systematic review of the quality of reporting for randomized controlled trials (RCTs) with infants and neonates that were published in high-impact journals and to identify RCT characteristics associated with quality of reporting.
RCTs that enrolled infants younger than 12 months and were published in 2005-2009 in 6 pediatric or general medical journals were reviewed. Eligible RCTs were evaluated for the presence of 11 quality criteria selected from the Consolidated Standards of Reporting Trials guidelines. The relationships between quality of reporting and key study characteristics were tested with nonparametric statistics.
Two reviewers had very good agreement regarding the eligibility of studies (κ = 0.85) and the presence of quality criteria (κ = 0.82). Among 179 eligible RCTs, reporting of the individual quality criteria varied widely. Only 50% included a flow diagram, but 99% reported the number of study participants. Higher quality of reporting was associated with greater numbers of study participants, publication in a general medical journal, and greater numbers of centers (P < .0001 for each comparison). Geographic region and positive study outcomes were not associated with reporting quality.
The quality of reporting of infant and neonatal RCTs is inconsistent, particularly in pediatric journals. Therefore, readers cannot assess accurately the validity of many RCT results. Strict adherence to the Consolidated Standards of Reporting Trials guidelines should lead to improved reporting.
对在高影响力期刊上发表的针对婴儿和新生儿的随机对照试验（RCT）的报告质量进行系统评价，并确定与报告质量相关的 RCT 特征。
对 2005-2009 年在 6 种儿科或普通医学期刊上发表的纳入 12 月龄以下婴儿的 RCT 进行了综述。从临床试验报告统一标准指南中选择了 11 个质量标准来评估合格 RCT 的存在情况。使用非参数统计方法检验报告质量与关键研究特征之间的关系。
两位评审员对研究的合格性（κ=0.85）和质量标准的存在（κ=0.82）具有非常好的一致性。在 179 项合格 RCT 中，报告的个别质量标准差异很大。只有 50%的研究报告了流程图，但 99%的研究报告了研究参与者的数量。报告质量较高与研究参与者数量较多、发表在普通医学期刊以及研究中心数量较多有关（每种比较的 P 值均<.0001）。地理位置和阳性研究结果与报告质量无关。
婴儿和新生儿 RCT 的报告质量不一致，尤其是在儿科期刊中。因此，读者无法准确评估许多 RCT 结果的有效性。严格遵守临床试验报告统一标准指南应会导致报告质量的提高。
