Quality of Reporting of Neonatal and Infant Trials in High-Impact Journals
Quality of Reporting of Neonatal and Infant Trials in High-Impact Journals
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DOI：
10.1542/peds.2011-0377
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发表时间：
2011-09-01
期刊：
影响因子：
8
通讯作者：
Schmidt, Barbara
中科院分区：
文献类型：
--
作者：
DeMauro, Sara B.;Giaccone, Annie;Schmidt, Barbara
目的：对高影响力期刊上发表的婴儿和新生儿随机对照试验 (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。 方法：对 2005-2009 年在 6 种儿科或普通医学期刊上发表的 12 个月以下婴儿入组的随机对照试验进行评价。对符合条件的 RCT 进行了评估，以确定是否存在选自《报告试验综合标准》指南的 11 项质量标准。使用非参数统计来测试报告质量和关键研究特征之间的关系。结果：两位评审员对于研究的资格（kappa = 0.85）和质量标准（kappa = 0.82）的存在非常一致。在 179 项符合条件的随机对照试验中，各个质量标准的报告差异很大。只有 50% 的受访者提供了流程图，但 99% 的受访者报告了研究参与者的数量。较高的报告质量与更多的研究参与者、在普通医学期刊上发表文章以及更多的中心相关（每次比较 P < .0001）。地理区域和积极的研究结果与报告质量无关。结论：婴儿和新生儿随机对照试验的报告质量不一致，特别是在儿科期刊中。因此，读者无法准确评估许多RCT结果的有效性。严格遵守试验报告综合标准指南应能改进报告。儿科2011; 128：e639-e644
OBJECTIVES: 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.METHODS: 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.RESULTS: Two reviewers had very good agreement regarding the eligibility of studies (kappa = 0.85) and the presence of quality criteria (kappa = 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. CONCLUSIONS: 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. Pediatrics 2011; 128: e639-e644