Pediatr Nephrol. 2010 Dec;25(12):2383-92. doi: 10.1007/s00467-010-1595-x. Epub 2010 Aug 6.
Limited pediatric-specific research can lead to sub-standard evidence for clinical decision making in children. We sought to systematically evaluate the methodological quality and the reporting standards of randomized controlled trials (RCTs) of transplantation trials in children. We included RCTs of kidney transplant recipients that had enrolled at least one child (aged 17 years or less) and that were reported in English language, peer reviewed journals from 2000 onward in the Cochrane Renal Group's specialized register. Trial reports were assessed against the 22 item checklist of the CONsolidated Standards Of Reporting Trials (CONSORT) statement. Twenty-seven RCTs were included. The reporting of the essential components of the methods, results and discussion domains was unsatisfactory. Mean CONSORT criteria score for the pediatric trials was 67% and 66% for trials including both adults and children (p value for the difference = 1.00). Trial reporting quality in pediatric transplantation trials is not different from trials involving adults. It is evident that the reporting standards of RCTs in both adult and pediatric transplantation require major improvements. This work bench-marks current standards for future quality improvement.
有限的儿科特定研究可能导致儿童临床决策的证据不足。我们旨在系统地评估儿童移植试验的随机对照试验（RCT）的方法学质量和报告标准。我们纳入了至少纳入一名儿童（年龄在 17 岁或以下）的 RCT，这些 RCT 是在 2000 年以后发表在同行评审的英文期刊上的 Cochrane Renal Group 的专业注册库中。试验报告按照 CONSORT 声明的 22 项清单进行评估。共纳入 27 项 RCT。方法、结果和讨论领域的基本内容的报告不尽如人意。儿科试验的 CONSORT 标准平均得分是 67%，包括成人和儿童的试验是 66%（差异的 p 值=1.00）。儿科移植试验的试验报告质量与涉及成人的试验无差异。显然，成人和儿科移植的 RCT 报告标准都需要重大改进。这项工作为未来的质量改进设定了当前的标准。
