Rüegger Christoph M, Dawson Jennifer A, Donath Susan M, Owen Louise S, Davis Peter G
Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, VIC, Australia.
Newborn Research, Department of Neonatology, University Hospital and University of Zürich, Zürich, Switzerland.
Acta Paediatr. 2017 Dec;106(12):1940-1944. doi: 10.1111/apa.14062. Epub 2017 Sep 20.
To determine the rate of nonpublication and discontinuation of randomised controlled trials (RCTs) in newborns.
This was a retrospective, cross-sectional study of RCTs registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) between 2008 and 2012.
Fifty trials were identified, of which 23 (46%) were retrospectively registered. Thirty trials (60%) were published. After a median follow-up of 8.0 (range 4.6-17.4) years from Research Ethics Committee approval, 15 of 41 completed trials (37%) remained unpublished, representing 5422 neonatal trial participants. Nine trials (18%) were discontinued, including four that were published. The most frequent reason for discontinuation was poor recruitment (n = 4). Sample size discrepancies between registration and publication were found in 17 (65%) of the 26 completed, published trials. In nine (35%) of these trials, the calculated sample size in the method section of the published article differed from the planned sample size in the trial registry (relative difference -20% to +33%).
Nonpublication and discontinuation of RCTs conducted in newborns is common. Additional efforts are needed to minimise the number of neonatal trial participants that are exposed to interventions without subsequent publication.
确定新生儿随机对照试验（RCT）的未发表率和中止率。
这是一项对2008年至2012年间在澳大利亚和新西兰临床试验注册中心（ANZCTR）注册的RCT进行的回顾性横断面研究。
共识别出50项试验，其中23项（46%）为回顾性注册。30项试验（60%）已发表。从研究伦理委员会批准起，经过中位数为8.0（范围4.6 - 17.4）年的随访，41项完成的试验中有15项（37%）仍未发表，涉及5422名新生儿试验参与者。9项试验（18%）被中止，其中4项已发表。中止的最常见原因是招募困难（n = 4）。在26项已完成并发表的试验中，有17项（65%）发现注册与发表之间存在样本量差异。在其中9项（35%）试验中，发表文章方法部分计算的样本量与试验注册计划的样本量不同（相对差异 -20%至 +33%）。
新生儿RCT的未发表和中止情况很常见。需要做出更多努力，以尽量减少在未后续发表的情况下接受干预的新生儿试验参与者数量。
