Johnson Austin L, Torgerson Trevor, Adewumi Mopileola Tomi, Kee Micah, Farahani Clay, Wehrmann Daniel J, Francis Carrie L, Vassar Matt
Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Int J Pediatr Otorhinolaryngol. 2021 Dec;151:110972. doi: 10.1016/j.ijporl.2021.110972. Epub 2021 Nov 10.
Randomized controlled trial (RCT) discontinuation and nonpublication are potential mechanisms of waste in resources and lead to decreased advancement of medical science and compromised ethical issues in all specialties. However, the prevalence of discontinued or unpublished RCTs regarding common pediatric otolaryngology disorders and interventions remains unclear.
Cross-sectional analysis.
Retrospective analysis of common pediatric otolaryngology RCTs registered in ClinicalTrials.gov up until November 2, 2018. Data were collected from the registry, and publication status was identified. If a reason for trial discontinuation or nonpublication was not identified through a systematic search, corresponding trialists were contacted through email.
After exclusion, 260 RCTs were included for analysis. Analysis found 198 (76%) RCTs were completed, and 62 (24%) trials were discontinued. The most commonly reported reasons for RCT discontinuation were program termination by sponsor or management (7/24; 29.2%), lack of participant enrollment, difficulty recruiting, or slow accrual (7/24; 29.2%). A total of 192 (192/260; 73.8%) published RCTs and 68 (68/260; 26.2%) unpublished RCTs were identified. Twenty-six (26/62; 42%) of the discontinued RCTs reached publication, while 36 (58%) remained unpublished. Regarding the completed RCTs, 166 of 198 (83.8%) completed trials reached publication, while 32 (32/198; 16.2%) remained unpublished after trial completion.
Approximately 1 in 4 of included RCTs were discontinued or did not reach publication. Findings suggest further guidance is needed for RCTs regarding common pediatric otolaryngology disorders and interventions.
NA.
随机对照试验（RCT）的中止和未发表是资源浪费的潜在机制，会导致医学科学发展减缓，并在所有专业中引发伦理问题。然而，关于常见小儿耳鼻喉科疾病和干预措施的RCT中止或未发表的发生率仍不清楚。
横断面分析。
对截至2018年11月2日在ClinicalTrials.gov上注册的常见小儿耳鼻喉科RCT进行回顾性分析。从注册库中收集数据，并确定发表状态。如果通过系统搜索未找到试验中止或未发表的原因，则通过电子邮件联系相应的试验人员。
排除后，纳入260项RCT进行分析。分析发现198项（76%）RCT已完成，62项（24%）试验中止。RCT中止最常报告的原因是赞助商或管理层终止项目（7/24；29.2%）、缺乏参与者入组、招募困难或入组缓慢（7/24；29.2%）。共识别出192项（192/260；73.8%）已发表的RCT和68项（68/260；26.2%）未发表的RCT。中止的RCT中有26项（26/62；42%）已发表，而36项（58%）仍未发表。对于已完成的RCT，198项中的166项（83.8%）已发表，而32项（32/198；16.2%）在试验完成后仍未发表。
纳入的RCT中约四分之一被中止或未发表。研究结果表明，对于常见小儿耳鼻喉科疾病和干预措施的RCT需要进一步指导。
无。
