Rentea Rebecca M, Oyetunji Tolulope A, Peter Shawn D St
Pediatric Surgery, Comprehensive Colorectal Center, Children's Mercy Hospital, 2401 Gillham Road, Kansas City, MO, 64108, USA.
Pediatr Surg Int. 2020 Aug;36(8):865-867. doi: 10.1007/s00383-020-04665-5. Epub 2020 May 11.
To provide the best evidence-based treatment for children, and timely evaluation of innovations, the role of the pediatric surgeon's participation in randomized controlled trials (RCTs) and prospective comparative studies is required. The ethical considerations of pediatric surgical RCTs pose unique practical difficulties in the design and performance of clinical trials in children. There are several ethical issues unique to pediatric surgical RCTs: diseases with low volume, an inability to conduct Phase 1 and 2 trials, parental emotional involvement, difficulty with recruitment in surgical trials, volume, and modified study design, issues with permission vs. assent and investigator bias. This article reviews the ethical aspects unique to pediatric surgical RCTs and prospective comparative studies.Level of evidence: Level 3.
为了给儿童提供最佳的循证治疗，并及时评估创新疗法，需要小儿外科医生参与随机对照试验（RCT）和前瞻性比较研究。小儿外科RCT的伦理考量在儿童临床试验的设计和实施中带来了独特的实际困难。小儿外科RCT存在几个独特的伦理问题：病例数少的疾病、无法进行1期和2期试验、家长的情感卷入、外科试验招募困难、病例数、研究设计的修改、同意与赞同的问题以及研究者偏倚。本文综述了小儿外科RCT和前瞻性比较研究中独特的伦理方面。证据级别：3级。
