Behavioral Clinical Trials in Moderate to Severe Pediatric Traumatic Brain Injury: Challenges, Potential Solutions, and Lessons Learned.
Behavioral Clinical Trials in Moderate to Severe Pediatric Traumatic Brain Injury: Challenges, Potential Solutions, and Lessons Learned.
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DOI：
10.1097/htr.0000000000000323
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Kurowski BG
中科院分区：
文献类型：
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作者：
Wade SL;Kurowski BG
本评论的目的是概述进行儿科创伤性脑损伤（TBI）干预临床试验时遇到的挑战，并分享克服这些问题的潜在解决方案。这篇评论来自于我们实施8项以家庭为中心的干预措施的随机临床试验（RCT）的经验，以减少儿童脑损伤后的儿童行为问题和照顾者/父母的痛苦。这些研究涉及来自8个临床中心的600多名参与者，支持对患有持续性TBI的儿童进行RCT的可行性，同时强调了有效性的潜在挑战和威胁。儿童TBI行为试验的挑战是显而易见的，但并非不可克服。仔细考虑本评论中概述的临床试验问题可以在规划临床试验时为设计选择和分析提供信息。至关重要的是，研究人员分享他们的失败以及他们的成功，以推动儿科TBI干预研究领域向前发展。
The purpose of this commentary is to outline the challenges encountered when conducting clinical trials of interventions for pediatric traumatic brain injury (TBI) and share potential solutions for surmounting these issues. This commentary grows out of our experience implementing 8 randomized clinical trials (RCTs) of family-centered interventions to reduce child behavior problems and caregiver/parent distress following pediatric brain injury. These studies, involving more than 600 participants from 8 clinical centers, support the feasibility of conducting RCTs with children who have sustained TBIs while highlighting potential challenges and threats to validity. The challenges of behavioral trials for pediatric TBI are apparent but not insurmountable. Careful consideration of the clinical trial issues outlined in this commentary can inform design choices and analyses when planning a clinical trial. It is critically important that investigators share their failures as well their successes to move the field of pediatric TBI intervention research forward.