Wade Shari L, Kurowski Brad G
Division of Physical Medicine and Rehabilitation, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
J Head Trauma Rehabil. 2017 Nov/Dec;32(6):433-437. doi: 10.1097/HTR.0000000000000323.
: 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.
本评论的目的是概述在开展小儿创伤性脑损伤（TBI）干预措施的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。本评论源于我们实施8项以家庭为中心的干预措施随机临床试验（RCT）的经验，这些措施旨在减少小儿脑损伤后儿童的行为问题以及照顾者/父母的痛苦。这些研究涉及8个临床中心的600多名参与者，支持了对遭受TBI的儿童进行RCT的可行性，同时突出了潜在的挑战和对有效性的威胁。小儿TBI行为试验的挑战显而易见，但并非无法克服。在规划临床试验时，仔细考虑本评论中概述的临床试验问题可为设计选择和分析提供参考。研究人员分享他们的失败与成功对于推动小儿TBI干预研究领域的发展至关重要。
