Discipline of General Practice, School of Medicine, The University of Queensland, 11 Salisbury Rd, Ipswich 4305, Australia.
BMC Pediatr. 2013 May 28;13:89. doi: 10.1186/1471-2431-13-89.
It is estimated that 22,800 children were living with an Acquired Brain Injury (ABI) (0.6% of children aged under 15 years) in Australia during 2003. Many children after a traumatic brain injury will experience difficulties with attention and concentration; a condition termed secondary Attention Deficit-Hyperactivity Disorder. There is conflicting evidence on whether treatment with stimulant therapy with medications such as methylphenidate or dexamphetamine will improve the attention and behavior of children with this condition.
METHODS/DESIGN: Single patient trials (n-of-1s or SPTs) evaluate the effect of titrated doses of psychostimulants methylphenidate or dexamphetamine compared to placebo on attention and behavior, in children with TBI and secondary ADHD. The aggregation of multiple SPTs will produce a population estimate of the benefit. Forty-two children will be registered into the trial through rehabilitation services at three large children's hospitals in Australia. Patients will complete up to 3 cycles of treatment. Each cycle is 2 weeks long comprising seven days each of treatment and placebo, with the first two days of each cycle considered a washout period and the data not analysed. The order of treatment and placebo is randomly allocated for each cycle. The Conners' Parent Rating Scales long forms will be employed to measure change in attention-deficit/hyperactivity and related problems of the child, and the primary outcome measure is the Conners' Global Index Parent Version. Secondary outcomes include the teacher and child (if aged > 12 years) Conners' Rating Scales, the Behaviour Rating Inventory of Executive Function among other measures. This study will provide high-level evidence using a novel methodological approach to inform clinicians about the most appropriate treatment for individual children. Through aggregation of individual trials, a population estimate of treatment effect will be provided to guide clinical practice in the treatment of children with secondary ADHD after a traumatic brain injury.
This study employs an innovative methodological approach on the effectiveness of CNS stimulants for secondary ADHD from a brain injury. The findings will both guide clinicians on treatment recommendations, and inform the concept and acceptance of SPTs in paediatric research.
Australian New Zealand Clinical Trials Registry. ACTRN12609000873224.
据估计，2003 年澳大利亚共有 22800 名儿童（占 15 岁以下儿童的 0.6%）患有后天性脑损伤（ABI）。许多创伤性脑损伤后的儿童会出现注意力和集中力方面的困难；这种情况被称为继发性注意缺陷多动障碍。关于兴奋剂治疗，例如使用哌醋甲酯或右旋苯丙胺治疗是否会改善这种情况儿童的注意力和行为，目前证据相互矛盾。
方法/设计：单病例试验（n-of-1 或 SPT）评估了在澳大利亚三家大型儿童医院的康复服务中注册的 42 名患有 TBI 和继发性 ADHD 的儿童，通过滴定剂量的哌醋甲酯或右旋苯丙胺与安慰剂相比，对注意力和行为的影响。多个 SPT 的汇总将产生对该获益的人群估计。患者将完成多达 3 个周期的治疗。每个周期为 2 周，包括治疗和安慰剂各 7 天，每个周期的前两天为洗脱期，不进行数据分析。每个周期的治疗和安慰剂顺序都是随机分配的。将使用 Conners 父母评定量表长表来衡量儿童注意力缺陷/多动及相关问题的变化，主要结局测量是 Conners 全球指数父母版本。次要结局包括教师和儿童（如果年龄大于 12 岁）Conners 评定量表、行为评定量表等。该研究将使用一种新颖的方法提供高水平的证据，为临床医生提供有关最适合个别儿童的治疗方法的信息。通过汇总个体试验，将提供治疗效果的人群估计值，以指导治疗创伤性脑损伤后继发性 ADHD 儿童的临床实践。
本研究采用了一种创新的方法，研究 CNS 兴奋剂治疗后天性脑损伤继发 ADHD 的有效性。研究结果将为临床医生提供治疗建议，并为 SPT 在儿科研究中的概念和接受提供信息。
澳大利亚新西兰临床试验注册中心。ACTRN12609000873224。
