Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Pennsylvania, USA.
J Med Ethics. 2010 Feb;36(2):106-10. doi: 10.1136/jme.2009.030676.
To assess parental permission for a neonate's research participation using the MacArthur competence assessment tool for clinical research (MacCAT-CR), specifically testing the components of understanding, appreciation, reasoning and choice.
Quantitative interviews using study-specific MacCAT-CR tools.
Parents of critically ill newborns would produce comparable MacCAT-CR scores to healthy adult controls despite the emotional stress of an infant with critical heart disease or the urgency of surgery. Parents of infants diagnosed prenatally would have higher MacCAT-CR scores than parents of infants diagnosed postnatally. There would be no difference in MacCAT-CR scores between parents with respect to gender or whether they did or did not permit research participation.
Parents of neonates undergoing cardiac surgery who had made decisions about research participation before their neonate's surgery.
The MacCAT-CR.
35 parents (18 mothers; 17 fathers) of 24 neonates completed 55 interviews for one or more of three studies. Total scores: magnetic resonance imaging (mean 36.6, SD 7.71), genetics (mean 38.8, SD 3.44), heart rate variability (mean 37.7, SD 3.30). Parents generally scored higher than published subject populations and were comparable to published control populations with some exceptions.
The MacCAT-CR can be used to assess parental permission for neonatal research participation. Despite the stress of a critically ill neonate requiring surgery, parents were able to understand study-specific information and make informed decisions to permit their neonate's participation.
使用麦克阿瑟临床研究能力评估工具（MacCAT-CR）评估新生儿参与研究的父母同意情况，特别是测试理解、欣赏、推理和选择的能力。
使用特定于研究的 MacCAT-CR 工具进行定量访谈。
尽管患有严重心脏病的婴儿的情绪压力或手术的紧迫性，患有危重新生儿的父母会产生与健康成人对照组相当的 MacCAT-CR 分数。与出生后诊断的婴儿的父母相比，产前诊断的婴儿的父母的 MacCAT-CR 分数会更高。父母的性别、是否允许研究参与不会对 MacCAT-CR 分数产生影响。
在新生儿手术前已对研究参与做出决定的正在接受心脏手术的新生儿的父母。
MacCAT-CR。
35 名新生儿的 24 名父母（18 名母亲；17 名父亲）完成了三个研究中的一个或多个研究的 55 次访谈。磁共振成像的总分（均值 36.6，标准差 7.71）、遗传学（均值 38.8，标准差 3.44）、心率变异性（均值 37.7，标准差 3.30）。父母的总得分普遍高于已发表的主题人群，与一些例外情况相比，与已发表的对照组人群相当。
MacCAT-CR 可用于评估新生儿研究参与的父母同意情况。尽管需要手术的危重新生儿压力很大，但父母能够理解特定于研究的信息并做出知情决策，允许其新生儿参与。
