PDF(Pubmed)
Abstract：
There is an increasing desire to study neurodevelopmental disorders (NDDs) together to understand commonalities to develop generic health promotion strategies and improve clinical treatment. Common data elements (CDEs) collected across studies involving children with NDDs afford an opportunity to answer clinically meaningful questions. We undertook a retrospective, secondary analysis of data pertaining to sleep in children with different NDDs collected through various research studies. The objective of this paper is to share lessons learned for data management, collation, and harmonization from a sleep study in children within and across NDDs from large, collaborative research networks in the Ontario Brain Institute (OBI). Three collaborative research networks contributed demographic data and data pertaining to sleep, internalizing symptoms, health-related quality of life, and severity of disorder for children with six different NDDs: autism spectrum disorder; attention deficit/hyperactivity disorder; obsessive compulsive disorder; intellectual disability; cerebral palsy; and epilepsy. Procedures for data harmonization, derivations, and merging were shared and examples pertaining to severity of disorder and sleep disturbances were described in detail. Important lessons emerged from data harmonizing procedures: prioritizing the collection of CDEs to ensure data completeness; ensuring unprocessed data are uploaded for harmonization in order to facilitate timely analytic procedures; the value of maintaining variable naming that is consistent with data dictionaries at time of project validation; and the value of regular meetings with the research networks to discuss and overcome challenges with data harmonization. Buy-in from all research networks involved at study inception and oversight from a centralized infrastructure (OBI) identified the importance of collaboration to collect CDEs and facilitate data harmonization to improve outcomes for children with NDDs.
摘要：
人们越来越希望一起研究神经发育障碍（NDD），以了解共同之处，以制定通用的健康促进策略并改善临床治疗。在涉及NDD儿童的研究中收集的通用数据元素（CDE）为回答有临床意义的问题提供了机会。我们进行了回顾，通过各种研究收集的不同NDD儿童睡眠相关数据的二次分析。本文的目的是分享数据管理方面的经验教训，排序规则,以及对NDD内外儿童的睡眠研究的协调，安大略省大脑研究所（OBI）的合作研究网络。三个合作研究网络贡献了人口统计数据和与睡眠有关的数据，内化症状，与健康相关的生活质量，患有六种不同NDD的儿童的疾病严重程度：自闭症谱系障碍；注意力缺陷/多动障碍；强迫症；智力障碍；脑瘫和癫痫。数据协调程序，派生,共享和合并，并详细描述了与疾病严重程度和睡眠障碍有关的示例。数据协调程序产生了重要的经验教训：优先考虑CDE的收集，以确保数据的完整性；确保上传未处理的数据进行协调，以促进及时的分析程序；在项目验证时保持与数据字典一致的变量命名的价值；以及与研究网络定期举行会议以讨论和克服数据协调方面的挑战的价值。从研究开始时涉及的所有研究网络的购买和集中式基础设施（OBI）的监督确定了合作收集CDE并促进数据协调以改善NDD儿童结果的重要性。
