Department of Radiology, Keck School of Medicine, University of Southern California and Childrens Hospital of Los Angeles, United States.
Department of Pediatrics, Memorial Hospital of Rhode Island, United States.
Dev Cogn Neurosci. 2021 Oct;51:100999. doi: 10.1016/j.dcn.2021.100999. Epub 2021 Aug 4.
A major challenge in designing large-scale, multi-site studies is developing a core, scalable protocol that retains the innovation of scientific advances while also lending itself to the variability in experience and resources across sites. In the development of a common Healthy Brain and Child Development (HBCD) protocol, one of the chief questions is "is fetal MRI ready for prime-time?" While there is agreement about the value of prenatal data obtained non-invasively through MRI, questions about practicality abound. There has been rapid progress over the past years in fetal and placental MRI methodology but there is uncertainty about whether the gains afforded outweigh the challenges in supporting fetal MRI protocols at scale. Here, we will define challenges inherent in building a common protocol across sites with variable expertise and will propose a tentative framework for evaluation of design decisions. We will compare and contrast various design considerations for both normative and high-risk populations, in the setting of the post-COVID era. We will conclude with articulation of the benefits of overcoming these challenges and would lend to the primary questions articulated in the HBCD initiative.
在设计大规模、多站点研究时,面临的主要挑战是开发一个核心的、可扩展的协议,该协议既要保留科学进步的创新性,又要适应各站点之间经验和资源的可变性。在制定通用的“健康大脑与儿童发育”(HBCD)协议时,首席问题之一是“胎儿 MRI 是否已经准备好投入使用?”尽管人们普遍认为通过 MRI 无创获得的产前数据具有价值,但关于实用性的问题仍然很多。在过去几年中,胎儿和胎盘 MRI 方法学取得了快速进展,但对于所获得的收益是否超过了支持大规模胎儿 MRI 协议的挑战,人们仍存在不确定性。在这里,我们将定义在具有不同专业知识的站点之间构建通用协议所固有的挑战,并提出一个用于评估设计决策的暂定框架。我们将在 COVID-19 时代的背景下,比较和对比规范人群和高危人群的各种设计考虑因素。最后,我们将阐明克服这些挑战的好处,并有助于阐明 HBCD 计划中提出的主要问题。