Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, 100 Woodruff Circle, Atlanta, GA, 30322, USA.
Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Rd NE, Atlanta, GA, 30322, USA.
BMC Med Res Methodol. 2022 Jul 25;22(1):203. doi: 10.1186/s12874-022-01675-w.
Collecting new data from cross-sectional/survey and cohort observational study designs can be expensive and time-consuming. Nested (hierarchically cocooned within an existing parent study) and/or Multipart (≥ 2 integrally interlinked projects) study designs can expand the scope of a prospective observational research program beyond what might otherwise be possible with available funding and personnel. The Brain, Bone, Heart (BBH) study provides an exemplary case to describe the real-world advantages, challenges, considerations, and insights from these complex designs. MAIN: BBH is a Nested, Multipart study conducted by the Specialized Center for Research Excellence (SCORE) on Sex Differences at Emory University. BBH is designed to examine whether estrogen insufficiency-induced inflammation compounds HIV-induced inflammation, leading to end-organ damage and aging-related co-morbidities affecting the neuro-hypothalamic-pituitary-adrenal axis (brain), musculoskeletal (bone), and cardiovascular (heart) organ systems. Using BBH as a real-world case study, we describe the advantages and challenges of Nested and Multipart prospective cohort study design in practice. While excessive dependence on its parent study can pose challenges in a Nested study, there are significant advantages to the study design as well. These include the ability to leverage a parent study's resources and personnel; more comprehensive data collection and data sharing options; a broadened community of researchers for collaboration; dedicated longitudinal research participants; and, access to historical data. Multipart, interlinked studies that share a common cohort of participants and pool of resources have the advantage of dedicated key personnel and the challenge of increased organizational complexity. Important considerations for each study design include the stability and administration of the parent study (Nested) and the cohesiveness of linkage elements and staff organizational capacity (Multipart).
Using the experience of BBH as an example, Nested and/or Multipart study designs have both distinct advantages and potential vulnerabilities that warrant consideration and require strong biostatistics and data management leadership to optimize programmatic success and impact.
从横断面/调查和队列观察性研究设计中收集新数据可能既昂贵又耗时。嵌套（嵌套在现有父研究中）和/或多部分（≥2 个完整链接项目）研究设计可以扩大前瞻性观察研究计划的范围，超出可用资金和人员可能实现的范围。“大脑、骨骼、心脏（BBH）”研究提供了一个典型案例，用于描述这些复杂设计的实际优势、挑战、考虑因素和见解。
BBH 是由埃默里大学性别差异卓越研究中心（SCORE）进行的嵌套、多部分研究。BBH 旨在研究雌激素不足引起的炎症是否会加剧 HIV 引起的炎症，导致终末器官损伤和与衰老相关的合并症影响神经下丘脑垂体肾上腺轴（大脑）、肌肉骨骼（骨骼）和心血管（心脏）器官系统。使用 BBH 作为实际案例研究，我们描述了嵌套和多部分前瞻性队列研究设计在实践中的优势和挑战。虽然嵌套研究过度依赖其母研究会带来挑战，但该研究设计也有显著优势。这些优势包括利用母研究的资源和人员；更全面的数据收集和数据共享选项；更广泛的研究人员合作社区；专门的纵向研究参与者；以及获取历史数据。共享参与者和资源库的多部分、相互链接的研究具有专门的关键人员的优势和组织复杂性增加的挑战。每个研究设计的重要考虑因素包括母研究（嵌套）的稳定性和管理以及链接元素和工作人员组织能力的凝聚力（多部分）。
以 BBH 的经验为例，嵌套和/或多部分研究设计都有明显的优势和潜在的弱点，需要考虑并需要强大的生物统计学和数据管理领导力，以优化项目的成功和影响。
