Gesualdo Patricia, Melin Jessica, Karban Rachel, Crouch Claire, Killian Michael, Hopkins Diane, Adamsson Annika, Stock Joanna, Johnson Suzanne Bennett, Baxter Judith
Barbara Davis Center for Diabetes, University of Colorado, Aurora, CO, USA.
Department of Clinical Sciences Malmö, Lund University, Sweden.
Contemp Clin Trials Commun. 2025 Jan 23;44:101405. doi: 10.1016/j.conctc.2024.101405. eCollection 2025 Apr.
Retention of study participants in observational studies is essential to maintaining the representativeness of the population, minimizing selection bias, and assuring sufficient statistical power. The aim of this report is to describe the structures and strategies used to retain participants in The Environmental Determinants of Diabetes in the Young (TEDDY) Study, an observational study of children at increased genetic risk for type 1 diabetes followed in an intensive protocol from birth until age 15.
Teague et al.'s systematic review of study retention strategies identified four domains: barrier reduction; community building; follow-up/reminder; and tracing strategies (1). TEDDY retention strategies were categorized into each of these domains. A fifth category presented strategies unique to TEDDY.
TEDDY employed over one hundred retention strategies during the 15 years of follow-up; many could be categorized within the Teague domains. Strategies unique to TEDDY included (1) study structures to support retention; (2) risk communication and education strategies specific to this population; (3) Data-informed retention strategies that addressed protocol challenges in real-time; and (4) implementation of a re-engagement protocol for those who had withdrawn from the study.
Pediatric cohort studies should include strategies, structures, and resources to address retention at the study's initiation and on an ongoing basis. Retention strategies should not remain static but change with the developmental needs of the child. Collecting and analyzing data on an ongoing basis permits retention strategies to be put in place to address protocol and retention challenges in real time.
ClinicalTrials.gov Identifier: NCT00279318.
在观察性研究中留住研究参与者对于维持人群的代表性、最小化选择偏倚以及确保足够的统计效力至关重要。本报告的目的是描述在“青少年糖尿病环境决定因素（TEDDY）研究”中用于留住参与者的结构和策略，这是一项对1型糖尿病遗传风险增加的儿童进行的观察性研究，从出生到15岁按照强化方案进行随访。
蒂格等人对研究保留策略的系统综述确定了四个领域：减少障碍；社区建设；随访/提醒；以及追踪策略（1）。TEDDY的保留策略被归类到这些领域中的每一个。第五类列出了TEDDY特有的策略。
在15年的随访期间，TEDDY采用了一百多种保留策略；许多策略可以归类到蒂格的领域中。TEDDY特有的策略包括：（1）支持保留的研究结构；（2）针对该人群的风险沟通和教育策略；（3）实时应对方案挑战的基于数据的保留策略；以及（4）为退出研究的人实施重新参与方案。
儿科队列研究应在研究开始时及持续过程中纳入应对保留问题的策略、结构和资源。保留策略不应一成不变，而应随儿童的发育需求而变化。持续收集和分析数据可使保留策略得以实施，以实时应对方案和保留方面的挑战。
ClinicalTrials.gov标识符：NCT00279318。
