Hughes Elizabeth K, Siero William, Gülenç Alisha, Clifford Susan A, Frugier Tony, Hall Simon M, Mohal Jatender, North Kathryn, Zaritski Natasha, Goldfeld Sharon, Saffery Richard, Wake Melissa
Murdoch Children's Research Institute, 50 Flemington Road, Parkville, VIC, 3052, Australia.
Department of Paediatrics, The University of Melbourne, Parkville, VIC, Australia.
BMC Public Health. 2025 Jan 3;25(1):20. doi: 10.1186/s12889-024-21108-1.
In a world confronted with new and connected challenges, novel strategies are needed to help children and adults achieve their full potential, to predict, prevent and treat disease, and to achieve equity in services and outcomes. Australia's Generation Victoria (GenV) cohorts are designed for multi-pronged discovery (what could improve outcomes?) and intervention research (what actually works, how much and for whom?). Here, we describe the key features of its protocol.
GenV is a whole-population longitudinal platform open to all ≈150,000 children born within a two-year window and residing in the state of Victoria and their parents. GenV is guided by its 6 principles of Inclusivity, Collaboration, Sustainability, Enhancement, Systematised Processes and Value and enabled by large-scale biobanking, IT and novel high-throughput technology infrastructure. Successive recruitment phases were designed to maximise GenV's inclusivity: (1) a smaller Advance Cohort from December 2020; (2) Newborn recruitment, with presence in 58 Victorian maternity services supporting face-to-face approach to parents of babies born 4 October 2021-3 October 2023; (3) Intensive remote recruitment to mid-2024 targeting those missed around birth; and (4) Ongoing indefinite enrolment of in-age children and their parents. Participants consent to universal (1) data linkage (e.g., state and federal physical and mental health, education, social, geospatial, ecological); (2) biosamples storage and use (e.g., residual clinical pregnancy and newborn screening, GenV-collected perinatal parent/infant saliva); (3) phenotypic and biosamples collection waves at child ages 6, 11 and 16 years, likely in schools and remotely for parents; and (4) opportunities for collaborative research integrated into GenV as a population registry (e.g., trials, natural experiments, depth subcohorts). Many participants supplement universal data with additional biosamples (e.g., infant stool, breast milk) and brief digital remote 'GenV and Me' assessments over the first 5 years. GenV will make all research data available, adhering to the principles of Open Science.
Launched in the COVID-19 pandemic and committed to diversity and inclusivity, GenV's parallel consented child and pre-midlife cohorts will be positioned to help address today's pressing issues such as chronic mental and physical health conditions, inequity, public health crises such as pandemics, and climate harm.
ClinicalTrials.gov: NCT05394363; retrospectively registered 23 May 2022 (8 months into recruitment).
在一个面临新的相互关联挑战的世界中，需要新的策略来帮助儿童和成人充分发挥其潜力，预测、预防和治疗疾病，并实现服务和结果的公平性。澳大利亚的维多利亚世代（GenV）队列旨在进行多方面的发现（什么可以改善结果？）和干预研究（什么真正有效、效果如何以及对谁有效？）。在此，我们描述其方案的关键特征。
GenV是一个全人群纵向平台，向在两年时间窗口内出生并居住在维多利亚州的所有约150,000名儿童及其父母开放。GenV以其包容性、协作性、可持续性、增强性、系统化流程和价值这6项原则为指导，并借助大规模生物样本库、信息技术和新型高通量技术基础设施得以实现。连续的招募阶段旨在最大限度地提高GenV的包容性：（1）从2020年12月开始的较小的先行队列；（2）新生儿招募，在维多利亚州的58家产科服务机构开展，为2021年10月4日至2023年10月3日出生婴儿的父母提供面对面服务；（3）到2024年年中进行密集远程招募，目标是那些在出生前后遗漏的人群；（4）持续无限期招募适龄儿童及其父母。参与者同意进行通用的（1）数据链接（例如，州和联邦的身心健康、教育、社会、地理空间、生态数据）；（2）生物样本存储和使用（例如，剩余的临床妊娠和新生儿筛查样本、GenV收集的围产期父母/婴儿唾液）；（3）在儿童6岁、11岁和16岁时进行表型和生物样本采集，可能在学校进行，对于父母则通过远程方式进行；（4）作为人群登记处融入GenV的合作研究机会（例如，试验、自然实验、深度亚队列）。许多参与者在前5年通过额外的生物样本（例如，婴儿粪便、母乳）和简短的数字远程“GenV与我”评估来补充通用数据。GenV将遵循开放科学原则提供所有研究数据。
GenV在新冠疫情期间启动，致力于多样性和包容性，其并行获得同意的儿童和中年前期队列将有助于解决当今紧迫的问题，如慢性身心健康状况、不平等、大流行等公共卫生危机以及气候危害。
ClinicalTrials.gov：NCT05394363；2022年5月23日追溯注册（招募进行8个月后）。
