Early Life Cohort Feasibility Study (ELC-FS)

我们汇集了英国四个国家的一个拥有深厚科学和操作专业知识的多学科团队，为英国新的早期生活队列提供招募的可行性研究。我们的主要目标是为新出生队列研究提供概念证明，这项研究将具有科学价值，为政策提供证据，在操作上是可行的，并获得公众的大力支持。为了实现这一目标，我们将设计并进行一项具有持久价值的数据收集，向新一代婴儿及其家庭面临的关键问题提供信息。代表性抽样和成功招募是提供这种性质的尖端研究所需的基本基础。这项工作的核心将是对我们是否有能力成功地获得四个国家出生婴儿的适当国家抽样框架，以及制定样本设计和招募战略的能力，以最大限度地提高总体参与度和代表性，并使传统上被视为难以接触到的群体参与纵向人口研究。这将包括对少数民族和贫困地区的出生进行过度抽样。我们将聘请父亲，包括那些出生时不在当地居住的父亲。我们将召集专家讨论对有需要的儿童进行研究的可能性。这项可行性研究的目的是利用久经考验的工具和新出现的技术，制定和测试对儿童早期发展和影响早期发展成果的多层次社会和生物进程进行高质量测量的方案。我们将部署多种数据收集模式和方法，包括面对面家访、通过设备收集数据(包括捕获睡眠和活动水平)和智能手机应用程序(以捕获婴儿与父母的互动、发育里程碑、饮食和对父母压力的瞬时评估)。我们将通过随机实验，测试从婴儿和父母那里收集的生物样本，包括口腔拭子、唾液和头发，将如何影响研究的参与。我们将制定一项战略，将电子健康和其他行政记录以及地质环境数据联系起来，这将成为未来任何研究的核心部分。除了为主要阶段的研究准备提供严格的科学方案测试外，我们将在这项可行性研究中收集的数据将对对婴儿健康和发育感兴趣的科学家和政策制定者具有重要价值。我们会谨慎地让公众参与，以确保公众接受拟议的抽样、数据收集和记录联系方法，并通过与家庭和儿童小组密切合作，确保研究满足其所代表的人民的需要。我们将与政策和从业人员网络密切合作，并将与学术数据用户协商，以确定可行性研究的证据需求和科学优先事项。项目结束时的评估阶段将支持对是否委托进行主要研究的决定。项目组将就一套商定的结果提供可靠的方法证据，为这一决定提供参考。我们的团队具有独特的经验，能够很好地完成这一雄心勃勃的项目，结合了纵向研究、早期生命科学、样本框架和与英国四个国家婴儿相关的记录链接、从婴儿和父母那里收集生物样本、统计方法、公众参与以及父亲参与纵向研究的领导和操作方面的专业知识。该项目的其他合作者和合作伙伴在样本设计、照顾儿童和有需要的儿童、与家庭和儿童、政策制定者和从业者以及国际协调方面提供深厚的专业知识。

We have brought together a multidisciplinary team across the four nations of the UK with deep scientific and operational expertise, to deliver a feasibility study of recruitment into a new early life cohort for the UK. Our major aim is to provide proof of concept for a new birth cohort study that would be scientifically valuable, provides evidence for policy, is operationally feasible and garners strong public support. To achieve this, we will design and undertake a data collection that is of lasting value, informing on key issues facing new generations of babies and their families. Representative sampling and successful recruitment are fundamental foundations required to deliver cutting edge research of this nature. At the heart of this exercise will be a test of our ability to successfully secure access to an appropriate national sampling frame of babies born in each of the four nations, and to devise a sample design and recruitment strategy that maximises participation and representativeness overall, and enables participation among groups that are traditionally seen as 'hard to reach' in longitudinal population research. This will include oversampling of ethnic minorities and births in deprived areas. We will engage fathers, including those non-resident at birth. We will bring together experts to discuss the potential for a study of children in need. The feasibility study will be designed to develop and test a protocol of high-quality measurements of early child development and the multilevel social and biological processes that affect early developmental outcomes, using both tried-and-tested instruments and newly-emerging technologies. We will deploy a variety of modes and methods of data collection, including an in-person home visit, data collection via devices (including to capture sleep and activity level), and by smartphone app (to capture infant-parent interactions, developmental milestones, diet and momentary assessments of parental stress). We will test how collection of bio-samples, including buccal swabs, saliva, and hair, from infant and parents would impact participation in the study, via a randomised experiment. We will develop a strategy for linking electronic health and other administrative records, as well as geo-environmental data, which will form a central part of any future study. In addition to providing rigorous testing of a scientific protocol in preparation for the main-stage study, the data we will collect in this feasibility study will be of great value for scientists and policy makers interested in infant health and development. We will undertake careful public engagement to ensure public acceptability of the proposed sampling, data collection and record linkage approaches, and will ensure the study serves the needs of the people it represents, by working closely with panels of families and children. We will engage closely with policy and practitioner networks and will consult with academic data users to determine evidence needs and scientific priorities for the feasibility study. An evaluation phase at the end of the project will support decision taking on whether a main study is commissioned. The project team will provide methodologically robust evidence on an agreed set of outcomes to inform this decision. Our team is uniquely experienced and well placed to deliver this ambitious project, combining expertise in the leadership and operations of longitudinal studies, the science of early life, sample frames and record linkages relating to babies in each of the four UK nations, collecting bio-samples from infants and parents, statistical methods, public engagement, and engagement of fathers in longitudinal research. Further collaborators and partners in the project provide deep expertise on sample design, looked after children and children in need, engaging with families and children, policymakers and practitioners, and international harmonisation.