Early Life Cohort Feasibility Study (ELC-FS)

我们汇集了一个跨英国四个国家的多学科团队，拥有深厚的科学和操作专业知识，为英国提供招募新的早期生命队列的可行性研究。我们的主要目标是为一项新的出生队列研究提供概念证明，该研究将具有科学价值，为政策提供证据，在操作上可行，并获得公众的大力支持。为了实现这一目标，我们将设计和进行具有持久价值的数据收集，为新一代婴儿及其家庭面临的关键问题提供信息。具有代表性的抽样和成功的招聘是提供这种性质的前沿研究所需的根本基础。这项工作的核心将是测试我们的能力，以成功地确保获得一个适当的国家抽样框架的婴儿出生在每个四个国家，并制定一个样本设计和招募策略，最大限度地提高参与和代表性的整体，并使参与群体之间的传统上被视为“难以达到”在纵向人口研究。这将包括对少数民族和贫困地区出生的过度抽样。我们将让父亲参与进来，包括那些出生时不居住的父亲。我们将召集专家讨论对有需要的儿童进行研究的可能性。可行性研究的目的是制定和测试一项高质量的测量方案，用于测量儿童早期发展以及影响早期发展结果的多层次社会和生物过程，使用经过试验和测试的仪器和新兴技术。我们将部署各种数据收集模式和方法，包括亲自家访，通过设备收集数据（包括捕获睡眠和活动水平），以及通过智能手机应用程序（捕获婴儿与父母的互动，发育里程碑，饮食和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生物样本（包括口腔拭子、唾液和毛发）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理环境数据联系起来，这将成为今后任何研究的核心部分。除了为准备主要阶段研究提供严格的科学方案测试外，我们在这项可行性研究中收集的数据将对关注婴儿健康和发育的科学家和政策制定者具有重要价值。我们会审慎地进行公众参与，确保公众接受拟议的抽样、数据收集和记录联系方法，并与家庭和儿童小组密切合作，确保研究符合其所代表的人的需要。我们将与政策和从业者网络密切合作，并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。项目结束时的评价阶段将有助于就是否委托进行主要研究作出决定。项目小组将提供关于一套商定成果的方法学上的有力证据，为这一决定提供依据。我们的团队经验丰富，能够很好地完成这个雄心勃勃的项目，结合了纵向研究的领导和操作方面的专业知识，早期生命科学，样本框架和与英国四个国家中的每个国家的婴儿有关的记录联系，收集婴儿和父母的生物样本，统计方法，公众参与以及父亲参与纵向研究。该项目的其他合作者和合作伙伴提供了关于样本设计的深入专业知识，照顾儿童和有需要的儿童，与家庭和儿童，政策制定者和从业人员以及国际协调的互动。

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.