Centre for Research in Public Health and Community Care, University of Hertfordshire, Hatfield, UK.
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Trials. 2021 Feb 23;22(1):157. doi: 10.1186/s13063-021-05107-w.
Approximately 418,000 people live in care homes in the UK, yet accessible, robust data on care home populations and organisation are lacking. This hampers our ability to plan, allocate resources or prevent risk. Large randomised controlled trials (RCTs) conducted in care homes offer a potential solution. The value of detailed data on residents' demographics, outcomes and contextual information captured in RCTs has yet to be fully realised. Irrespective of the intervention tested, much of the trial data collected overlaps in terms of structured assessments and descriptive information. Given the time and costs required to prospectively collect data in these populations, pooling anonymised RCT data into a structured repository offers benefit; secondary analyses of pooled RCT data can improve understanding of this under-researched population and enhance the future trial design. This protocol describes the creation of a project-specific repository of individual participant data (IPD) from trials conducted in care homes and subsequent expansion into a legacy dataset for wider use, to address the need for accurate, high-quality IPD on this vulnerable population.
Informed by scoping of relevant literature, the principal investigators of RCTs conducted in adult care homes in the UK since 2010 will be invited to contribute trial IPD. Contributing trialists will form a Steering Committee who will oversee data sharing and remain gatekeepers of their own trial's data. IPD will be cleaned and standardised in consultation with the Steering Committee for accuracy. Planned analyses include a comparison of pooled IPD with point estimates from administrative sources, to assess generalisability of RCT data to the wider care home population. We will also identify key resident characteristics and outcomes from within the trial repository, which will inform the development of a national minimum dataset for care homes. Following project completion, management will migrate to the Virtual Trials Archives, forming a legacy dataset which will be expanded to include international RCTs, and will be accessible to the wider research community for analyses.
Analysis of pooled IPD has the potential to inform and direct future practice, research and policy at low cost, enhancing the value of existing data and reducing research waste. We aim to create a permanent archive for care home trial data and welcome the contribution of emerging trial datasets.
英国约有 41.8 万人居住在养老院，但缺乏关于养老院人群和组织的可访问、可靠数据。这阻碍了我们规划、分配资源或预防风险的能力。在养老院进行的大型随机对照试验 (RCT) 提供了一种潜在的解决方案。在 RCT 中收集的关于居民人口统计学、结果和背景信息的详细数据的价值尚未得到充分实现。无论测试的干预措施如何，收集的试验数据大部分在结构化评估和描述性信息方面都有重叠。鉴于在这些人群中前瞻性收集数据所需的时间和成本，将匿名化的 RCT 数据汇总到一个结构化存储库中具有优势；对汇总的 RCT 数据进行二次分析可以提高对这一研究不足人群的理解，并增强未来的试验设计。本方案描述了从英国自 2010 年以来在成人护理院进行的 RCT 中创建特定于项目的个体参与者数据 (IPD) 存储库，并随后扩展为更广泛使用的遗留数据集，以满足对这一脆弱人群进行准确、高质量 IPD 的需求。
根据对相关文献的范围界定，将邀请自 2010 年以来在英国成人护理院进行的 RCT 的主要研究者贡献试验 IPD。参与的试验人员将组成指导委员会，负责监督数据共享并保持对自己试验数据的控制权。将与指导委员会协商对 IPD 进行清理和标准化，以确保准确性。计划分析包括对汇总的 IPD 与来自行政来源的点估计值进行比较，以评估 RCT 数据对更广泛的养老院人群的普遍性。我们还将从试验存储库中确定关键居民特征和结果，这将为养老院国家最小数据集的开发提供信息。项目完成后，管理层将迁移到虚拟试验档案，形成一个遗留数据集，该数据集将扩展到包括国际 RCT，并可供更广泛的研究界进行分析。
汇总 IPD 的分析有可能以低成本为未来的实践、研究和政策提供信息和指导，提高现有数据的价值并减少研究浪费。我们旨在为养老院试验数据创建一个永久性档案，并欢迎新兴试验数据集的贡献。
