Abstract
BackgroundApproximately 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.MethodsInformed 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.DiscussionAnalysis 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.
Highlights
Background and rationale {6a} Approximately 418,000 people live in care homes in the UK, yet accessible, reliable data on care homes, their residents and staff are lacking
We aim to create a permanent archive for care home trial data and welcome the contribution of emerging trial datasets
We will explain what data will be available in the trial repository, and ask members to identify research topics that may be important for further investigation. Their relatives, care home workers and managers are better placed to prioritise research questions on a more practical level; this exercise will ensure the right issues are being addressed. This protocol defines the methods to curate a repository of care home trials for individual participant data (IPD) analysis
Summary
Background and rationale {6a} Approximately 418,000 people live in care homes in the UK, yet accessible, reliable data on care homes, their residents and staff are lacking. Administrative data (e.g. UK Office of National Statistics census) provides information about age, sex and demographic change in care home population over time, but cannot be readily linked to the long-term health, function or quality of life of individual residents. 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, highquality IPD on this vulnerable population
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