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Study protocol
Protocol for the Development of a Repository of Individual Participant Data From Randomised Controlled Trials Conducted in UK Adult Care Homes (The Virtual International Care Homes Trials Archive (VICHTA))
Lisa Irvine
University of Hertfordshire
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1936-3584
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background 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 future trial design. This protocol describes the creation of a repository of individual participant data (IPD) from trials conducted in care homes, to address the need for accurate, high quality IPD on this vulnerable population.
Methods Informed by scoping of relevant literature, the principal investigators of RCTs conducted in adult care homes in 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 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 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 accessible to the wider research community for analyses.
Discussion 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.
Keywords
Care homes, long-term care, individual participant data (IPD), randomised trials, minimum dataset, data sharing
This is a list of supplementary files associated with this preprint. Click to download.
- Supplementarymaterials.docx
- PRISMAIPDchecklistVICHTARepository.docx
- DataProcessingFlowchartv3.jpg
Data processing flowchart
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CURRENT STATUS: Under Review
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Posted 21 Sep, 2020
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Editorial decision: Minor revision
On 18 Dec, 2020
Review #2 received
Received 16 Dec, 2020
Review #1 received
Received 15 Dec, 2020
Reviewer #2 agreed
On 05 Dec, 2020
Reviewer #1 agreed
On 16 Nov, 2020
Reviewers invited
Invitations sent on 13 Nov, 2020
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On 18 Sep, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Protocol for the Development of a Repository of Individual Participant Data From Randomised Controlled Trials Conducted in UK Adult Care Homes (The Virtual International Care Homes Trials Archive (VICHTA))
Lisa Irvine
University of Hertfordshire
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1936-3584
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 21 Sep, 2020
No community comments so far
Editorial decision: Minor revision
On 18 Dec, 2020
Review #2 received
Received 16 Dec, 2020
Review #1 received
Received 15 Dec, 2020
Reviewer #2 agreed
On 05 Dec, 2020
Reviewer #1 agreed
On 16 Nov, 2020
Reviewers invited
Invitations sent on 13 Nov, 2020
Editor assigned
On 05 Nov, 2020
Submission checks complete
On 18 Sep, 2020
First submitted
On 10 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background 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 future trial design. This protocol describes the creation of a repository of individual participant data (IPD) from trials conducted in care homes, to address the need for accurate, high quality IPD on this vulnerable population.
Methods Informed by scoping of relevant literature, the principal investigators of RCTs conducted in adult care homes in 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 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 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 accessible to the wider research community for analyses.
Discussion 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.