Challenges with timely outputs from the ESCP Research Committee and the ESCP Cohort Studies & Audits Working Group - and a potential solution in the form of a Federated ESCP Research Management Structure.
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Background
Given the large numbers of successfully recruited projects undertaken by ESCP in conjunction with the Birmingham Centre for Observational and Prospective Research (BiCOPS), as well as other ongoing research activities, there have been intermittent capacity issues within the Birmingham team for the timely analysis of projects.
ESCP has generated an excellent reputation for producing high quality outputs and publications from its audits and cohort studies, since the first one was run in 2015.
A central part of this is due to a core team retaining oversight of projects and analyses, including robust paper planning, data management and data handling strategies – for example in ensuring that data fields (and missing data) are treated in a consistent and homogenous manner. There is also an obligation of data protection which itself is tied into the requirements of ethics/IRB approvals, data sharing agreements and GDPR and Caldicott principles.
A solution - the federated model for new ESCP research projects
We have already instigated a ‘federated ESCP research management’ structure whereby a new project can be set up with key activities being undertaken at a different unit or hub, adhering to the established principles of the ESCP research programme and benefitting from the proven methodologies and network of active clinicians – whilst also bolstering research capacity and efficiency.
The CRAFT audit and cohort study is being undertaken in this manner; led by the University of Maastricht. In CRAFT, all data management, oversight and analysis are being undertaken in Maastricht, who also serve as the sponsor of the study, with the core team at the University of Birmingham providing oversight, guidance and support on the project.
Extending the federated model to include data analysis of previous ESCP projects
We now have the theoretical ability to outsource the analysis of already-conducted ESCP projects to external centres, leveraging the same principles as outlined above. There are key criteria which we feel must be met for the external centre if such a model is to be successful. These are outlined below.
- The external centre must be able to receive the anonymised dataset via a formal and binding data sharing agreement (and thus will likely need a legal department and appropriate IT governance and oversight to ensure appropriate data security for transfer, storage and analysis.)
- The transfer of the dataset and sign-off on the analyses plans must have the agreement of the lead investigator on the project in question, the chair of the research committee and the chair of the cohort studies and audits working group (assuming the project in question is a cohort study or an audit).
- The analyses and research questions should be pre-specified, thereby avoiding the risk of the splitting the data set into multiple, inappropriate publications.
- Appropriate and homogenous data handling strategies must be employed across papers to prevent the production of outputs which are internally inconsistent or contradictory.
- A dedicated single person must be identified at the external centre who has oversight of all analyses and primary papers.
- The person or team undertaking the analyses should have a proven track record in the handling and assessment of large and complex datasets, including the abilities to deal with missing data and potential hidden interaction effects.
- The dataset must not be transferred on to any third party; only the receiving institution can access and use the data.
- The publication policy of all papers produced as a result of the data transfer must be in line with authorship guidelines of the ESCP research committee/cohort and audit working group.
Thomas Pinkney - October 2024