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CCU074: Improving the accuracy, equity and efficiency of using healthcare systems data for recruitment to a clinical trial involving people with cardiovascular diseases and diabetes mellitus: a simulation study in the “Covid era” using the CVD‑COVID‑UK dataset
Safe People
Organisation name
University of Edinburgh
Organisation sector
Academic Institute
Applicant name(s)
Alice Hosking
Sub-licence arrangements (if any)?
No
Safe Projects
Project ID
CCU074
Lay summary
This project aims to improve the design of clinical studies of intracerebral haemorrhage (ICH), a type of stroke caused by bleeding in the brain. It’s important that sufficient numbers of people take part in a research study, to get a precise result. Often, we don’t manage to recruit enough people . It’s also important that the people taking part in a study are similar to people in the general population who have the condition, but people who take part in studies are often different to the average patient. Before the COVID-19 pandemic, we and other researchers would usually invite people to take part in research either in person or by post, using basic information held about them in their electronic health records. These methods can be slow or inaccurate. More recently, studies have used more detailed information in health records to accelerate COVID-19 research . We want to use detailed information in health records to identify people to take part in a study of ICH. However, during the Covid-19 pandemic fewer people were admitted to hospital with stroke compared to the three previous years. It is unclear why this happened and if patients can be identified in the same way as they were before the pandemic. We want to find out if using detailed information in health records might help us: • identify people with ICH who could be invited to take part research, and understand if this has changed during and since the pandemic • identify people who have not been well-represented in research in the past, and see if the pandemic changed how we can identify these people for research.
Public benefit statement
We will use this knowledge to design how we approach people by post for a study funded by the BHF, which will include thousands of people diagnosed with ICH before, during and since the Covid-19 pandemic. Our findings could help researchers designing other clinical trials in the future. Visit the BHF Data Science Centre website for more detailed information about project outputs. https://bhfdatasciencecentre.org/projects/ccu074/
Technical summary
This project accessed the following datasets within the Trusted Research Environment(s) for CVD-COVID-UK / COVID-IMPACT: - ENGLAND: - Civil Registration - Deaths - GPES Data for Pandemic Planning and Research (COVID-19) - Hospital Episode Statistics Admitted Patient Care - Medicines dispensed in Primary Care (NHSBSA data) - Secondary Care Prescribed Medicines (EPMA) - Sentinel Stroke National Audit Programme Clinical Dataset
Latest approval date
23/11/2023
Safe Data
Dataset(s) name
Data sensitivity level
De-Personalised
Safe Setting
Access type
TRE