Study Design
Cross-centre data collection
Cross-centre data collection
Cross-centre data collection
With a network of collaborators across neurosurgical and non-neurosurgical hospitals we will collect routine data on all patients diagnosed with a chronic subdural haematoma over the study collection period. Researchers from medicine for the older person, neurosurgery, and anaesthetics will help collect data.
Registry based design
Cross-centre data collection
Cross-centre data collection
We want to understand whether there is inequality in access to care or in outcomes. As such a 'consent first' approach could skew our results and prevent our findings from improving care. Because of this we are applying for a waiver to handle identifiable information without consent. This is done by applying to the Confidentiality Advisory Group. We are hoping to make this application in early 2026.
Site based surveys
Cross-centre data collection
Data collection window
Principal investigators in each neurosurgical unit will complete a baseline questionnaire, providing details on how care for cSDH is organised in their centre.
At study conclusion we will conduct an 'exit questionnaire' looking at perspectives on the registry, its benefits, and how it could be made better in a future version.
Data collection window
Data opt-out and follow-up
Data collection window
We are aiming to collect data from each neurosurgical unit in England and Wales. We will bring each network online for collection when we have two referring hospitals agreeing to collect data. We plan that each site will collect data for at least six months over a 1 year period that we hope will begin in August 2026.
Data opt-out and follow-up
Data opt-out and follow-up
Data opt-out and follow-up
Before any record is created clinician researchers within neurosurgical units will screen all cases against the national data opt-out list.
We will provide sites with materials to advertise the study across their wards and operating theatres so patients and their families know that data is being processed. This will give them the opportunity to opt-out or consent to further follow-up questionnaires (EQ-5D for quality of life and the GOS-E for outcome)
Secure data storage
Data opt-out and follow-up
Data opt-out and follow-up
All data will be collected via a secure instance of REDCAP built and run by the CAM:IDE team and stored on ISO27001 and NHS Digital Toolkit compliant servers based at the University of Cambridge.
Further information on how data is handled will be available in the study documents section once these have been reviewed by the ethics committee and confidentiality advisory group. This should be complete by Spring 2026.
Data collection
Data collection
Data collection
Principal investigators in each site will be alerted to the presence of a record for their completion. Data from local hospitals will only be collected from patients who have been screened against the national data opt-out by the coordinating neurosurgical unit. Identifiable data will only be visible to those caring for patients within their institution. The central research team will not have access to this data.
Onwards linkage
Data collection
Data collection
We will apply for approval to link our dataset to routine hospital records to understand longer-term outcomes and health trajectories. In those consenting to follow-up we will submit de-identified data to the TBI-REPORTER platform to support other brain injury research.