An observational study in Chronic Subdural Hematoma, sponsored by University Hospital Plymouth NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by University Hospital Plymouth NHS Trust · Observational
This study is aimed at improving reporting in Chronic Subdural Haematoma (CSDH) research studies, through development of a standardised Core Outcome Set (COS), a unified CSDH Definition and set of Data Elements (DE) for reporting.
The study design includes a Delphi survey process from two main stakeholder groups: Health-Care Professionals or Researchers (HCPR) and Patients or carers. HCPR, patients and carers will all be invited to complete the survey on the COS, only the HCPR survey will include questions on definition and DE. Results of the Delphi Survey will be discussed at a final consensus meeting before results are confirmed and published.
Chronic subdural haematoma (CSDH) is a collection of blood and fluid surrounded by membranes that accumulates on the brain surface over weeks to months. It predominately affects older people and often has a delayed association with a preceding head trauma.
There has been significant growth in the number of CSDH publications in recent years mirroring progress in potential management options but there is wide variation in how and when patient outcome is measured amongst studies. Much could be gained by agreeing a minimum set of standardized outcomes that should be measured and reported in all CSDH studies, known as a Core Outcome Set (COS).
The overall study design includes a Delphi survey process.This is a process whereby all outcomes and data elements from the CSDH literature and expert opinion are presented to a large group of patients, carers and HCPR via a survey. Each survey participant has the opportunity to rank the elements and outcomes in levels of importance to them, and the survey is then repeated including presentation of the results from the first round, in order to attempt to gain agreement between participants on what is important. All elements are then reviewed at a final "consensus" meeting
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's enrollment of 184 is below the median of 210 across 20 observational studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthcare Professionals, Researchers, patients and carers.
Inclusion Criteria:
All invited participants who provide consent to take part in 2 rounds of survey
All researchers and healthcare professionals involved in the management of patients with CSDH
Other: Survey
Patients who have previously had a diagnosis of CSDH, and their carers
Other: Survey
Delphi Survey on core outcomes, CSDH definition and data elements
CSDH Core Outcome Set (COS)
Definition of a Core Outcome Set (COS) for reporting in all future CSDH studies through a Delphi survey process including all relevant stakeholders.
Time frame: 3 months
CSDH Definition and Data Elements
Identify a unified CSDH definition and data elements (DE) for reporting in future CSDH studies, through a Delphi survey process including healthcare profession and research (HCPR) stakeholders.
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol, Clinical study report
Time frame: Protocol submitted for open publication prior to commencing study. Final study report will be published at end of study including full anonymised survey responses.
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Nov 2024, 42 months.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University Hospital Plymouth NHS Trust