Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural Haematoma
NCT ID: NCT04850612
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
184 participants
OBSERVATIONAL
2021-04-30
2025-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
NCT06364059
Combined Flow and Pressure Study of Craniospinal Dynamic
NCT05068128
Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage
NCT04177329
Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease
NCT05306834
Study of Factors Influencing Post-stroke Dementia
NCT01330160
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthcare professionals and researchers (HCPR)
All researchers and healthcare professionals involved in the management of patients with CSDH
Survey
Delphi Survey on core outcomes, CSDH definition and data elements
Patients and carers
Patients who have previously had a diagnosis of CSDH, and their carers
Survey
Delphi Survey on core outcomes, CSDH definition and data elements
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Survey
Delphi Survey on core outcomes, CSDH definition and data elements
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cambridge University Hospitals NHS Foundation Trust
OTHER
Erasmus Medical Center
OTHER
Université de Sherbrooke
OTHER
Barts & The London NHS Trust
OTHER
University Hospital Plymouth NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ellie Edlmann
Clinical Lecturer in Neurosurgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA_2020-21-303
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.