Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural Haematoma

NCT04850612 | Completed

• 1 other identifier: CA_2020-21-303
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Subdural Hematoma

Keywords

head injury; core outcome set; elderly

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• CSDH Definition and Data Elements

  3 months

Study Arms (2)

Healthcare professionals and researchers (HCPR)

All researchers and healthcare professionals involved in the management of patients with CSDH

Other: Survey

Patients and carers

Patients who have previously had a diagnosis of CSDH, and their carers

Other: Survey

Interventions

Survey OTHER

Delphi Survey on core outcomes, CSDH definition and data elements

Healthcare professionals and researchers (HCPR); Patients and carers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare Professionals, Researchers, patients and carers.

You may qualify if:

• All invited participants who provide consent to take part in 2 rounds of survey

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Erasmus Medical Center: collaborator
• Université de Sherbrooke: collaborator
• Barts & The London NHS Trust: collaborator

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Craniocerebral Trauma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Neurosurgery

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: April 30, 2021
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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.

Locations

GB (1)