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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Other: Survey

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• United Kingdom
  • Plymouth, United Kingdom
    • University Hospitals Plymouth NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthcare Professionals, Researchers, patients and carers.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthcare professionals and researchers (HCPR); All researchers and healthcare professionals involved in the management of patients with CSDH	Other: 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	Other: Survey; Delphi Survey on core outcomes, CSDH definition and data elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: elderly; head injury; core outcome set
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
• Other Study ID Numbers: CA_2020-21-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No