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

Chronic Subdural Hematoma Clinical Trial

— CODE-CSDH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04850612
• Other study ID #: CA_2020-21-303
• Status: Enrolling by invitation
• Start date: April 30, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: University Hospital Plymouth NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 1, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Other:
• Survey
Delphi Survey on core outcomes, CSDH definition and data elements

Locations

Country	Name	City	State
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust	Barts & The London NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Erasmus Medical Center, Université de Sherbrooke

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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