Skip to main content
OpenTrials
Completed

NCT Number: NCT04850612

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Survey

Other

Delphi Survey on core outcomes, CSDH definition and data elements

Primary outcomes

  1. CSDH Core Outcome Set (COS)

    Time frame: 3 months

    Definition of a Core Outcome Set (COS) for reporting in all future CSDH studies through a Delphi survey process including all relevant stakeholders.

Secondary outcomes

  1. CSDH Definition and Data Elements

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Collaborators

  • Barts & The London NHS Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • Erasmus Medical Center
  • Université de Sherbrooke

Registry information

Official study title

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

Acronym: CODE-CSDH

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Apr 20, 2021
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.