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

NCT04850612 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2025-06-17

No results posted yet for this study

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

Interventions

OTHER

Survey

Delphi Survey on core outcomes, CSDH definition and data elements

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Université de Sherbrooke

    collaborator OTHER

  • Barts & The London NHS Trust

    collaborator OTHER

  • University Hospital Plymouth NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2024-11-01
Completion
2025-02-01

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04850612 on ClinicalTrials.gov