Clinical trial NCT04850612: Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural Haematoma
Official title: Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Subdural Hematoma
Keywords: head injury
core outcome set
elderly
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: Erasmus Medical Center
name: Université de Sherbrooke
name: Barts & The London NHS Trust
First posted: 2021-04-20
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare Professionals, Researchers, patients and carers.

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.

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

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: CSDH Core Outcome Set (COS)
timeFrame: 3 months
Secondary outcomes:
measure: CSDH Definition and Data Elements
timeFrame: 3 months
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
References: