Head and traumatic brain injury in England: a cohort study

ISRCTN ISRCTN17705590
DOI https://doi.org/10.1186/ISRCTN17705590
IRAS number 301676
Secondary identifying numbers IRAS 301676
Submission date
08/11/2022
Registration date
10/11/2022
Last edited
07/12/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Head injuries are common, and result from a physical trauma to the head. Traumatic brain injuries (TBI) are due to head injuries, and so less common. A person can bump their head without injuring their brain. TBI can be mild, moderate or severe, but even mild TBI can result in clinically significant disordered cerebral function and new symptoms, including cognitive deficits, headaches, and depression. Symptoms in mild TBI can persist for months or even years, and lead to inability to return to normal function such as work. Severe TBI can lead to total dependency for all functions.

The difference between head injuries and TBI is important for health resource planning. People cannot be diagnosed with TBI unless they see a health professional following a head injury. This will be in an Emergency Department (ED), in a general practice, or in the case of sports concussion (a subgroup of mild TBI) at the side of the pitch. The number and incidence of head injuries and TBI is therefore important to know.

This study is designed to identify the population incidence of head injury and the rate of traumatic brain injury, stratified by geographic location, age, gender, and ethnicity. Head injuries and traumatic brain injuries are thought to be common but the data available are either 50 years out of date or based on small and limited cohorts. Accurate data would enable appropriate health resource allocation which would result in improved patient outcomes.

Who can participate?
The study population contains all patients that attended an ED in England in 2019.

What does the study involve?
Gathering of data regarding head injury from four linked data sets; ECDS, DIDS, APC-HES and ONS-mortality.

What are the possible benefits and risks of participating?
This study will utilize nationally available data sets for analysis and consequently presents no clinical risk to patients. Psedonymised records will be analysed by an a priori plan.

Where is the study run from?
Barts Health NHS Trust (UK)

When is the study starting and how long is it expected to run for?
March 2021 to Decmeber 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Ben Bloom, ben.bloom@nhs.net
Imogen Skene, i.skene@nhs.net

Contact information

Dr Ben Bloom
Principal Investigator

Barts Health NHS Trust
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom

ORCiD logoORCID ID 0000-0002-3016-4925
Phone +44 2035940045
Email ben.bloom@nhs.net
Ms Imogen Skene
Public

Barts Health NHS Trust
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom

ORCiD logoORCID ID 0000-0001-5215-2899
Phone +44 203540045
Email i.skene@nhs.net

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not applicable (retrospective study)
Scientific titleEpidemiology of head injury and traumatic brain injury in England: a cohort study
Study acronymTBI in England
Study objectivesThe primary objective of the study is to describe the population incidence of attendance to the ED with head injury amongst the population of England.
Ethics approval(s)Approved 27/01/2022, HRA and Health and Care Research Wales (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; hra.approval@nhs.net, HCRW.approvals@wales.nhs.uk), ref: 22/HRA/0365
Health condition(s) or problem(s) studiedDetermine population incidence of head injury and traumatic brain injury, and identify associated factors.
InterventionThis study will utilise data from four linked data sets; ECDS, DIDS, APC-HES and ONS-mortality.

A head injury cohort will be defined using ECDS chief complaint and diagnosis SNOMED CT values, and DIDS radiology values. Outcomes of traumatic brain injury, intracranial haemorrhage, neurosurgery, and mortality will be measured. Associated factors including age, sex, ethnicity, language, accommodation status, geographical region, index of multiple deprivation, injury characteristics and injury place will be assessed.
Intervention typeOther
Primary outcome measureIncidence of head injury attendance to Emergency Departments amongst the population of England measured using data from four linked data sets; ECDS, DIDS, APC-HES and ONS-mortality
Secondary outcome measuresMeasured using data from four linked data sets; ECDS, DIDS, APC-HES and ONS-mortality:
1. Population incidence of TBI amongst the population of England
2. Incidence of head injury amongst the population of people that attend EDs in England
3. Incidence of types of TBI by anatomical classification
4. Incidence of surgery for TBI
5. Rate of death due to TBI
6. The association (if any) with TBI of independent variables including age, sex, ethnicity and index of multiple deprivation
Overall study start date25/03/2021
Completion date31/12/2024

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participants25 million ED attendances, of which previous estimates of 1.4 million patients have head injuries.
Key inclusion criteriaThe study period is 01/11/2018 to 29/02/2020 and the population of interest includes all patients that attended an ED in England in 2019
Key exclusion criteriaSince this is a study aiming to identify the national population incidence of head injury, the national rate of ED attendance for head injury, and the association (if any) of possible predictors with TBI including age, sex, ethnicity and socio-economic group, all ED attendances in England will be the baseline population, and consequently there are no exclusion criteria within the study period.
Date of first enrolment01/11/2018
Date of final enrolment29/02/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Barts Health NHS Trust
The Royal London Hospital
80 Newark Street
London
E1 2ES
United Kingdom

Sponsor information

Barts Health NHS Trust
Hospital/treatment centre

Joint Research Management Office
Research Services for Barts Health NHS Trust and Queen Mary University
Dept W
69-89 Mile end road
London
E1 4UJ
England
United Kingdom

Phone +44 20 7882 7275
Email research.governance@qmul.ac.uk
Website http://www.bartshealth.nhs.uk/
ROR logo "ROR" https://ror.org/00b31g692

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to the data being protected and released into a prespecified governed environment.

Editorial Notes

07/12/2023: The following changes were made to the study record:
1. The overall study end date was changed from 31/12/2023 to 31/12/2024.
2. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
08/11/2022: Trial's existence confirmed by NHS HRA.