Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2402
Study information
Scientific title
A prospective study aiming to measure the population burden of injuries in the United Kingdom
Acronym
Study hypothesis
The UK Burden of Injuries Study is a prospective study which aims to measure the population burden of injuries in the UK. It is a mixed methods study with quantitative and qualitative components. Participants are recruited from injured people attending emergency departments or who have been admitted to hospital with injuries. Participants complete quality of life, health service utilisation and and work limitation questionnaires at baseline, 1, 4 and 12 months post injury or until they have completely recovered. Study specific data on patterns of recovery by injury type are combined with population estimates of injury from computerised inpatient, emergency department and mortality data and extrapolated to estimate the UK Burden of Injuries, primarily utilising the Disability Adjusted Life Years (DALYs) approach.
Ethics approval
Dyfed Powys Local Research Ethics Committee approved on the 24th May 2005 (ref: 05/WMW01/23)
Study design
Non-randomised observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Injuries and Accidents; Subtopic: Injuries and Accidents (all Subtopics); Disease: Injuries & Accidents
Intervention
The UKBOI Study was an observational study which combined prospectively collected data from an injured cohort with national and local mortality, inpatient and emergency department statistics and databases to estimate the UK burden of injuries. A total of 1517 injured individuals were recruited and followed up until recovery or to 1 year. Data were collected at baseline, 1, 4 and 12 months of follow up.
Follow up length: 12 months
Study entry: registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Change in health related quality of life from baseline (estimate of pre-injury status), measured using the EQ5D. Outcomes were measured at 1,4 and 12 months.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2005
Overall trial end date
20/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with an injury diagnosis identified in Emergency Departments
2. Male and female, lower age limit of 5 years
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Planned Sample Size: 1517; UK Sample Size: 1517
Participant exclusion criteria
Aged less than 5 years
Recruitment start date
01/09/2005
Recruitment end date
20/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Medicine
Swansea
SA2 8PP
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Room 720
Wellington House
133 - 155 Waterloo Road
London
SE1 8UG
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17996057
Publication citations
-
Protocol
Lyons RA, Towner EE, Kendrick D, Christie N, Brophy S, Phillips CJ, Coupland C, Carter R, Groom L, Sleney J, Evans PA, Pallister I, Coffey F, The UK burden of injury study - a protocol. [National Research Register number: M0044160889]., BMC Public Health, 2007, 7, 317, doi: 10.1186/1471-2458-7-317.