Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/04/2010
Date assigned
10/06/2010
Last edited
10/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ronan Lyons

ORCID ID

Contact details

School of Medicine
Swansea University
Grove Building
Singleton Park
Swansea
SA2 8PP
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17996057

Publication citations

  1. 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.

Additional files

Editorial Notes