ADVANCE: Armed services trauma rehabilitation outcome study
| ISRCTN | ISRCTN57285353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57285353 |
| Secondary identifying numbers | 357/PPE/12 |
- Submission date
- 13/11/2019
- Registration date
- 18/11/2019
- Last edited
- 08/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
The purpose of the study is to investigate the long-term outcomes of battlefield trauma casualties and to compare these outcomes to those of a similar group of non-battlefield trauma individuals
The outcomes being investigated include medical (in particular cardiovascular disease and osteoarthritis) and psychosocial outcomes. There is some evidence to suggest that battlefield trauma casualties may have some unfavourable outcomes but this evidence is limited. Also, the types of injuries sustained in previous conflicts are different from those sustained in recent conflicts and therefore it is still unclear whether or how the type of injuries we are seeing from Afghanistan and Iraq will affect the long-term outcome of injured servicemen.
It is important to investigate these different medical and psychosocial outcomes so we can, where possible, support the injured individuals but also to learn from these outcomes and try and prevent any adverse outcomes in future injured servicemen.
Who can participate?
1,200 men will be recruited at baseline and will consist of: 600 UK male armed forces personnel who sustained physical battlefield trauma, while on deployment, requiring aeromedical evacuation and direct UK hospital admission during 2003 or after (Exposed Group): and 600 men matched for age, sex, service, rank, deployment and combat role (Non-exposed group).
What does the study involve?
At the baseline visit and at subsequent visits over 20 years the following tests and investigations will be performed on all 1,200 participants:
Questionnaires, including details on demographic details, personal and family medical history, mental health, quality of life, sleep, relationship & sexual function, employment status, social outcomes, mobility, disability, function and pain.
Imaging – DEXA scan to measure body composition and bone mineral density. X-rays of hips and knees are assessed for evidence of osteoarthritis. Brain Magnetic resonance imaging (MRI) is used to investigate the prevalence and impacts of traumatic brain injury (TBI).
Blood and urine sampling – some routine tests of blood fats and sugars, hormones, full blood count, kidney & liver function, and inflammation markers. Some samples are stored for later analyses.
Spirometry is used to assess respiratory function.
Other investigations include tests called pulse wave velocity and heart rate variability, which assess artery stiffness and are used to measure cardiovascular health.
Other than mild discomfort in having a blood test, all investigations are non-invasive and do not cause any discomfort.
What are the possible benefits and risks of participating?
The results of the study are primarily designed to benefit battlefield trauma casualties of the future. However, the extra medical assessments received during the study are in some cases, above and beyond what would be received as standard clinical care in the military or the NHS. Any clinically significant medical issues/abnormalities detected are reported back to the participant's GP or hospital specialist.
There is some exposure to radiation throughout the lifetime of the study for participants from the X-rays and DEXA scans, equivalent to 2.5 mSv, which is equivalent to that from approximately 13 months of exposure to natural background radiation, based on the UK average
Where is the study run from?
The study is run from the Defence Medical Rehabilitation Centre (DMRC), Stanford Hall, Loughborough, Leicestershire, UK
When is the study starting and how long is it expected to run for?
Baseline recruitment August 2015 to March 2020 and the study is expected to continue for 20 years of follow-up
Who is funding the study?
Government funding from LIBOR funds and charitable funding from Help for Heroes, Headley Court Charity, The Nuffield Trust, Blesma, Forces in Mind Trust, and the Office for Veteran's Affairs. The UK Ministry of Defence contributes ‘in kind’
Who is the main contact?
Group Captain Alex Bennett
alexander.n.bennett@me.com
Contact information
Scientific
DMRC Stanford Hall
Nottingham
LE12 5BL
United Kingdom
 ORCID ID |
0000-0003-2985-5304 |
|---|---|
| Phone | +44 (0)7766 107558 |
| Alexander.n.bennett@btinternet.com |
Public
Imperial College London, Department of Bioengineering
Sir Michael Uren Hub
86 Wood Ln
London
W12 0BZ
United Kingdom
| e.miller@imperial.ac.uk |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | https://www.advancestudydmrc.org.uk/participant-information-sheet/ |
| Scientific title | Longitudinal cohort study to investigate long-term medical and psychosocial outcomes of physical battlefield trauma casualties |
| Study acronym | ADVANCE |
| Study hypothesis | The aim is to investigate the long-term cardiovascular, musculoskeletal and other health and psychosocial outcomes of UK armed services physical battlefield trauma patients |
| Ethics approval(s) | Approved 07/07/2008, Ministry of Defence Research Ethics Committee (MoDREC) (MODREC Secretariat, Bldg 005, G02, Dstl Porton Down, Salisbury, Wiltshire, SP4 0JQ; MODREC@dstl.gov.uk; +44 (0)1980 956351), ref: Protocol No: 357/PPE/12 |
| Condition | Military battlefield trauma |
| Intervention | Current interventions as of 08/04/2025: UK Armed Services personnel will be recruited (equal numbers of 'exposed' and 'controls', frequency matched for age, sex, service, rank, deployment and combat role). The 'exposed' group sustained physical battlefield trauma, while on deployment in Afghanistan or Iraq, requiring aeromedical evacuation and direct UK hospital admission in or after 2003. A ‘control' group are selected from uninjured servicemen after frequency matching for age, service, rank, date of deployment and combat role. Those who agree to participate are invited to attend health screening investigations at baseline, and at regular intervals after for 20 years. Previous interventions: UK Armed Services personnel will be recruited (equal numbers of 'exposed' and 'controls', frequency matched for age, sex, service, rank, deployment and combat role). The 'exposed' group sustained physical battlefield trauma, while on deployment in Afghanistan or Iraq, requiring aeromedical evacuation and direct UK hospital admission in or after 2003. A ‘control' group are selected from uninjured servicemen after frequency matching for age, service, rank, date of deployment and combat role. Those who agree to participate are invited to attend health screening investigations at baseline, and after 3, 5, 10, 15 and 20 years. Clinical Investigations performed (baseline): 1. Patient demographics: 1.1. Age 1.2. Sex 1.3. Regiment/unit 1.4. Job/role 1.5. Prosthetic components 2. All injuries documented 3. Date of injury/trauma 4. Injury severity score (Baker & O'Neill, 1976; Baker, O'Neill et al, 1974) 5. All subsequent trauma, requiring hospital admission, subsequent to commencing the study. 6. Past medical history 7. Smoking history 8. Drug History – prescribed and recreational 9. Method of discharge from Armed Services: 10. Blood tests: 10.1. Fasting lipids, glucose and HbA1c 10.2. Full blood count, urea and electrolytes and liver function and gamma GT. 10.3. hsCRP 10.4. HLA-B27 10.5. Serum and whole blood/plasma to be stored 11. Measurements and Imaging: 11.1. Pulse wave velocity assessment 11.2. DEXA- body composition and bone mineral density 11.3. Radiographs hips and knees 11.4. 6-minute walk test 11.5. BMI, abdominal circumference 11.6. BP and heart rate 11.7. SIGAM mobility grade 11.8. Spirometry (FEV1 and FVC) 11.9. Current medication 11.10. New fracture history 12. Questionnaires: 12.1. Amputee Mobility Predictor Questionnaire (AMPQ) 12.2. Prosthetic satisfaction (Numerical rating scale-NRS) 12.3. Prosthetic use questionnaire 12.4. Numerical rating scale- Back pain (frequency/intensity/impact) 12.5. Numerical rating scales- stump pain (frequency/intensity/impact) 12.6. Numerical rating scales- phantom pain (frequency/intensity /impact) 12.7. Oswestry disability index 12.8. Non arthritic hip score 12.9. Knee osteoarthritis outcomes score 12.10. Disability of the arm, shoulder and hand questionnaire 12.11. Pain manikin 12.12. European Quality of Life 5 Domains 12.13 Post traumatic stress disorder check list 12.14 Arizona Sexual Experience Scale (ASEX) 12.15. Alcohol use disorder identification test 12.16. Patient Health Questionnaire 9 12.17. Generalized Anxiety and Depression Score-7 (GAD 7) 12.18. Employment history |
| Intervention type | Other |
| Primary outcome measure | 1. Cardiovascular risk - as determined by pulse wave velocity at 20 years 2. Major Adverse Cardiovascular Endpoint (MACE) - Composite Cardiovascular Disease (CVD) endpoint of cardiovascular death, non-fatal myocardial infarction, stroke, transient ischaemic attack (TIA), arterial revascularization (coronary artery bypass grafting, percutaneous coronary intervention, carotid endarterectomy or stenting and peripheral arterial stenting or bypass) at 20 years 3. Osteoarthritis of the hip and knee - as determined by patient-reported outcomes and radiographic assessment at 20 years |
| Secondary outcome measures | Updated 08/04/2025: Measured at baseline and at regular intervals after for 20 years (previously at baseline, and after 3, 5, 10, 15 and 20 years): 1. Cardiovascular risk as determined by more traditional cardiovascular risk factors (e.g., blood pressure and diagnosis of hypertension, lipid profile, blood glucose/diabetes mellitus, smoking history, hsCRP and abdominal waist circumference) 2. Cardiovascular disease as determined by individual components of the primary composite CVD score and peripheral vascular disease and other CAD (angina). 3. Musculoskeletal disease (osteoarthritis and osteoporosis), 4. All-cause mortality 5. Pain - back and stump/phantom (if applicable) 6. Mental health 7. Psychosocial/QoL/occupational/other outcomes 8. Functional status |
| Overall study start date | 31/05/2012 |
| Overall study end date | 31/12/2040 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Male |
| Target number of participants | 1200 |
| Total final enrolment | 1145 |
| Participant inclusion criteria | Exposed Group: 1. UK Armed services personnel 2. Male 3. Sustained physical battlefield trauma, while on deployment in Operation Herrick (Afghanistan), requiring aeromedical evacuation and direct UK hospital admission 4. Injured during 2003 or after Non-Exposed Group: 1. UK Armed services personnel 2. Male 3. Previously deployed 4. No battlefield trauma, as defined in the inclusion criteria |
| Participant exclusion criteria | 1. Unwilling or unable to give informed consent 2. Established CVD (previous stroke or transient ischaemic attack [TIA], ischaemic heart disease [IHD], peripheral vascular disease) 3. Past medical history of diabetes 4. Past medical history of renal or liver disease 5. Aged <18 and >50 years 6. Active acute infection with systemic features of sepsis, at the time of first visit, as defined below. Potential participant with active acute infection will be considered for recruitment once the acute illness is treated and resolved 7. Two of three of: 7.1. Temperature >38ºC or <36ºC 7.2. Heart rate >90 beats/min 7.3. Respiratory rate >20 breaths/min |
| Recruitment start date | 05/08/2015 |
| Recruitment end date | 31/10/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stanford Hall
Nottingham
LE12 5BL
United Kingdom
Sponsor information
Government
Defence Medical Rehabilitation Centre (DMRC)
Stanford Hll
Loughborough
LE12 5BL
United Kingdom
| Phone | +44 (0)1494 494327 |
|---|---|
| Rich.Withnall651@mod.gov.uk | |
"ROR" |
https://ror.org/01bvxzn29 |
Funders
Funder type
Government
No information available
No information available
No information available
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 20/06/2022 | 20/06/2022 | Yes | No | |
| Other publications | Pain after combat injury in male UK military personnel deployed to Afghanistan | 22/03/2024 | 25/03/2024 | Yes | No |
Editorial Notes
08/04/2025: The interventions and secondary outcome measures were updated. Headley Court Charity, The Nuffield Trust, Blesma, Forces in Mind Trust, and the Office for Veteran's Affairs were added to the funders.
07/04/2025: A study contact was added.
25/03/2024: Publication reference added.
02/11/2023: The total final enrolment was added.
20/06/2022: Publication reference added.
09/06/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2020 to 31/10/2020.
2. The overall end date was changed from 31/12/2039 to 31/12/2040.
18/11/2019: Trial’s existence confirmed by Ministry of Defence Research Ethics Committee.
