Core Outcomes for research on Open Lower Limb Fractures (CO-OLLF): Development of a core outcome set and core outcome measurement set

Background

An open fracture is a break of a bone where part of the bone sticks out through the skin. Here, the broken bone is at risk of infection. This is a serious injury which may lead to a limb or life-threatening illness and later disability.

Approximately 4,100 people each year in the UK will suffer an open lower limb fracture (OLLF), commonly at the shin bone. Treatment of these devastating injuries is complex such that teams of surgeons are required to repair the bones, muscles, skin and in extreme cases blood vessels and nerves. Despite advances in medical care around 1 in 10 will require amputation of the leg. Treatment is very costly; in the USA the average lifetime cost of an OLLF is $160,000 where the limb is saved and $500,000 where amputation is required (UK cost information unavailable).

Unfortunately, we don’t yet know the best way of measuring the results (outcomes) from treatment of these injuries. Researchers have therefore reported outcomes in many ways, making it difficult to compare studies to find out the best way of treating OLLF. Researchers have often used outcomes that are important to them, such as x-ray appearance or amputation rate instead of asking patients what outcomes they think are most important. Outcomes that might be important to patients could include:

• leg appearance
• movement/mobility
• pain

Aims
We aim to develop a ‘Core Outcome Set’ (COS) that all future research on OLLF should measure and report as a minimum. A COS is a standardised set of outcomes that have been agreed with healthcare professionals and patients. This study also aims to identify how to measure core outcomes (i.e. which scales/measurement instruments are best). This will ensure comparisons can be made between future studies and research can be conducted for maximum patient benefit.

Benefit to patients: A COS for OLLF will:
• support routine use of patient preferred outcomes
• make research more comparable, allow effective testing of new technology and help efficient spending of NHS resources
• help avoid studies only reporting a selection of outcomes that were measured
• inform NICE when developing guidelines and TARN when conducting national audits on patient care of the most important outcomes to use

Contributors

Prof Matt Costa, Professor of Orthopaedic Trauma Surgery, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford – Senior Investigator & supervisor

Mr Xavier Griffin, Associate Professor of Orthopaedic Trauma Surgery, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford – Senior Investigator & supervisor

Dr Liz Tutton, Senior Research Fellow, Universities of Oxford and Warwick – Senior Investigator & supervisor

Prof Ray Fitzpatrick, Professor of Public Health and Primary Care, Nuffield Department of Population health, University of Oxford – Senior Investigator & supervisor

Mr Alex Aquilina. Clinical Research Fellow and DPhil student, University of Oxford – Principle Investigator

Mr Umraz Khan, Consultant Plastic Surgeon, Frenchay Hospital Bristol

Mr Abhilash Jain, Clinical Senior Lecturer Plastic Surgery, University of Oxford

Mr Mike Kelly, Consultant Trauma & Orthopaedic Surgery, North Bristol NHS Trust

Prof Sallie Lamb, Co-Director of the Oxford Clinical Trials Research Unit and Professor of Rehabilitation (University of Oxford)

Mr Iain McFayden, Consultant Trauma & Orthopaedic Surgery, University Hospitals of North Midlands NHS Trust

Dr Rebecca Kearney, Clinical Lecturer , University of Warwick

Prof Fiona Lecky, Director of Research, The Trauma Audit & Research Network

Dr Antoinette Edwards, Director of Operations, The Trauma Audit & Research Network

Publication

Journal: Bone Joint Research
Volume: 12
Issue: 4
Pages: 294 - 305
Year: 2023
DOI: 10.1302/2046-3758.124.BJR-2022-0164.R2

Further Study Information

Current Stage: Completed
Date: October 2015 - October 2020
Funding source(s): Funding to be confirmed


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Open fracture, Fractures

Target Population

Age Range: 16 - 100

Sex: Either

Nature of Intervention: Surgery, Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers
- Charities
- Consumers (caregivers)
- Ethicists
- Journal editors
- Patient/ support group representatives
- Policy makers
- Service commissioners
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Interview
- Nominal group technique (NGT)
- Systematic review
- Delphi process
- Focus group(s)

This project will be divided into four workstreams (WS) overseen by a central patient and public involvement group:

WS1. What are the outcome priorities for patients?

Important outcomes identified from qualitative research on patients recovering from OLLF will be fed-back to 10 patients and 10 healthcare professionals in three structured-discussion groups. Participants will work together to develop and map outcome statements onto the WHO’s International Classification of Functioning, Disability and Health model (ICF). Using nominal group technique, participants will prioritise outcome statements for inclusion in the COS.

WS2. What outcomes have been reported in the literature and what OMIs have been used to measure them?

A systematic review will be conducted to identify outcomes reported in clinical trials on OLLF, their quality of reporting and what OMIs have been used to measure them.

All outcomes and OMIs identified in WS1-2 will be fed into an inventory of outcomes.

WS3. What is the COS for OLLF?

Inventoried outcomes will be scored by patients and stakeholders by order of importance in an online-Delphi survey. This will be conducted over three-rounds where outcomes reaching consensus for inclusion in the COS will be shortlisted.
A minimum of 30 patients and stakeholders will be invited to an initial consensus meeting where each shortlisted outcome will be discussed before electronic-voting on inclusion in the COS.

WS4. How should the COS be measured?

Upon creation of the COS, inventoried OMIs will be matched to core outcomes. The measurement properties of all matched OMI’s will then be assessed for quality using recognised assessment criteria. OMIs reaching an acceptable standard of quality for each core outcome will then be shortlisted.
Participants from consensus meeting one will be re-invited to a second consensus meeting where shortlisted OMIs will be voted on to be included in the COMIS.

Lower limb open fractures occur predominately in a bimodal population of young males sustaining high energy traumatic injuries and older females sustaining low energy fragility open fractures.