COMET Initiative | The core outcomes for open lower limb fracture study

The core outcomes for open lower limb fracture study - how should core outcomes be measured?

Aims
A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome.

Methods
A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders.

Results
The Wales Lower Limb Trauma Recovery scale was identified, demonstrating validation evidence in the target population. In addition, ten candidate OMIs met the shortlisting criteria. Six patients, eight healthcare professionals, and 11 research methodologists attended the consensus meeting. Consensus was achieved for the EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and the Lower Extremity Functional Scale (LEFS) to measure ‘Quality of life’ and ‘Walking, gait and mobility’ in future research trials, audit, and clinical assessment, respectively. No instrument met consensus criteria to measure ‘Being able to return to life roles’ and ‘Pain or discomfort’. However, the EQ-5D-5L was found to demonstrate good face validity and could also be used pragmatically to measure these two outcomes, accepting limitations in sensitivity.

Conclusion
This study recommends the LEFS and EQ-5D-5L to measure the core outcome set for adult open lower limb fracture.

Contributors

Alexander L. Aquilina, Harry Claireaux, Christian O. Aquilina, Elizabeth Tutton, Ray Fitzpatrick, Matthew L. Costa, Xavier L. Griffin

Publication

Journal: Bone & Joint Research
Volume: 12
Issue: 6
Pages: 352 - 361
Year: 2023
DOI: 10.1302/2046-3758.126.BJR-2022-0280.R1

Further Study Information

Current Stage: Completed
Date:
Funding source(s):

Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Lower limb fracture, Open fracture

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention:

Stakeholders Involved

Study Type

- Recommendations for outcome measures (measurement/how)