Core Outcomes for research on Open Lower Limb Fractures (CO-OLLF)
Research type
Research Study
Full title
Core Outcomes for research on Open Lower Limb Fractures (CO-OLLF): Development of a core outcome set and core outcome measurement set
IRAS ID
235150
Contact name
Alexander Aquilina
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Summary of Research
An Open Lower Limb Fracture (OLLF) is a break 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.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.
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 be achieved by analysing interviews with patients recovering from OLLF conducted in a previous study for important patient outcomes. These outcomes will then be developed into outcome statements e.g. ‘body image is important’. Outcome statements will then be fed back to patients and healthcare professionals in structured-discussion groups to ensure they are understandable and representative of patient views. Outcomes important to healthcare professionals will be identified from a systematic review of the medical literature.
Patients and healthcare professionals will be invited to participate in an online survey and consensus meeting where they will vote for which outcomes should be included in a COS. Further work involving consensus will identify a portfolio of outcome measurement instruments which will allow effective measurement of the COS in clinical and research settings.
Summary of Results
Inconsistency in outcome-reporting hampers attempts to evaluate interventions to treat Open Lower Limb Fractures (OLLF). A Core Outcome Set (COS) establishes consensus over what outcomes are most important to key stakeholders, and how to measure them.
Candidate core outcomes were identified by a systematic review on outcome-reporting in the OLLF literature (82 outcomes), and a secondary thematic analysis of 25 in-depth patient interview transcripts exploring the lived experience of recovery from OLLF (88 outcomes). Outcomes were sequentially refined and reduced in number using structured discussion groups, a multi-stakeholder two-round Delphi survey and a consensus meeting resulting in a four-core outcome COS: ‘Walking, gait and mobility’; ‘Being able to return to life roles’; ‘Pain or discomfort’; and ‘Quality of life’.
A further systematic review was undertaken to identify which outcome measurement instruments may best measure the COS. Eleven instruments demonstrating good face validity were identified and presented to a group of patients, healthcare professionals and researchers with experience in outcome measurement at a second consensus meeting. Consensus was found for the EuroQol 5-Dimensions 5-levels and the Lower Extremity Functional scale for use in future trials and routine clinical assessment to measure: ‘Quality of life’ and ‘Walking, gait and mobility’, respectively.REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0051
Date of REC Opinion
1 Mar 2018
REC opinion
Further Information Favourable Opinion