Core outcomes for Open Lower Limb Fracture study (CO-OLLF)
Keywords: Core Outcome Set
Open Lower Limb Fracture
Open Fracture
Core Outcome Measurement Instrument Set
Consensus
Delphi Survey
Nominal Group Technique
Patient Reported Outcome

Open Lower Limb Fracture (OLLF) is a life-altering injury affecting 11.5 per 100,000 adults each year. OLLF causes significant morbidity, mortality and resource demand on the UK trauma infrastructure and deeply affects patient’s state of physical, mental and social well-being. Treatment is complex and multifaceted, such that an optimal treatment pathway for these devastating injuries remains unclear. Inconsistency in outcome-reporting and poor-quality studies hamper attempts to evaluate new interventions to improve function, recovery experience, and investigation into the effects of regional variation of treatment on recovery.
In order to improve research in this field, CO-OLLF recommends a Core Outcome Set (COS), where patients and key stakeholders established consensus over what outcomes are most important, and how to measure them. A COS will reduce outcome heterogeneity, outcome-reporting bias and promote better quality research meaningful to patients.
Candidate core outcomes were identified by; 1. A systematic review on outcome-reporting in the published literature on OLLF (82 outcomes), and 2. A secondary Thematic Analysis of 25 in-depth patient interview transcripts exploring the lived experience of recovery from OLLF (88 outcomes). Outcomes were sorted into 121 themes that were categorised to create an Inventory of Outcomes for OLLF. Outcomes were sequentially refined and reduced in number using a healthcare professional Structured Discussion Group (SDG) (121 to 77 outcomes), a patient SDG (77 to 71 outcomes) and a review by the Study Management Group (71 to 68 outcomes). A multi-stakeholder, two-round Delphi survey resulted in eleven outcomes reaching consensus for inclusion, following which, stakeholders were invited to a consensus meeting where a modified Nominal Group Technique was used; this found consensus for four core outcomes: 1. ‘Walking, gait and mobility’; 2. ‘Being able to return to life roles’; 3. ‘Pain or discomfort’; and 4. ‘Quality of life’.
A further systematic review was undertaken to identify which outcome instruments may best measure the COS. Eleven candidate instruments were identified demonstrating good face validity for measuring core outcomes. Following quality assessment, they were 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 (EQ-5D-5L) 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. Consensus was not met for the remaining two core outcomes. However, the EQ-5D-5L also demonstrates good face validity for measuring ‘Being able to return to life roles’ and ‘Pain or discomfort'. Therefore, it could be used pragmatically to measure these two outcomes whilst accepting limitations in its sensitivity. This study demonstrates that ‘Pain or discomfort’ is a fundamentally important outcome to measure and that there is a dearth of adequate OMIs capable of measuring its variability and complexity following OLLF. As such future PROM development work in lower limb trauma should consider creating region-specific measure for pain and discomfort.
Failure of this study to reach a consensus for all four core outcomes reflects a relative lack of adequately validated instruments for use in orthopaedic trauma. Next steps of the CO-OLLF study will include a multi-site feasibility trial collecting the OLLF COS, with a view toward implementation within the Trauma, Audit and Research Network.