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

[摘要] AimsA 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.MethodsA 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.ResultsThe 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.ConclusionThis study recommends the LEFS and EQ-5D-5L to measure the core outcome set for adult open lower limb fracture.

[学科分类] 骨科学

[关键词] Open fracture;Open lower limb fracture;Core outcome set;Outcome;open lower limb fractures;EQ-5D-5L;Lower Limb Trauma;healthcare professionals;Lower Extremity Functional Scale;patient-reported outcome measures (PROMs);open tibial fractures;Orthopaedic Trauma;Short-Form Health Survey