To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.Aims
Methods
The Manchester–Oxford Foot Questionnaire (MOXFQ) is a validated
16-item, patient-reported outcome measure for evaluating outcomes
of foot or ankle surgery. The original development of the instrument
identified three domains. This present study examined whether the
three domains could legitimately be summed to provide a single summary
index score. The MOXFQ and Short-Form (SF)-36 were administered to 671 patients
before surgery of the foot or ankle. Data from the three domains
of the MOXFQ (pain, walking/standing and social interaction) were
subjected to higher order factor analysis. Reliability and validity
of the summary index score was assessed.Objectives
Methods
