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
The responsiveness of the Manchester–Oxford Foot
Questionnaire (MOXFQ) was compared with foot/ankle-specific and
generic outcome measures used to assess all surgery of the foot
and ankle. We recruited 671 consecutive adult patients awaiting
foot or ankle surgery, of whom 427 (63.6%) were female, with a mean
age of 52.8 years (18 to 89). They independently completed the MOXFQ,
Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively
and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle
surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS)
scores corresponding to four foot/ankle regions. A transition item measured
perceived changes in foot/ankle problems post-surgery. Of 628 eligible
patients proceeding to surgery, 491 (78%) completed questionnaires
and 262 (42%) received clinical assessments both pre- and post-operatively. The
regions receiving surgery were: multiple/whole foot in eight (1.3%),
ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in
196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific
MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (>
0.8)
than any SF-36 domains, suggesting superior responsiveness. In analyses
that anchored change in scores and effect sizes to patients’ responses
to a transition item about their foot/ankle problems, the MOXFQ
performed well. The SF-36 and EQ-5D performed poorly. Similar analyses,
conducted within foot-region based sub-groups of patients, found
that the responsiveness of the MOXFQ was good compared with the
AOFAS. This evidence supports the MOXFQ’s suitability for assessing
all foot and ankle surgery.
We developed the Oxford ankle foot questionnaire to assess the disability associated with foot and ankle problems in children aged from five to 16 years. A survey of 158 children and their parents was carried out to determine the content, scaling, reliability and validity of the instrument. Scores from the questionnaire can be calculated to measure the effect of foot or ankle problems on three domains of children’s lives: physical, school and play, and emotional. Scores for each domain were shown to be internally consistent, stable, and to vary little whether reported by child or parent. Satisfactory face, content and construct validity were demonstrated. The questionnaire is appropriate for children with a range of conditions and can provide clinically useful information to supplement other assessment methods. We are currently carrying out further work to assess the responsiveness of questionnaire scores to change over time and with treatment.
