Abstract
BackgroundAnkle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture.MethodsWe performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type.ResultsThe searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980’s.ConclusionThis review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results.
Highlights
Ankle fractures cause considerable pain, loss of function and healthcare resource use
This review demonstrates the range of outcomes collected in clinical trials of interventions for adults with ankle fracture
Despite overarching current trends towards the use of Patient Reported Outcome Measure (PROM) in clinical research, this review demonstrates that objective and clinician assessed outcomes remain a commonly analysed primary outcome measure in clinical trials for this patient population
Summary
Ankle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture. Ankle fractures are a significant injury which cause pain, reduced function and have a substantial impact on activities of daily living for the individual [1]. In light of the increased incidence of ankle fractures, further high quality randomised controlled trials (RCTs) to determine optimal management strategies of this injury are required, as recommended by a Cochrane review of rehabilitation for ankle fractures completed in 2012 [6]. Meta-analyses are often confounded by a lack of homogeneity of methods and primary outcome measures used
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