Abstract
BackgroundAnkle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology.MethodsWe searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. s without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles.ResultsThe searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity.ConclusionsThere is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.
Highlights
Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems
This review demonstrates that at the time this review was undertaken, none of the Patient reported outcome measures (PROMs) used in clinical trials of interventions for ankle fracture had adequate evidence of measurement properties and we are unable to recommend a particular PROM for use in this context and patient population
This review shows that currently there is no PROM that can be recommended for use for the purpose of assessing outcome in clinical trials of interventions for ankle fracture
Summary
Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Ankle fractures cause significant pain, reduced mobility and subsequent limitation of usual activities [1]. Some fracture patterns, such as more severe bi-malleolar and tri-malleolar ankle fractures demonstrate a unimodal distribution, most commonly affecting an older female population, indicative of being an osteoporotic injury [2, 3]. Ankle fractures contribute to the increasing health and social care costs that accompanies an ageing population, the cost of managing fragility fractures [6]. This cost was approximately €37.5billion across six European countries in 2017; a figure that is forecasted to rise to €47.4 billion by the year 2030 [7]. It is of paramount importance that funding bodies continue to allocate resources for the conduct high quality clinical trials in order to establish the most cost-effective management strategies for ankle fractures [9, 10]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
