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AIMS: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. METHODS: A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods. DISCUSSION: The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open 2021;2(3):150-163.
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PURPOSE: Older people with dementia are at risk of adverse events associated with potentially inappropriate prescribing. AIM: to describe (1) how international tools designed to identify potentially inappropriate prescribing have been used in studies of older people with dementia, (2) the prevalence of potentially inappropriate prescribing in this cohort and (3) advantages/disadvantages of tools METHODS: Systematic literature review, designed and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). MEDLINE, EMBASE, PsychInfo, CINAHL, the Cochrane Library, the Social Science Citation Index, OpenGrey, Base, GreyLit, Mednar and the National Database of Ageing Research were searched in April 2016 for studies describing the use of a tool or criteria to identify potentially inappropriate prescribing in older people with dementia. RESULTS: Three thousand three hundred twenty-six unique papers were identified; 26 were included in the review. Eight studies used more than one tool to identify potentially inappropriate prescribing. There were variations in how the tools were applied. The Beers criteria were the most commonly used tool. Thirteen of the 15 studies using the Beers criteria did not use the full tool. The prevalence of potentially inappropriate prescribing ranged from 14 to 74% in older people with dementia. Benzodiazepines, hypnotics and anticholinergics were the most common potentially inappropriately prescribed medications. CONCLUSIONS: Variations in tool application may at least in part explain variations in potentially inappropriate prescribing across studies. Recommendations include a more standardised tool usage and ensuring the tools are comprehensive enough to identify all potentially inappropriate medications and are kept up to date.