We undertook a qualitative study to explore what is important to people with lower limb conditions requiring reconstruction (LLR) and how it impacted their quality of life (QOL), in order to develop a conceptual framework for a new patient reported outcome measure (PROM). This builds on a previous qualitative evidence synthesis of existing research to develop a preliminary conceptual framework as part of the Patient Reported Outcomes for Lower Limb Reconstruction (PROLLIT) study. Patients (n=32) and Orthopaedic staff (n=23) were interviewed (November 2020-June 2021) from three centres in England using one-to-one, semi-structured interviews. Patient interviews focused on experiences during and after LLR, including impact on QOL. Staff interviews explored important outcomes and goals for patients and how the LLR impacted QOL. Recordings were transcribed verbatim and analysed using thematic analysis.Introduction
Materials and Methods
There are currently no quality of life Patient Reported Outcome Measures (PROMs) that have been validated for patients with conditions requiring lower limb reconstructive surgery. The extent to which current generic and lower limb specific PROMs address relevant dimensions for these patients is unclear. We will present an overview of the PROLLIT (Patient-Reported Outcome Measure for Lower Limb Reconstruction) mixed-methods study. PROLLIT aims to establish the adequacy of current PROMS for this population, whether a new measure is required, and to develop a new measure if appropriate.Introduction
Materials and Methods
Patient reported outcome measures (PROMs) are used to understand the impact of lower limb reconstruction on patient's quality of life (QOL). Existing measures have not been developed to specifically capture patient experiences amongst adults with lower limb conditions that require reconstruction surgery. This systematic review of qualitative studies (qualitative evidence synthesis) aimed to identify what is important to these patients. MEDLINE, Embase, PsychINFO and Cinahl were searched from inception until November 2020. Studies were included if they employed qualitative research methods, involved patients requiring, undergoing or following lower limb reconstruction and explored patients' experiences of care, treatment, recovery and QOL. Mixed methods/population studies that did not separate the findings from each group and studies not in English were excluded. Included studies were analysed using thematic synthesis. The review followed the methodological framework published by the Cochrane Qualitative and Implementation Methods Group for qualitative evidence syntheses.Introduction
Materials and Methods
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. 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.Aims
Methods