Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients. A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts.Aims
Methods
A review of the literature on elbow replacement found no consistency in the clinical outcome measures which are used to assess the effectiveness of interventions. The aim of this study was to define core outcome domains for elbow replacement. A real-time Delphi survey was conducted over four weeks using outcomes from a scoping review of 362 studies on elbow replacement published between January 1990 and February 2021. A total of 583 outcome descriptors were rationalized to 139 unique outcomes. The survey consisted of 139 outcomes divided into 18 domains. The readability and clarity of the survey was determined by an advisory group including a patient representative. Participants were able to view aggregated responses from other participants in real time and to revisit their responses as many times as they wished during the study period. Participants were able to propose additional items for inclusion. A Patient and Public Inclusion and Engagement (PPIE) panel considered the consensus findings.Aims
Methods
There are concerns that patient-reported outcome measures (PROMs) currently used for adults requiring, undergoing or after undergoing lower limb reconstruction (LLR) are not adequately capturing the range of experiences important to these patients. The ‘Patient-Reported Outcome Measure for Lower Limb Reconstruction’ (PROLLIT) study developed a conceptual framework of outcomes identified as important and relevant by adult LLR patients. This review explored whether existing PROMs address these outcomes, and exhibit content validity in this population. A range of key PROMs was selected (n=32). Systematic and hand-searches were employed to find studies assessing content validity of these PROMs in the adult LLR population, along with PROM content and development information. A systematic review of content validity of the measures was carried out following ‘COnsensus-based Standards for the selection of health Measurement Instruments’ (COSMIN) guidance, alongside conceptual mapping of the content of the PROMs against the PROLLIT conceptual framework.Introduction
Materials & Methods
Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.Aims
Methods
Arthroplasties of the elbow, including total elbow arthroplasty, radial head arthroplasty, distal humeral hemiarthroplasty, and radiocapitellar arthroplasty, are rarely undertaken. This scoping review aims to outline the current research in this area to inform the development of future research. A scoping review was undertaken adhering to the Joanna Briggs Institute guidelines using Medline, Embase, CENTRAL, and trial registries, limited to studies published between 1 January 1990 and 7 February 2021. Endnote software was used for screening and selection, and included randomized trials, non-randomized controlled trials, prospective and retrospective cohort studies, case-control studies, analytical cross-sectional studies, and case series of ten or more patients reporting the clinical outcomes of elbow arthroplasty. The results are presented as the number of types of studies, sample size, length of follow-up, clinical outcome domains and instruments used, sources of funding, and a narrative review.Aims
Methods
This trial aims to assess the effectiveness of quality improvement collaboratives as a technique to introduce large-scale change and improve outcomes for patients undergoing primary elective total hip or total knee arthroplasty. 41 NHS Trusts that did not have; a preoperative anaemia screening and optimisation pathways, or a methicillin sensitive Staphylococcus Aureus (MSSA) decolonisation pathway, in place were randomised to one of two parallel collaboratives in a two arm, cluster randomised controlled trial. Each collaborative focussed on implementing one of these two preoperative pathways. Collaboratives took place from May 2018 to November 2019. 27 Trusts completed the trial. Outcome data were collected for procedures between November 2018 and November 2019. Co-primary outcomes were perioperative blood transfusion (within 7 days of surgery) and deep surgical site infections (SSI) caused by MSSA (within 90 days) for the anaemia and MSSA arms respectively. Secondary outcomes include deep and superficial SSIs (any organism), length of stay, critical care admissions, and readmissions. Process measures include the proportion of patients receiving each preoperative initiative. 19,254 procedures from 27 Trusts are included. Process measures show both preoperative pathways were implemented to a high degree (75.3% compliance in MSSA arm; 61.2% anaemia arm), indicating that QICs can facilitate change in the NHS. However, there were no improvements in blood transfusions (2.9% v 2.3% adjusted-OR 1.20, 95% CI 0.52–2.75, p=0.67), MSSA deep SSIs (0.13% v 0.14% adjusted-OR 1.01, 95%CI 0.42–2.46, p=0.98), or any secondary outcome. Whilst no significant improvement in patient outcomes were seen, this trial shows quality improvement collaboratives can successfully support the implementation of new preoperative pathways in planned surgery in the NHS.
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
This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder.Aims
Methods
A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods.Aims
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
Bone demonstrates good healing capacity, with a variety of strategies being utilized to enhance this healing. One potential strategy that has been suggested is the use of stem cells to accelerate healing. The following databases were searched: MEDLINE, CENTRAL, EMBASE, Cochrane Database of Systematic Reviews, WHO-ICTRP, ClinicalTrials.gov, as well as reference checking of included studies. The inclusion criteria for the study were: population (any adults who have sustained a fracture, not including those with pre-existing bone defects); intervention (use of stem cells from any source in the fracture site by any mechanism); and control (fracture healing without the use of stem cells). Studies without a comparator were also included. The outcome was any reported outcomes. The study design was randomized controlled trials, non-randomized or observational studies, and case series.Aims
Methods
There are many types of treatment used to manage the frozen shoulder, but there is no consensus on how best to manage patients with this painful and debilitating condition. We conducted a review of the evidence of the effectiveness of interventions used to manage primary frozen shoulder using the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Physiotherapy Evidence Database, MEDLINE and EMBASE without language or date restrictions up to April 2009. Two authors independently applied selection criteria and assessed the quality of systematic reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Data were synthesised narratively, with emphasis placed on assessing the quality of evidence. In total, 758 titles and abstracts were identified and screened, which resulted in the inclusion of 11 systematic reviews. Although these met most of the AMSTAR quality criteria, there was insufficient evidence to draw firm conclusions about the effectiveness of treatments commonly used to manage a frozen shoulder. This was mostly due to poor methodological quality and small sample size in primary studies included in the reviews. We found no reviews evaluating surgical interventions. More rigorous randomised trials are needed to evaluate the treatments used for frozen shoulder.
