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
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
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
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
Complex interventions, such as exercise for LBP, often have many treatment targets. Matching a primary outcome to the target(s) of exercise interventions may provide greater standardized mean differences (SMDs) than using an unmatched primary outcome. We aimed to explore whether the conclusions of exercise trials for LBP might differ with i) improved matching of outcomes to treatment targets and ii) the use of composite outcome measures. We investigated i) matching in five trials (n=1033) that used an unmatched primary outcome but included some of their matched outcomes as secondary outcomes; ii) composite outcomes in four trials (n=864). The composite consisted of standardised averaged matched outcomes. All analyses replicated the primary outcome analysis, applied to the matched or composite outcome in each dataset. When not possible, SMDs were calculated for the primary and matched outcomes. i) Of five trials, three had greater SMDs and increased statistical significance with matched outcomes (pooled effect SMD 0.35 (95% CI 0.16, 0.54), p=0.0003) compared to an unmatched primary outcome (pooled effect SMD 0.13 (95% CI 0.04, 0.23) p=0.007). ii) Of four composite outcomes: two matched trials had greater SMDs and improved statistical precision in the primary outcome than the composite outcome; two unmatched trials had greater SMDs and improved statistical precision in the composite compared to the primary outcome.Background
Methods and Results
The PROximal Fracture of the Humerus Evaluation by Randomisation
(PROFHER) randomised clinical trial compared the operative and non-operative
treatment of adults with a displaced fracture of the proximal humerus
involving the surgical neck. The aim of this study was to determine
the long-term treatment effects beyond the two-year follow-up. Of the original 250 trial participants, 176 consented to extended
follow-up and were sent postal questionnaires at three, four and
five years after recruitment to the trial. The Oxford Shoulder Score
(OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent
shoulder operations and fracture data were collected. Statistical
and economic analyses, consistent with those of the main trial were
applied.Aims
Patients and Methods
A pragmatic multicentre randomised controlled trial (PROFHER)
was conducted in United Kingdom National Health Service (NHS) hospitals
to evaluate the clinical effectiveness and cost effectiveness of
surgery compared with non-surgical treatment for displaced fractures
of the proximal humerus involving the surgical neck in adults. A cost utility analysis from the NHS perspective was performed.
Differences between surgical and non-surgical treatment groups in
costs and quality adjusted life years (QALYs) at two years were
used to derive an estimate of the cost effectiveness of surgery
using regression methods. Aims
Methods
Smaller studies indicate that yoga may be an effective treatment for chronic low back pain. We conducted a randomised trial to evaluate if yoga compared to usual care improves back function in patients with chronic or recurrent low back pain. Outcomes were assessed by postal questionnaires. The setting was 13 non-National Health Service premises. We recruited 313 adults with chronic or recurrent low back pain from primary care. 157 were randomised to usual care. 156 were randomised to a 12-class, gradually-progressing programme of yoga delivered by 12 teachers over three months. All received The Back Book. Primary outcome was back function (Roland Morris Disability Score) at three months. Secondary outcomes: back function at six and 12 months, back pain, pain self-efficacy and general health. Back function improved more in the yoga group: mean difference in changes from baseline at three (−2.17, 95% CI −3.31 to −1.03, p<0.001), six (−1.48, 95% CI −2.62 to −0.33, p=0.011) and 12 months (−1.57, −2.71 to −0.42, p=0.007). Improvement in pain self-efficacy at three and six months in the yoga group. No differences in general health and pain reduction. Two adverse events were reported by controls and 12 by the yoga group – 8 out of 12 reported pain which may have been due to yoga. 63 (40%) were not fully compliant with treatment and 23 (15%) did not attend any yoga classes.Purposes of the study and background
Summary of the methods used and the results
