Changes in lumbar muscle diffusion tensor indices with age.

Objective: To investigate differences in diffusion tensor imaging (DTI) parameters and proton density fat fraction (PDFF) in the spinal muscles of younger and older adult males. Methods: Twelve younger (19-30 years) and 12 older (61-81years) healthy, physically active male participants underwent T1W, T2W, Dixon and DTI of the lumbar spine. The eigenvalues (λ1, λ2, and λ3), fractional anisotropy (FA), and mean diffusivity (MD) from the DTI together with the PDFF were determined in the multifidus, medial and lateral erector spinae (ESmed, ESlat), and quadratus lumborum (QL) muscles. A two-way ANOVA was used to investigate differences with age and muscle and t-tests for differences in individual muscles with age. Results: The ANOVA gave significant differences with age for all DTI parameters and the PDFF (P < .01) and with muscle (P < .01) for all DTI parameters except for λ1 and for the PDFF. The mean of the eigenvalues and MD were lower and the FA higher in the older age group with differences reaching statistical significance for all DTI measures for ESlat and QL (P < .01) but only in ESmed for λ3 and MD (P < .05). Conclusions: Differences in DTI parameters of muscle with age result from changes in both in the intra- and extra-cellular space and cannot be uniquely explained in terms of fibre length and diameter. Advances in knowledge: Previous studies looking at age have used small groups with uneven age spacing. Our study uses two well defined and separated age groups.

Development and validation of open-source deep neural networks for comprehensive chest x-ray reading: a retrospective, multicentre study.

BACKGROUND: Artificial intelligence (AI) systems for automated chest x-ray interpretation hold promise for standardising reporting and reducing delays in health systems with shortages of trained radiologists. Yet, there are few freely accessible AI systems trained on large datasets for practitioners to use with their own data with a view to accelerating clinical deployment of AI systems in radiology. We aimed to contribute an AI system for comprehensive chest x-ray abnormality detection. METHODS: In this retrospective cohort study, we developed open-source neural networks, X-Raydar and X-Raydar-NLP, for classifying common chest x-ray findings from images and their free-text reports. Our networks were developed using data from six UK hospitals from three National Health Service (NHS) Trusts (University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals Birmingham NHS Foundation Trust, and University Hospitals Leicester NHS Trust) collectively contributing 2 513 546 chest x-ray studies taken from a 13-year period (2006-19), which yielded 1 940 508 usable free-text radiological reports written by the contemporary assessing radiologist (collectively referred to as the "historic reporters") and 1 896 034 frontal images. Chest x-rays were labelled using a taxonomy of 37 findings by a custom-trained natural language processing (NLP) algorithm, X-Raydar-NLP, from the original free-text reports. X-Raydar-NLP was trained on 23 230 manually annotated reports and tested on 4551 reports from all hospitals. 1 694 921 labelled images from the training set and 89 238 from the validation set were then used to train a multi-label image classifier. Our algorithms were evaluated on three retrospective datasets: a set of exams sampled randomly from the full NHS dataset reported during clinical practice and annotated using NLP (n=103 328); a consensus set sampled from all six hospitals annotated by three expert radiologists (two independent annotators for each image and a third consultant to facilitate disagreement resolution) under research conditions (n=1427); and an independent dataset, MIMIC-CXR, consisting of NLP-annotated exams (n=252 374). FINDINGS: X-Raydar achieved a mean AUC of 0·919 (SD 0·039) on the auto-labelled set, 0·864 (0·102) on the consensus set, and 0·842 (0·074) on the MIMIC-CXR test, demonstrating similar performance to the historic clinical radiologist reporters, as assessed on the consensus set, for multiple clinically important findings, including pneumothorax, parenchymal opacification, and parenchymal mass or nodules. On the consensus set, X-Raydar outperformed historical reporter balanced accuracy with significance on 27 of 37 findings, was non-inferior on nine, and inferior on one finding, resulting in an average improvement of 13·3% (SD 13·1) to 0·763 (0·110), including a mean 5·6% (13·2) improvement in critical findings to 0·826 (0·119). INTERPRETATION: Our study shows that automated classification of chest x-rays under a comprehensive taxonomy can achieve performance levels similar to those of historical reporters and exhibit robust generalisation to external data. The open-sourced neural networks can serve as foundation models for further research and are freely available to the research community. FUNDING: Wellcome Trust.

Patient Reidentification from Chest Radiographs: An Interpretable Deep Metric Learning Approach and Its Applications.

Purpose: To train an explainable deep learning model for patient reidentification in chest radiograph datasets and assess changes in model-perceived patient identity as a marker for emerging radiologic abnormalities in longitudinal image sets. Materials and Methods: This retrospective study used a set of 1 094 537 frontal chest radiographs and free-text reports from 259 152 patients obtained from six hospitals between 2006 and 2019, with validation on the public ChestX-ray14, CheXpert, and MIMIC-CXR datasets. A deep learning model was trained for patient reidentification and assessed on patient identity confirmation, retrieval of patient images from a database based on a query image, and radiologic abnormality prediction in longitudinal image sets. The representation learned was incorporated into a generative adversarial network, allowing visual explanations of the relevant features. Performance was evaluated with sensitivity, specificity, F1 score, Precision at 1, R-Precision, and area under the receiver operating characteristic curve (AUC) for normal and abnormal prediction. Results: Patient reidentification was achieved with a mean F1 score of 0.996 ± 0.001 (2 SD) on the internal test set (26 152 patients) and F1 scores of 0.947-0.993 on the external test data. Database retrieval yielded a mean Precision at 1 score of 0.976 ± 0.005 at 299 × 299 resolution on the internal test set and Precision at 1 scores between 0.868 and 0.950 on the external datasets. Patient sex, age, weight, and other factors were identified as key model features. The model achieved an AUC of 0.73 ± 0.01 for abnormality prediction versus an AUC of 0.58 ± 0.01 for age prediction error. Conclusion: The image features used by a deep learning patient reidentification model for chest radiographs corresponded to intuitive human-interpretable characteristics, and changes in these identifying features over time may act as markers for an emerging abnormality.Keywords: Conventional Radiography, Thorax, Feature Detection, Supervised Learning, Convolutional Neural Network, Principal Component Analysis Supplemental material is available for this article. © RSNA, 2023See also the commentary by Raghu and Lu in this issue.

UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol.

INTRODUCTION: The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. ETHICS AND DISSEMINATION: The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. TRIAL REGISTRATION NUMBER: ISRCTN13374625.

Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.

INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068.

More than skin-deep: visceral fat is strongly associated with disease activity, function and metabolic indices in psoriatic disease.

OBJECTIVE: To compare body composition between patients with psoriatic disease (PsD), including cutaneous psoriasis (PsO) and psoriatic arthritis (PsA), and controls, and to explore associations between disease activity and measures of function and metabolic derangement. METHODS: Body composition was assessed by air displacement plethysmography (ADP) and MRI-derived fat segmentation using an automated pipeline (FatSegNet). Function was assessed by Health Assessment Questionnaire (HAQ) and metabolic status by fasting lipid profile, insulin and adiponectin. Active and inactive PsO and PsA were defined by body surface area (BSA) and Psoriasis Area Severity Index (PASI) and minimal disease activity (MDA), respectively. RESULTS: Thirty patients (median disease duration 15 years; median age 52 years) and 30 BMI-matched controls were enrolled. Compared with controls, all MRI-derived body composition parameters-whole-body volume, subcutaneous adipose tissue (SAT), visceral adipose tissue (VAT), abdominal adipose tissue (AAT), VAT/AAT and VAT/SAT-were higher in the PsD group, specifically, those with active disease. Body mass, body fat, whole-body volume and whole-body VAT were correlated with higher triglycerides, cholesterol:HDL (high-density lipoprotein), insulin resistance and lower adiponectin as well as higher HAQ and lower MDA. CONCLUSIONS: In this pilot study, patients with PsD revealed excessive total adipose tissue and a greater volume of metabolically unfavourable ectopic fat, including VAT, compared with BMI-matched controls, which also correlated with HAQ, disease activity and overall dysmetabolism. We also provide the first evidence in patients with PsD for the clinical application of FatSegNet: a novel, automated and rapid deep learning pipeline for providing accurate MRI-based measurement of fat segmentation. Our findings suggest the need for a more integrated approach to the management of PsD, which considers both the metabolic and inflammatory burden of disease. More specifically, visceral fat is a surrogate marker of uncontrolled PsD and may be an important future target for both pharmacological and lifestyle interventions.

Time to reconsider the routine use of tourniquets in total knee arthroplasty surgery.

AIMS: Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay. RESULTS: We included 41 RCTs with 2,819 participants. SAEs were significantly more common in the tourniquet group (53/901 vs 26/898, tourniquet vs no tourniquet respectively) (risk ratio 1.73 (95% confidence interval (CI) 1.10 to 2.73). The mean pain score on the first postoperative day was 1.25 points higher (95% CI 0.32 to 2.19) in the tourniquet group. Overall blood loss did not differ between groups (mean difference 8.61 ml; 95% CI -83.76 to 100.97). The mean length of hospital stay was 0.34 days longer in the group that had surgery with a tourniquet (95% CI 0.03 to 0.64) and the mean duration of surgery was 3.7 minutes shorter (95% CI -5.53 to -1.87). CONCLUSION: TKA with a tourniquet is associated with an increased risk of SAEs, pain, and a marginally longer hospital stay. The only finding in favour of tourniquet use was a shorter time in theatre. The results make it difficult to justify the routine use of a tourniquet in TKA surgery. Cite this article: Bone Joint J 2021;103-B(5):830-839.

Tourniquet use in total knee replacement surgery: a feasibility study and pilot randomised controlled trial (SAFE-TKR study).

INTRODUCTION: Tourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible. METHODS: In a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months. RESULTS: We randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated. CONCLUSION: A full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial. TRIAL REGISTRATION NUMBER: ISRCTN20873088.

Psoriatic disease and body composition: A systematic review and narrative synthesis.

BACKGROUND: Obesity is a leading comorbidity in psoriatic disease, including both psoriasis (PsO) and psoriatic arthritis (PsA), and is associated with adverse metabolic and cardiovascular (CV) outcomes. Anthropometric parameters, such as weight, body mass index (BMI) and waist-to-hip ratio, have been extensively reported in psoriatic disease. However, the associations of body composition and fat distribution with psoriasis have not yet been fully defined. OBJECTIVES: To identify whether patients with psoriatic disease, including psoriatic arthritis, have altered body composition compared with the general population, and to review existing modalities for the assessment of body composition. METHODS: Electronic searches of the literature were conducted in PubMed, Medline (Ovid®), Embase (Ovid®), Cochrane Central Register of Controlled Trials (CENTRAL) and Google Scholar. Titles and abstracts were reviewed by two authors independently against a set of prespecified inclusion/exclusion criteria. The research question was answered with a systematic literature review and results were summarized narratively. RESULTS: Twenty-five full text articles met the inclusion criteria and were included in the final narrative analysis. The studies were of heterogeneous design and used a range of objective measures to assess body composition, including simple anthropometric measures, bioimpedance analysis (BIA), dual energy X-ray absorptiometry (DXA) and computed tomography (CT). Few studies met all the quality assessment criteria. Clinical heterogeneity prevented meta-analysis. CONCLUSIONS: Patients with psoriatic disease reveal defined body composition changes that are independent of obesity and the customary metabolic syndrome, including higher overall body fat, visceral fat and sarcopenia. These findings emphasize that patients with psoriatic disease should be screened for abnormal adipose effects beyond their weight and body mass index (BMI). Our findings show that the last decade has seen an exciting expansion of research interest in the development and validation of new modalities for the assessment of body composition. There is no consensus on the optimal assessment method of body composition for this diverse group; hence there is a need for validation of existing modalities and standardization of assessment tools.

Meniscal Tear Outcome (METRO) review: a protocol for a systematic review summarising the clinical course and patient experiences of meniscal tears in the current literature.

INTRODUCTION: Meniscal tears are a common knee injury with an incidence of 60 per 100 000. Management of meniscal tears can include either non-operative measures or operative procedures such as arthroscopic partial meniscectomy (APM). Despite substantial research evaluating the effectiveness of APM in the recent past, little is known about the clinical course or the experiences of patients with a meniscal tear. AIM: To summarise the short to long-term patterns of variability in outcome in patients with a meniscal tear.To summarise the evidence on patient experiences of meniscal tears. In particular, we will focus on patient experiences of treatment options, treatment pathways and their views of the outcomes used in meniscal tear research. METHODS AND ANALYSIS: Two search strategies will be developed to identify citations from EMBASE, MEDLINE, AMED, CENTRAL, Web of Science and Sociofile. The date of our planned search is 14 August 2020. For the quantitative review we will identify studies reporting patient-reported outcome measures in patients after a meniscal tear. The standardised mean change will be used to assess the variation in size of response and summarise the overall response to each treatment option. All studies will undergo quality assessment using either the Cochrane risk of bias or the Newcastle-Ottawa tool.A qualitative systematic review will be used to identify studies reporting views and experiences of patients with a meniscal tear. All studies will be assessed using the Critical Appraisal Skills Programme tool and if sufficient data are present a meta-synthesis will be performed to identify first, second and third-order constructs. ETHICS AND DISSEMINATION: Given the nature of this study, no formal ethical approval will be sought. Results from the review will be disseminated at national conferences and will be submitted to a peer-reviewed journal for publication. Lay summaries will be freely available via the study Twitter page. PROSPERO REGISTRATION NUMBER: CRD42019122179.

Meniscal tear outcome Study (METRO Study): a study protocol for a multicentre prospective cohort study exploring the factors which affect outcomes in patients with a meniscal tear.

INTRODUCTION: This study is designed to explore the baseline characteristics of patients under 55 years of age with a meniscal tear, and to describe the relationship between the baseline characteristics and patient-reported outcome measures (PROMs) over 12 months. Research has highlighted the need for a trial to investigate the effectiveness of arthroscopic meniscectomy in younger patients. Before this trial, we need to understand the patient population in greater detail. METHODS AND ANALYSIS: This is a multicentre prospective cohort study. Participants aged between 18 and 55 years with an MRI confirmed meniscal tear are eligible for inclusion. Baseline characteristics including age, body mass index, gender, PROMs duration of symptoms and MRI will be collected. The primary outcome measure is the Western Ontario Meniscal Evaluation Tool at 12 months. Secondary outcome measures will include PROMs such as EQ5D, Knee Injury and Osteoarthritis Outcome Score and patient global impression of change score at 3, 6 and 12 months. ETHICS AND DISSEMINATION: The study obtained approval from the National Research Ethics Committee West Midlands-Black Country research ethics committee (19/WM/0079) on 12 April 2019. The study is sponsored by the University of Warwick. The results will be disseminated via peer-reviewed publication. TRIAL REGISTRATION NUMBER: UHCW R&D Reference: IA428119. University of Warwick Sponsor ID: SC.08/18-19.

Preferences for portable ultrasound devices: a discrete choice experiment among abdominal aortic aneurysm surveillance patients and general ultrasound patients in England.

OBJECTIVE: To undertake an assessment of preferences as to how, where and by whom ultrasounds (US) should be performed in: (1) patients undergoing surveillance of abdominal aortic aneurysm (AAA) size (AAA group); and (2) patients being scanned for general abdominal conditions (general group). DESIGN: A discrete choice experiment (DCE) questionnaire was administered to patients attending US appointments. Analysis of questionnaire responses used conditional logit models and included validity checks. SETTING: West Midlands, England. PARTICIPANTS: 524 patients (223 in the AAA group and 301 in the general group) were recruited from the US outpatient department at University Hospital Coventry and Warwickshire. OUTCOME MEASURES: Coefficients for attributes in relation to their reference levels. RESULTS: The AAA group preferred to have their US performed in hospital while the general group had a preference for portable US at general practice surgeries. All patients had a strong preference for scanning by specialists, devices with a lower risk of underdiagnosis and receiving their results at the appointment where the scan takes place. The general group had a strong preference for the person performing the scan to know their medical history. CONCLUSIONS: Patients being scanned for general abdominal conditions prefer to be scanned in a general practice by practitioners who know their medical history. Patients undergoing surveillance of AAA size prefer to be scanned in a hospital setting. Both groups would prefer to be informed of the scan results as soon as possible. Further research is required to explore the clinical scenarios in which targeted scanning by community practitioners would be of benefit to patients.

Registry report on prediction by Pocock cardiovascular score of cerebral microemboli acutely following carotid endarterectomy.

BACKGROUND: Cerebral microemboli may lead to ischaemic neurological complications after carotid endarterectomy (CEA). The association between classical cardiovascular risk factors and acute cerebral microemboli following carotid surgery has not been studied. The aim of this study was to explore whether an established cardiovascular risk score (Pocock score) predicts the presence of cerebral microemboli acutely after CEA. SUBJECTS AND METHODS: Pocock scores were assessed for the 670 patients from the Carotid Surgery Registry (age 71±1 (SEM) years, 474 (71%) male, 652 (97%) Caucasian) managed from January 2002 to December 2012 in the Regional Vascular Centre at University Hospitals Coventry and Warwickshire NHS Trust, which serves a population of 950 000. CEA was undertaken in 474 (71%) patients for symptomatic carotid stenosis and in 196 (25%) asymptomatic patients during the same period. 74% of patients were hypertensive, 71% were smokers and 49% had hypercholesterolaemia. RESULTS: A high Pocock score (≥2.3%) was significantly associated with evidence of cerebral microemboli acutely following CEA (P=0.039, Mann-Whitney (MW) test). A Pocock score (≥2.3%) did not predict patients who required additional antiplatelet therapy (microemboli signal (MES) rate >50 hour-1: P=0.164, MW test). Receiver operating characteristic analysis also showed that the Pocock score predicts acute postoperative microemboli (area under the curve (AUC) 0.546, 95% CI 0.502 to 0.590, P=0.039) but not a high rate of postoperative microemboli (MES >50 hour-1: AUC 0.546, 95% CI 0.482 to 0.610, P=0.164). A Pocock score ≥2.3% showed a sensitivity of 74% for the presence of acute postoperative cerebral microemboli. A Pocock score ≥2.3% also showed a sensitivity of 77% and a negative predictive value of 90% for patients who developed a high microembolic rate >50 hour-1 after carotid surgery. CONCLUSION: These findings demonstrate that the Pocock score could be used as a clinical tool to identify patients at high risk of developing acute postoperative microemboli.

Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol.

INTRODUCTION: Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. METHODS AND ANALYSIS: This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by 'intention to treat'. There is a parallel health economic evaluation and qualitative study. ETHICS AND DISSEMINATION: Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website. TRIAL REGISTRATION NUMBER: ISRCTN12698674; Pre-results.

Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial.

BACKGROUND: Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery, including reshaping the hip, or with physiotherapist-led conservative care. We aimed to compare the clinical effectiveness of hip arthroscopy with best conservative care. METHODS: UK FASHIoN is a pragmatic, multicentre, assessor-blinded randomised controlled trial, done at 23 National Health Service hospitals in the UK. We enrolled patients with femoroacetabular impingement syndrome who presented at these hospitals. Eligible patients were at least 16 years old, had hip pain with radiographic features of cam or pincer morphology but no osteoarthritis, and were believed to be likely to benefit from hip arthroscopy. Patients with bilateral femoroacetabular impingement syndrome were eligible; only the most symptomatic hip was randomly assigned to treatment and followed-up. Participants were randomly allocated (1:1) to receive hip arthroscopy or personalised hip therapy (an individualised, supervised, and progressive physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre and was done by research staff at each hospital, using a central telephone randomisation service. Patients and treating clinicians were not masked to treatment allocation, but researchers who collected the outcome assessments and analysed the results were masked. The primary outcome was hip-related quality of life, as measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed in all eligible participants who were allocated to treatment (the intention-to-treat population). This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN64081839, and is closed to recruitment. FINDINGS: Between July 20, 2012, and July 15, 2016, we identified 648 eligible patients and recruited 348 participants: 171 participants were allocated to receive hip arthroscopy and 177 to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (319 of 348 participants). At 12 months after randomisation, mean iHOT-33 scores had improved from 39·2 (SD 20·9) to 58·8 (27·2) for participants in the hip arthroscopy group, and from 35·6 (18·2) to 49·7 (25·5) in the personalised hip therapy group. In the primary analysis, the mean difference in iHOT-33 scores, adjusted for impingement type, sex, baseline iHOT-33 score, and centre, was 6·8 (95% CI 1·7-12·0) in favour of hip arthroscopy (p=0·0093). This estimate of treatment effect exceeded the minimum clinically important difference (6·1 points). There were 147 patient-reported adverse events (in 100 [72%] of 138 patients) in the hip arthroscopy group) versus 102 events (in 88 [60%] of 146 patients) in the personalised hip therapy group, with muscle soreness being the most common of these (58 [42%] vs 69 [47%]). There were seven serious adverse events reported by participating hospitals. Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment, and the one in the personalised hip therapy group was not. There were no treatment-related deaths, but one patient in the hip arthroscopy group developed a hip joint infection after surgery. INTERPRETATION: Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement than did personalised hip therapy, and this difference was clinically significant. Further follow-up will reveal whether the clinical benefits of hip arthroscopy are maintained and whether it is cost effective in the long term. FUNDING: The Health Technology Assessment Programme of the National Institute of Health Research.

Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol.

INTRODUCTION: This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible. METHOD AND ANALYSIS: Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State Examination will be evaluated as outcome tools for measuring cognitive impairment at days 1, 2 and 7 postoperatively. Thigh pain, blood transfusion requirements, venous thromboembolism, revision surgery, surgical complications, mortality and Oxford knee and five-level EuroQol-5D scores will be collected over 12 months. Integrated qualitative research study: 30 trial patients and 20 knee surgeons will take part in semistructured interviews. Interviews will capture views regarding the pilot trial and explore barriers and potential solutions to a full trial. Multicentre cohort study: UK National Joint Registry data will be linked to Hospital Episode Statistics to estimate the relationship between tourniquet use and venous thromboembolic event, length of hospital stay, risk of revision surgery and death. The study will conclude with a multidisciplinary workshop to reach a consensus on whether a full trial is warranted and feasible. ETHICS AND DISSEMINATION: National Research Ethics Committee (West Midlands-Edgbaston) approved this study on 27 January 2016 (15/WM/0455). The study is sponsored by University of Warwick and University Hospitals Coventry and Warwickshire. The results will be disseminated via high-impact peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN20873088; Pre-results.

Identification of an optimal threshold for detecting human brown adipose tissue using receiver operating characteristic analysis of IDEAL MRI fat fraction maps.

PURPOSE: Lower fat fraction (FF) in brown adipose tissue (BAT) than white adipose tissue (WAT) has been exploited using Dixon-based Magnetic Resonance Imaging (MRI) to differentiate these tissues in rodents, human infants and adults. We aimed to determine whether an optimal FF threshold could be determined to differentiate between BAT and WAT in adult humans in vivo. METHODS: Sixteen volunteers were recruited (9 females, 7 males; 44.2 ±â€¯19.2 years) based on BAT uptake on 18F-FDG PET/CT. Axial 3-echo TSE IDEAL sequences were acquired (TR(ms)/TE(ms)/matrix/NEX/FoV(cm) = 440/10.7-11.1/512 × 512/3/30-40), of the neck/upper thorax on a 3T HDxt MRI scanner (GE Medical Systems, Milwaukee, USA), and FF maps generated from the resulting water- and fat-only images. BAT depots were delineated on PET/CT based on standardized uptake values (SUV) >2.5 g/ml, and transposed onto FF maps. WAT depots were defined manually within subcutaneous fat. Receiver operating characteristic (ROC) analyses were performed, and optimal thresholds for differentiating BAT and WAT determined for each subject using Youden's J statistic. RESULTS: There was large variation in optimal FF thresholds to differentiate BAT and WAT between subjects (0.68-0.85), with great variation in sensitivity (0.26-0.84) and specificity (0.62-0.99). FF was excellent or good at separating BAT and WAT in four cases (area under the curve [AUC] 0.84-0.92), but poor in 10 (AUC 0.25-0.68). CONCLUSION: Although this technique was effective at differentiating BAT and WAT in some cases, no universal cut-off could be identified to reliably differentiate BAT and WAT in vivo in adult humans on the basis of FF.

A prospective, observational cohort study of patients presenting to an emergency department with acute shoulder trauma: the Manchester emergency shoulder (MESH) project.

BACKGROUND: Fracture and dislocation of the shoulder are usually identifiable through the use of plain radiographs in an emergency department. However, other significant soft tissue injuries can be missed at initial presentation. This study used contrast enhanced magnetic resonance arthrography (MRA) to determine the pattern of underlying soft tissue injuries in patients with traumatic shoulder injury, loss of active range of motion, and normal plain radiography. METHODS: A prospective, observational cohort study. Twenty-six patients with acute shoulder trauma and no identifiable radiograph abnormality were screened for inclusion. Those unable to actively abduction their affected arm to 90° at initial presentation and at two week's clinical review were consented for MRA. RESULTS: Twenty patients (Mean age 44 years, 4 females) proceeded to MRA. One patient had no abnormality, three patients showed minimal pathology. Four patients had an isolated bony/labral injury. Eight patients had injuries isolated to the rotator cuff. Four patients had a combination of bony and rotator cuff injury. Four patients were referred to a specialist shoulder surgeon following MRA and underwent surgery. CONCLUSIONS: Significant soft tissue pathology was common in our cohort of patients with acute shoulder trauma, despite the reassurance of normal plain radiography. These patients were unable to actively abduct to 90° both at initial presentation and at two week's post injury review. A more aggressive management and diagnostic strategy may identify those in need of early operative intervention and provide robust rehabilitation programmes.