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The value of ultrasound-defined tenosynovitis and synovitis in the prediction of persistent arthritis.
OBJECTIVES
The value of ultrasound-defined tenosynovitis in predicting the persistence of inflammatory arthritis is not well described. In particular, the predictive utility of ultrasound-defined tenosynovitis of larger tendons is yet to be reported. We assessed the value of ultrasound-defined tenosynovitis alongside ultrasound-defined synovitis and clinical and serological variables in predicting persistent arthritis in an inception cohort of disease-modifying antirheumatic drug (DMARD)-naïve patients with early arthritis.
METHODS
One hundred and fifty DMARD-naïve patients with clinically apparent synovitis of one or more joints and a symptom duration ⩽3 months underwent baseline clinical, laboratory and ultrasound (of 19 bilateral joints and 16 bilateral tendon compartments) assessments. Outcomes were classified as persistent or resolving arthritis after 18 months follow-up. The predictive value of ultrasound-defined tenosynovitis for persistent arthritis was compared with those of ultrasound-defined synovitis, clinical and serological variables.
RESULTS
At 18 months, 99 patients (66%) had developed persistent arthritis and 51 patients (34%) had resolving disease. Multivariate logistic regression analysis showed that ultrasound-detected digit flexor tenosynovitis (OR: 6.6, 95% CI: 2.0 - 22.1, p = 0.002) provided independent predictive data for persistence over and above the presence of ultrasound-detected joint synovitis and rheumatoid factor antibodies. In the RF/ACPA-negative sub-cohort, ultrasound-defined digit flexor tenosynovitis remained a significant predictive variable (OR: 4.7, 95% CI: 1.4 - 15.8, p = 0.012), even after adjusting for ultrasound-defined joint synovitis.
CONCLUSION
Ultrasound-defined tenosynovitis provided independent predictive data for the development of persistent arthritis. The predictive role of ultrasound-defined digit flexor tenosynovitis should be further assessed; investigators should consider including this tendon site as a candidate variable when designing imaging-based predictive algorithms for persistent inflammatory arthritis development
Changes in the Management of Patients having Radical Radiotherapy for Lung Cancer during the First Wave of the COVID-19 Pandemic in the UK.
AIMS
In response to the COVID-19 pandemic, guidelines on reduced fractionation for patients treated with curative-intent radiotherapy were published, aimed at reducing the number of hospital attendances and potential exposure of vulnerable patients to minimise the risk of COVID-19 infection. We describe the changes that took place in the management of patients with stage I-III lung cancer from April to October 2020.
MATERIALS AND METHODS
Lung Radiotherapy during the COVID-19 Pandemic (COVID-RT Lung) is a prospective multicentre UK cohort study. The inclusion criteria were: patients with stage I-III lung cancer referred for and/or treated with radical radiotherapy between 2nd April and 2nd October 2020. Patients who had had a change in their management and those who continued with standard management were included. Data on demographics, COVID-19 diagnosis, diagnostic work-up, radiotherapy and systemic treatment were collected and reported as counts and percentages. Patient characteristics associated with a change in treatment were analysed using multivariable binary logistic regression.
RESULTS
In total, 1553 patients were included (median age 72 years, 49% female); 93 (12%) had a change to their diagnostic investigation and 528 (34%) had a change to their treatment from their centre's standard of care as a result of the COVID-19 pandemic. Age ≥70 years, male gender and stage III disease were associated with a change in treatment on multivariable analysis. Patients who had their treatment changed had a median of 15 fractions of radiotherapy compared with a median of 20 fractions in those who did not have their treatment changed. Low rates of COVID-19 infection were seen during or after radiotherapy, with only 21 patients (1.4%) developing the disease.
CONCLUSIONS
The COVID-19 pandemic resulted in changes to patient treatment in line with national recommendations. The main change was an increase in hypofractionation. Further work is ongoing to analyse the impact of these changes on patient outcomes
Socioeconomic deprivation, age and language are barriers to accessing personal health records: a cross-sectional study of a large hospital-based personal health record system.
OBJECTIVES
To investigate barriers to accessing a hospital-based personal health record (PHR) system.
DESIGN
Retrospective cross-sectional study.
SETTING
This study was conducted in a large secondary and tertiary acute care trust in Birmingham, UK.
PARTICIPANTS
Data were collected from 28 637 patients who attended liver medicine, diabetes, renal medicine or endocrinology specialist outpatient clinics from 1 June 2017 to 31 May 2018.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary outcome measure was sign up to and activation of the PHR. The secondary outcomes were the use of the PHR, defined as the number of logons and frequency of access of specific PHR functions.
RESULTS
8070 patients (28.2%) were signed up to the PHR and 4286 patients (53.1% of those signed up) went on to activate their PHR account. Patients aged 75 years and older were significantly less likely to be signed up (adjusted OR, aOR 0.40, 95% CI 0.36 to 0.44) or to activate (aOR 0.39, 0.32 to 0.47) their PHR than patients aged 35-54. Patients who did not need an interpreter were more likely to be signed up (aOR 1.63, 95% CI 1.33 to 1.99) and to activate (aOR 3.16, 95% CI 1.96 to 5.09) their PHR. Patients living in the least deprived areas were more than twice as likely to be signed up (aOR 2.31, 95% CI 2.04 to 2.63), and were three times more likely to activate their PHR (aOR 2.99, 95% CI 2.40 to 3.71), than those in the most deprived.
CONCLUSION
Socioeconomic deprivation, older age and non-English language were significant barriers to accessing a hospital-based PHR. Strategies are needed to account for these factors to ensure that PHRs do not widen health inequalities
The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials.
BACKGROUND
The assessment of patient-reported outcomes in clinical trials has enormous potential to promote patient-centred care, but for this potential to be realized, the patient-reported outcomes must be captured effectively and communicated clearly. Over the past decade, methodologic tools have been developed to inform the design, analysis, reporting, and interpretation of patient-reported outcome data from clinical trials. We formed the PROTEUS-Trials Consortium (Patient-Reported Outcomes Tools: Engaging Users and Stakeholders) to disseminate and implement these methodologic tools.
METHODS
PROTEUS-Trials are engaging with patient, clinician, research, and regulatory stakeholders from 27 organizations in the United States, Canada, Australia, the United Kingdom, and Europe to develop both organization-specific and cross-cutting strategies for implementing and disseminating the methodologic tools. Guided by the Knowledge-to-Action framework, we conducted consortium-wide webinars and meetings, as well as individual calls with participating organizations, to develop a workplan, which we are currently executing.
RESULTS
Six methodologic tools serve as the foundation for PROTEUS-Trials dissemination and implementation efforts: the Standard Protocol Items: Recommendations for Interventional Trials-patient-reported outcome extension for writing protocols with patient-reported outcomes, the International Society for Quality of Life Research Minimum Standards for selecting a patient-reported outcome measure, Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium recommendations for patient-reported outcome data analysis, the Consolidated Standards for Reporting of Trials-patient-reported outcome extension for reporting clinical trials with patient-reported outcomes, recommendations for the graphic display of patient-reported outcome data, and a Clinician's Checklist for reading and using an article about patient-reported outcomes. The PROTEUS-Trials website (www.TheProteusConsortium.org) serves as a central repository for the methodologic tools and associated resources. To date, we have developed (1) a roadmap to visually display where each of the six methodologic tools applies along the clinical trial trajectory, (2) web tutorials that provide guidance on the methodologic tools at different levels of detail, (3) checklists to provide brief summaries of each tool's recommendations, (4) a handbook to provide a self-guided approach to learning about the tools and recommendations, and (5) publications that address key topics related to patient-reported outcomes in clinical trials. We are also conducting organization-specific activities, including meetings, presentations, workshops, and webinars to publicize the existence of the methodologic tools and the PROTEUS-Trials resources. Work to develop communications strategies to ensure that PROTEUS-Trials reach key audiences with relevant information about patient-reported outcomes in clinical trials and PROTEUS-Trials is ongoing.
DISCUSSION
The PROTEUS-Trials Consortium aims to help researchers generate patient-reported outcome data from clinical trials to (1) enable investigators, regulators, and policy-makers to take the patient perspective into account when conducting research and making decisions; (2) help patients understand treatment options and make treatment decisions; and (3) inform clinicians' discussions with patients regarding treatment options. In these ways, the PROTEUS Consortium promotes patient-centred research and care
Metabolite selection for machine learning in childhood brain tumour classification.
MRS can provide high accuracy in the diagnosis of childhood brain tumours when combined with machine learning. A feature selection method such as principal component analysis is commonly used to reduce the dimensionality of metabolite profiles prior to classification. However, an alternative approach of identifying the optimal set of metabolites has not been fully evaluated, possibly due to the challenges of defining this for a multi-class problem. This study aims to investigate metabolite selection from in vivo MRS for childhood brain tumour classification. Multi-site 1.5 T and 3 T cohorts of patients with a brain tumour and histological diagnosis of ependymoma, medulloblastoma and pilocytic astrocytoma were retrospectively evaluated. Dimensionality reduction was undertaken by selecting metabolite concentrations through multi-class receiver operating characteristics and compared with principal component analysis. Classification accuracy was determined through leave-one-out and k-fold cross-validation. Metabolites identified as crucial in tumour classification include myo-inositol (P < 0.05, ), total lipids and macromolecules at 0.9 ppm (P < 0.05, ) and total creatine (P < 0.05, ) for the 1.5 T cohort, and glycine (P < 0.05, ), total N-acetylaspartate (P < 0.05, ) and total choline (P < 0.05, ) for the 3 T cohort. Compared with the principal components, the selected metabolites were able to provide significantly improved discrimination between the tumours through most classifiers (P < 0.05). The highest balanced classification accuracy determined through leave-one-out cross-validation was 85% for 1.5 T H-MRS through support vector machine and 75% for 3 T H-MRS through linear discriminant analysis after oversampling the minority. The study suggests that a group of crucial metabolites helps to achieve better discrimination between childhood brain tumours
Improving paediatric flow in an UK Paediatric Assessment Unit.
The 2010 Royal College of Paediatrics and Child Health (RCPCH) guidelines for acute paediatric services set standards for time to senior review for paediatric medical admissions in the UK as tier two doctor (registrar) review within 4 hours and consultant review within 14 hours. Our aim was to implement these standards in our unit through increasing proportions of reviews within these timeframes and measuring the impact on patient flow. Four quality improvement cycles were completed between March 2018 and March 2020 capturing data from 288 patient data sets. Recommendations included the extension of consultant on-site availability out of routine working hours (after cycle 1), highlighting patients awaiting consultant review during team handover (after cycle 2), and improving tier two doctor rostering (after cycle 3). After highlighting patients for consultant priority review, the proportion of patients seen within 14 hours improved from 53.3% (cycle 2) to 95% (cycle 3, p=0.005). Improved tier two doctor cover increased the proportion meeting registrar review within 4 hours from 82.9% (cycle 3) to 96.2% (cycle 4, p=0.028). A large proportion of paediatric patients were managed and discharged at tier two doctor level (65.6% over cycles 1-4). An inverse correlation was seen (R=-0.587) between time to discharge and the number of tier two doctors on shift (cycle 4). The interventions conducted demonstrated significant improvement in proportions of paediatric patients seen within the RCPCH timeframes. Adequate tier two doctor staffing is a priority for prompt review and discharge of acute paediatric patients. Future work aims to consider factors such as nursing rostering, bed management and the impact of COVID-19 on paediatric flow
A human factors approach to quality improvement in oxygen prescribing.
The safe hospital administration of oxygen has been shown to improve outcomes for specific patient groups, including those with chronic obstructive pulmonary disease (COPD). Oxygen prescribing is therefore recognised as a quality standard within the COPD Clinical Audit of the National Asthma and Chronic Obstructive Pulmonary Disease Programme. Oxygen prescription within our hospital electronic prescribing system showed poor compliance, despite previous quality improvement (QI) interventions. Using the functional resonance analysis method (FRAM), a human factors methodology, alongside existing QI approaches allowed capture of everyday work ('work-as-done') using qualitative data. This confirmed the complexity of the socio-technical healthcare system in which care is delivered and the variability of steps in the process, and provided new potential interventions to improve the safe administration of oxygen. The use of human factors tools within QI projects may help bridge normative models of work-as-prescribed and inductive models of work-as-done to support improvement and sustainability of care delivery interventions
Medical management of rhinitis in pregnancy.
Medical treatment options for patients with rhinitis during pregnancy need careful considerations. It is important to distinguish between the causes of rhinitis, as this can influence treatment. Conservative options are important for patients with pregnancy-induced rhinitis (PIR) and pre-existing allergic or non-allergic rhinitis. Education and knowledge that PIR symptoms will resolve after pregnancy can offer some relief. Other strategies such as exercise, positioning, saline nasal douching/lavage, and nasal valve dilators are safe in pregnancy and can have a benefit in these patients with rhinitis of any aetiology. The main medical therapies usually used in rhinitis cannot always be directly translated to pregnant patients due to potential teratogenic effects. Topical corticosteroids have generally shown to be safe with budesonide having the strongest recommendations. Oral corticosteroids are mostly used in moderate-severe disease and should be avoided in the first trimester. Oral decongestants have associations with cardiac, ear, gut and limb abnormalities and are not recommended in the first trimester. Loratadine and cetirizine have been the most well-studied second-generation antihistamines and are generally considered safe. There has been no reported increased risk of teratogenicity with anticholinergics or cromones, with the latter being one of the first line options in pregnant women with allergic rhinitis. The role of allergen immunotherapy needs further research, but current guidance states it can be continued if already initiated prior to pregnancy. The management of rhinitis in pregnancy can therefore be complex. This review aims to evaluate the current medical management options for rhinitis in pregnancy
Clinical disease characteristics of patients with Niemann-Pick Disease Type C: findings from the International Niemann-Pick Disease Registry (INPDR).
BACKGROUND
Niemann-Pick Disease Type C (NPC) is an autosomal recessive rare disease characterised by progressive neurovisceral manifestations. The collection of on-going large-scale NPC clinical data may generate better understandings of the natural history of the disease. Here we report NPC patient data from the International Niemann-Pick Disease Registry (INPDR).
METHOD
The INPDR is a web-based, patient-led independent registry for the collection of prospective and retrospective clinical data from Niemann-Pick Disease patients. Baseline data from NPC patients enrolled into the INPDR from September 2014 to December 2019 was extracted to analyse the demographic, genetic and clinical features of the disease.
RESULTS
A total of 203 NPC patients from six European countries were included in this study. The mean age (SD) at diagnosis was 11.2 years (14.2). Among enrolled patients, 168 had known neurological manifestations: 43 (24.2%) had early-infantile onset, 47 (26.4%) had late-infantile onset, 41 (23.0%) had juvenile onset, and 37 (20.8%) had adult onset. 10 (5.6%) patients had the neonatal rapidly fatal systemic form. Among the 97 patients with identified NPC1 variants, the most common variant was the c. 3182T > C variant responsible for the p.lle1061Thr protein change, reported in 35.1% (N = 34) of patients. The frequencies of hepatomegaly and neonatal jaundice were greatest in patients with early-infantile and late-infantile neurological onset. Splenomegaly was the most commonly reported observation, including 80% of adult-onset patients. The most commonly reported neurological manifestations were cognitive impairment (78.5%), dysarthria (75.9%), ataxia (75.9%), vertical supranuclear gaze palsy (70.9%) and dysphagia (69.6%). A 6-domain composite disability scale was used to calculate the overall disability score for each neurological form. Across all with neurological onset, the majority of patients showed moderate to severe impairments in all domains, except for 'swallowing' and 'seizure'. The age at diagnosis and death increased with increased age of neurological symptom onset. Miglustat use was recorded in 62.4% of patients and the most common symptomatic therapies used by patients were antiepileptics (32.9%), antidepressants (11.8%) and antacids (9.4%).
CONCLUSION
The proportion of participants at each age of neurological onset was relatively equal across the cohort. Neurological manifestations, such as ataxia, dysphagia, and dysarthria, were frequently observed across all age categories
Outcome of Femoral Angioplasty/Stenting Procedures in Different Ethnic Groups in England: A Retrospective Analysis of Hospital Episode Statistics and Review of Literature.
PURPOSE
Various studies, mainly from North America, report worse outcomes in ethnic minority populations submitted to revascularization for peripheral arterial disease (PAD). Limited nationwide data in relation to ethnicity are available from Europe.
OBJECTIVE
The objective of the study is to compare the outcomes of femoral angioplasty/stenting procedures among different ethnic groups in England during the 10-year period from 2006 to 2015.
MATERIALS AND METHODS
The "Hospital Episode Statistics" database has been searched using () codes to identify all cases of femoral angioplasty or stenting from English NHS Hospitals between January 1, 2006, and December 31, 2015. Subsequent mortality, second open or endovascular infrainguinal procedures, and major amputations on the same side within 2 years after the first procedure have been recorded. Patients were broadly categorized according to ethnicity as whites, Asians, and blacks. Chi-square test was used to demonstrate significant differences among ethnic groups and odds ratios (ORs) were calculated using white ethnic group as reference.
RESULTS
A total number of 70 887 femoral endovascular procedures were recorded in patients from the 3 ethnic groups. Two-year mortality in whites, Asians, and blacks was 18.3%, 22.1%, and 19.5% (p<0.001); rates of second endovascular procedure were 12.1%, 13.1%, and 13.5% (p=0.24); rates of open infrainguinal procedure were 5.6%, 4.5%, and 8.0% (p<0.001); and rates of major amputation were 4.8%, 4.1%, and 7.0% (p<0.001), respectively. Mortality was higher in Asians (OR=1.26, 95% confidence interval [CI]=1.10-1.45, p<0.01) compared with whites. On the contrary, blacks underwent more open arterial operations (OR=1.48, 95% CI=1.19-1.83, p<0.01) and more amputations (OR=1.49, 95% CI=1.18-1.87, p<0.01). There were no significant differences in the rates of second endovascular procedures.
CONCLUSION
Two-year mortality after femoral angioplasty/stenting is higher in Asians, whereas risk of limb loss is higher in blacks compared with whites. Reasons of these ethnic differences in outcomes following femoral endovascular procedures for PAD merit further study