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We hypothesised that vertebroplasty provides effective analgesia for patients with poorly controlled pain and osteoporotic spinal fractures of less than 6 weeks' duration. The effectiveness of vertebroplasty, using an adequate vertebral fill technique, in fractures of less than 6 weeks' duration has not been specifically assessed by previously published masked trials. This was a multicentre, randomised, double-blind, placebo-controlled trial of vertebroplasty in four hospitals in Sydney, Australia. We recruited patients with one or two osteoporotic vertebral fractures of less than 6 weeks' duration and Numeric Rated Scale (NRS) back pain greater than or equal to 7 out of 10. We used an automated telephone randomisation service provided by the National Health and Medical Research Council to assign patients (1:1; stratified according to age, degree of vertebral compression, trauma, corticosteroid use, and hospital) to either vertebroplasty or placebo, immediately before the procedure. Patients received conscious sedation. Vertebroplasty was done with the adequate vertebral fill technique and the placebo procedure with simulated vertebroplasty. Follow-up was for 6 months. Outcome assessors and patients were masked to treatment allocation. The primary outcome was the proportion of patients with NRS pain below 4 out of 10 at 14 days post-intervention in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01482793. Between Nov 4, 2011, and Dec 5, 2014, 120 patients were enrolled. 61 patients were randomly assigned to vertebroplasty and 59 to placebo. 24 (44%) patients in the vertebroplasty group and 12 (21%) in the control group had an NRS pain score below 4 out of 10 at 14 days (between-group difference 23 percentage points, 95% CI 6–39; p=0·011). Three patients in each group died from causes judged unrelated to the procedure. There were two serious adverse events in each group, related to the procedure (vertebroplasty group) and the fracture (control group). Vertebroplasty is superior to placebo intervention for pain reduction in patients with acute osteoporotic spinal fractures of less than 6 weeks' in duration. These findings will allow patients with acute painful fractures to have an additional means of pain management that is known to be effective. Education grant from CareFusion Corporation.

Background The English National Health Service has multiple waiting time standards relating to cancer diagnosis and treatment. Targets can have unintended effects, such as prioritisation based on targets instead of clinical need. In this case, a `threshold effect’ will appear as a spike in hospitals just meeting the target. Methods We conducted a retrospective study of publicly available cancer waiting time data, including a 2-week wait for a specialist appointment, a 31-day decision to first treatment and a 62-day referral to treatment standard that attracted a financial penalty. We examined the performance of hospital trusts against these targets by financial year to look for threshold effects, using Cattaneo et al. manipulation density test. Results Trust performance against cancer waiting targets declined over time, and this trend accelerated since the start of the Covid-19 pandemic. Statistical evidence of a threshold effect for the 2-week and 31-day standard was only present in a few years. However, there was strong statistical evidence of a threshold effect for the 62-day standard across all financial years ( p  < 0.01). Conclusion The data suggests that the effect of threshold targets alters hospital behaviour at target levels but does not do so equally for all standards. Evidence of threshold effects for the 62-day standard was particularly strong, possibly due to some combination of a smaller volume of eligible patients, a larger penalty, multiple waypoints where hospitals can intervene, baseline performance against the target and where the target is set (i.e. how much headroom is available). RCTs of the use of threshold targets and of different designs for such targets in the future would be extremely informative.

To demonstrate the diagnostic performance of rapid SARS-CoV-2 RT-LAMP assays, comparing the performance of genomic versus sub-genomic sequence target with subsequent application in an asymptomatic screening population. RT-LAMP diagnostic specificity (DSe) and sensitivity (DSe) was determined using 114 RT-PCR clinically positive and 88 RT-PCR clinically negative swab samples processed through the diagnostic RT-PCR service within the University Hospitals of Leicester NHS Trust. A swab-based RT-LAMP SARS-CoV-2 screening programme was subsequently made available to all staff and students at the University of Leicester (Autumn 2020), implemented to ISO 15189:2012 standards using NHS IT infrastructure and supported by University Hospital Leicester via confirmatory NHS diagnostic laboratory testing of RT-LAMP 'positive' samples. Validation samples reporting a Ct < 20 were detected at 100% DSe and DSp, reducing to 95% DSe (100% DSp) for all samples reporting a Ct < 30 (both genomic dual sub-genomic assays). Advisory screening identified nine positive cases in 1680 symptom free individuals (equivalent to 540 cases per 100,000) with results reported back to participants and feed into national statistics within 48 hours. This work demonstrates the utility of a rapid RT-LAMP assay for collapsing transmission of SARS-CoV-2 in an asymptomatic screening population.

Abstract Increases in the number of migrants (economic, educational, and involuntary) to Europe from countries with high incidence of communicable diseases [tuberculosis (TB), HIV, and hepatitis B (HBV) and C (HCV)]; has increased the need for cost-effective early disease diagnosis programmes to improve outcomes. We aimed to synthesize and evaluate current literature on community-based screening (CBS) initiatives in Europe, the diseases being screened for, and acceptance when offered. Database search (OVID Medicine, OBIFD EMCAre, and EMBRACE) of studies between January 2000 and January 2024 investigating CBS of newly arrived migrants for TB, HIV, HBV, and HCV in Europe (PROSPERO ID: 542289). Fifteen studies were included TB only (9/15, 60%), blood borne viruses (BBV) (2/15, 14%), and two or more diseases (4/15 26%). Ten (68%) studies were community-based, 3 (16%) in reception centres, 1 (8%) in primary care, and 1 (8%) mixed setting. Five (33%) studies included community leaders/members in recruitment and two (13%) performed follow-up on participants. Screening acceptance ranged from 41% to 100% (TB 41%–100%, BBV 78.5%–100%, TB/BBV 47.3%–100%) and disease prevalence ranged from 0.09% to 45.1% (TB 0.09%–45.1%, BBV 0.2%–8.7%, TB/BBV 3.2%–28.8%). There are few studies investigating CBS of TB or BBV in migrants in Europe, despite a rise in migration over the last decade. This review shows an urgent need for CBS of migrants for multiple infections that includes community members/leaders to improve acceptance rates and reduce disease mobility and mortality in a vulnerable population.

Background Axial involvement constitutes a specific domain of psoriatic arthritis (PsA). Interleukin (IL)-23 inhibitors have demonstrated improvement in axial PsA (axPsA) symptoms, but have not shown efficacy in treating ankylosing spondylitis (AS), suggesting differences in axPsA processes and treatments. In a post hoc, pooled analysis of patients with investigator- and imaging-confirmed sacroiliitis in two phase 3, randomized, placebo-controlled studies (DISCOVER-1 and DISCOVER-2), patients treated with guselkumab, an IL-23p19 inhibitor, had greater axial symptom improvements compared with placebo. Confirmatory imaging at baseline was restricted to the sacroiliac (SI) joints, occurred prior to/at screening, and was locally read. Methods The STAR study will prospectively assess efficacy outcomes in PsA patients with magnetic resonance imaging (MRI)-confirmed axial inflammation. Eligible, biologic-naïve patients with PsA ( N =  405) for ≥ 6 months and active disease (≥ 3 swollen and ≥ 3 tender joints, C-reactive protein [CRP] ≥ 0.3 mg/dL) despite prior non-biologic disease-modifying antirheumatic drugs, apremilast, and/or nonsteroidal anti-inflammatory drugs will be randomized (1:1:1) to guselkumab every 4 weeks (Q4W); guselkumab at week (W) 0, W4, then every 8 weeks (Q8W); or placebo with crossover to guselkumab at W24, W28, then Q8W. Patients will have Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4, spinal pain component score (0–10 visual analog scale) ≥ 4, and screening MRI-confirmed axial involvement (positive spine and/or SI joints according to centrally read Spondyloarthritis Research Consortium of Canada [SPARCC] score ≥ 3 in ≥ 1 region). The primary endpoint is mean change from baseline in BASDAI at W24; multiplicity controlled secondary endpoints at W24 include AS Disease Activity Score employing CRP (ASDAS), Disease Activity Index for PsA (DAPSA), Health Assessment Questionnaire – Disability Index (HAQ-DI), Investigator’s Global Assessment of skin disease (IGA), and mean changes from baseline in MRI SI joint SPARCC scores. Centrally read MRIs of spine and SI joints (scored using SPARCC) will be obtained at W0, W24, and W52, with readers blinded to treatment group and timepoint. Treatment group comparisons will be performed using a Cochran-Mantel-Haenszel or chi-square test for binary endpoints and analysis of covariance, mixed model for repeated measures, or constrained longitudinal data analysis for continuous endpoints. Discussion This study will evaluate the ability of guselkumab to reduce both axial symptoms and inflammation in patients with active PsA. Trial registration This trial was registered at ClinicalTrials.gov, NCT04929210 , on 18 June 2021. Protocol version: Version 1.0 dated 14 April 2021.

Background Migrants are at increased risk of infections including HIV, tuberculosis and viral hepatitis, with poorer outcomes. Early diagnosis and management can reduce morbidity, mortality and onward transmission. This systematic review summarises prevalence of HIV, latent and active tuberculosis and hepatitis B and C among UK migrants and evaluates associated risk factors. Methods PubMed/Medline, EMBASE, Web of Science and the Cochrane Library were systematically searched from 2004 to 11 June 2025. The review was conducted using PRISMA guidelines and registered with PROSPERO (registration CRD42024521191). Quality assessment was performed using the Joanna Briggs Institute Critical Appraisal Checklist for Prevalence Studies. High heterogeneity (I 2  = 95.2%, 99.2%, 87.2%, 96.9% and 91.6% for IGRA, active TB, HIV, HBV and HCV yields, respectively) indicated that meta-analysis was not appropriate. The impact of risk factors on prevalence was explored through meta-regression and descriptive analysis. Results Of 2033 identified records, 36 were included, reporting Interferon Gamma Release Assay (IGRA) ( n  = 13), active TB ( n  = 10), HIV ( n  = 12), HBV ( n  = 16) and HCV ( n  = 11) test yields. An additional two publications excluded from the main analysis for reporting duplicate study data were included in the risk factor analysis because they stratified prevalence by additional risk factors. Highest yield was for IGRA which, excluding one lower prevalence outlier (6.9% ( n  = 1617)), was 15.1%–22.1%. There was high heterogeneity in active TB prevalence: 62–1,484/100,000. HIV prevalence among larger studies ( n  > 200) was 0.18%–0.48%. HBV prevalence was 0.00%–8.93% (all studies) and 1.06%–4.75% for larger studies ( n  > 1000). HCV prevalence was lower: 0.00%–1.67%, with only two of 11 included estimates above 0.50%. There was considerable heterogeneity in risk factors analysed making comparisons difficult. Conclusions Despite heterogeneity, infection prevalence was generally high, particularly IGRA yield and HBV. This underscores the need to maintain effective monitoring, testing and treatment for key infections among migrant populations, especially given the rapidly evolving epidemiological and demographic landscape for this population.

Background Implementing Point-of-care ultrasound (POCUS) in community practice could help to decide upon and prioritise initial treatment, procedures and appropriate specialist referral or conveyance to hospital. A recent literature review suggests that image quality, portability and cost of ultrasound devices are all improving with widening indications for community POCUS, but evidence about community POCUS use is needed in the UK. We aimed to explore views of clinical practitioners, actively using ultrasound, on their experiences of using POCUS and potential facilitators and barriers to its wider implementation in community settings in the UK. Methods We conducted a qualitative interview study with practitioners from community and secondary care settings actively using POCUS in practice. A convenience sample of eligible participants from different clinical specialties and settings was recruited using social media adverts, through websites of relevant research groups and snowball sampling. Individual semi-structured interviews were conducted online using Microsoft Teams. These were recorded, transcribed verbatim, and analysed using a Framework approach supported by NVivo 12. Results We interviewed 16 practitioners aged between 40 and 62 years from different professional backgrounds, including paramedics, emergency physicians, general practitioners, and allied health professionals. Participants identified key considerations and facilitators for wider implementation of POCUS in community settings in the UK: resource requirements for deployment and support of working devices; sufficient time and a skilled workforce; attention to training, education and support needs; ensuring proper governance, guidelines and quality assurance; workforce considerations; enabling ease of use in assisting decision making with consideration of unintended consequences; and more robust evidence to support perceptions of improved patient outcomes and experience. Conclusions POCUS could be useful for improving patient journey and health outcomes in community care, but this requires further research to evaluate outcomes. The facilitators identified could help make community POCUS a reality.

Many workplaces offer health and wellbeing initiatives to their staff as recommended by international and national health organisations. Despite their potential, the influence of these initiatives on health behaviour appears limited and evaluations of their effectiveness are rare. In this research, we propose evaluating the effectiveness of an established behaviour change intervention in a new workplace context. The intervention, ‘mental contrasting plus implementation intentions’, supports staff in achieving their health and wellbeing goals by encouraging them to compare the future with the present and to develop a plan for overcoming anticipated obstacles. We conducted a systematic review that identified only three trials of this intervention in workplaces and all of them were conducted within healthcare organisations. Our research will be the first to evaluate the effectiveness of mental contrasting outside a solely healthcare context. We propose including staff from 60 organisations, 30 in the intervention and 30 in a waitlisted control group. The findings will contribute to a better understanding of how to empower and support staff to improve their health and wellbeing. Trial registration: ISRCTN17828539 .

Background Migrants' participation in health research is essential to give voice to their needs and inform evidence‐based practice. We conducted a mixed‐methods study with migrants living in Leicester, United Kingdom, to understand their perceptions of participation in health research and factors influencing participation. Methods Our study included a questionnaire and focus groups with migrants. Interviews and focus groups were also conducted with key informants. The study was carried out at two sites in Leicester. Questionnaire data were analysed descriptively in R. The COM‐B framework was used to thematically analyse interview and focus group transcripts. Workshops with public members of migrant origin helped with data interpretation and analysis. Results 119 questionnaires and 4 focus groups (n = 28) were completed with migrants. Seven interviews and one focus group (n = 7) were conducted with key informants. Questionnaire respondents originated from 34 different countries, with a significant proportion (25%) identifying themselves as asylum seekers/refugees. Migrants in the focus groups were from 16 different countries and were mainly asylum seekers/refugees (n = 18). The three components of the COM‐B model (Capability, Opportunity and Motivation) were identified as the main themes, and descriptive statistics from the questionnaire data have been used to supplement the 16 sub‐themes. Individual capabilities encompassing awareness and perception of research, language abilities and skills in the use of technology significantly influenced participation. Simultaneously, the presence or absence of opportunities such as costs, competing needs and priorities, healthcare access and experiences in the United Kingdom, language barriers, opportunities for learning and taking part, precarious living conditions and socio‐cultural norms and perceptions about health were found to be important for research participation. Motivations to take part in research included trust, context of the research, need‐based research, altruism, desire to be heard and receiving incentives. Conclusion Our study contributes to the limited evidence base exploring migrants' participation in health research. Our findings, grounded in the COM‐B model, exhibit how migrants' motivations, influenced by a host of individual capabilities and environmental and social opportunities, can influence motivation and impact research participation behaviour. These findings may support the design of accessible, inclusive, equitable and impactful health research involving underserved groups. Patient or Public Contribution Patient and Public Involvement and Engagement (PPIE) in the project was obtained through the EMBRACE (East Midlands Migrant Research Advisory Collaborative) group, which was created as a migrant specific advisory group in 2019. We recruited new migrant members into the group and involved them in the interpretation of the study results. We organised two workshops with the group, and in the first workshop, held in February 2024, nine members took part to review the preliminary results and offer insights in contextualising and interpreting the data. The research team took into consideration the feedback received at the workshop and integrated it into the analysis. The final analysis was presented to the group again in September 2024, and the discussions held at that workshop were instrumental in shaping this manuscript.

IntroductionThe aim of this study was to describe the real-world evidence for effectiveness, treatment persistence, and treatment patterns among patients in the community with rheumatoid arthritis treated with the JAK inhibitor tofacitinib.MethodsThis was a retrospective, non-interventional cohort study that extracted data for new users of tofacitinib or biologic disease-modifying antirheumatic drugs (bDMARDs) from the Australian Optimizing Patient outcomes in Australian RheumatoLogy (OPAL) dataset between March 2015 and September 2018. Patients were propensity score matched at a 1:2 tofacitinib to bDMARD ratio based on age, sex, and selected baseline treatment combinations. Treatment effectiveness was evaluated using disease status measures. Treatment persistence was calculated and the percentage of patients receiving monotherapy or combination therapy at treatment initiation was evaluated.ResultsData from 2810 patients were extracted and 1950 patients were included in the matched population (1300 bDMARD initiators and 650 tofacitinib initiators). Patients were predominantly aged 55 to 74 years (57.8%) and female (81.2%). After 18 months of treatment, 52.4% and 57.8% of patients had achieved disease activity score (DAS) remission in the bDMARD and tofacitinib groups, respectively. The median treatment persistence for tofacitinib was similar to that for bDMARDs: 34.2 months (95% CI 32.2 to not reached) and 33.8 months (95% CI 28.8 to 40.4), respectively. In the overall population, more patients were prescribed tofacitinib as monotherapy (43.4%) compared with bDMARD monotherapy (33.4%).ConclusionsTofacitinib demonstrated treatment effectiveness and persistence similar to bDMARDs. Overall, there was a trend for more use of tofacitinib as monotherapy than bDMARDs.Key Points• This study provides real-world evidence regarding effectiveness, treatment persistence, and treatment patterns, among patients with rheumatoid arthritis (RA) in the community being treated with tofacitinib.• The study suggests that tofacitinib is an effective and enduring intervention in RA with tofacitinib persistence and effectiveness comparable to bDMARDs.