Hypertension and diabetes control: faith-based centres offer a promise for expanding screening services and linkage to care in Ghana.

Background: Hypertension and type 2 diabetes mellitus (T2DM) are important contributors to noncommunicable disease related morbidity and mortality. Health systems could benefit from exploring the use of Faith-Based Centres (FBC) to screen and link suspected cases for further care in order to help achieve Sustainable Development Goal (SDG) 3. The study investigated the role of faith-based screening for T2DM and hypertension and the linkage of cases to the healthcare system and examined the care cascade in the Kassena Nankana Districts of Northern Ghana.

Prediction of total and regional body composition from 3D body shape.

Accurate assessment of body composition is essential for evaluating the risk of chronic disease. 3D body shape, obtainable using smartphones, correlates strongly with body composition. We present a novel method that fits a 3D body mesh to a dual-energy X-ray absorptiometry (DXA) silhouette (emulating a single photograph) paired with anthropometric traits, and apply it to the multi-phase Fenland study comprising 12,435 adults.

A longitudinal single-cell atlas of anti-tumour necrosis factor treatment in inflammatory bowel disease.

Precision medicine in immune-mediated inflammatory diseases (IMIDs) requires a cellular understanding of treatment response. We describe a therapeutic atlas for Crohn's disease (CD) and ulcerative colitis (UC) following adalimumab, an anti-tumour necrosis factor (anti-TNF) treatment. We generated ~1 million single-cell transcriptomes, organised into 109 cell states, from 216 gut biopsies (41 subjects), revealing disease-specific differences.

Baricitinib as monotherapy for treatment of rheumatoid arthritis: analysis of real-world data.

Objective: Baricitinib is an oral, reversible and selective inhibitor of Janus kinase (JAK)1 and JAK2 that is approved as monotherapy or in combination with methotrexate for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA) who have responded inadequately to disease-modifying antirheumatic drugs. Evidence supporting the approved monotherapy indication is growing in real-world settings that reflect routine clinical practice.

Methods: Results of separate analyses of real-world data from the observational prospective RA-BE-REAL, Erlangen Baricitinib cohort, the BSRBR-RA, and Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registries, and the retrospective ORBIT-RA and SUSTAIN long-term chart reviews were reported, documenting baseline data and outcomes for a total of 932 patients with active RA receiving baricitinib as monotherapy.

High-frequency episodic migraine: Time for its recognition as a migraine subtype?

Background: High-frequency episodic migraine (HFEM) has gained attention in the field of headache research and clinical practice. In this narrative review, we analyzed the available literature to assess the evidence that could help decide whether HFEM may represent a distinct clinical and/or biological entity within the migraine spectrum.

Methods: The output of the literature search included 61 papers that were allocated to one of the following topics: (i) socio-demographic features and burden; (ii) clinical and therapeutic aspects; (iii) pathophysiology; and (iv) classification.

Results from Arm A of Phase 1/2 DREAMM-6 trial: belantamab mafodotin with lenalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma.

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A 1-Year Weight Management Program for Difficult-to-Treat Asthma With Obesity: A Randomized Controlled Study.

Background: Obesity-associated asthma results in increased morbidity and mortality. We report 1-year asthma outcomes with a weight management regimen, the Counterweight-Plus Programme (CWP), compared with usual care (UC) in a single-center, randomized controlled trial in patients with difficult-to-treat asthma and obesity.

Research Question: Can use of the CWP result in improved asthma control and quality of life compared with UC at 1 year in patients with difficult-to-treat asthma and obesity?

Study Design And Methods: Adults with difficult-to-treat asthma and BMI ≥ 30 kg/m were randomized (1:1 CWP:UC) to treatment.

Rivaroxaban, in combination with low-dose aspirin, is associated with a reduction in proinflammatory and prothrombotic circulating vesicle signatures in patients with cardiovascular disease.

Background: Despite secondary prevention with aspirin, patients with stable cardiovascular disease (CVD) remain at elevated long-term risk of major adverse cardiovascular events. The Cardiovascular Outcomes in People Using Anticoagulant Strategies (COMPASS) double-blind, randomized clinical trial demonstrated that aspirin plus low-dose rivaroxaban (COMPASS regime) significantly decreased the incidence of major adverse cardiovascular events by 24% compared with aspirin alone. However, the mechanisms underlying these potential synergistic/nonantithrombotic effects remain elusive.

Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial.

Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside the baseplate on a monthly basis. Leakage has additional physical and psychosocial consequences, for instance, peristomal skin complications, feeling unable to cope, and self-isolation. An interventional, single-arm, multi-centre study was undertaken in the United Kingdom to evaluate a novel digital leakage notification system for ostomy care, including a support service (=test product) for 12 weeks in patients with a recent stoma formation (≤9 months).

Chronogram: an R package for data curation and analysis of infection and vaccination cohort studies.

Motivation: Observational cohort studies that track vaccine and infection responses offer real-world data to inform pandemic policy. Translating biological hypotheses, such as whether different patterns of accumulated antigenic exposures confer differing antibody responses, into analysis code can be onerous, particularly when source data is dis-aggregated.

Results: The R package chronogram introduces the class chronogram, where metadata is seamlessly aggregated with sparse infection episode, clinical and laboratory data.

Cycles of susceptibility: Immunity debt explains altered infectious disease dynamics post -pandemic.

The concept of immunity debt is a phenomenon resulting from the suppression of endemic pathogens during the COVID-19 pandemic due to non-pharmaceutical interventions (NPIs). The reduced circulation of various pathogens during the pandemic, particularly respiratory syncytial virus (RSV), altered typical infectious disease dynamics by reducing levels of population immunity usually acquired through exposure to infection. This concept is demonstrated through post-pandemic resurgence of diseases such as RSV and Group A Streptococcus, and highlights the interplay between reduced pathogen exposure and increased susceptibility in populations.

Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment.

Background: Use of electronic health records (EHR) to provide real-world data for research is established, but using EHR to deliver randomised controlled trials (RCTs) more efficiently is less developed. The Allergy AntiBiotics And Microbial resistAnce (ALABAMA) RCT evaluated a penicillin allergy assessment pathway versus usual clinical care in a UK primary care setting. The aim of this paper is to describe how EHRs were used to facilitate efficient delivery of a large-scale randomised trial of a complex intervention embracing efficient participant identification, supporting minimising GP workload, providing accurate post-intervention EHR updates of allergy status, and facilitating participant follow up and outcome data collection.

Improving analysis of cognitive outcomes in cardiovascular trials using different statistical approaches.

Background: The Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) questionnaires are commonly used to measure global cognition in clinical trials. Because these scales are discrete and bounded with ceiling and floor effects and highly skewed, their analysis as continuous outcomes presents challenges. Normality assumptions of linear regression models are usually violated, which may result in failure to detect associations with variables of interest.

Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials.

Background: It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials.