The global prevalence of type 2 diabetes (T2D) is rising and disproportionately affects South Asian adults, including those in the United Kingdom. South Asians develop T2D at a higher rate and at a younger age than their white British counterparts, at a lower body mass index. Active efforts to reduce adiposity can improve glycaemic control and in some cases achieve T2D remission. However, a substantial proportion of lean mass is lost while achieving weight loss, which may have physiological and metabolic consequences, affecting long-term health outcomes and quality of life for people living with T2D and obesity. We are examining the impact of a combined low energy diet and supervised exercise intervention versus a low energy diet alone for the preservation of lean mass in an understudied South Asian population living with T2D and excess adiposity.

This prospective, randomised, two-arm parallel-group, open-label, blinded-endpoint trial is being conducted in Leicester, UK. 36 South Asian adults aged 40–65 years within 10 years of T2D diagnosis and not on insulin therapy will be enrolled. Both intervention arms will receive an 800–900 kcal/day low energy diet for 12 weeks. Those randomised to the exercise group will additionally receive a mixture of supervised and home-based resistance and aerobic exercise training three times per week. The primary outcome is the difference in the change of lean mass between groups measured using dual-energy X-ray absorptiometry at baseline and 12 weeks and will be analysed using linear regression modelling.

The trial was approved by the NHS research ethics service (23/WM/0201). All participants will provide informed consent prior to enrolment, and the study will be conducted in accordance with the Declaration of Helsinki. Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial.

ISRCTN11175684.

We investigated symptoms reported before and after heart failure (HF) diagnosis and their associations with 3-month hospitalisation and mortality.

To examine associations between symptoms recorded in primary care and short-term hospitalisation and mortality in HF patients.

Landmark analysis using Royston-Parmar survival models at baseline (diagnosis), 6 and 12 months post-diagnosis.

Primary care database (Clinical Practice Research Datalink) linked to hospital and mortality data (1998–2020).

Adults (>40 years) with a first HF diagnosis.

Shortness of breath, ankle swelling, oedema, fatigue, chest pain, depression and anxiety in the 3 months before diagnosis and at 6 and 12 months.

3-month all-cause hospitalisation and mortality; secondary outcomes included HF and non-cardiovascular hospitalisation.

Among 86 882 HF patients (62 742 and 54 555 surviving to 6 and 12 months, respectively), the magnitude of symptom risk varied by timepoint. Specifically, the symptoms with the strongest associations with adverse outcomes were: depression for all-cause hospitalisation at diagnosis (HR: 1.26; 95% CI 1.15 to 1.39) and 6 months (1.46; 1.25 to 1.70); ankle swelling for mortality (1.49; 1.14 to 1.94) at 6 months and SOB for HF hospitalisation (1.18; 1.12 to 1.26) at diagnosis and 12 months (1.99; 1.68 to 2.35).

Symptoms persisted and were more prominent at 6 and 12 months post-diagnosis than at diagnosis.

The objective of this study is to co-produce a care bundle for women with multiple long-term health conditions (MLTC) that could be pilot tested and implemented in UK maternity services.

Online co-production workshops each attended by 20–30 key interest holders.

United Kingdom, October 2023-February 2024.

Women with experience of pregnancy with MLTC, healthcare professionals and other interest holders involved in commissioning, planning and delivering care for pregnant women with MLTC.

This study followed a three-step process: (1) a consolidated list of key components of care for pregnant women with MLTC was created through secondary analysis of prior collected qualitative data; (2) the list of care components was explored during four co-production workshops; and (3) findings from (1) and (2) were synthesised to develop a maternity care bundle of 4–5 key care components for pregnant women with MLTC.

A maternity care bundle of five key care components for pregnant women with MLTC.

A list of 25 care components was refined to develop a proposed care bundle of five components. These were provisions of early and reliable medication advice and decision support; creation of a ‘goals of care summary’ accessible to women and the care team; provision of continuity of midwifery care throughout pregnancy and postnatal care; provision of a named care coordinator; and a formal postnatal handover of care from the multidisciplinary care team to the General Practitioner (GP) and secondary care team involving the woman.

This study coproduced an evidence-based care bundle for pregnant women with MLTC to enhance communication and ensure individualised care and support. Further collaborative work with women and professionals is required to refine, implement and evaluate its impact on outcomes.

Enteric fever, primarily caused by Salmonella enterica Typhi and Salmonella enterica Paratyphi A (SPA), is endemic mainly in South Asia, disproportionately affecting school-age children. Although typhoid conjugate vaccines (TCVs) are effective and implemented in many countries, no licensed vaccine exists against paratyphoid A. Bivalent vaccines targeting both S. Typhi and SPA may address this gap. Although field efficacy trials are not considered feasible, controlled human infection models (CHIMs) offer an alternative pathway for evaluating vaccine efficacy. This will be the first efficacy study of a bivalent vaccine against typhoid and paratyphoid A using a paratyphoid CHIM.

This is a phase II multicentre, double-blind, randomised controlled trial assessing the efficacy and immunogenicity of a bivalent conjugate vaccine candidate, Serum Institute of India Typhoid Conjugate Vaccine (Bivalent) (SII-TCV(B)), against SPA using a CHIM in healthy UK adults aged 18–55 years. A total of 192 participants will be randomised 1:1 to receive either SII-TCV(B) or a licensed Vi-polysaccharide typhoid vaccine (Vi-PS). All participants will be orally challenged with S. Paratyphi A (strain NVGH308) 28 days postvaccination. Participants will be monitored closely for 14 days and treated at 14 days postchallenge or promptly on diagnosis, according to prespecified criteria. The primary objective is to evaluate vaccine efficacy of SII-TCV(B) against paratyphoid infection using a CHIM. The coprimary immunogenicity objective is to assess non-inferiority of the typhoid IgG response compared with a licensed Vi-PS control.

The study has received ethical approval from the Berkshire Research Ethics Committee (24/SC/0309) and regulatory approval from the UK Medicines and Healthcare products Regulatory Agency. Results will be disseminated via peer-reviewed publications and scientific meetings.

ISRCTN65855590.

To examine how patients and family members decide whether to accept a highly invasive intervention (aortic valve replacement (AVR)) when their condition (aortic stenosis (AS)) is asymptomatic and its course uncertain.

Nested, longitudinal, qualitative substudy of an ongoing randomised controlled trial (RCT) (NCT04204915) testing early intervention (EI) versus watchful waiting (WW) in patients with asymptomatic severe AS.

Six select UK sites of the RCT.

Select participants of the RCT, their next-of-kin and some who declined RCT participation.

73 interviews were conducted, with 41 participants.

Few knew much about AS before diagnosis. Uncertainty and the need for reliable information regarding symptoms and progress was a significant problem.

While some expressed unease at a major intervention for an asymptomatic condition, there were no outright objections to the idea.

Those who declined participation in the RCT did so for personal reasons, for example, their home circumstances did not permit the required period of recovery or they felt too old to risk intervention.

Reasons for accepting early intervention included the belief that the condition was serious and likely to deteriorate, and so better to have the intervention before such deterioration, as well as avoiding long waiting lists. Trusting clinicians’ judgement played a part in some decisions. Patients also wanted choice in the type of intervention received.

The longitudinal interviews (n=32) showed satisfaction in the early intervention group despite some problems in the the early recovery phase, especially for those undergoing surgical AVR.

Where evidence supports major intervention for an asymptomatic condition, patients are likely to accept the offer, although personal circumstances play an important role in decision-making. Where a condition is not well known to the public, such as AS, patients rely on clinicians and other resources to help decide. Liaison with patient groups in developing shared decision-making resources may help with complex decisions.

NCT04204915

Early screening for autism spectrum disorder (ASD) can enhance educational and health outcomes for affected children. This narrative systematic review explores school-based screening tools used around the world to identify children with ASD and explore the differences across socio-demographic groups.

Systematic review of electronic databases (EMBASE, MEDLINE, PsycINFO, Cochrane and Scopus) in October 2024 of papers published between 2011 and 2024.

Mainstream school-based settings globally.

Children aged 4–16 years old attending mainstream school.

School-based screening tools for ASD, including all types of informant and format of tools reported in eligible studies.

Primary outcomes included prevalence of screen positives, sensitivity and specificity of the screening tools. Secondary outcomes included participants’ sex, socioeconomic status and ethnicity, and the relation of this to the primary outcomes.

Of 7765 eligible articles, 14 studies were included in this review. We identified eight different school-based ASD screening tools. Study populations ranged from 103 to 16 556 children, with sensitivity and specificity varying by screening tool used, age group, setting and ASD prevalence. The percentage of children screening positive for ASD ranged from 0.7% to 8.5%. Studies were conducted in Europe (n=6), Western Pacific (n=4), the Americas (n=3) and Eastern Mediterranean (n=1) regions. No studies explicitly explored accuracy or validity outcomes based on ethnicity or socioeconomic status. Half of the 14 studies (n=7) reported the sensitivity and specificity of the screening tools; sensitivity ranged from 58% to 94% and specificity from 61% to 100%. There was insufficient evidence to recommend any single ASD screening tool.

ASD screening tools vary widely across the globe, with limited standardisation. Evidence is lacking on how ethnicity and socioeconomic status affect their effectiveness in schools. Given the dearth of scientific evidence in this field, collaboration among educators, researchers and policymakers is needed to establish the evidence base for universal screening, identify optimal tools, coordinate their use and ensure their validation for specific populations.