Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.

This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.

This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).

Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.

Post-COVID syndrome manifests with a diverse array of symptoms for which no standard care plan currently exists. Many questions were raised by patients, which underscored the need for a validated patient-reported outcome measure (PROM). Therefore, a post-COVID module was developed to be included in the Assessment of Burden of Chronic Conditions (ABCC-) tool. The ABCC-tool evaluates and visualises the perceived physical, emotional and social burden of one or multiple chronic disease(s) using a balloon diagram and aims to facilitate person-centred care and structured discussions between patients and healthcare professionals. This study explores the patients’ perspective on the content of the ABCC-tool for post-COVID and the tool’s usability in a home-based setting.

All patients who completed the ABCC-tool for post-COVID were invited for an online semi-structured interview. We selected post-COVID patients who had used the tool in the past three months. Interviews were audio recorded and analysed using a thematic approach with Atlas.ti version 23.

Nineteen post-COVID patients (10 males, mean age 56) were interviewed between May and August 2024. The tool was regarded as user-friendly, and patients indicated they would use the tool again in the future. Patients valued the tool’s broad range of topics, some of which are often overlooked in standard healthcare consultations. The tool was comprehensible and relevant according to all patients. The balloon diagram was easy to understand, but a legend explaining the colours of the balloons was preferred. Other suggestions for improvement included adding open-text fields and periodic reminders to increase usability and adding long-term data.

The ABCC-tool is a promising instrument for post-COVID patients, offering a structured way to monitor and communicate experienced burden in addition to standard healthcare consultations. Refinements addressing usability and comprehensiveness are recommended to facilitate its integration into clinical practices.

Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

ISRCTN12216466.

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Practice guidelines recommend addressing patient non-medical drivers of health such as access to nutritious food and transportation as part of whole-person care. Emergent electronic health record (EHR)-based tools can enable non-medical needs care coordination, but adoption commonly faces workflow and infrastructure barriers. Targeted implementation support strategies (eg, training, practice facilitation) can enhance technology adoption in healthcare settings, but no prior research has assessed if implementation strategies can improve how care managers use enabling technologies for non-medical needs care coordination. This study will test whether providing implementation support to primary care health centre care management teams improves the adoption of EHR-based enabling technologies to address patients’ non-medical needs.

This hybrid implementation-effectiveness type 2 pragmatic trial has a mixed methods design. The primary outcomes include: (1) Whether patients enrolled in care management programmes have been screened for unmet non-medical health-related needs and (2) Whether patients with identified unmet non-medical health-related needs received a referral to a community organisation to address their need. The secondary outcomes include: (1) Whether referrals for financial-related non-medical needs had a documented outcome in the EHR, such as successful connection to services, service unavailability or other disposition statuses, (2) Whether the referral outcomes indicated ‘successful connection to services’ and (3) Clinical markers including hypertension and diabetes control. Formative evaluation of barriers and facilitators to using EHR tools to conduct non-medical needs screening, referrals and tracking of receipt of services will include semi-structured interviews and a ‘guided tour’ of enabling technology used by care managers. A modified Delphi process will then inform the development of a set of implementation strategies for inclusion in the intervention. The intervention will be piloted in three health centres, refined, then tested in a stepped-wedge cluster-randomised trial in 20 health centres.

We obtained ethics approval for all study activities from Advarra Institutional Review Board (registration number #00000971). Results will be disseminated to Health Centres and Health Centre network nationally at meetings and we will disseminate to researchers via manuscripts in peer-reviewed journals and scientific meetings.

NCT06489002.

To examine the longitudinal impact of time-varying factors on US youth’s trajectories of initiation and use of e-cigarettes and cigarettes during the transition from adolescence to young adulthood.

Longitudinal.

Nationally representative US survey, the Population Assessment of Tobacco and Health (PATH) Study.

2682 US youth (aged 16–17) at wave (W)1 of the PATH Study across six waves (2013–2020) into young adulthood (aged 22–23).

Unweighted longitudinal latent class analyses identified trajectory classes of e-cigarette and cigarette use, separately. Nationally representative weighted multinomial logistic regression analyses examined time-varying harm perceptions, substance use problems and tobacco product first tried as predictors of these trajectory classes.

Five e-cigarette classes (2013–2020; 41.5% Persistent Never Use, 12.6% W5 Initiation, 19.9% W3 Initiation, 15.2% Prior Initiation, 10.8% High Frequency Past 30-Day (P30D) Use) and five cigarette classes (2013–2019; 58.6% Persistent Never Use, 11.5% W4 Initiation, 10.9% W2 Initiation, 9.6% Prior Initiation, 9.5% High Frequency P30D Use) were identified. Time-varying harm perceptions and substance use problems were associated with trajectories of initiation and use for both products. Cigarettes, cigarillos, other combustibles and any smokeless tobacco as first product tried were associated with e-cigarette initiation and/or progression to high frequency use. E-cigarettes and hookah as first product tried were associated with later cigarette initiation. High Frequency P30D Cigarette Use was less likely if the first product tried was e-cigarettes, cigarillos, hookah or any smokeless tobacco product.

Results reinforce the need for identification and intervention of early substance use among younger adolescents and targeted public health messaging to address changing harm perceptions and prevent initiation among older adolescents.

The aim of this study was to explore why patients with hard-to-heal ulcers are treated without an aetiological diagnosis, using a grounded theory approach.

The study employed a qualitative semistructured interview design to gain in-depth insights. Data were collected in 2024, and an explanatory model was formed in accordance with grounded theory analysis.

Interviews were conducted with healthcare staff across primary, community and specialist care units in Sweden, encompassing both public and private sectors and representing a wide geographical spread.

The study involved 23 healthcare professionals, including nurses (n=18), assistant nurses (n=2) and physicians (n=3), from 22 healthcare units that participated in a preceding national mapping study. Participants were selected purposively to represent various professional roles and healthcare levels.

The analysis resulted in a theoretical model based on two categories: Healthcare traditions and clinical practices and Clinical governance. The lack of an aetiological diagnosis can be attributed to a traditional division of tasks, where ulcer care falls within the nurses’ domain. As a result, patients often receive treatment without a physician’s involvement, especially in home healthcare. Barriers and enablers for a diagnosis are present on different levels; issues close to the patient as well as structural matters. The results illustrate how healthcare units can be positioned along a scale, from traditional work distribution to evidence-based guidelines.

This study can be used to get a deeper understanding of the challenges of current wound management, where clinical governance can support or undermine the movement from a traditional work distribution towards an evidence-based clinical practice. Furthermore, this study can provide a basis for discussing quality improvement, to obtain good and equal care for patients with hard-to-heal ulcers.

Photobiomodulation therapy (PBMT), particularly when combined with a static magnetic field (PBMT-sMF), is a promising non-pharmacological approach for managing musculoskeletal disorders. However, high-quality evidence for its efficacy in lateral epicondylitis remains limited.

The study aims to investigate the effectiveness of PBMT-sMF vs placebo in reducing pain, improving function and modulating inflammatory markers in individuals with lateral epicondylitis.

Multicentre, randomised, triple-blinded, placebo-controlled trial.

Three outpatient physiotherapy clinics in Brazil.

50 adults (18–50 years) with unilateral lateral epicondylitis and baseline pain ≥50 on the visual analogue scale (VAS).

Participants received either active PBMT-sMF (n=25) or placebo (n=25), 2 times per week for 3 weeks. PBMT-sMF involved multi-wavelength irradiation at 4 epicondyle sites (60 s; 27.1 J/site). The placebo group underwent the same procedure without active irradiation.

The primary outcome was degree of pain rating (VAS). Secondary outcomes included forearm disability (Patient-Rated Tennis Elbow Evaluation, PRTEE), grip strength, serum tumour necrosis factor-alpha (TNF-α) levels and treatment satisfaction. Assessments were conducted at baseline, post-treatment (3 weeks) and at 4-week follow-up.

PBMT-sMF yielded a higher responder rate (defined as the proportion of participants achieving at least a 30% reduction in pain intensity relative to baseline) than placebo (72% vs 40%, p=0.045), with a clinically and statistically significant between-group difference. Compared with placebo, the PBMT-sMF group showed significantly greater reductions in pain intensity both at the end of treatment (51.4±19.8 vs 36.9±22.6; p=0.0223) and at follow-up (37.4±24.1 vs 20.3±21.2; p=0.0049). TNF-α levels also decreased significantly in the PBMT-sMF group compared with placebo at both time points (p

PBMT-sMF significantly reduced pain intensity and TNF-α levels, suggesting an anti-inflammatory mechanism. Although functional outcomes were not improved, PBMT-sMF may be a valuable short-term, non-invasive option for lateral epicondylitis pain management.

NCT04829734 on ClinicalTrials.gov

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.

To investigate whether seafarers in Norway who were declared unfit for service at sea or received a time-limited health certificate had a higher risk of acute somatic hospital admissions compared with those who received a full health certificate.

Registry-based cohort study.

Seafarers in Norway who presented to a seafarer’s doctor to obtain a health certificate between 2018 and 2019, as required for work aboard Norwegian vessels. The study was conducted within Norway’s publicly funded healthcare system.

Norwegian seafarers aged 18–70 years who underwent medical examinations (n=43 758), including n=5452 females (12.5%).

Acute somatic hospital admission within 2 years of medical examination. HRs were estimated using Cox regression models in two separate time periods (0–3 months and 3–24 months), with adjustment for possible confounding from age, gender, level of education and centrality of residence (proximity to healthcare services).

The crude risk of acute somatic hospital admissions was higher for individuals who received a declaration of unfitness, as compared with those who received a full health certificate, in both follow-up periods: 0–3 months (HR=5.13, 95% CI: 3.27 to 8.04) and 3–24 months (HR=2.63, 95% CI: 2.07 to 3.34). Similarly, those with time-limited health certificates had a higher risk in both periods: 0–3 months (HR=2.02, 95% CI: 1.39 to 2.93) and 3–24 months (HR=2.45, 95% CI: 2.15 to 2.79). Adjustment of the analyses for socio-demographic factors did not change the effect estimates substantially.

These findings highlight the importance of comprehensive and continuous health assessments to help prevent adverse health outcomes and ensure safety at sea, particularly among vulnerable subgroups of seafarers.

Perinatal complications involving conflicts between maternal and fetal health interests present a unique challenge to health economic evaluations. No comprehensive synthesis exists of how such studies account for dual-patient outcomes. We aim to develop a scoping review protocol to map and critically examine the methodologies in this understudied area.

The scoping review will be conducted under the Joanna Briggs Institute (JBI) framework. It will include health economic studies, such as cost-effectiveness, cost utility and decision analysis studies, focusing on clinical conditions during pregnancy where maternal and fetal interests conflict. Cost analysis without effectiveness assessment will be excluded. Using comprehensive search strategies in Medline (Ovid), EMBASE (Elsevier) and Cochrane Library (Wiley), two independent reviewers will screen and identify relevant studies via abstract and full-text review. We will perform data extraction following an adapted form from the Consolidated Health Economic Evaluation Reporting Standards checklist, which includes the content details, such as the type of study, population, intervention, comparator, probability, utility, duration, cost, model types and uncertainty measurements. As we try to explore the impact of the health economic studies in clinical practice, we will include citation metrics of each study and whether the study was cited by practice guidelines and clinical trials in the data extraction. We will also apply the JBI Checklist for Economic Evaluations to assess the reporting completeness in each article. Results will be tabulated by clinical theme and synthesised narratively to highlight patterns in valuation approaches, gaps in current methods and impact on clinical guidelines.

This study does not require ethical approval as it involves secondary analysis of published data. Findings will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagement activities.

CRD42024557324