To qualitatively explore patients’ lived experiences and coping mechanisms following mitral valve replacement (MVR) at the National Cardiac Institute in Tanzania.

A descriptive qualitative study using in-depth interviews and thematic analysis.

The study was conducted at the National Cardiac Institute, located in Dar es Salaam, the sole tertiary cardiac centre in Tanzania offering open-heart surgery.

17 participants were purposively sampled. Inclusion criteria were as follows: patients aged ≥18 years, had at least 28 days post-MVR, without chronic conditions (eg, diabetes and HIV) and attending postoperative cardiac clinics.

Semi-structured interviews conducted in May 2024 using an interviewer guide explored post-MVR challenges, daily life adjustments, patient-provider interactions and coping strategies. Thematic analysis was employed to identify key themes.

Three primary themes emerged: (1) Quality of life after MVR, encompassing physical, social, economic and psychological challenges; (2) Quality of care after MVR, highlighting patient-provider interactions and access to services; and (3) Adapting to post-MVR life, including psychological adaptation and lifestyle modification. Participants reported improved quality of life through shared experiences and support.

Patients experienced physical, socio-economic and psychological challenges post-MVR. However, quality of life improved through access to care, peer support and adaptive coping. Adaptation to life with an artificial valve is feasible with robust support systems, even in resource-limited settings.

The first objective was to establish the feasibility of conducting a definitive trial to evaluate the effectiveness of mobility and strength training with or without protein supplements for pre-frail/frail older people with low protein intake. The second objective was to finalise outcome measures for a definitive trial.

Multicentre feasibility randomised controlled trial.

Four National Health Service (NHS) community trust physiotherapy departments. We recruited via clinical caseloads, an existing cohort study and community advertising. Participants were adults aged ≥60 years, frail or pre-frail, reporting walking difficulties or slow walking and low protein intake (

All participants undertook two times a week mobility and strength training supported by a physiotherapist for 24 weeks. Half of the participants were randomised (1:1) to receive 24 weeks of daily protein supplements to increase protein intake up to 1.6 g/kgBW/day.

Feasibility outcomes assessed recruitment, intervention fidelity, adherence, tolerance and study retention.

We assessed clinical data collection at baseline and 5–8 month follow-up including the short physical performance battery (SPPB), 6 min walk test (6MWT) and participant-reported outcomes. Outcome assessors were blinded.

All participants were analysed in the groups as randomised provided they were not withdrawn from the study before their treatment started and contributed outcome data (modified intention to treat). Our primary feasibility and secondary outcome measures were summarised using descriptive statistics such as mean and SD, median and IQR or counts with percentages. Secondary objectives were exploratory, and mean between group differences at follow-up were estimated for each continuous outcome using linear regression models adjusted for baseline outcome score and frailty status, and presented with associated 95% CIs.

Initially, recruitment focused on existing caseloads, but patients were more unwell and disabled than anticipated and ineligible. No participants were recruited from the cohort. A community recruitment strategy was implemented. We screened 952 older adults and 20 participants were randomised. We ran out of time to reach our target.

We achieved good intervention fidelity for both interventions. The median number of exercise sessions completed was 10.5/16 (IQR 7–13). Six participants received supplements which they tolerated well and took regularly. 14 participants (70%) attended follow-up assessments with no difference in retention between arms.

The median age of participants was 76 years (IQR 68.5–80.0) and 15/20 (75%) were frail. All clinical outcomes showed a trend towards larger improvements in the exercise and protein arm, but these were not statistically significant. For example, SPPB scores (mean difference 0.93, 95% CI (–2.70 to 4.56)) and 6MWT (mean difference 41.92 m, 95% CI (–39.05 to 122.89)) were both higher in the exercise and protein arm compared to control.

The study was not feasible based on the original protocol. Recruitment was the biggest challenge. We established a more efficient route to recruitment (community advertising) which requires further refinement. Clinical outcomes consistently favoured the exercise and protein group, which should be interpreted cautiously but suggest this question is worthy of further investigation.

ISRCTN30405954.

To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.

Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.

SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.

We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.

From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.

Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.

Pay-for-performance (P4P) programmes are increasingly implemented in healthcare to improve quality of care, but their application in dentistry remains limited. Evidence-based approaches are needed to guide incentive design in value-based dental care, particularly for preventive services, such as topical fluoride application in children. We sought to assess the potential cost-effectiveness of P4P incentives for increasing topical fluoride application among children and to illustrate how simulation modelling can identify conditions under which subgroup-specific incentive levels may be optimal.

We developed and validated a decision-analytic microsimulation model using nationally representative data from the National Health and Nutrition Examination Survey (NHANES 2011–2016) to simulate a cohort of 100 000 US children aged 0–19 years over a 10-year period starting in 2024. The model incorporated heterogeneity in demographic and clinical characteristics to estimate changes in dental caries, quality-adjusted life years (QALYs) and healthcare costs under hypothetical P4P programmes that increased topical fluoride coverage by 2.5% to 50% relative to the baseline rate of 24.5%, with incentive amounts ranging from 2.5% to 50% of provider salary. Sensitivity analyses assessed robustness to variation in key parameters.

Cumulative incidence of dental caries, QALYs, total healthcare costs and incremental cost-effectiveness ratios (ICERs).

Across a broad range of incentive–coverage combinations, P4P incentives were generally cost-effective. For example, a 10% salary-based incentive linked to a 5% relative coverage increase reduced 186.3 cases of tooth decay and yielded 33.8 QALY gains per 10 000 children, resulting in an ICER of $8501 per QALY gained. The intervention was estimated to be cost-saving at coverage increases ≥27.5%. Subgroup analysis indicated larger absolute benefits among racial/ethnic minority children.

P4P incentives to increase topical fluoride application in children could be cost-effective, and potentially cost-saving, under certain conditions. Cost-effectiveness modelling can help define incentive–coverage combinations that are likely to promote both efficiency and equity. Empirical studies are needed to validate provider responsiveness and establish achievable benchmarks for programme design.

Prostate cancer diagnosis and treatment planning depend on accurate histopathological assessment of needle biopsies, particularly through the Gleason scoring system. The inherently subjective nature of the grading creates variability between pathologists, potentially resulting in suboptimal patient management decisions. These reproducibility challenges extend beyond Gleason scoring to encompass other critical diagnostic and prognostic markers, including cancer volume quantification and detection of cribriform morphology patterns and perineural invasion. Artificial intelligence (AI) applications in digital pathology have emerged as promising solutions for enhancing diagnostic consistency and accuracy, with recent research demonstrating that automated systems can match expert-level performance in prostate biopsy evaluation. Nevertheless, comprehensive validation studies have revealed concerning limitations in model generalisability when deployed across different clinical environments and patient populations. Recent systematic reviews revealed widespread risk-of-bias limitations and insufficient external validation in AI diagnostic studies, highlighting critical needs for accumulated evidence supporting generalisability before clinical implementation. Rigorous external validation with preregistered protocols using independent datasets from diverse clinical settings remains essential to establish the reliability and safety of AI-assisted prostate pathology systems.

This study protocol establishes a framework for the retrospective external validation of an AI system developed for prostate biopsy assessment, to be conducted on the case-control samples of the National Prostate Cancer Register of Sweden, ProMort study (1998-2015). The primary aim is to evaluate the AI model’s diagnostic accuracy and Gleason grading performance using completely independent datasets separate from any model development or previously used validation cohorts. The diversity of the validation samples, spanning multiple geographic regions, temporal collection periods and reference standards, allows evaluation of model robustness across varied clinical contexts. Secondary aims encompass evaluating AI performance in cancer length estimation and detection of cribriform patterns and perineural invasion. This protocol delineates procedures for data collection, reference standard clarification and prespecified statistical analyses, ensuring comprehensive validation and reliable performance assessment. The study design conforms to established reporting guidelines Checklist for Artificial Intelligence in Medical Imaging (CLAIM) and Standards for Reporting Diagnostic Accuracy Studies using Artificial Intelligence (STARD-AI), and recognised best practices for AI validation in medical imaging.

Data collection and usage were approved by the Swedish Regional Ethics Review Board and the Swedish Ethical Review Authority (permits 2012/1586-31/1, 2016/613-31/2, 2019-01395, 2019-05220). The study adheres to the Declaration of Helsinki principles, and findings will be made available in open access peer-reviewed publications.

Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.

The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.

STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.

The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.

CTIS EU 2024-514620-17-00

In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

To explore how parents of children with de novo retinoblastoma (RB) experience the diagnostic process and acute treatment phase, and to identify factors that may support parental coping and adaptation.

A qualitative interview study using reflexive thematic analysis.

National Retinoblastoma Unit at Aarhus University Hospital, Denmark.

Thirty-one parents (21 mothers, 10 fathers) of 21 children diagnosed with de novo RB were recruited via hospital follow-up clinics and a support group day.

For most parents, the diagnostic process was short. In cases of diagnostic delay, parents described frustration and guilt due to missed symptoms. Receiving the RB diagnosis was described as a surreal experience, accompanied by feelings of shock, grief and loss of control. Parents faced challenges in adapting to rapid medical decisions and the unfamiliar demands of hospital protocols. However, meeting the clinical experts was a relief, as parents felt they were in capable hands, experiencing empathetic communication and a clearly framed treatment plan. Parents emphasised the importance of support systems, including family, healthcare professionals and the child’s resilience, as crucial for coping with and managing the diagnosis.

Parents faced a sudden and disruptive transition from symptom recognition to life-altering diagnosis and treatment. While professional care and communication were experienced as supportive, they did not eliminate the emotional impact. Clinical pathways should prioritise early validation of parental concerns and provide transparent communication, both prior to referral and throughout treatment. Future research should examine longer-term parental adjustment and identify interventions that support emotional resilience beyond the acute phase.

To examine the effects of 12 weeks group-based peer-led aquatic high-intensity interval training (AHIIT) compared with aquatic moderate continuous training (AMICT) on patient-reported outcome measures (PROMs) and quality-adjusted life-years (QALYs).

A single-blind, parallel-group, randomised trial with a 1:1 allocation ratio.

Community-based setting.

89 participants (mean age 62 (SD 13) years) with rheumatic and musculoskeletal diseases, including hip and knee osteoarthritis, fibromyalgia, rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, were randomly allocated to an AHIIT (n=44) or an AMICT (n=45) group.

The intervention consisted of AHIIT (four intervals of 4 min at high intensity, Borg scale 14–18) or AMICT (Borg scale 12–13), conducted twice weekly for 12 weeks.

Outcomes included disease activity (measured by the Patient Global Assessment), fatigue, pain and health-related quality of life (HRQoL), measured by the EQ-5D utility index (five-dimensional health status measure) and EQ VAS (self-rated overall health scale) for overall health, physical and social activities. All outcomes were assessed at baseline, 3 months and 6 months. To compare the overall benefit of these interventions, QALYs were estimated based on HRQoL. Linear mixed models for repeated measures were used to estimate the mean difference (95% CI) in outcomes.

No statistically significant differences between the groups were found in any outcomes at either three or 6 months (p>0.05).

No difference between the groups was found on PROMs and QALYs. Future research should include larger sample sizes and a non-exercising control group to better determine the efficacy of AHIIT and clarify the role of exercise intensity in symptom management.

NCT05209802.

The utility of brain MRI in dementia diagnosis offers critical insights into structural brain changes, such as hippocampal and thalamic atrophy, which are hallmark features of Alzheimer’s disease and Alzheimer’s disease-related dementias . However, its use, especially in low- and middle-income countries (LMICs), is affected by limited accessibility. This protocol outlines a systematic review and meta-analysis to assess the diagnostic utility, feasibility and challenges of integrating brain MRI for dementia diagnosis in LMICs.

The review follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols with a priori eligibility criteria and is registered in PROSPERO. Searches (from inception to September 2025) will be run in MEDLINE/PubMed, EMBASE, Web of Science and PsycINFO, with supplementary bibliography screening. Adults ≥50 years in LMIC settings undergoing brain MRI for dementia evaluation will be eligible. Data will be synthesised narratively and, where appropriate, via random-effects meta-analysis with planned subgroup analyses by MRI approach (qualitative vs quantitative), magnet strength, sequence availability and reference standard. Screening and data extraction are planned for 1 November to 30 December 2025.

Ethical approval was obtained from the Makerere University School of Medicine Research and Ethics Committee (Mak-SOMREC; Ref Mak-SOMREC-2022-337). For verification, contact the SOMREC Administrator at rresearch9@gmail.com. Departmental contact: Dr Geoffrey Erem, Head, Department of Radiology, Makerere University College of Health Sciences (dreremgeoffrey@gmail.com). Only published data will be used, with no new patient contact. Findings will be disseminated via peer-reviewed publication, conference presentations and policy briefs (and, where feasible, mainstream media) to inform clinical practice and training in LMICs.

CRD42024510241.

The prevalence of depression and mood disorders has been steadily rising in Australian youth, with a concomitant increase in antidepressant pharmacotherapy prescription rates. Yet, the tolerability and efficacy of antidepressant drugs in youth remain poor. Pharmacogenetic (PGx) testing, or the personalised and guided treatment of medication based on genetic data, has been suggested to improve the effectiveness and tolerability of antidepressants. However, limited studies have evaluated the utility of antidepressant PGx-guided treatment in adolescent and young adult populations. Thus, this pilot randomised controlled trial (RCT), the GENE-YD Study, will evaluate the feasibility for a large-scale RCT assessing the effect of PGx-guided antidepressant prescription vs treatment as usual in youth with major depressive disorder (MDD).

Eighty young people between 16 and 24 years of age and in the early stages of pharmacotherapy treatment for MDD will be recruited. Following initial screening, participants will be randomised on a 1:1 ratio to either the intervention or control study group. Participants in the intervention condition will have their treatment tailored based on their PGx profile. Participants randomised into the control group will have their prescription based on current best practice recommendations, or treatment as usual. Individuals will be assessed at drug prescription baseline and again 6 and 12 weeks following drug prescription. The primary outcome of the study will be to evaluate the feasibility and acceptability of the GENE-YD protocol. Specifically, this study will explore participation recruitment strategies and attrition to the study protocols to guide the recruitment processes of a large-scale RCT, along with participating satisfaction in overall study protocols. Secondary outcomes will inform the utility and variability of specific measures (eg, depression rating scales, quality of life measures and medication adherence scales) that may be scaled up for use in a future full-scale trial.

Ethics approval was granted by the Department of Health, Western Australia’s Human Research Ethics Committee (RGS0000006822) and recognised by the University of Western Australia’s Human Research Ethics Committee (2024/ET000685). All participants will be required to provide written informed consent. Results will be published in international peer-reviewed journals.

ACTRN12624000760572.

Implementation science research increases the uptake of evidence-based interventions, which may improve health equity among racial and ethnic minorities. However, it is unclear how anti-racism and anti-colonialism practices have been integrated into implementation science research. The objectives of this scoping review are to describe the current conceptualisations of racism and colonialism within the USA, examine racism or colonialism-conscious approaches and analyse gaps in the operationalisation of anti-racism or anti-colonialism within implementation science studies.

This scoping review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews guidelines. The Center for Chronic Disease Reduction and Equity Promotion Across Minnesota conceptual framework and an implementation science anti-racism lens will guide the study design and analysis. To determine study eligibility for the scoping review, articles will undergo abstract and full-text screening by two independent reviewers and discrepancies will be settled together. Data charting will be extracted from included articles by eight independent reviewers. The search strategy will use controlled vocabulary and natural language keywords related to health equity, health disparities and anti-racism/colonialism on six databases. The scoping review will include studies that applied implementation science theories, models or frameworks among US-based populations. Additionally, included studies will report any of the following implementation activities: implementation strategies, implementation outcomes, adaptations to evidence-based interventions, or evaluations of pre-implementation or implementation context.

No ethical approval was required for the scoping review. Dissemination will be through publication in a peer-reviewed journal and conference presentations.

The development of the target trial emulation (TTE) methodology has enhanced the conduct of non-randomised studies. By leveraging readily available routinely collected data, TTEs offer opportunities for complementing randomised controlled trials (RCTs), providing more precise estimates and improving the external validity of RCTs. To explore this potential, we selected a successfully completed RCT as a case study. In the FIRST-line support for Assistance in Breathing in Children (FIRST-ABC) step-up RCT, high flow nasal cannula (HFNC) was found to be non-inferior to continuous positive airway pressure (CPAP) in terms of time to liberation from respiratory support in the paediatric critical care setting. We will emulate the FIRST-ABC step-up trial using routinely collected data from the Paediatric Intensive Care Audit Network (PICANet) database.

This is a protocol for a TTE that will use longitudinally collected data from the PICANet database. The study aims to emulate the FIRST-ABC step-up RCT using an observational study design in a frequentist framework. We will benchmark the results against the published trial. The study will apply a new-user design by selecting children admitted to paediatric intensive care units that started HFNC or non-invasive ventilatory support (as a surrogate for CPAP). The eligibility criteria and selected outcomes will reflect those of FIRST-ABC within the constraints of the available routinely collected data. We will use advanced quantitative doubly robust methods to minimise the impact of confounding by indication and allow for heterogeneity according to child characteristics. The analysis will be repeated using a Bayesian approach for follow-up research.

The research received ethics approval from the London School of Hygiene & Tropical Medicine Research Ethics Committee. This study will expand the findings from the FIRST-ABC step-up RCT, providing additional insight from a large representative sample using real-world data. The frequentist and Bayesian approaches will enable a discussion about the advantages and drawbacks of the two strategies. The results will be disseminated to the research and clinical community and made accessible to the public. In addition, the study results will be used in future research, which aims to supplement RCTs with additional evidence from a TTE.

To determine the association between rates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection following home, community and work-related exposures, to assess real-world relative vaccine effectiveness, and to determine whether anti-receptor-binding domain (RBD) IgG levels were associated with the rates of subsequent infection.

Prospective cohort of 34 months’ duration (February 2021 to December 2023).

Teachers and education workers working ≥8 hours per week in the Canadian province of Ontario.

3155 education workers were eligible for the risk factor analysis; 2977 for the serological analysis.

Rate of SARS-CoV-2 infection.

1909 SARS-CoV-2 infections were reported (0.93 per 1000 participant-days); the highest incidence occurred during the period dominated by the Omicron BA.2 variant (2.01 per 1000 participant-days). Rates of infection were significantly higher following the repeal of the mask mandate. Compared with participants without known contact with an infected person, those in close contact with infected adult or child household members (adjusted HR (aHR) 1.43; 95% CI 1.24 to 1.65 and 1.39; 95% CI 1.17 to 1.65, respectively), coworkers (aHR 1.28; 95% CI 1.10 to 1.50), or individuals from more than one setting (aHR 1.44; 95% CI 1.27 to 1.64) had higher rates of infection. Participants with three or more doses of vaccine were 79%–87% less likely to develop SARS-CoV-2 than participants who had two or fewer vaccine doses. Blood samples with anti-RBD antibody levels in the highest quintile (≥5850 binding antibody unit/mL) were associated with a lower rate of subsequent infection (aHR 0.40; 95% CI 0.23 to 0.72) compared with samples with RBD levels below the threshold of detection.

Risk of SARS-CoV-2 infection in education workers occurred at home as well as the workplace, indicating the need to practise multiple intervention strategies whenever the potential for transmission of respiratory diseases is high. COVID-19 vaccines provided protection through December 2023.

The study aimed to assess the trends and factors associated with modern contraceptive use among female youths (15–24 years) in Tanzania from 2004 to 2022.

We performed secondary analysis of cross-sectional data from four consecutive Demographic and Health Surveys (DHS) in Tanzania: 2004, 2010, 2015/2016 and 2022.

Tanzania.

Sexually active female youths (n=8659).

The use of any modern contraceptive method, coded as Yes or No.

The sample had a median age of 21 (IQR 18–22 years), with 63.7% aged 20–24 years. Modern contraceptive use among female youths increased from 24.6% in 2004 to 32.1% in 2022. Consistent across surveys, modern contraceptive use was positively associated with secondary or higher education level, having one or more live births and engaging in sexual activity within the month preceding the survey. Additionally, adolescents (15–19 years) demonstrated a weak protective association, indicating a reduced likelihood of modern contraceptive use compared with young women (20–24 years). In 2015/2016 and 2022 surveys, primiparous, multiparous and married/cohabiting women were more likely to use modern contraceptives than nulliparous women.

Modern contraceptive use among female youths increased gradually in Tanzania between 2004 and 2022 Tanzania DHS. To sustain these upward trends and reduce the risk of unwanted pregnancies and sexually transmitted infections, public health policies should consider the factors positively associated with modern contraceptive use, particularly among young women aged 20–24 years, married/cohabiting, who have initiated childbearing and those with high education levels.

Food insecurity is increasing in the UK, impacting choice and diet quality. The current means-tested free school meals (FSM) policy was put in place to address dietary inequalities and food insecurity in school children. In secondary schools, approximately 20% of students who are eligible and registered do not take their FSM. Working across a range of schools that have variable levels of FSM uptake, this study aims to evaluate the effectiveness and cost-effectiveness of the current means-tested FSM policy in UK secondary schools on diet and food insecurity outcomes, understand what factors are associated with uptake and test the potential impact of any proposed policy change.

Secondary schools (n=32) in both Northern Ireland and the Midlands region of the UK are being recruited into the study. Data will be collected from school staff, governors, students and parents via questionnaires, as well as observational data of school eating environments. Qualitative data will be collected in selected case study schools (n=6–8). Multilevel modelling will be undertaken to evaluate the association between FSM uptake and fruit and vegetable intake, overall diet quality and food insecurity in all students. Economic evaluation will be conducted using a cost–utility approach. The effect of policy change will be modelled and school factors associated with FSM uptake explored using multiple methods.

Ethical approval has been obtained from Queen’s University Belfast Faculty of Medicine, Health and Life Sciences Research Ethical Committee (MHLS 23_55). Findings will be disseminated to key national and local agencies, to schools through reports and presentations, and to the public through media and open access publications.

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

CRD420251011399.

Head and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work.

Getting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.

The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement.

The trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist.

ISRCTN13855775.

Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Cross-sectional survey study, as part of a larger prospective cohort study.

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.