To determine individual and community-level predictors associated with timely initiation of breastfeeding among women in Tanzania.

Analytical cross-sectional study.

This was an analytical cross-sectional study that used the 2022 Tanzania Demographic and Health Survey, which was conducted across all regions of Tanzania.

Data from 4308 women were included.

The outcome variable was timely initiation of breastfeeding, defined as starting breastfeeding within the first hour after birth, coded as 1 if timely and 0 otherwise. Mixed-effects generalised linear model (family- Binomial and link-logit) approach was used to account for the hierarchical structure of the data. Four models were constructed to assess individual and community-level predictors. Adjusted prevalence ratios (APRs) with 95% CIs were reported.

Women aged 25–34 years were significantly more likely to initiate breastfeeding within 1 hour (APR=1.40; 95% CI 1.18 to 1.65). Vaginal delivery was strongly associated with the timely initiation of breastfeeding (TIBF) (APR=10.13; 95% CI 7.84 to 13.09), whereas home delivery (APR=0.29; 95% CI 0.24 to 0.36) was negatively associated with TIBF. Multiparity (APR=1.22; 95% CI 1.04 to 1.43) increased the likelihood of TIBF. Women in the richest wealth category were less likely to practise TIBF (APR=0.70; 95% CI 0.51 to 0.96). Approximately 12.3% of the variation in TIBF was explained by cluster-level differences.

Both individual and community-level factors influence TIBF in Tanzania, highlighting the need for strong communication between mothers and healthcare providers to consistently promote its importance across all ages and wealth groups.

Urgent and emergency care (UEC) systems in England face unprecedented pressures, with record accident and emergency attendances, persistent breaches of ambulance response targets and poorer outcomes for time-sensitive conditions. National UEC recovery plans have introduced multiple innovations—such as same-day emergency care, virtual wards and specialty hubs—to manage these pressures and improve patient flow. Rural coastal areas are particularly vulnerable to excessive demand due to higher levels of deprivation, older populations with complex health needs, seasonal surges that generate unpredictable demand and challenges in attracting and retaining staff. Following the Chief Medical Officer’s 2021 Annual Report, funding research and developing bespoke solutions to manage UEC demand and address geographical disparities has been recognised as a national priority. The Elevate study responds to this priority by identifying and evaluating innovative models of UEC in rural coastal communities in England.

The Elevate study is a 30-month, mixed-methods evaluation that comprises three interlinked work packages: (1) National service mapping—outlining provision of innovative models of UEC in rural coastal areas of England. This will be developed through document review and interviews with regional and national service leaders. (2) Quantitative analysis—quasiexperimental and longitudinal approaches will use National Health Service (NHS) England’s Emergency Care Data Set and linked routine NHS datasets to evaluate the impact of UEC models on health and process outcomes. Standard and bespoke metrics will be developed and used to assess performance. (3) Qualitative case studies—up to 12 case studies of UEC models in rural coastal communities. Interviews with patients and staff and non-participant observation will explore how and why different UEC models influence patient experience, clinical outcomes, resource use and the workforce. Findings will be integrated using the Consolidated Framework for Implementation Research to identify components of UEC models that are effective, scalable and sensitive to local context,

Ethical approval for qualitative components was granted by the North of Scotland Research Ethics Committee (25/NS/0099). Dissemination will include peer-reviewed publications, policy briefs, creative media and community engagement activities to ensure findings are communicated inclusively and effectively to policymakers, health and social care practitioners and the public.

Research Registry (researchregistry11126).

Fibrosing interstitial lung disease (F-ILD) are a heterogeneous group of diseases with multiple subtypes. Both idiopathic pulmonary fibrosis and other ILDs associated with a risk of developing progressive pulmonary fibrosis (PPF) are subtypes of this category. A multidisciplinary team discussion, including a chest high-resolution CT (HRCT), is usually considered the gold standard for diagnosis of F-ILD. Repeated HRCT is one of several established methods to assess progression and thus development of PPF, but it is associated with substantial costs and radiation exposure. Thoracic ultrasound (TUS) and other ultrasound (US) methods have emerged as radiation-free methods for both diagnosing and monitoring disease severity in F-ILD. Yet, consistent knowledge on the use of different TUS- and US methods in patients with F-ILD is limited.

The LORD study is a prospective cohort study conducted in participants with F-ILD at a tertiary ILD centre in Denmark. Physiological testing and patient-related outcome measures, together with TUS- and US examinations, will be performed at inclusion, after 6 and 12 months. The correlations between these assessments will be evaluated. HRCT will be conducted between 3 months prior to and 1 month after baseline, and after 1 year. At least 34 participants will be included.

The protocol was approved by the Danish Data Protection Agency (journal number: 22/45135) and the Science Ethics Committee for the Region of Southern Denmark (journal number: S-20220036). Results will be published in peer-reviewed international journals and will be presented at an international congress.

NCT06844331.

Older people who identify as lesbian, gay, bisexual, trans, queer or other marginalised sexualities and gender identities (LGBTQ+) still face significant barriers and inequalities when accessing adult social care services. Little is known about the preparedness of the care workforce to support older LGBTQ+ individuals, particularly within home care services. While a few previous reviews have examined the perspectives of older LGBTQ+ people on the preparedness of the home care workforce, none have included the perspectives of the workforce itself or compared both perspectives. This is a protocol for a rapid review that aims to explore what is known about the preparedness and practice needs of the home care workforce to support older LGBTQ+ people, with a particular focus on workforce perspectives.

A rapid review method was selected to expedite the review process to support further study development and dissemination. Two electronic databases, SCOPUS and Web of Science, will be searched, as well as six subject-specific databases, including Social Care Institute for Excellence, Skills for Care, Social Care Wales, Homecare Association, Stonewall UK, LGBT Foundation UK and SAGE US. There are no search date restrictions. Study quality will be assessed using the Quality Assessment with Diverse Studies tool and the Grading of Recommendations, Assessment, Development and Evaluations considerations will be used to consider certainty of evidence. Data will be synthesised using narrative synthesis, including a descriptive summary of included studies and their methodological quality. All preferred reporting items for review protocols have been included, as recorded by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol.

Ethical approval is not required for the protocol and review. Manuscripts for the protocol and completed review will be submitted to a peer-reviewed journal, and findings will be shared in webinars for the home care workforce and at academic conferences.

CRD420251038242.

Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.

An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.

Online.

Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.

Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.

Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.

The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.

Treatment failure remains a major challenge in tuberculosis (TB) management. Rapid and objective assessment of treatment response is essential, as existing tools have limited accuracy and slow turnaround times. The PATHFAST TB LAM Ag assay (PATHFAST-LAM), an automated chemiluminescent enzyme immunoassay, was developed to quantify lipoarabinomannan (LAM) in sputum within 1 hour. Previous studies have shown a strong correlation between sputum LAM concentration and culture-based bacterial load. However, its clinical utility for predicting poor outcomes during treatment has not been prospectively evaluated.

We will conduct a prospective longitudinal study enrolling newly diagnosed, bacteriologically confirmed patients with pulmonary TB at Rhodes Chest Clinic and Mbagathi County Referral Hospital in Nairobi, Kenya. We will follow participants throughout the 6-month treatment course, attempting to collect sputum weekly during weeks 1–4, biweekly during weeks 5–12 and monthly during months 3–6. We will measure LAM concentrations at these time points using the PATHFAST-LAM assay. The primary outcome is to assess whether changes in sputum LAM concentration during the intensive phase (baseline to week 4 and/or week 8) predict a composite poor outcome, defined as positive sputum culture at month 6, treatment failure, death during treatment or relapse within 3 months after treatment completion. The primary endpoint is the area under the curve from the receiver operating characteristic analysis, representing the predictive performance of changes in sputum LAM concentration for the composite poor outcome. We will identify the optimal cut-off value for LAM change and estimate sensitivity and specificity with 95% CIs using 2x2 tables. We will apply an adaptive design that allows sample-size re-estimation after interim analysis.

The study was approved by the Kenya Medical Research Institute (KEMRI/SERU/CRDR/124/5241) and Nagasaki University (250619327). Findings will be disseminated through peer-reviewed publications and scientific meetings.

NCT07157904.

Self-efficacy is a major factor in enabling individuals to follow behavioural goals. This applies to health behaviours including physical activity and exercise behaviour, a health topic especially important for persons suffering from health conditions. In subjects with already existing conditions, self-efficacy in exercise behaviour is a research field with a high volume of published articles, yet it has never been charted in its entirety. This systematic evidence map (SEM) provides a comprehensive overview of the current state in published empirical research.

Collecting, categorising and visualising the breadth of evidence via SEM following the Methods of Evidence Mapping by Schmucker et al.

Medline (via PubMed) and PsycINFO (via EbscoHost).

We searched for the terms ‘self-efficacy’ and any of the search terms ‘sport’ and ‘exercise’ in titles and abstracts. We included all empirical research studies published until 2022 that measured self-efficacy in relation to exercise. This SEM includes all studies on humans with a pre-existing condition. We extracted the data points authors, title, year, sample size (N), age groups, pre-existing condition(s), surveyed sport and method of measuring self-efficacy.

We extracted the data points from the full text (if available). In addition to a data table, we created a freely accessible evidence map in the form of graphs in this article.

The number of publications grew over time from single publications per year in the 1980s to over 100 per year in the beginning of the 2020s, adding up to 1342 included studies. Most research focuses on middle-aged and older adults. Research covers a wide variety of conditions, with endocrine, nutritional and metabolic diseases (22%) as well as diseases of the circulatory system (19%) being the most common disease groups. Most included studies (71%) do not specify a sport. Most (55%) papers used validated scales to measure self-efficacy, and we discovered 235 individually named scales among them.

This paper offers the first ever comprehensive list of empirical publications on self-efficacy in exercise behaviour in persons with pre-existing conditions in the form of a SEM. The research field was as wide as anticipated concerning total numbers, number of individual scales for measuring self-efficacy, as well as range in diagnosed conditions. Most research focusing on advanced age may be due to many diseases only manifesting later in life, and the lack of specification in types of sport points to the choice of sport being less important than getting enough exercise in general. Future research should examine the strength of evidence and the robustness and comparability of self-efficacy scales as well as underrepresented disease groups for public health considerations.

Since no primary data was collected, an ethics approval is not required for the presented work. In addition to the result being disseminated via the publication at hand, the data is being shared in detail via the Open Science Framework platform.

Health literacy (HL) is essential for making informed health-related decisions, for example enabling parents to reduce their child’s allergy risk. Health literacy does not, however, rely solely on an individual’s capacities, but is strongly influenced by external factors. Midwives provide important health advice to families, particularly since their relationship is close during a time of significant transition. This offers them a unique opportunity to positively influence the HL of parents, which in turn may support the health and well-being of the whole family. The aim of this study is to develop and evaluate an intervention that can support midwives in providing allergy prevention advice in a way that is in line with the concept of HL.

In accordance with the recommendations of the Medical Research Council framework in the first phase of this study, we will survey midwives (target sample size=379) in Germany regarding their practices, the potential barriers they face and enabling factors in providing advice on early childhood allergy prevention in an HL-responsive way. The data will be subjected to descriptive statistical analysis. Two co-design workshops will then be conducted with various stakeholders in two regions (Rhineland-Palatinate and Saxony) of Germany. Following the protocol proposed by the Stanford Design Thinking School, we will use design thinking to collect ideas for the intervention. Based on these ideas and our previous qualitative and quantitative study, we will develop an intervention in collaboration with didactic experts. The intervention will be piloted in three groups (midwives=10–15, midwives working as practice supervisors=5–10, students of midwifery=10–20). For the process evaluation, we will use observation protocols of the intervention conduct and qualitative interviews. For the outcome evaluation, we will use a questionnaire and observations in simulation laboratories with students of midwifery.

This study protocol was approved by the Ethics Committee of the University of Regensburg (ID 23-3441-101) and is in compliance with the Declaration of Helsinki. Participation in the study will only be possible after informed consent has been given. Our results will be presented at national and international conferences and published in scientific journals. Additionally, once it has been finalised, we will make the intervention available to educational institutions for (future) midwives.

Dysphagia, or difficulty in swallowing, significantly impacts the quality of life of the affected individuals. Diagnostic approaches, including video fluoroscopic swallowing studies and flexible endoscopic evaluation of swallowing, are the most commonly used methods for assessing swallowing function. Recent advancements have led to the development of artificial intelligence (AI), including machine learning (ML) and deep learning (DL), which will provide innovative approaches to dysphagia diagnosis and treatment planning. There is a limited synthesis of literature on AI tools in dysphagia. There is an urgent need for a more rigorous and structured scoping review that can address the existing gaps, provide a more comprehensive evidence synthesis, and establish clearer guidelines for the clinical implementation of AI in assessments and management of dysphagia. This review will include studies focusing on AI tools such as ML, DL and computer vision for assessing and managing dysphagia. The context will be clinical or therapeutic settings, and all language articles will be considered for the review. Studies not involving AI technologies, those without clinical outcomes and ethical approval, and those focusing solely on the paediatric population will be excluded. This scoping review will systematically map and synthesise the existing literature on the use of AI tools for the assessment and management of dysphagia.

This scoping review will follow JBI methodology and PRISMA ScR guidelines. Information to be searched from January 2000 to May 2025 will include MEDLINE (via Ovid), Scopus, CINAHL (via EBSCOhost), Cochrane Library, JBI Evidence Synthesis, ProQuest and Google Scholar. The titles, abstracts and full texts will be screened by two independent reviewers. Data extraction will use a study-specific customised form, with descriptive analysis employed to categorise studies by AI tools and outcomes.

Ethical approval is not mandatory for this scoping review as it does not entail the collection of any individual patient data. Secondary data from publicly accessible research papers will be used. All the data sources will be appropriately cited. The findings will be propagated through peer-reviewed publications and scientific presentations.

Open Science Framework: DOI 10.17605/OSF.IO/DYCE9.

To estimate condition-specific patient travel distances and associated carbon emissions across common chronic diseases in routine National Health Service (NHS) care, and to assess the potential carbon savings of modal shifts in transportation.

Retrospective population-based cohort study.

NHS Greater Glasgow and Clyde, Scotland.

6599 patients aged 50–55 years at diagnosis, including cardiovascular disease (n=1711), epilepsy (n=1044), cancer (n=716), rheumatoid arthritis (RA; n=172) and a matched control group based on age, sex and area-level deprivation (n=2956).

Annual home-to-clinic distances and associated carbon emissions modelled under four transport modes (petrol car, electric car, bus, train) across five time points: 2-year prediagnosis, diagnosis year and 2-year postdiagnosis.

Mean annual travel distances to hospital varied by condition and peaked at diagnosis. Patients with cancer had the highest travel distances (161 km/patient/year for men; 139 km/patient/year for women), followed by RA (approximately 78 km/patient/year). The matched control group travelled 2/patient/year to 8.0 kg CO₂/patient/year. Bus travel resulted in intermediate emissions, estimated between 10.5 and 8.0 kg CO₂/patient. When travel was modelled using electric vehicles, emissions dropped between 3.5 and 2.7 kg for all conditions. Train travel produced similarly low emissions. Reducing petrol car travel from 100% to 60% lowered emissions up to 6.6 kg CO₂/patient.

Condition-specific estimates of healthcare-related travel emissions provide baseline understanding of the opportunities and challenges for decarbonising healthcare. Emission reduction is most achievable through modal shift, yet such shifts depend on factors beyond NHS control—such as transport infrastructure, digital access and social equity. Multisectoral strategies, including targeted telemedicine and integrated transport and urban planning, are critical to achieving net-zero healthcare while maintaining equitable access to care.

To conduct a synthesis of existing empirical and grey literature to identify the contexts and mechanisms that enable the adoption, offer, uptake and return of faecal immunochemical testing (FIT) in the primary care pathway in England, UK, for patients with signs or symptoms of suspected colorectal cancer (CRC). From this, develop a theory about how specific programme activities lead to certain outcomes.

A realist synthesis.

Medline (OVID), EMBASE (OVID), CINAHL (EBSCO), Scopus (Elsevier) and grey literature sources until end of July 2023.

The purpose of the work was to determine how different factors interact within a health system to optimise the approach to implementing and using symptomatic FIT (sFIT) in clinical practice for patient benefit. The criteria used to bound the scope of the synthesis included date (published between 2017 and July 2023), exposure of interest (sFIT in the primary care pathway for patients with signs or symptoms of suspected CRC), geographic location of study (countries that make up the UK), language (English) and participants (adults). Any study design and type of publication was considered.

Given the recognised lack of literature on the implementation of sFIT, it was crucial to include insights from grey literature. To do this, key national groups and organisations—involved or related to this subject—were methodically identified and appropriate papers and reports identified.

A thematic approach was used to identify relevant data in included records and allow realist insights to be obtained. Inductive and deductive coding enabled detection of key data. Arguments were generated and developed into context–mechanism–outcome configurations (CMOCs). Iteratively, an initial list of 38 CMOCs was refined to 14 themes and 19 CMOCs. These were then structured to create a multifaceted, multilevel realist synthesis programme theory.

Systematic searching led to the full appraisal of 99 records to determine suitability of each to confirm, refute or help develop theory. Studies were assessed for rigour and relevance to inform selection. The process resulted in 45 records being chosen for inclusion, of which 28 were from database searches and 17 from grey literature sources.

The key contexts and mechanisms that help optimise adoption, offer, uptake and return of sFIT have been elucidated (although partially). These can be broadly summarised into the 10 ‘Cs’: creating a compelling Case and Conditions for change, reaching Consensus through Collaborative working, fostering a Culture that values Clinical judgement, building Confidence by developing Capabilities and, finally, ensuring Clarity and Coherence of both practical processes and safety netting procedures.

Fundamentally, optimising the adoption, offer, uptake and return of sFIT in primary care for patients with signs or symptoms of suspected CRC is predicated on developing the acceptability of this initiative to every stakeholder at every level within a health system.

Tuberculosis (TB) is a major global cause of morbidity and mortality. Emerging evidence in high-burden settings suggests significant long-term sequelae among people surviving TB; however, evidence from high-income, low-TB burden settings like Canada is lacking. In a person with TB infection, provision of TB preventive treatment (TPT) can prevent TB disease and its sequelae, but remains underused. We propose the Functional Outcomes, Lung health and Livelihood Outcomes among people With Tuberculosis study, a multicentre, prospective cohort study in Canada to help improve our understanding of the impacts of TPT and TB disease on individuals.

This is a prospective cohort study taking place in Montreal and Vancouver, Canada. We aim to recruit and retain at least 120 people with microbiologically confirmed TB disease, 340 people treated for TB infection and 120 without TB disease or infection who will be considered our unexposed group. All participants must be ≥6 years of age. Participants with TB disease or infection will be recruited within 2 weeks of treatment initiation. We will follow-up unexposed participants and participants with TB disease for 24 months, and participants with TB infection for 12 months. Throughout follow-up, participants will complete assessments measuring lung health and function, quality of life, disability, dyspnoea, psychological distress, as well as changes in employment and direct and indirect costs incurred because of treatment. Among participants with TB disease, our primary outcome is the difference in quality-adjusted life years between participants with TB disease and those unexposed at 24 months. For participants with TB infection, our primary outcome is the identification of non-patient characteristics (eg, patient cost, quality of life) associated with participant decision to discontinue treatment. Patient partners have contributed to the design of the study and will be involved with the study through to its dissemination.

This study has been approved by institutional ethics review boards at The Research Institute of the McGill University Health Centre (2025–10344) and The University of British Columbia (H24-02071). All participants will provide informed consent (and assent, if required) prior to participating in the study. We will disseminate study results to participants, national and international organisations, and through open-access peer-reviewed academic journals and conferences.

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

ISRCTN17922845.

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.

Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2–N3).

The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).

The study population consists of patients with operable OSCC and advanced nodal disease (N2–N3), adequate organ function, aged 18–65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.

This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies.

CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Australia-wide.

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

ISRCTN68786622.

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m² and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

ISRCTN68786622.

Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.

Cleft lip and palate significantly impact a child’s speech and facial appearance. Children undergo cleft repairs in infancy, but poor results from these initial repairs often lead to secondary surgery. In the late 1990s, cleft care provision in the UK was centralised to approximately 11 managed clinical networks or centres. This centralisation has been associated with improvements in speech and aesthetic outcomes, but little is known about the effect of centralisation on the use of secondary surgery. The purpose of this study was to compare the cumulative incidence of secondary cleft surgeries before and after centralisation and the proportion of children achieving good clinical outcomes without secondary surgery.

Retrospective, cross-sectional.

Two cross-sectional studies of 5-year-old children with non-syndromic unilateral cleft lip and palate were conducted, one precentralisation and one postcentralisation.

The cumulative incidence of secondary surgery from birth through age 5 was compared precentralisation and postcentralisation using Fisher’s exact test, as were facial appearance and speech outcomes at age 5. Risk ratios (RR) were estimated using log-binomial multivariable regression models that adjusted for sex and age at evaluation.

Postcentralisation, the proportion of children achieving good or excellent facial appearance increased from 16% to 42% (p

Centralisation of cleft care was associated with improved outcomes of primary lip and palate repairs and a corresponding reduction in secondary surgery.