Robotic rehabilitation on locomotion is a new approach in amyotrophic lateral sclerosis (ALS) and previous studies showed its feasibility. In this study, we aim to evaluate safety, patient’s experience and efficacy of a gait training programme with the Atalante exoskeleton, compared with usual care, on walking ability, functional capacity and other symptoms associated with ALS.

EXALS is a monocentric, prospective, interventional, open trial. 20 slowly progressing patients with gait deficits will be recruited. The study is conducted in three phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients practise their gait training at a rhythm of three sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment. An evaluation is planned before, in the middle and at the end of each phase. The primary outcome of the study is safety and tolerability of the Atalante exoskeleton. Secondary outcomes include: participants’ subjective impact and experience, attitude and motivation, efficacy and interactivity of the exoskeleton, walking ability, functional capacity, spasticity, balance, postural stability, lower limb muscle strength, quality of life, pain, fatigue, anxiety and depression. Statistical analyses will include descriptive methods for all variables and adverse events. Quantitative outcomes are analysed using repeated-measures ANOVA (analysis of variance) across the seven visits, with post hoc tests applied when appropriate. Nominal outcomes are evaluated using Cochran’s Q test with McNemar pairwise comparisons when significant. Associations between variables are examined using Spearman correlation coefficients. Missing data will be replaced using linear interpolation, and sensitivity analyses will be planned. Qualitative interview data are analysed using thematic analysis.

This study was approved by the French ethics committee CPP Nord-Ouest I (no. 23.02378.000201). Participant data are anonymised and securely stored in the laboratory’s database, accessible only to the research team. Results will be disseminated through peer-reviewed journals and conferences.

NCT06199284.

The objective of this scoping review is to identify and describe factors that affect access to post-sepsis care. Considering the burden faced by sepsis survivors, it is important to understand the facilitators and barriers to accessing post-sepsis care to facilitate the design and implementation of patient-centred and equitable pathways to care.

This scoping review will include studies that consider individuals who have experienced sepsis and any factors that may affect access to care, including comorbidities, discharge setting and social determinants of health. A comprehensive search of MEDLINE, Embase, Emcare, HealthSTAR and Scopus will be conducted. The extracted data will be summarised and presented thematically.

Approval from a research ethics board is not required for this review as it is a synthesis of information from studies where the primary investigators have already received approval from their respective ethics boards. Once complete, the review will be submitted for publication in a peer-reviewed journal, and the findings will be shared to local and national forums.

This review has been uploaded and registered under Open Science Framework. https://doi.org/10.17605/OSF.IO/JMFW2

Glaucoma is an optic neuropathy caused by the gradual degeneration of retinal ganglion cells. This study aimed to investigate the knowledge, attitude and practice (KAP) towards glaucoma among ophthalmic inpatients.

A web-based questionnaire.

Local hospital.

Ophthalmic inpatients (n=1238).

The primary outcome was the patients’ KAP.

Multivariable logistic regression analysis showed that rural residence (OR=0.488, 95% CI 0.313 to 0.762, p=0.002), college education or above (OR=4.996, 95% CI 2.942 to 8.483, p

Ophthalmic inpatients might have moderate knowledge and attitude, but a proactive practice towards glaucoma. A history of glaucoma, previous glaucoma surgery, education level, residency and alcohol consumption were potentially associated with knowledge and attitudes towards glaucoma among ophthalmic inpatients.

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

NCT07050823/NCT07093021/NCT07134855.

Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.

Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.

The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).

The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.

Trial registration number: COMET registration number 3485

Despite the benefits of early diagnosis, most cancers in sub-Saharan African (SSA) countries are diagnosed at an advanced stage due to late presentation of symptoms, inadequate referral systems and poor diagnostic capacity. Health communication interventions have been used extensively in high-income countries to increase people’s awareness of cancer symptoms and encourage timely help-seeking. However, in SSA, there is still limited evidence on the effectiveness of these interventions and existing evaluations are mainly focused on communicable diseases rather than cancer.

A randomised, multisite, controlled community trial will evaluate a culturally tailored health infographic toolkit delivered in rural and urban settings in the Western Cape Province in South Africa and Harare and surrounding provinces in Zimbabwe. Participants will be randomised to receive one of three African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) cancer awareness tools, coproduced with local communities, comprising health communication infographics with descriptions of breast, cervical and colorectal cancer symptoms plus messages to encourage consultation with primary care providers if symptoms occur, all presented in English and four local languages. We will recruit 144 participants in each of the three intervention groups (N=432). The primary outcome will be recall of symptoms and the secondary outcomes will be (1) intention to seek help, (2) emotional impact and (3) acceptability of the toolkit. Outcomes will be measured preintervention and at two points postintervention: after 15 min and 1 month.

Ethical approval was obtained in both participating countries, South Africa (148/2025) and Zimbabwe (363/2021). All participants will be required to provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and the AWACAN-ED programme website.

PACTR202505475803308.

Although neurofilament light chain (NfL) is used as a biomarker of neurodegenerative decline, its application in surgery- and anaesthesia-induced acute cognitive dysfunction remains uncertain. We aimed to synthesise existing evidence to evaluate the potential of NfL as a biomarker for perioperative neurocognitive disorder (PND).

Systematic review and meta-analysis.

PubMed, EMBASE, MEDLINE, the Cochrane Library and the Cochrane Central Register of Clinical Trials were systematically searched up to March 2024.

Observational studies—including cohort, case-control and cross-sectional designs—were included if they reported cerebrospinal fluid (CSF) or blood NfL levels in individuals with and without PND.

Three independent reviewers assessed each article. Quality scoring was conducted, and the extracted data were analysed using STATA. Risk of bias was evaluated using the Newcastle–Ottawa Scale. Meta-analytical model selection was guided by the I² statistic, with I²≤40% indicating low heterogeneity and the use of a fixed-effect model; random-effects models were used when this threshold was exceeded.

Within-group analyses showed significant postoperative increases in blood NfL levels in both the postoperative delirium (POD) group (standardised mean difference (SMD) = 0.49; 95% CI 0.34 to 0.64) and the no-POD group (SMD=0.67, 95% CI 0.53 to 0.81). Between-group comparisons revealed significantly higher preoperative CSF NfL levels in the POD group (SMD=0.27, 95% CI 0.07 to 0.47). Both preoperative and postoperative blood NfL levels were also significantly elevated in the POD group (SMD=0.53, 95% CI 0.40 to 0.66, and SMD=0.58, 95% CI 0.43 to 0.73, respectively).

This meta-analysis suggests that NfL may be a potential biomarker for POD. Further research is needed to clarify the association between CSF and blood NfL levels and other forms of PND.

CRD42024516907.

Persons with serious mental illness (SMI) often have coexisting medical conditions and experience a significantly reduced life expectancy compared with the general population. Peer support is considered an effective care approach for this population, and with rapid technological advancements, digital peer support, such as the DigiPer mobile application, can be a feasible self-management tool for persons with SMI. The study aims to assess the feasibility of DigiPer for persons with SMI in the Norwegian community mental health service settings.

This feasibility study will incorporate both qualitative and quantitative methods. The study consists of three phases: (1) simulation-based training among peer support workers using qualitative individual interviews; (2) pre–post study of DigiPer among peer support workers and service users using quantitative questionnaires and (3) process evaluation for peer support workers and service users using qualitative individual interviews. Peer support workers (n=5) and service users with SMI (n=15) will be recruited to evaluate the feasibility of DigiPer.

Ethics approval was granted from the Regional Committee for Medical Research Ethics (reference no. 853041), along with an assessment of processing of personal data by the Norwegian Agency for Shared Services in Education and Research (reference no. 810990). Findings will be disseminated through peer-reviewed publications and presentations at relevant national and international scientific conferences.

To assess nutrition-related knowledge, attitudes and practices among pregnant women, and identify socioeconomic and healthcare determinants.

A cross-sectional study on maternal nutrition during pregnancy.

Pregnant women attending primary healthcare centres in the south of Tehran from December 2022 to March 2024.

1535 pregnant women of all ages living in the south of Tehran (both Iranian and non-Iranian).

Pregnant women were systematically selected from primary healthcare centres. Data were collected via validated questionnaires and electronic health records. Statistical analyses included multivariate logistic regression (adjusted ORs (aORs) with 95% CIs) and generalised linear mixed models.

The findings revealed that a majority of pregnant women (83.3%; 95% CI 81.2% to 85.3%) exhibited low levels of nutritional knowledge (scores below 12), whereas 14% demonstrated moderate knowledge (scores between 12 and 17), and only 2.7% (95% CI 1.9% to 3.8%) possessed high nutritional knowledge (scores above 18). In terms of attitudes, 36.9% of respondents expressed positive views toward nutrition, with higher education significantly associated with positive attitudes (aOR=1.8; 95% CI 1.3 to 2.5, comparing higher vs lower education levels). Dietary variety was consistently reported by 65.4% of participants, while 8.5% lacked dietary variety. Statistically significant associations were observed between educational attainment, socioeconomic status and nutrition-related practices (p

As a cross-sectional study, these findings highlight substantial gaps in nutrition knowledge among pregnant women in Tehran, with socioeconomic status and education playing crucial roles in shaping dietary behaviours. Improving nutritional education through healthcare interventions is essential for enhancing maternal and fetal health outcomes.

To explore maternity care providers’ attitudes toward regional centralisation of vaginal breech birth (VBB) care and gather their recommendations for maintaining clinical proficiency.

Exploratory qualitative study using semi-structured interviews and thematic analysis.

10 hospital-based maternity care professionals (nine obstetricians and one clinical midwife), purposively sampled to represent experience and institutional diversity.

10 hospital maternity units in a metropolitan region of the Netherlands.

Key themes describing provider attitudes towards two proposed models of centralised care (mobile breech team, designated referral centre) and alternative strategies.

Three core themes emerged: (1) proficiency—providers valued regular exposure, formal training and peer support, expressing concern that centralisation would reduce overall workforce readiness; (2) organisation—concerns included unequal access, staffing burden, legal risks and inefficiencies in mobile teams and (3) alternatives—participants preferred a regional breech network with shared training, joint video review and expert on-call support.

Maternity care providers opposed full centralisation of VBB, favouring a networked model that distributes expertise and preserves local access. These insights highlight the importance of involving frontline providers in service redesign.

Not applicable.

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.

With the increasing prevalence of asthma in children, exercise has become an essential component of asthma management, playing a significant role in improving overall health and quality of life. However, children with asthma face numerous challenges when participating in exercise, including physical limitations due to symptoms, fear of exacerbations and lack of parental support. In addition to these barriers, some factors can promote or facilitate exercise in this population. Therefore, this qualitative meta-synthesis aims to explore these barriers and facilitators through a qualitative meta-synthesis, to provide a basis for developing targeted exercise interventions, optimising asthma management and improving the health status and quality of life of children with asthma.

This qualitative metasynthesis will adhere to the Joanna Briggs Institute (JBI) framework. The final systematic literature search will be performed in the following electronic databases to include publications from their inception until 31 December 2025: PubMed, Embase, CINAHL, Web of Science and the Cochrane Library. The search strategy will include controlled terms and keywords related to ‘asthma’, ‘child’, ‘exercise’ and ‘qualitative research’. The inclusion criteria will comprise qualitative or mixed-methods studies published in English that explore the barriers to and facilitators of exercise participation in children under 14 years of age with asthma, their families or healthcare providers. Grey literature and non-English studies will be excluded. Study selection, data extraction and methodological quality assessment (using the JBI Critical Appraisal Checklist) will be conducted independently by two reviewers. Data will be synthesised using thematic synthesis.

Ethical approval will not be required for this qualitative synthesis, as it solely encompasses data derived from previously published research. Findings will be disseminated through professional networks, conference presentations and submission to a peer-reviewed journal.

PROSPERO, CRD42025641502.

Transcranial magnetic stimulation (TMS) and upper extremity manipulation training have demonstrated clinical effectiveness in stroke rehabilitation. Post-stroke, the affected cerebral cortex often shows reduced excitability, which can limit the optimal outcomes of conventional manual training. To address this, we developed a new upper limb training method integrating TMS with active sensory training (AST) to enhance the fine motor ability in the upper limbs following stroke, potentially improving overall rehabilitation efficacy. However, the clinical effectiveness of this approach remains unclear. Importantly, we demonstrated the efficacy of the new rehabilitation strategy by using TMS in conjunction with AST in patients experiencing upper limb motor dysfunction after stroke.

This single-centre, single-blind, sham stimulation, randomised controlled clinical trial investigated the efficacy of AST combined with TMS in patients with stroke and upper limb motor dysfunction post-stroke (1–24 months post-onset) at Brunnstrom stages III–V. Upper limb motor function was evaluated before and 2 weeks after the intervention. The primary outcome was the Action Research Arm Test result, and the secondary indicators included results on the Fugl–Meyer Assessment Upper Extremity Scale, Modified Barthel Index, Semmes–Weinstein Monofilament, Erasmus MC revised Nottingham Sensory Assessment Scale, Embodied Sense of Self Scale (stroke version), functional near-infrared spectroscopy and neuroelectrophysiology. Between-group differences were analysed using independent t-tests, and within-group differences were examined with paired t-tests, with statistical significance set at p

This study was approved by the Ethics Committee of the Second Rehabilitation Hospital of Shanghai for ethical application (Approval number: 2024-34-01). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.

ChiCTR2500097067.

Women experiencing infertility employed various coping strategies to overcome the diverse stressors encountered. These coping strategies had their peculiar consequences or outcomes. This study aimed to explore the outcomes deduced from the coping strategies employed by women with infertility.

The study employed a qualitative descriptive research design to gain an in-depth understanding of the outcomes of coping strategies used by women with infertility. In-depth interviews were conducted using a semi-structured interview guide.

The study was carried out at a private fertility and specialist hospital within the Kumasi Metropolitan Assembly, where 15 women diagnosed with primary infertility were interviewed for 45 min to 1 hour each. With all participants completing the study, interviews were audiotaped with consent, transcribed verbatim and analysed using content analysis.

The findings revealed that women with infertility used various coping strategies to mitigate the psychosocial stressors encountered. The coping strategies employed had a varying impact on the well-being of women with infertility, from long-term (physical health, mental health and life satisfaction) to short-term (composure and reduced state anxiety) coping outcomes. The result of the coping strategy employed had a varying impact on the well-being of women with infertility.

Women with infertility shared how they experienced good physical health, mental health and life satisfaction after employing adaptive coping strategies like seeking social support. They also shared how they exercised composure and had reduced state anxiety after using some maladaptive coping strategies, such as self-control and avoidance.

Non-communicable diseases (NCDs) currently contribute to over 50% of the global disease burden. Digital tools bear the potential to mitigate the risk of NCDs by facilitating personalised, preventive healthcare. It is therefore pertinent to examine the specific components that contribute to the success or constrain the impact of digital health interventions (DHIs), with particular attention to the sustainability of their long-term effects. Additionally, it is important to provide an up-to-date perspective on emerging interventions and technologies that have not yet been comprehensively addressed in the literature. This protocol defines the methodology for an umbrella review to synthesise the available high-quality evidence from systematic reviews and meta-analyses regarding effectiveness of DHIs in influencing the primary prevention of NCDs.

Using a rigorous search strategy, the subsequent databases will be searched in December 2025: MEDLINE, Web of Science, CINAHL, Embase, Scopus and Epistemonikos. Following the Joanna Briggs Institute (JBI) methodology, the selected literature will be screened based on predefined inclusion criteria. This includes systematic reviews and meta-analyses published within the last 5 years, without restrictions on country or language, that evaluate the effectiveness of any DHI aimed at the primary prevention of NCDs. Suitable full-text articles will be extracted by four researchers and independently assessed for methodological quality by two researchers using the AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews) tool. The results will be presented in a summary table aligned with the review question and subquestions, accompanied by a narrative synthesis that explores the findings and their relevance to the research aims.

Ethical approval is not required as no primary data will be collected. The findings of this umbrella review will be published in a peer-reviewed journal and presented at academic conferences.

CRD420251139744.

Evidence-based, compassionate practice is a key objective in midwifery care, with particular emphasis on existential aspects of women’s experiences during the transition to motherhood. In 2014, a scoping review was published exploring this phenomenon. The interest in this review exemplified the growing scholarly and clinical interest in this subject. However, the scoping review is outdated and does not meet up-to-date methodological standards. This qualitative systematic review will synthesise qualitative studies that explore the existential aspects of becoming a mother, aiming to identify potential unmet needs and articulate women’s preferences for care during motherhood transition. Findings from this synthesis may contribute valuable insights for developing evidence-informed clinical guidelines that promote person-centred and holistic maternal care.

This qualitative systematic review will use framework synthesis based on Peter la Cour’s model of Existential health. The data will be collected from five databases (MEDLINE, Embase, PsycINFO, CINAHL and Web of Science), which will be searched from 2010 to the present day. Study selection will prioritise the transition to motherhood in contemporary Western countries.

Ethical approval is not required for a review, and findings will be disseminated in peer-reviewed journals, conferences and social media.

CRD420251018563.

The objective of this scoping review is to map out what has been published in the scientific literature on the relationship between climate change-related events and how these overlap with associated changes in resource availability, transactional sex and HIV incidence and prevalence, within fishing communities in the Lake Victoria basin. This objective is informed by the fact that climate change and the associated natural resource strains in the Lake Victoria region have exacerbated existing inequities within fishing communities. Vulnerable populations, especially women, engage in strategies such as transactional sex to cope with the uncertainty of natural resource-dependent livelihoods. This practice greatly increases women’s risk of contracting HIV in this region, with prevalence rates four to five times the national averages. This scoping review will thus show how the existing empirical literature reports on climate change, transformation in natural resources and livelihoods, and transactional sex and HIV in the Lake Victoria region.

Studies that meet the following inclusion criteria will be included: align with at least two of the major concepts of interest, including climate change, transactional sex, HIV/AIDS, Lake Victoria Basin and/or empirical studies; are published in English and after 2012; and focus on the Lake Victoria basin. The scoping review will be guided by the JBI Manual for Evidence Synthesis: Scoping Reviews, supported by the standard principles of Arksey and O’Malley. The specific search strategies to be implemented were developed with guidance from an experienced research librarian to align with the inclusion criteria. The search will be conducted in relevant global databases, with two reviewers screening the results and extracting relevant data points. Finally, results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews flow diagram, and summarised in figures, tables and text.

The scoping review is designed to comprehensively scope the existing literature and document the coverage of linkages between transactional sex, HIV/AIDS and sustainable livelihoods in the context of climate change with a view to informing health systems responses to human health specific to the HIV epidemic.

The proposed scoping review is registered with the Open Science Foundation (OSF), registration number:https://doi.org/10.17605/OSF.IO/9DTW4.

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC.

STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB–IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune–inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.

The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Clinicaltrial.gov: NCT07042724.

Social prescribing is an approach to addressing non-medical issues affecting people’s health and well-being (eg, loneliness, housing or financial problems). It has gained international traction over recent years as complementary to medical care. A larger research project, comparing social prescribing across European countries, is considering how to tailor provision for the following groups: (a) LGBTIQ+persons, (b) refugees and first-generation immigrants and (c) older adults living alone. As part of this research, a qualitative study will address the question: What are the enabling and limiting factors associated with implementing social prescribing, across different European countries, from the perspective of key stakeholders?

Five European countries (Austria, England, Germany, Poland, Portugal) will be involved. Researchers from each country will conduct approximately 20 semi-structured interviews (total number will be 100). Interviewees will be people receiving, delivering, managing and funding/commissioning social prescribing. Interviews will be audio-recorded and transcribed. A cross-country analysis will be undertaken; framework analysis will support this process, with a chart developed in Excel in which data from across the five countries is summarised by the researchers involved. Summaries will be based on a thematic framework that researchers from the five countries develop together after initially analysing their own data.

Ethical approval was initially secured through the University of Oxford’s Medical Sciences Interdivisional Research Ethics Committee (IDREC 1806086) for data collection in England. This approved application was then used to secure ethics approval in Austria (through Ludwig Boltzmann Gesellschaft), Germany (through Bergische Universität Wuppertal), Poland (through Wroclaw Medical University) and Portugal (through NOVA University of Lisbon). Dissemination will include an academic journal article and presentation at relevant conferences. It will also include short videos, written summaries/policy briefs and an infographic.

This project has received funding from the European Union’s Horizon Europe Research and Innovation Programme under grant agreement No 101155873. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.