Malnutrition is a highly prevalent chronic condition that contributes to higher morbidity and mortality in patients with multiple comorbidities. While positive effects of nutritional therapy in the in-hospital setting have recently been demonstrated, the benefits of long-term nutritional therapy after hospital discharge remain uncertain. Herein, we outline the design and rationale of the EFFORTII trial, the largest nutritional trial to date to assess the effects of continued nutritional support after hospital discharge in medical patients, with particular attention to key design decisions regarding nutritional strategy, patient selection criteria and study endpoints.

The Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery (EFFORTII) is an investigator-initiated, non-commercial randomised controlled trial designed to evaluate whether ongoing, individualised nutritional therapy after hospital discharge—targeted to meet specific energy and protein requirements—offers a cost-effective approach to lowering mortality, minimising complications and maintaining functional status compared with standard care. Eligible participants are adult, chronically ill medical inpatients at risk of malnutrition. Patients in the intervention group receive individualised nutritional therapy delivered by an experienced dietitian through a combination of telemedicine and in-person consultations. The intervention aims to meet personalised nutritional targets, supported by a trained dietitian. Control group patients receive nutritional counselling at discharge, but no structured nutritional management during follow-up. We designed the trial as an event-driven trial with a target of 247 mortality events (primary endpoint), which will be assessed over approximately 5 years until event-driven endpoint is met. The minimum total sample size is at least 802 participants, based on the assumed treatment HR of 0.70. The main trial is enrolling patients across multiple sites in Switzerland. During the trial, additional sites in Spain joined the study, and their data will be analysed using a patient-level pooled approach.

This study involves human participants and was first granted ethical approval by the Ethics Committee Northwest- and Central Switzerland and then by all participating local ethics committees. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.

NCT04926597.

Tuberculosis is the leading cause of death globally from a single infectious agent. Early diagnosis is critical to reducing morbimortality. In cases of negative smear microscopy or limited sputum production, bronchoalveolar lavage (BAL) samples offer an alternative for diagnosis. Culture, the gold standard, requires a high bacterial load, extensive infrastructure and is time-consuming. Xpert MTB/RIF provides faster results with a higher cost. Previous systematic reviews present substantial limitations, including significant heterogeneity. Therefore, the diagnostic utility of Xpert MTB/RIF using BAL samples in adults with negative or scant sputum for pulmonary tuberculosis (PTB) needs to be reassessed.

A systematic search of MEDLINE, Embase, LILACS and Web of Science will be conducted without language or publication date restriction. Cross-sectional diagnostic studies of negative or sputum-scarce adults with presumptive PTB who underwent bronchoscopy to obtain samples for Xpert MTB/RIF and culture will be included. Screening and data extraction will be performed independently. Methodological quality will be assessed using the QUADAS-2 tool. A bivariate hierarchical random-effects model will synthesise sensitivity and specificity. Meta-analysis will be performed using Meta-DiSc 2.0. Heterogeneity will be assessed using I² and Cochrane thresholds. Subgroup analyses will be performed based on study design, population differences, country, culture method and risk of bias. Publication bias will be investigated using a funnel plot. The certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. There was no patient or public involvement in the development of the systematic review protocol.

Ethical approval is not required as this study will use publicly available data. Findings will be disseminated through peer-reviewed publication.

CRD42025639440.

Gastric outlet obstruction syndrome (GOOS) is a clinically significant condition often associated with advanced malignancies, particularly gastric and pancreatic cancers. Management strategies focus on symptom relief, nutritional improvement and quality of life enhancement. Surgical gastrojejunostomy (GJ), especially laparoscopic GJ, is commonly recommended for patients with good functional status and life expectancy exceeding 2 months. The modified Devine partial stomach-partitioning gastrojejunostomy (PSPG) was introduced to address functional limitations of conventional GJ, including duodenogastric reflux and afferent loop syndrome. However, PSPG has not been widely adopted, and its role in malignant GOOS remains unclear.

This systematic review aims to synthesise the available evidence on the application, functional outcomes and oncological implications of the modified Devine technique in malignant GOOS.

This review follows Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. The PICO framework was employed to define eligibility criteria, focusing on studies examining PSPG for malignant GOOS as palliative surgery or a bridge to resection. Literature searches were conducted across Medline, EMBASE, Cochrane Library, ClinicalTrials.gov and grey literature sources using a prospectively registered search strategy, between August and October 2025, following protocol submission. Two independent reviewers will screen articles, extract data and assess quality using the Newcastle-Ottawa Scale where applicable. Data will be synthesised narratively.

As this study is a systematic review of published literature, formal ethical approval was not strictly required. In accordance with institutional policy, the protocol was submitted to the Institutional Review Board of Hospital Prof. Doutor Fernando Fonseca, which confirmed that the study met criteria for ethical exemption. Findings will be disseminated through peer-reviewed publication.

This study is registered in PROSPERO (CRD42024593540). Search strategy is registered in searchRxiv https://doi.org/10.1079/searchRxiv.2025.00838.

PROSPERO CRD42024593540

https://doi.org/10.1079/searchRxiv.2025.00838.

Cancer is the leading cause of death and morbidity among children and adolescents worldwide. Functionality-based interventions are relevant among children and adolescents with an oncological diagnosis, whence studies summarising evidence on this topic are needed. This systematic review will summarise evidence on the effect of interventions to improve functionality indicators among paediatric patients diagnosed with cancer.

This protocol will follow Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA)-Protocols reporting guidelines. The systematic review will be conducted according to the Cochrane Handbook and PRISMA 2020. Studies will be searched in MEDLINE (PubMed), Embase, Web of Science, CENTRAL, LILACS and PEDro. Additional searches will include Google Scholar, reference lists of included studies, relevant reviews and trial registries. Studies will be included if they implement a functionality-based intervention. They must evaluate effects among paediatric patients with an oncological diagnosis. Secondary outcomes will include health-related quality of life. There will be no limits to language or year of publication, and articles published in peer-reviewed journals will be accepted. Only randomised controlled trials will be included. Risk of bias will be assessed using the Cochrane Risk of Bias Tool 2. Two independent reviewers will select studies, extract data and assess risk of bias. A narrative synthesis and meta-analysis will be conducted if studies are clinically and methodologically homogeneous. Statistical heterogeneity will be assessed using Higgins’ inconsistency test (I^²). Meta-analysis may estimate combined effects using random-effects and the inverse variance method. The R statistical software will be used. The certainty of evidence will be evaluated for each outcome using the Grading of Recommendations Assessment, Development and Evaluation system.

This study used data from previously published studies, thus waiving submission to an Ethics Committee. Scientific dissemination strategies will include publication in peer-reviewed journals, conference presentations and workshops for the public.

CRD42024462833.

To examine the emotional, cognitive and dispositional experience of children and adolescents undergoing Lokomat rehabilitation by integrating self-evaluation, therapist observations and physiological metrics across repeated sessions, with the aim of characterising how patient experience evolves throughout paediatric robot-assisted gait training.

Prospective observational study using a multidimensional assessment approach combining self-report, therapist ratings and physiological measures.

Inpatients undergoing robot-assisted gait training (RAGT) with the Lokomat at the Scientific Institute Eugenio Medea in Bosisio Parini (Italy).

42 children and adolescents (N=42; mean age 11.66±5.59 years) undergoing RAGT.

Robot-assisted gait therapy with the Lokomat. Participants underwent 30-minute therapy sessions as per routine rehabilitation protocols, with treatment durations ranging from 15 to 20 sessions, as prescribed by their referring clinician.

Participants completed ad-hoc questionnaires about emotional, cognitive and dispositional factors before and after therapy; therapists provided structured assessments of patient engagement and psychological states. Physiological data, such as heart rate variability (HRV) and electrodermal activity (EDA), were recorded using wearable sensors to capture physiological correlates of emotional and cognitive engagement.

The results showed that by the end of Lokomat therapy, patients displayed increased cognitive engagement and better emotional regulation, along with higher vagal activity (normalised high-frequency) and increased phasic EDA responses. According to the therapists, patients appeared more confident, calm and cooperative. Sympathetic activation observed during satisfaction ratings reflected the involvement of the autonomic nervous system in positive emotional experiences.

This study, therefore, emphasises a multidimensional approach to rehabilitation, which involves subjective patient self-assessments, therapist observations and physiological signals in an effort to capture a more comprehensive patient experience. The findings highlight the importance of personalised, patient-centred approaches and contribute new evidence on the psychological and physiological effects of RAGT in paediatric populations. Further research is warranted to confirm these results and explore their clinical implications.

NCT05767268.

People with serious mental illness (SMI) can experience significant physical health challenges. The Health Champions intervention was developed to support their physical health through using trained volunteers. However, volunteer and patient perspectives on the impact and implementation of this intervention have yet to be understood.

To compare the views of patients and volunteers on the Health Champions intervention.

A qualitative thematic analysis was conducted on interviews with 29 study participants. Interviews were carried out either face-to-face, via Microsoft Teams, or by telephone and included 12 patients (6 men and 6 women) and 17 volunteers (the Health Champions) (5 men and 12 women).

Four overarching themes were identified, highlighting both similarities and differences between stakeholders’ perspectives: (1) supporting goal setting; (2) impact on positive lifestyle; (3) experiences and perception of the programme and (4) navigating challenges during the programme. Both groups found the programme to be largely successful, by motivating patients to work towards their physical health goals and facilitating successful matching of patients with volunteers. Volunteers and patients valued good communication with the research team. Though both groups shared some views on the challenges with scheduling and a lack of face-to-face contact during the COVID-19 pandemic, their perceptions on how patients incorporated their health changes during and after the programme, as well as other administrative concerns such as views on the efficacy of journaling and breakdown of roles, differed.

The Health Champions intervention was perceived as useful to improve the physical health of patients with SMI. Differences in the views between the two stakeholders may result from their distinct experiences and expectations. Future volunteering programmes should further support the diverse physical health needs of patients with SMI.

In chronic kidney disease (CKD), anaemia develops and evolves as kidney dysfunction progresses. The treatment of anaemia is described in clinical practice guidelines (CPGs), which are designed to report the most relevant evidence for clinical practice in disease management. This study will analyse CPGs for transparency, methodological quality and quality of recommendations for their implementation over time, and also compare recommendations for the treatment of anaemia outlined in these documents.

CPGs will be identified by conducting a systematic search of the data sources CINAHL, Embase, MEDLINE, Scielo, Scopus, ProQuest, Trip Database, Virtual Health Library, Web of Science, and guidelines on websites, published between January 2009 and December 2025. Three reviewers will, independently, evaluate the methodological quality of the guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE-II) tool and the quality of recommendations using the AGREE – Recommendations Excellence tool. The treatment recommendations for anaemia in CKD will be summarised and compared. Results will be presented in tables and descriptive statistics will be compiled for all domains of the tools.

This is a literature-based study and, therefore, no ethical approval will be required. Results of the study can be submitted for publication in high-impact, peer-reviewed scientific journals, and also presented at national and international conferences.

CRD42024629656.

To identify parent/caregiver perspectives prior to taking part in a transition care intervention involving group education sessions and peer support for parents/caregivers of adolescents with T1D.

Pre-intervention, semi-structured interviews were conducted with parents/caregivers of adolescents (14–16 years) with T1D followed in a tertiary care paediatric diabetes clinic and participating in a pilot, randomised controlled trial: The Group Education Trial to Improve Transition for Parents/Caregivers of Adolescents with T1D (ClinicalTrials.gov ID: NCT05445284). We conducted a reflexive thematic analysis to identify key aspects of the intervention that may help support parents/caregivers of adolescents with T1D during their transition to adult care.

Of the 17 parents/caregivers randomized to the intervention group, 13 completed pre-intervention interviews.

Four themes were generated from the parents/caregivers, including (1) Creating a Community of Learners (i.e., importance of fostering a bidirectional and supportive environment for parents/caregivers), (2) Psychological Perspectives of Parenting (i.e., acknowledgement of shifting parental/caregiver roles during adolescents’ transition), (3) Diabetes Management During Adolescence (i.e., identification of relevant diabetes education topics to be covered), and (4) Ideal Format and Delivery of the Program (i.e., practical recommendations for the logistics of the intervention).

The findings provide practical and pragmatic suggestions to refine the parent/caregiver-based transition of care intervention for a future, full-scale trial, including addressing parental/caregiver needs as they learn how to best support their adolescent with T1D during transition to adulthood. Future transition programmes for adolescents with T1D may also benefit by incorporating aspects of the current transition readiness program for parents/caregivers of adolescents with T1D.

Music-based training programmes, such as learning how to play an instrument or sing in a choir, have been suggested as potential interventions for promoting healthy brain ageing in older adults at risk of cognitive decline because of their ability to enhance cognitive functions and potentially promote neuroplasticity. However, there is limited empirical evidence in older adults at risk of dementia, especially that evaluates both piano and singing interventions and their effects on cognition and neuroplasticity. In this protocol, we outline a study to assess the efficacy of keyboard and singing music training programmes on reducing cognitive decline and other outcomes in older adults with Mild Cognitive Impairment (MCI).

This randomised, single-blind, controlled, parallel-group trial aims to enrol 432 individuals with MCI from the community in Sydney, Australia. Participants are randomly allocated to participate in either keyboard lessons, singing lessons or a film discussion control group once a week for 3 months. The primary objective is to assess the effectiveness of two music training programmes (keyboard and choral singing) for enhancing verbal memory after 3 months compared with control. Additionally, we will examine how these music-based interventions affect other aspects of cognition, mood, sleep, overall well-being, markers of brain plasticity and blood biomarkers of Alzheimer’s disease and neurodegeneration. Tertiary objectives are to identify factors that impact the success of the interventions, such as participation rates, engagement levels and key demographic and clinical features. Outcomes are collected at baseline and at 3 and 9 months. The primary endpoint analysis will include all randomised participants to estimate the treatment effect using intention-to-treat principles. Primary and secondary outcomes will be analysed using linear mixed models and effect size measures will be calculated.

This study will be the first robust, randomised controlled trial to assess the potential and relative value of music engagement for cognitive decline in high-risk MCI individuals, as well as broader effects on other markers of mental health, well-being and neurodegeneration. Co-designed with implementation in mind, the music interventions can potentially be delivered within memory clinic or community settings.

The Sydney University Human Research Ethics Committee (2023-026) has approved this protocol. The trial findings will be shared through conferences, publications and media.

Australian and New Zealand Clinical Trials Registry (ACTRN12623000407695), Registered 21/04/2023 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385552

2.02 29/11/2024.

Forming secure attachment relationships provides children with the best possible start to life. Children from families with high psychosocial vulnerability and complex mental health needs (eg, caregivers with lived experience of trauma, experiencing mental illness or substance abuse, current or past domestic violence, and/or current or a history of child protection issues) are at the greatest risk of experiencing attachment disturbances. Nurturing Connections is a new early intervention service launched by the New South Wales State Ministry of Health targeting both caregiver adversity and the caregiver-child attachment relationships in families with high psychosocial vulnerability and complex mental health needs. This paper outlines the evaluation protocol of the Nurturing Connections Programme.

A mixed-methods design will be used to undertake an implementation and outcomes evaluation. The study will draw on both qualitative and quantitative data, including routinely collected service data, surveys, participant observations, and semi-structured interview and yarning circle data. Appropriate descriptive and inferential techniques will be used to analyse quantitative data while thematic analysis will be drawn on to analyse qualitative data.

This research was approved by the South Eastern Sydney Local Health District Research Ethics Committee (2024/ETH01715). The Mid North Coast Local Health District also received ethics approval from the Aboriginal Health and Medical Research Council of New South Wales (2380/25). Evaluation findings will be shared via published manuscripts, conference presentations, as well as a final report to funding bodies.

Adolescent pregnancy is a global issue. Early childbearing is strongly linked to poverty and negative health outcomes, including increased neonatal death risk. This study explores spatial patterns of adolescent pregnancies and neonatal deaths and their association with socioeconomic characteristics.

This population-based study used spatial analysis techniques to investigate the geographical distribution of adolescent pregnancies, socioeconomic characteristics and neonatal mortality rate (NMR).

The 645 municipalities of State of Sao Paulo, Brazil.

All live births to mothers residing in the State of Sao Paulo, Brazil, between 2004 and 2020.

The socioeconomic indicators used were: municipal human development index and per capita income (PCI). Spatial patterns were assessed for spatial autocorrelation (Moran’s I, LISA), and smoothed using local Bayesian estimation. Spearman’s correlation was used to ascertain the relationship between the percentage of live births to adolescent mothers and socioeconomic indexes. This calculation was also undertaken between different maternal age groups of NMR.

The study analysed over 10 million live births, with 14.3% attributed to adolescent mothers. Spatial analysis revealed significant clustering of adolescent pregnancies, strongly associated with lower socioeconomic indicators. NMR also exhibited spatial clustering, particularly after smoothing. Statistically significant differences were observed in PCI medians between high–high and low–low clusters for adolescent births. High and low incidence areas of NMR, both in all maternal ages and stratified by adolescent and non-adolescent mothers, demonstrated considerable overlap.

The results indicated the existence of clustering areas of adolescent pregnancy and neonatal deaths and suggested that the prevalence of births to adolescent mothers is not distributed equally and is higher in lower socioeconomic developed areas.

Tobacco use accounts for approximately 1.35 million deaths annually in India, disproportionately affecting low-income individuals, men, rural residents, those without formal education and groups of low socioeconomic status (SES). Despite progress in tobacco control, scalable, low-cost solutions, such as brief advice interventions, are needed. This study explored priority implementation determinants for adapting an evidence-based brief advice/counselling intervention for high-reach, low-resource settings in Mumbai, India. The focal settings (health-focused and tuberculosis-focused non-governmental organisations (Health NGOs and TB NGOs) and dental clinics) served low-SES populations.

Mumbai-based and US-based team members conducted a qualitative study employing semistructured interviews to gather data from four groups connected to Health and TB NGOs and dental clinics: (1) 15 patients, (2) 33 practitioners, (3) nine practice leaders and (4) three policymakers. We used a team-based, critical, reflexive thematic analysis approach to analysis, grounded in the Exploration, Preparation, Implementation and Sustainment framework. We managed data with Nvivo software.

Participants were supportive but highlighted diverse challenges and supports required for implementing the intervention in these diverse settings. First, many noted that societal constraints such as economic insecurity and cultural factors were expected to limit tobacco control efforts for low-SES populations. Second, setting-specific intervention adaptations were identified as necessary to support integration and ensure access to support for all patients. Various participant groups highlighted different adaptation areas. For example, patients noted that tobacco was part of their routines and social lives, practitioners emphasised the need to design implementation plans that support integration alongside existing needs, and policymakers highlighted the need for uniform implementation strategies.

Adapting brief advice/counselling interventions for Health NGOs, TB NGOs and dental clinics in Mumbai will require strategic communication to support buy-in, thoughtful workflow integration and changes to funding and support mechanisms for organisations so meaningful reductions in tobacco use can be achieved among low-SES groups. In other words, there is a need to adapt both the intervention and the implementing system to allow for brief advice/counselling to contribute to broader tobacco control efforts.

R01 CA230355.

Mobile diagnostic imaging services provided at home increase accessibility and convenience, particularly for older adults, people with disabilities and other vulnerable groups. These services can reduce the need for patient travel and support the routine monitoring of chronic conditions. However, current guidelines often overlook user acceptance and environmental considerations within the home setting.

To map studies that identify the models, barriers and facilitators for performing home-based diagnostic imaging/graph according to end users.

A scoping review was conducted following the methodological framework of the Joanna Briggs Institute and reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist.

Studies that addressed mobile or portable diagnostic imaging or graph examinations conducted in the home for individuals of any age or health status were included. Studies were eligible if they reported on barriers, facilitators or user experiences. Studies that focused on wearable technologies were excluded.

The search strategy was developed using terms related to home-based diagnostic imaging/graph, portability, home setting and user perceptions. Searches were conducted in PubMed, Web of Science, Scopus, Embase, The ACM Guide to Computing Literature and LILACS, without restrictions on publication date or language. Additional grey literature was identified through Google Scholar.

Two reviewers independently extracted data using a standardised form that captured study characteristics, types of procedures, target populations and reported barriers and facilitators. Quantitative data were summarised using absolute and relative frequencies. Qualitative findings were synthesised through basic content analysis to identify and categorise recurring themes.

Data were charted in tables to organise and visually map study contexts, methodological features and thematic patterns related to implementation and user experience.

Twenty-six studies published between 1998 and 2023 across 15 countries were included. The diagnostic examinations included mostly polysomnography, X-ray imaging and ultrasonography. Seven categories of barriers were identified, such as physical discomfort, equipment-related challenges and procedural limitations. Seven facilitators were also reported, including perceived comfort, patient satisfaction and equipment usability.

This review identifies key factors affecting the delivery and user experience of mobile diagnostic imaging at home, including logistical, technical and environmental aspects. It reveals gaps in the literature and provides a basis for future research to inform more inclusive and effective public health policies and service design.

Open Science Framework (DOI 10.17605/OSF.IO/7UV5D).