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ReFIT study (reversing frailty in transplantation): protocol for a longitudinal study to assess clinical and biomedical changes in frailty through kidney transplantation

Por: Payne · T. · Shaw · A. · Hanjani · L. S. · Homes · R. · Giddens · F. · Ravuri · H. G. · Yap · C. X. · Walsh · J. · Kumar · V. · Garton · F. C. · Rhee · H. · Huang · A. · Francis · R. S. · Reid · N. · McAdams-DeMarco · M. · Gordon · E. · Midwinter · M. · Hubbard · R.
Introduction

Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

Methods and analysis

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

Ethics and dissemination

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

Diverse Parental Experiences of Kangaroo Care in Neonatal Units Across Healthcare Systems: A Meta‐Synthesis

ABSTRACT

Background

Kangaroo Care is an effective practice recommended by WHO for newborns, especially preterm infants, to reduce mortality and morbidity and improve health outcomes. Understanding parents' experiences with Kangaroo Care is vital as it can significantly influence uptake and sustained practice; however, experiences may vary across healthcare systems.

Aim

To explore parents' experiences of Kangaroo Care in neonatal units and to examine differences across international health systems.

Design

A qualitative meta-synthesis.

Review Methods

A systematic search of the literature was carried out over seven databases, including CINAHL, MEDLINE ALL, EMBASE, PsycINFO, Maternity & Infant Care, Scopus and Cochrane Library. Qualitative studies published in English from 2010 to January 2024 were included. Data extraction and quality appraisal, using the CASP Qualitative Checklist, were undertaken. Meta-synthesis of the included qualitative findings was carried out. The findings were reported following the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) guideline. The protocol was registered on PROSPERO (CRD42023483347).

Results

Twenty-five studies were included and four themes were identified: parental fulfilment from Kangaroo Care, Hardship in Kangaroo Care practice, Roadblocks and difficulties in adopting and Building bridges to encourage and support Kangaroo Care.

Conclusion

This review underscores the multifaceted nature of parental experiences, including positive and challenging aspects, as well as significant barriers and facilitators that influenced Kangaroo Care implementation. By understanding these experiences and factors that hinder and enable, healthcare systems and professionals can better support and empower parents to improve the effectiveness of Kangaroo Care.

Impact and Implications

Kangaroo Care is lifesaving, particularly in low-income countries, but can be a challenge for parents providing it. By addressing deficiencies in infrastructure and resources, barriers can be minimised, thereby encouraging the practice of Kangaroo Care. This is especially important in lower-middle- and low-income countries where the practice is most effective and the practice is lowest.

Patient or Public Contribution

This project is a meta-synthesis; therefore, no patient or public contribution was deemed necessary.

Palliative care consultation for end-of-life decision-making in hospitalised patients: protocol for a systematic review and meta-analysis

Por: Haddad · G. · Ajzenberg · H. · Davis · F. D. · Fogelman · P. A. · Korzick · K. · Marshall · M. F. · Naylor · D. · Swoboda · S. M. · Reid · J. · Oczkowski · S.
Introduction

Hospitalised patients nearing the end of life (EOL) often face complex treatment decisions, leading to potential conflicts among care teams, patients and families. Palliative care consultations may enhance decision-making processes, improve satisfaction and reduce unnecessary interventions. This systematic review will assess the impact of palliative care consultations on treatment decisions, family and patient satisfaction, and psychological outcomes in hospitalised adults.

Methods and analysis

We will include randomised controlled trials comparing palliative care consultations to standard care in hospitalised adults. The primary outcomes will include decisions to withhold or withdraw treatments, patient and family satisfaction with EOL decision-making, and psychological outcomes such as anxiety, depression and post-traumatic stress disorder. Secondary outcomes will include intensive care unit (ICU) and hospital length of stay, utilisation of potentially non-beneficial treatments, and the use of institutional policies or legal actions. Databases including MEDLINE, Embase, CINAHL, Cochrane CENTRAL and PsycINFO will be systematically searched from inception to September 2025. Two independent reviewers will screen studies and extract data using Covidence. Meta-analyses will use random-effects models to generate pooled estimates for primary and secondary outcomes. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool, and evidence certainty will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. Subgroup analyses will explore variations by ICU versus non-ICU settings, cancer versus non-cancer diagnoses and default versus clinician-initiated consultations.

Ethics and dissemination

Ethical approval is not required for this review. Findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD420250624190.

Move to improve: protocol for a single-arm, pragmatic feasibility trial of an individualised physical activity programme for children with chronic conditions

Por: Sivaramakrishnan · H. · Finlay-Jones · A. · Valentine · J. · Wood · F. M. · Naylor · L. H. · Haustead · L. · Davey · E. · Reid · S. · Shetty · V. B. · Graciet · J. · OMeara · D. · Robertson · A. · Davis · E. · Move to Improve Author Group · Elliott · Walwyn · Gottardo · Martin · Long
Introduction

Physical activity improves physical and psychosocial outcomes in healthy children and in children with a range of chronic health conditions. Unfortunately, children with chronic health conditions have lower levels of physical activity compared to their healthy peers due to multiple restrictions in physical activities and therefore tend to have lower levels of physical activity compared with their peers. This paper describes the protocol for Move to Improve, a pragmatic trial of an individualised physical activity intervention for children with chronic health conditions.

Methods and analysis

Using the RE-AIM framework, this study aims to test the feasibility of Move to Improve, an 8-week hospital-based individualised physical activity intervention. We will recruit 100 children aged 5–17 years who are diagnosed with type 1 diabetes, cancer, postburn injuries and cerebral palsy to a single-arm, pragmatic feasibility trial. The primary outcomes (objective moderate to vigorous physical activity, quality of life and goal attainment) and secondary outcomes (including aerobic capacity, body composition, motor function, grip strength and psychosocial outcomes) will be assessed at baseline, post intervention and at 6-month and 12-month follow-ups. We will conduct semistructured interviews with participants and their primary caregiver at a 2-month follow-up to capture aspects of feasibility. Quantitative data will be reported descriptively, and qualitative data will be analysed using thematic analysis. Data gathered from this study will inform service decision-making and future trials.

Ethics and dissemination

The study has received ethics approval from the Government of Western Australia Child and Adolescent Health Service Human Research Ethics Committee (RGS6677). Findings of this research will be communicated to the public through peer-reviewed publications, conference presentations, reports, infographics and information sheets. Modifications to the protocol will be outlined in the trial registry and journal publications. Authorship will be in accordance with the International Committee of Medical Journal Editors.

Trial registration number

Australian and New Zealand Clinical Trials Registry Number: ACTRN12624000836538.

Free school meals, diet quality and food insecurity in secondary school students: protocol for a multiple-methods study - the CANTEEN study

Por: Alving-Jessep · E. · Pallan · M. · Ansell · E. · Hamill · L. · McConnell · C. · McIlwee · D. · McKinley · M. C. · Moore · S. E. · Murphy · M. · Neville · C. · ONeill · C. · Sevel · E. · Adab · P. · Bryant · M. · Chambers · S. · Cardwell · C. R. · Ensaff · H. · Evans · C. · Reid · S. · Holfor
Introduction

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

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

Ethics and dissemination

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

Finding the optimal regimen for Mycobacteroides abscessus treatment (FORMaT) in people with Mycobacteroides abscessus pulmonary disease: a multicentre, randomised, multi-arm, adaptive platform trial

Por: Jong · T. · Baird · T. · Barr · H. L. · Bell · S. · Bigirumurame · T. · Brady · K. · Burke · A. · Byrnes · J. · Caudri · D. · Clark · J. E. · Coin · L. J. M. · Goh · F. · Grimwood · K. · Hicks · D. · Jayawardana · K. · Joshi · S. · Lee · K. · Qvist · T. · Reid · D. · Rice · M. · Roberts · J. A.
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration numbers

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

Predictive Capacity of the Integrated Care for Older People Screening Tool to Assess Fall Risk in Older Adults in Geriatric Care

ABSTRACT

Aim

To evaluate the predictive capacity of the Integrated Care for Older People screening tool for the risk of falls in older people receiving care at a healthcare service.

Design

A cross-sectional study.

Method

This study was conducted in a geriatric healthcare service in the southeast region of Brazil. The convenience sample included older people aged 60 and over living at home. The study used the Fall Risk Score to assess the risk of falls and the Integrated Care for Older People screening tool to track intrinsic capacity. The data was analysed using logistic regression to analyse the association between the six Intrinsic Capacity domains, for the early detection of impairment and risk of falls.

Results

A total of 253 older adults participated in the study, most of whom were identified as having a high risk of falls. Logistic regression analysis across six association models revealed that the models including the Intrinsic Capacity domains of locomotion and hearing had a significant association with having a higher risk of falls. Care plans should prioritise the domains most strongly associated with fall risk, guiding targeted strategies to enhance older adults' safety.

Conclusion

The Integrated Care for Older People screening tool, in the locomotion and hearing domains, is associated with the risk of falls in older people from the community receiving care in a geriatric healthcare service. Future longitudinal studies could show whether other domains of intrinsic capacity can predict the occurrence of falls.

Relevance to Clinical Practice

This study highlights the Integrated Care for Older People screening tool as essential in nursing practice, especially for assessing the locomotion and hearing domains of intrinsic capacity. Early detection of impairments helps identify increased fall risk in older adults, enabling nurses to implement targeted, person-centred interventions that enhance safety, autonomy and overall quality of life.

Patient or Public Contribution

No patient or public contribution.

Reporting Method

This study complied with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for cross-sectional studies.

Impact of the Diabetes Conversation MapTM Program on Knowledge Retention, Self‐Management, and Self‐Efficacy Among Diabetic Patients: A Randomized Controlled Trial

ABSTRACT

Background

Diabetes mellitus is a growing global health concern, with a high prevalence in Egypt. Type 2 diabetes imposes substantial health and economic challenges. Diabetes Self-Management Education and Support (DSMES) programs, such as the Diabetes Conversation Map, have demonstrated promise in enhancing patient knowledge, self-management, and self-efficacy. However, evidence regarding their direct impact remains scarce, necessitating further investigation.

Objective

This study aimed to evaluate the effectiveness of the Diabetes Conversation Map program in improving knowledge retention, self-management, and self-efficacy among type 2 diabetes patients in Egypt.

Methods

A prospective, parallel, two-arm randomized controlled trial was conducted at the Damanhour Health Insurance Outpatient Diabetic Clinic in Egypt. A total of 120 adult patients with type 2 diabetes were randomized into a control group (n = 60), receiving standard diabetes education, and an intervention group (n = 60), attending 8 weekly interactive sessions using the Diabetes Conversation Map. Primary outcomes were assessed using validated questionnaires at baseline, post-intervention, and 3 months later.

Results

The intervention group exhibited significant improvements in knowledge, self-management, and self-efficacy compared to the control group (p < 0.001). Additionally, positive correlations between these outcomes were observed post-intervention, replacing negative correlations observed at baseline.

Linking Evidence to Action

The Diabetes Conversation Map program effectively enhances patient knowledge, self-management, and self-efficacy, supporting its integration into routine diabetes education. Healthcare providers should implement structured, interactive educational interventions to empower patients in managing their condition. Regular follow-ups and reinforcement strategies are necessary to sustain long-term self-efficacy improvements. Policymakers should consider incorporating evidence-based diabetes education into national healthcare programs. Future research should explore digital adaptations of the program to enhance accessibility and engagement.

Trial Registration

Registration No: R000061691, Trial ID: UMIN000054044

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