Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

NCT06436560.

Low physical functioning and frailty are prevalent in non-geriatric vulnerable populations such as people experiencing homelessness, addiction and mental health challenges. The objective of this study was to explore the feasibility and impact of a targeted exercise intervention with protein supplementation for women experiencing homelessness, addiction and mental health challenges.

Mixed-methods feasibility study.

A women’s-only day service for people with homelessness and addiction issues, in Dublin, Ireland.

Women experiencing homelessness, addiction and mental health challenges.

The intervention was a 10-week low-threshold exercise and protein supplementation pre-post programme (LEAP-W). Qualitative interviews were conducted following the intervention with programme participants and key stakeholders.

The primary outcome was feasibility measured by recruitment, retention, adherence, safety and acceptability, and secondary outcomes measured pre-post intervention change in physical function, pain, nutritional and frailty status, and overall health status.

Overall, 33 participants were recruited. Data generated demonstrated that LEAP-W was feasible by its safety, acceptability and high retention in certain subgroups, and high adherence to the exercise and protein supplement; its impact was demonstrated by pre-post intervention improvement in multiple domains (strength (chair stand test), balance (the single leg stance test), pain and quality of life/mental health (mental component summary of the Short Form-12; 95% CI, p

Targeted exercise interventions with trauma-sensitive, flexible design can be successfully delivered and yield impact in women with complex needs who experience homelessness, addiction and mental health challenges. Service design should be considered when delivering interventions to this population. Further higher-powered longitudinal studies are warranted.

NCT06264895.

Falls represent the most frequent reason older people are admitted to hospital and significantly increase the likelihood of functional decline, healthcare utilisation and early mortality. The aim of this study is to comprehensively delineate the burden of falls amongst community-dwelling older people in Ireland.

Population-representative analysis of Wave 6 of the Irish Longitudinal Study on Ageing (TILDA) estimating incidence of falls requiring medical attention and emergency department (ED) attendance, fractures and fear of falling over 12 months. Additional data detailing falls-risk increasing drugs (FRIDs) and prior falls were also analysed.

Using Central Statistics Office Census 2022, the population of older people in Ireland was multiplied by the proportion of TILDA participants with each outcome of interest to yield population-level estimates.

Population-representative sample of 2299 (55% female) community-dwelling people in Ireland aged ≥70 years.

Almost 12% (proportion 0.12 (95% CI 0.10 to 0.13)) of participants, corresponding to almost 62 000 older people in Ireland, reported a fall requiring medical attention in 12 months, with 6% (proportion 0.06 (95% CI 0.05 to 0.07)), or over 32 000 people, attending ED due to a fall. Over 3% (proportion 0.03 (95% CI 0.03 to 0.04)) reported sustaining a fracture. Almost half of participants reporting a fall requiring medical attention were prescribed FRIDs, and over half had also reported a fall when assessed at the prior wave of the study (ie, 2 years ago).

The burden of falls amongst community-dwelling older people is considerable; 1 in 8 required medical attention for a fall and 1 in 16 attended the ED with falls over 12 months.

Currently, there is no national falls strategy in Ireland. These findings, alongside our ageing population, underscore the need for strengthened falls-prevention strategies to reduce avoidable morbidity and healthcare utilisation.

This study aims to evaluate a structured nurse-led follow-up programme coordinated by an advanced practice nurse (APN) as an alternative to conventional postdischarge care for patients with heart failure (HF). The main objective is to assess the clinical effectiveness and economic efficiency of the programme using quality-adjusted life years and healthcare costs related to resource use as outcome measures.

A quasiexperimental multicentre study will be conducted including an intervention group and a comparison group of patients discharged with HF from three public hospitals in the province of Málaga, Spain. The intervention group will be followed by an APN using a structured follow-up model, while the comparison group will receive standard care. Sociodemographic, clinical, quality of life, self-care, therapeutic adherence and healthcare resource utilisation data will be collected. The economic evaluation will be conducted from the perspective of the public healthcare system through a cost-utility analysis.

The study protocol has been approved by the corresponding Research Ethics Committee. All participants will provide written informed consent prior to inclusion. The results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences.

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.

More knowledge and resources are required to strengthen ‘leadership and governance’ (L+G) as a central building block to further develop emergency care (EC) systems in low-income and middle-income countries (LMICs).

This scoping review aimed to examine and map the impact of individual, collective or institutional L+G on the development of EC systems (prehospital and facility-based) in LMICs.

English language publications from January 2005 to April 2024 that linked any L+G action with the development and capacity of everyday EC in LMICs, specifically excluding disaster responses.

Medline (Ovid), Embase (Ovid), CINAHL, Web of Science (Clarivate), Central (Cochrane Central Register of Controlled Trials), Global Health (Ovid) and select grey literature.

Data from all eligible papers were jointly extracted using a piloted tool developed from the literature and WHO’s EC Systems Framework. L+G descriptors included level (from clinical to national) and components (informed by Siddiqi et al’s LMIC health system ‘good governance’ framework and a synthesis of EC policy documents). Impact of L+G on EC systems and key lessons were extracted from each publication.

From an initial 9713 items, 129 papers were included for final analysis and divided by EC component: prehospital (n=35), facility-based (n=53) and ‘whole of EC system’ (n=41). Qualitative and descriptive papers were most common, and 72 out of a possible 131 LMICs were represented. Findings were heterogeneous across all building blocks of EC systems and for different components of leadership and/or governance. Cross-cutting L+G themes were identified that demonstrated consistent impact across all EC systems development: government recognition, vision and human rights framing; coalition-building for effective partnerships and trained, empowered EC clinicians demonstrating emotionally intelligent, transformational leadership.

Applying new models such as Theories of Change and Social Network Analysis concepts may assist to illuminate how effective L+G is attained, what are the essential components and how these influence EC systems for better patient-centred outcomes. Further understanding the role of L+G for EC systems has utility for future EC clinician leadership training and policy-maker awareness, to strengthen resilience of overall health systems against likely future shocks.

There is substantial literature on opioid pharmacotherapies from a service user perspective, mostly focused on methadone and buprenorphine. However, as a relatively new formulation, much less is known about user experiences and views of Long-Acting Injectable Buprenorphine (LAIB). To date, no published reviews have qualitatively described LAIB service user experience. The objective of this scoping review is to identify and describe the peer-reviewed qualitative studies examining the service user experience of LAIB.

This scoping review will follow the methodology described by Arksey and O’Malley, further adapted by Levac et al and others. The search strategy will be developed in collaboration with an expert librarian and will include searches of Medline, Embase, PsycINFO, CINAHL, Scopus and Web of Science as well as citation chaining. The search dates will range from 2016, when LAIB was first approved, to the date of the final search. Included studies will investigate the perspectives and experiences of LAIB treatment participants with opioid dependence, within an Opioid Treatment Programme (OTP). For service users, the pharmacological formulation of LAIB significantly reshapes both the clinical practice and the social dynamics within OTPs. To effectively capture the depth and nuance of service users’ experiences, this review will be limited to qualitative, mixed-method, case series or case study designs, with a further restriction to peer-reviewed articles published in English. Identified references, with duplicates removed, will be imported into Covidence for title/abstract screening, full-text review and data extraction by two independent reviewers. All decisions on data inclusion or exclusion will be by consensus agreement, using a third reviewer if necessary. A living experience researcher will lead analysis of manuscript content in NVivo using inductive coding to produce a descriptive thematic analysis. The narrative summary will present key study characteristics, quality appraisal and synthesised findings that describe service user experiences and perspectives of LAIB, guided by the Systematic Reviews and Meta-Analysis for Scoping Reviews checklist.

This scoping review undertakes secondary analysis of data in the public domains only and thus does not require ethics approval given no participants are directly involved. The results of the review will be published in a peer-reviewed journal, presented at relevant academic and community conferences, and discussed and disseminated to/with community organisations, service users and policy-makers.

Prepublication history and additional supplemental material for this paper are available online. To view these files, visit: Open Science Framework https://doi.org/10.17605/OSF.IO/XMHKN.

Frontotemporal dementia (FTD) remains challenging to diagnose owing to the marked clinical heterogeneity associated with the disease. This heterogeneity stems from the complex interplay of various clinical phenotypes, genetic mutations and underlying neuropathologies, such as TDP-43 and tau proteinopathies. Currently, there is no single confirmed biomarker that can reliably diagnose disease, specifically disease stage, disease subtype and underlying neuropathology. Recent research has indicated that neuroimaging techniques hold the most promise for the discovery of FTD biomarkers. We propose a protocol for a systematic review and meta-analysis to identify MRI and fluorodeoxyglucose positron emission tomography (FDG-PET) biomarkers associated with clinical, genetic and pathological subtypes of FTD. We aim to address the following research questions: can regional MRI volumetry and FDG-PET hypometabolism differentiate (1) FTD patients from healthy controls; (2) sporadic cases of FTD from healthy controls; (3) genetic cases of FTD (MAPT, GRN, and C9orf72 mutations); and (4) underlying neuropathology, specifically discriminating between tau- and TDP-43-based FTD?

Literature searches will be performed across three databases: Ovid Medline, Ovid Embase and Web of Science. Publications that have fewer than five participants, are non-human-based, not written in the English language or contain unpublished data will be excluded. Two independent investigators will screen and subsequently evaluate which publications to include. Should any disagreements arise, a third investigator will settle the discrepancy. After the random-effects meta-analysis has been used to extract and pool the data, I² analysis will be used to quantify heterogeneity.

Ethics approval will not be required for this research. On completion, the systematic review and meta-analysis will be published in a peer-reviewed journal.

CRD42024545302.

Temporomandibular disorders (TMDs) are a prevalent group of musculoskeletal conditions affecting the temporomandibular joint, associated structures and masticatory muscles. The internet has become a primary source of health information for many patients; however, the readability, reliability, content and quality of online information on TMDs vary widely. A comprehensive synthesis of the characteristics and evaluation methods of such content is currently lacking.

This scoping review will follow the Joanna Briggs Institute methodology and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Peer-reviewed primary and secondary studies assessing online information on TMDs will be included if they report on readability, reliability, content or quality. Eligible information sources include publicly available websites, videos and social media; discussion forums and printed materials will be excluded. No language, date or geographical restrictions will be applied. A three-step search strategy will be implemented across PubMed, Web of Science, Embase, PsycINFO and CINAHL, followed by citation tracking. Screening will be conducted independently by two reviewers using Rayyan. Data will be extracted with a pilot-tested charting tool and synthesised narratively and descriptively in tabular and graphical formats.

As this study will only use data from publicly available sources, ethical approval is not required. Findings will be disseminated through publication in a peer-reviewed journal, conference presentations and professional networks, with the aim of guiding the development of accessible and reliable digital resources for individuals seeking information on TMDs.

This protocol has been prospectively registered on the Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/TAH7K.

Knee osteoarthritis (OA) is a leading cause of disability in older adults, with health and economic impacts. Despite pharmacological advances, exercise continues to be a fundamental pillar in the management of OA, with lower limb strength training showing significant benefits. Virtual reality (VR)-based interventions have emerged as innovative tools, providing immersive environments to facilitate functional movement exercises. VR offers pain relief, improved functionality and reduced fall risks, although its efficacy in OA management requires further exploration. The main aim of the study is to assess whether a VR-based intervention provides superior improvements in pain, stiffness, physical function and movement biomechanics compared with conventional therapeutic exercise in adults aged 60 years and older with knee OA.

This is a protocol for a randomised controlled trial comparing the effects of immersive VR interventions with conventional therapeutic exercises in individuals aged 60 years and older with knee OA. Participants are allocated 1:1 to experimental (VR) and control groups. The VR intervention involves 18 supervised sessions over 8 weeks, using Meta Quest 3 goggles to perform functional movements in virtual environments. The control group follows standard therapeutic exercise protocols per Osteoarthritis Research Society International guidelines. Outcomes include OA-related symptoms, kinematic performance, pain intensity, kinesiophobia and fall risk. Secondary measures assess cybersickness, depressive symptoms, medication use and comorbidities. Assessments occur at baseline, ninth week, sixth and ^12th months. Data analysis employs intention-to-treat principles, leveraging descriptive statistics, t-tests and multiple imputations for missing data.

This study was approved by the A Coruña-Ferrol Research Ethics Committee (reference: 2023/557), under the Galician Health Service. All participants will be required to provide written informed consent prior to their inclusion in the study. Participant data will be pseudonymised and securely stored. Additionally, anonymised datasets will be deposited in open-access repositories (Zenodo).

NCT06362785.

Most clinical practice guidelines (CPGs) for assessing and managing people’s chronic pain focus on specific pain conditions, body sites or life course stages. This creates complexity for clinicians making care choices in the absence of a diagnosis and/or where a person experiences more than one pain condition. Specific to this context is the ICD-11 classification of chronic primary pain where an experience of pain cannot be better accounted for by another condition. CPGs for chronic primary pain, agnostic to condition or body part, may support clinicians towards best pain care since many of the principles of person-centred chronic pain care are transdiagnostic. The two aims of this systematic review are to (1) identify and appraise CPGs for chronic primary pain, relevant across the life course and (2) map the CPG content against a pain care priority framework to evaluate the extent to which the CPG content aligns with the priorities of people with lived chronic pain experience.

We will systematically search nine scholarly databases, the Epistemonikos database and international and national guidelines clearinghouses. CPGs published within 2015–2025, in any language, that offer recommendations about assessment and/or management of chronic primary pain for people of any age, excluding hospitalised inpatients or institutionalised populations, will be included. Pairs of reviewers will independently screen citations for eligibility and appraise CPG quality and implementation potential using the Appraisal of Guidelines for Research and Evaluation (AGREE)-II and the AGREE-Recommendations Excellence tools, respectively. Data extraction will include the citation and scope characteristics of each CPG, methods used to develop recommendations, verbatim recommendations, guiding principles or practice information and narrative excerpts related to the GRADE Evidence-to-Decision (EtD) considerations (or equivalent). We will use the PROGRESS-PLUS framework as a checklist to identify whether determinants of health equity were considered by guideline developers. CPG recommendations will be organised according to common topics and categorised in a matrix according to strength and direction. Qualitative content analysis will be used to synthesise excerpts relating to GRADE EtD considerations (or equivalent), and we will map extracted data against an established chronic pain care priority framework to determine the extent to which the CPGs align with values and preferences of people with lived experience. Interpretation will be informed by an interdisciplinary Advisory Group, including lived experience partners.

Ethical approval is not required for this systematic review. Results will be disseminated through publication in an open-access peer-reviewed journal, through professional societies, and integrated into education curricula and public-facing resources. Reporting will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.

CRD420251000482.

Dietary (poly)phenols have beneficial properties that may play a relevant role in the management of overweight/obesity and cardiometabolic risk factors, modulating physiological and molecular pathways involved in energy metabolism, adiposity and gut microbiota-derived metabolites.

The Prevention/Precision Diet in Araucanía (PREDIET-ARAC) trial is a randomised, single-blind, parallel arm, placebo-controlled, clinical trial designed to assess the potential health benefits of (poly)phenol intake through either diet or supplementation. The study will evaluate the effectiveness of a healthy plant-based diet (PBD) rich in (poly)phenols compared with (poly)phenol supplementation during a caloric restriction intervention.

A total of 99 adults (aged 25–45 years) with overweight or obesity (body mass index: 25–35 kg/m²) and cardiovascular risk factors will be recruited from primary health centres in Temuco, Araucanía Region, Chile. Participants will be randomised (stratified by age:

Dietary data will be collected using dedicated software through three 24-hour dietary recalls at baseline and post-intervention. (Poly)phenol intake will be estimated using the Phenol-Explorer database. The main data collection will include general and lifestyle questionnaires, anthropometric and bioimpedance measurements, blood pressure assessments using sphygmomanometers, physical activity monitoring through accelerometers and strength evaluations via dynamometry. Blood samples will be collected at both baseline and after 12 weeks. For the analysis of plasma metabolites, a large-scale targeted metabolomics approach will be employed, specifically utilising ultra-high performance liquid chromatography coupled to tandem mass spectrometry. The healthy PBD will be primarily supplied by the food industry, encompassing a selection of regional and Latin American foods: blueberries, apple, nuts, olive oil and coffee. A descriptive and inferential statistical plan will be conducted, based on comparison tests, regression models and machine-learning algorithms.

This trial adheres to the Declaration of Helsinki and the CONSORT statement. Signed informed consent will be obtained from all participants. Ethical approval has been granted by the Ethical-Scientific Committee of the Health Service of Araucanía Sur, Chile (Approval No 11250095–58) and the Biosafety Committee of the Catholic University of Temuco. Findings will be disseminated through peer-reviewed publications, conference presentations and engagement with healthcare professionals and policymakers.

NCT06911346.

Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

DRKS00034899.

V2.1, 6 June 2024.