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Enhancing Quality of Life for Individuals with Stroke (EQL): a study protocol for co-creating a social support and context-informed intervention to improve self-management, health and well-being in older adults recovering at home

Por: Kylen · M. · Falk Johansson · M. · McCarthy · L. · Meijering · L. · Tomsone · S. · Tistad · M. · Elf · M.
Introduction

Enhancing Quality of Life for Individuals with Stroke (EQL-stroke) is an international, collaborative multiphase project aiming to strengthen supported self-management for older adults recovering from stroke at home in Sweden, Latvia and the Netherlands. Existing poststroke pathways may provide insufficient support for self-management during the transition from hospital to home, and there is limited evidence on interventions that integrate social networks and everyday environmental context.

Methods and analysis

EQL-stroke uses a participatory, multimethod design across three phases. Phase I generates knowledge through policy review, qualitative interviews and people–place mapping (~25 participants per country) and includes cross-cultural adaptation of the Collective Efficacy of Networks Scale. Phase II co-designs and specifies a tailored social network-informed supported self-management intervention (the Network-Based Intervention), including core components and principles for local adaptation (~15 participants per country). Phase III will recruit approximately 20–40 stroke survivors for a single-arm pilot feasibility study with an 8-week follow-up and embedded process evaluation to assess feasibility, acceptability and fidelity in routine practice.

Ethics and dissemination

Ethical approval has been obtained from the Swedish Ethical Review Authority (reg. no. 2025-00083-01), the Rīgas Stradina Universitāte Research Ethical Committee (reg. no. Rīgas Stradina Universitāte Research Ethical Committee) and the Research Ethics Committee of the Faculty of Spatial Sciences, University of Groningen (reg. no. 2025-07). Findings will be disseminated through peer-reviewed publications, stakeholder engagement activities and patient/public channels.

Effectiveness of an online interval group therapy for children with developmental language disorders: protocol for a randomised controlled intervention study

Por: Heiland · A. · Siemons-Lühring · D. · Speckemeier · C. · Klaar · L. · Treger · P. · Sonntag · K. · Scharpenberg · M. · Tücke · J. · Neusser · S. · Brannath · W. · Mathmann · P. · Voss · T. · Neumann · A. · Rieger · T. · Heiming-Al Yosef · J. · Hesping · A. · Kanaan · O. · Weber · M.
Introduction

With a prevalence of around 7.6%, developmental language disorders (DLDs) without comorbidities are among the most common and most frequently treated childhood disorders. Standard DLD therapy in Germany consists of individual therapy sessions once per week within speech–language therapy practices. In reality, these sessions only take place every 10–14 days on average. Online therapy may be beneficial but is not yet standard practice in Germany. Although DLD group therapy has been proven to be effective, it is rarely undertaken in Germany. The aim of this study is to compare the effectiveness of online DLD therapy for small groups of children with standard one-to-one therapy.

Methods and analysis

The effectiveness of two treatment settings is evaluated in 212 children with moderate-to-severe DLD (ages 3 years to 6 years 11 months) in the multicentre, block randomised controlled trial (RCT) THErapy ONline. Five centres in Germany participate. Children are randomly assigned to the intervention group (online interval-intensive therapy, IG1, n=106) or the control group (extensive standard in-person therapy, IG2, n=106). A speech and language assessment is conducted at baseline (study entry, T0), 12 months (T1) and 18 months (T2) after therapy start. The co-primary outcome parameters are the speech and language test scores of phonological speech sound production, expressive vocabulary, grammar production and language comprehension at T1. The secondary outcome parameters comprise two composite speech and language test scores at T1 and T2, including phonological working memory scores and the individual scores of the aforementioned tests at T2, as well as process evaluation parameters (time expenditure, resource utilisation, such as salary costs of speech–language therapists, additional costs of the online therapy, adherence to appointments and therapy acceptance).

Ethics and dissemination

This study has been approved by the Institutional Ethics Review Board of Westphalia-Lippe (2022-282 f-S). Parents provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences.

Trial registration number

DRKS00030068

Understanding tonic and phasic irritability in developmental psychopathology among help-seeking children and adolescents in Switzerland: Protocol for the longitudinal multimodal UTOPICA study

Por: Urben · S. · Giovannini · J. · Dietsche · A. · Abi-Kheir · M. · Schmidt · L. · Koenig · J. · Stringaris · A. · Plessen · K. J. · Kaess · M. · Mürner-Lavanchy · I.
Introduction

Irritability represents one of the most common causes of referral to child and adolescent mental health services. Conceptually, tonic irritability (i.e., persistent grumpy mood) can be distinguished from phasic irritability (i.e., temper outbursts). The objective of this research project is to develop a fine-grained, ecologically valid and multimodal characterisation of tonic and phasic irritability to better understand the differential role of the two components in developmental psychopathology.

Methods and analysis

The study has a longitudinal observational and experimental design and involves two sites: (a) the Division of Child and Adolescent Psychiatry at the University Hospital of Lausanne and (b) the Division of Youth Mental Health at the Faculty of Psychology at the University of Basel. 220 help-seeking and healthy youths aged 8–14 years and their families will participate in the study consisting of a baseline assessment (i.e., self-report, interviews, cognitive assessments, autonomic measures, as well as in-situ experiments), an ecological momentary assessment (EMA) phase (over 2 weeks, including experience sampling method, cognitive assessment and passive monitoring) and a 1-year follow-up. Statistical analyses will include multilevel regression (e.g., linear mixed modelling).

Ethics and dissemination.

We obtained ethical approval from the local ethics committees (Cantonal Research Ethics Commission on Human Beings, CER-VD, #2023-01846) and data collection began in January 2025. The results of the present study will be published in peer-reviewed scientific journals and will be presented at key conferences in the field of child and adolescent mental health, as well as at conferences focusing on EMA. Additionally, findings will be disseminated to practitioners, the educational sector and associations working with youths. We further intend to make the findings accessible to the general public through social media, for instance.

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Biopsychosocial trajectories in older adults with planned intensive care: a protocol for a prospective observational study (GeriICU)

Por: Schumann · J. · Köhring · W. · Simm · A. · Grosskopf · A. · Szabo · G. · Schneider · T. · Prell · T.
Background

Older adults admitted to intensive care units (ICUs) following elective surgery face heterogeneous trajectories of recovery spanning the physical, cognitive and social domains. Biological ageing processes, including cellular senescence, may modulate these outcomes. Here, we present the protocol for an analytic prospective observational cohort study integrating biopsychosocial assessments and senescence-associated biomarkers to identify predictors of health-related quality of life (HRQoL) and post-ICU recovery.

Methods and analysis

Single-centre, prospective cohort study at the University Hospital Halle (Saale), Germany. Adults aged 60 years or older scheduled to undergo elective surgery and who have a planned postoperative stay in the ICU of at least 24 hours and who are able to provide consent will be enrolled. Baseline pre-ICU data will include the following: medical history, comorbidity, medications, routine laboratory values and a comprehensive geriatric assessment (eg, frailty, mobility, handgrip strength, Timed Up & Go, cognition, mood, loneliness, social status and EuroQol 5-Dimension 5-Level, EQ-5D-5L). A 5 mL serum sample will be collected for a senescence-associated secretory phenotype panel and additional ageing biomarkers. Skin autofluorescence will be used to estimate advanced glycation end-products. Telephone follow-ups at 3 and 6 months ascertain HRQoL, functional outcomes, psychosocial outcomes, rehospitalisations and institutionalisation. The primary endpoint is defined as a stable or improved HRQoL (EQ-5D-5L) at 3/6 months vs baseline. We intend to use multivariable predictive modelling with elastic-net regularisation and conduct internal validation using bootstrap resampling and cross-validation.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Medical Faculty, Martin-Luther-University Halle-Wittenberg (No. 2025-112). Written informed consent is obtained from all participants. The results of this study will be reported in a peer-reviewed journal.

Trial registration number

DRKS00037969.

Relatives' Experiences of Circulatory Death Following Out‐of‐Hospital Cardiac Arrest and Their Hypothetical Perspectives on Organ Donation: A Qualitative Study

ABSTRACT

Aims

To explore relatives' experiences of the circulatory death of a family member following out-of-hospital cardiac arrest and to explore their hypothetical perspectives on being asked to decide about organ donation in this situation. This study forms part of a broader initiative undertaken to assess the prerequisites for implementing uncontrolled donation after circulatory death in Sweden with a focus on ethical issues.

Design

A qualitative design, using semi-structured interviews with open-ended questions.

Methods

Data were collected in Sweden between March 2024 and September 2024 and analysed using reflexive thematic analysis with an inductive, descriptive approach. Included were 13 bereaved relatives, four men and nine women.

Findings

The analysis generated three themes: ‘Fluctuating between hope and despair’, which describes relatives' experiences of their family member's sudden cardiac arrest; ‘Exposed to vulnerability’, concerning their experiences of death and their perspectives on reasoning about the deceased person's wishes regarding donation; and ‘Balancing a major life change’, which involves experiences of facilitators and barriers to dealing with the loss.

Conclusions

Awareness of the deceased family member's wishes regarding organ donation facilitates relatives' ability to support the deceased's known or presumed wishes. Compassionate and communicatively competent healthcare professionals influence relatives' capacity to reason about the deceased's wishes and cope with their experience of loss. Ensuring sufficient time for goodbyes and providing follow-up may facilitate emotional processing and should be considered when implementing uncontrolled donation after circulatory death.

Implication for the Profession

Policies and clinical practice should ensure that relatives are adequately informed and supported in reasoning on their family members' wishes regarding organ donation. To achieve this, nurses and other healthcare professionals require training in compassionate and empathetic communication strategies. Such training is essential both for guiding relatives through reasoning about their family preferences and for providing emotional support during the grieving process.

Impact

What is already known? ○

Organ donation after sudden death in out-of-hospital cardiac arrest is a complex process that raises ethical issues concerning both the timing and the content of conversation with the deceased's relatives, as well as the relatives' capacity to reason about the deceased's wishes in the context of sudden death.

Knowing the wishes of the deceased person, personal beliefs, and receiving clear, direct, and honest information from nurses and other healthcare professionals prepares relatives to reason about the deceased's known or presumed wishes regarding organ donation.

What were the main findings? ○

The quality of nurses' and healthcare professionals' communicative competence and their behaviours influence relatives' ability to reason and reflect on organ donation.

Factors that facilitate family members' experiences of donation following out-of-hospital cardiac arrest and death include awareness of the deceased's wishes regarding organ donation, being able to see with their own eyes that their family member is dead, and having sufficient time to say farewell.

Follow-up from health care services could have an impact on relatives' experiences and their processing of loss.

Where and on whom will the research have an impact? ○

This research has an impact on organ donation services, pre-hospital emergency care, and emergency department operations. It can assist nurses and physicians in planning ethical and family-centred care in cases of out-of-hospital sudden death and uncontrolled donation after circulatory death.

Reporting Method

COREQ-checklist.

Patient or Public Contributions

No patient or public involvement in design, conduct or reporting.

Effects of fermented versus unfermented red cabbage on symptoms, immune response, inflammatory markers and the gut microbiome in young adults with allergic rhinoconjunctivitis: a randomised controlled trial protocol

Por: Ngoumou · G. B. · Ngandeu Schepanski · S. · Blakeslee · S. B. · Diedering · A. · Twal · E. · Raue · S. L. · Schroeder · M. · Wicaksono · W. A. · Stritter · W. · Berg · G. · Seifert · G.
Introduction

Allergic rhinoconjunctivitis (ARC) is a highly prevalent immune-mediated condition associated with substantial symptom burden, impaired quality of life and increased healthcare use. Emerging evidence highlights the role of the gut microbiome in immune regulation and allergic disease. Fermented foods may contain live microbes (when unpasteurised or uncooked) and bioactive postbiotic metabolites that can modulate immune responses. Despite growing interest in dietary strategies targeting the microbiome, no randomised controlled trial has compared fermented versus unfermented red cabbage for ARC.

Methods and analyses

This single-centre, randomised, controlled trial with a sensory-matched, unfermented cabbage comparator investigates the effects of daily consumption of fermented red cabbage for 8 weeks compared with an unfermented red cabbage control in young adults (18–35 years) with ARC. A total of 158 participants will be randomly assigned (1:1). The primary outcome is change in Total Nose and Eye Symptom Score from baseline to week 8. Secondary outcomes include daily symptoms and medication use captured via mobile ecological momentary assessments, quality of life, psychological well-being, gastrointestinal symptoms, systemic inflammatory markers, total IgE, immune cell profile and metagenomic characterisation of stool samples. A nested qualitative component explores participants’ experiences and acceptability of the intervention. Analyses will include mixed-effects models, time-series analyses incorporating daily pollen counts and comprehensive microbiome statistics. Safety outcomes and adverse events will also be assessed.

Ethics and dissemination

This study was approved by the Ethics Committee of Charité—Universitätsmedizin Berlin (EA4/043/25) and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated through peer-reviewed publications, conference presentations and a lay summary provided to participants. Anonymised datasets and analysis scripts will be made available in public repositories, and metagenomic sequencing data will be deposited in an international sequence archive to ensure transparency and reproducibility.

Trial registration number

DRKS00036475.

Co-STARS: a feasibility evaluation of a co-produced mental health literacy training package to reduce mental health inequities for Black young people in underserved communities - study protocol for a randomised controlled trial with an external pilot, pro

Por: Kumarendran · B. · Cherrington · E. · Bandyopadhyay · S. · Crowe · F. · Machaczek · K. K. · Brown · L. · Campbell · N. · Jordan · G. · Pope · M. A. · Antonovic · M. · Taylor · M. · W · N. · Mahamud · A. · Chandan · J. S. · Griffiths · S. L. · on behalf of the Co-STARS youth co-produc
Introduction

Severe mental illness such as psychosis is among the most disabling illnesses worldwide, disproportionately affecting minoritised ethnic groups and those in socioeconomic disadvantage. In the UK, people from Black ethnic backgrounds are more likely to experience a first episode of psychosis and to be detained under the Mental Health Act than White British people. There is a clear need for mental health services to improve cultural awareness and understanding of the broader social needs of minoritised groups, as well as the need to improve mental health literacy (MHL) within Black communities to empower individuals to seek timely mental health support. This protocol describes our programme of work which aims to assess the feasibility, acceptability and cost-effectiveness of Co-STARS, which is a co-produced, culturally appropriate tiered training package.

Methods and analysis

We co-produced a culturally appropriate, place-based, tiered MHL training package (Co-STARS) to deliver within underserved Black communities and via an e-learning package implemented among staff within mental health trusts. The training will be evaluated in stages. First, a pilot cluster randomised controlled trial will assess the feasibility and acceptability (defined as participants’ perceptions of the training’s relevance, usefulness and delivery) of a lived experience-led MHL training package delivered by Black young people with experience of mental ill health, to underserved communities in Birmingham, UK. Acceptability will be quantified through participation and completion rates and explored qualitatively via focus groups and interviews. Second, a stepped-wedge cluster randomised trial will evaluate the feasibility of an e-learning training programme for mental health professionals. We will embed a process evaluation to explore change mechanisms and identify barriers and enablers for future implementation. Third, we will use realist-informed participatory systems mapping and novel epidemiological analyses to explore downstream effects (ie, improved care access for Black ethno-racial groups within the intervention areas). Last, a cost-effectiveness framework will be developed to assess whether the intervention is good value for money in future efficacy trials. In the cluster trial, eight clusters will be randomised to the intervention arm (face-to-face training in the community) and control arm (display of MHL materials) with pre- and post-assessments in 120 participants from 8 clusters, 3 weeks apart. In the stepped wedge trial, six clusters (clinical teams within NHS mental health trusts) including 120 NHS staff in total, will move from control phase to intervention phase in a stepped wedge manner, with pre-assessments and post-assessments.

Ethics and dissemination

This proposal was reviewed by the Research Governance of the University of Birmingham and UK Research and Innovation (UKRI) grant reviewers. Ethics approval was granted by East of Scotland Research Ethics Service. The findings will be communicated in research conferences, stakeholder meetings, via social media, through publication in peer-reviewed journals and as a policy document.

Trial registration number

ISRCTN10517405.

A Realist Evaluation of the Implementation and Use of Patient‐Reported Outcomes in Four Value‐Based Healthcare Programmes

ABSTRACT

Aim

To investigate what works when using Patient-Reported Outcome Measures (PROMs), for whom, in what contexts, and why in four Value-Based Healthcare (VBHC) programmes.

Design

Realist evaluation.

Methods

Evaluation of Heart Failure, Parkinson's Disease, Epilepsy and Cataract surgery programmes using data from a scoping review, documentary analysis, questionnaires, quantitative routinely collected data and semi-structured interviews with staff, patients and carers (July 2022–August 2023). Programme theories and logic models were developed, tested and refined.

Results

We conducted 105 interviews (67 patients, 21 carers and 17 staff) and collected data from 230 patients (66 Epilepsy, 140 Heart Failure and 24 Parkinson's Disease) and 14 staff via questionnaires. Clinicians used PROMs data to regularly monitor patients with Heart Failure and Epilepsy, which resulted in better triage and tailoring treatment, prioritisation of access based on the urgency of need, and facilitation of referral to relevant professionals. In Heart Failure, this further resulted in a more efficient provision of care and better use of resources, care closer to home, improved health outcomes (e.g., better symptom management) and service redesign. The same was not observed in Epilepsy, as patients who required mental health treatment had to be referred, but they were not always able to access specialist services. PROMs were discontinued in Cataract surgery services mainly due to the lack of integrated IT systems, which caused an increased workload and staff resistance. In Parkinson's Disease, patients were asked to complete PROMs even though the information was not consistently being used.

Conclusions

Findings challenge the orthodoxy that implementing PROMs is universally good and brings about real improvements in patient outcomes in a VBHC context. PROMs are generally ill-suited for long-term use with patients in routine care without further adaptation. Greater staff and patient involvement are imperative to enhance the acceptability and relevance of the programmes.

Implications for the Profession and/or Patient Care

Patient-Reported Outcome Measures can improve care when embedded in well-supported systems. Implementation must be realistic, involve staff and patients, and be underpinned by clear leadership and robust digital infrastructure. Co-designed patient-facing tools can improve accessibility and engagement.

Impact

What problem did the study address? There is limited evidence on how Patient-Reported Outcome Measures function across different routine healthcare contexts. What were the main findings? Patient-Reported Outcome Measures improved care in Heart Failure but not in other services, largely due to contextual barriers. Where and on whom will the research have an impact? Findings are relevant for clinicians, service designers, and policymakers seeking to implement meaningful person-centred outcome measurement in long-term conditions.

Reporting Method

We adhered to Realist and Meta-narrative Evidence Syntheses: Evolving Standards II guidance and to the Guidance for Reporting Involvement of Patients and the Public.

Patient or Public Contribution

The study was developed alongside a wide range of patient and public stakeholders involved in the Aneurin Bevan University Health Board Value-Based Healthcare programme, third sector and specific individuals and groups representing the four included services (i.e., St. David's Hospice Care, British Heart Foundation, Digital Communities Wales, Epilepsy Action, Digital Communities Wales, Parkinson's UK Cymru, Race Equality First, Aneurin Bevan Community Health Council, Value- Based Healthcare Patient Reference Group and Wales Council of the Blind). A total of 10 virtual meetings were strategically planned to address gaps, assist in the interpretation of findings, and ensure that outcomes were pertinent and accessible to the specific needs and circumstances of under-represented or vulnerable groups.

Top 10 priorities for problematic hip replacement research: a priority setting partnership led by the British Hip Society and the James Lind Alliance

Por: Board · T. N. · Khan · A. · Sorial · A. K. · Divecha · H. M. · Lamb · J. N. · Reed · M. · Khanduja · V. · Whitehouse · M. R. · OBrien · F. · Staley · K. · Ellis · P. · on behalf of the Problematic Hip Replacement Steering Group · Jones · Clarke · Harle · Briggs · Kearney · Daboo · A
Objectives

To identify and prioritise research uncertainties regarding the assessment, management and rehabilitation of patients with problematic hip replacements through a national Priority Setting Partnership (PSP).

Design

A national PSP using the James Lind Alliance (JLA) methodology.

Setting

UK.

Participants

Patients, carers and healthcare professionals (HCPs) involved in the care of patients with problematic hip replacements.

Methods

A steering group was established. The James Lind Alliance methodology was followed throughout. A nationwide survey was conducted to collect unanswered questions. These were refined, prioritised through an interim survey and ranked at a final consensus workshop.

Results

The initial survey yielded 201 questions, refined to 32. The interim survey had 191 respondents, leading to 19 questions at the final workshop. The top 10 research priorities were agreed on.

Conclusions

This PSP identified key research priorities for problematic hip replacements, focusing on diagnosis, pain management, perioperative optimisation and infection. These priorities can inform researchers and funders to improve outcomes for affected patients.

Developing consensus definitions and methods for non-visually impairing eye conditions for population-based eye surveys in Nigeria: a Delphi study

Por: Aghaji · A. · Okoye · O. · Nwachukwu · N. Z. · Ezegwui · I. · Okoye · O. · Umeh · R. · Gilbert · C. E. · The Nigeria National Non-Visually Impairing Conditions Study Group · Ada · Onochie · Nkiru · Ifeoma · Obiekwe · Rich · Clare · Lawan · Emem · Ebere · Dupe · Korede · Feyi · Kayo
Objective

To establish consensus definitions for non-visually impairing eye conditions (NVICs) and their methods of assessments to provide standards for use in population-based eye surveys.

Design

A literature review of NVICs in sub-Saharan Africa, a questionnaire of inquiry based on the literature review developed by an expert panel and a modified Delphi exercise with three iterative rounds with eye health experts.

Setting

Eye health academia and community eye health in Nigeria.

Participants

Nigerian ophthalmologists, including subspecialists experienced in population-based eye health surveys.

Main outcome measures

Definitions and statements where at least 70% of the respondents agreed or strongly agreed.

Results

Forty-two ophthalmologists practising in Nigeria with experience in conducting population-based eye health surveys were invited to take part in the Delphi exercise. There were three rounds with response rates of 39/42 (92.9%) in round 1, (94.9%) in round 2 and 100% in round 3. Consensus for NVICs to be included in population-based eye surveys, their definitions and methods for assessment was reached by the third round.

Conclusions

We propose case definitions for NVICs to be assessed in population-based eye surveys through a modified Delphi approach with an expert panel of ophthalmologists from across Nigeria. These case definitions will allow for standardisation of NVICs in population-based eye surveys to assess the prevalence and magnitude of the different types of NVICs for planning purposes. Further studies are needed to validate these case definitions and inform their evolution.

Randomised, double-blind, parallel group, placebo-controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants in the UK: BALLOON study - study protocol

Por: Kotecha · S. J. · Lowe · J. · Gillespie · D. · Perez-Alijas · M. · Aboklaish · A. F. · Mahachi · T. L. · Cumming · O. S. · Harris · D. · Hubbard · M. · Thomas-Jones · E. · Jones · T. · Ladell · K. · Moore · C. · Humpreys · I. · Grigg · J. · Berrington · J. · Kotecha · S.
Introduction

A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.

Methods and analysis

542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.

Ethics and dissemination

Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.

Trial registration number

ISRCTN14019493.

Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study

Por: Thor · A. · Bengtsson · M. · Dowgierd · K. · Epifanov · S. · Fichter · A. M. · Jelovac · D. · Korn · P. N. · Nilsson · J. L. · Pastore · G. · Rughubar · V. · Smolka · W. · Talvilahti · J. · Thiem · D. · Thieringer · F. · Ulmner · M. · Wolvius · E. B. · Zubillaga Rodriguez · I. · Kumar · V
Introduction

Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.

Methods and analysis

This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.

Ethics and dissemination

Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.

Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022–23; Ethikkommission Nordwest- und Zentralschweiz, 2019–02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019–04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025–18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19–589; Komisja Bioetyczna przy Warmiłsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019–0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.

Trial registration number

NCT03991728.

Disclosure experiences in LGBTQ+ healthcare staff: a systematic review and meta-synthesis

Por: Prakkash · R. · Manning · L. · Becares · L. · Hatch · S. L. · Akande · I. · Dorrington · S.
Objective

Workplace disclosure of Lesbian, Gay, Bisexual, Transgender and Queer (LGBTQ+) identity by healthcare employees is an understudied area and existing reviews of LGBTQ+ disclosure in the healthcare sector focus on patient perspectives, overlooking the unique challenges that healthcare professionals encounter. The aim of this study was to conduct a systematic review and meta-synthesis of existing qualitative studies exploring disclosure experiences of LGBTQ+ healthcare employees.

Method

The literature search integrated current research from 2011 to March 2023 and focused on qualitative studies exploring disclosure experiences of LGBTQ+ healthcare professionals. Ovid served as the primary platform for literature searches, supplemented by forward and backward citation tracking and additional searches in academic databases such as Google Scholar and Scopus. The studies underwent quality evaluation using the Critical Appraisal Skills Programme 2022 checklist and were synthesised using thematic analysis.

Results

The findings revealed seven studies with five prominent themes: (1) risk associated with disclosure, (2) making the decision to disclose, (3) cost of non-disclosure, (4) cost of disclosure and (5) benefit of disclosure. Additionally, five critical factors of disclosure were identified: level, scope, time, elements and method. Finally, the risk–benefit analysis underscored the dilemma and balance between authenticity and conformity, largely influenced by pervasive heteronormativity, resulting in a significant mental toll.

Conclusions

The findings must be interpreted considering certain limitations, such as the lack of generalisability of studies. However, the findings emphasise the critical need for cultivating trusting and accepting healthcare work environments for LGBTQ+ staff.

Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia

Por: Bussmann · B. M. · George · B. · Robinson · M. · Grist · J. · Sukumar · P. · Chinherende · E. · Sheerin · F. · Enzhil · V. · Rider · O. · Jones · B. · Sabharwal · A. · Herring · N.
Introduction

Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.

Methods and analysis

RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.

Ethics and dissemination

This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.

Trial registration number

ISRCTN49861434.

ALARUM: Active One Health surveillance in LMICs to monitor and predict Antimicrobial Resistance Using Metagenomics - a cross-sectional study protocol

Por: van der Sande · M. A. B. · Valia · D. · Tigoi · C. · Stoesser · N. · Stamm · L. · Marten · A. · Riems · B. · Musyimi · R. · Sibidou · Y. · Schurch · A. C. · Tiendrebeogo · E. W. · Mwaringa · S. · Kohns Vasconcelos · M. · Ingelbeen · B. · Tinto · H. · Bielicki · J. A. · Cooper · B. S. · B
Background

In rural sub-Saharan Africa (sSA), the burden of antimicrobial resistance (AMR) remains high. As AMR continues to rise, there is a strong need for practical, implementable surveillance to monitor and mitigate risks, as well as inform timely, evidence-based clinical decision-making. Emerging evidence points to possible community-level drivers, such as transmission between human, animal and environmental reservoirs as contributing factors, yet microbiological surveillance or opportunities for wastewater-based surveillance are often limited and insufficient in these settings. Therefore, alternative sustainable and affordable approaches are needed. We intend to build on the demonstrated potential of metagenomic profiling of pooled faecal material, which accurately predicted population-level AMR prevalence in invasive Enterobacterales infections.

Methods and analysis

We aim to validate this metagenomic pooled approach on additional populations, and to evaluate whether AMR patterns could be similarly predicted from surveillance of community One Health reservoirs. We will assemble existing data from hospital-based microbiology diagnostic laboratories in rural Burkina Faso and Kenya, and determine to what extent community-level metagenomic data, and/or faecal material of patients on hospital admission, can predict AMR in clinical isolates. We will perform community-level surveys in eight clusters per country, randomly selecting 15 households per cluster. We will systematically sample suspected environmental AMR exposure sites in and around households (soil, drinking water, latrines, chicken faeces) and collect data on community-level antibiotic use, hygiene practices, contact with domestic animals and sanitary facilities. Samples and data will be collected twice: during the dry and during the rainy season.

In addition to evaluating the accuracy of predicting resistance in clinical isolates, we will quantify community-level exposure risks. We will conduct metagenomic profiling on pooled DNA extracts from human stool samples (hospital and community-level) and from household environments. Bayesian statistical models will quantify relationships between AMR gene abundance in the environment and in human stool, and invasive bacteria identified among clinical patients, accounting for geography and seasonality. A cost-utility analysis will determine under what circumstances the use of pooled metagenomic data to inform empirical antibiotic policies would represent an efficient use of resources.

Ethics and dissemination

The proposed surveillance protocol is developed in partnership with local communities and local and international researchers and has received ethical approval in Kenya and Burkina Faso. It will assess whether intermittent, pooled-sample metagenomics provides a viable, low-cost and practical approach for population-level AMR surveillance in settings that—like many in rural sSA—lack systematic microbiological diagnostics and where sewage systems for wastewater-based surveillance are absent. By providing an alternative to routine microbiological-based surveillance where this proves challenging to implement, this approach may help improve treatment outcomes, contribute to equity and public health. Findings will be disseminated through peer-reviewed publications and academic conferences and will contribute to the recently proposed WHO AMR surveillance strategy, which combines survey-based approaches with routine AMR surveillance.

Left atrial strain and all-cause mortality in patients with heart failure with reduced ejection fraction: a retrospective cohort study

Por: Özbek · B. T. · Modin · D. · Sengelov · M. · Jorgensen · P. G. · Bruun · N. E. · Fritz-Hansen · T. · Biering-Sorensen · T.
Background

The prognostic value of left atrial (LA) strain in patients with heart failure with reduced ejection fraction (HFrEF) has not been fully elucidated. Therefore, this study investigated the prognostic value of LA strain in HFrEF patients in relation to all-cause mortality.

Methods

A total of 822 echocardiograms from HFrEF patients admitted to a heart failure clinic were analysed offline. To calculate left atrial reservoir strain (LA RS) and left atrial contractile strain (LA CS), LA two-dimensional speckle tracking was performed in the 4-chamber, 2-chamber and 3-chamber view. The end-point was all-cause mortality. The association between LA strain parameters and outcome was examined using Cox regression.

Results

The median follow-up time was 40 months and follow-up was 100% complete. During follow-up, a total of 137 patients (16.7%) died of all causes. In a final multivariable model adjusted for clinical and echocardiographic parameters including global longitudinal strain, LA RS and LA CS were significantly associated with all-cause death during follow-up (LA RS, HR 0.96, 95% CI 0.92 to 0.99, p=0.014, pr. 1% increase) (LA CS, HR 0.95, 95% CI 0.92 to 0.98, p=0.002, pr. 1% increase).

When added to the final multivariable model, both LA RS and LA CS contributed with incremental prognostic value as determined by C-statistic (LA RS: C-stat difference 0.007, 95% CI 0.000 to 0.020, p=0.050) (LA CS: C-stat difference 0.009, 95% CI 0.000 to 0.023, p=0.030).

Conclusion

In HFrEF patients, LA RS and LA CS were associated with all-cause mortality and contributed incremental prognostic value in addition to established prognostic measures.

Genetic, lifestyle and environmental influences on health: a Finnish biobank recall study protocol (BioRecall)

Por: Sillanpää · E. · Föhr · T. · Kurtti · E. · Aittola · K. · Mäkelä · J. · Southerington · T. · Lakka · T. A. · Jokela · T. · Ahtiainen · M. · Laakkonen · E. · Rantakokko · M. · Ravi · S.
Introduction

Non-communicable diseases are the leading causes of premature mortality worldwide. Both genetic predispositions and environmental exposures affect disease risk. While biobanks have increased understanding of genetic predictors of these diseases, environmental influences are expected to have a greater impact on disease development. Individuals also create their own environments and lifestyles based on genetically regulated preferences, leading to gene–environment interactions that require large datasets to study. Finnish biobanks typically lack sufficient lifestyle and environmental data, which limits their use. We present a protocol for a biobank-recall study (BioRecall) to collect data on lifestyle and environmental exposures and combine these findings with genotypes, biological samples and clinical outcomes.

Methods and analysis

All previously genotyped donors from the Central Finland Biobank who have been diagnosed with type 2 diabetes and have consented to recall will be invited to participate in the pilot study. The preliminary feasibility assessment reveals that there are 1580 suitable candidates. Participants will complete an electronic questionnaire on a secure online platform. The questionnaire includes validated questions on lifestyles, anthropometrics, weight loss history, health, symptoms, work characteristics, emotional states and residential environments. Postcode information will facilitate the addition of spatial environmental data. Genotype and related clinical data will be provided in the study in accordance with the Finnish Biobank Act and combined with questionnaire data.

Ethics and dissemination

The Human Sciences Ethics Committee of the University of Jyväskylä delivered a favourable statement regarding the study protocol (1671/13.00.04.00/2023). Central Finland Biobank approved the research plan (no: BB24-0333-A01). The data collected will be returned to the Central Finland Biobank for research purposes with the participants’ consent. Permission for data usage can then be applied through standard protocols of the Fingenious service (https://site.fingenious.fi/en/). If successful, the study will be expanded to other donors and Finnish biobanks.

Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study

Por: Gunning · S. G. S. · Page · J. · Rossdale · J. · Charters · P. F. P. · Hudson · B. · Lyen · S. · Mackenzie Ross · R. · Seatter · A. · Bartlett · J. W. · Austin · L. · Myring · G. · McLeod · H. · Mitchell · P. · Stimpson · D. · Cookson · A. · Suntharalingam · J. · Rodrigues · J. C. L.
Introduction

Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

Methods and analysis

This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI’s interpretation of CTPA images.

A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI’s influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

Ethics and dissemination

This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

Trial registration number

NCT06093217.

Development of a resilience assessment tool for cardiac care pathways in Europe: a mixed-methods study

Por: V Carvalho · A. S. · Brito Fernandes · O. · Piek · J. J. · Mauri · J. · Sanz Escartin · A. · Wijns · W. · Klazinga · N. · Kringos · D.
Objectives

To develop a resilience assessment tool for cardiac care pathways in Europe, informed by stakeholder insights on the impact of COVID-19, emerging innovations and recommendations to enhance resilience.

Design

Mixed-methods study comprising three phases: (1) survey among European cardiac care providers; (2) five multistakeholder focus groups and (3) participatory tool development. Quantitative data were analysed using descriptive statistics, and qualitative data were analysed thematically.

Setting

The survey targeted cardiology professionals from the 27 European Union Member States and Ukraine who worked during the COVID-19 pandemic. Focus group participants were purposefully sampled to represent clinical, organisational and policy perspectives.

Participants

A total of 177 survey respondents and 40 informants in focus groups.

Results

Six key resilience dimensions of cardiac care pathways were identified: workforce, organisation of care delivery, governance and trust, communication and cooperation, medical devices and products, and data collection and use. Staff shortages and infrastructure capacity were key challenges during the pandemic. The most frequent measures were the reallocation of health staff (75%; n=133) and repurposing infrastructures (38%; n=32). Participants discussed the six resilience dimensions around a total of 17 subdimensions and 39 recommended actions to enhance resilience were identified. The resulting resilience assessment tool included four components: (1) mapping a context-specific cardiac care pathway; (2) stakeholder identification critical to participate in collective self-assessment; (3) a preparedness checklist generating a visual heat map and (4) a resource toolkit.

Conclusions

The resilience assessment tool offers step-by-step guidance to strengthening cardiac care pathways across six key resilience dimensions, supported by actionable recommendations. The tool enables the identification of context-specific vulnerabilities and improvement priorities, thereby supporting healthcare professionals and policymakers in enhancing preparedness and ensuring care continuity before, during and after crises. Its implementation is currently being piloted in European hospitals to evaluate and refine its practical applicability.

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