The Validating Outcomes by Including Consumer Experience (VOICE) project is developing patient reported experience measure (PREM) tools to collect consumer feedback for Indigenous primary healthcare (IPHC) services’ accreditation and quality improvement processes. This study aimed to explore the views of health service staff about: (1) optimising the feasibility of collection, analysis and interpretation of findings; and (2) resourcing requirements for implementation of the PREM.

A participatory action research qualitative study design, guided by an Indigenous advisory group. Our team of Indigenous and non-Indigenous researchers conducted semistructured focus groups and individual interviews with IPHC staff. Focus groups and interviews were recorded, transcribed and thematically analysed. Multiple sense-making meetings were conducted with the Indigenous advisory group.

Eight partner IPHC services across four Australian states and territories.

All staff were eligible and invited to participate in the study via purposive and snowball sampling. Administrative staff (eg, receptionist, programme facilitator), clinicians/practitioners (eg, general practitioner, nurse, Aboriginal and Torres Strait Islander health workers and practitioners) and service managers (eg, CEO, practice manager) from partner health services participated.

63 staff participated; 44 attended across 13 focus groups, with the remainder participating in individual interviews. The majority of participants were between 35 years and 55 years old (52%), female (66%) and working in frontline IPHC service delivery roles (56%). Equal numbers identified as Indigenous (50%) and non-Indigenous (50%). Many had worked in the Indigenous health and well-being sector for over 10 years (40%). ‘Culturally safe care’ and ‘accountability’ were identified as primary themes and key reasons for gathering consumer feedback. Subthemes identified were ‘Relationships’, ‘trust and respect’, ‘communication about consumer feedback’, ‘timing and frequency of requesting consumer feedback’, ‘health service systems’, ‘health service and staff capacity’, ‘staff skills’ and ‘structure and administration of the PREM’. All themes and subthemes need to be considered for the successful design and implementation of PREMs in IPHC settings.

Many of the issues identified are not currently considered in the process of collecting PREM data for accreditation yet, if addressed, would likely improve the quality and relevance of data collected. The findings from this study will inform the co-design and validation of Indigenous-specific PREM tools to collect consumer feedback. Critically, service and community input will ensure the PREM tools meet service needs for continuous quality improvement and accreditation and reflect the priorities and values of Indigenous peoples.

Current guideline-recommended antibiotic treatment durations for ventilator-associated pneumonia (VAP) are largely standardised, with limited consideration of individual patient characteristics, pathogens or clinical context. This one-size-fits-all approach risks both overtreatment—promoting antimicrobial resistance and adverse drug events—as well as undertreatment, increasing the likelihood of pneumonia recurrence and sepsis-related complications. There is a critical need for VAP-specific biomarkers to enable individualised treatment strategies. The Ventilator-associated pneumonia Biomarker Evaluation (VIBE) study aims to identify a dynamic alveolar biomarker signature associated with treatment response, with the goal of informing personalised antibiotic duration in future clinical trials.

VIBE is a prospective, observational, case-cohort study of 125 adult patients with VAP in Michigan Medicine University Hospital intensive care units. Study subjects will undergo non-bronchoscopic bronchoalveolar lavage on the day of VAP diagnosis (Day 1) and then on Days 3 and 5. Alveolar biomarkers (quantitative respiratory culture bioburden, alveolar neutrophil percentage and pathogen genomic load assessed via BioFire FilmArray polymerase chain reaction) will be assessed. An expert panel of intensivists, blinded to biomarker data, will adjudicate each patient’s Day 10 outcome as VAP clinical cure (control) or treatment failure (case). Absolute biomarker levels and mean-fold changes in biomarker levels will be compared between groups. Data will be used to derive a composite temporal alveolar biomarker signature predictive of VAP treatment failure.

Ethical approval was obtained from the University of Michigan Institutional Review Board (IRB #HUM00251780). Informed consent will be obtained from all study participants or their legally authorised representatives. Findings will be disseminated through peer-reviewed publications, conferences and feedback into clinical guidelines committees.

Poststroke depression affects approximately 30% of stroke survivors and is linked to worse functional outcomes, cognitive decline, reduced quality of life and increased mortality. While early treatment of poststroke mental health conditions is critical, current pharmacological options offer limited efficacy. Music listening interventions are a promising, low-risk, accessible and affordable alternative that may enhance recovery through engagement of reward-related brain circuits. However, most music listening studies have focused on the acute stage of stroke, lack objective measures of music engagement and rarely assess underlying neural mechanisms. To address these gaps, we propose a feasibility study of a remotely delivered music-listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural and physiological changes.

We will conduct a parallel group randomised controlled feasibility trial enrolling 60 patients with chronic stroke from a well-characterised stroke registry in New York City. Participants will be randomised to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week preintervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (ie, track identity, duration and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioural outcomes related to mental health will be assessed at baseline, preintervention, postintervention and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity and heart rate) will be collected preintervention and postintervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, treatment fidelity, feasibility, acceptability and participant burden. Secondary outcomes include recruitment and randomisation rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for poststroke mental health recovery.

The study was approved by New York University’s Institutional Review Board (FY2024-8826). All human participants will provide written informed consent prior to participation and will be adequately compensated for their time. Results will be reported in peer-reviewed journals.

NCT07127159.

This study aims to analyse the barriers and facilitators towards an implementation of active breaks (ABs) intervention inside the workplace.

This study used a mixed-methods approach, incorporating virtual focus groups and an online questionnaire, conducted among the workers of Alma Mater Studiorum - University of Bologna (Italy). A total of 30 participants (N=30), including administrative and academic staff, PhD candidates, specialised trainees and research fellows, were involved in the study. Key themes and subthemes related to the barriers and facilitators of ABs interventions at the university were identified and categorised according to the three levels of the socio-ecological model.

The most commonly reported barriers are: lack of time, lack of motivation (intrapersonal level); lack of influence, lack of awareness (social level); physical space, organisational support (environmental level). The most commonly reported facilitators are: access to information, flexible work hours (intrapersonal level); group support, awareness programmes (social level); adequate spaces, organisational structure (environmental level). A significant majority (81.48%) recognised the problem of sedentary time at work, with strong interest (92.59%) in workplace interventions to reduce it. Flexibility in timing for ABs (44.44%) was preferred over fixed schedules, with preference for dedicated areas (37.04%) and outdoor spaces (29.63%). The majority (62.96%) preferred taking ABs in small groups open to all, with a qualified kinesiologist (40.74%) leading the management.

This study identified barriers and facilitators to an ABs intervention from the perspective of administrative staff, residents and researchers. These findings could help institutions foster an environment that promotes physical activity, reduces sedentary behaviour and promotes the well-being and safety of workers through an integrated and individual-centred approach.

This study uses nationally representative survey data from the USA to estimate the relationship between a history of heart attack or stroke with the prevalence of mental health symptoms.

Cross-sectional.

Data from the 2019 and the 2018 National Health Interview Survey (NHIS) sample adult interview.

30 872 adults from the 2019 NHIS and 24 593 adults from the 2018 NHIS were analysed separately; a history of heart attack or stroke was determined based on participants’ recollection of previous communications with health professionals.

Poisson log-linear regressions with robust SEs were employed to estimate the relative prevalence of mental health symptoms associated with a history of heart attack or stroke. Mental health outcomes included moderate-to-severe depression symptoms according to the Patient Health Questionnaire, moderate-to-severe anxiety symptoms according to the General Anxiety Disorder scale and serious psychological distress according to the Kessler Psychological Distress scale.

The prevalence of moderate-to-severe symptoms of depression, anxiety and serious psychological distress was more than two times as high among individuals with a history of heart attack or stroke compared with those without such a history. After adjusting for potentially confounding socio-demographic and health variables, survivors of heart attack were 33% and 40% more likely and survivors of stroke were 59% and 52% more likely to experience depression and anxiety symptoms, compared with adults without these conditions. Additionally, survivors of stroke were 76% more likely to have serious psychological distress than those without a stroke history.

Findings from this study highlight the increased mental health problems experienced by heart attack or stroke survivors relative to adults without these conditions. They underscore the importance of addressing mental health concerns among adults who have experienced a heart attack or stroke.

Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.

Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.

The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.

NCT02727296.

Haematuria contributes significantly to emergency urology admissions with over 4 per 1000 annual UK emergency admissions and 10% readmitted within 30 days. However, there is limited focus on optimising inpatient pathways internationally. Existing studies highlight a substantial underlying malignancy rate (32%) in patients presenting with visible haematuria, yet many receive inconsistent care, leading to prolonged hospital stays and increased resource use. A systematic review performed by our research group found no large-scale prospective studies have been performed in this area, and little is known about current practice. This study aims to address these gaps by investigating current management practices and their impact on outcomes, with the goal of informing evidence-based guidelines and improving patient care.

The Ward AdmiSsion of Haematuria: an Observational mUlticentre sTudy is an international, multicentre prospective observational study designed to describe the management of patients with unplanned admission to hospital with haematuria under the care of the urology team. The study will use a collaborative methodology using the British Urology Researchers in Surgical Training model. This model delivers international multicentre studies by empowering trainees to lead all aspects of multi-centre clinical studies, building research skills cost-effectively while shaping the future urological consultant workforce. Data on demographics, comorbidities, management practices and outcomes will be collected using a standardised case report form and analysed using multilevel linear regression modelling. Primary outcomes include length of stay, while secondary outcomes cover hospitalisation free survival, mortality, readmission rates at 90 days and resource use. The study was launched in January 2024 and will continue follow-up data collection through December 2025. Patient and public involvement (PPI) has been integral to the study design, ensuring that outcomes reflect patient priorities and that the research addresses key areas of concern.

Ethical and regulatory approvals will be obtained as required in each participating region. In the UK, the study is classified as a service evaluation and does not require individual patient consent. Participating sites must obtain local audit department approval. Data will be collected and stored securely, ensuring patient confidentiality. Results will be disseminated through scientific conferences, peer-reviewed publications and patient advocacy groups.

Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.

This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.

No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.

Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.

A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.

This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.

To explore the experience of primary healthcare (PHC) professionals in their professional role during the pandemic and to describe collective coping strategies.

We conducted a qualitative study using interviews, focus groups and photovoice techniques from February to September 2021. The qualitative data were transcribed, aggregated and analysed, from a hermeneutic perspective, using applied thematic analysis and ethnographic approaches.

Primary Care Health Madrid region (Spain).

Convenience sampling was used to select 71 multidisciplinary primary care professionals who were working in 12 PHCs representing diverse socioeconomic, social vulnerability and COVID impact levels in the Madrid region (Spain).

Findings from this study show how lack of protection in the early days, uncertainty about how the disease would evolve and the daily challenges they faced have had an impact on the participants’ perceptions of their professional role. Nuanced differences in impact were found between men and women, age groups, professional roles and territories. The questioning of the basic foundations of primary care and the lack of prospects led to a feeling of demotivation. They perceive a wide gap between their levels of involvement and commitment, the recognition they receive and the attention to resources they need to do their work to a high standard. The support of their colleagues was seen as the most valuable resource for coping with the crisis.

The practitioners’ discourses offer knowledge that could help to face new global health threats; they also identify an urgent need to restore the role and motivation of PHC professionals as part of a wider regeneration of health systems.

The high prevalence of loneliness in young people, aged 10–24 years, is increasingly recognised as an urgent global health concern. The experience of loneliness is linked to a wide range of adverse physical and mental health outcomes. A lack of loneliness scales that can accurately capture the authentic experiences of young people has hampered progress in our understanding of the aetiology and sequelae of youth loneliness, as well as the development of preventative policies and interventions. Here, we provide a protocol for developing and validating an age-sensitive loneliness scale for young people aged 10–24 years: the Youth Loneliness Scale (YLS). The scale is designed to measure loneliness in the general population of young people in the UK.

The scale is coproduced with young people from design to dissemination. The scale development process follows a three-phased, multistep approach that includes item development, scale construction and scale evaluation. Item development is achieved via deductive (literature review) and inductive methods (arts workshops and focus groups), as well as a Delphi survey of experts (by profession and experience) for initial refinement. The scale is then constructed via pretesting items in cognitive interviews with young people, and exploratory testing for preliminary evaluation and refinement. Finally, the scale is administered in confirmatory testing, where a full psychometric evaluation is provided.

The project was approved by the Queen Mary University of London Research Ethics Committee (Reference: 2024-0231-341) as the lead site and subsequently endorsed by the University of Manchester Research Ethics Committee. The YLS scale and results of its psychometric evaluation will be published open-access. The protocol provided here will allow researchers to evaluate the final scale generated against the plans set out. We also encourage the use and adaptation of the protocol to develop age-sensitive loneliness scales for other populations.

Variations in mental health and sexual and reproductive health (SRH) outcomes of girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, gender fluid, agender, queer, gender neutral) youth with intersectional identities exist and have largely been ignored in the literature. There is a lack of information on how these health services meet the health needs of girls/women and gender-diverse youth with intersectional identities and the quality of such services. The objective of this global realist review is to identify how, why, for whom, in what contexts and to what extent mental health and SRH services meet the health needs of girls/women (cisgender and transgender) and gender-diverse youth (10–25 years) with intersectional identities.

The protocol has been registered with PROSPERO and will follow Realist and Meta-narrative Evidence Syntheses Quality Standards for Realist Reviews. We will identify the programme theory and implementation determinants of mental health and SRH services for girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, fluid, agender, queer, gender neutral) youth (10–25 years). The scope of the review will be defined in the first stage and will include consultations with youth Advisory Group members and initial programme theory development. An iterative search of scholarly bibliographic databases (MEDLINE, Embase, APA PsycInfo, CINAHL, Web of Science, IBSS) in addition to a grey literature search will take place in the second stage. The third stage will include evidence extraction and synthesis. In the final stage, the narrative will be developed and refined in consultation with Youth Advisory Group members, and findings will be disseminated.

The study was approved by the Research Ethics Board at the Centre for Addiction and Mental Health (2023/153). Findings will be disseminated through peer-reviewed publications, youth-friendly materials and webinars and national and international conferences.

CRD42024532422.

Gastroenteropancreatic neuroendocrine tumours (GEP NET) are malignant neoplasms that impact survival. Somatostatin analogues (SSA) are used for treating hormonal symptoms caused by GEP NET and have antiproliferative effects. They are used as first-line therapy in patients with advanced GEP NET, but disease control is limited to a median progression-free survival (mPFS) of 14–32 months. Second-line treatment options include targeted therapy (everolimus or sunitinib), or peptide receptor radionuclide therapy (PRRT) with ¹⁷⁷Lu-DOTATATE. In patients suffering from a NET-related hormonal syndrome, SSA is generally continued life-long. However, there is no consensus on whether it is beneficial to continue SSA in non-functional NET upon disease progression. Due to the ongoing activity of the somatostatin receptor pathway in GEP NET progressing on first-line SSA, we hypothesise that SSA have an added efficacy in second-line therapy.

The SAUNA trial is an international, multicentre, open-label, randomised, controlled, pragmatic clinical trial. 270 patients with advanced, non-functional GEP NET and progression under first-line SSA will be included in substudy 1 (PRRT; n=142) or substudy 2 (targeted therapy (everolimus/sunitinib); n=128) per investigator’s choice of second-line therapy and will be randomised (1:1) per substudy between SSA continuation or SSA withdrawal arms. Co-primary endpoints are the difference in progression-free survival (PFS) according to the RECIST (Response Evaluation Criteria In Solid Tumours) V.1.1 criteria and difference in time to deterioration (TTD) in quality of life (QoL) per substudy after initiating second-line therapy with or without SSA. Secondary endpoints include the PFS rate at 18 months, the difference in pooled PFS and TTD combining both substudies, overall survival, response rates, QoL, costs, cost-effectiveness and toxicity. The study design was developed in cooperation with the Belgium and Dutch patient organisations.

The study has been approved on 31 May 2023 by the Ethical Committees and Regulatory Authorities of the concerned member states (EU CT number 2022-502703-30-00). Both the trial management group and the steering committee will oversee good governance of this trial. Results of the study will be published in peer-reviewed international journals and presented at international conferences.

NCT05701241.

Diabetes is one of the most common long-term health conditions worldwide, placing a huge economic burden on health services. Diabetes self-management education and support programmes can support people with diabetes to manage their condition; however, uptake of face-to-face services remains low. Digital self-management tools are becoming increasingly available. MyWay Diabetes is a digital platform that offers a comprehensive self-management and education programme accessible through a mobile app and website and allows patients to access their personal healthcare records. Following successful implementation in Scotland, MyWay Diabetes is now being rolled out in three geographical areas in England. We plan to undertake three qualitative studies, as part of a larger mixed-methods research programme, to assess whether MyWay Diabetes is acceptable across diverse patient groups and healthcare professionals and gather views of patients who do not currently use the digital service.

We will conduct three online focus group studies. (1) One focus group with healthcare professionals (n=6–10) to understand their perceptions of implementing MyWay Diabetes in their local regions. (2) Up to four focus groups with existing users of MyWay Diabetes (n=24–40) across the three geographical areas in England to explore their acceptability of the platform. (3) Up to three focus groups with people living with diabetes who do not currently use MyWay Diabetes (n=18–30). Data will be collected using online videoconferencing and analysed thematically using template analysis.

Ethical approval was granted by South Central – Berkshire Research Ethics Committee (ref: 25/SC/0125) and The University of Manchester Proportionate Research Ethics Committee (ref: 2025-23064-42006). Study results will be disseminated through peer-reviewed journals, conference presentations, MyWay Digital Health platforms and national bodies. The evidence from this broader mixed-methods evaluation will inform decisions for platform improvement and regional and national commissioning across the National Health Service in England.