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Ayer — Marzo 4th 2026Tus fuentes RSS

Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol

by Claire L. Chan, Saskia Eddy, Jennie Hejdenberg, Ben Morgan, Heather M. Morgan, Gillian Lancaster, Clare Robinson, Sandra M. Eldridge

Background

The National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications.

Methods

The study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document.

Discussion

This work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications.

Protocol Registration

Open Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG.

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Development and evaluation of a mobile health (mHealth) application for smoking cessation among adolescents in Indonesia: a mixed methods randomised controlled trial study protocol

Por: Ilmaskal · R. · Prabandari · Y. S. · Oktaria · V.
Introduction

Adolescent smoking poses a critical public health challenge in Indonesia, where approximately 7.4% of adolescents are current smokers. This issue is compounded by the tobacco industry’s aggressive marketing strategies, particularly targeting youth. Mobile health (mHealth) interventions offer promising alternatives for smoking cessation because of their accessibility and adaptability. However, while mHealth applications have shown potential in promoting smoking cessation, their efficacy remains inconsistent, particularly among adolescent populations in low- and middle-income countries. This study aims to develop an innovative mHealth intervention model designed explicitly for adolescent users.

Methods and analysis

This study used a mixed-methods, sequential, exploratory approach, including a randomised controlled trial. The research will be conducted in three phases: (1) a qualitative study to inform the app’s design; (2) a development phase using the Rapid Application Development model; and (3) a single-blind, two-arm randomised controlled trial to evaluate the app’s efficacy. Participants will be randomised into either the mHealth intervention group or a paper-based control group using block randomisation to ensure balanced allocation and minimise bias. The protocol is compliant with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for transparency and reporting. The study population will consist of adolescent smokers aged 13–15 years who reside in Padang City. A total of 110 participants will be recruited, with 55 adolescents in the intervention group and 55 in the control group. The primary outcome is smoking abstinence at 1-, 3- and 6-month follow-ups, which will be assessed through a self-report questionnaire. Secondary outcomes include changes in self-efficacy, motivation, social support, nicotine dependence and user engagement with the intervention.

Ethics and dissemination

The study complies with protocols, the Helsinki Declaration, the principles of Good Health Research Practice and regulatory requirements. The protocol was approved by the Medical and Health Research Ethics Committee, Faculty of Medicine, Public Health and Nursing, Gadjah Mada University (Ref No: KE-FK-0864-EC-2025). Informed consent will be obtained from both adolescents and their parents/guardians, ensuring confidentiality and voluntary participation. The results of this study will be published in peer-reviewed journals.

Trial registration number

NCT07198828.

Trans-sectoral patient pathways in urgent and emergency care (TRANSPARENT study): protocol for a prospective, mixed-methods study in Germany

Por: Bienzeisler · J. · Hertwig · M. K. · Heidemeyer · H. · Alhaskir · M. · Majeed · R. W. · Kombeiz · A. · Hoy · W. · Huening · S. · Goettgens · F. · Unterkofler · J. · Rademacher · S. · Panagiotidis · D. · Marewski · V. · Sommer · A. · Schirrmeister · W. · Walcher · F. · Otto · R. · Ehrentr
Introduction

Urgent and emergency care in Germany is delivered across multiple, loosely connected sectors. In the absence of coherent, time-resolved data on patient movements between emergency medical services (EMS), out-of-hours ambulatory care, emergency departments (EDs) and inpatient care, inefficiencies and coordination gaps remain difficult to quantify. A process-centric, trans-sectoral analysis is required to characterise real-world patient pathways and identify actionable levers for improvement. The study aims to reconstruct, model and analyse patient pathways for urgent health complaints across all relevant sectors of the healthcare system in a German model region.

Methods and analysis

We will employ a mixed-methods observational study design. Routine data from EMS, out-of-hours ambulatory care, EDs and subsequent inpatient care will be pseudonymised at source, linked via a trusted third party and analysed within a trusted research environment. Time-stamped event logs will support process mining for discovery, conformance and performance analysis alongside descriptive statistics with stratification by context, such as setting, time of day, urgency and patient cohorts. Anonymous cross-sectional surveys of patients and front-line professionals, complemented by quarterly snapshot surveys in out-of-hours ambulatory care and interviews, will provide convergent evidence on the motives, barriers and coordination of utilisation behaviour. Enrolment for surveys is anticipated from the fourth quarter of 2025; routine data capture covers 1 January–31 December 2026; analyses and dissemination run until 31 December 2027.

Ethics and dissemination

The study received ethical approval from the Ethics Committee of the Medical Faculty at RWTH Aachen University (EK 25-351). Survey modules are conducted anonymously with voluntary participation and without collection of direct identifiers; routine care data are processed in pseudonymised form and analysed within a trusted research environment. Stakeholder interviews will be conducted with informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summary reports for participating institutions and stakeholders, complemented by plain-language materials to support patient-centred navigation.

Trial registration number

DRKS00035916.

Relationships between alcohol use and dementia: protocol for an observational study in the UK Clinical Practice Research Datalink

Por: Fatih · N. · Bhaskaran · K. · Kwok · A. C. H. · Ebmeier · K. P. · Nichols · T. · Gelernter · J. · Christodoulou · M. D. · Topiwala · A.
Introduction

Alcohol consumption is an increasingly recognised modifiable risk factor for dementia, yet whether it has differential impacts on dementia subtypes and its role in disease progression remains unclear. This study aims to: (1) quantify the association between alcohol intake and incidence of dementia subtypes and (2) examine whether individuals who drink heavily and develop dementia referred to hereafter as ‘alcohol-related’—have poorer post-diagnosis outcomes compared with other dementia cases. Clarifying these relationships will determine whether alcohol selectively increases risk for specific dementia phenotypes or broadly heightens neurodegenerative vulnerability, with implications for prevention, clinical counselling and therapeutic targeting.

Methods and analysis

This population-based cohort study of alcohol and dementia will use linked UK electronic health records from Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics (ONS). Participants will be eligible if they have available linked data from January 1998, when ONS death registrations became available, until the end of follow-up. Alcohol exposure will be defined through self-reported recorded weekly alcohol units and diagnostic codes for harmful or dependent alcohol use. Primary outcomes including incident all-cause and subtype-specific dementia (eg, Alzheimer’s, vascular, Lewy body, Parkinson’s, frontotemporal) as well as secondary outcomes (ie, mortality, care-home entry and neuropsychiatric symptoms). Key covariates encompassing socio-demographic factors, smoking and relevant comorbidities will be adjusted for. Multivariable Cox proportional hazards and Fine-Gray competing risk models will estimate associations with dementia incidence. Post-diagnosis prognosis will be compared for dementia in individuals with a history of heavy alcohol use (‘alcohol-related’) and dementia in individuals with minimal alcohol exposure (‘non-alcohol-related’) cases using survival and logistic regression models. Multiple testing correction will be applied across dementia subtype comparisons. Alcohol exposure will be modelled continuously and non-linearly using restricted cubic splines and categorically using binary indicators of harmful/dependent use. Missing covariate data will be assessed and addressed using appropriate methods, including multiple imputation and complete-case analysis. Data extraction and analysis are scheduled from October 2025 to October 2026.

Ethics and dissemination

Use of de-identified routine data will proceed under existing Research Ethics Committee and data governance approvals. Findings will be disseminated via open-access peer-reviewed journals, academic conferences and summaries targeted at patient, public and policy audiences. The results of this study will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) guidelines.

Comparing community-based monitoring to hospital-based care of patients with quiescent age-related macular degeneration: a qualitative study of patient and practitioner perspectives on acceptability and access

Por: Vougioukalou · S. · Read · S. M. · Csontos · J. K. · Jones · A. · Jaber · A. · Sharma · A. · Balaskas · K.
Objectives

This process evaluation explores patient and healthcare professional acceptability of community-based monitoring versus hospital-based care for patients with quiescent neovascular age-related macular degeneration (QnAMD).

Design

Qualitative process evaluation was conducted as part of a randomised controlled trial.

Setting

Six hospitals and six community-based practices.

Participants

25 patients and 16 healthcare professionals (ophthalmologists and optometrists). This approach helped differentiate between common issues and those specific to community-based monitoring.

Intervention

The Quality-Assured Follow-Up of QnAMD by non-medical practitioners trial aimed to examine whether non-medical practitioners follow-up patients with QnAMD in the community in a safe and clinically and cost-effective way. The process evaluation aimed to examine whether the intervention was acceptable by patients and professionals. The process evaluation was based on interviews which contained open-ended questions focused on patient experience and confidence in community-based care, issues concerning the practicalities of the organisation and management of the clinic, and resources including IT and digital equipment. The theory of acceptability framework was used to interpret the findings.

Results

Patients reported positively on the experience of receiving QnAMD services in the community and highlighted staff professionalism and clear communication. Key themes were the proximity of care provision for patients, IT interoperability and the real-world costs of running the service. Some patients randomised to the hospital showed preference for the intervention to take place in the hospital, mediated mainly by prior experience of hospital care and travel distance. The location of the clinic and transport routes affected the experience of attending appointments, with strong preference expressed for proximity to one’s home. Inaccessibility due to non-modifiable internal building structures in the community and parking in hospital eye services was reported by a small proportion of patients. Healthcare professionals reported positively about their ability to deliver QnAMD services in community settings but raised concerns about the compatibility of technological infrastructure that facilitates the sharing of optical coherence tomography image and video files. Some optometrists were also concerned about the financial sustainability of the intervention after the end of the trial due to the costs involved in the administration of QnAMD follow-up care.

Conclusions

The delivery of QnAMD services in the community by non-medical personnel was broadly accepted by both patients and practitioners. This implies that non-medical practitioners can follow up patients with QnAMD in the community in a safe way. Further research would be needed to establish whether similar results would be obtained during routine practice outside a research project and whether the long-term follow-up for QnAMD would be financially sustainable for independent as well as chain community optometry practices.

Trial registration number

NCT03893474.

A systematic review of the scope and impact of rural primary healthcare innovations using digital health technology

Por: MacAskill · W. · Gill · P. · Woloszczuk · C. · Alam · K. · Wallis · K. · McGrail · M. R. · Kondalsamy-Chennakesavan · S. · Nasir · B. F.
Objectives

Digital technology in primary healthcare service delivery can enhance accessibility, service delivery and health outcomes in rural populations. The objective of this systematic review is to review and synthesise the scope and impact of digital health technology innovations within rural primary healthcare settings.

Design

Systematic review.

Data sources

Articles published on PubMed, PsycINFO, Cochrane Central, SCOPUS, Web of Science, EMBASE and CINAHL between January 2013 and October 2025 were searched using key search terms.

Eligibility criteria

Patient, intervention, context, outcome model criteria guided article eligibility. Included articles were undertaken in rural populations, used digital health technology for treatment or management, explored the impact of digital health technology on rural primary healthcare and reported on healthcare outcomes. Included articles were in the English language and presented peer-reviewed primary research.

Data extraction and synthesis

Extraction was performed using a bespoke standardised template by multiple reviewers. Quality assessment was undertaken using the Mixed Methods Appraisal Tool. Descriptive analysis and conventional inductive content analysis were applied to quantitative and qualitative data, respectively. The review is written in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement guidelines.

Results

66 studies were included in the review. Most studies were conducted in the USA (n=26). Most studies focused on adult patient populations, with limited representation of Indigenous (In=3) and paediatric populations (n=2). Telemedicine/telehealth interventions using audio, video or both were the most common (n=36). Remote patient monitoring or point-of-care testing was integrated into 21 studies. Physical health conditions, particularly diabetes (n=17), cardiovascular diseases (n=11) and general primary healthcare concerns (n=13) were commonly reported. Others reported on areas including mental health, hypertension, obesity and pregnancy care.

Conventional inductive content analysis identified key themes: cost and time effectiveness, quality healthcare provision, consumer acceptance from both patients and practitioners, and healthcare service provider perspectives. Uptake barriers included staff workload and patient non-compliance, while facilitators encompassed process standardisation and practitioner acceptance and endorsement. Consumer acceptance was linked to satisfaction, willingness to engage and improved health outcomes and well-being.

Conclusions

Digital health interventions in rural primary healthcare offer significant potential to improve healthcare delivery, reduce costs and enhance patient access, satisfaction and health outcomes. However, careful consideration of factors such as feasibility, consumer and practitioner acceptance, and recognition of limitations is crucial for successful implementation. The review underscores the importance of flexible policies to support emerging digital healthcare solutions, including the integration of artificial intelligence. Overall, digital health interventions offer a promising avenue to improve healthcare outcomes in rural areas and should be prioritised for government funding and investment.

PROSPERO registration number

CRD42023477233.

Protective factors for maternal mental health and life satisfaction during the COVID-19 pandemic: a longitudinal analysis

Por: Johannessen · P. M. · Madsen · C. · Hart · R. K. · Lund · I. O. · Pettersen · J. H. · Gustavson · K. · Roysamb · E. · Nesvag · R. · Brandlistuen · R. E. · Ask · H.
Objective

Mothers’ mental health and life satisfaction may have been negatively affected due to challenges during the COVID-19 pandemic. Given the risk of future crises, knowledge of possible mitigating factors in this population is essential. This study aims to examine whether the pandemic affected the level of protective factors such as social support, physical activity and employment situation, and how these factors are associated with mental distress and life satisfaction.

Design

Longitudinal cohort study.

Outcome measures

Primary outcomes were mental distress (measured by the eight-item version of the Hopkins Symptom Checklist) and life satisfaction (measured by the Satisfaction With Life Scale). As the first step, we investigated changes in the levels of social support (defined by the number and frequency of social contact), physical activity (average hours of physical activity during a week), employment situation (actively working vs sick leave or unemployed), alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption) and relationship satisfaction (measured by the five-item version of the Relationship Satisfaction Scale).

Methods

We analysed data from two waves of the Norwegian Mother, Father and Child Cohort Study (n=~18 000 mothers); one pre-pandemic wave and one wave where half of the sample responded after the onset of the pandemic, with pandemic exposure being defined by questionnaire response timing rather than cohort recruitment. To assess changes in protective factors over time and pandemic exposure, we used difference-in-differences analyses and regression discontinuity design. Associations between protective factors with mental distress and life satisfaction, and possible moderation by pandemic exposure, were investigated using multiple regression models with interaction terms adjusted for potential confounders.

Results

Apart from physical activity, which declined less across time in the pandemic group (B=0.09, 99% CI 0.05 to 0.12), protective factors did not change during the pandemic. Social support, employment situation and relationship satisfaction were associated with mental distress and life satisfaction, whereas physical activity showed a unique relationship with mental distress. Most associations were similar across pandemic exposure groups, except employment situation which appeared to have a stronger protective effect in the pandemic group (β=–0.12, 99% CI –0.24 to –0.00).

Conclusions

Changes over time in self-reported levels of protective factors were generally consistent among mothers independent of the pandemic. These factors appear to play an equally important role for mental distress and life satisfaction both under ordinary circumstances and during public health crises. Our findings enhance the understanding of how potential protective factors among mothers are associated with mental distress and life satisfaction in the context of a global stressor. Future studies should investigate additional mitigating factors that may be particularly relevant during global crises and explore the causal relationship between protective factors, mental health and life satisfaction.

Understanding acute vertigo in emergency care in a large London teaching hospital: patient and physician perspectives on diagnostic challenges and digital support

Por: Cortese · E. · Ramsay · A. I. G. · Koohi · N. · Kaski · D.
Background

Acute vertigo is a common but diagnostically challenging presentation in emergency departments (EDs), where rapid distinction of life-threatening conditions—like stroke—is critical. Patient and clinician perspectives are often overlooked, and real ED needs and possibilities remain poorly understood. While smartphone-based clinical decision support tools (CDSTs) show promise, evidence on required features for trust and adoption is limited. The UK’s 2025 10-Year Health Plan highlights digital innovation and AI in urgent care, underscoring the need to address these gaps.

Objective

To explore the experiences of emergency physicians and patients with acute vertigo during the diagnostic process; identify real-world challenges, needs and opportunities within the ED setting; and assess participants’ perceptions of the acceptability of implementing a smartphone-based decision-support tool (CDST) to aid in acute vertigo diagnosis.

Design

Qualitative study using semi-structured interviews and reflexive thematic analysis.

Setting

Emergency Department of University College London Hospitals NHS Foundation Trust (UCLH), UK.

Participants

10 emergency physicians with experience in managing acute vertigo and 10 patients who had recently presented to the ED with symptoms of acute vertigo.

Results

The analyses identified challenges and needs when diagnosing acute vertigo in the ED and participants’ views on future smartphone-based CDST development to assist the diagnostic process. Clinicians emphasised diagnostic complexity, limited training and system-level constraints—like lack of space, time and resources—as major challenges. Patients emphasised the need for better communication and clearer diagnostic pathways. Both groups saw potential in smartphone-based CDSTs to improve diagnostic efficiency and accuracy by offering structured assessments and helping clinicians identify serious conditions.

Conclusions

This study offers insights into real-world constraints of diagnosing acute vertigo in the ED. Findings suggest that aligning CDST design with clinical workflows, user trust and environmental realities may facilitate adoption and impact in emergency care settings.

Gender dynamics in authorship of scientific publications in obstetrics and gynaecology: a 10-year bibliometric analysis of six high-impact journals

Por: Bobotis · S. · Stathi · D. · Verigos · E. · Geropoulos · G. · Arsenaki · E. · Paraskevaidi · M. · Tzafetas · M. · Mitra · A. · Kyrgiou · M. · Kechagias · K. S.
Objective

Although obstetrics and gynaecology (O&G) is a predominantly female specialty, previous studies have suggested that women remain under-represented in academic authorship. This study evaluates trends in female and male first and last authorship in six leading O&G journals (Human Reproduction Update, American Journal of Obstetrics and Gynecology, British Journal of Obstetrics and Gynaecology, Obstetrics and Gynecology, Gynecologic Oncology and Best Practice & Research Clinical Obstetrics & Gynaecology) between January 2013 and December 2023.

Methods

A bibliometric analysis was conducted using the Web of Science database. The gender of the first and last authors was determined using Genderize.io, with a probability threshold of ≥75% for classification. Binary logistic regression was performed to model the probability of authorship by gender across journals.

Results

Among 57 310 publications, 38 455 first (43.8% male and 56.2% female) and 38 950 last authors (58.6% male and 41.4% female) were identified and analysed. Over the past decade, female authorship has shown a clear upward trend, with first authorship increasing from 43% (1141/2636) in 2013 to 69% (2769/4036) in 2023, and last authorship increasing from 29% (770/2700) to 54% (2180/4047). First authorship was statistically more likely to be held by women in Human Reproduction Update (1.23, 95% CI 1.02 to 1.48), American Journal of Obstetrics & Gynecology (1.63, 95% CI 1.58 to 1.70) and Obstetrics & Gynecology (2.33, 95% CI 2.22 to 2.45). However, female last authorship was significantly more likely only in Obstetrics & Gynecology (1.21, 95% CI 1.16 to 1.27).

Conclusion

Despite an increasing trend in female representation in first and last authorships over the past decade, a significant gender disparity persists. While women now constitute the majority of first authors, last authorship remains disproportionately male, reflecting ongoing barriers to female leadership in O&G research. These findings highlight the need for targeted institutional efforts to promote gender equity in academic medicine.

Global scoping review of key domains of patient-reported experience of care measures across life stages and healthcare technical areas

Objectives

Patient-reported experience measures (PREMs) are measures of patients’ perceptions of care they receive. PREMs are critical in developing and evaluating programmes that aim to improve patient healthcare experiences and quality of care (QoC) according to patient-defined needs. This review aims to map key domains of PREMs across distinct healthcare technical areas and life stages from globally available literature.

Design

A scoping review adapting Arksey and O’Malley’s framework and Joanna Briggs Institute’s guidelines for the conduct of scoping reviews.

Data sources

Google Scholar, PubMed, WHO, US Academy of Medicine and USAID Momentum.

Eligibility

PREMs literature from electronic repositories of grey and peer-reviewed publications, published in English historically up to September 2023.

Data extraction and analysis

Two lead reviewers with support from the technical working group co-created a review framework of healthcare technical areas, life stages and PREMs domains. We screened eligible articles, prioritising reviews except for technical areas with no reviews, where we then selected individual studies. We charted, analysed and synthesised data from 52 eligible articles.

Results

PREMs literature has recently increased, especially in low-income and middle-income countries (LMICs), although studies in high-income countries (HICs) dominate in proportion (n=38; 73.1%). Out of 52 eligible articles, technical areas with most publications were sexual and reproductive health (n=21; 40.4%) and general outpatient care (n=11; 21.2%). Studies in adulthood (n=24; 46.2%) and from pregnancy and birth to postnatal (n=16; 30.8%) were most represented. PREMs studies reported mostly on communication and rapport (n=33; 63.5%) and respect and dignity (n=42; 80.8%) domains. Nearly a quarter (n=12; 23.1%) of the articles included only validated tools; the rest included a combination of validated and unvalidated measures. Of the tools relating to life stages of babies, younger children and older adults, the majority (n=17; 94.4%) included patient proxies.

Conclusion

PREMs, as an important component of QoC measurement, are increasing across several healthcare technical areas and life stages with commonalities and notable distinctions in measurement domains and tools. Evidence on PREMs largely comes from HICs. Evidence on critical, yet sometimes overlooked domains, highlights key QoC implementation gaps. The adaptation and utilisation of PREMs in programmes, especially in LMICs and under-represented technical areas, present opportunities to close the QoC disparities in those settings. Strategic, concerted efforts towards the harmonisation of PREMs tools across multiple life course stages and technical areas are critically needed in high-level quality improvement efforts.

Virtual reality for visions (VRV): a proof-of-concept study examining the development of a new treatment for distressing visual hallucinations in people with psychosis

Por: Dudley · R. · Sargeant · S. · Gibbs · C. · Prentice · L. · McCartney · L. · Aynsworth · C. · Maskey · M. · Skeggs · A.
Introduction

Visual Hallucinations (VHs) (seeing things that others do not, or visions) are a common feature of psychosis, causing significant distress and disability. Services rarely ask about these important experiences, and crucially there are no proven beneficial psychological treatments. There are at least two key challenges faced when treating VHs. First, people report not knowing why they see things others don’t, which leads them to feel alone and different from others. Second, they feel they cannot trust their own eyes to tell what is real or not, which can lead to fears they will be hurt or harmed by the VH, or even if they know the experience is not real, they may fear that they are losing their mind, or that they are not able to control or manage their experiences. For these reasons, they may struggle to put skills and strategies into practice when in the presence of the VH. Consequently, we have developed a novel treatment that addresses these core issues. First, we have a psycho-education and coping strategies package called Visual Unusual Sensory Experiences (VUSE) that uses the best aspects of digital technology (animations, videos) to explain why people have VHs and provides normalising information to help the person to feel less alone. It introduces coping strategies that are then tested in Virtual Reality sessions (VR for Visions VRV) where a representation of the visual experience is provided, enabling the person to safely develop skills and gain a sense of mastery and empowerment. We now plan to test this approach in a proof-of-concept study to help determine if this will help people use these skills in the real world and so help reduce distress, improve functioning and quality of life. We will address uncertainties in the feasibility of developing and delivering this treatment and inform its future use in a larger trial.

Methods and analysis

The study is a single arm feasibility trial (n=16) evaluating VUSE+VRV and treatment as usual. The study is recruiting people with psychosis and distressing VHs in one NHS Trust and uses independent but non-blind research assistants to undertake assessments before, during and after treatment (at baseline, 6, 12 week) and at follow-up (16 weeks). Quantitative information on recruitment rates, adherence and completion of outcome assessments (VHs, other psychiatric symptoms, quality of life and perceived recovery) will be collected. Qualitative interviews will capture service-users’ experience of therapy. Analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention.

Ethics and dissemination

The trial has received NHS Ethical and Health Research Authority approval (25/EM/0077). Informed consent will be obtained from all participants. Findings will be disseminated directly to participants, and services as well as through open access peer-reviewed publication(s).

Trial registration number

ISRCTN11350954.

Adverse effects of non-invasive brain stimulation as a treatment for mental disorders: protocol for a systematic review and meta-analysis

Por: Koelsch · C. · Mirlach · T. · Kinfe · T. M. · Hurlemann · R. · Mutz · J. · Selaskowski · B. · Kiebs · M.
Introduction

Mental disorders affect nearly one billion people worldwide, posing major challenges to public health. While conventional treatments like psychotherapy and pharmacotherapy are effective for many patients, they are often associated with adverse effects and high non-response rates, underscoring the need for alternative approaches. Non-invasive brain stimulation techniques such as transcranial magnetic stimulation, transcranial electric stimulation and transcranial focused ultrasound stimulation are increasingly used to treat psychiatric conditions. Although these methods show promising efficacy, data on their adverse effects remain fragmented and inconsistently reported. This meta-analysis aims to systematically compare the type and frequency of adverse effects, tolerability, and acceptability across different brain stimulation techniques and mental disorders. The findings will help improve safety monitoring and support more personalised, well-tolerated treatment strategies.

Methods and analysis

A systematic literature search of the Embase, MEDLINE(R), AMED (Allied and Complementary Medicine) and APA PsycINFO via OVID will be performed. Eligible studies include randomised controlled trials (RCTs) that compare active treatments or an active treatment with sham control, including both parallel group and cross-over studies, as well as prospective non-randomised studies such as case–control studies and pre–post studies investigating adverse effects of non-invasive brain stimulation in psychiatric populations. Included studies report on the frequency of adverse effects in a standardised manner. Primary outcomes comprise the incidence of specific adverse effects, dropout rates due to adverse effects (tolerability) and overall dropout rates (acceptability). Risk of bias will be assessed using the Cochrane RoB 2.0 tool for RCTs and the NHLBI quality assessment tool for pre–post studies. The quality of case–control studies will be assessed using the Newcastle-Ottawa scale. Provided that sufficient data are available and the network of comparisons is adequately connected, a network meta-analysis will be conducted to compare adverse effects and tolerability across interventions.

Ethics and dissemination

No ethical approval is needed to conduct this work. The findings will be submitted for publication in peer-reviewed journals and presented at scientific meetings.

PROSPERO registration number

CRD420251164554

Evaluating the delivery of trauma and orthopaedic education in UK medical schools: a national cross-sectional survey protocol (TENDON study)

Por: Nazar · N. · OHanlon · C. · Kolhe · S. · Bellamy · M. · Barberon · M. · Khajuria · A. · Low · W. X. · Geetala · R. · Chahal · K. · Banaszkiewicz · P. · McCaskie · A. · McDonnell · S.
Introduction

Musculoskeletal (MSK) conditions account for up to one-third of general practice consultations and over one-fifth of emergency department attendances in the UK. Postpandemic, the elective orthopaedic surgery backlog remains one of the most substantial across surgical specialties. Despite this burden, undergraduate exposure to trauma and orthopaedics (T&O) remains limited and inconsistent. Most UK medical students receive only 2–3 weeks of T&O teaching, with up to 40% of foundation doctors feeling underprepared to manage MSK conditions. The Evaluation of Trauma and Orthopaedic Teaching in Medical Schools Nationally (TENDON Study) aims to evaluate the current state of undergraduate T&O education in UK medical schools from both student and educator perspectives.

Methods and analysis

This national, prospective, cross-sectional survey will be conducted between 25 July and 27 October 2025. A dual-instrument electronic survey was developed through Qualtrics, informed by the British Orthopaedic Association (BOA) Undergraduate Curriculum and UK Medical Licensing Assessment content map. Participants will include medical students (Years 1–6), foundation doctors and orthopaedic educators recruited through British Orthopaedic Medical Students Association and BOA networks, and designated school representatives. Survey domains include curriculum coverage, teaching methods, clinical exposure and self-reported competence. Quantitative data will be analysed using descriptive and inferential statistics; qualitative data will undergo thematic analysis. Reporting will follow the Checklist for Reporting Of Survey Studies framework, with relevant elements drawn from the Checklist for Reporting Results of Internet E-Surveys checklist.

Ethics and dissemination

Ethical approval was obtained from the Human Biology Research Ethics Committee, University of Cambridge. Findings will be disseminated via peer-reviewed publication, conference presentations and summary reports to curriculum leads and relevant educational bodies.

Evaluating the impact of a national brain health education course for older adults with intellectual and developmental disabilities and caregivers: Brain Health-IDD Program protocol

Por: Lunsky · Y. · Bobbette · N. · Chiu · M. · Thakur · A. · Patel · P. · Volpe · T. · Balogh · R. · Baskin · A. · Beaudoin · M.-J. · Dever · M. J. · Durbin · A. · Fogle · A. · Kelly · C. · Lake · J. · Lefkowitz · G. · Mallett · H. · McCabe · J. · Noonan · J. · Selick · A. · Shooshtari · S. · Socka
Introduction

Adults with intellectual and/or developmental disabilities (IDD) experience higher rates of age-related health concerns, including dementia, than adults without disabilities. Despite this, current efforts to support brain health in ageing have often excluded this population. To address this gap, we will codesign, codeliver and evaluate a national virtual brain health education programme, Brain Health-IDD, for ageing individuals with IDD, family caregivers and health and social care providers.

Methods and analysis

This study will evaluate the Brain Health-IDD Program, an interactive virtual psychoeducation course codesigned and coled by an interdisciplinary team of clinicians and people with lived experience. Three participant groups will be recruited from across Canada: adults with IDD, aged 40 years and older; family caregivers who have a family member with IDD aged 40 years and older or who are themselves aged 60 years and older; and health or social service providers who support adults with IDD aged 40 years and older. Outcomes will be measured at baseline, postcourse and 3-month follow-up. Data will be collected through structured surveys, including both closed and open-ended questions, and focus group interviews.

Primary outcomes are participation, satisfaction and changes in knowledge and self-efficacy related to brain health among the three participant groups. Secondary outcomes for both adults with IDD and family caregivers include changes in health-related behaviours (social connections, sleep hygiene and physical activity), physical health, mental wellbeing, resilience and whether cognitive screening is initiated for adults with IDD and for caregivers. For health and social service providers, secondary outcomes include changes in brain health promotion practices and whether cognitive screening for older adults with IDD is initiated.

Analysis of open-text survey responses and qualitative data from focus group interviews will explore the experiences of participants with the Brain Health-IDD Program.

Ethics and dissemination

Institutional ethics approval was obtained from the Centre for Addiction and Mental Health Research Ethics Board. Programme findings and resources will be shared with advocacy groups, disability agencies, family caregiver organisations, clinicians and policymakers in the fields of disability, health and ageing at the provincial, national and international levels.

Testing oral nicotine pouches versus nicotine replacement therapy for cigarette harm reduction in Appalachia: The ARISE study protocol

by Amy Wermert, Theodore M. Brasky, Alison M. Newton, Alice Hinton, Hayley Curran, Amy K. Ferketich, Matthew J. Carpenter, Peter G. Shields, Patrick Tomko, Theodore L. Wagener, Brittney Keller-Hamilton

Background

With the highest cancer incidence and mortality rates in the country, rural Appalachia has experienced a decades-long health decline, due in part to high smoking rates. Cigarette smoking prevalence exceeds 30% in much of the region. Oral nicotine pouches (ONPs), which contain nicotine but no tobacco, present an unexplored opportunity to reduce cigarette smoking and cancer incidence.

Objectives

We outline the protocol for the Appalachian Research to Impact Smoking’s Effects (ARISE) study, a randomized controlled trial to determine whether ONPs affect cigarette smoking patterns short- and long-term, and to evaluate their abuse liability versus nicotine replacement therapy (NRT) in a large sample of Appalachian smokers (clinicaltrials.gov: NCT06763536).

Methods

Between 2025 and 2029, we will recruit 1,000 adult smokers living in rural Appalachian counties across 11 states. Participants will be identified via media outreach, mobile cancer screening, community events, and respondent-driven sampling, then randomized to ONP or NRT and complete four study phases: Baseline, Sampling, Switch, and Observation. In the Sampling phase, participants will receive varied flavors and nicotine strengths of their assigned product and select preferred options for use. During the Switch Phase, they will attempt to quit smoking and switch completely to their assigned product. The Observation phase will monitor tobacco use after discontinuation of study products. Study procedures will be conducted online and by mail, including surveys, expired carbon monoxide verification, and product delivery. The primary outcome is 7-day biochemically verified cigarette abstinence at the end of the Switch Phase. Secondary outcomes include switching rates, product appeal, craving, withdrawal, dependence, and purchases during the Observation phase. An intention-to-treat log-binomial regression model will estimate the effect of intervention assignment on cigarette abstinence.

Conclusions

Results will inform whether and how ONPs should be regulated, approached clinically, and used in public health interventions to reduce the burdens of cigarette smoking in Appalachia.

Measuring and monitoring safety of older adults living in retirement homes: a scoping review protocol

Por: Backman · C. · Engel · F. D. · Tonjock Kolle · A. · Papp · R. · Lam · A. · Freeman · L. · Li · W. · Sterling · E. · Fung · S. G. · Sinha · S. K. · Manis · D. R. · Wang · T.-F. · Kehoe MacLeod · K. · Hecimovich · C. · Webber · C. · Maskerine · C. · Syrowatka · A. · Fancott · C. · Kobewka · D
Background

The global population of older adults has grown at an unprecedented rate, and projections indicate that the number of older adults will continue to increase considerably in the coming decades. The clinical complexity of older adults living in retirement homes, also known as assisted living settings, is also increasing, and the regulations to ensure quality and safety standards in retirement homes are highly variable. The purpose of this scoping review is to map and summarise the methods used to monitor and measure the safety of older adults living in retirement homes, providing an overview of existing approaches and areas requiring further investigation.

Methods

This scoping review will follow the five stages of the Arksey and O’Malley scoping review process. We will report this review using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A comprehensive search of four electronic databases (MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and Web of Science Core Collection) will be performed, and reference lists of included articles will be searched. We will conduct a two-step screening process, data extraction and analysis of the included studies. We will include all primary study designs that report on safety measurement and monitoring of any type of harms. Relevant grey literature will also be identified. We will exclude studies that only report results from facilities providing 24-hour skilled nursing care or specialised care services, and those not published in English or French. This protocol is registered on the Open Science Framework (osf.io/8rheq).

Ethics and dissemination

No ethical approval is needed for the review, and we plan to present the results at research conferences and in a peer-reviewed article. Our findings may inform future research studies that seek to support and improve safety practices in retirement homes.

Relationship between exercise beliefs, happiness, quality of life and sociodemographic characteristics in pregnant women in Eastern Turkey: a cross-sectional study

Por: Taskaya · B. · Ciftci · N. · Durmus · M. · Sahin · F. · Yildiz · M. · Yıldırım · H.
Objective

This study was conducted to examine the relationship between exercise health beliefs, happiness and quality of life among pregnant women, and to evaluate how sociodemographic characteristics are associated with these variables.

Design

The study was conducted using a cross-sectional descriptive study design. Data were collected through face-to-face interviews using a convenience sampling approach. ‘Personal Information Form’, ‘Exercise Health Belief Model Scale’, ‘Oxford Happiness Scale Short Form’ and ‘Short Form (SF-12) Quality of Life Scale’ were used to collect data. Descriptive statistics (mean, SD, percentage), Pearson correlation analysis and simple linear regression were applied.

Setting

The study was conducted at Family Health Centres located in a provincial centre in Eastern Turkey.

Participants

A total of 1090 pregnant women who visited the Family Health Centres participated in the study.

Results

The mean score for the Exercise Health Belief Model Scale was 113.98±20.49, the mean score for the Oxford Happiness Scale Short Form was 18.45±4.05 and the mean score for the SF-12 Quality of Life Scale was 85.34±10.29. A positive and moderately significant correlation was found between exercise health beliefs, happiness and quality of life (r=0.31–0.38, p

Conclusions

Higher levels of exercise health beliefs were associated with increased happiness and quality of life in pregnant women. These findings suggest that nursing interventions aimed at strengthening exercise beliefs may contribute to maternal well-being during pregnancy.

Perspective of healthcare professionals on barriers and facilitators in exploring end-of-life care preferences of patients with pulmonary fibrosis: A qualitative study

by Lian Trapman, Lea M Dijksman, Jan C. Grutters, Saskia C.C.M. Teunissen, Everlien de Graaf

Background

Progressive pulmonary fibrosis is a lethal disease with a survival of 3–5 years with optimal medication treatment. Palliative care and advance care planning are therefore receiving increasing attention in the literature. However, structural implementation in clinical practice is still lacking. The aim of this study was to explore the needs, facilitators, and barriers for communication on the topic of end-of-life preferences of patients from the perspective of healthcare professionals.

Methods

A generic qualitative study was performed with focus groups and individual semi structured interviews with healthcare professionals. Data collection and analysis were performed iteratively. A thematic analysis was performed, following the methods of Braun and Clarke.

Results

Three focus groups and seven individual semi-structured interviews were conducted. Three themes were generated: (1) a lack of vision on palliative care, resulting in different approaches within the same clinic and showing the need for optimization of collaboration; (2) the importance of a learning-driven environment to support healthcare professionals skills and knowledge; and (3), the central role of the individual professional in developing skills and knowledge.

Conclusions/discussion

This study underscores the importance of behavioral and organizational change in palliative care to optimize conversations exploring values, preferences, and needs for end-of-life care for patients with pulmonary fibrosis. Leveraging the shared motivation of healthcare professionals to provide optimal care, integrating these findings into training and coaching programs can further enhance patient-centered approach in palliative care.

Ethnic and immigrant disparities in dialysis prevalence and chronic kidney disease trajectories in Toronto

Por: Sikaneta · T. · Martin · S. · Mucsi · I. · Lofters · A. K. · Taskapan · H. · Tam · P. · Mahdavi · S.
Background

Large differences exist in chronic kidney disease (CKD) rates between countries, but differences within diverse populations living in the same setting with universal healthcare are not well understood.

Objectives

To compare dialysis prevalence, CKD risk factors and control, and CKD progression by ethnicity and birth country in an ethnoculturally diverse setting with high rates of kidney disease and universal healthcare.

Setting

Scarborough, Toronto’s most diverse region and site of Canada’s largest regional dialysis programme.

Design and participants

Double observational cohort study of 2397 participants: a retrospective cohort of 1116 residents who received dialysis between 2016–2019, and a prospective cohort of 1281 individuals with non-dialysis CKD followed for 3 years between 2010–2015 in Scarborough.

Outcome measurements

Dialysis prevalence, calculated by comparing frequencies of birth countries and ethnicities in the dialysis cohort with census-derived community frequencies. Secondary outcome measurements were traditional CKD risk factor prevalence (diabetes, hypertension, cardiovascular disease) and control (haemoglobin A1c, blood pressure); and CKD progression (estimated glomerular filtration rate decline, proteinuria) adjusted for socioeconomic status in the non-dialysis cohort.

Results

Dialysis prevalence was 4.2 times higher in immigrants (p

Conclusions

Despite universal healthcare access, marked disparities in CKD risks and rates exist within ethnoculturally diverse immigrants living in this Canadian kidney disease hotspot. More focused research and tailored interventions are required.

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