FreshRSS

🔒
☐ ☆ ✇ BMJ Open

Dementia-related volumetric assessments in neuroradiology reports: a natural language processing-based study

Por: Mayers · A. J. · Roberts · A. · Venkataraman · A. V. · Booth · C. · Stewart · R. — Septiembre 29th 2025 at 07:52
Objectives

Structural MRI of the brain is routinely performed on patients referred to memory clinics; however, resulting radiology reports, including volumetric assessments, are conventionally stored as unstructured free text. We sought to use natural language processing (NLP) to extract text relating to intracranial volumetric assessment from brain MRI text reports to enhance routine data availability for research purposes.

Setting

Electronic records from a large mental healthcare provider serving a geographic catchment of 1.3 million residents in four boroughs of south London, UK.

Design

A corpus of 4007 de-identified brain MRI reports from patients referred to memory assessment services. An NLP algorithm was developed, using a span categorisation approach, to extract six binary (presence/absence) categories from the text reports: (i) global volume loss, (ii) hippocampal/medial temporal lobe volume loss and (iii) other lobar/regional volume loss. Distributions of these categories were evaluated.

Results

The overall F1 score for the six categories was 0.89 (precision 0.92, recall 0.86), with the following precision/recall for each category: presence of global volume loss 0.95/0.95, absence of global volume loss 0.94/0.77, presence of regional volume loss 0.80/0.58, absence of regional volume loss 0.91/0.93, presence of hippocampal volume loss 0.90/0.88, and absence of hippocampal volume loss 0.94/0.92.

Conclusions

These results support the feasibility and accuracy of using NLP techniques to extract volumetric assessments from radiology reports, and the potential for automated generation of novel meta-data from dementia assessments in electronic health records.

☐ ☆ ✇ BMJ Open

Validation of a Qigong quality of life questionnaire (3Q instrument) in patients with cancer: a study protocol

Por: Xu · J. · Li · H. · Stylianou · S. · Sze · D. M.-y. · Chan · V. W. S. · Yang · A. W. H. — Septiembre 29th 2025 at 07:52
Introduction

Cancer has impacted patients’ quality of life (QoL). Qigong, a type of mind-body exercise, has been adopted by some patients with cancer to improve their QoL. However, various lengthy questionnaires were used to assess Qigong’s effects which made data synthesis difficult. Therefore, a simplified Qigong QoL Questionnaire (3Q instrument) has been developed to assess cancer patients’ QoL when they practise Qigong. This study aims to validate this instrument and contribute to the standardisation and simplification of the outcome measures for the studies on Qigong.

Methods and analysis

A total of 173 patients with cancer practising Qigong in Australia and China will be recruited to evaluate QoL using the 3Q instrument and Functional Assessment of Cancer Therapy–General (FACT-G) questionnaire. SPSS Statistics V.29 software will be used for data analyses. Exploratory factor analysis will be conducted to identify the factor structures of the 3Q instrument. The internal consistency of the 3Q instrument will be evaluated by Cronbach’s alpha. Test–retest reliabilities will be confirmed by intraclass correlations. Content validity will be assessed by the Spearman’s correlation coefficient. Construct validity will be established through confirmatory factor analysis. Criterion validity will be assessed against FACT-G, and Spearman’s correlation coefficient will be adopted to calculate their correlations.

Ethics and dissemination

This study has been approved by the RMIT University Human Research Ethics Committee (HREC26229). The findings from the present study will be submitted to peer-reviewed journals for publication and/or presented at conferences.

☐ ☆ ✇ BMJ Open

Economic burden of moderate and severe anxiety and depression symptoms among adults in Saudi Arabia: evidence from a cross-sectional web panel survey

Por: Arulsamy · K. · Alfaisal · A. · Puri · J. · Alluhidan · M. · Altwaijri · Y. · Al-Habeeb · A. · Hamza · M. M. · Cetinkaya · V. · Finkelstein · E. A. — Septiembre 26th 2025 at 09:32
Objective

Anxiety and depression are among the top contributors to disability in the Kingdom of Saudi Arabia (KSA), but little is known about their economic impact. This study estimates the economic burden of moderate to severe symptoms of anxiety and depression among adults in KSA.

Design and setting

A cross-sectional survey was administered via a web panel. Participants were asked to fill out the Patient Health Questionnaire-4 (PHQ-4) for themselves and on behalf of other household members to capture prevalence rates. Those who reported at least moderate symptoms of anxiety or depression filled out a longer survey with questions on healthcare utilisation and productivity losses due to symptoms. These responses were monetised using prevalence rates and population estimates to calculate per-person and total annual costs.

Participants

Prevalence estimates are based on responses from 1164 participants on behalf of 3202 Saudi adults. Of these, 269 individuals with symptoms completed the longer survey.

Primary outcome measures

Prevalence of anxiety and depression; healthcare utilisation (medications, outpatient, inpatient) and productivity losses due to absenteeism and presenteeism.

Results

In total, 26.2% reported at least moderate symptoms consistent with anxiety and/or depression. Among those with symptoms, direct healthcare costs due to anxiety and depression averaged Saudi riyal (SAR) 3431.95 per person annually. Indirect costs via absenteeism and presenteeism averaged SAR 9702.87 and SAR 24 577.28 per person assuming that anxiety and/or depression episodes last for 6 months. Summing up the healthcare costs and productivity losses yields a total annual economic burden of SAR 163.3 billion. Absenteeism accounts for 24.8% of this total (SAR 40.5 billion), presenteeism accounts for 62.8% (SAR 102.5 billion) and healthcare resource utilisation accounts for 12.4%(SAR 20.3 billion).

Conclusions

The overall prevalence of anxiety and depression in KSA is estimated at 26.2%. The economic burden associated with these symptoms amounts to SAR 163.3 billion or 4.1% of GDP. Absenteeism and presenteeism costs account for the vast majority of the total, but a large percentage (nearly 60%) also report emergency department visits and unplanned hospital admissions. Evidence-based interventions should be considered to address the health and economic burden of these conditions in KSA.

☐ ☆ ✇ BMJ Open

Rapid response teams and recommended ward-based management of acute deterioration: a single-centre retrospective cohort study in an inner-city London (UK) teaching hospital

Por: Hadfield · S. · Zentar · M. · McPhail · M. · Helme · E. · Broderick · R. · Logan · F. · Loveridge · R. · Madine · E. · Vining · I. · Wendon · J. · Metaxa · V. · Hadfield · D. — Septiembre 26th 2025 at 09:32
Objectives 

  • To describe the associations between Rapid Response Team (RRT) patient review and other predefined clinical management actions, with risk of in-hospital cardiac arrest and in-hospital mortality in the first unplanned admission (UPA) to the adult intensive care unit (ICU) from the ward environment for each patient.

  • To describe a novel RRT assessment tool for ward-based care for patients who were deteriorating.

  • Design

    A retrospective cohort study.

    Setting

    A large multispecialty, tertiary referral and teaching hospital in England, UK.

    Participants

    The study included 3175 consecutive adult ICU UPAs from hospital wards over a 6-year period (2014–2019).

    Outcome measures

    Ward-based management of deterioration prior to ICU admission was assessed by the RRT, using a scored checklist—the UPA score. Admissions were compared in two groups according to their exposure to an RRT review in the 72 hours before ICU admission. Associations with in-hospital cardiac arrest within 24 hours before ICU admission and all-cause in-hospital mortality were estimated, using unadjusted and adjusted odds ratios (aORs) with 95%CI.

    Results

    RRT review occurred in 1413 (44.5%) admissions and was associated with reduced odds of in-hospital cardiac arrest (aOR 0.51; 95% CI 0.36 to 0.78; p

    Conclusions and relevance

    An RRT review in the 72 hours prior to ICU admission was associated with reduced odds of in-hospital cardiac arrest but did not impact in-hospital mortality. Higher UPA scores were associated with increased incidence of both in-hospital cardiac arrest and in-hospital mortality. In addition, this study describes a novel and adaptable RRT scoring tool (the UPA score) for safety monitoring and quality improvement.

    ☐ ☆ ✇ BMJ Open

    Single-centre, prospective cohort to predict optimal individualised treatment response in multiple sclerosis (POINT-MS): a cohort profile

    Por: Christensen · R. · Cruciani · A. · Al-Araji · S. · Bianchi · A. · Chard · D. · Fourali · S. · Hamed · W. · Hammam · A. · He · A. · Kanber · B. · Maccarrone · D. · Moccia · M. · Mohamud · S. · Nistri · R. · Passalis · A. · Pozzilli · V. · Prados Carrasco · F. · Samdanidou · E. · Song · J. · W — Septiembre 25th 2025 at 11:09
    Purpose

    Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.

    Participants

    POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.

    Findings to date

    748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm3, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm2. When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).

    Future plans

    Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.

    ☐ ☆ ✇ BMJ Open

    Scalability evaluation of a complex community-based falls prevention intervention in Australian stroke rehabilitation

    Por: Lin · I. · Day · S. · Dean · C. M. · Clemson · L. M. · Glinsky · J. V. · Cusick · A. · Lannin · N. A. · Scrivener · K. — Septiembre 25th 2025 at 11:09
    Objectives

    To investigate the scalability of the multi-component Falls After Stroke Trial (FAST) intervention tailored to community-dwelling adults with stroke to enable post-trial implementation.

    Design

    A mixed-methods formative evaluation of FAST data guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.

    Setting

    Community settings across three states in Australia.

    Participants

    Stroke participants were a subset of FAST trial participants (n=50) who were community-dwelling adults who had experienced a stroke up to 5 years prior and were at risk of falling. Therapists who delivered the intervention in the trial (interventionists) were physiotherapists and occupational therapists, trained in the FAST intervention.

    Interventions

    The FAST intervention is an individually tailored home safety and functional exercise programme designed to reduce falls and improve community mobility. It is offered over a 6-month period using 10 home visits, two telephone calls and programme resources, for example, manual and worksheets.

    Primary and secondary outcome measures

    Trial data, including interventionist training records and delivery data, resources and stroke participants’ adherence data were used to assess the Adoption, Implementation and Maintenance dimensions of the RE-AIM framework.

    Results

    The FAST intervention was delivered by 22 interventionists. High implementation fidelity was shown with 90% of the stroke participants receiving FAST dose and content. Effective strategies supporting implementation included standardised programme resources, comprehensive pre-programme training, regular interventionist feedback and interventionist mentoring from experts. Online training and peer support networks will be required for scale up.

    Conclusions

    This study identifies how a complex intervention to prevent falls after stroke was successfully delivered. The AIM dimensions provided insights to FAST features essential for scale-up. Interventionist training, resources and mentoring/feedback were essential for adoption within the trial. Training and resources should be accessible in an online format for scale up (maintenance).

    Trial registration number

    ACTRN12619001114134.

    ☐ ☆ ✇ BMJ Open

    Leading practices in the development and delivery of case-based learning programmes for health and social care provider education: a scoping review protocol

    Por: Saari · M. E. · Hudani · A. · Cardozo · V. · Giosa · J. L. — Septiembre 25th 2025 at 11:09
    Introduction

    As care needs increase in complexity, a shift to people-centred, integrated care is required to meet the full range of health and social care needs of clients. However, limited opportunities exist for care providers to develop interprofessional competencies as part of pre-licensing and/or continuing education. New learning models, such as case-based learning (CBL), that facilitate the development of interprofessional competencies and are aligned with practice realities of providers are needed. This scoping review will collate and codify leading practices and knowledge gaps in the development and delivery of CBL programmes in pre-licensing and continuing education for health and social care providers.

    Methods and analysis

    A scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. MEDLINE, CINAHL Plus, Scopus, ERIC Institute of Education Sciences, PsycINFO and Education Source will be searched for peer-reviewed literature; Google Scholar, ProQuest Dissertations and Web of Science will be searched for grey literature. Reference lists of full-text scholarly sources, key journals and authors will be searched manually. Study selection and extraction will be conducted by two independent reviewers. English sources published between 2014 and 2024 that discuss CBL epistemologies, characteristics, delivery mechanisms, programme limitations and/or programme evaluation in health and social care pre-licensing and/or professional training will be included. Data will be analysed using directed content analysis and synthesised as a narrative summary.

    Ethics and dissemination

    This scoping review protocol was reviewed by the Southlake Health Research Ethics Board and received ethics exemption. Findings will be disseminated through peer-reviewed publication, conferences, professional networks and social media, and used to inform the development of an evidence-based training programme for health and social care providers.

    Registration details

    Open Science Framework https://doi.org/10.17605/OSF.IO/6YXHN

    ☐ ☆ ✇ BMJ Open

    Ventilator-associated pneumonia biomarker evaluation (VIBE) study: protocol for a prospective, observational, case-cohort study

    Por: Albin · O. · Nadimidla · S. · Saravolatz · L. · Barker · A. · Wayne · M. · Rockney · D. · Jean · R. · Nguyen · A. · Diwan · M. · Pierce · V. · Roman · A. · McSparron · J. · Dickson · R. · Rao · K. · Napolitano · L. M. · Wunderink · R. · Kaye · K. — Septiembre 24th 2025 at 03:32
    Introduction

    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.

    Methods and analysis

    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.

    Ethics and dissemination

    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.

    ☐ ☆ ✇ BMJ Open

    Multimorbidity before, during and after pregnancy among women in low-income and middle-income countries: protocol for a scoping review

    Por: Ramokolo · V. · Roomaney · R. A. · Maqungo · M. · Nyirenda · M. · Puri · P. · Yakubu · K. · Gummidi · B. · Zembe-Mkabile · W. · Xu · X. · McCauley · M. — Septiembre 24th 2025 at 03:32
    Introduction

    The co-occurrence of multiple long-term conditions, that is, multimorbidity, is increasing globally and is associated with lower quality of life and increased risk of death. The risk and prevalence of multimorbidity are higher among women compared with men, but currently, evidence focusing on women’s multiple long-term conditions during the perinatal period is limited. Existing evidence needs to be examined to determine the extent to which maternal multimorbidity or women’s multiple health needs related to pregnancy have been addressed, especially for women living in low-income and middle-income countries (LMICs) where this burden of disease is the highest. The objective of this scoping review is to map existing evidence in LMICs on (a) Study designs and data sources, (b) Context-relevant definitions and descriptions, (c) Associated risk and protective factors, (d) Relevant maternal and infant health outcomes and (e) Treatments and interventions used to manage multiple long-term conditions before, during and after pregnancy.

    Methods and analysis

    This scoping review will be conducted using Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement extension for scoping reviews. This review will include observational, experimental or quasi-experimental studies, as well as systematic or umbrella reviews, on multimorbidity in women of reproductive age (15–49 years) in prepregnancy, pregnancy or up to 6 weeks after childbirth in LMICs. The studies will focus on definitions, risk and protective factors and management strategies for multiple long-term conditions before, during and after pregnancy. Studies of morbidity in women with a single index condition or conditions that are not related to pregnancy or childbirth will be excluded. A search strategy will be developed using thesaurus (including MeSH) and free-text terms for ‘maternal morbidity’ or ‘multiple long-term conditions’ and associated keywords such as multimorbidity, co-morbidity and unmet health needs related to pregnancy and/or childbirth for women living in LMICs. Electronic (EBSCOhost (CINAHL Ultimate, STM Source, Medline Ultimate), Cochrane Library, Web of Science or Scopus and Google Scholar) and grey literature databases will be searched from database inception. Reference lists and bibliographies of key topic articles will also be searched, and any additional papers that meet the inclusion criteria will be obtained. There will be no limitations on dates or languages. Records will be independently screened, selected and extracted by two researchers. Data will be presented in tables and narrative summaries.

    Ethics and dissemination

    Ethics approval is not required as this scoping review will summarise previously published data. Findings from the review will be disseminated through various platforms, including peer-reviewed journals, conferences and community meetings.

    Study registration

    Open Science Framework (https://doi.org/10.17605/OSF.IO/FYCR8).

    ☐ ☆ ✇ BMJ Open

    Assessing a visual editor for healthcare questionnaires based on the fast healthcare interoperability resources (FHIR) standard: protocol for a cross-sectional, mixed-methods usability evaluation using eye-tracking and retrospective think-aloud

    Por: Vogel · C. · Pryss · R. · Heuschmann · P. · Rücker · V. · Winter · M. — Septiembre 19th 2025 at 06:54
    Background

    Digitalisation in healthcare has resulted in fragmented solutions and limited interoperability. The Fast Healthcare Interoperability Resources (FHIR) standard is increasingly adopted to enable standardised data exchange, yet its complexity creates usability challenges for clinicians and developers. To address these challenges, this study evaluates the usability of an enhanced FHIR Questionnaire Resource Editor designed to improve workflow efficiency, accessibility and user satisfaction in creating and managing healthcare questionnaires.

    Methods and analysis

    This mixed-methods usability evaluation will recruit 10 healthcare professionals and/or informatics experts via convenience sampling. The study will consist of four general phases: (1) an initial session to familiarise users with the tool; (2) a task analysis phase supported by eye-tracking to identify strengths and weaknesses; (3) retrospective think-aloud interviews to explore strategies used during tasks and (4) completion of a validated usability questionnaire, such as the System Usability Scale, to quantify user satisfaction. We will analyse quantitative data using descriptive and inferential statistics. Qualitative feedback will be examined through thematic analysis and affinity mapping. The primary outcome is to assess the editor’s usability and accessibility and to identify areas for improvement.

    Ethics and dissemination

    This study protocol has been reviewed and approved by the Ethics Committee of the Medical Faculty at the University of Würzburg (ethikkommission@uni-wuerzburg.de) under approval number (24/24-sc). All participants will provide informed consent. Results will be disseminated through peer-reviewed journals, conferences and open-access platforms to inform future iterations of FHIR-based tools.

    ☐ ☆ ✇ BMJ Open

    iHEART trial: study protocol for a German multicentre randomised controlled trial on the feasibility and acceptance of an internet-based preoperative intervention to optimise patient expectations and improve outcomes after heart surgery

    Por: Compere · V. N. · Balci · S. · Heinz · C. · Schade-Brittinger · C. · Rastan · A. J. · Salzmann-Djufri · M. · Niemann · B. · Boening · A. · Choi · Y.-H. · Zarski · A.-C. · Laferton · J. · Euteneuer · F. · Rief · W. · Salzmann · S. — Septiembre 18th 2025 at 03:51
    Introduction

    Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.

    Methods and analysis

    In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based guidance (iEXPECT limited). The intervention includes four 20 min online modules addressing surgical benefits, side effects and coping strategies. Modules are accompanied by personalised guidance provided through feedback on each module via email or telephone (three before surgery, three booster sessions at 6, 12 and 18 weeks postsurgery). Assessments occur at baseline (5–21 days before surgery), preoperatively (day before surgery), 7 days postsurgery and 6 months later. Primary feasibility outcomes include recruitment (≥1 participant/week/centre), retention (≥49% completing 6-month follow-up including biomarkers) and engagement (≥75% completing ≥1 presurgery module). Acceptability is measured by self-reported enjoyment, usefulness and impact, with acceptance defined as mean scores >3.4 (5-point Likert scale) and CSQ-I ratings. Secondary outcomes include psychological measures, inflammatory markers and heart rate variability.

    Ethics and dissemination

    Ethical approval was granted by the Ethics Committees of Philipps University Marburg (AZ 229/23 BO) and the University of Giessen (AZ 186/23). All participants provide written informed consent. Results will be shared via publications, conferences and public outreach with relevant consumer advocacy groups.

    Trial registration number

    DRKS00033284.

    ☐ ☆ ✇ BMJ Open

    Glaucoma rehabilitation with action video games and exercise: study protocol of an active-controlled trial (GRADE)

    Por: Yihong · P. · Thompson · B. · Winser · S. · Lau · I. · Suen · V. · Cheung · M. · Cheong · A. M. Y. — Septiembre 18th 2025 at 03:51
    Introduction

    Glaucoma is the second leading cause of moderate to severe visual impairment worldwide, primarily affecting peripheral vision and increasing the risk of falls due to impaired balance and mobility. While traditional physical training (PT) is used for fall prevention, its effectiveness may be limited by low patient engagement. Action video games (AVGs) may offer a more engaging alternative for improving balance and mobility in individuals with glaucoma.

    Methods and analysis

    This prospective, two-arm, single-blind, active-control trial will involve 56 patients with glaucoma with moderate to severe peripheral field loss and intact cognitive function, who have not previously undergone balance training. Participants will be randomly assigned in a 1:1 ratio to either a physically interactive action video-game training (AVG) group or a conventional PT group. The AVG group will use a Nintendo Switch gaming station for 20 sessions of 45 min each, conducted two to three sessions per week over 8 weeks. These sessions will involve standing game exercises using game controllers or body sensors, focusing on muscle stretching and strengthening, balance improvement and fitness. The PT group will engage in traditional PT for the same duration and frequency. The primary outcome is the change in mobility function after 20 sessions, measured by the narrow path walking test. Secondary outcomes include balance function (modified Clinical Test of Sensory Interaction and Balance, motor control test, landing balance test, five-time sit-to-stand test and time up and go test), visual cognition (reaction time test and useful field of view test) and patient-reported outcomes (validated questionnaires). Exploratory outcomes include fall frequency, fear of falling, visual function and serum brain-derived neurotrophic factor levels (one of the biomarkers related to exercise). Assessments will occur at seven time points: baseline (T1), after 10 sessions (T2), after 20 sessions (T3), 1-month post-training (T4) and 3, 6 and 9 months after all training sessions (T5–T7).

    Ethics and dissemination

    The human ethics approval was obtained from the respective ethics board of the Hong Kong Polytechnic University (ID: HSEARS20210722001). The study protocol will conform to the principles of the Declaration of Helsinki. Results will be disseminated through peer-reviewed journals and conferences.

    Trial registration number

    NCT06000865.

    ☐ ☆ ✇ BMJ Open

    Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

    Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E. — Septiembre 17th 2025 at 06:57
    Objectives

    To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

    Design

    This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

    Setting

    An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

    Participants

    Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

    Interventions

    Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

    Primary and secondary outcomes

    The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

    Results

    We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

    Conclusions

    We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

    Trial registration number

    The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

    ☐ ☆ ✇ BMJ Open

    Development and psychometric evaluation of a new self-report measure to assess patient engagement behaviours and capacity in the USA: the Patient Engagement Capacity Survey

    Por: Gregory · M. E. · Sieck · C. J. · Walker · D. M. · Di Tosto · G. · Edwards · M. C. · McAlearney · A. S. · Gebretsadik · S. · DeVos · T. V. · Hefner · J. L. — Septiembre 16th 2025 at 03:21
    Objective

    Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.

    Design

    Measure development and psychometric evaluation.

    Setting and participants

    A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.

    Methods

    An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.

    Primary and secondary outcome measures

    Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).

    Results

    The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.

    Conclusions

    The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.

    ☐ ☆ ✇ BMJ Open

    Mapping behavioural interventions to reduce sugar-sweetened beverage (SSB) consumption among US adults: a scoping review protocol

    Por: Cruz · J. · Palma · H. · Marshall · C. D. · Castellon-Lopez · Y. · Datta · G. D. · Torres · V. — Septiembre 15th 2025 at 05:56
    Introduction

    Sugar-sweetened beverages (SSBs) are sugary drinks such as sodas, fruit drinks and sweetened teas and are the leading source of added sugars in the American diet. SSBs are also linked to chronic diseases like type 2 diabetes, cardiovascular disease and certain cancers. Despite their well-known health risks, SSB consumption remains high in the United States of America (USA), with 63% of adults consuming them daily, often exceeding the recommended limit of 50 g of added sugar per day. Though efforts to reduce SSB intake through educational programmes, policy initiatives and taxes exist, further research is needed to assess the effectiveness of interventions to reduce SSB consumption in the USA. Understanding the role of behavioural interventions in lowering SSB consumption among adults is critical to address public health strategies.

    Methods and analysis

    The proposed scoping review will be conducted in accordance with the Joanna Briggs Institute methodological framework for scoping reviews. An advanced search will be conducted in three electronic databases: PubMed, PsycINFO and Scopus. The reference lists of included studies will also be reviewed to identify additional relevant literature. All identified citations will be compiled in EndNote, and duplicate citations will be eliminated. Identification of studies will occur through the three-step search process: (1) initial screening of studies according to inclusion criteria, (2) eligibility determined through full-text assessment and (3) inclusion of qualified studies meeting the criteria. To be included, studies must report on an existing behavioural intervention to reduce SSB consumption. All studies will undergo screening by two independent reviewers. Any disagreements that arise will be resolved through discussion or with an additional reviewer. A data extraction tool has been developed to extract relevant data from all eligible studies. The extracted data will be presented in a diagrammatic form, alongside a narrative summary, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews reporting guidelines.

    Ethics and dissemination

    Ethics approval was not sought as all data will be collected from published literature. We will present our findings at relevant conferences and submit manuscripts for publication in peer-reviewed journals.

    ☐ ☆ ✇ BMJ Open

    Flap sparing in postoperative radiotherapy versus standard flap-agnostic radiotherapy of oral cavity cancers (OPTIFLAP): protocol for a de-escalation, randomised, non-inferiority, phase III trial

    Por: Thariat · J. · Leconte · A. · Lequesne · J. · Vela · A. · Carsuzaa · F. · Dejean · C. · Renard · S. · Pereira · S. · Lebars · S. · Nadin · L. · Plisson · L. · Bastit · V. · Woisard · V. · Hervieu-Klisnick · Z. · Lasne-Cardon · A. · Clarisse · B. — Septiembre 15th 2025 at 05:56
    Introduction

    The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.

    Methods and analysis

    The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.

    Ethics and dissemination

    The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.

    Trial registration number

    NCT06798922.

    ☐ ☆ ✇ BMJ Open

    Developing and validating a risk prediction model for conversion to type 2 diabetes mellitus in women with a history of gestational diabetes mellitus: protocol for a population-based, data-linkage study

    Por: Versace · V. · Boyle · D. · Janus · E. · Dunbar · J. · Feyissa · T. R. · Belsti · Y. · Trinder · P. · Enticott · J. · Sutton · B. · Speight · J. · Boyle · J. · Cooray · S. D. · Beks · H. · OReilly · S. · Mc Namara · K. · Rumbold · A. R. · Lim · S. · Ademi · Z. · Teede · H. J. — Septiembre 15th 2025 at 05:56
    Introduction

    Women with gestational diabetes mellitus (GDM) are at seven-fold to ten-fold increased risk of type 2 diabetes mellitus (T2DM) when compared with those who experience a normoglycaemic pregnancy, and the cumulative incidence increases with the time of follow-up post birth. This protocol outlines the development and validation of a risk prediction model assessing the 5-year and 10-year risk of T2DM in women with a prior GDM diagnosis.

    Methods and analysis

    Data from all birth mothers and registered births in Victoria and South Australia, retrospectively linked to national diabetes data and pathology laboratory data from 2008 to 2021, will be used for model development and validation of GDM to T2DM conversion. Candidate predictors will be selected considering existing literature, clinical significance and statistical association, including age, body mass index, parity, ethnicity, history of recurrent GDM, family history of T2DM and antenatal and postnatal glucose levels. Traditional statistical methods and machine learning algorithms will explore the best-performing and easily applicable prediction models. We will consider bootstrapping or K-fold cross-validation for internal model validation. If computationally difficult due to the expected large sample size, we will consider developing the model using 80% of available data and evaluating using a 20% random subset. We will consider external or temporal validation of the prediction model based on the availability of data. The prediction model’s performance will be assessed by using discrimination (area under the receiver operating characteristic curve, calibration (calibration slope, calibration intercept, calibration-in-the-large and observed-to-expected ratio), model overall fit (Brier score and Cox-Snell R2) and net benefit (decision curve analysis). To examine algorithm equity, the model’s predictive performance across ethnic groups and parity will be analysed. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-Artificial Intelligence (TRIPOD+AI) statements will be followed.

    Ethics and dissemination

    Ethics approvals have been received from Deakin University Human Research Ethics Committee (2021–179); Monash Health Human Research Ethics Committee (RES-22-0000-048A); the Australian Institute of Health and Welfare (EO2022/5/1369); the Aboriginal Health Research Ethics Committee of South Australia (SA) (04-23-1056); in addition to a Site-Specific Assessment to cover the involvement of the Preventative Health SA (formerly Wellbeing SA) (2023/SSA00065). Project findings will be disseminated in peer-reviewed journals and at scientific conferences and provided to relevant stakeholders to enable the translation of research findings into population health programmes and health policy.

    ☐ ☆ ✇ BMJ Open

    Randomised controlled trial to measure effectiveness and cost-effectiveness of a digital social intervention promoted by primary care clinicians to adults with asthma to improve asthma control: protocol

    Por: Karampatakis · G. D. · Wood · H. E. · Griffiths · C. J. · Taylor · S. J. · Toffolutti · V. · Bird · V. J. · Lea · N. C. · Ashcroft · R. · Coulson · N. S. · Panzarasa · P. · Li · X. · Sheikh · A. · Relton · C. · Sastry · N. · Watson · J. S. · Mant · J. · Marsh · V. · Day · B. · Mihaylova · B — Septiembre 12th 2025 at 05:14
    Introduction

    In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

    Methods and analysis

    An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

    Ethics and dissemination

    The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

    Trial registration number

    NCT06849245.

    ☐ ☆ ✇ BMJ Open

    Implementing relational continuity in general practice--understanding who needs it, when, to what extent, how and why: a realist review protocol

    Por: Tzortziou Brown · V. · Park · S. · Mahtani · K. R. · Taylor · S. · Owen-Boukra · E. C. · Taylor · J. · Richards · O. · Begum · S. · Wong · G. — Septiembre 10th 2025 at 05:45
    Introduction

    Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

    Methods and analysis

    We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

    Dissemination and ethics

    Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

    ☐ ☆ ✇ BMJ Open

    Are we closing the gender gap in academic oncology? An observational study of gender disparities in participant engagement at the ASCO 2024 annual meeting

    Por: Puhr · H. C. · Cammarota · A. · Ettaieb · M. · Flierman · I. · Gisinger · T. · Glas · A. · Guven · D. C. · Siebenhüner · A. · Steindl · A. · Szydlik · V. · Valpione · S. · Yip · M. · van Laarhoven · H. W. M. — Septiembre 10th 2025 at 05:45
    Objective

    Despite global efforts, gender disparities in oncology may persist. Understanding these disparities within the context of major conferences can inform strategies to promote gender inclusiveness in the field. This study evaluates the participation of women and men at the American Society of Clinical Oncology (ASCO) 2024 congress, focusing on chairs, speakers and audience questioners.

    Design

    Observational study.

    Setting

    152 recorded sessions of the ASCO 2024 annual meeting, one of the largest conferences in the field of oncology, available on the ASCO website.

    Participants

    Individuals serving as chairs, speakers and audience members who asked questions.

    Primary and secondary outcome measures

    In this observational study, gender for chairs, speakers and audience questioners across 152 sessions of the ASCO 2024 congress was assessed by two independent reviewers using audio and video recordings. Speaking times for questions and responses were also evaluated. Statistical analyses, including 2 and unpaired t-tests, were conducted to analyse the data.

    Results

    Women were well represented as chairs (n=124) and speakers (n=402) in 66% and 95% of sessions, respectively. However, only 21% of questions from the audience were posed by women, while 37% of questions were asked by men and 42% online or by chairs/speakers. Women were more likely to pose questions when the sessions were chaired by women (71% vs 53%; p=0.047). There were no statistically significant gender disparities concerning speaking time (questions: p=0.30; responses: 0.53). The response dynamics indicated a pattern of gender homogeneity, with individuals more frequently responding to questions from their own gender.

    Conclusions

    While the balanced representation of women in leadership roles at the ASCO 2024 congress reflects positive development in gender equality, disparities in active participation persist. These findings underscore the need for strategies that not only promote women in visible roles but also foster an environment that supports their active engagement in scientific discussions.

    ❌