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☐ ☆ ✇ BMJ Open

Going the distance: a cross-sectional geospatial analysis quantifying province-wide inequities in travel-based access, and fragility of access to French-language primary care provided by family physicians in Ontario, Canada

Por: Belanger · C. · Timony · P. E. · Belizaire · A. · Desilets · A. · Fitzsimon · J. P. · Gauthier · A. P. · Godfrey · L. · Karunananthan · S. · Kehoe MacLeod · K. · Muray · M.-N. · Peixoto · C. · Bjerre · L. M. — Abril 3rd 2026 at 15:57
Objectives

Language-concordant care, or healthcare in one’s preferred language, is important both for health equity and for improving health outcomes. Linguistic minorities, like Francophones in Ontario, Canada, are at risk of poorer clinical outcomes if they receive non-language-concordant primary care. However, common ratio-based access measures can provide misleading views of minorities’ actual access levels. This cross-sectional geospatial study demonstrates a new way to measure primary care access using average travel time to the nearest five English- and French-speaking family physicians. We also introduce the concept of primary care access fragility, where a region’s primary care access may depend on one or a few local family physicians. Our research question is: are there differences in travel burden and access fragility for census subdivisions (CSDs) across language (English/French), rurality (urban/rural) and region (north/south) in the province of Ontario, Canada?

Design

We conducted a cross-sectional geospatial analysis to estimate English-language and French-language primary care travel burdens and access fragility in Ontario, Canada. We used population and boundary data from Statistics Canada’s 2021 census, road-network data from OpenStreetMaps, and family physician practice locations and language abilities from the College of Physicians and Surgeons of Ontario. We measured travel burden using Valhalla, an open-source road-network analysis platform.

Setting

We conducted our analysis for Ontario, Canada’s 577 CSDs, which correspond roughly to municipalities and with populations ranging from 5 inhabitants in Rainy Lake 17B to a high of 2 794 356 in Toronto.

Participants

Using public data from January 2026, we identified 15 762 family physicians practising in Ontario, of whom 11.0% reported speaking French. Patient data were obtained from the most recent 2021 census.

Primary and secondary outcome measures

Our first primary outcome measures were CSD-level mean travel time to the nearest five English-speaking family physicians, and CSD-level mean travel time to the nearest five French-speaking family physicians, which we compared to explore regional inequities in travel burden. Our secondary outcome measures were based on a novel notion of the travel burden component of ‘primary care access fragility’. This metric indicates how dependent a region’s access is on a small number of local physicians and is defined as the difference between the CSD-level mean travel time to the nearest one physician and to the nearest five physicians. As the difference in travel times grows, so too does access fragility.

Results

Median differences in French-language and English-language travel burdens were strongly significant across rurality, regions and overall (median difference 13.4 min, p

Conclusions

Compared with the general public, Ontario’s French-speakers face higher travel burdens to language-concordant family physicians and higher access fragility, especially in rural and northern regions. Our results are of interest to policymakers and health-system planners, and our methods are applicable to other populations and regions.

☐ ☆ ✇ BMJ Open

Delivering hospital care at home in a Dutch Tertiary University Hospital: protocol for a prospective feasibility cohort study evaluating a Virtual Ward for early discharge of inpatients

Por: van Herwerden · M. C. · Scholte · N. T. B. · Mkrtchjan · A. · Feyz · L. · Mol · A. P. · Aitken · J. · de Boer · R. A. · Chandoesing · P. P. · Gommers · D. A. M. P. J. · De Haan · B. · Den Hoed · C. M. · van den Hoogen · M. W. F. · Peeters · R. P. · Wlazlo · N. · Van Der Boon · R. M. — Febrero 24th 2026 at 16:52
Introduction

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

Methods and analysis

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

Ethics and dissemination

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

Trial registration number

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

☐ ☆ ✇ BMJ Open

Family interventions in dementia mental health environments (FIND ME): a mixed-methods protocol

Por: Wolverson · E. · Gillam · J. · Dunn · R. · Hoe · J. · Underwood · B. R. · Mwale · S. · Credland · N. · Robertson · M. · Wyatt · M. · Lane · R. · Featherstone · K. — Enero 28th 2026 at 14:51
Introduction

Admission to a mental health ward can be distressing for people living with dementia and their carers. While carer involvement is associated with improved outcomes, carers often report feeling excluded from decision-making and support during admissions. There is limited understanding of how wards engage with carers and what strategies might enhance involvement. This study seeks to address this gap by exploring carer and patient experiences during and after admission and co-producing evidence-based strategies for improved support and involvement.

Methods and analysis

The FIND ME study uses a convergent parallel mixed-methods design. A national online survey will map provision of mental healthcare for people with dementia across the UK. Narrative interviews will be undertaken with carers of current inpatients (n=24) and recently discharged individuals (n=24), with opportunities for dyadic interviews with people with dementia. Ethnographic fieldwork across three wards (30 days per site) will provide insight into organisational cultures, staff practices and carer involvement. Evidence-based co-design workshops with carers, people with dementia and staff will use these findings to identify priorities and develop practical strategies for service improvement. Finally, a feasibility study will test the acceptability, relevance and potential for implementation of these co-designed strategies. Quantitative data will be analysed descriptively, while qualitative data will undergo narrative and thematic analysis. Triangulation across datasets will ensure rigour.

Ethics and dissemination

Ethical approval has been granted by London Camberwell St Giles Research Ethics Committee and the Health Research Authority (REC Ref: 25/LO/0040). Informed consent will be obtained from all participants, with capacity assessed in line with the Mental Capacity Act (2005). Dissemination will include peer-reviewed publications, conference presentations and freely available multilingual resources for carers, people with dementia and ward staff, supported by NHS and third-sector partners.

Trial registration number

NIHR161439

☐ ☆ ✇ BMJ Open

Time-weighted mean arterial pressure and pump flow during cardiopulmonary bypass in adults and its effects on neurological outcome parameters: a retrospective study protocol

Por: Klivinyi · C. · Schoerghuber · M. · Schreiber · N. · Fida · S. · Fritz · M. · Pannold · J. · Holler · M. · Orlob · S. · Bornemann-Cimenti · H. — Diciembre 26th 2025 at 04:45
Introduction

Cardiopulmonary bypass has been used to perform complex cardiac surgery for over 70 years. Advances in bypass techniques and perioperative medicine have increased the safety of cardiac procedures, leading to reduced morbidity and mortality. Nevertheless, cardiopulmonary bypass still carries risks, including systemic inflammation and dysfunction of various organs. To date, optimal blood pressure management during cardiopulmonary bypass remains a subject of ongoing debate. Conflicting evidence exists regarding negative outcomes associated with both low and high mean arterial pressures. Current clinical guidelines recommend a broad target range for mean arterial pressure during cardiopulmonary bypass, which underscores the existing gap in knowledge. In non-cardiac surgery, the time-weighted average of mean arterial pressure has been used to determine minimum safe thresholds, with greater deviation from 65 mm Hg associated with an increased risk of adverse outcomes. However, the definition and reporting of low blood pressure during cardiopulmonary bypass varies between studies, and the use of time-weighted averages below the threshold is still uncommon. Details on pump flow during extracorporeal circulation are seldom reported.

Methods and analysis

We plan to conduct a retrospective, single-centre data analysis to investigate the effects of both arterial blood pressure and extracorporeal pump flow, including their time-weighted averages and areas under defined thresholds, during cardiopulmonary bypass on neurological outcomes in adult patients undergoing cardiac surgery between 2014 and 2023. The study will include both elective and emergency procedures, with separate analyses conducted based on the urgency and complexity of the operations. Digitally recorded anaesthesia and perfusion records will be imported and validated to extract information on haemodynamic parameters, neurological monitoring and extracorporeal circulation. Ischaemic and haemorrhagic strokes will be identified by screening postoperative brain imaging records for keywords indicating neurological events. Diagnostic data and additional patient and procedural information will be extracted from the local cardiac surgery database and hospital information system. Information about incidence and course of postoperative delirium will be extracted from the patient data management system used in intensive care. We expect to include approximately 500–700 cases per year in the final analysis.

Ethics and dissemination

The local ethics committee approved our study (Ethics Committee of the Medical University of Graz, IRB00002556, 36-296 ex 23/24). We aim to publish the results of our study preferably in an open access format.

Trial registration number

The study protocol was registered at the Center for Open Science (https://doi.org/10.17605/OSF.IO/FAMV3).

☐ ☆ ✇ BMJ Open

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 — Diciembre 19th 2025 at 11:20
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.

☐ ☆ ✇ BMJ Open

Development of a set of value-based healthcare preconditions supporting military trauma patients in military operations: a Delphi study

Por: van der Wal · H. · Dulk · T. · van Dongen · T. · Hoencamp · R. · Ahaus · K. — Diciembre 19th 2025 at 11:20
Objectives

To explore the perceived importance of essential Value-Based Healthcare (VBHC) and patient-centred care elements within operational military healthcare among wounded service members (WSM), military surgeons (MS) and medical commanders, and to identify preconditions that enable the delivery of patient-centred care and relevant medical outcomes during military operations.

Design

A two-round Delphi study was conducted following the Accurate Consensus Reporting Document guideline. An initial list of 17 preconditions was developed through a narrative-style literature review and expert-panel discussion. Preconditions were rated on a four-point Likert scale (‘not important’ to ‘very important’) to reach consensus on ‘military-oriented’ preconditions for patient-centred trauma care.

Setting

An in-person expert-panel meeting and subsequent online Delphi surveys conducted between March 2020 and September 2022.

Participants

The expert panel consisted of Dutch military healthcare leaders and clinical specialists. A total of 30 participants completed both Delphi rounds, including 17 MS and commanding officers (Group 1) and 13 WSM (Group 2) with deployment experience in Uruzgan, Afghanistan, ensuring balanced representation of care providers, facilitators and recipients.

Outcome measures

Primary outcome: identification of military-oriented preconditions essential for patient-centred and value-based trauma care. Secondary outcome: conceptual contribution to the future development of patient-centred outcome measures for military trauma populations.

Results

Consensus was reached on 10 preconditions perceived as important or very important. While Group 1 prioritised operational readiness and procedural efficiency, Group 2 emphasised communication, shared decision-making and family involvement. Both groups rated informed consent, timely treatment registration and patient safety as the most critical elements, demonstrating convergence between logistic-oriented and patient-oriented perspectives.

Conclusions

Integrating VBHC principles into military medical doctrine can reconcile operational readiness with patient-centred care. The consensus-based preconditions identified in this study provide a foundation for developing measurable outcomes that reflect value for both patients and the military health system and can guide future VBHC implementation in trauma-related operational care.

☐ ☆ ✇ BMJ Open

Dual checkpoint inhibitor therapy versus dual targeted therapy of untreated metastatic BRAF-mutant melanoma: a systematic review of randomised controlled trials

Por: Peinemann · F. · Baradaran · S. · Arnolds · K. B. · Hoemberg · M. — Diciembre 17th 2025 at 11:54
Objective

Dual immune checkpoint inhibitor (ICI) therapy might improve the outcome of adult patients with untreated metastatic BRAF-mutant melanoma. We synthesised the evidence of its effect on overall survival (OS) and adverse events.

Design

Systematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Data sources

MEDLINE and the Cochrane Library were searched through 15 May 2025.

Eligibility criteria for selecting studies

We included randomised controlled trials (RCTs) assessing the effects of first-line dual ICI therapy compared with first-line dual targeted therapy (TT) on adult patients with metastatic BRAF-mutant melanoma. We considered articles in English or German language.

Data extraction and synthesis

Two independent reviewers extracted data and assessed risk of bias. Time-to-event data were pooled using the generic inverse-variance method and expressed as HRs with 95% CIs. Dichotomous data were pooled using the Mantel-Haenszel method and expressed as risk ratios (RRs). Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic). GRADE assessed the certainty of the evidence.

Results

We identified two RCTs (305 participants) with parallel assignment and intention-to-treat analyses. The primary beneficial outcome was overall survival (OS), and OS favoured the first-line ICI group: HR 0.66 (95% CI 0.49 to 0.90) I2=0%. In contrast, the primary adverse outcome was treatment-related adverse events of grade 3 or higher (TRAEs), and TRAE favoured the first-line TT group: RR 1.18 (95% CI 1.01 to 1.39) I2=0%. The certainty of the evidence was graded as moderate.

Conclusions

The evidence base is compatible with a favourable effect of first-line nivolumab plus ipilimumab for adults with untreated metastatic BRAF-mutant melanoma on survival and an unfavourable effect on toxicity when compared with first-line TT. Future RCTs could provide more data on therapy failure and quality of life.

PROSPERO registration number

CRD420251006128.

☐ ☆ ✇ BMJ Open

Organising maternal and newborn care in high-income countries: a scoping review of organisational elements and their association with outcomes

Por: Liebregts · J. · Goodarzi · B. · Valentijn · P. · Downe · S. · Erwich · J. J. · Burchell · G. · Batenburg · R. · de Jonge · A. · Verhoeven · C. J. M. · VOICE Study Group · Burzynska · de Graaf · van Heemstra · Rippen · Koster · van der Voort · Kaiser · Fransen · Berks · Haga · Vermo — Diciembre 15th 2025 at 06:41
Introduction

Countries face challenges in maternal and newborn care (MNC) regarding costs, workforce and sustainability. Organising integrated care is increasingly seen as a way to address these challenges. The evidence on the optimal organisation of integrated MNC in order to improve outcomes is limited.

Objectives

(1) To study associations between organisational elements of integrated care and maternal and neonatal health outcomes, experiences of women and professionals, healthcare costs and care processes and (2) to examine how the different dimensions of integrated care, as defined by the Rainbow Model of Integrated Care, are reflected in the literature addressing these organisational elements.

Results

We included 288 papers and identified 23 organisational elements, grouped into 6 categories: personal continuity of care; interventions to improve interdisciplinary collaboration and coordination; care by a midwife; alternative payment models (non-fee-for-service); place of birth outside the obstetric unit and woman-centred care. Personal continuity, care by a midwife and births outside obstetric units were most consistently associated with improved maternal and newborn outcomes, positive experiences for women and professionals and potential cost savings, particularly where well-coordinated multidisciplinary care was established. Positive professional experiences of collaboration depended on clear roles, mutual trust and respectful interdisciplinary behaviour. Evidence on collaboration interventions and alternative payment models was inconclusive. Most studies emphasised clinical and professional aspects rather than organisational integration, with implementation barriers linked to prevailing biomedical system orientations.

Conclusions

Although the literature provides substantial evidence of organisational elements that contribute to improved outcomes, a significant gap remains in understanding how to overcome the barriers in sustainable implementation of these elements within healthcare systems. Interpreted through a systems and transition science lens, these findings suggest that strengthening integrated maternity care requires system-level changes aligning with WHO policy directions towards midwifery models of person-centred care.

☐ ☆ ✇ BMJ Open

Influence of the COVID-19 pandemic on drug and healthcare utilisation among First Nations with diabetes in Alberta, Canada: a retrospective cohort study

Por: Weaver · O. · Sarin · C. · Samanani · S. · Crowshoe · L. · Ye · M. · Eurich · D. T. — Diciembre 3rd 2025 at 17:58
Objectives

The purpose of this study was to assess changes in diabetes management and healthcare utilisation among First Nations with diabetes in Alberta before and during the COVID-19 pandemic.

Design

This analysis used a retrospective cohort in a case–control design. Individual-level administrative health datasets (1 April 2018 to 31 March 2022) were linked and data were formatted as a segmented interrupted time series.

Setting

This study took place in Alberta, Canada using administrative data.

Participants

Adult First Nations and non-First Nations (matched 1:1) with diabetes and living in Alberta were included (n=28 101; 53% female, 47% male).

Primary and secondary outcome measures

The primary outcome was the change in incidence rate of general practitioner (GP) visits, emergency department (ED) visits, hospitalisations and diabetes-related drug dispenses during-COVID-19 versus pre-COVID-19, quantified using generalised linear regressions. The secondary outcome was to report the reasons for non-drug outcomes pre-COVID-19 and during-COVID-19, based on primary diagnosis International Statistical Classification of Diseases and Related Health Problems codes.

Results

Pre-COVID-19, baseline rates of GP visits, ED visits, hospitalisations and drug dispenses were significantly higher among First Nations compared with non-First Nations (rate differences 398.32 (391.97–404.67), 100.58 (98.32–102.84), 14.49 (13.56–15.43), 876.98 (868.72–885.24) per 100 person-years (PY); p

Conclusions

Healthcare utilisation was substantially elevated among First Nations compared with non-First Nations peoples before and during COVID-19. While the generalisability of our findings to other health systems and populations may be limited, our findings are clinically applicable among First Nations across Alberta in order to help direct public health programming post-COVID-19.

☐ ☆ ✇ BMJ Open

Developing a minimum dataset for a national patient registry on Long COVID in Canada: a Delphi consensus-based study

Por: Mazurik · K. · Amah · A. · Dumitrescu · D. I. · Ejalonibu · H. · Chavda · B. · Kemp · D. · Frederick · D. E. · Mclean · C. · Decary · S. · Gruneir · A. · Halas · G. · Hoens · A. · Kho · M. · Long COVID Web · Groot · G. · Bhereur · Cao · Cheung · Decary · Grant · Gruneir · Halas · Hoens · Kh — Diciembre 3rd 2025 at 17:58
Objectives

To develop survey items for a national patient registry on Long COVID using a modified Delphi process.

Design

This study was based on a modified Delphi process involving three rounds of anonymous, online surveys to develop consensus on and prioritise survey elements to be included in a minimum dataset for use in a national patient registry in Canada. Initial Long COVID items were identified through an environmental scan of the literature.

Setting

This study focused on healthcare systems in Canada and was conducted online.

Participants

A panel of 52 experts (patients, caregivers, clinicians and researchers) participated in all three rounds of the online survey. These participants were recruited through the Long COVID Web network and word of mouth.

Results

In total, 243 survey elements related to care, quality of life and symptoms were included in round 1 of the survey. 200 reached consensus and moved to round 2 with two additional elements being developed based on open-ended responses. In round 2, participants ranked these survey elements and 34 advanced. In round 3, 33 survey elements met the threshold of consensus with one added a priori. The 33 survey elements were then used to develop a Long COVID minimum dataset, which consists of 48 items.

Conclusions

The findings affirm broad consensus for collecting data related to fatigue, post-exertional malaise, cardiovascular issues, respiratory problems and cognitive issues. This highlighted the desire for quality-of-life indicators and information related to care utilisation, quality and access.

☐ ☆ ✇ BMJ Open

Transtympanic sodium thiosulphate to prevent cisplatin-related hearing loss: a protocol for randomised controlled multicentre phase III trial, the SOUND trial

Por: Burger · A. V. M. · Duinkerken · C. W. · Jansen · J. C. · Keereweer · S. · Cals · F. L. · Stokroos · R. J. · de Boer · J. P. · Exterkate · L. · van der Velden · L.-A. · Hoetink · A. E. · Nuijen · B. · Hauptmann · M. · van Sluis · K. E. · Bruintjes · T. D. · Zuur · C. L. — Diciembre 3rd 2025 at 17:58
Introduction

Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

Methods and analysis

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m2. Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

Ethics and dissemination

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

Trial registration number

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

☐ ☆ ✇ BMJ Open

Conventional and tablet-supported physical training to reduce falls and fall-related injuries in community-dwelling older adults: protocol of the randomised SURE-footed into the future Fall Intervention Trial (SURE-FIT)

Por: Schoene · D. · Gross · M. · Finger · B. · Lahmann · N. A. · Raeder · K. · Vorwerg-Gall · S. · König · H.-H. · Grochtdreis · T. · Stöger · D. · Handschuh · A. · Unseld · T. · Rothenbacher · D. · Büchele · G. · Rapp · K. — Noviembre 28th 2025 at 18:14
Introduction

Exercise-based interventions are well-established in reducing falls and fall-related injuries, but adherence and accessibility remain key challenges, particularly in rural areas. While conventional in-person training is widely used, digital interventions may offer scalable solutions to enhance engagement and reach. However, pragmatic trials evaluating the real-world effectiveness of conventional and digitally supported fall prevention interventions are lacking, limiting the evidence base for their implementation in routine healthcare settings. The SURE-Footed into the Future Fall Intervention Trial (SURE-FIT) aims to compare the effectiveness of two structured fall prevention interventions—a conventional centre-based exercise programme and a hybrid telemedical programme combining in-person and tablet-supported training—against a wait-list control group in reducing falls and fall-related injuries among community-dwelling older adults.

Methods and analysis

This study is a pragmatic three-arm, parallel-group, randomised controlled superiority trial with a 1:1:1 allocation ratio. Participants (≥65 years, community-dwelling, planned n=2778) will be randomly assigned to (1) conventional centre-based training supplemented with printed materials for home-based continuation (conventional group), (2) a hybrid model integrating centre-based and tablet-supported training for continuation (tablet group) or (3) a wait-list control group. The intervention includes a 9-week supervised phase followed by 43 weeks of independent home-based training. The primary outcomes are the incidence rate of falls and fall-related injuries over 12 months. Secondary outcomes include physical functioning, physical activity, concerns about falling, loneliness and the risk of low protein intake. A process evaluation will assess intervention feasibility and implementation. Additionally, qualitative interviews will be conducted with participants, course instructors and municipal stakeholders to explore experiences, facilitators and challenges related to programme participation and implementation. A health-economic evaluation will be conducted to assess the cost-effectiveness of the structured fall prevention interventions. Data collection will take place at baseline and every 3 months via standardised questionnaires, with a subgroup undergoing physical performance testing and sensor-based activity monitoring. Analyses will follow an intention-to-treat approach.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Ulm University (271/23). Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed publications, scientific conferences and national fall prevention initiatives. Additionally, results will be shared with key municipal representatives, and the German National Association of Senior Citizens’ Organisations (BAGSO). A publicly accessible website will provide ongoing access to study information and findings in plain language.

Trial registration number

DRKS00032878, German Clinical Trials Register

☐ ☆ ✇ BMJ Open

Prevalence of sexually transmitted infections among military personnel: a systematic review protocol

Por: Shoemaker · E. S. · Sandstrom · E. · Dangerfield · C. D. · Linton · J. · Cholette · F. · McClarty · L. M. · Lazarus · L. · Herpai · N. · Pavlova · D. · Pickles · M. · Becker · M. — Noviembre 28th 2025 at 03:17
Introduction

Military personnel are a unique population with heightened vulnerability to sexually transmitted infections (STIs), often exhibiting higher prevalence rates than civilians due to demographic, environmental and occupational factors. These vulnerabilities underscore the need for global prevalence estimates to guide effective, evidence-based interventions. This study aims to quantify the global burden of STIs among military personnel, providing a comprehensive and up-to-date assessment.

Methods and analysis

This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Guidelines (2020). Using the CoCoPop (Condition, Context, and Population) framework, a comprehensive search strategy will be conducted in MEDLINE, Embase, Global Health and Scopus to retrieve peer-reviewed records published between January 2010 and June 2025. Eligible studies will report numerical STI prevalence data among military personnel. Studies with insufficient information to calculate prevalence or those relying on self-reported STI data will be excluded. Data extraction will include study details, military descriptors, STI prevalence and diagnostic methods. Risk of bias will be assessed using the Joanna Briggs Institute critical assessment tool for prevalence and incidence studies. Prevalence estimates with 95% CIs will be reported for each STI and, where appropriate, pooled for curable STIs. Subgroup analyses will stratify prevalence by geographic region, service status, deployment status and socioeconomic factors. Heterogeneity will be evaluated within predefined subgroups using the I² statistic. Data will be presented in comprehensive tables and visualised with graphical tools, including forest plots for subgroup analyses and pooled estimates.

Ethics and dissemination

Ethical approval is not required for this review. The results will be disseminated through a peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD42023472113.

☐ ☆ ✇ BMJ Open

Study protocol for a randomised controlled trial to determine the efficacy of lisdexamfetamine for the treatment of acute methamphetamine withdrawal in inpatient settings

Por: Acheson · L. S. · Siefried · K. J. · Lintzeris · N. · Dunlop · A. J. · Haber · P. S. · Arunogiri · S. · Christmass · M. · Doyle · M. · Donoghoe · M. · Nagle · J. · Clifford · B. · McKetin · R. · Lubman · D. I. · Brett · J. · Taylor · N. · Carr · A. · Levin · F. R. · Shoptaw · S. · Ezard · N — Noviembre 28th 2025 at 03:17
Introduction

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

Methods and analysis

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

Ethics and dissemination

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

Trial registration number

ACTRN12624001061527.

☐ ☆ ✇ BMJ Open

Psychosocial adjustment in patients with diabetic retinopathy in northeastern Iran: a qualitative study based on the transactional stress theory

Por: Salehnezhad · A.-S. · Sedghi · F. · Mahdizadeh · M. · Jamali · J. · Shoeibi · N. · Vahedian-Shahroodi · M. — Noviembre 27th 2025 at 03:23
Objectives

This study aimed to explore the psychosocial adaptation processes and coping methods among patients with diabetic retinopathy (DR), emphasising the importance of understanding their lived experiences.

Design

A qualitative study using semi-structured interviews.

Setting

A tertiary eye hospital in northeastern Iran.

Participants

The participants comprised patients with DR, their families and healthcare professionals.

Methods

Qualitative data were analysed based on transactional stress theory using deductive thematic analysis to identify psychosocial adaptation concepts.

Results

65% of participating patients had DR for more than 5 years. Analysis of 49 patient and 14 healthcare professional interviews revealed 6 key themes encompassing 15 categories and 33 subcategories: primary appraisal (threat perception, motivational assessment, self-blame), secondary appraisal (perceived control over disease outcomes, perceived control over emotions, self-efficacy), coping efforts (problem management, emotional regulation), meaning-based coping (positive reassessment, reinforcement of religious beliefs, constructive approach), moderators (seeking information, all-encompassing assistance) and adaptation (emotional health, individual-social functioning).

Conclusions

The analysis revealed that deficits in disease awareness, financial and systemic barriers and emotional distress significantly impeded adaptive coping. Conversely, self-efficacy, social and organisational support, and meaning-based coping strategies were key facilitators. Our findings suggest that facilitating positive psychosocial adjustment in patients with DR may require interventions that address these specific barriers and leverage these facilitators, such as providing comprehensive disease knowledge and constructing robust support systems. This study highlights the potential value of a holistic care approach that integrates medical treatment, targeted patient education and psychological support to improve the overall quality of life for these patients.

☐ ☆ ✇ BMJ Open

Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis

Por: Preesman · E. · Drechsel · K. · Crommelin · H. · Broekmans · F. · Verpoest · W. · Broer · S. · On behalf of the LUMO Study Group · LUMO Study Group · Musters · Cantineau · Heusden · Heteren · Koks · Koning · Lashley · Kuijper · Santbrink · Janse · Mol · Tecklenburg · Krom · Verhoe — Noviembre 20th 2025 at 07:42
Introduction

Couples diagnosed with unexplained subfertility are advised to start mild ovarian hyperstimulation and intrauterine insemination (MOH-IUI) as a primary treatment. Natural feedback mechanisms and hormone release are affected by artificially stimulated cycles and induced ovulation. Additional luteal support could positively affect progesterone patterns in the luteal phase. The LUMO study evaluates whether the addition of exogenous progesterone in the luteal phase following MOH-IUI treatment cycle will improve pregnancy and live birth rates.

Methods and analysis

A multicentre randomised, double-blind, controlled trial will be conducted in Dutch fertility clinics, academic and non-academic hospitals. There are two treatment arms: group A progesterone luteal phase support; group B placebo, without crossover. All initiated MOH-IUI cycles within 6 months after randomisation are included (study period). Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure. Treatment is continued until the onset of menstruation, a negative pregnancy test (IUI+14 days), a miscarriage or until 7 weeks of gestation in case of a viable pregnancy. Follow-up ends at 12 months after the end of study period (18 months after study randomisation). The primary outcome is cumulative pregnancy rate, achieved within 6 months after randomisation, leading to live birth. A total of 1008 patients (504 patients in each group) will be included.

Ethics and dissemination

The study was approved by the Central Committee on Research Involving Human Subjects on 30 January 2023. All participating sites have the approval of the local Board of Directors to participate in the LUMO study. An informed consent form will be signed by all participants. Study results will be presented at (inter)national conferences and published in peer-reviewed journals. It is expected that the results of this trial will be used to draft national guidelines on this issue.

Trial registration number

The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461).

☐ ☆ ✇ BMJ Open

Perception of primary-secondary care collaboration among general practitioners and specialists and the perceived potential for innovation: an exploratory qualitative study

Por: Crasborn · M. · van Aken · M. O. · van der Hoeven · B. L. · Numans · M. E. · van Smoorenburg · S. · Pepping · R. M. C. · Vos · R. C. · The Hague Consortium Of Network CarE Redesign and Transition — Noviembre 14th 2025 at 06:04
Objectives

Our objective was to examine the barriers and facilitators encountered by primary and secondary healthcare professionals when collaborating at the care continuum between primary and secondary care. We aimed to identify specific challenges, observed benefits and proposed changes. By analysing these experiences and identifying opportunities for redesign, we aimed to define specific domains that could improve collaboration, thereby supporting sustainable access to and quality of care in the face of rising demand and constrained resources.

Design

A qualitative exploratory study using semi-structured interview data guided by two domains of the Consolidated Framework for Implementation Research (CFIR), including Inner Setting—Tension for Change and Individual Characteristics, as well as selected implementation outcomes defined by Proctor et al, all viewed through a service (re)design lens.

Setting

Consultation and communication between primary and secondary healthcare professionals in a Dutch urbanised area.

Participants

37 users of collaboration services (eg, telephone, correspondence) were interviewed between August 2021 and October 2022, including 14 general practitioners (GPs) (10 females, 4 males) and 23 specialists (10 females, 13 males).

Results

Four key domains with subthemes, subdivided per operation and CFIR domain, were identified as central to optimising the collaboration of professionals within the primary-secondary care continuum: (1) software and record integration; (2) seamless personal interaction; (3) eliminating a sense of ‘us vs them’ and (4) gaps in continuity of care.

Conclusions

This study reveals that healthcare professionals in both primary and secondary care face similar collaboration challenges due to system-level issues and inadequate collaboration tools, leading to increased workload, miscommunication and reduced quality of care. Improving collaboration between GPs and specialists requires not only adjustments to individual services, but a comprehensive overhaul of the referral and back-referral process. A more integrated approach, addressing key domains, is crucial for enhancing care quality, streamlining workflows and improving health outcomes.

☐ ☆ ✇ PLOS ONE Medicine&Health

Safety and efficacy of quick-soluble gelatin microparticles for transarterial embolization of the lower urinary tract: Preclinical study in a rabbit urinary bladder embolization model

Por: Sunghoon Jeon · Keunho Kim · Cheolwon Choe · Juil Choi · Gun Lee · Chung-Do Lee · Hyeon-Jeong Moon · Jun-Gyu Park · Jin-kyung Kim · Namsoon Lee · Dongwoo Chang — Noviembre 12th 2025 at 15:00

by Sunghoon Jeon, Keunho Kim, Cheolwon Choe, Juil Choi, Gun Lee, Chung-Do Lee, Hyeon-Jeong Moon, Jun-Gyu Park, Jin-kyung Kim, Namsoon Lee, Dongwoo Chang

Quick-soluble gelatin microparticles (QS-GMP) are emerging embolic agents under investigation for temporary vascular occlusion, offering reduced ischemic risk compared to permanent materials. The aim of this preclinical study was to evaluate the safety and efficacy of QS-GMP for transarterial embolization in a rabbit model of urinary bladder embolization. Twelve male New Zealand White rabbits underwent bilateral umbilical artery embolization using QS-GMP. Animals were assigned to four time-points (immediately, 3, 7, and 14 days post-embolization), with comprehensive assessments including clinical observations, hematologic and serum biochemical analysis, angiography, and histopathology. The procedure was technically feasible in all animals without intraoperative complications. Temporary hematuria and a transient decrease in body weight were observed post-procedure, both of which resolved spontaneously. Complete occlusion of the cranial vesical artery and absence of bladder wall perfusion were achieved immediately after embolization, followed by full recanalization at 3 days. Angiographic imaging at 7 and 14 days revealed transient hypervascularization of the bladder wall. Histopathological analysis showed marked edema, epithelial necrosis, and inflammatory infiltration at 3 and 7 days, with full urothelial regeneration observed at 14 days. No signs of ureteral or renal injury, or adverse systemic responses were detected. These findings suggest that QS-GMP may serve as a feasible option for temporary arterial occlusion in future veterinary lower urinary tract applications, although further long-term evaluation is warranted.
☐ ☆ ✇ Worldviews on Evidence-Based Nursing

Evidence‐Based Educational Initiative for Nurses in an Epilepsy Monitoring Unit

Por: Shivani Bhatnagar · Joy Shoemaker — Noviembre 12th 2025 at 05:25

ABSTRACT

Background

The National Association of Epilepsy Centers (NAEC) published guidelines on caring for patients admitted to an in-patient epilepsy monitoring unit (EMU) in 1997. These guidelines serve as the foundation for nursing practices in this specialized field. However, there is a significant variation in nursing knowledge and confidence in caring for this patient population. This highlights the need for a standardized epilepsy education program for bedside nurses in these units, which is currently lacking.

Aim of the Initiative

This initiative aimed to determine the best evidence-based strategies for improving nurse knowledge and confidence in caring for inpatients in the EMU. The evidence-based practice initiative used the seven step process, a systematic approach to implementing evidence-based practice in healthcare. It involves asking a clinical question, searching for the best evidence, critically appraising the evidence, integrating the evidence with clinical expertise and patient values, and evaluating the outcomes.

Implementation

After completing the first three steps of the process, it was recommended that an educational program be developed. This program included modules on understanding epilepsy, recognizing different seizure types, managing seizures in an inpatient setting, and ensuring patient safety during video-electroencephalography (VEEG).

Outcomes

This initiative showed a significant improvement in nurses' knowledge and confidence in caring for patients admitted to EMU. Notably, the administration of anti-seizure medications (ASMs) became more consistent, and the response to different seizure types was more uniform.

Practice Implication

Standardized educational programs for patients admitted to an EMU are needed. The evidence-based education program developed at a free-standing Midwest pediatric hospital may be helpful for nurses in other pediatric EMUs.

Linking Evidence to Action

Standardized education improves nurse knowledge and confidence, but access and consistency across shifts remain challenges. A structured, evidence-based module series tailored to EMU care enhances nurse preparedness and promotes safer, more consistent patient care. Ongoing education and leadership support are essential to sustain these improvements.

☐ ☆ ✇ BMJ Open

Examining the role of staff and team communication in reducing seclusion, restraint and forced tranquilisation in acute inpatient mental health settings: protocol for the Communication and Restraint Reduction (CaRR) study

Por: Cibelli · F. · Forbes · T. · McCabe · R. · Anderson · J. E. · Hoe · J. · Tahir · S. · McKeown · G. J. · Brew · B. · Deamer · F. · Lavelle · M. — Noviembre 6th 2025 at 06:00
Introduction

Over 100 000 service users are admitted to acute mental health wards annually, many involuntarily. Wards are under incredible pressure due to high bed occupancy rates and staff shortages. In a recent survey, over 80% of mental health nurses reported experiencing aggression and violence within their role. National and international policy dictates that mental health ward staff manage incidents of aggression and violence using communication, known as de-escalation. However, de-escalation practice is variable, and there is little empirical evidence to underpin training. As such, there is still a reliance on more restrictive practices, including seclusion and physical restraint.

Aim

The aim of this study is to identify the communication and organisational factors that characterise effective management of service users’ behaviour and distress in acute adult inpatient mental health wards, reducing the reliance on more restrictive practices (eg, seclusion and restraint).

Methods and analysis

This observational study will be conducted on mental health wards in England. It will be comprised of three work packages (WPs).

  • A microanalysis of communication during de-escalation incidents from Body Worn Camera footage on wards (n=64), to identify staff communication practices that lead to effective management of service users’ distress.

  • Ethnographic observations of ward routine practice, alongside interviews and questionnaires with staff and service users, to examine how challenging behaviour is anticipated, planned for and responded to on wards, and staff experiences and perceptions of this process.

  • Triangulation of the findings from WPs 1 and 2 to examine the relationship between approaches to aggression management and staff communication, exploring the similarities and differences within and between wards.

  • Ethics and dissemination

    Ethical approval for sites in England has been granted by the Wales Research Ethics Committee 3, REF 22/WA/0066. Findings will be disseminated through peer-reviewed journals, scientific conferences and service user and clinical networks.

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