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☐ ☆ ✇ BMJ Open

What is the impact of an allied health service-learning programme for rural communities: a study protocol using the RE-AIM/PRISM framework

Por: McNeil · R. · McGrath · R. L. · Ackland · K. · Oates · R.-K. · Woodhart · L. · Wright · K. — Octubre 1st 2025 at 08:29
Introduction

People in rural areas of Australia experience poorer health in almost every indicator compared with urban populations; however, rural communities have lower access to primary health, allied health and specialist healthcare. Timely access to care is compounded by persistent and widespread health workforce issues, including attracting and retaining staff.

Australian University Departments of Rural Health (UDRH) have been established to address the needs of rural populations with the goal of improving recruitment and retention of health professionals across rural and remote Australia. The work-integrated learning team within The University of Melbourne works with nursing and allied health university students on clinical placement to provide exposure to working in rural health, with a remit to build the capacity of the existing and future workforce. The service-learning model aims to provide reciprocal benefits to stakeholders through purposefully co-designed placements that respond to rural health needs by providing services to underserved communities and ensuring university students are exposed to real world, diverse practice settings.

The overarching aim of this project is to determine the impact of the SL programme for key stakeholders, predominately end users and those stakeholders involved in the delivery of the SL model. The key stakeholders are host site staff, allied health university students, allied health supervisors and the end users of the programme. End users are those individuals that have received allied health services through the programme, such as clients, residents and children.

Methods and analysis

This study will adopt a convergent mixed methods methodology underpinned by a RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance)/PRISM (Practical, Robust Implementation Sustainability Model) approach. Data collection will include document review, existing programme data review and primary data collection. This will involve conducting surveys and interviews with allied health university students, host organisations and allied health supervisors, and interviews with adult recipients of the service-learning programme. Art-based consultation will be conducted with school-aged children recipients of the service-learning programme. Analysis will be underpinned by the RE-AIM/PRISM framework to inform programme learnings and impact for key stakeholders.

Ethics and dissemination

This study has been approved by the University of Melbourne Human Research Ethics Committee (Project ID: 30409).

Findings will be published in a stakeholder project report and peer-review journals in the fields of rural health, implementation science and work integrated learning.

☐ ☆ ✇ BMJ Open

Investigation of prophylactic clip haemorrhage control for colorectal cold snare polypectomy in patients taking antithrombotic drugs (PERCOLD): study protocol--a multicentre prospective parallel-group non-inferiority RCT phase 3 trial

Por: Okimoto · K. · Matsumura · T. · Taida · T. · Ishikawa · T. · Koshibu · Y. · Shu · N. · Ozeki · Y. · Furuya · M. · Mamiya · Y. · Nakazawa · H. · Ohyama · Y. · Takahashi · S. · Horio · R. · Goto · C. · Kurosugi · A. · Sonoda · M. · Kaneko · T. · Ohta · Y. · Matsusaka · K. · Inaba · Y. · Kato · J. — Octubre 1st 2025 at 08:29
Introduction

The effect of prophylactic clipping for colorectal cold snare polypectomy (CSP) on delayed bleeding (DB) in patients with antithrombotic drugs remains unverified. The aim of the PERCOLD study is to demonstrate the non-inferiority of DB rates in cases without prophylactic clips compared with cases with prophylactic clips in patients taking antithrombotic drugs for colorectal CSP through randomised controlled trial (RCT).

Methods and analysis

This study is a multicentre prospective parallel-group RCT phase 3 trial that is being conducted at 14 institutions in Japan at the time of writing this manuscript. After providing consent, patients will undergo screening and assessment for study enrolment eligibility. Patients taking antithrombotic drugs (aged 20 years or older at the time of consent and who have agreed to participate in this study) will be selected if they have a preoperative suspected adenoma (including sessile serrated lesion) with an endoscopic diameter of

Ethics and dissemination

The trial protocol has been approved by the Chiba University Certified Clinical Research Reviewer Board (CRB3180015), which serves as the central ethics committee, and registered with Japan Registry of Clinical Trials. The current protocol V.1.7, dated 4 October 2024. Written informed consent for participation in the study will be obtained from all participating patients. All participating institutions have formally agreed to conduct the study in accordance with this central approval, and local site permissions were obtained as required by each institution. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.

Trial registration number

Japan Registry of Clinical Trials (jRCT1032230086).

☐ ☆ ✇ BMJ Open

Efficacy of a mobile app-based intervention to improve eating behaviours and lifestyle in infants of mothers with metabolic risk factors: study protocol of a randomised controlled trial

Por: Chan · D. · Leong · K. · Ong · C. · Ku · C. W. · Chan · J. K. Y. · Chua · M. C. · Yap · F. · Loy · S. L. — Octubre 1st 2025 at 08:29
Introduction

Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

Methods and analysis

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m2) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethics and dissemination

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

Trial registration number

NCT06457750.

☐ ☆ ✇ BMJ Open

Patients sense of gain experience and its influencing factors: a cross-sectional study in Foshan, China

Por: Xia · P. · Liang · B. · Zeng · Q. · Wang · L. · Zhai · L. · Li · M. · Chen · L. · Yang · H. · He · H. · Xu · X. · Gong · W. — Octubre 1st 2025 at 08:29
Objectives

Patients’ sense of gain experience (PSGE) is the comprehensive feeling throughout the treatment process, which is a critical benchmark for evaluating comprehensive medical and health system reform in China. This study aims to assess the current status of PSGE in public hospitals and identify important associated factors, providing evidence-based recommendations for improving healthcare services.

Design

This was a cross-sectional study conducted from October to November 2023.

Setting

A total of 14 public hospitals in Foshan, Guangdong Province, China.

Participants

There were 3223 responses, including 1592 from outpatients and 1631 from inpatients.

Primary outcome measure

PSGE was assessed across five domains: time accessibility, service accessibility, cost affordability, patient participation and efficacy predictability. Participants were also asked to provide an overall rating of the PSGE.

Results

The overall score for PSGE was 4.47±0.53 (mean±SD), with service accessibility receiving the highest score (4.68±0.50) and affordability the lowest (4.17±0.86). Secondary hospitals scored an overall PSGE of 4.55±0.50, while tertiary hospitals scored 4.42±0.54. Key factors associated with PSGE were overall satisfaction (β=0.164, p

Conclusions

This study found that patients reported a positive PSGE with service accessibility but reported a less positive PSGE with cost affordability. A tier-based disparity was evident, with secondary hospitals outperforming tertiary hospitals in overall PSGE outcome. Stronger PSGE was positively associated with higher scores in overall satisfaction, treatment satisfaction, satisfaction with medical reforms, patient loyalty and hospital reputation. Demographic and institutional factors, such as hospital level, patient type and household registration, were associated with the PSGE. Efforts can be focused on enhancing clinicians’ willingness and competence in discussing treatment costs during clinical encounters. It is essential for policymakers to address disparities in healthcare experiences among patient groups across hospital tiers to advance equitable, patient-centred systems.

☐ ☆ ✇ BMJ Open

Intrauterine high-dose intravenous immunoglobulin therapy during pregnancy for women with a history of pregnancy ending in documented neonatal haemochromatosis (NH001): study protocol

Por: Sasaki · A. · Yachie · A. · Mizuta · K. · Takahashi · H. · Okada · N. · Toma · T. · Motomura · K. · Matsumoto · K. · Wada · Y. S. · Ito · Y. · Ito · R. · Kasahara · M. · Fukuda · A. · Inoue · E. · Yamaguchi · K. · Nakamura · H. · Wada · S. · Sako · M. — Octubre 1st 2025 at 08:29
Introduction

Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

Methods and analysis

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

Ethics and dissemination

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

Protocol version

28 October 2024, V.8.0.

Trial registration number

jRCT1091220353.

☐ ☆ ✇ BMJ Open

Investigating the use and impact of community Care (Education) and Treatment Reviews (C(E)TRs) in people with intellectual disability and autistic people: protocol for a cohort study using electronic health records

Por: McCoy · B. · Bell · L. · Wang · K. · Jin · H. · Hassiotis · A. · Strydom · A. · Downs · J. · Carter · B. · Shetty · H. · Stewart · R. · Ali · A. · Sheehan · R. — Octubre 1st 2025 at 08:29
Introduction

Care (Education) and Treatment Reviews (C(E)TRs) are intended to reduce unnecessary psychiatric hospital admission and length of stay for people with intellectual disability and autistic people. The use and impact of C(E)TRs have not been systematically evaluated since their introduction in England in 2015. The aims of this study are to describe the demographic and clinical profiles of people who receive a community C(E)TR and to investigate their effects on admission, length of hospital stay and clinical and functional change.

Methods and analysis

We will conduct a retrospective cohort study using de-identified data from electronic health records derived from two large National Health Service mental health providers in London, England, including one replication site. Data will be extracted using the Clinical Record Interactive Search (CRIS) tool for all people with recorded intellectual disability and/or autism who received mental healthcare from 2015. We will identify community C(E)TR events using keyword searches. Community C(E)TRs will be examined in two ways: (1) In a community cohort, we will capture data in the 6-month periods before and after a community C(E)TR and compare this to a matched control group and (2) In a hospital cohort, we will compare groups who did and did not receive a community C(E)TR prior to their admission. We will describe the socio-demographic and clinical profiles of each group and their health service use, and compare C(E)TR and no C(E)TR groups using t-tests (or a non-parametric equivalent). The primary outcomes are admission to a psychiatric hospital (community cohort) and length of psychiatric hospital admission and clinical change (hospital cohort). Admission to psychiatric hospital will be estimated using propensity score weighting and difference-in-differences methods. Cox’s proportional hazard model will be used for length of hospital admission and repeated-measures analysis of variance (ANOVA) will be used to assess clinical change.

Ethics and dissemination

Use of CRIS to examine de-identified clinical data for research purposes has overarching ethical approval. This study has been granted local approval by the South London and Maudsley CRIS Oversight Committee. Findings will be disseminated in an open-access peer-reviewed academic publication, at conference presentations, and to service users and carers in accessible formats.

☐ ☆ ✇ BMJ Open

Knowledge, attitude and practice of artificial intelligence among dietitians in Saudi Arabia: a cross-sectional study

Por: Alhazmi · A. · Ibrahem · M. · Dawria · A. — Octubre 1st 2025 at 08:29
Objectives

This study assesses the knowledge, attitudes and practices (KAP) of licensed dietitians in Saudi Arabia regarding artificial intelligence (AI) in dietetics and identifies sociodemographic factors associated with higher AI knowledge and use, along with perceived benefits and concerns.

Design

Descriptive, cross-sectional study with an analytical component.

Setting

Conducted online across Saudi Arabia, targeting licensed dietitians in public and private healthcare sectors.

Participants

161 licensed dietitians completed the study. Inclusion criteria consisted of current registration and active practice in either clinical or community settings.

Primary and secondary outcome measures

The primary outcomes were levels of AI-related KAPs assessed via a structured questionnaire. The secondary outcomes examined associations between KAP and demographic factors.

Results

Among participants, 62.7% reported using AI in practice; 72.3% found it easy to use and 63.4% believed it improved their work. Higher knowledge was significantly linked to being aged 24–40, female, married, Saudi, a university graduate and employed (p

Conclusions

Dietitians in Saudi Arabia generally recognise AI’s value in dietetic practice, particularly in programme development and personalisation. However, concerns about diminished human interaction remain. Structured training and further longitudinal research are recommended to support balanced AI integration.

☐ ☆ ✇ BMJ Open

Association between green space exposure and elderly health: a systematic review and meta-analysis protocol

Por: Che · Y. · Wang · M. · Tan · X. · Zhang · N. · Yu · S. · Yan · P. — Octubre 1st 2025 at 08:29
Background

Global urbanisation is intensifying alongside steadily expanding older adult populations. The resulting air pollution profoundly impacts human health by exacerbating diseases, particularly among vulnerable elderly groups. Evidence demonstrates that green spaces mitigate air pollutant effects on health. Recent studies indicate green space exposure benefits older adults physiologically, psychologically and socially. However, existing systematic reviews have not synthesised the health impacts on this demographic. Consequently, this protocol outlines a systematic review and meta-analysis to evaluate how green space exposure affects health outcomes in older adults.

Methods and analysis

This systematic review protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. A comprehensive search strategy will be applied across: (1) electronic databases (eg, PubMed, Web of Science), (2) the National Institute for Health and Care Excellence and (3) the Guidelines International Network database. Grey literature will be searched via GreyNet International, covering records from each database’s inception to November 2024. The study will analyse associations between green space exposure and health outcomes in older adults. Two researchers will independently screen literature, extract data and assess risk of bias. Heterogeneity will be assessed with a focus on study design, exposure variables and outcome measures. If sufficient homogeneity exists, a meta-analysis will be undertaken; otherwise, a narrative synthesis will be performed.

Ethics and dissemination

This study requires no ethics approval because it uses publicly available data from published studies. The completed review will be published in a peer-reviewed journal and disseminated at relevant conferences.

PROSPERO registration number

PROSPERO (CRD42024619700).

☐ ☆ ✇ BMJ Open

Assessing the impact of the COVID-19 pandemic among internally displaced persons in Burkina Faso, Mali and Niger: a cross-sectional study using respondent-driven sampling

Por: Pham · P. N. · Keegan · K. · Johnston · L. G. · Diallo · D. Y. · OMealia · T. · Goh · M. · Vinck · P. — Octubre 1st 2025 at 08:29
Objectives

Documenting evidence on global health strategies and programmes that provide safeguards for vulnerable populations and strengthen overall pandemic preparedness is essential. This study aimed to identify factors associated with adherence to COVID-19 mitigation measures, COVID-19-related symptoms and testing, as well as pandemic-related income loss among internally displaced persons (IDPs) in urban and remote areas of Burkina Faso, Niger and Mali.

Design

This cross-sectional study used fixed-site respondent-driven sampling (RDS).

Setting

Primary care settings across six urban and remote locations in Burkina Faso, Mali and Niger.

Participants

4144 internally displaced adults, who had been forced from their homes within 5 years of the survey, participated in the study. The survey was conducted between August and October 2021 in two selected locations in three countries: Kaya (n=700) and Ouahigouya (n=715) in Burkina Faso; Bamako (n=707) and Ménaka (n=700) in Mali; and Niamey (n=733), and Diffa (n=589) in Niger. Participants were included if they were born in the study countries, displaced due to conflict, violence or disaster, aged 18 years or older, and living or working in the study site for at least 1 month.

Primary and secondary outcome measures

The primary outcomes measured were adherence to COVID-19 mitigation measures, presence of COVID-19 symptoms, COVID-19 testing and vaccination rates and pandemic-related income loss.

Results

Among 4144 IDPs surveyed across 6 sites in Burkina Faso, Mali and Niger, over half (52%) reported experiencing at least one COVID-19 symptom in the preceding 2 weeks. However, 8% had ever been tested for COVID-19, and fewer than 5% had received a vaccine in all sites except Diffa, where 54% reported vaccination. While willingness to be vaccinated was high (ranging from 56.6% in Bamako to 89.5% in Niamey), access remained limited. Compliance with public health measures varied; for example, 41.7% of IDPs were able to maintain physical distance from non-household members, and just 60.2% reported wearing a mask. Chronic health conditions were consistently associated with higher odds of COVID-19 symptoms (Ménaka OR: 14.65; 95% CI: 7.36 to 29.17). Economic vulnerability was widespread, with more than half of IDPs in Bamako (58.1%) and Niamey (66.4%) reporting income loss due to the pandemic, and average monthly income declining by over 50% in most sites. IDPs in urban areas generally reported greater exposure to COVID-19 risk factors, while those in remote settings reported lower adherence and poorer access to basic preventive measures.

Conclusions

This is the first known RDS study to explore the impact of the COVID-19 pandemic on IDPs. Findings suggest that IDPs in urban areas may face heightened risks of exposure and infection, underscoring the need to prioritise them in public health efforts. Low testing and vaccination rates and significant income loss call for advocacy and economic relief to address these vulnerabilities. Future pandemic responses should integrate health interventions with targeted support, especially mitigating income loss to bolster IDPs’ resilience.

☐ ☆ ✇ BMJ Open

Clinical outcomes of levosimendan administration in veno-arterial extracorporeal membrane oxygenation: a meta-analysis

Por: Zhao · G.-m. · Zhao · G.-m. · Zhang · H. · Chen · W. · Zhou · J.-X. · Li · H.-l. — Octubre 1st 2025 at 08:29
Objectives

To evaluate the effectiveness of levosimendan in promoting weaning from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with refractory cardiogenic shock through a meta-analysis of clinical trials.

Design

Systematic review and meta-analysis.

Data sources

PubMed, Embase, the Cochrane Library and Web of Science were systematically searched from inception to January 2025.

Eligibility criteria

Studies were included if they were clinical trials comparing outcomes between patients receiving levosimendan and those not receiving it during VA-ECMO support. Eligible studies reported on at least one of the predefined outcomes.

Data extraction and synthesis

Two independent reviewers extracted data and assessed study quality. The primary outcome was successful VA-ECMO weaning. Secondary outcomes included 30-day mortality, in-hospital mortality, duration of ECMO support and length of stay in the intensive care unit (ICU). A random-effects model was used to synthesise data and estimate pooled effect sizes, with heterogeneity assessed using the I² statistic.

Results

Involving 2083 patients across 16 studies, levosimendan significantly improved VA-ECMO weaning success (OR=2.44, 95% CI: 1.72 to 3.48; p2=57%) compared with the control group. Additionally, it notably reduced 30-day mortality (OR=0.48, 95% CI: 0.29 to 0.81; p=0.006; I2=56%) and in-hospital mortality (OR=0.47, 95% CI: 0.26 to 0.88; p=0.02; I2=70%). Noteworthy, however, is the association of levosimendan with prolonged VA-ECMO support (days; n=1314; weighted mean difference (WMD): 2.86, 95% CI: 1.73 to 4.00; p2=60%) and extended ICU stay (days; n=629; WMD: 5.69, 95% CI: 2.19 to 9.20; p=0.001; I2=61%).

Conclusions

Levosimendan improves VA-ECMO weaning success and reduces mortality. Further high-quality randomised controlled trials (RCTs) are required to confirm its clinical benefits in VA-ECMO patients. While the findings consolidate existing evidence favouring levosimendan, they also highlight residual heterogeneity and moderate-to-high risk of bias in several included studies. Therefore, future investigations, particularly well-powered RCTs with robust methodology, may help further delineate its role in specific patient populations.

☐ ☆ ✇ BMJ Open

Diagnostic and therapeutic impact of ultrasound tomography in lower extremity varicose veins: protocol for a paired accuracy study and randomised controlled trial in a tertiary hospital in China

Por: Zhang · W. · Lan · F. · Yuan · S. · Guo · J. · Li · Y. · Pan · Y. · Zheng · Y. — Octubre 1st 2025 at 08:29
Background

Chronic venous disease, particularly lower extremity varicose veins (VVs) and incompetent perforating veins (IPVs), is a prevalent condition associated with significant morbidity, including venous ulcers and post-surgical recurrence. Current diagnostic modalities for IPVs—such as digital subtraction angiography, CT venography, magnetic resonance venography and conventional ultrasound—are limited by ionising radiation, operator dependency or inadequate spatial resolution. Ultrasound tomography (UT), an emerging automated 3D imaging technology, offers comparable resolution, wider field of view and reduced operator bias compared with conventional ultrasound. Preliminary studies suggest UT improves IPV detection rates, yet its diagnostic accuracy and clinical utility remain unvalidated in large-scale trials. This study aims to evaluate UT’s diagnostic performance and its impact on surgical outcomes in a paired-design and randomised controlled trial (RCT), addressing a critical gap in non-invasive venous assessment.

Methods

This study combines a paired diagnostic trial and a prospective, triple-blind RCT. In the paired trial (n=84), patients with VVs (Clinical-Etiological-Anatomical-Pathophysiological C2–C5) receive both conventional ultrasound and UT combined with Doppler examination to compare IPV detection sensitivity against surgical findings. The RCT (n=264) randomises patients to conventional ultrasound group (control group) or conventional ultrasound+UT group (intervention group). After examination, all patients undergo standardised treatment (radiofrequency ablation with sclerotherapy and selective IPV ligation), with follow-up extending to 5 years. The primary endpoint is 1-year recurrence rates and secondary endpoints, including 3-month, 3-year and 5-year recurrence rates, as well as Venous Clinical Severity Scores, quality of life and Aberdeen Varicose Vein Questionnaire scores.

Ethics and dissemination

The study has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital (approval number: 2024-132). Written informed consent will be obtained from each participant, and final results will be published in peer-reviewed journals.

Trial registration number

The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier: ChiCTR2500097289.

☐ ☆ ✇ BMJ Open

Effect of liposomal bupivacaine combined with bupivacaine hydrochloride for transversus thoracic muscle plane block and pectoral nerves block in modified radical mastectomy for breast cancer: protocol for a randomised controlled trial

Por: Zhou · J. · Zhou · R. · Tang · S.-H. · Chen · Z. · Zhang · J. · Yang · D. — Octubre 1st 2025 at 08:29
Introduction

The incidence of acute pain subsequent to modified radical mastectomy (MRM) for breast cancer approximates 40%, with more than half of these cases evolving into chronic pain. Currently, the commonly employed analgesic schemes in clinical practice still have inadequacies. Liposomal bupivacaine (LB) is bupivacaine encapsulated in liposomes, and it is reported that its duration of action can extend up to 72 hours. This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle plane (TTP) block and pectoral nerves (PECS) block after MRM for breast cancer.

Methods and analysis

In this prospective, randomised, controlled trial, we will enrol 80 female patients aged 30 to 65 years who are scheduled to undergo MRM under general anaesthesia in combination with nerve block. They will be randomly assigned in a 1:1 ratio to the LB+BHCl group (Group A) and the BHCl group (Group B). All patients will undergo ultrasound-guided TTP+PECS block prior to surgery. The primary outcomes are the cumulative pain visual analogue scale (VAS) scores from 6 to 72 hours post-surgery and the quality of recovery, assessed using the QoR-40 score at 72 hours post-surgery. The secondary outcomes include the time to first analgesic rescue, the consumption of analgesic drugs within 72 hours postoperatively, the occurrence of adverse events and the VAS scores at 6 and 12 months postoperatively.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee of the Affiliated Hospital of Yangzhou University (2024 Ke Lun Shen (2024-07-01)). All patients will provide written informed consent. The results of this study will be published in a peer-reviewed journal.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2400089933).

☐ ☆ ✇ BMJ Open

Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study

Por: Alodayni · H. M. · Smith · S. · Poushpas · S. · Swagell · K. · Mandic · D. · Johnson · N. A. · Jaffer · U. · Davies · A. · Normahani · P. — Octubre 1st 2025 at 08:29
Introduction

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

Methods and analysis

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

Ethics and dissemination

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

Trial registration number

ClinicalTrials.gov, NCT06619223.

☐ ☆ ✇ BMJ Open

Mindsets and menses: decoding young womens attitudes towards menstrual leave - an observational study from South India

Por: George · N. · Mahendran · P. · Kulothungan · K. · Dharmaraj · R. B. · Muniyapillai · T. · Subramanian · T. · Muthu Ranga Babu · A. · Arumugam · A. · Subramanian · S. · Shabash Khan · S. · Selvam · S. · Veeraragavan Suresh Babu · A. — Septiembre 30th 2025 at 09:49
Objective

The primary objective of this study is to investigate the perceived need and attitudinal perspectives regarding menstrual leave policies among young women in rural South India. The secondary objective was to determine the socio-demographic, menstrual and workplace-related factors associated with attitudes towards menstrual leave among young women.

Design

An analytical cross-sectional study was performed from May 2023 to August 2023.

Setting

In a rural district of Tamil Nadu, South India.

Participants

The study encompassed 955 young female students above 18 years of age enrolled in educational institutions in a rural district of Tamil Nadu, India. Participants were pursuing diverse professional programmes including medical, dental, allied health sciences, pharmacy and engineering courses.

Outcome measures

The primary outcomes included assessment of basic menstrual characteristics (age of menarche, regularity, product usage and pain experiences), pain evaluation using the WaLIDD scale (which measured working ability, anatomical pain location, pain intensity via Wong Baker scale and pain duration) and attitude assessment through a 10-dimension Likert scale. The attitude assessment explored both supportive factors (pain management, environmental considerations, medical leave allocation, menstruation normalisation and performance impact) and potential concerns (medicalisation, perceptions of fragility, stigma, disclosure issues and abnormal leave usage). Secondary outcome measures encompassed the analysis of factors influencing these attitudes, followed by a multivariable linear regression model to identify significant predictors.

Results

Among 955 female students (mean age 19.56±1.33 years), the majority supported menstrual leave for maintaining hygiene (82.3%) and managing dysmenorrhoea (75.8%). A substantial proportion (64.4%) viewed it as a means of normalising menstruation discourse, while 61.6% believed it could enhance workplace performance. However, concerns existed about medicalising menstruation (47.9%) and reinforcing gender stereotypes (43.4%). Multivariate analysis revealed that medical students (B=0.67, 95% CI: 1.34 to 2.00), those with graduate-educated fathers (B=1.64, 95% CI: 0.31 to 2.97), earlier age at menarche (B=–0.23, 95% CI: –0.45 to –0.01) and participants reporting menstrual interference with daily activities (B=0.96, 95% CI: 0.02 to 0.89) held significantly more positive attitudes.

Conclusion

While young women generally support menstrual leave policies, particularly for hygiene and pain management, there are significant concerns about workplace stigmatisation and gender stereotyping. Educational background, parental education and personal menstrual experiences significantly influence attitudes toward menstrual leave. These findings suggest the need for carefully structured menstrual leave policies that balance biological needs with workplace/student place equality concerns.

☐ ☆ ✇ BMJ Open

Leveraging emotional intelligence to alleviate mental health: protocol of a cluster randomised controlled trial among parents of children with neurodevelopmental disorders in Bangladesh

Por: Salwa · M. · Chowdhury · S. M. · Rois · R. · Uddin · M. K. · Akhter · S. · Nahar · K. · Mullick · A. R. · Mannan · M. · Kundu · G. K. · Fatema · K. · Maruf Haque Khan · M. · Haque · M. A. — Septiembre 30th 2025 at 09:49
Background

Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.

Methods and analysis

This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost–utility analysis of direct and indirect costs.

Ethics and dissemination

Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.

Trial registration number

NCT06166550.

☐ ☆ ✇ BMJ Open

Australian research priorities for inherited retinal diseases: a James Lind Alliance priority setting partnership

Por: Robertson · E. G. · Hetherington · K. · Prain · M. · Ma · A. · Ayton · L. N. · Jamieson · R. V. · Shepard · E. · Boyd · L. · Hall · J. · Boyd · R. · Karandrews · S. · Feller · H. · Simunovic · M. P. · Grigg · J. R. · Yamamoto · K. · Wakefield · C. E. · Gonzalez-Cordero · A. — Septiembre 30th 2025 at 09:49
Objectives

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

Design

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Setting

Australia-wide.

Participants

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

Outcome measure

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

Results

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

Conclusion

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

☐ ☆ ✇ BMJ Open

ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared with standard colonoscopy in patients at risk of colorectal disease - a study protocol

Por: Ibrahim · H. · Haritakis · M. · Ballantine · L. · McCormack · K. · Cotton · S. · Hudson · J. · Atkin · K. · Rogers · S. · Nixon · L. S. · Verghese · A. · Holmes · H. · Treweek · S. · MacLennan · G. · Dolwani · S. · Gardner · G. · Hurt · C. · Watson · A. · Turvill · J. — Septiembre 30th 2025 at 09:49
Background

Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.

Aims and objectives

The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.

Methods

We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.

Anticipated impact

The study findings will provide the evidence base to inform future colorectal diagnostic services.

Ethics and dissemination

The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.

Trial registration number

ISRCTN16126290.

☐ ☆ ✇ BMJ Open

Nutritional status and its influencing factors among elderly patients with malignant tumours: a retrospective study from a tertiary hospital in Chengdu, China

Por: Duan · R. · Wang · F. · Zhang · T. · Feng · T. · Ren · T. — Septiembre 30th 2025 at 09:49
Objective

To investigate the nutritional status and its influencing factors in elderly patients aged 60 years and above with malignant tumours.

Design

A retrospective observational study.

Setting

The First Affiliated Hospital of Chengdu Medical College, a tertiary care hospital in Chengdu, China.

Participants

A total of 450 elderly patients with cancer (aged ≥60 years) admitted between January 1, 2022, and January 1, 2023. Patients were selected based on their clinical records, excluding those with communication disorders, mental illness or incomplete data.

Primary outcome measures

Nutritional status was assessed using the Patient-Generated Subjective Global Assessment (PG-SGA). Participants were categorised based on the presence or absence of malnutrition. Multivariate logistic regression was used to identify independent risk factors for malnutrition.

Results

Of the 450 patients included, 63.7% were male and 36.3% female, with a median age of 69 years. The prevalence of severe malnutrition was 46.4%. Univariate analysis showed significant associations between malnutrition and factors such as older age (p

Conclusions

Malnutrition is highly prevalent in elderly patients with cancer and is significantly associated with age, BMI, albumin levels and self-care ability. Early identification and targeted nutritional interventions may improve outcomes and quality of life in this population.

☐ ☆ ✇ BMJ Open

The effects of oliceridine and sufentanil on postoperative nausea and vomiting in abdominal surgery (EOSPONVAS): protocol for a multicentre, two-arm, randomised controlled trial

Por: Luo · J. · Wang · L. · Jie · Z. · Li · Y. · Geng · C. · Li · P. · Wang · T. · Shi · Y. · Fan · X. · Zhang · L. · Xu · T. — Septiembre 30th 2025 at 09:49
Introduction

Oliceridine is a novel μ-opioid receptor selective agonist that provides analgesia while reducing μ-receptor-mediated adverse effects such as postoperative nausea and vomiting (PONV). Evidence in abdominal surgery remains limited. This study aims to determine whether oliceridine reduces PONV and improves recovery in abdominal surgery.

Methods and analysis

This is a prospective, multicentre, two-arm, randomised trial. Participants aged 18–65 years, with American Society of Anesthesiologists physical status I–III and a body mass index of 18.5–23.9 kg/m², undergoing elective major abdominal surgery, will be eligible for inclusion. Gynaecological surgeries are excluded. All patients must require postoperative intravenous patient-controlled analgesia (PCIA) and give written consent. 494 participants will be randomised to oliceridine group or sufentanil group. The primary outcome is the incidence of PONV within 48 hours postsurgery. Secondary outcomes include vomiting frequency, nausea severity score, use of rescue antiemetics, resting numerical rating scale (NRS) pain score, Quality of Recovery-15 (QoR-15) score, time to first postoperative flatus, intensive care unit (ICU) length of stay (LOS), hospital LOS and PCIA metrics (effective attempts and total volume used). Safety outcomes include other opioid-related adverse effects (ORAEs) (eg, respiratory depression, pruritus, dizziness, headache), complications related to PONV (eg, electrolyte disturbances, wound dehiscence) and other perioperative complications.

Ethics and dissemination

This protocol was approved (Version V3.0, 2025-01-14) by the Ethics Committee of Changhai Hospital (CHEC-2025–069), the Shanghai Public Health Clinical Centre (2025-S024-01) and the Wusong Central Hospital of Baoshan District, Shanghai (2025-17-01). It complies with the Declaration of Helsinki. Results will be shared via conferences and peer-reviewed journals.

Trial registration number

Chinese Clinical Trial Registry (ID: ChiCTR2400089262).

☐ ☆ ✇ BMJ Open

Exploring the correlation between knowledge of multiple sclerosis, medication beliefs, access to care and depression in MS patients: a cross-sectional study

Por: Muflih · S. · Albtoush · D. A. · Al-Shatnawi · S. F. · Alshogran · O. Y. · Abu-Saleh · S. Y. · Alabbadi · I. · Al Bawab · A. Q. — Septiembre 30th 2025 at 09:49
Background

Multiple sclerosis (MS) is a common autoimmune illness that causes inflammation, demyelination and neurological damage. Symptom relief and immunotherapy are part of the treatment, but several healthcare barriers significantly influence outcomes and quality of life.

Objectives

This study aimed to assess different aspects among patients with MS, such as their knowledge of the disease, access to care, medications’ beliefs and depression, and to evaluate any correlations between these variables and their impact on the presence of depression.

Methods

A cross-sectional study was conducted from May 2024 to October 2024 at Al-Basheer Hospital, King Abdullah University Hospital (KAUH), Princess Basma Teaching Hospital and the Multiple Sclerosis Society of Amman. 200 participants were recruited after confirming consent. Data were collected through face-to-face interviews using validated instruments, covering sociodemographics, beliefs about medicines, knowledge about MS, access to care and levels of depression.

Results

This study involved 200 patients with MS with a median age of 36 years, mostly women (70.5%), non-smokers (65%) and insured (77.5%). The majority had high education (58%) but low income (67%), with a mean duration of MS disease of 7.8 years after diagnosis. The majority (79.5%) were unaware of their MS type. Beliefs about medications varied, with 22% accepting, 48.5% ambivalent, 14.5% sceptical and 15% indifferent. Disease knowledge was high, with patients recognising MS as an immune, non-contagious and non-curable disease that affects women more than men. Despite good access to care, a percentage of patients needed to travel long distances for care. Depression affected 58% of participants, and it was influenced by access to care, concerning beliefs, income and education. Other variables such as gender, health insurance, the duration of the disease and the necessity of medications had no significant influence.

Conclusion

In conclusion, patients with MS deal with various challenges, such as difficulties in accessing care, associated with psychological factors such as depression. Addressing these barriers by optimising patients' beliefs about medications, enhancing access to care and focusing on the level of knowledge of the disease is crucial for ensuring better and optimal treatment outcomes, as well as decreasing the risk of depression development.

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