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AnteayerBMJ Open

Bayesian randomised controlled trial of guided parent-delivered cognitive behavioural therapy for children with anxiety disorders via remote sessions in Japan: a study protocol

Por: Okawa · S. · Blackwell · S. E. · Violato · M. · Creswell · C. · Ishikawa · S.-i. · Obikane · E. · Takahashi · T. · Arai · H. · Nakamura · H. · Ishitsuka · K. · Shimizu · E. · Sasaki · T.
Introduction

Guided parent-delivered cognitive behavioural therapy (GPD-CBT) is an evidence-based, low-burden treatment programme for childhood anxiety disorders with demonstrated efficacy, cost-effectiveness and accessibility. However, it has been tested primarily in Western countries, and the efficacy and cost-effectiveness have not been evaluated in Japanese families. The current study aims to examine GPD-CBT’s efficacy and cost-effectiveness in Japanese samples and explore potential cultural adaptations of the programme.

Method and analysis

This study is designed as a Bayesian single-blind randomised controlled trial with two parallel groups: GPD-CBT (intervention group) and a waitlist control group. The primary outcome is remission of primary anxiety disorders evaluated through diagnostic interviews by independent evaluators. Secondary outcomes include child and parent-reported child anxiety symptoms, depressive symptoms and life interference. Additionally, measures of parental psychological characteristics, programme acceptability and quality of life are collected. We will conduct qualitative interviews with parents who participated in the programme and therapists who delivered the intervention to explore potential cultural adaptations. We aim to recruit 54–170 families, depending on the results of sequential Bayesian analyses. GPD-CBT consists of seven weekly 20 min sessions and a 1-month follow-up session. Assessments will be conducted at baseline, 13 weeks post randomisation (primary endpoint for between-group comparison), with an additional 25 weeks post randomisation. The waitlist control group will receive GPD-CBT after the 13-week assessment.

Ethics and dissemination

This study has been approved by the Ethics Review Committees of Chiba University and the University of Tokyo. We will disseminate results through academic conference presentations and peer-reviewed journal publications. If the GPD-CBT intervention proves efficacious, we will promote wider implementation in Japan through the development of training programmes for mental health professionals and key stakeholders.

Trial registration numbers

jRCT1032250421 (https://jrct.mhlw.go.jp/latest-detail/jRCT1032250421) and jRCT1030250422 (https://jrct.mhlw.go.jp/latest-detail/jRCT1030250422) registered on 9 October 2025.

Knowledge, attitude and use of menstrual cup among females of Siddharthanagar Municipality, Nepal: a community-based cross-sectional study

Por: Bhattarai · A. · Shrestha · V. L. · Bist · A.
Objectives

Although menstrual cups have a long history and numerous benefits, many women of reproductive age remain unaware. This study assessed the knowledge, attitude and use regarding menstrual cups and its associated factors among females of reproductive age in Siddharthanagar Municipality, Lumbini Province, Nepal.

Design

Cross-sectional study

Setting

Siddharthanagar municipality, Rupandehi was taken as the study setting.

Participant

A total of 250 women of reproductive age group (15–49 years) residing in Siddharthanagar Municipality.

Outcome measure

Knowledge, attitude and use of menstrual cups were assessed by a pretested structured tool. The knowledge scores for each question were given as one mark for a correct response, and the overall scores were categorised using a modified Bloom’s cut-off as follows: good knowledge≥60% and poor knowledge80%), neutral (60%–80%) and unfavourable (2 test and multivariable logistic regression analysis were performed to determine factors associated with knowledge, attitude and use at the 5% level of significance.

Results

This study found that the majority (88.04%) had poor knowledge about the menstrual cup, with 31.2% of participants expressing a favourable attitude. Only 10.6% of participants had used a menstrual cup. The odds of adequate knowledge among the participants with bachelor and higher level of education was 3.470 times (adjusted OR (aOR)=3.470, 95% CI 1.08 to 11.10) as compared with participants with secondary or lower level of education, adjusting for other explanatory variables. The odds of having adequate knowledge among participants who were employed was 1.66 times (aOR=1.66, 95% CI 1.24 to 5.83) compared with those who were unemployed, which was 2.487 times (aOR=2.487, 95% CI 1.24 to 7.95) in case of favourable attitude. Similarly, the odds of using a menstrual cup among the participants with an adequate level of knowledge was 7.960 times (aOR=7.960, 95% CI 2.70 to 23.40) as compared with participants who had an inadequate level of knowledge, adjusting for other explanatory variables.

Conclusion

Our study revealed that, despite their advantages, participants have limited knowledge and usage of menstrual cups. This highlights the need for advocacy and education about menstrual cups to enable informed choices, enhance women’s quality of life and protect the environment by reducing waste from disposable menstrual products.

Implementation strategies for the WHO Safe Childbirth Checklist: a scoping review

Por: Gama · Z. A. d. S. · Semrau · K. E. A. · Rosendo · T. M. S. d. S. · Freitas · M. R. d. · Saraiva · C. O. P. d. O. · Westgard · C. M. · Mita · C. · Tuller · D. E. · Freitas · K. d. M. S. · Molina · R. L.
Background

The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.

Objectives

To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.

Eligibility criteria

We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.

Sources of evidence

We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.

Charting methods

This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).

Results

34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.

Conclusions

SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.

Registration

Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.

Trimodal age distribution of frequent attendance at the emergency department: a descriptive analysis of national, English, secondary care data using a retrospective cohort

Por: Marshall · C. · Kumar · A. · Saraiva · S. · West · R. M. · Mason · S. M. · Burton · C. D. · van der Feltz-Cornelis · C. M. · Lee · W. · Bojke · C. · Mattock · R. · de la Haye · S. · Relton · S. D. · Guthrie · E.
Objectives

Frequent use of emergency departments (EDs) places a considerable burden on healthcare systems. Although frequent attenders are known to have complex physical, mental health and social needs, national-level evidence on their characteristics and patterns of attendance remains limited. This study aimed to provide a comprehensive, population-level description of frequent ED attendance in England, with a focus on age-based subgroups.

Design

Retrospective cohort study.

Setting

EDs in England via the Hospital Episode Statistics and the Emergency Care Dataset data linked with primary care prescribing and mortality data, between March 2016 and March 2021.

Participants

The dataset received from National Health Service Digital contained approximately 150 million ED attendances by 30 million adult (>18 years) patients over the time period April 2016 to March 2021. A random sample of 5 million people was used for this analysis.

Outcome measures

The primary outcome was the number of attendances in each financial year by frequent attenders compared with the remaining patients, split by age bands. Patients were classified as frequent attenders if they had ≥5 or ≥10 ED attendances within a rolling 12-month period. Secondary outcomes included demographic, diagnostic and prescribing characteristics, as well as the number of different ED sites visited.

Results

A Gaussian mixture model was used to identify age-based subgroups. Descriptive statistics were used to summarise key features; 95% CIs were reported where applicable. Among 3.91 million unique adult ED attenders, there were 8.7 million attendances. Of these, 222 160 individuals (5.7%) had ≥5 attendances in a year, accounting for 12.6% of total attendances. A trimodal age distribution was identified, with three distinct peaks corresponding to ages 18–34, 35–64 and 65+. Frequent attenders were more likely to live in deprived areas and have a history of psychotropic or analgesic prescribing. Mental health diagnoses and polypharmacy were particularly common in the younger and middle-aged groups. Multisite attendance was uncommon, with over 80% of frequent attenders using only one ED site annually.

Conclusions

This national analysis reveals a trimodal age pattern among frequent ED attenders, with differing clinical and socio-demographic profiles across age groups. These findings highlight the need for age-tailored approaches to managing high-intensity ED use and inform targeted service development.

Prospective, multicentre trial on preoperative biliary drainage by endoscopic ultrasound-guided hepaticogastrostomy for resectable/borderline resectable pancreatic cancer with biliary obstruction: the PROLOGUE study - a study protocol

Por: Yagi · S. · Hijioka · S. · Nagashio · Y. · Harai · S. · Agarie · D. · Yamashige · D. · Okamoto · K. · Fukuda · S. · Kuwada · M. · Komori · Y. · Kurita · Y. · Hasegawa · S. · Kubota · K. · Ishida · Y. · Ushio · J. · Takeshita · K. · Yoshino · K. · Ishiwatari · H. · Okusaka · T.
Introduction

Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer.

Methods and analysis

This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance.

Ethics and dissemination

This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal.

Trial registration number

UMIN ID: 000055173.

Factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 in primary healthcare settings in Nepal: a cross-sectional study

Por: Timalsena · D. · Nakarmi · C. S. · Mali · S. · Dhakal · A. · Bharati · A. · Bishwokarma · A. · Adhikari · A. · Poudel · B. · Rai · B. K. · Baral · P. P. · Bhattarai · S. · Dixit · L. · Pokharel · Y. · Rhodes · E. · Xu · D. R. · Spiegelman · D. · Shrestha · A.
Objective

To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.

Design

Cross-sectional study.

Setting

PHC facilities across various provinces in Nepal.

Participants

A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.

Main outcome measures

The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.

Results

Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).

Conclusion

Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.

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