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).

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

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.

Japan Registry of Clinical Trials (jRCT1032230086).

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.

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.

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).

NCT06457750.

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.

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.

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.

28 October 2024, V.8.0.

jRCT1091220353.

Medication returned by patients to healthcare facilities is a critical aspect of reverse logistics, intersecting healthcare delivery, patient safety and environmental sustainability, especially in low- and middle-income countries (LMICs) where systemic inefficiencies and socio-cultural factors may exacerbate the issue. While emerging medication return programmes are recognised for their potential to enhance resource efficiency and prevent misuse, they also signal inefficiencies in medical supply chains, prescribing practices and patient-provider interactions. This scoping review aims to systematically map the incidence and drivers of medication returned to health facilities by patients in LMICs.

This review follows Arksey and O'Malley’s scoping review framework and the PRISMA-ScR reporting guidelines. Searches will be conducted in Google Scholar, PubMed, CINAHL, Embase, Web of Science and Scopus, supplemented by grey literature sources and reference list screening. Searches will include studies from January 2005 to December 2025 and English-language publications, reflecting both the relevance of recent evidence and practical considerations for screening and analysis. Eligible studies must address the incidence or drivers of medication returned in LMICs and meet predefined inclusion criteria based on the Population, Concept, Context framework. Data will be extracted using a standardised charting form and analysed using narrative synthesis, supported by descriptive statistics and thematic analysis.

No ethical approval is required as this scoping review will analyse publicly available literature. Findings will be disseminated through peer-reviewed publications, academic conferences and healthcare organisations, with all data and search strategies made openly accessible through Springer Nature’s protocols.io preprint repository to support transparency and future research.

Springer Nature’s protocols.io dx.doi.org/10.17504/protocols.io.3byl4wd5ovo5/v1.

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.

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

In a rural district of Tamil Nadu, South India.

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.

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.

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.

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.

The prevention of treatment discontinuation is crucial in mitigating the adverse consequences of diabetes. This study aimed to identify the psychosocial factors and patient experiences associated with the discontinuation of diabetes treatment.

A cross-sectional study was conducted.

A nationwide online survey with convenience sampling.

Participants, aged 40–79 years, who reported living with diabetes, were included.

Treatment continuation status was the outcome variable. Participants who previously received regular treatment but were not currently under medical care were classified as the treatment discontinuation group. Psychological factors (mood and anxiety disorders, self-esteem, procrastination), social factors (loneliness, economic difficulties, adverse childhood experiences) and patient experiences and opinions regarding diabetes were assessed.

A total of 4715 individuals were included in the analysis. After adjusting for confounders, psychological distress (adjusted OR (AOR)=1.87, 95% CI (1.06 to 3.30), p=0.032) and higher procrastination (AOR=2.64, 95% CI (1.25 to 5.56), p=0.011) were significantly associated with treatment discontinuation. Overall, 9.7% of participants reported financial hardship, and 12.1% reported diabetes burnout during their course of treatment. Financial hardships (p=0.002), difficulty with child or older adult care (p

Psychological distress and higher procrastination levels were significantly associated with diabetes treatment discontinuation, after adjusting for potential confounders. The treatment discontinuation group reported significantly more psychosocial challenges than the continuation group. Healthcare providers and systems should prioritise addressing the psychosocial characteristics, experiences and challenges faced by individuals with diabetes.

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.

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.

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.

NCT06166550.

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

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

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

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

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

This study aimed to investigate the associations between body mass index (BMI), physical activity levels (PALs) and sociodemographic factors (gender, age, education and marital status) with different outcomes (symptoms) of osteoarthritis (OA) severity, in patients with knee OA.

Cross-sectional study.

The sample included 200 participants from southern Bosnia and Herzegovina (61 males, 65.1±9.01 years of age) who had been diagnosed with primary knee OA.

OA symptoms as evidenced by the Western Ontario and McMaster Universities OA Index (WOMAC) scale, including three subscores (WOMAC-pain, WOMAC-stiffness, WOMAC-functionality) and total WOMAC score. The predictors included age (in years), gender (male or female), BMI, PAL, education level, urban/rural living environment and marital status (partnership).

Female gender was correlated with the WOMAC-pain, WOMAC-stiffness and WOMAC-total. Older age was correlated with the WOMAC-pain and WOMAC-total. Patients who were better educated and reported higher PAL had better WOMAC functionality. BMI was the most significant factor of influence, with higher WOMAC-pain (OR 1.44, 95% CI 1.27 to 1.65), WOMAC-stiffness (OR 1.20, 95% CI 1.1 to –1.33), WOMAC-functionality (OR 1.26, 95% CI 1.13 to 1.40) and WOMAC-total (OR 1.29, 95% CI 1.6 to –1.44) scores in patients with higher BMI.

Results indicate the necessity of controlling body weight in patients with diagnosed knee OA irrespective of gender. Further prospective studies are warranted in order to establish causality between variables.

Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.

This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.

This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.

NCT06770075.

This paper examines the impact of India’s National Publicly Funded Health Assurance Scheme, Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (PM-JAY), in Haryana on out-of-pocket (OOP) expenses and catastrophic health expenditure (CHE).

We conducted a case-control study using a stratified random sampling approach.

Six districts in Haryana, based on utilisation, were selected: Mewat, Faridabad, Sonipat, Ambala, Kurukshetra and Karnal.

A total sample size of 772 individuals, that is, 386 PM-JAY beneficiaries (cases) and non-beneficiaries (controls) each.

Data were collected using a semistructured questionnaire covering household demographics and expenditure details. The interview gathered information on hospitalisation within the past year, types of ailments, the type of empanelled facility visited, expenditure details and borrowing/selling of assets for treatment.

Mean OOP expenditure was calculated for beneficiaries and non-beneficiaries based on the type of healthcare provider. The impact of PM-JAY on OOP expenditure was analysed using a generalised linear model controlling for religion, caste, type of house, type of family, morbidity patterns, type of disease, type of health facility, hospital stay duration, average distance to the facility and travel time. CHE was defined as OOP payments ≥30% of household income. Logistic regression was used to assess the determinants of CHE.

We found that direct medical expenses incurred for hospitalisations were 65% lower for beneficiaries (11 131 rupees) compared with non-beneficiaries (31 675 rupees). While OOP expenditures are similar for both groups in public empanelled hospitals, non-beneficiaries incur OOP costs three times higher than PM-JAY beneficiaries in private empanelled hospitals. Factors, including the disease type, average distance from home to the facility, average travel time and type of hospital, significantly influence these expenses. Furthermore, the prevalence of CHE is significantly lower among PM-JAY beneficiaries (13.3%) compared with non-beneficiaries (45.9%), with an OR of 7.15 (95% CI: 4.74 to 10.80; p

Our analysis shows the scheme’s impact on decreasing OOP expenditure and CHE. To enhance the scheme’s effectiveness, the study highlights the necessity of addressing non-medical expenses and expanding coverage for indirect costs, such as food, accommodation and transportation. Additionally, strengthening the supply side through improved drug availability at healthcare facilities is crucial for enhancing financial protection and access to care.

There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.

This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.

This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.

NCT06360783.

Poststroke depression affects approximately 30% of stroke survivors and is linked to worse functional outcomes, cognitive decline, reduced quality of life and increased mortality. While early treatment of poststroke mental health conditions is critical, current pharmacological options offer limited efficacy. Music listening interventions are a promising, low-risk, accessible and affordable alternative that may enhance recovery through engagement of reward-related brain circuits. However, most music listening studies have focused on the acute stage of stroke, lack objective measures of music engagement and rarely assess underlying neural mechanisms. To address these gaps, we propose a feasibility study of a remotely delivered music-listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural and physiological changes.

We will conduct a parallel group randomised controlled feasibility trial enrolling 60 patients with chronic stroke from a well-characterised stroke registry in New York City. Participants will be randomised to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week preintervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (ie, track identity, duration and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioural outcomes related to mental health will be assessed at baseline, preintervention, postintervention and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity and heart rate) will be collected preintervention and postintervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, treatment fidelity, feasibility, acceptability and participant burden. Secondary outcomes include recruitment and randomisation rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for poststroke mental health recovery.

The study was approved by New York University’s Institutional Review Board (FY2024-8826). All human participants will provide written informed consent prior to participation and will be adequately compensated for their time. Results will be reported in peer-reviewed journals.

NCT07127159.