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).

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.

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.

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

Australia-wide.

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.

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.

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.

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.

Ischaemic heart disease (IHD) is a leading cause of morbidity and mortality worldwide. Despite strong recommendations, the implementation rate of outpatient cardiac rehabilitation (CR) in Japan remains low. Mobile health technologies, such as Personal Health Record (PHR) applications combined with wearable devices, may enhance adherence to rehabilitation programmes. This study aims to evaluate the effectiveness of a continuous support programme that integrates a PHR app and counselling services in improving the continuation rate of outpatient CR and exercise tolerance in patients with IHD.

This is a single-blind randomised controlled trial with a parallel-group design. A total of 72 participants with IHD will be recruited from the outpatient departments of Maebashi Red Cross Hospital, Gunma Saiseikai Maebashi Hospital, Okayama University Hospital, Okayama Red Cross Hospital, Momoyama-kai Ono Internal Clinic, Hiroshima University Hospital, Tshuyama Jifu-kai Tsuyama Chuo Hospital and Shinpu-kai Tamashima Chuo Hospital. Participants will be randomly allocated to either the intervention group, which will receive a wearable device, a PHR app, counselling services and a rehabilitation notebook, or the control group, which will receive a wearable device and a rehabilitation notebook without the PHR app and counselling. The primary outcome is the change in peak oxygen uptake from baseline to 150 days. Secondary outcomes include changes in anaerobic threshold, number of outpatient rehabilitation visits, daily steps and vital signs. Data will be analysed using a generalised estimating equations for primary outcomes and appropriate statistical tests for secondary outcomes, following an intention-to-treat approach.

Ethical approval for this study was obtained from the ethics committee of the Kyoto University Graduate School and Faculty of Medicine (C1669-1). In addition, permission to conduct the study was granted by the director of each participating institution. Participants will provide informed consent prior to participation. Findings will be disseminated through peer-reviewed journals, conferences and summary reports to stakeholders.

This trial is registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (trial identifier: UMIN000055823).

Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Japan Registry of Clinical Trials (jRCT1012240051).

Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is an intensive rehabilitation programme for children with cerebral palsy (CP) delivered in a day camp setting recognised to promote the acquisition of specific functional abilities and independence. Currently, during HABIT-ILE camps, families are minimally involved in their child’s motor learning processes. This explains the challenges reported by both families and therapists, including difficulties in reinforcing skills at home, limited transfer to other functional goals and a lack of confidence in parents’ adaptive competence (self-determination and empowerment). Increasing family involvement in intensive motor rehabilitation programmes and the child’s developmental process by reinforcing skills at home could help reduce the parental impact of the child’s disability, enhance family satisfaction and strengthen their resources to support their child’s daily learning during and after the camp.

To address this, we developed the PARTNER programme, which combines HABIT-ILE with a structured home component focused on parent coaching.

We designed a non-inferiority, mixed-methods, multicentre randomised controlled trial to compare the efficacy at 3 months of the PARTNER programme (35 hours HABIT-ILE+15 hours home programme) with the standard HABIT-ILE programme (50 hours) on the bimanual performance (Assisting Hand Assessment) of children with unilateral CP aged 3–5 years. The secondary aims are to compare the 3-month efficacy of the programmes on occupational performance, functional skills and upper limb activity levels, as well as families’ resources, the parent–child relationship, the quantity and quality of resources available in the home to stimulate the child’s motor development, and parental perceptions of their child’s disability and their child’s abilities (qualitative study). The tertiary aim is to conduct a cost-effectiveness analysis of care consumption in each group up to 6 months after the end of the programmes.

Target recruitment is 66 children (33 in each group) from 3 centres in France. Outcomes will be evaluated before the interventions, immediately after, at 3 months and up to 6 months for the cost-effectiveness analysis. Families in the PARTNER group will receive specific coaching and extensive support to perform the home programme. The coaching will focus on enhancing their resources.

The study protocol has been reviewed, and ethics approval obtained from the Protection of Persons Committee (PPC) (PPC number: 2024-A01051-46). The results from this study will be actively disseminated through manuscript publications and conference presentations.

NCT06963151.

Prolonged QTc is a major risk factor for ventricular arrhythmias and sudden cardiac death (SCD). Anaemia’s impact on the QT interval is unclear and conflicting despite its association with increased mortality.

We investigated the association between anaemia and the prevalence of QTc prolongation, as well as potential gender differences in this relationship. Additionally, we examined whether haemoglobin levels were associated with QTc prolongation.

Observational cross-sectional study.

Sheshdeh, Fasa, Iran.

We analysed data from 5741 participants from the general population (aged 35–70 years) with no history of ischaemic heart disease; myocardial infarction; amiodarone use; multiple blood transfusions; or supplementation with iron, folic acid or cobalamin.

Anaemia was defined according to WHO guidelines (haemoglobin 450 ms in men or >470 ms in women.

Among 5741 participants, mean QTc was 427.91±24.75 ms, with QTc prolongation in 7.14%. Anaemia raised the odds of QTc prolongation by 60% (OR=1.60, 95%CI 1.12 to 2.28, p=0.010), particularly in females (OR=1.73, 95%CI 1.12 to 2.66, p=0.013), but not in males. Higher haemoglobin levels were associated with lower QTc prolongation risk (OR=0.91 per unit increase, 95% CI 0.85 to 0.97, p=0.005). No significant associations were observed between anaemia type/severity and QTc prolongation among anaemic individuals.

Anaemia was significantly associated with QTc prolongation, particularly in females. Anaemia type/severity did not affect QTc prolongation. Anaemia is associated with increased odds of QTc prolongation, particularly in women. While causality cannot be inferred from this cross-sectional analysis, the findings suggest that clinicians may consider QTc monitoring in anaemic patients, especially women and exercise caution when prescribing QT-prolonging medications. Prospective studies are needed to confirm whether anaemia directly contributes to QTc prolongation or arrhythmic risk.

Exposure to prescription opioids following traumatic injury can increase the risk of developing tolerance, persistent opioid use and opioid use disorder. The mechanisms underlying opioid tolerance or dependence are not well understood, and no biomarkers predict risk. Opioid exposure causes epigenetic modifications, including alterations in microRNA (miRNA) expression. Several miRNAs, which regulate synaptic plasticity, are hypothesised to underlie substance use disorders and influence µ-opioid receptor levels, modulating opioid tolerance. This project aims to develop a bio-behavioural signature to predict persistent opioid use and chronic pain up to 6 months post-discharge.

The study will use a prospective cohort design, enrolling 180 adult patients at a Level I Trauma Center who are prescribed opioids at discharge. Prospective data will be collected in the hospital and at 7 days and 1, 3 and 6 months post-discharge. Biological data (genotyping and miRNA levels) and clinical measures of opioid use, pain, pain sensitivity (EEG) and psychosocial functioning will be collected at each time point. Bayesian regression methods will be used to identify baseline clinical, genetic, epigenetic and psychosocial predictors of opioid use and pain outcomes at 6 months post-discharge. Growth mixture modelling will identify distinct subgroups with varying trajectories, followed by Bayesian hierarchical modelling to predict trajectory classification based on predictor variables.

Ethics approval for this study was obtained from the University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects (HSC-MS-24–0314). Findings will be disseminated in peer-reviewed scientific journals and at national and international conferences.

With an ageing population, prevention of frailty among older adults has become a critical public health issue. Dietary habits are one of the essential components in frailty prevention, which involves promoting changes in dietary behaviours, such as including dietary variety. However, community-level health promotion interventions face significant challenges, including limited spatial access to food, which is important as it is not easy to change the behaviour of older adults. The dissemination of community-level health promotion interventions targeting dietary behavioural changes among older adults remains unclear. Therefore, this study aimed to evaluate the effects of supermarket-based health promotion interventions on dietary variety among older Japanese adults.

This study is a cluster non-randomised parallel-group comparative trial involving 15 supermarkets in the Yamanashi and Nagano Prefectures, Japan. Seven supermarkets will be assigned to the intervention group and eight to the control group. The intervention group will receive a health promotion programme consisting of three components to enhance dietary diversity: information, education and support delivery. The intervention design incorporates social marketing strategies, and programme evaluation will be conducted concurrently. Data, including the Dietary Variety Score (DVS) for the primary outcome, will be collected through postal and electronic surveys at baseline and at 1, 2 and 3 years, with the 3-year follow-up serving as the primary endpoint for effectiveness evaluation. Statistical analyses will use a generalised linear mixed model, focusing on changes in the DVS as the primary outcome. Sensitivity and subgroup analyses will be performed to assess the generalisability of the findings.

The Tokyo Metropolitan Institute for Geriatrics and Gerontology Research Ethics Committee has approved the research protocol (approval number: R23-116). The results will be disseminated through conference presentations and publication in peer-reviewed international journals.

UMIN000056023.

Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.

The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.

This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.

jRCT1062220035.

Traumatic brain injury (TBI) often causes permanent neurological dysfunction. Although no medication has been validated yet to prevent secondary injury of brain tissue, recent animal studies have reported that perampanel, a glutamine receptor antagonist, could improve the neurological functions of animals with TBI by mitigating the abnormal calcium influx and cell death around the site of primary injury. The present study aims to elucidate the efficacy of perampanel administration in improving the neurological function of patients with TBI.

The perampanel for alleviation of secondary injury in TBI trial is a multicentre, phase-II, open-label randomised controlled trial targeting patients with mild-to-moderate TBI. This trial will include adult TBI patients with a Glasgow Coma Scale score of 9–14 from five tertiary centres. Patients with epilepsy as a comorbidity, delayed presentation of symptoms (>24 hours after injury) or Injury Severity Score of ≥25 will be excluded. The study participants will be randomly assigned to either the perampanel group (2 mg/day) or the control group (fosphenytoin administered at a dose of 15–18 mg/kg/day, followed by 5–7.5 mg/kg/day of fosphenytoin). In both groups, the medication will be initiated within 12 hours of the TBI diagnosis and continued for 7 days. The antiepileptic drugs can be increased, changed or added as necessary if early post-traumatic seizures are observed. The primary outcome is favourable neurological outcome, defined as a Glasgow Outcome Scale Extended score of ≥5 at 90 days after the TBI diagnosis, which will then be compared between the groups through an intention-to-treat analysis.

The present study has been approved by the Certified Review Board of Keio at the principal institution (approval number: N20240004). Written informed consent will be obtained from all participants or their legal representatives. The results will be disseminated via publications and presentations.

Japan Registry of Clinical Trials (jRCTs031250067).

Indigenous Mayan-Yucatecan communities in Mexico have a high prevalence of chronic non-communicable diseases (NCDs) such as diabetes, hypertension, obesity and rheumatic diseases (RMDs). According to the syndemic theory, these diseases combined with social, economic and cultural factors affect the quality of life. The aim of this protocol is to describe the methodological process to create, implement and evaluate a Syndemic-Based Care Model (SCM), using a Community Based-Participatory Research (CBPR) strategy in three Mayan-Yucatecan communities.

This is a convergent mixed-methods protocol. The quantitative component is a before-after study, and the qualitative component is an ethnographic study. The intervention will be a SCM co-constructed with Mayan communities based on their particular needs and aiming for reduction of the negative impact of NCD/RMD through a multidisciplinary approach. We will follow four phases of the CBPR: (1) situational analysis, through community censuses and semistructured interviews to understand the prevalence of NCDs and the syndemics in these communities; (2) co-construction of the elements of a SCM based on the health priorities identified by researchers, community members and healthcare workers; (3) implementation of this SCM and (4) evaluation of the SCM through (1) statistical analyses involving the construction of a syndemic index through stepwise logistic regression of the normalised and standardised key clinical, social and economic variables; interval and ratio variables will be normalised by their z-score and categorical variables will be one-hot encoded; similarity and social networks analysis with clustering to identify syndemic subpopulations; and cost-effectiveness and cost-utility analyses using Markov modelling and (2) narrative and thematic qualitative analysis of the SCM’s implementation and impact on community members’ health, function and quality of life.

Research ethics boards of participant institutions approved this research protocol. This project will be presented to municipal authorities, community meetings and community leaders for observation and acceptance. For people who wish to participate, informed consent will be provided written and verbally in Spanish or Mayan-Yucatecan according to the participant preferences, and it can be signed by either autograph or fingerprint. The results of this research will be disseminated to various groups: (a) local and regional authorities of the Mexican health system and municipal authorities; (b) the participating communities will be informed in an assembly of the results and (c) academic dissemination will be done through publications in public science journals and institutional press releases and will also be presented at national and international congresses or symposia.

To investigate the relationship between demographic characteristics and extracurricular achievements among UK medical students.

National, cross-sectional survey.

All 44 UK medical schools recognised by the General Medical Council.

8,395 medical students.

Binary indicators of extracurricular engagement, including PubMed-indexed authorship, academic presentations, quality improvement projects, leadership roles and academic prizes. Logistic regression models were used to explore associations with demographic and extracurricular achievement predictors.

Logistic regression analysis showed that students from private schools (OR 1.35, CI 1.20 to 1.53, p

Significant disparities in extracurricular achievement exist among UK medical students, principally associated with gender, private schooling and familial links to medicine. Apparent ethnic differences were largely attenuated after adjustment for other variables, indicating socioeconomic factors as stronger predictors of engagement. Given the role of these achievements in postgraduate selection, targeted interventions by medical schools and professional bodies to widen access to funding, mentorship and structured guidance for all students, regardless of perceived advantage, may support equitable opportunity without undermining merit-based standards.

To explore factors influencing UK medical students’ specialty choices and examine variations in these influences across demographic groups and stages of training.

National, cross-sectional online survey.

All 44 UK medical schools recognised by the General Medical Council.

8,395 medical students.

The primary outcome was the specialty preferences of UK medical students. The secondary outcomes were factors behind these preferences and how these factors vary across demographic groups and different stages of training.

General Practice (15.3%), Paediatrics (10.6%) and Anaesthetics (9.9%) were the most preferred specialties among final-year students. Work-life balance (84.1%), compatibility with family life (78.2%), positive training experiences (85.2%) and future specialty outlook (74.9%) were key factors influencing specialty choice. Only 23.1% of students felt confident about securing a specialty training post, with confidence higher among males (OR 1.36, 95% CI 1.21 to 1.52, p

This study highlights disparities in specialty preferences and influencing factors among UK medical students. A focus on improving career guidance, exposure to various specialties and supporting equitable access to training opportunities is essential for fostering a motivated and sustainable medical workforce.

Adherence to treatment strategies is essential for preventing future complications during diabetes management. This study evaluated the association between dropout history, glycated haemoglobin (HbA1c) levels and subsequent risks of dropout (missed appointment)in patients with type 2 diabetes.

This was a secondary analysis of a cluster-randomised trial (the Japan Diabetes Outcome Intervention Trial 2 Large-Scale Trial), focusing on the non-intervention group over the study period.

Data were obtained from a multisite trial conducted in Japan, encompassing patients with type 2 diabetes who received routine clinical care at participating clinics.

A total of 996 patients with type 2 diabetes from the non-intervention group were included in the analysis. Baseline characteristics (eg, age, sex, smoking status, occupational status and diabetes medication use) were recorded at study entry.

The primary outcome measure was subsequent treatment dropout. The Cox proportional hazards model with the Huber/White method was used to estimate HRs and 95% CIs, with adjustment for age, sex, smoking status, occupational status and diabetes medication use at baseline.

Participants with treatment dropout history had a higher dropout rate than those without dropout history (multivariable-adjusted HR=3.59; 95% CI=2.25 to 5.71). Overall, HbA1c levels were not significantly associated with dropout risk. However, among the 855 participants without dropout history, the dropout risk was higher in the group with HbA1c level ≥10.0% (HR=3.76; CI=1.29 to 10.9) than in the group with HbA1c level of 6.0–6.9%.

This prospective cohort study of Japanese patients with type 2 diabetes suggests that dropout history is strongly associated with a higher subsequent dropout risk. High HbA1c levels (≥10%) may be related to a higher dropout risk in patients without a dropout history. These findings may provide actionable indicators for tailored interventions, enhancing targeted healthcare strategies and improving continuity of care.

UMIN000002186.

Atopic dermatitis (AD) is a chronic inflammatory skin condition that impairs the quality of life of affected paediatric patients and their families. Dupilumab, an antagonist of the shared alpha chain subunit of the cytokines interleukin-4 and interleukin-13, has revolutionised the management of moderate-to-severe AD by effectively targeting type 2 inflammation. However, live attenuated vaccines, including live attenuated influenza vaccines (LAIVs), are contraindicated during dupilumab therapy owing to limited safety data. This restriction poses challenges to immunisation strategies, particularly in paediatric populations. This study aims to evaluate the safety and efficacy of LAIV in paediatric patients with AD undergoing dupilumab therapy.

This multicentre, prospective, single-arm, open-label trial will enrol 50 paediatric patients aged 2–18 years with AD undergoing dupilumab treatment. The participants will receive intranasal LAIV, followed by a 25-week observation period after vaccination. The primary outcome is the proportion of participants with a four-fold or greater increase in haemagglutination inhibition titres against influenza strains A(H1N1), A(H3N2) and B at 4 weeks post vaccination. The secondary outcomes include the incidence of influenza and systemic or local adverse events, such as injection site reactions, fever and other influenza-like symptoms observed within 4 weeks of vaccination. Exploratory endpoints include the evaluation of immunosuppressive markers such as neutrophil counts, lymphocyte subsets and serum immunoglobulin G levels. Safety analyses will assess the frequency of each adverse event, whereas efficacy analyses will focus on immunogenicity and influenza incidence during the 25-week follow-up period. This study aims to provide critical safety and immunogenicity data to guide immunisation strategies in biologically treated paediatric patients with AD.

This study complies with the principles of the Declaration of Helsinki and received ethics approval from the Institutional Review Board of Chiba University Hospital as a specified clinical trial. Informed consent and assent will be obtained as appropriate based on the participants’ ages. These findings will be disseminated through peer-reviewed journals and scientific conferences to inform clinical vaccination strategies for biologically treated populations.

jRCTs031240442.

Gestational diabetes is a common metabolic disorder in pregnancy which identifies a substantial increased risk of future diabetes. Despite this risk, many individuals are not screened for dysglycaemia in the postpartum period. Continuous glucose monitoring (CGM) is an evolving technology that provides details of an individual’s glucose levels throughout the day; however, it has not yet been evaluated as a screening tool for postpartum dysglycaemia. To address this gap, this prospective cohort study will examine the use of CGM in the early postpartum period to predict the risk of maternal dysglycaemia after delivery.

The Predicting Dysglycaemia in Individuals with Gestational Diabetes Immediately Postpartum using CGM (PREDISPOSE) study is a prospective cohort study designed to assess the ability of a CGM device (Freestyle Libre 2) worn in the postpartum period to detect persistent dysglycaemia in individuals with gestational diabetes. The study will recruit 240 individuals with gestational diabetes. Each participant will wear the CGM immediately postpartum and before attending routine postpartum diabetes screening, consisting of a 75-gram oral glucose tolerance test (OGTT) and related blood work (haemoglobin A1c (HbA1c), complete blood count and lipid profile). The primary outcome is the accuracy of the area under the curve for all glucose measurements from the first CGM wear to detect postpartum dysglycaemia. We will perform sensitivity and specificity analyses to determine optimal CGM cut-offs to diagnose diabetes or prediabetes. Secondary outcomes include the incidence of postpartum dysglycaemia (based on 75-gram OGTT and/or HbA1c), incidence of postpartum dyslipidaemia, patient acceptability of CGM testing, data variability from CGM and cardiometabolic health outcomes diagnosed in years one, two and five after delivery.

All participating sites have received ethics approval of the current protocol and have started recruitment of participants to the study. The ethics boards that approved this study are the Biomedical Research Ethics Board at the University of Manitoba, the Conjoint Health Research Ethics Board at the University of Calgary, the Mount Sinai Hospital Research Ethics Board at Mount Sinai Hospital and the Comité d'éthique de la Recherche at Université Laval. Study results will be disseminated through conference presentations and publication in a peer-reviewed journal, regardless of study findings.

NCT04972955. Registration date: 28 June 2021.

Childhood cancer treatment can cause subfertility in adulthood. Ovarian or testicular tissue preservation is a rapidly evolving field with significant potential benefits. However, the establishment of patient-centred reproductive survivorship pathways remains a challenge in clinical settings due to a lack of robust evidence to inform its development. Patient and public involvement and engagement (PPIE) consultation may help ensure that future studies align with patient needs and that tailored survivorship care pathways are developed for young people with preserved fertility tissue.

This PPIE consultation aimed to identify priority areas for future research that would support the development of a tailored survivorship care pathway for childhood cancer survivors who have preserved tissue for future fertility.

Recruitment occurred through national networks, including collaborations with advocacy groups such as Candlelighters and clinical networks. Data were collected via telephone or online unstructured interviews, with some supplementary email exchanges. Thematic analysis was used to identify emergent themes. The Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 guidelines were used to help guide PPIE.

An online focus group and/or a one-to-one interview with e-mail interactions.

In total, 12 unique participants took part in a focus group and/or interview. Participants included parents of children who had stored tissue, young adult cancer survivors with stored tissue and five clinicians from the leading National Health Service (NHS) centres in the UK.

Six key themes emerged that highlighted unmet needs and priority areas for research: (1) Lack of communication and information; (2) unmet needs in follow-up care; (3) emotional impact and psychological support; (4) importance of patient and parental involvement; (5) desire for information and education; and (6) long-term concerns and support. Parents, young adults and healthcare clinicians found talking about fertility issues difficult. They noted that consistency of care, education resources and access to emotional support were important areas where improvements could be made. We used thematic analysis to help identify patterns in the data, and we used the Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 reporting guidelines for PPIE work.

PPIE provided valuable insights into the experiences of childhood cancer survivors with preserved fertility tissue, their parents and clinicians, highlighting priority areas to guide future research and ensure it addresses the concerns of care recipients. Our findings suggest that childhood cancer survivors who preserve tissue for future fertility need personalised follow-up care with information and psychological support. A larger sample of participants, studied using a qualitative research design, is needed to capture the full range of experiences, needs and preferences and to ensure that care is inclusive and relevant to the wider population.

The open, prospective Community-Based chronic Care Lesotho (ComBaCaL) cohort is the first study to comprehensively investigate socioeconomic indicators, common chronic diseases and their risk factors in a remote rural setting in Lesotho. It serves as a platform for implementing nested trials using the Trials within Cohorts (TwiCs) design to assess community-based chronic care interventions. In this study, we present the cohort’s sociodemographic and chronic disease risk factor profile, including self-reported HIV prevalence and hypertension and diabetes care cascades.

Since February 2023, community health worker (CHWs) supported by a clinical decision support and data collection application have enrolled inhabitants from 103 randomly selected rural villages in Butha-Buthe and Mokhotlong districts in Northeast Lesotho. As of 31 May 2024, the cohort includes 5008 households with 14 735 participants (55% female, median age 19 years). The cohort’s socioeconomic status is low with an International Wealth Index of 26, a monthly household income of US$42.4 and low levels of formal education. Among the 7917 adult participants, 42.5% are overweight or obese, with higher rates among women, and 33.1% smoke tobacco, with higher rates among men. Self-reported HIV prevalence is 15.1% with a 98.4% treatment rate. Hypertension prevalence is 17% with a 56% control rate and diabetes prevalence is 4% with a 39% control rate.

The cohort’s low socioeconomic status is linked to multiple health risks including insufficient access to clean energy, essential healthcare services, adequate sanitary facilities and secure food supply. Besides the expected high HIV prevalence, we found significant hypertension, diabetes and cardiovascular risk factor prevalences. While treatment and control rates for diabetes and hypertension are higher than in similar settings, they remain below global targets.

Ongoing cluster-randomised TwiCs, which will be completed in 2025, are assessing the effectiveness of community-based, CHW-led care interventions for diabetes and hypertension. CHWs will continue to closely monitor the cohort and integrate additional measurements such as HIV testing. This will provide further insights into the dynamics and interactions of chronic diseases and inform the development of future nested trials on innovative community-based prevention and care interventions.

NCT05596773.