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Effectiveness of Kushal Maa, a group-based mhealth interactive education and social support intervention for maternal and neonatal health outcomes: study protocol for a multisite randomised controlled trial in India
Introduction
Perinatal care continuity across the full continuum is essential for optimising maternal and infant health; however, a stark gap occurs post partum, with less than one half of Indian mothers receiving postpartum care due to significant logistical and sociocultural barriers, particularly for periurban and rural residents. To overcome these barriers and reduce women’s postpartum isolation, our international team of maternal and infant health clinicians and researchers developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention, Kushal Maa (‘informed-mother’), confirming feasibility and acceptability and preliminary effectiveness. The current study seeks to estimate the effectiveness of the Kushal Maa intervention compared with standard care on maternal and neonatal health-related behaviours and health, characterise the mechanisms of intervention impact and evaluate the cost-effectiveness of the Kushal Maa intervention in improving postpartum maternal and neonatal health compared with the standard of care.
Methods and analysis
We will conduct a prospective, parallel block-randomised controlled trial with a 1:1 allocation ratio among 2100 pregnant women across three geographically diverse Indian states. Inclusion criteria for women: aged 18+years of age at enrolment, in the last trimester of pregnancy (30–33 weeks of gestation), with any parity, carrying single or multiple gestation (1-2), with knowledge of site-specific local language and had access to a mobile phone. Participants will be block-randomised in groups of 15. Intervention participants will receive 28 tailored education and support sessions weekly via audio/video conference facilitated by trained moderators (four prenatal and 24 weekly postpartum sessions through 6 months) and will be engaged in WhatsApp groups for health education videos and peer discussion via text chat. Control participants receive the standard of care. Data will be collected at four points: 30–33 weeks of pregnancy (enrolment), 6 weeks, 3 months and 6 months postpartum (endline). Investigators, outcome assessors and data analysts will be blinded to group allocation. Primary outcomes will be measured at 6 weeks, 3 months and 6 months post partum and include: postpartum depression (using Edinburgh Postnatal Depression Scale), exclusive breastfeeding and met need for postpartum family planning. Secondary outcomes include other maternal and child health knowledge, outcomes and maternal and newborn healthcare use indicators. We will use intention-to-treat analysis. Mixed-effects models will account for clustering due to the group-oriented delivery of the intervention and repeated measures.
Ethics and dissemination
This study has been approved by the Health Ministry Screening Committee, Government of India and approved by ethics boards at the Post-Graduate Institute for Medical Education and Research, Chandigarh (Ref:001208, IEC-06/2022–2471), Maharashtra University of Health Sciences (Ref: MUHS/EC/06/2024), Sangath (Ref: AB_2022_81) and the University of California, San Francisco (Ref: 21–35730). All research activities will be performed in accordance with the Declaration of Helsinki. On completion, findings will be disseminated to stakeholders through diverse strategies. Results will be published in academic journals and presented at conferences.
Trial registration number
ClinicalTrials.gov: NCT05268588 Clinical Trials Registry – India: CTRI/2022/07/043889.
Multicomponent intervention for controlling hypertension in the adult rural population of Pakistan: a protocol for a hybrid type III implementation-effectiveness cluster randomised controlled trial
Introduction
Though prior trials have shown the effectiveness of community-based hypertension detection and care delivery models, their adoption and translation to practice has been slow. In this study, we will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) in Pakistan that comprises health education, blood pressure (BP) monitoring and referrals by lady health workers (LHWs) and hypertension management by physicians in primary care settings.
Methods and analysis
In this 24-month hybrid type III implementation-effectiveness cluster-randomised controlled trial, we will recruit 3000 adult hypertensive patients from two rural districts of Pakistan. We will engage public health sector managers, physicians and LHWs and use the Consolidated Framework for Implementation Research to identify barriers and facilitators to the implementation of an already proven-to-be-effective MCHI. Using Expert Recommendations for Implementing Change and the modified Delphi technique, a set of implementation strategies addressing barriers will be identified. The strategies will be categorised as level 1 (requiring a change in processes), level 2 (requiring a change in infrastructure) and level 3 (financial restructuring). Basic health units and 250–300 households from their catchment will be considered as clusters. Clusters will be randomised in a ratio of 1:1 to intervention and control. While MCHI will be offered in both trial arms (intervention and control), the aforementioned implementation strategies will be randomised to the intervention arm only, starting with level 1 and moving to levels 2 and 3 as needed. Baseline and 6-monthly follow-up surveys, each of 6 months duration, will be conducted to collect data from the recruited participants on sociodemographics, cardiovascular disease (CVD) risk factors, CVD-related expenses and quality of life. The primary outcome will be the mean difference in BP-lowering medications per participant between the intervention and control arms. The primary outcome will be analysed using a linear mixed model with fixed effects for baseline value of the outcome. Additional outcomes include implementation outcomes: proportion of LHWs conducting health education, BP screening and monitoring, facility referrals and proportion of physicians diagnosing and treating hypertensive patients; effectiveness outcomes: proportion of participants with controlled BP and improved EQ-5D-5L score.
Ethics and dissemination
Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University Pakistan (ERC # 2023-9084-26739). Findings will be reported to: (1) study participants; (2) funding body and institutes collaborating and supporting the study; (3) provincial and district health departments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications
Trial registration number
NCT06726057.
Impact assessment of Benazir Nashonuma Programme (BNP) on maternal, child health and nutritional status in Pakistan: a quasi-experimental study protocol
Introduction
Maternal and child malnutrition is a significant public health concern in Pakistan, with 40% of children under five being stunted. In response, the Government of Pakistan initiated the Benazir Nashonuma Programme (BNP), a nutritional supplementation programme for pregnant women, mothers of children aged 0 to 23 months and children aged 6 to 24 months. This study aims to evaluate the effectiveness of the BNP in reducing childhood stunting and improving maternal and child health outcomes.
Methods and analysis
A quasi-experimental longitudinal study comprising baseline, midline and endline surveys will be conducted across 18 districts (9 intervention and 9 control) in Pakistan. The surveys will use a two-stage cluster sampling method to enrol 13 200 children aged 0–59 months and their mothers from the Benazir Income Support Programme households. The primary outcome of interest is the prevalence of under-five stunting. We will use a difference-in-differences approach to estimate the impact by comparing the documented changes over time between the intervention and control groups.
Ethics and dissemination
This study will provide critical insights into the effectiveness of the BNP in addressing childhood undernutrition in Pakistan. The findings will inform policy and programmatic decisions aimed at reducing undernutrition in resource-constrained settings. Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University and the Pakistan National Bioethics Committee.
Trial registration number
NCT06025786.
Evaluating DOAC dipstick testing in the management of acute stroke: protocol for a multicentre, prospective, observational registry study
Introduction
Direct oral anticoagulants (DOACs) are preferred over vitamin K antagonists for stroke prophylaxis in non-valvular atrial fibrillation. Yet, DOAC use is regarded as a contraindication for intravenous thrombolysis in acute ischaemic stroke. The stratification of patients into ‘on-therapy’ and ‘off-therapy’ categories based on their plasma DOAC concentrations is particularly crucial in the acute phase of stroke when decisions for thrombolysis or anticoagulation reversal are time-sensitive. The novel point-of-care DOAC dipstick assay (DOASENSE) rapidly assesses urine for clinically significant DOAC levels, potentially broadening eligibility for thrombolysis or targeted reversal therapy. This multicentre prospective observational registry study aims to evaluate the accuracy and clinical utility of DOAC dipstick testing compared with plasma DOAC assays in acute stroke management across regional Australian hospitals.
Methods and analysis
This multicentre, prospective, observational study will enrol participants presenting to hospitals across Victoria and Tasmania with acute ischaemic stroke or intracerebral haemorrhage with DOAC ingestion within 48 hours of presentation. Plasma DOAC concentrations measured by chromogenic assays will be compared with rapid urine dipstick results from DOASENSE testing. There is a target sample size of 146 participants. The primary outcomes are as follows: (1) proportion of ischaemic stroke participants with off-therapy plasma DOAC levels and (2) eligibility for reperfusion therapy based on DOASENSE and plasma DOAC concentrations. Secondary outcomes are follows: (1) ischaemic stroke aetiology for participants with on-therapy vs off-therapy DOAC levels; (2) proportion of participants meeting criteria for pharmacological DOAC reversal based on DOASENSE outcomes; (3) incidence of false-negative and false positive DOASENSE results in clinically significant DOAC plasma concentrations at a threshold of ≥30 ng/mL and (4) an exploratory analysis of any false negative DOASENSE assays to identify potential contributing factors.
Ethics and dissemination
Ethics approval has been granted by the Eastern Health Human Research Ethics Committee (reference number: 99628). Dissemination of findings will occur through peer-reviewed publications and academic conferences.
Cross-sectional study of the rates of military sexual trauma (MST) and associations with adverse mental health outcomes among UK female ex-service personnel: a study protocol
Introduction
This study investigates the rates of military sexual trauma (MST) and its associations with adverse mental health among a sample of UK female ex-service personnel who served during the Iraq/Afghanistan eras.
Methods and analysis
Female ex-service personnel, who participated in the fourth phase (Phase 4) of the King’s Centre for Military Health Research (KCMHR) Health and Well-being Cohort Study (2022–2023) and consented to be recontacted for follow-up studies (n=295), are being invited to participate in an online questionnaire between July 2024 and February 2025. The questionnaire contains surveys and questions related to experiences of sexual harassment and sexual assault during and outside of military service, disordered eating and broader female health issues. While the questionnaire relates to several female health topics, this study focuses on the surveys related to experiences of sexual trauma and eating disorders. Sociodemographic variables and some health variables, including post-traumatic stress disorder (PTSD), complex PTSD, common mental disorders, alcohol misuse, physical somatisation and social support, will be extracted from participants’ pre-existing data collected in Phase 4 of the KCMHR Cohort Study. Analyses will assess rates of MST, and hierarchical multiple logistic regressions will investigate associated health impacts. Rates and ORs, employing 95% CIs, will be reported.
Ethics and dissemination
This study has been granted full ethical approval by the King’s College London Research Ethics Committee (Ref: HR/DP-23/24–39040). Participants provide informed consent before participating and have access to a signposting booklet containing contact details for a range of support services. A risk protocol is in place, which outlines the procedure to be undertaken if a participant contacts the research team in distress. Findings will form part of a PhD thesis and will be further disseminated through peer-reviewed publication and dissemination with veteran mental health services and charities, and relevant government departments.
Advancing health equity and the role of digital health technologies: a scoping review
Background
Health disparities persist, posing significant health, social and economic challenges. Digital health technologies (DHTs) present a promising opportunity to address these inequities and advance health equity. Despite this potential, a comprehensive and structured overview of existing frameworks and guidelines on advancing health equity and a clear understanding of the potential of DHTs in their implementation to systematically close the healthcare gap is yet to be done.
Objective
To this end, our objectives are twofold: first, to identify frameworks and guidelines that promote health equity and second, to pinpoint the role of DHTs as an avenue for their implementation. We conducted a scoping review informed by Arksey and O’Malley’s five-stage framework, methodological guidelines by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
Sources of evidence
A comprehensive search was conducted across seven databases on 6 December 2023: PubMed, EMBASE, Cochrane, PsycINFO, Scopus, Web of Science and WISO.
Eligibility criteria
We included primary and secondary studies published in English between 2010 and 2023 focusing on advancing health equity for priority populations.
Charting methods
For the analysis, we applied multistaged coding approaches to answer our twofold objective.
Results
The search identified 6419 studies, of which 38 met our final inclusion criteria and were included in this review. We extracted 559 recommendations on advancing health equity and synthesised these into 82 distinct recommendations across five levels of initiative and 19 areas of initiative. Thereby, 24% of the included studies explicitly mentioned the use of (digital) technology with 10 impact opportunities on advancing health equity.
Conclusion
Our synthesis offers key insights into the advancement of health equity across different levels of initiative and the role of DHTs in their implementation. This offers practitioners and researchers alike a comprehensive overview to make health equity advancement more tangible and actionable.
Registration details
https://osf.io/94pht
Proposta di legge per l'educazione alimentare a scuola
Associazione Longaevitas avvia raccolta firme, “allarme obesità”
Proposta di legge per l'educazione alimentare a scuola
Associazione Longaevitas avvia raccolta firme, “allarme obesità”
Proposta di legge per l'educazione alimentare a scuola
Associazione Longaevitas avvia raccolta firme, “allarme obesità”
What drives clinic follow-up after traumatic spinal injury? An observational cohort study from Tanzania
Objectives
To evaluate factors associated with clinic follow-up after traumatic spinal injury (TSI) in Tanzania, focusing on demographic, injury-related and hospital variables. We hypothesised that socioeconomic and injury-specific factors would predict follow-up adherence.
Design
Retrospective observational cohort study.
Setting
Tertiary government referral centre for neurosurgery and orthopaedics in Dar es Salaam, Tanzania.
Participants
443 adults with TSI admitted between September 2016 and October 2021. Inclusion criteria included survival to discharge and availability of the discharge date. Patients with missing data were excluded.
Primary and secondary outcome measures
Primary outcomes were any clinic follow-up and 1-year follow-up post-discharge. Secondary outcome was time to loss of follow-up. Logistic regression was used to identify factors associated with follow-up, and Kaplan-Meier survival analysis assessed follow-up duration.
Results
Of 443 patients (85.8% male, median age 34 years), 52.4% returned for follow-up. Independent factors associated with return included private insurance (adjusted OR (aOR) 2.69, 95% CI 1.38 to 5.45, p=0.005), involvement in a road traffic accident (aOR 2.15, 95% CI 1.22 to 3.83, p=0.009), lumbar injuries (aOR 2.26, 95% CI 1.30 to 4.00, p=0.004), neurological improvement at discharge (aOR 3.52, 95% CI 1.72 to 7.64, p=0.001) and hospital stays shorter than 24 days (aOR 1.63, 95% CI 1.07 to 2.47, p=0.022). Among those who returned, only 25.4% completed 1 year of follow-up. Predictors of 1-year follow-up included being female (aOR 4.87, 95% CI 2.31 to 10.56, p
Acceptability and implementation of a comprehensive digital diabetes self-management platform (MyWay Diabetes): a qualitative protocol
Introduction
Diabetes is one of the most common long-term health conditions worldwide, placing a huge economic burden on health services. Diabetes self-management education and support programmes can support people with diabetes to manage their condition; however, uptake of face-to-face services remains low. Digital self-management tools are becoming increasingly available. MyWay Diabetes is a digital platform that offers a comprehensive self-management and education programme accessible through a mobile app and website and allows patients to access their personal healthcare records. Following successful implementation in Scotland, MyWay Diabetes is now being rolled out in three geographical areas in England. We plan to undertake three qualitative studies, as part of a larger mixed-methods research programme, to assess whether MyWay Diabetes is acceptable across diverse patient groups and healthcare professionals and gather views of patients who do not currently use the digital service.
Methods and analysis
We will conduct three online focus group studies. (1) One focus group with healthcare professionals (n=6–10) to understand their perceptions of implementing MyWay Diabetes in their local regions. (2) Up to four focus groups with existing users of MyWay Diabetes (n=24–40) across the three geographical areas in England to explore their acceptability of the platform. (3) Up to three focus groups with people living with diabetes who do not currently use MyWay Diabetes (n=18–30). Data will be collected using online videoconferencing and analysed thematically using template analysis.
Ethics and dissemination
Ethical approval was granted by South Central – Berkshire Research Ethics Committee (ref: 25/SC/0125) and The University of Manchester Proportionate Research Ethics Committee (ref: 2025-23064-42006). Study results will be disseminated through peer-reviewed journals, conference presentations, MyWay Digital Health platforms and national bodies. The evidence from this broader mixed-methods evaluation will inform decisions for platform improvement and regional and national commissioning across the National Health Service in England.
Thrombectomy Versus Medical Management for Pediatric Arterial Ischemic Stroke With Large Baseline Infarct
Stroke, Ahead of Print. BACKGROUND:Multiple recent randomized trials have demonstrated the benefit of thrombectomy over medical management alone in adult patients with large vessel occlusion (LVO) stroke and large infarct on baseline imaging. Cohort studies have also identified improved functional outcomes in pediatric patients who received thrombectomy. However, the role of thrombectomy in pediatric stroke with large baseline infarct remains uncertain.METHODS:A case-control study was undertaken using pooled data from 3 cohort studies of pediatric stroke (Save ChildS, Save ChildS Pro, Pediatric LVO Stroke Study). Pediatric patients of age 1 to 18 years with acute anterior circulation LVO stroke presenting within 24 hours since last seen well with an Alberta Stroke Program Early Computed Tomography (CT) Score of 0 to 5 on CT or magnetic resonance imaging were included. Isolated M2 occlusion or focal cerebral arteriopathy–inflammatory subtype cases were excluded. Thrombectomy-treated patients were compared with patients who received medical management alone. The primary clinical outcome was the pediatric modified Rankin Scale score at 90 days, compared between groups using ordinal logistic regression.RESULTS:Of 56 pediatric patients with anterior circulation LVO and low Alberta Stroke Program Early CT Score presenting between January 1, 2000 and August 31, 2023 from 45 centers across Europe, North America, and Australia, 40 patients were eligible for inclusion (female: n=14, 35.0%; mean age, 9.1 years; range, 1.5–17; SD, 5.27). Thrombectomy-treated patients (n=24) had significantly better pediatric modified Rankin Scale scores at 90 days than medical management alone patients (n=16; odds ratio, 3.68 [95% CI, 1.11–12.21];P=0.034). There was no significant difference between groups in the rate of symptomatic intracranial hemorrhage (P=0.806).CONCLUSIONS:In this multicentre case-control study, pediatric patients (age, 1–18 years) with anterior circulation LVO stroke and low Alberta Stroke Program Early CT Score who received thrombectomy had significantly better functional outcomes than those treated with medical management alone. Exclusion of pediatric patients from thrombectomy based on low Alberta Stroke Program Early CT Score alone may not be appropriate.
Case 6-2025: A 62-Year-Old Man with Abdominal Pain
New England Journal of Medicine, Volume 392, Issue 24, Page 2495-2496, June 26, 2025.
Gene Therapy for Infantile-Onset Pompe’s Disease
New England Journal of Medicine, Volume 392, Issue 24, Page 2477-2478, June 26, 2025.
AAV9-Mediated Gene Therapy for Infantile-Onset Pompe’s Disease
New England Journal of Medicine, Volume 392, Issue 24, Page 2438-2446, June 26, 2025.