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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.
Chirurgia per dimagrire riduce rischio di tumore del colon-retto
Agisce riducendo i livelli di molecole chiamate acidi biliari
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.
How did staffing strategies change amid COVID-19 and post pandemic? A qualitative study
Objectives and design
A qualitative study was undertaken to explore the nature of staffing strategies from the perspectives of nursing, medicine and health disciplines employed in a hospital setting.
Setting
Interviews were conducted in six hospitals in Canada between November 2022 and September 2023.
Results
118 healthcare professionals and leaders who experienced changes in staffing strategies participated in this study. Three themes emerged to describe new or adaptive staffing strategies: (1) valuing new roles and teams; (2) being redeployed; and (3) enhancing coverage.
Conclusions
Our study elucidates the staffing strategies that were employed during the COVID-19 pandemic that included creating new and adapting existing roles and teams; redeploying healthcare professionals; and enhancing coverage. Study findings can be used to guide leaders to use a proactive systematic approach to staffing models that includes adaptable and flexible staffing models within local contexts.
Identifying lifelong factors that impact brain health and functional outcomes in adults with childhood-onset type 1 diabetes: the cognition and longitudinal assessments of risk factors over 30 years (CLARiFY) – diabetes complications study protocol
Introduction
Type 1 diabetes (T1D) is associated with changes in brain structure, cognition, mental health, and functional outcomes. While these changes have been linked to dysregulated glycaemic control, findings are inconsistent, and their long-term impact remains unclear. Most evidence comes from cross-sectional or short-term longitudinal studies, limiting insights into causal associations. To address this, we aim to study individuals with T1D approximately 30 years after onset to assess how early dysglycaemic insults during neurodevelopment influence cognitive and functional outcomes in mid-adulthood.
Methods and analysis
This protocol paper outlines an observational, case/control, cross-sectional/longitudinal and descriptive study that follows up the original Royal Children’s Hospital (RCH) Diabetes Cohort Study. The initial study recruited children in Australia diagnosed with T1D between 1990 and 1992, conducting five waves of data collection. We now introduce the Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications Study to assess brain, cognition and functional outcomes in mid-adulthood, approximately 30 years post-T1D onset. Both T1D participants from the original cohort and healthy controls will participate in semistructured interviews, neuroimaging and cognitive testing. T1D participants will also undergo complications screening. Data from this study and previous waves will be used to (Aim 1) explore cross-sectional and longitudinal impacts of T1D on brain health over 30 years. Linear regression will analyse cross-sectional outcomes, and multivariate analysis will assess cognitive variables jointly. Longitudinal outcomes will be examined using linear mixed-effects regression for IQ patterns, with secondary outcomes analysed via generalised linear models. Additionally, linear mixed-effects regression (Aim 2) will identify T1D-related metabolic factors affecting brain outcomes, with covariate selection informed by the construction of directed acyclic graphs (DAGs).
Ethics and dissemination
The study was approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC 35 240F and 2019.065). The research findings will be disseminated through peer-reviewed publications, conference presentations, and print and social media. Participants will receive a summary of the study findings on its completion.
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
Randomised waitlist-controlled trial of a 10-week community programme using a plant-based diet in a predominantly Maori population in Tairawhiti (Gisborne)
Objectives
Investigate the impact of a 10-week whole-food plant-based (WFPB) community programme on weight and type 2 diabetes up to 36 months postintervention.
Design
Randomised waitlist-controlled trial.
Setting
Community-based General Practice clinic classified as ‘Very Low-Cost Access’ in Gisborne, the main city of the Tairāwhiti region of New Zealand.
Participants
Adults (n=56) aged 30–72 years, with obesity (Body Mass Index (BMI) ≥30) and glycated haemoglobin (HbA1c≥40 mmol/mol) in the last 6 months. Of the participants, 59% identified as Māori and 5% as Pasifika.
Intervention
A 10-week programme consisting of 2 hours, two times per week sessions (40 hours total), involving skills-based learning and health education.
Primary and secondary outcome measures
Primary measures were changes in weight, BMI and HbA1c. Secondary measures included changes in cholesterol, waist circumference, exercise levels, plant-based and non-plant-based dietary scores and association with Big Five Inventory personality traits. The primary endpoint was assessed at post-treatment (10 weeks), with follow-up at 6 and 36 months postintervention.
Results
Differences between the intervention and waitlist control groups at 10 weeks were compared with independent samples t-tests. In intention-to-treat analyses, the intervention group demonstrated significantly greater weight loss of 3.3 kg (95% CI (0.8 to 5.7), p
Microplastiche: il rischio non è solo ambientale
Tumore colon retto – Studio rileva presenza di microplastiche nei tessuti tumorali del colon-retto, aprendo interrogativi su salute umana e rischio oncologico.
Translational Insights Into Pericyte-Mediated Regulation of Cerebral Blood Flow: Implications for Ischemic Stroke
Stroke, Ahead of Print. Microvascular reperfusion stands as a critical therapeutic objective in ischemic stroke management. Pericytes, specialized contractile mural cells enveloping cerebral capillaries, serve as master regulators of capillary tone and regional hemodynamics, exerting a profound influence on post-ischemic stroke blood flow dynamics. Despite their pivotal role in microcirculatory control, there are limited therapeutic targets specifically aimed at regulating their activity. Here, we summarize the multifaceted roles of pericytes in ischemic stroke and discuss various pericyte-related strategies for ischemic stroke. While these interventions offer some benefits, they also present notable limitations, including adverse reactions, structural instability, suboptimal efficacy, and challenges in clinical translation. Future efforts directed toward deciphering the spatiotemporal responses of pericytes across different ischemic phases and achieving their selective and effective regulation are expected to yield novel strategies for precision microcirculatory rehabilitation.
Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study
Introduction
Chronic low back pain (LBP) is among the world’s leading causes of disability and declines in quality of life. Despite considerable financial and research investment, current interventions demonstrate only modest success or are associated with deleterious side effects. Furthermore, most treatment efforts are directed towards LBP that has already become chronic, rather than interventions capable of preventing pain chronicity in the first instance. Transcranial direct current stimulation (tDCS), a portable and cost-effective form of non-invasive brain stimulation, presents a potential means of targeting acute pain and preventing the transition to chronic pain. However, this approach has been limited primarily to experimental settings that require intensive appointments and specialist expertise. Thus, this assessor-blinded, participant-blinded, and therapist-blinded, randomised controlled trial aims to explore the effectiveness of home-based tDCS for improving pain and disability in people with acute LBP. This may provide insight into the potential for tDCS to expedite recovery from acute LBP and prevent pain chronicity.
Methods and analysis
40 individuals with acute LBP (onset
Using qualitative research and the person-based approach to coproduce an inclusive intervention for postpartum blood pressure self-management
Objective
To coproduce an inclusive intervention for blood pressure (BP) self-management post partum.
Design
Using the person-based approach, an intervention was coproduced in three phases. Phase 1 entailed intervention coproduction with a diverse patient and public involvement panel and stakeholders (clinical, academic, government and third sector-based). Phase 2 involved intervention optimisation through think-aloud interviews with former patients and clinicians. Phase 3 was user-testing followed by semistructured interviews with current patients and their clinicians.
Setting
Patients and clinicians from primary and secondary care drawn from Southern and Northern England.
Participants
Seven former patients and 11 clinicians participated in think-aloud interviews to provide their views of intervention prototypes (phase 2). Additionally, 23 patients and 9 of their clinicians participated in semistructured interviews after using the intervention for 2 weeks (phase 3).
Intervention
An interactive patient app—My BP Care—and accompanying leaflet to support BP self-monitoring. These were linked to a clinician dashboard with alerts and an emailing system to facilitate appropriate titration of patient medication.
Results
The intervention was codeveloped following these guiding principles to ensure it was accessible and inclusive: easily comprehensible, motivating, simple and quick to use. Interview findings indicated that patient adherence to the intervention was promoted by the initial patient training conducted by the midwives, the enhanced clinical oversight they felt they received as a result of the intervention, the free BP monitor they received, reassurance they received of the medication safety for them and their baby, the intervention’s simplicity and the motivating reminders they received.
Conclusions
Through coproduction with a diverse group of patients and stakeholders, and optimisation through testing among further diverse patients and clinicians, we developed a multicomponent intervention that is accessible and engaging for diverse patients, compatible with prevailing clinical practice and adaptable to different clinical contexts.
Improvements in Cardiometabolic Risk Factors by Weight Reduction: A Post Hoc Analysis of Adults With Obesity Randomly Assigned to Tirzepatide
Annals of Internal Medicine, Ahead of Print.
Annual cases of colon cancer by age group after Medicaid expansion in the USA in 2014: a difference-in-differences study
Background
Studies examining the association between Medicaid expansion (ME) under the Affordable Care Act (ACA) and colon cancer incidence have produced mixed results.
Objective
To re-visit the association between the ACA-ME and annual cases of colon cancer.
Design
Difference-in-differences (DiD).
Setting
The primary analyses used data from the National Cancer Database from 2010 to 2018, a hospital-based cancer registry in the USA. We also conducted exploratory analyses using data from the Surveillance, Epidemiology and End Results (SEER) registry.
Patients
Patients aged 40 and older with newly diagnosed colon cancer.
Measurements
The primary outcome was the percent change in colon cancer of all stages. Secondary outcomes were percent changes in stage I and stage IV cases.
Results
Among those aged 40–49, we observed a statistically significant greater increase in stage I colon cancer in expansion states relative to non-expansion states (DiD (percent change) 9.7% (95% CI, 2.5% to 17.4%)). In those aged 50–64, we did not observe statistically significant differences between the two state groups in any of the outcomes. Among those aged 65+, we observed a statistically significant relative decrease for all stages in ACA-ME states (–1.0% (95% CI, –1.0% to –3.0%)) and for stage IV (–3.0% (95% CI, –2.0% to –5.0%)). We explored our findings among younger individuals (
Una nuova strategia rende i tumori del colon-retto sensibili all'immunoterapia
Oncologi, ‘è un cambio di paradigma significativo’
Tumori, creato un test che prevede se cancro resisterà a chemio
Consentirà di personalizzare cure sin dal momento della diagnosi