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Prevalence, risk factors and outcomes of macrosomia in Africa: a systematic review and meta-analysis

Por: Ayoola · S. O. · Adeoye · I. A. · Asowata · O. J. · Adediran · K. · Bello · S.
Objective

Macrosomia is an emerging but neglected obstetric challenge in Africa, associated with potentially life-threatening complications to both the mother and the fetus, including maternal and neonatal morbidity and mortality. This study aimed to determine the pooled prevalence, associated risk factors, and neonatal and maternal outcomes of macrosomia by performing a systematic review and meta-analysis.

Design

We conducted a systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

We conducted a comprehensive search of PubMed, EMBASE and Web of Science to extract data from those that have investigated various aspects of the prevalence, risk factors and outcomes of macrosomia from the earliest records to 26 August 2025. Appropriate search terms were used for each database.

Eligibility criteria for selecting studies

We included observational studies that examined the prevalence, risk factors and outcomes of macrosomia in Africa.

Data extraction and synthesis

Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Joanna Briggs Institute Critical Appraisal tool and the Newcastle-Ottawa Quality Assessment Scale. Meta-analyses were performed using random-effects models to estimate the pooled prevalence of macrosomia. The I2 statistic was used to examine statistical heterogeneity. Egger’s test and Funnel plot were used to evaluate publication bias. Grading of Recommendations Assessment, Development and Evaluation to assess the quality of the meta-analysis.

Results

A total of 29 studies comprising 269 934 mother–infant pairs from 9 African countries were included. The pooled prevalence of macrosomia in Africa was 6.35% (95% CI 5.22% to 7.48%), with substantial heterogeneity (I²=94.9%). Sensitivity analysis excluding one outlier study reporting a prevalence of 35.89% produced a similar pooled estimate (6.02%, 95% CI 4.94% to 7.10%). Significant risk factors for macrosomia included male neonate (OR=1.58, 95% CI 1.05 to 2.11), gestational age ≥40 weeks (OR=1.54, 95% CI 1.11 to 1.97) and history of macrosomia (OR=5.44, 95% CI 1.82 to 9.06). With respect to outcomes, macrosomia was associated with an increased risk of shoulder dystocia (OR=2.07, 95% CI 1.12 to 3.03), and a reduced risk of postpartum haemorrhage (OR=0.86, 95% CI 0.82 to 0.91), while no significant associations were observed for gestational diabetes mellitus, caesarean delivery, neonatal mortality or maternal mortality.

Conclusions

Macrosomia remains a significant public health concern in Africa, with a pooled prevalence of 6.35%. There are multiple risk factors associated with macrosomia in Africa, including the male sex, prolonged gestation and a prior history of macrosomia. Also, macrosomia increases the likelihood of shoulder dystocia and other delivery complications. Preventive strategies and targeted interventions are needed to reduce the burden of macrosomia in Africa. At the same time, enhanced obstetric preparedness for macrosomic deliveries is essential to mitigate the associated adverse perinatal outcomes. However, our study is limited by high heterogeneity and publication and language biases, which should be addressed in future studies.

PROSPERO registration number

CRD42023485419.

Autism outcomes and neurobehavioural markers in young children born to mothers with HIV in Kenya: a protocol for the Alama project

Por: Oyungu · E. · Keehn · B. · McHenry · M. S. · Monahan · P. O. · Joseph · R. M. · Yoon · S.-Y. · Carlucci · J. G. · Saina · C. · Khaitan · A. · Baliddawa · J. · McNally Keehn · R.
Introduction

The over 14 million African children who are HIV-exposed but uninfected (CHEU) are at risk for poor health outcomes, including neurodevelopmental conditions such as autism; however, no study to date has examined autism in CHEU in Africa, where the vast majority of these children live. Scalable diagnostic and neurobehavioural tools, including powerful, low-cost approaches such as eye-tracking, for detection and study of mechanistic neural processes are necessary to advance autism research in these settings. The objective of this study is to examine autism diagnostic outcomes and eye-tracking biomarkers in relation to CHEU while at the same time building capacity for neuro-health research in Kenya.

Methods and analysis

This study will leverage a longitudinally assessed cohort of CHEU and children who are HIV-unexposed and uninfected (CHUU) with well characterised HIV-related and contextual exposures. We will first determine and compare autism diagnostic outcomes between young CHEU and CHUU across a large cohort (n=850) of Kenyan children using research-grade autism assessment tools, and, second, determine whether neurobehavioural eye-tracking markers predict autism outcomes across this cohort.

Ethics and dissemination

Human subjects approvals have been obtained from Moi University Institutional Review and Ethics Committee (IREC; IREC/909/2024; Approval #0004835), Kenya’s National Commission for Science, Technology and Innovation (NACOSTI; Reference #NACOSTI/P/25/415028), the Institutional Review Board of the Indiana University School of Medicine (Protocol #23171), with reliance agreements executed with Purdue University and Boston University. Dissemination of findings will occur through multiple channels within the research and clinical community, including peer-reviewed journal publications and conference abstracts and presentations. As part of capacity building efforts, the research team will also communicate study results to policy makers, the lay public and other health systems involved in the care of young children with disabilities via study-hosted workshops and conferences.

Function‐Focused Care Efficacy in Long‐Term Care: A Concept Analysis Using the Hybrid Model

ABSTRACT

Aim

This study aimed to conceptualise ‘function-focused care efficacy’ for direct care workers in long-term care facilities by identifying the domains and attributes of this concept using a hybrid model.

Design

A hybrid model concept analysis was employed in three stages: theoretical, fieldwork and final analysis.

Methods

Data were collected in South Korea from December 9 to December 20, 2024, through literature reviews and interviews with long-term care professionals and gerontological experts. The study comprised in-depth interviews with five participants from long-term care facilities. Data were analysed utilising content analysis.

Results

The final conceptualisation identified six domains and 13 attributes across three dimensions: plan, action and evaluation. The plan dimension encompassed personalised care (identifying residual function and designing tailored care plans) and collaborative care (communication among staff, multi-team approach and cooperation with family). The action dimension covered daily care (supporting daily activities and integrated care), motivational care (encouraging and praising) and ethical care (positive attitude and respect). The evaluation dimension focused on function evaluation (observing and documenting functional changes).

Conclusion

This study conceptualises function-focused care efficacy as the belief that direct care workers can effectively plan personalised and collaborative care, motivate older adults to maintain independence, provide integrated care in daily activities, deliver ethical care with respect and positive attitudes and assess functional changes. These findings can inform a measurement instrument and training programmes to enhance care workers' efficacy in function-focused care.

Implications for the Profession and/or Patient Care

Enhancing function-focused care efficacy can potentially improve the quality of care provided to older adults, promoting their independence and well-being.

Impact

The study aimed to conceptualise function-focused care efficacy among LTCF direct care workers. It identified six domains and 13 attributes across planning, action and evaluation dimensions. This framework can guide the development of efficacy measurement tools.

Reporting Method

N/A.

Patient or Public Contribution

No patient or public contribution.

Mealtime Support by Direct Care Workers in Long‐Term Care Facilities: Secondary Behavioural Analysis of Videos

ABSTRACT

Aim

This study aimed to address two objectives: (1) To analyse the meal support behaviours of direct care workers in long-term care facilities in South Korea and (2) to explore associations between mealtime support behaviours and caregiver characteristics.

Design

Secondary analysis of behavioural coding of cross-sectional video recordings.

Methods

Positive and negative staff behaviours at mealtimes were coded using the Mealtime Engagement Scale and Cue Utilization and Engagement in Dementia tool, respectively. Statistical analyses, including t-tests and analysis of variance, were used to examine differences in mealtime support behaviours based on caregiver characteristics.

Results

The average mealtime duration of residents was 19.03 ± 5.30 min. Positive meal support behaviours accounted for 91.1% of the observed interactions, whereas negative interactions accounted for 8.9%. The most frequent positive behaviour observed was ‘providing one-on-one assistance’, whereas the most frequent negative behaviour was ‘leaving the resident alone’. Positive meal support behaviours were observed at significant higher frequencies among caregivers working during day shifts than those working during rotating shifts. Additionally, positive behaviours were associated with a higher carer-resident ratio.

Conclusion

Positive mealtime support behaviours were frequently observed but were concentrated in a few specific actions. Negative behaviours, such as leaving the resident alone, were still observed in a considerable portion of mealtime interactions. Training programmes focusing on diverse positive mealtime support behaviours should be developed to improve the quality of dementia care in long-term care facilities.

Implications for the Profession and/or Patient Care

The findings emphasise the need for targeted training programmes to improve mealtime support and overall care quality in long-term care facilities. This approach signals a transformative shift in caregiver training, fostering more personalised and effective care for older adults with dementia.

Impact

This study quantified positive and negative mealtime support behaviours. These findings contribute to understanding caregiver behaviours during mealtimes in dementia care, offering evidence-based insights for developing targeted training programmes and improving quality of care in long-term care facilities.

Reporting Method

We adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines.

Patient or Public Contribution

No patient or public contribution.

American Heart Associations Lifes Simple 7 for cardiovascular health assessment among Iranian adults: a national cross-sectional study from STEPwise approach to non-communicable diseases risk factor surveillance (STEPS) survey 2021

Por: Azadnajafabad · S. · Rezaei · S. · Almasi · G. · Ahmadi · N. · Golestani · A. · Rashidi · M.-M. · Abbasi-Kangevari · M. · Rezaei · N. · Rezaei · N. · Farzi · Y. · Ghasemi · E. · Yoosefi · M. · Haghshenas · R. · Nasserinejad · M. · Kazemi · A. · Abdolhamidi · E. · Saeedi Moghaddam · S.
Objective

To assess cardiovascular health (CVH) metrics using the American Heart Association’s Life’s Simple 7 (LS7) tool as a comprehensive measure of several metabolic and behavioural risk factors for cardiovascular diseases.

Design

Cross-sectional study, nationally representative Iran STEPwise approach to non-communicable diseases risk factor surveillance (STEPS) survey 2021.

Setting

Iran, 2020–2021.

Participants

25 202 adult individuals aged 25 years and older participated in the STEPS survey.

Outcome measures

Using the LS7 framework, seven factors were assessed: current smoking, body mass index (BMI), physical activity level, modified healthy diet score components, total cholesterol, blood pressure and fasting plasma glucose (FPG). Each factor was categorised into three levels of poor, intermediate and ideal, according to the LS7 methodology.

Results

The study participants had a sex distribution of 55.5% females. The findings revealed a high prevalence of ideal levels of smoking (80.1%; 95% CI 79.3 to 81.0), total cholesterol (69.4%; 95% CI 68.5 to 70.4) and FPG (61.0%; 95% CI 60.0 to 62.1). BMI and blood pressure were ideal in about one-third of the population (33.0%; 95% CI 32.1 to 34.0, and 30.5%; 95% CI 29.6 to 31.4, respectively). However, only 13.3% (95% CI 12.6 to 14.0) of participants achieved ideal levels of physical activity, and a mere 0.4% (95% CI 0.3 to 0.6) adhered to an ideal healthy diet. Modest disparities in CVH metrics were observed across provinces and between two sexes. Ideal CVH status was significantly associated with lower risks of major diseases such as ischaemic heart disease, diabetes and chronic kidney disease.

Conclusions

Despite favourable scores in some CVH metrics, critical gaps in diet and physical activity highlight the need for intensive public health efforts to enhance CVH in Iran. The study emphasises the urgency of implementing region- and sex-specific public health policies.

Comparative risk of the neurodegenerative outcomes between sodium-glucose co-transporter 2 (SGLT2) inhibitors and thiazolidinediones in type 2 diabetes: a multicentre cohort study using the Korean healthcare database (2014-2025)

Por: Park · S. J. · Kim · H. J. · Seo · M. · Byun · D. W. · Suh · K. · Yoo · M. H. · Yang · H. · Lee · I. · Kwon · S. H. · Kim · M. · Mok · J.-O. · Kim · D.-Y. · Sohn · S. Y. · Park · R. W. · Seo · W.-W. · Kwon · S. Y. · Rhee · S. Y. · Kwon · J.-M. · Cha · J. M. · Park · H. K.
Objective

Type 2 diabetes mellitus has been associated with an increased risk of cognitive decline and dementia, with patients being 1.5–2 times more likely to develop these conditions. While both sodium-glucose co-transporter 2 (SGLT2) inhibitors and thiazolidinediones (TZDs) have shown potential neuroprotective effects in previous studies, their comparative effectiveness for preventing neurodegenerative outcomes has not been established. This study aimed to compare the risk of stroke, dementia and Alzheimer’s disease (AD) between patients treated with SGLT2 inhibitors and those treated with TZDs.

Design

Multicentre, retrospective, observational, new-user, active-comparator cohort study.

Setting

Electronic health record-based databases from 11 secondary and tertiary institutions in South Korea from 1 January 2014 to 31 July 2025. The study period began in 2014, following the post-marketing surveillance initiation of SGLT2 inhibitors in Korea (November 2013), to ensure adequate drug availability and clinical adoption.

Participants

Patients aged 40 years or older who were newly prescribed either SGLT2 inhibitors or TZDs without prior exposure.

Interventions

Propensity score matching (1:1) was performed using sex as the primary covariate due to data availability constraints in the Observational Medical Outcomes Partnership Common Data Model framework. The HRs with 95% CIs were measured via Cox regression analysis.

Results

The study analysed 24 172 matched pairs for stroke outcomes (40 483 person-years in the SGLT2 inhibitor group and 39 363 person-years in the TZD group), 25 111 matched pairs for dementia (41 924 person-years in the SGLT2 inhibitor group and 40 726 person-years in the TZD group) and 25 237 matched pairs for AD (42 139 person-years in the SGLT2 inhibitor group and 40 895 person-years in the TZD group) across 11 participating hospitals. After a 1:1 propensity score matching, the SGLT2 inhibitors showed no significant difference in stroke risk (HR 1.18, 95% CI 0.62 to 2.23, p=0.62), while having significant reductions in dementia risk (HR 0.66, 95% CI 0.45 to 0.98, p=0.04) and AD risk (HR 0.54, 95% CI 0.35 to 0.83, p=0.005). Moreover, these protective effects for neurodegenerative outcomes were shown to be consistent across multiple hospital sites.

Conclusions

SGLT2 inhibitors are associated with a reduced risk of dementia and AD compared with TZDs in patients aged 40 years or older with type 2 diabetes and have neutral effects on stroke risk. These findings confirm the potential selective neuroprotective benefits of SGLT2 inhibitors for neurodegenerative outcomes, which may inform therapeutic decision-making for diabetic patients at risk of cognitive decline.

Prevalence and risk factors of chronic kidney disease among Iranian adults with and without diabetes: a cross-sectional study using STEPS 2021 national survey

Por: Ataei · S. M.-N. · Almasi · G. · Kazemi · A. · Ahmadi · N. · Golestani · A. · Rashidi · M.-M. · Rezaei · N. · Azadnajafabad · S. · Rezaei · N. · Dilmaghani-Marand · A. · Ghasemi · E. · Farzi · Y. · Yoosefi · M. · Rezaee · K. · Foroutan Mehr · E. · Nasserinejad · M. · Haghshenas · R. · Al
Objectives

Chronic kidney disease (CKD) is a global health concern and a major long-term complication of diabetes, yet its burden remains understudied in regions with limited epidemiological data. This study aimed to evaluate the prevalence of CKD and its associated risk factors in the Iranian adult population, stratified by diabetes status.

Design

Population-based cross-sectional study.

Setting

Nationally representative survey across Iran (STEPS 2021).

Participants

17 607 adults aged ≥25 years with complete kidney function and albuminuria data, selected through systematic sampling with weighting to ensure national representativeness.

Primary and secondary outcome measures

CKD was defined as an estimated glomerular filtration rate (eGFR)

Results

The national prevalence of CKD was 11.9% (95% CI 11.2% to 12.6%), with 9.1% (8.5% to 9.9%) among individuals without diabetes and 28.6% (26.2% to 31.1%) among those with diabetes. According to KDIGO classification, 88.1% (87.4% to 88.8%) were at low risk, 9.0% (8.4% to 9.6%) at moderate risk, 2.0% (1.6% to 2.4%) at high risk and 0.9% (0.7% to 1.1%) at very high risk. Albuminuria was more prevalent than low eGFR in both groups with (22.5% (20.4% to 24.8%) vs 10.3% (8.7% to 12.1%)) and without (5.7% (5.2% to 6.3%) vs 4.3% (3.8% to 4.8%)) diabetes. Diabetes was more strongly linked to albuminuria than low eGFR and was progressively associated with higher risk categories (adjusted ORs (aORs) 2.41 (2.03–2.86) for moderate, 2.63 (1.74–3.97) for high, 3.93 (2.56–6.07) for very high vs low-risk). CKD prevalence was highest in northwest Iran, increased significantly with age, with a stronger association observed for low eGFR than albuminuria, and was associated with hypertension (aOR 2.41 (2.07–2.82)), dyslipidaemia (1.60 (1.31–1.94)), obesity (1.94 (1.59–2.36)), ischaemic heart disease (1.53 (1.25–1.87)) and physical inactivity (1.40 (1.20–1.62)). Higher socioeconomic status and education were associated with lower odds of CKD.

Conclusions

CKD is a major burden, especially in individuals with diabetes, with regional and socioeconomic disparities. Addressing risk factors, integrating CKD into non-communicable disease surveillance and prioritising it in global health agendas, including the Sustainable Development Goals, are essential.

Recurrent COVID-19 infection and the risk of exacerbation, mortality and long covid in patients with chronic obstructive pulmonary disease: a nationwide retrospective cohort study

Por: Lee · H. W. · Choi · K. Y. · Lee · J.-K. · Yoon · W. S. · Kim · Y. · Yoo · K.-H. · Hwang · Y. I.
Objectives

To evaluate how recurrent COVID-19 infections influence the clinical course of patients with chronic obstructive pulmonary disease (COPD), focusing on moderate-to-severe symptom flare-ups, all-cause mortality and long covid.

Design

Nationwide retrospective cohort study.

Setting

Korean Health Insurance Review and Assessment database covering the entire Korean population between January 2020 and December 2023.

Participants

A total of 313 760 patients aged ≥40 years who met an established operational definition of COPD based on diagnostic codes and inhaled therapy prescriptions. Patients were stratified by the number of COVID-19 events: none, one, two or three or more.

Primary and secondary outcome measures

The primary outcomes were moderate-to-severe COPD exacerbations and all-cause mortality. The secondary outcome was long covid, defined by WHO criteria using International Classification of Diseases (ICD)-10 codes persisting ≥2 months within 3 months after infection.

Results

Among 313 760 patients, 154 095 (49.1 %) experienced at least one COVID-19 event. COVID-19 infection was associated with increased risk of exacerbations (adjusted HR (aHR) 1.64, 95% CI 1.62 to 1.66) and mortality (aHR 2.25, 95 % CI 2.19 to 2.31). Risk rose progressively with repeated infections, reaching an aHR of 2.41 for exacerbations and 2.93 for mortality after three or more events. Long covid was more frequent in patients with multiple infections, but most cases occurred after the first event, with diminishing occurrence after subsequent infections.

Conclusion

Recurrent COVID-19 infections in patients with COPD were linked to progressively higher risk of exacerbations and mortality, whereas the burden of long covid was greatest after the first infection. Preventing the initial infection and reducing reinfection risk remain critical components of COPD care in the post-COVID-19 era.

The Role of Advance Care Planning on Community Dwelling Adults' Coping Abilities and Death Attitudes: A Sequential Mixed‐Methods Study

ABSTRACT

Aim

To (1) examine the attitudes of community-dwelling adults towards death and their ability to cope with death, as well as (2) understand the influence of advance care planning on community-dwelling adults' death attitudes and coping with death.

Design

A sequential explanatory mixed-methods study was conducted in Singapore.

Methods

In Phase I, a case–control study was conducted to examine the differences in death attitudes and coping with death ability between community-dwelling adults who have completed advance care planning and those who have not. A univariate general linear model was used to compute the mean difference in death attitudes and coping with death scores. In Phase II, a descriptive qualitative study was conducted to provide an in-depth understanding of the influence of advance care planning among community-dwelling adults. Thematic analysis was used for qualitative analysis. Mixed-methods analysis was conducted to integrate the quantitative and qualitative data.

Results

In Phase I, 80 community-dwelling adults who had completed advance care planning and 81 community-dwelling adults who did not have advance care planning were included. Adults who had completed advance care planning had significantly higher coping with death scores (t = 4.14, p < 0.01). In Phase II, a purposive sample of 24 adults who had completed advance care planning was selected for individual semi-structured interviews. From the thematic analysis, three themes were developed: (1) Advance care planning enables coping with death, (2) overcoming fear of death with advance care planning and (3) confronting death with advance care planning.

Conclusion

Advance care planning may influence death attitudes and coping with death. Further work on longitudinal designs and among individuals from different age groups should be used to gain further in-depth understanding of the impacts of advance care planning.

Implications for the Profession and/or Patient Care

Strategies to enhance one's coping abilities with death and death attitudes should be developed to stimulate the uptake of advance care planning.

Reporting Method

This paper was reported according to the Good Reporting of A Mixed Methods Study framework.

Patient or Public Contribution

Community-dwelling adults participated in the survey and interviews.

Social Determinants of Health and Falls Among Community‐Dwelling Older Adults: A Zero‐Inflated Negative Binomial Regression Analysis

ABSTRACT

Introduction

Falls among older adults represent a major public health challenge, yet research examining the role of social determinants of health (SDOH) in fall risk remains limited. This study aimed to identify factors associated with fall occurrence and fall frequency among community-dwelling older adults in Korea, with particular emphasis on SDOH.

Design

A cross-sectional study design.

Methods

We used a large nationwide sample (n = 9746) from the 2023 National Survey of Older Koreans. The number of falls in the past year served as the dependent variable. Independent variables included a range of socioeconomic and environmental variables as SDOH, alongside biological and behavioral variables. A zero-inflated negative binomial (ZINB) regression analysis was employed to address excess zeros and overdispersion in fall count data.

Results

Among participants, 94.8% experienced no falls, 3.2% reported a single fall, and 1.9% reported recurrent falls. In the logit model for fall occurrence, higher household income level, absence of age-friendly housing, higher access to parks, and lower access to welfare centers were associated with higher risk of fall occurrence. In the count model for fall frequency, higher education level, presence of age-friendly housing, and outdoor mobility barriers were associated with higher fall frequency within the at-risk group.

Conclusions

The findings provide empirical evidence on the critical roles of SDOH in falls among community-dwelling older adults. Specifically, a ZINB regression analysis identified distinct sets of SDOH associated with fall occurrence versus fall frequency, highlighting the complex and multifaceted nature of fall patterns among older adults.

Clinical Relevance

Healthcare providers and policymakers seeking to reduce falls should implement tailored, SDOH-integrated strategies by addressing the different mechanisms underlying fall occurrence and fall frequency.

K-LARS trial: protocol for a multicentre randomised controlled trial evaluating a knowledge-enhanced digital intervention to prevent low anterior resection syndrome in Korea

Por: Ryoo · S.-B. · Ahn · H.-M. · Nam · B.-H. · Song · Y. M. · Sohn · D. K.
Introduction

Low anterior resection syndrome (LARS) is a common functional complication after sphincter-preserving surgery for rectal cancer that significantly impairs the quality of life. Current postoperative management strategies are suboptimal, and effective preventive approaches are lacking. This study aims to evaluate the impact of a mobile-based, knowledge-enhanced digital intervention for reducing the incidence of major LARS.

Setting

This is a multicentre, open-label, parallel-group, randomised controlled trial to be conducted across three academic medical centres in Korea.

Methods and analysis

A total of 300 adult patients who underwent low anterior resection or stoma reversal after rectal cancer surgery will be randomly assigned in a 1:1 ratio to the intervention group (mobile digital programme) or the control group (standard educational materials). The digital programme includes daily symptom monitoring, exercise suggestions, dietary recommendations and structured feedback from healthcare providers during clinical visits based on outcomes. The primary outcome is the incidence of major LARS (score ≥30) at 12 months postoperatively. Secondary outcomes include longitudinal changes in LARS score, quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), EORTC QLQ-Colorectal Cancer 29 (CR29)), European Quality of Life 5 Dimensions Level Version (EQ-5D-5L), patient satisfaction and programme adherence. Statistical analyses will include stratified chi-squared tests and mixed-effects models based on the intention-to-treat principle.

Ethics and dissemination

The trial received ethical approval from the Institutional Review Board of the National Cancer Centre, Korea. Written informed consent will be obtained from all participants. The findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT07041515.

Tiny Bites, a digital health intervention delivered in early childhood education and care centres to support educators and caregivers to prevent childhood obesity: study protocol for a cluster randomised controlled trial

Por: Yoong · S. L. · Lum · M. · Leung · G. K. W. · Pearson · N. · Truby · H. · Dix · C. · Moumin · N. A. · Wolfenden · L. · Ananthapavan · J. · Grady · A. · Wiggers · J. · Delaney · T. · Rychetnik · L. · Romiti · M. · Lamont · H. · Stanley · S. · Lim · M. · Oldmeadow · C. · Mastersson · N. · Suth
Introduction

Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.

Aim

To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.

Methods and analysis

This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.

Ethics and dissemination

Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.

Trial registration number

ACTRN12624000576527.

Molecular characterization of <i>Rhipicephalus microplus</i> and <i>Haemaphysalis bispinosa</i> ticks from cattle across Thailand: Regional identification and evidence of different genetic sub-structures between mainland and penins

by Danai Sangthong, Pradit Sangthong, Warin Rangubpit, Prapasiri Pongprayoon, Eukote Suwan, Kannika Wongpanit, Wissanuwat Chimnoi, Pacharathon Simking, Sinsamut Sae Ngow, Serge Morand, Roger W. Stich, Sathaporn Jittapalapong

Phylogenetic and population genetic analyses were conducted on tick specimens collected from cattle in northern, northeastern, central, and southern regions of Thailand. Morphological identification indicated these ticks consisted of three species, Rhipicephalus microplus from all four regions, R. sanguineus from the northern and northeastern regions, and a Haemaphysalis species only collected from the northeastern region. Analysis of cytochrome c oxidase subunit I gene (COI) sequences identified R. microplus clades A and C, while clade B was not detected in this study. The same analysis indicated specimens morphologically identified as Haemaphysalis were H. bispinosa, confirming previous reports of their prevalence in northeastern Thailand. H. bispinosa showed low haplotype and nucleotide diversity, suggesting either a bottleneck or founder effect. Both R. microplus clades displayed high haplotype diversity and low nucleotide diversity, a pattern associated with population expansion. Genetic structural analysis revealed significant genetic differences in R. microplus clade A, especially between mainland (northern, northeastern, and central regions) and peninsular (southern region) populations, which indicated limited gene flow between these areas while suggesting movement of these ticks across the mainland. The sequence analyses described in this report enhance understanding of the natural history of ticks in Thailand and are expected to guide and strengthen tick control strategies across Southeast Asia.

Prognostic role of effective radiation dose to immune cells in esophageal cancer treated with definitive chemoradiation

by Yoo Kyung Choi, Seok Hyun Son, Hong Seok Jang, In-Ho Kim, Sea-Won Lee, Soo-Yoon Sung

Background

Radiotherapy for locally advanced esophageal cancer can induce lymphopenia, potentially worsening outcomes. This study examines the association between clinical outcomes and the effective dose to the immune cells (EDIC), a measure of lymphocyte radiation exposure.

Methods

We retrospectively analyzed 107 patients with locally advanced esophageal squamous cell carcinoma treated with definitive concurrent chemoradiotherapy (CCRT). The EDIC was calculated based on the mean lung dose, mean heart dose, and integral total body dose using established models. Patients were stratified into high (n = 42) and low (n = 65) effective dose to the immune cells (EDIC) groups using a cut-off value of 4.28 Gy. Survival outcomes, including overall survival (OS), progression-free survival (PFS), locoregional failure-free survival (LRFS), and distant metastasis-free survival (DMFS), were assessed.

Results

The 5-year OS and PFS rates were significantly lower in the high EDIC group than in the low EDIC group (51.9% vs. 66.6%, p = 0.043; 20.8% vs. 31.8%, p = 0.002, respectively). Multivariate analysis identified high EDIC as an independent predictor of poorer OS (hazard ratio (HR): 2.06, 95% confidence interval (CI): 1.1–3.86, p = 0.024) and PFS (HR: 1.7, 95% CI: 1.04–2.78, p = 0.034). Similarly, the 5-year LRFS and DMFS rates were significantly lower in the high EDIC group than in the low EDIC group (24.1% vs. 34.9%, p = 0.003; 29.0% vs. 44.0%, p = 0.018, respectively).

Conclusion

A higher EDIC is an independent predictor of poor survival in patients with esophageal squamous cell carcinoma undergoing CCRT. Reducing radiation exposure to the immune system through optimized radiation planning and lymphocyte-sparing techniques may improve patient outcomes.

Repeated application of transcranial ultrasound maintains spatial and recognition memory in 5xFAD mice with reduction of amyloid-β burden

by Seung-Schik Yoo, Anvita Reddy, William Carroll, Kanyapat Ploypradith

Pharmacological removal of amyloid beta protofibrils has emerged as a promising therapeutic strategy to delay the onset of Alzheimer’s disease (AD) symptoms. As a non-pharmacological and noninvasive alternative, transcranial application of low-intensity ultrasound through intact skull can induce convective acoustic streaming, which has been shown to enhance cerebrospinal fluid solute transport and facilitate the clearance of interstitial solutes. This has led to the development of device-based approaches aimed at removing the precursors of amyloid beta (Aβ) plaques and mitigating cognitive decline in AD. We applied non-thermal, non-cavitational ultrasound (400 kHz frequency) in a pulsed mode (75 ms pulse duration, 2 Hz repetition rate) to the hippocampal region of male 5xFAD mice for 30 minutes weekly, starting at 10 weeks of age and continuing for 15 weeks (until 6 months of age). Spatial and recognition memory performance was assessed monthly using the Y-maze spontaneous alternation (SA) and novel object recognition (NOR) tests. A control group of age-matched mice underwent the same procedures with receiving zero acoustic output. Mice subjected to transcranial ultrasound (tUS) treatment maintained both SA and NOR performance throughout the entire experimental period, whereas mice that received sham tUS exhibited a progressive decline in memory beginning at 3–4 months of age. Congo Red staining of the brain sections revealed a significant (> 40%) reduction in Aβ plaques in the sonicated group. Histological analysis confirmed that repeated ultrasound exposure did not cause any detectable tissue damage. These findings suggest that low intensity tUS may serve as a novel, noninvasive therapeutic strategy to delay the onset of AD symptoms through the reduction of Aβ burden.

Bridging the representation gap in the surgical workforce: a scoping review protocol of programmes and interventions to support surgical careers for underrepresented minority learners

Por: Qureshi · A. R. · Halabian · N. · Malhotra · A. K. · Majeed · M. · Bhatt · V. · Anifowose · A. · Alam · A. · Nguyen · D.-D. · Yibrehu · B. · Ayoo · K. · Bondzi-Simpson · A. · Brar · S. · UpSurge Research Group · Covelli
Introduction

Despite increasing proportions of underrepresented minority (URM) medical school graduates, their progression into surgical training and leadership remains disproportionately low. Barriers such as financial constraints, limited mentorship and implicit bias contribute to this disparity, creating a disconnect between the diversity of patient populations and those providing care. While interventions such as mentorship programmes and pipeline initiatives have been implemented, their overall effectiveness has not been systematically evaluated. The primary aim of this scoping review is to map the current landscape of interventions, programmes and policies designed to enhance access to surgical careers for URM learners.

Methods and analysis

Searches will be conducted on EMBASE, Web of Science and OVID MEDLINE. Three independent reviewers will screen references, extract data and perform analyses with disagreements adjudicated by a fourth reviewer. This review will include studies conducted across all levels of training: secondary (high school or secondary school), postsecondary (undergraduate, medical school) and postgraduate (residency, fellowship), with no geographical restrictions. The definition of URM will be accepted as reported within each individual study, allowing for variability in racial, ethnic, gender, socioeconomic or other criteria. The review will include any structured interventions, programmes or policies aimed at increasing URM representation in surgical education. Data on the nature, duration and target population of each intervention will be extracted. The primary outcome will be the reported impact of interventions on URM representation or participation in surgical education. Secondary outcomes will include characteristics of the study participants, definitions of URM status and any qualitative or quantitative evaluations of intervention effectiveness.

Ethics and dissemination

Research ethics approval is not required under University of Toronto policy. Study results will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Results will be disseminated to relevant stakeholders at conference presentation(s) and submitted for publication in a peer-reviewed journal.

Protocol for an observational cohort study integrating real-world data and microsimulation to assess imaging surveillance strategies in stage I-IIIA NSCLC patients in OneFlorida+

Por: Braithwaite · D. · Karanth · S. D. · Bian · J. · Meza · R. · Jeon · J. · Tammemagi · M. · Wheeler · M. · Cao · P. · Rackauskas · M. · Shrestha · P. · Yoon · H.-S. · Borondy Kitts · A. · Verma · H. · Blair · M. C. · Chen · A. · Das · D. · Lou · X. · Wu · Y. · Han · S. · Hochhegger · B. · Guo · Y
Introduction

Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.

Methods and analysis

PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.

Ethics and dissemination

This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.

Identifying bio-behavioural signatures of persistent opioid use risk in trauma injury patients: a protocol for a prospective cohort study

Por: Schmitz · J. M. · Yoon · J. H. · Kluwe-Schiavon · B. · Harvin · J. A. · Gunaratne · P. H. · Mouton · D. · Motley · K. · Fox · E. E. · Vincent · J. · Tarbet · M. · Walss-Bass · C.
Introduction

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.

Methods and analysis

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 and dissemination plan

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.

A Mobile App for Comprehensive Symptom Management in People With Parkinson’s Disease: A Pilot Usability Study

imageThere is an increasing need for highly accessible health management platforms for comprehensive symptoms of Parkinson disease. Mobile apps encompassing nonmotor symptoms have been rarely developed since these symptoms are often subjective and difficult to reflect what individuals actually experience. The study developed an app for comprehensive symptom management and evaluated its usability and feasibility. A single-group repeated measurement experimental design was used. Twenty-two participants used the app for 6 weeks. Monitoring of nonmotor symptoms, games to address motor symptoms, and medication management were incorporated in the app. Quantitative outcomes were self-assessed through an online questionnaire, and one-on-one telephone interviews were conducted to understand the user's point of view. The successful experience of self-monitoring had improved participants' self-efficacy (Z = −3.634, P
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