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Integrating Dental Healthcare into Primary Health Care through an implementation model in two districts of Karnataka in India: An implementation research study protocol

Por: Chilgod · L. · Krishna B M · R. · Raveendran · R. · B Hebbar · P.
Introduction

Despite progress in primary care, access to oral health remains limited in India. Integrating oral health into primary care can improve oral health outcomes for communities, especially in rural areas. This study aims to develop an implementation model for integrating dental healthcare into primary healthcare systems in Chamarajanagar and Mysuru districts of Karnataka.

Methods and analysis

A mixed-methods implementation research approach will be adopted for this study, comprising three phases: formative, pilot and implementation and evaluation.

A mixed-methods study at the district level will be conducted to capture diverse perspectives and characterise inequalities in oral healthcare access and literacy levels across urban, rural and tribal areas. Oral health literacy surveys, facility preparedness checklists and in-depth interviews will be conducted. With a consultative approach involving stakeholders, we ensure their input in the design and pilot the integrated interventions to build a replicable model for integrating dental health services into primary healthcare.

Through this structured approach, the study seeks to improve overall oral health outcomes and achieve sustainable improvements in oral health at both community and system levels.

Ethics and dissemination

This study has been approved by the Institutional Ethics Committee at the Institute of Public Health Bengaluru (IPH/23-24/E/374). Findings will be disseminated through workshops, presentations and publications in peer-reviewed journals.

Young adult perspectives on media content related to suicide in South India: a qualitative study

Por: Armstrong · G. · Kumar · S. · Mohanraj · R. · Krishnamoorthy · S. · Vijayakumar · L.
Objectives

The important role of responsible media reporting as a low-cost, effective population-level suicide prevention strategy is well documented. However, research into its potential to generate protective effects and how this is perceived by audiences is underexplored in the Indian context. This qualitative study aimed to explore young adults’ experiences of exposure to current suicide-related and purpose-designed content in the media.

Design

This qualitative study was nested within a larger randomised controlled trial. A semi-structured interview guide was designed to explore participant perspectives and experiences regarding exposure to media content.

Setting

The study was conducted with media professionals in Nepal.

Participants

A purposive sample of 20 young adults (10 males, 10 females) participated in the study. Interviews were audio-recorded and transcribed, and an inductive-deductive approach to thematic analysis was followed.

Results

Participants shared a range of contrasting experiences related to suicide content in the media and their responses to purpose-designed media content. They reported typical characteristics of current media reporting of suicides involving sensationalism, exaggeration and simplistic assumptions and underscored its impact on mental health. The purpose-designed content elicited a sense of surprise among participants. It stimulated curiosity, improved understanding, challenged misconceptions and instilled hope. In contrast to existing media coverage, they viewed protective content as a valuable means of educating people about recovery and encouraging help-seeking.

Conclusions

This study uncovers unique insights into how young adults in the Indian context perceive and experience suicide reporting in the media. Our audience research indicates that current reporting styles may have harmful effects, while a more hopeful, recovery-oriented approach could offer significant benefits. These insights can be used to support meaningful collaborations between stakeholders in our efforts to encourage safe and respectful reporting that meets audiences’ needs to be kept informed.

Trial registration

CTRI/2022/09/045439.

GIS-based land suitability evaluation and multi-criteria decision analysis for sustainable enset (Ensete ventricosum (Welw.) Cheesman) cultivation in Hadiya Zone, Central Ethiopia

by Alemu Ersino Ersado, Venkata Krishna Talluri

Land suitability analysis is a key approach for evaluating the potential of land resources for specific uses and for supporting sustainable agricultural planning. In Ethiopia, where agriculture forms the backbone of rural livelihoods, identifying suitable land for staple crops is essential to ensure food security and long-term productivity. This study evaluated the actual land suitability for enset (Ensete ventricosum) cultivation in the Hadiya Zone, Central Ethiopia, by systematically comparing the spatial distribution of key environmental factors with established enset crop requirement standards. For each parameter, spatial data were overlaid with enset-specific ecological thresholds derived from relevant literature and expert consultation. Based on the FAO land evaluation framework, all factors were classified into five suitability classes: Very Highly Suitable (S1), Highly Suitable (S2), Moderately Suitable (S3), Marginally Suitable (N1), and Permanently Not Suitable (N2), enabling the identification of spatial variability in enset suitability and supporting subsequent multi-criteria evaluation and weighted overlay analysis. The analysis evaluated criteria such as soil properties (type, depth, organic carbon content, pH, and texture), topographic situation (slope and elevation), climate variables (rainfall and temperature), and LULC. The integrated analysis revealed that enset cultivation is highly favorable across most of the study area, with 57.72% classified as highly suitable (S1), 36.89% as moderately suitable (S2), 0.16% as marginally suitable (S3), and 5.23% as currently not suitable (N1), while no areas were identified as permanently unsuitable (N2). Overall, the results highlight the strong natural potential of the Hadiya Zone for enset cultivation, although localized constraints related to soil fertility, water availability, and slope conditions may require targeted management interventions.

Development of a lifelong core outcome set for oesophageal atresia {+/-} tracheoesophageal fistula: the OCELOT study

Por: Thursfield · R. · Gorst · S. · Teunisson · N. · Lansdale · N. · Faulkner · J. · Krishnan · U. · Kovesi · T. · Slater · G. · Cullis · P. · Bray · L. · Donne · A. · Teague · W. · Losty · P. D. · Carr · S. · Gray · V. · Gutierrez-Gammino · L. · Nah · S. A. · Hall · N. J.
Background

Despite anatomical correction, people born with oesophageal atresia±tracheoesophageal fistula (OA-TOF) experience lifelong morbidity. Core outcome sets (COSs) are recognised as a means of improving research quality and, as a consequence, improving patient outcomes; one was not available for this population.

Objective

The scope of the study was to develop a COS for people born with OA-TOF that would be applicable regardless of age or geographic location.

Study design

Patient input was paramount to this study. For long-list generation, in addition to the systematic review (SR), patients and representatives were invited to participate in focus groups, interviews or complete activity packs to ascertain outcomes that matter most to them. International consensus was then sought using a two-step Delphi survey followed by an online consensus meeting.

Results

Eight outcomes were identified through patient events that had not been picked up from SR. 175 people completed the Delphi survey from 26 countries and health care professionals from 13 different disciplines. 24 outcomes met predefined criteria for inclusion and following discussion and voting in the consensus meeting, and 14/24 outcomes were agreed for inclusion in the COS.

Conclusion

14 outcomes have been agreed on to form the COS. 12 of these outcomes are relevant to people of all ages, 1 to paediatric population and 1 to adult cohorts. The COS is, therefore, truly applicable lifelong, which was the scope of the project. This COS will help reduce research heterogeneity, enabling better quality research outcomes and more comparable data.

How threshold customisation affects the performance of a multiclass X-ray AI model for primary care triage: a retrospective study

Por: Sim · J. Z. T. · Lin · J. · Fong · Q. W. · Soon · A. Y. Q. · Khin · L. W. · Balakrishnan · S. · Lin · T. · Wong · S. · Tan · C. H.
Objectives

To describe the structured process of threshold optimisation for a commercially available multiclass chest X-ray (CXR) deep learning model, to evaluate its diagnostic performance across different operating thresholds, and to estimate its potential operational impact within an artificial intelligence (AI)-enabled triage workflow in a primary care setting.

Design

Retrospective diagnostic performance evaluation with threshold-based analysis.

Setting

Primary care radiography services in Singapore, using data derived from two primary care clinics and a tertiary hospital.

Participants

A total of 816 adult frontal chest radiographs were included (multiethnic Asian, 464 males, 352 females; mean age 60.8 years). Images were selected to represent the spectrum of findings often encountered in primary care. Exclusion criteria included paediatric studies, lateral or oblique radiographs, and findings not supported by the AI model (eg, bony abnormalities and medical devices).

Primary and secondary outcome measures

Primary outcome measures were sensitivity, specificity, and negative and positive predictive value (NPV and PPV). Secondary outcomes included estimated potential operational improvement, which is calculated by dividing the number of true negatives by the total number of CXRs.

Results

At the default threshold of 0.15, the AI model achieved a sensitivity of 87.3% (95% CI 83.9% to 90.4%) and an NPV of 87.0% (95% CI 83.6% to 90.2%). Lowering the threshold to 0.10 increased sensitivity to 93.2% (95% CI 90.7% to 95.5%) and NPV to 91.3% (95% CI 88.2% to 94.3%), with specificity of 71.7% (95% CI 67.3% to 76.1%). These trade-offs were considered acceptable for a safety-focused co-triage workflow prioritising minimisation of false negatives.

Conclusions

Threshold optimisation is critical for adapting AI models to context-specific clinical workflows. Our study shows that adjusting the operating threshold enabled prioritisation of sensitivity and NPV, supporting safe AI-assisted triage in primary care. This is a deeply collaborative process that must involve radiology and clinical teams: selecting appropriate thresholds aligned with clinical objectives for safe and effective implementation. Future work will assess real-world operational impact and user acceptance following prospective deployment.

Social determinants of health and risk of lower extremity amputation in patients with peripheral artery disease in Canada: protocol for a systematic review and meta-analysis

Por: Chowdhury · A. · Sheikh · F. · Azab · S. M. · de Souza · R. J. · Banfield · L. · Balakrishnan · N. · Anand · S. S.
Introduction

Peripheral artery disease (PAD) affected approximately 800 000 Canadians aged 25 years or older in 2015 and it poses a substantial risk of lower extremity amputation (LEA). While clinical risk factors for amputation are well-established, the impact of social determinants of health (SDoH) on amputation risk remains unclear, particularly in a Canadian context.

Objectives

This systematic review aims to: (1) synthesise evidence on the associations between multilevel SDoH domains and LEA (both major and/or minor) risk in Canadian PAD patients including intersectional effects of race and ethnicity with another SDoH domain, and (2) evaluate the statistical methodologies used in the researched literature to inform future study design and analysis approaches.

Methods and analysis

We will systematically search MEDLINE, Embase, EmCare, Global Health, Cumulative Index to Nursing and Allied Health Literature and Web of Science for studies examining SDoH and LEA in Canadian patients with PAD (including chronic limb-threatening ischaemia which is a severe form of PAD). Date limits for each database will be from inception through December 2025. SDoH will be categorised using a modified Healthy People 2030 SDoH framework under six domains: economic stability, education, food, neighbourhood and physical environment, healthcare system and community and social context. Two reviewers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third reviewer. Data will be extracted on study characteristics, SDoH measures, outcomes and statistical methods. Risk of bias will be assessed using RoB 2 for randomised trials, ROBINS-I for non-randomised studies of interventions and ROBINS-E for studies investigating exposures. A narrative synthesis, and where data permit, a Bayesian hierarchical meta-analysis using both effect size and contingency table approaches will be conducted. Statistical heterogeneity will be explored through subgroup analyses and meta-regression, examining study design, SDoH measurement approaches and population characteristics.

Ethics and dissemination

As a systematic review and meta-analysis, ethics approval is not required. For institutional oversight, we provide the contact of Dr Sonia Anand (Associate Vice-President, Global Health, McMaster University; anands@mcmaster.ca). Results will be reported following PRISMA guidelines and disseminated through a peer-reviewed publication.

PROSPERO registration number

CRD420251115759.

Genetic ablation of interleukin-17A augments fibrosis in a mouse model of cholestatic liver injury

by Takashi Kitagataya, Anuradha Krishnan, Kirsta E. Olson, Florencia Gutierrez, Michelle Baez-Faria, Maria Eugenia Guicciardi, Kevin D. Pavelko, Adiba I. Azad, Gregory J. Gores

Aim

The underlying mechanisms contributing to cholestatic liver injury remain unclear. The pro-inflammatory leukocyte-restricted cytokine interleukin-17A (IL-17A) has been implicated in human cholestatic liver injury. However, mechanistic insights are lacking and require further exploration in preclinical models. Herein, we examined the effect of IL-17A genetic ablation in a mouse model of cholestatic liver injury.

Method

Age and gender-matched littermate wild type (WT) and Il-17a-/- C57BL/6 mice were fed an intermittent 0.1% 3,5-diethoxycarbonyl-1,4-dihydrocollidine (DDC) diet for 21 days to induce cholestatic liver injury or a control diet.

Results

As compared to WT littermates, Il-17a-/- mice displayed more abundant desmin-positive myofibroblasts and increased fibrosis. NanoString analysis of intrahepatic leukocyte populations using a fibrosis-related gene panel identified upregulation of Tnfsf14 (encoding the protein LIGHT) in the DDC-fed Il-17a-/- mice. Although mass cytometry identified an increase in myeloid cells in both genotypes of the DDC-fed mice, we could not identify LIGHT expression in this cell lineage. Instead, the upregulation of LIGHT expression was largely restricted to a CD4+ T cell population as assessed by flow cytometry. Enhanced LIGHT expression was observed in a Th1+ CD4+ T cell population. LIGHT activated primary human hepatic stellate cells in vitro, suggesting that LIGHT stimulation of hepatic fibrogenesis may be direct.

Conclusion

Taken together, these data suggest that IL-17A restrains expression of the profibrogenic cytokine, LIGHT, by Th1-polarized CD4+ T cells, and implicate a role for LIGHT in cholestatic fibrogenesis in DDC-fed mice; a finding which requires validation in additional models.

Device-assessed sleep health among older patients with heart failure: a cross-sectional study using actigraphy

Por: Krishnan · S. · Taylor · S. · Edwardson · C. L. · Rowlands · A. V. · Squire · I. B. · Sze · S.
Objective

Poor sleep is common among patients with heart failure (HF) and is associated with adverse cardiovascular outcomes. The utility of actigraphy in sleep assessment, especially among older adults, remains underexplored. This study aimed to assess sleep health among older adults with HF using actigraphy and explore associations between sleep parameters and cardiac biomarkers, functional performance and quality of life (QoL).

Design

A cross-sectional study.

Setting

The study was conducted at an outpatient HF clinic within a tertiary cardiology service in a National Health Service hospital in the UK between March and October 2023.

Participants

A total of 150 older adults aged ≥65 years with a diagnosis of HF were enrolled.

Methods

Participants were given a wrist-accelerometer to wear for 7 days. On Day 0, patients completed a 4-metre walk test (4MWT), handgrip strength test (HGST), Timed Up and Go test (TUGT), Barthel Index (BI), Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and frailty assessment (Clinical Frailty Scale, CFS). Subsequently, they were fitted with an accelerometer, with the device configured to start recording the following day (Day 1). Sleep outcomes were calculated after a 7-day wear period and averaged across valid nights (minimum 3 nights of recording, noon-to-noon with ≥16 hours wear-time). Sleep parameters studied include average sleep efficiency, sleep period time window, sleep duration, sleep onset and wake up time, wake after sleep onset (WASO), sleep interruptions and Sleep Regularity Index (SRI). Inefficient sleep was defined as sleep efficiency

Outcome measures

The primary outcome measure was sleep efficiency; all other sleep parameters were classified as secondary or exploratory outcomes.

Results

Accelerometry data from 145 participants were analysed; 42% had inefficient sleep based on average sleep efficiency across valid nights. These patients had significantly higher plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (p=0.044). No statistically significant difference was noted in 4MWT, HGST, TUGT, BI, KCCQ-12 and CFS between patients with sleep efficiency

Conclusions

Older adults with HF who had inefficient sleep had significantly higher NT-proBNP levels. Lower sleep efficiency was associated with higher functional dependence and frailty. Sleep irregularity was linked to HF symptom load, frailty, functional performance and QoL, while sleep fragmentation was associated with impaired gait speed.

Understanding the acceptance of medical marijuana among Malaysian adults: a cross-sectional online survey

Por: Rahman · A. B. · Naserrudin · N. A. · Seman · Z. · Zin · Z. M. · Dapari · R. · Hassan · M. R. · Rashid · A. A. · Dahaban · M. U. M. · Jahaya · N. H. · Balamurugan · H. · Krishnan · M.
Background

Global discussions surrounding the medical use of marijuana have gained momentum; yet in Malaysia, cannabis remains strictly prohibited under the Dangerous Drugs Act 1952. Despite its legal status, there is growing public discourse on its potential therapeutic benefits. Understanding public acceptance is critical for informing future health policies and public education efforts.

Methods

This study used a cross-sectional design, web-based survey among Malaysians aged 18 years and above using convenience and snowball sampling methods. The survey collected data on sociodemographic characteristics, lifestyle factors (eg, smoking and drug use), awareness of medical marijuana and perceived risk. Multivariable logistic regression analysis was performed to identify factors associated with acceptance of medical marijuana decriminalisation.

Results

Out of 2047 respondents, 88.4% supported medical marijuana decriminalisation based on clinical evidence. Key predictors of acceptance included male gender (adjusted OR (AOR) 1.71; 95% CI 1.29 to 2.26), higher education (Bachelor’s degree AOR 1.56; 95% CI 1.09 to 2.23 and Master’s/PhD AOR 2.04; 95% CI 1.34 to 3.10), self-employment (AOR 1.84; 95% CI 1.22 to 2.77) and private sector employment (AOR 1.40; 95% CI 1.03 to 1.89). Behavioural factors, such as smoking (AOR 1.58; 95% CI 1.10 to 2.27), prior drug use (AOR 1.86; 95% CI 1.30 to 2.67) and low perceived risk (AOR 5.82; 95% CI 3.48 to 9.73), were also significantly associated with acceptance.

Conclusions

A large proportion of Malaysian adults supported the clinical use of medical marijuana. Acceptance was strongly associated with demographic and behavioural factors, particularly gender, education and perceived risk. These findings may guide the development of targeted public health education and inform future discussions on regulatory approaches in Malaysia.

The journey to healing: exploring travel challenges and associated costs for cancer care at a tertiary care centre in Puducherry, Southern India - a mixed methods study

Por: Devaraj · L. · Ayiraveetil · R. · Arikrishnan · K. · Sahu · S. K. · Ganesan · P. · Karunanithi · G. · Auroprem · S. P. · Srinivasan · T. S. · Thulasingam · M.
Objectives

This study aims to assess travel time, associated costs, challenges and factors influencing healthcare facility choices among persons with cancer in Southern India.

Design

An explanatory sequential mixed methods study.

Setting

The study was conducted in the cancer care outpatient department at a tertiary care centre in Puducherry, Southern India.

Participants

A total of 192 persons with cancer aged 18 to 65 years, diagnosed with breast, lip and oral cavity, cervical, lung or upper gastrointestinal cancers, and attending the cancer care centre between 2023 and 2024, were enrolled in the study through systematic random sampling. Additionally, 10 in-depth interviews were conducted using purposive sampling.

Results

Of the 192 participants, 89 (46.4%) belonged to a lower socioeconomic group, and 178 (92.7%) reported experiencing financial hardship while undergoing cancer treatment. The median travel time to a tertiary care centre was 4.3 hours (IQR: 2.07–7.3), with a median direct non-medical cost of Indian Rupees (INR) 453 (IQR: 200–987). Median expenditures for travel, food and accommodation were INR 200 (IQR: 123–400), INR 360 (IQR: 150–613) and INR 30 (IQR: 20–60), respectively, per single visit. A significant proportion of participants (n=146, 76%) were unaware of nearby cancer treatment centres and relied on peer recommendations when choosing their place of treatment. Key challenges identified included long-distance travel, financial burden due to high food and transportation costs and limited affordability for accommodation.

Conclusion

The study highlights that prolonged travel time and associated costs pose substantial financial strain on cancer-affected families. Enhancing awareness of available healthcare facilities, implementing patient-friendly travel and accommodation support systems and decentralising cancer care services can improve accessibility and mitigate both travel and financial burdens.

Interventions Addressing Compassion Fatigue Among Nurses: A Scoping Review

ABSTRACT

Aim

To identify and synthesise intervention programs designed to address compassion fatigue among nurses, with a focus on their types and core characteristics.

Design

A scoping review.

Methods

This review was conducted according to the scoping review guidelines proposed by Arksey and O'Malley and met the requirements of PRISMA-ScR guidelines.

Data Sources

Literature published between January 2015 and March 2025 was thoroughly searched in Scopus, PubMed, Cochrane Library, APA PsycNet, Science Direct, and ProQuest. Major search terms included ‘compassion fatigue’, ‘secondary traumatic stress’, ‘burnout’, ‘nurses’ and ‘intervention’.

Results

Fourteen studies met the inclusion criteria. Interventions were categorised as: (1) Enhancement of Organisation and Social Support, (2) Development of Individual Psychological Capacities, (3) Systemic-level Interventions, these results align with the framework of the job demands resources theory.

Conclusion

This review highlights diversity in the focus. While some emphasised on strengthening the job resources and building the personal individual-based resources, few others focused on system level interventions to address compassion fatigue in nurses. The findings also emphasise the importance and need for customised and accessible support strategies at both individual and organisational levels. Nurse well-being and resilience interventions promote balanced job settings and quality health care support.

Implications for the Profession and/or Patient Care

This review provides a foundation for designing comprehensive, empirically supported strategies to address compassion fatigue in nursing. Future research should focus on integrating individual and systemic support to build a healthy work environment.

Impact

This review helps to understand the core characteristics and types of existing interventions addressing compassion fatigue among nurses, and highlights the need to focus on both individual as well as organisational needs and outcomes, thereby enhancing the well-being of nurses and creating healthy work environments.

Reporting Method

PRISMA-ScR was used in this scoping review.

Patient or Public Contribution

No patient or public contribution.

Predicting burnout, anxiety and depression among Canadian healthcare professionals during the COVID-19 pandemic: a cross-sectional secondary analysis study

Por: Balakrishnar · K. · Long · B.-Z. S. · Premji · R. · Choi · C. · Sathananthan · A. · Choppella · M. · Mazur · M. · Nowrouzi-Kia · B.
Objectives

This study aimed to identify the predictors of burnout, anxiety and depression among healthcare professionals during the COVID-19 pandemic.

Design

A secondary quantitative analysis of data from the Mental Health Research Canada (MHRC).

Setting

Healthcare professionals across Canada during the COVID-19 pandemic.

Participants

1439 Canadian healthcare professionals.

Measures

Data from MHRC, collected between April 2020 and January 2024, including sociodemographic factors and measures of burnout, anxiety and depression.

Results

In total, 1439 participants were included in the analysis. Women (OR: 2.25; 95% CI 1.46 to 3.48), younger workers (OR: 2.29; 95% CI 1.29 to 4.06) and mental health professionals (OR: 2.59; 95% CI 1.11 to 6.01) were more likely to experience burnout. Meanwhile, men (OR: 2.05; 95% CI 1.40 to 3.00), younger workers (OR: 8.58; 95% CI 4.12 to 17.86) and physicians (OR: 2.01; 95% CI 1.16 to 3.46) had an increased likelihood of being diagnosed with anxiety. Similar findings were obtained for depression, where men (OR: 1.74; 95% CI 1.18 to 2.56), young workers (OR: 5.22; 95% CI 2.68 to 10.18), physicians (OR: 2.11; 95% CI 1.22 to 3.64), visible minorities (OR: 2.29; 95% CI 1.55 to 3.38) and those with a physical impairment (OR: 4.79; 95% CI 2.55 to 8.97) were more likely to receive a diagnosis since the COVID-19 pandemic.

Conclusions

These findings underscore the need for targeted clinical interventions among healthcare professionals during and beyond public health emergencies. Specifically, healthcare institutions should implement accessible mental health programmes, regular psychological assessments and workload management strategies for those who face increased vulnerabilities to mental health struggles.

Is metformin therapy in conjunction with lifestyle modifications more effective than lifestyle modifications alone in lowering the risk of gestational diabetes mellitus in pregnant women with metabolic dysfunction-associated steatotic liver disease (MASLD

Por: Jayaseelan · V. · Subbaiah · M. · Arikrishnan · K. · Govindarajalu · R. · Pulavarthi · S. · Nanda · N. · Nasreen Vadakkepeediyakkal · K. · Mohan · P. · Murugesan Sivagurunathan · G. · Musthafa · M. K. · Duraiswamy · M. · Pulikkot Suragi · S.
Background

Metabolic dysfunction-associated steatotic liver disease (MASLD) and gestational diabetes mellitus (GDM) are prevalent metabolic disorders in pregnancy, posing significant risks to maternal and fetal health. This study evaluates the effectiveness of metformin, in combination with lifestyle modifications, compared with lifestyle modifications alone, in reducing the incidence of diabetes, pro-inflammatory liver markers, adverse maternal and neonatal outcomes and total gestational weight gain in pregnant women diagnosed with MASLD in the first trimester.

Methods

This parallel-arm, randomised controlled trial will recruit pregnant women (≤14 weeks of gestation) with confirmed MASLD from antenatal clinics of tertiary care public hospitals in Puducherry, India. Participants will be consecutively enrolled until a sample size of 296 is reached. Block randomisation will ensure balanced group allocation, with allocation concealment maintained using sequentially numbered opaque sealed envelopes. The intervention group will receive oral metformin (500 mg two times per day) alongside structured lifestyle modification counselling, while the control group will receive lifestyle modification counselling alone. Primary outcomes include GDM incidence, changes in pro-inflammatory markers, MASLD grading (assessed via liver function tests and ultrasound) and adverse maternal outcomes such as hypertensive disorders, polyhydramnios, genitourinary infections, caesarean delivery and postpartum haemorrhage. Neonatal outcomes assessed include macrosomia, stillbirth, intrauterine death, birth injury, shoulder dystocia, respiratory distress and neonatal hypoglycaemia. The secondary outcome is total gestational weight gain. Participants will be followed at 24–28 weeks, 34–36 weeks and post partum (within 6 weeks of delivery). Data collection will be conducted using a pretested structured questionnaire, with data entry and management performed using REDCap software. Statistical analysis will be conducted using STATA V.4, applying both intention-to-treat and per-protocol analyses. Effect sizes will be reported as proportions and relative risks with 95% CIs, ensuring robust statistical inference.

Conclusions

This study provides a rigorous framework to assess metformin’s role in managing MASLD and preventing GDM, thereby promoting favourable maternal and neonatal outcomes. Findings will contribute to improved clinical management, public health strategies and policy recommendations.

Ethics and dissemination

The study was approved by the JIPMER Institutional Ethics Committee (JIP/AEC/2023/01/011), and the findings will be disseminated through peer-reviewed journals and academic conferences.

Trial registration number

CTRI/2023/12/060930.

Protocol for a cervical screening implementation trial comparing two approaches for delivering HPV self-collection in low-resource settings in India: a type 3 hybrid cluster randomised controlled trial (SHE-CAN)

Por: Oommen · A. M. · Ashfaq · M. · Tonsing · M. V. · Cherian · A. G. · Singarayar · P. · Viswanathan · V. · Muniswamy · V. · Hawkes · D. · Abraham · P. · Pricilla · R. A. · Manoharan · R. · Zomawia · E. · Oldenburg · B. · Saville · M. · Krishnaraj · K. · T S · S. · Basu · P. · Brotherton · J.
Background

Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

Methods

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

Analysis

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics and dissemination

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

Trial registration number

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

Effectiveness of fresh frozen plasma in the resolution of coagulopathy in human patients following hemotoxic snakebites: a systematic review and meta-analysis

Por: Ganessane · E. · Mohammed Muthanikkatt · A. · Manu Ayyan · S. · Abraham · S. V. · Krishnamoorthy · Y.
Objective

To assess the effectiveness of fresh frozen plasma (FFP) as an adjunctive treatment to anti-snake venom (ASV) for resolving venom-induced consumption coagulopathy (VICC) in patients with hemotoxic snakebites.

Design

Systematic review and meta-analysis, reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Data sources

MEDLINE, ScienceDirect, Embase, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Europe PubMed Central, Directory of Open Access Journals, Google Scholar, ClinicalTrials.gov and WHO ICTRP were searched from inception to 30 July 2025 using multiple terms, including ‘fresh frozen plasma’, ‘plasma transfusion’, ‘hemotoxic snakebite’, ‘vasculotoxic snakebite’, ‘coagulopathy in snake bite’ and ‘venom-induced consumption coagulopathy’.

Eligibility criteria

We included randomised controlled trials and observational studies in the English language comparing antivenom alone with antivenom with FFP in patients with hemotoxic snakebite-induced coagulopathy. Studies must have reported coagulopathy resolution as measured by international normalised ratio (INR) normalisation or 20 min whole blood clotting test (WBCT) correction. Non-English publications, case reports, case series, reviews, conference abstracts, preclinical studies and studies lacking full-text availability or without quantitative INR or WBCT outcome data were excluded.

Data extraction and synthesis

Two independent reviewers extracted data using standardised extraction forms and assessed risk of bias using the Cochrane Risk of Bias 2 tool for randomised controlled trials and the Newcastle–Ottawa scale for observational studies. Data were pooled using random-effects meta-analysis and expressed as ORs with 95% CIs. Statistical heterogeneity was assessed using I² statistics, and the certainty of evidence was evaluated using the Grades of Recommendation, Assessment, Development and Evaluation approach.

Results

Four studies involving 370 patients were included (two randomised controlled trials and two prospective observational studies). The pooled analysis demonstrated that adjunctive FFP significantly increased the likelihood of coagulopathy resolution compared with antivenom alone (OR=7.71, 95% CI 2.20 to 27.04, p=0.001). No evidence of a significant difference in mortality was observed between groups (OR=4.96, 95% CI 0.55 to 44.60, p=0.15). High heterogeneity was noted among the four studies (I² = 67%), but a subgroup analysis of three studies, which used INR as the outcome assessment method, showed lower heterogeneity (I² = 25%). Adverse events were inconsistently reported across studies.

Conclusions

FFP as an adjunct to antivenom significantly improves coagulopathy resolution in patients with hemotoxic snakebite-induced coagulopathy. However, the certainty of evidence is very low because of methodological limitations, small sample sizes and significant heterogeneity. Although FFP shows promise for rapid coagulopathy correction, mortality benefits are not established, and it should not replace timely antivenom administration or comprehensive supportive care.

Study registration

PROSPERO, CRD42023483336.

Single catheter strategy for transradial angiography and primary percutaneous coronary intervention enhances procedural efficiency, microvascular outcomes, and cost-effectiveness: Implications for STEMI healthcare in resource-limited settings

by Mohajit Arneja, Swetharajan Gunasekar, Dharaneswari Hari Narayanan, Joshma Joseph, Harilalith Kovvuri, Sharath Shanmugam, Pavitraa Saravana Kumar, Asuwin Anandaram, Vinod Kumar Balakrishnan, Jayanty Venkata Balasubramaniyan, Sadhanandham Shanmugasundaram, Sankaran Ramesh, Nagendra Boopathy Senguttuvan

Background

Faster time to reperfusion can be achieved by minimizing various patient and system-level delays that contribute to total ischemic time. Procedural delays within the catheterization laboratory represent a non-negligible and modifiable component in the chain of reperfusion, but remain unquantified by conventional metrics such as door-to-ballon (D2B) time. Universal catheter approaches have rapidly gained traction as an alternative to the traditional two catheter approach for transradial coronary interventions. However, their utility for both diagnostic angiography and subsequent angioplasty is limited, and the impact of this strategy on reperfusion outcomes has remained unexplored. We utilized a procedural metric termed fluoroscopy-to-device (FluTD) time to quantify the efficiency of a single catheter strategy, and assessed its impact on epicardial and myocardial perfusion.

Methods and results

In this retrospective study, consecutive STEMI patients undergoing transradial primary PCI (pPCI) at a tertiary care center in India between May 2022 to October 2024 were analyzed. Patients were divided into two groups: 51 underwent PCI using a single universal guiding catheter (UGC), and 51 underwent the conventional two-catheter (CTC) approach. The primary outcome of the study was a comparison of the FluTD time between the two procedural strategies. Secondary outcomes included myocardial blush grade (MBG), Thrombolysis in Myocardial Infarction (TIMI) flow grade, total fluoroscopy time, radiation dose, device safety and efficacy, and procedural success.The median FluTD time was significantly shorter in the UGC compared to the CTC group (3 minutes [IQR 3–4] vs. 10 minutes [IQR 8–17], p  Conclusion

A single catheter strategy for both angiography and pPCI in STEMI patients was associated with a significant reduction in FluTD time and improved microvascular perfusion, without compromising device safety or efficacy. In low- and middle-income countries (LMICs), where intra- and extra-procedural delays are often more pronounced, inclusion of the single catheter strategy can optimize catheterization workflows and yield substantial cost-savings.

Artificial intelligence tools for the assessment and management of dysphagia: protocol for a scoping review

Por: Sreedevi · E. V. · Iyer K · S. · Thankappan · K. · Janakiram · C. · Karuveettil · V. · Krishnan · R. · Guntha · R. · Roe · J. · Menon · J. R.
Introduction

Dysphagia, or difficulty in swallowing, significantly impacts the quality of life of the affected individuals. Diagnostic approaches, including video fluoroscopic swallowing studies and flexible endoscopic evaluation of swallowing, are the most commonly used methods for assessing swallowing function. Recent advancements have led to the development of artificial intelligence (AI), including machine learning (ML) and deep learning (DL), which will provide innovative approaches to dysphagia diagnosis and treatment planning. There is a limited synthesis of literature on AI tools in dysphagia. There is an urgent need for a more rigorous and structured scoping review that can address the existing gaps, provide a more comprehensive evidence synthesis, and establish clearer guidelines for the clinical implementation of AI in assessments and management of dysphagia. This review will include studies focusing on AI tools such as ML, DL and computer vision for assessing and managing dysphagia. The context will be clinical or therapeutic settings, and all language articles will be considered for the review. Studies not involving AI technologies, those without clinical outcomes and ethical approval, and those focusing solely on the paediatric population will be excluded. This scoping review will systematically map and synthesise the existing literature on the use of AI tools for the assessment and management of dysphagia.

Methods and analysis

This scoping review will follow JBI methodology and PRISMA ScR guidelines. Information to be searched from January 2000 to May 2025 will include MEDLINE (via Ovid), Scopus, CINAHL (via EBSCOhost), Cochrane Library, JBI Evidence Synthesis, ProQuest and Google Scholar. The titles, abstracts and full texts will be screened by two independent reviewers. Data extraction will use a study-specific customised form, with descriptive analysis employed to categorise studies by AI tools and outcomes.

Ethics and dissemination

Ethical approval is not mandatory for this scoping review as it does not entail the collection of any individual patient data. Secondary data from publicly accessible research papers will be used. All the data sources will be appropriately cited. The findings will be propagated through peer-reviewed publications and scientific presentations.

Trial registration number

Open Science Framework: DOI 10.17605/OSF.IO/DYCE9.

Implementing timeliness metrics for household contact tracing and TB preventive treatment through TB champions in the public sector, India: an explanatory mixed-methods study

Por: Nair · D. · Thekkur · P. · Thiagesan · R. · Vyas · A. · Paul · S. · Mishra · B. K. · Hota · P. K. · Khogali · M. · Zachariah · R. · Berger · S. D. · Satyanarayana · S. · Kumar · A. M. V. · Bochner · A. F. · Ananthakrishnan · R. · Harries · A. D.
Objectives

A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.

Design

This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).

Setting

The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.

Participants

In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.

Primary outcome measures

The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.

Results

In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.

Conclusions

TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.

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