There is limited research exploring the age-related difference in communication when describing pain experiences. This project aimed to identify key differences between adolescents’, young adults’ and adults’ (i) preferred communication method, (ii) language content and (iii) lexical amount and variety when discussing their persistent pain experience using chatbot technology.

An exploratory concurrent nested mixed-methods design using a comparative analysis.

Participants were recruited through a convenience sampling strategy from two tertiary multidisciplinary pain centres in Australia.

20 adolescents, 20 young adults and 20 adults completed a pain history assessment using the Dolores application. The inclusion criteria for this study were (i) persistent non-cancer pain for at least 3 months, (ii) 10 years of age and over and (iii) adequate expressive and receptive language skills to complete the required tasks in English, as determined by clinicians in the treating team.

Drawn, voice and typed responses provided by participants during the chatbot interaction were analysed using content analysis. Fisher’s exact tests and ² tests were used to examine differences between age groups. Strong effect size estimates generated from comparative analyses suggested that adolescents were the most likely age group to utilise drawing (p=0.153, Cramer’s V=0.268), preferred typing over speaking (p==0.007, Cramer’s V=0.433). Young adults used the greatest number and variety of words in response to chatbot questions including evaluative language (p=0.097, Cramer’s V=0.296). Adults tended to use more metaphors (p=0.085, Cramer’s V=0.305) and had a strong preference for speaking over typing (p=

The results of this study provide insights into age-related differences in communication and preferences when using technology to communicate about persistent pain. Future research exploring individualised age-related approaches to pain assessment, supported by the findings of this study, in comparison to current standardised assessments administered by clinicians are warranted.

Global migration has steadily risen, with 16% of the UK population born abroad. Migrants (defined here as foreign-born individuals) face unique health risks, including potential higher rates and delays in diagnosis of infectious and non-communicable diseases, compounded by significant barriers to healthcare. UK Public Health guidelines recommend screening at-risk migrants, but primary care often faces significant challenges in achieving this, exacerbating health disparities. The Health Catch-UP! tool was developed as a novel digital, multidisease screening and catch-up vaccination solution to support primary care to identify at-risk adult migrants and offer individualised care. The tool has been shown to be acceptable and feasible and to increase migrant health screening in previous studies, but to facilitate use in routine care requires the development of an implementation package. This protocol describes the development and optimisation of an implementation package for Health Catch-UP! following the person-based approach (PBA), a participatory intervention development methodology, and evaluates our use of this methodological approach for migrant participants.

Through engagement with both migrants and primary healthcare professionals (approximately 80–100 participants) via participatory workshops, focus groups and think-aloud interviews, the study aims to cocreate a comprehensive Health Catch-UP! implementation package. This package will encompass healthcare professional support materials, patient resources and potential Health Catch-UP! care pathways (delivery models), developed through iterative refinement based on user feedback and behavioural theory. The study will involve three linked phases (1) planning: formation of an academic–community coalition and cocreation of guiding principles, logic model and intervention planning table, (2) intervention development: focus groups and participatory workshops to coproduce prototype implementation materials and (3) intervention optimisation: think-aloud interviews to iteratively refine the final implementation package. An embedded mixed-methods evaluation of how we used the PBA will allow shared learning from the use of this methodology within the migrant health context.

Ethics approval granted by the St George’s University Research Ethics Committee (REC reference: 2024.0191). A community celebration event will be held to recognise contributions and to demonstrate impact.

The objective of this study was to explore medical practitioners’ understanding of antimicrobial resistance (AMR) and its aspects, such as its causes, possible outcomes and how doctors can contribute to its prevention.

This qualitative study was conducted in Sri Lankan healthcare settings.

Using convenience sampling, the study included allopathic medical practitioners aged 18–60 years, excluding intern-medical officers, until data saturation.

One-on-one interviews were conducted online or in person, depending on each participant’s preference. A structured questionnaire was used to triangulate the information.

Data were categorised into four: (1) understanding, awareness and identifying AMR as an issue among medical practitioners, (2) knowledge and understanding of factors that contribute to AMR development among medical practitioners, (3) knowledge and understanding of the outcome of AMR and (4) knowledge and understanding of preventive measures against AMR among medical officers. Interviewees showed an awareness of AMR; however, their knowledge was not up to date. Key reasons for inappropriate antibiotic use included unavailability and poor quality of antibiotics and unawareness of updated guidelines, especially in the government sector. In the private sector, patient pressure, the need to attract patients and the high cost of investigations contributed to misuse. Additionally, low patient literacy about AMR was a significant factor.

This study revealed that although medical practitioners in Sri Lanka are aware of AMR, their knowledge remains limited in certain areas. Several challenges contributed to inappropriate antibiotic use, including the availability and quality of antibiotics, external pressures from patients and financial constraints. The findings of this study highlight the urgent need for continuous medical education and public awareness campaigns to improve both practitioner and patient understanding of AMR. Addressing these issues is essential for effectively preventing and managing AMR in healthcare settings in Sri Lanka.

To estimate the treatment outcomes among individuals treated for hypertension in the public sector in 89 districts across 15 states in India and to identify the risk factors for uncontrolled blood pressure (BP).

An analysis of a cohort of people with hypertension from 2018 to 2022 from public sector health facilities.

All India Hypertension Control Initiative (IHCI) implementing districts using digital information systems across 15 states of India, namely Andhra Pradesh, Bihar, Goa, Gujarat, Jharkhand, Karnataka, Maharashtra, Nagaland, Puducherry, Punjab, Rajasthan, Sikkim, Tamil Nadu, Uttar Pradesh and West Bengal.

Individuals aged 30 years or older, who were diagnosed with hypertension or on medication at the time of registration between 1 January 2018 and 31 December 2021 were included in the study.

Treatment outcomes were controlled BP, uncontrolled BP and missed visits in the reporting quarter (1 January 2022–31 March 2022). We analysed the risk factors for uncontrolled BP.

Out of 1, 235, 453 hypertensive individuals enrolled in the IHCI project across 15 states, 1, 046, 512 remained under care, with 44% BP control. The control varied from 26% to 57% in various types of facilities. The states of Maharashtra, Punjab and Rajasthan had above 50% control, while Nagaland, Jharkhand and Bihar had below 25%. BP control declined from 68% when defined using a single recent reading to 52% when defined using the two-visit readings. Younger individuals (

We documented the implementation of IHCI strategies at scale and measured treatment outcomes in a large cohort. Overall, BP control improved with variations across states. We need focused strategies to improve control in higher-level facilities, among males and people with diabetes. Using two BP readings may support consistent treatment adherence.

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

A prospective cohort study.

A large tertiary care centre.

12 245 women who delivered after 22 weeks gestation in the year 2022.

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

CTRI/2022/03/041343.

Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.

Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.

The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.

CTRI/2024/06/068838.

Artificial intelligence (AI)-based clinical decision support systems (CDSSs) are currently being developed to aid prescribing in primary care. There is a lack of research on how these systems will be perceived and used by healthcare professionals and subsequently on how to optimise the implementation process of AI-based CDSSs (AICDSSs).

To explore healthcare professionals’ perspectives on the use of an AICDSS for prescribing in co-existing multiple long-term conditions (MLTC), and the relevance to shared decision making (SDM).

Qualitative study using template analysis of semistructured interviews, based on a case vignette and a mock-up of an AICDSS.

Healthcare professionals prescribing for patients working in the English National Health Service (NHS) primary care in the West Midlands region.

A purposive sample of general practitioners/resident doctors (10), nurse prescribers (3) and prescribing pharmacists (2) working in the English NHS primary care.

The proposed tool generated interest among the participants. Findings included the perception of the tool as user friendly and as a valuable complement to existing clinical guidelines, particularly in a patient population with multiple long-term conditions and polypharmacy, where existing guidelines may be inadequate. Concerns were raised about integration into existing clinical documentation systems, medicolegal aspects, how to interpret findings that were inconsistent with clinical guidelines, and the impact on patient-prescriber relationships. Views differed on whether the tool would aid SDM.

AICDSSs such as the OPTIMAL tool hold potential for optimising pharmaceutical treatment in patients with MLTC. However, specific issues related to the tool need to be addressed and careful implementation into the existing clinical practice is necessary to realise the potential benefits.

Multimorbidity or the presence of two or more long-term conditions is now common in people undergoing surgery. However, current care pathways often miss these healthcare encounters to support long-term health promotion. Therefore, there is a need for practical, scalable approaches that can be integrated into routine surgical care, for which limited solutions exist at present. We have co-designed a structured preoperative checklist to help identify and manage long-term conditions in patients listed for elective surgery. This study aims to evaluate the feasibility and acceptability of this preoperative checklist in patients undergoing elective surgery.

This is a mixed-methods feasibility study in one National Health Service trust in the UK. We will recruit up to 50 adults scheduled for elective surgery and use the checklist during initial surgical clinic appointments. Quantitative data will include recruitment and retention rates, completion of the checklist and baseline clinical characteristics, analysed using descriptive statistics. Qualitative data will be collected through semistructured interviews with up to 16 patients and clinicians. These interviews will be analysed thematically, guided by the Consolidated Framework for Implementation Research. Triangulation of quantitative and qualitative data will allow us to explore fidelity, acceptability, barriers and facilitators to implementation and refine the intervention ahead of a future pilot cluster randomised trial.

This study has received approval from the Yorkshire & The Humber - Sheffield Research Ethics Committee (approval number: 25/YH/0045). All participants will give written informed consent. Results will be published in peer-reviewed journals and shared with participants, the public and policy stakeholders.

To externally validate and subsequently repurpose/recalibrate the easily accessible kidney failure risk equation (KFRE) for a prevalent transplant population with an estimated glomerular filtration rate (eGFR)

Retrospective cohort study using UK Renal Registry data.

68 adult UK kidney centres.

4092 patients with grafts at least 2 years old and eGFR2 from 2009 to 2018.

Death-censored allograft failure at 2 years, defined as dialysis initiation, re-transplantation or, in the absence of the former two, the recorded date of transplant failure.

The KFRE was calculated at baseline using the 2-year, 8-variable non-North American KFRE, and performance was assessed using Harrell’s C-statistic and calibration plots. The model was recalibrated using Cox Regression (2009–2013 cohort) and temporally validated using the 2014–2018 cohort. Clinical utility was assessed using decision-curve analysis, estimating per-100-patient gains in timely planning and reductions in unnecessary interventions compared with eGFR triggers.

The original KFRE had excellent discrimination but was miscalibrated, underpredicting graft failure. Temporal validation demonstrated that the performance of the recalibrated KFRE could be maintained across time periods (Harrell’s C-index of 0.81 (95% CI 0.80 to 0.83); O/E (Observed/Expected events) ratio 1.00 (95% CI 0.93 to 1.07). It identified 9/100 more patients for timely intervention and 13/100 more for whom intervention could be delayed compared with a late clinical trigger of an eGFR2.

While there are other prognostic models, this is the first study to focus on the understudied and clinically important cohort of patients with an eGFR

Refugees experience significant health needs and well-being inequities. Smoking tobacco, nutrition disorders, alcohol use and physical inactivity are potential contributors to developing non-communicable diseases and mental health conditions. This study aims to explore refugees’ health promotion needs in a regional town in New South Wales (NSW), Australia, suggest appropriate health promotion methods, and co-design a health promotion intervention. Privileging refugees’ voices and experiences is central to co-designing appropriate health promotion interventions.

We will employ a two-phase participatory qualitative co-design method. As there is a lack of knowledge about refugees’ health needs, a participatory research design has the potential to explore the topics holistically. The social–ecological model and the behaviour change wheel model will guide this study. During Phase 1, a semistructured interview guide will be used for in-depth interviews and focus group discussions with refugees. A deductive reflexive thematic analysis will be applied to analyse data using NVivo. In Phase 2, two workshops will be conducted with refugees and health professionals. A reflexive thematic analysis will be performed to identify the top health promotion strategies.

Ethical approval was obtained from the Human Research Ethics Committee (HREC) of the North Coast NSW Local Health District (HREA370 2023/ETH00444). The Human Research Ethics Committee approved a minimisation of duplication at a regional university in Australia (SCU HREC 2024/106). Study findings will be disseminated through embedding chapters in the PhD thesis, publishing high-quality papers and presenting at conferences, lay reports, newsletters and media.

The demand for home care services has increased with the growth of the older population. Currently, home care workers (HCWs) are experiencing challenges such as poor working conditions, high turnover, fragmented services and dissatisfied clients, which are indicative of limitations on HCWs’ ability to provide quality integrated home care to older people. Therefore, we conducted a scoping review to identify the key elements that affect the capabilities of the HCWs in providing quality integrated care to older people in their homes.

Scoping review.

PubMed, PsycINFO, Scopus, CINAHL, Cochrane, Analysis & Policy Observatory, Australian Association of Gerontology (Australia), WHO, Trove (Australia), Social Care Online (UK) and Google between January 2014 and August 2025.

Studies were included if they focused on the analysis of HCWs’ experience in providing care to older people within home settings and were published in the English language between January 2014 and August 2025.

19 studies met the inclusion criteria out of 2844 retrieved articles. Most studies were conducted in North America (n=8). Qualitative studies were the most commonly reported (n=16). The findings of the studies were combined and categorised into four themes using a narrative synthesis approach. The four themes identified were HCWs’ capability through (1) collaborative practice, (2) education and training, (3) structural conditions at work and (4) personal attributes.

This scoping review on home care for older people highlights four interconnected pillars that shape HCWs’ capabilities. This review provides valuable insights to inform the standards and policies to strengthen HCWs’ capabilities across these domains. Future study is needed to explore the measures taken by agencies to understand and address key elements of HCWs’ capability.

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.

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

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

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.

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.

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.

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

This study aimed to determine the characteristics of acute poisoning patients.

This was a prospective cohort study.

The study was conducted for 1 year (1 July 2023 to 30 June 2024) at a tertiary care hospital in Sindh, Pakistan.

From the patients who arrived at the emergency department due to poisoning, 1404 were registered and included in the study.

The data were collected on demographics (gender, age, residential area, education, employment) and poisoning characteristics, prehospital care, treatment, and services at the hospital, and treatment outcomes (survived and died). A ² test was used to find the association between independent variables and treatment outcomes. A multivariate logistic regression model was used to determine the predictors of death at a 95% CI.

The majority of patients were male (57.1%) and aged ≤30 years (77.6%). The poisoning was primarily intentional (67.5%), and pesticides (56.1%) were commonly involved in the poisoning. The patients were managed mainly by symptomatic treatment (98.1%) and gastric lavage (65.1%). Multivariate logistic regression indicated that delayed reporting (adjusted OR (AOR)=2.00; 95% CI 1.20 to 3.36; p=0.008) and non-existence of antidote (AOR=1.81; 95% CI 1.08 to 3.03; p=0.025) increased the odds of death while unintentional poisoning (AOR=0.27; 95% CI 0.14 to 0.51; p

The study found that the intentional pesticide poisoning within uneducated, young populations in rural areas was significantly prevalent, and early identification and management of severe cases and extended hospital stays influenced survival.

Interprofessional co-debriefing, whereby facilitators from different healthcare professional backgrounds jointly facilitate debriefings, is increasingly common in simulation-based education. This approach can enhance learning by incorporating diverse perspectives and distributing cognitive workload, but it may also expose tensions linked to professional identity, hierarchy and power dynamics between debriefers. While learner outcomes and debriefing strategies in general are well studied, little is known about faculty experiences of interprofessional co-debriefing or how sociocultural factors influence this practice. Addressing this gap is crucial to optimise faculty development and support effective interprofessional education. This study will qualitatively explore the experiences and perceptions of simulation educators engaged in interprofessional co-debriefing, with a focus on the influence of sociocultural factors on their practice.

This UK-based qualitative study will recruit up to 30 healthcare simulation educators with experience of interprofessional co-debriefing. Participants will be purposively sampled from simulation networks, centres and academic institutions, with snowball sampling to broaden reach. Semistructured interviews will be conducted online via Microsoft Teams, guided by a topic framework developed by the research team. Interviews will be audio-recorded, transcribed verbatim and anonymised. Underpinned by constructivist and constructionist paradigms, data will be analysed using reflexive thematic analysis following Braun and Clarke’s six-phase approach. Three researchers will independently code transcripts, with themes refined through iterative team discussions to ensure rigour and transparency.

Ethical approval has been granted by the University of Glasgow School of Medical and Life Sciences Ethics Committee (Ref No: 200240285). All participants will provide informed written consent, and data will be handled in accordance with data protection regulations. Findings will be disseminated via peer-reviewed publications, conference presentations and professional networks, with a summary provided to participants. This study will offer novel insights into the underexplored area of interprofessional co-debriefing, specifically how sociocultural dynamics may influence and shape practice, potentially informing faculty development and best practice moving forward.

To project the future burden of cancer mortality in India by forecasting age-standardised mortality rates (ASMRs) for 23 major cancer types up to the year 2030, providing crucial evidence for long-term health planning and resource allocation.

A retrospective analysis and time-series forecasting study. Participants Aggregated, national-level cancer mortality data for the population of India from 2000 to 2019 were used.

Aggregated, national-level cancer mortality data for the population of India from 2000 to 2019 were used.

Annual ASMR data for 23 cancer types were obtained from the Global Cancer Observatory. Autoregressive Integrated Moving Average was employed to forecast ASMR until 2030. For each cancer site, the model with the minimum Bayesian Information Criterion was chosen for males, females and both sexes combined.

The projections reveal diverging mortality patterns across different cancer types. For both genders, the ASMR for mouth oropharynx had the highest estimation of 13.75 (95% CI: 12.69 to 14.81) per 100000 population by 2030 from a baseline of 10.21 in 2000. Breast and cervical cancer showed estimations of 6.62 and 6.03 in 2030, respectively. Conversely, mortality rate projections for several cancers declined, most notably cervical cancer and stomach cancer

Our projections indicate a rise linked lifestyle and metabolic factors and a decline in infection-related and tobacco-related cancers. These underscore the need for strengthening preventive and screening programmes for the former, while continuing to invest in successful interventions for the latter.

Dietary modification, particularly low-carbohydrate diet, and diabetes self-management education (DSME) have shown promise in improving glycaemic control among persons with type 2 diabetes mellitus (T2DM). However, real-world evidence from India is limited. This protocol describes the methods of a cluster randomised trial to determine the effectiveness and feasibility of adopting a low-carbohydrate diet among persons with T2DM.

Our cluster-randomised trial with a mixed-method process evaluation will use computer-generated block randomisation sequence to randomise Urban Primary Health Centres (UPHCs) (n=16) to either continue delivering the usual guideline-based care under the National Programme for Prevention and Control of Non-Communicable Diseases (NPNCD) or our study intervention. The study intervention will comprise a personalised nutrition counselling focusing on (i) low-carbohydrate diet (

We will include persons with T2DM, over the age of 30 years and above, irrespective of comorbidities, registered in the selected UPHC under care for diabetes for at least a month and with an glycated haemoglobin (HbA1c) level ≥6.5% during the screening test. We will collect data electronically using semistructured questionnaires and measure HbA1c, blood pressure, lipid profile, serum creatinine and body weight at baseline, 3, 6, 9 and 12 months after enrolment. We will use a difference in difference analysis, adjusted for clustering, to compare the change in HbA1c at the follow-up visits compared with baseline across the two study arms. We will conduct both intention-to-treat and per-protocol analysis, exploring reasons for differences in effect size.

The study protocol was reviewed and approved by the Scientific Advisory Committee/Institutional Human Ethics Committee of the research institution (NIE/IHEC/202302-03). The findings of this study will be disseminated through publication in peer-reviewed journals.

Clinical Trials Registry-India (CTRI/2024/02/062202).