Despite implementation of the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD), screening coverage for oral, breast and cervical cancers remains below 2%. Screening quality is inadequately addressed and delays in diagnosis and treatment initiation continue to persist. This multisite implementation research aims to improve district-level coverage and quality of screening, early diagnosis and timeliness of treatment initiation through a model co-developed within the NP-NCD context.

The study will be conducted in three phases across seven districts in diverse regions of India. In phase I (formative), the current status, barriers and facilitators of cancer screening, diagnosis and treatment initiation under NP-NCD will be assessed. In phase II (optimisation), a model (package of implementation strategies) will be co-developed and iteratively optimised with multistakeholder engagement at the subdistrict level to improve screening coverage and quality and strengthen the referral system for early diagnosis and treatment initiation. In phase III (scale-up and evaluation), the model will be implemented at the district level and evaluated for improvements in screening, early diagnosis and treatment initiation. A convergent mixed-methods design will be used, incorporating household surveys, facility assessments and stakeholder interviews. Implementation Research Logic Model will guide planning, execution and evaluation in the present study. Determinants of screening coverage and quality, early diagnosis and treatment initiation will be assessed using the Consolidated Framework for Implementation Research. Implementation strategies for the model will be finalised using the Expert Recommendations for Implementing Change framework. Implementation and service outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.

Ethical approval has been obtained from all study sites. The study findings will be disseminated at the state, national and global levels through meetings and conferences and submitted to a peer-reviewed journal for publication.

CTRI/2025/08/092672.

Despite extensive efforts in data collection, quality and safety measurement remains a significant global challenge, with limited understanding of how and under what conditions quality and patient safety surveillance systems function effectively. With the aim of informing the development and effective functioning of quality and patient safety surveillance systems, a rapid realist review was conducted to develop a set of theories that address how, why, for whom and in what context quality and patient safety surveillance systems work.

Rapid realist review to inform recommendations and intervention design for the monitoring and evaluation phase of the QS Signals Project, reported according to Realist and Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidelines.

Initial programme theories were constructed based on data collected from key articles on quality and patient safety surveillance systems, consultation with an expert panel, informal meetings with a project team charged with developing a quality and patient safety surveillance system for maternal and infant health and a review of the project’s planning documents. A three-phase iterative search of PubMed, PsycInfo, CENTRAL, CINAHL and grey literature was conducted, including studies in healthcare settings across all patient groups.

Documents were assessed for relevance (alignment with the theory under test), richness (depth of insight) and rigour (trustworthiness and coherence of data).

Context–mechanism–outcome configurations were generated, iteratively refined and grouped under relevant programme theories to contribute to theory refinement.

The review process resulted in the development of 11 final programme theories, identifying mechanisms operating at organisational and national levels. Effective systems were enabled by leadership commitment, organisational readiness for change and a supportive safety culture. Clear governance structures, including defined local and national roles, strengthened accountability and coordination. The establishment of multidisciplinary clinical advisory groups facilitated the selection of meaningful safety indicators. Sustainable financial investment and adequate human and technical resources were critical for implementation. Robust data governance frameworks enhanced trust, transparency and appropriate data use. User-centred system design improved data accessibility and usability, while feedback loops supported learning and continuous improvement.

Quality and patient safety surveillance systems function most effectively when supported by strong leadership, clear governance structures, adequate resources and a learning-oriented culture that enables the meaningful use of safety data. The findings emerging from this review provide comprehensive, practical and testable systems-level programme theories to inform future research on the development of quality and patient safety surveillance systems across diverse healthcare settings and international contexts.

Masculinising chest surgery, also known as top surgery, is the most requested gender-affirming procedure among transgender and gender-diverse (TGD) adolescents, yet research on patient experiences remains limited. This study explored the experiences of TGD adolescents who were seeking or had undergone masculinising chest surgery.

Qualitative secondary analysis using existing themes framework and data from the GENDER-Q (GQ) and GENDER-Q Youth (GQY) research programmes, which aim to develop comprehensive patient-reported outcome measures for gender-affirming care.

Participants were sampled from five high-volume gender-affirming care clinics, three in Canada and two in the United States. Interviews were conducted online.

35 GQ and GQY participants aged 13–18 years who were assigned female at birth, identified as trans men or non-binary, and were pursuing (n=19) or had undergone (n=16) masculinising chest surgery.

Three major themes emerged: chest appearance, health-related quality of life (HRQL) and gender practices. Most participants expected a flatter chest that aesthetically aligned with their gender identity. Presurgery participants anticipated that surgery would allow them to engage in previously avoided physical activities and would enhance their relationships. Postoperative participants reported increased physical activity, mental resilience, bodily connection and social comfort. Most reported binder use and related reliance or discomfort as motivators for pursuing surgery.

This study highlights the multidimensional experiences surrounding masculinising chest surgery on TGD adolescents with impacts on chest appearance, HRQL and gender practices. Centering adolescents’ perspectives, these findings underscore the importance of accessible, affirming surgical care and provide valuable insights for clinicians, policymakers and future research.

Some cancers are diagnosed late, making them harder to treat. People with an undiagnosed cancer may use over-the-counter medications to manage non-specific cancer-related symptoms that often mimic other more common, easily treatable conditions. Results from the original Cancer Loyalty Card Study (CLOCS) suggest there may be an increase in purchases of pain and indigestion medication 8–9 months before an ovarian cancer diagnosis. We aim to validate the CLOCS findings by exploring whether a significant change in medication purchases could be an indication for early signs of the following cancer types: oesophageal, stomach (gastric), colorectal (bowel), pancreatic, liver, bladder, endometrial, uterine sarcoma, ovarian and vulval, using data collected through store loyalty cards.

Using a retrospective case-control design, we aim to recruit 1450 participants with one of the cancers of interest (cases) and 1450 participants without cancer (controls) in the UK who (or whose household members) hold a loyalty card with at least one participating high street retailer. We will use pre-existing loyalty card data to compare past purchase patterns of cases with those of controls. To assess cancer risk in participants and their purchasing patterns, we will collect information on demographic characteristics, health risk factors, lifestyle habits and behaviours, family history of cancer and any symptoms experienced prior to diagnosis (cases) and in the last year prior to study recruitment (controls). In addition, cases will be asked about their cancer diagnosis.

CLOCS-2 was reviewed and approved by the East Midlands-Leicester South Research Ethics Committee (23/EM/0224). Study outcomes will be disseminated through peer-reviewed publications, conferences, presentations to the research communities as well as patients and the public, the study website and other social media outlets.

NCT06447064, CPMS58679; pre-results.

Anaemia is highly prevalent among the indigenous population globally. Several interventions have been used to prevent and manage nutritional anaemia, including dietary measures, health education, oral iron supplements, food fortification and intravenous iron therapy. This protocol describes a systematic review and meta-analysis to assess the effectiveness of interventions for the prevention and treatment of nutritional anaemia in indigenous populations worldwide.

The review will include randomised controlled trials, quasi-experimental studies and observational studies evaluating interventions, including but not limited to iron and folic acid supplementation, dietary modifications, food fortification, deworming and health education. A robust search strategy will be developed, and six electronic bibliographic databases and Google Scholar will be searched from 2000 to 2025. Two reviewers will independently screen the identified studies, extract data, conduct a critical appraisal and evaluate quality using the Joanna Briggs Institute tool. Based on the level of heterogeneity, a meta-analysis will be conducted using either a fixed-effect or random-effects model, with pooled estimates, and 95% CIs. The I² statistic will be used to evaluate heterogeneity. When meta-analysis is not feasible, narrative synthesis will be conducted. The impact of the intervention type and delivery model will be investigated using subgroup analysis.

This systematic review has been registered with PROSPERO. Ethical approval is not required as the study does not collect primary data from participants. The findings will be communicated via peer-reviewed journal articles and presentations at national and international conferences.

CRD420251120554.

While health research about persons of South Asian ancestry has been conducted for decades in Canada, it often uses pathologising approaches that fail to consider historical, social and political factors shaping health disparities. Further, this research rarely engages South Asian communities in meaningful ways, reinforcing feelings of disconnect and longstanding mistrust. Greater collaboration and transparency are needed to build trust and generate credible findings. The aims of this research protocol are to (1) examine how community engagement has been implemented in health research involving South Asian populations, (2) explore the experiences of both South Asian community members and academics involved in community-engaged research and (3) develop a framework guiding health research with and for South Asian communities in Canada, titled PRinciples to Operationalize Community Engagement, Equity, and Sustainability in South Asian Health Research in Canada (PROCESS).

This ongoing codesigned concurrent multimethods study is being conducted with community partners across Canadian provinces. First, the scoping review is examining how community engagement has been operationalised in health research involving South Asian populations in Canada. We are performing a search in Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, Web of Science, Scopus and PsycINFO databases for articles published between 2003 and 2024 referring to the concept of community engagement in South Asian health research. Two reviewers are independently completing abstract and full-text reviews based on preselected eligibility criteria. Data are being extracted from peer-reviewed studies using a data extraction framework. Findings will be aggregated and synthesised using descriptive content analyses. Second, a qualitative descriptive study is being conducted to explore the experiences of diverse stakeholders, including academics and community partners who are partaking in academic health research focused on South Asians. Semistructured interviews are being analysed using an inductive thematic content analysis. Results from the scoping review and qualitative interviews will be triangulated to detect emerging themes and patterns, which will enable the identification of principles to be incorporated within a draft of the PROCESS framework. In the final phase, we will use a modified Delphi process to iteratively codevelop the PROCESS framework with community partners and researchers across Canada.

The Faculty of Medicine and Health Sciences Institutional Review Board at McGill University approved the study’s protocol (24-05-080). Results will be submitted for publication in peer-reviewed journals and presented in academic and community forums. Results will also be shared with diverse audiences across Canada through multiple formats, including articles, conferences, infographics and social media, with the aim of raising awareness and promoting the adoption of research principles and practices for engaging South Asian communities in health research. This research received funding from the Canadian Institutes of Health Research (Grant #507768).

To assess and compare the diagnostic accuracy of non-ophthalmologist-led diabetic retinopathy screening (DRS) at health and wellness centres (HWCs) and offline artificial intelligence (AI)-assisted community-based screening, using specialist grading as the reference standard in India.

Pragmatic diagnostic accuracy study in primary healthcare settings. The settings included HWCs and community-based screening sites in rural Block Boothgarh, Mohali District, Punjab, India. A total of 600 people with diabetes aged ≥30 years were enrolled across three screening models: (1) non-ophthalmologist-led DRS at the HWC, (2) AI-assisted smartphone-based DRS in the community and (3) standard referral-based care. Retinal images were captured using non-mydriatic fundus cameras and independently graded by two masked human graders; a senior retina specialist resolved any disagreements. The AI was assessed for its ability to detect diabetic retinopathy (DR) and referable diabetic retinopathy (RDR). Diagnostic performance metrics were reported.

The non-ophthalmologist-led model demonstrated 86.4% sensitivity (95% CI 65.1% to 97.1%) and 94.3% specificity (95% CI 88.5% to 97.7%) for DR detection, with an ungradability rate of 8%. For RDR, sensitivity reached 95.8% (95% CI 78.9% to 99.9%) and specificity was 93.1% (95% CI 88.0% to 96.5%). The offline AI-assisted model achieved 93.3% sensitivity (95% CI 68.1% to 99.8%) and 85.1% specificity (95% CI 76.9% to 91.2%) for RDR, but with a higher ungradability rate (38%), mainly due to cataracts and poor image quality. Both approaches effectively identified referable cases; however, the non-ophthalmologist-led model demonstrated greater accuracy and operational feasibility.

This study demonstrates that non-ophthalmologist-led DRS at HWCs can enhance access to primary care. Offline AI-enabled screening demonstrates potential for community use but is currently limited by image quality and binary classification outputs. Integrating both approaches may strengthen DRS coverage in resource-limited settings.

CTRI/2022/10/046283.

Obesity affects over a quarter of the UK population and can lead to serious health issues. NHS Specialist Weight Management Services (WMS) offer treatments including lifestyle advice, psychological support and medications, but access and availability vary by region. Although around 4 million people could be eligible for NHS Specialist WMS annually, capacity is limited to 35 000, severely limiting overall access for those who need it. While digital technology has started to be used in WMS, more evidence is needed to confirm its long-term effectiveness, acceptability and cost-effectiveness. This study explores the use of Gro Health W8Buddy, a digital platform and app providing remote Specialist WMS. It aims to determine the long-term health benefits of remote WMS pathway Gro Health W8Buddy compared with standard NHS WMS delivered in hospitals, and to improve patients access to services.

The study is a real-world evaluation with observational data collection. We will recruit 450 study participants from four NHS specialist WMS who will choose either standard NHS WMS or the digital pathway Gro Health W8Buddy. Participants are being given the option to choose their pathway to generate real-world evidence. We will measure and analyse health outcomes including weight loss, time taken to be treated and cost-effectiveness, at 18 months and follow up at 24 months for later analysis (outside of this core funding). We will gather experiential data from patients and healthcare professionals through surveys, observation and interviews.

Ethical approval has been obtained from NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (Supplementary Figure 3) (REC reference: 25/EM/0147). Our findings will be disseminated through academic publications, conference presentations and stakeholder engagement.

ISRCTN89168871; Pre-results.

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.

The rise of electronic nicotine delivery systems (ENDS) has introduced new challenges to tobacco control and regulation, particularly among young adults, raising questions about their safety. This umbrella review aimed to synthesise existing systematic reviews with or without meta-analyses to evaluate the health impacts of ENDS.

We conducted a systematic literature search via the PICO strategy across multiple databases, focusing on e-cigarettes, ENDS and e-liquids, while excluding non-nicotine e-cigarette and nicotine replacement therapies (NRTs). Health outcomes include a range of clinical diseases and physiological changes. Quality assessment was performed via assessing the methodoligcal quality of systematic reviews 2 (AMSTAR-2), and the findings were synthesised narratively and in tables, prioritising the highest-rated reviews. The meta-analyses used R software (V.4.3) random effects models, and evidence quality was assessed via the Grading of Recommendations, Assessment, Development and Evaluation criteria.

Of the 5055 records, 69 systematic reviews were included. Systematic reviews have indicated increased risks of cardiovascular and respiratory diseases, mental health issues and substance abuse with ENDS use, especially among adolescents. Cardiovascular risk factors included increased heart rate (mean difference (MD) 1.41, 95% CI 0.81 to 2.01, I²=91%) from 25 studies; increased blood pressure (MD for systolic blood pressure=0.51 mm Hg, 95% CI 0.26 to 0.75, I²=89%; MD for diastolic blood pressure=0.59 mm Hg, 95% CI 0.35 to 0.83, I²=82%) from 23 studies; endothelial dysfunction and increased platelet activity. Respiratory risk factors included reduced lung function and a higher incidence of asthma in nine studies (OR 1.30, 95% CI 1.1 to 1.55; I²=43%) and chronic obstructive pulmonary disease. Mental health concerns, such as depression and suicidality, were also prevalent among adolescent ENDS users. Nine studies reported a negative effect of ENDS on periodontal health. Evidence of carcinogens has been found in the urinary examinations of ENDS users in some studies. The adverse events reported in seven randomised controlled trials with 2611 participants were similar between ENDS and NRT (RR 1.13, 95% CI 0.83 to 1.54, I²=12%).

Exposure to ENDS is harmful to various organ systems, especially cardiovascular and respiratory systems. Comprehensive regulatory measures and public health strategies are necessary to curb the use of ENDS, particularly among young people.