To develop predictive models for early and overall tuberculosis (TB) deaths for prospective use at TB diagnosis in resource-constrained TB programme settings.

Statewide cohort study using routinely captured secondary data.

With the majority of TB deaths being early (within 2 months), India’s TB programme’s information management system (Ni-kshay)-dependent death prediction models (using age, gender, TB site, previous treatment, microbiological confirmation, HIV, diabetes and bank account availability) are not feasible for prospective use, as few variables are captured at diagnosis. Utilising routinely captured triage variables for severe illness at diagnosis (body mass index, pedal oedema, respiratory rate, oxygen saturation and ability to stand without support) from an ongoing statewide and state-specific differentiated TB care initiative to reduce TB deaths in Tamil Nadu state (southern India, 80 million population with 0.1 million annual notifications), robust models for prospective use were developed.

Adults (aged ≥15 years) with TB (not known to be drug-resistant at diagnosis) that were notified from public facilities of Tamil Nadu from July 2022 to June 2023.

Early and overall (within 12 months of notification) TB deaths. Area under the receiver operating characteristic curve (AUC) was used to assess accuracy of models built using modified Poisson regression.

Among 55 971 adults, the overall death rate was 7.4%, and 67.9% of the deaths were early. In predicting overall deaths, accuracy of the model using all Ni-kshay variables (AUC 0.716 (95% CI 0.707 to 0.725)) was as good as the model using triage variables for severe illness only (AUC 0.701 (95% CI 0.691 to 0.711)). To the latter, adding potentially capturable Ni-kshay variables at diagnosis (age, gender, TB site, previous treatment and microbiological confirmation) significantly improved model accuracy (AUC 0.754 (95% CI 0.745 to 0.763)). Further addition of remaining Ni-kshay variables did not improve accuracy significantly. Death prediction equations were generated for these models.

Simple and easily measurable triage variables for severe illness should be routinely captured at TB diagnosis. A death prediction calculator (http://44.208.93.99/) based on these variables (specifically triage variables for severe illness combined with age, gender, TB site, previous treatment and microbiological confirmation) may be used by Indian states and high TB burden countries seeking scalable, data-driven interventions to reduce TB deaths.

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.

This scoping review identifies existing registries collecting data on Klinefelter’s syndrome (KS) patients and what data are collected, with the purpose of identifying any KS-specific registries. Findings to be used to inform future registry development.

A comprehensive scoping review was conducted. Multiple sources were reviewed and articles screened based on inclusion criteria and exclusion criteria.

Searches performed across multiple sources including PubMed, Embase, the Cochrane Library, WHO International Clinical Trials Registry Platform, Orphanet, EU Clinical Trials Register, King’s College London Library and charity organisation webpages.

The included studies were required to focus on KS patients with reported data from an active registry that routinely collects data on KS patients.

Basic information about registries identified in included articles was extracted. Registries identified were contacted with a standardised set of questions to collect additional contextual information. Findings are presented in tables.

The scoping review included 18 articles. From those, 10 registries storing KS patient data were identified. Only one of those registries was KS-specific. Only three out of 10 registries collected data that encompassed genetic, clinical and social variables. Most data included in registries were collected exclusively from medical records, although some registries included data from patient surveys. Registries that received government funding had more KS participants than those that did not.

With only one KS-specific registry existing worldwide and none within the UK, this review has identified a need for the development of further KS-specific registries. Data collected could be used to develop an accurate KS phenotype and therefore lead to increased diagnosis of the disorder, improving the lives of people with KS.

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.

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.

The study was conducted with media professionals in Nepal.

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.

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.

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.

CTRI/2022/09/045439.

The Government of India launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) to expand access to affordable generics through private retail outlets named as Jan Aushadhi Kendras (JAKs). This study examines the association of PMBJP with out-of-pocket expenditure (OOPE), catastrophic health expenditure (CHE) and impoverishment rate (IR) attributable to medicines.

A cross-sectional observational study was conducted across nine Indian states in 2022–2023.

Outpatient (OPD) and inpatient (IPD) departments of secondary and tertiary government hospitals, private pharmacies and JAKs in 18 districts of India

A total of 10 336 patients were recruited from OPD (n=2881) and IPD (n=1009) departments of government hospitals as well as pharmacy settings (n=6446). Data on sociodemographics, disease severity, number of generic prescriptions, source of acquiring medicines and medicine-related OOPE were collected through semistructured interviews and periodic follow-ups.

Primary outcomes included mean OOPE on medicines, incidence of CHE (≥40% of non-food consumption expenditure on medicines), IR among JAK and non-JAK users were the primary outcomes of the study. Secondary outcomes comprised awareness of JAKs, generic prescribing rates in hospitals and the factors associated with OOPE, CHE and IR.

Patients procuring medicines exclusively from JAKs reported the lower mean OOPE (OPD: 172; IPD: 275; pharmacy: 307), compared with significantly higher spending at private pharmacies (OPD: 1085; IPD: 3165; pharmacy: 1031). After adjusting for covariates, OOPE among exclusive JAK users was significantly lower relative to private pharmacy users by 60.6%–89.3%. Furthermore, matched analysis confirmed 42% lower expenses, compared with private pharmacies. The likelihood of CHE was also significantly greater among private pharmacy users. However, utilisation of JAKs remained limited, mainly due to low awareness, perceived stock shortages and low rates of generic prescribing.

PMBJP is associated with significant reduction in OOPE and financial hardship, positioning it as an effective cost-containment intervention within India’s universal health coverage framework. Strengthening supply chains, promoting generic prescribing and integrating JAKs with public facilities would further maximise its impact.

The goal of this study was to identify strategies and assess priorities to increase human papillomavirus (HPV) vaccination among unvaccinated young adults using a concept mapping approach.

The concept mapping process was conducted in two phases. In phase 1, eligible participants generated qualitative statements in response to a topic prompt. In phase 2, participants organised and grouped the statements by perceived similarity, and then rated each statement on a scale of perceived effectiveness. Multidimensional scaling and hierarchical cluster analysis were conducted to develop a conceptual map of the data.

This study was conducted at a university in the southwestern USA.

Eligibility criteria for participation included individuals (1) aged 18–26, (2) who had not received any dose of the HPV vaccine or were unsure if they had received the vaccine and (3) who were enrolled students at the study site institution. 24 participants engaged in the concept mapping process; five participated in phase 1 only, five participated in phase 2 only and 14 participated in both phases.

The 41 statements generated were organised into five cluster concepts: media and messaging, information and education, promotion, legal and accessibility. Accessibility was the highest-rated cluster for effectiveness followed by information and education. Exploratory trends across participant demographics were also identified. Differences in perceived effectiveness of the cluster concepts were observed by gender, race, political affiliation and vaccination status.

This study provides valuable preliminary insights into strategies and factors perceived influential in enhancing HPV vaccination from the perspective of unvaccinated young adults. Using concept mapping, multiple factors were identified that varied in their degree of perceived effectiveness across different groups. Future HPV vaccination interventions should consider multi-component elements to ensure their success and reduce the burden of HPV-related disease.

Ankle fracture fixation surgery may be performed with or without the use of a tourniquet. Surgeons who use a tourniquet report reduced intraoperative bleeding, which improves the visualisation of anatomical structures. This may facilitate more accurate fracture fixation and restoration of the anatomical configuration of the ankle joint, potentially leading to improved functional outcomes. An additional proposed benefit of tourniquet use is reduced operative time. In contrast, surgeons who choose not to use a tourniquet report concerns that it may exacerbate postoperative pain and increase the risk of venous thromboembolism, surgical site infection and other complications. However, existing clinical trials are limited by small sample sizes and high risk of bias, preventing the ability to draw robust conclusions. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the potential benefits and risks of tourniquet use in ankle fracture fixation surgery.

This study comprises a two-centre, participant-blinded and surgeon-blinded parallel-arm RCT and an integrated qualitative interview study. A computer-generated randomisation service will allocate up to 50 patients to undergo ankle fracture fixation surgery either with or without the use of a tourniquet. Participants will be followed up for 3 months postoperatively. Primary outcomes include recruitment and retention rates, data completeness, success of blinding and adherence to allocated intervention. Secondary outcomes include postoperative pain, quality of the surgical field, intraoperative blood loss, blood transfusions, procedure duration, skin assessment, awareness of tourniquet use, health-related quality of life (EuroQol-5D-5L), Olerud-Molander Ankle Score and intraoperative and postoperative complications. The integrated qualitative study will consist of semistructured interviews with up to 12 patients and 12 trauma and orthopaedic surgeons (~24 interviews). Interviews will explore perspectives on the feasibility trial, identify factors associated with unblinding and examine barriers and potential solutions to the design and delivery of a future definitive trial. Interviews will be analysed using inductive thematic analysis.

National Research Ethics Committee (East of England-Essex) approved this study on the 8 May 2025 (REC 25/EE/0051). The results will be disseminated via peer-reviewed publication.

ISRCTN91783787.

South Asia bears a high cancer burden, low universal health coverage and high out-of-pocket expenditure. Access to anticancer medicines is challenging and is influenced by determinants—National Essential Medicines List (NEML), registration and local production—yet these are rarely evaluated. This study evaluates these determinants in eight South Asian countries.

Multimethod study using a document analysis phase and semistructured interviews.

Eight South Asian countries (Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka) for document analysis, with stakeholder interviews conducted in six countries, excluding Bhutan and Maldives.

Data were collected from eight regulatory authorities and 30 interviews with drug supply chain stakeholders across six South Asian countries.

The inclusion of 67 anticancer medicines from the 2023 WHO Essential Medicines List (EML) into NEML, their registration and local production, along with macrolevel indicators and stakeholders’ perspectives regarding them.

The median number of medicines included in NEMLs, registered and locally produced was 23.5, 45 and 6.5, respectively. Local production correlated positively with NEML inclusion (=0.884, p=0.004) and negatively with healthcare expenditure (r = –0.732, p=0.039). Three countries listed >50% of the WHO EML medicines on their NEMLs; six had >50% registered. Local production remained limited, with imports dominating supply. Qualitative analysis identified three key barriers to improving availability: financial constraints, a weak regulatory system and insufficient strategic planning.

Access to anticancer medicines is constrained by systemic misalignment between NEML inclusion, registration and local production, undermined by weak regulatory coordination, limited strategic planning and financial constraints. Strengthening regulatory coordination, improving registration efficiency and supporting regional production strategies aligned with guided WHO guidance may help improve equitable access to cancer medicines in the region.

Recovery after extremity fracture is influenced by injury-related impairments, functional capacity, symptom severity and psychosocial well-being, emphasising the need for patient-reported outcome measures (PROMs). Despite increasing adoption of Patient-Reported Outcomes Measurement Information System (PROMIS) and legacy PROMs in orthopaedic research, substantial knowledge gaps remain regarding their measurement properties, comparability and clinical utility, particularly in fracture populations. Our aim is to develop meaningful guidance to clinicians regarding the use of PROMs in treating orthopaedic fracture patients.

A prospective cohort of 1500 patients across 14 centres presenting with isolated extremity fractures being treated operatively or non-operatively will be recruited prospectively. We will aim to recruit 300 patients for each of five fracture types: isolated hip, tibial shaft, ankle/pilon, proximal humerus and distal radius fracture. All procedures and management will be performed according to the site’s standard of care and treatment protocol. For patients treated non-operatively, the index visit (first study assessment) will be performed at the first orthopaedic treatment encounter (eg, emergency department visit or outpatient fracture clinic). Surgically treated patients will have PROMs collected anytime from the day of the surgery up to discharge from hospital for the index visit. Follow-up visits will be performed at 2–3 weeks, 6–8 weeks, 10–13 weeks, 6 months and 1 year after the index visit. At baseline, we will document injury data, demographic and sociodemographic data, and radiographic classification using the AO classification system. Patient-perceived functioning will be assessed with PROMIS Physical Function (PF), PROMIS Upper Extremity, PROMIS Global Health, Knee and Injury Osteoarthritis Outcome Score-12, Hip Disability and Osteoarthritis Outcome Score-12, Foot and Ankle Ability Measure and Quick Disabilities of the Arm, Shoulder and Hand. The following domains and PROMs will also be captured: symptoms of anxiety and depression (PROMIS Anxiety; PROMIS Depression), patient activation (Patient Activation Measures (PAM)-10) and a patient’s ability to fulfil social roles (PROMIS Social Roles).

The range and normative limits of the PROMs collected will be defined using standard descriptive statistics. We will crosswalk or validate PROMIS measures with legacy instruments for PF using an Item Response Theory (IRT)-based linking model and compare it to non-IRT models (such as equipercentile linking). Lastly, we will assess the PROM-based recovery trajectory after fracture, overall and after adjusting for relevant demographic, clinical or biopsychosocial factors.

Ethics approval for this study was granted from the local Ethics Committees or Institutional Review Board at each of the participating sites prior to patient enrolment. Austin: Institutional Review Board University of Texas at Austin, STUDY00000262; Boston: Mass General Brigham, 2019P000397; Los Angeles: Cedars-Sinai, Office of Research Compliance and Quality Improvement, STUDY00000081; Miami: University of Miami Human Subject Research Office, 20221353; Bogotá: Comité Corporativo de Ética en Investigación, CCEI-15607-2023; Berlin: GoFitFast: under Homburg approval; Recovery/Linking: Ethikkommission Charité Universitätsmedizin Berlin, EA2/026/21; Homburg: GoFitFast: Ethikkommission der Ärztekammer des Saarlandes, 232/19; Recovery/Linking: under Charité approval; Murnau: under umbrella from Homburg and Charité, GoFitFast: under Homburg approval, Recovery/Linking: under Charité approval; Tübingen: GoFitFast: Ethik-Kommission, Universitätsklinikum Tübingen, 393/2022BO2; Freiburg: Ethik-Kommission Albert-Ludwigs-Universität Freiburg, 21–1401; Rostock: Ethikkommission an der Universitätsmedizin Rostock, A 2024–0113; Innsbruck: Ethikkommission der Medizinischen Universität Innsbruck, 1258/2021; Oxford: HRA and Health and Care Research Wales, 20/EE/0051; London: HRA and Health and Care Research Wales, 20/EE/0051; Groningen: Medical Ethics Review Board University Medical Center Groningen, METc 2023/187 16882; Non-WMO waiver; Zwolle: Medical Ethics Review Board University Medical Center Groningen, METc 2023/187 16882; Non-WMO waiver. The results of this study will be published in peer-reviewed journals and presented at different conferences.

NCT04113044

Maternal human milk feedings continue an offspring’s exposure to the programming stimuli of maternal metabolism during the postnatal period. While considerable research focuses on associations between in utero environments and offspring metabolic disease, few studies have been able to specifically measure how human milk composition modifies programming of children’s growth in conjunction with comprehensive measures of maternal glycaemia during pregnancy.

The Glycemia Range and Offspring Weight and adiposity in response To Human milk (GROWTH) Study is a longitudinal cohort enrolling women with a singleton pregnancy who (1) undergo serial testing of glycaemia during pregnancy and (2) are intending to provide their breast milk through direct breastfeeding or pumped milk as the primary nutrition for their infant. Enrolment started in October 2023 and is expected to be completed in December 2026. Key procedures include virtual lactation support visits, serial human milk sampling at three time points, maternal and infant blood sampling, serial maternal and child anthropometric measurements and diet assessment. After delivery, mother–child dyads are followed until children turn 2 years of age. The primary exposure variable is maternal glycaemia obtained from a fasting, 3 hour 100 g oral glucose tolerance test performed at 24–28 weeks of gestation, and the primary outcome measure is the composite of human milk linoleic and docosahexaenoic acid concentrations in milk samples collected at 1 month postpartum.

Lurie Children’s Hospital Institutional Review Board (IRB) provides central oversight of the GROWTH Study in conjunction with each participating centre’s IRB. The GROWTH Study data has the potential to inform perinatal health and future research in lactation and human milk science by providing comprehensive measures of human milk composition and early childhood growth and body composition parameters impacted by maternal metabolism in pregnancy.

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.

This study aims to explore the history of prior abortions and the factors influencing them among young women seeking abortion services in Foshan, Guangdong, China.

This is a retrospective, cross-sectional study of young women seeking abortion care.

Gynaecological outpatient clinics at the Department of Gynaecology, Foshan Women and Children Hospital Affiliated to Guangdong Medical University, Foshan, Guangdong, China, between 2013 and 2023.

A total of 7361 young women aged 12–25 years seeking abortion services.

Data on abortion history, sociodemographic factors, contraceptive use and postabortion contraceptive choices were collected and analysed, with special emphasis on the incidence of repeat abortions and the factors associated with them.

Of the 7361 participants, 34.2% reported at least one previous abortion, underscoring a notable public health concern. The mean age of the participants was 22.30 years (SD=2.13). Women with a history of abortion were significantly older than those without (22.57 vs 22.08 years, p

This study underscores the need for targeted interventions to address the multifaceted factors leading to repeat abortions among young women in China. The results offer valuable insights for improving reproductive health outcomes in this vulnerable population and highlight the importance of expanding access to contraceptive education and services in China.

Settings with insufficient human resources struggle to provide timely eye care services and information to the population. mHealth (mobile healthcare) is a promising solution; however, evidence on the effectiveness of interactive voice response (IVR) and real-time phone-based education remains scarce, despite their potential to be scalable and cost-effective. This study aims to implement the Virtual Baithak, an interactive mHealth platform, to improve eye-health literacy among older adults residing in rural India. The objectives are to (1) Develop and validate the Virtual Baithak for improving vision health and (2) Determine its effectiveness, feasibility and acceptability among the older adults.

This 3-armed, parallel, randomised controlled trial of 14 months duration will enrol 381 older adults (aged 60 years and above). Participants will be blinded and randomly (computer-generated) assigned to either of the three groups based on the intervention for eye-health education they receive: both IVR and group calls moderated by a healthcare professional, only IVR and usual care. The two intervention arms will receive the information weekly over a 3-month period through the Virtual Baithak platform, which will be designed for this study using a participatory research approach to develop the content. The primary study outcomes are digital health literacy and vision health knowledge scores, measured at baseline and 14 months. The secondary outcomes include m-health technology acceptance and usage practices. A mixed-method process evaluation will be conducted to assess the intervention feasibility and implementation, including in-depth interviews with participants. The qualitative data will be thematically analysed to explore factors that promote or restrain the implementation. The inferential statistical quantitative analysis will be performed using linear mixed models.

The study has been approved by the ‘Institute Ethics Committee,’ PGIMER, Chandigarh, India (PGI/IEC/2022/EIC000282 dated 18 February 2022). The results will be disseminated via presentations and/or publications at the national and international levels.

CTRI/2023/02/049383, dated 1 February 2023.