Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.

Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.

The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).

The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.

Trial registration number: COMET registration number 3485

The COmmunity HEalth System InnovatiON (COHESION) project (2016–2019) was a 4-year collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It conducted formative health system research using tracer chronic conditions, non-communicable diseases (diabetes and hypertension) and one neglected tropical disease per country (schistosomiasis in Mozambique, leprosy in Nepal and neurocysticercosis in Peru).

Findings guided the co-creation of interventions to improve diagnosis and management through a participatory approach with communities, primary healthcare workers and regional health authorities.

As a continuation of this effort, the research team initiated the COHESION Implementation project (COHESION-I) with two objectives: (1) implement and evaluate the context-specific co-created interventions in Mozambique, Nepal and Peru (Component 1) and (2) adapt the COHESION approach to India, a country that did not benefit from a formative phase previously (Component 2). This protocol manuscript focuses on Component 1.

A mixed-methods, pre–post quasi-experimental design will be used, including quantitative, qualitative, economic and process evaluations. Each country will have three arms: (1) co-created and co-designed interventions; (2) only co-designed intervention and (3) the usual care arm. Data will be collected longitudinally over 18 months to assess the effect of the interventions. The main outcomes include patient satisfaction (Patient Satisfaction Questionnaire Short Form), health system responsiveness (WHO responsiveness domains) and quality of life (EuroQol 5 dimensions 5 levels). The qualitative evaluation will explore how satisfaction is perceived among service users with chronic conditions and healthcare workers. Other outcomes per type of evaluation will be considered such as perceived value of health services, cost estimation and acceptability of the intervention components, among others.

Approvals were obtained from Ethics Committees of Universidad Peruana Cayetano Heredia (Peru), Universidade Eduardo Mondale (Mozambique) and Nepal Health Research Council (Nepal). Results will be disseminated through peer-reviewed publications and scientific conferences.

NCT06989502.

Prolonged glucocorticoid (GC) use is associated with significant morbidity and mortality, including the development of GC induced adrenal insufficiency. Recent guidance from the European Society of Endocrinology and Endocrine Society provides a framework for tapering GCs. However, there is limited understanding of current practice across endocrine and other medical specialties, including barriers and challenges to GC weaning. This study aimed to establish how GCs are weaned in patients across endocrine and non-endocrine specialists.

Anonymous online surveys were disseminated to all members of the Society for Endocrinology and all members of the Association of Southeast Asian Nations Federation of Endocrine Societies and the Endocrine and Metabolic Society of Singapore. Non-endocrine specialists were surveyed in the UK and in Singapore.

A total of 306 (258 endocrine specialists and 48 non-endocrine specialists) responded to the survey. Approaches to discontinuing prednisolone were heterogeneous. Among endocrine respondents, only 78% would fully wean the prednisolone, with 50.4% switching to hydrocortisone to wean and 12.6% favouring long-term GC replacement without further investigations. Among the non-endocrine respondents, 16.7% would stop prednisolone abruptly and 10.4% would refer to endocrinology to supervise weaning. The most common barrier to weaning GCs reported by both endocrine and non-endocrine specialists was relapse of the underlying condition (55.9% and 70.8%, respectively).

Relapse of the underlying condition is common, and endocrinology input may not be appropriate when this occurs. There remains a need to develop an evidence-based approach for safe and effective GC weaning and hypothalamic–pituitary–adrenal axis assessment.

More knowledge and resources are required to strengthen ‘leadership and governance’ (L+G) as a central building block to further develop emergency care (EC) systems in low-income and middle-income countries (LMICs).

This scoping review aimed to examine and map the impact of individual, collective or institutional L+G on the development of EC systems (prehospital and facility-based) in LMICs.

English language publications from January 2005 to April 2024 that linked any L+G action with the development and capacity of everyday EC in LMICs, specifically excluding disaster responses.

Medline (Ovid), Embase (Ovid), CINAHL, Web of Science (Clarivate), Central (Cochrane Central Register of Controlled Trials), Global Health (Ovid) and select grey literature.

Data from all eligible papers were jointly extracted using a piloted tool developed from the literature and WHO’s EC Systems Framework. L+G descriptors included level (from clinical to national) and components (informed by Siddiqi et al’s LMIC health system ‘good governance’ framework and a synthesis of EC policy documents). Impact of L+G on EC systems and key lessons were extracted from each publication.

From an initial 9713 items, 129 papers were included for final analysis and divided by EC component: prehospital (n=35), facility-based (n=53) and ‘whole of EC system’ (n=41). Qualitative and descriptive papers were most common, and 72 out of a possible 131 LMICs were represented. Findings were heterogeneous across all building blocks of EC systems and for different components of leadership and/or governance. Cross-cutting L+G themes were identified that demonstrated consistent impact across all EC systems development: government recognition, vision and human rights framing; coalition-building for effective partnerships and trained, empowered EC clinicians demonstrating emotionally intelligent, transformational leadership.

Applying new models such as Theories of Change and Social Network Analysis concepts may assist to illuminate how effective L+G is attained, what are the essential components and how these influence EC systems for better patient-centred outcomes. Further understanding the role of L+G for EC systems has utility for future EC clinician leadership training and policy-maker awareness, to strengthen resilience of overall health systems against likely future shocks.

To explore the views and perspectives of British South Asian (BSA) women and Positive Health Programme (PHP) facilitators on the usefulness and experiences of the PHP intervention for managing postnatal depression (PND) in primary care settings.

Qualitative study with semi-structured interviews to explore perceptions of acceptability and implementation. A patient and public involvement group provided their insights and feedback on study topic guides, analysis and outcomes.

We sampled trial participants from the PHP intervention database to ensure variation in geographic setting, age, socioeconomic status and ethnicity. PHP facilitators involved in the trial were also invited to participate in an interview.

Interviews with study participants were conducted at participants’ homes, and community centres, or via phone. Interviews with PHP facilitators were conducted via phone or online. Interview recordings were transcribed verbatim and analysed using thematic analysis and subsequently the Theoretical Framework of Acceptability (TFA) was applied. Recruitment took place between February 2017 and March 2020.

Thirty interviews were conducted—19 trial participants and 11 PHP facilitators. The PHP intervention was viewed positively, with appreciation of its therapeutic content and components such as childcare and refreshments that facilitated engagement. Participants reported improved confidence and well-being and supported their needs. Participants understood the intervention’s purpose. Both intervention participants and facilitators noted strengthened self-efficacy.

Some participants experienced difficulties balancing childcare and attendance, implying a need for logistical assistance. Stigma about mental health in the BSA community was viewed as persistent, recommending future programmes efforts on strategies to reduce stigma and develop supportive environment.

This study demonstrates the possibility of PHP intervention being integrated into routine care by providing culturally tailored support for BSA women with PND, primarily through family engagement and facilitator support. Future research on scalability, alongside community engagement efforts, will strengthen its acceptability and broader applicability.

ISRCTN10697380.

Immunisation is one of the most valuable, impactful and cost-effective public health interventions which delivers positive health, social and economic benefits. Globally, 4 million deaths worldwide are prevented by childhood vaccination every year. In Ethiopia, despite huge progress being made, the routine immunisation coverage has never reached the targeted figures and planned goals. Pastoralist communities are often disproportionately under-vaccinated, and there is often a confluence of interrelated factors that drive this outcome. This study enables us to identify factors affecting immunisation service utilisation in the pastoralist communities of Ethiopia, which helps to design effective and context-specific interventions.

This study aims to explore the behavioural and social drivers (BeSDs) of routine immunisation among the communities with high numbers of zero-dose and under-immunised children in Afar, Somali and Gambella regions of Ethiopia.

A qualitative exploratory study was conducted in three selected regions of Ethiopia (Gambella, Somali and Afar) from 9 November 2023 to 30 December 2023. Purposive sampling was used. A total of 33 interviews were conducted in the three regions. Sample size was determined based on idea saturation. Data was collected using interview guides. The interview guide was developed after reviewing relevant literature, desk review and using the journey to health and immunisation framework. A separate interview guide was developed for the journey mapping exercise, in-depth interview, healthcare workers discussion guide, focus group discussion and observation. Data was analysed thematically.

Behavioural (lack of awareness, lack of reminder/forgetting, misperception about vaccines, negative previous experience, lost card and fear of post-vaccination adverse events).

Structural (language barrier, long distance from home to facility, high cost of transportation, long waiting time, limited training of healthcare professionals and incentives, inconvenient service hours, shortage of health professionals, disrespect by the healthcare provider), Socio-cultural (competing priorities, low community engagement, lack of decision-making autonomy, limited husband involvement, workload, rural residence and larger family size were the commonly mentioned barriers to routine immunisation uptake. On the other hand, structural (house to house visit by health extension workers, counselling about adverse events, presence of outreach service, affordability (free of charge)), behavioural and socio-cultural (knowledge of adverse event management, and respect from community) were enablers to routine immunisation service uptake in pastoralist communities.

The study found several individual and contextual factors affecting routine immunisation uptake in pastoralist communities. Context-specific and tailored interventions which address zero dose drivers should be designed so as to enhance vaccine uptake. The findings suggested the need to design context-specific interventions to address the aforementioned barriers to immunisation.

Behavioural intention is a strong predictor of actual behaviour; however, many health interventions fail among individuals with a high intention to adopt healthy behaviours. This discrepancy, known as the intention-behaviour gap, remains a critical challenge in health promotion. The purpose of this study is to present a protocol designed to explore the predictability of perceptual factors that hinder the conversion of intention into weight loss behaviour among young adults.

This study employs a sequential explanatory mixed-methods design, comprising two distinct phases. In the first phase, a quantitative cross-sectional survey with a descriptive-analytical approach will be conducted to assess the frequency of behavioural intention to lose weight and weight loss behaviours. A multistage cluster sampling method will recruit young individuals aged 18–29 years with a body mass index of ≥25 kg/m² in Malekan County, Iran. Data will be collected using a structured questionnaire that includes sociodemographic information, physical activity measurements, a dietary adherence questionnaire and items assessing subjective norms, attitudes, perceived behavioural control and behavioural intention based on the Theory of Planned Behaviour. In the second phase, a qualitative study will be conducted using a purposive sampling strategy to select participants who can provide insights into the quantitative findings. Data collection in this phase will primarily involve in-depth individual interviews. A grounded theory approach will be used to develop a comprehensive understanding of the factors that impede the conversion of intention into behaviour among young individuals.

This protocol has been approved by the Ethics Committee of Tabriz University of Medical Sciences (IR.TBZMED.REC.1403.646). Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications, conference presentations and reports to relevant health authorities.

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 explore and understand the disease priorities and preferences for rapid diagnostic testings (RDTs) among community members and stakeholders.

Qualitative study using focused group discussions and in-depth interviews. Thematic analysis was applied to identify themes of disease priorities and RDT preferences.

uMsunduzi Municipality, KwaZulu-Natal, South Africa.

49 community members and five community stakeholders were recruited through a combination of convenience and purposeful sampling using community events and meetings.

Participants prioritised both communicable diseases (HIV, tuberculosis) and non-communicable diseases (diabetes, cardiovascular disease, hypertension and cancer), aligning with national health priorities. They supported RDTs for early diagnosis and home-based testing to mitigate barriers to accessing diagnostic care. A need for post-test support, such as digital support tools, was also highlighted.

Community perspectives highlighted a demand for accessible, rapid and decentralised diagnostic tools for high-burden diseases in KwaZulu-Natal. RDTs have the potential to improve health outcomes and reduce health disparities through improved access to diagnostic healthcare services. The community members are potential end users of RDTs, especially in resource-constrained settings. Therefore, their perspectives should be considered in the development and implementation of RDTs to enhance acceptability and public health impact.

Radioembolisation (RE) is gaining traction as a robust treatment option for patients with hepatocellular cancer (HCC) across all cancer stages. RE allows the delivery of targeted high-dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Traditionally, radiation has been delivered using ⁹⁰Yttrium ([⁹⁰Y]Y)-labelled microspheres, either glass or resin. The success of RE is dependent on the dose delivered to the tumour. When using [⁹⁰Y]Y microspheres, dose prediction is calculated through a ^99mTechnitium ([^99mTc]Tc)-macroaggregated albumin (MAA) scan, which allows the calculation of the dose to be administered to the tumour. However, [^99mTc]Tc-MAA is not a true surrogate of [⁹⁰Y]Y microspheres, and this will impact on the final dose delivered. [¹⁶⁶Ho]Ho, like [⁹⁰Y]Y, is a beta emitter but unlike [⁹⁰Y]Y also emits gamma-radiation, allowing for quantitative nuclear imaging. The primary aim of this pilot study was to investigate the safety and efficacy of dosimetry-based individualised ¹⁶⁶Holmium ([¹⁶⁶Ho]Ho-RE) in patients with HCC.

15 eligible participants will be recruited to receive [¹⁶⁶Ho]Ho-RE. The primary objective is to establish the toxicity profile of dosimetry-based individualised [¹⁶⁶Ho]Ho-RE. The secondary objective is to assess efficacy as measured by modified Response Evaluation Criteria in Solid Tumours (mRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Additional exploratory objectives include quality of life assessment and identification of a radiomic signature of response. The results from this study will be combined with the prospective iHEPAR study to form a larger analysis.

The study has received approval from the East Midlands—Nottingham 1 Research Ethics Committee—approval number 23/EM/0239. The study will be performed in compliance with the Declaration of Helsinki and the principles of Good Clinical Practice. Signed informed consent will be obtained from each patient before study entry. The results will be disseminated through publication in a peer-reviewed scientific journal.

Clinicaltrials.gov NCT06302400.

Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.

Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).

Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.

ACTRN12624000658516.

To examine the longitudinal impact of time-varying factors on US youth’s trajectories of initiation and use of e-cigarettes and cigarettes during the transition from adolescence to young adulthood.

Longitudinal.

Nationally representative US survey, the Population Assessment of Tobacco and Health (PATH) Study.

2682 US youth (aged 16–17) at wave (W)1 of the PATH Study across six waves (2013–2020) into young adulthood (aged 22–23).

Unweighted longitudinal latent class analyses identified trajectory classes of e-cigarette and cigarette use, separately. Nationally representative weighted multinomial logistic regression analyses examined time-varying harm perceptions, substance use problems and tobacco product first tried as predictors of these trajectory classes.

Five e-cigarette classes (2013–2020; 41.5% Persistent Never Use, 12.6% W5 Initiation, 19.9% W3 Initiation, 15.2% Prior Initiation, 10.8% High Frequency Past 30-Day (P30D) Use) and five cigarette classes (2013–2019; 58.6% Persistent Never Use, 11.5% W4 Initiation, 10.9% W2 Initiation, 9.6% Prior Initiation, 9.5% High Frequency P30D Use) were identified. Time-varying harm perceptions and substance use problems were associated with trajectories of initiation and use for both products. Cigarettes, cigarillos, other combustibles and any smokeless tobacco as first product tried were associated with e-cigarette initiation and/or progression to high frequency use. E-cigarettes and hookah as first product tried were associated with later cigarette initiation. High Frequency P30D Cigarette Use was less likely if the first product tried was e-cigarettes, cigarillos, hookah or any smokeless tobacco product.

Results reinforce the need for identification and intervention of early substance use among younger adolescents and targeted public health messaging to address changing harm perceptions and prevent initiation among older adolescents.

Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are sexually transmitted pathogens that are highly prevalent in developing countries and are strongly associated with pregnancy complications. In Chad, screening for these sexually transmitted infections (STIs) in pregnant women is based solely on patient-reported symptoms, even though these infections are frequently asymptomatic. This study aims to determine the prevalence of M. genitalium, C. trachomatis, N. gonorrhoeae and T. vaginalis infections, as well as their associated risk factors.

In this cross-sectional study, we recruited pregnant women attending antenatal clinics at seven hospitals in N’Djamena. Endocervical swabs were collected, and DNA was extracted. Infections were diagnosed using PCR. Risk factors were identified using a structured questionnaire, and associations were assessed using logistic regression.

A total of 525 pregnant women were enrolled, of whom 78.5% resided in urban areas, with a mean age of 25.16±5.54 years. Overall, 23.99% of the study population were diagnosed with at least one STI. The individual prevalence of M. genitalium, N. gonorrhoeae, C. trachomatis and T. vaginalis infections was 13.33%, 5.14%, 0.95% and 4.57%, respectively. Coinfections were low, with M. genitalium-T. vaginalis at 0.95%, M. genitalium-N. gonorrhoeae at 0.38% and other combinations at 0.19% each. Women residing in rural areas had nearly two times the odds of M. genitalium infection compared with urban residents (OR=1.98), indicating a higher risk. AgeM. genitalium infection (OR=1.71) were also associated with significantly increased risk.

This study demonstrates a high prevalence of STIs among pregnant women in Chad, underscoring the need for systematic screening rather than solely relying on syndromic management.

Black ethnic cohorts, when compared with white cohorts, have disproportionately higher rates of essential hypertension and related complications. Ethnic differences in the renin-angiotensin-aldosterone system have been identified in black ethnic cohorts displaying a low-renin, salt-sensitive phenotype in comparison to white individuals. Studies have highlighted lower levels of aldosterone in black cohorts compared with white cohorts. However, when renin is considered, in the form of the aldosterone-renin ratio (ARR), the ARR is higher in black cohorts. The Framingham study highlighted that people in the upper quartile for baseline aldosterone were more likely to have a higher blood pressure and develop hypertension at 4 year follow-up. Therefore, the inappropriately suppressed aldosterone may be contributing to the ethnic differences in hypertension prevalence and prognosis.

Four databases will be searched (MEDLINE, Embase, Scopus and Cochrane Library) to identify eligible studies from database creation to August 2025. Two investigators will independently review the search results and document reasons for full-text exclusions. The main outcomes are to assess if there are ethnic differences in baseline aldosterone, baseline plasma renin activity (PRA) and ARR. We will also look at ethnic differences in regulatory mechanisms of aldosterone, such as serum potassium and 24 hour urinary electrolytes, that may explain the potential differences in aldosterone and ARR in black and white ethnic cohorts. Studies looking at normotensive and hypertensive individuals will be included. Studies in paediatric populations (

As this review will involve analysis of previously published data, ethical approval is not required. The results will be submitted to a peer-reviewed journal.

CRD420251025642.

Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2–N3).

The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).

The study population consists of patients with operable OSCC and advanced nodal disease (N2–N3), adequate organ function, aged 18–65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.

This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies.

CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

V. 2.0 dated 21 May 2024.

NCT03194308.

This study aimed to evaluate the cost-effectiveness of integrating nutritional support into India’s National Tuberculosis Elimination Programme (NTEP) using the MUKTI initiative.

Economic evaluation.

Primary data on the cost of delivering healthcare services, out-of-pocket expenditure and health-related quality of life among patients with tuberculosis (TB) were collected from Dhar district of Madhya Pradesh, India.

Integration of nutritional support (MUKTI initiative) into the NTEP of India.

Routine standard of care in the NTEP of India.

Incremental cost per quality-adjusted life year (QALY) gained.

A mathematical model, combining a Markov model and a compartmental susceptible–infected–recovered model, was used to simulate outcomes for patients with pulmonary TB under NTEP and MUKTI protocols. Primary data collected from 2615 patients with TB, supplemented with estimates from published literature, were used to model progression of disease, treatment outcomes and community transmission dynamics over a 2-year time horizon. Health-related quality of life was assessed using the EuroQol 5-Dimension 5-Level scale. Costs to the health system and out-of-pocket expenditures were included. A multivariable probabilistic sensitivity analysis was undertaken to estimate the effect of joint parameter uncertainty. A scenario analysis explored outcomes without considering community transmission. Results are presented based on health-system and abridged societal perspectives.

Over 2 years, patients in the NTEP plus MUKTI programme had higher life years (1.693 vs 1.622) and QALYs (1.357 vs 1.294) than those in NTEP alone, with increased health system costs (11 538 vs 6807 (US$139 vs US$82)). Incremental cost per life year gained and QALY gained were 67 164 (US$809) and 76 306 (US$919), respectively. At the per capita gross domestic product threshold of 161 500 (US$1946) for India, the MUKTI programme had a 99.9% probability of being cost-effective but exceeded the threshold when excluding community transmission.

The findings highlight the potential benefits of a cost-effective, holistic approach that addresses socio-economic determinants such as nutrition. Reduction in community transmission is the driver of cost-effectiveness of nutritional interventions in patients with TB.