Gastrointestinal bleeding (GIB) is a common cause of hospitalisation and decompensation in the hospital, is routinely managed by a wide variety of subspecialties, and requires a host of both technical and non-technical skills (NTS). Simulation-based training (SBT) exercises are an excellent means of training physicians and other healthcare professionals in both technical skills and NTS and are frequently used to teach and assess management of high-stress situations such as cardiopulmonary resuscitation and trauma situations. The manner in which SBT is used to train other types of clinical situations—and at what frequency—is less clear. The extent to which such training programmes are evaluated is also not clear. Here, we intend to characterise the body of literature describing SBT programmes for bedside management of GIB. In doing so, we will gain valuable insight into the current state of SBT as it relates to training healthcare professionals to handle complicated clinical situations.

Our review will follow the six-stage framework outlined by Arksey and O’Malley while considering elaborations and guidance made by Levac et al and the Joanna Briggs Institute. The protocol and review will be created in alignment with the preferred reporting items for systematic reviews and meta-analyses—scoping review checklist and explanatory paper. Using a carefully constructed search strategy, the following databases will be queried from their inception through 31 December 2025: PubMed, Embase, Scopus, Web of Science and ERIC. Following the initial database query and two-step screening process, included articles will be systematically examined and will serve as our data source. Our efforts will ultimately answer the following research question: How is simulation-based training currently used to teach bedside management of GIB to physicians (residents, fellows and attending physicians), and how are these simulation-based training exercises studied and evaluated?

Ethical approval from the Institutional Review Board is not required for this study since all investigations are being carried out on previously published manuscripts. Final results will be compiled and submitted for publication once the study has been completed and all data has been charted/analysed.

Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO₂) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO₂ 90%–96%) compared with usual care.

The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO₂ 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO₂2 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

NCT06374225.

Stillbirth remains a major global health challenge, with India bearing a substantial share of the burden. Despite the availability of evidence-based interventions, stillbirth rates (SBRs) remain high due to gaps in healthcare access, quality and the effective delivery of maternal and neonatal care. This study aims to develop and implement an optimised, context-specific model to reduce SBRs in Sangrur district, Punjab.

This mixed-methods implementation research will adopt a sequential explanatory design. The study will be conducted over 3 years in four blocks of Sangrur. Data will be collected through baseline and endline surveys, verbal autopsies of stillbirths, direct observations of antenatal and intrapartum care, and qualitative interviews with community members and healthcare providers. The intervention package will focus on preconception and antepartum care, intrapartum care and strengthening health systems. The study will use the plan-do-check-act model for continuous improvement, and real-time data collection through electronic systems will support timely decision-making.

The study expects to achieve a 25% reduction in SBRs through the optimised delivery of high-quality antenatal and intrapartum care services. Additionally, the research will provide critical evidence on the barriers and facilitators to optimise service delivery, as well as insights into the health system and community factors influencing stillbirth outcomes. This study aims to create a scalable and adaptable intervention model to reduce SBRs in low-resource settings like Sangrur and Punjab. The findings will inform future maternal and neonatal health policies and provide a framework for the broader implementation of similar interventions in other regions of India.

The study protocol has been approved by the International Institute of Health Management Research, Delhi (IIHMR) Institutional Ethics Committee (IRB/2024-2025/01). The study is funded through a competitive call for proposals on stillbirths by the Indian Council of Medical Research (ICMR) under the National Health Research Priority Projects (5/7BMIPR/2022-RBMCH). The research has been awarded by ICMR (project ID NHRP05586) to IIHMR under grant number 5/7/BMIPR/2022-RCN.

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).

Heart failure is the chronic stage of any disease that leads to cardiac functional impairment, affecting between 1% and 7% of the world’s population.1 Racial/ethnic differences are present, with black patients reporting greater incidence, prevalence and severity of heart failure compared with whites.2 One conceptual model has hypothesised that patients with heart failure can have nighttime dyspnoea or palpitations, sleep fragmentation or...

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.

Randomised controlled trials have aimed to assess the effectiveness of stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for individuals diagnosed with early-stage non-small cell lung cancer (NSCLC) but have failed to recruit sufficient numbers of patients. Non-randomised studies for early-stage NSCLC have reported mixed outcomes following curative SABR versus surgical resection, but did not fully address confounding by indication. The Surgery Or RadioTherapy for early-stage cancer study (SORT) will assess the comparative effectiveness of SABR with curative intent versus surgical resection for NSCLC with a target trial emulation approach, as this can reduce biases in observational studies that aim to estimate the causal effect of interventions.

The SORT study will use the National Cancer Registry for individuals diagnosed with early-stage NSCLC in England during 2015–2020 (inclusive) who received SABR with curative intent or surgical resection. These data will be linked to Hospital Episode Statistics, National Radiotherapy Data Set and the Systemic Anti-Cancer Therapy dataset to obtain information on clinical and sociodemographic characteristics and the treatment received. This target trial emulation will define study population eligibility criteria and regimens for SABR with curative intent and surgical resection. We will reduce the risk of residual confounding with instrumental variable analyses that will exploit geographical variation across the National Health Service in England in the use of SABR with curative intent versus surgical resection for early-stage NSCLC. The primary outcome will be 3-year all-cause mortality after treatment initiation. Secondary outcomes will include 3-month, 6-month, 12-month and 24-month all-cause and lung-cancer mortality, time to death, numbers of hospitalisations, incremental costs and incremental cost-effectiveness.

Ethical approval was obtained from the London School of Hygiene and Tropical Medicine Research Ethics Committee (reference number 29 717–1). Results will be disseminated to clinicians, patients, policy-makers and researchers.

Depression affects more than 350 million people worldwide.1 Even though guidelines support using antidepressants to treat moderate and severe depression, nearly 50% of people do not respond to antidepressants2 and 25% discontinue them.3 Studies suggest that adding statins to antidepressants can improve antidepressant adherence, but these studies have been underpowered to test outcomes.4

De Giorgi and colleagues used the largest UK-based...