Despite the availability of a safe and effective vaccine, 2000–3000 neonates die of tetanus yearly, predominantly in low- to middle-income countries (LMICs). Inaccurate coverage estimates and vaccination records, together with variability in vaccine response, make identifying individuals who lack protective immunity and may benefit from vaccination difficult. A more direct measure of protective immunity is widely accepted as anti-tetanus IgG concentration at or above 0.1 IU/mL. This study aims to evaluate the performance of a novel saliva-based point-of-care lateral flow test (CIS-IMMUNE Tet) for the binary classification of tetanus protective immune status (protected/unprotected) against WHO threshold-based classification of IgG concentration.

This is a diagnostic test accuracy study with a cross-sectional design conducted in Rwanda. A total of 390 participants will be prospectively enrolled through direct invitation by health centres and community health workers using a convenience sampling approach. Participants will be enrolled into four groups: children aged 5–10 years, healthy adults aged 18–25 years, pregnant women and adults aged 18–45 years with known immunosuppression. This sample size was estimated assuming a specificity of 85% based on proof-of-concept data, with a lower bound of the 95% CI no less than 65%, a significance level of 0.05 and 80% power using the exact binomial method (SAS POWER procedure). Protective immunity will be determined by analysis of anti-tetanus toxoid IgG concentrations in serum by ELISA and analysis of saliva samples using the CIS IMMUNE® Tet test. Test performance will be evaluated by estimating sensitivity, specificity, positive and negative likelihood ratios, each with CIs, for detecting protective immunity using the serum reference standard.

This study protocol was approved by the Rwanda National Ethics Committee (reference RNEC587/2024) and the University of Birmingham (reference ERN_5194-Oct2025). Results will be published in peer-reviewed medical journals and presented at national and international conferences.

The healthcare challenges associated with multimorbidity, population ageing and socioeconomic disadvantage are well known. This requires primary care services to adapt to greater population complexity and embrace new models of care. One example is the community paramedic (CP) role, which can provide screening, education and care coordination for complex and underserved populations. While relatively new in Australia, CPs have the potential to bridge primary care gaps especially in rural settings with workforce shortages. In this study, we are implementing an established and evidence-based Canadian CP programme (CP@clinic) in a new context: rural Australian community health services. The aim of our realist evaluation is to explore and explain how, why, for whom and in what circumstances CP@clinic works to improve health and social outcomes; benefit the paramedic workforce; bridge the gaps in primary healthcare and reduce emergency healthcare utilisation.

Realist methodology is a theory-driven approach that explores how the causal mechanisms of an intervention are shaped by different contexts, leading to a variety of outcomes. We have developed an initial programme theory based on the Canadian experience and an earlier Australian pilot of CP@clinic. We will collect qualitative and quantitative data, including individual health and social outcomes, emergency services usage, healthcare costs, case reports, interviews with participants, paramedics and external stakeholders and process data. Analysis will follow a realist paradigm, using retroduction to compare findings to the original programme theory enabling us to confirm, refute and interrogate the proposed mechanisms.

Ethical approval has been granted (McMaster University HiREB15194; La Trobe University HEC24495, 22038 and 22295). We have developed a multilevel dissemination plan to inform government, the paramedic profession, project stakeholders and consumers. The work is funded by the Australian government with annual reports provided. Other dissemination products will include journal articles, conference presentations, government presentations and submissions, an implementation guidebook and national webinar.

Low-income and-middle-income countries (LMICs) contribute to the maximum burden of stillbirth globally, which affects parents in various tangible and intangible ways, emphasising the need for having a provision of parental leave to recover from the physical and mental/emotional drain. In response to this, we conducted a scoping review with the objective of identifying provision of leave within maternity benefit policies after stillbirth in LMICs.

The study is conducted in accordance with Joanna Briggs Institute guidelines, using the population, concept and context framework to define the research questions. The International Labour Organization (ILO) global care policy portal and documents from selected international United Nations (UN) organisations were reviewed to assess the inclusion of stillbirth within maternity leave policies. Additionally, country-specific maternity leave policies were retrieved from official government sources for LMICs. Fuerther, databases including PubMed, Web of Science, Scopus and ProQuest were searched for studies from LMICs to identify literature with recommendations around leave policy. Study selection and data extraction were conducted by two independent reviewers with arbitration by a third reviewer.

This study noted a stark difference in the leave policy; although all 49 LMICs included in the review had a national maternity leave policy, 67.3% did not align with ILO’s Convention number 183. In contrast, only 10 countries (

Leave grant showed stark disparity. Ignoring the need for physical rest may have long-term health implications. Organisations should have a provision to support women having a stillbirth. Having a provision for flexible leave options allows women to decide when they are emotionally and physically ready to return, rather than forcing a one-size-fits-all solution.

Sexually transmitted infections (STIs) have emerged as significant public health concerns, imposing a substantial burden on both individuals and the healthcare system of the country. Additionally, STIs may also result in major extensive psychological consequences that profoundly affect individuals with STIs. Despite the government’s implementation of different initiatives aimed at addressing STI-related challenges, these conditions are associated with shame and stigma which act as barriers to the effective utilisation of healthcare services. The purpose of the present study is to generate evidence on barriers and facilitators to service utilisation and management of STIs in India.

Indian Council of Medical Research, New Delhi, is conducting a multi-centre study employing a mixed-method approach. The study involves different levels of healthcare systems, including both government and private healthcare facilities across seven sites in several states of India, including Maharashtra, Rajasthan, Punjab, Bihar, Uttar Pradesh and New Delhi. For the quantitative data, individuals seeking healthcare services related to STIs will be enrolled and assessed using a semi-structured pilot-tested questionnaire. In-depth interviews and focus group discussions will also be conducted with different stakeholders as per the standard guidelines of the qualitative method by the designated trained project staff. Descriptive and inferential statistics will be applied to the quantitative data, while the qualitative data will be analysed using a deductive approach with thematic content analysis.

The study protocol has been approved by the ethics review committees of all the participating sites individually. The findings from this study will be published in peer-reviewed journals and disseminated through scientific conferences and meetings among policy-makers and government agencies. AIIMS/IEC/2024/609; AIIMS/Pat/IEC/2024/1205; F. 7/BIOETHICS/AIIMS-RBL/APPROEM/2021/1; KIMSDU/IEC/11/2022; LHMC/IEC/2024/11; IEC/02/EX/2024; PGI/IEC/2024EIC000373.

To identify values and preferences regarding smoking cessation interventions among adults with severe mental illness

Systematic review with best-fit framework synthesis

MEDLINE, EMBASE, Web of Science, CINAHL and Scopus from inception to 14 November 2025.

Studies with any design, in any clinical and geographical setting, reporting on adult (18+) current or past smokers with a diagnosis of schizophrenia, bipolar or mood disorder, including major depressive disorder or post-traumatic stress disorder. We selected all quantitative and qualitative findings regarding patients’ values and preferences, including beliefs, attitudes, behaviours and perceived barriers and facilitators, in relation to smoking cessation interventions.

Two reviewers independently screened studies. After a pilot to increase accuracy, data were extracted by one reviewer and verified by another. Risk of bias was assessed using the Mixed Methods Appraisal Tool. We used the best-fit framework synthesis methodology to synthesise the data.

Of 14 970 identified articles, 65 were included. Most studies were of moderate to high quality. Financial costs posed a significant barrier, while education and social support emerged as important facilitators. Patients preferred personal interactions with healthcare providers. Their motivation for cessation varied and was influenced by habits and perceived nicotine dependence. Health concerns and financial savings were primary drivers for reflective motivation. Beliefs regarding treatment varied. Although commonly used, scepticism about nicotine replacement therapy and concerns about the long-term safety of electronic delivery systems were reported. Overall, patients preferred personalised, flexible programmes and emphasised the need for tailored approaches. Digital interventions, especially mobile apps, that provide support, motivational content and relevant information, were perceived as appealing and helpful when sufficiently considering accessibility and usability aspects. Patients commonly perceived smoking as a coping mechanism for negative emotions. Developing new coping strategies and creating smoke-free environments were deemed to contribute to successful cessation.

Patient-centred care for people with severe mental illness should leverage behavioural and pharmacological strategies for smoking cessation. Flexibility, accessibility and ongoing support appeared important for addressing stress, withdrawal symptom interpretation and relapse vulnerability in this population.

CRD42022337933.

To summarise the evidence on long-term and infrequent harms following selected spinal and paraspinal injections and denervation procedures for chronic non-cancer spine pain.

Systematic review and meta-analysis.

MEDLINE, EMBASE and Cumulative Index to Nursing and Allied Health Literature from inception to October 2023.

Non-randomised studies reporting on harms of selected interventional procedures administered to adults living with chronic axial or radicular non-cancer spine pain with ≥4 weeks of follow-up.

A parallel guideline panel provided input on the scope, design and interpretation of this systematic review, including selection of adverse events for consideration. Systematic literature screening, data abstraction and risk of bias appraisal were conducted independently and in duplicate by pairs of reviewers. We used random-effects models for all meta-analyses and the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the certainty of evidence.

We included 60 longitudinal studies (56 non-comparative, 4 comparative) that enrolled 4966 patients with chronic non-cancer spine-related pain. 31 studies investigated radiofrequency ablation or denervation, 22 epidural injections and 11 joint injections or nerve blocks. Low certainty evidence suggests that joint targeted steroid injection and epidural steroid injection for chronic spine pain may result in temporary altered level of consciousness (incidence: 2.1%; 95% CI 1.1% to 4.0%), joint radiofrequency nerve ablation, joint targeted steroid injection and epidural injection of local anaesthetic and steroids may result in deep infection (incidence: 0.7%; 95% CI 0.3% to 2.0%), epidural steroid injection, joint radiofrequency nerve ablation and joint targeted injection of local anaesthetic and steroids may result in dural puncture (incidence: 1.4%; 95% CI 0.5% to 4.3%), and dorsal root ganglion radiofrequency and joint radiofrequency nerve ablation with or without joint-targeted injection of steroids may result in prolonged pain or stiffness (incidence: 8.6%; 95% CI 6.3% to 11.6%). Several interventional procedures may result in metabolic complications and prolonged sensory deficits, but the supporting evidence was only very low certainty. Most complications resolved spontaneously or with conservative management.

Low certainty evidence suggests that several common interventional procedures for chronic spine pain show risk of deep infection, dural puncture, temporary altered level of consciousness and prolonged pain or stiffness. Other harms are uncertain due to very low certainty evidence, and catastrophic outcomes were not reported in the small studies that contributed to our analyses.

Live attenuated vaccines (LAVs) are recommended during moderate corticosteroid therapy (

To test the safety and immunogenicity of LAVs in NS in children on moderate dose corticosteroid therapy (1.5 mg/kg alternate day dose with maximum 40 mg alternate day dose; early arm) vs those off corticosteroid therapy for 4 weeks (standard arm), we are conducting a single-centre, open-label, non-inferiority RCT at a tertiary care centre in South India (VACCINES trial: Vaccines in Children on Corticosteroids for NEphrotic Syndrome). Eligible children (after inclusion and exclusion criteria) will be enrolled after obtaining written informed consent (from a legally accepted representative/parents) as well as assent for children aged >12 years. Two doses of measles, mumps, rubella (MMR) and/or varicella vaccines will be administered 12 weeks apart, after the initial assessment of seroprotection. Immunological assessment of humoral and cellular immunity will be evaluated in eligible participants. Randomisation into the standard and early arms will be performed during the last 2 weeks of alternate-day therapy (stratified into first episode and relapse patients). Seroconversion assessments will be made at 4, 12, 16 and 52 weeks into the study. The primary objective is to compare the proportion of participants who demonstrate seroconversion after 4 weeks of the first intervention. The secondary outcomes are the antibody geometric mean titres and adverse event profiles including serious events. With a non-inferiority margin of 15% (assuming 86% seroconversion in healthy controls), power of 85% and an alpha error of 5%, 100 patients (including 10% attrition) will be randomised (1:1). Comparisons with 50 healthy children will also be made. The occurrence of three serious adverse events directly attributable to the intervention constitutes a stopping rule. An interim analysis after recruitment of 50% is planned to be presented to an institutional Data Safety Monitoring Board. The first patient was enrolled on 30 June 2025, and enrolment is expected to be completed by February 2028.

The trial has been approved by the Institutional Review Board (IRB) of the Christian Medical College, Vellore (IRB min 2411130, dated 20 November 2024). Results will be published in a peer-reviewed journal and may be presented at medical conferences.

Clinical Trials Registry – India, CTRI/2025/01/078854 (Jan 16, 2025).