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.

After resuscitation from out of hospital cardiac arrest (OHCA), mechanical ventilation (MV) and respiratory management are fundamental to support patients in the intensive care unit (ICU) and to minimise secondary brain injury. Best practices for MV and association with clinical outcomes in patients with OHCA remain unclear.

This protocol describes a pre-planned respiratory-focused series of sub-analyses within the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, an ongoing interventional study evaluating 6-month mortality after randomisation in patients admitted to ICUs following OHCA. The primary aim is to describe real-world ventilator settings and gas-exchange targets during the first 72 hours after ICU admission in patients receiving invasive mechanical ventilation after OHCA. Secondary aims include to estimate the incidence of respiratory complications during ICU stay (eg, ventilator-associated pneumonia, acute respiratory distress syndrome, barotrauma); and to explore the association between early ventilator settings/gas-exchange parameters and 6-month outcomes (mortality and neurological status). Exploratory aim is to characterise weaning and extubation practices, including timing and failure rates.

Eligible patients will include adult STEPCARE participants receiving invasive MV after return of spontaneous circulation with available respiratory data recorded within the STEPCARE database.

Data collected in the STEPCARE trial that will be analysed include patients’ prehospital characteristics; clinical examination at hospital admission and at ICU admission; ventilator settings and arterial blood gases recorded at predefined time points during ICU stay. In particular: MV setting (mode, tidal volume, positive end-expiratory pressure, fraction of inspired oxygen, tidal volume, mechanical power, plateau/driving pressures), gas-exchange values (arterial partial pressure of oxygen and carbon dioxide, pH, arterial saturation of oxygen), timing of measurements and the occurrence/timing of respiratory complications and weaning outcomes.

The STEPCARE study has been approved by the regional ethics committee at Lund University (Dnr 2022-02425-01, Approved IRB on 2022-06-18) and by all ethics boards in the participating countries. No additional ethical approval is required for this predefined secondary analysis, as no further data collection or interventions will be performed. Findings will be disseminated through publication in peer-reviewed journals and, where appropriate, conference abstracts and presentations. Patients and the public were not involved.

NCT05564754.

Active learning strategies, including case-based learning (CBL), problem-based learning (PBL) and team-based learning (TBL), have been extensively studied in clinical and basic science education; however, their application in public health programmes remains under-explored. Public health professionals address population-level challenges that differ substantially from clinical practice, making it necessary to evaluate whether these pedagogies are effective in this field. This review examines how CBL, PBL and TBL have been used in public health education and what outcomes have been reported.

Scoping review was conducted using the Levac and Colquhoun framework, an adaptation of Arksey and O’Malley’s approach.

PubMed, Scopus and Google Scholar were searched for studies published between 2000 and 2025. Eligible studies included those involving students enrolled in undergraduate or postgraduate public health programmes, such as bachelor’s or master’s programmes in public health, epidemiology and biostatistics, global health, community medicine or health policy as well as employees working in public health-related fields. Data were extracted using a predefined template capturing study characteristics, population characteristics, student satisfaction and study objectives. All articles were thematically analysed.

Results

Overall, 22 studies were included. Of these, 11 focused on PBL, 2 on CBL, 3 on both CBL and PBL and 6 on TBL. Public health topics addressed included general public health practice (n=5), global health (n=3), health literacy or education (n=3) and occupational health or medicine (n=2); remaining studies covered leadership, nutrition, health behaviour, climate and health, ageing and mental health. Six themes emerged: skill development, real-world relevance, diversity and inclusion, blended learning, innovative approaches and challenges. Key challenges for PBL included cognitive overload and implementation constraints; for CBL, inequitable participation and resource-intensive implementation; and for TBL, increased student time burden and difficulty adapting to complex simulations.

Active learning methods enhance critical thinking and problem-solving in public health education but face implementation barriers, including faculty training requirements and resource constraints. Future research should examine long-term outcomes and the integration of emerging technologies.

Acute febrile illness is a major cause of morbidity and healthcare seeking in sub-Saharan Africa, including Mozambique. However, few studies have explored the perceptions and practices related to clinical management of acute febrile illness. Our aim was to understand the perceptions, knowledge and practices of healthcare professionals and community members regarding the management of acute febrile illness.

A qualitative study was conducted using a thematic analysis approach. Eight focus group discussions (FGDs) and three in-depth interviews (IDIs) were conducted in two Mozambican provinces across four healthcare facilities. Purposive sampling was used to select participants, comprising both healthcare professionals and community members. Data were analysed thematically through manual coding, applying inductive and deductive approaches, in line with established qualitative analytical frameworks.

The study included a total of 60 participants, 28 healthcare professionals who participated in FGDs (25) and IDIs (3) and 32 community members who participated in FGDs. Major causes of fever, according to healthcare professionals, were upper and lower respiratory infections, malaria, diarrhoeal diseases and COVID-19. The diagnostic approach for febrile patients primarily included screening, malaria testing and other non-specific investigations depending on availability at health facilities. Antibiotics and antipyretics were the most commonly prescribed treatments. The healthcare professionals reported a decrease in prescribing antimalarials due to extensive training on malaria case management. In contrast, community members reported relying primarily on home-based and traditional practices to treat acute febrile illness before seeking care at health facilities. These practices are related to sociocultural habits, such as the use of traditional medicine and self-medication. The main barriers to seeking care at health facilities were the perception of poor quality of care, long waiting times, cultural beliefs and lack of medicines.

Proper management of non-malarial febrile illness remains a major challenge for both healthcare professionals and communities. Training, adherence to case management protocols and efforts to change behaviours to mitigate harmful sociocultural practices are urgently necessary to improve febrile illness management.

To examine whether exposure to anti-herpetic drugs (AHDs: acyclovir, valacyclovir, famciclovir) is associated with reduced risk of Alzheimer’s disease (AD) treatment initiation.

Population-based retrospective matched cohort study.

University Groningen community pharmacy database IADB.nl, covering approximately 125 Dutch pharmacies (1994–2024).

262 757 adults aged 50–80 years without prior dementia or AD treatment. Exposed individuals with antiherpetic prescriptions (n=23 887) were matched 1:10 to unexposed controls (n=238 870) by age, sex and calendar time.

AHDs: acyclovir, valacyclovir, famciclovir.

Initiation of AD drug treatment, defined as at least two prescriptions for rivastigmine, donepezil, galantamine or memantine within 1 year. Cox proportional hazards models estimated HRs with 95% CIs, adjusted for comorbidities and medications. Analyses were stratified by period (1994–2018 vs 2019–2024) and drug type.

During follow-up, 2495 participants initiated AD treatment. The age of the participants was 65 (SD 9), and 59% were female. Any AHD exposure was associated with 90% reduced hazard of AD treatment (HR 0.09, 95% CI 0.07 to 0.13, p

AHD exposure was consistently associated with markedly lower risk of AD treatment initiation, with similar findings observed in recent years. These findings support the hypothesis that herpesvirus reactivation may contribute to AD pathogenesis and suggest antiviral therapy could have preventive implications. Confirmation through prospective studies and randomised trials is needed.

Emerging evidence supports a role for interleukin 6 (IL-6), a pro-inflammatory cytokine, in the pathogenesis of treatment-resistant major depressive disorder (TRD). However, interventional studies targeting IL-6 in this population remain scarce. Tocilizumab is a humanised monoclonal antibody that inhibits IL-6 signalling and is approved for the treatment of autoimmune conditions such as rheumatoid arthritis. The primary objective of this study is to examine whether IL-6 inhibition via tocilizumab can impact depressive symptoms, inflammation-related biomarkers and cognition in patients with TRD. A secondary objective is to compare the biological profiles of patients with TRD with elevated inflammation to those of healthy controls.

This is a proof-of-concept, randomised, parallel-group, triple-blind, placebo-controlled clinical trial. 22 adult outpatients diagnosed with TRD and evidence of low-grade inflammation (serum C reactive protein≥3 mg/L) will be randomised (1:1) to receive either one intravenous infusion of tocilizumab (8 mg/kg; maximum 800 mg) or normal saline, administered as an add-on to their ongoing treatment. Psychiatric, cognitive and biomarker assessments will be performed at baseline and at follow-up visits on days 7, 14 and 28 post-infusion. Additionally, 10 healthy controls with no psychiatric history will undergo the same baseline assessments for biomarker comparison.

The study has been approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre (Project number: 2025-0245, CAAE: 88904825.7.0000.5327). Findings will be disseminated through peer-reviewed publications, scientific meetings and, on request, lay summaries for participants.

NCT07052058.

In patients with a hip fracture, anaemia has been associated with increased transfusion requirements, poor functional outcomes, prolonged hospital stays and increased mortality. While anaemia in elderly patients with hip fractures has traditionally been attributed to bleeding during or after surgery, many of these patients are anaemic on hospital admission. Thus, detecting and managing anaemia in the perioperative, postoperative and, most significantly, the preoperative period is important to avoid the need for blood transfusions and to improve patient outcomes. The protocol for this clinical trial is designed to evaluate the efficacy and safety of both combined intravenous and topical tranexamic acid (TXA) therapy, or topical administration alone, assessing its effect on blood loss and the need for blood transfusions in elderly patients undergoing hip fracture surgery.

This is a multicentre, double-blinded, randomised, placebo-controlled trial with a 1:1 allocation ratio. Patients of both sexes, aged ≥65 years, who are admitted to the emergency department and will undergo hip fracture surgery are eligible for enrolment. Eligible patients who provide their consent will be stratified according to the type of fracture (intracapsular and extracapsular) and whether or not they are suitable for intravenous TXA therapy, and they will then be randomly allocated to receive either TXA or a placebo. The primary outcome is the blood transfusion rate from patient admission to the emergency department until discharge, while the secondary outcomes include: the preoperative, perioperative and postoperative haemoglobin and haematocrit levels; the preoperative and postoperative occult and total blood loss; the mean length of hospital stay; and any adverse events assessed for up to 1 year after patient discharge.

The study was approved by the Basque Country Ethics Committee (Ref.: 2021012) and the Spanish Agency for Medicines and Healthcare Products (Agencia Española de Medicamentos y Productos Sanitarios). All participants will provide their written informed consent prior to study inclusion. The trial’s results, regardless of its outcomes, will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals, and they will be made publicly available through the European Union Clinical Trials Register after the end of the clinical trial.

EudraCT Number 2020-002144-23; EUCT Number 2024-519349-31-00.

An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.

The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.

This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.

NCT06331195.

To assess the relationship between the structural position of individuals within their village network and symptoms of depression and postpartum depression, among men and women.

Community-based, observational, cross-sectional study.

176 villages in the Copan region of Honduras.

Village residents, comprising 25 605 adults surveyed in a census-based study; using data collected between October 2015 and December 2019.

Symptoms of depression and postpartum depression, among men and women.

Across all participants, 34.99% reported depression symptoms (40.50% for women and 27.62% for men). Among recent parents with a new child in the last 6 months, 28.89% reported postpartum depression symptoms (31.29% for women and 24.31% for men). Women with higher social intransitivity (ie, a greater proportion of friend-pairs among their friends that were not themselves connected) had higher odds of depression symptoms (OR=1.27, 95% CI 1.14 to 1.41), an association not found for men nor in postpartum parents. Because this coefficient is estimated on a 0–1 scale, it corresponds to approximately 2.4% higher odds of depression per 10 percentage-point increase in social intransitivity. In a signed-network decomposition that also included adversarial ties, only the proportion of incomplete/no-tie friend-pairs was associated with depression in women (OR=1.03, 95% CI 1.01 to 1.04), corresponding to approximately 3% higher odds of depression per 10 percentage-point increase.

We report that structural social network position and connectedness beyond dyadic ties, including the friendships and adversarial ties of a person’s friends, are associated with depression. These findings highlight the importance of linking psychological health to broader social connections in the context of face-to-face relationships.

Scaling and root planing (SRP) combined with adjunctive antibiotic therapy is widely adopted in the management of periodontitis in patients with type 2 diabetes mellitus (T2DM), with the aims of ameliorating glycaemic control, alleviating local inflammation and facilitating periodontal tissue regeneration. As a topically administered adjunctive antibiotic for periodontal treatment, minocycline hydrochloride (MH) ointment has shown favourable clinical efficacy in systemically healthy patients with periodontitis. However, robust evidence supporting its clinical efficacy and potential glycaemic-improving effects in patients with periodontitis complicated by T2DM remains limited. The present study is designed to test the null hypothesis that no significant differences in clinical outcomes exist between SRP combined with MH and SRP alone in the management of periodontitis among patients with T2DM, with its primary objective to investigate whether MH as an SRP adjunct confers superior clinical benefits to SRP alone.

We will conduct a randomised, single-blind, placebo-controlled clinical trial. 56 patients with T2DM-associated stage III/IV periodontitis will be recruited from the Department of Periodontology, Peking University School and Hospital of Stomatology, Beijing, China. Eligible participants will be randomised into two groups: the experimental group will undergo SRP combined with topically administered MH ointment and the control group will undergo SRP with a matched placebo. The primary outcomes will include probing depth (PD) changes at periodontal pocket sites with a baseline PD ≥6 mm at 6 months post-baseline, with a specific focus on the percentage of such sites with PD reduced to ≤5 mm. The secondary outcomes will comprise PD changes at pocket sites with a baseline PD ≥5 mm at 6 months post-baseline, as well as clinical attachment loss, the plaque index, bleeding index, the levels of IL-1β, IL-17, calprotectin and insulin levels in gingival crevicular fluid and serum, complete blood count, blood biochemistry, including glycated haemoglobin levels, and the composition of subgingival plaques at baseline, and 2 and 6 months post-baseline.

This study was approved by the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-2024102139b). Results will be published in a peer-reviewed scientific journal.

ChiCTR2400092305.

V.3.1 (date: 6 January 2026).

To synthesise evidence from systematic reviews on difficult intravenous access (DIVA) in adults, focusing on definitions, diagnostic criteria, risk factors and clinical interventions to guide clinical practice and health policy.

Umbrella review of systematic reviews and meta-analyses.

Any clinical setting involving adult patients requiring peripheral venous access (including hospital, emergency and outpatient care).

A systematic search was performed in PubMed, CINAHL, Cochrane, Scopus and Web of Science in July 2025.

Systematic reviews and meta-analyses published from 2014 to 2025 that addressed DIVA in the adult population were included. Primary studies and protocols were excluded.

Methodological quality was assessed using the Risk Of Bias In Systematic Reviews tool. Data extraction followed the Joanna Briggs Institute methodology for overviews and the Preferred Reporting Items for Overviews of Reviews reporting guideline.

Seven reviews (six systematic reviews and one meta-analysis) were included. Three analytical dimensions emerged: (1) the conceptual and operational definition of DIVA, identifying common elements such as ≥2 failed attempts, lack of visible or palpable veins and a documented history of difficult access; (2) risk factors and clinical assessment, highlighting obesity, chronic diseases, prior chemotherapy, venous invisibility or non-palpability and the limited validation of diagnostic tools and (3) interventions, including organisational strategies (escalation protocols, specialised teams), technological resources (ultrasound guidance) and clinical measures (pain management and technique optimisation).

DIVA is a multifactorial challenge that requires a standardised definition to improve clinical identification. Effective management relies on a combination of specialised training, the use of ultrasound technology and the implementation of escalation protocols to ensure patient safety and efficiency.

CRD420251084947.

This study aimed to determine the associations between adherence to the 24-hour movement guidelines and symptoms of anxiety and depression among Colombian university students.

Cross-sectional study.

1125 individuals (mean age 20.2±2.5 years; 56.7% female).

Students sampled from a single public university.

Participants completed validated self-report instruments: the International Physical Activity Questionnaire-Short Form to assess physical activity (PA), sedentary behaviour (SB) and the Pittsburgh Sleep Quality Index to assess sleep duration. Symptoms of depression and anxiety were measured using the Hospital Anxiety and Depression Scale, with a score of ≥11 used to classify elevated symptoms. Binary logistic regression models were used to estimate associations between adherence to the 24-hour movement guidelines (meeting all three, two, one or none) and mental health outcomes, adjusting for potential confounders.

Only 15.5% of students met all three components of the 24-hour movement guidelines. Meeting a greater number of components was significantly associated with lower odds of depressive and anxiety symptoms. In fully adjusted analyses, students who met all three guidelines were less likely to report anxiety symptoms (OR=0.26; 95%CI 0.13 to 0.54) and depressive symptoms (OR=0.42; 95%CI 0.22 to 0.79) compared with those who met none. Among individual behaviours, sufficient PA and adequate sleep were independently associated with lower odds of both outcomes, whereas high SB was associated with higher odds of elevated symptoms.

In this cross-sectional study, adherence to a greater number of 24-hour movement guideline components was associated with lower levels of anxiety and depressive symptoms in a graded manner. However, the cross-sectional design precludes inference regarding directionality or causality, and bidirectional associations or residual confounding remain possible. Longitudinal and interventional studies are needed to determine whether integrated daily movement behaviours influence mental health outcomes in young adults, particularly in Latin American populations.

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.

The DREAMSPHEN study (Dose REduction of Antipsychotics vs. Maintenance treatment in schizophrenia after Stratification based on psychotic PHENotype) aims to compare the benefits and risks of a hyperbolic tapering method for antipsychotics to the maintenance of antipsychotics in a sample of clinically stabilised patients with schizophrenia spectrum disorder.

A sample of 288 patients will be recruited from 12 centres in France. Inclusion criteria are: diagnosis of schizophrenia spectrum disorder (according to the 5th version of the Diagnostic and Statistical Manual of mental disorders, DSM-5), minimum of 3 months remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine and long-acting antipsychotic injection). First, the psychotic phenotype of the patients (cycloid psychosis vs other psychotic phenotype) will be assessed. Then, patients will be randomised either to the maintenance of treatment (MT) or to the antipsychotics dose reduction (DR) arm. DR will follow a hyperbolic schema according to Horowitz protocol. Patients will be assessed at baseline, and every 2 months until 24 months follow-up regarding social functioning, psychotic and negative symptoms, side effects of antipsychotic medication, cognitive functioning, patient satisfaction, substance and alcohol use, and quality of life. The primary outcome will be a good social functioning after 24 months defined as a score at the Personal and Social Performance Scale >70. Secondary outcome measures will include: psychotic and negative symptoms, hospitalisation for psychotic episode, antipsychotic dose, antipsychotic side effects, withdrawal symptoms, cognitive functioning, patient’s well-being and quality of life. Safety measures will include death, admissions to psychiatric hospital, psychotic relapses and severe self-harm.

The DREAMSPHEN trial aims to better identify patients with psychotic disorders who are most likely to benefit from antipsychotic tapering with an aim to inform future clinical treatment guidelines for antipsychotic treatment. DREAMSPHEN V2.0 of the 14 May 2025 has received ethical approval from Comité de protection des personnes Ile de France IV (N° 2023-509558-80-00) on 17 July 2025.

EU Clinical Trials Register – EudraCT no. 2023-509558-80-00. Clinical trials: NCT07152184. Registered on 9 August 2025.

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.

Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.

A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol

The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.

EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.

To prospectively assess pregnancy-related care sought and obstacles and stress experienced by newly pregnant people.

The ADAPT Study, a longitudinal cohort study, followed 2015 non-pregnant participants aged 15–34 years for a year. Those with confirmed incident pregnancies were followed through their pregnancies and for 3 years.

We recruited participants from 23 reproductive and primary care facilities located in five southwestern states with different sociopolitical reproductive health contexts (restrictive, Arizona and West Texas; protective, southeastern California, Nevada and New Mexico).

334 people reported a new pregnancy within 1 year of enrolment; 324 with outcome data are included in this analysis.

Types of pregnancy care sought (‘Have you looked into where or how you could get (prenatal care, abortion care or adoption services)?’) and care-seeking stress (‘How stressful was it to find (prenatal, abortion or adoption) care for this pregnancy?’).

Most participants (83%, 270/324) sought prenatal care; 43% (138/324) sought abortion care; and 5% (17/324) sought adoption services. Overall, 17%, 29% and 23%, respectively, reported that care-seeking was extremely/quite a bit stressful. Abortion care-seeking was associated with significantly more stress than seeking prenatal care in the ordinal (adjusted odds ratio (aOR 1.70, 95% CI 1.10 to 2.62) but not logistic (aOR 1.33, 95% CI 0.74 to 2.38) model. Adoption care-seeking stress did not differ from prenatal care-seeking stress in either model. Participants who experienced any type of abortion care-seeking obstacle and those recruited in a state with a restrictive policy environment (aOR 2.72, 95% CI 1.09 to 6.80) reported more care-seeking stress than their counterparts.

People who seek pregnancy care often experience some care-seeking stress, regardless of the type of care they seek. Findings point to the need to reduce the burden of the pregnancy care-seeking process across all types of pregnancy care.

NCT03888404.

To explore the impact of acute worsening events (AWEs), defined as clinically relevant deteriorations in peak expiratory flow, reliever use and/or symptoms, on patients’ daily lives and identify behaviours linked to their recognition and management.

A qualitative international substudy was conducted in the Netherlands, Spain, the USA, Canada and the UK (2023–2024).

19 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) from a randomised clinical trial participated. Interviews, triggered by AWEs and repeated 6 weeks later, were audio-recorded, transcribed and analysed.

Patients varied in identifying bad days, reporting inability to perform physical activities, symptom worsening or the need for add-on treatment. Recognition of AWEs depended on their duration: shorter events (

AWEs significantly impact daily life but vary widely in recognition and thresholds for seeking care. Limited awareness of daily disease variations may contribute to both under-reporting of worsening events to healthcare providers and suboptimal self-management in COPD.

NCT05492877.

Genitourinary syndrome of menopause (GSM) is a chronic, oestrogen-deficient condition that is frequently underdiagnosed and undertreated. Although low-dose vaginal estriol improves epithelial trophism and microbial balance, a substantial proportion of women report persistent symptoms. High-quality randomised evidence evaluating combined therapeutic strategies remains scarce. Energy-based modalities, including the erbium:YAG (Er:YAG) laser (=2940 nm), have been proposed as adjunctive treatments. This trial aims to assess the efficacy of Er:YAG laser therapy combined with vaginal estriol compared with estriol alone in postmenopausal women with GSM.

This is a single-centre, randomised, double-blind, controlled clinical trial. Postmenopausal women aged 45–70 years with vaginal pH ≥5.0 and at least one moderate GSM symptom (Visual Analogue Scale ≥4) will be eligible. Exclusion criteria include current systemic or local hormone therapy, previous vaginal energy-based treatment, abnormal cervical cytology and body mass index ≥35 kg/m². All participants will receive vaginal estriol cream (0.5 mg per dose) daily for 14 days, followed by twice-weekly administration for 16 weeks. Participants will be randomised (1:1) to receive either estriol plus sham Er:YAG laser or estriol plus active Er:YAG laser. Three laser sessions will be delivered at approximately 4-week intervals. Assessments will occur at baseline, monthly during treatment and 4 months after the final session. The primary outcome is the Vulvovaginal Health Index, with the primary endpoint defined as the change from baseline to 4 months post-treatment, reflecting sustained effect. Secondary outcomes include GSM symptom severity, vaginal microbiome composition (16S rRNA sequencing), quality of life (Menopause Rating Scale) and sexual function (Female Sexual Function Index). Data will be analysed using repeated-measures analysis of variance or appropriate non-parametric tests, with significance set at p

Ethical approval has been obtained from the Human Research Ethics Committee of UNINOVE. Written informed consent will be obtained. Findings will be disseminated via peer-reviewed journals and scientific meetings.

NCT06873971.