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Tuberculosis death prediction calculator for prospective use at diagnosis in resource-constrained programme settings: a statewide cohort study

Por: Shanmugasundaram · S. · Shewade · H. D. · Srinivasan · R. · Frederick · A. · Sabarinathan · R. · Harish · P. · Balu · D. · Melfha · J. M. · Gayathri · K. · Vijayaprabha · R. · Jeyakumar · A. · Kabir · D. · Eraivan · M. · Bhatnagar · T. · Murhekar · M. V.
Objectives

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

Design

Statewide cohort study using routinely captured secondary data.

Setting

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.

Participants

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.

Outcome measures

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.

Results

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.

Conclusion

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.

Ventilation strategies and outcomes after out-of-hospital cardiac arrest: protocol for a pre-planned sub-analysis of the STEPCARE trial

Por: Battaglini · D. · Gualdi · F. · Cammarota · G. · McGuigan · P. J. · Thomas · M. · Skrifvars · M. B. · Niemelä · V. H. · Reinikainen · M. · Bass · F. · Young · P. J. · Lilja · G. · Dankiewicz · J. · Hammond · N. E. · Hästbacka · J. · Levin · H. · Moseby-Knappe · M. · Saxena · M. · Tia
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

ClinicalTrials.gov

NCT05564754.

Perceptions of healthcare professionals and community members on acute febrile illness management in Maputo and Quelimane City: a qualitative study

Por: Monteiro · V. D. C. O. · Nhassengo · P. · Muamine · E. · Alho · P. · Manganhe · Y. · Zandamela · A. · Cambe · M. I. · Gudo · E. S. · Craveiro · I.
Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Add-on tocilizumab versus placebo for resistant major depression in psychiatric outpatients with low-grade inflammation in a tertiary public hospital in Southern Brazil: randomised triple-blind clinical trial protocol

Por: Portal · P. H. G. · Peixoto · G. N. · de Matos · M. R. · da Silva · L. C. N. · Alexandrino · G. B. · Dutra · P. H. G. · Carniel · B. P. · da Rocha · N. S.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT07052058.

Effect of a culturally adapted heart-healthy diet with phytosterols and/or krill oil on lipid-related outcomes in familial hypercholesterolaemia: protocol for a multicentre randomised controlled trial in Brazil

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT06331195.

Enhancing screening, early diagnosis and treatment initiation of oral, breast and cervical cancer in selected districts of India: an implementation research protocol

Por: Kankaria · A. · Shukla · P. · Vijayakumar · M. · Sachdeva · A. · Subramanian · M. J. · Borah · P. K. · Sahoo · S. S. · Nirgude · A. · Prusty · R. K. · T S · S. · Asuri · K. · Verma · P. · Sharma · J. · Dhaliwal · R. S. · Begum · S. · Kaur · T. · ICMR-NHRP Cancer Screening Group · Bhatla
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

CTRI/2025/08/092672.

Barriers and facilitators to service utilisation and management of sexually transmitted infections in India: a multicentric mixed-method approach study protocol

Por: Aggarwal · S. · Khandekar · J. · Banerjee · B. · Agarwal · P. · Paul · S. · Parashar · M. · Goel · A. D. · Lakshmi · P. V. M. · Datkhile · K. · Naik · B. N. · Goel · M. · Verma · V. · Rajan · S. · Das · C. · Nigam · K.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Effects of Erbium:YAG laser combined with vaginal estriol therapy in postmenopausal women with Genitourinary Syndrome of Menopause: protocol for a randomised, double-blind, controlled trial

Introduction

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.

Methods and analysis

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

Ethics and dissemination

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.

Trial registration number

NCT06873971.

Clinical relevance of intracranial stenosis as false-positive findings of a deep learning algorithm trained to detect large vessel occlusions: a retrospective cohort study of a supraregional stroke centre

Por: Jungmann · M. · Manschikow · S. · Hönning · A. · Spohn · F. · Sparenberg · P. · Mutze · S. · Goelz · L.
Objectives

This study aims to explore the ability to identify high-grade intracranial arterial stenosis (ICAS) by an artificial intelligence (AI) designed to detect large vessel occlusions (LVO) and the clinical relevance of these ‘false positive’ findings.

Design

We are presenting a retrospective cohort study.

Setting

The study was conducted at a supraregional stroke centre of an urban tertiary care provider.

Participants

Consecutive stroke cases treated between January 2023 and December 2023 of patients >18 years of both sexes and any ethnicity were eligible for inclusion. 934 patients (52.7% male) with a mean age of 71.7±13.6 years (25–101 years) were included.

Interventions

CT angiographies were analysed by a deep learning algorithm for LVO detection of the anterior circulation. AI results were compared with radiology reports and secondary focused evaluation.

Primary and secondary outcome measures

Diagnostic accuracies for ICAS detection by the AI were calculated.

Results

Primary reports identified 30 ICAS and nine additional ICAS were detected during secondary evaluation (incidence 4.2%). The sensitivity of radiology reports was 77% (95% CI 0.61 to 0.89), the specificity 99% (95% CI 0.98 to 1.00), negative predictive value (NPV) 99% (95% CI 0.98 to 0.99) and positive predictive value (PPV) 79% (95% CI 0.65 to 0.88). The AI identified 13 of 39 ICAS correctly. 18 false positive cases (neither LVO nor ICAS) were flagged by the AI. The sensitivity of the algorithm was 33% (95% CI 0.19 to 0.50), the specificity 98% (95% CI 0.97 to 0.99), the NPV 97% (95% CI 0.96 to 0.98) and PPV 42% (95% CI 0.28 to 0.58).

Conclusion

Detection of high-grade ICAS by an algorithm trained to identify LVO is per se a false positive finding but occurred in 13 of 39 cases. Dedicated training for ICAS might lead to a beneficial tool during the diagnostic work-up for ischaemic stroke.

Trial registration

German Register for Clinical Trials (DRKS: DRKS00034019 https://drks.de/search/de/trial/DRKS00034019).

Use of ultrasound for early detection of ICU patients at risk of acquiring swallowing disorders: EIDAR, a prospective diagnostic study protocol

Por: Pineda · J. A. · Diaz · C. · Plasse · C. · Ruiz de la Fuente · J. M. · Duvillard · C. · Bozorg-Grayeli · A. · Pennecot · C. · Labruyere · M. · Andreu · P. · Roudaut · J.-B. · Taha · A. · Morariu-Patrichi · A. · Jacquier · M. · Sow · A.-K. · Fournel · I. · Quenot · J.-P.
Introduction

Postextubation swallowing disorders (SD) are common in the intensive care unit (ICU) and are associated with severe complications, including aspiration pneumonia, a three-fold increase in reintubation risk and higher mortality. While fibreoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopy are gold standards for diagnosis, they are often impractical or impossible to perform on intubated patients. The use of ultrasound offers a non-invasive, bedside alternative to evaluate the musculoskeletal structures involved in swallowing. The Echographie Identifier les troubles de Déglutition Acquis en Réanimation (EIDAR) study aims to evaluate the diagnostic performance of pre-extubation ultrasound in identifying patients at risk of SD following mechanical ventilation.

Methods and analysis

This prospective, monocentric diagnostic study conducted at the Dijon University Hospital ICU will include 100 adult patients ventilated for ≥48 hours. The primary outcome is the presence of SD, defined as a Penetration-Aspiration Scale score >2 during a FEES procedure performed 3 to 24 hours postextubation and independently assessed by an otolaryngologist blinded to index test results. Pre-extubation cervical ultrasound (Index Test) will be performed within 3 hours prior to extubation and measure hyoid bone ascension (primary variable of interest), geniohyoid muscle surface area and digastric muscle cross-sectional area. The diagnostic performance of cervical ultrasonographic parameters will be assessed using their discriminative capacity via a receiver operating characteristic curve. The feasibility of the ultrasound procedure in a critical care setting will also be assessed.

Ethics and dissemination

The study received a favourable opinion from the independent ethics committee CPP Ouest III and is registered with the French health authority ANSM (national agency on safety in medicine and health products). It is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Participants or their proxies provide free and informed oral consent. Results will be submitted for publication in peer-reviewed medical journals and presented at international conferences.

Trial registration numbers

RCB 2023-A00461-44 and NCT05922085

Socioeconomic burden of osteoarthritis in Sub-Saharan Africa and the determinants of healthcare inequities: a scoping review protocol

Introduction

Access to musculoskeletal healthcare services in Sub-Saharan Africa is inadequate. As osteoarthritis is the most prevalent chronic osteoarticular disease globally, it’s essential to understand its social and economic impact, as well as the determinants of inequities in access to healthcare services in Sub-Saharan Africa. The absence of systematised knowledge on this topic makes this review pertinent. However, due to data scarcity, assessing this burden is challenging. The objective of this scoping review is to map and summarise the available literature up to 2025 on the socioeconomic burden and health inequity determinants among the Sub-Saharan African population with osteoarthritis.

Methods and analysis

A predefined search strategy will be applied to MEDLINE (via PubMed), Embase, African Journals Online and African Index Medicus to incorporate articles relevant to adults diagnosed with osteoarthritis who are residents of sub-Saharan Africa. We will also include grey literature sources such as Google Scholar, Research Square, manuals, books, medical society websites, secondary databases, theses and dissertation repositories and conference proceedings. Study selection will be conducted in two stages by a pair of reviewers who will independently screen titles and abstracts according to the eligibility criteria, followed by a full-text review of the selected studies. The search period was from October 2025 to January 2026. Data extraction will be performed using a standardised charting form developed by the review team.

Ethics and dissemination

This scoping review maps evidence on OA-related socioeconomic impacts and healthcare inequities in Sub-Saharan Africa. As a secondary data analysis, ethical approval is not required. Findings will be disseminated via peer-reviewed journals and academic conferences to clinicians and policymakers.

Identifying social determinants of health subgroups and their associations with health outcomes in a prospective US adult COVID-19 cohort: an analysis of the INSPIRE registry

Por: Burrola-Mendez · Y. · Lin · E. · Parrish · C. · Hsu · C. · Hill · M. J. · Gottlieb · M. · Rising · K. L. · Wisk · L. E. · Gentile · N. L. · Geyer · R. E. · Weinstein · R. A. · Santangelo · M. · Gatling · K. · Dyal · J. W. · Elmore · J. G. · Rodriguez · R. M. · Watts · P. · Chen · J. · Diao
Objective

To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.

Design

Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.

Setting

Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and Seattle).

Participants

Adults aged ≥18 years, fluent in English or Spanish, with self-reported acute COVID-19 symptoms and a confirmed positive SARS-CoV-2 test within 42 days before enrolment (9 December 2020 to 12 August 2022), and access to an internet-connected device. Exclusions included incarceration, inability to provide informed consent, lack of confirmed SARS-CoV-2 infection or no internet access. Of 3791 eligible participants with complete baseline data, 2897 (76.4%) completed the 3-month follow-up and 2666 (70.3%) completed the 6-month follow-up; most were aged 18–49 years (74–75%), female (66–67%), white (86.6–87.5%) and non-Hispanic (86.6–87.5%).

Outcome measures

Prespecified primary outcomes were physical and mental health (Patient-Reported Outcomes Measurement Information System (PROMIS)-29 V.2.1 T-scores for depression, anxiety, fatigue, sleep disturbance, pain interference, physical function and social participation), cognitive function (PROMIS Cognitive Function Short Form 8 T-scores) and missed workdays due to illness (binary: >1 week vs ≤1 week, from a single-item survey). All measures were self-reported and collected at baseline, 3 months and 6 months; no changes from protocol.

Results

LCA identified a 4-class model as optimal (lowest Bayesian Information Criterion (BIC) after evaluating 1–7 class models; significant demographic differences (2 p

Conclusions

In this US prospective cohort, SDOH-based subgroups showed persistent disparities in health outcomes post-SARS-CoV-2 infection. Findings highlight the urgent need for intersectional approaches to address systemic inequities in post-COVID-19 recovery.

Trial registration number

NCT04610515.

The LIFE study: a cross-sectional study protocol for LIfestyle risk Factors for chronic disease across the stagEs of reproductive ageing

Por: Pernoud · L. E. · Noll · J. L. · Gardiner · P. A. · Dean · M. · Broadhouse · K. M. · Walker · M. A. · Wright · H. H. · Villani · A. · Scott · J. · Metse · A. P. · Schaumberg · M. A.
Introduction

The dynamic physiological and hormonal changes through the menopause transition predispose women to an increased risk of chronic diseases including cardiovascular disease, metabolic disease, depression and dementia. The underlying mechanisms remain unclear, yet it is thought that chronic systemic inflammation and changes to lifestyle behaviours play important roles. The LIfestyle risk Factors for chronic disease across the stagEs of reproductive ageing (LIFE study) is a cross-sectional study aimed to characterise how hormonal and lifestyle (physical activity, diet and sleep) differences across pre, peri and postmenopause influence chronic systemic inflammation, visceral adiposity, cognitive function and sleep health.

Methods and analysis

Women aged between 40 and 65 years were recruited and classified into pre, peri or postmenopausal groups. Body composition measures and blood samples were collected. Sleep and physical activity were objectively measured using activPAL4 and ActiGraph GT9X link accelerometer over 7 days. Participants were also provided with a sleep diary. Physical function was assessed using the Short Physical Performance Battery. Cognitive function was evaluated using Addenbrooke’s Cognitive Examination-III and Cambridge Neuropsychological Test Automated Battery. Participants completed a series of questionnaires: Depression, Anxiety and Stress Scale-21, RuSATED, Berlin Questionnaire, Insomnia Severity Index, Activities-specific Balance Confidence Scale and the Australian Eating Survey.

Ethics and dissemination

Ethical approval was received from the relevant University Human Research Ethics Committee (ethics approval number #S221718) prior to the commencement of the research project. Data collection is ongoing and expected to be completed by April 2026. Results are expected to be available from July 2026. Findings will be disseminated in national and international conferences and in peer-reviewed journals and expected to inform how differences in lifestyle behaviours across menopause influence chronic systemic inflammation, visceral adiposity and cognitive function. Understanding and characterising the links between lifestyle behaviours and menopausal symptoms will inform targeted strategies to improve long-term well-being, heart, brain and metabolic health.

Prevalence of PRISm and COPD and associated factors in a university medical centre spirometry unit: a cross-sectional analysis

Por: Akiki · Z. · Khoueiry · E. · Smayra · E. · Nader · A. · El Teress · K. · Safi · C. · El Ashkar · I. · Majed · A. · Fawaz · A. · Salameh · P. · Gaspard · D.
Objectives

Preserved Ratio Impaired Spirometry (PRISm) is a new spirometric entity defined in international guidelines, associated with overall worse outcomes. It remains unclear whether this represents a distinct entity or an early phase of multiple other diseases, such as chronic obstructive pulmonary disease (COPD) and restrictive lung diseases. There is a notable scarcity of data on PRISm, particularly in Lebanon. This study aimed to evaluate the prevalence of PRISm and COPD, and their associated factors, among individuals aged 40 years and above who underwent spirometry in a single university medical centre between 2022 and 2024.

Setting

Outpatient Pulmonary Function Tests Laboratory at a Lebanese university medical centre.

Participants

All individuals aged 40 years or older who performed spirometry between 2022 and 2024

Methods

A retrospective analysis of pulmonary function tests (PFTs) and demographics was performed. Patients were classified based on the spirometry patterns that are consistent with COPD (forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC)1/FVC≥0.7 and FEV11/FVC≥0.7 and FEV1≥80%). A small number of PFTs did not meet the above criteria and were classified as ‘others’; they were excluded from the main analysis but retained for descriptive estimation of PRISm and COPD prevalence over the past 3 years. The prevalence and associated risk factors of PRISm and COPD were assessed. Descriptive, bivariate and multinomial regression models were performed using IBM’s Statistical Package for the Social Sciences V.29.

Results

A total of 698 PFTs were performed for 639 patients. The prevalence of PRISm and COPD in the centre between 2022 and 2024 was 11% and 17%, respectively. Compared with normal PFTs, subjects with PRISm were older (adjusted OR; aOR (95% CI)=1.03 (1.002 to 1.05); p=0.03) and more likely to be ex-smokers (aOR=2.19 (1.12 to 4.30); p=0.022); patients with COPD were older (aOR 1.09 (1.07 to 1.12); p

Conclusion

These findings highlight PRISm as a potentially relevant pattern within chronic airway disease. Within the context of Sustainable Development Goal 3 on non-communicable diseases, they underscore the importance of identifying this subgroup for closer clinical attention. Further longitudinal and multicentre studies are needed to better understand the clinical significance of PRISm and its relationship to chronic airway diseases.

Humanistic care in the ICU: effects on patient dignity, delirium and family satisfaction - a non-randomised clinical trial protocol

Por: Asgari · P. · Fattah Ghazi · S. · Mansoor Samaei · F.
Introduction

Critical care patients face varying degrees of physical and psychological stress; in recent decades, the increasing focus on technologies and clinical processes has led to dehumanisation. In contrast, humanistic care has been introduced as an essential care paradigm, emphasising comprehensive care and considering all stakeholders in the care process (patient, family and staff). In addition to improving clinical outcomes, this approach focuses on family satisfaction, preserving the human dignity of patients and reducing the incidence of acute cognitive disorders such as delirium; therefore, the aim of this study is to assess the impact of humanistic care on these three key areas in the intensive care unit (ICU).

Methods and analysis

This non-randomised clinical trial was performed in the ICU. There are two distinct groups (194 patients)—a control group that receives usual care and an intervention group that receives both usual care and a set of targeted interventions based on the seven components of the Humanising Intensive Care (HU-CI) model (‘open-door ICU’, ‘communication’, ‘patient well-being’, ‘caring for professionals’, ‘post-ICU syndrome’, ‘end-of-life care’ and ‘humanised infrastructure’) for three main groups including healthcare personnel, patients and their families. The primary outcome is delirium (Confusion Assessment Method for the Intensive Care Unit tool), and secondary outcomes are family satisfaction (Family Satisfaction in the Intensive Care Units Questionnaire) and human dignity (Patient Dignity Inventory). Finally, the data will be analysed through STATA V.18 software using the statistical methods of independent t-test or its non-parametrical equivalent, 2 or Fisher’s exact tests, Mann-Whitney or Kruskal-Wallis tests, multivariate binary logistic regression models or analysis of covariance, and non-linear mixed models.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of the Tehran University of Medical Sciences (Ethical code: IR.TUMS.FNM.REC.1404.086). Informed consent will be obtained from all participants. The data will be shared on reasonable request to the corresponding author.

Trial registration number

IRCT registration number: IRCT20250727066651N1. Registration date: 30 July 2025.

Measured and supervised physical exercise for older individuals with asthma, chronic obstructive pulmonary disease and obstructive sleep apnoea (MIOLI): protocol of a randomised controlled trial

Por: Äijö · M. · Komulainen · P. · Lönnroos · E. · Lindholm · H. · Hiltunen · S. · Tikkanen · H. · Rantakokko · M. · Venojärvi · M.
Introduction

Asthma, chronic obstructive pulmonary disease (COPD) and obstructive sleep apnoea (OSA) are prevalent chronic respiratory diseases associated with increased comorbidity, mortality and healthcare costs. Physical activity and exercise are widely recommended as part of treatment for these conditions, yet the specific effects of Nordic walking (NW) remain underexplored. The aims of this randomised controlled trial (RCT) are to improve physical fitness, functional capacity and respiratory health and increase regular physical activity and quality of life of older adults with asthma and/or COPD and/or OSA through a supervised 3-month group-based NW intervention combined with resistance, balance and mobility training.

Methods and analysis

This single-blinded, parallel-group RCT will recruit 100 adults aged 55–80 years diagnosed with asthma and/or COPD and/or OSA in the Northern Savo region of Finland. Participants will be randomly allocated to either an intervention group or a control group.

The intervention group will participate in a 12-week supervised exercise programme consisting of progressive NW sessions twice per week and resistance, balance and mobility training once per week. The primary outcome is a change in cardiorespiratory endurance. Secondary outcomes include functional capacity, physical activity level, spirometry parameters and quality of life. The control group will continue their usual physical activity and receive physical activity guidance after 12 weeks. Measurements were conducted at baseline, three and 9 months. Data will be analysed according to the intention-to-treat principle. Group differences over time will be examined using appropriate parametric or non-parametric methods depending on data distribution.

Ethics and dissemination

Ethical approval was obtained from the Regional Medical Research Ethics Committee of Eastern Finland Collaborative Area (892/13.00/2023). Findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

Trial registration number

The trial is registered at ISRCTN12097135, registration date: 7 June 2024.

Completeness of the COVID-19 vaccination schedule and associated factors among persons experiencing homelessness in Brazil: a national cross-sectional study

Por: Soares Tenorio de Araujo · J. · Berra · T. Z. · Tartaro · A. F. · Rosa · R. J. · Tavares · R. B. V. · Alves · Y. M. · Pelodan · M. E. P. · Moura · H. S. D. · Ferezin · L. P. · Ramos · A. C. V. · do Nascimento · M. C. · Lima de Freitas · G. · Arcencio · R. A.
Objectives

To analyse the completeness of the COVID-19 vaccination schedule and identify factors associated with vaccine uptake.

Design

Cross-sectional study.

Setting

Data were collected through face-to-face interviews conducted in all 26 Brazilian state capitals and the Federal District between 2022 and 2023, using a sequential sampling approach.

Participants

A total of 1392 individuals aged 18 years or older experiencing homelessness for at least 6 months were included.

Primary and secondary outcome measures

The primary outcome was the completeness of the COVID-19 vaccination schedule (complete vs incomplete), based on self-reported vaccination status. Secondary analyses examined sociodemographic, institutional and behavioural factors associated with vaccine uptake using binary logistic regression.

Results

Completion of the vaccination schedule was positively associated with receiving government aid (OR: 1.58; 95% CI 1.09 to 2.30), visits from street clinic health agents (OR: 3.19; 95% CI 1.95 to 5.36), prior COVID-19 diagnosis (OR: 5.77; 95% CI 3.17 to 11.15), support for mandatory vaccination (OR: 3.76; 95% CI 2.48 to 5.76), trust in vaccine efficacy (OR: 3.92; 95% CI 2.63 to 5.89), seeking information from community sources (OR: 1.91; 95% CI 1.01 to 3.88) and trust in federal authorities (OR: 1.57; 95% CI 1.06 to 2.31).

Conclusions

This study identified structural, social and individual factors associated with complete COVID-19 vaccination among people experiencing homelessness in Brazil. Although overall coverage was substantial, gaps in vaccination completeness persisted. Social support, healthcare outreach and trust in vaccines were associated with higher uptake, highlighting important barriers and facilitators to vaccination in socially vulnerable populations.

Integrating Dental Healthcare into Primary Health Care through an implementation model in two districts of Karnataka in India: An implementation research study protocol

Por: Chilgod · L. · Krishna B M · R. · Raveendran · R. · B Hebbar · P.
Introduction

Despite progress in primary care, access to oral health remains limited in India. Integrating oral health into primary care can improve oral health outcomes for communities, especially in rural areas. This study aims to develop an implementation model for integrating dental healthcare into primary healthcare systems in Chamarajanagar and Mysuru districts of Karnataka.

Methods and analysis

A mixed-methods implementation research approach will be adopted for this study, comprising three phases: formative, pilot and implementation and evaluation.

A mixed-methods study at the district level will be conducted to capture diverse perspectives and characterise inequalities in oral healthcare access and literacy levels across urban, rural and tribal areas. Oral health literacy surveys, facility preparedness checklists and in-depth interviews will be conducted. With a consultative approach involving stakeholders, we ensure their input in the design and pilot the integrated interventions to build a replicable model for integrating dental health services into primary healthcare.

Through this structured approach, the study seeks to improve overall oral health outcomes and achieve sustainable improvements in oral health at both community and system levels.

Ethics and dissemination

This study has been approved by the Institutional Ethics Committee at the Institute of Public Health Bengaluru (IPH/23-24/E/374). Findings will be disseminated through workshops, presentations and publications in peer-reviewed journals.

Consultation-Liaison psychiatry in a high-complexity university hospital in Turin, Italy: an observational study with a focus on delirium and predictive factors of clinical outcome

Por: Bozzatello · P. · Novelli · R. · Schisano · R. · Montemagni · C. · Rocca · P. · Bellino · S.
Background and aim

This observational study aims to provide an overview of consultation-liaison psychiatry (CLP) activity within the high-intensity, complex hospital setting of the ‘Azienda Ospedaliera Universitaria Città della Salute e della Scienza’ in Turin. The study is mainly focused on delirium-related features and predictive factors of clinical outcome.

Method

A retrospective analysis was conducted on 500 psychiatric consultations provided by the University Facility of Psychiatry. Additional analysis was performed in a subgroup of patients with a diagnosis of delirium (143 subjects). The Delirium Rating Scale-Revised-98 (DRS-R-98) was administered at the time of consultation (T0) and 1 week later (T1). Descriptive statistics were performed on the whole sample. In the subgroup of patients with delirium, linear regression for continuous variables and one-way analysis of variance for categorical variables were conducted. Stepwise multiple regression was performed with DRS-R-98 (difference of DRS-R-98 score between T0 and T1) as the dependent variable.

Results

The majority of requests for consultation came from the internal medicine department or from orthopaedic and trauma units and concerned male patients with a positive history of psychiatric disorders. Although psychiatric re-evaluations were frequently required, transfers to the psychiatric ward were rare (9.8%), and there were no compulsory psychiatric admissions in our sample. In addition to delirium, the most frequent reason for requesting CLP evaluation was depressive disorder. Among the 143 cases of delirium, the mean age and prevalence of males were higher than in the whole sample. Mortality was also higher (28%) than in the whole sample (17.6%). In the stepwise multiple regression analysis, variables significantly and independently associated with DRS-R-98 included: age (t=–4.074; p

Conclusions

CLP interventions in our high-complexity general university hospital were mainly requested for patients with mood disorders and delirium. CLP service provides an important opportunity to identify unknown psychiatric disorders or symptoms below the diagnostic threshold. Predictors of improvement of delirium-related symptoms are young age and the use of atypical antipsychotics, while BDZ treatment can be considered a negative predictor of outcome in patients with delirium. Further research on this topic is recommended to better understand the relevance of CLP, particularly the effects of this type of intervention in the management of delirium.

Effect of yoga on musculoskeletal complaints in women during endocrine treatment for breast cancer: protocol of the randomised controlled COBRA trial

Por: Veenhuizen · S. G. A. · Gal · R. · Cramer · H. · Bijlsma · R. M. · Blickle · P. · van der Palen · J. · Wagenaar · Q. R. C. M. · van Leer · E. · Konings · I. · van den Bongard · D. H. J. G. · May · A. M. · Monninkhof · E. M.
Introduction

Approximately 40% of women stop endocrine therapy for hormone-receptor-positive breast cancer within the first 5 years of prescribed treatment because of side effects. Musculoskeletal complaints are among the most frequently reported side effects. The Cancer Of the BReast Asanas (COBRA) study examines the effect of an 18-week yoga programme on endocrine therapy-associated musculoskeletal complaints in women with breast cancer.

Methods and analysis

In total, 140 women will be randomised in a 1:1 ratio to the intervention or waitlist control group. The intervention programme consists of two times a week 1-hour supervised Hatha or (easy) Vinyasa yoga classes at a yoga or sports centre for 18 weeks and once per week a half-hour at home using videos. The waitlist control group is asked to maintain their habitual lifestyle during the first 18 weeks and will participate in a similar yoga programme to the intervention group for the following 18 weeks. The control group yoga programme is offered live-remote. The primary outcome (musculoskeletal complaints) is assessed with the Brief Pain Inventory questionnaire at baseline and 18 weeks (primary comparison) and additionally at 36 weeks. Secondary outcomes include lower and upper extremity joint complaints, menopausal symptoms, fatigue, sleep, quality of life, anxiety and depression, cognitive complaints and habitual physical activity (all patient-reported), vital signs and anthropometrics, physical fitness, blood biomarkers, medication use, safety data and patient and teacher experiences. At baseline and 18 weeks, cognitive complaints are also assessed with an online neuropsychological test battery.

Ethics and dissemination

The COBRA study was approved by the Medical Ethical Committee of the University Medical Center Utrecht. The study started on 8 October 2024, and 65 participants have been included (20 January 2026). Results will be submitted to an international peer-reviewed journal.

Trial registration number

NCT06480513.

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