FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
Hoy — Marzo 4th 2026Tus fuentes RSS

Pragmatic, open-label, multicentre, randomised controlled trial to guide initial therapy for immune checkpoint inhibitor-induced inflammatory arthritis comparing standard of care (prednisolone) to adalimumab without glucocorticoids: REACT trial protocol

Por: Fisher · B. A. · Rowe · A. · Hodson · C. · Wilkhu · M. · Williams · E. · Turner · E. · Allard · A. · Blake · T. · Bombardieri · M. · Cope · A. P. · Dubey · S. · Mankia · K. · Malley · T. · Moore · O. · Payne · M. · Plummer · R. · Tilby · M. · Tillett · T. · Wong · E. · Wu · Y. · Filer · A. · Pra
Introduction

Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.

A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.

Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.

Methods and analysis

REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).

The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.

Ethics and dissemination

The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

ISRCTN18217497.

AnteayerTus fuentes RSS

Exploring stress and coping among black women in early midlife with elevated blood pressure in a safety-net health system: a qualitative focus group protocol

Por: Sprague · B. N. · Beverly · A. R.
Introduction

Black women in early midlife experience disproportionate exposure to stress and elevated cardiovascular risk, including hypertension. Despite this, few stress management interventions are designed with and for this population. This study aims to explore the lived experiences of stress and coping among black women in early midlife with elevated blood pressure to inform the codesign of a culturally relevant, multilevel stress management intervention.

Methods and analysis

We will conduct one-time, semistructured focus groups with black women aged 35–50 who have elevated blood pressure, recruited from a large safety-net health system. Data will be analysed using a constructivist grounded theory approach, with inductive theme development supported by line-by-line, focused and theoretical coding. The Social Determinants of Cardiovascular Disease framework will serve as a sensitising guide to multilevel contextual factors rather than a prescriptive coding structure. An artificial intelligence (AI)-assisted analytic component will complement human-led analysis by supporting preliminary theme exploration and enhancing transparency.

Ethics and dissemination

Approved by the Indiana University Institutional Review Board (Protocol #21785). All participants will provide written informed consent. Findings will be shared via peer-reviewed publications, conference presentations and lay summaries for stakeholders.

Development and evaluation of a mobile health (mHealth) application for smoking cessation among adolescents in Indonesia: a mixed methods randomised controlled trial study protocol

Por: Ilmaskal · R. · Prabandari · Y. S. · Oktaria · V.
Introduction

Adolescent smoking poses a critical public health challenge in Indonesia, where approximately 7.4% of adolescents are current smokers. This issue is compounded by the tobacco industry’s aggressive marketing strategies, particularly targeting youth. Mobile health (mHealth) interventions offer promising alternatives for smoking cessation because of their accessibility and adaptability. However, while mHealth applications have shown potential in promoting smoking cessation, their efficacy remains inconsistent, particularly among adolescent populations in low- and middle-income countries. This study aims to develop an innovative mHealth intervention model designed explicitly for adolescent users.

Methods and analysis

This study used a mixed-methods, sequential, exploratory approach, including a randomised controlled trial. The research will be conducted in three phases: (1) a qualitative study to inform the app’s design; (2) a development phase using the Rapid Application Development model; and (3) a single-blind, two-arm randomised controlled trial to evaluate the app’s efficacy. Participants will be randomised into either the mHealth intervention group or a paper-based control group using block randomisation to ensure balanced allocation and minimise bias. The protocol is compliant with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for transparency and reporting. The study population will consist of adolescent smokers aged 13–15 years who reside in Padang City. A total of 110 participants will be recruited, with 55 adolescents in the intervention group and 55 in the control group. The primary outcome is smoking abstinence at 1-, 3- and 6-month follow-ups, which will be assessed through a self-report questionnaire. Secondary outcomes include changes in self-efficacy, motivation, social support, nicotine dependence and user engagement with the intervention.

Ethics and dissemination

The study complies with protocols, the Helsinki Declaration, the principles of Good Health Research Practice and regulatory requirements. The protocol was approved by the Medical and Health Research Ethics Committee, Faculty of Medicine, Public Health and Nursing, Gadjah Mada University (Ref No: KE-FK-0864-EC-2025). Informed consent will be obtained from both adolescents and their parents/guardians, ensuring confidentiality and voluntary participation. The results of this study will be published in peer-reviewed journals.

Trial registration number

NCT07198828.

Protocol for the development and testing of a web-based patient decision aid for early-stage breast cancer patients within a cancer centre care: a mixed-method approach

Por: Sdinami · S. · Sebri · V. · Monzani · D. · Zagami · P. · Criscitiello · C. · Grasso · R. · Bagnardi · V. · Curigliano · G. · Pravettoni · G.
Introduction

Early breast cancer (BC) detection enhances survival, with treatment options influenced by cancer stage, pathological characteristics and patient preferences. Patient decision aids (PDAs) promote shared decision-making (SDM), enhancing patients’ engagement, adherence to treatment and satisfaction. However, few PDAs for early-stage BC patients exist in the Italian context.

Methods and analysis

A first developmental phase will include a systematic review on current PDAs and semistructured interviews with patients and healthcare professionals. Outcomes will be used to develop a first draft of PDA. Following international guidelines, the PDA will be sent to patients to gather first qualitative feedback and subsequently quantitative feedback regarding the attractiveness, usability and comprehensibility of the tool and patients’ health literacy. Once having reached a final version of PDA, a pilot randomised controlled trial study will be implemented: a control group will receive standard care (n=75) and an experimental group (n=75) will receive standard care and the PDA. Depression, anxiety, SDM, quality of life (QoL) and distress levels will be assessed through validated questionnaires in both groups at three different time points. Measures will include attractiveness, usability and comprehensibility of the PDA as well as efficacy measures assessed through evaluation of patients’ levels of anxiety, depression, distress and QoL.

Ethics and dissemination

This protocol was approved by the ethical committee Comitato Etico Territoriale Lombardia 2 of the Istituto di Ricovero e Cura a Carattere Scientifico European Institute of Oncology (L2-253; approved in November 2024). All participants will be given written and verbal information, and informed consent will be obtained from all participants across all phases of our project. Participation in the study will be fully voluntary. All the methodologies mentioned in this protocol will be carried out according to both national and international declarations, guidelines and regulations compliant with proper ethical research involving human subjects. Results will be published in peer-reviewed journals, through traditional academic pathways. This protocol study has been registered on clinicaltrials.gov in January 2025 (Identifier: NCT06762496).

Trial registration number

NCT06762496.

Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial

Por: Coudroy · R. · Telias · I. · Jonkman · A. · Thille · A. W. · Diehl · J.-L. · Peron · N. · Ko · M. · Bourion · A.-A. · Tiribelli · N. · Fredes · S. · Gutierrez · M. · Manchado Bruno · A. · Vasquez · D. N. · Pratto · R. A. · Plotnikow · G. A. · Bianchini · F. · Accoce · M. · Dorado · J. · Sp
Introduction

Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

Methods and analysis

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics and dissemination

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

Trial registration number

NCT03963622.

Chrysin ameliorates methotrexate-induced hippocampal neurogenesis impairment by suppressing of oxidative stress and upregulating antioxidant enzyme activity in rodents

by Tanaporn Anosri, Soraya Kaewngam, Ram Prajit, Kornrawee Suwannakot, Nataya Sritawan, Anusara Aranarochana, Wanassanan Pannangrong, Jariya Umka Welbat, Peter Wigmore, Apiwat Sirichoat

Methotrexate (MTX) is used in treating several malignancies. However, MTX neurotoxicity remains a significant clinical side effect, leading to cell division malformation, and neurogenesis impairment. Chrysin, a flavonoid compound found in natural products, demonstrates various biological characteristics, including neuroprotective and antioxidant properties. The purpose of this study was to investigate the ameliorative effect of chrysin on oxidative damage and neurogenesis impairment caused by MTX. Male Sprague-Dawley rats were randomly divided into four groups, including the vehicle, MTX (75 mg/kg), chrysin (10 mg/kg), and chrysin+MTX groups. Chrysin was orally administered for 15 days. MTX was administered intravenously on days 8 and 15. The hippocampal neural stem cells were evaluated using sex determining region Y-box 2 (sox2) and nestin immunofluorescence staining. Antioxidant enzyme expression and the levels of oxidative stress marker were assessed. Additionally, the expressions of nuclear factor erythroid 2-related factor 2 (Nrf2), brain-derived neurotrophic factor (BDNF), cAMP-response element binding (CREB), and phosphorylated CREB (pCREB) were evaluated using Western blotting. Results showed that MTX significantly decreased the activity of antioxidant enzymes and produced oxidative stress. MTX also impaired neurogenesis, evidenced by decreased sox2 and nestin-positive cells and decreased expression of Nrf2, BDNF, CREB, and pCREB in the hippocampus and prefrontal cortex. However, chrysin significantly reversed the effects of MTX on these parameters. In conclusion, chrysin exhibits neuroprotective effects against MTX-induced neurogenesis impairment by upregulating antioxidant enzyme activity, reducing oxidative stress, and improving protein expression related to neurogenesis.

A cultural lens on decision-making in treatment decisions about inflammatory bowel disease: a qualitative analysis with South Asian patients, caregivers and clinicians in Canada

Por: Suryaprakash · N. · Ruzycki · S. M. · Raman · M. · Singh · S. · Nasser · Y. · Rai · P. P. K. · Sidhu · K. · Sidhu · S. · Marshall · D. A.
Objective

There are limited data about how South Asian (SA) patients, their caregivers and their physicians make decisions about treatment, in particular advanced therapies. The study aimed to explore how SA people with inflammatory bowel disease (IBD), their family members and clinicians experience and perceive treatment-related decision-making with the aim of identifying strategies to improve treatment decision-making in Canada.

Design

A descriptive qualitative study with in-depth semi-structured interviews.

Setting

Canada.

Participants

Adults residing in Canada, who self-identified as SA, had received treatment or cared for someone who received treatment for IBD from a gastroenterologist in Canada, and who spoke and understood English, Hindi and/or Punjabi were eligible to participate in the study. Clinician participants (eg, nurses, gastroenterologists, colorectal surgeons) were eligible if they had experience treating SA patients with IBD.

Interventions

Data from 1:1, semi-structured interviews were analysed using deductive and inductive thematic analysis.

Results

The length of time spent in Canada played a central role in patient perspectives on decision-making around IBD treatment. First or second-generation SA people, residency status, family and community involvement, universal factors like stigma, medication costs and preferences for non-pharmacological treatments influenced decision-making. Patient and caregiver participants reported high satisfaction with treatment-related decision-making processes, while clinician participants self-reported lesser satisfaction.

Conclusions

Clinicians and researchers working with SA patients in chronic disease specialties can use these findings to meet the healthcare needs and reduce disparities in optimal treatment for this patient population.

Trial registration

N/A.

From ADHD symptoms to parental stress: The roles of functional impairment, family functioning, and parental ADHD

by Nitchawan Jongrakthanakij, Thanavadee Prachason, Nida Limsuwan, Komsan Kiatrungrit, Masatha Thongpan, Passaporn Lorterapong, Pattarabhorn Wisajun, Sudawan Jullagate

Background

Raising a child with Attention-Deficit/Hyperactivity Disorder (ADHD) is associated with significant parental stress. However, the complex relationships between factors in the child and family in shaping this stress are not well understood. This study aimed to elucidate these interrelationships and identify the key determinants of parental stress.

Methods

A cross-sectional study included 127 children and adolescents with ADHD (70.9% males; mean age 9.6 ± 3.3 years) and their caregivers, recruited from the ADHD Registry at Ramathibodi Hospital, Bangkok (2019–2023). Caregivers completed standardized measures of parental stress, child ADHD symptoms, child functional impairment, family functioning, and parental ADHD symptoms. Structural equation modeling was used to examine pathways from child and parental ADHD symptoms to parental stress, with functional impairment and family functioning specified as mediators.

Results

Examining child- and family-related factors separately, child ADHD symptoms indirectly influenced parental stress via functional impairment, whereas parental ADHD symptoms significantly influenced parental stress both directly and indirectly via family functioning. In the integrated model examining both child- and family-related factors concurrently, the direct and indirect pathways from parental ADHD symptoms to parental stress via family functioning remained significant, but not the pathway from child ADHD symptoms to parental stress via functional impairment.

Conclusions

Functional impairment, parental ADHD, and family functioning, rather than child ADHD symptoms, are key determinants of parental stress in families of children with ADHD. These factors should be routinely assessed and targeted to alleviate parental stress more effectively than focusing on child ADHD symptoms alone.

Patient Engagement Interventions to Improve Medication Management of Older Patients Across Transitions of Care: A Mixed Methods Systematic Review

ABSTRACT

Aims

Identify and describe patient engagement interventions used to improve medication management in older adults during transitions of care.

Design

A mixed-methods systematic review.

Methods

A comprehensive search of all study designs was conducted. Studies were categorised using the ladder of patient and family engagement, a framework that positions engagement from low (passive) to high (active partnership) patient engagement.

Data Sources

Six databases were searched from inception to April 2024.

Results

The search yielded 29 reports, with 25 classified as studies. Most interventions (n = 19, 76%) were low-level interventions that comprised informing patients in a passive manner. Interventions that facilitated high-level engagement (n = 6, 24%) where patients were integrated in the decision-making process were associated with consistently improved patient and healthcare long-term outcomes.

Conclusions

While low and high-level engagement interventions were associated with significantly decreased hospital readmission rates, high-level interventions consistently demonstrated positive patient outcomes. Interventions supporting older adults beyond discharge achieved meaningful and lasting patient and healthcare outcomes for older adults.

Implications for the Profession and/or Patient Care

Findings provide clinical reference for designing engagement interventions, highlighting long-term benefits of partnership-based approaches and continuity beyond discharge.

Impact

Engagement in medication management during transitions of care varied significantly. High-level engagement was consistently linked to improved patient and healthcare outcomes but was often resource intensive. This review identifies the need to design balanced interventions that align with the preferences of older adults and real-world contextual healthcare settings.

Reporting Method

PRISMA guidelines.

Patient or Public Contribution

No patient or public contribution.

Protocol Registration

PROSPERO (registration number CRD42024557385).

Palliative care utilisation in migrant populations: protocol for a scoping review

Por: Gao · A. · Kutty · A. · Lau · C. · Chopra · M. · Cutler · C. · Chakraborty · A. · Ni · D. Y. · Nolen · A. · Bonares · M.
Introduction

Migrants are vulnerable to structural barriers that compromise their health status and simultaneously decrease their access to healthcare, including palliative care. Literature on palliative care access in migrant populations is limited by a focus on migration to high-income countries; under-representation of refugees, asylum seekers and migrant workers; and no investigation of intersectional factors. We seek to conduct a scoping review of palliative care utilisation in migrant populations, including both academic and grey literature, including articles from low- to middle-income countries and about refugees, asylum seekers and migrant workers. The review will map out what is already known and what remains unknown about palliative care utilisation in migrants; identify the factors associated with palliative care utilisation; and determine the extent to which intersectionality has been examined.

Methods and analysis

This scoping review will adhere to the methodological framework developed by the Joanna Briggs Institute, and reporting will be in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines. A search strategy developed by a health sciences librarian will be conducted on Ovid MEDLINE, Embase, CINAHL and PsycINFO in addition to grey literature sources up to 7 July 2025. Articles will be included if they studied migrant populations and reported on palliative care utilisation. Two independent reviewers will screen titles and abstracts and review full texts. Data extraction will be performed independently and in duplicate using a standardised, pilot-tested form. Findings will be synthesised thematically, with particular attention to countries of destination, migrant subgroups and intersectional factors.

Ethics and dissemination

Since this is a scoping review and uses only previously published data, it does not require approval by a research ethics board. Findings will be disseminated as an abstract for presentation at a palliative care conference and a manuscript for publication in a peer-reviewed journal.

Trial registration number

Open Science Framework (gy75v).

Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS

Por: Trad · G. · Lenglet · T. · Ledoux · I. · Querin · G. · Blancho · S. · Marchand-Pauvert · V. · Hogrel · J.-Y. · Pradat · P.-F.
Introduction

Robotic rehabilitation on locomotion is a new approach in amyotrophic lateral sclerosis (ALS) and previous studies showed its feasibility. In this study, we aim to evaluate safety, patient’s experience and efficacy of a gait training programme with the Atalante exoskeleton, compared with usual care, on walking ability, functional capacity and other symptoms associated with ALS.

Methods and analysis

EXALS is a monocentric, prospective, interventional, open trial. 20 slowly progressing patients with gait deficits will be recruited. The study is conducted in three phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients practise their gait training at a rhythm of three sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment. An evaluation is planned before, in the middle and at the end of each phase. The primary outcome of the study is safety and tolerability of the Atalante exoskeleton. Secondary outcomes include: participants’ subjective impact and experience, attitude and motivation, efficacy and interactivity of the exoskeleton, walking ability, functional capacity, spasticity, balance, postural stability, lower limb muscle strength, quality of life, pain, fatigue, anxiety and depression. Statistical analyses will include descriptive methods for all variables and adverse events. Quantitative outcomes are analysed using repeated-measures ANOVA (analysis of variance) across the seven visits, with post hoc tests applied when appropriate. Nominal outcomes are evaluated using Cochran’s Q test with McNemar pairwise comparisons when significant. Associations between variables are examined using Spearman correlation coefficients. Missing data will be replaced using linear interpolation, and sensitivity analyses will be planned. Qualitative interview data are analysed using thematic analysis.

Ethics and dissemination

This study was approved by the French ethics committee CPP Nord-Ouest I (no. 23.02378.000201). Participant data are anonymised and securely stored in the laboratory’s database, accessible only to the research team. Results will be disseminated through peer-reviewed journals and conferences.

NCT06199284.

Trajectory, healthcare utilisation and recovery in 3590 individuals with long covid: a 4-year prospective cohort analysis

Por: Prashar · J. · Hillman · T. · Wall · E. C. · Sarna · A. · Mi · E. · Bell · R. · Sahota · J. · Zandi · M. · McNamara · P. · Livingston · R. · Gore · R. · Lunken · C. · Bax · E. · Nyam · R. · Rafie Manzelat · A. M. · Hishmeh · L. · Attree · E. · Cone · S. · Banerjee · A. · Heightman · M.
Objective

To characterise long-term trajectory of recovery in individuals with long covid.

Design

Prospective cohort.

Setting

Single-centre, specialist post-COVID service (London, UK).

Participants

Individuals aged ≥18 years with long covid (hospitalised and non-hospitalised) from April 2020 to March 2024.

Main outcome measures

Routine, prospectively collected data on symptoms, quality of life (including Fatigue Assessment Scale (FAS) and EuroQol 5 Dimensions (EQ-5D), return to work status and healthcare utilisation (investigations, outpatient and emergency attendances). The primary outcome was recovery by self-reported >75% of ‘best health’ (EQ-5D Visual Analogue Scale) and was assessed using Cox proportional hazards regression models over 4 years. Linked National Health Service England registry data provided secondary care healthcare utilisation and expenditure.

Results

We included 3590 individuals (63.3% female, 73.5% non-hospitalised, median age 50.0 years, 71.9% with ≥2 doses of COVID-19 vaccination), who were followed up for a median of 136 (0–346) days since first assessment and 502 (251–825) days since symptom onset. At first assessment, 33.2% of employed individuals were unable to work. Dominant symptoms were fatigue (78.7%), breathlessness (68.1%) and brain fog (53.5%). 33.4% of individuals recovered to >75% of best health prior to clinic discharge (recovery occurred median 202 (94–468) days from symptom onset). Vaccinated individuals were more likely to recover faster (pre: HR 2.93 (2.00–4.28) and post: HR 1.34 (1.05–1.71) COVID-19 infection), whereas recovery hazard was inversely associated with FAS (HR 0.37 (0.33–0.42)), myalgia (HR 0.59 (0.45–0.76)) and dysautonomic symptoms (HR 0.46 (0.34–0.62)). There was high secondary care healthcare utilisation (both emergency and outpatient care). Annual inpatient and outpatient expenditure was significantly lower in hospitalised individuals while under the service. When compared with the prereferral period, emergency department attendances were reduced in non-hospitalised patients with long covid, but outpatient costs increased.

Conclusions

In the largest long covid cohort from a single specialist post-COVID service to date, only one-third of individuals under follow-up achieved satisfactory recovery. Fatigue severity and COVID-19 vaccination at presentation, even after initial COVID-19 infection, was associated with long covid recovery. Ongoing service provision for this and other post-viral conditions is necessary to support care, progress treatment options and provide capacity for future pandemic preparedness. Research and clinical services should emphasise these factors as the strongest predictors of non-recovery.

Comparative Analyses of Cyanoacrylates for Barrier Protection and Incontinence‐Related Wash‐Off Resistance

ABSTRACT

A comprehensive skincare regimen involves cleansing, moisturising, and using skin barrier protectants. Cyanoacrylate-based protectants safeguard vulnerable skin from damage caused by moisture, friction, and shear. This research involved two ex vivo and two clinical studies comparing the wear duration and wash-off resistance of a 100% cyanoacrylate and a solvent-cyanoacrylate mixture. Effectiveness was assessed using an ex vivo porcine skin model simulating urinary incontinence, evaluated with Lucifer yellow dye penetration and Corneometry, and a clinical model using Corneometry. Two single-blind clinical studies measured skin surface electrical capacitance in healthy volunteers. Study 1 (n = 42) evaluated the wear duration over 8 days, while Study 2 (n = 52) examined wash-off resistance after nine washes with various cleansers. Ex vivo results showed that both products were effective under repeated moisture and abrasion conditions, with the 100% cyanoacrylate outperforming the solvent-cyanoacrylate mixture. In clinical studies, both products maintained barrier protection throughout Study 1 (p < 0.007) and none of the cleansers significantly degraded either product in Study 2. In conclusion, the 100% cyanoacrylate provided superior protection compared to the solvent-cyanoacrylate mixture. Both products demonstrated comparable wear duration and wash-off resistance in clinical studies, but the 100% cyanoacrylate was more effective in ex vivo testing under harsh conditions.

Exploring the mechanisms of yoga-based cardiac rehabilitation in heart failure via assessment of endothelial function, genomics and arterial health (Yoga-EndOmics): a study protocol

Por: Shetty · V. V. · Patil · L. R. · Patil · S. G. · Aithal · K. · Oli · A. K. · Yenagi · V. A. · Kaulgud · R. S. · Dharne · M. · Chandra Sekaran · A. M. · Prabhakaran · D.
Introduction

Heart failure (HF) remains a major global health challenge, particularly in low-resource settings where access to comprehensive cardiac rehabilitation (CR) is limited. Yoga, a culturally contextualised mind-body intervention, holds promise as an adjunctive therapy in CR. The Yoga-EndOmics study aims to evaluate the effects of Yoga-based cardiac rehabilitation (Yoga-CaRe) on gene expression, endothelial function, vascular biomarkers and clinical outcomes in systolic HF, providing mechanistic insights into its potential integration into conventional cardiac rehabilitation.

Methods and analysis

This is a prospective, randomised, open-label, blinded-endpoint (PROBE) mechanistic trial enrolling 78 patients with HF with reduced ejection fraction (HFrEF). Participants will be randomised in a 1:1 ratio to receive either a structured Yoga-CaRe intervention or enhanced standard care for 3 months. The Yoga-CaRe group will attend 20 supervised sessions with guided home practice involving tailored asanas, pranayama and meditation. Primary outcomes are changes in endothelial-dependent flow-mediated dilation (FMD) and functional exercise capacity at 3 months. Secondary outcomes include changes in arterial compliance and stiffness, circulating biomarkers of endothelial dysfunction, oxidative stress and inflammation, and immediate changes in global gene expression profiles in peripheral blood mononuclear cells following the Yoga-CaRe intervention. Data will be analysed using analysis of covariance (ANCOVA) for between-group comparisons and significant analysis of microarray (SAM) for global gene expression profiles.

Ethics and dissemination

The study has received ethical clearance from the Institutional Ethics Committee of the SDM College of Medical Sciences and Hospital, India (SDMIEC/2025/1072) and is registered with the Clinical Trials Registry of India. Findings will be disseminated through peer-reviewed journals, scientific conferences and stakeholder engagement platforms to inform future integrative strategies in HF management.

Trial registration number

CTRI/2023/12/060758

Transforming scholarly landscapes: The influence of large language models on academic fields beyond computer science

by Aniket Pramanick, Yufang Hou, Saif M. Mohammad, Iryna Gurevych

Large Language Models (LLMs) have ushered in a transformative era in Natural Language Processing (NLP), reshaping research and extending NLP’s influence to other fields of study. However, there is little to no work examining the degree to which LLMs influence other research fields. This work empirically and systematically examines the influence and use of LLMs in fields beyond NLP. We curate 106 LLMs and analyze ∼148k papers citing LLMs to quantify their influence and reveal trends in their usage patterns. Our analysis reveals not only the increasing prevalence of LLMs in non-CS fields but also the disparities in their usage, with some fields utilizing them more frequently than others since 2018, notably Linguistics and Engineering together accounting for ∼45% of LLM citations. Our findings further indicate that most of these fields predominantly employ task-agnostic LLMs, proficient in zero or few-shot learning without requiring further fine-tuning, to address their domain-specific problems. This study sheds light on the cross-disciplinary impact of NLP through LLMs, providing a better understanding of the opportunities and challenges.

Meanings and practices of solidarity in global health: a qualitative investigation - study protocol

Por: Nouvet · E. · Ndu · M. · Pratt · B. · Arguedas Ramirez · G. · Prainsack · B. · Karunakara · U. · DeVries · J. · Owusu · S. A. · Atuire · C.
Introduction

Solidarity in global health is often invoked as an ethical imperative to guide responses to global health challenges. Its meanings and practices across diverse contexts, however, remain under-explored. Deepening an understanding of how solidarity is conceptualised, enacted and perceived by a diverse array of actors within the global health ecosystem is crucial to advancing meaningful and measurable application of this commitment in global health.

Methods and analysis

This qualitative study uses interpretive research methodology to explore perspectives on solidarity among key global health stakeholders: community-level leaders in civil society organisations working on global health issues; research institute directors in the Global South; and individuals with experience of funding decision-making with major global health funding and agenda setting organisations (‘global health influencers’). Data will be gathered through semi-structured interviews and analysed using inductive and deductive reflexive thematic analysis, to identify patterns and differences in how these global health stakeholders recognise and define solidarity or its absence in their day-to-day work, while remaining attentive to conceptual tensions, participant interpretations of solidarity that may be unfamiliar to our team, and our role as researchers in shaping what we register and emphasise as significant in our reporting of findings.

Ethics and dissemination

Ethics approval was obtained from the Western University Health Sciences Research Ethics Board (HSREB) in Ontario, Canada # 2024-123965-87873 and the Ethics Committee for the Humanities, University of Ghana # ECH 163/23–24 and University of Oxford, Oxford Tropical Research Ethics Committee (OxTREC) waiver dated 10 April 2024. Study results will be submitted for peer-reviewed publication. Results will also be summarised in an open access report and presented at various stakeholder meetings and in online webinars.

Protocol registration

The final protocol was registered with Open Science Framework on 28 October 2023. View only link: https://osf.io/gryp5/?view_only=8baff435a35847f09a342408d38ee35b.

Digital support for chronic dyspnoea management in primary care: protocol for the BREATHE (Breathlessness Rapid Evaluation and Therapy) cluster randomised controlled trial

Por: Martin · A. · Sunjaya · A. P. · Giskes · K. · McKeough · Z. · Hespe · C. M. · Arnott · C. · Billot · L. · Campain · A. · Scowcroft · C. P. · Atkins · E. R. · Jan · S. · Scott · H. A. · Chua · A.-V. · Jenkins · C. R. · on behalf of the BREATHE Investigators · Peiris · Marks · Praveen
Introduction

Chronic dyspnoea is a prevalent symptom, and primary care is ideally placed to identify and manage it. However, chronic dyspnoea is under-reported by patients and can be a diagnostic dilemma for practitioners. A fully automated system of patient screening, coupled with a clinical decision support system (CDSS) that uses a validated and evidence-based dyspnoea algorithm, may improve detection, diagnosis and management of the condition. There is currently no CDSS validated for chronic dyspnoea diagnosis and management in primary care in Australia. The objectives of this study are to assess the clinical impact of a CDSS for chronic dyspnoea in primary care. We hypothesise that the use of the CDSS will lead to a clinically significant improvement in patient-reported dyspnoea scores, reduced time to diagnosis and healthcare costs at 12 months compared with standard care.

Methods and analysis

The BREATHE study is an open-label, cluster-randomised controlled trial of standard of care compared with a CDSS. General practices (n=40) in metropolitan, regional/rural and rural/remote settings will be recruited and randomised equally to pre-screening for chronic dyspnoea and usual standard-of-care management or pre-screening and CDSS-guided management. The CDSS includes an algorithm derived from a robust data and clinical knowledge model and incorporates evidence-based recommendations for the assessment and management of chronic dyspnoea. It is integrated into general practice medical software systems, fitting in the workflow of general practitioners (GPs). Eligible patients will be ≥18 years old and will have previously consented to receive SMS communication from their practice. In-scope patients will receive an automated text message prior to their GP appointment and will be screened for chronic dyspnoea (≥4 weeks). Patients identified with chronic dyspnoea will be invited to participate in the BREATHE study and followed up for 12 months. The primary outcome is improvement in the Dyspnoea-12 (D-12) score from baseline to 12 months, measured by the Dyspnoea-12 (D-12) questionnaire. Secondary outcomes include disease-specific questionnaires to assess changes in clinical outcomes, time to final diagnosis, quality of life, healthcare utilisation and costs incurred to patients.

Trial registration number

The trial is registered at ANZCTR (ACTRN12624001451594). ANZCTR is a primary registry that meets the requirements of the ICMJE and is listed on the ICTRP Registry Network.

Ethics and dissemination

The study protocol has been approved by the University of New South Wales Human Research Ethics Committee (HREC) (iRECS6645) and complies with the National Health and Medical Research Council ethical guidelines. Participating practices and each GP will provide written, informed consent. All patients being screened will provide electronic informed consent. Results of the study will be disseminated through various forums, including peer-reviewed publications and presentation at national and international conferences. Following the study, participating practices will be provided with a summary of the findings of the study, together with a full copy of any publications and a plain language statement for participants, which will be made available in the practice reception area.

Implementation of the community health system innovation project in three low- and middle-income countries: COHESION-I study protocol

Por: Lazo-Porras · M. · Bernabe-Ortiz · A. · Damasceno · A. · Sharma · S. K. · Praveen · D. · Mayo-Puchoc · N. · Aya Pastrana · N. · Bazan Maccera · M. · Chauque · A. · Cahuana-Hurtado · L. · Cardenas · M. K. · Gautam · U. · Khanal · V. K. · Jessen · N. · Mugabe · N. · Pereyra · R. · Pesant
Background

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT06989502.

Determinants of treatment decisions in advanced dementia: a protocol for a cross-cultural mixed-methods study

Por: Lima · J. P. · Mbuagbaw · L. · Prasad · M. · Kumar · A. · Wafeu · G. S. · Bonnet · R. · Agoritsas · T. · Li · S. · Liu · Z. · Alonso-Coello · P. · Akio Nishijuka · F. · Mirza · R. · Matos Silva · C. · Alshanketi · R. · Alsahafi · I. · Alnuaimi · A. · Heen · A. F. · Schwartz · L. · Guyatt
Introduction

Values and preferences are key determinants of optimal care, and variability in patient values and preferences often dictates differences in patient management. Clinicians’ views of patients’ values and preferences may differ across cultural aspects and stage of training, but the extent to which this is the case remains uncertain. One key value and preference issue is the trade-off between quantity and quality of life, and this issue is particularly prominent among patients with dementia. We therefore propose to investigate the extent to which physicians’ perceptions of optimal management for patients living with advanced dementia may differ due to cross-cultural factors and stage of medical training.

Methods and analysis

We will conduct a sequential explanatory mixed-methods study (QUAN -> qual). First, we will administer paper-based or electronic surveys during educational sessions, conferences and rounds to medical students, residents and physicians in ten countries, either in person or online. Following that, a qualitative inquiry, guided by the findings of the quantitative study and the principles of the interpretive description design, will inform an in-depth exploration of the predictive factors identified in the quantitative data analysis.

Ethics and dissemination

The Hamilton Integrated Research Ethics Board at McMaster University has approved this study (approval number 2024-17651). We will disseminate our findings in peer-reviewed publications and present results at conferences as oral and poster presentations.

❌