Adenotonsillectomy is the primary treatment for type 1 obstructive sleep apnoea (OSA1). Although polysomnography (PSG) remains the gold standard for measuring Apnoea-Hypopnoea Index, it is a labour-intensive procedure and does not correlate with improvements in quality of life postadenotonsillectomy. Mouth breathing is associated with poorer quality of life in children. Mandibular movement (MM), which measures mouth opening, is a validated measure of respiratory effort that can be easily and safely assessed in children using the JAWAC technology. This study aims to evaluate the relationship between changes in quality of life and changes in mouth opening in children with OSA1 after undergoing adenotonsillectomy. Secondary objectives include evaluating changes in quality of life, clinical symptoms and other MM and PSG metrics in the same population.

This exploratory, non-randomised, monocentric, prospective cohort study with a non-blinded single arm will include 50 children aged 3–7 years, undergoing adenotonsillectomy at the Clinique Saint Jean, Montpellier, France. Quality of life will be measured using the parent version of the Paediatric Quality of Life Inventory and MM metrics will be measured during PSG using the JAWAC system during the inclusion visit and 3 months after adenotonsillectomy. The primary outcome will be the correlation between the changes in quality of life and mouth opening (1/10 mm) postadenotonsillectomy. Secondary analyses will evaluate changes in clinical symptoms, PSG measures and other MM metrics including respiratory effort, as well as the associations between these measures.

This study was approved by an independent ethics committee (Comité de Protection des Personnes Est) on 24 March 2025 (2024-A02761-46) and will be conducted in accordance with French law, good clinical practice and the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

NCT06973928.

We aimed to investigate the effect of first visit to different levels of medical institutions on diagnostic and treatment delays of pulmonary tuberculosis (PTB) patients, assess the current situation and potential problems of different-level medical institutions, and put forward constructive recommendations for policy-making to reduce the delayed behaviours among PTB patients in the Ningxia Hui Autonomous Region (NHAR).

NHAR, China.

We collected information on all PTB patients in the NHAR identified through China’s National Tuberculosis Information Management System (TBIMS) between 2015 and 2019. Propensity score matching (PSM) was used to create balanced data excluding the effects of covariates. The inverse probability of treatment weight was used to verify the robustness of the PSM results. Binary logistic regression was used to assess the correlation between first-visit medical institution levels and diagnostic and treatment delays.

Diagnostic and treatment delays of PTB patients.

We collected 11 202 confirmed PTB cases from TBIMS during 2015–2019.

Among 11 202 confirmed PTB cases, 1497 (13.4%) had diagnostic delays, with a median diagnostic delay of 1 day (IQR: 0–7 days). Among 7593 PTB cases, 1056 (13.9%) had treatment delays, with a median treatment delay of 0 days (IQR: 0–1 days). After adjustment by propensity value matching, the possibility of diagnostic delay (OR=0.84, 95% CI 0.72 to 0.99) and treatment delay (OR 0.37, 95% CI 0.32 to 0.44) of county medical institutions was significantly higher than that of above-municipal medical institutions.

More effective measures should be implemented to improve rapid diagnosis and treatment technology and the capacity of county medical institutions, clarify the referral process and reduce the occurrence of delayed behaviours.

Interstitial lung diseases (ILDs) are a heterogeneous group of diseases characterised by varying degrees of inflammation and fibrosis. Among these, fibrotic interstitial lung disease (FILD) is receiving increasing attention. Many questions remain about FILD, such as identifying which ILDs are likely to progress to FILD, the timing of such progression, early recognition methods and biomarkers for FILD recognition and progression, highlighting the urgent need for a large multicentre FILD cohort to advance relevant studies.

The Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China (FIRST) study is a prospective, multicentre cohort study of FILD conducted across 40 hospitals/centres in China, aiming to reveal clinical phenotype and further integrate multidimensional data to develop prediction models for fibrosis progression. The study will enrol more than 10 000 patients, using existing national ILD cohorts, and will collect comprehensive clinical, imaging, histological and biological data to support histopathological, imaging and biomarker-related studies. The primary outcome is fibrosis progression within 12 months, with secondary outcomes including the natural history, mortality, comorbidities and treatment conditions of FILD, using a standardised data collection and follow-up approach supported by an Electronic Data Capture system.

The study’s protocol has undergone a thorough review and received approval from the Ethics Committee of China-Japan Friendship Hospital and the other participating sites currently enrolling patients. The findings of the study will be shared with the broader scientific community through publication in peer-reviewed journals.

NCT06655090; Pre-results

Transitions of care (TOC) between hospital, ambulatory and home settings for high-risk adults with chronic diseases are complex, costly and often result in poor health outcomes. Suboptimal care transitions lead to medication errors, non-adherence, decreased self-management skills and inadequate follow-up, all of which contribute to readmissions or emergency department visits. The Transitional Care Model aims to address these challenges through patient-centred, in-home interventions. We propose to implement and evaluate TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for Chronic Obstructive Pulmonary Disease (COPD) patients. This study will evaluate the added value of a virtual, pharmacy-based intervention integrated into an existing COPD TOC program within a single healthcare system.

Informed by the Proctor Framework implementation, service and health outcome domains, we will conduct a randomised controlled trial comparing the addition of at-home pharmacy team-based virtual visits to the standard of care (ie, our existing COPD TOC programme). Adult patients hospitalised for a COPD exacerbation will be randomised to receive the standard COPD TOC programme alone or the standard programme plus TELE-TOC virtual at-home pharmacy visits. We will use a pragmatic type II hybrid effectiveness-implementation trial. The primary effectiveness outcome is inhaler technique at 30 days postdischarge, and the primary implementation outcome is the proportion of patients receiving the intervention. Intention-to-treat analysis will be applied to all outcomes with ² and logistic regression models adjusting for demographic factors. Treatment effects through 30 days will be assessed with generalised estimating equations and generalised linear mixed models.

This study, the waiver of consent and the opt-out flyer were approved by the University of Chicago Institutional Review Board (23–0934). Dissemination of the findings is planned for up to 4 years of completion of the study to local, regional and national conferences and peer-reviewed journals.

NCT05897125.

To characterise the aetiological spectrum of thoracic granulomatous diseases and identify diagnostic features that facilitate differentiation among causes.

Retrospective multicentre observational study.

Two tertiary hospitals in south-central China. Patient data were consecutively enrolled from 1 June 2020 to 30 June 2023.

Of 2486 patients with pathologically confirmed thoracic granulomas initially identified, exclusions were applied for specimens outside the lung/pleura/mediastinum (579), incomplete demographic/imaging/pathology data (280) or lack of follow-up (231). A total of 1396 patients met all criteria (853 from hospital 1 and 543 from hospital 2) and were included in the final analysis.

We quantified the aetiologic distribution of thoracic granulomatous diseases and examined age-stratified/lesion-location differences in aetiologic patterns. We also evaluated associations between histopathological features and specific aetiologies and compared the diagnostic accuracy across sampling modalities.

Among the 1396 enrolled cases, a confident, probable and uncertain diagnosis was made in 1086 cases, 307 cases and 84 cases. Infectious granulomas predominated (89.4%; 1248/1396), with tuberculosis comprising 87.8% (1096/1248) of infectious cases. Among non-infectious granulomas, sarcoidosis was most common (65.8%; 50/76). Patients aged ≥60 years had a higher proportion of infectious granulomas than younger groups (≥60 years: 389/422; 40–60 years: 633/714;

Most thoracic granulomas arise from mycobacterial or fungal infection, while sarcoidosis is the leading non-infectious cause. Thoracoscopy and surgical biopsy show superior diagnostic yields, and special staining aids differentiation of fungal aetiologies. Findings support a multidisciplinary approach to improve diagnostic accuracy.

Nintedanib is approved for the treatment of interstitial lung disease (ILD) with progressive pulmonary fibrosis (PPF). Real-life data on nintedanib treatment for this indication and on the combined use of antifibrotic and immunomodulatory drugs are limited. This study was aimed to collect detailed real-life data from all patients with non-idiopathic pulmonary fibrosis (IPF) PPF at the Hospital District of Helsinki and Uusimaa to identify the gap between patients included in randomised controlled trials and real-life patients.

This retrospective, real-life study characterised all patients with non-IPF PPF diagnosed and treated at the Hospital District of Helsinki and Uusimaa.

Thirty-one patients were identified as having non-IPF fibrotic ILD and meeting the PPF criteria in 2022 and 2023.

The most common diagnosis was connective tissue disease–ILDs, with 13 patients (42%), followed by fibrotic idiopathic non-specific interstitial pneumonia (iNSIP), with 10 (32%) patients. The most common radiological pattern was NSIP in 18 (58%) patients.

Among the 30 patients treated with nintedanib, six (20%) had to permanently discontinue treatment owing to side effects. Of the 19 patients who continued to receive nintedanib at the end of the follow-up period and for whom the dose was known, 9 (47%) continued to receive nintedanib at the full dose (150 mg two times per day) and 10 (53%) at the reduced dose (100 mg two times per day). Twenty-seven (87%) patients received immunomodulatory treatment at the time of PPF.

In our cohort, the underlying diagnoses and immunomodulatory treatments received significantly differed from those in the phase III licensing trial. More patients received nintedanib at a reduced dose than at a full dose, despite limited evidence of its efficacy and effectiveness. This highlights the large gap in evidence and the need for additional real-world data.

This study aimed to explore the mediating role of inspiratory muscle strength between abdominal obesity and lung function in young people.

Cross-sectional study.

This survey was conducted in Peking University Health Science Center, Beijing, China.

404 subjects aged 18 and older.

Forced expiratory volume in one second percent (FEV1%) predicted ≥80% was defined as the normal lung function.

A total of 404 subjects were included, with maximal inspiratory pressure of 65.27±29.55 cmH₂O. Among them, 61 subjects (15.10%) had central obesity, 106 subjects (26.24%) had a FEV1% predicted

This study highlighted the mediating role of inspiratory muscle strength between abdominal obesity and lung function.

Idiopathic pulmonary fibrosis (IPF), an unknown aetiology type of interstitial lung disease (ILD), carries the poorest prognosis and is more common in males and the elderly. Gender differences in baseline presentation, lung function and comorbidities may have an impact on prognostic outcomes.

The aim of this study was to explore gender differences in clinical features, comorbidities and outcomes in IPF in a UK cohort.

This was a retrospective cohort study analysing data from the British Thoracic Society UK IPF ILD Registry from January 2013 to February 2024. We compared baseline characteristics between males and females, and a survival analysis in both genders was performed using the Cox proportional hazards model.

We identified 6666 IPF patients with a mean age at diagnosis of 74.1±8.1. Our cohort was predominantly male (5197, 78%), with a higher proportion of current and ex-smokers compared with females (69.9% vs 59.9%, p

Gender differences in baseline characteristics and prognostic factors were observed in IPF. A gender-based approach in managing IPF is warranted, and further studies are needed to clarify these differences and their impact on IPF management.

Acute hypoxaemic respiratory failure is a common reason for intensive care unit (ICU) admission. Non-invasive respiratory support strategies such as high-flow nasal oxygen (HFNO) and helmet non-invasive ventilation may reduce the need for invasive mechanical ventilation and death. The High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure pilot trial is designed to compare helmet non-invasive ventilation combined with HFNO vs HFNO alone in patients with acute hypoxaemic respiratory failure and to determine the feasibility of a larger randomised controlled trial.

This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.

Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.

ClinicalTrials.gov Identifier: NCT05078034.

Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of lungs to noxious particles and gases. The inflammatory and reparative processes occurring in the lungs induce a ‘spill-over’ of inflammatory mediators into the circulation, resulting in an increase in systemic inflammation, which is further increased during acute exacerbations of COPD (AECOPD), leading to the development of extra-pulmonary comorbidities, such as cognitive impairment. Cognitive impairment affects up to 61% of people living with COPD. Heightened levels of inflammation have been linked to increased risk of cognitive impairments; however, the exact mechanisms remain unclear, thus hampering the development of therapeutics. This study aims to determine whether patients hospitalised with an acute COPD exacerbation show impaired cognitive function compared with recovery (~day 45), and whether such dysfunction is associated with systemic inflammation and oxidative stress.

A prospective, observational study will be conducted at Austin Health in Victoria, Australia. Eligible participants will be assessed during admission for AECOPD and following stabilisation (approximately day 45). The primary outcome is the difference in cognitive function between admission for AECOPD to recovery using non-verbal cognitive tests. Secondary outcomes are changes in systemic markers of inflammation, oxidative stress and ACE2 catalytic activity. Tertiary outcomes are anxiety and depression scores.

Ethical approval has been granted in Australia by Austin Health Human Research Ethics Committee (HREC 56099) with governance approval at Austin Hospital. The results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. Findings will be disseminated to consumers in publications for lay audiences.

Cystic fibrosis (CF) is an inherited condition, affecting approximately 150 000 people worldwide. Physical activity (PA) is an integral component in the management of CF. However, it is estimated that only a third of young people (with and without CF) achieve UK Chief Medical Officer guideline recommended levels of activity. The aim of this research was to use the person-based approach to develop an intervention supporting families with young people (aged 6–12 years) with CF to incorporate PA as a sustainable habit in their lives to increase the likelihood of sustained PA levels going into adolescence and adulthood.

Using the person-based approach, intervention content was created and iteratively adapted. This was initially guided by relevant literature; the guiding principles, logic model and preliminary content were developed via co-production with patient and public involvement (PPI) representatives (n=8) with lived experience of CF. The intervention was further refined/optimised using qualitative think-aloud and retrospective interviews, the results of the preliminary evaluation are reported. Think-aloud interviews were rapidly analysed using a table of changes analysis and used to inform adaptations to content. Retrospective interviews were analysed thematically.

Community settings in the UK.

Participants included six families with a child with CF aged between 6 years and 12 years old.

Intervention content consisted of nine sections and was delivered as a printable PDF file. Informed by the Capability, Opportunity, Motivation and Behaviour framework and self-determination theory, content focused on promotion of PA as a family activity that is fun, enjoyable, quick and achievable. It promoted ‘movement to make you feel good"’ and in short bursts of activity. Promotion of PA as medicine was avoided. The final intervention was considered to be engaging and acceptable.

Qualitative methods and PPI facilitated the development of a family-focused intervention supporting the integration of PA into daily life. This was viewed as acceptable and engaging among families of people with CF. Future research now needs to explore the effectiveness of the intervention for increasing PA behaviour.

Patients eligible for lung cancer screening are at risk for structural lung abnormalities, especially emphysema. Our aim was to assess the association between emphysema as determined by radiologist and quantitative CT (QCT) analysis, and the presence of spirometric abnormalities in an urban largely minority population undergoing lung cancer screening.

Retrospective cohort study.

Centralised lung cancer screening programme in an urban academic medical centre in Philadelphia, Pennsylvania, USA.

2111 individuals who underwent low-dose CT (LDCT) from October 2021 to October 2022 had CT scans interpreted by radiologists for the presence of emphysema, 629 of whom underwent spirometry. 181 patients underwent AI-assisted QCT analysis for emphysema at –950 and –910 HU, all of whom underwent spirometry.

Diagnostic tests for presence of emphysema as defined by radiologist and by AI-assisted QCT analysis for emphysema and the association with spirometric obstruction.

A total of 2111 individuals underwent LDCT from October 2021 to October 2022. 323 (51.4%) individuals with radiology-determined emphysema had airflow obstruction. 108 (17.2%) individuals without emphysema had no airflow obstruction. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of radiology detected emphysema for airflow obstruction are 81.3%, 53.4%, 72.2%, 59.34%, respectively. In the Temple Healthy Chest Initiative (THCI) QCT subcohort of 181 individuals who underwent spirometry and low-attenuation area (%LAA)-910 HU, 91 (50%) individuals had %LAA-910 HU≥6% and airflow obstruction. 33 (18%) individuals with %LAA-910

Data from the THCI demonstrates high rates of emphysema as detected by radiologic qualitative interpretation and quantitative analysis. Using a cut-off of ≥6% for LAA at –910 HU, there is a high sensitivity and PPV for associated spirometric obstruction and thus should drive providers to obtain prebronchodilator spirometry to detect chronic obstructive pulmonary disease at an earlier stage.

Bronchoscopic thermal vapour ablation (BTVA) is a bronchoscopic lung volume reduction technique, also recommended by the global initiative for chronic obstructive lung disease (GOLD) guidelines. Previous studies on BTVA have primarily focused on segmental treatment, targeting the most severely affected lung segments while preserving healthier areas. However, there is considerable variability in the severity of emphysema within subsegments of these lung segments, suggesting that a more precise approach could potentially improve treatment outcomes. This study aims to evaluate the efficacy and safety of subsegmental BTVA, which may better preserve healthy lung tissue while more accurately targeting the most severely affected regions in patients with severe emphysema.

This is a prospective, multicentre, randomised, controlled, open-label clinical trial conducted in China. A total of 100 patients with severe emphysema, who continue to experience significant symptoms despite optimal medical therapy according to GOLD guidelines, will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either the experimental group (subsegmental BTVA) or the control group (segmental BTVA), both receiving optimal medical therapy. BTVA will be performed in two separate procedures, with the second procedure occurring at least 6 weeks and no more than 6 months after the first. The primary endpoint is the change in forced expiratory volume in 1 s at 6 months following the second procedure. Secondary endpoints include changes in lung volumes, quality of life (measured by the St. George’s respiratory questionnaire for chronic obstructive pulmonary disease patients), other parameters in pulmonary function tests, and 6 min walk distance at 6 and 12 months, etc.

The trial protocol was approved by the Ethics Committee of Shanghai Chest Hospital (IS23073). Additionally, study approval was obtained from local regulatory boards at each site before the study commenced. The results will be published in a peer-reviewed journal.

This trial was registered on ClinicalTrials.gov on 16 November 2023 (NCT06152107).

The prevalence of pulmonary nodules (PNs) has been rising in China, but PN patients’ perceptions towards the management remain underexplored. This study aimed to investigate the knowledge, attitudes and behaviours (KAB) regarding PN management among Chinese patients.

A cross-sectional study was conducted to evaluate the KAB scores using a self-designed questionnaire.

The study included 519 PN patients (275 males, aged 41.07±19.47) diagnosed at Wenzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medicine University between November 2022 and January 2023. Participants completed a self-designed questionnaire assessing their KAB regarding PN management.

The primary outcomes included mean scores for KAB, with secondary outcomes examining correlations and associations with demographic factors.

The mean KAB scores were 4.24±2.93 (range: 0–10), 17.97±4.88 (range: 0–32) and 31.30±11.98 (range: 0–52). Pearson’s correlation analysis revealed a weakly positive correlation between knowledge and behaviour (r=0.248, p

PN patients demonstrate insufficient knowledge and moderate attitudes and behaviours regarding PN management. These findings highlight the need for targeted educational interventions to improve understanding among PN patients.

Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.

This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p

This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.

Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

Heroin users have a high burden of respiratory morbidity, including premature lung function impairment. Further, methadone treatment has been found to aggravate lung function impairment and can independently cause asthma. However, the lung function status among heroin users on medication-assisted therapy (MAT) in Tanzania is yet to be studied. This study aimed to assess the magnitude, pattern and factors associated with lung function impairment among heroin users on MAT.

This was a quantitative, analytical cross-sectional study.

This study was conducted at MAT Clinic at Muhimbili National Hospital in Dar-es-Salaam, Tanzania.

Individuals aged 18 years or above with heroin use disorder on stable dose of methadone without heroin withdrawal symptoms (Maintenance Phase of Treatment) were recruited.

Participants were enrolled through systematic sampling technique. Data were collected using a questionnaire, and lung functions were measured using a spirometer. Lung function impairment was defined as the percentage of participants with forced expiratory volume in 1 s (FEV1)

We enrolled 302 participants into the study (mean age of 42.78±7.56 years). Lung function impairment was observed in 28.5% of participants, with an average age of 44±8 years. Restrictive lung disease was the most common pattern of lung function impairment affecting 13.2% of the participants. The predictors of lung function impairment were being underweight (OR) 4.73, 95% CI) 2.61–8.59, p

Heroin users on MAT have a high magnitude of lung function impairment. Routine lung function testing is recommended.

Mediastinal and/or hilar lymphadenopathy (MHL) is increasingly identified owing to various underlying conditions. Minimally invasive biopsy techniques, including endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), transbronchial mediastinal cryobiopsy (TBMC) and transbronchial forceps biopsy (TBFB), are common diagnosis tools. However, their safety and diagnostic efficiency remain unclear. This trial aims to compare the diagnostic yield and safety of these three techniques.

This study is a three-arm, parallel-design, randomised controlled trial involving 972 adult patients with MHL recruited from multiple medical centres. Participants will be randomly assigned to the EBUS-TBNA, TBMC via a tunnel or TBFB via a tunnel group. The primary outcome is diagnostic yield, and the secondary outcomes include diagnostic sensitivity, sample quality and procedure-related complications. Statistical analyses will be conducted using the appropriate methods. An independent sample ² test will be used to test the differences in the diagnostic yield and incidence of procedure-related complications.

Ethics approval was obtained from the China-Japan Friendship Hospital Ethics Committee (2022-KY-194).

Written informed consent will be obtained from all patients or their guardians before their enrolment in the study. This study will be conducted per the principles established in the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice.

www.clinicaltrials.gov (NCT06262620).

Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.

Given the global trend toward population ageing, chronic obstructive pulmonary disease (COPD) has emerged as an increasingly common health concern. As a chronic pulmonary disorder frequently encountered in clinical settings, COPD typically involves multiple organ-system impairments. Among these impairments, dysphagia is a significant complication in elderly patients with COPD. Dysphagia profoundly compromises the patients’ quality of life and increases risks such as malnutrition and aspiration pneumonia, thereby exacerbating the overall disease burden. Although systematic reviews evaluating dysphagia prevalence in COPD populations, the quantitative synthesis of associated risk factors has been hindered by inadequate reporting in the original studies. At present, no systematic reviews or meta-analyses specifically address the risk factors associated with dysphagia among elderly patients with COPD. Therefore, this systematic review aims to identify and systematically analyse these risk factors, ultimately providing reliable evidence to facilitate early identification and improve clinical management strategies.

The literature will be meticulously searched through a variety of electronic databases, including Web of Science, PubMed, Embase, Cochrane Library, China Biomedical Literature Service System (CBM), Chinese Scientific Journal Database (VIP), Wan Fang Database and China National Knowledge Infrastructure (CNKI). We will conduct a thorough investigation of the literature focusing on risk factors associated with dysphagia in elderly individuals diagnosed with COPD, spanning from the inception of each database up to October 2025. Two investigators will independently review the literature, evaluate the quality of studies and extract data based on clearly defined inclusion and exclusion criteria to maintain rigour and consistency. The analysis will employ Stata V.14.0 software for the purposes of data merging and assessment of potential biases. OR along with 95% CI will serve as integrated statistical metrics. Statistical heterogeneity will be assessed using the I² statistic.

Since this study involves an analysis of previously published literature without direct patient participation, obtaining ethical approval is not required. The outcomes of the current investigation will be disseminated through academic journals following a stringent peer-review process.

CRD420251006411.

Flexible bronchoscopy (FB) is widely used for diagnostic and therapeutic procedures in pulmonary medicine. However, FB can cause respiratory and haemodynamic complications, especially in patients with pre-existing lung and/or cardiovascular comorbidities. Despite the range of oxygenation and ventilatory approaches available to prevent these risks, evidence regarding their real-world application and clinical impact is limited. The OxyFOB study aims to assess the prevalence and outcomes of various oxygenation and ventilatory support strategies used during FB across Europe.

The OxyFOB study is a large, prospective, international, observational cohort study which aims to involve over 10 000 FB procedures across European centres. Eligible participants include all adults undergoing FB for diagnostic, therapeutic or procedural indications. Data are collected via a standardised electronic case report form and encompass demographic information, procedural details and clinical outcomes. The primary endpoint is the prevalence of oxygenation and ventilatory support strategies: conventional oxygen therapy, high-flow oxygen therapy, continuous positive airway pressure, non-invasive ventilation and invasive mechanical ventilation. Secondary outcomes include periprocedural respiratory and haemodynamic events, patient comfort, dyspnoea and postprocedural complications. Statistical analyses include descriptive statistics, subgroup comparisons and multivariate logistic regression.

The study has received ethical approval from the coordinating centre (protocol n. 22/2022 on the 20 January 2022, by the ‘Comitato Etico Sezione Area Centro - Regione Calabria’) and all participating sites. Informed consent is given from all patients or their legal representatives. Findings will be disseminated through peer-reviewed publications and presentations at international meetings. Data will be managed and made available on reasonable request to support further research.

ClinicalTrials.gov ID: NCT05681962. Registered January 2023.