Utility of nasal application of lignocaine gel using cotton tip swab versus squirting with slip-tip syringe for transnasal fibreoptic bronchoscopy: a pilot randomised controlled trial.

BACKGROUND: During flexible fibreoptic bronchoscopy through the nasal route, anaesthesia of the nasal passage is achieved by lignocaine gel application by a slip-tip syringe or with the help of a cotton tip swab. No studies in existing literature have compared the two techniques in terms of efficacy. METHODS: 137 consecutive patients undergoing bronchoalveolar lavage (BAL) were recruited over a 2-year period. The patients underwent BAL after nasal anaesthesia-either by slip-tip syringe or by cotton tip swab smeared with 2% lignocaine gel. Patients were monitored for intraprocedural epistaxis, discomfort and improvement in operator visibility of nasal passage. RESULTS: 67 patients were randomised to cotton swab and 70 patients to the gel instillation group. There were no significant differences in terms of epistaxis, 29.9% in the cotton tip swab (95% CI 19.3% to 42.3%) versus 24.3% in the gel instillation group (95% CI 14.8% to 36%) or detection of nasal blocks, 7.5% in the cotton tip swab (95% CI 2.5% to 16.6%) versus 10% in the gel instillation group (95% CI 4.1% to 19.5%) in the two groups, although a significant difference was there in terms of visibility, 73.1% in the cotton tip swab (95% CI 60.9% to 83.2%) versus 42.9% in the gel instillation group (95% CI 31.1% to 55.3%). There was no difference in the mean pain score across the two groups either during the procedure or 1 hour after it. A short systematic review of existing literature on the topic has been provided for comparison. CONCLUSION: Application of 2% lignocaine gel by slip-tip syringe and cotton tip swab are equivalent in terms of observed and narrated pain experienced by patients, frequency of epistaxis and nasal blocks. Vision was better preserved in the cotton tip swab group.

Investigation of adverse reactions in healthcare personnel working in Level 3 barrier protection PPE to treat COVID-19.

PURPOSE OF THE STUDY: The aim of our study was to investigate potential adverse reactions in healthcare professionals working in Level 3 barrier protection personal protective equipment (L3PPE) to treat patients with COVID-19. STUDY DESIGN: By using a convenience sampling approach, 129 out of 205 randomly selected healthcare professionals from the First Affiliated Hospital of Zhejiang University School of Medicine were invited to take part in a WeChat messaging app survey, Questionnaire Star, via a survey link. Healthcare personnel details were collected, including profession, years of professional experience and adverse reactions while wearing L3PPE. Survey results were divided by profession and years of professional experience; differences in adverse reactions were compared. RESULTS: Among the 129 healthcare professionals surveyed, 21 (16.28%) were doctors and 108 (83.72%) were nurses. A total of 122 (94.57%) healthcare professionals experienced discomfort while wearing L3PPE to treat patients with COVID-19. The main reasons for adverse reactions and discomfort include varying degrees of adverse skin reactions, respiratory difficulties, heat stress, dizziness and nausea. Doctors had a lower incidence of rashes (χ2=4.519, p=0.034) and dizziness (χ2=4.123, p=0.042) when compared with nurses. Junior (8.5 years of experience or fewer) healthcare personnel also experienced a higher rate of heat stress when compared with senior personnel (more than 8.5 years greater) (χ2=5.228, p=0.022). CONCLUSION: More attention should be offered to healthcare personnel wearing L3PPE to treat patients with COVID-19 because they are susceptible to developing adverse reactions.

Smouldering ashes: burning questions after the outbreak of electronic cigarette or vaping-associated lung injury (EVALI).

In the summer of 2019, the Center for Disease Control and Prevention (CDC) declared an emergency of electronic cigarettes and/or vaping (vaping)-associated lung injury (EVALI) in the USA. The outbreak abated by January 2020, which the CDC attributed to heightened public awareness, 'user actions to reduce risk' and potentially the removal of vitamin E acetate (VEA) from vaping products (VEA is an oily chemical cutting agent, strongly associated with the disease). Even though the EVALI outbreak appears to be over, numerous epidemiological and medical questions are left still open. First, why were there practically no cases outside the USA, which represents nearly a quarter of the global vaping market? Comparative studies to map the differences in device/fluids/user habits between countries might be needed urgently. Second, what is the pathomechanism that sickens vapers irrespective of VEA exposure? VEA was only confirmed in about half of the cases and the presumed toxicity is yet to be determined. Aetiology/epidemiology focused research is needed to investigate/interpret the broader context to explain the outbreak. Third, could any socioeconomic/environmental factors have influenced the course of the outbreak? Finally, what should we expect in the years to come? Was EVALI a serious but reversible emergency medicine condition or is vaping as detrimental to long-term health as smoking? Besides the complex legislative, regulatory, ethical aspects of EVALI, biomedical research is also difficult: in-vitro experiments have limited inferential value to real real-life vaping due to its complexity; user habits are self-reported and under-researched; there is an active black market pouring unknown quality counterfeit products and, in the USA, federal restrictions limit cannabis research. Vaping is a toxicological, multidimensional conundrum; therefore, stringent quality control, transparent legal/ethical boundaries, meticulous international research and user education are paramount to prevent potential future outbreaks and determine the parameters safe vaping (if these exist).

Associations with resident physicians' early adoption of electronic cigarettes for smoking cessation.

BACKGROUND: Use of the electronic cigarette for nicotine delivery has increased dramatically in recent years. Information continues to emerge on its role as a smoking cessation aid, but little is known about resident physician use of the device in clinical practice. METHODS: In 2015, an electronic survey was administered to resident physicians in one healthcare system in Columbus, Ohio. The survey included questions about personal smoking exposure, knowledge, beliefs, attitudes about electronic cigarettes and early adoption of electronic cigarettes with patients. Data were dichotomised based on a 'stages of change' model that assessed resident physician adoption of electronic cigarettes for therapeutic use. Data were analysed through χ2 tests and logistic regression using ORs and 95% CIs. RESULTS: Of 338 residents, 142 (42%) responded. Of all residents, 25 (17.7%) reported that they have been recommending electronic cigarettes to their patients for the past 6 months or longer. In the multivariate model, residents ≥postgraduate year (PGY)-3 (OR=3.68, 95% CI 1.20 to 11.29), peer-reviewed article exposure (OR=6.65, 95% CI 1.56 to 28.38) and the view that addictive potential is definitely or somewhat less than traditional cigarettes (OR=5.05, 95% CI 1.48 to 17.24) were associated with recommendation of electronic cigarettes. CONCLUSIONS: Few residents report recommending electronic cigarettes to patients who smoke. These residents consider the electronic cigarette less addicting than traditional cigarettes, supporting harm reduction strategies over strict abstinence. Most residents require further evidence-based education on efficacy and long-term safety of electronic cigarettes before recommending to their patients.

Evaluation of a disposable sheath bronchoscope system for use in the deployed field hospital.

At present, UK field hospitals use standard flexible bronchoscopes which require specialised disinfection services that are not integral to the hospital. This leads to prolonged turnover of used bronchoscopes as they have to be sent away to external facilities, which takes 1-3 days and is dependent on air transport to other facilities. In contingency operations, off site sterilisation facilities may not be available. There is a need for a bronchoscope system which can be rapidly cleaned and reused. We evaluated the Vision Sciences EndoSheath Bronchoscopy system, which uses a disposable outer sheath to remove the need for specialised disinfection. We report our experience of using this system in a deployed field hospital in Afghanistan.

Primary blast lung injury at a NATO Role 3 hospital.

BACKGROUND: Primary blast lung injury (PBLI) is defined as lung contusion from barotrauma following an explosive mechanism of injury (MOI). Military data have focused on PBLI characteristics following evacuation from the combat theatre; less is known about its immediate management and epidemiology in the deployed setting. We conducted a quality improvement project to describe the prevalence, clinical characteristics, management strategies and evacuation techniques for PBLI patients prior to evacuation. METHODS: Patients admitted to a Role 3 hospital in southwest, Afghanistan, from January 2008 to March 2013 with a blast MOI were identified through the Department of Defense Trauma Registry; International Classification of Diseases 9 codes and patient record review were used to identify the PBLI cohort from radiology reports. Descriptive statistics and Fishers exact test were used to report findings. RESULTS: Prevalence of PBLI among blast injured patients with radiology reports was 11.2% (73/648). The population exhibited high Injury Severity Scores median 25 (IQR 14-34) and most received a massive blood transfusion (mean 33.4±38.3 total blood products/24 h). The mean positive end expiratory pressure (PEEP) requirement was 6.2±3.7 (range 5-15) cm H2O and PaO2 to FiO2 ratio was 297±175.2 (66-796) mm Hg. However, 16.6% of patients had a PaO2 to FiO2 ratio <200, 13.3% required PEEP ≥10 cm H2O and one patient required specialised evacuation for respiratory failure. A dismounted MOI (72.8%) and evacuation from point of injury by the Medical Emergency Response Team (62.3%) appeared to be associated with worse lung injury. Only eight of the 73 PBLI patients died and of the five with retrievable records, none died from respiratory failure. CONCLUSIONS: PBLI has a low prevalence and conventional lung protective ventilator management is generally appropriate immediately after injury; application of advanced modes of ventilation and specialised evacuation assistance may be required. PBLI may be a marker of underlying injury severity since all deaths were not due to respiratory failure. Further work is needed to determine exact MOI in mounted and dismounted casualties.

Validation of oxygen saturations measured in the community by emergency medical services as a marker of clinical deterioration in patients with confirmed COVID-19: a retrospective cohort study.

OBJECTIVES: To evaluate oxygen saturation and vital signs measured in the community by emergency medical services (EMS) as clinical markers of COVID-19-positive patient deterioration. DESIGN: A retrospective data analysis. SETTING: Patients were conveyed by EMS to two hospitals in Hampshire, UK, between 1 March 2020 and 31 July 2020. PARTICIPANTS: A total of 1080 patients aged ≥18 years with a COVID-19 diagnosis were conveyed by EMS to the hospital. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary study outcome was admission to the intensive care unit (ICU) within 30 days of conveyance, with a secondary outcome representing mortality within 30 days of conveyance. Receiver operating characteristic (ROC) analysis was performed to evaluate, in a retrospective fashion, the efficacy of different variables in predicting patient outcomes. RESULTS: Vital signs measured by EMS staff at the first point of contact in the community correlated with patient 30-day ICU admission and mortality. Oxygen saturation was comparably predictive of 30-day ICU admission (area under ROC (AUROC) 0.753; 95% CI 0.668 to 0.826) to the National Early Warning Score 2 (AUROC 0.731; 95% CI 0.655 to 0.800), followed by temperature (AUROC 0.720; 95% CI 0.640 to 0.793) and respiration rate (AUROC 0.672; 95% CI 0.586 to 0.756). CONCLUSIONS: Initial oxygen saturation measurements (on air) for confirmed COVID-19 patients conveyed by EMS correlated with short-term patient outcomes, demonstrating an AUROC of 0.753 (95% CI 0.668 to 0.826) in predicting 30-day ICU admission. We found that the threshold of 93% oxygen saturation is prognostic of adverse events and of value for clinician decision-making with sensitivity (74.2% CI 0.642 to 0.840) and specificity (70.6% CI 0.678 to 0.734).

SABA prescriptions and asthma management practices in Singapore: results from a cross-sectional, observational SABINA III study.

OBJECTIVES: To evaluate asthma characteristics and treatment patterns, including short-acting ß2-agonist (SABA) prescriptions, in primary and specialist care in the Singapore cohort of the SABA use IN Asthma (SABINA III) study. DESIGN: Cross-sectional, observational study. SETTING: Multicentre study conducted at five sites across Singapore. METHODS: In patients with asthma (aged ≥12 years), data on demographics, disease characteristics and asthma treatment prescriptions were collected using electronic case report forms. Patients were classified by investigator-defined asthma severity (guided by 2017 Global Initiative for Asthma recommendations) and practice type (primary/specialist care). RESULTS: Of the 205 patients analysed (mean (SD) age, 53.6 (16.8) years; female, 62%), 55.9% were enrolled by specialists and 44.1% by primary care physicians. Most study patients (80.5%) had moderate-to-severe asthma (86.0% in specialist care and 74.4% in primary care). In the 12 months before study enrolment, 18.0% of patients experienced ≥1 severe exacerbation. Asthma was well or partly controlled in 78.0% of patients. Overall, 17.1% of all patients were overprescribed SABA (≥3 SABA canisters/year) in the preceding 12 months, and overprescription was greater in specialist versus primary care (26.3% vs 5.6%). Only 2.9% of patients were prescribed SABA monotherapy, while 41.0% received SABA in addition to maintenance therapy. Among the latter, 40.5% were overprescribed SABA. Overall, a higher percentage of patients prescribed ≥3 SABA canisters (vs 0-2 SABA canisters) were assessed as having uncontrolled asthma during the study visit (42.9% vs 17.6%). Maintenance therapy in the form of inhaled corticosteroids (ICS) or ICS/long-acting ß2 agonist fixed-dose combinations were prescribed to 14.1% and 84.9% of patients, respectively, in the 12 months before enrolment. CONCLUSIONS: In this Singapore cohort, ~17% of all patients and more than 40% of patients prescribed SABA in addition to maintenance therapy were overprescribed SABA. These findings emphasise the need to align clinical practices with the latest evidence-based treatment recommendations. TRIAL REGISTRATION: NCT03857178.

Comparing performance of primary care clinicians in the interpretation of SPIROmetry with or without Artificial Intelligence Decision support software (SPIRO-AID): a protocol for a randomised controlled trial.

INTRODUCTION: Spirometry is a point-of-care lung function test that helps support the diagnosis and monitoring of chronic lung disease. The quality and interpretation accuracy of spirometry is variable in primary care. This study aims to evaluate whether artificial intelligence (AI) decision support software improves the performance of primary care clinicians in the interpretation of spirometry, against reference standard (expert interpretation). METHODS AND ANALYSIS: A parallel, two-group, statistician-blinded, randomised controlled trial of primary care clinicians in the UK, who refer for, or interpret, spirometry. People with specialist training in respiratory medicine to consultant level were excluded. A minimum target of 228 primary care clinician participants will be randomised with a 1:1 allocation to assess fifty de-identified, real-world patient spirometry sessions through an online platform either with (intervention group) or without (control group) AI decision support software report. Outcomes will cover primary care clinicians' spirometry interpretation performance including measures of technical quality assessment, spirometry pattern recognition and diagnostic prediction, compared with reference standard. Clinicians' self-rated confidence in spirometry interpretation will also be evaluated. The primary outcome is the proportion of the 50 spirometry sessions where the participant's preferred diagnosis matches the reference diagnosis. Unpaired t-tests and analysis of covariance will be used to estimate the difference in primary outcome between intervention and control groups. ETHICS AND DISSEMINATION: This study has been reviewed and given favourable opinion by Health Research Authority Wales (reference: 22/HRA/5023). Results will be submitted for publication in peer-reviewed journals, presented at relevant national and international conferences, disseminated through social media, patient and public routes and directly shared with stakeholders. TRIAL REGISTRATION NUMBER: NCT05933694.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.

INTRODUCTION: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. METHODS AND ANALYSIS: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. TRIAL REGISTRATION NUMBER: ISRCTN16830506. PROTOCOL VERSION: 5.0, 10 Oct 2023.

Understanding the outcome and management of children aged 2-59 months with chest indrawing pneumonia: a study protocol for an observational study in Ethiopia, India, Nigeria, Pakistan, Uganda and Zambia.

INTRODUCTION: Childhood pneumonia is a leading cause of morbidity and mortality among children aged 2-59 months, particularly in low-income and middle-income countries (LMICs), where healthcare providers face significant challenges in diagnosing and treating childhood pneumonia. Many LMICs have taken steps to address this issue by revising their national policies and aligning them with WHO's revised guidelines for pneumonia management. These revised guidelines aim to facilitate the outpatient management of children aged 2-59 months chest indrawing pneumonia. Despite these efforts, there is limited empirical evidence regarding the management and outcomes of these children in primary-level healthcare settings. This study aims to assess the survival status of children aged 2-59 months with chest indrawing pneumonia presenting at primary healthcare facilities. METHODS AND ANALYSIS: A prospective, observational cohort study will be conducted in Ethiopia, Nigeria, Uganda, Zambia, India and Pakistan on children aged 2-59 months presenting at selected primary-level healthcare facilities with chest indrawing pneumonia. Eligible participants will be enrolled and managed by facility healthcare providers who are trained in Integrated Management of Childhood Illness and will be followed up on day 15 to record the treatment-related information and vital status, including conducting verbal autopsies in case of child death. The sample size for each site will be 310. The analysis will involve exploring site-specific trends before conducting a pooled analysis of de-identified data from all sites. The first data collection started at the Ethiopian site in September 2022, followed by other sites. The data collection will continue until June 2025. ETHICS AND DISSEMINATION: The study protocol, enrolment forms and consent forms will undergo ethical review by the Institutional Review Boards of the University of Gondar, Gondar, Ethiopia; the INCLEN Trust International Independent Ethics Committee, New Delhi, India; Ethical Review Committee of the University of Ibadan, Ethical Review Committees of Lagos State and Ethical Review Committee of University College London, UK; Institutional Review Board, International Research Force, Islamabad, Pakistan; Institutional Review Board, People's Primary Healthcare Initiative-Sindh, Karachi and National Bioethics Committee, Islamabad, Pakistan; Makerere University School of Biomedical Sciences Research Ethical Committee, Kampala, Uganda; University of Zambia Biomedical Research Ethics committee, Lusaka, Zambia and Ethical Review Committee of WHO, Geneva, Switzerland. Ethical procedures include WHO and local review board evaluations, parental consent in the local/national language, permits enrolment, follow-up, and, if required, clinical video recording for children with chest indrawing pneumonia, ensuring their eligibility. Adherence to local regulations encompasses precollection ethical approvals, risk management strategies and secure, de-identified data storage. Findings will be disseminated through seminars, publications and meetings, engaging diverse stakeholders to foster collaborations. TRIAL REGISTRATION NUMBER: ISRCTN12687253.

Neurological outcomes and mortality of hyperoxaemia in patients with acute brain injury: protocol for a systematic review and meta-analysis.

INTRODUCTION: Oxygen is frequently prescribed in neurocritical care units. Avoiding hypoxaemia is a key objective in patients with acute brain injury (ABI). However, several studies suggest that hyperoxaemia may also be related to higher mortality and poor neurological outcomes in these patients. The evidence in this direction is still controversial due to the limited number of prospective studies, the lack of a common definition for hyperoxaemia, the heterogeneity in experimental designs and the different causes of ABI. To explore the correlation between hyperoxaemia and poor neurological outcomes and mortality in hospitalised adult patients with ABI, we will conduct a systematic review and meta-analysis of observational studies and RCTs. METHODS AND ANALYSIS: The systematic review methods have been defined according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and follow the PRISMA-Protocols structure. Studies published until June 2024 will be identified in the electronic databases MEDLINE, Embase, Scopus, Web of Science, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature and ClinicalTrials.gov. Retrieved records will be independently screened by four authors working in pairs, and the selected variables will be extracted from studies reporting data on the effect of 'hyperoxaemia' versus 'no hyperoxaemia on neurological outcomes and mortality in hospitalised patients with ABI. We will use covariate-adjusted ORs as outcome measures when reported since they account for potential cofounders and provide a more accurate estimate of the association between hyperoxaemia and outcomes; when not available, we will use univariate ORs. If the study presents the results as relative risks, it will be considered equivalent to the OR as long as the prevalence of the condition is close to 10%. Pooled estimates of both outcomes will be calculated applying random-effects meta-analysis. Interstudy heterogeneity will be assessed using the I2 statistic; risk of bias will be assessed through Risk Of Bias In Non-Randomised Studies of Interventions, Newcastle-Ottawa or RoB2 tools. Depending on data availability, we plan to conduct subgroup analyses by ABI type (traumatic brain injury, postcardiac arrest, subarachnoid haemorrhage, intracerebral haemorrhage and ischaemic stroke), arterial partial pressure of oxygen values, study quality, study time, neurological scores and other selected clinical variables of interest. ETHICS AND DISSEMINATION: Specific ethics approval consent is not required as this is a review of previously published anonymised data. Results of the study will be shared with the scientific community via publication in a peer-reviewed journal and presentation at relevant conferences and workshops. It will also be shared key stakeholders, such as national or international health authorities, healthcare professionals and the general population, via scientific outreach journals and research institutes' newsletters.

HAP-FAST: a feasibility study incorporating qualitative, mechanistic and costing sub-studies alongside a randomised pilot trial comparing chest x-ray to low-dose CT scan and empirical antibiotics to antibiotics guided by the BIOFIRE® FILM ARRAY® pneumonia plus panel in adults with suspected non-ventilator-associated hospital-cquired pneumonia.

INTRODUCTION: Non-ventilator-associated hospital-acquired pneumonia (nv-HAP) is the most common healthcare-associated infection (HCAI), is associated with high mortality and morbidity and places a major burden on healthcare systems. Diagnosis currently relies on chest x-rays to confirm pneumonia and sputum cultures to determine the microbiological cause. This approach leads to over-diagnosis of pneumonia, rarely identifies a causative pathogen and perpetuates unnecessary and imprecise antibiotic use. The HAP-FAST study aims to evaluate the feasibility of a randomised trial to evaluate the clinical impact of low-dose, non-contrast-enhanced thoracic CT scans and rapid molecular sputum analysis using the BIOFIRE® FILMARRAY® pneumonia plus panel (FAPP) for patients suspected with nv-HAP. METHODS AND ANALYSIS: The HAP-FAST feasibility study consists of a pilot randomised trial, a qualitative study, a costing analysis and exploratory analyses of clinical samples to investigate the immune-pathophysiology of HAP. Participants are identified and recruited from four acute hospitals in the Northwest of the UK. Using a Research Without Prior Consent model, the pilot trial will recruit 220 adult participants, with or without mental capacity, and with suspected HAP. HAP-FAST is a non-blinded, sequential, multiple assignment, randomised trial with two possible stages of randomisation: first, chest x-ray (CXR) or CT; second, if treated as nv-HAP, FAPP or standard microbiological processing alone (no FAPP). Pathogen-specific antibiotic guidance will be provided for FAPP results. Randomisation uses a web-based platform and followed up for 90 days. The feasibility of a future trial will be determined by assessing trial processes, outcome measures and patient and staff experiences. ETHICS AND DISSEMINATION: This study has undergone combined review by the UK NHS Research Ethics Committee and Health Research Authority. Results will be disseminated via peer-reviewed journals, via the funders' website and through a range of media to engage the public. TRIAL REGISTRATION NUMBER: NCT05483309.

Treatment pathways, economic burden and clinical outcomes in new users of inhaled corticosteroid/long-acting B2-agonist dual therapy with chronic obstructive pulmonary disease in a primary care setting in England: a retrospective cohort study.

OBJECTIVE: Management of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA) improves lung function and health status and reduces COPD exacerbation risk versus monotherapy. This study described treatment use, healthcare resource utilisation (HCRU), healthcare costs and outcomes following initiation of single-device ICS/LABA as initial maintenance therapy (IMT). DESIGN: Retrospective cohort study. SETTING: Primary care, England. DATA SOURCES: Linked data from the Clinical Practice Research Datalink Aurum and Hospital Episode Statistics datasets. PARTICIPANTS: Patients with COPD and ≥1 single-device ICS/LABA prescription between July 2015 and December 2018 were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Treatment pathways, COPD-related HCRU and healthcare costs, COPD exacerbations, time to triple therapy, medication adherence (proportion of days covered ≥80%) and indexed treatment time to discontinuation. Data for patients without prior maintenance therapy history (IMT users) and non-triple users were assessed over a 12-month follow-up period. RESULTS: Of 13 451 new ICS/LABA users, 5162 were IMT users (budesonide/formoterol, n=1056; beclomethasone dipropionate/formoterol, n=2427; other ICS/LABA, n=1679), for whom at 3 and 12 months post-index, 45.6% and 39.4% were still receiving any ICS/LABA. At >6 to ≤12 months, the proportion of IMT users with ≥1 outpatient visit (10.1%) and proportion with ≥1 inpatient stay (12.6%) had increased from those at 3 months (9.0% and 7.4%, respectively). Inpatient stays contributed most to total COPD-related healthcare costs. For non-triple IMT users, at 3 and 12 months post-index, 4.5% and 13.7% had ≥1 moderate-to-severe COPD exacerbation. Time to triple therapy initiation and time to discontinuation of index medication ranged from 45.9 to 50.2 months and 2.3 to 2.8 months between treatments. Adherence was low across all time points (21.5-27.6%). Results were similar across indexed therapies. CONCLUSIONS: In the year following treatment initiation, ICS/LABA adherence was poor and many patients discontinued or switched therapies, suggesting that more consideration and optimisation of treatment is required in England for patients initiating single-device ICS/LABA therapy.

Impact of omitting annual reviews for COPD on patient reported care quality- outcomes from the Asthma+Lung COPD patient passport.

BACKGROUND: Regular clinical reviews of people with COPD provide an opportunity to optimise management and are recommended in national and international guidelines. However, there are limited data about the relationship between having an annual review and other aspects of care quality, which might influence decision-making by healthcare professionals and commissioners. METHOD: Using data from 74 827 people with COPD completing the Asthma+Lung UK COPD Patient Passport, between 2014 and 2022, we conducted adjusted logistic regression (adjusting for year) and compared receipt of key items of care between those reporting that they had had an annual review (65.3%) and those who did not (34.7%). To further capture patient experience, we also analysed 4228 free-text responses to the 2021 Asthma+Lung UK annual COPD survey to the question 'What is the one thing that could improve your COPD care?' RESULTS: We found that the absence of an annual review was associated with significantly worse COPD care across all domains studied; in particular, inhaler training (yes: 80.8% vs no: 38.4%, adjusted OR (AOR): 8.18, 95% CI (7.89 to 8.47), having a written care plan (89.6% vs 56.9%, AOR 6.68 (95% CI 6.35 to 7.05) and medication knowledge (72.6% vs 33.6%, AOR 5.73 (95% CI 5.51 to 5.96). Thematic analysis of the 2021 COPD survey responses identified three areas to improve care: (1) access and support from healthcare services, (2) improved treatment effectiveness and (3) interaction between COPD and the social environment. DISCUSSION: Failure to deliver annual COPD reviews is associated with worse patient-reported experience of care quality. In parallel, people with COPD express a desire for greater support and access to healthcare services.

High continuous positive airway pressures versus non-invasive positive pressure ventilation in preterm neonates: protocol for a multicentre pilot randomised controlled trial.

INTRODUCTION: Low pressure nasal continuous positive airway pressure (nCPAP) has long been the mainstay of non-invasive respiratory support for preterm neonates, at a constant distending pressure of 5-8 cmH2O. When traditional nCPAP pressures are insufficient, other modes including nasal intermittent positive pressure ventilation (NIPPV) are used. In recent years, high nCPAP pressures (≥9 cmH2O) have also emerged as an alternative. However, the comparative benefits and risks of these modalities remain unknown. METHODS AND ANALYSIS: In this multicentre pilot randomised controlled trial, infants <29 weeks' gestational age (GA) who either: (A) fail treatment with traditional nCPAP or (B) being extubated from invasive mechanical ventilation with mean airway pressure ≥10 cmH2O, will be randomised to receive either high nCPAP (positive end-expiratory pressure 9-15 cmH2O) or NIPPV (target mean Paw 9-15 cmH2O). Primary outcome is feasibility of the conduct of a larger, definitive trial as assessed by rates of recruitment and protocol violations. The main secondary outcome is failure of assigned treatment within 7 days postrandomisation. Multiple other clinical outcomes including bronchopulmonary dysplasia will be ascertained. All randomised participants will be analysed using intention to treat. Baseline and demographic variables as well as outcomes will be summarised and compared using univariate analyses, and a p<0.05 will be considered significant. ETHICS AND DISSEMINATION: The trial has been approved by the respective research ethics boards at each institution (McMaster Children's Hospital: Hamilton integrated REB approval #2113; Royal Alexandra Hospital: Health Research Ethics Board approval ID Pro00090244; Westmead Hospital: Human Research Ethics Committee approval ID 2022/ETH01343). Written, informed consent will be obtained from all parents/guardians prior to study enrolment. The findings of this pilot study will be disseminated via presentations at national and international conferences and via publication in a peer-reviewed journal. Social media platforms including Twitter will also be used to generate awareness. TRIAL REGISTRATION NUMBER: NCT03512158.