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17
result(s) for
"Bakerly, Nawar D."
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Improving quality in adult long covid services: Findings from the LOCOMOTION quality improvement collaborative
by
Darbyshire, Julie
,
Bakerly, Nawar D.
,
Davies, Helen
in
Breathing pattern disorder
,
Cardiac arrhythmia
,
Clinics
2024
The protracted form of COVID-19 known as ‘long covid’ was first described in 2020. Its symptoms, course and prognosis vary widely; some patients have a multi-system, disabling and prolonged illness. In 2021, ring-fenced funding was provided to establish 90 long covid clinics in England; some clinics were also established in Scotland and Wales. The NIHR-funded LOCOMOTION project implemented a UK-wide quality improvement collaborative involving ten of these clinics, which ran from 2021 to 2023. At regular online meetings held approximately 8-weekly, participants prioritised topics, discussed research evidence and guidelines, and presented exemplar case histories and clinic audits. A patient advisory group also held a priority-setting exercise, participated in quality meetings and undertook a service evaluation audit. The goal of successive quality improvement cycles aimed at changing practice to align with evidence was sometimes hard to achieve because definitive evidence did not yet exist in this new condition; many patients had comorbidities; and clinics were practically constrained in various ways. Nevertheless, much progress was made and a series of ‘best practice’ guides was produced, covering general assessment and management; breathing difficulties; orthostatic tachycardia and other autonomic symptoms; fatigue and cognitive impairment; and vocational rehabilitation. This paper summarises key findings with the frontline clinician in mind.
Journal Article
Non-typeable Haemophilus influenzae protein vaccine in adults with COPD: A phase 2 clinical trial
by
Schembri, Stuart
,
Arora, Ashwani K.
,
Brightling, Christopher
in
adjuvants
,
Adults
,
Allergy and Immunology
2019
•An investigational NTHi vaccine was tested for the first time in adults with COPD.•The vaccine had acceptable safety and reactogenicity.•Vaccine-elicited antibody concentrations were higher than baseline 1 year post-dose 2.
Loss of airway microbial diversity is associated with non-typeable Haemophilus influenzae (NTHi) infection and increased risk of exacerbation in chronic obstructive pulmonary disease (COPD). We assessed the safety and immunogenicity of an investigational vaccine containing NTHi antigens, recombinant protein D (PD) and combined protein E and Pilin A (PE-PilA), and AS01 adjuvant in adults with moderate/severe COPD and prior exacerbations.
In this phase 2, observer-blind, controlled trial (NCT02075541), 145 COPD patients aged 40–80 years randomly (1:1) received two doses of NTHi vaccine or placebo 60 days apart, on top of standard care.
Reactogenicity in the 7-day post-vaccination period was higher following NTHi vaccine than placebo. Most solicited adverse events (AEs) were mild/moderate. At least one unsolicited AE was reported during the 30-day post-vaccination period by 54.8% of NTHi vaccine and 51.4% of placebo recipients. One serious AE (placebo group) was assessed by the investigator as vaccine-related. Anti-PD, anti-PE and anti-PilA geometric mean antibody concentrations increased up to 30 days after each NTHi vaccine dose, waned thereafter, but remained higher than baseline (non-overlapping confidence intervals) up to 13 months post-dose 2. The frequency of specific CD4+ T cells increased following two doses of NTHi vaccine and remained higher than baseline. Exploratory analysis showed a statistically non-significant lower yearly rate of moderate/severe exacerbations in the NTHi vaccine group than following placebo (1.49 versus 1.73) in the one-year period post-dose 2, with estimated vaccine efficacy of 13.3% (95% confidence interval −24.2 to 39.5; p = 0.44).
The NTHi vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in adults with COPD.
Journal Article
Effectiveness of Fluticasone Furoate–Vilanterol for COPD in Clinical Practice
by
Collier, Susan
,
Crawford, Jodie
,
Vestbo, Jørgen
in
Administration, Inhalation
,
Aged
,
Androstadienes - administration & dosage
2016
In an open-label, randomized trial conducted in 75 general practices, once-daily treatment for chronic obstructive pulmonary disease with inhaled fluticasone furoate–vilanterol was associated with a lower rate of moderate or severe exacerbations than usual care.
Guidelines on the management of chronic obstructive pulmonary disease (COPD) are based on numerous randomized, controlled trials of efficacy, which are usually generated for registration purposes.
1
However, these trials have included patients who were selected with the use of strict criteria and were closely monitored, and therefore the results have limited relevance to everyday clinical practice.
2
To counter this, it has been proposed that integrated comparative effectiveness trials involve more representative patients and be conducted in much less restricted environments.
3
–
5
The Salford Lung Study was designed to evaluate the effectiveness and safety of the once-daily inhaled combination of fluticasone . . .
Journal Article
Advancing Digital Solutions to Overcome Longstanding Barriers in Asthma and COPD Management
by
Bosnic-Anticevich, Sinthia
,
Hew, Mark
,
van der Palen, Job
in
Asthma
,
Care and treatment
,
Chronic obstructive pulmonary disease
2023
Maintenance therapy delivered via inhaler is central to asthma and chronic obstructive pulmonary disease (COPD) management. Poor adherence to inhaled medication and errors in inhalation technique have long represented major barriers to the optimal management of these chronic conditions. Technological innovations may provide a means of overcoming these barriers. This narrative review examines ongoing advances in digital technologies relevant to asthma and COPD with the potential to inform clinical decision-making and improve patient care. Digital inhaler devices linked to mobile apps can help bring about changes in patients' behaviors and attitudes towards disease management, particularly when they build in elements of interactivity and gamification. They can also support ongoing technique education, empowering patients and helping providers maximize the value of consultations and develop effective action plans informed by insights into the patient's inhaler use patterns and their respiratory health. When combined with innovative techniques such as machine learning, digital devices have the potential to predict exacerbations and prompt pre-emptive intervention. Finally, digital devices may support an advanced precision medicine approach to respiratory disease management and help support shared decision-making. Further work is needed to increase uptake of digital devices and integrate their use into care pathways before their full potential in personalized asthma and COPD management can be realized.
Journal Article
Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial
by
Jensen Jens-Ulrik Stæhr
,
Mathioudakis, Alexander G
,
Vestbo Jørgen
in
Antibiotics
,
Binomial distribution
,
Bronchodilators
2026
BackgroundIn real-world chronic obstructive pulmonary disease (COPD) care, poor adherence often leads to treatment discontinuations. Discontinuing inhaled corticosteroids (ICS) can trigger withdrawal effects transiently increasing exacerbation risk; but evidence for long-acting muscarinic antagonists (LAMA) withdrawal remains limited.MethodsWe performed a post hoc analysis of the 52-week, double-blind, Effect of Indacaterol Glycopyrronium versus Fluticasone Salmeterol on COPD Exacerbations trial that compared long-acting beta-2 agonist (LABA)+LAMA with LABA+ICS in 3362 patients with moderate-to-severe COPD and exacerbation history. Potential withdrawal effects after discontinuing LAMA or ICS were suggested by monthly exacerbation incidence plots during the first quarter of follow-up. Participants were stratified by their baseline use of these therapies, and outcomes were compared between the first and subsequent quarters among those who continued versus discontinued each treatment. Multivariable mixed-effects models assessed differences in exacerbation rates, with temporal variation in treatment effects interpreted as indicative of withdrawal effects.ResultsDiscontinuing LAMA was associated with a marked, transient increase in moderate-to-severe exacerbations during the first versus subsequent quarters (p=0.001; rate ratio up to 2.2 (95% CI 1.2 to 4.1) in the subgroup least influenced by concomitant ICS use). This observation was not confirmed for severe exacerbations, likely due to low event count. In contrast, discontinuing ICS was associated with a significant early rise in severe exacerbations (p=0.023), though the difference for moderate-to-severe events did not reach statistical significance. Importantly, ICS withdrawal effects appeared consistent regardless of baseline blood eosinophil count.ConclusionOur findings suggest potent LAMA and ICS treatment withdrawal effects on exacerbations, highlighting the importance of treatment adherence and accounting for withdrawal effects in clinical trials.Trial registration numberNCT01782326.
Journal Article
Obtaining real-world evidence: the Salford Lung Study
by
Leather, David
,
Woodcock, Ashley
,
New, John P
in
Administration, Inhalation
,
Adrenergic beta-Agonists - administration & dosage
,
Adrenergic beta-Agonists - therapeutic use
2014
We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can facilitate concurrent safety monitoring and data collection without direct patient contact for large randomised study populations in pRCTs. The Salford Lung Study is the world's first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomise over 7000 patients. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention.
HZC115151 ASTHMA STUDY CLINICALTRIALSGOV REGISTRATION: NCT01706198 COPD STUDY CLINICALTRIALSGOV REGISTRATION: NCT01551758.
Journal Article