ResearchPad - 1731 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Severe Asthma Toolkit: an online resource for multidisciplinary health professionals—needs assessment, development process and user analytics with survey feedback]]> https://www.researchpad.co/article/elastic_article_9115 Severe asthma imposes a significant burden on individuals, families and the healthcare system. New treatment and management approaches are emerging as effective options for severe asthma. Translating new knowledge to multidisciplinary healthcare professionals is a priority. We developed ‘The Severe Asthma Toolkit’ (https://toolkit.severeasthma.org.au) to increase awareness of severe asthma, provide evidence-based resources and support decisionmaking by healthcare providers.SettingRoundtable discussions and a survey of Australians clinicians were conducted to determine clinician preferences, format and content for a severe asthma resource.ParticipantsA reference group from stakeholder and consumer bodies and severe asthma experts provided advice and feedback. A multidisciplinary team of international experts was engaged to develop content. Written content was based on up-to-date literature. Peer and editorial review were performed to finalise content and inform web design. Website design focused on user experience, navigation, engagement, interactivity and tailoring of content for a clinical audience.ResultsA web-based resource was developed. Roundtable discussions and a needs assessment survey identified the need for dedicated severe asthma management resources to support skills training. The end-product, which launched 26 March 2018, includes an overview of severe asthma, diagnosis and assessment, management, medications, comorbidities, living with severe asthma, establishing a clinic, paediatrics/adolescents and clinical resources. Analytics indicate access by users worldwide (32 169 users from 169 countries). User survey results (n=394) confirm access by the target audience (72% health professionals), who agreed the toolkit increased their knowledge (73%) and confidence in managing severe asthma (66%), and 75% are likely to use the resource in clinic.ConclusionsThe Severe Asthma Toolkit is a unique, evidence-based internet resource to support healthcare professionals providing optimal care for people with severe asthma. It is a comprehensive, accessible and independent resource developed by leading severe asthma experts to improve clinician knowledge and skills in severe asthma management. ]]> <![CDATA[Achieving Control of Asthma in Children in Africa (ACACIA): protocol of an observational study of children’s lung health in six sub-Saharan African countries]]> https://www.researchpad.co/article/elastic_article_9090 Little is known about asthma control in the rising number of African children who suffer from this condition. The Achieving Control of Asthma in Children in Africa (ACACIA) study is an observational study collecting evidence about paediatric asthma in urban areas of Ghana, Malawi, Nigeria, South Africa, Uganda and Zimbabwe. The primary objectives are: (1) to identify 3000 children aged between 12 years and 14 years with asthma symptoms; and (2) to assess their asthma control, current treatment, knowledge of and attitudes to asthma and barriers to achieving good control. Secondary objective is to develop interventions addressing identified barriers to good symptom control.Methods and analysisEach centre will undertake screening to identify 500 school children with asthma symptoms using questions from the Global Asthma Network’s questionnaire. Children identified to have asthma symptoms will fill in a digital survey, including: Asthma Control Test, questions on medication usage and adherence, medical care, the Brief-Illness Perception questionnaire and environmental factors. Exhaled nitric oxide testing and prebronchodilator and postbronchodilator spirometry will be performed. A subgroup of children will participate in focus group discussions. Results will be analysed using descriptive statistics and comparative analysis. Informed by these results, we will assess the feasibility of potential interventions, including the adaption of a UK-based theatre performance about asthma attitudes and digital solutions to improve asthma management.Ethics and disseminationThe ACACIA study has been reviewed by the Queen Mary University of London Ethics of Research Committee in the UK. All African centres have received local ethical approval for this study. Study results will be published in academic journals and at conferences. Study outputs will be communicated to the public via newsfeeds on the ACACIA website and Twitter, and through news media outlets and other local dissemination.Trial registration number269211. ]]> <![CDATA[Prevalence and risk factors for wheeze, decreased forced expiratory volume in 1 s and bronchoconstriction in young children living in Havana, Cuba: a population-based cohort study]]> https://www.researchpad.co/article/N9c0f72e8-35ee-45c3-9f4c-4e5d3ef32212 Asthma has not been extensively studied in low-income and middle-income countries, where risk factors and access to treatment may differ from more affluent countries. We aimed to identify the prevalence of asthma and local risk factors in Havana, Cuba.SettingFour municipalities in Havana, Cuba.ParticipantsA population-based cohort study design of young children living in Havana, Cuba. Children were recruited from primary care centres at age 12–15 months.Primary and secondary outcome measuresData on wheeze in the past 12 months, asthma treatment and environmental exposures collected regularly until the age of 6 years, when forced expiratory volume in 1 s (FEV1) and reversibility to aerosolised salbutamol were also measured.Results1106 children provided data at the age of 6 years old. The prevalence of wheeze in the previous 12 months was 422 (38%), and 294 (33%) of the study population had bronchodilatation of 12% or more in FEV1 after administration of inhaled salbutamol. In the previous 12 months, 182 (16%) of the children had received inhaled corticosteroids, 416 (38%) salbutamol inhalers and 283 (26%) a course of systemic steroids.Wheeze in the first year and a family history of asthma were both positively associated with bronchodilatation to inhaled salbutamol (1.94%; 95% CI 0.81 to 3.08 and 1.85%; CI 0.14 to 3.57, respectively), while paracetamol use in the first year was associated with wheeze at 6 years (OR 1.64, 95% CI 1.14 to 2.35). There were large differences in FEV1, bronchodilatation and risk of wheeze across different geographical areas.ConclusionsAsthma is common in young children living in Havana, and the high prevalence of systemic steroids administrated is likely to reflect the underuse of regular inhaled corticosteroids. If replicated in other comparable low-income and middle-income countries, this represents an important global public health issue. ]]> <![CDATA[Defining high probability when making a diagnosis of asthma in primary care: mixed-methods consensus workshop]]> https://www.researchpad.co/article/Ndbf1a2fe-f607-414f-b975-774b73c536d9 Making the diagnosis of asthma is challenging. Guidelines recommend that clinicians identify a group at ‘high probability’ of asthma. High probability, however, is not numerically defined giving rise to uncertainty. The aim of this work was to build consensus on what constitutes a high probability of asthma in primary care. High probability was defined as the probability threshold at which there is enough information to make a firm diagnosis of asthma, and a subsequent negative test would not alter that opinion (assumed to be a false negative).DesignMixed-methods study.SettingA consensus workshop using modified nominal group technique was held during an international respiratory conference.ParticipantsInternational conference attendees eligible if they had knowledge/experience of working in primary care, respiratory medicine and spoke English.MethodsParticipants took part in facilitated discussions and voted over three rounds on what constituted a high probability of asthma diagnosis. The workshop was audio-recorded, transcribed and qualitatively analysed.ResultsBased on final votes, the mean value for a high probability of asthma in primary care was 75% (SD 7.6), representing a perceived trade-off between limiting the number of false positives (more likely if a lower threshold was used) and pragmatism on the basis that first-line preventive therapies (ie, low-dose inhaled corticosteroids) are relatively low risk. The need to review response to treatment was strongly emphasised for detecting non-responders and reviewing the diagnosis.ConclusionA consensus probability of 75% was the threshold at which the primary care participants in this workshop felt confident to establish the diagnosis of asthma, albeit with the caveat that a review of treatment response was essential. Contextual factors, including availability and timing of tests and the ease with which patients could be reviewed, influenced participants’ decision making. ]]> <![CDATA[Protocol for a multicentre randomised controlled trial to investigate the effect on asthma-related quality of life from breathing retraining in patients with incomplete asthma control attending specialist care in Denmark]]> https://www.researchpad.co/article/N2d89c861-3997-4a83-9f7b-6f44d11eb604

Introduction and aim

Uncontrolled asthma is a global health challenge with substantial impact on quality of life (QoL) and overall healthcare costs. Unrecognised and/or unmanaged comorbidities often contribute to presence of uncontrolled asthma. Abnormalities in breathing pattern are termed dysfunctional breathing and are not only common in asthma but also lead to asthma-like symptoms and reduced QoL, and, in keeping with this, improvement with breathing normalisation. Evidence-based guidelines recommend breathing retraining interventions as an adjuvant treatment in uncontrolled asthma. Physiotherapy-based breathing pattern modification interventions incorporating relaxation have been shown to improve asthma-related QoL in primary care patients with impaired asthma control. Despite anecdotal reports, effectiveness of breathing retraining in patients referred to secondary care with incomplete asthma control has not been formally assessed in a randomised controlled trial (RCT). We aim to investigate the effect of breathing exercises on asthma-related QoL in patients with incomplete asthma control despite specialist care.

Methods and analysis

This two-armed assessor-blinded multicentre RCT will investigate the effect of physiotherapist-delivered breathing retraining on asthma QoL questionnaire (MiniAQLQ) in addition to usual specialist care, recruiting from seven outpatient departments and one specialised clinic representing all regions of Denmark during 2017–2019. We will include 190 consenting adults with incomplete asthma control, defined as Asthma Control Questionnaire 6-item score ≥0.8. Participants will randomly be allocated to either breathing exercise programme in addition to usual care (BrEX +UC) or UC alone. BrEX compiles three physiotherapy sessions and encouragement to perform home exercise daily. Both groups continue usual secondary care management. Primary outcome is between-group difference in MiniAQLQ at 6 months. Secondary outcomes include patient-reported outcome measures, spirometry and accelerometer.

Ethics and dissemination

Ethics Committee, Region Zealand (SJ-552) and Danish Data Protection Agency (REG-55–2016) approved the trial. Results will be reported in peer-reviewed scientific journals.

Trial registration number

NCT03127059; Pre-results.

]]>
<![CDATA[Vitamin D in the prevention of exacerbations of asthma in preschoolers (DIVA): protocol for a multicentre randomised placebo-controlled triple-blind trial]]> https://www.researchpad.co/article/N034fe1b2-904d-483d-82e8-ab37afe218e3

Introduction

Preschoolers have the highest rate of emergency visits and hospitalisations for asthma exacerbations of all age groups, with most triggered by upper respiratory tract infections (URTIs) and occurring in the fall or winter. Vitamin D insufficiency is highly prevalent in Canadian preschoolers with recurrent asthma exacerbations, particularly in winter. It is associated with more URTIs and, in patients with asthma, more oral corticosteroid (OCS) use. Although evidence suggests that vitamin D supplements significantly decrease URTIs and asthma exacerbations requiring OCS, there is insufficient data in preschoolers. This study aims to determine the impact of vitamin D3 supplementation on exacerbations requiring OCS, in preschoolers with recurrent URTI-induced asthma exacerbations.

Methods and analysis

This is a phase III, randomised, triple-blind, placebo-controlled, parallel-group multicentre trial of vitamin D3 supplementation in children aged 1–5 years, with asthma triggered by URTIs and a recent history of frequent URTIs and OCS use. Children (n=865) will be recruited in the fall and early winter and followed for 7 months. They will be randomised to either the (1) intervention: two oral boluses of 100 000 international unit (IU) vitamin D3 (3.5 months apart) with 400 IU vitamin D3 daily; or (2) control: identical placebo boluses with daily placebo. The primary outcome is the number of exacerbations requiring OCS per child, documented by medical and pharmacy records. Secondary outcomes include number of laboratory-confirmed viral URTIs, exacerbation duration and severity, parent functional status, healthcare use, treatment deintensification, cost and safety.

Ethics and dissemination

This study has received ethical approval from all sites. Results will be disseminated via international conferences and manuscripts targeting paediatricians and respirologists, and to families of asthmatic children via our Quebec parents–partners outreach programme. If proven effective, findings may markedly influence the management of URTI-induced asthma in high-morbidity preschoolers and could be directly implemented into practice with an update to clinical guidelines.

Trial registration number

NCT03365687.

]]>
<![CDATA[Direct costs of overdiagnosed asthma: a longitudinal, population-based cohort study in British Columbia, Canada]]> https://www.researchpad.co/article/N1f10a115-614a-4d18-ba4a-25165a6d1346

Objectives

A current diagnosis of asthma cannot be objectively confirmed in many patients with physician-diagnosed asthma. Estimates of resource use in overdiagnosed cases of asthma are necessary to measure the burden of overdiagnosis and to evaluate strategies to reduce this burden. We assessed differences in asthma-related healthcare resource use between patients with a confirmed asthma diagnosis and those with asthma ruled out.

Design

Population-based, prospective cohort study.

Setting

Participants were recruited through random-digit dialling of both landlines and mobile phones in the province of British Columbia, Canada.

Participants

We included 345 individuals ≥12 years of age with a self-reported physician diagnosis of asthma. The diagnosis of asthma was reassessed at the end of 12 months of follow-up using a structured algorithm, which included a bronchodilator reversibility test, methacholine challenge test, and if necessary medication tapering and a second methacholine challenge test.

Primary and secondary outcome measures

Self-reported annual asthma-related direct healthcare costs (2017 Canadian dollars), outpatient physician visits and medication use from the perspective of the Canadian healthcare system.

Results

Asthma was ruled out in 86 (24.9%) participants. The average annual asthma-related direct healthcare costs for participants with confirmed asthma were $C497.9 (SD $C677.9) and for participants with asthma ruled out, $C307.7 (SD $C424.1). In the adjusted analyses, a confirmed diagnosis was associated with higher direct healthcare costs (relative ratio (RR)=1.60, 95% CI 1.14 to 2.22), increased rate of specialist visits (RR=2.41, 95% CI 1.05 to 5.40) and reliever medication use (RR=1.62, 95% CI 1.09 to 2.35), but not primary care physician visits (p=0.10) or controller medication use (p=0.11).

Conclusions

A quarter of individuals with a physician diagnosis of asthma did not have asthma after objective re-evaluation. These participants still consumed a significant amount of asthma-related healthcare resources. The population-level economic burden of asthma overdiagnosis could be substantial.

]]>
<![CDATA[Feasibility trial of a digital self-management intervention ‘My Breathing Matters’ to improve asthma-related quality of life for UK primary care patients with asthma]]> https://www.researchpad.co/article/N746cd635-a8f4-42b2-bbd1-2d21cc3f9700

Objective

To assess the feasibility of a randomised controlled trial (RCT) and acceptability of an asthma self-management digital intervention to improve asthma-specific quality of life in comparison with usual care.

Design and setting

A two-arm feasibility RCT conducted across seven general practices in Wessex, UK.

Participants

Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet.

Interventions

‘My Breathing Matters’ (MBM) is a digital asthma self-management intervention designed using theory, evidence and person-based approaches to provide tailored support for both pharmacological and non-pharmacological management of asthma symptoms.

Outcomes

The primary outcome was the feasibility of the trial design, including recruitment, adherence and retention at follow-up (3 and 12 months). Secondary outcomes were the feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control.

Results

Primary outcomes: 88 patients were recruited (target 80). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0–25, IQR 8). Consistent trends were observed to improvements in asthma-related patient-reported outcome measures.

Conclusions

This study demonstrated the feasibility and acceptability of a definitive RCT that is required to determine the clinical and cost-effectiveness of a digital asthma self-management intervention.

Trial registration number

ISRCTN15698435.

]]>
<![CDATA[Endotype-driven prediction of acute exacerbations in chronic obstructive pulmonary disease (EndAECOPD): protocol for a prospective cohort study]]> https://www.researchpad.co/article/N39dbe70a-2400-4479-ae19-28b5c8aab211

Introduction

Current strategies for the prevention of acute exacerbations in chronic obstructive pulmonary disease (COPD) are primarily based on clinical measurements but fail to target the pathophysiological mechanisms, namely endotypes, of the disease. Studies identifying endotypes underlying exacerbation susceptibility and discovering specific biomarkers may lead to the development of targeted therapeutics but are lacking. This study aims to assess a broad spectrum of biomarkers at multiple biological levels (genetics, airway inflammation and respiratory microbiome) for their ability in predicting acute exacerbations of COPD, thus enables high-resolution disease endotyping and may lead to precision treatment of the disease.

Methods and analysis

In this prospective cohort study, participants with stable COPD (n=600) will be recruited and assessed for demographics, symptom scores, spirometry, medication use and comorbidities at baseline. Blood will be obtained for genotyping variants in a panel of nine genes. Induced sputum will be collected for the profile of microbiota using 16S rRNA gene sequencing, quantification of bacterial load, inflammatory mediators assay and sputum cytometry. Participants will be followed up for their exacerbations till 12 months and reassessed for the clinical measurements as baseline. The primary outcomes are total number of exacerbations, severe exacerbations, moderate exacerbations and time to first exacerbation. The secondary outcomes are changes in lung function and symptom scores. The effect of biomarkers representing genetic variants, airway inflammation and respiratory microbiome on predicting the frequent exacerbator phenotype and exacerbation frequency will be analysed with multivariable modelling, and time to first exacerbation with a Cox regression model.

Ethics and dissemination

The study has been approved by the Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University (No. 2018–298). The results of the study will be published on peer-reviewed journals.

Trial registration number

ChiCTR1800019063.

]]>
<![CDATA[Effects of birth weight and growth on childhood wheezing disorders: findings from the Born in Bradford Cohort]]> https://www.researchpad.co/article/5af53991463d7e1cbea42b0b

Objectives

To examine the effects of birth weight and childhood growth on childhood wheezing disorders. We hypothesised that low birth weight and fast growth during early age would increase the risk of wheezing disorders.

Setting

Observational secondary analysis of data from the Born in Bradford cohort.

Participants

All children who were born at the Bradford Royal Infirmary hospital between March 2007 and December 2010 were eligible for the study. A total of 13 734 and 1598 children participated in the analyses of the effects of birth weight and growth on wheezing disorders, respectively.

Primary and secondary outcome measures

Wheezing disorders diagnosis (diagnosed as asthma or had wheezing symptom) during the ages of 0–7 years were the primary outcome measures. Diagnosis of asthma and occurrence of wheezing during the same period were secondary outcome measures. Birth weight was classified as normal (2.5–4.0 kg), low (<2.5 kg) and high (>4.0 kg). Growth mixture models were used to drive growth pattern outcomes which were classified as ‘normal’, ‘fast’ and ‘slow’ growth based on their velocities between birth and 36 months.

Results

The adjusted relative risks (RRs) of wheezing disorders diagnosis for the low and high birthweight children were 1.29 (95% CI 1.12 to 1.50; p=0.001) and 0.91 (95% CI 0.79 to 1.04; p=0.17), respectively. The adjusted RRs of wheezing disorders diagnosis were 1.30 (95% CI 0.56 to 3.06; p=0.54) and 0.60 (95% CI 0.16 to 2.18; p=0.44), respectively, for the ‘fast’ and ‘slow’ growth as compared with the ‘normal’ growth.

Conclusions

Low birth weight is associated with an increased risk of wheezing disorders; however, there is a weak evidence that suggests high birthweight children have a reduced risk in this birth cohort. Low birth weight coupled with a slower growth until 3 months and a sharp growth between 3 and 12 months has an increased risk of wheezing disorders diagnosis.

]]>
<![CDATA[Protocol for a systematic literature review and network meta-analysis of the clinical benefit of inhaled maintenance therapies in chronic obstructive pulmonary disease]]> https://www.researchpad.co/article/5c9e5787d5eed0c48423fc59

Introduction

Chronic obstructive pulmonary disease (COPD) exacerbations progress the course of disease and impair lung function. Inhaled maintenance therapy reduces exacerbations. It is not yet established which inhaled therapy combination is best to reduce exacerbations, lung function decline and symptom burden.

Methods and analysis

MEDLINE, EMBASE and the Cochrane Library will be searched for articles between January 2011 and May 2018 using a pre-specified search strategy. Conference proceedings will be searched. Systematic reviews (with or without meta-analysis), randomised controlled trials (RCTs), cohort studies and case controlled studies comparing six interventions comprising different combinations of long-acting bronchodilators and inhaled corticosteroids in unison or on their own. The primary outcome is the reduction in moderate-to-severe exacerbations. Secondary outcomes include: lung function, quality of life, mortality and other adverse events. Titles and abstracts will screened by the primary researcher. A second reviewer will repeat this on a proportion of records. The Population, Intervention, Comparator, Outcomes and Study framework will be used for data extraction. A network meta-analyses of outcomes from RCTs and real-world evidence will be integrated if feasible. The 95% credible interval will be used to assess the statistical significance of each summary effect. Ranking of interventions will be based on their surface under cumulative ranking area.

Ethics and dissemination

COPD exacerbations are burdensome to patients. We aim to report results that provide clinicians with a more informed choice of which inhaled therapy combinations are best to reduce exacerbations, improve disease burden and reduce lung function and exercise capacity decline, compared with the potential harms, in certain populations with COPD.

PROSPERO registration number

CRD42018088013.

]]>
<![CDATA[Meteorological factors and risk of community-acquired Legionnaires’ disease in Switzerland: an epidemiological study]]> https://www.researchpad.co/article/5acc8811463d7e4524cc252e

Objectives

The aim of this study was to identify meteorological factors that could be associated with an increased risk of community-acquired Legionnaires’ disease (LD) in two Swiss regions.

Design

Retrospective epidemiological study using discriminant analysis and multivariable Poisson regression.

Setting

We analysed legionellosis cases notified between January 2003 and December 2007 and we looked for a possible relationship between incidence rate and meteorological factors.

Participants

Community-acquired LD cases in two Swiss regions, the Canton Ticino and the Basle region, with climatically different conditions were investigated.

Primary outcome measures

Vapour pressure, temperature, relative humidity, wind, precipitation and radiation recorded in weather stations of the two Swiss regions during the period January 2003 and December 2007.

Results

Discriminant analysis showed that the two regions are characterised by different meteorological conditions. A multiple Poisson regression analysis identified region, temperature and vapour pressure during the month of infection as significant risk factors for legionellosis. The risk of developing LD was 129.5% (or 136.4% when considering vapour pressure instead of temperature in the model) higher in the Canton Ticino as compared to the Basle region. There was an increased relative risk of LD by 11.4% (95% CI 7.70% to 15.30%) for each 1 hPa rise of vapour pressure or by 6.7% (95% CI 4.22% to 9.22%) for 1°C increase of temperature.

Conclusions

In this study, higher water vapour pressure and heat were associated with a higher risk of community-acquired LD in two regions of Switzerland.

]]>
<![CDATA[Impact of anaemia on lung function and exercise capacity in patients with stable severe chronic obstructive pulmonary disease]]> https://www.researchpad.co/article/5af26659463d7e3ed4426e72

Objective

This study intended to search for potential correlations between anaemia in patients with severe chronic obstructive pulmonary disease (COPD; GOLD stage III) and pulmonary function at rest, exercise capacity as well as ventilatory efficiency, using pulmonary function test (PFT) and cardiopulmonary exercise testing (CPET).

Setting

The study was undertaken at Shanghai Pulmonary Hospital, a tertiary-level centre affiliated to Tongji University. It caters to a large population base within Shanghai and referrals from centres in other cities as well.

Participants

157 Chinese patients with stable severe COPD were divided into 2 groups: the anaemia group (haemoglobin (Hb) <12.0 g/dL for males, and <11 g/dL for females (n=48)) and the non-anaemia group (n=109).

Primary and secondary outcome measures

Arterial blood gas, PFT and CPET were tested in all patients.

Results

(1) Diffusing capacity for carbon monoxide (DLCO) corrected by Hb was significantly lower in the anaemia group ((15.3±1.9) mL/min/mm Hg) than in the non-anaemia group ((17.1±2.1) mL/min/mm Hg) (p<0.05). A significant difference did not exist in the level of forced expiratory volume in 1 s (FEV1), FEV1%pred, FEV1/forced vital capacity (FVC), inspiratory capacity (IC), residual volume (RV), total lung capacity (TLC) and RV/TLC (p>0.05). (2) Peak Load, Peak oxygen uptake (), Peak %pred, Peak , Peak pulse and the ratio of increase to WR increase () were significantly lower in the anaemia group (p<0.05); however, Peak minute ventilation (VE), Lowest /carbon dioxide output () and Peak dead space/tidal volume ratio (VD/VT) were similar between the 2 groups (p>0.05). (3) A strong positive correlation was found between Hb concentration and Peak in patients with anaemia (r=0.702, p<0.01).

Conclusions

Anaemia has a negative impact on gas exchange and exercise tolerance during exercise in patients with severe COPD. The decrease in amplitude of Hb levels is related to the quantity of oxygen uptake.

]]>
<![CDATA[Multicentre, non-interventional study to assess the profile of patients with uncontrolled rhinitis prescribed a novel formulation of azelastine hydrochloride and fluticasone propionate in a single spray in routine clinical practice in the UK]]> https://www.researchpad.co/article/5bf50de4d5eed0c4848613ce

Objective

The aims of this study were (1) to characterise the type of patient prescribed MP-AzeFlu (Dymista, a novel formulation of azelastine hydrochloride, fluticasone propionate and excipients in a single spray) in real life in the UK and physicians' reasons for prescribing it and (2) to quantify the personal and societal burden of allergic rhinitis (AR) in the UK prior to MP-AzeFlu prescription.

Design, setting and participants

This multicentre, non-interventional study enrolled patients (n=193) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its licensed indications. Information was gathered on patient demographics, AR history and symptom severity, symptomatology and AR treatments in the previous calendar year (prior to MP-AzeFlu prescription). Physicians also recorded the number of previous AR visits, specific reasons for these visits and their reason for prescribing MP-AzeFlu.

Results

Most patients had seasonal AR either alone (10.4%) or in combination with perennial AR (35.2%), but many had AR of unknown origin (35.8%). Prior to MP-AzeFlu prescription, patients reported troublesome symptoms (78.2%) and sleep disturbance (64.8%), with congestion considered the most bothersome (54.4%) and ocular symptoms reported by 68.4% of patients. The most frequent reason for MP-AzeFlu prescription was that other therapies were not sufficient in the past (78.8%) or not sufficient to treat acute symptoms (16.1%). 79.3% of patients reported using ≥2 AR therapies in the past year. An average of 1.6 (SD 1.9) doctor visits due to AR were reported prior to MP-AzeFlu prescription.

Conclusions

In the UK, MP-AzeFlu was prescribed for individuals (≥12 years) with moderate/severe AR irrespective of (1) previous AR treatment (mono or multiple), (2) previous or likely treatment failure, (3) phenotype, (4) number of previous physician visits for AR and (5) for the relief of both acute symptoms and in anticipation of allergen exposure.

]]>
<![CDATA[Prevalence of nocturnal cough in asthma and its potential as a marker for asthma control (MAC) in combination with sleep quality: protocol of a smartphone-based, multicentre, longitudinal observational study with two stages]]> https://www.researchpad.co/article/5c59e110d5eed0c484111513

Introduction

Nocturnal cough is a burdensome asthma symptom. However, knowledge about the prevalence of nocturnal cough in asthma is limited. Furthermore, prior research has shown that nocturnal cough and impaired sleep quality are associated with asthma control, but the association between these two symptoms remains unclear. This study further investigates the potential of these symptoms as markers for asthma control and the accuracy of automated, smartphone-based passive monitoring for nocturnal cough detection and sleep quality assessment.

Methods and analysis

The study is a multicentre, longitudinal observational study with two stages. Sensor and questionnaire data of 94 individuals with asthma will be recorded for 28 nights by means of a smartphone. On the first and the last study day, a participant’s asthma will be clinically assessed, including spirometry and fractionated exhaled nitric oxide levels. Asthma control will be assessed by the Asthma Control Test and sleep quality by means of the Pittsburgh Sleep Quality Index. In addition, nocturnal coughs from smartphone microphone recordings will be labelled and counted by human annotators. Relatively unrestrictive eligibility criteria for study participation are set to support external validity of study results. Analysis of the first stage is concerned with the prevalence and trends of nocturnal cough and the accuracies of smartphone-based automated detection of nocturnal cough and sleep quality. In the second stage, patient-reported asthma control will be predicted in a mixed effects regression model with nocturnal cough frequencies and sleep quality of past nights as the main predictors.

Ethics and dissemination

The study was reviewed and approved by the ethics commission responsible for research involving humans in eastern Switzerland (BASEC ID: 2017–01872). All study data will be anonymised on study termination. Results will be published in medical and technical peer-reviewed journals.

Trial registration number

NCT03635710; Pre-results.

]]>
<![CDATA[Early intervention of patients at risk for acute respiratory failure and prolonged mechanical ventilation with a checklist aimed at the prevention of organ failure: protocol for a pragmatic stepped-wedged cluster trial of PROOFCheck]]> https://www.researchpad.co/article/5afefc40463d7e1ed32769b4

Introduction

Acute respiratory failure (ARF) often presents and progresses outside of the intensive care unit. However, recognition and treatment of acute critical illness is often delayed with inconsistent adherence to evidence-based care known to decrease the duration of mechanical ventilation (MV) and complications of critical illness. The goal of this trial is to determine whether the implementation of an electronic medical record-based early alert for progressive respiratory failure coupled with a checklist to promote early compliance to best practice in respiratory failure can improve the outcomes of patients at risk for prolonged respiratory failure and death.

Methods and analysis

A pragmatic stepped-wedged cluster clinical trial involving 6 hospitals is planned. The study will include adult hospitalised patients identified as high risk for MV >48 hours or death because they were mechanically ventilated outside of the operating room or they were identified as high risk for ARF on the Accurate Prediction of PROlonged VEntilation (APPROVE) score. Patients with advanced directives limiting intubation will be excluded. The intervention will consist of (1) automated identification and notification of clinician of high-risk patients by APPROVE or by invasive MV and (2) checklist of evidence-based practices in ARF (Prevention of Organ Failure Checklist—PROOFCheck). APPROVE and PROOFCheck will be developed in the pretrial period. Primary outcome is hospital mortality. Secondary outcomes include length of stay, ventilator and organ failure-free days and 6-month and 12-month mortality. Predefined subgroup analysis of patients with limitation of aggressive care after study entry is planned. Generalised estimating equations will be used to compare patients in the intervention phase with the control phase, adjusting for clustering within hospitals and time.

Ethics and dissemination

The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings.

Trial registration number

NCT02488174.

]]>
<![CDATA[Use of corticosteroids during pregnancy and risk of asthma in offspring: a nationwide Danish cohort study]]> https://www.researchpad.co/article/5ad5b8fb463d7e495607b45b

Objective

To examine whether in utero exposure to local and systemic corticosteroids is associated with asthma development in offspring.

Design

Cohort study.

Setting

Denmark.

Participants

We included all singletons born alive in Denmark between 1996 and 2009. Data on maternal corticosteroid use, asthma in offspring and covariates were obtained from medical registries.

Main outcome measures

We compared asthma risks of children prenatally exposed to corticosteroids and of children of former corticosteroid users with that of unexposed children. We computed absolute risks and used proportional-hazards regression to compute adjusted HRs (aHRs). Using logistic regression we compared exposed children with unexposed siblings in a ‘within-mother-between-pregnancy’ analysis. Adjustment addressed varying length of follow-up.

Results

We identified 877 778 children, 3.6% of whom were prenatally exposed to systemic (n=5327) or local (n=24 436) corticosteroids. A total of 105 677 children developed asthma during follow-up with a 10-year risk of 18.4% among the exposed and 13.5% among the unexposed. The aHR was 1.54 (95% CI 1.45 to 1.65) for systemic use, 1.45 (95% CI 1.40 to 1.50) for local use and 1.32 (95% CI 1.30 to 1.34) for former use. The adjusted OR of the ‘within-mother-between-pregnancy’ analysis was 1.11 (95% CI 0.98 to 1.25).

Conclusions

These population-based data do not support a strong causal association between maternal corticosteroid use during pregnancy and increased asthma risk in offspring.

]]>
<![CDATA[Health-related quality of life after pulmonary embolism: a cross-sectional study]]> https://www.researchpad.co/article/5b29b6f4463d7e25dc2ebc99

Objectives

The psychological effects of acute pulmonary embolism (PE) have scarcely been studied. The aims of this study were to evaluate health-related quality of life (HRQoL) in patients with a history of PE compared with that of the general population and buddy controls, and to explore factors that may predict impaired HRQoL.

Design

Cross-sectional.

Setting

Haematology and thrombosis unit in Fredrikstad, Norway.

Participants

213 consecutive patients treated for PE were identified from hospital registries. Eligible patients were scheduled for a single study visit, including a functional capacity test (6 min walking test). HRQoL was assessed using the EuroQol 5D dimensions 3-level (EQ-5D-3L) questionnaire, of which the results were compared with Danish population norms and age-matched and sex-matched buddy controls. The buddy controls were recruited by asking every patient to hand over the EQ-5D questionnaire to 2 age-matched and sex-matched friends or relatives. Multivariable regression analyses were used to examine possible determinants of reduced HRQoL.

Results

Mean age was 61 years (SD 15), 117 (55%) were males, and median time since diagnosis was 3.8 years (range 0.3–9.5). Mean EuroQol visual analogue scale (EQ VAS) was 67 in PE as compared with 81 in the general population (p<0.005) and corresponding EQ-5D index values were 0.80 and 0.86 (p<0.005). Patients reported more problems in all 5 EQ-5D compared with both the buddy controls and the general population, p<0.05. Shorter 6 min walking distance (β=0.09, p<0.005) and patient-reported dyspnoea (β=11.27, p<0.005) were independent predictors of lower EQ VAS scores.

Conclusions

Our findings show that patients with a history of PE have impaired HRQoL when compared with the general population and buddy controls. Reduced functional capacity and persistent dyspnoea were the main predictors of this impairment.

]]>
<![CDATA[Association between exposure in the cement production industry and non-malignant respiratory effects: a systematic review]]> https://www.researchpad.co/article/5bf50de8d5eed0c48486142a

Objectives

Based on findings from a systematic literature search, we present and discuss the evidence for an association between exposure to cement dust and non-malignant respiratory effects in cement production workers.

Design and setting

Systematic literature searches (MEDLINE and Embase) were performed. Outcomes were restricted to respiratory symptoms, lung function indices, asthma, chronic bronchitis, chronic obstructive pulmonary disease, pneumoconiosis, induced sputum or fraction of exhaled nitric oxide (FeNO) measurements.

Participants

The studies included exposed cement production workers and non-exposed or low-exposed referents.

Primary and secondary outcomes

The searches yielded 594 references, and 26 articles were included. Cross-sectional studies show reduced lung function levels at or above 4.5 mg/m3 of total dust and 2.2 mg/m3 of respiratory dust. ORs for symptoms ranged from 1.2 to 4.8, while FEV1/FVC was 1–6% lower in exposed than in controls. Cohort studies reported a high yearly decline in FEV1/FVC ranging from 0.8% to 1.7% for exposed workers. 1 longitudinal study reported airflow limitation at levels of exposure comparable to ∼1 mg/m3 respirable and 3.7–5.4 mg/m3 total dust. A dose–response relationship between exposure and decline in lung function has only been shown in 1 cohort. 2 studies have detected small increases in FeNO levels during a work shift; 1 study reported signs of airway inflammation in induced sputum, whereas another did not detect an increase in hospitalisation rates.

Conclusions

Lack of power, adjustment for possible confounders and other methodological issues are limitations of many of the included studies. Hence, no firm conclusions can be drawn. There are few longitudinal data, but recent studies report a dose–response relationship between cement production dust exposure and declining lung function indicating a causal relationship, and underlining the need to reduce exposure among workers in this industry.

]]>
<![CDATA[Investigating fractional exhaled nitric oxide (FeNO) in chronic obstructive pulmonary disease (COPD) and asthma–COPD overlap (ACO): a scoping review protocol]]> https://www.researchpad.co/article/5b4a18f4463d7e40ecbbc4fb

Introduction

During the last decade, many articles have been published, including reviews on fractional exhaled nitric oxide (FeNO) use and utility in clinical practice and for monitoring and identifying eosinophilic airway inflammation, especially in asthma, and evaluating corticosteroid responsiveness. However, the exact role of FeNO in patients with chronic obstructive pulmonary disease (COPD) and its ability to distinguish patients with COPD and those having concomitant asthma, that is, asthma–COPD overlap (ACO) is still unclear and needs to be defined. Due to the broad topics of FeNO in chronic airway disease, we undertook a scoping review. The present article describes the protocol of a scoping review of peer-reviewed published literature specific to FeNO in COPD/ACO over the last decade.

Methods and analysis

We used Joanna Briggs Institute Reviewers’ Manual scoping review methodology as well as Levac et al’s and Arksey et al’s framework as guides. We searched a variety of databases, including Medline, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, Web of Science, and BioSciences Information Service (BIOSIS) on 29 June 2016. Additional studies will be recognised by exploring the reference list of identified eligible studies. Screening of eligible studies will be independently performed by two reviewers and any disagreement will be solved by the third reviewer. We will analyse the gathered data from article bibliographies and abstracts.

Ethics and dissemination

To investigate the body of published studies regarding the role of FeNO in patients with COPD and its usefulness in the clinical setting, a scoping review can be used as a modern and pioneer model, which does not need ethics approval. By this review, new insights for conducting new research specific to FeNO in COPD/ACO population will emerge. The results of this study will be reported in the scientific meetings and conferences, which aim to provide information to the clinicians, primary care providers and basic science researchers.

]]>