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Introduction The study aimed to compare prevalence of comorbid allergic manifestations and rhinitis, allergy testing and associations with patient-related outcomes in patients with asthma and COPD.Methods Cross-sectional study of randomly selected Swedish patients with a doctor’s diagnosis of asthma (n = 1291) or COPD (n = 1329). Self-completion questionnaires from 2014 provided data on demographics, rhinitis, allergic symptoms at exposure to pollen or furry pets, exacerbations, self-assessed severity of disease and scores from the Asthma Control Test (ACT) and the COPD Assessment Test (CAT), and records were reviewed for allergy tests.Results Allergic manifestations were more common in asthma (75%) compared with COPD (38%). Rhinitis was reported in 70% of asthma and 58% of COPD patients. Allergy tests had been performed during the previous decade in 28% of patients with asthma and in 8% of patients with COPD.In patients with asthma; comorbid allergy and rhinitis were both independently associated with increased risk for poor asthma symptom control (ACT < 20) (OR [95% CI] 1.41 [1.05 to 1.87] and 2.13 [1.60 to 2.83]), exacerbations (1.58 [1.15 to 2.17] and 1.38 [1.02 to 1.86]), and self-assessed moderate/severe disease (1.64 [1.22 to 2.18] and 1.75 [1.33 to 2.30]). In patients with COPD, comorbid allergy and rhinitis were both independently associated with increased risk for low health status (CAT ≥ 10) (OR [95% CI] 1.46 [1.20 to 1.95] and 2.59 [1.97 to 3.41]) respectively, with exacerbations during the previous six months (1.91 [1.49 to 2.45] and 1.57 [1.23 to 2.01]), and with self-assessed moderate/severe disease (1.70 [1.31 to 2.22] and 2.13 [1.66 to 2.74]).Conclusion Allergic manifestations and rhinitis are more common in asthma than COPD but associated with worse outcomes in both diseases. This highlights the importance of examining and treating comorbid allergy and rhinitis, not only in asthma but also in COPD.

Abstract Background Breathlessness is common in the population and can be related to a range of medical conditions. We aimed to evaluate the burden of breathlessness related to different medical conditions in a middle-aged population. Methods Cross-sectional analysis of the population-based Swedish CArdioPulmonary bioImage Study of adults aged 50–64 years. Breathlessness (modified Medical Research Council [mMRC] ≥ 2) was evaluated in relation to self-reported symptoms, stress, depression; physician-diagnosed conditions; measured body mass index (BMI), spirometry, venous haemoglobin concentration, coronary artery calcification and stenosis [computer tomography (CT) angiography], and pulmonary emphysema (high-resolution CT). For each condition, the prevalence and breathlessness population attributable fraction (PAF) were calculated, overall and by sex, smoking history, and presence/absence of self-reported cardiorespiratory disease. Results We included 25,948 people aged 57.5 ± [SD] 4.4; 51% women; 37% former and 12% current smokers; 43% overweight (BMI 25.0–29.9), 21% obese (BMI ≥ 30); 25% with respiratory disease, 14% depression, 9% cardiac disease, and 3% anemia. Breathlessness was present in 3.7%. Medical conditions most strongly related to the breathlessness prevalence were (PAF 95%CI): overweight and obesity (59.6–66.0%), stress (31.6–76.8%), respiratory disease (20.1–37.1%), depression (17.1–26.6%), cardiac disease (6.3–12.7%), anemia (0.8–3.3%), and peripheral arterial disease (0.3–0.8%). Stress was the main factor in women and current smokers. Conclusion Breathlessness mainly relates to overweight/obesity and stress and to a lesser extent to comorbidities like respiratory, depressive, and cardiac disorders among middle-aged people in a high-income setting—supporting the importance of lifestyle interventions to reduce the burden of breathlessness in the population.

Abstract Spirometry should be used to confirm a diagnosis of chronic obstructive pulmonary disease (COPD). This test is not always performed, leading to possible misdiagnosis. We investigated whether the proportion of patients with diagnostic spirometry has increased over time as well as factors associated with omitted or incorrectly interpreted spirometry. Data from medical reviews and a questionnaire from primary and secondary care patients with a doctors’ diagnosis of COPD between 2004 and 2010 were collected. Data were compared with a COPD cohort diagnosed between 2000 and 2003. Among 703 patients with a first diagnosis of COPD between 2004 and 2010, 88% had a diagnostic spirometry, compared with 59% (p

Abstract The aim of this study was to describe factors associated with having COPD regularly reviewed in primary care by a nurse or physician and assess whether there was de-prioritisation for COPD in multimorbid patients. We defined de-prioritisation as not having at least one check-up by a physician during a two-year period. Among 713 COPD patients in the Swedish PRAXIS study, 473 (66%) had at least one check-up during the study period (ending in 2014). Patients with check-ups were more likely to have three or more comorbid conditions (31.9% vs. 24.6%) and exacerbations (35.1% vs. 21.7%) than those without. Compared with those without comorbidity, those with three or more diagnoses had increased relative risk ratios (and 95% CI) for consultations discussing COPD with only a physician (5.63 (2.68–11.79)), COPD-nurse only (1.67 (0.83–3.37)) or both (2.11 (1.09–4.06)). COPD patients received more frequent check-ups considering COPD if they had comorbidity or a history of exacerbations. We found no evidence of de-prioritisation for COPD in multimorbid patients.

AbstractObjective To compare the level of exercise self-efficacy, symptoms, functional capacity and health status and investigate the association between these variables in patients with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF). Additionally, to investigate how diagnosis, symptoms and patient characteristics are associated with exercise self-efficacy in these patient groups.Design Cross-sectional study.Setting Primary care.Subjects Patients (n = 150) with COPD (n = 60), CHF (n = 60) and a double diagnosis (n = 30).Main outcome measures Swedish SCI Exercise Self-Efficacy score, modified Medical Research Council Dyspnea score (mMRC), fatigue score, pain severity score, Hospital Anxiety and Depression Scale, functional capacity measured as six-minute walking distance and health status measured by a Visual Analogue Scale.Results Levels of exercise self-efficacy, health status and symptoms were alike for patients with COPD and patients with CHF. Functional capacity was similar after correction for age. Associations with exercise self-efficacy were found for slight dyspnea (mMRC = 1) (R −4.45; 95% CI −8.41– −0.50), moderate dyspnea (mMRC = 2) (−6.60;−10.68– −2.52), severe dyspnea (mMRC ≥ 3) (−9.94; −15.07– −4.80), fatigue (−0.87;−1.41– −0.32), moderate pain (−3.87;−7.52– −0.21) and severe pain (−5.32;−10.13– −0.52), symptoms of depression (−0.98;−1.42– −0.55) and anxiety (−0.65;−0,10– −0.32), after adjustment for diagnosis, sex and age.Conclusion and implications Patients with COPD or CHF have similar levels of exercise self-efficacy, symptoms, functional capacity and health status. More severe symptoms are associated with lower levels of exercise self-efficacy regardless of diagnosis, sex and age. When forming self-management groups with a focus on exercise self-efficacy, it seems more relevant to consider level of symptoms than the specific diagnosis of COPD or CHF.Key pointsExercise training is an important part of self-management in patients with COPD and chronic heart failure (CHF). High exercise self-efficacy is required for optimal exercise training.Patients with COPD and CHF have similar symptoms and similar levels of exercise self-efficacy, functional capacity and health status.Not the diagnosis, but symptoms of dyspnea, fatigue, pain, depression and anxiety are important factors influencing exercise self-efficacy and need to be addressed.When forming self-management groups with a focus on exercise self-efficacy, it seems more relevant to consider the level of symptoms than the specific diagnosis of COPD or CHF.

Objectives Nocturnal hypoxia in obstructive sleep apnoea (OSA) is a potential risk factor for cancer. We aimed to investigate the association between OSA measures and cancer prevalence in a large national patient cohort.Design Cross-sectional study.Settings 44 sleep centres in Sweden.Participants 62 811 patients from the Swedish registry for positive airway pressure (PAP) treatment in OSA, linked to the national cancer registry and national socioeconomic data (the course of DIsease in patients reported to Swedish CPAP, Oxygen and VEntilator RegistrY cohort).Outcome measures After propensity score matching for relevant confounders (anthropometric data, comorbidities, socioeconomic status, smoking prevalence), sleep apnoea severity, measured as Apnoea-Hypopnoea Index (AHI) or Oxygen Desaturation Index (ODI), were compared between those with and without cancer diagnosis up to 5 years prior to PAP initiation. Subgroup analysis for cancer subtype was performed.Results OSA patients with cancer (n=2093) (29.8% females, age 65.3 (SD 10.1) years, body mass index 30 (IQR 27–34) kg/m2) had higher median AHI (n/hour) (32 (IQR 20–50) vs 30 (IQR 19–45), n/hour, p=0.002) and median ODI (n/hour) (28 (IQR 17–46) vs 26 (IQR 16–41), p

BackgroundThe long-term sequelae after COVID-19 constitute a challenge to public health and increased knowledge is needed. We investigated the prevalence of self-reported persistent symptoms and reduced health-related quality of life (HRQoL) in relation to functional exercise capacity, 6 months after infection, and explored risk factors for COVID-19 sequalae.MethodsThis was a prospective, multicenter, cohort study including 434 patients. At 6 months, physical exercise capacity was assessed by a 1-minute sit-to-stand test (1MSTST) and persistent symptoms were reported and HRQoL was evaluated through the EuroQol 5-level 5-dimension (EQ-5D-5L) questionnaire. Patients with both persistent symptoms and reduced HRQoL were classified into a new definition of post-acute COVID syndrome, PACS+. Risk factors for developing persistent symptoms, reduced HRQoL and PACS+ were identified by multivariable Poisson regression.ResultsPersistent symptoms were experienced by 79% of hospitalized, and 59% of non-hospitalized patients at 6 months. Hospitalized patients had a higher prevalence of self-assessed reduced overall health (28 vs. 12%) and PACS+ (31 vs. 11%). PACS+ was associated with reduced exercise capacity but not with abnormal pulse/desaturation during 1MSTST. Hospitalization was the most important independent risk factor for developing persistent symptoms, reduced overall health and PACS+.ConclusionPersistent symptoms and reduced HRQoL are common among COVID-19 survivors, but abnormal pulse and peripheral saturation during exercise could not distinguish patients with PACS+. Patients with severe infection requiring hospitalization were more likely to develop PACS+, hence these patients should be prioritized for clinical follow-up after COVID-19.

ABSTRACTPurpose Co-morbidities are common in chronic obstructive pulmonary disease (COPD) and are associated with increased morbidity and mortality. The aim of the present study was to explore the prevalence of several comorbid conditions in severe COPD, and to investigate and compare their associations with long-term mortality.Methods In May 2011 to March 2012, 241 patients with COPD stage 3 or 4 were included in the study. Information was collected on sex, age, smoking history, weight and height, current pharmacological treatment, number of exacerbations the recent year and comorbid conditions. At December 31st, 2019, mortality data (all-cause and cause specific) were collected from the National Cause of Death Register. Data were analyzed using Cox-regression analysis with gender, age, previously established predictors of mortality and comorbid conditions as independent variables, and all-cause mortality and cardiac and respiratory mortality, respectively, as dependent variables.Results Out of 241 patients, 155 (64%) were deceased at the end of the study period; 103 patients (66%) died of respiratory disease and 25 (16%) of cardiovascular disease. Impaired kidney function was the only comorbid condition independently associated with increased all-cause mortality (HR (95% CI) 3.41 (1.47-7.93) p=0.004) and respiratory mortality (HR (95%CI) 4.63 (1.61 to 13.4), p = 0.005). In addition, age ≥70, BMI

Abstract A gap exists between guidelines and real-world clinical practice for the management and treatment of chronic obstructive pulmonary disease (COPD). Although this has narrowed in the last decade, there is room for improvement in detection rates, treatment choices and disease monitoring. In practical terms, primary care practitioners need to become aware of the huge impact of COPD on patients, have non-judgemental views of smoking and of COPD as a chronic disease, use a holistic consultation approach and actively motivate patients to adhere to treatment. This article is based on discussions at a virtual meeting of leading Nordic experts in COPD (the authors) who were developing an educational programme for COPD primary care in the Nordic region. The article aims to describe the diagnosis and lifelong management cycle of COPD, with a strong focus on providing a hands-on, practical approach for medical professionals to optimise patient outcomes in COPD primary care.

Abstract Background Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascular disease, but data from randomized controlled trials (RCT) are lacking. The aim of this RCT is to investigate whether beta-blocker therapy in patients with COPD without diagnosed cardiovascular disease is associated with a decreased 1-year risk of the composite endpoint of death, exacerbations, or cardiovascular events. Methods The Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) study is an open-label, multicentre, prospective RCT. A total of 1700 patients with COPD will be randomly assigned to either standard COPD care and metoprolol at a target dose of 100 mg per day or to standard COPD care only. The primary endpoint is a composite of death, COPD exacerbations, and cardiovascular events. Major exclusion criteria are ischemic heart disease, left-sided heart failure, cerebrovascular disease, critical limb ischemia, and atrial fibrillation/flutter. Study visits are an inclusion visit, a metoprolol titration visit at 1 month, follow-up by telephone at 6 months, and a final study visit after 1 year. Outcome data are obtained from medical history and record review during study visits, as well as from national registries. Discussion BRONCHIOLE is a pragmatic randomized trial addressing the potential of beta-blockers in patients with COPD. The trial is expected to provide relevant clinical data on the efficacy of this treatment on patient-related outcomes in patients with COPD. Trial registration ClinicalTrials.gov, ID: NCT03566667 . Registered on 25 June 2018.

Background The functional impact of breathlessness is assessed using the modified Medical Research Council (mMRC) scale for chronic respiratory disease and with the New York Heart Association Functional Classification (NYHA) scale for heart failure. We evaluated agreement between the scales and their concurrent validity with other clinically relevant patient-reported outcomes in cardiorespiratory disease. Methods Outpatients with stable chronic respiratory disease or heart failure were recruited. Agreement between the mMRC and NYHA scales was analysed using Cramér's V and Kendall's tau B tests. Concurrent validity was evaluated using correlations with clinically relevant measures of breathlessness, anxiety, depression, and health-related quality of life. Analyses were conducted for all participants and separately in chronic obstructive pulmonary disease (COPD) and heart failure. Results In a total of 182 participants with cardiorespiratory disease, the agreement between the mMRC and NYHA scales was moderate (Cramér's V: 0.46; Kendall's tau B: 0.57) with similar results for COPD (Cramér's V: 0.46; Kendall's tau B: 0.66) and heart failure (Cramér's V: 0.46; Kendall's tau B: 0.67). In the total population, the scales correlated in similar ways to other patient-reported outcomes. Conclusion In outpatients with cardiorespiratory disease, the mMRC and NYHA scales show moderate to strong correlations and similar associations with other patient-reported outcomes. This supports that the scales are comparable when assessing the impact of breathlessness on function and patient-reported outcomes.

IntroductionCovid-19 can cause chronic hypoxic respiratory failure, but the impact on the need for long-term oxygen therapy (LTOT) is unknown. The aim was to investigate change in incidence and characteristics of patients starting LTOT in Sweden 2020 after the outbreak of the pandemic.Material and methodsPopulation-based observational study using data from the National Registry for Respiratory Failure (Swedevox) and from a survey to all centres prescribing LTOT in Sweden. Swedevox data provided information on incidence of LTOT and characteristics of patients starting LTOT during 2015-2020.ResultsBetween March-Dec 2020, 131 patients started LTOT due to covid-19, corresponding to 20.5% of incident LTOT in Sweden. Compared with 2015-19, the total number of patients starting LTOT did not increase. No significant differences in patient characteristics or underlying causes of hypoxemia were found between patients starting LTOT during 2020 compared 2015-2019. The majority of the LTOT centres estimated that, since the start of the pandemic, the incidence of LTOT was unchanged and the time devoted for LTOT work was the same or slightly less.ConclusionsCovid-19 caused one fifth of all LTOT starts during the pandemic in 2020. The LTOT incidence overall did not increase possibly due to reduction in other infections.

Abstract Objective Long-term oxygen therapy (LTOT) during 15 h/day or more prolongs survival in patients with chronic obstructive pulmonary disease (COPD) and severe hypoxemia. No randomized controlled trial has evaluated the net effects (benefits or harms) from LTOT 24 h/day compared with 15 h/day or the effect in conditions other than COPD. We describe a multicenter, national, phase IV, non-superiority, registry-based, randomized controlled trial (R-RCT) of LTOT prescribed 24 h/day compared with 15 h/day. The primary endpoint is all-cause-mortality at 1 year. Secondary endpoints include cause-specific mortality, hospitalizations, health-related quality of life, symptoms, and outcomes in interstitial lung disease. Methods/design Patients qualifying for LTOT are randomized to LTOT 24 h/day versus 15 h/day during 12 months using the Swedish Register for Respiratory Failure (Swedevox). Planned sample size in this pragmatic study is 2126 randomized patients. Clinical follow-up and concurrent treatments are according to routine clinical practice. Mortality, hospitalizations, and incident diseases are assessed using national Swedish registries with expected complete follow-up. Patient-reported outcomes are assessed using postal questionnaire at 3 and 12 months. Discussion The R-RCT approach combines the advantages of a prospective randomized trial and large clinical national registries for enrollment, allocation, and data collection, with the aim of improving the evidence-based use of LTOT. Trial registration Clinical Trial registered with www.clinicaltrials.gov, Title: REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.

Chronic breathlessness occurs across many different conditions, often independently of disease severity. Yet, despite being strongly linked to adverse outcomes, the consideration of chronic breathlessness as a stand-alone therapeutic target remains limited. Here we use data-driven techniques to identify and confirm the stability of underlying features (factors) driving breathlessness across different cardiorespiratory diseases. Questionnaire data on 182 participants with main diagnoses of asthma (21.4%), COPD (24.7%), heart failure (19.2%), idiopathic pulmonary fibrosis (18.7%), other interstitial lung disease (2.7%), and “other diagnoses” (13.2%) were entered into an exploratory factor analysis (EFA). Participants were stratified based on their EFA factor scores. We then examined model stability using 6-month follow-up data and established the most compact set of measures describing the breathlessness experience. In this dataset, we have identified four stable factors that underlie the experience of breathlessness. These factors were assigned the following descriptive labels: 1) body burden, 2) affect/mood, 3) breathing burden and 4) anger/frustration. Stratifying patients by their scores across the four factors revealed two groups corresponding to high and low burden. These two groups were not related to the primary disease diagnosis and remained stable after 6 months. In this work, we identified and confirmed the stability of underlying features of breathlessness. Previous work in this domain has been largely limited to single-diagnosis patient groups without subsequent re-testing of model stability. This work provides further evidence supporting disease independent approaches to assess breathlessness.

Purpose Chronic hypoxic and hypercapnic respiratory failure and obstructive sleep apnoea (OSA) are chronic diseases associated with decreased quality of life and increased mortality. The rationale behind the set up the retrospective nationwide DISCOVERY cohort was to study several questions including disease course and risk factors for incident disease, impaired quality of life, hospitalisation risk and mortality in patients with chronic respiratory failure with long-term oxygen therapy (LTOT), long-term mechanical ventilation (LTMV) and obstructive sleep apnoea (OSA) on treatment with continuous positive airway pressure (CPAP).Participants and settings Data from the national quality registry for respiratory insufficiency and sleep apnoea (Swedevox) and a population-based control group from Statistics Sweden were merged with governmental registries, the Swedish Cancer Registry, the Swedish Cause of Death Registry, the Swedish Drug registry, the Swedish National Patient Registry and the Swedish Dental Health Registry and with national quality registries for diabetes, rheumatic diseases (Swedish Rheumatology Quality Registry), stroke (RiksStroke), heart failure (RiksSvikt), acute heart infarction care (SwedeHeart) and intensive care (SIR) and with socioeconomic data from Statistics Sweden (SCB).Findings to date The cohort comprises 25 804 unique patients with LTOT since 1987 (54.1% females, age 73.3±9.8 years, body mass index (BMI) 26.6±6.5 kg/m2), 8111 with LTMV since 1996 (48.6% women, age 60.6±16.9 years, BMI 32.9±10.8 kg/m2), 65 809 with OSA on CPAP since 2010 (29.5% women, age 57.2±12.5 years, BMI 31.9±6.2 kg/m2) and 145 224 persons in a population-based control group from same time span up to March 2018 (51.7% women, age 49.9±20.4 year, BMI 24.9±4.0 years).Future plans In patients with chronic respiratory failure and sleep apnoea important questions regarding comorbidity burden, hospitalisation rate, mortality and treatment outcomes are still unexplored to a large extent. The DISCOVERY cohort will provide unique opportunities by its size and comprehensiveness to fill this clinically relevant gap of knowledge.

Introduction Breathlessness is the cardinal symptom in both cardiac and respiratory diseases, and includes multiple dimensions. The multidimensional instrument Dyspnoea-12 has been developed to assess both physical and affective components of breathlessness. This study aimed to perform a clinical validation of the Swedish version of Dyspnoea-12 in outpatients with cardiorespiratory disease.Methods Stable outpatients with cardiorespiratory disease and self-reported breathlessness in daily life were recruited from five Swedish centres. Assessments of Dyspnoea-12 were performed at baseline, after 30–90 min and after 2 weeks. Factor structure was tested using confirmatory factor analysis and internal consistency using Cronbach’s alpha. Test–retest reliability was analysed using intraclass correlation coefficients (ICCs). Concurrent validity at baseline was evaluated by examining correlations with lung function and several instruments for the assessment of symptoms and health status.Results In total, 182 patients were included: with the mean age of 69 years and 53% women. The main causes of breathlessness were chronic obstructive pulmonary disease (COPD; 25%), asthma (21%), heart failure (19%) and idiopathic pulmonary fibrosis (19%). Factor analysis confirmed the expected underlying two-component structure with two subdomains. The Dyspnoea-12 total score, physical subdomain score and affective subdomain scores showed high internal consistency (Cronbach’s alpha 0.94, 0.84 and 0.80, respectively) and acceptable reliability after 2 weeks (ICC total scores 0.81, 0.79 and 0.73). Dyspnoea-12 showed concurrent validity with the instruments modified Medical Research Council scale, COPD Assessment Test, European Quality of Life-Five Dimensions-Five levels, the Functional Assessment of Chronic Illness Therapy-Fatigue, the Hospital Anxiety and Depression Scale, and with forced expiratory volume in 1 s in percentage of predicted value. The results were consistent across different cardiorespiratory conditions.Conclusion The Dyspnoea-12 is a valid instrument for multidimensional assessment of breathlessness in Swedish patients with cardiorespiratory diseases.

Introduction Breathlessness is a cardinal symptom in cardiorespiratory disease. An instrument for measuring different aspects of breathlessness was recently developed, the Multidimensional Dyspnea Profile (MDP). This study aimed to validate the MDP in terms of the underlying factor structure, internal consistency, test–retest reliability and concurrent validity in Swedish outpatients with cardiorespiratory disease.Methods Outpatients with stable cardiorespiratory disease and breathlessness in daily life were recruited. Factor structure of MDP was analysed using confirmatory factor analysis; internal consistency was analysed using Cronbach’s alpha; and test–retest reliability was analysed using intraclass correlation coefficients (ICCs) for patients with unchanged breathlessness between assessments (baseline, after 30–90 min and 2 weeks). Concurrent validity was evaluated using correlations with validated scales of breathlessness, anxiety, depression and health-related quality of life.Results In total, 182 outpatients with cardiorespiratory disease and breathlessness in daily life were included; 53.3% were women; main diagnoses were chronic obstructive pulmonary disease (24.7%), asthma (21.4%), heart failure (19.2%) and idiopathic pulmonary fibrosis (18.7%). The MDP total, immediate perception and emotional response scores, and individual item scores showed expected factor structure and acceptable measurement properties: internal consistency (Cronbach’s alpha, range 0.80–0.93); test–retest reliability at 30–90 min and 2 weeks (ICC, range 0.67–0.91); and concurrent validity. There was no evidence of a learning effect. Findings were similar between diagnoses.Discussion MDP is a valid instrument for multidimensional measurement of breathlessness in Swedish outpatients across cardiorespiratory diseases.

Background Breathlessness, the subjective sensation of breathing discomfort, is common and appears in the daily life of people with cardiorespiratory diseases. Physicians often rely on patient’s history based on symptom recall. The relation between recalled and experienced breathlessness is still poorly understood. This paper presents the protocol for a study primarily aimed at evaluating the relationship between experienced breathlessness and (1) recalled breathlessness and (2) predicted future breathlessness.Methods A mobile phone application will be used to collect data during daily life. Medically stable participants, ≥18 years of age with mean daily breathlessness of Numerical Rating Scale (NRS) 3/10 and able to use a mobile phone with internet will rate their breathlessness intensity on a 0–10 NRS prompted the user several times daily for 1 week. Participants will recall their breathlessness each day and week. Multivariable random effects regression models will be used for statistical analyses.Results Results of the study will be submitted for publication in peer-reviewed journals and presented at relevant conferences.Discussion This protocol describes a study aimed at investigating previously unknown areas of the experience and recall of breathlessness using a new method of data collection.Registration details Prospectively registered with ClinicalTrials.gov (Nr: NCT03468205).Ethics and dissemination The study has received ethical approval from the Regional Ethical Review Board Lund (DNr 2017/149). After a general study information including that participation is entirely voluntary, participants will answer the eligibility criteria and be asked to consent to participate before entering the study questions. Written informed consent to participate will be obtained for participants in the clinical sub-cohort. Participation can be discontinued at the discretion of the participant in which case no further data will be collected.

Most of the information about the benefits, safety aspects, and cost effectiveness of pharmacological treatment in the respiratory field has been obtained from traditional efficacy studies, such as randomised controlled trials (RCT). The highly controlled environment of an RCT does not always reflect everyday practice. The collection, analysis, and application of effectiveness data to generate Real World Evidence (RWE) through pragmatic trials or observational studies therefore has the potential to improve decision making by regulators, payers, and clinicians. Despite calls for more RWE, effectiveness data are not widely used in decision making in the respiratory field. Recent advances in data capture, curation, and storage combined with new analytical tools have now made it feasible for effectiveness data to become routine sources of evidence to supplement traditional efficacy data. In this paper, we will examine some of the current data gaps, diverse types of effectiveness data, look at proposed frameworks for the positioning of effectiveness data, as well as provide examples from therapeutic areas. We will give examples of both previous effectiveness studies and studies that are ongoing within the respiratory field. Effectiveness data hold the potential to address several evidentiary gaps related to the effectiveness, safety, and value of treatments in patients with respiratory diseases.

Background: Dyspnoea, the feeling of breathing discomfort, consists of multiple dimensions that can vary in intensity, including the level of unpleasantness, qualities or descriptors of the sensation, emotional responses, and impact on function. No validated instrument for multidimensional measurement of dyspnoea is available in Swedish. The Multidimensional Dyspnea Profile (MDP) was recently developed to measure the unpleasantness, sensory qualities, and emotional responses of dyspnoea across diseases and settings. We aimed to take forward a Swedish version of the MDP. Methods: Translation and linguistic validation of the MDP was conducted in collaboration with a specialised company in the field (Mapi, Lyon, France). The structured process involved forward and backward translations by two independent certified translators, input from an in-country linguistic consultant, the developers, and three respiratory physicians. Understandability and acceptability were evaluated through in-depth interviews with five patients with dyspnoea in accordance with international guidelines. Results and Conclusion: A Swedish version of the MDP was obtained and linguistically validated. The MDP includes 11 rated items: the immediate unpleasantness of the sensation, the presence and intensity of five sensory qualities, and the intensity of five emotional responses to dyspnoea. The time period of measurement is specified by the user. The MDP is copyrighted by the developers but can be used free of charge in the context of non-funded academic research. Conclusion: The MDP is the first instrument for measuring multiple dimensions of dyspnoea available in Swedish and should be validated across diseases and settings. Multidimensional measurement is essential for improved assessment and management of dyspnoea in research and clinical care.

Breathlessness is associated with major adverse health outcomes and is twice as common in women as men in the general population. We evaluated whether this is related to their lower absolute lung volumes.Cross-sectional analysis of the population-based Swedish CardioPulmonarybioImage Study (SCAPIS) Pilot, including static spirometry and diffusing capacity (n = 1,013; 49% women). Breathlessness was measured using the modified Medical Research Council (mMRC) scale and analyzed using ordinal logistic regression adjusting for age, pack-years of smoking, body mass index, chronic airway limitation, asthma, chronic bronchitis, depression and anxiety in all models.Breathlessness was twice as common in women as in men; adjusted odds ratio (OR) 2.20 (95% confidence interval, 1.32-3.66). Lower absolute lung volumes were associated with increased breathlessness prevalence in both men and women. The sex difference in breathlessness was unchanged when adjusting for lung function in %predicted, but disappeared when controlling for absolute values of total lung capacity (OR 1.12; 0.59-2.15), inspiratory capacity (OR 1.26; 0.68-2.35), forced vital capacity (OR 0.84; 0.42-1.66), forced expiratory volume in one second (OR 0.70; 0.36-1.35) or lung diffusing capacity (OR 1.07; 0.58-1.97).In the general population, the markedly higher prevalence of breathlessness in women is related to their smaller absolute lung volumes.

Introduction: Our aim was to investigate changes in smoking prevalence, smoking cessation support and factors associated with successful smoking cessation in patients with asthma and COPD. Methods: Questionnaires about available smoking cessation resources were completed by 54 primary health-care centers and 14 hospitals in central Sweden in 2005 and 2012. Patient data were collected using record reviews and patients questionnaires for two cohorts of randomly selected asthma and COPD patients in 2005 (n = 2306; with a follow up in 2012), and in 2014/2015 (n = 2620). Smoking prevalence, available individual and group smoking cessation support, and factors associated with successful smoking cessation were explored. Results: Smoking prevalence decreased from 11% to 6% (p

Introduction: Only a selected proportion of chronic obstructive pulmonary disease (COPD) patients are managed in secondary care. The aim of this study was to characterize disease severity, treatment and structure of secondary care for COPD in Sweden. Methods: Information was collected from 29 of 33 existing secondary care units of respiratory medicine in Sweden, using both individual data from 373 consecutively enrolled COPD patients with Global initiative on Obstructive Lung Disease (GOLD) stage III–IV and a structural questionnaire about available resources at the units. Patient data included exacerbations, health status assessed by COPD Assessment Test (CAT), lung function, comorbid conditions, pharmacological treatment and vaccinations. Structural data included available smoking cessation support, multidisciplinary rehabilitation, physical training, patient education and routine follow-up after exacerbations at the respective unit. All patients were reclassified according to the GOLD 2014 group A–D classification. Multiple linear regression investigated associations of available resources with number of exacerbations and CAT score. Results: According to GOLD 2014, 87% of the population were GOLD D and 13% were GOLD C. Triple inhaled therapy were prescribed in 88% of the patients. Over 75% of the units had resources for smoking cessation, multidisciplinary rehabilitation, physical training and patient education. Routine follow-up after exacerbations was available in 35% of the units. Being managed at units with access to structured patient education was associated with statistically significantly fewer exacerbations (adjusted regression coefficient (95% confidence interval) −0.79 (−1.39 to −0.19), p = 0.010). Conclusion: Most stage III–IV COPD patients managed at secondary care respiratory units in Sweden have maximized inhaled therapy and high risk disease even when reclassified according to GOLD 2014. Most units have access to smoking cessation, rehabilitation and patient education. Patients managed at units with structured patient education have a lower exacerbation risk.

Introduction: The aim was to investigate how the pattern of pharmacological treatment in Swedish patients with chronic obstructive pulmonary disease (COPD) has changed over a decade, and to identify factors associated with treatment. Methods: Data on patient characteristics and pharmacological treatment were collected using questionnaires from two separate cohorts of randomly selected primary and secondary care patients with a doctor’s diagnosis of COPD in central Sweden, in 2005 (n = 1111) and 2014 (n = 1329). Cross-tabulations and chi-square tests were used to compare maintenance treatment in 2005 and 2014, and to investigate the distribution of treatment by the 2017 Global Initiative for Obstructive Lung Disease (GOLD) ABCD groups. Multinomial logistic regression was used to analyze associations with the major types of recommended treatments: bronchodilator therapy, combined long-acting beta-2-antagonists (LABA) + inhaled corticosteroids (ICS), and triple inhaled therapy. Results: The proportion of patients with no maintenance treatment, with only LABA + ICS, and with sole ICS statistically significantly decreased (36 vs. 31%, 16 vs. 12% and 5 vs. 2%, respectively), and the proportion with triple inhaled therapy statistically significantly increased (29 vs. 40%). In 2014, triple inhaled therapy was the most common treatment in all GOLD groups except group A. In 2014, previous frequent exacerbations [OR (95% CI) 2.34 (1.62 to 3.36)], worse COPD Assessment Test score [1.07 (1.05 to 1.09)], female sex [2.13 (1.56 to 2.91)], and access to a specific responsible doctor [1.95 (1.41 to 2.69)] were associated with triple inhaled therapy. Current smoking [0.40 (0.28 to 0.57)] and overweight [0.62 (0.41 to 0.93)] were inversely associated with triple inhaled therapy. Conclusions: Over the last decade, triple inhaled therapy has increased, and no maintenance treatment, ICS, or LABA + ICS has decreased. Triple inhaled therapy is the most common treatment and is associated with previous exacerbations, higher symptom level, female sex, and having a specific responsible doctor.

Long-term oxygen therapy (LTOT) ≥ 15 h/day improves survival in hypoxemic chronic obstructive pulmonary disease (COPD). LTOT 24 h/day is often recommended but may pose an unnecessary burden with no clear survival benefit compared with LTOT 15 h/day. The aim was to test the hypothesis that LTOT 24 h/day decreases all-cause, respiratory, and cardiovascular mortality compared to LTOT 15 h/day in hypoxemic COPD. This was a prospective, observational, population-based study of COPD patients starting LTOT between October 1, 2005 and June 30, 2009 in Sweden. Overall and cause-specific mortality was analyzed using Cox and Fine-Gray regression, controlling for age, sex, prescribed oxygen dose, PaO2 (air), PaCO2 (air), Forced Expiratory Volume in one second (FEV1), WHO performance status, body mass index, comorbidity, and oral glucocorticoids. A total of 2,249 included patients were included with a median follow-up of 1.1 years (interquartile range, 0.6-2.1). 1,129 (50%) patients died and no patient was lost to follow-up. Higher LTOT duration analyzed as a continuous variable was not associated with any change in mortality rate (hazard ratio [HR] 1.00; (95% confidence interval [CI], 0.98 to 1.02) per 1 h/day increase above 15 h/day. LTOT exactly 24 h/day was prescribed in 539 (24%) patients and LTOT 15-16 h/day in 1,231 (55%) patients. Mortality was similar between the groups for all-cause, respiratory and cardiovascular mortality. In hypoxemic COPD, LTOT 24 h/day was not associated with a survival benefit compared with treatment 15-16 h/day. A design for a registry-based randomized trial (R-RCT) is proposed.