Chronic Airways Assessment Test : Psychometric properties in patients with asthma and/or COPD

Acknowledgements The authors would like to thank the patients who participated in this study and wish to acknowledge the work of the NOVELTY Scientific Community and the NOVELTY study investigators, who are listed in full below, and Sharon MacLachlan (Evidera, London, UK), who participated in the analysis of sections of the data. Medical writing support, under the direction of the authors, was provided by Niall Tyrer, MBiolSci, CMC Connect, a division of IPG Health Medical Communications, funded by AstraZeneca, Cambridge, UK, in accordance with Good Publication Practice (GPP 2022) guidelines (Ann Intern Med 2022; 175(9):1298–1304). Funding The NOVELTY study was funded by AstraZeneca.Peer reviewedPublisher PD

Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD

ACKNOWLEDGEMENTS The authors wish to acknowledge the work of the NOVELTY study investigators, who are listed in full in the supplementary material, and Sharon MacLachlan (Evidera, London, UK), who participated in the analysis of sections of the data. Medical writing support, under the direction of the authors, was provided by Lauren McNally, MSci, CMC Connect, McCann Health Medical Communications, and was funded by AstraZeneca, Cambridge, UK, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015; 163: 461–464). Support statement: The NOVELTY study is funded by AstraZenecaPeer reviewedPublisher PD

Treatable traits in the NOVELTY study

Background and objective: Asthma and chronic obstructive pulmonary disease (COPD) are two prevalent and complex diseases that require personalized management. Although a strategy based on treatable traits (TTs) has been proposed, the prevalence and relationship of TTs to the diagnostic label and disease severity established by the attending physician in a real-world setting are unknown. We assessed how the presence/absence of specific TTs relate to the diagnosis and severity of ‘asthma’, ‘COPD’ or ‘asthma + COPD’. Methods: The authors selected 30 frequently occurring TTs from the NOVELTY study cohort (NOVEL observational longiTudinal studY; NCT02760329), a large (n = 11,226), global study that systematically collects data in a real-world setting, both in primary care clinics and specialized centres, for patients with ‘asthma’ (n = 5932, 52.8%), ‘COPD’ (n = 3898, 34.7%) or both (‘asthma + COPD’; n = 1396, 12.4%). Results: The results indicate that (1) the prevalence of the 30 TTs evaluated varied widely, with a mean ± SD of 4.6 ± 2.6, 5.4 ± 2.6 and 6.4 ± 2.8 TTs/patient in those with ‘asthma’, ‘COPD’ and ‘asthma + COPD’, respectively (p < 0.0001); (2) there were no large global geographical variations, but the prevalence of TTs was different in primary versus specialized clinics; (3) several TTs were specific to the diagnosis and severity of disease, but many were not; and (4) both the presence and absence of TTs formed a pattern that is recognized by clinicians to establish a diagnosis and grade its severity. Conclusion: These results provide the largest and most granular characterization of TTs in patients with airway diseases in a real-world setting to date

Heterogeneity within and between physician-diagnosed asthma and/or COPD : NOVELTY cohort

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Chronic Airways Assessment Test: psychometric properties in patients with asthma and/or COPD

Plain language summary Chronic Airways Assessment Test: a questionnaire adapted to assess overall health in asthma and/or COPD What is it about? Asthma and chronic obstructive pulmonary disease (COPD) can have a significant effect on a person’s health and wellbeing. For people with these conditions, most of the health questionnaires available for use in patient care are designed for one specific diagnosis – either asthma (e.g. Asthma Control Test) or COPD (e.g. COPD Assessment Test [CAT]). A small number of questionnaires are available for use in both asthma and COPD, but these either take too long to complete, or do not focus on the overall health of patients. Since the symptoms in asthma and COPD overlap, a health questionnaire is needed for use in both asthma and COPD that can be completed during a routine visit to a doctor. This questionnaire could also help with research into the impact of lung diseases in people who have an unclear diagnosis. The CAT was changed so that people with asthma or COPD (or both) could use the same test. We named this new version the Chronic Airways Assessment Test (CAAT). Our goal was to determine whether CAAT scores meant the same level of health in people with asthma, COPD, or both conditions. The CAAT has eight questions, each scored 0 to 5, and takes only a few minutes to complete. The first three questions ask about the person’s symptoms, including how often they cough and whether they have chest mucus or chest tightness. The remaining five questions ask how the person’s asthma or COPD (or both) affects their daily life. These questions ask about shortness of breath, difficulties doing activities at home, confidence in leaving their home, whether they sleep soundly and how much energy they have. We found that the CAAT performed similarly in people with asthma or COPD (or both). This indicates that the CAAT score means a similar thing for someone with asthma, COPD or both conditions. Why is it important? The CAAT is a quick and simple way for patients to share with their doctor how bad their symptoms are and how much they affect their daily life. The development of the CAAT means that only one questionnaire is needed to measure the effect of a person’s symptoms on their current level of health, whether they have asthma, COPD, or both. This will allow doctors to improve the level of care patients receive

Frequent productive cough : Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study

Introduction: Persistent cough with sputum production is an important clinical trait in chronic obstructive pulmonary disease (COPD). We defined "frequent productive cough" based on 2 questions from the St George's Respiratory Questionnaire (SGRQ) and sought to determine its occurrence and associated outcomes in patients with physician-assigned asthma and/or COPD from the NOVELTY study. Methods: Frequent productive cough was defined as cough and sputum production most or several days/week for the past 3 months (scoring &gt;= 3 for both SGRQ questions). Relationships with baseline disease characteristics and exacerbations over 12 months' follow-up were examined using logistic regression. Results: Baseline SGRQ data were available for 7125 patients, of whom 31.3% had frequent productive cough. It was more common in asthma + COPD (38.8%) and COPD (38.1%) than asthma (25.0%), increasing with physician-assessed severity, and in current versus former and never smokers. Patient-reported symptomatic worsening was more common in patients with versus without frequent productive cough. Reduced post-bronchodilator FEV1 (odds ratio [OR] per 10% decrement 1.14 [95% confidence interval 1.11-1.16]) and history of pollutant exposure at home/work (OR 1.50 [1.33-1.69]) were associated with frequent productive cough in all diagnoses. Patients with baseline frequent productive cough were more likely to have &gt;= 1 exacerbation over the subsequent 12 months (OR 1.71 [1.52-1.93]), including exacerbations requiring hospital admission and those treated with oral corticosteroids. Conclusions: Frequent productive cough represents an important indicator of adverse clinical outcomes across asthma and/or COPD. Research into the underlying pathologic mechanisms is required to support targeted therapy development

Relationships between symptoms and lung function in asthma and/or chronic obstructive pulmonary disease in a real-life setting : the NOVEL observational longiTudinal studY

Background: The relationships between spirometric assessment of lung function and symptoms (including exacerbations) in patients with asthma and/or chronic obstructive pulmonary disease (COPD) in a real-life setting are uncertain. Objectives: To assess the relationships between baseline post-bronchodilator (post-BD) spirometry measures of lung function and symptoms and exacerbations in patients with a physician-assigned diagnosis of asthma and/or COPD. Design: The NOVEL observational longiTudinal studY (NOVELTY) is a global, prospective, 3-year observational study. Methods: Logistic regression analysis was used to evaluate relationships. Spirometry measures were assessed as percent predicted (%pred). Symptoms were assessed at baseline, and exacerbations were assessed at baseline and Year 1. Results: A total of 11,181 patients in NOVELTY had spirometry data (asthma, n = 5903; COPD, n = 3881; asthma + COPD, n = 1397). A 10% lower post-BD %pred forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) – adjusted for age and sex – were significantly associated with dyspnea (modified Medical Research Council ⩾ grade 2), frequent breathlessness [St George’s Respiratory Questionnaire (SGRQ)], frequent wheeze attacks (SGRQ), nocturnal awakening (Respiratory Symptoms Questionnaire; ⩾1 night/week), and frequent productive cough (SGRQ). Lower post-BD %pred FEV1 and, to a lesser extent, lower post-BD %pred FVC were significantly associated with ⩾1 physician-reported exacerbation at baseline or Year 1. This association was stronger in patients with COPD than in those with asthma. Conclusion: In a real-life setting, reduced lung function is consistently associated with symptoms in patients with asthma, COPD, or asthma + COPD. The relationship with exacerbations is stronger in COPD only than in asthma

Frequent productive cough: Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study

Introduction: Persistent cough with sputum production is an important clinical trait in chronic obstructive pulmonary disease (COPD). We defined "frequent productive cough" based on 2 questions from the St George's Respiratory Questionnaire (SGRQ) and sought to determine its occurrence and associated outcomes in patients with physician-assigned asthma and/or COPD from the NOVELTY study. Methods: Frequent productive cough was defined as cough and sputum production most or several days/week for the past 3 months (scoring >= 3 for both SGRQ questions). Relationships with baseline disease characteristics and exacerbations over 12 months' follow-up were examined using logistic regression. Results: Baseline SGRQ data were available for 7125 patients, of whom 31.3% had frequent productive cough. It was more common in asthma + COPD (38.8%) and COPD (38.1%) than asthma (25.0%), increasing with physician-assessed severity, and in current versus former and never smokers. Patient-reported symptomatic worsening was more common in patients with versus without frequent productive cough. Reduced post-bronchodilator FEV1 (odds ratio [OR] per 10% decrement 1.14 [95% confidence interval 1.11-1.16]) and history of pollutant exposure at home/work (OR 1.50 [1.33-1.69]) were associated with frequent productive cough in all diagnoses. Patients with baseline frequent productive cough were more likely to have >= 1 exacerbation over the subsequent 12 months (OR 1.71 [1.52-1.93]), including exacerbations requiring hospital admission and those treated with oral corticosteroids. Conclusions: Frequent productive cough represents an important indicator of adverse clinical outcomes across asthma and/or COPD. Research into the underlying pathologic mechanisms is required to support targeted therapy development

The burden of mild asthma: Clinical burden and healthcare resource utilisation in the NOVELTY study

Background: Patients with mild asthma represent a substantial proportion of the population with asthma, yet there are limited data on their true burden of disease. We aimed to describe the clinical and healthcare resource utilisation (HCRU) burden of physician-assessed mild asthma.Methods: Patients with mild asthma were included from the NOVEL observational longiTudinal studY (NOVELTY; NCT02760329), a global, 3-year, real-world prospective study of patients with asthma and/or chronic obstructive pulmonary disease from community practice (specialised and primary care). Diagnosis and severity were based on physician discretion. Clinical burden included physician-reported exacerbations and patient-reported measures. HCRU included inpatient and outpatient visits.Results: Overall, 2004 patients with mild asthma were included; 22.8% experienced ≥1 exacerbation in the previous 12 months, of whom 72.3% experienced ≥1 severe exacerbation. Of 625 exacerbations reported, 48.0% lasted >1 week, 27.7% were preceded by symptomatic worsening lasting >3 days, and 50.1% required oral corticosteroid treatment. Health status was moderately impacted (St George's Respiratory Questionnaire score: 23.5 [standard deviation ± 17.9]). At baseline, 29.7% of patients had asthma symptoms that were not well controlled or very poorly controlled (Asthma Control Test score <20), increasing to 55.6% for those with ≥2 exacerbations in the previous year. In terms of HCRU, at least one unscheduled ambulatory visit for exacerbations was required by 9.5% of patients, including 9.2% requiring ≥1 emergency department visit and 1.1% requiring ≥1 hospital admission.Conclusions: In this global sample representing community practice, a significant proportion of patients with physician-assessed mild asthma had considerable clinical burden and HCRU