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Below you can see details and summaries of NOVELTY publications and presentations to date.
This article reported the baseline characteristics of patients participating in the NOVELTY study and revealed substantial heterogeneity within, and overlap between, physician-assigned diagnostic labels and physician-assessed severity categories in patients with asthma and/or COPD in terms of clinical, physiological and biomarker characteristics. Clinical characteristics associated with poor patient outcomes were higher with greater physician-assessed severity but were also present in patients with mild disease. These results suggest that current diagnostic and severity classifications poorly differentiate between clinically important phenotypes. Treatment strategies to improve outcomes for patients with asthma and/or COPD would be better targeted towards individual characteristics and disease traits than their diagnostic label.
Reddel HK et al. Eur Respir J 2021
This article described the development of the Respiratory Symptoms Questionnaire (RSQ) and assessed the psychometric validity of the RSQ in patients with physician-assigned diagnoses of asthma and/or COPD. The internal consistency, structural validity and psychometric performance of the RSQ were evaluated using baseline data from patients who had completed the RSQ in the NOVELTY study. Results of this analysis demonstrated that the RSQ is a valid, easy-to-administer patient-reported tool for assessing and monitoring respiratory symptoms in patients with asthma and/or COPD.
Karlsson N et al. ERJ Open Res 2021;7:00828-2020.
This ePoster aimed to describe the humanistic burden on patients with physician-assessed mild asthma. The results suggested that many patients with physician-assessed mild asthma had some degree of humanistic burden, with almost a third of patients reporting poor asthma symptom control. Disease-specific health-related quality of life was lower in patients with physician-assessed mild asthma compared with those who had no history of respiratory disease, with a subset of patients reporting poor overall health status.
Golam, S. et al. Value in Health 2020;23(Suppl2):S730.
This ePoster aimed to compare spirometric markers of airflow obstruction and reversibility in asthma and/or COPD. Increasing physician-assessed severity was associated with decreased mean pre-bronchodilator forced expiratory volume in 1 second (FEV1), forced expiratory flow between 25% and 75% of forced vital capacity (FVC), peak expiratory flow rate and post-bronchodilator FEV1/FVC. Bronchodilator reversibility of these markers did not distinguish patients with a physician diagnosis of asthma from those with COPD. The authors concluded that while spirometry remains an important marker of disease severity, the use of bronchodilator reversibility to confirm the diagnosis of asthma in clinical trials should be challenged.
Hughes R et al. Eur Respir J 2020;56(Suppl 64):3759.
This ePoster aimed to evaluate the distribution of factors associated with blood eosinophil count in patients with physician-assigned asthma or COPD using baseline data from NOVELTY. The results revealed that 19% of patients with physician-assigned asthma and/or COPD had an elevated blood eosinophil count, which was numerically higher in patients with asthma than in patients with COPD. Increased blood eosinophil count was found to be associated with male sex, more frequent patient-reported episodes of symptomatic worsening, higher levels of fractional exhaled nitric oxide, greater forced expiratory volume in 1 second reversibility, frequent mucoid cough and obesity, irrespective of physician-assigned diagnosis.
Müllerová H et al. Eur Respir J 2020;56(Suppl 64):2990.
This ePoster aimed to identify the factors associated with physician-assigned severity of either asthma or COPD using baseline data from NOVELTY. Greater physician-assessed severity was associated with frequency of prior exacerbations, worse lung function, increasing bronchodilator responsiveness and modified Medical Research Council dyspnoea score for both diagnoses. Greater severity was associated with allergic and non-allergic rhinitis and emphysema in patients with asthma and COPD, respectively. The authors concluded that in the NOVELTY study, greater physician-assigned severity was associated with worse respiratory symptoms, lower lung function and exacerbation history in patients with asthma or COPD.
Papi A et al. Eur Respir J 2020;56(Suppl 64):2201.
This ePoster described the physician- and patient-reported burden of disease in patients with physician-assessed mild asthma, using baseline data from the NOVELTY study. The results demonstrated that many patients with physician-assessed mild asthma had a high disease burden, with nearly one-third of patients demonstrating poor symptom control and one in four patients having at least one exacerbation during the previous 12 months. Oral corticosteroids were used to treat half of the exacerbations and a quarter of the incidences of symptom worsening required corticosteroid treatment.
Golam SM et al. Eur Respir J 2020;56(Suppl 64):969.
This ePoster described the distribution of exacerbations and characterised patients with physician-assigned COPD (both with and without a concomitant diagnosis of asthma), stratified by exacerbation frequency. Frequent exacerbations were more common among patients with concomitant asthma versus those without concomitant asthma. Patients with COPD and a history of exacerbations had a higher disease burden, more work impairment and higher healthcare utilisation than those without exacerbations.
Müllerová H et al. Eur Respir J 2020;56(Suppl 64):2474.
This ePoster compared the baseline characteristics of patients with physician-assigned COPD with ‘normal’ spirometry or with Preserved Ratio but Impaired Spirometry (PRISm), compared with patients with Global Initiative for Obstructive Lung Disease (GOLD) 1 COPD. Patients in the normal spirometry and PRISm groups tended to be younger and female, and had higher body mass index, earlier onset of symptoms and lower smoking exposure, compared with patients in the GOLD 1 group. They also tended to have similar respiratory symptoms, exacerbations and were prescribed similar medications compared with patients in the GOLD 1 group. The authors concluded that patients were frequently diagnosed and treated for COPD based on a variety of background risk factors and clinical features, without meeting recommended spirometric criteria.
Agustí A et al. Eur Respir J 2020;56(Suppl 64):2195.
This review article examined the value of observational studies, alongside randomised controlled trials (RCTs), in the field of obstructive lung disease. The authors discussed the increasing importance of observational studies in broader patient populations due to the limitations of the strict inclusion criteria used in RCTs. They concluded that there is a need for large, inclusive observational studies such as NOVELTY to enhance our understanding of disease mechanisms and treatment.
Vestbo J et al. ERJ Open Res 2020;6:00044-2020; doi: 10.1183/23120541.00044-2020.
This poster evaluated the reliability and validity of the Respiratory Symptoms Questionnaire (RSQ) as a general measure of respiratory symptoms in patients with asthma and/or COPD, using baseline data from NOVELTY. These results support the reliability and validity of the RSQ, indicating that it is a suitable patient-reported tool for assessing respiratory symptoms and their impact on patient’s activity without assuming a specific diagnostic label.
Müllerová H et al. Am J Respir Crit Care Med 2020;201:A7752.
This poster characterised the relationship between patient-reported cough and mucus production in patients with physician-assigned asthma and/or COPD. It also described the association between frequent mucoid cough and physician-assigned diagnosis and severity. The results suggested that patients often experienced both frequent cough and frequent mucus production, irrespective of diagnosis. Frequent mucoid cough occurred more often with greater physician-assigned severity and was most common in those with physician-assigned asthma+COPD or COPD compared with those with physician-assigned asthma.
Hughes R et al. Am J Respir Crit Care Med 2020;201:A5080.
This exploratory analysis of the genetics of obstructive lung disease in whole exome sequences (WES) did not identify any significant enrichment of deleterious rare variants among patients with physician-assigned asthma and/or COPD compared to controls. Further analyses of WES data are needed, to search for genetic variants associated with specific disease phenotypes of obstructive lung disease.
Lassi G et al. Am J Respir Crit Care Med 2020;201:A4001.
This review article examined the evolving clinical definitions of severe asthma and severe COPD and evaluated their influence on trial design. The authors concluded that a new approach to defining severe obstructive lung disease is needed for the biologic era. They recommended a phenotype- and endotype-focused approach to future research to identify novel biomarkers and potential therapeutic targets.
Martin RJ et al. Eur Respir J 2019; 54: 1900108; doi: 10.1183/13993003.00108-2019.
This poster described baseline characteristics of NOVELTY patients by physician-assigned severity of asthma and/or COPD. The analysis showed that across physician-assigned diagnoses of asthma, asthma and COPD and COPD, more severe disease (as assigned by physician judgement) was associated with lower lung function, higher blood neutrophil counts and worse patient-reported outcomes, but that clinical features often overlapped across diagnosis and severity groups.
Vestbo J et al. Eur Respir J 2019; 54: PA5029.
This oral presentation described the application of novel statistical approaches to account for missing data uncertainty in cluster predictions in complex real-world data. The random forest method combined with multiple imputation provided a flexible framework for the evaluation of cluster variability due to missing data. This approach could be used to improve the determination of discrete clinical clusters from complex data-sets, for example in the NOVELTY study.
This poster described baseline characteristics of NOVELTY patients and showed that clinical, physiological and inflammatory characteristics often overlapped across physician-assigned diagnoses of asthma and COPD. These results suggested that current diagnostic categories may generalise complex, heterogeneous obstructive lung diseases. Such overlaps may limit the potential for exploration of important underlying mechanisms of disease, eventually leading to personalised therapies.
Reddel HK et al. Am J Respir Crit Care Med 2019; 199: A7394.
This poster described the NOVELTY study design and its anticipated outcomes. It summarised the data to be collected in NOVELTY at yearly visits and/or 3-month follow-ups, and how these data will be used to gain insights into the diagnosis, assessment and management of patients with asthma and COPD, with the ultimate aim of improving patient outcomes.
This abstract was an encore of the abstract from the methodology article published in ERJ Open Research.
This article described the NOVELTY study design and its anticipated outcomes. It summarised the data to be collected in NOVELTY (including clinical assessments, spirometry, biospecimens, patient-reported outcomes and healthcare utilisation [HCU]) at yearly visits and/or 3-month follow-ups, and how these data will be used to identify phenotypes and endotypes associated with different trajectories for symptom burden, clinical progression or remission and HCU. Results from the study may allow much more precise patient classification according to clinical outcomes and biomarker profiles over time and support the development of novel therapies and a personalised approach across obstructive lung disease.
Reddel HK et al. ERJ Open Res 2019; 5: 00036-2018.
A NOVEL observational longiTudinal studY in patients with asthma and/or COPD: NOVELTY protocol and rationale Oral presentation at the International Primary Care Respiratory Group (IPCRG) World Conference, 31 May–2 June 2018, Porto, Portugal This presentation described the rationale, research questions and study design of NOVELTY. The strengths of NOVELTY include its size and global nature (up to 12,000 patients across 19 countries), enrolment of patients across the spectrum of diagnoses and severities and from both primary care and specialist clinical practices, broad inclusion and minimal exclusion criteria, the wide range of data collected (including biospecimens), and the longitudinal follow-up over 3 years.
This presentation summarised the rationale for the NOVELTY study and described the objectives and methodology of the study. The heterogeneity among patients with asthma and/or COPD presents a need for a revised taxonomy of these diseases, but there are few prospective, observational studies across asthma, COPD and asthma–COPD overlap diagnoses. NOVELTY is a global, prospective, observational, longitudinal cohort study of patients with a diagnosis or suspected diagnosis of asthma and/or COPD that aims to describe patient characteristics, treatment patterns and burden of illness over time, and to identify phenotypes and endotypes associated with differential outcomes.
Gerhardsson de Verdier M et al. Respir Res 2018; 19: REGABS18003.
This poster described the feasibility analysis conducted on electronic medical records (EMRs) from five different database sources in the USA. The databases analysed had high completeness for patient demographic and characteristics data, and partial completeness for respiratory-related variables. However, lung function data, and to a lesser extent treatment dosage information, were either not recorded during the 1-year assessment period, or were not recorded in a structured format; therefore, disease severity could not be classified using these data for many patients. EMRs are potential sources of patient data for observational studies such as NOVELTY, and can be useful in guiding study design. However, data availability and completeness issues currently limit their use.
Reddel HK et al. Am J Respir Crit Care Med 2017; 195: A2032.
This analysis provided an estimation on the numbers of primary care patients in Sweden potentially eligible for NOVELTY, and algorithm-based disease severity distributions. While primary care electronic medical records (EMRs) are a potential source of patient data for observational studies like NOVELTY and can help guide study design, limited data availability and completeness limit their use. Data required for NOVELTY are not routinely collected in Swedish EMRs, so data will be collected using a custom-designed electronic case report form and patient-reported outcomes.
Despite the limitations of the electronic medical record (EMR) feasibility analysis (e.g. only a selected sample of EMRs and only 1-year follow up) in the NOVELTY study, EMRs will be used as a complementary data source for some countries. However, data for NOVELTY will primarily be collected from electronic case report forms completed by the treating healthcare professional, and from patient questionnaires completed every 3 months.
This abstract was an encore of the BTS 2016 abstract.
This analysis revealed the numbers of primary care patients potentially eligible for NOVELTY, and an algorithm-based estimation of disease severity distribution. The analysed electronic medical records (EMRs) appeared to be representative of the national asthma/COPD population, according to age and gender. COPD disease severity based on lung function could not be determined due to missing data, and a high proportion of patients classified from treatment level as having severe/very severe asthma or COPD reflects Australian prescribing patterns, which vary from clinical guidelines. This highlights a limitation of classifying severity based on prescriptions, which may be influenced by variations in prescribing patterns.
Reddel HK et al. Respirology 2017; 22 (S2): TP‐022.
This feasibility analysis of electronic medical records (EMRs) in 11 countries revealed the numbers of patients potentially eligible for the NOVELTY study, and the estimated severity distribution across clinical practices. Differences in the completeness of EMRs – in terms of variables included – provided insights into clinical practice around the world; a lack of lung function data suggests divergences in the diagnosis and management of asthma and COPD between clinical guidelines (which recommend lung function tests) and clinical practice, or that data are not recorded in readily accessible formats.
EMRs represent a potential data source for NOVELTY in some countries, and this analysis informed the study design.
Reddel HK et al. Thorax 2016; 71 (Suppl 3): P138.
This poster presented the findings from a feasibility analysis of electronic medical records (EMRs) from six European countries involved in NOVELTY: France, Germany, Italy, Spain, Sweden and the UK. The analysis provided a picture of current clinical practice for patients with asthma and/or COPD in these countries. Disease severity based on treatment use could not be classified for a high proportion of patients, implying that disease management practices differ between countries and clinical guidelines. Many of the selected EMRs also lacked data on variables such as prescriptions and lung function tests, indicating that these variables may not have been collected over the period studied, or were not recorded in an accessible format.
Wang X et al. Value in Health 2016; 19 (7): A367.
This poster described how electronic medical records (EMRs) from eight countries in Europe, North America and the Asia-Pacific region were generally representative of national data with regards to patient age and gender, and physician age, gender, specialty and geographical coverage. These findings suggest that EMRs may be generalisable to the national populations, and confirms the concept of performing an EMR-based feasibility assessment to guide the NOVELTY study design.
Wang X et al. Pharmacoepidemiol Drug Saf 2016; 25 (S3): 1055.
This poster presented insights into current clinical practice in Australia, China and Japan for patients with asthma and/or COPD. Many variables of interest to NOVELTY were not routinely collected in electronic medical records (EMRs). The findings indicated that for many EMRs, treatment and disease monitoring differed from that used in international clinical guidelines, and highlighted that international clinical guidelines, national guidelines and standard clinical practice do not necessarily correlate. The analysis led to the decision to collect data for the NOVELTY study from Australia, China and Japan using electronic case reports rather than EMRs.
Wang X et al. Value in Health 2016; 19 (7): A852.
This poster described the feasibility analysis conducted on 11 country-specific electronic medical record (EMR) data sources (the USA, Canada, the UK, France, Germany, Italy, Spain, Sweden, Japan, China and Australia), to gain insights into the proportions of patients with different disease severities and to identify the variables routinely recorded on patients within current clinical care, in order to optimise NOVELTY study design.
Considerable differences in the type of information recorded between countries were observed, reflecting differences in clinical practice and EMR documentation. While patient demographics were routinely captured, disease- and treatment-related variables were not. The analysis provides insight into clinical practices, and highlights those variables not routinely collected and which will therefore require specific training in the NOVELTY study.
Wang X et al. Value in Health 2016; 19 (3): A81.
This invited presentation described a feasibility analysis performed on electronic medical records (EMRs) from 11 countries to assess EMR variable coverage and completeness in each country, and a survey of physicians in selected countries to identify routine clinical practices. EMRs identified a large patient population that would be eligible for the NOVELTY study. Some countries had EMRs that included considerable patient and disease information, such as laboratory test results, spirometer and healthcare utilisation, whereas EMRs from other countries did not. For a few countries (e.g. Sweden and the UK), EMRs had sufficient information to be used as supplementary data sources in the NOVELTY study.