Meeting abstracts from the Respiratory Effectiveness Group 2015 Winter Summit – databases and registries around the world: maximizing the yield

Abstract

: Current guidelines typically adopt a mechanistic approach to therapeutic management rather than a more individualized approach, guided by analysis of a patient’s problems. The result is that many patients end up on high levels of medications, possibly over-treated, yet uncontrolled. Guidelines currently recommend solutions based on the mean outcomes from registration trials. As such, they are probably applicable to only around 5% of the respiratory population that lies either side of that mean and not the majority of patients, eg, those with comorbidities and lifestyle complications. While the guidelines’ approach puts evidence at the center of their decision making, an evidence-based approach that will benefit the patient must put the patient at the center and adapt the available evidence to their specific needs. Examination of databases goes some way to seeing what happens in real-life and (to some degree) reflects this more patient-centric approach to evaluation of the evidence. By considering the interaction Abstract: In recent years we have developed different epidemiological studies with data obtained from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of Catalonia’s population). In one of them newly diagnosed COPD patients in the years 2007–2012 were identified through a diagnostic algorithm, and patients with a diagnostic spirometry were included and classified based on GOLD severity stages. Information about the initial treatment patterns was collected. No information regarding Modified Medical Research Council Dyspnea Scale (mMRC) or the COPD assessment test (CAT) was available but previous diagnosis of asthma and exacerbations during the previous year were collected. We identified 15,312 patients with newly diagnosed COPD. The frequency of patients with a previous diagnosis of asthma or frequent exacerbations was similar between groups (up to 6.6% of patients with previous asthma and 24.5% of frequent exacerbations). Regarding treatment, milder patients were more likely to receive short-acting bronchodilators in monotherapy (21% of patients in GOLD 1 versus 14.8% in GOLD 4) or no treatment after diagnosis (38.7% GOLD 1 versus 13.6% GOLD 4) while patients in GOLD 4 received triple therapy more frequently compared to GOLD 1 (36.6% versus 5.7%). Few patients were treated with double therapy (from 1.6% patients in GOLD 1 to 4% in GOLD 3). The percentage of patients treated with inhaled corticosteroid was higher in the severe groups (28.3%, 37.3%, 51.3%, 59.3% for GOLD 1 to 4 respectively). Other studies are ongoing on the prevalence of AAT determinations in primary care and the compliance with once daily and twice daily long-acting muscarinic antagonists in COPD in primary care. Background: The large-scale international implementing Helping Asthma in Real People (iHARP) project, which arose from the pilot project in Ireland in 2009, aims to improve the management of patients with moderate-to-severe asthma using validated assessment tools. The database that emanated from the iHARP project is described here. Methods: Five thousand adult patients with ( old) were recruited from the UK the Netherlands Spain (11%), and The patients had $ 2 prescriptions for fixed-dose combination inhaled corticosteroid/long-acting β - agonist therapy delivered via a dry powder inhaler or metered dose inhaler (with or without spacers) in Background: France has a publicly funded health insurance system, covering the whole population. The Système national d’information inter-régimes de l’Assurance maladie (SNIIRAM) records all claims of medical resource utilization from the national population, including the PMSI (Programme Médicalisé des Systèmes d’Information or Medicalized Program of Information System, ie, hospital activity and expenditure data). The EGB (échantillon général des bénéficiaires), a 1% random sample of the SNIIRAM, is also available for research projects. Aim: To describe claims data available in France for observational research, ie, SNIIRAM and EGB, and to provide examples of studies conducted with these resources. Methods: SNIIRAM and EGB will be described, with advantages and limitations. Access to these resources and organization of data management and analysis will be discussed. Finally, three projects will be briefly presented to illustrate the interest of using French claims data, more specifically in respiratory medicine/allergy: Results: SNIIRAM/EGB contain exhaustive data on medical resource utilization, with individual linkages between primary (eg, medical contacts and pharmacy refills) and secondary care. EGB (N . 500,000, data are by the of well-argued requests. In both datasets, diagnoses are missing, unless patients hospitalized or suffer from severe conditions; results from investigations (eg, blood sampling, radiology) are also missing. Hospital stays are recorded, with details of diagnoses (International Classification of Diseases-10 codes), procedures, diagnosis related group (DRG) codes, and admission/discharge dates. Dates of death are recorded. SNIIRAM can be linked to external medical records, eg, using a trusted third party procedure. RATIO identified a group of patients at higher risk of asthma exacerbations; APSI suggested an effect of immunotherapy in children; SINGULAIR concluded to the non-inferiority of montelukast compared to inhaled corticosteroids in infants. Conclusion: French reimbursement data provide high quality data on exposure to therapy, and occurrence of major outcomes in a large, longitudinal, population. Despite their limitations, they may be used to assess exhaustive individual Health Care Utilization, and to study drug use (including adherence), and positive or adverse effects of interventions in real-life setting. Abstract: The Canadian Primary Care Sentinel Surveillance Network or CPCSSN is a primary care research initiative – it is the first pan-Canadian multi-disease electronic medical record surveillance system using health information from electronic medical records in the offices of participating primary care family physicians across the country. This database is still in its relative infancy. Inconsistent data entry necessitates data cleaning. For respiratory disease, COPD is currently the only one with work having been accomplished. Multiple codes have been amalgamated into COPD including chronic bronchitis, emphysema, chronic airflow obstruction not otherwise defined and the use of tiotropium, ipratropium and salbutamol as long as a diagnosis of asthma was not made. Smoking status has also been a particularly trying process, with multiple potential codes causing confusion including non-smoker, ex-smoker, smoker trying to quit, smoking, nicotine addiction etc. We will discuss opportunities for its use both in Canada and hopefully within a future Respiratory Effectiveness Group initiative. Abstract: This abstract reports an interim analysis of a prospective observational cohort study designed to assess the rate, the patterns, and the drivers of adherence by COPD patients. We assessed adherence using medication belief questionnaires, pharmacy refill records, visual assessment of technique, and via an acoustic recording device attached to the inhaler (INCA TM ). To date we have enrolled 161 patients with COPD who have used the INCA TM adapted salmeterol/fluticasone inhaler for up to 3 months after discharge from hospital. The purpose of this study is to follow 400 patients for 90 days after an exacerbation to identify the relationship between adherence and the patient’s clinical course. The clinical characteristics of this cohort are noteworthy for the number of comorbidities (Charlson co-morbidity 5.8), the number of concurrent medications (mean 16), the presence of extreme hyperinflation, (cough peak expiratory flow rate 170), the level of health literacy (33), and the extremely high prevalence of mild cognitive impairment in this group (78%). These latter points suggest that a strategy to address adherence needs to be based on a framework used for patients with mild cognitive impairment. The calculated rate of adherence was 0.6 ± 0.3, and the calculated rate of inhaler errors was 0.35 ± 0.3 with combined actual rate of adherence 0.28 ± 0.3. In the first month after discharge, the rate of use was higher in those who did not have an exacerbation 32 ± 32 compared to those who did 19 ± 30. Hence, it is important to evaluate adherence as part of evaluating the clinical course of a patient with COPD. Four distinct patterns of Background: Poor inhaler technique has been identified as an important reason for sub-optimal asthma control. 1 To date, inhaler technique has only been studied in a small number of studies and only in patients receiving inhaled corticosteroid monotherapy. 2 to evaluate the prognostic role of inhaler technique and other patient- and treatment-related factors in asthma control in patients receiving fixed dose combination therapy (FDC) ± short-acting β 2 -agonist therapy. each two control: controlled/partly controlled versus Background: Errors in inhaler device handling are associated with having poor asthma control. Therefore, health care practitioners (HCP) are advised to assess and train patients in the use of their inhalers at every visit. It has been shown that demonstrating correct inhaler technique to patients helps them achieve and maintain correct inhaler technique. However, few HCP demonstrate correct inhaler technique as most are often not trained in the use of inhalers. Aim: This study aimed to examine the ease of device mastery for Turbuhaler ® (TH) versus Spiromax (SP) by trainee HCP, based on the hypothesis that SP is more intuitive. Methods: This randomized, cross-over group study comprises three visits over 2 months (Figure 1). Results of visit one are reported here. The study examined device mastery of inhaler technique i