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Pragmat Obs Res. 2018 Aug 10;9:29-42. doi: 10.2147/POR.S151615. eCollection 2018.

Performance of database-derived severe exacerbations and asthma control measures in asthma: responsiveness and predictive utility in a UK primary care database with linked questionnaire data.

Author information

1
Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA.
2
Respiratory Effectiveness Group, Cambridge, UK.
3
Health Services and Performance Research EA 7425 HESPER, Université Claude Bernard Lyon 1, Lyon, France.
4
Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.
5
Observational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore, dprice@opri.sg.
6
Department of Medicine, National Jewish Health, University of Colorado School of Medicine, Denver, CO, USA.
7
Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
8
Department Allergology, University Hospital "Sv. Ivan Rilski", Sofia, Bulgaria.
9
Department of Haematology, University of Cambridge, Cambridge, UK.
10
Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK, dprice@opri.sg.

Abstract

Background:

Observational research is essential to evaluate the real-life effectiveness of asthma treatments and can now make use of outcomes derived from electronic medical records.

Aim:

The aim of this study was to investigate the utility of several database outcome measures in asthma.

Methods:

This study identified cohorts of patients with active asthma from a UK primary care database - Optimum Patient Care Research Database - approximately 10% of which was prospectively supplemented with questionnaire data. The "Questionnaire cohort" included patients aged 18-60 years with valid questionnaire data and 1 year of continuous primary care data. Separate "ICS initiation" and "ICS step-up" cohorts included patients aged 5-60 years initiated on inhaled corticosteroids (ICSs), who had 1 year of continuous primary care data before, and after, this index visit. Database measures of asthma symptom control and exacerbations were identified in the Optimum Patient Care Research Database and cross-tabulated with corresponding patient-reported (questionnaire) data. Responsiveness of the database outcomes was analyzed, using McNemar's and Wilcoxon's signed rank tests, and Poisson regression was used to estimate the association between database outcomes and future risk of database exacerbations, in the ICS initiation cohort.

Results:

The final study included 2,366 Questionnaire cohort patients and 51,404 ICS initiation patients. Agreement between patient-reported and database-recorded exacerbations was fair (kappa 0.35). Following the initiation of ICS, database risk domain asthma control (based on exacerbations) improved (proportion of patients with uncontrolled asthma decreased from 24.9% to 18.6%; P<0.001) and mean number of database exacerbations decreased from 0.09 to 0.08 per patient per year (P=0.001). However, another measure of asthma control which includes short-acting beta-agonist prescription as part of the definition did not show this improvement. Patients with prior exacerbations had a higher risk of future exacerbation (rate ratio [95% confidence interval], 3.23 [3.03-3.57]).

Conclusion:

Asthma control and exacerbations derived from primary care databases were responsive, with the exception of short-acting beta-agonist prescriptions, and useful for risk prediction.

KEYWORDS:

asthma control; asthma exacerbations; electronic health records; real-life effectiveness; validation study

Conflict of interest statement

Disclosure David B Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva (Sanofi Generics); payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Skyepharma, Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis, Teva Pharmaceuticals; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. Helen K Reddel or her institute has received unconditional research grants from AstraZeneca and GlaxoSmithKline; honoraria from Astra-Zeneca, GlaxoSmithKline, Novartis, Teva Pharmaceuticals, Mundipharma, and Boehringer Ingelheim for independent medical education, from AstraZeneca and GlaxoSmithKline for independent consulting and from AstraZeneca, GlaxoS-mithKline, Merck, Novartis, and Boehringer Ingelheim for data safety monitoring boards and/or advisory boards. Gene Colice is a full-time employee of AstraZeneca and holds stock and stock options in the company. Guy Brusselle has, within the last 5 years, received honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmith-Kline, Novartis, Pfizer, Teva Pharmaceuticals, UCB, and Zambon; he is a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi/Regeneron, and Teva Pharmaceuticals. The authors report no other conflicts of interest in this work.

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