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.
Video abstract
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Acknowledgments
This study was jointly supported by the Respiratory Effectiveness Group and the Observational and Pragmatic Research Institute Pte Ltd.
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.