Expert Commentary & Five-year View
Traditionally, asthma-practice guidelines have focused on optimizing lung function and the FDA requires increases in lung function to be the primary outcome in clinical trials of new asthma therapy. Improved lung function has been an important measure of BD therapy, but long-term asthma control when maintained on controller therapy has been increasingly emphasized and is arguably an even more important outcome. Asthma guidelines have consistently described the goals of asthma treatment as encompassing not only the control of the patients' short-term symptoms, but also risk prevention – preventing recurrent AEs. Protection from side effects of therapeutic interventions and long-term protection from adverse outcomes such as airway remodeling and fixed-airway obstruction should also be considered in the guidelines.
The clinical usefulness of these asthma outcome measures is also affected by the rapidity of symptom changes over time in response to treatment. Symptoms and lung function may change quickly from day to day or even hour to hour and can respond rapidly to initiation of treatment, whereas airway responsiveness tends to change slowly with therapeutic interventions. How patients with asthma should be assessed and how therapeutic outcomes should be evaluated are important and challenging issues. Outcome measures to evaluate therapeutic asthma interventions are now increasingly available. Harmonizing major clinical outcomes to allow comparison across studies can benefit asthma treatment in clinical practices and research. This article highlights the major issues in measuring asthma outcomes. Comprehensive understanding of the effects of therapeutic agents on asthma requires assessment of standard clinical indicators of lung function and AHR, multidimensional indicators of asthma control such as symptoms and their severity and the effect on day-to-day functioning and wellbeing. Finally, evaluating asthma self-management and adherence to therapeutic recommendations is critical.
Disclaimer
The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry.
Financial & competing interests disclosure
Ron Hays was supported in part by the National Institute on Aging Grant P30AG021684 and National Center on Minority Health and Health Disparities Grant 2P20MD000182. Joannie Shen is an advisory member to the the National Committee on Quality Assurance (NCQA) for respiratory care quality performance measures. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Expert Rev Pharmacoeconomics Outcomes Res. 2011;11(4):447-453. © 2011 Expert Reviews Ltd.
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