Page 118 - Comprehensive treatment of patients with glucocorticoid-dependent severe asthma

Chapter 7
Comparative effectiveness research (CER) is increasingly applied in asthma to evaluate the outcome of clinical interventions.[15;19;20] It provides the basis for rational decision making about the care of individual patients with asthma and how best to deliver this care in real world settings [21]. Therefore, we designed this pragmatic randomized clinical trial to assess the outcome (cumulative dose of oral corticosteroids, asthma control and asthma related quality of life) of an Internet-based management tool in comparison with conventional asthma treatment over a period of 6 months.
Methods
Subjects
Eligible patients were adults (18-75 years) with a diagnosis of severe refractory asthma according to the major and minor criteria recommended by the American Thoracic Society [1]. They had uncontrolled asthma despite intensive follow-up by an asthma specialist for at least one year, chronic treatment with oral corticosteroids, and high dose of inhaled corticosteroids plus long-acting bronchodilators. All were non-smokers with a maximum smoking history of 15 pack-years and had access to internet or mobile phone.
Study Design
We conducted a 6 months pragmatic, prospective, randomized, controlled study involving outpatients from 2 academic tertiary care hospitals and 4 large community hospitals in The Netherlands. The study was designed according to the CONSORT recommendations for pragmatic trials [22]. Patients were randomly allocated to one of two strategies: dose adjustment of oral corticosteroids guided by an internet-based management tool (internet group) or according to conventional asthma treatment by the pulmonologist (conventional management group). All patients were followed for 6 months, and had the same monthly follow-up visit at their own pulmonologist. Pulmonologists were instructed not to change the maintenance dose of ICS during the study, unless strictly necessary on clinical grounds. The study was approved by the Ethics Committees of all participating institutions. All patients provided written informed consent. The authors were solely responsible for the study design, data analysis, interpretation and for the writing and approving of the manuscript.
116