Pragmatic research tales: The ELEVATE study as an illustration of the issues involved in implementing pragmatic research

Background: Despite increased asthma preventative treatment there is evidence that large numbers of patients continue to suffer significant symptoms and lifestyle limitation. Possible reasons include lack of disease recognition, poor adherence with inhaled corticosteroids and inability of inhaled steroids to fully control asthma. As earlier studies have been short term, and far from "real-life", the NHS' National Coordinating Centre for Health Technology Assessment sought a study to look at both the short and long term impact on quality of life, clinical status and resource utilisation of using leukotriene receptor antagonists (LTRAs). ELEVATE was conceived in response to this need and the GPIAG was successful in winning this research bid in conjunction with the University of East Anglia. Study objectives and design: The study's objective is to compare quality of life comparing LTRAs with alternative therapies at steps 2 & 3 of the National Asthma Guidelines for 720 adult patients. The study is a pragmatic randomised controlled trial over 2 years that will provide information about broadly generalisable patients in "real world" general practice.