Authors: Pearson M.; Barnes N.¹; Thomas M.²; Tate H.³; Simnett S.⁴

Source: Journal of Evaluation in Clinical Practice, Volume 10, Number 2, May 2004 , pp. 297-305(9)

Publisher: Wiley-Blackwell

Abstract:

Rationale, aims and objectives

The randomized controlled trial (RCT) is considered the gold standard methodology for determining the efficacy and tolerability of new treatments. However, RCTs cannot provide information on the effectiveness of interventions as they are used in real life. This study was conducted to investigate the effectiveness of montelukast, a leukotriene receptor antagonist, in the real-world management of asthma, through a large-scale, retrospective, observational study: the National Montelukast Survey. Methods

In order to ensure a robust methodology for the National Montelukast Survey we performed three pilot studies involving a total of almost 400 patients. During the pilots, the design of the study was extensively modified from a simple prescriber questionnaire used in the first pilot to the ‘triangulated’ methodology encompassing the perspectives of patient, prescriber and independent observer used in the National Montelukast Survey. Good levels of interobserver agreement confirmed the robustness of the final methodology. Conclusions

Achieving a robust methodology was dependent on the extensive piloting. It is possible to collect reliable observational data relating to treatment outcomes. We believe our methods are likely to have more widespread applicability and offer a potential improvement over postmarketing surveillance.

Keywords: asthma; audit; montelukast; retrospective

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2753.2003.00434.x

Affiliations: 1: Consultant Respiratory Physician, London Chest Hospital, London, UK 2: GPIAG Clinical Research Fellow, Department of General Practice and Primary Care, University of Aberdeen, Aberdeen, UK 3: Consultant Statistician, New House Farm, Debden, Essex, UK 4: Formerly Clinical Research Associate, Merck Sharp and Dohme, Hertford Road, Hoddesdon, Hertfordshire, UK

Publication date: 2004-05-01

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