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Open Access Highly Accessed Study protocol

Asthma control cost-utility randomized trial evaluation (ACCURATE): the goals of asthma treatment

Persijn J Honkoop12*, Rik JB Loymans3, Evelien H Termeer4, Jiska B Snoeck-Stroband1, Moira J Bakker1, Willem JJ Assendelft2, Peter J Sterk5, Gerben ter Riet3, Tjard RJ Schermer4 and Jacob K Sont1

Author Affiliations

1 Dept of Medical Decision Making Leiden University Medical Center (LUMC) P.O. Box 9600 2300 RC Leiden, The Netherlands

2 Dept of Public Health and Primary Care Leiden University Medical Center (LUMC) P.O. Box 9600 2300 RC Leiden, The Netherlands

3 Dept of General Practice and Dept of Respiratory Medicine Academic Medical Center-University of Amsterdam (AMC) P.O. Box 22700 1100 DE Amsterdam, The Netherlands

4 Dept of Primary and Community Care Radboud University Nijmegen Medical Centre (RUNMC) P.O. Box 9101 6500 HB Nijmegen, The Netherlands

5 Dept of Respiratory Medicine Academic Medical Center-University of Amsterdam (AMC) P.O. Box 22700 1100 DE Amsterdam, The Netherlands

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BMC Pulmonary Medicine 2011, 11:53  doi:10.1186/1471-2466-11-53

Published: 24 November 2011

Abstract

Background

Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial is whether maximal doses of (combination) therapy should be used for long periods in an attempt to achieve complete control of all features of asthma. An additional question is whether patients and society value the potential incremental benefit, if any, sufficiently to concur with such a treatment approach. We assessed patient preferences and cost-effectiveness of three treatment strategies aimed at achieving different levels of clinical control:

1. sufficiently controlled asthma

2. strictly controlled asthma

3. strictly controlled asthma based on exhaled nitric oxide as an additional disease marker

Design

720 Patients with mild to moderate persistent asthma from general practices with a practice nurse, age 18-50 yr, daily treatment with inhaled corticosteroids (more then 3 months usage of inhaled corticosteroids in the previous year), will be identified via patient registries of general practices in the Leiden, Nijmegen, and Amsterdam areas in The Netherlands. The design is a 12-month cluster-randomised parallel trial with 40 general practices in each of the three arms. The patients will visit the general practice at baseline, 3, 6, 9, and 12 months. At each planned and unplanned visit to the general practice treatment will be adjusted with support of an internet-based asthma monitoring system supervised by a central coordinating specialist nurse. Patient preferences and utilities will be assessed by questionnaire and interview. Data on asthma control, treatment step, adherence to treatment, utilities and costs will be obtained every 3 months and at each unplanned visit. Differences in societal costs (medication, other (health) care and productivity) will be compared to differences in the number of limited activity days and in quality adjusted life years (Dutch EQ5D, SF6D, e-TTO, VAS). This is the first study to assess patient preferences and cost-effectiveness of asthma treatment strategies driven by different target levels of asthma control.

Trial registration

Netherlands Trial Register (NTR): NTR1756