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J Allergy Clin Immunol. 2012 Jan;129(1):112-8. doi: 10.1016/j.jaci.2011.10.030. Epub 2011 Nov 21.

Adherence to inhaled corticosteroids: an ancillary study of the Childhood Asthma Management Program clinical trial.

Author information

1
Department of Medicine, Section of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois at Chicago, Ill 60612, USA. jakris@uic.edu

Abstract

BACKGROUND:

Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited.

OBJECTIVE:

We sought to compare subjective and objective measurements of children's adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes.

METHODS:

In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 μg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes.

RESULTS:

Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, -0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes.

CONCLUSION:

Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.

PMID:
22104610
PMCID:
PMC3350797
DOI:
10.1016/j.jaci.2011.10.030
[Indexed for MEDLINE]
Free PMC Article
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