Noncompliance and treatment failure in children with asthma,☆☆,

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Abstract

BACKGROUND: Accurate and reliable information about children’s use of inhaled medications is needed because of the growing reliance on these drugs in the treatment of asthma and the excessive morbidity and mortality attributable to this disease. OBJECTIVE: This study was designed to evaluate the adherence of children with asthma to regimens of inhaled corticosteroids and β-agonists. METHODS: Data collected electronically by metered-dose inhaler monitors were compared with data recorded by patients on traditional diary cards. A volunteer sample of 24 children, between 8 and 12 years old, who had asthma for which they were receiving both inhaled corticosteroids and β-agonists, participated over a 13-week period. Each child was accompanied by a parent to all study visits. The main outcome measures were the use of medication as reported by diary card entries and recorded by electronic monitoring and disease exacerbation, as indicated by requirement for oral corticosteroids. RESULTS: The median use of inhaled corticosteroids reported by patients on their diaries was 95.4%, whereas the median actual use was 58.4%. More than 90% of patients exaggerated their use of inhaled steroids, and diary entries of even the least compliant subjects reflected a high level of adherence. The children who experienced exacerbation of disease sufficient to require a burst of oral corticosteroids differed markedly from the others in their adherence to prescribed therapy as recorded by the electronic monitors. The median compliance with inhaled corticosteroids was 13.7% for those who experienced exacerbations and 68.2% for those who did not. CONCLUSIONS: Electronic monitoring demonstrated much lower adherence to prescribed therapy than was reported by patients on diary cards. Low rates of compliance with prescribed inhaled corticosteroids were associated with exacerbation of disease. Poor control of asthma should alert the physician to the possibility of noncompliance. (J Allergy Clin Immunol 1996;98:1051-7.)

Section snippets

Subjects

The study participants were 24 children (14 boys and 10 girls) with asthma, between 8 and 12 years old. They were recruited from an ambulatory clinic by using a convenience sample of children who required both inhaled corticosteroid and β-agonist therapy and reliably kept their clinic appointments. Children who were known to be noncompliant with therapy were excluded. Each child was accompanied to every visit by a parent. All subjects had been prescribed inhaled corticosteroids and β-agonists

RESULTS

Primary results are summarized in the Table I. Diary entries stated that the median use of β-agonists was 78.2% of prescribed dose and that steroid use was a striking 95.4%. The median raw compliance for β-agonist and inhaled steroid doses taken, as recorded by the Chronolog, was 62.1% and 58.4%, respectively. However, the time-corrected compliance comprising only doses taken within the correct window was 48% for β-agonists and 32% for inhaled corticosteroids (Fig. 1). Ninety-two percent of the

DISCUSSION

This study compared information regarding the use of medication from patient diaries with that recorded by electronic monitoring devices. Children and their parents were not informed about the recording capability of the Chronologs and did not receive any feedback, nor were data analyzed until the study was completed. It is important to emphasize that this investigation was conducted without disturbing the preexisting doctor-patient relationship. Each patient’s care was directed by his or her

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From the Departments of aPediatrics and b Biostatistics, National Jewish Center for Immunology and Respiratory Medicine, Denver; and cThe Johns Hopkins Asthma and Allergy Center, Baltimore.

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Reprint requests: Henry Milgrom, MD, National Jewish Center for Immunology, 1400 Jackson St., Denver, CO 80206.

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