Original article
Adherence to treatment in children and adolescent patients with cystic fibrosis

https://doi.org/10.1016/j.jadohealth.2004.09.013Get rights and content

Abstract

Purpose

The purpose of this study was to monitor medication adherence in cystic fibrosis (CF) patients and its correlation with disease severity and patient age.

Methods

Children less than 12 years of age (group 1) and adolescents 12 years of age and older (group 2) were recruited from the University of Michigan CF Center. The study duration was 3 months. A total of 22 patients per group were enrolled. Adherence to ADEKs, an oral multivitamin, and dornase alfa, a nebulized mucolytic medication, was monitored. Adherence to ADEKs was monitored by using the Medication Event Monitoring System (MEMS) SmartCaps (APREX, AARDx, Inc., Union City, California). Dornase alfa adherence rate was monitored by counting empty medication vials.

Results

Thirty-three patients completed the study, 15 patients in group 1 and 18 patients in group 2. The overall mean adherence rates for ADEKs and dornase alfa were (± SD) 63.6% ± 24.0% and 66.5% ± 31.2%, respectively. The median ADEKs and dornase alfa adherence rate for group 1 was 84.6% and 79.1%, respectively (p = .08); and for group 2 was 56.7% vs. 78.4%, respectively (p = .07). There was a trend toward significance, suggesting that the adherence rate for ADEKs was higher than for dornase alfa (p = .08) in group 1. Group 2 showed a trend toward adherence to dornase alfa than to ADEKs (p = .07). There was a trend for ADEKs adherence between groups 1 and 2 (p = .09), but not for dornase alfa (p = .93).

Conclusion

Parental supervision and disease severity are likely to play a major role in adherence to medical management. Partnership with patients and families about the treatment plan might be important for improving adherence rate. The MEMS SmartCaps is an electronic monitoring technology that should be used to measure drug adherence objectively both in further larger clinical trials and in the outpatient setting.

Section snippets

Study design

Children younger than 12 years of age (group 1) and adolescents 12 years of age and older (group 2) with CF, attending the University of Michigan CF Center, were recruited to participate in this study.

The study was conducted over a 3-month period. Patients were recruited during a routine clinic visit to our CF Center. A total of 22 clinically stable patients per group were enrolled. The adherence rate to 2 medications was evaluated. The first medication was ADEKs (multivitamin supplement, plus

Results

Forty-four patients were enrolled (22 patients for each group) between October 2001 and April 2002. Clinical characteristics of the 2 groups at baseline are summarized in Table 1. Participants’ nutritional status was evaluated by their height for age and weight for age. Their illness severity was assessed by their forced expiratory volume in 1 second (FEV1) percent predicted. The mean FEV1 ± SD for group 1 was 89.7 ± 22.6 vs. 67.9 ± 26.0, which indicates that the younger age group has less

Discussion

Previous studies mainly have evaluated adherence to medication in CF patients subjectively by relying on patient/parent questionnaires, diaries, and self-reporting [3], [6], [7], [8]. In this study, the adherence rates to 2 medications commonly used in CF patient management were measured objectively. The first medication was ADEKs, an orally administered multivitamin especially formulated for CF patients. ADEKs adherence was evaluated using the MEMS monitors. They are special pharmacy vial caps

Acknowledgment

Supported in part by the Cystic Fibrosis Foundation Traineeship grant, Axcon Scandipharm, Inc., Birmingham, AL and Genentech, Inc., South San Francisco, CA.

Presented in part in a poster session at the North American Cystic Fibrosis Conference, New Orleans, LA, October 3–7, 2002; at the 13th Annual Pediatric Research Symposium, receiving honorable mention, University of Michigan, Ann Arbor, MI, October 18, 2002; and at the American Thoracic Society International Conference, Seattle, WA, May

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