Abstracts S149
J ALLERGY CLIN IMMUNOL VOLUME 121, NUMBER 2
573
Asthma Control is Predictive of Health-Related Quality of Life: Survey Using the Asthma Control Testä and Childhood Asthma Control Testä C. Garris1, M. Schatz2, T. Guilbert3, E. A. Davis1, T. Bonus4, M. Bonafede5; 1GlaxoSmithKline, Research Triangle Park, NC, 2Kaiser Permanente Medical Center, San Diego, CA, 3University of WisconsinMadison, Madison, WI, 4Harris Interactive, Rochester, NY, 5Albany College of Pharmacy Research Institute for Health Outcomes, Albany, NY. RATIONALE: Understanding asthma control is important in successful management and prevention of asthma symptoms. This study examines the relationship between asthma control and health-related quality of life (HRQL). METHODS: A cross-sectional internet study using validated questionnaires was conducted in December 2006 with 700 adults and 250 children who received asthma treatment in the past year. The Asthma Control Test (ACT) ä for respondents ages 12 years or Childhood ACT (C-ACT)ä for ages 4 to 11 years, questionnaires used to assess asthma control, were administered along with the general HRQL questionnaire Short Form 12 (SF-12) for adults 18 years, and the asthma-specific pediatric HRQL questionnaire PedsQL for children 4 to 17 years. ACT/C-ACT scores were dichotomized into ‘‘controlled’’ (scores 20) or ‘‘not well-controlled’’ (scores 19). HRQL questionnaire scores range from 0 to 100. Simple linear regressions were used to model the relationship between controlled and not well-controlled asthma (predictor) and HRQL scores (outcome). RESULTS: ACT/C-ACT scores 19 were a significant predictor of decreased HRQL for adults (p < 0.01) and children ages 4 to 11 and 12 to 17 (p < 0.01). Overall, HRQL scores for patients whose asthma was not well-controlled were significantly less (mean decrease [95% CI]- adults: 7.0 [5.0-9.0]; children 4 to 11 years: 14.9 [8.4-21.4]; 12 to 17 years: 13.5 [5.8-21.1]) compared to patients with controlled asthma. CONCLUSION: Patients assessed by ACT/C-ACT whose asthma is not well-controlled are significantly more likely to experience lower HRQL. Improving patients’ asthma control may lead to better HRQOL. Funding: GlaxoSmithKline
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Perception of Indoor Exposure to Environmental Tobacco Smoke (ETS) in Urban Parents of Children wtih Asthma A. M. Butz1, P. Parham1, R. Lewis1, E. C. Matsui1, J. Brosnan1, D. Williams2, P. Eggleston1, P. Breysse2; 1Johns Hopkins University School of Medicine, Baltimore, MD, 2Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD. RATIONALE: ETS exposure is associated with asthma exacerbations and should be assessed during routine asthma care visits. However, parental report of smoking exposure may not accurately reflect objective measures of ETS exposure. METHODS: Monitoring for airborne nicotine and particulate matter (PM) was conducted in homes of 44 children with persistent asthma and who lived with a smoker. Urine cotinine (UC) and parent self-report of cigarette use (SR) were measured during clinic visits while airborne nicotine (AN) and PM levels were measured in the child’s bedroom and family room during home visits. Relationships between SR cigarette use and objective measures of ETS exposure were examined. RESULTS: Children were primarily male (66%), African American (95%), with mean age 9.4 years (SD1.8). Over half (52%) reported night awakening 1 night/week and 52% reported an ED visit within last 6 months. Most household smokers were the child’s primary caregiver (68%) who reported a mean of 10 cigarettes/day smoked in the home. Smoking locations were: parent’s bedroom (73%), living room (50%), kitchen
(33%) and car (30%). UC, AN, and PM levels were high (medians: UC: 21.3 ng/ml; AN: 1.43mg/m3; PM2.5: 30.7mg/m3). The objective ETS measures were strongly correlated with one another (AN vs. PM2.5: rs 5 0.88; AN vs. UC: rs 5 0.80), but not parent SR (SR vs. AN: rs 5 0.41; SR vs. PM2.5: rs 5 0.44; SR vs. UC: rs 5 0.46). CONCLUSIONS: Objective measures of ETS exposure provide a more accurate assessment on which to base environmental control recommendations rather than parent’s report of child’s ETS exposure. Funding: NIEHS, EPA
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The Relationship Between Adherence Monitoring and Study Efficacy in ICS Trials A. G. Weinstein1, B. Lee2, K. Williams3; 1Jefferson Medical College, Newark, DE, 2William and Mary College, Williamsburg, VA, 3Henry Ford Health System, Detroit, MI. RATIONALE: Research subjects may not follow protocols as directed, resulting in lower estimates of medication efficacy. Some investigators have used subjective measures (SM) (i.e., history/diary card) and objective measures (OM) (i.e., canister weights, pill counts, dose counters and electronic devices) to assess adherence. Measuring adherence may improve protocol compliance and hence these studies may demonstrate greater clinical effect. METHODOLOGY: Eighteen asthma studies evaluating the effect of inhaled corticosteroid (ICS) medication on FEV-1 were selected from a publication by Sin and colleagues (JAMA 2004; 92:367.) This systematic review provided summary effect sizes, thereby allowing studies to be compared. We categorized studies according to the method of measuring adherence (i.e., none, SM, or OM) and whether the study demonstrated a statistically significant improvement in FEV-1 from baseline. RESULTS: Of the 18 studies examined, 6 measured treatment adherence objectively, 7 used subjective measures; and 5 did not measure adherence. Studies measuring adherence were not more likely to demonstrate a significant FEV-1 effect when compared with studies not measuring adherence (P 5 1.0, two-tailed Fisher’s Exact). Similarly, no difference was seen when limiting the comparison to studies using OM or SM vs. no measures of adherence. Lastly, studies measuring adherence objectively were not more likely to show a significant improvement in FEV-1 when compared with studies measuring adherence subjectively. CONCLUSION: We did not observe a relationship between measuring ICS adherence and whether the study demonstrated a significant improvement in FEV-1. Other study design factors (dose, subject number and study length) may have an effect on clinical outcome.
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CONCLUSION: Results indicate self-report data is not consistent with the actual claims data generated by MCOs. This illustrates that even a three month recall period may not be reliable. Over-reporting of emergency room visits by self-report suggests some participants’ perceptions of emergency room facility use for asthma exacerbations includes urgent care and hospital-based outpatient visits. Funding: National Institute of Nursing Research