Cynthia Rand

Long-term effects of budesonide or nedocromil in children with asthma

BACKGROUND Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use. METHODS We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 microg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms. RESULTS There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups. CONCLUSIONS In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity.

Measurement of children's asthma medication adherence by self report, mother report, canister weight, and Doser CT

BACKGROUND Accurate assessment of medication adherence has been difficult to achieve but is essential to drug evaluation in clinical trials and improved outcomes in clinical care. OBJECTIVE This study was conducted to compare four adherence assessment methods: child report, mother report, canister weight, and electronic measurements of metered dose inhaler (MDI) actuation. METHODS Participants included 27 children with mild-to-moderate asthma who were followed prospectively for 6 months. All patients used an MDI equipped with an electronic Doser attached to their inhaled steroid. At each 2-month follow-up visit, Doser and canister weight data were recorded, while child and mother were interviewed separately regarding medication use. RESULTS Children and mothers reported, on average, over 80% adherence with the prescribed inhaled steroid. Canister weight revealed, on average, adherence of 69%, significantly lower than self-report. When adherence recorded by the electronic Doser was truncated to no more than 100% of prescribed daily use, average adherence was 50%. Older children and adolescents, nonwhite children, and those from poorer functioning families were least adherent. CONCLUSIONS Electronic adherence monitoring was significantly more accurate than self-report or canister weight measures. Such accuracy is an essential prerequisite to increasing understanding of the treatment, setting, and patient factors that influence adherence, and to the consequent design of effective intervention strategies.

Home environmental intervention in inner-city asthma: a randomized controlled clinical trial

BACKGROUND Airborne pollutants and indoor allergens increase asthma morbidity in inner-city children; therefore, reducing exposure, if feasible, should improve asthma morbidity. OBJECTIVE To conduct a randomized controlled trial of methods to reduce environmental pollutant and allergen exposure in the homes of asthmatic children living in the inner city. METHODS After the completion of questionnaires, spirometry and allergen skin tests, home inspection, and measurement of home air pollutant and allergen levels, 100 asthmatic children aged 6 to 12 years were randomized to the treatment group (home-based education, cockroach and rodent extermination, mattress and pillow encasings, and high-efficiency particulate air cleaner) or to the control group (treated at the end of the 1-year trial). Outcomes were evaluated by home evaluations at 6 and 12 months, clinic evaluation at 12 months, and multiple telephone interviews. RESULTS In the treatment group, 84% received cockroach extermination and 75% used the air cleaner. Levels of particulate matter 10 microm or smaller declined by up to 39% in the treatment group but increased in the control group (P < .001). Cockroach allergen levels decreased by 51% in the treatment group. Daytime symptoms increased in the control group and decreased in the treatment group (P = .04). Other measures of morbidity, such as spirometry findings, nighttime symptoms, and emergency department use, were not significantly changed. CONCLUSIONS A tailored, multifaceted environmental treatment reduced airborne particulate matter and indoor allergen levels in inner-city homes, which, in turn, had a modest effect on morbidity.

Electronic Monitoring of Medication Adherence: When Is High-Tech Best?

The accurate measurement of medication adherence is challenging, particularly in pediatrics. Electronic monitoring has been proposed as a possible “gold standard” for medication adherence measurement. Electronic monitoring permits the evaluation of patterns of medication use and dose-response relationship and may be a useful part of adherence promotion interventions. The use of these devices, however, is not without costs and cautions including, expense, malfunctioning, and interference with existing adherence routines. This review examines the costs and benefits of using electronic monitoring of adherence as well as the reliability and validity of electronic monitoring in general and, where possible, for specific devices (i.e., MEMS, MDIlog, and Doser). Finally, we provide recommendations for quality control protocols to minimize many of the problems encountered when using such devices. Ultimately, the choice of adherence measurement strategy should be based on the goal of the study and the resources available.

Use of Community Health Workers With Inner-City Children who Have Asthma

Use of community health workers (CHWs) to obtain health, social, and environmental information from African-American inner-city children with asthma was one component of a larger intervention study designed to reduce morbidity in African-American children with asthma. A subset of 140 school-aged children with asthma was recruited and enrolled in a program to receive home visits by CHWs for the purposes of obtaining medical information and teaching basic asthma education to the families. Data obtained by the CHWs revealed low inhaled steroid use, high β2 agonist use, frequent emergency-room visits, decreased primary-care visits, and increased allergen and irritant exposure. Appropriately recruited and trained CHWs are effective in obtaining useful medical information from inner-city families with children with asthma and providing basic asthma education in the home.

Randomized trial of the effect of drug presentation on asthma outcomes: The American Lung Association Asthma Clinical Research Centers

BACKGROUND Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. OBJECTIVE The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. METHODS A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. RESULTS Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. CONCLUSIONS Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

The effects of contingent payment and frequent workplace monitoring on smoking abstinence

This study examined the relative contribution of contingent payment and worksite CO monitoring to the long-term maintenance of smoking abstinence. Forty-seven hospital employees who had abstained from smoking for five days (confirmed by CO analysis) were randomly assigned to one of three follow-up groups: (a) contingent payment/frequent monitoring (n = 17); (b) noncontingent payment/frequent monitoring (n = 16); or (c) non-contingent payment/infrequent monitoring (n = 14). Contingent payment combined with frequent CO monitoring delayed but did not ultimately prevent subjects relapse to smoking by the end of the six month follow-up. Contingent subjects maintained CO values less than or equal to 11 ppm significantly longer than did either the Non-contingent or the Control subjects (p = .03). CO monitoring alone had no effect on abstinence outcomes; both Noncontingent and Control subjects showed high rates of early relapse.

Effects of a Focused Patient-Centered Care Curriculum on the Experiences of Internal Medicine Residents and their Patients

BACKGROUNDTraditional residency training may not promote competencies in patient-centered care.AIMTo improve residents’ competencies in delivering patient-centered care.SETTING/PARTICIPANTSInternal medicine residents at a university-based teaching hospital in Baltimore, Maryland.PROGRAM DESCRIPTIONOne inpatient team admitted half the usual census and was exposed to a multi-modal patient-centered care curriculum to promote knowledge of patients as individuals, improve patient transitions of care, and reduce barriers to medication adherence.PROGRAM EVALUATIONAnnual resident surveys (N = 40) revealed that the intervention was judged as professionally valuable (90%) and important to their training (90%) and offered experiences not available during other rotations (88%). Compared to standard inpatient rotation evaluations (n = 163), intervention rotation evaluations (n = 51) showed no differences in ratings for traditional medical learning, but higher ratings for improving how housestaff address patient medication adherence, communicate with patients about post-hospital transition of care, and know their patients as people (all p < 0.01). On post-discharge surveys, patients from the intervention team (N = 177, score 90.4, percentile ranking 97%) reported greater satisfaction with physicians than patients on standard teams (N = 924, score 86.1, percentile ranking 47%) p < 0.01).DISCUSSIONA patient-centered inpatient curriculum was associated with higher satisfaction ratings in patient-centered domains by internal medicine residents and with higher satisfaction ratings of their physicians by patients. Future research will explore the intervention’s impact on clinical outcomes.

Social Factors Associated With Behavioral Problems in Children With Asthma

The objective of this study was to describe the proportion of children with a behavior problem and examine which independent variables are associated with the presence of a behavior problem in a group of 392 inner-city children with asthma. Data on child asthma symptoms, medication use, health-care utilization, and school absences were obtained from the parent during a structured telephone interview. Included in the interview was a measure of behavior problems and social support questions. Children classified with a high level of asthma symptoms were more than twice as likely to experience a behavior problem than children classified with a low level of asthma symptoms (P= 0.002). Use of theophylline medication was not correlated with behavior problems (P = 0.45). Significant variables were low level of social support and high or moderate level of asthma symptoms. We have identified a group of children at risk for behavior problems, specifically in families that lack adequate social and financial resources.

Room-specific characteristics of suburban homes as predictors of indoor allergen concentrations

BACKGROUND Room characteristics predicting indoor allergen exposure in suburban homes have not been clearly identified. OBJECTIVE To examine relationships between room characteristics and concentrations of indoor allergens in homes of suburban asthmatic patients. METHODS The homes of 339 asthmatic children ages 6 to 17 years were studied. Home inspections were conducted by a trained technician, and dust samples were analyzed for indoor allergen content. A high allergen concentration was defined as 8 microg (U)/g or more of fine dust. RESULTS Infrequent sheet washing and wall-to-wall carpet were risk factors for high bedroom dust mite concentrations. Infrequent sheet washing was also a risk factor for high Fel d 1 concentrations. Food remains in the bedroom was a risk factor for high bedroom Bla g 1 levels, and exposed food, leaks, and dirty pots were all risk factors for high kitchen Bla g 1 levels. The combination of lack of mattress or pillow encasements, infrequent sheet washing, and carpeting was associated with a 24-fold increase in odds of a high dust mite concentration (odds ratio [OR], 24.1; 95% confidence interval [CI], 3.2-181.4). Among non-cat owners, the combination of stuffed toys on the bed, lack of mattress or pillow encasements, and infrequent sheet washing was associated with a 49-fold increase in odds of a high Fel d 1 level (OR, 49.4; 95% CI, 2.8-887.3). The combination of leaks, exposed food, and dirty pots was associated with a high kitchen Bla g 1 concentration (OR, 10.6; 95% CI, 2.8-40.5). CONCLUSIONS Specific room characteristics predict high indoor allergen exposure among children with asthma, and a combination of these characteristics may further increase the risk of high allergen exposure.