Cynthia S. Rand

Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy

OBJECTIVES To evaluate the validity of patient report, pharmacy dispensing records, and pill counts as measures of antihypertensive adherence using electronic monitoring as the validation standard. METHODS The study was conducted among 286 members of Harvard Pilgrim Health Care, a managed care organization, who were at least 18 years of age, on monotherapy for hypertension, and had prescription drug coverage. Prescription refill adherence during the 12 months before enrollment was determined from their automated pharmacy dispensing records. Participants were interviewed about their medication adherence before and after a 3-month electronic monitoring period during which pill counts were also performed. Adherence to both recommended number and timing of doses was estimated from electronic monitoring data. Data analysis was based on statistical correlation and analysis of variance. RESULTS Electronic adherence monitoring revealed that the proportion of prescribed doses consumed was higher (0.92) than the proportion of doses taken on time (0.63). The correlation between adherence to quantity and timing of doses was 0.32. Concurrent pill counts and earlier refilling patterns were moderately correlated with electronic monitoring (pill count: r = .52 with quantity and r = .17 with timing; refill adherence r = .32 with quantity and r = .22 with timing). There was considerable misclassification of adherence reported by patients, although nonadherence was generally accurately reported. CONCLUSIONS Deviation from recommended timing of doses appears to be greater than from prescribed number of doses. Pharmacy dispensing records demonstrate predictive validity as measures of cumulative exposure and gaps in medication supply. Adherence levels determined from pill counts and pharmacy dispensing records correlate more closely with quantity than with timing of doses. Nonadherence reported by patients can serve as a qualitative indicator and predictor of reduced adherence.

The childhood asthma management program (CAMP): Design, rationale, and methods

The Childhood Asthma Management Program (CAMP) is a multicenter, randomized, double-masked clinical trial designed to determine the long-term effects of three inhaled treatments for mild to moderate childhood asthma: budesonide (a glucocorticoid used daily) and albuterol (a short-acting beta-agonist bronchodilator used as needed); nedocromil (a nonsteroid anti-inflammatory agent used daily) and albuterol; and placebo and albuterol. One thousand forty-one children (32% from ethnic minority groups), aged 5 to 12 years at screening, are currently participating. The primary outcome measure is lung growth as indicated by postbronchodilator forced expiratory volume in 1 second (FEV1) percent of predicted, observed over 5- to 6-year period. The trial also assesses differences between treatment groups with respect to airway responsiveness, morbidity, physical growth and development, and psychological growth and development. This report describes the design of the trial, the rationale for the design choices made, and the methods used to carry out the trial.

Nonadherence in Asthmatic Patients: Is there a Solution to the Problem ?

LEARNING OBJECTIVES Reading this article will reinforce the readers awareness of the relationship between adherence and treatment outcome, of the causes of nonadherence, of methods of measurement, and of steps toward successful intervention. DATA SOURCES Articles on adherence to asthma therapy were reviewed. A MEDLINE database using subject keywords was searched from 1990 through 1997. STUDY SELECTION Pertinent articles were chosen, with preferential presentation of results from controlled studies. RESULTS There is no evidence of recent improvement in the rates of nonadherence, and patients continue on average to take about 50% of prescribed medication. Nonadherence assessment is most accurate when it can be measured objectively, and relies neither on patient report nor physician estimate. The consequences of nonadherence are measured in patient suffering, financial cost, and serious compromise of clinical trial outcomes. Underlying causes of nonadherence are traced to characteristics of the disease, treatment, patient, and caregiver system. CONCLUSION Improved adherence will lead to improved disease control, but only if medical care systems encourage and support the allocation of sufficient resources to allow barriers to self-management to be discussed and solutions negotiated. Attempts to improve adherence outside of the caregiver-patient relationship are less likely to succeed. Special programs for difficult-to-manage patients are necessary to change behavior, although significant illness improvement and cost savings are likely to result.

Psychological factors associated with medication nonadherence in asthmatic children

Adherence with inhaled beta-agonists and corticosteroids in 24 asthmatic children was tracked over 3 months utilizing the metered-dose inhaler chronolog (MDIC). Patients seldom took all of their medications as prescribed, and failed to take any inhaled corticosteroid doses on a median of 41.8% of days or inhaled beta-agonists on 28.1% of days despite prescribed daily use. Medication nonadherence was correlated with lower levels of asthma knowledge (Asthma Knowledge Questionnaire) and family dysfunction (Family Assessment Device), but not child behavior disorder (Child Behavior Checklist). Patients tended to dramatically over-report medication use. Improved identification of the markers of nonadherence can directly facilitate more efficient targeting of behavioral interventions, resulting in improved adherence, better illness control, and less requirement of urgent medication intervention.

Measuring Adherence to Behavioral and Medical Interventions

Measuring adherence to medical and behavioral interventions is important to clinicians and researchers since inadequate adherence can reduce the effectiveness of an intervention. Unfortunately, there is no gold standard for measuring adherence across health behaviors. Adherence needs to be defined situationally with parameters of acceptable adherence carefully delineated and appropriate to the health behavior being studied. Additionally, measurement methods must be valid, reliable, and sensitive to change; this paper reviews these criteria. Methods used to measure adherence to dietary interventions include 24-hour recalls, food diaries, and food frequency questionnaires. Direct and indirect calorimetry, doubly labeled water, and a variety of self-report methods can be used to measure adherence in physical activity interventions. Adherence to pharmacological interventions is assessed using self-report methods, biochemical measures, medication counts, and the automated pharmacy database review strategy. The strengths and weaknesses of these methods for measuring adherence to dietary, physical activity, and pharmacological interventions are reviewed. Control Clin Trials 2000;21:188S-194S

Medications Used by Children With Asthma Living in the Inner City

Objective. The purpose of the study was to examine medication use reported by families participating in an urban school-based community intervention program and to relate this use to other social and medical variables. Design. The design of the study was a cross-sectional questionnaire survey. Setting. Patients and their families recruited from elementary schools in a community setting were interviewed between December 1991 and January 1992. Participants. A total of 508 children with asthma were identified by school health records and teacher surveys. Their families confirmed the diagnosis and agreed to enter the study. Questionnaires were completed by 392 families. Intervention. The 392 families participated in a controlled trial of asthma education after providing the data that are the basis of this report. Results. More than half of the children took two or more medications for asthma. Thirty-one percent took theophylline alone or in combination with an adrenergic agent; 11% took some form of daily antiinflammatory medication, either cromolyn (8%) or inhaled steroids (3%). The pattern of medication use related to measures of severity and to regular visits to physicians or nurses. In general, however, children were undermedicated. A total of 78 children (20%) reported no medication or over-the-counter medication use, although 37% reported asthma severe enough to be associated with ≥20 days of school missed per month, and 37% had had an emergency room visit for asthma in the past 6 months. More than half of children ≥9 years old supervised their own medication. Conclusions. We concluded that undermedication is common in poor children with asthma living in urban areas. Antiinflammatory medications are used less commonly than in the general population, and theophylline is used more often. School children may be likely to supervise their own medication.

Inhaler competence in asthma: Common errors, barriers to use and recommended solutions

Whilst the inhaled route is the first line administration method in the management of asthma, it is well documented that patients can have problems adopting the correct inhaler technique and thus receiving adequate medication. This applies equally to metered dose inhalers and dry powder inhalers and leads to poor disease control and increased healthcare costs. Reviews have highlighted these problems and the recent European Consensus Statement developed a call to action to seek solutions. This review takes forward the challenge of inhaler competence by highlighting the issues and suggesting potential solutions to these problems. The opportunity for technological innovation and educational interventions to reduce errors is highlighted, as well as the specific challenges faced by children. This review is intended as a policy document, as most issues faced by patients have not changed for half a century, and this situation should not be allowed to continue any longer. Future direction with respect to research, policy needs and practice, together with education requirements in inhaler technique are described.

Emergency department visits by urban African American children with asthma

BACKGROUND Asthma morbidity among African American children has been identified as a significant national health concern. High emergency department use is one index of this morbidity and may reflect disease severity, disease management, and social factors. OBJECTIVE This study examined the prevalence and correlates of emergency department use and other indices of asthma morbidity among a sample of urban, low-income, African American children. METHODS Parents of 392 elementary school children with asthma who had consented to participate in an asthma education program were interviewed by phone according to a standardized protocol. RESULTS Children had a mean of 6.2 days of restricted activity (SD 8.1) and 7.9 symptomatic nights (SD 8.1). The mean number of school days missed because of asthma was 9.7 (SD 13.5). Among children with asthma symptoms in the past 12 months, 73.2% could identify a specific physician or nurse who provided asthma care. For those families without an identified asthma primary care provider, 39.3% received their usual asthma care from the emergency department. A total of 43.6% of the children had been to the emergency department for asthma care without hospitalization in the previous 6 months. Close to 80% of children reported using one or more prescribed asthma medication, and of these only 12% reported using inhaled anti-inflammatory medications. Families of children who had used the emergency department in the prior 6 months reported more asthma symptoms, lower social support, problems paying for health care, and the absence of a hypoallergenic mattress cover and that they had seen a physician for regular asthma care in the past 6 months. CONCLUSIONS We conclude that asthma management for children in the inner city relies on episodic care and emergency care, that asthma medication management does not conform to current guidelines, and that asthma symptoms resulting in school absences and workdays lost are prevalent.

Addressing asthma health disparities: A multilevel challenge

Substantial research has documented pervasive disparities in the prevalence, severity, and morbidity of asthma among minority populations compared with non-Latino white subjects. The underlying causes of these disparities are not well understood, and as a result, the leverage points to address them remain unclear. A multilevel framework for integrating research in asthma health disparities is proposed to advance both future research and clinical practice. The components of the proposed model include health care policies and regulations, operation of the health care system, provider/clinician-level factors, social/environmental factors, and individual/family attitudes and behaviors. The body of research suggests that asthma disparities have multiple, complex, and interrelated sources. Disparities occur when individual, environmental, health system, and provider factors interact with one another over time. Given that the causes of asthma disparities are complex and multilevel, clinical strategies to address these disparities must therefore be comparably multilevel and target many aspects of asthma care. Several strategies that could be applied in clinical settings to reduce asthma disparities are described, including the need for routine assessment of the patients beliefs, financial barriers to disease management, and health literacy and the provision of cultural competence training and communication skills to health care provider groups.

Household mouse allergen exposure and asthma morbidity in inner-city preschool children

BACKGROUND Inner-city children experience disproportionate asthma morbidity, and suspected reasons include indoor environmental exposures. OBJECTIVE To determine if mouse allergen exposure is a risk factor for asthma morbidity. METHODS Preschool children with asthma were recruited from inner-city Baltimore, MD. Skin testing was performed and blood was collected at the baseline visit for quantification of mouse allergen specific IgE. A questionnaire evaluated symptoms, medication, and health care use at baseline, 3 months, and 6 months. A trained technician collected dust samples from the childs home for analysis of Mus m 1 at baseline, 3 months, and 6 months. Outcomes were compared between mouse-sensitized, highly exposed children and all other children. RESULTS A total of 127 children had complete data for mouse sensitization status and bedroom settled dust mouse allergen levels at baseline. The mean age of the children was 4.4 years, 92% were African American, and 26% were sensitized to mouse. Mouse-sensitized children exposed to higher levels of Mus m 1 (>0.5 microg/g) had 50% more days of symptoms (incidence rate ratio [IRR], 1.5; 95% confidence interval [CI], 1.1-2.1) and 80% more days of beta-agonist use than other children (IRR, 1.8; 95% CI, 1.3-2.5). Children in the sensitized and highly exposed group were also more likely to have an unscheduled physician visit (odds ratio [OR], 3.1; 95% CI, 1.6-6.3), emergency department visit (OR, 2.1; 95% CI, 1.1-4.1), and hospitalization (OR, 36.6; 95% CI, 4.1-327.3) than other children. These associations between mouse allergen exposure and asthma symptoms and morbidity remained statistically significant after adjusting for potential confounders, including atopy and cockroach sensitization and exposure. CONCLUSIONS In mouse-sensitized inner-city children, exposure to mouse allergen may be an important cause of asthma morbidity.