A School- and Home-Based Intervention to Improve Adolescents' Physical Activity and Healthy Eating: A Pilot Study.

This study evaluated feasibility, acceptability, and preliminary efficacy of a 12-week Guys/Girls Opt for Activities for Life (GOAL) intervention on 10- to 13-year-old adolescents' body mass index (BMI), percent body fat, physical activity (PA), diet quality, and psychosocial perceptions related to PA and healthy eating. Parent-adolescent dyads from two schools were enrolled. Schools were assigned to either GOAL (38 dyads) or control (43 dyads) condition. The intervention included an after-school club for adolescents 2 days/week, parent-adolescent dyad meeting, and parent Facebook group. Intervention adolescents had greater autonomous motivation for PA and self-efficacy for healthy eating than control adolescents (both p < .05). Although between-group differences were not significant, close-to-moderate effect sizes resulted for accelerometer-measured moderate-to-vigorous PA and diet quality measured via 24-hr dietary recall (d = .46 and .44, respectively). A trivial effect size occurred for percent body fat (d = -.10). No differences emerged for BMI. Efficacy testing with a larger sample may be warranted.

Dietary Intake Among Head Start Preschooler-caregiver Dyads.

PURPOSE: The purpose of this study was to examine the relationship between Head Start preschooler-caregiver dyad's dietary intake and factors influencing dietary intake. DESIGN AND METHODS: A cross-sectional, correlational design was used. Height and weight were measured. Caregivers completed an online survey assessing demographics, dietary intake, feeding practices, and psychosocial factors. RESULTS: Seventy dyads, recruited from two urban Head Start centers in the Midwestern U.S., participated. The mean age for preschoolers and caregivers was 3.90 (63% female) and 28.97 years (94% female), respectively. About 43% of preschoolers and 81% of caregivers were overweight/obese. Sixty-seven percent of caregivers, but only 9% of preschoolers, met the fruit/vegetable (F/V) recommendation. Preschoolers' F/V intake was not significantly correlated with their caregivers' F/V intake after adjusting for demographics and psychosocial factors (B = 0.05, p = .607). Caregiver race (B = -0.71, p = .05), nutrition knowledge (B = -0.35, p = .017), perceived caregiver weight (B = -0.85, p = .035), perceived child weight (B = 1.09, p = .029), and concerns of preschoolers' weight (B = 0.79, p = .004) were significantly correlated with preschoolers' F/V intake, after adjusting for demographics, caregiver F/V intake, and other psychosocial factors. CONCLUSIONS: The study findings indicate the critical need to improve preschoolers' dietary intake and the important influence of caregivers on their preschoolers' dietary intake. Given the few limitations of the study (e.g., small sample size, food frequency questionnaire), interpretation and application of the study's findings warrant caution. PRACTICE IMPLICATIONS: Pediatric practitioners and researchers need to design effective programs to improve low-income Head Start preschoolers' dietary intake, thereby helping to curb the current childhood obesity epidemic.

Imaging during low back pain ED visits: a claims-based descriptive analysis.

OBJECTIVE: Low back pain (LBP) is a common reason for emergency department (ED) visits. This study aimed to determine the frequency and type of nonindicated imaging during LBP ED visits and to describe demographic and prior health care use characteristics among the nonindicated population. METHODS: This study included index ED events for LBP occurring during 2011 through 2012 for Blue Cross Blue Shield of Michigan commercial members ages 18 to 64 years. We identified LBP imaging indications within 12 months before the index event. Frequency estimates of patient demographics, imaging prevalence, type of imaging, and prior health care use characteristics stratified by imaging and indication status are presented with 95% confidence intervals (CIs). RESULTS: Of the 14838 total events, 51.9% (95% CI, 51.1%-52.7%) did not have indications for imaging. Patients without imaging indications were less likely to have had ED visits, hospital stays, LBP, lower back imaging, primary care physician visits, and back-related specialist visits in the past year compared with patients with indications. Among nonindicated patients, 30.1% (95% CI, 29.1%-31.1%) received imaging; of these, 26.2% received advanced imaging (computed tomography or magnetic resonance imaging). Nonindicated patients who received imaging were slightly older than those who did not receive imaging (27.6% [95% CI, 25.8%-29.4%] were ages 55-64 years vs 20.6% [95% CI, 19.6%-21.7%]) and had a higher prevalence of observation/treatment room use (7.3% [95% CI, 6.2%-8.4%] vs 1.2% [95% CI, 0.9%-1.4%]). CONCLUSIONS: Our results suggest that a substantial proportion of the patient population presenting to the ED for LBP receives nonindicated imaging, revealing opportunities to reduce costs and radiation exposure.

Immune response to COVID-19 vaccination in a population with a history of elevated exposure to per- and polyfluoroalkyl substances (PFAS) through drinking water.

BACKGROUND: Exposure to per- and polyfluoroalkyl substances (PFAS) has been linked to lower vaccine-induced antibody concentrations in children, while data from adults remains limited and equivocal. Characteristics of PFAS exposure and age at vaccination may modify such effects. OBJECTIVE: We used the mass administration of novel COVID-19 vaccines to test the hypothesis that prior exposure to environmentally-relevant concentrations of PFAS affect antibody response to vaccines in adolescents and adults. METHODS: Between April and June 2021, 226 participants aged 12-90 years with a history of exposure to PFAS in drinking water and who received an mRNA COVID-19 vaccine participated in our prospective cohort study. SARS-CoV-2 anti-spike and anti-nucleocapsid antibodies (IgG) were quantified before the first and second vaccine doses and again at two follow-ups in the following months (up to 103 days post dose 1). Serum PFAS concentrations (n = 39 individual PFAS) were measured once for each participant during baseline, before their first vaccination. The association between PFAS exposure and immune response to vaccination was investigated using linear regression and generalized estimating equation (GEE) models with adjustment for covariates that affect antibody response. PFAS mixture effects were assessed using weighted quantile sum and Bayesian kernel machine regression methods. RESULTS: The geometric mean (standard deviation) of perfluorooctane sulfonate and perfluorooctanoic acid serum concentrations in this population was 10.49 (3.22) and 3.90 (4.90) µg/L, respectively. PFAS concentrations were not associated with peak anti-spike antibody response, the initial increase in anti-spike antibody response following vaccination, or the waning over time of the anti-spike antibody response. Neither individual PFAS concentrations nor their evaluation as a mixture was associated with antibody response to mRNA vaccination against COVID-19. IMPACT STATEMENT: Given the importance of understanding vaccine response among populations exposed to environmental contaminants and the current gaps in understanding this relationship outside of early life/childhood vaccinations, our manuscript contributes meaningful data from an adolescent and adult population receiving a novel vaccination.

Short-term outdoor temperature change and emergency department visits for asthma among children: a case-crossover study.

Although weather changes are known to cause asthma symptoms, their impact on asthma-related health-care utilization is poorly understood. The objective of the present study was to determine the association between short-term outdoor temperature change and asthma-related emergency department (ED) visits among children 3-18 years of age in Detroit, Michigan, in 2000-2001. Descriptive analyses of patient and ED visit characteristics were performed. A case-crossover study utilizing time-stratified controls was conducted to determine the impact of maximum temperature change and change rate measured during 4-, 8-, 12-, and 24-hour periods. Multivariable conditional logistic regression demonstrated the relation between ED visits and temperature change after controlling for other weather and pollutant measures. There were 4,804 asthma-related ED visits during the study period, and they occurred most frequently in the fall and during morning hours. The case-crossover study showed a statistically significant inverse relation between ED visits and maximum 24-hour temperature change after adjustment for climatic factors (for temperature change, odds ratio = 0.992, P = 0.04; for temperature change rate, odds ratio 0.972, P = 0.01). The association persisted after air pollutant measures were added to the model, although the association was not significant. Despite the finding that a greater 24-hour temperature change decreased the risk of asthma-related ED visits, the overall results suggested a negligible association with short-term temperature change.

Faculty education to improve integration of genomics education in nursing curriculum.

Nurses play a crucial role in providing healthcare and need to possess essential knowledge and skill to integrate genomics into practice. Nursing faculty is charged with the education of nurses however, studies show the majority of faculty in the United States is ill-prepared to teach genetics/genomics concepts. Our aim was to increase genetics/genomics content in our college's nursing curriculum by bolstering our faculty knowledge and confidence through the implementation of a face-to-face educational program. Therefore, we launched an intentional, strategic plan in fall 2017. First a comprehensive review of the college's undergraduate nursing curriculum for genetics/genomics content was conducted. Five development workshops on genetics/genomics were delivered over an academic year with knowledge and confidence in genetics/genomics was measured pre- and post-workshops. After the workshops, faculty revised curriculum and added genetics/genomics content to align with the competencies. Participants in the end-of-program survey reported higher confidence levels in all genomics-related tasks and answered more knowledge-based items, as compared to participants in the pre-workshop survey. Changes to the curriculum were made to integrate genetics/genomics in BSN courses and an online genetics course was developed. Genetics/genomics workshops can improve faculty knowledge and confidence and facilitate the integration of genetic/genomic content in undergraduate nursing curricula.

Association of daily asthma emergency department visits and hospital admissions with ambient air pollutants among the pediatric Medicaid population in Detroit: time-series and time-stratified case-crossover analyses with threshold effects.

BACKGROUND: Asthma morbidity has been associated with ambient air pollutants in time-series and case-crossover studies. In such study designs, threshold effects of air pollutants on asthma outcomes have been relatively unexplored, which are of potential interest for exploring concentration-response relationships. METHODS: This study analyzes daily data on the asthma morbidity experienced by the pediatric Medicaid population (ages 2-18 years) of Detroit, Michigan and concentrations of pollutants fine particles (PM2.5), CO, NO2 and SO2 for the 2004-2006 period, using both time-series and case-crossover designs. We use a simple, testable and readily implementable profile likelihood-based approach to estimate threshold parameters in both designs. RESULTS: Evidence of significant increases in daily acute asthma events was found for SO2 and PM2.5, and a significant threshold effect was estimated for PM2.5 at 13 and 11 µg m(-3) using generalized additive models and conditional logistic regression models, respectively. Stronger effect sizes above the threshold were typically noted compared to standard linear relationship, e.g., in the time series analysis, an interquartile range increase (9.2 µg m(-3)) in PM2.5 (5-day-moving average) had a risk ratio of 1.030 (95% CI: 1.001, 1.061) in the generalized additive models, and 1.066 (95% CI: 1.031, 1.102) in the threshold generalized additive models. The corresponding estimates for the case-crossover design were 1.039 (95% CI: 1.013, 1.066) in the conditional logistic regression, and 1.054 (95% CI: 1.023, 1.086) in the threshold conditional logistic regression. CONCLUSION: This study indicates that the associations of SO2 and PM2.5 concentrations with asthma emergency department visits and hospitalizations, as well as the estimated PM2.5 threshold were fairly consistent across time-series and case-crossover analyses, and suggests that effect estimates based on linear models (without thresholds) may underestimate the true risk.

Asthma exacerbation and proximity of residence to major roads: a population-based matched case-control study among the pediatric Medicaid population in Detroit, Michigan.

BACKGROUND: The relationship between asthma and traffic-related pollutants has received considerable attention. The use of individual-level exposure measures, such as residence location or proximity to emission sources, may avoid ecological biases. METHOD: This study focused on the pediatric Medicaid population in Detroit, MI, a high-risk population for asthma-related events. A population-based matched case-control analysis was used to investigate associations between acute asthma outcomes and proximity of residence to major roads, including freeways. Asthma cases were identified as all children who made at least one asthma claim, including inpatient and emergency department visits, during the three-year study period, 2004-06. Individually matched controls were randomly selected from the rest of the Medicaid population on the basis of non-respiratory related illness. We used conditional logistic regression with distance as both categorical and continuous variables, and examined non-linear relationships with distance using polynomial splines. The conditional logistic regression models were then extended by considering multiple asthma states (based on the frequency of acute asthma outcomes) using polychotomous conditional logistic regression. RESULTS: Asthma events were associated with proximity to primary roads with an odds ratio of 0.97 (95% CI: 0.94, 0.99) for a 1 km increase in distance using conditional logistic regression, implying that asthma events are less likely as the distance between the residence and a primary road increases. Similar relationships and effect sizes were found using polychotomous conditional logistic regression. Another plausible exposure metric, a reduced form response surface model that represents atmospheric dispersion of pollutants from roads, was not associated under that exposure model. CONCLUSIONS: There is moderately strong evidence of elevated risk of asthma close to major roads based on the results obtained in this population-based matched case-control study.

Prevalence of work-related asthma in Michigan, Minnesota, and Oregon.

INTRODUCTION: Adults who have asthma that is caused or aggravated by triggers at work experience a reduced quality of life. In this study, the authors sought to estimate the proportion of asthma that is associated with work using a state-based survey of adults with asthma. METHODS: In 2005, Michigan, Minnesota, and Oregon piloted the Behavioral Risk Factor Surveillance System Adult Asthma Call-Back Survey, with sample sizes of 867, 469, and 1072, respectively. Six questions addressing work-related asthma (WRA) were analyzed to generate estimates of the proportion of adult asthma that is work-related and compare those with and without WRA. RESULTS: Over half of all adults with asthma (53%) reported that their asthma was caused or made worse by any job they ever had, and among these respondents reporting WRA, only 21.5% to 25.1% reported ever telling or being told by a health professional that their asthma was work-related. Additionally, adults with WRA consistently reported poorer asthma control and higher health care utilization than adults with non-WRA. CONCLUSIONS: WRA is a common but frequently unrecognized health problem, and this lack of recognition might contribute to poorer asthma control among adults with WRA. Because early recognition, treatment, and management of WRA are crucial for improving long-term prognosis, clinicians need to include assessment of workplace triggers in both their diagnostic and treatment plans for adult patients with asthma.

An examination of EPPM predictions when threat is perceived externally: an asthma intervention with school workers.

Little research informs the use of the Extended Parallel Process Model (EPPM) of persuasion when threat and efficacy judgments are rendered for someone other than the message recipient. Nevertheless, a wide range of health promotion consists of influencing such judgments. Two studies examine the utility of using the EPPM in a context involving threats to others. Results show that the expected measurement models hold in this new context, and that an additive model is a stronger fit than a multiplicative one when considering how threat and efficacy combine to affect behavioral intentions but not when considering behavior. The study also examines the effects of a print intervention implemented with school employees in Michigan derived from the EPPM. The results are discussed in terms of their theoretical import and their application in this new context.

Asthma surveillance using Medicaid administrative data: a call for a national framework.

Connecticut, Michigan, and New York have successfully used Medicaid administrative data to conduct surveillance of asthma prevalence, related health service utilization and costs, and quality of asthma care. Since these assessments utilize beneficiary-level data, a wide range of population-based summaries is feasible. Opportunities exist to build upon the collective experiences of these three states to establish a national framework for asthma surveillance using Medicaid administrative data. This framework could be designed to respond to each state's unique data considerations and asthma management priorities, while establishing standardized criteria to enhance the comparability of asthma surveillance data among states. Importantly, a common asthma case definition using comparable methods is necessary to enable comparisons of prevalence estimates between states. Case definitions that could serve as the foundation for such a framework are presented. Mechanisms to foster sharing of methodologies and experiences will be instrumental for broad implementation across states. This collaboration will be of increasing importance as states experience mounting financial pressures due to increasing Medicaid enrollment and dwindling resources.

Pregnancy hypertension and its associations with pre-pregnancy depression, anxiety, antidepressants, and anxiolytics.

INTRODUCTION: Few studies have examined pre-pregnancy depression/anxiety and antidepressant/anxiolytic medication use in relation to hypertension disorders of pregnancy, i.e. chronic hypertension (CH), pre-eclampsia (PE), and gestational hypertension (GH). METHODS: This nested case-control study uses Blue Cross Blue Shield of Michigan (BCBSM) claims data of women with singleton live birth pregnancies (2010-2014) enrolled from 2 years prior to last menstrual period to ninety days after delivery. All women with ICD-9CM codes for CH, PE, GH, or unspecified hypertension were included as cases; women without hypertension were randomly sampled as controls. Linkage to Michigan birthfiles resulted in a sample of 12,647 women. Using weighted logistic regression, cases and controls were compared for depression and/or anxiety diagnoses (ICD-9CM codes) and anti-depressant and/or anxiolytic prescriptions throughout the study period. Depression and anxiety were defined as primary diagnosis in ≥1 inpatient or ≥2 outpatient visits. RESULTS: Among women with hypertension disorders of pregnancy, 59% had PE or GH, referred to here as pregnancy hypertension (PH). PH was associated with anti-depressant use prior to LMP only, (aOR = 1.2 95%CI 1.0, 1.5), continued use, (aOR = 1.4 95%CI 1.1, 1.7), and initiation of anxiolytic medication during pregnancy, (aOR = 2.5 95%CI 1.6, 4.2). In this latter group, 96% started medication before PH diagnosis. CH and PH were not associated with depression or anxiety in the absence of anti-depressants/anxiolytics. CONCLUSION: While anti-depressants/anxiolytics may be useful indicators in risk stratification for pregnancy hypertension, the same does not appear to be true for depression/anxiety without related medication use.

Investigating asthma deaths among children and young adults: Michigan Asthma Mortality Review.

OBJECTIVE: We developed a surveillance system to investigate asthma deaths in children and young adults. METHODS: A rapid asthma death notification and investigation system for Michigan was developed to identify interventions to prevent future deaths among people aged 2-34 years. Multidisciplinary panels to determine causal factors and recommend preventative actions reviewed information from death certificates, autopsies, next-of-kin interviews, and medical records. An annual report was disseminated to public health workers, health-care providers, insurers, and others. RESULTS: Eighty-six asthma deaths in Michigan residents, aged 2-34, occurred from 2002-2004. Sixty-one next of kin were interviewed and medical records were obtained for 84 of the deceased. Summaries were prepared on each of the deceased and were reviewed by expert panels, which reached consensus on causal factors and potential preventive action for each death. Each year an annual report, which summarized the causal factors and potential preventive activity, was prepared. CONCLUSION: This review has informed and catalyzed interventions to improve asthma care and management in Michigan. Factors leading to the review's success and future activities are discussed.

Pediatric asthma surveillance using Medicaid claims.

OBJECTIVE: The purpose of this study was to describe the prevalence of asthma among children using alternative case definitions applied to administrative claims data, and to assess year-to-year classification concordance. METHODS: This study was a retrospective cohort analysis of 357,729 children 0-18 years using 2001-2002 Michigan Medicaid claims. Asthma cases were classified using six alternative definitions based on outpatient, emergency department, inpatient, and pharmacy claims for asthma, including the Health Plan Employer Data Information Set (HEDIS) persistent asthma criteria commonly used for assessments of asthma health care quality: at least one asthma inpatient admission or emergency department visit, four or more asthma medications events, or four asthma outpatient visits and two asthma medication events. RESULTS: Overall, asthma prevalence varied widely between alternative case definitions, ranging from 14.9% based on claims evidence of any type of asthma utilization to 3.7% when restricted to those with four or more asthma medication dispensing events. Among cases meeting HEDIS persistent asthma criteria in 2001, 55.5% met these criteria in 2002. Those with four or more asthma medication dispensing events had the best overall classification concordance between 2001 and 2002. Utilization of asthma services and prevalence estimates were highest among children younger than 5 years old, but year-to-year classification concordance was poorest among these cases (p < 0.0001), irrespective of case definition. CONCLUSIONS: While overall asthma prevalence may remain relatively stable from year to year, individuals may not be classified consistently as cases over time, regardless of case definition. Studies that identify asthma cases in one year and assess asthma outcomes in a subsequent year may introduce substantial bias as a result of case misclassification. Among the case definitions considered in this study, our findings suggest that this bias is minimized among cases classified using the four or more asthma medication dispensing events criterion.

Dialing in: effect of telephonic wellness coaching on weight loss.

OBJECTIVE: To estimate the effect of telephonic wellness coaching on weight loss in a commercially insured population. STUDY DESIGN: Pre-post evaluation design. METHODS: Self-reported weight was obtained from 2 annual health assessment questionnaires administered during 2008 and 2010. Baseline (T1) information from these questionnaires was used to identify overweight/obese individuals and to determine targets for a 4-call wellness coaching program. Overweight/obese individuals identified at T1 were classified into following groups: (1) targeted for wellness coaching (N = 1448, including 1050 participants and 398 nonparticipants); (2) not targeted for wellness coaching, but targeted for other telephonic wellness care management (WCM) programs (N = 1270); (3) not targeted for any WCM programs (N = 7586). Weight reported on questionnaires a year later (T2) was used to calculate weight change between T1 and T2. Paired t-tests were used to detect significant weight changes over time. Multivariable linear regressions were used to compare weight changes between the groups. Stratified analysis was conducted to determine the effectiveness of telephonic wellness coaching for subgroups based on participants' selected health goals, intensity of the intervention received and initial stage of change. RESULTS: The group targeted for wellness coaching reported an average weight change of -0.44 kg (95% confidence interval [CI], -0.76 to -0.16) at T2, significantly more weight loss than reported by the group not targeted for any WCM programs. Participants who started in preparation stage and completed the program reported weight change of -1.43 kg (95% CI, -2.17 to -0.68), highest among program participants. CONCLUSIONS: Small weight loss was observed for obese/individuals targeted for telephonic wellness coaching.

Barriers and facilitators for utilization of genetic counseling and risk assessment services in young female breast cancer survivors.

Introduction. Women diagnosed with breast cancer at a young age are more likely to carry a cancer predisposing genetic mutation. Per the current NCCN recommendations, women diagnosed under age 50 should be referred to cancer genetic counseling for further risk evaluation. This study seeks to assess patient-reported barriers and facilitators to receiving genetic counseling and risk assessment among a community-based population of young breast cancer survivors (YBCS). Methods. Through the Michigan Cancer Surveillance Program, a state-based cancer registry, 488 women diagnosed with breast cancer before age 50 in 2006-2007 were identified. They received a mail survey regarding family history and facilitators and barriers to receiving genetic counseling and risk assessment. Results. Responses were received from 289 women (59.2%). One hundred twenty-two (42.2%) reported having received cancer genetic counseling. The most frequent reason identified for receiving services was to benefit their family's future. The top reasons for not attending were "no one recommended it" and "medical insurance coverage issues." Discussion. This study is the first published report using a state cancer registry to determine facilitators and barriers to receiving genetic counseling and risk assessment among YBCS. These findings demonstrate the need for additional awareness and education about appropriate indications for genetic services.

Long-acting ß-agonist monotherapy among children and adults with asthma.

OBJECTIVES: To determine the prevalence of long-acting ß-agonist (LABA) monotherapy among a Medicaid-enrolled population with asthma and to describe continued LABA monotherapy use. STUDY DESIGN: Retrospective cohort. METHODS: Administrative Medicaid claims data for Michigan were used to identify children and adults with asthma, defined as having 4 or more asthma medication­dispensing events during a calendar year between 2006 and 2008. We determined the annual prevalence of LABA monotherapy, defined as having at least 1 dispensing event for a LABA medication in the absence of any other maintenance therapy. The cohort using LABA monotherapy was followed up for 12 months after the identification year to assess continued LABA monotherapy and the frequency of missed opportunities for changes in therapy. Analyses included prevalence proportions, median numbers of office visits, and χ(2) tests to test for significant differences between subgroups. RESULTS: LABA monotherapy among persons with asthma was uncommon (<1%) and decreased over time. LABA monotherapy was more prevalent among female subjects, persons of white race, and older age groups. The prevalence of continued LABA monotherapy during the followup year was 41.2% among the cohort of LABA monotherapy users. Most users of continued LABA monotherapy (92.9%) had at least 1 missed opportunity for therapy change or patient education during the follow-up period. CONCLUSION: Although our results indicate that LABA monotherapy was rare, this study provides further evidence supporting enhanced information sharing between points of service about medication utilization that is inconsistent with accepted guidelines.

Spirometry use among pediatric primary care physicians.

OBJECTIVE: This study explores the use of spirometry in primary care settings. METHODS: A 4-page survey was mailed to a national, random sample of office-based family physicians and pediatricians. Survey items addressed knowledge, attitudes, and practices regarding spirometry and standardized clinical vignettes. Data were analyzed by using χ2 tests and multivariate logistic regression. RESULTS: Among the 360 respondents who provided care to children with asthma, 52% used spirometry in clinical practice, whereas 80% used peak flow meters and 10% used no lung function tests. Only 21% routinely used spirometry for all guideline-recommended clinical situations. More family physicians than pediatricians reported using spirometry (75% vs 35%; P<.0001), and family physicians were more comfortable in interpreting spirometric results (50% vs 25%; P<.0001). Only one-half of respondents interpreted correctly the spirometric results in a standardized clinical vignette, and the frequency of underrating asthma severity increased with the inclusion of spirometric results. The most common barriers to the use of spirometry, that is, time and training, were cited more often by physicians who did not use spirometry. Two-thirds of respondents agreed that they would want additional training regarding implementing spirometry in their clinical practices. CONCLUSIONS: The use of spirometry in primary care settings for children with asthma does not conform to national guidelines. Widespread implementation of national asthma guidelines likely would require a major educational initiative to address deficiencies in spirometry interpretation and other barriers.

Randomized dose-ranging controlled trial of AQ-13, a candidate antimalarial, and chloroquine in healthy volunteers.

OBJECTIVES: To determine: (1) the pharmacokinetics and safety of an investigational aminoquinoline active against multidrug-resistant malaria parasites (AQ-13), including its effects on the QT interval, and (2) whether it has pharmacokinetic and safety profiles similar to chloroquine (CQ) in humans. DESIGN: Phase I double-blind, randomized controlled trials to compare AQ-13 and CQ in healthy volunteers. Randomizations were performed at each step after completion of the previous dose. SETTING: Tulane-Louisiana State University-Charity Hospital General Clinical Research Center in New Orleans. PARTICIPANTS: 126 healthy adults 21-45 years of age. INTERVENTIONS: 10, 100, 300, 600, and 1,500 mg oral doses of CQ base in comparison with equivalent doses of AQ-13. OUTCOME MEASURES: Clinical and laboratory adverse events (AEs), pharmacokinetic parameters, and QT prolongation. RESULTS: No hematologic, hepatic, renal, or other organ toxicity was observed with AQ-13 or CQ at any dose tested. Headache, lightheadedness/dizziness, and gastrointestinal (GI) tract-related symptoms were the most common AEs. Although symptoms were more frequent with AQ-13, the numbers of volunteers who experienced symptoms with AQ-13 and CQ were similar (for AQ-13 and CQ, respectively: headache, 17/63 and 10/63, p = 0.2; lightheadedness/dizziness, 11/63 and 8/63, p = 0.6; GI symptoms, 14/63 and 13/63; p = 0.9). Both AQ-13 and CQ exhibited linear pharmacokinetics. However, AQ-13 was cleared more rapidly than CQ (respectively, median oral clearance 14.0-14.7 l/h versus 9.5-11.3 l/h; p < or = 0.03). QTc prolongation was greater with CQ than AQ-13 (CQ: mean increase of 28 ms; 95% confidence interval [CI], 18 to 38 ms, versus AQ-13: mean increase of 10 ms; 95% CI, 2 to 17 ms; p = 0.01). There were no arrhythmias or other cardiac AEs with either AQ-13 or CQ. CONCLUSIONS: These studies revealed minimal differences in toxicity between AQ-13 and CQ, and similar linear pharmacokinetics.