Evaluating efficacy of a novel dentifrice in reducing probing depths in Stage I and II periodontitis maintenance patients: A randomized, double-blind, positive controlled clinical trial.

BACKGROUND: Compliance to periodontal maintenance therapy (PMT) is essential for long-term periodontal health. Between PMT visits, patients must maintain good oral hygiene. A dentifrice with demonstrable clinical benefits for use between PMT visits would be highly desirable. The aim of this clinical study was to investigate the effect of a novel dental gel on probing depths (PD) and inflammation when used as a home care dentifrice in Stage I and II periodontitis patients. METHODS: This double-blind clinical study randomized 65 subjects with Stage I and II periodontitis to the novel dental gel containing 2.6% EDTA, and a commercially available anti-gingivitis dentifrice with 0.454% stannous fluoride. Primary endpoint was PD at 6 months for those sites with baseline PD ≥ 4 mm and secondary endpoints included whole mouth mean scores of modified gingival index (MGI), modified sulcus bleeding index (mSBI) and plaque index (PI). No SRP was performed at baseline. RESULTS: Subjects using the novel dentifrice showed significant PD reductions of 1.18 mm (from 4.27 mm at baseline to 3.09 mm at 6 months) compared to 0.93 mm (from 4.23 mm at baseline to 3.30 mm at 6 months) shown for those using the positive control dentifrice. Difference between treatments at 6 months was 0.21 mm with P-value = 0.0126. Significant improvements in MGI (P = 0.0000), mSBI (P = 0.0000), and PI (P = 0.0102) were also observed in 6 months. CONCLUSION: The novel dentifrice showed significant reductions in PD and gingival inflammation over 6 months solely as a home care dentifrice without baseline SRP in Stage I and II periodontitis maintenance patients.

Seven Essential Elements for Creating Effective Children's Media to Promote Peacebuilding: Lessons from International Coproductions of Sesame Street and Other Children's Media Programs.

Children's media have the capacity to prepare young learners to develop the knowledge, attitudes, and skills they need to contribute to a more peaceful world. Research suggests international coproductions of Sesame Street and other children's media efforts are linked to positive impact on how viewers perceive themselves and their own cultures, as well as how they perceive others. Creating such media, however, relies on a commitment to a complex development process where the educational needs of children are considered alongside intra- and intergroup dynamics and political realities. This paper presents a practitioners' perspective on the essential components of children's media programs for peacebuilding and, in so doing, recommends a way forward for producing children's media in this domain.

Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial.

INTRODUCTION: Pateclizumab (MLTA3698A) is a humanized mAb against lymphotoxin α (LTα), a transiently expressed cytokine on activated B and T cells (Th1, Th17), which are implicated in rheumatoid arthritis (RA) pathogenesis. This study was conducted to assess the safety, tolerability, < NOTE: For clarity and per AMA/S-W Style, please restore the use of Oxford/serial commas (ie: David likes vanilla, strawberry, and chocolate ice cream) throughout. and biologic activity of single and multiple doses of intravenous (IV) or subcutaneous (SC) pateclizumab in RA patients. METHODS: The single ascending dose (SAD) phase in patients with stable RA consisted of six cohorts (4:1 active:placebo at 0.3 mg/kg IV, 1.0 mg/kg IV, 1.0 mg/kg SC, 3.0 mg/kg IV, 3.0 mg/kg SC, and 5.0 mg/kg IV; n = 5/cohort). In the multiple ascending dose (MAD) phase, patients with prespecified RA disease activity received three doses of pateclizumab or placebo (4:1) every 2 weeks (1.0 mg/kg SC, n = 10; 3.0 mg/kg SC, n = 20; or 5.0 mg/kg IV, n = 5). Safety and tolerability were assessed throughout, and clinical activity was determined after three doses (Week 6). RESULTS: We observed no serious adverse events (AEs) or dose-limiting toxicities, and the majority of AEs were mild to moderate. The pharmacokinetic profiles were linear, and clearance was independent of dose. Reductions in levels of serum CXCL13 were observed, supporting the biologic activity of pateclizumab on the LTα pathway. Patients receiving pateclizumab in the 3.0 mg/kg MAD group (3.0 mg/kg SC) demonstrated ACR20, ACR50, and ACR70 response rates at week 6 of 75%, 56% and 25%, respectively, compared with 57%, 29%, and 0% in the placebo group. The median Disease Activity Score in 28 joints, C-reactive protein, reduction was 28% for pateclizumab, versus 8.4% for placebo. CONCLUSIONS: Pateclizumabwas generally well-tolerated in RA patients. Preliminary evidence of clinical activity was observed in active RA patients at the dose level targeted for clinical effect.

Racial disparities in asthma-related health outcomes in severe or difficult-to-treat asthma.

BACKGROUND: The underlying reasons for racial disparities in asthma morbidity are not well understood. Multivariate epidemiologic studies evaluating the presence and extent of racial differences in a large cohort of adults with severe or difficult-to-treat asthma are lacking. OBJECTIVE: To analyze an extensive array of clinical and patient-reported outcomes, using multivariate analysis with a sequential approach, to explain racial differences in asthma-related outcomes in one of the largest cohorts of difficult-to-treat asthmatic patients. METHODS: Black and white patients (> or = 18-years-old at baseline) were included (n = 2,128). Differences between the 2 racial groups were assessed using several outcome measures at month 12. Assessments were adjusted for confounding variables using a sequence of statistical models. RESULTS: Most patients were white (88.6%). Blacks were slightly younger, less educated, and more likely to live in urban areas than whites. Blacks were more likely to have severe asthma and to be treated with 3 or more long-term controllers. Poorer quality of life, more asthma control problems, and higher risk of emergency department visits were observed in blacks compared with whites; differences were not explained by adjustment for broad sets of confounding variables. Differences in asthma-related health outcomes remained statistically significant after adjusting for asthma severity. CONCLUSIONS: Asthma is a serious health problem in blacks and is not explained by differences in demographics, severity, or other health conditions.

Subspecialty differences in asthma characteristics and management.

OBJECTIVE: To determine the nature and extent to which asthma characteristics and management differ between allergy and pulmonary subspecialists. PATIENTS AND METHODS: We used baseline data from 3342 adults enrolled in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study, a multicenter, observational cohort recruited from subspecialty practices across the United States. Information on physician subspecialty, asthma history, allergic status, lung function, medication use, and recent health care use was collected from January 1, 2001, through April 30, 2004, via study coordinator-administered interviews and self-administered validated questionnaires. RESULTS: In the TENOR study, 2407 patients (72%) were treated by allergists and 935 (28%) by pulmonologists. Patients treated by pulmonologists were more likely to be black, be less educated, and have lower incomes than those treated by allergists. Pulmonary patients had more severe asthma as indicated by physician assessment, Global Initiative for Asthma classification, lung function, and number of asthma control problems. Regular use of a short-acting beta-agonist and systemic corticosteroid use were also higher among pulmonologist-treated patients than allergist-treated patients, consistent with greater asthma severity. Although evidence of allergic disease was prevalent in both types of patients, those treated by an allergist were more likely to receive skin testing or immunotherapy. In multivariate analyses adjusted for demographic differences, patients treated by pulmonologists were more likely to report health care use for asthma in the past 3 months. CONCLUSION: In general, asthma patients treated by pulmonologists have lower socioeconomic status, have more severe disease, require more medication, and report greater health care use than those treated by allergists.

Insurance status and asthma-related health care utilization in patients with severe asthma.

BACKGROUND: Medicaid insurance has been associated with worse asthma outcomes, but the degree to which demographic factors contribute to this relationship has not been well explored. OBJECTIVE: To evaluate whether insurance status is independently associated with health care utilization (HCU) and asthma control when demographic differences are taken into account. METHODS: We used baseline data from adults with severe asthma in the Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study. HCU was defined as hospitalization or emergency department visit for asthma in the past 3 months. Asthma control was evaluated using the Asthma Therapy Assessment Questionnaire. Multiple logistic regression was used to compare HCU and asthma control in patients with Medicaid vs those with private health insurance. RESULTS: Of 1315 patients analyzed, 130 (9.9%) had Medicaid insurance and 1,185 (90.1%) had private insurance. Medicaid insurance was associated with younger age, female sex, race other than white, obesity, active smoking, lower education level, and unemployment. In unadjusted analyses, Medicaid patients had significantly higher HCU (odds ratio [OR], 3.08; 95% confidence interval [CI], 2.11-4.50) and poorer asthma control (OR, 2.56; 95% CI, 1.84-3.57) compared with patients with private insurance. After adjusting for demographic differences, insurance status was no longer associated with HCU (OR, 1.43; 95% CI, 0.92-2.23), and the strength of its association with asthma control was reduced (OR, 1.67; 95% CI, 1.17-2.40). CONCLUSIONS: Medicaid insurance is not associated with increased HCU in patients with severe asthma once demographic factors have been taken into account but remains modestly associated with poorer asthma control.

Assessing productivity loss and activity impairment in severe or difficult-to-treat asthma.

OBJECTIVES: Asthma can be associated with substantial productivity loss and activity impairment, particularly among those with the most severe disease. We sought to assess the performance characteristics of an asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) in patients with either severe or difficult-to-treat asthma. METHODS: We analyzed 2529 subjects from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. The WPAI:Asthma was administered at baseline and at 12 months. Asthma control and quality-of-life were simultaneously assessed using the Asthma Therapy Assessment Questionnaire and Mini-Asthma Quality-of-Life Questionnaire, respectively. RESULTS: Severe versus mild-to-moderate asthma was associated with a greater percentage of impairment at work (28% vs. 14%), at school (32% vs. 18%), and in daily activities (41% vs. 21%). At baseline, greater asthma control problems correlated with higher levels of impairment as measured by the WPAI (work: r = 0.54, school: r = 0.37, activity: r = 0.55). Over the 12-month follow-up period, improved quality-of-life correlated with decreased levels of impairment (work: r = -0.42, school: r = -0.36, activity: r = -0.48). In multivariate analyses, greater than 10% overall work impairment at baseline predicted emergency visits (OR 2.6 [1.6, 4.0]) and hospitalization (OR 4.9 [1.8, 13.1]) at 12 months. CONCLUSIONS: The WPAI:Asthma correlates with other self-reported asthma outcomes in the expected manner and predicts health-care utilization at 12 months when administered to patients with severe or difficult-to-treat asthma.

Risk factors associated with persistent airflow limitation in severe or difficult-to-treat asthma: insights from the TENOR study.

BACKGROUND: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study is among the largest to assess persistent airflow limitation and the first to evaluate a wide range of potential risk factors in high-risk patients with severe or difficult-to-treat asthma. A better understanding is needed regarding factors associated with persistent airway obstruction; this study was performed to determine demographic and clinical characteristics associated with persistent airflow limitation. METHODS: Data from adult patients (>or= 18 years old) with severe or difficult-to-treat asthma were evaluated. Patients with COPD, obesity with a restrictive respiratory pattern, or a >or= 30 pack-year history of smoking were excluded. Patients with persistent airflow limitation (postbronchodilator FEV1/FVC ratio

Asthma control, severity, and quality of life: quantifying the effect of uncontrolled disease.

BACKGROUND: Current practice guidelines emphasize the importance of attaining asthma control. We sought to quantify the degree of quality-of-life impairment associated with different levels of asthma control. METHODS: We analyzed prospective data for 987 adults in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. Asthma control was assessed by using the Asthma Therapy Assessment Questionnaire, a validated index of control problems ranging from 0 to 4. Disease-specific quality of life and preference-based health utilities were assessed after 12 months of follow-up by using the Mini-Asthma Quality of Life Questionnaire (AQLQ) and EuroQoL 5-D (EQ-5D). We used multiple linear regression to model the relationship between asthma control and the AQLQ and EQ-5D while controlling for severity classification and lung function. RESULTS: Asthma control varied widely, even within a population with predominantly moderate-to-severe disease. An inverse relationship was observed between the number of asthma control problems and quality of life. Specifically, poorer control at baseline predicted worse AQLQ and EQ-5D scores at follow-up. Asthma control remained an independent predictor of disease-specific quality of life and general health in multivariate models and was a better longitudinal predictor of health status than asthma severity at baseline. CONCLUSION: Poor asthma control is associated with a substantial degree of impairment and predicts quality of life at 12 months, even after taking baseline asthma severity into account. CLINICAL IMPLICATIONS: Self-assessed measures of asthma control might help to identify and manage those patients at greatest risk for future health impairment.

Digital childhood: electronic media and technology use among infants, toddlers, and preschoolers.

OBJECTIVES: The objectives of this study were to describe media access and use among US children aged 0 to 6, to assess how many young children fall within the American Academy of Pediatrics media-use guidelines, to identify demographic and family factors predicting American Academy of Pediatrics media-use guideline adherence, and to assess the relation of guideline adherence to reading and playing outdoors. METHODS: Data from a representative sample of parents of children aged 0 to 6 (N = 1051) in 2005 were used. Descriptive analyses, logistic regression, and multivariate analyses of covariance were used as appropriate. RESULTS: On a typical day, 75% of children watched television and 32% watched videos/DVDs, for approximately 1 hour and 20 minutes, on average. New media are also making inroads with young children: 27% of 5- to 6-year-olds used a computer (for 50 minutes on average) on a typical day. Many young children (one fifth of 0- to 2-year-olds and more than one third of 3- to 6-year-olds) also have a television in their bedroom. The most common reason given was that it frees up other televisions in the house so that other family members can watch their own shows (54%). The majority of children aged 3 to 6 fell within the American Academy of Pediatrics guidelines, but 70% of 0- to 2-year-olds did not. CONCLUSIONS: This study is the first to provide comprehensive information regarding the extent of media use among young children in the United States. These children are growing up in a media-saturated environment with almost universal access to television, and a striking number have a television in their bedroom. Media and technology are here to stay and are virtually guaranteed to play an ever-increasing role in daily life, even among the very young. Additional research on their developmental impact is crucial to public health.

Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma.

BACKGROUND: Young patients with severe or difficult-to-treat asthma are an understudied population. OBJECTIVE: To assess age-associated and gender-associated differences in children and adolescents in the observational study, The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens. METHODS: Cross-sectional baseline data for patients greater than or equal to 6 years and less than or equal to 17 years (n = 1261) were stratified by age group (6-8, 9-11, 12-14, and 15-17 years). The chi(2) test for categorical variables and analysis of variance for continuous variables were used to identify differences among age groups, stratified by gender. RESULTS: Most patients had moderate (55%) or severe (41%) asthma by physician assessment. Of those using greater than or equal to 3 long-term controllers (62%), 53% of children (6-11 years) and 44% of adolescents (12-17 years) reported an oral corticosteroid burst and 25% and 19%, respectively, had an emergency department visit in the previous 3 months; 10% and 15%, respectively, reported past intubation. In females, weight for age ranged between the 67th and 70th percentiles; height for age was between the 42nd and 54th percentiles (P < .01 among age groups). Lung function was lower in adolescents than children: prebronchodilator percent predicted forced expiratory volume in 1 second (FEV(1))/forced vital capacity was 0.92 (6-8 years) and 0.83 (15-17 years), P less than .05, in males; and 0.94 (6-8 years) and 0.87 (15-17 years), P less than .05, in females. CONCLUSIONS: Children and adolescents demonstrated high rates of health care use and loss of lung function, despite using multiple long-term controllers. CLINICAL IMPLICATIONS: Asthma treatments that prevent loss of lung function and reduce health care resource use are needed in young patients with severe or difficult-to-treat asthma.

Recent asthma exacerbations: a key predictor of future exacerbations.

OBJECTIVE: The objective of this analysis was to investigate whether patients with severe or difficult-to-treat asthma who experienced recent severe asthma exacerbations are at increased risk of future asthma exacerbations. METHODS: We conducted a 1.5-year prospective analysis of 2780 patients 12 > or =years of age from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study. Severe exacerbations were defined as either an asthma-related emergency department visit or night of hospitalization in the 3 months prior to study visit; a secondary analysis assessed prior steroid bursts as an independent predictor and outcome. Potential confounding was assessed by statistical adjustment for demographic and clinical factors, as well as asthma severity and asthma control. RESULTS: Compared with patients without a recent severe exacerbation, patients with a recent exacerbation were at increased risk of future exacerbation (odds ratio=6.33; 95% CI 4.57, 8.76), even after adjustment for demographics and clinical factors (odds ratio=3.77; 95% CI 2.62, 5.43), asthma severity (physician-assessed: odds ratio=5.62; 95% CI 4.03, 7.83), National Asthma Education and Prevention Program (odds ratio=5.07; 95% CI 3.62, 7.11), Global Initiative for Asthma (odds ratio=5.32; 95% CI 3.80, 7.47), and asthma control (odds ratio=3.90; 95% CI 2.77, 5.50). CONCLUSION: This analysis suggests that recent severe asthma exacerbations are a strong independent factor predicting future exacerbations and, as such, should be considered as part of the clinical assessment of patients with severe or difficult-to-treat asthma.

Gender differences in IgE-mediated allergic asthma in the epidemiology and natural history of asthma: Outcomes and Treatment Regimens (TENOR) study.

BACKGROUND: The TENOR study consists of a large cohort of subjects with severe or difficult-to-treat asthma. The objective of this analysis was to evaluate demographic and clinical characteristics of subjects 12 years of age or older with immunoglobulin E (IgE)-mediated allergic asthma (skin test positive with an IgE level = 30 to =700 IU/mL), and specifically, to assess gender differences in this cohort. METHODS: A total of 4,756 subjects were enrolled by 283 US study sites between January and October 2001. Of those subjects 12 years or older at baseline with an IgE measure and who were skin tested (n = 2,843), 1,783 (63%) were skin test positive and had an IgE level between = 30 to = 700 IU/mL. RESULTS: Compared to males, females reported significantly greater healthcare utilization (steroid bursts in previous 3 months: 50% vs 42%, p < 0.001; unscheduled office visits in previous 3 months: 50% vs 36%, p < 0.0001; missed 1+ days of work/school in previous 2 weeks: 14% vs 10%, p < 0.01). Females also reported significantly more asthma control problems and lower asthma-related quality of life (4.6 +/- 1.3 vs 5.2 +/- 1.2; p < 0.0001); the difference was clinically meaningful. Asthma triggers and allergic comorbidities, such as allergic rhinitis and atopic dermatitis, were more common in female subjects. Despite their overall worse health outcomes, female subjects demonstrated better lung function, had similar treatment patterns, and showed no differences in physician-assessed asthma severity when compared with males. CONCLUSIONS: The reasons for these gender differences in subjects with IgE-mediated allergic asthma are complex, but results from this analysis suggest that detailed evaluations of asthma patients, including symptom-related questions and asthma-related healthcare utilization, are needed to accurately assess asthma severity and control.

Asthma in older adults: observations from the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) study.

BACKGROUND: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) was a 3-year, multicenter, observational study of 4,756 patients 6 years or older with severe or difficult-to-treat asthma by physician evaluation. More than 280 pulmonologist and allergist sites across the United States participated. OBJECTIVE: To compare health care utilization (HCU), medication use, asthma control, and quality of life (QoL) in older (> or =65 years; n = 566) and younger (18-64 years; n = 2,912) adult patients in TENOR. METHODS: Patients had to be under a physician's care for at least 1 year and have high medication use or HCU in the past year. Heavy smokers (> or =30 pack-years) and patients with cystic fibrosis were excluded. RESULTS: Although older patients in TENOR had worse lung function as measured by decreased percent predicted forced expiratory volume in 1 second (FEV1) (P < .001), they had significantly lower HCU compared with younger patients. They also had higher use of inhaled corticosteroids and better QoL than younger patients. Older patients reported fewer problems controlling their asthma (P < .001) but reported worse communication with their physicians (P = .02). CONCLUSIONS: Older patients in TENOR appeared to do better than younger patients, despite having worse lung function. Older patients in TENOR may have received more aggressive care than older asthmatic patients in other studies, based on a higher use of inhaled and oral corticosteroids. Whether differences in treatment or disease influenced other physiologic or inflammatory outcomes that contribute to the disconnect between HCU and FEV1 awaits further study.

Time well spent? Relating television use to children's free-time activities.

OBJECTIVES: This study assessed the claim that children's television use interferes with time spent in more developmentally appropriate activities. METHODS: Data came from the first wave of the Child Development Supplement, a nationally representative sample of children aged 0 to 12 in 1997 (N = 1712). Twenty-four-hour time-use diaries from 1 randomly chosen weekday and 1 randomly chosen weekend day were used to assess children's time spent watching television, time spent with parents, time spent with siblings, time spent reading (or being read to), time spent doing homework, time spent in creative play, and time spent in active play. Ordinary least squares multiple regression was used to assess the relationship between children's television use and time spent pursuing other activities. RESULTS: Results indicated that time spent watching television both with and without parents or siblings was negatively related to time spent with parents or siblings, respectively, in other activities. Television viewing also was negatively related to time spent doing homework for 7- to 12-year-olds and negatively related to creative play, especially among very young children (younger than 5 years). There was no relationship between time spent watching television and time spent reading (or being read to) or to time spent in active play. CONCLUSIONS: The results of this study are among the first to provide empirical support for the assumptions made by the American Academy of Pediatrics in their screen time recommendations. Time spent viewing television both with and without parents and siblings present was strongly negatively related to time spent interacting with parents or siblings. Television viewing was associated with decreased homework time and decreased time in creative play. Conversely, there was no support for the widespread belief that television interferes with time spent reading or in active play.