MinKyoung Song

''Real-life'' effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study *

OBJECTIVE To evaluate the 16- and 52-week effectiveness of add-on omalizumab treatment under real-life heterogeneity in patients, settings, and physicians in an open-label, multicenter, pharmaco-epidemiologic study of patients with severe persistent allergic asthma in Belgium. METHODS Effectiveness outcomes included improvement in 2005 global initiative for asthma (GINA) classification, physician-rated global evaluation of treatment effectiveness (GETE), quality of life (Juniper asthma-related quality of life (AQLQ) and European quality of life questionnaire 5 dimensions (EQ-5D)), and severe asthma exacerbations. Patients studied included both intent-to-treat and per-protocol populations. RESULTS The sample (n=158) had a mean age of 48.17+/-17.18 years, and a slight majority were female (53.8%). Despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists, all patients experienced frequent symptoms and had exacerbations in the past year. At 16 weeks, >82% had good/excellent GETE (P values <0.001), >82% had an improvement in total AQLQ scores of > or =0.5 points (P<0.001), and >91% were severe exacerbation-free (P<0.001). At 52 weeks, >72% had a good/excellent GETE rating (P<0.001), >84% had improvements in total AQLQ score of > or =0.5 points (P<0.001), >56% had minimally important improvements in EQ-5D utility scores (P=0.012), and >65% were severe exacerbation-free (P<0.001). Significant reductions in healthcare utilization compared to the one year prior to treatment were noted. CONCLUSION The PERSIST study shows better physician-rated effectiveness, greater improvements in quality of life, greater reductions in exacerbation rates, and greater reductions in healthcare utilization than previously reported in efficacy studies. Under real-life conditions, omalizumab is effective as add-on therapy in the treatment of patients with persistent severe allergic asthma.

Meeting the 2008 Physical Activity Guidelines for Americans Among U.S. Youth

BACKGROUND Participation in physical activity brings health benefits for adolescents. However, limited data are available on the percentage of U.S. adolescents who engage in levels of aerobic and muscle-strengthening activities recommended in the 2008 Physical Activity Guidelines for Americans (2008 Guidelines). PURPOSE To examine the prevalence at which U.S. adolescents aged 12-17 years meet the 2008 Guidelines, and whether demographic and BMI variables influence that prevalence. METHODS Using data from an interviewer-administered self-report questionnaire in the 1999-2006 National Health and Nutrition Examination Survey (analyzed in 2011), estimates were made of the percentage of adolescents who engaged in recommended levels of aerobic and muscle-strengthening activities (≥60 minutes of aerobic activity/day and participation in muscle-strengthening activities ≥3 days/week). RESULTS Among 6547 U.S. adolescents aged 12-17 years, 16.3% (95% CI=14.9%, 17.9%) met both aerobic and muscle-strengthening guidelines; 14.7% (13.3%, 16.2%) met the aerobic guideline only, 21.3% (19.4%, 23.3%) met the muscle-strengthening guideline only, and 47.8% (45.4%, 50.1%) met neither guideline. Adjusted for covariates, odds of meeting either the aerobic or muscle-strengthening guideline only or both guidelines versus meeting neither guideline were (p<0.05) higher among boys than girls. The odds of meeting the aerobic guideline only were higher among underweight/normal-weight adolescents than among obese adolescents. No clear pattern was observed by family groups according to poverty-to-income ratio. CONCLUSIONS Less than 20% of adolescents reported engaging in recommended levels of both aerobic and muscle-strengthening activities.

Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim

The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of Zarzio(®) in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates statistical methodologies from the social and behavioral sciences; assesses factors predictive of poor treatment response; and evaluates the congruence of treatment with EORTC guidelines and the approved label. This pan-European study will recruit at least 1000 patients from a minimum of 75 centers and follow them for maximum 6 cycles of chemotherapy. Apart from descriptive and associative procedures, statistical analysis will include variance attribution methods; hierarchical linear, logistic, and Poisson modeling; Kaplan-Meier time-to-event analysis, Mantel-Cox log-rank or generalized Wilcoxon-Breslow tests, and Cox proportional hazards modeling; and clustering and related data mining techniques.

The Relationship between Childhood Obesity, Low Socioeconomic Status, and Race/Ethnicity: Lessons from Massachusetts

BACKGROUND Previous studies have shown race/ethnicity, particularly African American and/or Hispanic status, to be a predictor of overweight/obese status in children. However, these studies have failed to adjust for low socioeconomic status (SES). This study assessed whether race/ethnicity remained an independent predictor of childhood obesity when accounting for variations in SES (low-income) among communities in Massachusetts. METHODS This study was based on 2009 summarized data from 68 Massachusetts school districts with 111,799 students in grades 1, 4, 7, and 10. We studied the relationship between the rate of overweight/obese students (mean = 0.32; range = 0.10-0.46), the rate of African American and Hispanic students (mean = 0.17; range = 0.00-0.90), and the rate of low-income students (mean = 0.27; range = 0.02-0.87) in two and three dimensions. The main effect of the race/ethnicity rate, the low-income rate, and their interaction on the overweight and obese rate was investigated by multiple regression modeling. RESULTS Low-income was highly associated with overweight/obese status (p < 0.0001), whereas the effect of race/ethnicity (p = 0.27) and its interaction (p = 0.23) with low-income were not statistically significant. For every 1% increase in low-income, there was a 1.17% increase in overweight/obese status. This pattern was observed across all African American and Hispanic rates in the communities studied. CONCLUSIONS Overweight/obese status was highly prevalent among Massachusetts students, varying from 10% to 46% across communities. Although there were higher rates of overweight/obese status among African American and Hispanic students, the relationship disappeared when controlling for family income. Our findings suggest low SES plays a more significant role in the nations childhood obesity epidemic than race/ethnicity.

Self-Care and Health Outcomes of Diabetes Mellitus:

Studies show that self-care improves diabetes mellitus (DM) outcomes; however, previous studies have focused on self-care maintenance, and little is known about self-care management. The objective of this study is to examine the influence of DM self-care maintenance and management on number of hospitalizations and hospitalization days. A cohort design with secondary analysis of data from the Health and Retirement Study 2002-2004 was used. Data from 726 adults with DM were analyzed with logistic regression and negative binomial regression adjusting for covariates. Self-care maintenance and management were significant determinants of hospitalization outcomes. Establishing a goal for HbA1c (self-care management) and eating ≥2 snacks or desserts per day (self-care maintenance) were associated with a decrease in hospitalizations (IRR = 0.860, p = .001; IRR = 0.914, p = .043, respectively). DM self-care maintenance and management influence health outcomes but in different ways. These data provide evidence that both elements are needed in the education of patients about DM.

Physical Activities of U.S. High School Students—2010 National Youth Physical Activity and Nutrition Survey

BACKGROUND The 2008 Physical Activity Guidelines recommend youth participate in a variety of physical activities; however, few nationally representative studies describe the types and variety of youth activity. This study assessed the most frequently reported types and variety of activities among U.S. high school students, and examined the association between variety and meeting the 2008 Guidelines for aerobic activity (aerobic guideline). METHODS We analyzed data on 8628 U.S. high school students in grades 9-12 from the 2010 National Youth Physical Activity and Nutrition Survey. Types of physical activity were assessed by identifying which activities each student reported in the past 7 days. Variety was assessed by the total number of different activities each student reported. Percentage (95% CI) of students who reported engaging in each activity was assessed. Logistic regression was used to examine the association between variety and meeting the aerobic guideline. RESULTS Walking was the most frequently reported activity among U.S. high school students. On average, students reported participating in 6 different activities. Variety was positively associated with meeting the aerobic guideline. CONCLUSIONS These findings support encouraging youth to participate in many physical activities and may be useful for developing interventions that focus on the most prevalent activities.

Enhanced Physical Activity Improves Selected Outcomes in Children With ADHD: Systematic Review

This review examines associations between physical activity (PA) and cognitive, behavioral, and physiological outcomes in children with attention-deficit/hyperactivity disorder (ADHD). We reviewed studies on participants ≤18 years old, published in English between January 1998 and December 2014, in PubMed, CINAHL, PsycINFO, and Cochrane Reviews. Twenty-six studies were grouped into two categories: those that did and did not account for effects of ADHD medications. The first category showed lower levels of PA and improved cognitive and behavioral outcomes in youth whose ADHD was treated with medications. The second category showed a positive association between PA levels and cognitive and behavioral outcomes in youth whose ADHD was not treated with medications. For both categories of studies, results were inconclusive regarding physiological outcomes. Randomized controlled trials are needed to better clarify the relationship between PA and outcomes in youth with ADHD, and particularly to understand the impact of ADHD medications on that relationship.

Improving women's cardiovascular health: a position statement from the International Council on Women's Health Issues.

Cardiovascular disease (CVD) is the number one killer of women worldwide, and it remains the primary cause of death and disability in both developed and developing countries. The International Council on Womens Health Issues is an international nonprofit association dedicated to the goals of promoting the health, health care, and the well-being of women. Based on the outcomes of a facilitated discussion at its 18th biannual meeting, delegates aim to raise awareness about the potent influence of gender-specific factors on the development, progression, and outcomes of CVD. Key recommendations for decreasing the burden of CVD are also discussed.

A review of diabetes mellitus-specific family assessment instruments.

Family dynamics and attributes are increasingly recognized as affecting management of diabetes mellitus (DM); however, little research has been done on the validity and usefulness of family assessment instruments (FAIs). This article reviewed the literature that employs DM-specific FAIs and evaluates whether the instruments comprehensively captured family attributes/processes and were robust enough to be useful in understanding the relationship between family attributes/issues and DM-related health care. Studies using eight instruments were identified through a search of literature published from 1982 to 2010 and were analyzed with criteria derived from the measurement and family literatures. The findings of this study revealed that DM-specific FAIs yield useful data about family-related phenomenon; however, some domains of DM-specific care, such as family dynamics/functioning, were not overtly measured. Suggestions for improving DM-specific FAIs are provided and a rationale for why DM-specific and non-DM-specific FAIs is needed to fully measure family issues related to family dynamics/attributes on DM patient care.

Relationships of Musculoskeletal Symptoms, Sociodemographics, and Body Mass Index With Leisure-Time Physical Activity Among Nurses

Nurses have a high prevalence of musculoskeletal symptoms from patient handling tasks such as lifting, transferring, and repositioning. Comorbidities such as musculoskeletal symptoms may negatively affect engagement in leisure-time physical activity (LTPA). However, limited data are available on the relationship between musculoskeletal symptoms and LTPA among nurses. The purpose of this study was to describe musculoskeletal symptoms and LTPA, and to examine the relationships of musculoskeletal symptoms, sociodemographics, and body mass index with LTPA among nurses. Cross-sectional data on sociodemographics, employment characteristics, musculoskeletal symptoms, body mass index, and LTPA were collected from a statewide random sample of 454 California nurses from January to July 2013. Descriptive statistics, bivariate and multiple logistic regressions were performed. We observed that non-White nurses were less likely to engage in regular aerobic physical activity than White nurses (odds ratio [OR] = 0.61; 95% confidence interval [CI] = [0.40, 0.94]). Currently working nurses were less likely to engage in regular aerobic physical activity than their counterparts (OR = 0.48; 95% CI = [0.25, 0.91]). Nurses with higher body mass index were less likely to perform regular aerobic physical activity (OR = 0.93; 95% CI = [0.89, 0.97]) or muscle-strengthening physical activity (OR = 0.92; 95% CI = [0.88, 0.96]). This study found no evidence that musculoskeletal symptoms may interfere with regular engagement in LTPA. Physical activity promotion interventions should address employment-related barriers, and particularly target racial minority nurses and those who have a high body mass index.