Veronica L. Irvin

Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time.

Background We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time. Methods We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >

Sorting out the competing effects of acculturation, immigrant stress, and social support on depression: a report on Korean women in California.

500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality. Results 17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings. Conclusions The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.

Parent/Child Training to Increase Preteens' Calcium, Physical Activity, and Bone Density: A Controlled Trial

This research identifies stressors that correlate with depression, focusing on acculturation, among female Korean immigrants in California. Telephone interviews were conducted with female adults of Korean descent (N = 592) from a probability sample from 2006 to 2007. Sixty-five percent of attempted interviews were completed, of which over 90% were conducted in Korean. Analyses include descriptive reports, bivariate correlations, and structural equation modeling. Findings suggest that acculturation did not have a direct impact on depression and was not associated with social support. However, acculturation was associated with reduced immigrant stress which, in turn, was related to decreased levels of depression. Immigrant stress and social support were the principal direct influences on depression, mediating the effect for most other predictors. Stressful experiences associated with immigration may induce depressive feelings. Interventions should facilitate acculturation thereby reducing immigrant stress and expand peer networks to increase social support to assuage depression.

Rethinking Acculturation: A Study of Alcohol Use of Korean American Adolescents in Southern California.

Purpose. To test effects of parent/child training designed to increase calcium intake, bone-loading physical activity (PA), and bone density. Design. Two-group randomized controlled trial. Setting. Family-based intervention delivered at research center. Subjects. 117 healthy children aged 10–13 years (58.1% female, 42.7% Hispanic, 40.2% White). Ninety-seven percent of participants had at least one parent graduate from high school and 37.2 % had at least one parent graduate from a 4-year university. Intervention. Children and parents were randomly assigned to diet and exercise (experimental) or injury prevention (control) interventions. Children were taught in eight weekly classes how to engage in bone-loading PA and eat calcium-rich foods or avoid injuries. Parents were taught behavior management techniques to modify childrens behaviors. Measures. Measures at baseline and at 3, 9, and 12 months included 24-hour diet and PA recalls, and bone mineral density (BMD) by dual-energy x-ray absorptiometry. Analysis. Analysis of variance and generalized estimating equations (GEE) assessed group by time differences. Comparisons were conducted separately for boys and girls. Results. For boys, cross-sectional differences between experimental and control groups were achieved for 3- and 9-month calcium intake (1352 vs. 1052 mg/day, 1298 vs. 970 mg/day, p < .05). For girls, marginal cross-sectional differences were achieved for high-impact PA at 12 months (p < .10). For calcium intake, a significant group by time interaction was observed from pretest to posttest for the full sample (p = .008) and for girls (p = .006) but not for boys. No significant group by time differences in calcium were observed across the follow-up period. No group by time differences were observed for high-impact PA. Among boys, longitudinal group by time differences reached significance for total hip BMD (p = .045) and femoral neck BMD (p = .033), even after adjusting for skeletal growth. Similar differential increases were observed among boys for bone mineral content (BMC) at the hip (p = .068) and total body (p = .054) regions. No significant group by time interaction effects were observed for girls at any bone site for BMD. For BMC, control girls showed a significant increase (p = .03) in spine BMC compared to intervention girls. Conclusion. This study demonstrated that parent/preteen training can increase calcium intake and attenuate the decline in high-impact PA. Results suggest that more powerful interventions are needed to increase activity levels and maximize bone mineral accrual during preadolescent years.

Home Smoking Restrictions Among Koreans in Seoul

Given the considerable variability in drinking practices among Asian American groups, the generalizations that suggest an increase in their alcohol use associated with acculturation need to be questioned. Also, the experience of children of immigrants growing up in the United States may be much more complex than a focus on acculturation can capture. Informed by the theory of segmented assimilation, this study addresses two research questions: (1) Is acculturation associated with alcohol use of Korean American adolescents? and (2) What other social, economic, and cultural forces influence their alcohol use? Survey data were collected from 202 adolescents of Korean descent. Multivariate regression analyses revealed that acculturation was not a significant predictor of most measures of alcohol use, while peer influence, scholastic achievement/ aspirations, and current smoking were predictive. Gender and social class were unrelated to drinking. Findings suggest focusing research on an integrative approach to understanding drinking in complex social, economic, and social contexts may be useful.

Compliance with Smoke-Free Policies in Korean Bars and Restaurants in California: a Descriptive Analysis

The prevalence and correlates of home smoking bans in the Republic of Korea were examined using population-based data from telephone interviews with 500 Seoul adult residents in 2002. Most (97%) respondents indicated that they smoked, or that their spouse, other family member, or a regular friend smoked. Nearly all indicated that environmental tobacco smoke (ETS) is harmful. Only 19% of homes banned smoking, 65% allowed smoking anywhere, and 16% allowed smoking by special guests or in certain areas. The odds of having a full ban were significantly greater for men, married individuals, those less than 35 years or more than 50 years of age, non-smokers, individuals whose nonspouse family members did not smoke, and individuals with more sources of anti-ETS messages. Home smoking bans should be promoted by media campaigns and other tobacco control activities, because knowledge of the effects of ETS was already high.

Smoking Trajectories among Koreans in Seoul and California: Exemplifying a Common Error in Age Parameterization

BACKGROUND Compliance with Californias smoke-free restaurant and bar policies may be more a function of social contingencies and less a function of legal contingencies. The aims of this study were: 1) to report indications of compliance with smoke-free legislation in Korean bars and restaurants in California; 2) to examine the demographic, smoking status, and acculturation factors of who smoked indoors; and 3) to report social cues in opposition to smoking among a sample of Koreans in California. MATERIALS AND METHODS Data were collected by telephone surveys administered by bilingual interviewers between 2007-2009, and included California adults of Korean descent who visited a Korean bar or restaurant in a typical month (N=2,173, 55% female). RESULTS 1% of restaurant-going participants smoked inside while 7% observed someone else smoke inside a Korean restaurant. Some 23% of bar-going participants smoked inside and 65% observed someone else smoke inside a Korean bar. Presence of ashtrays was related to indoor smoking in bars and restaurants. Among participants who observed smoking, a higher percentage observed someone ask a smoker to stop (17.6%) or gesture to a smoker (27.0%) inside Korean restaurants (N=169) than inside Korean bars (n=141, 17.0% observed verbal cue and 22.7% observed gesture). Participants who smoked inside were significantly younger and more acculturated than participants who did not. Less acculturated participants were significantly more to likely to be told to stop smoking. CONCLUSIONS Ten years after implementation of ordinances, smoking appears to be common in Korean bars in California.

Health-related quality of life among adults with diverse rare disorders

Immigration to a nation with a stronger anti-smoking environment has been hypothesized to make smoking less common. However, little is known about how environments influence risk of smoking across the lifecourse. Research suggested a linear decline in smoking over the lifecourse but these associations, in fact, might not be linear. This study assessed the possible nonlinear associations between age and smoking and examined how these associations differed by environment through comparing Koreans in Seoul, South Korea and Korean Americans in California, United States. Data were drawn from population based telephone surveys of Korean adults in Seoul (N=500) and California (N=2,830) from 2001-2002. Locally weighted scatterplot smoothing (lowess) was used to approximate the association between age and smoking with multivariable spline logistic regressions, including adjustment for confounds used to draw population inferences. Smoking differed across the lifecourse between Korean and Korean American men. The association between age and smoking peaked around 35 years among Korean and Korean American men. From 18 to 35 the probability of smoking was 57% higher (95%CI, 40 to 71) among Korean men versus 8% (95%CI, 3 to 19) higher among Korean American men. A similar difference in age after 35, from 40 to 57 years of age, was associated with a 2% (95%CI, 0 to 10) and 20% (95%CI, 16 to 25) lower probability of smoking among Korean and Korean American men. A nonlinear pattern was also observed among Korean American women. Social role transitions provide plausible explanations for the decline in smoking after 35. Investigators should be mindful of nonlinearities in age when attempting to understand tobacco use.

Lifestyle Behaviors Predict Negative and Positive Changes in Self-reported Health: The Role of Immigration to the United States for Koreans

BackgroundTwenty-five to 30 million Americans live with a rare disease (RD) and share challenges unique to RD. The majority of research on RDs has focused on etiology, treatment and care, while the limited health-related quality of life (HRQL) research has been restricted to single RDs, small samples, or non-validated measures. This study reports HRQL among adults with diverse RDs, and compares their scores to those of the U.S. population and people with common chronic health conditions.MethodsWe conducted a cross-sectional survey of adults living in the U.S. diagnosed with any RD. Participants were recruited through RD organizations and completed the online survey between December 2016 and May 2017 (n = 1218). HRQL was assessed using the standardized Patient-Reported Outcomes Measurement Information System (PROMIS). RDs were classified into categories defined by Orphanet. Means and 95% confidence intervals were calculated for the main sample and for RD categories and were compared to published U.S. population norms and common chronic disease norms. Intercorrelations were conducted between HRQL, demographics, and RD experiences.ResultsWhen compared to the norms for the U.S. population and for those with common chronic diseases, mean HRQL scores were significantly poorer across all six PROMIS domains for the main sample, and were usually poorer when analyzed by sub-sets of specific RD classifications. People with rare systemic and rheumatologic, neurological, and immune diseases had the poorest HRQL. Participants had poorer HRQL if they had multiple RDs, lower income, were female, or older. Having symptoms longer was associated with worse HRQL, however, having a formal diagnosis longer was associated with better HRQL.ConclusionsThis study is the first to examine HRQL in a large, heterogeneous sample of RDs using validated measures. There is a significant disparity in HRQL among people with RD compared to the general population and people with common chronic diseases. Poor HRQL could be attributed to challenges accessing diagnoses, medical information, treatment, psychosocial support, and coping with stigma and uncertainty. As most individuals with RDs will not be cured in their lifetimes, identifying ways to improve HRQL is crucial to patient-centered care and should be a funding priority.

Secondhand smoke exposure among nonsmoking adults in Seoul, Korea.

Studies of changes in health following immigration are inconsistent, and few are based on longitudinal designs to test associations based on change. This study identified factors that predicted changes in self-reported health (SRH) among California residents of Korean descent. A sample of California residents of Korean descent were interviewed and followed-up 2 or 3 times by telephone during 2001-2009. The questionnaires dealt with SRH, lifestyle behaviors (smoking, physical activity, and fast food consumption), and socioeconomic measures. Statistical analysis included random-intercepts longitudinal regression models predicting change in SRH. A similar percentage of respondents reported improved and deteriorating SRH (30.3% and 29.1%, respectively). Smoking, consumption of fast foods, age, percentage of life spent in the United States, and being female were predictors of deteriorating SRH, whereas physical activity, education, and living with a partner were predictive of improvement in SRH. The effect of immigration on SRH is influenced by socioeconomic factors and lifestyle practices. Results support promotion of healthy lifestyle practices among immigrants.