OBJECTIVE: To estimate the efficacy of a psycho-behavioral intervention in reducing intimate partner violence recurrence during pregnancy and postpartum and in improving birth outcomes in African-American women. METHODS: We conducted a randomized controlled trial for which 1,044 women were recruited. Women were randomly assigned to receive either intervention (n=521) or usual care (n=523). Individually tailored counseling sessions were adapted from evidence-based interventions for intimate partner violence and other risks. Logistic regression was used to model intimate partner violence victimization recurrence and to predict minor, severe, physical, and sexual intimate partner violence. RESULTS: Women randomly assigned to the intervention group were less likely to have recurrent episodes of intimate partner violence victimization (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.80). Women with minor intimate partner violence were significantly less likely to experience further episodes during pregnancy (OR 0.48, 95% CI 0.26-0.86, OR 0.53, 95% CI 0.28-0.99) and postpartum (OR 0.56, 95% CI 0.34-0.93). Numbers needed to treat were 17, 12, and 22, respectively, as compared with the usual care group. Women with severe intimate partner violence showed significantly reduced episodes postpartum (OR 0.39, 95% CI 0.18-0.82); the number needed to treat was 27. Women who experienced physical intimate partner violence showed significant reduction at the first follow-up (OR 0.49, 95% CI 0.27-0.91) and postpartum (OR 0.47, 95% CI 0.27-0.82); the numbers needed to treat were 18 and 20, respectively. Women in the intervention group had significantly fewer very preterm neonates (1.5% intervention group, 6.6% usual care group; P=.03) and an increased mean gestational age (38.2+/-3.3 intervention group, 36.9+/-5.9 usual care group; P=.016). CONCLUSION: A relatively brief intervention during pregnancy had discernible effects on intimate partner violence and pregnancy outcomes. Screening for intimate partner violence as well as other psychosocial and behavioral risks and incorporating similar interventions in prenatal care is strongly recommended. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00381823. LEVEL OF EVIDENCE: I.
 
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OBJECTIVE: To examine temporal changes in maternal weight and the association with major structural anomalies and other factors, such as diabetes, in our primary obstetric population. METHODS: We conducted a serial, cross-sectional study using a perinatal database to identify all women with singletons who delivered in our system from 1991 to 2004. Three 5-year time epochs were defined to compare patient cohorts. Maternal weight, body mass index (BMI), diabetes status, incidence of major anomalies, and demographic data were compared. Multiple logistic regression was performed to estimate factors contributing to anomaly rates. RESULTS: A total of 41,902 pregnancies were included. In each time epoch, there was an increase in the mean maternal weight, the mean BMI, the proportion of women weighing in excess of 200 lb, the proportion with a BMI higher than 29, the prevalence of pregestational diabetes, and the prevalence of major anomalies (all P<.001). There was no significant independent association between maternal obesity and the presence of a major anomaly. In a multivariable logistic model, the major factor contributing to the increasing rate of congenital anomalies was the prevalence of pregestational diabetes (odds ratio 3.8, 95% confidence interval 2.1-6.6). The population-attributable risk of anomalies related to obesity increased from essentially 0% in 1991-1994 to 6.1% in 2000-2004, whereas that related to diabetes increased from 3.3% to 9.2% during the same time periods. CONCLUSION: Although the prevalence of maternal obesity and anomaly have increased, maternal weight alone was not associated with an increase in congenital anomalies. Instead, diabetes was significantly associated with the increase in the rate of anomalies seen in our population. Identification of maternal weight as a risk factor in epidemiologic studies may be a surrogate for pregestational diabetes. LEVEL OF EVIDENCE: II.
 
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BACKGROUND: Increasing evidence has incriminated active smoking as a causal factor for tuberculosis (TB). However, the effect of secondhand tobacco smoke exposure on TB has not been similarly elucidated. METHODS: A cohort of 15 486 female never-smokers aged 65 to 74 years and living with their surviving husband were enrolled at 18 Elderly Health Centers in Hong Kong from 2000 to 2003 and followed up prospectively through linkage with the territory-wide TB notification registry and death registry for TB and death until December 31, 2008, using an identity card number as a unique identifier. The relationship between passive smoking and the development of TB was assessed with adjustment for other baseline characteristics. RESULTS: Passive exposure to secondhand tobacco smoke in the household was independently associated with obstructive lung disease (odds [OR], 1.43; 95% confidence interval [CI], 1.16-1.77) and diabetes mellitus (OR, 1.13; 95% CI, 1.02-1.26) at baseline and with the development of both active TB (hazard ratio [HR], 1.49; 95% CI, 1.01-2.19) and culture-confirmed TB (HR, 1.70; 95% CI, 1.04-2.80) on prospective follow-up after potentially confounding background variables were controlled for. Passive smoking accounted for 13.7% of active TB and for 18.5% of culture-positive TB in this cohort. CONCLUSIONS: Similar to active smoking, passive exposure to secondhand tobacco smoke in the household also predisposes to the development of TB. Increased emphasis should therefore be put on tobacco control in national TB programs.
 
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CONTEXT: Prevalence of obesity is increasing globally. The effect of obesity on mortality and morbidity and its implication on the future prevalence of disability in the older population has not been conclusively analyzed. OBJECTIVE: To determine the influence of overweight and obesity on mortality and disability by quantifying the effect in terms of disability-free life expectancy and years lost to disability (YLD) in the older people. DESIGN, SETTING AND PARTICIPANTS: For 5980 participants from the Rotterdam Study cohort, regression techniques were used to estimate the association of body mass index (BMI) and waist circumference (WC) separately with mortality, incident disability and recovery from disability. Disability was assessed using the Stanford Health Assessment Questionnaire Disability Index, an activity of daily living scale. Multistate life table methodology was used to calculate life expectancies. MAIN OUTCOME MEASURES: In total, 15-year mortality risk, 6-year disability incidence, total life expectancy, healthy life expectancy and years of disabled life expectancy. RESULTS: We observed 2388 deaths. Our analysis revealed no association between body mass index, or WC and mortality in the healthy population. Body mass index and WC were related to disability (`overweight` 25 < or =BMI <30, odd ratio (OR)=1.33, 95% confidence interval (CI) (1.10; 1.61), `obesity I` 30< or = BMI <35, OR=2.03, 95% CI (1.55; 2.65)) and negatively to recovery from disability. We observed an increase of years lost to disability with increasing weight for men (`normal weight`-4.69 years, `overweight`-5.87 years and `obesity I`-7.06 years) and for women (`normal weight`-10.95 years, `overweight`-12.82 years, `obesity I`-15.17 years and `obesity II/III`-13.13 years). CONCLUSION: Results do not support the hypothesis that an increased body weight reduces total life expectancy in the older people. Although increased body weight was associated with a higher risk of becoming and remaining disabled. These results remained using WC.
 
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OBJECTIVES: We assessed whether widowhood is associated with risk of diagnosis with a sexually transmitted infection (STI) among older adults in the United States and whether the associations observed in men differed before and after the introduction of sildenafil, the first oral erectile dysfunction medication approved by the Food and Drug Administration. METHODS: We used Cox proportional hazards regression to analyze the time to first STI diagnosis in a random sample of married, Medicare-eligible couples aged 67 to 99 years in 1993 (N = 420 790 couples). RESULTS: Twenty-one percent of male and 43% of female participants lost a spouse during the 9-year study period. Only 0.65% of men and 0.97% of women were diagnosed with an STI. Widowhood was associated with an increased risk of STI diagnosis for men only, with the largest effects found 0.5 to 1 year after a wife`s death. Effects for men were larger after the introduction of sildenafil. CONCLUSIONS: Widowhood in older men, but not women, increased the risk for STIs, especially in the postsildenafil era. Clinicians should address sexual health issues with older patients, especially bereaved men taking erectile dysfunction medications.
 
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OBJECTIVE: The goal was to investigate the effect of a ``cough trick`` technique on self-reported pain of children receiving routine immunizations. The strategy requires minimal equipment, time, or training for parents, children, and nursing staff members. METHODS: A randomized, controlled, unblinded, within-subject study of 68 children receiving prekindergarten (ages 4-5) or pre-junior high school (ages 11-13) immunizations was performed. Participants were recruited from an outpatient pediatric clinic at a large public hospital in the Midwest. The strategy required a single ``warm-up`` cough of moderate force, followed by a second cough that coincided with needle puncture. The principle outcome was self-reported pain, although parent and nurse report of pain was used to support the accuracy of self-report. Older participants and all nurses completed a measure of their satisfaction with the procedure. RESULTS: In the initial analysis, the procedure was found not to be effective. However, post hoc tests revealed that the procedure was effective at a statistically and clinically significant level for participants identified as Hispanic white or non-Hispanic white but not for those identified as non-Hispanic black. Participants and clinic nurses found the procedure acceptable and effective. CONCLUSIONS: The results of this study suggest that the cough trick can be an effective strategy for the reduction of pain for some children undergoing routine immunizations. However, additional research is needed to clarify the observed moderation by self-identified race.
 
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OBJECTIVE: To determine whether modifying eating behaviour with use of a feedback device facilitates weight loss in obese adolescents. DESIGN: Randomised controlled trial with 12 month intervention. SETTING: Hospital based obesity clinic. PARTICIPANTS: 106 newly referred obese young people aged 9-17. INTERVENTIONS: A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy. MAIN OUTCOME MEASURES: Change in body mass index (BMI) standard deviation score (SDS) over 12 months with assessment 18 months after the start of the intervention. Secondary outcomes were body fat SDS, metabolic status, quality of life evaluation, change in portion size, and eating speed. RESULTS: Using the last available data on all participants (n=106), those in the Mandometer group had significantly lower mean BMI SDS at 12 months compared with standard care (baseline adjusted mean difference 0.24, 95% confidence interval 0.11 to 0.36). Similar results were obtained when analyses included only the 91 who attended per protocol (baseline adjusted mean difference 0.27, 0.14 to 0.41; P<0.001), with the difference maintained at 18 months (0.27, 0.11 to 0.43; P=0.001) (n=87). The mean meal size in the Mandometer group fell by 45 g (7 to 84 g). Mean body fat SDS adjusted for baseline levels was significantly lower at 12 months (0.24, 0.10 to 0.39; P=0.001). Those in the Mandometer group also had greater improvement in concentration of high density lipoprotein cholesterol (P=0.043). CONCLUSIONS: Retraining eating behaviour with a feedback device is a useful adjunct to standard lifestyle modification in treating obesity among adolescents. TRIAL REGISTRATION: ClinicalTrials.gov NCT00407420.
 
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CONTEXT: Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use. OBJECTIVE: To assess the relative efficacies of 5 smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons. DESIGN: A randomized, double-blind, placebo-controlled clinical trial. SETTING: Two urban research sites. PATIENTS: One thousand five hundred four adults who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications. INTERVENTIONS: Participants were randomized to 1 of 6 treatment conditions: nicotine lozenge, nicotine patch, sustained-release bupropion, nicotine patch plus nicotine lozenge, bupropion plus nicotine lozenge, or placebo. In addition, all participants received 6 individual counseling sessions. MAIN OUTCOME MEASURES: Biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse. RESULTS: All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (odds ratios, 1.63-2.34). With such protection, only the nicotine patch plus nicotine lozenge (odds ratio, 2.34, P < .001) produced significantly higher abstinence rates at 6-month postquit than did placebo. CONCLUSION: While the nicotine lozenge, bupropion, and bupropion plus lozenge produced effects that were comparable with those reported in previous research, the nicotine patch plus lozenge produced the greatest benefit relative to placebo for smoking cessation.
 
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BACKGROUND: Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children. METHODS: We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine--the pooled vaccine group--or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale. RESULTS: A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group. CONCLUSIONS: Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.)
 
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Background: Tobacco dependence is a chronic, relapsing condition that may require extended treatment. Objective: To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers. Design: Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156) Setting: Academic center. Participants: 568 adult smokers. Intervention: In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks). Measurements: The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence. Results: At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment. Limitation: The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected. Conclusion: Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy. Primary Funding Source: National Institutes of Health.
 
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