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Background: Cardiovascular disease (CVD) remains a leading cause of death in people living with HIV. Myocardial fibrosis is well-described in HIV infection acquired in adulthood. We evaluate the burden of fibrosis by cardiac magnetic resonance in people with perinatal HIV infection. Methods: Individuals with perinatally acquired HIV (pnHIV) diagnosed before 10 years-old and on antiretroviral treatment for ≥ 6 months were matched with uninfected controls. Patients with significant cardiometabolic co-morbidities and pregnancy were excluded. Diffuse fibrosis was assessed by cardiac magnetic resonance (CMR) with native T1 mapping for calculation of extracellular volume fraction (ECV). Viability was assessed with late gadolinium enhancement. The normality of fibrosis was assessed using the Komogrov-Smirnov test. Fibrosis between the groups was analyzed using a Mann-Whitney U test, as the data was not normally distributed. Statistical significance was defined as a p-valve < 0.05. Results: Fourteen adults with pnHIV group and 26 controls (71% female and 86% Black race) were assessed. The average (± standard deviation) age in the study group was 29 (± 4.3) years-old. All pnHIV had been on ART for decades. Demographic data, CMR functional/volumetric data, and pre-contrast T1 mapping values were similar between groups. Diastolic function was normal in 50% of pnHIV patients and indeterminate in most of the remainder (42%). There was no statistically significant difference in ECV between groups; p = 0.24. Conclusion: Perinatally-acquired HIV was not associated with diffuse myocardial fibrosis. Larger prospective studies with serial examinations are needed to determine whether pnHIV patients develop abnormal structure or function more often than unaffected controls. [ABSTRACT FROM AUTHOR]

Pulmonary hypertension (PH) is a significant health problem that contributes to high morbidity and mortality in diverse cardiac, pulmonary, and systemic diseases in children. Evidence-based advances in PH care have been challenged by a paucity of quality endpoints for assessing clinical course and the lack of robust clinical trial data to guide pharmacologic therapies in children. While the landmark adult AMBITION trial demonstrated the benefit of up-front combination PH therapy with ambrisentan and tadalafil, it remains unknown whether upfront combination therapy leads to more rapid and sustained clinical benefits in children with various categories of PH. In this article, we describe the inception of the Kids Mod PAH Trial, a multicenter Phase III trial, to address whether upfront combination therapy (sildenafil and bosentan vs. sildenafil alone) improves PH outcomes in children, recognizing that marked differences between the etiology and therapeutic response between adults and children exist. The primary endpoint of this study is WHO functional class (FC) 12 months after initiation of study drug therapy. In addition to the primary outcome, secondary endpoints are being assessed, including a composite measure of time to clinical worsening, WHO FC at 24 months, echocardiographic assessment of PH and quantitative assessment of right ventricular function, 6-min walk distance, and NT-proBNP levels. Exploratory endpoints include selected biomarkers, actigraphy, and assessments of quality of life. This study is designed to pave the way for additional clinical trials by establishing a robust infrastructure through the development of a PPHNet Clinical Trials Network. [ABSTRACT FROM AUTHOR]

Correlated categorical data often arise from studies involving cluster randomized trials, a cluster sampling scheme, or repeated measurements. The intra-cluster correlation coefficient (ICC) is used to estimate the average correlation within clusters. There have been numerous methods proposed to estimate ICC for correlated binary data, the ANOVA method for continuous data, and several methods for time-to-event outcomes. However, no method currently exists to estimate ICC for nominal or ordinal categorical responses with more than two categories. We developed a method based on resampling principles to estimate the ICC and its 95% confidence interval for categorical variables. We conducted a simulation study to show how our method estimates the population ICC under varying event rates, numbers of clusters, and cluster sizes. We also used real study datasets to estimate the ICC for ordinal and nominal categorical variables. We observed that the resampling method estimates the population ICC well for moderate to large numbers of clusters and moderate to large cluster sizes. [ABSTRACT FROM AUTHOR]

Opioid prescribing for postoperative pain management is challenging because of inter‐patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6‐guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype‐guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient‐reported pain‐related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype‐guided opioid selection for improving postoperative pain control and reducing opioid‐related risks. [ABSTRACT FROM AUTHOR]

The parametric survival model with Weibull distribution can be used to model a wide range of practical lifetime data. While there have been several studies comparing the fit of various distributions to right-censored and interval censored data, there are no recommendations in the literature on optimal distributions to use for left-censored heavy-tailed data. Parametric Reverse Hazards (PRH) has gained considerable attention from time-to-event data researchers for its excellent properties and appropriateness to analyzing left-censored survival data. To analyze left-censored with heavy-tailed data, we derived the PRH model for a variety of distributions including the Exponential, Log-normal, Inverse Gaussian, Log-logistic, Gompertz–Makeham, Gamma, Generalized Gamma, Inverse Gamma, Generalized Inverse Gamma, Weibull, Inverse Weibull, Generalized Inverse Weibull, Modified Weibull, Flexible Weibull, Power Generalized Weibull, and Marshal–Olkin distributions. Extensive statistical simulations were used to assess the performance of the derived PRH models and compare these to establish a guideline for which distribution/s would "best" fit for left-censored heavy-tailed data. We then applied the best performing model to the South Carolina Enhanced HIV/AIDS Reporting Surveillance System data to explain the effects of different demographic, social, and treatment factors on patients' viral load transition from detectable-to-undetectable levels. [ABSTRACT FROM AUTHOR]

Right-skewed heavy-tailed survival data commonly arise in health-related studies, and the probability distributions proposed to model such survival data are not adequately described in the literature. Although a wide selection of survival distributions is available, applied researchers often face the challenge of choosing a right model for analyzing survival data with these special features in distributional shape. In this article, we evaluated some of the most popular parametric families of distributions as well as nonparametric approaches to model right-censored data using several goodness of fit measures. We carried out extensive simulation studies with different censoring rates to compare the performance of survival models using sixteen different parametric families and the Bernstein polynomials-based nonparametric model to analyze right-skewed heavy-tailed survival data. We also illustrated the use of both parametric and nonparametric approaches to model observed viral load (VL) data from HIV/AIDS patients where we defined the survival outcome as transitioning from an undetectable VL status to a detectable VL status over time. In addition, we used bootstrap samples drawn from the observed VL data and evaluated the estimation properties of all sixteen parametric distributions and the Bernstein polynomial-based method. Finally, results from simulation, observed VL data, and the bootstrap samples were compared using four different divergence-based information criteria. Overall, among the parametric families, the power generalized Weibull model was found to provide adequate fit under several scenarios (censoring rates, choice of information criterion, etc.). The other two families to be competitive with power generalized Weibull were the Burr XII and generalized Gamma distributions. [ABSTRACT FROM AUTHOR]

Aims: Patient-reported quality of life (QOL) is a highly prognostic and clinically relevant endpoint in patients with heart failure (HF) with preserved ejection fraction (HFpEF). The relationships between QOL and different markers of HF severity remain unclear, particularly as they relate to functional capacity and directly measured activity levels. We hypothesized that QOL would demonstrate a stronger relationship with measures of exercise capacity and adiposity compared to other disease measures.Methods and Results: This is a secondary analysis of the National Heart, Lung, and Blood Institute-sponsored RELAX, NEAT-HFpEF and INDIE-HFpEF trials to determine the relationships between QOL (assessed by the Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure Questionnaire) and different domains reflecting HF severity, including maximal aerobic capacity (peak oxygen consumption), submaximal exercise capacity (6-min walk distance), volume of daily activity (accelerometry), physician-estimated functional class, resting echocardiography, and plasma natriuretic peptide levels. A total of 408 unique patients with chronic HFpEF were split into tertiles of QOL scores defined as QOLworst, QOLintermediate , QOLbest . The QOLworst HFpEF group was youngest, with a higher body mass index, greater prevalence of class II obesity and diabetes, and the lowest N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. After adjustment for age, sex and body mass index, poorer QOL was associated with worse physical capacity and activity levels, assessed by peak oxygen consumption, 6-min walk distance and actigraphy, but was not associated with NT-proBNP or indices from resting echocardiography. QOL was similarly reduced in patients with and without prior HF hospitalization.Conclusions: Quality of life in HFpEF is poorest in patients who are young, obese and have diabetes, and is more robustly tied to measures reflecting functional capacity and daily activity levels rather than elevations in NT-proBNP or prior HF hospitalization. These findings have major implications for the understanding of QOL in HFpEF and for the design of future clinical trials targeting symptom improvement in HFpEF.Clinical Trial Registration: RELAX, NCT00763867; NEAT-HFpEF, NCT02053493; INDIE-HFpEF, NCT02742129. [ABSTRACT FROM AUTHOR]

Purpose: To determine whether a selected set of mRNA biomarkers expressed in individual cumulus granulosa cell (CC) masses show association with oocyte developmental competence, embryo ploidy status, and embryo outcomes. Methods: This prospective observational cohort pilot study assessed levels of mRNA biomarkers in 163 individual CC samples from 15 women stimulated in antagonist cycles. Nineteen mRNA biomarker levels were measured by real-time PCR and related to the development of their corresponding individually cultured oocytes and subsequent embryos, embryo ploidy status, and live birth outcomes. Results: PAPPA mRNA levels were significantly higher in CC from oocytes that led to euploid embryos resulting in live births and aneuploid embryos compared to immature oocytes by ANOVA. LHCGR mRNA levels were significantly higher in CC of oocytes resulting in embryos associated with live birth compared to immature oocytes and oocytes resulting in arrested embryos by ANOVA. Using a general linearized mixed model to assess ploidy status, CC HSD3B mRNA levels in oocytes producing euploid embryos were significantly lower than other oocyte outcomes, collectively. When transferred euploid embryos outcomes were analyzed by ANOVA, AREG mRNA levels were significantly lower and PAPPA mRNA levels significantly higher in CC from oocytes that produced live births compared to transferred embryos that did not form a pregnancy. Conclusions: Collectively, PAPPA, LHCGR, and AREG mRNA levels in CC may be able to identify oocytes with the best odds of resulting in a live birth, and HSD3B1 mRNA levels may be able to identify oocytes capable of producing euploid embryos. [ABSTRACT FROM AUTHOR]

Plasma HIV viral load (VL) is the clinical indicator used to evaluate disease burden for HIV-infected patients. We developed a covariate-adjusted, three-state, homogenous continuous time Markov chain model for HIV/AIDS disease burden among subgroups. We defined Detectable and Undetectable HIV VL levels as two transient states and Death as the third absorbing state. We implemented the exact maximum likelihood method to estimate the parameters with related asymptotic distribution to conduct hypothesis testing. We evaluated the proposed model using HIV-infected individuals from South Carolina (SC) HIV surveillance data. Using the developed model, we estimated and compared the transition hazards, transition probabilities, and the state-specific duration for HIV-infected individuals. We examined gender, race/ethnicity, age, CD4 count, place of residence, and antiretroviral treatment regimen prescribed at the beginning of the study period. We found that patients with a higher CD4 count, increased age, heterosexual orientation, white, and single tablet regimen users were associated with reduced risk of transitioning to a Detectable VL from an Undetectable VL, whereas shorter time since diagnosis, being male, and injection drug use increased the risk of the same transition. [ABSTRACT FROM AUTHOR]

Meaningful improvement in patient safety encompasses a vast number of quality metrics, but a single measure to represent the overall level of safety is challenging to produce. Recently, Perla et al. established the Whole-Person Measure of Safety (WPMoS) to reflect the concept of global risk assessment at the patient level. We evaluated the WPMoS across an entire state to understand the impact of urban/rural setting, academic status, and hospital size on patient safety outcomes. The population included all South Carolina (SC) inpatient discharges from January 1, 2008, through to December 31, 2013, and was evaluated using established definitions of highly undesirable events (HUEs). Over the study period, the proportion of hospital discharges with at least one HUE significantly decreased from 9.7% to 8.8%, including significant reductions in nine of the 14 HUEs. Academic, large, and urban hospitals had a significantly lower proportion of hospital discharges with at least one HUE in 2008, but only urban hospitals remained significantly lower by 2013. Results indicate that there has been a decrease in harm events captured through administrative coded data over this 6-year period. A composite measure, such as the WPMoS, is necessary for hospitals to evaluate their progress toward reducing preventable harm. [ABSTRACT FROM AUTHOR]

We propose a three-parameter distribution referred to as the reflected- shifted-truncated gamma (RSTG) distribution to model negatively skewed data. Various properties of the proposed distribution are derived. The estimation of the model parameters is approached by maximum likelihood methods and the observed information matrix is derived. Monte Carlo simulations are performed to compare the performances of the proposed methods of estimation for both small and large samples. Using information theoretic criteria, we compare the RSTG distribution to the exponential, generalized F, generalized gamma, Gompertz, log-logistic, lognormal, Rayleigh, and Weibull distributions in three negatively skewed real datasets. [ABSTRACT FROM AUTHOR]

Background: Screening older veterans in Veterans Affairs Medical Center (VAMC) primary care clinics for risky drinking facilitates early identification and referral to treatment.Objective: This study compared two behavioral health models, integrated care (a standardized brief alcohol intervention co-located in primary care clinics) and enhanced referral care (referral to specialty mental health or substance abuse clinics), for reducing risky drinking among older male VAMC primary care patients. VAMC variation was also examined.Method: A secondary analysis of longitudinal data from the Primary Care Research in Substance Abuse and Mental Health for Elderly (PRISM-E) study, a multisite randomized controlled trial, was conducted with a sample of older male veterans (n = 438) who screened positive for risky drinking and were randomly assigned to integrated or enhanced referral care at five VAMCs.Results: Generalized estimating equations revealed no differences in either behavioral health model for reducing risky drinking at a 6-month follow-up (AOR: 1.46; 95% CI: 0.42-5.07). Older veterans seen at a VAMC providing geriatric primary care and geriatric evaluation and management teams had lower odds of risky drinking (AOR: 0.24; 95% CI: 0.07-0.81) than those seen at a VAMC without geriatric primary care services.Conclusions: Both integrated and enhanced referral care reduced risky drinking among older male veterans. However, VAMCs providing integrated behavioral health and geriatric specialty care may be more effective in reducing risky drinking than those without these services. Integrating behavioral health into geriatric primary care may be an effective public health approach for reducing risky drinking among older veterans. [ABSTRACT FROM AUTHOR]

Objective: To evaluate differences in hospital readmission risk across all payers in South Carolina (SC).Data Sources/study Setting: South Carolina Revenue and Fiscal Affairs Office (SCRFA) statewide all payer claims database including 2,476,431 hospitalizations in SC acute care hospitals between 2008 and 2014.Study Design: We compared the odds of unplanned all-cause 30-day readmission for private insurance, Medicare, Medicaid, uninsured, and other payers and examined interaction effects between payer and index admission characteristics using generalized estimating equations.Data Collection: SCRFA receives claims and administrative health care data from all SC health care facilities in accordance with SC state law.Principal Findings: Odds of readmission were lower for females compared to males in private, Medicare, and Medicaid payers. African Americans had higher odds of readmission compared to whites across private insurance, Medicare, and Medicaid, but they had lower odds among the uninsured. Longer length of stay had the strongest association with readmission for private and other payers, whereas an increased number of comorbidities related to the highest readmission odds within Medicaid.Conclusions: Associations between index admission characteristics and readmission likelihood varied significantly with payer. Findings should guide the development of payer-specific quality improvement programs. [ABSTRACT FROM AUTHOR]

Community viral load is an aggregate measure of HIV viral load in a particular geographic location, community, or subgroup. Community viral load provides a measure of disease burden in a community and community transmission risk. This study aims to examine community viral load trend in South Carolina and identify differences in community viral load trends between selected population subgroups using a state-wide surveillance dataset that maintains electronic records of all HIV viral load measurements reported to the state health department. Community viral load trends were examined using random mixed effects models, adjusting for age, race, gender, residence, CD4 counts, HIV risk group, and initial antiretroviral regimen during the study period, and time. The community viral load gradually decreased from 2004 to 2013 ( p < 0.0001). The number of new infections also decreased ( p = 0.0001) over time. A faster rate of decrease was seen among men compared to women ( p < 0.0001), men who have sex with men ( p = 0.0001) compared to heterosexuals, patients diagnosed in urban areas compared to that in rural areas ( p = 0.0004), and patients prescribed single-tablet regimen compared to multiple-tablet regimen ( p < 0.0001). While the state-wide community viral load decreased over time, the decline was not uniform among residence at diagnosis, HIV risk group, and single-tablet regimen versus multiple-tablet regimen subgroups. Slower declines in community viral load among females, those in rural areas, and heterosexuals suggest possible disparities in care that require further exploration. The association between using single-tablet regimen and faster community viral load decline is noteworthy. [ABSTRACT FROM AUTHOR]

Background: Syphilis is prevalent among men who have sex with men (MSM) in China. Syphilis partner notification (PN) programs targeting MSM has been considered as one of effective strategies to prevention and control of the infection in the population. We examined willingness and preferences for PN among MSM to measure feasibility and optimize uptake. Methods: Participation in a syphilis PN program was measured using a factorial survey from both the perspective of the index patient and the partner. Respondents were recruited from April-July 2011 using convenience sampling at two sites—a MSM sexually transmitted disease (STD) clinic and a MSM community based organization (CBO). Respondents first evaluated three factorial survey vignettes to measure probability of participation and then an anonymous sociodemographic questionnaire. A two-level mixed linear model was fitted for the factorial survey analysis. Results: In 372 respondents with mean age (± SD) 28.5 (± 6.0) years, most were single (82.0%) and closeted gays (66.7%). The Internet was the most frequent place to search for sex. Few (31.2%) had legal names for casual partners, but most had instant messenger (86.5%) and mobile phone numbers (77.7%). The mean probability of participation in a syphilis PN program was 64.5% (± 32.4%) for index patients and 63.7% (± 32.6%) for partners. Referral of the partner to a private clinic or MSM CBO for follow-up decreased participation compared to the local Center for Disease Control and Prevention (CDC) or public STD clinic. Conclusions: Enhanced PN services may be feasible among MSM in South China. Internet and mobile phone PN may contact partners untraceable by traditional PN. Referral of partners to the local CDC or public STD clinic may maximize PN participation. [ABSTRACT FROM AUTHOR]

Various methods have been proposed to estimate intra-cluster correlation coefficients (ICCs) for correlated binary data, and many are very sensitive to the type of design and underlying distributional assumptions. We proposed a new method to estimate ICC and its 95% confidence intervals based on resampling principles and U-statistics, where we resampled with replacement pairs of individuals from within and between clusters. We concluded from our simulation study that the resampling-based estimates approximate the population ICC more precisely than the analysis of variance and method of moments techniques for different event rates, varying number of clusters, and cluster sizes. [ABSTRACT FROM PUBLISHER]

Background: Intellectual disability (ID), autism, and epilepsy share frequent yet variable comorbidities with one another. In order to better understand potential genetic divergence underlying this variable risk, we studied genes responsible for monogenic IDs, grouped according to their autism and epilepsy comorbidities. Methods: Utilizing 465 different forms of ID with known molecular origins, we accessed available genetic databases in conjunction with gene ontology (GO) to determine whether the genetics underlying ID diverge according to its comorbidities with autism and epilepsy and if genes highly penetrant for autism or epilepsy share distinctive features that set them apart from genes that confer comparatively variable or no apparent risk. Results: The genetics of ID with autism are relatively enriched in terms associated with nervous system-specific processes and structural morphogenesis. In contrast, we find that ID with highly comorbid epilepsy (HCE) is modestly associated with lipid metabolic processes while ID without autism or epilepsy comorbidity (ID only) is enriched at the Golgi membrane. Highly comorbid autism (HCA) genes, on the other hand, are strongly enriched within the nucleus, are typically involved in regulation of gene expression, and, along with IDs with more variable autism, share strong ties with a core protein-protein interaction (PPI) network integral to basic patterning of the CNS. Conclusions: According to GO terminology, autism-related gene products are integral to neural development. While it is difficult to draw firm conclusions regarding IDs unassociated with autism, it is clear that the majority of HCA genes are tightly linked with general dysregulation of gene expression, suggesting that disturbances to the chronology of neural maturation and patterning may be key in conferring susceptibility to autism spectrum conditions. [ABSTRACT FROM AUTHOR]

To reduce the many adverse health outcomes associated with intimate partner violence (IPV), high-risk groups need to be specifically targeted in the fight against domestic violence in India. This study aims to examine the prevalence and correlates of IPV in HIV-positive and HIV-negative women from India. A convenience sample of HIV-positive and HIV-negative women responded to questionnaires to assess their experience and perception of violence. Multivariate logistic regression analysis was used to model the association between IPV and age, education, employment status, contraception use, age at first marriage, and HIV status. Although adjusting for age, education, employment status, contraception use, age at first marriage, and HIV status, women who are employed were 3.5 times more likely to suffer IPV (confidence interval [CI] = [1.5, 8.5]), women aged 18 or above at first marriage are 0.3 times less likely to face IPV (CI = [0.1, 0.6]), and women who use contraception are 7 times more likely to suffer IPV (CI = [1.4, 30.2]). Also, HIV-positive women are 3 times more likely to face sexual violence compared with HIV-negative women (CI = [1.1, 7.6]). [ABSTRACT FROM AUTHOR]

On a population level, trends in viral load (VL) and CD4 cell counts can provide a marker of infectivity and an indirect measure of retention in care. Thus, observing the trend of CD4/VL over time can provide useful information on disparities in populations across the HIV care continuum when stratified by demography. South Carolina (SC) maintains electronic records of all CD4 cell counts and HIV VL measurements reported to the state health department. We examined temporal trends in individual HIV VLs reported in SC between January 1, 2005 and December 31, 2012 by using mixed effects models adjusting for gender, race/ethnicity, age, baseline CD4 count, HIV risk category, and residence. Overall VL levels gradually decreased over the observation period. There were significant differences in the VL decline by gender, age groups, rural/urban residence, and HIV risk exposure group. There were significant differences in CD4 increases by race/ethnicity, age groups, and HIV risk exposure group. However, the population VL declines were slower among individuals aged 13-19 years compared to older age groups ( p<0.0001), among men compared to women ( p=0.002), and among people living with HIV/AIDS (PLWHA) with CD4 count ≤200 cell/mm3 compared to those with higher CD4 counts ( p<0.0001). Significant disparities were observed in VL decline by gender, age, and CD4 counts among PLWHA in SC. Population based data such as these can help streamline and better target local resources to facilitate retention in care and adherence to medications among PLWHA. [ABSTRACT FROM AUTHOR]

Purpose To gain a better understanding of the HIV epidemic in rural South Carolina (SC) by contrasting 3 definitions of rural and urban areas. Methods The sample included newly diagnosed HIV cases aged ≥18 years in SC between January 1, 2005, and December 31, 2011. Each individual was assigned a rural or urban status as defined by the Office of Management and Budget (OMB), Census Bureau (CB), and Rural Urban Commuting Area (RUCA) classifications. Descriptive statistics were conducted to compare sociodemographic characteristics, CD4 counts, viral loads, and time to AIDS diagnosis between rural and urban populations. Kappa statistics measured the agreement between the 3 definitions of rurality. Findings Depending on the definition used, the proportion of newly diagnosed HIV cases in rural areas varied from 23.3% to 32.0%. Based on the OMB and RUCA definitions, rural residents with HIV were more likely to be older, women, black, and non-Hispanic, report heterosexual contact, and have an AIDS diagnosis within 1 year of their HIV diagnosis. The OMB and RUCA definitions had a nearly perfect agreement (kappa = 0.8614; 95% CI = 0.8457, 0.8772), while poor agreements were noted between the OMB and CB or the RUCA and CB definitions. Conclusion When examining the rural HIV epidemic, how 'rural' is defined matters. Using 3 definitions of rurality, statistically significant differences were found in demographic characteristics, timing of HIV diagnosis and the proportion of rural residents diagnosed with HIV in SC. The findings suggest possible misclassification biases that may adversely influence services and resource distribution. [ABSTRACT FROM AUTHOR]

Cells of Azotobacter chroococcum MAL-201 (MTCC 3853) are capable of accumulating the intracellular poly(3-hydroxybutyric acid) [P(3HB)], accounting for 65-71 % of its cell dry weight and also capable of synthesizing the enzyme alkaline phosphatase (APase), when grown in glucose and tricalcium phosphate containing nitrogen-free modified Stockdale medium. The concentration of insoluble phosphate in broth medium was optimized as 0.25 % (w/v) for growth and biosynthesis of APase. However, the suboptimal concentration of phosphate (0.1 %, w/v) appeared as the best suited for accumulation of P(3HB) by the strain. The significant differences were observed in biosynthesis of polymer and APase enzyme under variable phosphate concentrations. Glucose, 3.0 % (w/v) was recorded as the optimum concentration for all of the three parameters. The continuation of APase biosynthesis was observed during the period of significant decline in the cellular content of the polymer in the late phase of growth. In order to study the role of P(3HB), the rate of autodigestion of biopolymer and phosphate solubilization rate ( k, mineralization constant) were determined in carbon-free medium under batch cultivation process and the parameters were found to be positively correlated. The maximum phosphate solubilization rate ( k = 0.0154) by the strain MAL-201 timed at the 10th hour of incubation when the rate of polymer degradation concomitantly attained its peak corresponding to 87 mg/l/h and then declined gradually. Only a negligible amount of residual polymer remained undigested. These data strongly support the functional role of P(3HB) in response to multinutritional stress condition. [ABSTRACT FROM AUTHOR]

Background: The positive effects of early developmental intervention (EDI) on early child development have been reported in numerous controlled trials in a variety of countries. An important aspect to determining the efficacy of EDI is the degree to which dosage is linked to outcomes. However, few studies of EDI have conducted such analyses. This observational cohort study examined the association between treatment dose and children’s development when EDI was implemented in three low and low-middle income countries as well as demographic and child health factors associated with treatment dose. Methods: Infants (78 males, 67 females) born in rural communities in India, Pakistan, and Zambia received a parent-implemented EDI delivered through biweekly home visits by trainers during the first 36 months of life. Outcome was measured at age 36 months with the Mental (MDI) and Psychomotor (PDI) Development Indices of the Bayley Scales of Infant Development-II. Treatment dose was measured by number of home visits completed and parent-reported implementation of assigned developmental stimulation activities between visits. Sociodemographic, prenatal, perinatal, and child health variables were measures as correlates. Results: Average home visits dose exceeded 91% and mothers engaged the children in activities on average 62.5% of days. Higher home visits dose was significantly associated with higher MDI (mean for dose quintiles 1–2 combined = 97.8, quintiles 3–5 combined = 103.4, p = 0.0017). Higher treatment dose was also generally associated with greater mean PDI, but the relationships were non-linear. Location, sociodemographic, and child health variables were associated with treatment dose. Conclusions: Receiving a higher dose of EDI during the first 36 months of life is generally associated with better developmental outcomes. The higher benefit appears when receiving ≥91% of biweekly home visits and program activities on ≥67% of days over 3 years. It is important to ensure that EDI is implemented with a sufficiently high dose to achieve desired effect. To this end groups at risk for receiving lower dose can be identified and may require special attention to ensure adequate effect. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer, a rare outcome of high-risk human papillomavirus (HPV) infection, disproportionately affects African American women, who are about twice more likely than European American women to die of the disease. Most cervical HPV infections clear in about one year. However, in some women HPV persists, posing a greater risk for cervical dysplasia and cancer. The Carolina Women's Care Study (CWCS) was conducted to explore the biological, genetic, and lifestyle determinants of persistent HPV infection in college-aged European American and African American women. This paper presents the initial results of the CWCS, based upon data obtained at enrollment. Methods: Freshman female students attending the University of South Carolina were enrolled in the CWCS and followed until graduation with biannual visits, including two Papanicolaou tests, cervical mucus collection, and a questionnaire assessing lifestyle factors. We recruited 467 women, 293 of whom completed four or more visits for a total of 2274 visits. Results and conclusion: CWCS participants were 70% European American, 24% African American, 3% Latina/Hispanic, and 3% Asian. At enrollment, 32% tested positive for any HPV. HPV16 infection was the most common (18% of infections). Together, HPV16, 66, 51, 52, and 18 accounted for 58% of all HPV infections. Sixty-four percent of all HPV-positive samples contained more than one HPV type, with an average of 2.2 HPV types per HPV-positive participant. We found differences between African American and European American women in the prevalence of HPV infection (38.1% African American, 30.7% European American) and abnormal Papanicolaou test results (9.8% African-American, 5.8% European American). While these differences did not reach statistical significance at enrollment, as the longitudinal data of this cohort are analyzed, the sample size will allow us to confirm these results and compare the natural history of HPV infection in college-aged African American and European American women. [ABSTRACT FROM AUTHOR]

To develop effective public-health intervention strategies for preventing person-to-person disease transmission, it is extremely essential to know the underlying biological processes and the probability of transmission. However, it is unethical to design studies to estimate the probability of person-to-person disease transmission because such studies would involve infecting an uninfected person with a disease. Statistical modeling is a very important technique used to estimate disease transmission probabilities among individuals. By using data from different independent studies, researchers may be able to obtain enough information about an infected person's infectiousness and the susceptibility of an uninfected person to estimate disease transmission probabilities. In this paper, we developed a statistical modeling technique to estimate probabilities of person-to-person disease transmission from an infected to an uninfected person. We used this new modeling technique to estimate the probability of male-to-female, penile - vaginal human immunodeficiency virus (HIV) transmission in one sexual contact. We developed two different sets of male-to-female HIV transmission probability estimates for different infectiousness and susceptibility values using two models. This newly developed modeling technique can be used to estimate person-to-person transmission probabilities for different diseases and routes of transmission. [ABSTRACT FROM AUTHOR]

Background: Oral clefts are one of the most common birth defects with significant medical, psychosocial, and economic ramifications. Oral clefts have a complex etiology with genetic and environmental risk factors. There are suggestive results for decreased risks of cleft occurrence and recurrence with folic acid supplements taken at preconception and during pregnancy with a stronger evidence for higher than lower doses in preventing recurrence. Yet previous studies have suffered from considerable design limitations particularly non-randomization into treatment. There is also well-documented effectiveness for folic acid in preventing neural tube defect occurrence at 0.4 mg and recurrence with 4 mg. Given the substantial burden of clefting on the individual and the family and the supportive data for the effectiveness of folic acid supplementation as well as its low cost, a randomized clinical trial of the effectiveness of high versus low dose folic acid for prevention of cleft recurrence is warranted. Methods/design: This study will assess the effect of 4 mg and 0.4 mg doses of folic acid, taken on a daily basis during preconception and up to 3 months of pregnancy by women who are at risk of having a child with non syndromic cleft lip with/without palate (NSCL/P), on the recurrence of NSCL/P. The total sample will include about 6,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg and the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects, as well as the two study groups (4mg, 0.4 mg) to that of a historical control group. The study has been approved by IRBs (ethics committees) of all involved sites. Results will be disseminated through publications and presentations at scientific meetings. Discussion: The costs related to oral clefts are high, including long term psychological and socio-economic effects. This study provides an opportunity for huge savings in not only money but the overall quality of life. This may help establish more specific clinical guidelines for oral cleft prevention so that the intervention can be better tailored for at-risk women [ABSTRACT FROM AUTHOR]

Objectives. To examine factors associated with smoke exposure among pregnant women in rural India. Methods. We conducted a survey of exposure to second-hand smoke (SHS) and solid fuel smoke (SFS) among 736 pregnant women. Odds ratios (OR) and 95%% confidence intervals (CI) were computed using logistic regression models to assess the relationship between demographic variables and exposure to SHS and to SFS. Results. While few respondents smoked cigarettes, 19.9%% of women and 27.8%% of children were frequently or always exposed to SHS, and 43.5%% were at high and 46.7%% at medium risk for SFE. Low educational levels and illiteracy were associated with exposure. Conclusions. Smoke exposure is a serious health risk for many poor women and children in India. [ABSTRACT FROM AUTHOR]

Background: This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design: This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include socialemotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion: The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential to inform about strategies for reducing neurodevelopmental disabilities in at-risk young children in low and middle income countries. [ABSTRACT FROM AUTHOR]

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Objective. To investigate the side effects of 600 μg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH). Methods. One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe. Results. Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns. Conclusions. Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks. [ABSTRACT FROM AUTHOR]

Objective. The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss ≥ 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. Methods. We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n = 808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs); (2) the study duration, representing exposure of the ANM to ongoing training and monitoring; and (3) duration of the second stage of labor as a measure of improved delivery practices. Results. As the study duration increased, the duration of the second stage of labor decreased (-0.12, p = 0.001) and as the duration of the second stage of labor decreased, the rate of PPH decreased (0.0282; 95% CI 0.0201-0.0363). For each 10-minute increase in the duration of second stage labor increased PPH odds by 7.1% and each 30-day duration of the trial decreased PPH odds by 3.4%. Additionally, a patient delivered by an original ANM was 3.14 times more likely to have a PPH compared to a patient delivered by a replacement ANM. Conclusions. Declining PPH rates were associated with improved skills and delivery practices that decreased duration of the second stage of labor. These improvements appeared to be consistent with the introduction of the more skilled replacement ANMs as well as ongoing training and monitoring for all ANMs over the duration of the trial. [ABSTRACT FROM AUTHOR]

Correlated data arise in a longitudinal studies from epidemiological and clinical research. Random effects models are commonly used to model correlated data. Mostly in the longitudinal data setting we assume that the random effects and within subject errors are normally distributed. However, the normality assumption may not always give robust results, particularly if the data exhibit skewness. In this paper, we develop a Bayesian approach to bivariate mixed model and relax the normality assumption by using a multivariate skew-normal distribution. Specifically, we compare various potential models and illustrate the procedure using a real data set from HIV study. Copyright © 2006 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Discusses a study which investigated the incidence of gonorrhea and chlamydia from 1985 through 1996 among soldiers at Fort Bragg, North Carolina. Methods; Incidence of gonorrhea in male soldiers; Incidence rate of chlamydia in women soldiers.

Objectives. This study evaluated the iron sufficiency of the Russian diet. Methods. Data were obtained from 24-hour dietary recalls conducted in 4 rounds (1992 through 1994) of a nationally representative longitudinal survey of 10548 women and children. Iron bioavailability was estimated via algorithms adjusting for enhancers (heme, vitamin C) and inhibitors (tannins in tea, phytates in grains) consumed at the same meal. Results. Dietary iron intakes were deficient in the most vulnerable groups: young children and women of reproductive age. Poverty status was strongly associated with deficiency. After adjustment for enhancers and inhibitors, estimated bio-available iron intakes at 3% to 4% of total iron were inadequate in all women and children. Conclusions. These dietary data suggest that Russian women and children are al high risk of iron deficiency. Grain products rich in phytates, which inhibit absorption, were the major food source of iron in Russia. High intakes of tea and low consumption of vitamin C also inhibited iron bioavailability. Since changes in eating behavior could potentially double iron bioavailability, educational programs should be explored as a strategy for improving iron nutriture. [ABSTRACT FROM AUTHOR]

Presents information on a study whose objectives were to describe the dietary information, analytical steps and computer algorithms needed for iron bioavailability adjustments. Demonstration of effects of various dietary factors on calculated iron absorption; Basis for study; Methodology of study; Findings obtained; What future research on dietary iron adequacy should be based on.

Objectives: Warrior Transition Units (WTUs) are specialized military units co‐located with major military treatment facilities providing a Triad of Care involving primary care physicians, case managers, and military leadership to soldiers needing comprehensive medical care. We describe the rationale and methods for studying behavioral health care in WTUs and characterize soldiers assigned to WTUs. Methods: The Army Warrior Care Project (AWCP) analyzes U.S. Department of Defense Military Health System data to examine behavioral health problems and service utilization among Army soldiers who were assigned to WTUs after returning from Afghanistan and Iraq deployments, FY2008–2015. Results: WTU members (N = 31,094) comprised 3.5% of the AWCP cohort (N = 883,091). Almost all (96.5%) had one WTU assignment for a median of 327 days; 77.3% were assigned before deployment ended, ≤30 or >365 days post‐deployment; 59.4% had deployment‐related behavioral health diagnoses. Conclusions: An overwhelming majority of soldiers had one WTU assignment for almost a year. A substantial proportion of WTU soldiers had psychological impairment, which limited performance of their military duties. The AWCP is the first longitudinal study of redeployed soldiers assigned to WTUs and provides a unique opportunity to advance our understanding of behavioral health among soldiers needing comprehensive medical care after combat deployments. [ABSTRACT FROM AUTHOR]