Scholars@Duke
Hrishikesh Chakraborty

Hrishikesh Chakraborty

Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
hrishikesh.chakraborty@duke.edu
3850, Office Room# 4114, Durham, NC 27715
300 W. Morgan Street, Room # 487, Durham, NC 27701

Selected Publications

Higher versus Lower Phosphate Targets for Patients Undergoing In-Center Hemodialysis: A Randomized Controlled Trial.

Journal Article J Am Soc Nephrol · July 10, 2025 KEY POINTS: The HiLo pragmatic, multicenter randomized trial compared a higher versus lower serum phosphate target in patients undergoing maintenance hemodialysis. The HiLo trial was terminated early due to insufficient enrollment and inadequate phosphate ... Full text Link to item Cite

Electronic Clinical Decision Support Tools to Manage Patients with Lower Respiratory Tract Infection: Clinicians' Perspectives in Sri Lanka.

Journal Article Am J Trop Med Hyg · May 7, 2025 In low-resource settings, providers often manage lower respiratory tract infections (LRTIs) without diagnostic tests, which may cause antibacterial overuse. Electronic clinical decision support tools (eCDSTs) can support evidence-based decision-making and ... Full text Link to item Cite

Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.

Journal Article Contemp Clin Trials · May 2025 The distinguishing characteristics of pragmatic clinical trials merits special attention when developing a monitoring plan. Pragmatic clinical trials are large in scope; participants are often identified from records or routinely collected data; investigat ... Full text Link to item Cite

The Dietary Biomarkers Development Consortium: An Initiative for Discovery and Validation of Dietary Biomarkers for Precision Nutrition.

Journal Article Curr Dev Nutr · May 2025 UNLABELLED: Diet is a complex exposure that affects health across the lifespan. Objective biomarkers that can reliably reflect intake of nutrients, foods, and dietary patterns with sufficient accuracy are an important tool for assessing associations of die ... Full text Link to item Cite

Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial.

Journal Article BMJ Open · March 26, 2025 INTRODUCTION: Low back pain (LBP) is a key source of medical costs and disability, impacting over 31 million Americans at any given time and resulting in US$100-US$200 billion per year in total healthcare costs. LBP is one of the leading causes of ambulato ... Full text Link to item Cite

R package to estimate intracluster correlation coefficient for nominal and ordinal data

Journal Article Computer Methods and Programs in Biomedicine Update · January 1, 2025 Background and Objective: : The intracluster correlation coefficient (ICC) is a critical parameter to assess the degree of similarity or correlation between observations within the same cluster or group. It is commonly applied in cluster-randomized trials ... Full text Cite

Electronic Clinical Decision Support Tools: Strategies to Improve the Management of Lower Respiratory Tract Infections in Low-Resource Settings.

Journal Article Am J Trop Med Hyg · December 4, 2024 Lower respiratory tract infection (LRTI) is a common reason for hospitalization and antibacterial use globally. There is considerable overlap in the clinical presentation of bacterial and viral LRTIs. Low- or middle-income countries (LMICs) face the dual c ... Full text Link to item Cite

Design and Rationale of the Phase 2 Baricitinib Study in Apolipoprotein L1-Mediated Kidney Disease (JUSTICE).

Journal Article Kidney Int Rep · September 2024 INTRODUCTION: Individuals of recent West African ancestry develop focal segmental glomerulosclerosis (FSGS) and hypertension-attributed end-stage kidney disease (HTN-ESKD) at 4 times the rate of White Americans. Two protein-coding variants of the Apolipopr ... Full text Link to item Cite

Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigators.

Journal Article Clin Transl Sci · August 2024 Chronic pain is a prevalent condition with enormous economic burden. Opioids such as tramadol, codeine, and hydrocodone are commonly used to treat chronic pain; these drugs are activated to more potent opioid receptor agonists by the hepatic CYP2D6 enzyme. ... Full text Link to item Cite

Modeling Negatively Skewed Survival Data in Accelerated Failure Time and Correlated Frailty Models

Journal Article Journal of the Indian Society for Probability and Statistics · June 1, 2024 Negatively skewed survival data arise in public health and in statistical research. Commonly used distributions are not always well suited to this data. The reflected-shifted-truncated gamma (RSTG) distribution is effective in modeling negatively skewed su ... Full text Cite

Survival Function Estimation for Multiple Sequential Time-to-Events

Journal Article Journal of the Indian Society for Probability and Statistics · June 1, 2024 Data on multiple time-to-events occurring in a natural sequence are observed in many prospective clinical studies. The estimation of survival functions for such time-to-events gained the attention of many researchers, and the related literature has recorde ... Full text Cite

Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression.

Journal Article Clin Transl Sci · June 2024 Specific selective serotonin reuptake inhibitors (SSRIs) metabolism is strongly influenced by two pharmacogenes, CYP2D6 and CYP2C19. However, the effectiveness of prospectively using pharmacogenetic variants to select or dose SSRIs for depression is uncert ... Full text Link to item Cite

Diffuse myocardial fibrosis is uncommon in people with perinatally acquired human immunodeficiency virus infection.

Journal Article AIDS Res Ther · March 4, 2024 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 wi ... Full text Link to item Cite

Kids Mod PAH trial: A multicenter trial comparing mono- versus duo-therapy for initial treatment of pediatric pulmonary hypertension.

Journal Article Pulm Circ · October 2023 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 e ... Full text Link to item Cite

Diffuse Myocardial Fibrosis is Uncommon in People with Perinatally Acquired Human Immunodeficiency Virus Infection.

Journal Article Res Sq · September 26, 2023 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 wi ... Full text Link to item Cite

Impact of Policy Change on Access to Medication for Opioid Use Disorder in Primary Care.

Journal Article South Med J · April 2023 OBJECTIVES: The opioid overdose epidemic is escalating. Increasing access to medications for opioid use disorder in primary care is crucial. The impact of the US Department of Health and Human Services' policy change removing the buprenorphine waiver train ... Full text Link to item Cite

A method to estimate intra-cluster correlation for clustered categorical data

Journal Article Communications in Statistics Theory and Methods · January 1, 2023 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. Ther ... Full text Open Access Cite

Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators.

Journal Article Clin Transl Sci · October 2022 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 formati ... Full text Link to item Cite

Modeling Right-skewed Heavy-tail Right-censored Survival Data with Application to HIV Viral Load

Journal Article Bulletin of the Malaysian Mathematical Sciences Society · September 1, 2022 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 ... Full text Cite

Parametric Regression Model Based on Reversed Hazard Rate: An Application to left censored heavy tailed HIV Viral Load Data

Journal Article Bulletin of the Malaysian Mathematical Sciences Society · September 1, 2022 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 n ... Full text Cite

Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension.

Journal Article Contemp Clin Trials · August 2022 RATIONALE AND OBJECTIVE: APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) ... Full text Link to item Cite

Renal Failure After Primary Organ Transplantation

Conference AMERICAN JOURNAL OF TRANSPLANTATION · 2022 Cite

Establishing the value of genomics in medicine: the IGNITE Pragmatic Trials Network.

Journal Article Genet Med · July 2021 PURPOSE: A critical gap in the adoption of genomic medicine into medical practice is the need for the rigorous evaluation of the utility of genomic medicine interventions. METHODS: The Implementing Genomics in Practice Pragmatic Trials Network (IGNITE PTN) ... Full text Open Access Link to item Cite

Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.

Journal Article Am J Kidney Dis · June 2021 RATIONALE & OBJECTIVE: Hyperphosphatemia is a risk factor for poor clinical outcomes in patients with kidney failure receiving maintenance dialysis. Opinion-based clinical practice guidelines recommend the use of phosphate binders and dietary phosphate res ... Full text Link to item Cite

Male Circumcision Reduces Penile HPV Incidence and Persistence: A Randomized Controlled Trial in Kenya.

Journal Article Cancer Epidemiol Biomarkers Prev · June 2021 BACKGROUND: Male circumcision reduces the risk of human immunodeficiency virus infection in men. We assessed the effect of male circumcision on the incidence and natural history of human papillomavirus (HPV) in a randomized clinical trial in Kisumu, Kenya. ... Full text Link to item Cite

Preexposure Prophylaxis Outcomes in an Urban Community in North Carolina: Discontinuation of Care and Sexually Transmitted Infections.

Journal Article Sex Transm Dis · March 1, 2021 BACKGROUND: Few studies have examined long-term outcomes among persons who initiate preexposure prophylaxis (PrEP) in the South, including PrEP discontinuation and sexually transmitted infection (STI) rates. METHODS: Care discontinuation (>6 months without ... Full text Link to item Cite

Ultrafiltration in Acute Heart Failure: Implications of Ejection Fraction and Early Response to Treatment From CARRESS-HF.

Journal Article J Am Heart Assoc · December 15, 2020 Background Ultrafiltration is not commonly used because of higher incidence of worsening renal function without improved decongestion. We examined differential outcomes of high versus low fluid removal and preserved versus reduced ejection fraction (EF) in ... Full text Open Access Link to item Cite

Angiotensin-Neprilysin Inhibition in Black Americans: Data From the PIONEER-HF Trial.

Journal Article JACC Heart Fail · October 2020 OBJECTIVES: This study compared the efficacy and safety of sacubitril/valsartan to enalapril in Black and non-Black Americans with acute decompensated heart failure (ADHF). BACKGROUND: Black patients have a different response to treatment with angiotensin- ... Full text Link to item Cite

Annexin A1 is a Potential Novel Biomarker of Congestion in Acute Heart Failure.

Journal Article J Card Fail · August 2020 OBJECTIVES: This study sought to identify the role of annexin A1 (AnxA1) as a congestion marker in acute heart failure (AHF) and to identify its putative role in predicting clinical outcomes. BACKGROUND: AnxA1 is a protein that inhibits inflammation follow ... Full text Link to item Cite

Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity.

Journal Article Eur J Heart Fail · June 2020 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 unc ... Full text Link to item Cite

Early cardiac dysfunction in children and young adults with perinatally acquired HIV.

Journal Article AIDS · March 15, 2020 OBJECTIVE: To define the prevalence of early cardiac dysfunction in children and young adults with perinatally acquired HIV and predictors of cardiac function. DESIGN: Cross-sectional design. METHODS: Early cardiac dysfunction was defined as left ventricul ... Full text Link to item Cite

Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure: Secondary Analysis of the Open-label Extension of the PIONEER-HF Trial.

Journal Article JAMA Cardiol · February 1, 2020 IMPORTANCE: In PIONEER-HF, among stabilized patients with acute decompensated heart failure (ADHF), the in-hospital initiation of sacubitril/valsartan was well tolerated and led to improved outcomes compared with enalapril. However, there are limited data ... Full text Link to item Cite

Spironolactone in Acute Heart Failure Patients With Renal Dysfunction and Risk Factors for Diuretic Resistance: From the ATHENA-HF Trial.

Journal Article Can J Cardiol · September 2019 BACKGROUND: Acute heart failure (HF) patients with renal insufficiency and risk factors for diuretic resistance may be most likely to derive incremental improvement in congestion with the addition of spironolactone. METHODS: The Aldosterone Targeted Neuroh ... Full text Link to item Cite

Army Warrior Care Project (AWCP): Rationale and methods for a longitudinal study of behavioral health care in Army Warrior Transition Units using Military Health System data, FY2008-2015.

Journal Article Int J Methods Psychiatr Res · September 2019 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 comprehen ... Full text Link to item Cite

A three-state continuous time Markov chain model for HIV disease burden

Journal Article Journal of Applied Statistics · July 4, 2019 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 de ... Full text Cite

Cumulus cell pappalysin-1, luteinizing hormone/choriogonadotropin receptor, amphiregulin and hydroxy-delta-5-steroid dehydrogenase, 3 beta- and steroid delta-isomerase 1 mRNA levels associate with oocyte developmental competence and embryo outcomes.

Journal Article J Assist Reprod Genet · July 2019 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 observati ... Full text Link to item Cite

Characterization of the Obese Phenotype of Heart Failure With Preserved Ejection Fraction: A RELAX Trial Ancillary Study.

Journal Article Mayo Clin Proc · July 2019 OBJECTIVE: To characterize the obese heart failure with preserved ejection fraction (HFpEF) phenotype in a multicenter cohort. PATIENTS AND METHODS: This was a secondary analysis of the randomized clinical trial RELAX (Phosphodiesterase-5 Inhibition to Imp ... Full text Link to item Cite

ANNEXIN A1 A NOVEL BIOMARKER FOR CONGESTION IN ACUTE HEART FAILURE?

Conference Journal of the American College of Cardiology · March 2019 Full text Cite

History of Atrial Fibrillation and Trajectory of Decongestion in Acute Heart Failure.

Journal Article JACC Heart Fail · January 2019 OBJECTIVES: This study sought to characterize the course of decongestion among patients hospitalized for acute heart failure (AHF) by history of atrial fibrillation (AF) and/or atrial flutter (AFL). BACKGROUND: AF/AFL and chronic heart failure (HF) commonl ... Full text Link to item Cite

Outcomes for PrEP Users in the Southern US: Persistence and STIs

Conference AIDS RESEARCH AND HUMAN RETROVIRUSES · October 1, 2018 Link to item Cite

A new generalization of the gamma distribution with application to negatively skewed survival data

Journal Article Communications in Statistics Simulation and Computation · August 9, 2018 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 appr ... Full text Cite

R package to estimate intracluster correlation coefficient with confidence interval for binary data.

Journal Article Comput Methods Programs Biomed · March 2018 BACKGROUND AND OBJECTIVE: The Intracluster Correlation Coefficient (ICC) is a major parameter of interest in cluster randomized trials that measures the degree to which responses within the same cluster are correlated. There are several types of ICC estima ... Full text Link to item Cite

Statewide Longitudinal Progression of the Whole-Patient Measure of Safety in South Carolina.

Journal Article J Healthc Qual · 2018 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 ... Full text Open Access Link to item Cite

Comparing behavioral health models for reducing risky drinking among older male veterans.

Journal Article Am J Drug Alcohol Abuse · September 2017 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 ... Full text Link to item Cite

Differences in Hospital Readmission Risk across All Payer Groups in South Carolina.

Journal Article Health Serv Res · June 2017 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 hospitali ... Full text Link to item Cite

HIV community viral load trends in South Carolina.

Journal Article Int J STD AIDS · March 2017 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 ... Full text Link to item Cite

Modeling Occurrence of Dengue Cases in Malaysia.

Journal Article Iran J Public Health · November 2016 Open Access Link to item Cite

Resampling method to estimate intra-cluster correlation for clustered binary data

Journal Article Communications in Statistics Theory and Methods · April 17, 2016 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 a ... Full text Cite

Determinants of Intimate Partner Violence Among HIV-Positive and HIV-Negative Women in India.

Journal Article J Interpers Violence · February 2016 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 i ... Full text Link to item Cite

Genes with high penetrance for syndromic and non-syndromic autism typically function within the nucleus and regulate gene expression.

Journal Article Mol Autism · 2016 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 ... Full text Open Access Link to item Cite

Optimizing Partner Notification Programs for Men Who Have Sex with Men: Factorial Survey Results from South China.

Journal Article PLoS One · 2016 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 ... Full text Open Access Link to item Cite

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Journal Article Critical Care Medicine · December 2015 Full text Cite

Cluster randomized trials: Considerations for design and analysis

Journal Article Journal of Statistical Theory and Practice · July 3, 2015 Scientists often use randomized controlled trials to compare a newly developed treatment to the existing one, or to a placebo. Patients are randomly assigned to a treatment, and they are compared with respect to the outcome of interest. The cluster randomi ... Full text Cite

Rural-urban differences in HIV viral loads and progression to AIDS among new HIV cases.

Journal Article South Med J · March 2015 OBJECTIVE: The human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic in the United States has shifted to the South, where an increasing proportion is occurring in rural areas. We sought to gain a better understanding of the af ... Full text Link to item Cite

Disparities in viral load and CD4 count trends among HIV-infected adults in South Carolina.

Journal Article AIDS Patient Care STDS · January 2015 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 population ... Full text Link to item Cite

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Journal Article Critical Care Medicine · December 2014 Full text Cite

Dose of early intervention treatment during children's first 36 months of life is associated with developmental outcomes: an observational cohort study in three low/low-middle income countries.

Journal Article BMC Pediatr · October 25, 2014 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 ... Full text Open Access Link to item Cite

Solubilization of tricalcium phosphate by P(3HB) accumulating Azotobacter chroococcum MAL-201.

Journal Article World J Microbiol Biotechnol · May 2014 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), ... Full text Link to item Cite

Folic Acid Fortification and Women's Folate Levels in Selected Communities in Brazil - A First Look.

Journal Article Int J Vitam Nutr Res · 2014 BACKGROUND: Several countries have implemented mandatory folic acid fortification of wheat flour and selected grain products to increase the folate intake of reproductive-aged women. Brazil implemented a folic acid fortification program in 2004. No previou ... Full text Link to item Cite

Defining the rural HIV epidemic: correlations of 3 definitions--South Carolina, 2005-2011.

Journal Article J Rural Health · 2014 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 Decembe ... Full text Link to item Cite

Periconceptional use of folic acid and risk of miscarriage - findings of the Oral Cleft Prevention Program in Brazil.

Journal Article J Perinat Med · July 2013 OBJECTIVE: We report on the risk of miscarriage with high- and low-dosage periconceptional folic acid (FA) supplementation from a double-blind randomized clinical trial for prevention of orofacial cleft recurrence in Brazil. METHODS: Women at risk of recur ... Full text Link to item Cite

Statistical models to estimate male-to-female HIV transmission probabilities

Journal Article Model Assisted Statistics and Applications · June 17, 2013 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 s ... Full text Cite

Extremely low birth weight and infant mortality rates in the United States.

Journal Article Pediatrics · May 2013 OBJECTIVE: Infant mortality rates (IMR) and neonatal mortality rates (NMR) in the United States have not decreased recently. The purpose of this study was to determine the contributions of birth weight and gestational age subgroups to the IMR and NMR in th ... Full text Link to item Cite

Randomized trial of early developmental intervention on outcomes in children after birth asphyxia in developing countries.

Journal Article J Pediatr · April 2013 OBJECTIVE: To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. STUDY DESIGN: This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and ma ... Full text Link to item Cite

High dosage folic acid supplementation, oral cleft recurrence and fetal growth.

Journal Article Int J Environ Res Public Health · February 4, 2013 OBJECTIVES: To evaluate the effects of folic acid supplementation on isolated oral cleft recurrence and fetal growth. PATIENTS AND METHODS: The study included 2,508 women who were at-risk for oral cleft recurrence and randomized into two folic acid supplem ... Full text Open Access Link to item Cite

HPV prevalence at enrollment and baseline results from the Carolina Women's Care Study, a longitudinal study of HPV persistence in women of college age.

Journal Article Int J Womens Health · 2013 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 infectio ... Full text Open Access Link to item Cite

Mixed model variance adjustments when missing values are multiply imputed

Journal Article Journal of Medical Statistics and Informatics · 2013 Full text Cite

Oral cleft prevention program (OCPP).

Journal Article BMC Pediatr · November 26, 2012 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 ... Full text Open Access Link to item Cite

Causes of community stillbirths and early neonatal deaths in low-income countries using verbal autopsy: an International, Multicenter Study.

Journal Article J Perinatol · August 2012 OBJECTIVE: Six million stillbirths (SB) and early neonatal deaths (END) occur annually worldwide, mostly in rural settings distant from health facilities. We used verbal autopsy (VA), to understand causes of non-hospital, community-based SB and END from fo ... Full text Link to item Cite

Neurodevelopmental outcomes in infants requiring resuscitation in developing countries.

Journal Article J Pediatr · May 2012 OBJECTIVE: To determine whether resuscitation of infants who failed to develop effective breathing at birth increases survivors with neurodevelopmental impairment. STUDY DESIGN: Infants unresponsive to stimulation who received bag and mask ventilation at b ... Full text Link to item Cite

The effect of systematic pediatric care on neonatal mortality and hospitalizations of infants born with oral clefts.

Journal Article BMC Pediatr · December 28, 2011 BACKGROUND: Cleft lip and/or palate (CL/P) increase mortality and morbidity risks for affected infants especially in less developed countries. This study aimed at assessing the effects of systematic pediatric care on neonatal mortality and hospitalizations ... Full text Open Access Link to item Cite

Antiretroviral Therapy Initiation and CD4 Progression over time among HIV Infected Adults in Central Africa

Journal Article International Journal of Medicine and Public Health · November 11, 2011 Full text Cite

Challenges and Implemented Solutions for the Oral Cleft Prevention Trial in Brazil

Journal Article International Journal of Medicine and Public Health · August 25, 2011 Full text Cite

Pregnant women and children's exposure to tobacco and solid fuel smoke in southwestern India.

Journal Article J Matern Fetal Neonatal Med · July 2011 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% confidenc ... Full text Link to item Cite

An alternative strategy for perinatal verbal autopsy coding: single versus multiple coders.

Journal Article Trop Med Int Health · January 2011 OBJECTIVE: To determine the comparability between cause of death (COD) by a single physician coder and a two-physician panel, using verbal autopsy. METHODS: The study was conducted between May 2007 and June 2008. Within a week of a perinatal death in 38 ru ... Full text Link to item Cite

High mortality rates for very low birth weight infants in developing countries despite training.

Journal Article Pediatrics · November 2010 OBJECTIVE: The goal was to determine the effect of training in newborn care and resuscitation on 7-day (early) neonatal mortality rates for very low birth weight (VLBW) infants. The study was designed to test the hypothesis that these training programs wou ... Full text Link to item Cite

Newborn care training of midwives and neonatal and perinatal mortality rates in a developing country.

Journal Article Pediatrics · November 2010 OBJECTIVE: This study was designed to test the hypothesis that 2 training programs would reduce incrementally 7-day neonatal mortality rates for low-risk institutional deliveries. METHODS: Using a train-the-trainer model, certified research midwives sequen ... Full text Link to item Cite

Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT).

Journal Article BMC Pediatr · April 30, 2010 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 ... Full text Open Access Link to item Cite

Newborn-care training and perinatal mortality in developing countries.

Journal Article N Engl J Med · February 18, 2010 BACKGROUND: Of the 3.7 million neonatal deaths and 3.3 million stillbirths each year, 98% occur in developing countries. An evaluation of community-based interventions designed to reduce the number of these deaths is needed. METHODS: With the use of a trai ... Full text Link to item Cite

Intracluster correlation adjustments to maintain power in cluster trials for binary outcomes.

Journal Article Contemp Clin Trials · September 2009 Adequately powered sample size calculations for cluster randomized trials primarily depend on the event rate variability, effect size, average cluster size, and intracluster correlation (ICC). Furthermore, an ICC estimate depends on event rate variability ... Full text Link to item Cite

Evaluation of cluster-randomized trials on maternal and child health research in developing countries.

Journal Article Trop Med Int Health · August 2009 OBJECTIVE: To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 w ... Full text Link to item Cite

Birth asphyxia survivors in a developing country.

Journal Article J Perinatol · March 2009 OBJECTIVE: Determine the baseline incidence of birth asphyxia in neonatal intensive care unit (NICU) survivors in a developing country and the early neurodevelopmental outcomes of such infants. STUDY DESIGN: This cross-sectional, prospective study collecte ... Full text Link to item Cite

Side effects of oral misoprostol for the prevention of postpartum hemorrhage: results of a community-based randomised controlled trial in rural India.

Journal Article J Matern Fetal Neonatal Med · January 2009 OBJECTIVE: To investigate the side effects of 600 microg 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 rando ... Full text Link to item Cite

A simulation based technique to estimate intracluster correlation for a binary variable.

Journal Article Contemp Clin Trials · January 2009 Cluster randomized trials have become the design of choice for evaluating the effect of selected interventions on well-known health indicators such as neonatal mortality rate, episiotomy rate, and postpartum hemorrhage rate in a community setting. Determin ... Full text Link to item Cite

Community-based newborn care in Bangladesh.

Journal Article Lancet · November 1, 2008 Full text Link to item Cite

Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol.

Journal Article J Matern Fetal Neonatal Med · August 2008 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 >or= 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misopro ... Full text Link to item Cite

Effect of WHO newborn care training on neonatal mortality by education.

Journal Article Ambul Pediatr · 2008 BACKGROUND: Ninety-nine percent of the 4 million neonatal deaths per year occur in developing countries. The World Health Organization (WHO) Essential Newborn Care (ENC) course sets the minimum accepted standard for training midwives on aspects of infant c ... Full text Link to item Cite

Bivariate random effect model using skew-normal distribution with application to HIV-RNA.

Journal Article Stat Med · March 15, 2007 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 error ... Full text Link to item Cite

Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

Journal Article Lancet · October 7, 2006 BACKGROUND: Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-po ... Full text Link to item Cite

A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627].

Journal Article BMC Womens Health · April 11, 2005 BACKGROUND: A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The rout ... Full text Open Access Link to item Cite

Estimating correlation by using a general linear mixed model: evaluation of the relationship between the concentration of HIV-1 RNA in blood and semen.

Journal Article Stat Med · May 15, 2003 Estimating the correlation coefficient between two outcome variables is one of the most important aspects of epidemiological and clinical research. A simple Pearson's correlation coefficient method is usually employed when there are complete independent da ... Full text Link to item Cite

Viral burden in genital secretions determines male-to-female sexual transmission of HIV-1: a probabilistic empiric model.

Journal Article AIDS · March 30, 2001 OBJECTIVE: To develop a model to predict transmission of HIV-1 from men to women. DESIGN: HIV-1 in seminal plasma, and endocervical CCR5 receptors were correlated with epidemiological studies of HIV-1 transmission to develop a probabilistic model. SETTINGS ... Full text Link to item Cite

Cervical dysplasia in women infected with the human immunodeficiency virus (HIV): a correlation with HIV viral load and CD4+ count.

Journal Article Gynecol Oncol · March 2001 OBJECTIVES: The incidence of cervical dysplasia and carcinoma is known to be increased in HIV-infected women. In addition, there is a positive correlation between HIV viral load (VL), CD4+ count, and opportunistic infections, as well as the incidence of va ... Full text Link to item Cite

Effects of genital tract inflammation on human immunodeficiency virus type 1 V3 populations in blood and semen.

Journal Article J Virol · October 2000 We have examined cell-free viral populations in the blood plasma and seminal plasma compartments of men infected with subtype C human immunodeficiency virus type 1 (HIV-1) using the V3-specific heteroduplex tracking assay (V3-HTA). We studied two cohorts o ... Full text Link to item Cite

Trends of gonorrhea and chlamydial infection during 1985-1996 among active-duty soldiers at a United States Army installation.

Journal Article Clin Infect Dis · April 2000 High rates of sexually transmitted diseases (STDs) have been reported in military populations. However, it remains uncertain whether the incidence of STDs is higher among military personnel than in the civilian population. The annual incidence of gonorrhea ... Full text Link to item Cite

Comparison of blood collected in acid-citrate-dextrose and EDTA for use in human immunodeficiency virus peripheral blood mononuclear cell cultures.

Journal Article J Clin Microbiol · February 2000 Paired blood samples collected in acid-citrate-dextrose and EDTA were compared for human immunodeficiency virus (HIV) infectivity on the day of collection or after 1 day of storage at room temperature. No significant differences between the anticoagulants ... Full text Link to item Cite

Trichomonas vaginalis as a cause of urethritis in Malawian men.

Journal Article Sex Transm Dis · August 1999 BACKGROUND AND OBJECTIVES: Trichomonas vaginalis is one of the most common sexually transmitted infections. In Malawi, rates of trichomoniasis in women are high. The prevalence of T. vaginalis infection in men is expected to be high but has not previously ... Full text Link to item Cite

The effect of Plasmodium falciparum malaria on HIV-1 RNA blood plasma concentration.

Journal Article AIDS · March 11, 1999 OBJECTIVES: This study was undertaken to determine the relative effect of malaria infection on HIV concentration in blood plasma, and prospectively to monitor viral concentrations after antimalarial therapy. DESIGN: A prospective, double cohort study was d ... Full text Link to item Cite

Deficient dietary iron intakes among women and children in Russia: evidence from the Russian Longitudinal Monitoring Survey.

Journal Article Am J Public Health · April 1998 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 10,548 women and children. I ... Full text Link to item Cite

Adjustment of iron intake for dietary enhancers and inhibitors in population studies: bioavailable iron in rural and urban residing Russian women and children.

Journal Article J Nutr · August 1997 Although determining iron intakes is essential in assessing adequacy of iron in the diet, estimating iron availability may be more useful for evaluating whether iron requirements are met. Our objectives were to describe the dietary information, analytical ... Full text Link to item Cite

Dietary iron deficiency among Russian women and children

Journal Article FASEB Journal · December 1, 1996 This study evaluates the iron sufficiency of the Russian diet using data from 24-hour dietary recalls conducted in 2 rounds of a nationally representative longitudinal survey of 7,200 households. Unavailability was estimated using algorithms adjusting for ... Cite

A mixed model approach for intent-to-treat analysis in longitudinal clinical trials with missing values

Report Missing values and dropouts are common issues in longitudinal studies in all areas of medicine and public health. Intent-to-treat (ITT) analysis has become a widely accepted method for the analysis of controlled clinical trials. In most controlled ... Full text Cite