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Articles 91 - 120 of 159
Full-Text Articles in Statistics and Probability
Scaling Down To Scale Up: A Health Economic Analysis Of Integrating Point-Of-Care Syphilis Testing Into Antenatal Care In Zambia During Pilot And National Rollout Implementation., Katharine D. Shelley, Éimhín M. Ansbro, Alexander Tshaka Ncube, Sedona Sweeney, Colette Fleischer, Grace Tembo Mumba, Michelle M. Gill, Susan Strasser, Rosanna W. Peeling, Fern Terris-Prestholt
Scaling Down To Scale Up: A Health Economic Analysis Of Integrating Point-Of-Care Syphilis Testing Into Antenatal Care In Zambia During Pilot And National Rollout Implementation., Katharine D. Shelley, Éimhín M. Ansbro, Alexander Tshaka Ncube, Sedona Sweeney, Colette Fleischer, Grace Tembo Mumba, Michelle M. Gill, Susan Strasser, Rosanna W. Peeling, Fern Terris-Prestholt
GW Biostatistics Center
Maternal syphilis results in an estimated 500,000 stillbirths and neonatal deaths annually in Sub-Saharan Africa. Despite the existence of national guidelines for antenatal syphilis screening, syphilis testing is often limited by inadequate laboratory and staff services. Recent availability of inexpensive rapid point-of-care syphilis tests (RST) can improve access to antenatal syphilis screening. A 2010 pilot in Zambia explored the feasibility of integrating RST within prevention of mother-to-child-transmission of HIV services. Following successful demonstration, the Zambian Ministry of Health adopted RSTs into national policy in 2011. Cost data from the pilot and 2012 preliminary national rollout were extracted from project records, …
Treatment-Induced Changes In Plasma Adiponectin Do Not Reduce Urinary Albumin Excretion In The Diabetes Prevention Program Cohort., Kieren J. Mather, Qing Pan, William C. Knowler, Tohru Funahashi, George A. Bray, Et Al.
Treatment-Induced Changes In Plasma Adiponectin Do Not Reduce Urinary Albumin Excretion In The Diabetes Prevention Program Cohort., Kieren J. Mather, Qing Pan, William C. Knowler, Tohru Funahashi, George A. Bray, Et Al.
GW Biostatistics Center
BACKGROUND AND OBJECTIVES: Molecular data suggests that adiponectin may directly regulate urinary albumin excretion. In the Diabetes Prevention Program (DPP) we measured adiponectin and albuminuria before and after intervention, and we previously reported increases in adiponectin with interventions. Here we have used the DPP dataset to test the hypothesis that treatment-related increases in adiponectin may reduce albuminuria in obesity.
DESIGN, SETTING, PARTICIPANTS AND METHODS: We evaluated cross-sectional correlations between plasma adiponectin and urinary albumin excretion at baseline, and the relationship of treatment-related changes in adiponectin and albuminuria. Baseline and follow-up urine albumin to creatinine ratios (ACR (albumin to creatinine ratio)) …
The Cost-Effectiveness Of Diabetes Prevention: Results From The Diabetes Prevention Program And The Diabetes Prevention Program Outcomes Study, William H. Herman
The Cost-Effectiveness Of Diabetes Prevention: Results From The Diabetes Prevention Program And The Diabetes Prevention Program Outcomes Study, William H. Herman
GW Biostatistics Center
Background
The Diabetes Prevention Program (DPP) was a randomized, controlled clinical trial. It demonstrated that among high-risk individuals with impaired glucose tolerance, diabetes incidence was reduced by 58 % with lifestyle intervention and 31 % with metformin compared to placebo. During the Diabetes Prevention Program Outcomes Study (DPPOS), all DPP participants were unmasked to their treatment assignments, the original lifestyle intervention group was offered additional lifestyle support, the metformin group continued metformin, and all three groups were offered a group-implemented lifestyle intervention. Over the 10 years of combined DPP/DPPOS follow-up, diabetes incidence was reduced by 34 % in the lifestyle …
Skin Collagen Advanced Glycation Endproducts (Ages) And The Long-Term Progression Of Sub-Clinical Cardiovascular Disease In Type 1 Diabetes, Vincent M. Monnier, Wanjie Sun, Xiaoyu Gao, David R. Sell, Patricia Cleary, John M. Lachin, Saul Genuth, The Dcct/Edic Research Group
Skin Collagen Advanced Glycation Endproducts (Ages) And The Long-Term Progression Of Sub-Clinical Cardiovascular Disease In Type 1 Diabetes, Vincent M. Monnier, Wanjie Sun, Xiaoyu Gao, David R. Sell, Patricia Cleary, John M. Lachin, Saul Genuth, The Dcct/Edic Research Group
GW Biostatistics Center
BACKGROUND:
We recently reported strong associations between eight skin collagen AGEs and two solubility markers from skin biopsies obtained at DCCT study closeout and the long-term progression of microvascular disease in EDIC, despite adjustment for mean glycemia. Herein we investigated the hypothesis that some of these AGEs (fluorescence to be reported elsewhere) correlate with long-term subclinical cardiovascular disease (CVD) measurements, i.e. coronary artery calcium score (CAC) at EDIC year 7-9 (n = 187), change of carotid intima-media thickness (IMT) from EDIC year 1 to year 6 and 12 (n = 127), and cardiac MRI outcomes at EDIC year 15-16 (n …
Quality Control Measures Over 30 Years In A Multicenter Clinical Study: Results From The Diabetes Control And Complications Trial / Epidemiology Of Diabetes Interventions And Complications (Dcct/Edic) Study., Gayle M Lorenzi, Barbara H Braffett, Valerie L Arends, Ronald P Danis, Lisa Diminick, Kandace A Klumpp, Anthony D Morrison, Elsayed Z Soliman, Michael W Steffes, Patricia A Cleary
Quality Control Measures Over 30 Years In A Multicenter Clinical Study: Results From The Diabetes Control And Complications Trial / Epidemiology Of Diabetes Interventions And Complications (Dcct/Edic) Study., Gayle M Lorenzi, Barbara H Braffett, Valerie L Arends, Ronald P Danis, Lisa Diminick, Kandace A Klumpp, Anthony D Morrison, Elsayed Z Soliman, Michael W Steffes, Patricia A Cleary
GW Biostatistics Center
No abstract provided.
The Cost-Effectiveness Of Diabetes Prevention: Results From The Diabetes Prevention Program And The Diabetes Prevention Program Outcomes Study, William Herman
The Cost-Effectiveness Of Diabetes Prevention: Results From The Diabetes Prevention Program And The Diabetes Prevention Program Outcomes Study, William Herman
GW Biostatistics Center
Background
The Diabetes Prevention Program (DPP) was a randomized, controlled clinical trial. It demonstrated that among high-risk individuals with impaired glucose tolerance, diabetes incidence was reduced by 58 % with lifestyle intervention and 31 % with metformin compared to placebo. During the Diabetes Prevention Program Outcomes Study (DPPOS), all DPP participants were unmasked to their treatment assignments, the original lifestyle intervention group was offered additional lifestyle support, the metformin group continued metformin, and all three groups were offered a group-implemented lifestyle intervention. Over the 10 years of combined DPP/DPPOS follow-up, diabetes incidence was reduced by 34 % in the lifestyle …
Pregnant And Postpartum Women’S Experiences And Perspectives On The Acceptability And Feasibility Of Copackaged Medicine For Antenatal Care And Pmtct In Lesotho, Michelle M. Gill, Heather J. Hoffman, Appolinaire Tiam, Florence M. Mohai, Mokone Majoalane, Anthony Isavwa, Laura Guay, +4 Additional Authors
Pregnant And Postpartum Women’S Experiences And Perspectives On The Acceptability And Feasibility Of Copackaged Medicine For Antenatal Care And Pmtct In Lesotho, Michelle M. Gill, Heather J. Hoffman, Appolinaire Tiam, Florence M. Mohai, Mokone Majoalane, Anthony Isavwa, Laura Guay, +4 Additional Authors
Epidemiology Faculty Publications
Objective. To improve PMTCT and antenatal care-related service delivery, a pack with centrally prepackaged medicine was rolled out to all pregnant women in Lesotho in 2011. This study assessed acceptability and feasibility of this copackaging mechanism for drug delivery among pregnant and postpartum women.
Methods. Acceptability and feasibility were assessed in a mixed method, cross-sectional study through structured interviews (SI) and semistructured interviews (SSI) conducted in 2012 and 2013.
Results. 290 HIV-negative women and 437 HIV-positive women (n=727) participated. Nearly all SI participants found prepackaged medicines acceptable, though modifications such as size reduction of the pack were …
Clinical Significance Of Left Atrial Anatomic Abnormalities Identified By Cardiac Computed Tomography, Ara V. Vehian, Brian G. Choi, Satinder Rekhi, Heather A. Young, Raman S. Dusaj, Robert K. Zeman
Clinical Significance Of Left Atrial Anatomic Abnormalities Identified By Cardiac Computed Tomography, Ara V. Vehian, Brian G. Choi, Satinder Rekhi, Heather A. Young, Raman S. Dusaj, Robert K. Zeman
Epidemiology Faculty Publications
Purpose: The clinical significance of newly identified left atrial anatomic abnormalities (LAAA)— accessory appendages, diverticula, septal pouches—by multidetector CT (MDCT) remains unclear. Similar anatomical outpouchings, i.e., the left atrial appendage, have been associated with cardioembolisms and arrhythmia. To test the hypothesis that LAAA are also associated with increased risk of these events, we performed a retrospective analysis to examine the association of LAAA in patients undergoing CT with embolic events and arrhythmia.
Methods: 242 patients (mean age 56 SD 12 years, 41% female) were selected who had CT coronary angiography performed with 64-row MDCT between 2007 and 2012 if complete …
Parity And Diabetes Risk Among Hispanic Women From Colombia: Cross-Sectional Evidence, Pablo Cure, Heather J. Hoffman, Carlos Cure-Cure
Parity And Diabetes Risk Among Hispanic Women From Colombia: Cross-Sectional Evidence, Pablo Cure, Heather J. Hoffman, Carlos Cure-Cure
Epidemiology Faculty Publications
Objective
The association between parity and type 2 diabetes has been studied in developed countries and in Singapore and Chinese women but not in Hispanics. Herein we evaluated the association between parity (number of live births) with diabetes in a group of Hispanic postmenopausal women from Colombia.
Research design and methods
Herein we evaluated the association between parity and diabetes in a population of 1,795 women from Colombia. Women were divided in birth categories (0 [referent], 1 or 2, 3–5, 6 or > births). Medical history of diabetes and anthropometric characteristics were recorded. Logistic regressions were performed in order to find …
Implementation Of Point-Of-Care Diagnostics Leads To Variable Uptake Of Syphilis, Anemia And Cd4+ T-Cell Count Testing In Rural Maternal And Child Health Clinics., Caroline De Schacht, Carlota Lucas, Nádia Sitoe, Rhoderick Machekano, Patrina Chongo, Laura Guay, Et Al.
Implementation Of Point-Of-Care Diagnostics Leads To Variable Uptake Of Syphilis, Anemia And Cd4+ T-Cell Count Testing In Rural Maternal And Child Health Clinics., Caroline De Schacht, Carlota Lucas, Nádia Sitoe, Rhoderick Machekano, Patrina Chongo, Laura Guay, Et Al.
Epidemiology Faculty Publications
INTRODUCTION: Anemia, syphilis and HIV are high burden diseases among pregnant women in sub-Saharan Africa. A quasi-experimental study was conducted in four health facilities in Southern Mozambique to evaluate the effect of point-of-care technologies for hemoglobin quantification, syphilis testing and CD4+ T-cell enumeration performed within maternal and child health services on testing and treatment coverage, and assessing acceptability by health workers.
METHODS: Demographic and testing data on women attending first antenatal care services were extracted from existing records, before (2011; n = 865) and after (2012; n = 808) introduction of point-of-care testing. Study outcomes per health facility were compared …
A Systematic Review And Meta-Regression Analysis Of Lung Cancer Risk And Inorganic Arsenic In Drinking Water., Steven H. Lamm, Hamid Ferdosi, Elisabeth K. Dissen, Ji Li, Jaeil Ahn
A Systematic Review And Meta-Regression Analysis Of Lung Cancer Risk And Inorganic Arsenic In Drinking Water., Steven H. Lamm, Hamid Ferdosi, Elisabeth K. Dissen, Ji Li, Jaeil Ahn
Epidemiology Faculty Publications
High levels (> 200 µg/L) of inorganic arsenic in drinking water are known to be a cause of human lung cancer, but the evidence at lower levels is uncertain. We have sought the epidemiological studies that have examined the dose-response relationship between arsenic levels in drinking water and the risk of lung cancer over a range that includes both high and low levels of arsenic. Regression analysis, based on six studies identified from an electronic search, examined the relationship between the log of the relative risk and the log of the arsenic exposure over a range of 1-1000 µg/L. The …
Mediation Analysis Of Gestational Age, Congenital Heart Defects, And Infant Birth-Weight, Adane F. Wogu, Christopher A. Loffredo, Ionut Bebu, George Luta
Mediation Analysis Of Gestational Age, Congenital Heart Defects, And Infant Birth-Weight, Adane F. Wogu, Christopher A. Loffredo, Ionut Bebu, George Luta
GW Biostatistics Center
Background
In this study we assessed the mediation role of the gestational age on the effect of the infant’s congenital heart defects (CHD) on birth-weight.
Methods
We used secondary data from the Baltimore-Washington Infant Study (1981–1989). Mediation analysis was employed to investigate whether gestational age acted as a mediator of the association between CHD and reduced birth-weight. We estimated the mediated effect, the mediation proportion, and their corresponding 95% confidence intervals (CI) using several methods.
Results
There were 3362 CHD cases and 3564 controls in the dataset with mean birth-weight of 3071 (SD = 729) and 3353 (SD = 603) …
Access To Hiv Prevention And Care For Hiv-Exposed And Hiv-Infected Children: A Qualitative Study In Rural And Urban Mozambique, Caroline De Schacht, Carlota Lucas, Caterina Mboa, Michelle Gill, Eugenia Macasse, Stelio A. Dimande, Emily A. Bobrow, Laura Guay
Access To Hiv Prevention And Care For Hiv-Exposed And Hiv-Infected Children: A Qualitative Study In Rural And Urban Mozambique, Caroline De Schacht, Carlota Lucas, Caterina Mboa, Michelle Gill, Eugenia Macasse, Stelio A. Dimande, Emily A. Bobrow, Laura Guay
Epidemiology Faculty Publications
Background Follow-up of HIV-exposed children for the delivery of prevention of mother-to-child transmission services and for early diagnosis and treatment of HIV infection is critical to their survival. Despite efforts, uptake of postnatal care for these children remains low in many subSaharan African countries. Methods A qualitative study was conducted in three provinces in Mozambique to identify motivators and barriers to improve uptake of and retention in HIV prevention, care and treatment services for HIV-exposed and HIV-infected children. Participant recommendations were also gathered. Individual interviews (n=79) and focus group discussions (n=32) were conducted with parents/caregivers, grandmothers, community leaders and health …
Prognostic Value Of Lymphocyte Vascular Density And E-Cadherin In Inflammatory Breast Cancer, Paul H. Levine, Heather J. Hoffman, Audra Macneil, Salman Hashmi, Sherry X. Yang, Stephen Hewitt, Kenneth L. Van Golen, Sandra M. Swain
Prognostic Value Of Lymphocyte Vascular Density And E-Cadherin In Inflammatory Breast Cancer, Paul H. Levine, Heather J. Hoffman, Audra Macneil, Salman Hashmi, Sherry X. Yang, Stephen Hewitt, Kenneth L. Van Golen, Sandra M. Swain
Epidemiology Faculty Publications
Background: We recently evaluated four laboratory assays, vascular endothelial growth factor D (VEGF-D), E-cadherin, lymphatic vessel density (LVD) measured by podoplanin, and intra-lymphatic tumor emboli (ILTE), which showed notable differences between inflammatory breast cancer (IBC) and non-inflammatory locally advanced breast cancer (LABC). In this study we investigated the potential of the three most quantitatively measured markers, E-cadherin, LVD and VEGF-D, to predict survival in the IBC patients.
Materials and Methods: This study involved the 100 cases identified in the Inflammatory Breast Cancer Registry (IBCR) whose tumors were previously evaluated for the four assays noted above. Living patients were recontacted and …
Identifying Change Points In A Covariate Effect On Time-To-Event Analysis With Reduced Isotonic Regression, Yong Ma, Yinglei Lai, John M. Lachin
Identifying Change Points In A Covariate Effect On Time-To-Event Analysis With Reduced Isotonic Regression, Yong Ma, Yinglei Lai, John M. Lachin
GW Biostatistics Center
Isotonic regression is a useful tool to investigate the relationship between a quantitative covariate and a time-to-event outcome. The resulting non-parametric model is a monotonic step function of a covariate X and the steps can be viewed as change points in the underlying hazard function. However, when there are too many steps, over-fitting can occur and further reduction is desirable. We propose a reduced isotonic regression approach to allow combination of small neighboring steps that are not statistically significantly different. In this approach, a second stage, the reduction stage, is integrated into the usual monotonic step building algorithm by comparing …
A Review Of Software For Analyzing Molecular Sequences, Haema Nilakanta, Kimberly L. Drews, Suzanne Firrell, Mary A. Foulkes, Kathleen A. Jablonski
A Review Of Software For Analyzing Molecular Sequences, Haema Nilakanta, Kimberly L. Drews, Suzanne Firrell, Mary A. Foulkes, Kathleen A. Jablonski
GW Biostatistics Center
Background Over the past ten years, there has been an explosion of microbiome research. Many software packages for analyzing microbial sequences such as the 16S gene from 454 sequencers and Illumina platforms are available. But for a new researcher, it is difficult to know which package to choose. We present a systematic review of packages for the analysis of molecular sequences used to describe and compare microbial communities. This review gives students and researchers information to help choose the best analytic pipeline for their project. To the best of our knowledge, this is the first review of such software.
Findings …
Applications Of The Wei-Lachin Multivariate One-Sided Test For Multiple Outcomes On Possibly Different Scales, John M. Lachin
Applications Of The Wei-Lachin Multivariate One-Sided Test For Multiple Outcomes On Possibly Different Scales, John M. Lachin
GW Biostatistics Center
Many studies aim to assess whether a therapy has a beneficial effect on multiple outcomes simultaneously relative to a control. Often the joint null hypothesis of no difference for the set of outcomes is tested using separate tests with a correction for multiple tests, or using a multivariate T2-like MANOVA or global test. However, a more powerful test in this case is a multivariate one-sided or one-directional test directed at detecting a simultaneous beneficial treatment effect on each outcome, though not necessarily of the same magnitude. The Wei-Lachin test is a simple 1 df test obtained from a simple …
Hiv Testing Implementation In Two Urban Cities: Practice, Policy And Perceived Barriers, Camden J. Hallmark, Jennifer Skillicorn, Thomas P. Giordano, Jessica A. Davila, Marlene Mcneese, Nestor Rocha, Avemaria Smith, Stacey Cooper, Amanda D. Castel
Hiv Testing Implementation In Two Urban Cities: Practice, Policy And Perceived Barriers, Camden J. Hallmark, Jennifer Skillicorn, Thomas P. Giordano, Jessica A. Davila, Marlene Mcneese, Nestor Rocha, Avemaria Smith, Stacey Cooper, Amanda D. Castel
Epidemiology Faculty Publications
Background
Although funding has supported the scale up of routine, opt-out HIV testing in the US, variance in implementation mechanisms and barriers in high-burden jurisdictions remains unknown.
Methods
We conducted a survey of health care organizations in Washington, DC and Houston/Harris County to determine number of HIV tests completed in 2011, policy and practices associated with HIV testing, funding mechanisms, and reported barriers to testing in each jurisdiction and to compare results between jurisdictions.
Results
In 2012, 43 Houston and 35 DC HIV-testing organizations participated in the survey. Participants represented 85% of Department of Health-supported testers in DC and 90% …
Incidence And Trends Of Blastomycosis-Associated Hospitalizations In The United States, Amy E. Seitz, Naji Younes, Claudia A. Steiner, Rebecca Prevots
Incidence And Trends Of Blastomycosis-Associated Hospitalizations In The United States, Amy E. Seitz, Naji Younes, Claudia A. Steiner, Rebecca Prevots
Epidemiology Faculty Publications
We used the State Inpatient Databases from the United States Agency for Healthcare Research and Quality to provide state-specific age-adjusted blastomycosis-associated hospitalization incidence throughout the entire United States. Among the 46 states studied, states within the Mississippi and Ohio River valleys had the highest age-adjusted hospitalization incidence. Specifically, Wisconsin had the highest age-adjusted hospitalization incidence (2.9 hospitalizations per 100,000 person-years). Trends were studied in the five highest hospitalization incidence states. From 2000 to 2011, blastomycosis-associated hospitalizations increased significantly in Illinois and Kentucky with an average annual increase of 4.4% and 8.4%, respectively. Trends varied significantly by state. Overall, 64% of …
Lifestyle And Metformin Interventions Have A Durable Effect To Lower Crp And Tpa Levels In The Diabetes Prevention Program Except In Those Who Develop Diabetes., Ronald B Goldberg, Marinella G Temprosa, Kieren J Mather, Trevor J Orchard, Abbas E Kitabchi, Karol E Watson
Lifestyle And Metformin Interventions Have A Durable Effect To Lower Crp And Tpa Levels In The Diabetes Prevention Program Except In Those Who Develop Diabetes., Ronald B Goldberg, Marinella G Temprosa, Kieren J Mather, Trevor J Orchard, Abbas E Kitabchi, Karol E Watson
GW Biostatistics Center
OBJECTIVE: We evaluate whether lifestyle and metformin interventions used to prevent diabetes have durable effects on markers of inflammation and coagulation and whether the effects are influenced by the development of diabetes.
RESEARCH DESIGN AND METHODS: The Diabetes Prevention Program was a controlled clinical trial of 3,234 subjects at high risk for diabetes who were randomized to lifestyle, metformin, or placebo interventions for 3.4 years. Diabetes was diagnosed semiannually by fasting glucose and annually by oral glucose tolerance testing. In addition to baseline testing, anthropometry was performed every 6 months; fasting insulin yearly; and hs-CRP, tissue plasminogen activator (tPA), and …
Inflammatory Breast Cancer Clusters: A Hypothesis, Paul H. Levine, Salman Hashmi, Ashley A. Minaei, Carmela Veneroso
Inflammatory Breast Cancer Clusters: A Hypothesis, Paul H. Levine, Salman Hashmi, Ashley A. Minaei, Carmela Veneroso
Epidemiology Faculty Publications
Reproduced with permission of Baishideng Publishing Group, World Journal of Clinical Oncology.
Association Between Class Iii Obesity (Bmi Of 40-59 Kg/M2) And Mortality: A Pooled Analysis Of 20 Prospective Studies, Cari M. Kitahara, Alan J. Flint, Amy Berrington De Gonzalez, Leslie Bernstein, Michelle Brotzman, Kim Robien, +30 Additional Authors
Association Between Class Iii Obesity (Bmi Of 40-59 Kg/M2) And Mortality: A Pooled Analysis Of 20 Prospective Studies, Cari M. Kitahara, Alan J. Flint, Amy Berrington De Gonzalez, Leslie Bernstein, Michelle Brotzman, Kim Robien, +30 Additional Authors
Epidemiology Faculty Publications
Background
The prevalence of class III obesity (body mass index [BMI]≥40 kg/m2) has increased dramatically in several countries and currently affects 6% of adults in the US, with uncertain impact on the risks of illness and death. Using data from a large pooled study, we evaluated the risk of death, overall and due to a wide range of causes, and years of life expectancy lost associated with class III obesity.
Methods and Findings
In a pooled analysis of 20 prospective studies from the United States, Sweden, and Australia, we estimated sex- and age-adjusted total and cause-specific mortality rates (deaths per …
Rationale, Design, And Baseline Characteristics Of A Randomized, Placebo-Controlled Cardiovascular Outcome Trial Of Empagliflozin (Empa-Reg Outcometm), Bernard Zinman, Silvio E. Inzucchi, John M. Lachin, Christoph Wanner, Roberto Ferrari, David Fitchett, Erich Bluhmki, Stefan Hantel, Joan Kempthorne-Rawson, Jennifer Newman, Odd Erik Johansen, Hans Juergen Woerle, Uli C. Broedl
Rationale, Design, And Baseline Characteristics Of A Randomized, Placebo-Controlled Cardiovascular Outcome Trial Of Empagliflozin (Empa-Reg Outcometm), Bernard Zinman, Silvio E. Inzucchi, John M. Lachin, Christoph Wanner, Roberto Ferrari, David Fitchett, Erich Bluhmki, Stefan Hantel, Joan Kempthorne-Rawson, Jennifer Newman, Odd Erik Johansen, Hans Juergen Woerle, Uli C. Broedl
Epidemiology Faculty Publications
Background
Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOMETM trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on microvascular outcomes.
Methods
Patients who …
Gwas Identifies An Nat2 Acetylator Status Tag Single Nucleotide Polymorphism To Be A Major Locus For Skin Fluorescence, Karen M. Eny, Helen L. Lutgers, John Maynard, Barbara E.K. Klein, Kristine E. Lee, Patricia A. Cleary, +20 Additional Authors
Gwas Identifies An Nat2 Acetylator Status Tag Single Nucleotide Polymorphism To Be A Major Locus For Skin Fluorescence, Karen M. Eny, Helen L. Lutgers, John Maynard, Barbara E.K. Klein, Kristine E. Lee, Patricia A. Cleary, +20 Additional Authors
Epidemiology Faculty Publications
Aims/hypothesis
Skin fluorescence (SF) is a non-invasive marker of AGEs and is associated with the long-term complications of diabetes. SF increases with age and is also greater among individuals with diabetes. A familial correlation of SF suggests that genetics may play a role. We therefore performed parallel genome-wide association studies of SF in two cohorts.
Methods
Cohort 1 included 1,082 participants, 35–67 years of age with type 1 diabetes. Cohort 2 included 8,721 participants without diabetes, aged 18–90 years.
Results
rs1495741 was significantly associated with SF in Cohort 1 (p < 6 × 10−10), which is known to tag theNAT2 acetylator phenotype. The fast acetylator genotype was associated …
Assessing The Impact Of Misclassification When Comparing Prevalence Data: A Novel Sensitivity Analysis Approach, Ninet Sinaii, Sean D. Cleary, Pamela Stratton
Assessing The Impact Of Misclassification When Comparing Prevalence Data: A Novel Sensitivity Analysis Approach, Ninet Sinaii, Sean D. Cleary, Pamela Stratton
Epidemiology Faculty Publications
Background: A simple sensitivity analysis technique was developed to assess the impact of misclassification and verify observed prevalence differences between distinct populations.
Methods: The prevalence of self-reported comorbid diseases in 4,331 women with surgically-diagnosed endometriosis was compared to published clinical and population-based prevalence estimates. Disease prevalence misclassification was assessed by assuming over-reporting in the study sample and under-reporting in the general (comparison) population. Over- and under-reporting by 10%, 25%, 50%, 75%, and 90% was used to create a 5×5 table for each disease. The new prevalences represented by each table cell were compared by p-values, prevalence odds ratios, and 95% …
Venue-Based Recruitment Of Women At Elevated Risk For Hiv: An Hiv Prevention Trials Network Study, Danielle F. Haley, Carol E. Golin, Wafaa M. El-Sadr, James P. Hughes, Jing Wang, Irene Kuo, +13 Additional Authors
Venue-Based Recruitment Of Women At Elevated Risk For Hiv: An Hiv Prevention Trials Network Study, Danielle F. Haley, Carol E. Golin, Wafaa M. El-Sadr, James P. Hughes, Jing Wang, Irene Kuo, +13 Additional Authors
Epidemiology Faculty Publications
Background: The challenge of identifying and recruiting U.S. women at elevated risk for HIV acquisition impedes prevention studies and services. HIV Prevention Trials Network (HPTN) 064 was a U.S. multisite, longitudinal cohort study designed to estimate HIV incidence among women living in communities with prevalent HIV and poverty. Venue-based sampling (VBS) methodologies and participant and venue characteristics are described.
Methods: Eligible women were recruited from 10 U.S. communities with prevalent HIV and poverty using VBS. Participant eligibility criteria included age 18–44 years, residing in a designated census tract/zip code, and self-report of at least one high-risk personal and/or male sexual …
The Impact Of Salsalate Treatment On Serum Levels Of Advanced Glycation End Products In Type 2 Diabetes., Joshua I Barzilay, Kathleen A. Jablonski, Vivian Fonseca, Steven E Shoelson, Allison B Goldfine, Christopher Strauch, Vincent M Monnier, Tinsal-T2d Research Consortium.
The Impact Of Salsalate Treatment On Serum Levels Of Advanced Glycation End Products In Type 2 Diabetes., Joshua I Barzilay, Kathleen A. Jablonski, Vivian Fonseca, Steven E Shoelson, Allison B Goldfine, Christopher Strauch, Vincent M Monnier, Tinsal-T2d Research Consortium.
GW Biostatistics Center
OBJECTIVE Salsalate is a nonacetylated salicylate that lowers glucose levels in people with type 2 diabetes (T2D). Here we examined whether salsalate also lowered serum-protein-bound levels of early and advanced glycation end products (AGEs) that have been implicated in diabetic vascular complications. RESEARCH DESIGN AND METHODS Participants were from the Targeting Inflammation Using Salsalate for Type 2 Diabetes (TINSAL-T2D) study, which examined the impact of salsalate treatment on hemoglobin A1c (HbA1c) and a wide variety of other parameters. One hundred eighteen participants received salsalate, 3.5 g/day for 48 weeks, and 109 received placebo. Early glycation product levels (HbA1c and fructoselysine …
Genetic Risk Of Progression To Type 2 Diabetes And Response To Intensive Lifestyle Or Metformin In Prediabetic Women With And Without A History Of Gestational Diabetes Mellitus., Shannon D Sullivan, Kathleen A. Jablonski, Jose C Florez, Dana Dabelea, Paul W Franks, Sam Dagogo-Jack, Catherine Kim, William C Knowler, Costas A Christophi, Robert Ratner, Diabetes Prevention Program Research Group.
Genetic Risk Of Progression To Type 2 Diabetes And Response To Intensive Lifestyle Or Metformin In Prediabetic Women With And Without A History Of Gestational Diabetes Mellitus., Shannon D Sullivan, Kathleen A. Jablonski, Jose C Florez, Dana Dabelea, Paul W Franks, Sam Dagogo-Jack, Catherine Kim, William C Knowler, Costas A Christophi, Robert Ratner, Diabetes Prevention Program Research Group.
GW Biostatistics Center
OBJECTIVE The Diabetes Prevention Program (DPP) trial investigated rates of progression to diabetes among adults with prediabetes randomized to treatment with placebo, metformin, or intensive lifestyle intervention. Among women in the DPP, diabetes risk reduction with metformin was greater in women with prior gestational diabetes mellitus (GDM) compared with women without GDM but with one or more previous live births.
RESEARCH DESIGN AND METHODS We asked if genetic variability could account for these differences by comparing β-cell function and genetic risk scores (GRS), calculated from 34 diabetes-associated loci, between women with and without histories of GDM.
RESULTS β-Cell function was …
Metabolic Syndrome Components And Their Response To Lifestyle And Metformin Interventions Are Associated With Differences In Diabetes Risk In Persons With Impaired Glucose Tolerance, H. Florez, M. Temprosa, Trevor J. Orchard, Kieren J. Mather, Santica M. Marcovina, Elizabeth Barrett-Connor, Edward Horton, C. D. Saudek, F. X. Pi-Sunyer, R. E. Ratner, R. B. Goldberg
Metabolic Syndrome Components And Their Response To Lifestyle And Metformin Interventions Are Associated With Differences In Diabetes Risk In Persons With Impaired Glucose Tolerance, H. Florez, M. Temprosa, Trevor J. Orchard, Kieren J. Mather, Santica M. Marcovina, Elizabeth Barrett-Connor, Edward Horton, C. D. Saudek, F. X. Pi-Sunyer, R. E. Ratner, R. B. Goldberg
GW Biostatistics Center
Aims
To determine the association of metabolic syndrome (MetS) and its components with diabetes risk in participants with impaired glucose tolerance (IGT), and whether intervention-related changes in MetS lead to differences in diabetes incidence.
Methods
We used the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATP III) revised MetS definition at baseline and intervention-related changes of its components to predict incident diabetes using Cox models in 3234 Diabetes Prevention Program (DPP) participants with IGT over an average follow-up of 3.2 years.
Results
In an intention-to-treat analysis, the demographic-adjusted hazard ratios (95% confidence interval) for diabetes in those with MetS (vs. …
Concomitant Socioeconomic, Behavioral, And Biological Factors Associated With The Disproportionate Hiv Infection Burden Among Black Men Who Have Sex With Men In 6 U.S. Cities, Kenneth H. Mayer, Lei Wang, Beryl A. Koblin, Sharon B. Mannheimer, Manya Magnus, +13 Additional Authors
Concomitant Socioeconomic, Behavioral, And Biological Factors Associated With The Disproportionate Hiv Infection Burden Among Black Men Who Have Sex With Men In 6 U.S. Cities, Kenneth H. Mayer, Lei Wang, Beryl A. Koblin, Sharon B. Mannheimer, Manya Magnus, +13 Additional Authors
Epidemiology Faculty Publications
Background
American Black men who have sex with men (MSM) are disproportionately affected by HIV, but the factors associated with this concentrated epidemic are not fully understood.
Methods
Black MSM were enrolled in 6 US cities to evaluate a multi-component prevention intervention, with the current analysis focusing on the correlates of being newly diagnosed with HIV compared to being HIV-uninfected or previously diagnosed with HIV.
Results
HPTN 061 enrolled 1553 Black MSM whose median age was 40; 30% self-identified exclusively as gay or homosexual, 29% exclusively as bisexual, and 3% as transgender. About 1/6th(16.2%) were previously diagnosed with HIV (PD); …