281 results match your criteria: "George Washington University Biostatistics Center[Affiliation]"
ZnT8 autoantibody prevalence is low in youth with type 2 diabetes and associated with higher insulin sensitivity, lower insulin secretion, and lower disposition index.
J Clin Transl Endocrinol
September 2022
Saint Louis University Health Sciences Center, Saint Louis, MO, United States.
Aim: ZnT8 autoantibody positivity (ZnT8+) is associated with risk for type 1 diabetes and with metabolic complications in adults. Our aim was to assess prevalence of ZnT8 + in the Treatment of T2D in Adolescents and Youth (TODAY) cohort and describe associated phenotypic outcomes.
Methods: TODAY participants were 13.
Digitally recorded and remotely classified lung auscultation compared with conventional stethoscope classifications among children aged 1-59 months enrolled in the Pneumonia Etiology Research for Child Health (PERCH) case-control study.
BMJ Open Respir Res
May 2022
Global Program in Respiratory Sciences, Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Background: Diagnosis of pneumonia remains challenging. Digitally recorded and remote human classified lung sounds may offer benefits beyond conventional auscultation, but it is unclear whether classifications differ between the two approaches. We evaluated concordance between digital and conventional auscultation.
View Article and Find Full Text PDFAssociation of Body Mass Index With the Use of Health Care Resources in Low-Risk Nulliparous Pregnancies After 39 Weeks of Gestation.
Obstet Gynecol
May 2022
Departments of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Health Sciences Center, Salt Lake City, Utah, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective: To compare health care medical resource utilization in low-risk nulliparous pregnancies according to body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) categories.
Methods: This is a secondary analysis of a multicenter randomized controlled trial of induction of labor between 39 0/7 39 and 4/7 weeks of gestation compared with expectant management in low-risk nulliparous pregnant people, defined as those without standard obstetric indications for delivery at 39 weeks. Body mass index at randomization was categorized into four groups (lower than 25, 25-29, 30-39, and 40 or higher).
Amniocentesis to diagnose congenital cytomegalovirus infection following maternal primary infection.
Am J Obstet Gynecol MFM
July 2022
Washington University in St. Louis, MO (Dr Macones).
Background: Congenital cytomegalovirus infection following maternal primary cytomegalovirus infection affects approximately 0.4% of newborns in the United States but may be hard to diagnose prenatally.
Objective: To evaluate the current sensitivity and specificity of amniocentesis in detecting congenital cytomegalovirus infection.
Information is power: The experiences, attitudes and needs of individuals who chose to have prenatal genomic sequencing for fetal anomalies.
Prenat Diagn
June 2022
Department of Pediatrics, Columbia University Irving Medical Center, New York, New York, USA.
Objective: This study sought to evaluate the experiences of individuals who chose to participate in a study and receive prenatal genomic sequencing (pGS) for fetuses with congenital structural anomalies.
Method: Individuals who received research results of prenatal sequencing were invited to participate in semi-structured interviews about their experiences. A constructivist grounded theory approach was used to code and analyze interviews.
Patients can experience different disease journeys and clinical trials that investigate the benefit of oncology treatments need to account for this diversity. When defining the treatment effect of interest in a trial, researchers thus have to account for events occurring after treatment initiation, such as the start of a new therapy, before observing the variable of interest. We review the estimand framework recently introduced by the International Council for Harmonisation(ICH, 2019)to structure discussions on the relationship between patient journeys and the treatment effect of interest in oncology trials.
View Article and Find Full Text PDFLike most complex(or multifactorial)diseases, cancer results not from a single factor, but rather from the interaction of multiple genes and environmental factors. Thus patients can experience different signs and symptoms that reflect more than one consequence of suffering the disease. When evaluating the effects of new treatments in cancer clinical trials, the multidimensional assessment using multiple outcomes to measure improvements in the patients' signs and symptoms associated with treatments would be preferred.
View Article and Find Full Text PDFEarly initiation of rivaroxaban after reperfusion therapy for stroke patients with nonvalvular atrial fibrillation.
PLoS One
April 2022
Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
Background: The optimal timing of initiating oral anticoagulants after reperfusion therapy for ischemic stroke is unknown. Factors related to early initiation of rivaroxaban and differences in clinical outcomes of stroke patients with nonvalvular atrial fibrillation (NVAF) who underwent reperfusion therapy was investigated.
Methods: From data of 1,333 NVAF patients with ischemic stroke or transient ischemic attack (TIA) in a prospective multicenter study, patients who started rivaroxaban after intravenous thrombolysis and/or mechanical thrombectomy were included.
Maternal Diabetes and Intrapartum Fetal Electrocardiogram.
Am J Perinatol
May 2024
University of Pittsburgh, Pittsburgh, Pennsylvania.
Objective: Fetal electrocardiogram (ECG) ST changes are associated with fetal cardiac hypoxia. Our objective was to evaluate ST changes by maternal diabetic status and stage of labor.
Methods: This was a secondary analysis of a multicentered randomized-controlled trial in which laboring patients with singleton gestations underwent fetal ECG scalp electrode placement and were randomly assigned to masked or unmasked ST-segment readings.
Importance: It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity.
Objective: To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications.
Design, Setting, And Participants: Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study.
Noninvasive Prediction of Congenital Cytomegalovirus Infection After Maternal Primary Infection.
Obstet Gynecol
March 2022
Departments of Obstetrics and Gynecology, Brown University, Providence, Rhode Island, University of Texas Medical Branch at Galveston, Galveston, Texas, Northwestern University, Chicago, Illinois, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Alabama at Birmingham, Birmingham, Alabama, The Ohio State University, Columbus, Ohio, Duke University, Durham, North Carolina University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, Case Western Reserve University, Cleveland, Ohio, University of Texas Health Science Center at Houston and Children's Memorial Hermann Hospital, Houston, Texas, Stanford University, Stanford, California, University of Texas Southwestern Medical Center, Dallas, Texas University of Pennsylvania, Philadelphia, Pennsylvania, University of Pittsburgh, Pittsburgh, Pennsylvania, Madigan Army Medical Center, Joint Base Lewis-McChord, Washington, and Washington University in St. Louis, St. Louis, Missouri; the Departments of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, and Duke University, Durham, North Carolina; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective: To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection.
Methods: We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection.
Objective: To evaluate whether hypertensive disorders of pregnancy (HDP) among low-risk nulliparous women expectantly managed at or after 39 weeks of gestation are associated with adverse outcomes.
Design: Secondary analysis of a randomised trial.
Setting: Multicentre, USA.
Objective: Antenatal and early neonatal nutritional environment may influence later metabolic health. Infants of mothers with gestational diabetes mellitus (GDM) have higher risk for childhood obesity and metabolic syndrome (MetS). Leptin and adiponectin are known biomarkers for MetS and may guide interventions to reduce later obesity.
View Article and Find Full Text PDFRacial and Ethnic Inequities in Cesarean Birth and Maternal Morbidity in a Low-Risk, Nulliparous Cohort.
Obstet Gynecol
January 2022
Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch at Galveston, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, and the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective: To evaluate race and ethnicity differences in cesarean birth and maternal morbidity in low-risk nulliparous people at term.
Methods: We conducted a secondary analysis of a randomized trial of expectant management compared with induction of labor in low-risk nulliparous people at term. The primary outcome was cesarean birth.
Prenatal Nicotine or Cannabis Exposure and Offspring Neurobehavioral Outcomes.
Obstet Gynecol
January 2022
Departments of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah, University of Texas-Southwestern, Dallas, Texas, Columbia University, New York, New York, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Medical Branch at Galveston, Galveston, Texas, University of Alabama at Birmingham, Birmingham, Alabama, Northwestern University, Chicago, Illinois, Brown University, Providence, Rhode Island, University of Texas-Houston, Houston, Texas, The Ohio State University, Columbus, Ohio, Case Western Reserve University, Cleveland, Ohio, and University of Pittsburgh, Pittsburgh, Pennsylvania; the Department of Pathology, University of Utah Health and ARUP Laboratories, Salt Lake City, Utah; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective: To study the association between nicotine or cannabis metabolite presence in maternal urine and child neurodevelopmental outcomes.
Methods: We conducted a secondary analysis of two parallel multicenter randomized controlled trials of treatment for hypothyroxinemia or subclinical hypothyroidism among pregnant individuals enrolled at 8-20 weeks of gestation. All maternal-child dyads with a maternal urine sample at enrollment and child neurodevelopmental testing were included (N=1,197).
Bridging Therapy With Heparin Before Starting Rivaroxaban in Ischemic Stroke or Transient Ischemic Attack With Non-Valvular Atrial Fibrillation.
Circ J
May 2022
Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center.
Article Synopsis
- - The study investigated how bridging therapy with heparin before starting rivaroxaban affects outcomes in patients with non-valvular atrial fibrillation (NVAF) who suffered from ischemic stroke or transient ischemic attack (TIA).
- - Over 90 days, researchers tracked 1,308 patients, noting that while there wasn't a significant link between bridging therapy and individual ischemic events or major bleeding, the combined risk of these events was notably higher for those who received heparin.
- - Ultimately, the findings suggest that patients with NVAF who underwent bridging therapy experienced more frequent composite outcomes of ischemic events and bleeding compared to those who directly began treatment with rivaroxaban.
Oral Glucose Tolerance Test in Pregnancy and Subsequent Maternal Hypertension.
Am J Perinatol
December 2023
Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.
Article Synopsis
- The study investigates whether the glucose response during the oral glucose tolerance test (OGTT) in pregnancy can predict the risk of developing hypertension later in life.
- It analyzes data from participants who had abnormal glucose tests during pregnancy, assessing their blood pressure years later and looking for correlations with OGTT values and trends.
- Results indicate a significant relationship between certain OGTT outcomes—specifically, a 2-hour glucose level and a monophasic response pattern—with higher risks of elevated blood pressure and hypertension in the long term.
Association between Hypertensive Disorders of Pregnancy and Long-Term Neurodevelopmental Outcomes in the Offspring.
Am J Perinatol
July 2022
Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Objective: The long-term impact of hypertensive disorders of pregnancy (HDP) exposure on offspring health is an emerging research area. The objective of this study was to evaluate the association between a maternal diagnosis of HDP (gestational hypertension and preeclampsia) and adverse neurodevelopmental outcomes in the offspring.
Study Design: This was a secondary analysis of two parallel multicenter clinical trials of thyroxine therapy for subclinical hypothyroid disorders in pregnancy.
Fetal Tachycardia in the Setting of Maternal Intrapartum Fever and Perinatal Morbidity.
Am J Perinatol
January 2024
Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.
Objective: The fetal consequences of intrapartum fetal tachycardia with maternal fever or clinical chorioamnionitis are not well studied. We evaluated the association between perinatal morbidity and fetal tachycardia in the setting of intrapartum fever.
Study Design: Secondary analysis of a multicenter randomized control trial that enrolled 5,341 healthy laboring nulliparous women ≥36 weeks' gestation.
Resolution of Hydronephrosis and Pain to Predict Stone Passage for Patients With Acute Renal Colic.
Urology
January 2022
Department of Emergency Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC. Electronic address:
Objective: To study patients who presented to the Emergency Department with acute renal colic to determine if resolution of hydronephrosis and pain accurately predicts stone passage on follow-up CT.
Materials And Methods: This is a secondary analysis of a multicenter prospective randomized clinical trial of patients diagnosed by computed tomography (CT) scan with a symptomatic ureteral stone < 9 mm in diameter. Participants were followed after randomization to evaluate for analgesic use and to assess stone passage and hydronephrosis on a repeat CT scan obtained at 29-36 days.
Outcomes in Twins Compared With Singletons Subsequent to Preterm Prelabor Rupture of Membranes.
Obstet Gynecol
November 2021
Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas, Northwestern University, Chicago, Illinois, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, Brown University, Providence, Rhode Island, and the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective: To compare maternal and neonatal outcomes after preterm prelabor rupture of membranes (PROM) from 23 to 34 weeks of gestation in twin compared with singleton gestations.
Methods: We conducted a secondary analysis of an obstetric cohort of 115,502 individuals and their singleton or twin neonates born in 25 hospitals nationwide (2008-2011). Those with preterm PROM from 23 0/7 through 33 6/7 weeks of gestation were included; neonates with major fetal anomalies were excluded.
Longitudinal changes in vascular stiffness and heart rate variability among young adults with youth-onset type 2 diabetes: results from the follow-up observational treatment options for type 2 diabetes in adolescents and youth (TODAY) study.
Acta Diabetol
February 2022
Cincinnati Children's Hospital Medical Center & University of Cincinnati, Cincinnati, OH, USA.
Aims: (1) To describe changes in arterial stiffness and heart rate variability (HRV) over a 5-year interval, (2) examine changes by sex and race-ethnicity, and (3) evaluate the risk factors associated with the longitudinal changes in arterial stiffness and HRV.
Methods: Participants with youth-onset type 2 diabetes enrolled in the observational follow-up phase of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial had arterial stiffness [(pulse wave velocity, augmentation index, brachial distensibility] and six indices of HRV measured 5 years apart. Multivariable linear regression models assessed risk factors associated with changes in the outcomes over time.
Intrapartum Fetal Electrocardiogram in Small- and Large-for-Gestational Age Fetuses.
Am J Perinatol
December 2021
Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Objective: This study aimed to evaluate whether intrapartum fetal electrocardiogram (ECG) tracings with ST-elevation or depression occur more frequently in each stage of labor in small-for-gestational age (SGA) or large-for-gestational age (LGA), as compared with appropriate-for-gestational age (AGA) fetuses.
Study Design: We conducted a secondary analysis of a large, multicenter trial in which laboring patients underwent fetal ECG waveform-analysis. We excluded participants with diabetes mellitus and major fetal anomalies.
Maternal and Neonatal Outcomes in Nulliparous Participants Undergoing Labor Induction by Cervical Ripening Method.
Am J Perinatol
July 2023
Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Objective: This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals.
Study Design: This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included.
Intrapartum Resuscitation Interventions for Category II Fetal Heart Rate Tracings and Improvement to Category I.
Obstet Gynecol
September 2021
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD; the Departments of Obstetrics and Gynecology, the University of Texas Medical Branch at Galveston, Galveston, Texas, the University of Utah Health Sciences Center, Salt Lake City, Utah, the University of Texas McGovern Medical School at UT Health, Houston, Texas, the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, the University of Alabama at Birmingham, Birmingham, Alabama, Columbia University, New York, New York, Northwestern University, Chicago, Illinois, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Brown University, Providence, Rhode Island, Stanford University, Stanford, California, Wayne State University, Detroit, Michigan, and the University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.
Objective: To evaluate intrapartum resuscitation interventions and improvement in category II fetal heart rate (FHR) tracings.
Methods: This secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis included all participants with category II FHR tracings undergoing intrauterine resuscitation: maternal oxygen, intravenous fluid bolus, amnioinfusion, or tocolytic administration. Fetal heart rate pattern-recognition software was used to confirm category II FHR tracings 30 minutes before intervention and to analyze the subsequent 60 minutes.