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Huiman Xie Barnhart

James B. Duke Distinguished Professor
Biostatistics & Bioinformatics, Division of Biostatistics
Duke Box 3850, Durham, NC 27710
2424 Erwin Road, SUITE1102 Hock Plaza, Durham, NC 27710

Selected Publications


Clinical characteristics and HLA associations of azithromycin-induced liver injury.

Journal Article Aliment Pharmacol Ther · September 2024 BACKGROUND: Azithromycin (AZ) is a widely used antibiotic. The aim of this study was to characterise the clinical features, outcomes, and HLA association in patients with drug-induced liver injury (DILI) due to AZ. METHODS: The clinical characteristics of ... Full text Link to item Cite

Genetic variants associated with immune-mediated liver injury from checkpoint inhibitors.

Journal Article Hepatol Commun · September 1, 2024 BACKGROUND: The clinical features, liver histology, and genetic variants in 57 patients with moderate to severe immune-mediated liver injury from checkpoint inhibitors (ILICI) are presented. METHODS: Between 2010 and 2022, 57 high-causality ILICI cases wer ... Full text Link to item Cite

Comparison of Measures of Pain Intensity During Sickle Cell Disease Vaso-Occlusive Episodes.

Journal Article J Pain · August 21, 2024 We aimed to determine the minimal clinically important difference (MCID) in pain severity and agreement between the visual analog scale (VAS) and the verbal numeric rating scale (NRS) in people with sickle cell disease (SCD) experiencing an acute vaso-occl ... Full text Link to item Cite

Characterisation of an outbreak of acute liver injury after ingestion of plant-based food supplement.

Journal Article Aliment Pharmacol Ther · August 2024 BACKGROUND: In April 2022, French Lentil and Leek Crumble (FLLC), a new frozen food preparation manufactured by Daily Harvestâ„¢ (containing Tara flour) was offered as a natural high-protein meal product. Soon thereafter, widespread anecdotal reports of acut ... Full text Link to item Cite

Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.

Journal Article Med Care · July 18, 2024 BACKGROUND/OBJECTIVE: Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression. METHODS: We evaluated the effect of a pharmacist-led intervention focused on ... Full text Link to item Cite

Drug-induced liver injury (DILI) ascribed to non-steroidal anti-inflammatory drugs (NSAIDs) in the USA-Update with genetic correlations.

Journal Article Liver Int · June 2024 OBJECTIVE: To describe patients with NSAID-DILI, including genetic factors associated with idiosyncratic DILI. METHODS: In DILIN, subjects with presumed DILI are enrolled and followed for at least 6 months. Causality is adjudicated by a Delphic approach. H ... Full text Link to item Cite

Drug-Induced Liver Injury in Pregnancy: The U.S. Drug-Induced Liver Injury Network Experience.

Journal Article Obstet Gynecol · June 1, 2024 There are limited data on the causative agents and characteristics of drug-induced liver injury in pregnant individuals. Data from patients with drug-induced liver injury enrolled in the ongoing multicenter Drug-Induced Liver Injury Network between 2004 an ... Full text Link to item Cite

Amiodarone and Dronedarone Causes Liver Injury with Distinctly Different Clinical Presentations.

Journal Article Dig Dis Sci · April 2024 OBJECTIVE: To describe hepatotoxicity due to amiodarone and dronedarone from the DILIN and the US FDA's surveillance database. METHODS: Hepatotoxicity due to amiodarone and dronedarone enrolled in the U.S. Drug Induced Liver Injury Network (DILIN) from 200 ... Full text Link to item Cite

HLA-B*53:01 Is a Significant Risk Factor of Liver Injury due to Phenytoin and Other Antiepileptic Drugs in African Americans.

Journal Article Am J Gastroenterol · January 1, 2024 INTRODUCTION: To investigate human leukocyte antigen alleles associated with liver injury due to antiepileptic drugs (AEDs) in African Americans (AA). METHODS: In this study, 21 AA with AED drug-induced liver injury (DILI), 176 AA with DILI due to non-AEDs ... Full text Link to item Cite

Vancomycin-Induced Liver Injury, DRESS, and HLA-A∗32:01.

Journal Article J Allergy Clin Immunol Pract · January 2024 BACKGROUND: Intravenous vancomycin therapy can cause liver injury as well as "drug reaction with eosinophilia and systemic symptoms" (DRESS) syndrome. This study aimed to better define the clinical features and HLA associations of vancomycin-induced liver ... Full text Link to item Cite

Trial Design with Win Statistics for Multiple Time-to-Event Endpoints with Hierarchy

Journal Article Statistics in Biopharmaceutical Research · January 1, 2024 The conventional approach to the analysis of composite endpoints is time-to-first event analysis. However, this approach has been criticized because it ignores the differences in clinical severity and may end up emphasizing the less severe time-to-event. T ... Full text Cite

Biomarkers of erythropoiesis response to intravenous iron in a crossover pilot study in unexplained anemia of the elderly.

Journal Article Hematology · December 2023 Anemia is common in older adults, but often unexplained. Previously, we conducted a randomized, controlled trial of intravenous (IV) iron sucrose to study its impact on the 6-minute walk test and hemoglobin in older adults with unexplained anemia and ferri ... Full text Link to item Cite

When Is Suspected Drug-Induced Liver Injury (DILI) Not DILI? An Analysis of Unlikely Cases From the Drug-Induced Liver Injury Network.

Journal Article Am J Gastroenterol · December 1, 2023 INTRODUCTION: Diagnosis of drug-induced liver injury (DILI) is difficult. We reviewed cases in the DILI Network prospective study that were adjudicated to have liver injury due to other causes to discover pearls for improved diagnostic accuracy. METHODS: C ... Full text Link to item Cite

A comparison of the effect of patient-specific versus weight-based protocols to treat vaso-occlusive episodes in the emergency department.

Journal Article Acad Emerg Med · December 2023 BACKGROUND: Vaso-occlusive crises (VOCs) cause debilitating pain and are a common cause of emergency department (ED) visits, for people with sickle cell disease (SCD). Strategies for achieving optimal pain control vary widely despite evidence-based guideli ... Full text Open Access Link to item Cite

The Impact of Patient Age and Corticosteroids in Patients With Sulfonamide Hepatotoxicity.

Journal Article Am J Gastroenterol · September 1, 2023 INTRODUCTION: Sulfonamides are widely used to treat and prevent various bacterial and opportunistic infections. The aim of this study was to describe the clinical presentation and outcomes of a large cohort of patients with sulfonamide hepatotoxicity. METH ... Full text Link to item Cite

Identification of Reduced ERAP2 Expression and a Novel HLA Allele as Components of a Risk Score for Susceptibility to Liver Injury Due to Amoxicillin-Clavulanate.

Journal Article Gastroenterology · March 2023 BACKGROUND & AIMS: Drug-induced liver injury (DILI) due to amoxicillin-clavulanate (AC) has been associated with HLA-A∗02:01, HLA-DRB1∗15:01, and rs2476601, a missense variant in PTPN22. The aim of this study was to identify novel risk factors for AC-DILI ... Full text Link to item Cite

Clinical features, outcomes, and HLA risk factors associated with nitrofurantoin-induced liver injury.

Journal Article J Hepatol · February 2023 BACKGROUND & AIMS: Nitrofurantoin (NTF) is widely used for the treatment (short-term) and prevention (long-term) of urinary tract infections. We aimed to describe the clinical characteristics, outcomes, and HLA risk factors for NTF-induced liver injury (NT ... Full text Link to item Cite

Multiparametric Quantitative Imaging Biomarkers for Phenotype Classification: A Framework for Development and Validation.

Journal Article Acad Radiol · February 2023 This manuscript is the third in a five-part series related to statistical assessment methodology for technical performance of multi-parametric quantitative imaging biomarkers (mp-QIBs). We outline approaches and statistical methodologies for developing and ... Full text Link to item Cite

Multiparametric Quantitative Imaging in Risk Prediction: Recommendations for Data Acquisition, Technical Performance Assessment, and Model Development and Validation.

Journal Article Acad Radiol · February 2023 Combinations of multiple quantitative imaging biomarkers (QIBs) are often able to predict the likelihood of an event of interest such as death or disease recurrence more effectively than single imaging measurements can alone. The development of such multip ... Full text Link to item Cite

Liver Injury Associated with Turmeric-A Growing Problem: Ten Cases from the Drug-Induced Liver Injury Network [DILIN].

Journal Article Am J Med · February 2023 BACKGROUND: Turmeric is a commonly used herbal product that has been implicated in causing liver injury. The aim of this case series is to describe the clinical, histologic, and human leukocyte antigen (HLA) associations of turmeric-associated liver injury ... Full text Link to item Cite

Clinical characteristics and HLA associations of azithromycin-induced liver injury.

Journal Article Aliment Pharmacol Ther · September 2024 BACKGROUND: Azithromycin (AZ) is a widely used antibiotic. The aim of this study was to characterise the clinical features, outcomes, and HLA association in patients with drug-induced liver injury (DILI) due to AZ. METHODS: The clinical characteristics of ... Full text Link to item Cite

Genetic variants associated with immune-mediated liver injury from checkpoint inhibitors.

Journal Article Hepatol Commun · September 1, 2024 BACKGROUND: The clinical features, liver histology, and genetic variants in 57 patients with moderate to severe immune-mediated liver injury from checkpoint inhibitors (ILICI) are presented. METHODS: Between 2010 and 2022, 57 high-causality ILICI cases wer ... Full text Link to item Cite

Comparison of Measures of Pain Intensity During Sickle Cell Disease Vaso-Occlusive Episodes.

Journal Article J Pain · August 21, 2024 We aimed to determine the minimal clinically important difference (MCID) in pain severity and agreement between the visual analog scale (VAS) and the verbal numeric rating scale (NRS) in people with sickle cell disease (SCD) experiencing an acute vaso-occl ... Full text Link to item Cite

Characterisation of an outbreak of acute liver injury after ingestion of plant-based food supplement.

Journal Article Aliment Pharmacol Ther · August 2024 BACKGROUND: In April 2022, French Lentil and Leek Crumble (FLLC), a new frozen food preparation manufactured by Daily Harvestâ„¢ (containing Tara flour) was offered as a natural high-protein meal product. Soon thereafter, widespread anecdotal reports of acut ... Full text Link to item Cite

Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.

Journal Article Med Care · July 18, 2024 BACKGROUND/OBJECTIVE: Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression. METHODS: We evaluated the effect of a pharmacist-led intervention focused on ... Full text Link to item Cite

Drug-induced liver injury (DILI) ascribed to non-steroidal anti-inflammatory drugs (NSAIDs) in the USA-Update with genetic correlations.

Journal Article Liver Int · June 2024 OBJECTIVE: To describe patients with NSAID-DILI, including genetic factors associated with idiosyncratic DILI. METHODS: In DILIN, subjects with presumed DILI are enrolled and followed for at least 6 months. Causality is adjudicated by a Delphic approach. H ... Full text Link to item Cite

Drug-Induced Liver Injury in Pregnancy: The U.S. Drug-Induced Liver Injury Network Experience.

Journal Article Obstet Gynecol · June 1, 2024 There are limited data on the causative agents and characteristics of drug-induced liver injury in pregnant individuals. Data from patients with drug-induced liver injury enrolled in the ongoing multicenter Drug-Induced Liver Injury Network between 2004 an ... Full text Link to item Cite

Amiodarone and Dronedarone Causes Liver Injury with Distinctly Different Clinical Presentations.

Journal Article Dig Dis Sci · April 2024 OBJECTIVE: To describe hepatotoxicity due to amiodarone and dronedarone from the DILIN and the US FDA's surveillance database. METHODS: Hepatotoxicity due to amiodarone and dronedarone enrolled in the U.S. Drug Induced Liver Injury Network (DILIN) from 200 ... Full text Link to item Cite

HLA-B*53:01 Is a Significant Risk Factor of Liver Injury due to Phenytoin and Other Antiepileptic Drugs in African Americans.

Journal Article Am J Gastroenterol · January 1, 2024 INTRODUCTION: To investigate human leukocyte antigen alleles associated with liver injury due to antiepileptic drugs (AEDs) in African Americans (AA). METHODS: In this study, 21 AA with AED drug-induced liver injury (DILI), 176 AA with DILI due to non-AEDs ... Full text Link to item Cite

Vancomycin-Induced Liver Injury, DRESS, and HLA-A∗32:01.

Journal Article J Allergy Clin Immunol Pract · January 2024 BACKGROUND: Intravenous vancomycin therapy can cause liver injury as well as "drug reaction with eosinophilia and systemic symptoms" (DRESS) syndrome. This study aimed to better define the clinical features and HLA associations of vancomycin-induced liver ... Full text Link to item Cite

Trial Design with Win Statistics for Multiple Time-to-Event Endpoints with Hierarchy

Journal Article Statistics in Biopharmaceutical Research · January 1, 2024 The conventional approach to the analysis of composite endpoints is time-to-first event analysis. However, this approach has been criticized because it ignores the differences in clinical severity and may end up emphasizing the less severe time-to-event. T ... Full text Cite

Biomarkers of erythropoiesis response to intravenous iron in a crossover pilot study in unexplained anemia of the elderly.

Journal Article Hematology · December 2023 Anemia is common in older adults, but often unexplained. Previously, we conducted a randomized, controlled trial of intravenous (IV) iron sucrose to study its impact on the 6-minute walk test and hemoglobin in older adults with unexplained anemia and ferri ... Full text Link to item Cite

When Is Suspected Drug-Induced Liver Injury (DILI) Not DILI? An Analysis of Unlikely Cases From the Drug-Induced Liver Injury Network.

Journal Article Am J Gastroenterol · December 1, 2023 INTRODUCTION: Diagnosis of drug-induced liver injury (DILI) is difficult. We reviewed cases in the DILI Network prospective study that were adjudicated to have liver injury due to other causes to discover pearls for improved diagnostic accuracy. METHODS: C ... Full text Link to item Cite

A comparison of the effect of patient-specific versus weight-based protocols to treat vaso-occlusive episodes in the emergency department.

Journal Article Acad Emerg Med · December 2023 BACKGROUND: Vaso-occlusive crises (VOCs) cause debilitating pain and are a common cause of emergency department (ED) visits, for people with sickle cell disease (SCD). Strategies for achieving optimal pain control vary widely despite evidence-based guideli ... Full text Open Access Link to item Cite

The Impact of Patient Age and Corticosteroids in Patients With Sulfonamide Hepatotoxicity.

Journal Article Am J Gastroenterol · September 1, 2023 INTRODUCTION: Sulfonamides are widely used to treat and prevent various bacterial and opportunistic infections. The aim of this study was to describe the clinical presentation and outcomes of a large cohort of patients with sulfonamide hepatotoxicity. METH ... Full text Link to item Cite

Identification of Reduced ERAP2 Expression and a Novel HLA Allele as Components of a Risk Score for Susceptibility to Liver Injury Due to Amoxicillin-Clavulanate.

Journal Article Gastroenterology · March 2023 BACKGROUND & AIMS: Drug-induced liver injury (DILI) due to amoxicillin-clavulanate (AC) has been associated with HLA-A∗02:01, HLA-DRB1∗15:01, and rs2476601, a missense variant in PTPN22. The aim of this study was to identify novel risk factors for AC-DILI ... Full text Link to item Cite

Clinical features, outcomes, and HLA risk factors associated with nitrofurantoin-induced liver injury.

Journal Article J Hepatol · February 2023 BACKGROUND & AIMS: Nitrofurantoin (NTF) is widely used for the treatment (short-term) and prevention (long-term) of urinary tract infections. We aimed to describe the clinical characteristics, outcomes, and HLA risk factors for NTF-induced liver injury (NT ... Full text Link to item Cite

Multiparametric Quantitative Imaging Biomarkers for Phenotype Classification: A Framework for Development and Validation.

Journal Article Acad Radiol · February 2023 This manuscript is the third in a five-part series related to statistical assessment methodology for technical performance of multi-parametric quantitative imaging biomarkers (mp-QIBs). We outline approaches and statistical methodologies for developing and ... Full text Link to item Cite

Multiparametric Quantitative Imaging in Risk Prediction: Recommendations for Data Acquisition, Technical Performance Assessment, and Model Development and Validation.

Journal Article Acad Radiol · February 2023 Combinations of multiple quantitative imaging biomarkers (QIBs) are often able to predict the likelihood of an event of interest such as death or disease recurrence more effectively than single imaging measurements can alone. The development of such multip ... Full text Link to item Cite

Liver Injury Associated with Turmeric-A Growing Problem: Ten Cases from the Drug-Induced Liver Injury Network [DILIN].

Journal Article Am J Med · February 2023 BACKGROUND: Turmeric is a commonly used herbal product that has been implicated in causing liver injury. The aim of this case series is to describe the clinical, histologic, and human leukocyte antigen (HLA) associations of turmeric-associated liver injury ... Full text Link to item Cite

Multiparametric Data-driven Imaging Markers: Guidelines for Development, Application and Reporting of Model Outputs in Radiomics.

Journal Article Acad Radiol · February 2023 This paper is the fifth in a five-part series on statistical methodology for performance assessment of multi-parametric quantitative imaging biomarkers (mpQIBs) for radiomic analysis. Radiomics is the process of extracting visually imperceptible features f ... Full text Link to item Cite

Multiparametric Quantitative Imaging Biomarker as a Multivariate Descriptor of Health: A Roadmap.

Journal Article Acad Radiol · February 2023 Multiparametric quantitative imaging biomarkers (QIBs) offer distinct advantages over single, univariate descriptors because they provide a more complete measure of complex, multidimensional biological systems. In disease, where structural and functional d ... Full text Link to item Cite

Incidence of Hepatitis E Infection in American Patients With Suspected Drug-Induced Liver Injury Is Low and Declining: The DILIN Prospective Study.

Journal Article Am J Gastroenterol · September 1, 2022 INTRODUCTION: Hepatitis E virus (HEV) infection rarely causes icteric hepatitis, yet 10%-40% of adult Americans have serological evidence of previous infection. The aim of this study was to investigate the incidence, presentation, and outcome of acute and ... Full text Link to item Cite

A revised electronic version of RUCAM for the diagnosis of DILI.

Journal Article Hepatology · July 2022 BACKGROUND AND AIMS: Roussel Uclaf Causality Assessment Method (RUCAM) for DILI has been hindered by subjectivity and poor reliability. We sought to improve the RUCAM using data from the Drug-Induced Liver Injury Network (DILIN) and the Spanish DILI Regist ... Full text Link to item Cite

Garcinia cambogia, Either Alone or in Combination With Green Tea, Causes Moderate to Severe Liver Injury.

Journal Article Clin Gastroenterol Hepatol · June 2022 BACKGROUND & AIMS: Garcinia cambogia, either alone or with green tea, is commonly promoted for weight loss. Sporadic cases of liver failure from G cambogia have been reported, but its role in liver injury is controversial. METHODS: Among 1418 patients enro ... Full text Link to item Cite

Leflunomide-induced liver injury: Differences in characteristics and outcomes in Indian and US registries.

Journal Article Liver Int · June 2022 BACKGROUND: Leflunomide, a disease-modifying anti-rheumatic drug, has been associated with elevations of serum aminotransferases. Herein, we describe the clinical, laboratory features and outcomes of 17 patients with leflunomide/teriflunomide hepatotoxicit ... Full text Link to item Cite

Value of liver biopsy in the diagnosis of drug-induced liver injury.

Journal Article J Hepatol · May 2022 BACKGROUND & AIMS: The utility of liver biopsy in diagnosing or staging idiosyncratic drug-induced liver injury (DILI) is unclear. The aim of this study was to determine whether liver histology impacted causality assessment in suspected DILI using a novel ... Full text Link to item Cite

Clinical characteristics of antiepileptic-induced liver injury in patients from the DILIN prospective study.

Journal Article J Hepatol · April 2022 BACKGROUND & AIMS: Antiepileptic drugs (AEDs) are a common cause of drug-induced liver injury (DILI). Over the last few decades, several newer AEDs were approved for marketing in the United States, and they are increasingly prescribed for indications other ... Full text Link to item Cite

Allopurinol hepatotoxicity is associated with human leukocyte antigen Class I alleles.

Journal Article Liver Int · August 2021 BACKGROUND/AIMS: Allopurinol can cause HLA class I-associated life-threatening severe skin reactions. However, HLA risk and association with clinical features in allopurinol hepatotoxicity are unknown. METHODS: Eleven of 17 patients with suspected allopuri ... Full text Link to item Cite

HLA-B*35:01 and Green Tea-Induced Liver Injury.

Journal Article Hepatology · June 2021 BACKGROUND AND AIMS: Herbal supplements, and particularly multi-ingredient products, have become increasingly common causes of acute liver injury. Green tea is a frequent component in implicated products, but its role in liver injury is controversial. The ... Full text Link to item Cite

Differences in NT-proBNP Response and Prognosis in Men and Women With Heart Failure With Reduced Ejection Fraction.

Journal Article J Am Heart Assoc · May 18, 2021 Background NT-proBNP (N-terminal pro-B-type natriuretic peptide) is a prognostic biomarker in heart failure (HF) with reduced ejection fraction. However, it is unclear whether there is a sex difference in NT-proBNP response and whether the therapeutic goal ... Full text Link to item Cite

Trial design of comparing patient-specific versus weight-based protocols to treat vaso-occlusive episodes in sickle cell disease (COMPARE-VOE).

Journal Article Contemp Clin Trials · February 2021 OBJECTIVES: Painful vaso-occlusive episodes (VOE) are the most common reason for emergency department (ED) visits experienced by patients with sickle cell disease (SCD). The National Heart, Lung and Blood Institute (NHLBI) evidence-based recommendations fo ... Full text Link to item Cite

Human Leukocyte Antigen B*14:01 and B*35:01 Are Associated With Trimethoprim-Sulfamethoxazole Induced Liver Injury.

Journal Article Hepatology · January 2021 BACKGROUND AND AIMS: Trimethoprim (TMP)-sulfamethoxazole (SMX) is an important cause of idiosyncratic drug-induced liver injury (DILI), but its genetic risk factors are not well understood. This study investigated the relationship between variants in the h ... Full text Link to item Cite

Liver injury associated with kratom, a popular opioid-like product: Experience from the U.S. drug induced liver injury network and a review of the literature.

Journal Article Drug Alcohol Depend · January 1, 2021 BACKGROUND: Kratom is a botanical product used as an opium substitute with abuse potential. METHODS: Assessment of suspected cases of kratom-induced liver injury in a prospective US cohort. RESULTS: Eleven cases of liver injury attributed to kratom were id ... Full text Link to item Cite

Publisher Correction: Genome-wide association of polycystic ovary syndrome implicates alterations in gonadotropin secretion in European ancestry populations.

Journal Article Nat Commun · April 28, 2020 An amendment to this paper has been published and can be accessed via a link at the top of the paper. ... Full text Link to item Cite

Significant Medical Comorbidities Are Associated With Lower Causality Scores in Patients Presenting With Suspected Drug-Induced Liver Injury.

Journal Article Clin Transl Gastroenterol · April 2020 INTRODUCTION: Drug-induced liver injury (DILI) is a diagnosis of exclusion, and it can be challenging to adjudicate when there are multiple comorbidities and concomitant medications. In this study, we tested the hypothesis that comorbidity burden impacts t ... Full text Link to item Cite

Development and Validation of a Model Consisting of Comorbidity Burden to Calculate Risk of Death Within 6 Months for Patients With Suspected Drug-Induced Liver Injury.

Journal Article Gastroenterology · November 2019 BACKGROUND & AIMS: Patients with drug-induced liver injury (DILI) frequently have comorbid conditions, but the effects of non-liver comorbidities on outcomes are not well understood. We investigated the association between comorbidity burden and outcomes o ... Full text Link to item Cite

Incident anaemia in older adults with heart failure: rate, aetiology, and association with outcomes.

Journal Article Eur Heart J Qual Care Clin Outcomes · October 1, 2019 AIMS: Limited data exist on the epidemiology, evaluation, and prognosis of otherwise unexplained anaemia of the elderly in heart failure (HF). Thus, we aimed to determine the incidence of anaemia, to characterize diagnostic testing patterns for potentially ... Full text Link to item Cite

Importance of Hepatitis C Virus RNA Testing in Patients with Suspected Drug-Induced Liver Injury.

Journal Article Dig Dis Sci · September 2019 BACKGROUND AND AIMS: The aims were to review the diagnosis, testing and presentation of acute hepatitis C (HCV) in patients initially diagnosed to have drug-induced liver injury (DILI) enrolled in the US DILI Network. METHODS: All patients with suspected D ... Full text Link to item Cite

Antimicrobials and Antiepileptics Are the Leading Causes of Idiosyncratic Drug-induced Liver Injury in American Children.

Journal Article J Pediatr Gastroenterol Nutr · August 2019 OBJECTIVES: The aim of this study was to provide an overview of the presenting features, etiologies, and outcomes of children enrolled in the Drug-induced Liver Injury Network (DILIN) prospective and retrospective studies. METHODS: Consecutive definite, hi ... Full text Link to item Cite

Severe and protracted cholestasis in 44 young men taking bodybuilding supplements: assessment of genetic, clinical and chemical risk factors.

Journal Article Aliment Pharmacol Ther · May 2019 BACKGROUND: Bodybuilding supplements can cause a profound cholestatic syndrome. AIM: To describe the drug-Induced liver injury network's experience with liver injury due to bodybuilding supplements. METHODS: Liver injury pattern, severity and outcomes, pot ... Full text Link to item Cite

Sclerosing Cholangitis-Like Changes on Magnetic Resonance Cholangiography in Patients With Drug Induced Liver Injury.

Journal Article Clin Gastroenterol Hepatol · March 2019 Drug-induced liver injury can lead to changes of the biliary tree that resemble sclerosing cholangitis. These changes can be seen on magnetic resonance cholangiopancreatography. Idiosyncratic drug-induced liver injury (DILI) has a variable presentation inc ... Full text Link to item Cite

NT-proBNP Goal Achievement Is Associated With Significant Reverse Remodeling and Improved Clinical Outcomes in HFrEF.

Journal Article JACC Heart Fail · February 2019 OBJECTIVES: This study aims to assess the association between biomarker-guided therapy and left ventricular (LV) remodeling. BACKGROUND: In patients with heart failure with reduced ejection fraction (HFrEF), it is unclear if lowering natriuretic peptides r ... Full text Link to item Cite

Genetic Polymorphisms Implicated in Nonalcoholic Liver Disease or Selected Other Disorders Have No Influence on Drug-Induced Liver Injury

Journal Article Hepatology Communications · January 1, 2019 With the application of genetic testing to contemporary medical diagnostics and practice, it has become apparent that the phenotypes of many disorders are modulated by host genetic factors. The aim of the current study was to determine whether selected sin ... Full text Cite

The role of HLA-A*33:01 in patients with cholestatic hepatitis attributed to terbinafine.

Journal Article J Hepatol · December 2018 BACKGROUND & AIMS: Terbinafine is an antifungal agent that has been associated with rare instances of hepatotoxicity. In this study we aimed to describe the presenting features and outcomes of patients with terbinafine hepatotoxicity and to investigate the ... Full text Link to item Cite

Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.

Journal Article Contemp Clin Trials · June 2018 UNLABELLED: Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This man ... Full text Open Access Link to item Cite

Echocardiography Core Laboratory Reproducibility of Cardiac Safety Assessments in Cardio-Oncology.

Journal Article J Am Soc Echocardiogr · March 2018 BACKGROUND: As the potential for cancer therapy-related cardiac dysfunction is increasingly recognized, there is a need for the standardization of echocardiographic measurements and cut points to guide treatment. The aim of this study was to determine the ... Full text Link to item Cite

Ambulatory blood pressure in the dash diet trial: Effects of race and albuminuria.

Journal Article J Clin Hypertens (Greenwich) · February 2018 We evaluated whether low-grade albuminuria or black race modulates ambulatory blood pressure (BP) or nocturnal BP response to the DASH diet. Among 202 adults enrolled in the DASH multicenter trial who were fed the DASH or control diet for 8 weeks, reductio ... Full text Link to item Cite

Cytokine profiles in acute liver injury-Results from the US Drug-Induced Liver Injury Network (DILIN) and the Acute Liver Failure Study Group.

Journal Article PLoS One · 2018 Changes in levels of cytokines and chemokines have been proposed as possible biomarkers of tissue injury, including liver injury due to drugs. Recently, in acute drug-induced liver injury (DILI), we showed that 19 of 27 immune analytes were differentially ... Full text Open Access Link to item Cite

Racial differences in nocturnal dipping status in diabetic kidney disease: Results from the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study.

Journal Article J Clin Hypertens (Greenwich) · December 2017 While racial variation in ambulatory blood pressure (BP) is known, patterns of diurnal dipping in the context of diabetic kidney disease have not been well defined. The authors sought to determine the association of race with nocturnal dipping status among ... Full text Open Access Link to item Cite

Identification and Characterization of Fenofibrate-Induced Liver Injury.

Journal Article Dig Dis Sci · December 2017 BACKGROUND: Fenofibrate is a commonly used hypolipidemic associated with rare instances of hepatotoxicity, and routine liver biochemistry monitoring is recommended. AIMS: The aim of this study is to describe the presenting clinical features, liver histopat ... Full text Link to item Cite

Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide.

Journal Article Circ Heart Fail · December 2017 BACKGROUND: Mitochondrial dysfunction and energy depletion in the failing heart are innovative therapeutic targets in heart failure management. Elamipretide is a novel tetrapeptide that increases mitochondrial energy; however, its safety, tolerability, and ... Full text Link to item Cite

Associations of gender and a proxy of female menopausal status with histological features of drug-induced liver injury.

Journal Article Liver Int · November 2017 BACKGROUND & AIM: Gender and menopause may contribute to type and severity of drug-induced liver injury (DILI) by influencing host responses to injury. The aim of this study was to assess the associations of gender and female age 50 [a proxy of menopause] ... Full text Link to item Cite

Death and liver transplantation within 2 years of onset of drug-induced liver injury.

Journal Article Hepatology · October 2017 UNLABELLED: Drug-induced liver injury (DILI) is an important cause of death and indication for liver transplantation (fatality). The role of DILI in these fatalities is poorly characterized, particularly when fatalities occur >26 weeks after DILI onset. We ... Full text Link to item Cite

Idiosyncratic Drug Induced Liver Injury in African-Americans Is Associated With Greater Morbidity and Mortality Compared to Caucasians.

Journal Article Am J Gastroenterol · September 2017 OBJECTIVES: Idiosyncratic drug induced liver injury (DILI) is a rare but potentially serious liver disorder and a major cause of significant liver injury. Limited data exist on racial differences in DILI incidence, presentation, and course. METHODS: We com ... Full text Link to item Cite

Minocycline hepatotoxicity: Clinical characterization and identification of HLA-B∗35:02 as a risk factor.

Conference J Hepatol · July 2017 BACKGROUND & AIMS: Minocycline hepatotoxicity can present with prominent autoimmune features in previously healthy individuals. The aim of this study was to identify genetic determinants of minocycline drug-induced liver injury (DILI) in a well-phenotyped ... Full text Link to item Cite

Comparison of Associations of Reduced Estimated Glomerular Filtration Rate With Stroke Outcomes Between Hypertension and No Hypertension.

Journal Article Stroke · June 2017 BACKGROUND AND PURPOSE: We compared the association of low estimated glomerular filtration rate (eGFR) with stroke outcomes among patients with hypertension and without hypertension. METHODS: We used the China stroke registry to identify patients on discha ... Full text Link to item Cite

Association of Liver Injury From Specific Drugs, or Groups of Drugs, With Polymorphisms in HLA and Other Genes in a Genome-Wide Association Study.

Journal Article Gastroenterology · April 2017 BACKGROUND & AIMS: We performed a genome-wide association study (GWAS) to identify genetic risk factors for drug-induced liver injury (DILI) from licensed drugs without previously reported genetic risk factors. METHODS: We performed a GWAS of 862 persons w ... Full text Link to item Cite

Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements.

Journal Article Hepatology · April 2017 UNLABELLED: Bile duct loss during the course of drug-induced liver injury is uncommon, but can be an indication of vanishing bile duct syndrome (VBDS). In this work, we assess the frequency, causes, clinical features, and outcomes of cases of drug-induced ... Full text Link to item Cite

Methods for assessing the reliability of quality of life based on SF-36.

Journal Article Stat Med · December 30, 2016 The 36-Item Short Form Health Survey (SF-36) has been widely used to measure quality of life. Reliability has been traditionally assessed by intraclass correlation coefficient (ICC), which is equivalent to Cronbach's alpha theoretically. However, it is a s ... Full text Link to item Cite

Choice of agreement indices for assessing and improving measurement reproducibility in a core laboratory setting.

Journal Article Stat Methods Med Res · December 2016 Clinical core laboratories, such as Echocardiography core laboratories, are increasingly used in clinical studies with imaging outcomes as primary, secondary, or surrogate endpoints. While many factors contribute to the quality of measurements of imaging v ... Full text Link to item Cite

Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.

Journal Article J Am Soc Echocardiogr · December 2016 BACKGROUND: There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results. METHODS: Twe ... Full text Open Access Link to item Cite

Assessing agreement with relative area under the coverage probability curve.

Journal Article Stat Med · August 15, 2016 There has been substantial statistical literature in the last several decades on assessing agreement, and coverage probability approach was selected as a preferred index for assessing and improving measurement agreement in a core laboratory setting. With t ... Full text Link to item Cite

Amoxicillin-Clavulanate-Induced Liver Injury.

Journal Article Dig Dis Sci · August 2016 BACKGROUND AND AIMS: Amoxicillin-clavulanate (AC) is the most frequent cause of idiosyncratic drug-induced injury (DILI) in the US DILI Network (DILIN) registry. Here, we examined a large cohort of AC-DILI cases and compared features of AC-DILI to those of ... Full text Link to item Cite

Short-term effects of the DASH diet in adults with moderate chronic kidney disease: a pilot feeding study.

Journal Article Clin Kidney J · August 2016 BACKGROUND: Although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP) for adults with normal kidney function, evidence is lacking regarding its safety and efficacy in chronic kidney disease (CKD). We aimed to test the effe ... Full text Open Access Link to item Cite

Echocardiographic agreement in the diagnostic evaluation for infective endocarditis.

Journal Article Int J Cardiovasc Imaging · July 2016 Echocardiography is essential for the diagnosis and management of infective endocarditis (IE). However, the reproducibility for the echocardiographic assessment of variables relevant to IE is unknown. Objectives of this study were: (1) To define the reprod ... Full text Link to item Cite

Statistical Issues in Testing Conformance with the Quantitative Imaging Biomarker Alliance (QIBA) Profile Claims.

Journal Article Acad Radiol · April 2016 A major initiative of the Quantitative Imaging Biomarker Alliance is to develop standards-based documents called "Profiles," which describe one or more technical performance claims for a given imaging modality. The term "actor" denotes any entity (device, ... Full text Open Access Link to item Cite

A simulation study of nonparametric total deviation index as a measure of agreement based on quantile regression.

Journal Article J Biopharm Stat · 2016 Total deviation index (TDI) captures a prespecified quantile of the absolute deviation of paired observations from raters, observers, methods, assays, instruments, etc. We compare the performance of TDI using nonparametric quantile regression to the TDI as ... Full text Link to item Cite

The use of routine non density calibrated clinical computed tomography data as a potentially useful screening tool for identifying patients with osteoporosis.

Journal Article Clin Cases Miner Bone Metab · 2016 OBJECTIVES: To evaluate whether lumbar vertebral body density CT attenuation values measured in Hounsfield Units (HUs) on routine Computed Tomography (CT) examinations can be reliably measured with limited variability, and to evaluate for a correlation bet ... Full text Link to item Cite

Numeric score-based conditional and overall change-in-status indices for ordered categorical data.

Journal Article Stat Med · November 30, 2015 Planned interventions and/or natural conditions often effect change on an ordinal categorical outcome (e.g., symptom severity). In such scenarios, it is sometimes desirable to assign a priori scores to observed changes in status, typically giving higher we ... Full text Link to item Cite

Persistent liver biochemistry abnormalities are more common in older patients and those with cholestatic drug induced liver injury.

Journal Article Am J Gastroenterol · October 2015 OBJECTIVES: The long-term outcomes of patients with drug induced liver injury (DILI) are not well described. The aim of this study was to determine the frequency and severity of persistent liver biochemistry abnormalities in DILI patients followed over 2 y ... Full text Link to item Cite

Genome-wide association of polycystic ovary syndrome implicates alterations in gonadotropin secretion in European ancestry populations.

Journal Article Nat Commun · August 18, 2015 Polycystic ovary syndrome (PCOS) is a common, highly heritable complex disorder of unknown aetiology characterized by hyperandrogenism, chronic anovulation and defects in glucose homeostasis. Increased luteinizing hormone relative to follicle-stimulating h ... Full text Link to item Cite

Quality Improvement Implementation: Improving Reproducibility in the Echocardiography Laboratory.

Journal Article J Am Soc Echocardiogr · August 2015 BACKGROUND: Interpretative variability can adversely affect echocardiographic reliability, but there is no widely accepted method to minimize variability and improve reproducibility. METHODS: A continuous quality improvement process was devised that involv ... Full text Link to item Cite

Features and Outcomes of 899 Patients With Drug-Induced Liver Injury: The DILIN Prospective Study.

Journal Article Gastroenterology · June 2015 BACKGROUND & AIMS: The Drug-Induced Liver Injury Network is conducting a prospective study of patients with DILI in the United States. We present characteristics and subgroup analyses from the first 1257 patients enrolled in the study. METHODS: In an obser ... Full text Link to item Cite

Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN).

Journal Article Liver Int · May 2015 BACKGROUND & AIMS: Because of the lack of objective tests to diagnose drug-induced liver injury (DILI), causality assessment is a matter of debate. Expert opinion is often used in research and industry, but its test-retest reliability is unknown. To determ ... Full text Link to item Cite

The influence of angle of insonation and target depth on speckle-tracking strain.

Journal Article J Am Soc Echocardiogr · May 2015 BACKGROUND: Speckle-tracking strain is almost universally cited as being independent of angle of insonation, but there are minimal confirmatory studies, and this claim may not be consistent with the known limitations of ultrasound axial and lateral spatial ... Full text Link to item Cite

ECHOCARDIOGRAPHY CORE LAB REPRODUCIBILITY OF CARDIAC SAFETY ASSESSMENTS IN CARDIO-ONCOLOGY

Conference Journal of the American College of Cardiology · March 2015 Full text Cite

Quantitative imaging biomarkers: a review of statistical methods for computer algorithm comparisons.

Journal Article Stat Methods Med Res · February 2015 Quantitative biomarkers from medical images are becoming important tools for clinical diagnosis, staging, monitoring, treatment planning, and development of new therapies. While there is a rich history of the development of quantitative imaging biomarker ( ... Full text Link to item Cite

Statistical issues in the comparison of quantitative imaging biomarker algorithms using pulmonary nodule volume as an example.

Journal Article Stat Methods Med Res · February 2015 Quantitative imaging biomarkers are being used increasingly in medicine to diagnose and monitor patients' disease. The computer algorithms that measure quantitative imaging biomarkers have different technical performance characteristics. In this paper we i ... Full text Link to item Cite

The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions.

Journal Article Stat Methods Med Res · February 2015 The development and implementation of quantitative imaging biomarkers has been hampered by the inconsistent and often incorrect use of terminology related to these markers. Sponsored by the Radiological Society of North America, an interdisciplinary group ... Full text Open Access Link to item Cite

Abernethy Malformation.

Journal Article Radiographics · 2015 Full text Link to item Cite

A prospective randomized wait list control trial of intravenous iron sucrose in older adults with unexplained anemia and serum ferritin 20-200 ng/mL.

Journal Article Blood Cells Mol Dis · December 2014 Anemia is common in older persons and is associated with substantial morbidity and mortality. One third of anemic older adults have unexplained anemia of the elderly (UAE). We carried out a randomized, wait list control trial in outpatients with UAE and se ... Full text Link to item Cite

Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network.

Journal Article Hepatology · October 2014 UNLABELLED: The Drug-Induced Liver Injury Network (DILIN) studies hepatotoxicity caused by conventional medications as well as herbals and dietary supplements (HDS). To characterize hepatotoxicity and its outcomes from HDS versus medications, patients with ... Full text Link to item Cite

Spectrum of statin hepatotoxicity: experience of the drug-induced liver injury network.

Journal Article Hepatology · August 2014 UNLABELLED: The HMG-CoA reductase inhibitors (statins) are widely prescribed for patients with hyperlipidemia and are generally well tolerated. Mild elevations in serum aminotransferases arise in up to 3% of treated patients, but clinically apparent drug-i ... Full text Link to item Cite

Idiosyncratic drug-induced liver injury is associated with substantial morbidity and mortality within 6 months from onset.

Journal Article Gastroenterology · July 2014 BACKGROUND & AIMS: Little is known about the incidence of drug-induced liver injury (DILI) and risk factors for adverse outcomes. We evaluated short-term outcomes of a large cohort of patients with DILI enrolled in an ongoing multicenter prospective study. ... Full text Link to item Cite

To transfuse or not to transfuse in upper gastrointestinal hemorrhage? That is the question.

Conference Hepatology · July 2014 BACKGROUND: The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial. We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy. MET ... Full text Link to item Cite

Secondary analysis of APPLE study suggests atorvastatin may reduce atherosclerosis progression in pubertal lupus patients with higher C reactive protein.

Journal Article Ann Rheum Dis · March 2014 OBJECTIVE: Participants in the Atherosclerosis Prevention in Paediatric Lupus Erythematosus (APPLE) trial were randomised to placebo or atorvastatin for 36 months. The primary endpoint, reduced carotid intima medial thickness (CIMT) progression, was not me ... Full text Link to item Cite

Hepatic histological findings in suspected drug-induced liver injury: systematic evaluation and clinical associations.

Journal Article Hepatology · February 2014 UNLABELLED: Drug-induced liver injury (DILI) is considered to be a diagnosis of exclusion. Liver biopsy may contribute to diagnostic accuracy, but the histological features of DILI and their relationship to biochemical parameters and outcomes are not well ... Full text Open Access Link to item Cite

Hepatic histological findings in suspected drug-induced liver injury: Systematic evaluation and clinical associations

Journal Article Hepatology · 2014 Drug-induced liver injury (DILI) is considered to be a diagnosis of exclusion. Liver biopsy may contribute to diagnostic accuracy, but the histological features of DILI and their relationship to biochemical parameters and outcomes are not well defined. We ... Full text Cite

Volumetric quantification of lung nodules in CT with iterative reconstruction (ASiR and MBIR).

Journal Article Med Phys · November 2013 PURPOSE: Volume quantifications of lung nodules with multidetector computed tomography (CT) images provide useful information for monitoring nodule developments. The accuracy and precision of the volume quantification, however, can be impacted by imaging a ... Full text Link to item Cite

Catechins in dietary supplements and hepatotoxicity.

Journal Article Dig Dis Sci · September 2013 BACKGROUND: Many herbal dietary supplements (HDS) contain green tea extract (GTE) and its component catechins, although their presence may not always be indicated on the product label. PURPOSE: Because GTE and catechins have been implicated in human hepato ... Full text Link to item Cite

Precision of iodine quantification in hepatic CT: effects of iterative reconstruction with various imaging parameters.

Journal Article AJR Am J Roentgenol · May 2013 OBJECTIVE: The objective of this study was to evaluate the feasibility of using iterative reconstructions in hepatic CT to improve the precision of Hounsfield unit quantification, which is the degree to which repeated measurements under unchanged condition ... Full text Link to item Cite

Profiles of serum cytokines in acute drug-induced liver injury and their prognostic significance.

Journal Article PLoS One · 2013 UNLABELLED: Drug-induced liver injury (DILI) is the most common cause of acute liver failure in the United-States. The aim of the study was to describe serum immune profiles associated with acute DILI, to investigate whether there are profiles associated w ... Full text Open Access Link to item Cite

Assessing agreement with intraclass correlation coefficient and concordance correlation coefficient for data with repeated measures

Journal Article Computational Statistics and Data Analysis · January 1, 2013 The intraclass correlation coefficient and the concordance correlation coefficient are two popular scaled indices for assessing the closeness between observers who make measurements for quantitative responses. These two indices are usually based on subject ... Full text Cite

Cardiovascular toxicity of epoetin-alfa in patients with chronic kidney disease.

Journal Article Am J Nephrol · 2013 BACKGROUND: Recombinant erythropoietin has become a routine component of care of patients with chronic kidney disease reducing the need for blood transfusions but raising the risks for cardiovascular events. We undertook this secondary analysis of subjects ... Full text Link to item Cite

Racial differences in the association of CD14 polymorphisms with serum total IgE levels and allergen skin test reactivity.

Journal Article J Asthma Allergy · 2013 BACKGROUND: The CD14 C-159T single nucleotide polymorphism (SNP) has been investigated widely as a candidate genetic locus in patients with allergic disease. There are conflicting results for the association of the CD14 C-159T SNP with total serum immunogl ... Full text Open Access Link to item Cite

A new permutation-based method for assessing agreement between two observers making replicated quantitative readings.

Journal Article Stat Med · September 10, 2012 The coefficient of individual equivalence is a permutation-based measure of agreement between two observers making replicated readings on each subject. It compares the observed disagreement between the observers to the expected disagreement under individua ... Full text Link to item Cite

Effect of hemoglobin target on progression of kidney disease: a secondary analysis of the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) trial.

Journal Article Am J Kidney Dis · September 2012 BACKGROUND: Conflicting relationships have been described between anemia correction using erythropoiesis-stimulating agents and progression of chronic kidney disease (CKD). This study was undertaken to examine the impact of target hemoglobin level on progr ... Full text Link to item Cite

Impact of higher hemoglobin targets on blood pressure and clinical outcomes: a secondary analysis of CHOIR.

Journal Article Nephrol Dial Transplant · September 2012 BACKGROUND: Targeting a higher hemoglobin in patients with chronic kidney disease leads to adverse cardiovascular outcomes, yet the reasons remain unclear. Herein, we sought to determine whether changes in erythropoiesis-stimulating agent (ESA) dose and in ... Full text Link to item Cite

Reply

Journal Article Arthritis and Rheumatism · August 1, 2012 Full text Cite

Identifying error-making patterns in assessment of mammographic BI-RADS descriptors among radiology residents using statistical pattern recognition.

Journal Article Acad Radiol · July 2012 RATIONALE AND OBJECTIVE: The objective of this study is to test the hypothesis that there are patterns in erroneous assessment of BI-RADS features among radiology trainees when interpreting mammographic masses and that these patterns can be captured in ind ... Full text Link to item Cite

Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series.

Journal Article Ann Intern Med · June 19, 2012 BACKGROUND: Flavocoxid is a prescription medical food that is used to treat osteoarthritis. It is a proprietary blend of 2 flavonoids, baicalin and catechins, which are derived from the botanicals Scutellaria baicalensis and Acacia catechu, respectively. O ... Full text Link to item Cite

Characterization of adrenal nodules with dual-energy CT: can virtual unenhanced attenuation values replace true unenhanced attenuation values?

Journal Article AJR Am J Roentgenol · April 2012 OBJECTIVE: The purpose of our study was to investigate whether virtual unenhanced adrenal nodule attenuation values can replace true noncontrast attenuation values. MATERIALS AND METHODS: Twenty-three incidentally discovered adrenal nodules (19 adenomas an ... Full text Link to item Cite

Quantitative CT: technique dependence of volume estimation on pulmonary nodules.

Journal Article Phys Med Biol · March 7, 2012 Current estimation of lung nodule size typically relies on uni- or bi-dimensional techniques. While new three-dimensional volume estimation techniques using MDCT have improved size estimation of nodules with irregular shapes, the effect of acquisition and ... Full text Link to item Cite

Diagnostic accuracy of intra-abdominal fluid collection characterization in the era of multidetector computed tomography.

Journal Article Am Surg · February 2012 The purpose of this study was to test the hypothesis that with improved technology, the presence of abscess in a postoperative fluid collection may be prospectively made. This is an Institutional Review Board-approved, Health Insurance Portability and Acco ... Link to item Cite

Use of atorvastatin in systemic lupus erythematosus in children and adolescents.

Journal Article Arthritis Rheum · January 2012 OBJECTIVE: Statins reduce atherosclerosis and cardiovascular morbidity in the general population, but their efficacy and safety in children and adolescents with systemic lupus erythematosus (SLE) are unknown. This study was undertaken to determine the 3-ye ... Full text Link to item Cite

Gray-scale inversion radiographic display for the detection of pulmonary nodules on chest radiographs.

Journal Article Clin Imaging · 2012 The purpose of this study was to investigate gray-scale inversion in nodule detection on chest radiography. Simulated nodules were superimposed randomly onto normal chest radiographs. Six radiologists interpreted 144 chest radiographs during three reading ... Full text Link to item Cite

Assessing agreement with repeated measures for random observers.

Journal Article Stat Med · December 30, 2011 Agreement studies are often concerned with assessing whether different observers for measuring responses on the same subject or sample can produce similar results. The concordance correlation coefficient (CCC) is a popular index for assessing the closeness ... Full text Link to item Cite

Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial.

Journal Article JAMA · September 28, 2011 CONTEXT: Intra-aortic balloon counterpulsation (IABC) is an adjunct to revascularization in patients with cardiogenic shock and reduces infarct size when placed prior to reperfusion in animal models. OBJECTIVE: To determine if routine IABC placement prior ... Full text Link to item Cite

64-section multidetector CT of the upper abdomen: optimization of a saline chaser injection protocol for improved vascular and parenchymal contrast enhancement.

Journal Article Eur Radiol · September 2011 OBJECTIVES: To prospectively investigate the effect of varying the injection flow rates of a saline chaser on vascular and parenchymal contrast enhancement during abdominal MDCT. METHODS: 100 consecutive patients were randomly assigned to four injection pr ... Full text Link to item Cite

Effect of varying contrast material iodine concentration and injection technique on the conspicuity of hepatocellular carcinoma during 64-section MDCT of patients with cirrhosis.

Journal Article Br J Radiol · August 2011 OBJECTIVES: The aim of this study was to compare the intraindividual effects of contrast material with two different iodine concentrations on the conspicuity of hepatocellular carcinoma (HCC) and vascular and hepatic contrast enhancement during multiphasic ... Full text Link to item Cite

Thromboembolic complications after Neuroform stent-assisted treatment of cerebral aneurysms: the Duke Cerebrovascular Center experience in 235 patients with 274 stents.

Journal Article Neurosurgery · August 2011 BACKGROUND: The Neuroform Stent has facilitated the endovascular treatment of wide-necked cerebral aneurysms. It is unknown which factors pose risks of thromboembolic events after stent placement. OBJECTIVE: This series is the largest single-center study r ... Full text Link to item Cite

Self-referral in medical imaging: a meta-analysis of the literature.

Journal Article J Am Coll Radiol · July 2011 PURPOSE: In the current political and economic climate, there is a desire to reduce health care costs; diagnostic imaging expenditure is one area of particular interest. The authors present a meta-analysis of the relative frequency of imaging utilization i ... Full text Link to item Cite

Lung nodule detection in pediatric chest CT: quantitative relationship between image quality and radiologist performance.

Journal Article Med Phys · May 2011 PURPOSE: To determine the quantitative relationship between image quality and radiologist performance in detecting small lung nodules in pediatric CT. METHODS: The study included clinical chest CT images of 30 pediatric patients (0-16 years) scanned at tub ... Full text Link to item Cite

A new permutation-based method for assessing agreement between two observers making replicated binary readings.

Journal Article Stat Med · April 15, 2011 A new coefficient for assessing agreement between two observers using a permutation-based method is introduced in this article. When observations are binary, this coefficient compares the observed disagreement (probability of discordance) between the obser ... Full text Link to item Cite

Quantitative CT: Technique dependency of volume assessment for pulmonary nodules

Conference Progress in Biomedical Optics and Imaging - Proceedings of SPIE · December 1, 2010 Current lung nodule size assessment methods typically rely on one-dimensional estimation of lesions. While new 3D volume assessment techniques using MSCT scan data have enabled improved estimation of lesion size, the effect of acquisition and reconstructio ... Full text Cite

Laboratory markers of cardiovascular risk in pediatric SLE: the APPLE baseline cohort.

Journal Article Lupus · October 2010 As part of the Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Trial, a prospective multicenter cohort of 221 children and adolescents with systemic lupus erythematosus (SLE) (mean age 15.7 years, 83% female) underwent baseline measurem ... Full text Link to item Cite

Intercourse compliance, ovulation, and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial.

Journal Article Fertil Steril · September 2010 OBJECTIVE: To investigate the relationship among intercourse compliance, ovulation, and the occurrence of pregnancy in the Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (RMNPPCOS) Trial. DESIGN: Post hoc data analysis of subjects i ... Full text Link to item Cite

Body mass index and intercourse compliance.

Journal Article Fertil Steril · September 2010 OBJECTIVE: To investigate the relationship between body mass index and intercourse compliance in the Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (RMN PPCOS) Trial. DESIGN: Post hoc data analysis of subjects in the RMN PPCOS Trial ... Full text Link to item Cite

Detection of pancreatic tumors, image quality, and radiation dose during the pancreatic parenchymal phase: effect of a low-tube-voltage, high-tube-current CT technique--preliminary results.

Journal Article Radiology · August 2010 PURPOSE: To intraindividually compare a low-tube-voltage (80 kVp), high-tube-current (675 mA) computed tomographic (CT) technique with a high-tube-voltage (140 kVp) CT protocol for the detection of pancreatic tumors, image quality, and radiation dose durin ... Full text Link to item Cite

Dual-energy CT for characterization of adrenal nodules: initial experience.

Journal Article AJR Am J Roentgenol · June 2010 OBJECTIVE: The purpose of this study was to determine whether use of dual-energy technique can improve the diagnostic performance of CT in the differential diagnosis of adrenal adenomas and metastatic lesions. SUBJECTS AND METHODS: Thirty-one adrenal nodul ... Full text Link to item Cite

Estimation of coefficients of individual agreement (CIAs) for quantitative and binary data using SAS and R.

Journal Article Comput Methods Programs Biomed · May 2010 The coefficients of individual agreement (CIAs), which are based on the ratio of the intra- and inter-observer disagreement, provide a general approach for evaluating agreement between two fixed methods of measurements or human observers. In this paper, pr ... Full text Link to item Cite

Observer detection limits for a dedicated SPECT breast imaging system.

Journal Article Phys Med Biol · April 7, 2010 An observer-based contrast-detail study is performed in an effort to evaluate the limits of object detectability using a dedicated CZT-based breast SPECT imaging system under various imaging conditions. A custom geometric contrast-resolution phantom was de ... Full text Link to item Cite

Individualized computer-aided education in mammography based on user modeling: concept and preliminary experiments.

Journal Article Med Phys · March 2010 PURPOSE: The authors propose the framework for an individualized adaptive computer-aided educational system in mammography that is based on user modeling. The underlying hypothesis is that user models can be developed to capture the individual error making ... Full text Link to item Cite

A secondary analysis of the CHOIR trial shows that comorbid conditions differentially affect outcomes during anemia treatment.

Journal Article Kidney Int · February 2010 Featured Publication The CHOIR trial in anemic patients with chronic kidney disease compared epoetin-alfa treatment with low (11.3 g/l) and high (13.5 g/l) hemoglobin targets on the composite end point of death, hospitalization for heart failure, stroke, and myocardial infarct ... Full text Link to item Cite

Percutaneous abscess drainage in patients with perforated acute appendicitis: effectiveness, safety, and prediction of outcome.

Journal Article AJR Am J Roentgenol · February 2010 OBJECTIVE: The purposes of this study were to retrospectively investigate the effectiveness and safety of CT-guided percutaneous drainage in the treatment of patients with acute appendicitis complicated by perforation and to identify CT findings and proced ... Full text Link to item Cite

Evaluation of wedging of lower thoracic and upper lumbar vertebral bodies in the pediatric population.

Journal Article AJR Am J Roentgenol · February 2010 OBJECTIVE: Anterior wedging of thoracolumbar vertebral bodies is often seen in children. The purpose of our study was to show whether mild anterior wedging of pediatric thoracolumbar junction vertebral bodies can be seen as a normal variant, rather than as ... Full text Link to item Cite

Predictors of pregnancy in women with polycystic ovary syndrome

Journal Article Obstetrical and Gynecological Survey · January 1, 2010 Full text Cite

Applications of the repeatability of quantitative imaging biomarkers: a review of statistical analysis of repeat data sets.

Journal Article Transl Oncol · December 2009 Featured Publication Repeat imaging data sets performed on patients with cancer are becoming publicly available. The potential utility of these data sets for addressing important questions in imaging biomarker development is vast. In particular, these data sets may be useful t ... Full text Link to item Cite

Predictors of pregnancy in women with polycystic ovary syndrome.

Journal Article J Clin Endocrinol Metab · September 2009 CONTEXT: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. The selection of first-line therapies for ovulation induction is empiric. OBJECTIVE: The aim of the study was to develop a clinically useful predictive model of ... Full text Link to item Cite

Premature atherosclerosis in pediatric systemic lupus erythematosus: risk factors for increased carotid intima-media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohort.

Journal Article Arthritis Rheum · May 2009 Featured Publication OBJECTIVE: To evaluate risk factors for subclinical atherosclerosis in a population of patients with pediatric systemic lupus erythematosus (SLE). METHODS: In a prospective multicenter study, a cohort of 221 patients underwent baseline measurements of caro ... Full text Link to item Cite

Comparison of ICC and CCC for assessing agreement for data without and with replications

Journal Article Computational Statistics and Data Analysis · December 15, 2008 The intraclass correlation coefficient (ICC) has been traditionally used for assessing reliability between multiple observers for data with or without replications. Definitions of different versions of ICCs depend on the assumptions of specific ANOVA model ... Full text Cite

Medication adherence and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome Trial.

Journal Article Fertil Steril · October 2008 We investigated whether poor adherence with metformin tablets may have contributed to the poor success rates seen in the metformin-containing arms of the Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial. Median adherence for both metformin and clomiphe ... Full text Link to item Cite

Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes.

Journal Article Kidney Int · September 2008 Featured Publication Trials of anemia correction in chronic kidney disease have found either no benefit or detrimental outcomes of higher targets. We did a secondary analysis of patients with chronic kidney disease enrolled in the Correction of Hemoglobin in the Outcomes in Re ... Full text Link to item Cite

Extended-release metformin does not reduce the clomiphene citrate dose required to induce ovulation in polycystic ovary syndrome.

Journal Article J Clin Endocrinol Metab · August 2008 CONTEXT: When used for ovulation induction, higher doses of clomiphene may lead to antiestrogenic side effects that reduce fecundity. It has been suggested that metformin in combination with clomiphene can restore ovulation to some clomiphene-resistant ano ... Full text Link to item Cite

A general approach to evaluating agreement between two observers or methods of measurement from quantitative data with replicated measurements.

Journal Article Stat Methods Med Res · April 2008 Featured Publication We present a general approach to the definition and estimation of coefficients for evaluating agreement between two fixed methods of measurements or human observers. The measured variable is assumed to be continuous with a finite second moment. No other di ... Full text Link to item Cite

Repeatability and reproducibility of phase analysis of gated single-photon emission computed tomography myocardial perfusion imaging used to quantify cardiac dyssynchrony.

Journal Article Nucl Med Commun · April 2008 BACKGROUND: A novel method to quantify dyssynchrony has been developed using phase analysis of gated single-photon emission computed tomography perfusion imaging. We report on the effect of variability in image reconstruction on the phase analysis results ... Full text Link to item Cite

Ovulatory response to treatment of polycystic ovary syndrome is associated with a polymorphism in the STK11 gene.

Journal Article J Clin Endocrinol Metab · March 2008 Featured Publication CONTEXT: Clomiphene and insulin sensitizers such as metformin are used to induce ovulation in polycystic ovary syndrome (PCOS), but the ovulatory response is variable, and the causes of this variation are poorly understood. OBJECTIVE: Our objective was to ... Full text Link to item Cite

Sample size for comparing correlated concordance rates.

Journal Article J Biopharm Stat · 2008 Featured Publication We consider collecting the measurements of a gold standard and two methods with error from each site of subjects. We propose an asymptotic test statistic to compare the concordance rates of two methods with the gold standard and a closed-form sample size f ... Full text Link to item Cite

Computer programs for the concordance correlation coefficient.

Journal Article Comput Methods Programs Biomed · October 2007 Featured Publication The CCC macro is presented for computation of the concordance correlation coefficient (CCC), a common measure of reproducibility. The macro has been produced in both SAS and R, and a detailed presentation of the macro input and output for the SAS program i ... Full text Link to item Cite

Anaemia of CKD--the CHOIR study revisited.

Journal Article Nephrol Dial Transplant · July 2007 Full text Link to item Cite

Guest editor's note for the special issue on assessing agreement

Journal Article Journal of Biopharmaceutical Statistics · July 1, 2007 Full text Cite

Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome.

Journal Article N Engl J Med · February 8, 2007 Featured Publication BACKGROUND: The polycystic ovary syndrome is a common cause of infertility. Clomiphene and insulin sensitizers are used alone and in combination to induce ovulation, but it is unknown whether one approach is superior. METHODS: We randomly assigned 626 infe ... Full text Link to item Cite

Utility of screening for other causes of infertility in women with "known" polycystic ovary syndrome.

Journal Article Fertil Steril · February 2007 We investigated the prevalence of abnormal screening results (questionnaire and testing for other causes of oligo-ovulation, male or tubal factor infertility) in a group of 1,313 oligo-ovulatory women (included and excluded subjects) whose condition was sc ... Full text Link to item Cite

An overview on assessing agreement with continuous measurements.

Journal Article J Biopharm Stat · 2007 Featured Publication Reliable and accurate measurements serve as the basis for evaluation in many scientific disciplines. Issues related to reliable and accurate measurement have evolved over many decades, dating back to the nineteenth century and the pioneering work of Galton ... Full text Link to item Cite

Comparison of concordance correlation coefficient and coefficient of individual agreement in assessing agreement.

Journal Article J Biopharm Stat · 2007 Featured Publication In method comparison and reliability studies, it is often important to assess agreement between multiple measurements made by different methods, devices, laboratories, observers, or instruments. For continuous data, the concordance correlation coefficient ... Full text Link to item Cite

Assessing individual agreement.

Journal Article J Biopharm Stat · 2007 Featured Publication Evaluating agreement between measurement methods or between observers is important in method comparison studies and in reliability studies. Often we are interested in whether a new method can replace an existing invasive or expensive method, or whether mul ... Full text Link to item Cite

Assessing observer agreement in studies involving replicated binary observations.

Journal Article J Biopharm Stat · 2007 Featured Publication We propose a new approach to evaluating agreement between two observers making binary observations on a set of subjects. This approach compares the probability of disagreement (or discordance) between the observers to the probability of disagreement betwee ... Full text Link to item Cite

Correction of anemia with epoetin alfa in chronic kidney disease.

Journal Article N Engl J Med · November 16, 2006 BACKGROUND: Anemia, a common complication of chronic kidney disease, usually develops as a consequence of erythropoietin deficiency. Recombinant human erythropoietin (epoetin alfa) is indicated for the correction of anemia associated with this condition. H ... Full text Link to item Cite

The Pregnancy in Polycystic Ovary Syndrome study: baseline characteristics of the randomized cohort including racial effects.

Journal Article Fertil Steril · October 2006 Featured Publication OBJECTIVE: To report the baseline characteristics and racial differences in the polycystic ovary syndrome (PCOS) phenotype from a large multicenter clinical trial (PPCOS). DESIGN: Double-blind, randomized trial of three treatment regimens (with extended re ... Full text Link to item Cite

The weighted generalized estimating equations approach for the evaluation of medical diagnostic test at subunit level.

Journal Article Biom J · August 2006 Featured Publication Sensitivity and specificity are common measures used to evaluate the performance of a diagnostic test. A diagnostic test is often administrated at a subunit level, e.g. at the level of vessel, ear or eye of a patient so that the treatment can be targeted a ... Full text Link to item Cite

Early childhood growth and development in rural Guatemala.

Journal Article Early Hum Dev · July 2006 BACKGROUND: Small size at birth and in early childhood has been associated with impaired neurodevelopment in studies from developing countries, but few have examined associations with growth. AIMS: The objective of this study was to assess the relationship ... Full text Link to item Cite

Coefficients of agreement for fixed observers.

Journal Article Stat Methods Med Res · June 2006 Featured Publication Agreement between fixed observers or methods that produce readings on a continuous scale is usually evaluated via one of several intraclass correlation coefficients (ICCs). This article presents and discusses a few related issues that have not been raised ... Full text Link to item Cite

Assay validation for left-censored data.

Journal Article Stat Med · November 15, 2005 Featured Publication In laboratory validation studies, it is often important to assess agreement between two assays, based on different techniques. Oftentimes, both assays have lower limits of detection and thus measurements are left censored. For example, in studies of Human ... Full text Link to item Cite

Health status and quality of life reported by incident patients after 1 year on haemodialysis or peritoneal dialysis.

Journal Article Nephrol Dial Transplant · October 2005 BACKGROUND: It has been suggested that there are no large differences in the quality of life of incident patients starting on haemodialysis (HD) and peritoneal dialysis (PD), but few studies have addressed this issue. METHODS: Association of modality with ... Full text Link to item Cite

Maternal and childhood nutrition and later blood pressure levels in young Guatemalan adults.

Journal Article Int J Epidemiol · August 2005 BACKGROUND: Low birth weight and subsequent rapid child growth are associated with later blood pressure levels. The role of maternal and child nutrition in this association remains unclear. METHODS: We studied 450 men and women (ages 21-29 years) born duri ... Full text Link to item Cite

Assessing intra, inter and total agreement with replicated readings.

Journal Article Stat Med · May 15, 2005 Featured Publication In clinical studies, assessing agreement of multiple readings on the same subject plays an important role in the evaluation of continuous measurement scale. The multiple readings within a subject may be replicated readings by using the same method or/and r ... Full text Link to item Cite

Growth and diet quality are associated with the attainment of walking in rural Guatemalan infants.

Journal Article J Nutr · December 2004 The attainment of gross motor milestones is an important indicator of motor development in early life; however, little is known about factors affecting gross motor development in children from developing countries. The purpose of this study was to examine ... Full text Link to item Cite

Maternal and child nutritional supplementation are inversely associated with fasting plasma glucose concentration in young Guatemalan adults.

Journal Article J Nutr · April 2004 Featured Publication Cardiovascular disease and diabetes may be programmed early in life by abnormal development associated with undernutrition. We investigated whether maternal nutritional status (MNS; height, pregnancy weight gain, nonpregnant BMI, and prenatal supplementati ... Full text Link to item Cite

Comparison of linear growth patterns in the first three years of life across two generations in Guatemala.

Journal Article Pediatrics · March 2004 Featured Publication OBJECTIVE: The secular increase in height is assumed to result from long-term improvements in nutritional intakes and reductions in infectious disease burdens. Nutritional supplementation in early life reduces stunting in chronically undernourished populat ... Full text Link to item Cite

Relative importance of birth size and postnatal growth for women's educational achievement.

Journal Article Early Hum Dev · January 2004 BACKGROUND: Child undernutrition, commonly measured by growth failure, is associated with functional disadvantages later in life. AIMS: To assess relationships between child growth and women's educational achievement (EA). STUDY DESIGN AND SUBJECTS: Women ... Full text Link to item Cite

Selected as the best paper in the 1990s: Reducing frailty and falls in older persons: an investigation of tai chi and computerized balance training.

Journal Article J Am Geriatr Soc · December 2003 Featured Publication OBJECTIVES: To evaluate the effects of two exercise approaches, tai chi (TC) and computerized balance training (BT), on specified primary outcomes (biomedical, functional, and psychosocial indicators of frailty) and secondary outcomes (occurrences of fall) ... Full text Link to item Cite

Effects of early childhood supplementation on the educational achievement of women.

Journal Article Pediatrics · November 2003 Featured Publication OBJECTIVE: Malnutrition during early childhood has been suggested to cause functional disadvantages in adults, including reduced intelligence and lower educational achievement (EA). We assessed the effects of improved nutrition in early life on the EA of w ... Full text Link to item Cite

A global sensitivity analysis of performance of a medical diagnostic test when verification bias is present.

Journal Article Stat Med · September 15, 2003 Featured Publication Current advances in technology provide less invasive or less expensive diagnostic tests for identifying disease status. When a diagnostic test is evaluated against an invasive or expensive gold standard test, one often finds that not all patients undergo t ... Full text Link to item Cite

Evaluating medical diagnostic tests at the subunit level in the presence of verification bias.

Journal Article Stat Med · July 15, 2003 Featured Publication We advocate that medical diagnostic tests should be evaluated at the subunit level instead of the patient level if a disease can occur in multiple parts/units within a patient, for example, vessels, segments, ears, eyes etc. When a non-invasive test is com ... Full text Link to item Cite

Prospective study of protein-energy supplementation early in life and of growth in the subsequent generation in Guatemala.

Journal Article Am J Clin Nutr · July 2003 Featured Publication BACKGROUND: The secular increase in height is assumed to result from long-term improvements in nutritional intakes and reductions in infectious disease burdens. Nutritional supplementation in early life reduces stunting in chronically undernourished popula ... Full text Link to item Cite

Factors associated with severity of injury resulting from acute releases of hazardous substances in the manufacturing industry.

Journal Article J Occup Environ Med · July 2003 Data from the Hazardous Substances Emergency Events Surveillance system was used to identify factors associated with the severity of injuries of victims (an ordinal outcome variable) harmed in acute chemical release events in the manufacturing industry. We ... Full text Link to item Cite

An estimated score method for missing and auxiliary covariates in two stage studies

Journal Article Journal of Statistical Planning and Inference · July 1, 2003 We consider the following type of two stage studies. First, a full scale study is conducted by observing an outcome Y, imperfect surrogate measure T of the unobserved covariate of interest X, and covariates U for all members of a cohort, where the cohort i ... Full text Cite

Associations between prenatal and postnatal growth and adult body size and composition.

Journal Article Am J Clin Nutr · June 2003 BACKGROUND: Adult body size and composition (ABSC) measures are associated with work capacity and productivity, reproductive performance, and chronic disease risk. Growth failure in early childhood may have important long-term consequences through its infl ... Full text Link to item Cite

Randomized trial of pallidotomy versus medical therapy for Parkinson's disease.

Journal Article Ann Neurol · May 2003 Thirty-six patients with Parkinson's disease (PD) were randomized to either medical therapy (N = 18) or unilateral GPi pallidotomy (N = 18). The primary outcome variable was the change in total Unified Parkinson's Disease Rating Scale (UPDRS) score at 6 mo ... Full text Link to item Cite

Accounting for nonignorable verification bias in assessment of diagnostic tests.

Journal Article Biometrics · March 2003 Featured Publication A "gold" standard test, providing definitive verification of disease status, may be quite invasive or expensive. Current technological advances provide less invasive, or less expensive, diagnostic tests. Ideally, a diagnostic test is evaluated by comparing ... Full text Link to item Cite

Prediction of native coronary artery disease progression following PTCA or CABG in the Emory Angioplasty Versus Surgery Trial.

Journal Article Med Sci Monit · February 2003 BACKGROUND: The natural history of atherosclerosis progression following revascularization procedures (PTCA or CABG) limits the long-term benefits of these procedures and requires continuation of risk management. MATERIAL/METHODS: Of 392 patients with mult ... Link to item Cite

Overall concordance correlation coefficient for evaluating agreement among multiple observers.

Journal Article Biometrics · December 2002 Featured Publication Accurate and precise measurement is an important component of any proper study design. As elaborated by Lin (1989, Biometrics 45, 255-268), the concordance correlation coefficient (CCC) is more appropriate than other indices for measuring agreement when th ... Full text Link to item Cite

Weighted least-squares approach for comparing correlated kappa.

Journal Article Biometrics · December 2002 Featured Publication In the medical sciences, studies are often designed to assess the agreement between different raters or different instruments. The kappa coefficient is a popular index of agreement for binary and categorical ratings. Here we focus on testing for the equali ... Full text Link to item Cite

Joint models for toxicology studies with dose-dependent number of implantations.

Journal Article Risk Anal · December 2002 Featured Publication Many chemicals interfere with the natural reproductive processes in mammals. The chemicals may prevent the fertilization of an egg or keep a zygote from implanting in the uterine wall. For this reason, toxicology studies with pre-implantation exposure ofte ... Full text Link to item Cite

Neuropsychological and psychiatric sequelae of pallidotomy for PD: clinical trial findings.

Journal Article Neurology · March 26, 2002 OBJECTIVE: To evaluate the neuropsychological and psychiatric sequelae of unilateral posterior pallidotomy for treatment of PD. METHODS: Patients with idiopathic PD completed baseline and 3- and 6-month assessments after random assignment to an immediate s ... Full text Link to item Cite

Modeling concordance correlation via GEE to evaluate reproducibility.

Journal Article Biometrics · September 2001 Featured Publication Clinical studies are often concerned with assessing whether different raters/methods produce similar values for measuring a quantitative variable. Use of the concordance correlation coefficient as a measure of reproducibility has gained popularity in pract ... Full text Link to item Cite

The impact of lesion laterality on neuropsychological change following posterior pallidotomy: A review of current findings

Journal Article Brain and Cognition · 2000 This paper reviews seven studies evaluating the impact of lesion laterality on the neuropsychological sequelae of posterior pallidotomy for treatment of Parkinson's disease. Left lesions of the internal globus pallidus (GPi) were associated with subtle def ... Full text Cite

Early childhood nutrition, education and fertility milestones in Guatemala.

Journal Article J Nutr · December 1999 Data on fertility milestones were collected in 1994 and linked to information collected in a trial conducted in eastern Guatemala between 1969 and 1977, to examine whether early childhood nutrition was associated with the timing of fertility milestones. In ... Full text Link to item Cite

Testing proportionality in the proportional odds model fitted with GEE.

Journal Article Stat Med · June 15, 1999 Featured Publication Generalized estimating equations (GEE) methodology as proposed by Liang and Zeger has received widespread use in the analysis of correlated binary data. Miller et al. and Lipsitz et al. extended GEE to correlated nominal and ordinal categorical data; in pa ... Full text Link to item Cite

A regression model for multivariate random length data.

Journal Article Stat Med · January 30, 1999 Featured Publication Multivariate random length data occur when we observe multiple measurements of a quantitative variable and the variable number of these measurements is also an observed outcome for each experimental unit. For example, for a patient with coronary artery dis ... Full text Link to item Cite

Family members' perceptions of quality of life change in dementia SCU residents

Journal Article Journal of Applied Gerontology · January 1, 1999 Global ratings of change in residents 'physical, emotional, social and cognitive functioning were obtained in interviews with family members of 67 special care unit (SCU) residents and 16 non-SCU control group residents of an intermediate care facility (IC ... Full text Cite

Goodness-of-fit tests for GEE modeling with binary responses.

Journal Article Biometrics · June 1998 Featured Publication Analysis of data with repeated measures is often accomplished through the use of generalized estimating equations (GEE) methodology. Although methods exist for assessing the adequacy of the fitted models for uncorrelated data with likelihood methods, it is ... Link to item Cite

Effect of Plasma Homocyst(e)ine Levels on Adverse Cardiovascular Outcomes After PTCA or CABG in EAST

Journal Article Journal of the American College of Cardiology · February 1998 Full text Cite

ANOVA for repeated ordinal data with small sample size? A comparison of ANOVA, MANOVA, WLS and GEE methods by simulation

Journal Article Communications in Statistics Part B: Simulation and Computation · January 1, 1998 Repeated ordinal outcomes are common in behavioral and medical sciences. Due to the familiarity, simplicity and robustness of ANOVA methodology, this approach has been frequently used for repeated ordinal data. Weighted least squares (WLS) and generalized ... Full text Cite

A probit model for multivariate random length ordinal data

Journal Article Communications in Statistics - Theory and Methods · January 1, 1998 Multivariate random length ordinal data are data such that the ordinal response variable is observed a random number of times for each experimental unit. For example, depression may occur a random number of times and the severity of each depression episode ... Full text Cite

A generalized estimating equation approach for modeling random length binary vector data.

Journal Article Biometrics · September 1997 Featured Publication A common measure in clinical trials and epidemiologic studies is the number of events such as seizures, hospitalizations, or bouts of disease. Frequently, a binary measure of severity for each event is available but is not incorporated in the analysis. Thi ... Link to item Cite

Self-report benefits of Tai Chi practice by older adults.

Journal Article J Gerontol B Psychol Sci Soc Sci · September 1997 Older persons who are willing to begin exercise programs are often not willing to continue them. At the Atlanta FICSIT (Frailty and Injuries: Cooperative Studies of Intervention Techniques) site, individuals aged 70+ were randomized to Tai Chi (TC), indivi ... Full text Link to item Cite

Angioplasty or surgery for multivessel coronary artery disease: comparison of eligible registry and randomized patients in the EAST trial and influence of treatment selection on outcomes. Emory Angioplasty versus Surgery Trial Investigators.

Journal Article Am J Cardiol · June 1, 1997 Featured Publication The Emory Angioplasty versus Surgery Trial (EAST) showed that multivessel patients eligible for both percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass surgery (CABG) had equivalent 3-year outcomes regarding survival, myocardial infa ... Full text Link to item Cite

The effect of Tai Chi Quan and computerized balance training on postural stability in older subjects

Journal Article Physical Therapy · May 6, 1997 Background and Purpose. This study explored whether two exercise programs would affect the ability to minimize postural sway of 72 relatively inactive, older subjects who participated in the Atlanta FICSIT trial. Subjects. Subjects were randomly assigned t ... Cite

The effect of Tai Chi Quan and computerized balance training on postural stability in older subjects. Atlanta FICSIT Group. Frailty and Injuries: Cooperative Studies on Intervention Techniques.

Journal Article Phys Ther · April 1997 Featured Publication BACKGROUND AND PURPOSE: This study explored whether two exercise programs would affect the ability to minimize postural sway of 72 relatively inactive, older subjects who participated in the Atlanta FICSIT trial. SUBJECTS: Subjects were randomly assigned t ... Full text Link to item Cite

Effectiveness of revascularization in the Emory angioplasty versus surgery trial. A randomized comparison of coronary angioplasty with bypass surgery.

Journal Article Circulation · June 1, 1996 BACKGROUND: The Emory Angioplasty Versus Surgery Trial (EAST) was designed to determine whether percutaneous transluminal coronary angioplasty (PTCA) is as effective as coronary artery bypass graft surgery (CABG) in restoring arterial perfusion capacity in ... Full text Link to item Cite

Natural history of human immunodeficiency virus disease in perinatally infected children: an analysis from the Pediatric Spectrum of Disease Project.

Journal Article Pediatrics · May 1996 Featured Publication OBJECTIVE: To describe the progression of human immunodeficiency virus (HIV) disease through clinical stages from birth to death among a large number of perinatally infected children. METHODS: The Pediatric Spectrum of Disease (PSD) project, coordinated by ... Link to item Cite

Reducing frailty and falls in older persons: an investigation of Tai Chi and computerized balance training. Atlanta FICSIT Group. Frailty and Injuries: Cooperative Studies of Intervention Techniques.

Journal Article J Am Geriatr Soc · May 1996 Featured Publication OBJECTIVE: To evaluate the effects of two exercise approaches, Tai Chi (TC) and computerized balance training (BT), on specified primary outcomes (biomedical, functional, and psychosocial indicators of frailty) and secondary outcomes (occurrence of falls). ... Full text Link to item Cite

Emory Angioplasty Versus Surgery Trial (EAST): design, recruitment, and baseline description of patients.

Journal Article Am J Cardiol · March 23, 1995 Featured Publication In patients with multivessel coronary artery disease who require revascularization there is uncertainty as to the selection of the appropriate patients for percutaneous transluminal coronary angioplasty (PTCA) as opposed to coronary artery bypass grafting ... Link to item Cite

Multiple population models for multivariate random length data--with applications in clinical trials.

Journal Article Biometrics · March 1995 Featured Publication This paper focuses on the development and study of multiple population models for multivariate random length data, of the type often encountered in clinical trials. If experimental outcomes per subject consist of multiple measurements of a quantitative var ... Link to item Cite

A randomized trial comparing coronary angioplasty with coronary bypass surgery. Emory Angioplasty versus Surgery Trial (EAST).

Journal Article N Engl J Med · October 20, 1994 Featured Publication BACKGROUND: The clinical benefit of percutaneous transluminal coronary angioplasty (PTCA) as compared with coronary-artery bypass grafting (CABG) for patients with multivessel coronary artery disease has not been established. To determine the outcomes of t ... Full text Link to item Cite

Overview of multinomial models for ordinal data

Journal Article Communications in Statistics - Theory and Methods · January 1, 1994 The purpose of this paper is to relate a number of multinomial models currently in use for ordinal response data in a unified manner. By studying generalized logit models, proportional generalized odds ratio models and proportional generalized hazard model ... Full text Cite

Models for multivariate random length data with applications in clinical trials

Journal Article Drug Information Journal · 1993 This paper focuses on the development of models for multivariate random length data encountered in clinical or medical trials. When a patient's data consist of multiple responses of a certain quantitative variable and a random number of such responses, an ... Cite