Journal articleClin Pharmacol Ther · July 25, 2026
Elevated aminotransferases with concomitant jaundice in drug-induced liver injury (DILI) are associated with adverse outcomes, but the prognostic significance of very high aminotransferases without jaundice is unclear. We examined selected outcomes of pati ...
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Journal articleLiver Int · July 2026
BACKGROUND: We aimed to investigate and characterise DILI due to approved therapies for inflammatory bowel disease (IBD). METHODS: Using the Drug-Induced Liver Injury Network (DILIN) prospective study, we evaluated definite, highly likely, or probable DILI ...
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Journal articleNEJM Evid · June 2026
BACKGROUND: Prior analyses of trials comparing direct oral anticoagulants (DOACs) to warfarin in atrial fibrillation (AF) have not routinely incorporated patient preferences, despite substantial variation in how patients value the trade-off between outcome ...
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Journal articleJ Biopharm Stat · May 11, 2026
The win ratio (WR) is a widely used metric to compare treatments in randomized clinical trials with hierarchically ordered endpoints. Counting-based approaches, such as Pocock's algorithm, are the standard for WR estimation. However, this algorithm treats ...
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Journal articleAm J Gastroenterol · January 1, 2026
INTRODUCTION: Fluoroquinolones (FQ) have a favorable safety profile, but the risk of drug-induced liver injury (DILI) is well described. The aim of this study was to identify clinical features and HLA genetic variants associated with FQ-DILI in a large nat ...
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Journal articleActa Pharmaceutica Sinica B · January 1, 2026
Anti-hypertensive (anti-HTN) drugs are widely prescribed, but the features of associated drug-induced liver injury (DILI) are poorly defined. A total of 2207 patients enrolled in the Drug-Induced Liver Injury Network (DILIN) from 2003 to 2024 were adjudica ...
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Journal articleAliment Pharmacol Ther · November 2025
INTRODUCTION: Cephalosporins are widely prescribed antibiotics due to their efficacy and safety. Although rare, idiosyncratic drug-induced liver injury (DILI) has been reported with their use. Here, we characterise the clinical features and HLA association ...
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Journal articleJ Emerg Nurs · July 2025
INTRODUCTION: National guidelines for the acute management of sickle cell disease vaso-occlusive episodes recommend the use of a patient-specific or a weight-based protocol. The authors compared patient satisfaction with pain management between those rando ...
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Journal articleAm J Gastroenterol · June 12, 2025
INTRODUCTION: Drug reaction with eosinophilia and systemic symptoms (DRESS) can sometimes occur in patients with drug-induced liver injury (DILI). However, detailed studies of DRESS in patients with DILI from the United States are lacking. We investigated ...
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Journal articleStat Med · May 2025
Win measures, such as win ratio, win odds, net benefit, and desirability of outcome ranking (DOOR), have become popular approaches for the analysis of hierarchical endpoints in clinical studies. Sample size and power calculations with win measures based on ...
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Journal articleDrug Saf · February 2025
BACKGROUND: The attribution of drug-induced liver injury (DILI) to specific herbal and dietary supplements (HDS) is confounded by inaccurate labels and undisclosed ingredients. The US Drug-Induced Liver Injury Network (DILIN) determines the attribution of ...
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Journal articleDrug Saf · February 2025
BACKGROUND: The incidence of drug-induced liver injury (DILI) is not known for most prescription medications. We aimed to estimate the incidence of DILI for commonly prescribed outpatient drugs. METHODS: To establish a baseline estimate of DILI incidence, ...
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Journal articleLiver Int · February 2025
BACKGROUND AND AIMS: Short courses of intravenous (iv) methylprednisolone (MP) can cause drug induced liver injury (DILI). The aim of this study was to assess the clinical features and HLA associations of MP-related DILI enrolled in the US DILI Network (DI ...
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Journal articleStatistics in Biopharmaceutical Research · January 1, 2025
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 ...
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Journal articleJ Pain · December 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 ...
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Journal articleAm J Gastroenterol · October 18, 2024
INTRODUCTION: Hyman Zimmerman observed that hepatocellular (HC) drug-induced liver injury (DILI) with jaundice had a mortality rate of ≥ 10% (Hy Law). Hy Law does not specify the timing of liver tests nor the definition of HC DILI versus cholestatic or mix ...
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Journal articleMed Care · October 1, 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 ...
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Journal articleAliment 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 ...
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Journal articleHepatol 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 ...
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Journal articleAliment Pharmacol Ther · August 2024
BACKGROUND: In April 2022, French Lentil and Leek Crumble (FLLC), a new frozen food preparation manufactured by Daily Harvest™ (containing Tara flour) was offered as a natural high-protein meal product. Soon thereafter, widespread anecdotal reports of acut ...
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Journal articleLiver 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 ...
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Journal articleObstet 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 ...
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Journal articleDig 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 ...
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Journal articleAm 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 ...
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Journal articleJ 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 ...
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Journal articleHematology · 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 ...
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Journal articleAm 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 ...
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Journal articleAcad 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 ...
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Journal articleAm 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 ...
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Journal articleGastroenterology · 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 ...
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Journal articleJ 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 ...
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Journal articleAcad 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 ...
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Journal articleAcad 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 ...
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Journal articleAm 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 ...
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Journal articleAcad 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 ...
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Journal articleAcad 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 ...
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Journal articleAm 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 ...
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Journal articleHepatology · 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 ...
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Journal articleClin 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 ...
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Journal articleLiver 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 ...
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Journal articleJ 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 ...
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Journal articleJ 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 ...
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Journal articleLiver 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 ...
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Journal articleHepatology · 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 ...
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Journal articleJ 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 ...
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Journal articleContemp 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 ...
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Journal articleHepatology · 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 ...
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Journal articleDrug 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 ...
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Journal articleNat 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. ...
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Journal articleClin 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 ...
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Journal articleGastroenterology · 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 ...
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Journal articleEur 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 ...
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Journal articleDig 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 ...
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Journal articleJ 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 ...
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Journal articleAliment 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 ...
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Journal articleClin 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 ...
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Journal articleJACC 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 ...
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Journal articleHepatology 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 ...
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Journal articleJ 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 ...
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Journal articleContemp 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 ...
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Journal articleJ 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 ...
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Journal articleJ 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 ...
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Journal articlePLoS 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 ...
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Journal articleJ 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 ...
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Journal articleDig 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 ...
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Journal articleCirc 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 ...
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Journal articleLiver 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] ...
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Journal articleHepatology · 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 ...
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Journal articleAm 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 ...
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Journal articleStroke · 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 ...
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Journal articleGastroenterology · 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 ...
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Journal articleHepatology · 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 ...
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Journal articleStat 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 ...
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Journal articleStat 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 ...
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Journal articleJ 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 ...
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Journal articleStat 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 ...
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Journal articleDig 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 ...
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Journal articleClin 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 ...
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Journal articleInt 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 ...
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Journal articleAcad 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, ...
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Journal articleJ 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 ...
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Journal articleClin 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 ...
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Journal articleStat 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 ...
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Journal articleAm 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 ...
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Journal articleNat 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 ...
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Journal articleJ 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 ...
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Journal articleGastroenterology · 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 ...
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Journal articleLiver 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 ...
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Journal articleJ 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 ...
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Journal articleStat 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 ( ...
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Journal articleStat 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 ...
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Journal articleStat 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 ...
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Journal articleBlood 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 ...
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Journal articleHepatology · 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 ...
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Journal articleHepatology · 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 ...
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Journal articleGastroenterology · 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. ...
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Journal articleAnn 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 ...
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Journal articleHepatology · 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 ...
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Journal articleHepatology · 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 ...
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Journal articleMed 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 ...
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Journal articleDig 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 ...
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Journal articleAJR 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 ...
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Journal articlePLoS 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 ...
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Journal articleComputational 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 ...
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Journal articleAm 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 ...
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Journal articleJ 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 ...
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Journal articleStat 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 ...
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Journal articleAm 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 ...
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Journal articleNephrol 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 ...
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Journal articleAcad 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 ...
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Journal articleAnn 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 ...
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Journal articleAJR 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 ...
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Journal articlePhys 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 ...
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Journal articleAm 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 ...
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Journal articleArthritis 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 ...
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Journal articleClin 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 ...
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Journal articleStat 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 ...
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Journal articleJAMA · 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 ...
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Journal articleEur 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 ...
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Journal articleBr 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 ...
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Journal articleNeurosurgery · 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 ...
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Journal articleJ 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 ...
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Journal articleMed 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 ...
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Journal articleStat 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 ...
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Journal articleLupus · 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 ...
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Journal articleFertil 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 ...
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Journal articleFertil 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 ...
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Journal articleRadiology · 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 ...
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Journal articleAJR 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 ...
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Journal articleComput 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 ...
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Journal articlePhys 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 ...
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Journal articleMed 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 ...
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Journal articleKidney Int · February 2010
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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 ...
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Journal articleAJR 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 ...
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Journal articleAJR 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 ...
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Journal articleTransl Oncol · December 2009
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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 ...
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Journal articleJ 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 ...
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Journal articleArthritis Rheum · May 2009
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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 ...
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Journal articleComputational 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 ...
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Journal articleFertil 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 ...
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Journal articleKidney Int · September 2008
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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 ...
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Journal articleJ 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 ...
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Journal articleStat Methods Med Res · April 2008
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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 ...
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Journal articleNucl 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 ...
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Journal articleJ Clin Endocrinol Metab · March 2008
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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 ...
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Journal articleJ Biopharm Stat · 2008
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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 ...
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Journal articleComput Methods Programs Biomed · October 2007
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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 ...
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Journal articleN Engl J Med · February 8, 2007
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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 ...
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Journal articleFertil 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 ...
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Journal articleJ Biopharm Stat · 2007
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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 ...
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Journal articleJ Biopharm Stat · 2007
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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 ...
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Journal articleJ Biopharm Stat · 2007
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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 ...
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Journal articleJ Biopharm Stat · 2007
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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 ...
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Journal articleN 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 ...
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Journal articleFertil Steril · October 2006
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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 ...
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Journal articleBiom J · August 2006
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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 ...
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Journal articleEarly 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 ...
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Journal articleStat Methods Med Res · June 2006
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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 ...
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Journal articleStat Med · November 15, 2005
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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 ...
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Journal articleNephrol 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 ...
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Journal articleInt 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 ...
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Journal articleStat Med · May 15, 2005
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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 ...
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Journal articleJ 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 ...
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Journal articleJ Nutr · April 2004
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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 ...
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Journal articlePediatrics · March 2004
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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 ...
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Journal articleEarly 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 ...
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Journal articleJ Am Geriatr Soc · December 2003
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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) ...
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Journal articlePediatrics · November 2003
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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 ...
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Journal articleStat Med · September 15, 2003
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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 ...
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Journal articleStat Med · July 15, 2003
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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 ...
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Journal articleAm J Clin Nutr · July 2003
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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 ...
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Journal articleJ 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 ...
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Journal articleJournal 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 ...
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Journal articleAm 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 ...
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Journal articleAnn 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 ...
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Journal articleBiometrics · March 2003
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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 ...
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Journal articleMed 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 ...
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Journal articleBiometrics · December 2002
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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 ...
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Journal articleBiometrics · December 2002
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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 ...
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Journal articleRisk Anal · December 2002
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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 ...
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Journal articleNeurology · 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 ...
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Journal articleBiometrics · September 2001
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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 ...
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Journal articleBrain 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 ...
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Journal articleJ 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 ...
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Journal articleStat Med · June 15, 1999
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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 ...
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Journal articleStat Med · January 30, 1999
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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 ...
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Journal articleJournal 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 ...
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Journal articleBiometrics · June 1998
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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 ...
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Journal articleCommunications 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 ...
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Journal articleCommunications 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 ...
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Journal articleBiometrics · September 1997
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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 ...
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Journal articleJ 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 ...
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Journal articleAm J Cardiol · June 1, 1997
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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 ...
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Journal articlePhysical 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 ...
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Journal articlePhys Ther · April 1997
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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 ...
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Journal articleCirculation · 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 ...
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Journal articlePediatrics · May 1996
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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 ...
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Journal articleJ Am Geriatr Soc · May 1996
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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). ...
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Journal articleAm J Cardiol · March 23, 1995
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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 ...
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Journal articleBiometrics · March 1995
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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 ...
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Journal articleN Engl J Med · October 20, 1994
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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 ...
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Journal articleCommunications 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 ...
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Journal articleDrug 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 ...
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