Browsing by Author "Yow, Eric"

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    Avascular necrosis in pediatric systemic lupus erythematosus: a brief report and review of the literature.
    (Pediatr Rheumatol Online J, 2015-04-23) Gurion, Reut; Tangpricha, Vin; Yow, Eric; Schanberg, Laura E; McComsey, Grace A; Robinson, Angela Byun; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators
    UNLABELLED: Avascular necrosis (AVN) occurs in several chronic illnesses, including systemic lupus erythematosus (SLE), but can also occur in healthy children. There are multiple theories to explain why and how AVN occurs, but an exact mechanism has yet to be unraveled. AVN in the pediatric lupus population is understudied. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) trial, provides an excellent venue to conduct an exploratory analysis to assess associations between AVN and demographics, SLE disease activity and vitamin D deficiency. Herein we present a brief report describing our findings, as well as reviewing the literature on AVN in SLE and other entities. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00065806.
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    Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.
    (Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography, 2016-12) Crowley, Anna Lisa; Yow, Eric; Barnhart, Huiman X; Daubert, Melissa A; Bigelow, Robert; Sullivan, Daniel C; Pencina, Michael; Douglas, Pamela S

    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

    Twenty unique clinical studies were identified reporting echocardiographic data quality for determinations of left ventricular (LV) volumes (n = 13), ejection fraction (n = 12), mass (n = 9), outflow tract diameter (n = 3), and mitral Doppler peak early velocity (n = 4). To better understand the range of possible estimates of data quality and to compare their utility, reported reproducibility measures were tabulated, and de novo estimates were then calculated for missing measures, including intraclass correlation coefficient (ICC), 95% limits of agreement, coefficient of variation (CV), coverage probability, and total deviation index, for each variable for each study.

    Results

    The studies varied in approaches to reproducibility testing, sample size, and metrics assessed and values reported. Reported metrics included mean difference and its SD (n = 7 studies), ICC (n = 5), CV (n = 4), and Bland-Altman limits of agreement (n = 4). Once de novo estimates of all missing indices were determined, reasonable reproducibility targets for each were identified as those achieved by the majority of studies. These included, for LV end-diastolic volume, ICC > 0.95, CV < 7%, and coverage probability > 0.93 within 30 mL; for LV ejection fraction, ICC > 0.85, CV < 8%, and coverage probability > 0.85 within 10%; and for LV mass, ICC > 0.85, CV < 10%, and coverage probability > 0.60 within 20 g.

    Conclusions

    Assessment of data quality in echocardiographic clinical research is infrequent, and methods vary substantially. A first step to standardizing echocardiographic quality reporting is to standardize assessments and reporting metrics. Potential benefits include clearer communication of data quality and the identification of achievable targets to benchmark quality improvement initiatives.
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    Methods of creatine kinase-MB analysis to predict mortality in patients with myocardial infarction treated with reperfusion therapy.
    (Trials, 2013-05-02) Lopes, Renato D; Lokhnygina, Yuliya; Hasselblad, Victor; Newby, Kristin L; Yow, Eric; Granger, Christopher B; Armstrong, Paul W; Hochman, Judith S; Mills, James S; Ruzyllo, Witold; Mahaffey, Kenneth W
    BACKGROUND: Larger infarct size measured by creatine kinase (CK)-MB release is associated with higher mortality and has been used as an important surrogate endpoint in the evaluation of new treatments for ST-segment elevation myocardial infarction (STEMI). Traditional approaches to quantify infarct size include the observed CK-MB peak and calculated CK-MB area under the curve (AUC). We evaluated alternative approaches to quantifying infarct size using CK-MB values, and the relationship between infarct size and clinical outcomes. METHODS: Of 1,850 STEMI patients treated with reperfusion therapy in the COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA) (percutaneous coronary intervention (PCI)-treated) and the COMPlement inhibition in myocardial infarction treated with thromboLYtics (COMPLY) (fibrinolytic-treated) trials, 1,718 (92.9%) (COMMA, n = 868; COMPLY, n = 850) had at least five of nine protocol-required CK-MB measures. In addition to traditional methods, curve-fitting techniques were used to determine CK-MB AUC and estimated peak CK-MB. Cox proportional hazards modeling assessed the univariable associations between infarct size and mortality, and the composite of death, heart failure, shock and stroke at 90 days. RESULTS: In COMPLY, CK-MB measures by all methods were significantly associated with higher mortality (hazard ratio range per 1,000 units increase: 1.09 to 1.13; hazard ratio range per 1 standard deviation increase: 1.41 to 1.62; P <0.01 for all analyses). In COMMA, the associations were similar but did not reach statistical significance. For the composite outcome of 90-day death, heart failure, shock and stroke, the associations with all CK-MB measures were statistically significant in both the COMMA and COMPLY trials. CONCLUSIONS: Sophisticated curve modeling is an alternative to infarct-size quantification in STEMI patients, but it provides information similar to that of more traditional methods. Future studies will determine whether the same conclusion applies in circumstances other than STEMI, or to studies with different frequencies and patterns of CK-MB data collection.
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    Percutaneous coronary intervention outcomes in patients with stable coronary disease and left ventricular systolic dysfunction.
    (ESC heart failure, 2019-12) DeVore, Adam D; Yow, Eric; Krucoff, Mitchell W; Sherwood, Matthew W; Shaw, Linda K; Chiswell, Karen; O'Connor, Christopher M; Ohman, Erik Magnus; Velazquez, Eric J
    AIMS:We sought to better understand the role of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD) and moderate or severe left ventricular systolic dysfunction. METHODS AND RESULTS:Using data from the Duke Databank for Cardiovascular Disease, we analysed patients who underwent coronary angiography at Duke University Medical Center (1995-2012) that had stable CAD amenable to PCI and left ventricular ejection fraction ≤35%. Patients with acute coronary syndrome or Canadian Cardiovascular Society class III or IV angina were excluded. We used propensity-matched Cox proportional hazards to evaluate the association of PCI with mortality and hospitalizations. Of 901 patients, 259 were treated with PCI and 642 with medical therapy. PCI propensity scores created from 24 variables were used to assemble a matched cohort of 444 patients (222 pairs) receiving PCI or medical therapy alone. Over a median follow-up of 7 years, 128 (58%) PCI and 125 (56%) medical therapy alone patients died [hazard ratio 0.87 (95% confidence interval 0.68, 1.10)]; there was also no difference in the rate of a composite endpoint of all-cause mortality or cardiovascular hospitalization [hazard ratio 1.18 (95% confidence interval 0.96, 1.44)] between the two groups. CONCLUSIONS:In this well-profiled, propensity-matched cohort of patients with stable CAD amenable to PCI and moderate or severe left ventricular systolic dysfunction, the addition of PCI to medical therapy did not improve long-term mortality, or the composite of mortality or cardiovascular hospitalization. The impact of PCI on other outcomes in these high-risk patients requires further study.
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    RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design.
    (American heart journal, 2024-07) Krychtiuk, Konstantin A; Starks, Monique A; Al-Khalidi, Hussein R; Mark, Daniel B; Monk, Lisa; Yow, Eric; Kaltenbach, Lisa; Jollis, James G; Al-Khatib, Sana M; Bosworth, Hayden B; Ward, Kimberly; Brady, Sarah; Tyson, Clark; Vandeventer, Steve; Baloch, Khaula; Oakes, Megan; Blewer, Audrey L; Lewinski, Allison A; Hansen, Carolina Malta; Sharpe, Edward; Rea, Thomas D; Nelson, R Darrell; Sasson, Comilla; McNally, Bryan; Granger, Christopher B; RACE-CARS NC Counties
    Out-of-hospital cardiac arrest (OHCA) occurs in nearly 350,000 people each year in the United States (US). Despite advances in pre and in-hospital care, OHCA survival remains low and is highly variable across systems and regions. The critical barrier to improving cardiac arrest outcomes is not a lack of knowledge about effective interventions, but rather the widespread lack of systems of care to deliver interventions known to be successful. The RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial is a 7-year pragmatic, cluster-randomized trial of 62 counties (57 clusters) in North Carolina using an established registry and is testing whether implementation of a customized set of strategically targeted community-based interventions improves survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. The multifaceted intervention comprises rapid cardiac arrest recognition and systematic bystander CPR instructions by 9-1-1 telecommunicators, comprehensive community CPR training and enhanced early automated external defibrillator (AED) use prior to emergency medical systems (EMS) arrival. Approximately 20,000 patients are expected to be enrolled in the RACE CARS Trial over 4 years of the assessment period. The primary endpoint is survival to hospital discharge with good neurologic outcome defined as a cerebral performance category (CPC) of 1 or 2. Secondary outcomes include the rate of bystander CPR, defibrillation prior to arrival of EMS, and quality of life. We aim to identify successful community- and systems-based strategies to improve outcomes of OHCA using a cluster randomized-controlled trial design that aims to provide a high level of evidence for future application.