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Zhang L.,Centers for Disease Control and Prevention | Gwinn M.,McKing Consulting Corporation | Hu D.J.,Centers for Disease Control and Prevention
Public Health Genomics | Year: 2013

About 180 million people worldwide are chronically infected with hepatitis C virus (HCV), with 3-4 million newly infected each year. Only 15-25% of acute HCV infections clear spontaneously, and the remainder persists as chronic HCV infection. More than 350,000 people die every year from hepatitis C-related liver failure and cancer. There is currently no vaccine and the standard-of-care therapies-peg-interferon alpha (pegIFN) plus ribavirin (RBV)-are expensive and have serious side effects. Also, they may be effective in only 40-50% of patients infected with HCV genotype 1, the most common HCV genotype in the US. Interleukin 28B (IL28B) genotype was recently and convincingly associated with response to pegIFN and RBV therapy. It has emerged as a robust pretreatment predictor of sustained virological response (SVR, i.e. virologic clearance) to pegIFN and RBV as well as to new triple therapy regimens that include a direct-acting antiviral agent with pegIFN and RBV and increase SVR rates as much as 75% in patients infected with HCV genotype 1. Testing for IL28B genotype may contribute to clinical decision-making and could inform clinical guidelines and public health policies. © 2013 S. Karger AG, Basel.


Kaye W.E.,McKing Consulting Corporation | Sanchez M.,Centers for Disease Control and Prevention | Wu J.,Centers for Disease Control and Prevention
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration | Year: 2014

Uncertainty about the incidence and prevalence of amyotrophic lateral sclerosis (ALS), as well as the role of the environment in the etiology of ALS, supports the need for a surveillance system/registry for this disease. Our aim was to evaluate the feasibility of using existing administrative data to identify cases of ALS. The Agency for Toxic Substances and Disease Registry (ATSDR) funded four pilot projects at tertiary care facilities for ALS, HMOs, and state based organizations. Data from Medicare, Medicaid, the Veterans Health Administration, and Veterans Benefits Administration were matched to data available from site-specific administrative and clinical databases for a five-year time-period (1 January 2001-31 December 2005). Review of information in the medical records by a neurologist was considered the gold standard for determining an ALS case. We developed an algorithm using variables from the administrative data that identified true cases of ALS (verified by a neurologist). Individuals could be categorized into ALS, possible ALS, and not ALS. The best algorithm had sensitivity of 87% and specificity of 85%. We concluded that administrative data can be used to develop a surveillance system/registry for ALS. These methods can be explored for creating surveillance systems for other neurodegenerative diseases. © 2014 Informa Healthcare.


Schauer G.L.,Centers for Disease Control and Prevention | Schauer G.L.,Emory University | Pederson L.L.,McKing Consulting Corporation | Malarcher A.M.,Centers for Disease Control and Prevention
Nicotine and Tobacco Research | Year: 2016

Introduction: It is unclear how use of other tobacco products impacts cigarette-smoking cessation. We assessed differences in past year cigarette smoking quit attempts and use of counseling and medication among current cigarette-only users, cigarette and cigar users, and cigarette and smokeless tobacco (SLT) users. Methods: Data came from 24 448 current cigarette-only, 1064 cigarette and cigar only, and 508 cigarette and SLT only users who responded to the 2010-2011 Tobacco Use Supplement to the Current Population Survey. Demographic, smoking, and cessation characteristics were computed by group. Bivariate and multivariable logistic regression models assessed the relationship of tobacco use group to making a past year quit attempt, and use of counseling or medication during the last quit attempt. Results: Dual users of cigarettes and cigars or SLT had similar interest in quitting and prevalence of reported past year quit attempts compared to cigarette-only users. In unadjusted analyses, cigarette and SLT users had higher odds of trying to quit in the past year compared to cigarette-only users (odds ratio [OR] = 1.31, 95% confidence interval [CI] = 1.05, 1.64); no differences were found for cigarette and cigar users. However, adjusting for demographic and cigarette smoking variables, both groups of dual users had similar odds as cigarette-only users for having made a past year cigarette smoking quit attempt, and to have used counseling or medication during the last quit attempt. Conclusion: Dual tobacco use was not associated with decreased attempts to quit smoking cigarettes; however, use of evidence-based treatment was sub-optimal among cigarette-only and dual users, and should be increased. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.


Phillips K.A.,University of California at San Francisco | Ann Sakowski J.,University of California at San Francisco | Trosman J.,University of California at San Francisco | Douglas M.P.,University of California at San Francisco | And 4 more authors.
Genetics in Medicine | Year: 2014

Purpose:There is uncertainty about when personalized medicine tests provide economic value. We assessed evidence on the economic value of personalized medicine tests and gaps in the evidence base.Methods:We created a unique evidence base by linking data on published cost-utility analyses from the Tufts Cost-Effectiveness Analysis Registry with data measuring test characteristics and reflecting where value analyses may be most needed: (i) tests currently available or in advanced development, (ii) tests for drugs with Food and Drug Administration labels with genetic information, (iii) tests with demonstrated or likely clinical utility, (iv) tests for conditions with high mortality, and (v) tests for conditions with high expenditures.Results:We identified 59 cost-utility analyses studies that examined personalized medicine tests (1998-2011). A majority (72%) of the cost/quality-adjusted life year ratios indicate that testing provides better health although at higher cost, with almost half of the ratios falling below $50,000 per quality-adjusted life year gained. One-fifth of the results indicate that tests may save money.Conclusion:Many personalized medicine tests have been found to be relatively cost-effective, although fewer have been found to be cost saving, and many available or emerging medicine tests have not been evaluated. More evidence on value will be needed to inform decision making and assessment of genomic priorities. © American College of Medical Genetics and Genomics.


Rha B.,Centers for Disease Control and Prevention | Burrer S.,Centers for Disease Control and Prevention | Park S.,McKing Consulting Corporation | Trivedi T.,Centers for Disease Control and Prevention | And 2 more authors.
Emerging Infectious Diseases | Year: 2013

Noroviruses are the leading cause of gastroenteritis in the United States, but timely measures of disease are lacking. BioSense, a national-level electronic surveillance system, assigns data on chief complaints (patient symptoms) collected during emergency department (ED) visits to 78 subsyndromes in near real-time. In a series of linear regression models, BioSense visits mapped by chief complaints of diarrhea and nausea/vomiting subsyndromes as a monthly proportion of all visits correlated strongly with reported norovirus outbreaks from 6 states during 2007-2010. Higher correlations were seen for diarrhea (R = 0.828-0.926) than for nausea/vomiting (R = 0.729-0.866) across multiple age groups. Diarrhea ED visit proportions exhibited winter seasonality attributable to norovirus; rotavirus contributed substantially for children <5 years of age. Diarrhea ED visit data estimated the onset, peak, and end of norovirus season within 4 weeks of observed dates and could be reliable, timely indicators of norovirus activity.


Khoury M.J.,Centers for Disease Control and Prevention | Khoury M.J.,U.S. National Cancer Institute | Gwinn M.,Centers for Disease Control and Prevention | Gwinn M.,McKing Consulting Corporation | And 2 more authors.
Genetics in Medicine | Year: 2012

Three articles in this issue of Genetics in Medicine describe examples of knowledge integration, involving methods for generating and synthesizing rapidly emerging information on health-related genomic technologies and engaging stakeholders around the evidence. Knowledge integration, the central process in translating genomic research, involves three closely related, iterative components: knowledge management, knowledge synthesis, and knowledge translation. Knowledge management is the ongoing process of obtaining, organizing, and displaying evolving evidence. For example, horizon scanning and infoveillance use emerging technologies to scan databases, registries, publications, and cyberspace for information on genomic applications. Knowledge synthesis is the process of conducting systematic reviews using a priori rules of evidence. For example, methods including meta-analysis, decision analysis, and modeling can be used to combine information from basic, clinical, and population research. Knowledge translation refers to stakeholder engagement and brokering to influence policy, guidelines and recommendations, as well as the research agenda to close knowledge gaps. The ultrarapid production of information requires adequate public and private resources for knowledge integration to support the evidence-based development of genomic medicine. © 2012 American College of Medical Genetics and Genomics.


Fein S.B.,McKing Consulting Corporation | Li R.,Centers for Disease Control and Prevention | Chen J.,Centers for Disease Control and Prevention | Scanlon K.S.,Centers for Disease Control and Prevention | Grummer-Strawn L.M.,Centers for Disease Control and Prevention
Pediatrics | Year: 2014

Methods: The Y6FU sample was a subset of those who participated in IFPSII. The IFPSII participants were drawn from a national consumer opinion panel; neither the IFPSII nor the Y6FU sample is nationally representative. The Y6FU sampling frame included all qualified participants who answered at least the first postnatal questionnaire. One questionnaire was administered by mail in 2012, and nonrespondents were contacted for a telephone interview. Survey topics included measures of health, development, diet, physical activity, screen time, and family medical history. We attempted to contact 2958 mothers and obtained completed questionnaires from 1542, a response rate of 52.1%. We conducted 2 sample evaluations, 1 comparing respondents and nonrespondents on data from IFPSII and the other comparing Y6FU respondents with 6-year-old participants in the National Survey of Children's Health.Results: Y6FU mothers are more likely to be white, married, older, and of higher education and income than both nonresponders and nationally representative mothers. Comparisons also revealed health-related differences and similarities.Conclusions: Although not nationally representative, the Y6FU provides a valuable database because of its wide coverage of diet and health issues and its unique ability to link early feeding patterns with outcomes at age 6 years.Objective: We describe methods used in the Year 6 Follow-Up (Y6FU) of children who participated in the Infant Feeding Practices Study II (IFPSII). This study consists of a questionnaire administered 6 years after the IFPSII to characterize the health, development, and diet quality of the children. Copyright © 2014 by the American Academy of Pediatrics.


Palomaki G.E.,Brown University | Melillo S.,Centers for Disease Control and Prevention | Melillo S.,McKing Consulting Corporation | Bradley L.A.,Centers for Disease Control and Prevention | And 2 more authors.
JAMA - Journal of the American Medical Association | Year: 2010

Context: Associations between chromosome 9p21 single-nucleotide polymorphisms (SNPs) and heart disease have been reported and replicated. If testing improves risk assessments using traditional factors, it may provide opportunities to improve public health. Objectives: To perform a targeted systematic review of published literature for effect size, heterogeneity, publication bias, and strength of evidence and to consider whether testing might provide clinical utility. Data Sources: Electronic search via HuGE Navigator through January 2009 and review of reference lists from included articles. Study Selection: English-language articles that tested for 9p21 SNPs with coronary heart/artery disease or myocardial infarction as primary outcomes. Included articles also provided race, numbers of participants, and data to compute an odds ratio (OR). Articles were excluded if reporting only intermediate outcomes (eg, atherosclerosis) or if all participants had existing disease. Twenty-five articles were initially identified and 16 were included. A follow-up search identified 6 additional articles. Data Extraction: Independent extraction was performed by 2 reviewers and consensus was reached. Credibility of evidence was assessed using published Venice criteria. Data Synthesis: Forty-seven distinct data sets from the 22 articles were analyzed, including 35 872 cases and 95 837 controls. The summary OR for heart disease among individuals with 2 vs 1 at-risk alleles was 1.25 (95% confidence interval [CI], 1.21-1.29), with low to moderate heterogeneity. Age at disease diagnosis was a significant covariate, with ORs of 1.35 (95% CI, 1.30-1.40) for age 55 years or younger and 1.21 (95% CI, 1.16-1.25) for age 75 years or younger. For a 65-year-old man, the 10-year heart disease risk for 2 vs 1 at-risk alleles would be 13.2% vs 11%. For a 40-year-old woman, the 10-year heart disease risk for 2 vs 1 at-risk alleles would be 2.4% vs 2.0%. Nearly identical but inverse results were found when comparing 1 vs 0 at-risk alleles. Three studies showed net reclassification indexes ranging from -0.1% to 4.8%. Conclusion: We found a statistically significant association between 9p21 SNPs and heart disease that varied by age at disease onset, but the magnitude of the association was small. ©2010 American Medical Association. All rights reserved.


Stewart A.,McKing Consulting Corporation | Stewart A.,Centers for Disease Control and Prevention
PLoS Currents | Year: 2013

Statin drugs are highly effective in lowering blood concentrations of LDL-cholesterol, with concomitant reduction in risk of major cardiovascular events. Although statins are generally regarded as safe and well-tolerated, some users develop muscle symptoms that are mostly mild but in rare cases can lead to life-threatening rhabdomyolysis. The SEARCH genome-wide association study, which has been independently replicated, found a significant association between the rs4149056 (c.521T>C) single-nucleotide polymorphism (SNP) in the SLCO1B1 gene, and myopathy in individuals taking 80 mg simvastatin per day, with an odds ratio of 4.5 per rs4149056 C allele. The purpose of this paper is to assemble evidence relating to the analytical validity, clinical validity and clinical utility of using SLCO1B1 rs4149056 genotyping to inform choice and dose of statin treatment, with the aim of minimising statin-induced myopathy and increasing adherence to therapy. Genotyping assays for the rs4149056 SNP appear to be robust and accurate, though direct evidence for the performance of array-based platforms in genotyping individual SNPs was not found. Using data from the SEARCH study, calculated values for the clinical sensitivity, specificity, positive- and negative-predictive values of a test for the C allele to predict definite or incipient myopathy during 5 years of 80 mg/day simvastatin use were 70.4%, 73.7%, 4.1% and 99.4% respectively. There is a need for studies comparing the clinical validity of SLCO1B1 rs4149056 genotyping with risk scores for myopathy based on other factors such as racial background, statin type and dose, gender, body mass index, co-medications and co-morbidities. No direct evidence was found for clinical utility of statin prescription guided by SLCO1B1 genotype.


Marcus G.,Centers for Disease Control and Prevention | Green D.R.,McKing Consulting Corporation | Gaffney C.,McKing Consulting Corporation
Public Health Reports | Year: 2010

Objectives. Newborn hearing screening programs have been implemented by all 50 states and most U.S. territories to detect hearing loss in infants and prevent delays in speech, language, and social and emotional development. To monitor progress toward national goals, the Centers for Disease Control and Prevention (CDC) collects data from state and territorial programs. This article summarizes findings from the CDC Early Hearing Detection and Intervention (EHDI) Hearing Screening and Follow-up Survey (HSFS) and provides a summary of recent efforts to identify infants with hearing loss in the U.S. Methods. The HSFS was sent to representatives of U.S. EHDI programs to gather aggregate screening, diagnostic, intervention, and demographic data for 2005 and 2006. We analyzed these data to evaluate progress toward national goals. Results. In 2005 and 2006, more than 90% of infants were screened for hearing loss. Of these infants, 2% in both years did not pass their final screening. Out of those not passing the final screening, approximately two-thirds were not documented as having a diagnostic finding. In both years, the reason reported for the majority of infants was loss to follow-up/loss to documentation (LFU/LTD). Although the majority of infants with permanent hearing loss were receiving intervention, more than 30% were classified as LFU/LTD and could not be documented as receiving intervention services. Conclusions. The HSFS enables the collection of more complete data that highlight the progress in screening infants for hearing loss. However, data indicate improvements are needed to reduce LFU/LTD and meet the national benchmarks.

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