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1.  Transforming Epidemiology for 21st Century Medicine and Public Health 
In 2012, the National Cancer Institute (NCI) engaged the scientific community to provide a vision for cancer epidemiology in the 21st century. Eight overarching thematic recommendations, with proposed corresponding actions for consideration by funding agencies, professional societies, and the research community emerged from the collective intellectual discourse. The themes are (i) extending the reach of epidemiology beyond discovery and etiologic research to include multilevel analysis, intervention evaluation, implementation, and outcomes research; (ii) transforming the practice of epidemiology by moving towards more access and sharing of protocols, data, metadata, and specimens to foster collaboration, to ensure reproducibility and replication, and accelerate translation; (iii) expanding cohort studies to collect exposure, clinical and other information across the life course and examining multiple health-related endpoints; (iv) developing and validating reliable methods and technologies to quantify exposures and outcomes on a massive scale, and to assess concomitantly the role of multiple factors in complex diseases; (v) integrating “big data” science into the practice of epidemiology; (vi) expanding knowledge integration to drive research, policy and practice; (vii) transforming training of 21st century epidemiologists to address interdisciplinary and translational research; and (viii) optimizing the use of resources and infrastructure for epidemiologic studies. These recommendations can transform cancer epidemiology and the field of epidemiology in general, by enhancing transparency, interdisciplinary collaboration, and strategic applications of new technologies. They should lay a strong scientific foundation for accelerated translation of scientific discoveries into individual and population health benefits.
PMCID: PMC3625652  PMID: 23462917
big data; clinical trials; cohort studies; epidemiology; genomics; medicine; public health; technologies; training; translational research
2.  Use of Hundreds of Electrocardiograhpic Biomarkers for Prediction of Mortality in Post-Menopausal Women: The Women’s Health Initiative 
Simultaneous contribution of hundreds of electrocardiographic biomarkers to prediction of long-term mortality in post-menopausal women with clinically normal resting electrocardiograms (ECGs) is unknown.
Methods and Results
We analyzed ECGs and all-cause mortality in 33,144 women enrolled in Women’s Health Initiative trials, who were without baseline cardiovascular disease or cancer, and had normal ECGs by Minnesota and Novacode criteria. Four hundred and seventy seven ECG biomarkers, encompassing global and individual ECG findings, were measured using computer algorithms. During a median follow-up of 8.1 years (range for survivors 0.5–11.2 years), 1,229 women died. For analyses cohort was randomly split into derivation (n=22,096, deaths=819) and validation (n=11,048, deaths=410) subsets. ECG biomarkers, demographic, and clinical characteristics were simultaneously analyzed using both traditional Cox regression and Random Survival Forest (RSF), a novel algorithmic machine-learning approach. Regression modeling failed to converge. RSF variable selection yielded 20 variables that were independently predictive of long-term mortality, 14 of which were ECG biomarkers related to autonomic tone, atrial conduction, and ventricular depolarization and repolarization.
We identified 14 ECG biomarkers from amongst hundreds that were associated with long-term prognosis using a novel random forest variable selection methodology. These were related to autonomic tone, atrial conduction, ventricular depolarization, and ventricular repolarization. Quantitative ECG biomarkers have prognostic importance, and may be markers of subclinical disease in apparently healthy post-menopausal women.
PMCID: PMC3893688  PMID: 21862719
Electrocardiography; epidemiology; women; prognosis
3.  The Longitudinal Study of Implantable Cardioverter Defibrillators: Methods and Clinical Characteristics of Patients Receiving Implantable Cardioverter Defibrillators for Primary Prevention in Contemporary Practice 
Implantable cardioverter defibrillators (ICDs) are increasingly used for primary prevention followingrandomized controlled trials (RCTs) demonstrating that they reduce the risk of death in patients with left ventricular systolic dysfunction (LVSD). The extent to which the clinical characteristics and long-term outcomes of unselected, community-based patients with LVSD undergoing primary prevention ICD implantation in a real-world setting compare with those enrolled in the RCTs is not well characterized. The Longitudinal Study of ICDs is being conducted to address these questions.
Methods and Results
The study cohort includes consecutive patients undergoing primary prevention ICD placement between 1/1/2006 and 12/31/2009 in seven health plans. Baseline clinical characteristics were acquired from the NCDRICD Registry. Longitudinal data collection is underway and will include hospitalization, mortality, and resource utilization from the Virtual Data Warehouse. Data regarding ICD therapies will be obtained through chart abstraction and adjudicated by a panel of experts in device therapy. Compared with the populations of primary prevention ICD therapy RCTs, the cohort (n=2,621) is on average significantly older (by 2.5-6.5 years); more often female, more often from racial and ethnic minority groups, and has a significantly higher burden of coexisting conditions. The cohort is similar, however, to a national population undergoing primary prevention ICD placement.
Patients undergoing primary prevention ICD implantation in the Longitudinal Study of ICDs differ from those enrolled in the RCTs that established the efficacy of ICDs. Understanding a broad range of health outcomes, including ICD therapies, in this cohort will provide patients, clinicians, and policy-makers with contemporary data to inform decision-making.
PMCID: PMC3526187  PMID: 23170006
arrhythmia; electrophysiology; epidemiology
5.  Future Directions for Cardiovascular Disease Comparative Effectiveness Research 
Comparative effectiveness research (CER) aims to provide decision-makers the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart Lung and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address eight clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER.
PMCID: PMC3416944  PMID: 22796257
comparative effectiveness; research methods; clinical trials
6.  Rigorous science as the road to better public health 
In the current issue of Population Health Metrics, two reports paint a bleak picture of American public health. Both physical inactivity and obesity remain highly prevalent; yet, it is not clear that increased physical activity will reduce the burden of obesity. There continue to be widespread disparities in life expectancy across United States counties. These reports appear against a backdrop of debate regarding how we should allocate our scarce resources for improving health: should we focus more on improving access to high-quality medical care, or should we instead focus on more and better public health interventions? While optimal solutions remain obscure, a look at prior successes suggests that ultimately they will come from the conduct and implementation of rigorous science, and in particular event-driven trials.
PMCID: PMC3710508  PMID: 23842137
Public health; Population science; Obesity; Physical activity; Life-expectancy; Randomized trials
7.  Cardiovascular Epidemiology in a Changing World—Challenges to Investigators and the National Heart, Lung, and Blood Institute 
American Journal of Epidemiology  2012;175(7):597-601.
Over the past 60 years, revolutionary discoveries made by epidemiologists have contributed to marked declines in cardiovascular disease morbidity and mortality. Now, in an era of increasingly constrained resources, researchers in cardiovascular epidemiology face a number of challenges that call for novel, paradigm-shifting approaches. In this paper, the authors pose to the community 4 critical questions: 1) How can we avoid wasting resources on studies that provide little incremental knowledge? 2) How can we assure that we direct our resources as economically as possible towards innovative science? 3) How can we be nimble, responding quickly to new opportunities? 4) How can we identify prospectively the most meritorious research questions? Senior program staff at the National Heart, Lung, and Blood Institute invite the epidemiology community to join them in an ongoing Web-based blog conversation so that together we might develop novel approaches that will facilitate the next generation of high-impact discoveries.
PMCID: PMC3390031  PMID: 22415032
cardiovascular diseases; epidemiology; National Institutes of Health (U.S.); research
8.  Quantitative Electrocardiography for Predicting Postoperative Atrial Fibrillation after Cardiac Surgery 
Journal of electrocardiology  2011;44(6):761-767.
Atrial fibrillation (AF) after cardiac surgery is a common marker of poor outcomes. Quantitative electrocardiographic (ECG) measurements may be valuable predictors of postoperative AF.
We evaluated clinical and ECG predictors of postoperative AF in 13,356 patients who underwent cardiac surgery in sinus rhythm.
4,724 patients (35%) developed postoperative AF. P-wave amplitude in lead aVR and V1 were the strongest ECG predictors. A less negative P-wave amplitude in lead aVR was associated with increased risk for postoperative AF (OR 1.46, CI 1.32–1.61), as was a more positive or a more negative P-wave amplitude in lead V1 (OR 1.25, CI 1.16–1.36) after adjusting for clinical and procedural predictors of postoperative AF. Reclassification analysis showed a 7% discrimination improvement (p<0.0001).
P-wave amplitude in lead aVR and lead V1 are powerful predictors of postoperative AF and in combination with other clinical predictors can guide application of prophylactic interventions.
PMCID: PMC3096700  PMID: 21276589
9.  And What About Exercise? Fitness and Risk of Death in “Low-Risk” Adults 
PMCID: PMC3487347  PMID: 23130175
editorials; exercise; risk, low; Framingham Risk Score; cardiovascular diseases
10.  Emerging Cardiovascular Risk Factors That Account for a Significant Portion of Attributable Mortality Risk in Chronic Kidney Disease 
The American Journal of Cardiology  2008;101(12):1741-1746.
Chronic kidney disease (CKD) increases cardiovascular risk and mortality. However, traditional cardiovascular risk factors do not adequately account for the substantial increase in mortality observed in CKD. The aim of this study was to examine the relative contributions of novel cardiovascular risk factors to the risk between CKD and mortality. The study population included 4,680 consecutive new patients from a tertiary care preventive cardiology program from 1996 to 2005. Estimated glomerular filtration rate was calculated using the Modification of Diet in Renal Disease (MDRD) method. Baseline levels of traditional (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, hypertension, triglycerides, total cholesterol, and fasting glucose) and emerging (apolipoproteins A-I and B, lipoprotein[a], fibrinogen, homocysteine, and high-sensitivity C-reactive protein) risk factors were examined. All-cause mortality was obtained from the Social Security Death Index. There were 278 deaths over a median follow-up period of 22 months. CKD (estimated glomerular filtration rate ≤60 ml/min/1.73 m2) was strongly associated with mortality after adjusting for traditional cardiovascular risk factors (hazard ratio 2.31, 95% confidence interval 1.77 to 3.11, p <0.001) and with the addition of propensity score (hazard ratio 2.33, 95% confidence interval 1.75 to 3.10, p <0.001). Of all the traditional and emerging risk factors monitored, only the addition of homocysteine and fibrinogen significantly attenuated the association between CKD and mortality (adjusted hazard ratio 1.73, 95% confidence interval 1.23 to 2.34, p <0.001), explaining 38% of the attributable mortality risk from CKD. A significant interaction (p = 0.004) between homocysteine and estimated glomerular filtration rate was observed whereby the annual mortality rate in subjects with CKD with homocysteine <10 μmol/L (the bottom tertile) was similar to those with normal renal function (1% per year), whereas homocysteine levels ≥12.5 μmol/L (the top tertile) were associated with a sevenfold greater mortality risk. In conclusion, homocysteine and fibrinogen levels explain nearly 40% of the attributable mortality risk from CKD.
PMCID: PMC3354958  PMID: 18549850
11.  The Scientific Foundation for Personal Genomics: Recommendations from a National Institutes of Health–Centers for Disease Control and Prevention Multidisciplinary Workshop 
The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed.
PMCID: PMC2936269  PMID: 19617843
behavioral sciences; epidemiologic methods; evidence-based medicine; genetics; genetic testing; genomics; medicine; public health
12.  Outcomes Research in Cardiovascular Imaging 
In July of 2008, the National Heart, Lung, and Blood Institute convened experts in noninvasive cardiovascular imaging, outcomes research, statistics, and clinical trials to develop recommendations for future randomized controlled trials of the use of imaging in: 1) screening the asymptomatic patient for coronary artery disease; 2) assessment of patients with stable angina; 3) identification of acute coronary syndromes in the emergency room; and 4) assessment of heart failure patients with chronic coronary artery disease with reduced left ventricular ejection fraction. This study highlights several possible trial designs for each clinical situation.
PMCID: PMC2739093  PMID: 19560655
cardiovascular imaging; chest pain diagnosis; clinical trials
13.  Outcomes Research in Cardiovascular Imaging: Report of a Workshop sponsored by the National Heart Lung and Blood Institute 
JACC. Cardiovascular imaging  2009;2(7):897-907.
PMCID: PMC2790271  PMID: 19608141
cardiovascular imaging; chest pain diagnosis; clinical trials
14.  How One Division at NHLBI Establishes Its Scientific Priorities 
PMCID: PMC2758646  PMID: 19520248
16.  Comparative Effectiveness Research: The View from NHLBI 
PMCID: PMC2692180  PMID: 19298925

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