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Michael J. Pencina

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https://www.readbyqxmd.com/read/28503947/recommendations-for-data-monitoring-committees-from-the-clinical-trials-transformation-initiative
#1
Karim A Calis, Patrick Archdeacon, Raymond Bain, David DeMets, Miriam Donohue, M Khair Elzarrad, Annemarie Forrest, John McEachern, Michael J Pencina, Jane Perlmutter, Roger J Lewis
Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28464332/a-comparison-of-risk-prediction-methods-using-repeated-observations-an-application-to-electronic-health-records-for-hemodialysis
#2
Benjamin A Goldstein, Gina Maria Pomann, Wolfgang C Winkelmayer, Michael J Pencina
An increasingly important data source for the development of clinical risk prediction models is electronic health records (EHRs). One of their key advantages is that they contain data on many individuals collected over time. This allows one to incorporate more clinical information into a risk model. However, traditional methods for developing risk models are not well suited to these irregularly collected clinical covariates. In this paper, we compare a range of approaches for using longitudinal predictors in a clinical risk model...
May 2, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28442125/relation-of-risk-factors-and-abdominal-aortic-calcium-to-progression-of-coronary-artery-calcium-from-the-framingham-heart-study
#3
Oyere K Onuma, Karol Pencina, Saadia Qazi, Joseph M Massaro, Ralph B D'Agostino, Michael L Chuang, Caroline S Fox, Udo Hoffmann, Christopher J O'Donnell
Coronary artery calcium (CAC) and abdominal aortic calcium (AAC) on multidetector computed tomography (MDCT) permit assessment of the presence and burden of coronary and systemic atherosclerosis. Risk factors for progression of CAC and AAC and the association of AAC with CAC progression have not been well characterized in a community-dwelling cohort. We studied 1,959 asymptomatic participants from the Framingham Heart Study who underwent serial MDCT scans with a median interval of 6.1 years. Primary outcomes were (a) the incidence of CAC and AAC (CAC >0 and AAC >0 with baseline CAC = 0 and AAC = 0) and (b) absolute progression of CAC (CAC > baseline CAC and AAC > baseline AAC)...
May 15, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28418481/comparison-of-recommended-eligibility-for-primary-prevention-statin-therapy-based-on-the-us-preventive-services-task-force-recommendations-vs-the-acc-aha-guidelines
#4
Neha J Pagidipati, Ann Marie Navar, Hillary Mulder, Allan D Sniderman, Eric D Peterson, Michael J Pencina
Importance: There are important differences among guideline recommendations for using statin therapy in primary prevention. New recommendations from the US Preventive Services Task Force (USPSTF) emphasize therapy based on the presence of 1 or more cardiovascular disease (CVD) risk factors and a 10-year global CVD risk of 10% or greater. Objective: To determine the difference in eligibility for primary prevention statin treatment among US adults, assuming full application of USPSTF recommendations compared with the American College of Cardiology/American Heart Association (ACC/AHA) guidelines...
April 18, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28389572/prognostic-value-of-noninvasive-cardiovascular-testing-in-patients-with-stable-chest-pain-insights-from-the-promise-trial
#5
Udo Hoffmann, Maros Ferencik, James E Udelson, Michael H Picard, Quynh A Truong, Manesh R Patel, Megan Huang, Michael J Pencina, Daniel B Mark, John F Heitner, Christopher B Fordyce, Patricia A Pellikka, Jean-Claude Tardif, Matthew J Budoff, George Nahhas, Benjamin J Chow, Andrzej S Kosinski, Kerry L Lee, Pamela S Douglas
Background -Optimal management of patients with stable chest pain relies on the prognostic information provided by noninvasive cardiovascular testing, but there are limited data from randomized trials comparing anatomic with functional testing. Methods -In the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial, patients with stable chest pain and intermediate pre-test probability for obstructive coronary artery disease (CAD) were randomized to functional testing (exercise electrocardiography, nuclear stress, or stress echocardiography) or coronary computed tomography angiography (CTA)...
April 7, 2017: Circulation
https://www.readbyqxmd.com/read/28359194/data-monitoring-committees-promoting-best-practices-to-address-emerging-challenges
#6
Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam, Michael J Pencina, David J Gordon, Kenneth W Mahaffey, Charles H Hennekens, James D Neaton, Gail D Pearson, Tomas Lg Andersson, Marc A Pfeffer, Susan S Ellenberg
BACKGROUND AND PURPOSE: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. METHODS: An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28291892/association-of-preceding-antithrombotic-treatment-with-acute-ischemic-stroke-severity-and-in-hospital-outcomes-among-patients-with-atrial-fibrillation
#7
MULTICENTER STUDY
Ying Xian, Emily C O'Brien, Li Liang, Haolin Xu, Lee H Schwamm, Gregg C Fonarow, Deepak L Bhatt, Eric E Smith, DaiWai M Olson, Lesley Maisch, Deidre Hannah, Brianna Lindholm, Barbara L Lytle, Michael J Pencina, Adrian F Hernandez, Eric D Peterson
Importance: Antithrombotic therapies are known to prevent stroke for patients with atrial fibrillation (AF) but are often underused in community practice. Objectives: To examine the prevalence of patients with acute ischemic stroke with known history of AF who were not receiving guideline-recommended antithrombotic treatment before stroke and to determine the association of preceding antithrombotic therapy with stroke severity and in-hospital outcomes. Design, Setting, and Participants: Retrospective observational study of 94 474 patients with acute ischemic stroke and known history of AF admitted from October 2012 through March 2015 to 1622 hospitals participating in the Get With the Guidelines-Stroke program...
March 14, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28198422/low-density-lipoprotein-cholesterol-and-survival-in-pulmonary-arterial-hypertension
#8
Grzegorz Kopeć, Marcin Waligóra, Anna Tyrka, Kamil Jonas, Michael J Pencina, Tomasz Zdrojewski, Deddo Moertl, Jakub Stokwiszewski, Paweł Zagożdżon, Piotr Podolec
Low-density lipoprotein cholesterol(LDL-C) is a well established metabolic marker of cardiovascular risk, however, its role in pulmonary arterial hypertension (PAH) has not been determined. Therefore we assessed whether LDL-C levels are altered in PAH patients, if they are associated with survival in this group and whether pulmonary hypertension (PH) reversal can influence LDL-C levels. Consecutive 46 PAH males and 94 females were age matched with a representative sample of 1168 males and 1245 females, respectively...
February 15, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28178877/nonparametric-estimation-and-inference-for-polytomous-discrimination-index
#9
Jialiang Li, Qunqiang Feng, Jason P Fine, Michael J Pencina, Ben Van Calster
Polytomous discrimination index is a novel and important diagnostic accuracy measure for multi-category classification. After reconstructing its probabilistic definition, we propose a nonparametric approach to the estimation of polytomous discrimination index based on an empirical sample of biomarker values. In this paper, we provide the finite-sample and asymptotic properties of the proposed estimators and such analytic results may facilitate the statistical inference. Simulation studies are performed to examine the performance of the nonparametric estimators...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28135837/rejoinder
#10
Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam, Michael J Pencina, David J Gordon, Kenneth W Mahaffey, Charles H Hennekens, James D Neaton, Gail D Pearson, Tomas Lg Andersson, Marc A Pfeffer, Susan S Ellenberg
No abstract text is available yet for this article.
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28041858/combining-clinical-and-angiographic-variables-for-estimating-risk-of-target-lesion-revascularization-after-drug-eluting-stent-placement
#11
Joshua M Stolker, David J Cohen, Kevin F Kennedy, Michael J Pencina, Suzanne V Arnold, Neal S Kleiman, John A Spertus
BACKGROUND: Drug-eluting stents (DES) reduce restenosis but require prolonged antiplatelet therapy, when compared with bare metal stents. Ideally, the patient should be involved in this risk:benefit assessment prior to selecting DES, to maximize the benefits and cost-effectiveness of care, and to improve medication adherence. However, accurate estimation of restenosis risk may require angiographic factors identified at cardiac catheterization. METHODS: In a large PCI registry, we used logistic regression to identify clinical and angiographic predictors of clinically-driven target lesion revascularization (TLR) over the first year after stent placement...
April 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/27920071/estimation-of-risk-for-initial-atherosclerotic-cardiovascular-disease-events-taking-stock-and-moving-forward
#12
Peter W F Wilson, Michael J Pencina
No abstract text is available yet for this article.
December 6, 2016: Circulation
https://www.readbyqxmd.com/read/27908393/association-of-30-day-readmission-metric%C3%A2-for-heart-failure-under-the-hospital%C3%A2-readmissions-reduction-program%C3%A2-with-quality-of-care-and%C3%A2-outcomes
#13
Ambarish Pandey, Harsh Golwala, Haolin Xu, Adam D DeVore, Roland Matsouaka, Michael Pencina, Dharam J Kumbhani, Adrian F Hernandez, Deepak L Bhatt, Paul A Heidenreich, Clyde W Yancy, James A de Lemos, Gregg C Fonarow
OBJECTIVES: This study sought to determine whether processes of care and long-term clinical outcomes for heart failure (HF) admissions across Get With The Guidelines-Heart Failure (GWTG-HF) program participating centers differ according to HF-specific risk-adjusted 30-day readmission rates (excess readmission ratio [ERR]) as determined by the Hospital Readmission Reduction Program (HRRP). BACKGROUND: HRRP penalizes hospitals with higher than expected risk-adjusted 30-day readmission rates (ERR >1) for common conditions including HF...
December 2016: JACC. Heart Failure
https://www.readbyqxmd.com/read/27908345/determining-when-to-add-nonstatin-therapy-a-quantitative-approach
#14
Jennifer G Robinson, Roeland Huijgen, Kausik Ray, Jane Persons, John J P Kastelein, Michael J Pencina
BACKGROUND: Costs and uncertainty about the benefits of nonstatin therapies limit their use. OBJECTIVES: The authors sought to identify patients who might benefit from the addition of a nonstatin to background statin therapy. METHODS: We performed systematic reviews of subgroup analyses from randomized trials and observational studies with statin-treated participants to determine estimated 10-year absolute risk of atherosclerotic cardiovascular disease (ASCVD) and to define high-risk and very high-risk patients...
December 6, 2016: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/27852603/controlling-for-informed-presence-bias-due-to-the-number-of-health-encounters-in-an-electronic-health-record
#15
Benjamin A Goldstein, Nrupen A Bhavsar, Matthew Phelan, Michael J Pencina
Electronic health records (EHRs) are an increasingly utilized resource for clinical research. While their size allows for many analytical opportunities, as with most observational data there is also the potential for bias. One of the key sources of bias in EHRs is what we term informed presence-the notion that inclusion in an EHR is not random but rather indicates that the subject is ill, making people in EHRs systematically different from those not in EHRs. In this article, we use simulated and empirical data to illustrate the conditions under which such bias can arise and how conditioning on the number of health-care encounters can be one way to remove this bias...
December 1, 2016: American Journal of Epidemiology
https://www.readbyqxmd.com/read/27809784/a-comparison-of-time-dependent-cox-regression-pooled-logistic-regression-and-cross-sectional-pooling-with-simulations-and-an-application-to-the-framingham-heart-study
#16
Julius S Ngwa, Howard J Cabral, Debbie M Cheng, Michael J Pencina, David R Gagnon, Michael P LaValley, L Adrienne Cupples
BACKGROUND: Typical survival studies follow individuals to an event and measure explanatory variables for that event, sometimes repeatedly over the course of follow up. The Cox regression model has been used widely in the analyses of time to diagnosis or death from disease. The associations between the survival outcome and time dependent measures may be biased unless they are modeled appropriately. METHODS: In this paper we explore the Time Dependent Cox Regression Model (TDCM), which quantifies the effect of repeated measures of covariates in the analysis of time to event data...
November 3, 2016: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/27732706/risk-prediction-with-electronic-health-records-the-importance-of-model-validation-and-clinical-context
#17
Benjamin A Goldstein, Ann Marie Navar, Michael J Pencina
No abstract text is available yet for this article.
December 1, 2016: JAMA Cardiology
https://www.readbyqxmd.com/read/27732688/do-not-over-p-value-your-research-article
#18
Laine E Thomas, Michael J Pencina
No abstract text is available yet for this article.
December 1, 2016: JAMA Cardiology
https://www.readbyqxmd.com/read/27699818/discrimination-slope-and-integrated-discrimination-improvement-properties-relationships-and-impact-of-calibration
#19
Michael J Pencina, Jason P Fine, Ralph B D'Agostino
Discrimination slope, defined as the slope of a linear regression of predicted probabilities of event derived from a prognostic model on the binary event status, has recently gained popularity as a measure of model performance. It is as a building block for the integrated discrimination improvement that equals the difference in discrimination slopes between the two models being compared. Several authors have pointed out that it does not make sense to apply the integrated discrimination improvement and discrimination slope when working with mis-calibrated models, whereas others have raised concerns about the ability of improving discrimination slope without adding new information...
October 3, 2016: Statistics in Medicine
https://www.readbyqxmd.com/read/27647847/relationship-of-albuminuria-and-renal-artery-stent-outcomes-results-from-the-coral-randomized-clinical-trial-cardiovascular-outcomes-with-renal-artery-lesions
#20
Timothy P Murphy, Christopher J Cooper, Karol M Pencina, Ralph D'Agostino, Joseph Massaro, Donald E Cutlip, Kenneth Jamerson, Alan H Matsumoto, William Henrich, Joseph I Shapiro, Katherine R Tuttle, David J Cohen, Michael Steffes, Qi Gao, D Christopher Metzger, William B Abernethy, Stephen C Textor, John Briguglio, Alan T Hirsch, Sheldon Tobe, Lance D Dworkin
Randomized clinical trials have not shown an additional clinical benefit of renal artery stent placement over optimal medical therapy alone. However, studies of renal artery stent placement have not examined the relationship of albuminuria and treatment group outcomes. The CORAL study (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) is a prospective clinical trial of 947 participants with atherosclerotic renal artery stenosis randomized to optimal medical therapy with or without renal artery stent which showed no treatment differences (3(5...
November 2016: Hypertension
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