David Madigan

David Madigan

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David Madigan

Publications by authors named "David Madigan"

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Comment on "How pharmacoepidemiology networks can manage distributed analyses to improve replicability and transparency and minimize bias".

Pharmacoepidemiol Drug Saf 2019 Jul 8;28(7):1032-1033. Epub 2019 May 8.

Observational Health Data Sciences and Informatics, New York, NY.

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http://dx.doi.org/10.1002/pds.4798DOI Listing
July 2019

Bayesian hierarchical vector autoregressive models for patient-level predictive modeling.

PLoS One 2018 14;13(12):e0208082. Epub 2018 Dec 14.

Department of Statistics, Columbia University, New York, NY, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0208082PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6294362PMC
May 2019

Improving reproducibility by using high-throughput observational studies with empirical calibration.

Philos Trans A Math Phys Eng Sci 2018 Sep;376(2128)

Observational Health Data Sciences and Informatics (OHDSI), New York, NY 10032, USA.

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http://rsta.royalsocietypublishing.org/lookup/doi/10.1098/rs
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http://dx.doi.org/10.1098/rsta.2017.0356DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6107542PMC
September 2018

Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database.

Open Access J Contracept 2018 11;9:29-32. Epub 2018 Apr 11.

Department of Statistics, Columbia University, New York, NY, USA.

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http://dx.doi.org/10.2147/OAJC.S161737DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5919164PMC
April 2018

Causal Inference for Meta-Analysis and Multi-Level Data Structures, with Application to Randomized Studies of Vioxx.

Psychometrika 2017 06 7;82(2):459-474. Epub 2016 Jul 7.

Philips Research North America, Cambridge, MA, USA.

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http://dx.doi.org/10.1007/s11336-016-9507-zDOI Listing
June 2017

Detecting adverse drug reactions following long-term exposure in longitudinal observational data: The exposure-adjusted self-controlled case series.

Stat Methods Med Res 2016 12 31;25(6):2577-2592. Epub 2014 Mar 31.

Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, USA.

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http://dx.doi.org/10.1177/0962280214527531DOI Listing
December 2016

Robust empirical calibration of p-values using observational data.

Stat Med 2016 09;35(22):3883-8

Department of Biomathematics and Department of Human Genetics, David Geffen School of Medicine, University of California, Los Angeles, CA, U.S.A.

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http://dx.doi.org/10.1002/sim.6977DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5108459PMC
September 2016

Association Between Trauma Center Type and Mortality Among Injured Adolescent Patients.

JAMA Pediatr 2016 08;170(8):780-6

Division of Trauma and Burn Surgery, Children's National Medical Center, Washington, DC.

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http://dx.doi.org/10.1001/jamapediatrics.2016.0805DOI Listing
August 2016

Hierarchical Models for Multiple, Rare Outcomes Using Massive Observational Healthcare Databases.

Stat Anal Data Min 2016 Aug 17;9(4):260-268. Epub 2016 Jul 17.

Department of Biomathematics, David Geffen School of Medicine at UCLA, Los Angeles, California, U.S.A.

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http://dx.doi.org/10.1002/sam.11324DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5423675PMC
August 2016

Characterizing treatment pathways at scale using the OHDSI network.

Proc Natl Acad Sci U S A 2016 07 6;113(27):7329-36. Epub 2016 Jun 6.

Observational Health Data Sciences and Informatics, New York, NY 10032; Department of Statistics, Columbia University, New York, NY 10027.

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http://dx.doi.org/10.1073/pnas.1510502113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4941483PMC
July 2016

Reassessing mechanism as a predictor of pediatric injury mortality.

J Surg Res 2015 Dec 24;199(2):641-6. Epub 2015 Jun 24.

Division of Trauma and Burn Surgery, Joseph E. Robert, Jr. Center for Surgical Care, Children's National Medical Center, Washington, District of Columbia. Electronic address:

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http://dx.doi.org/10.1016/j.jss.2015.06.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636960PMC
December 2015

Birth month affects lifetime disease risk: a phenome-wide method.

J Am Med Inform Assoc 2015 Sep 2;22(5):1042-53. Epub 2015 Jun 2.

Department of Biomedical Informatics Observational Health Data Sciences and Informatics (OHDSI) Department of Systems Biology Department of Medicine, Columbia University, New York, NY, USA

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http://dx.doi.org/10.1093/jamia/ocv046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4986668PMC
September 2015

Optimizing the leveraging of real-world data to improve the development and use of medicines.

Value Health 2015 Jan 27;18(1):127-30. Epub 2014 Nov 27.

Columbia University, New York, NY, USA.

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http://dx.doi.org/10.1016/j.jval.2014.10.009DOI Listing
January 2015

Bayesian methods for design and analysis of safety trials.

Pharm Stat 2014 Jan-Feb;13(1):13-24. Epub 2013 Jul 30.

Eli Lilly and Company, Indianapolis, IN, USA.

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http://dx.doi.org/10.1002/pst.1586DOI Listing
October 2014

High-dimensional, massive sample-size Cox proportional hazards regression for survival analysis.

Biostatistics 2014 Apr 4;15(2):207-21. Epub 2013 Oct 4.

Department of Statistics, Columbia University, New York, NY 10027, USA.

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http://dx.doi.org/10.1093/biostatistics/kxt043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3944969PMC
April 2014

Interpreting observational studies: why empirical calibration is needed to correct p-values.

Stat Med 2014 Jan 30;33(2):209-18. Epub 2013 Jul 30.

Department of Medical Informatics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands; Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD, U.S.A.

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http://dx.doi.org/10.1002/sim.5925DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4285234PMC
January 2014

Discussion: An estimate of the science-wise false discovery rate and application to the top medical literature.

Biostatistics 2014 Jan 25;15(1):36-9; discussion 39-45. Epub 2013 Sep 25.

Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD 20814, USAJanssen Research and Development LLC, Titusville, NJ 08560, USA.

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http://dx.doi.org/10.1093/biostatistics/kxt037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3862211PMC
January 2014

Multiple self-controlled case series for large-scale longitudinal observational databases.

Biometrics 2013 Dec 11;69(4):893-902. Epub 2013 Oct 11.

Department of Statistics, Columbia University, New York, New York, U.S.A.

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http://dx.doi.org/10.1111/biom.12078DOI Listing
December 2013

Large-scale parametric survival analysis.

Stat Med 2013 Oct 28;32(23):3955-71. Epub 2013 Apr 28.

Department of Statistics, Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.

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http://dx.doi.org/10.1002/sim.5817DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3796130PMC
October 2013

Managing data quality for a drug safety surveillance system.

Drug Saf 2013 Oct;36 Suppl 1:S49-58

College of Pharmacy, University of Florida, Gainesville, FL, USA,

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http://dx.doi.org/10.1007/s40264-013-0098-7DOI Listing
October 2013

Empirical performance of the case-control method: lessons for developing a risk identification and analysis system.

Drug Saf 2013 Oct;36 Suppl 1:S73-82

Department of Statistics, Columbia University, 1255 Amsterdam Avenue, New York, NY, 10027, USA,

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http://link.springer.com/10.1007/s40264-013-0105-z
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http://dx.doi.org/10.1007/s40264-013-0105-zDOI Listing
October 2013

Empirical performance of the self-controlled case series design: lessons for developing a risk identification and analysis system.

Drug Saf 2013 Oct;36 Suppl 1:S83-93

Department of Biomathematics, David Geffen School of Medicine at UCLA, University of California, Los Angeles, CA, USA,

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http://dx.doi.org/10.1007/s40264-013-0100-4DOI Listing
October 2013

Empirical performance of a self-controlled cohort method: lessons for developing a risk identification and analysis system.

Drug Saf 2013 Oct;36 Suppl 1:S95-106

Janssen Research and Development LLC, 1125 Trenton-Harbourton Road, Room K30205, PO Box 200, Titusville, NJ, 08560, USA,

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http://dx.doi.org/10.1007/s40264-013-0101-3DOI Listing
October 2013

Empirical performance of the calibrated self-controlled cohort analysis within temporal pattern discovery: lessons for developing a risk identification and analysis system.

Drug Saf 2013 Oct;36 Suppl 1:S107-21

Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden,

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http://dx.doi.org/10.1007/s40264-013-0095-xDOI Listing
October 2013

Evaluation of disproportionality safety signaling applied to healthcare databases.

Drug Saf 2013 Oct;36 Suppl 1:S123-32

Oracle Health Sciences, Burlington, Massachusetts, USA,

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http://dx.doi.org/10.1007/s40264-013-0106-yDOI Listing
October 2013

Empirical performance of LGPS and LEOPARD: lessons for developing a risk identification and analysis system.

Drug Saf 2013 Oct;36 Suppl 1:S133-42

Department of Medical Informatics, Erasmus University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands,

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http://dx.doi.org/10.1007/s40264-013-0107-xDOI Listing
October 2013

A comparison of the empirical performance of methods for a risk identification system.

Drug Saf 2013 Oct;36 Suppl 1:S143-58

Janssen Research and Development LLC, 1125 Trenton-Harbourton Road, Room K30205, PO Box 200, Titusville, NJ, 08560, USA,

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http://dx.doi.org/10.1007/s40264-013-0108-9DOI Listing
October 2013

Evaluating the impact of database heterogeneity on observational study results.

Am J Epidemiol 2013 Aug 5;178(4):645-51. Epub 2013 May 5.

Department of Statistics, Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.

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http://dx.doi.org/10.1093/aje/kwt010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3736754PMC
August 2013

Does design matter? Systematic evaluation of the impact of analytical choices on effect estimates in observational studies.

Ther Adv Drug Saf 2013 Apr;4(2):53-62

Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD and Department of Medical Informatics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.

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http://dx.doi.org/10.1177/2042098613477445DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110833PMC
April 2013

Disproportionality methods for pharmacovigilance in longitudinal observational databases.

Stat Methods Med Res 2013 Feb 30;22(1):39-56. Epub 2011 Aug 30.

Department of Statistics, Columbia University, New York, USA.

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http://dx.doi.org/10.1177/0962280211403602DOI Listing
February 2013

Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership.

Stat Med 2012 Dec 27;31(30):4401-15. Epub 2012 Sep 27.

Johnson & Johnson Pharmaceutical Research and Development LLC, Titusville, NJ 08560, USA.

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http://doi.wiley.com/10.1002/sim.5620
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http://dx.doi.org/10.1002/sim.5620DOI Listing
December 2012

Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies.

Am Heart J 2012 Aug 3;164(2):186-93. Epub 2012 Jul 3.

Department of Statistics, Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.

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http://dx.doi.org/10.1016/j.ahj.2012.05.002DOI Listing
August 2012

Dynamic logistic regression and dynamic model averaging for binary classification.

Biometrics 2012 Mar 12;68(1):23-30. Epub 2011 Aug 12.

Department of Statistics, Columbia University, New York, New York 10025, USA.

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http://dx.doi.org/10.1111/j.1541-0420.2011.01645.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3831847PMC
March 2012

When should case-only designs be used for safety monitoring of medical products?

Pharmacoepidemiol Drug Saf 2012 Jan;21 Suppl 1:50-61

Department Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC, Canada.

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http://dx.doi.org/10.1002/pds.2330DOI Listing
January 2012

What can we really learn from observational studies?: the need for empirical assessment of methodology for active drug safety surveillance and comparative effectiveness research.

Epidemiology 2011 Sep;22(5):629-31

Department of Statistics, Columbia University, New York, NY 10027, USA.

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http://dx.doi.org/10.1097/EDE.0b013e318228ca1dDOI Listing
September 2011

Quantitative signal detection for vaccines.

Hum Vaccin 2010 Aug 1;6(8):681. Epub 2010 Aug 1.

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http://dx.doi.org/10.4161/hv.6.8.12020DOI Listing
August 2010

Influence of the MedDRA hierarchy on pharmacovigilance data mining results.

Int J Med Inform 2009 Dec 18;78(12):e97-e103. Epub 2009 Feb 18.

ProSanos Corporation, Harrisburg, PA 17102, USA.

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http://dx.doi.org/10.1016/j.ijmedinf.2009.01.001DOI Listing
December 2009

Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.

Arch Intern Med 2009 Nov;169(21):1976-85

Department of Geriatrics and Palliative Medicine, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1070, New York, NY 10029, USA.

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http://dx.doi.org/10.1001/archinternmed.2009.394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2830805PMC
November 2009

The impact of injury coding schemes on predicting hospital mortality after pediatric injury.

Acad Emerg Med 2009 Jul 22;16(7):639-45. Epub 2009 Jun 22.

Division of Trauma and Burns, Children's National Medical Center, Washington, DC, USA.

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http://dx.doi.org/10.1111/j.1553-2712.2009.00446.xDOI Listing
July 2009

Bayesian logistic injury severity score: a method for predicting mortality using international classification of disease-9 codes.

Acad Emerg Med 2008 May;15(5):466-75

Department of Surgery, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.

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http://dx.doi.org/10.1111/j.1553-2712.2008.00105.xDOI Listing
May 2008

Issues in applied statistics for public health bioterrorism surveillance using multiple data streams: research needs.

Stat Med 2007 Apr;26(8):1834-56

Centers for Disease Control and Prevention (CDC), Division of Emergency Preparedness and Response, National Center for Public Health Informatics, 1600 Clifton Rd., NE. MS D45, Atlanta, GA 30333, USA.

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http://dx.doi.org/10.1002/sim.2793DOI Listing
April 2007

The role of data mining in pharmacovigilance.

Expert Opin Drug Saf 2005 Sep;4(5):929-48

Pfizer, Inc., Risk Management Strategy, New York, NY, USA.

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http://www.tandfonline.com/doi/full/10.1517/14740338.4.5.929
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http://dx.doi.org/10.1517/14740338.4.5.929DOI Listing
September 2005

A Sequential Monte Carlo Method for Bayesian Analysis of Massive Datasets.

Data Min Knowl Discov 2003 Jul;7(3):301-319

RAND, PO Box 2138, Santa Monica, CA 90407-2138,

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http://dx.doi.org/10.1023/A:1024084221803DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2753529PMC
July 2003

A two-way messaging system to enhance antiretroviral adherence.

J Am Med Inform Assoc 2003 Jan-Feb;10(1):11-5

Department of Anesthesiology, University of Washington, Seattle, Washington, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC150355PMC
http://dx.doi.org/10.1197/jamia.m1047DOI Listing
March 2003