Volume 21; Issue Supplement

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Pharmacoepidemiology and Drug Safety
Volume 21; Issue Supplement

Pharmacoepidemiology and Drug Safety

Volume 21; Issue Supplement

1

The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program

Susan Forrow, Daniel M. Campion, Lisa J. Herrinton, Vinit P. Nair, Melissa A. Robb, Marcus Wilson, Richard Platt

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 100 KB

english, 2012

2

A systematic review of validated methods for identifying orthopedic implant removal and revision using administrative data

Jasvinder A Singh, Joseph A Kundukulam, Mohit Bhandari

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 117 KB

english, 2012

3

A systematic review of validated methods for identifying depression using administrative data

Lisa Townsend, James T Walkup, Stephen Crystal, Mark Olfson

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 129 KB

english, 2012

4

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Melissa A. Robb, Judith A. Racoosin, Rachel E. Sherman, Thomas P. Gross, Robert Ball, Marsha E. Reichman, Karen Midthun, Janet Woodcock

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 67 KB

english, 2012

5

A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data

Susan E. Andrade, Leslie R. Harrold, Jennifer Tjia, Sarah L. Cutrona, Jane S. Saczynski, Katherine S. Dodd, Robert J. Goldberg, Jerry H. Gurwitz

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 187 KB

english, 2012

6

A systematic review of validated methods for identifying heart failure using administrative data

Jane S. Saczynski, Susan E. Andrade, Leslie R. Harrold, Jennifer Tjia, Sarah L. Cutrona, Katherine S. Dodd, Robert J. Goldberg, Jerry H. Gurwitz

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 129 KB

english, 2012

7

Design for validation of acute myocardial infarction cases in Mini-Sentinel

Sarah L. Cutrona, Sengwee Toh, Aarthi Iyer, Sarah Foy, Elizabeth Cavagnaro, Susan Forrow, Judith A. Racoosin, Robert Goldberg, Jerry H. Gurwitz

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 105 KB

english, 2012

8

A systematic review of validated methods for identifying lymphoma using administrative data

Ronald A. Herman, Bradley Gilchrist, Brian K. Link, Ryan Carnahan

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 112 KB

english, 2012

9

Design considerations in an active medical product safety monitoring system

Joshua J. Gagne, Bruce Fireman, Patrick B. Ryan, Malcolm Maclure, Tobias Gerhard, Sengwee Toh, Jeremy A. Rassen, Jennifer C. Nelson, Sebastian Schneeweiss

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 113 KB

english, 2012

10

A systematic review of validated methods for identifying atrial fibrillation using administrative data

Paul N. Jensen, Karin Johnson, James Floyd, Susan R. Heckbert, Ryan Carnahan, Sascha Dublin

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 183 KB

english, 2012

11

Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative data: summary of findings and suggestions for future research

Ryan M. Carnahan

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 119 KB

english, 2012

12

A policy framework for public health uses of electronic health data

Deven McGraw, Kristen Rosati, Barbara Evans

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 82 KB

english, 2012

13

Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot

Andrea J. Cook, Ram C. Tiwari, Robert D. Wellman, Susan R. Heckbert, Lingling Li, Patrick Heagerty, Tracey Marsh, Jennifer C. Nelson

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 170 KB

english, 2012

14

Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative and claims data: methods and lessons learned

Ryan M. Carnahan, Kevin G. Moores

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 100 KB

english, 2012

15

A systematic review of validated methods for identifying transfusion-related sepsis using administrative and claims data

Ryan M. Carnahan, Ronald A. Herman, Kevin G. Moores

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 98 KB

english, 2012

16

The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise

Michael Nguyen, Robert Ball, Karen Midthun, Tracy A. Lieu

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 162 KB

english, 2012

17

Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data

Jennifer C. Nelson, Andrea J. Cook, Onchee Yu, Clara Dominguez, Shanshan Zhao, Sharon K. Greene, Bruce H. Fireman, Steven J. Jacobsen, Eric S. Weintraub, Lisa A. Jackson

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 313 KB

english, 2012

18

A systematic review of validated methods for identifying transfusion-related ABO incompatibility reactions using administrative and claims data

Ryan M. Carnahan, Vicki R. Kee

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 87 KB

english, 2012

19

A systematic review of validated methods for identifying acute respiratory failure using administrative and claims data

Natalie Jones, Gary Schneider, Sumesh Kachroo, Philip Rotella, Ruzan Avetisyan, Matthew W. Reynolds

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 70 KB

english, 2012

20

A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data

Gary Schneider, Sumesh Kachroo, Natalie Jones, Sheila Crean, Philip Rotella, Ruzan Avetisyan, Matthew W. Reynolds

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 109 KB

english, 2012

21

Using high-dimensional propensity scores to automate confounding control in a distributed medical product safety surveillance system

Jeremy A. Rassen, Sebastian Schneeweiss

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 254 KB

english, 2012

22

A systematic review of validated methods for identifying seizures, convulsions, or epilepsy using administrative and claims data

Vicki R. Kee, Brad Gilchrist, Mark A. Granner, Nicola R. Sarrazin, Ryan M. Carnahan

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 122 KB

english, 2012

23

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

Malcolm Maclure, Bruce Fireman, Jennifer C. Nelson, Wei Hua, Azadeh Shoaibi, Antonio Paredes, David Madigan

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 674 KB

english, 2012

24

A systematic review of validated methods for identifying erythema multiforme major/minor/not otherwise specified, Stevens–Johnson Syndrome, or toxic epidermal necrolysis using administrative and claims data

Gary Schneider, Sumesh Kachroo, Natalie Jones, Sheila Crean, Philip Rotella, Ruzan Avetisyan, Matthew W. Reynolds

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 77 KB

english, 2012

25

A systematic review of validated methods for identifying infection related to blood products, tissue grafts, or organ transplants using administrative data

Ryan M. Carnahan, Kevin G. Moores, Eli N. Perencevich

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 105 KB

english, 2012

26

A systematic review of validated methods for identifying hypersensitivity reactions other than anaphylaxis (fever, rash, and lymphadenopathy), using administrative and claims data

Gary Schneider, Sumesh Kachroo, Natalie Jones, Sheila Crean, Philip Rotella, Ruzan Avetisyan, Matthew W. Reynolds

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 100 KB

english, 2012

27

A systematic review of validated methods for identifying pancreatitis using administrative data

Kevin Moores, Bradley Gilchrist, Ryan Carnahan, Thad Abrams

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 103 KB

english, 2012

28

A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data

James T. Walkup, Lisa Townsend, Stephen Crystal, Mark Olfson

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 115 KB

english, 2012

29

Design considerations, architecture, and use of the Mini-Sentinel distributed data system

Lesley H. Curtis, Mark G. Weiner, Denise M. Boudreau, William O. Cooper, Gregory W. Daniel, Vinit P. Nair, Marsha A. Raebel, Nicolas U. Beaulieu, Robert Rosofsky, Tiffany S. Woodworth, Jeffrey S. Brow

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 151 KB

english, 2012

30

A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent

Bruce Fireman, Sengwee Toh, Melissa G. Butler, Alan S. Go, Hylton V. Joffe, David J. Graham, Jennifer C. Nelson, Gregory W. Daniel, Joe V. Selby

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 120 KB

english, 2012

31

A systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data

Natalie Jones, Gary Schneider, Sumesh Kachroo, Philip Rotella, Ruzan Avetisyan, Matthew W. Reynolds

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 72 KB

english, 2012

32

A systematic review of validated methods for identifying ventricular arrhythmias using administrative and claims data

Leonardo Tamariz, Thomas Harkins, Vinit Nair

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 84 KB

english, 2012

33

A systematic review of validated methods for identifying venous thromboembolism using administrative and claims data

Leonardo Tamariz, Thomas Harkins, Vinit Nair

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 97 KB

english, 2012

34

The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction

Richard Platt, Ryan M. Carnahan, Jeffrey S. Brown, Elizabeth Chrischilles, Lesley H. Curtis, Sean Hennessy, Jennifer C. Nelson, Judith A. Racoosin, Melissa Robb, Sebastian Schneeweiss, Sengwee Toh, Ma

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 190 KB

english, 2012

35

The U.S. Food and Drug Administration's Mini-Sentinel Program

Richard Platt, Ryan Carnahan

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 3.54 MB

english, 2012

36

Evaluation of total hip arthroplasty devices using a total joint replacement registry

Elizabeth W. Paxton, Christopher F. Ake, Maria C.S. Inacio, Monti Khatod, Danica Marinac-Dabic, Art Sedrakyan

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 157 KB

english, 2012

37

Incorporating initial treatments improves performance of a mortality prediction model for patients with sepsis

Tara Lagu, Michael B. Rothberg, Brian H. Nathanson, Jay S. Steingrub, Peter K. Lindenauer

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 345 KB

english, 2012

38

Role of disease risk scores in comparative effectiveness research with emerging therapies

Robert J. Glynn, Joshua J. Gagne, Sebastian Schneeweiss

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 256 KB

english, 2012

39

Prior event rate ratio adjustment: numerical studies of a statistical method to address unrecognized confounding in observational studies

Menggang Yu, Dawei Xie, Xingmei Wang, Mark G. Weiner, Richard L. Tannen

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 270 KB

english, 2012

40

Merging of the National Cancer Institute–funded cooperative oncology group data with an administrative data source to develop a more effective platform for clinical trial analysis and comparative effectiveness research: a report from the Children's Oncology Group

R. Aplenc, B. T. Fisher, Y. S. Huang, Y. Li, T. A. Alonzo, R. B. Gerbing, M. Hall, D. Bertoch, R. Keren, A. E. Seif, L. Sung, P. C. Adamson, A. Gamis

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 220 KB

english, 2012

41

Assessing the applicability of trial evidence to a target sample in the presence of heterogeneity of treatment effect

Carlos O. Weiss, Jodi B. Segal, Ravi Varadhan

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 272 KB

english, 2012

42

Linkage of routinely collected oncology clinical data with health insurance claims data—an example with aromatase inhibitors, tamoxifen, and all-cause mortality

David D. Dore, Caihua Liang, Najat Ziyadeh, Heather Norman, Martha Bayliss, John D. Seeger

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 172 KB

english, 2012

43

When to randomize, or ‘Evidence-based medicine needs Medicine-based evidence’

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 356 KB

english, 2012

44

Comparative effectiveness research using matching-adjusted indirect comparison: an application to treatment with guanfacine extended release or atomoxetine in children with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder

James Signorovitch, M. Haim Erder, Jipan Xie, Vanja Sikirica, Mei Lu, Paul S. Hodgkins, Eric Q. Wu

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 145 KB

english, 2012

45

Identification of metastatic cancer in claims data

Beth L. Nordstrom, Joanna L. Whyte, Marilyn Stolar, Catherine Mercaldi, Joel D. Kallich

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 181 KB

english, 2012

46

Analyzing partially missing confounder information in comparative effectiveness and safety research of therapeutics

Sengwee Toh, Luis A. García Rodríguez, Miguel A. Hernán

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 109 KB

english, 2012

47

Confronting “confounding by health system use” in Medicare Part D: comparative effectiveness of propensity score approaches to confounding adjustment

Jennifer M. Polinski, Sebastian Schneeweiss, Robert J. Glynn, Joyce Lii, Jeremy A. Rassen

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 115 KB

english, 2012

48

Performance of propensity score methods when comparison groups originate from different data sources

Bradley G. Hammill, Lesley H. Curtis, Soko Setoguchi

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 114 KB

english, 2012

49

Simulation study of instrumental variable approaches with an application to a study of the antidiabetic effect of bezafibrate

Bing Cai, Sean Hennessy, James H. Flory, Daohang Sha, Thomas R. Ten Have, Dylan S. Small

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 104 KB

english, 2012

50

Dynamic marginal structural modeling to evaluate the comparative effectiveness of more or less aggressive treatment intensification strategies in adults with type 2 diabetes

Romain Neugebauer, Bruce Fireman, Jason A. Roy, Patrick J. O'Connor, Joe V. Selby

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 279 KB

english, 2012

51

Reweighted Mahalanobis distance matching for cluster-randomized trials with missing data

Robert A. Greevy Jr., Carlos G. Grijalva, Christianne L. Roumie, Cole Beck, Adriana M. Hung, Harvey J. Murff, Xulei Liu, Marie R. Griffin

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 108 KB

english, 2012

52

One-to-many propensity score matching in cohort studies

Jeremy A. Rassen, Abhi A. Shelat, Jessica Myers, Robert J. Glynn, Kenneth J. Rothman, Sebastian Schneeweiss

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 375 KB

english, 2012

53

Methods for developing and analyzing clinically rich data for patient-centered outcomes research: an overview

Sebastian Schneeweiss, John D. Seeger, Scott R. Smith

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 74 KB

english, 2012

54

Abstracts

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 3.88 MB

english, 2012

55

Author Index

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

File:

PDF, 130 KB

2012

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