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Pharmacoepidemiology and Drug Safety

© John Wiley & Sons, Ltd.

Cover image for Vol. 21 Issue S1

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

January 2012

Volume 21, Issue Supplement S1

Pages 1–303

Issue edited by: Richard Platt, Ryan Carnahan

  1. Original Reports

    1. Top of page
    2. Original Reports
    3. Miscellaneous
    1. You have free access to this content
      The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction (pages 1–8)

      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 and Mark G. Weiner

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2343

    2. You have free access to this content
      The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety (pages 9–11)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2311

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      The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program (pages 12–17)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2242

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      A policy framework for public health uses of electronic health data (pages 18–22)

      Deven McGraw, Kristen Rosati and Barbara Evans

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2319

    5. You have free access to this content
      Design considerations, architecture, and use of the Mini-Sentinel distributed data system (pages 23–31)

      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 and Jeffrey S. Brown

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2336

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      Design considerations in an active medical product safety monitoring system (pages 32–40)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2316

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      Using high-dimensional propensity scores to automate confounding control in a distributed medical product safety surveillance system (pages 41–49)

      Jeremy A. Rassen and Sebastian Schneeweiss

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2328

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      When should case-only designs be used for safety monitoring of medical products? (pages 50–61)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2330

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      Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data (pages 62–71)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2324

    10. You have free access to this content
      Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot (pages 72–81)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2320

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      Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative and claims data: methods and lessons learned (pages 82–89)

      Ryan M. Carnahan and Kevin G. Moores

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2321

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      Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative data: summary of findings and suggestions for future research (pages 90–99)

      Ryan M. Carnahan

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2318

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      A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data (pages 100–128)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2312

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      A systematic review of validated methods for identifying heart failure using administrative data (pages 129–140)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2313

    15. You have free access to this content
      A systematic review of validated methods for identifying atrial fibrillation using administrative data (pages 141–147)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2317

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      A systematic review of validated methods for identifying ventricular arrhythmias using administrative and claims data (pages 148–153)

      Leonardo Tamariz, Thomas Harkins and Vinit Nair

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2340

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      A systematic review of validated methods for identifying venous thromboembolism using administrative and claims data (pages 154–162)

      Leonardo Tamariz, Thomas Harkins and Vinit Nair

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2341

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      A systematic review of validated methods for identifying depression using administrative data (pages 163–173)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2310

    19. You have free access to this content
      A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data (pages 174–182)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2335

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      A systematic review of validated methods for identifying seizures, convulsions, or epilepsy using administrative and claims data (pages 183–193)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2329

    21. You have free access to this content
      A systematic review of validated methods for identifying pancreatitis using administrative data (pages 194–202)

      Kevin Moores, Bradley Gilchrist, Ryan Carnahan and Thad Abrams

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2334

    22. You have free access to this content
      A systematic review of validated methods for identifying lymphoma using administrative data (pages 203–212)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2315

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      A systematic review of validated methods for identifying infection related to blood products, tissue grafts, or organ transplants using administrative data (pages 213–221)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2332

    24. You have free access to this content
      A systematic review of validated methods for identifying transfusion-related sepsis using administrative and claims data (pages 222–229)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2322

    25. You have free access to this content
      A systematic review of validated methods for identifying transfusion-related ABO incompatibility reactions using administrative and claims data (pages 230–235)

      Ryan M. Carnahan and Vicki R. Kee

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2325

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      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 (pages 236–239)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2331

    27. You have free access to this content
      A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data (pages 240–247)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2327

    28. You have free access to this content
      A systematic review of validated methods for identifying hypersensitivity reactions other than anaphylaxis (fever, rash, and lymphadenopathy), using administrative and claims data (pages 248–255)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2333

    29. You have free access to this content
      A systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data (pages 256–260)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2338

    30. You have free access to this content
      A systematic review of validated methods for identifying acute respiratory failure using administrative and claims data (pages 261–264)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2326

    31. You have free access to this content
      A systematic review of validated methods for identifying orthopedic implant removal and revision using administrative data (pages 265–273)

      Jasvinder A Singh, Joseph A Kundukulam and Mohit Bhandari

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2309

    32. You have free access to this content
      Design for validation of acute myocardial infarction cases in Mini-Sentinel (pages 274–281)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2314

    33. You have free access to this content
      A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent (pages 282–290)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2337

    34. You have free access to this content
      The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise (pages 291–297)

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2323

  2. Miscellaneous

    1. Top of page
    2. Original Reports
    3. Miscellaneous
    1. You have free access to this content
      The U.S. Food and Drug Administration's Mini-Sentinel Program (pages 1–303)

      Richard Platt and Ryan Carnahan

      Article first published online: 31 JAN 2012 | DOI: 10.1002/pds.3230

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