Display options
Cite
Nelson JC, Wellman R, Yu O, et al. A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data. EGEMS (Wash DC). 2016;4(1):1219doi: 10.13063/2327-9214.1219.
Nelson, J. C., Wellman, R., Yu, O., Cook, A. J., Maro, J. C., Ouellet-Hellstrom, R., Boudreau, D., Floyd, J. S., Heckbert, S. R., Pinheiro, S., Reichman, M., & Shoaibi, A. (2016). A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data. EGEMS (Washington, DC), 4(1), 1219. https://doi.org/10.13063/2327-9214.1219
Nelson, Jennifer C, et al. "A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data." EGEMS (Washington, DC) vol. 4,1 (2016): 1219. doi: https://doi.org/10.13063/2327-9214.1219
Nelson JC, Wellman R, Yu O, Cook AJ, Maro JC, Ouellet-Hellstrom R, Boudreau D, Floyd JS, Heckbert SR, Pinheiro S, Reichman M, Shoaibi A. A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data. EGEMS (Wash DC). 2016 Sep 06;4(1):1219. doi: 10.13063/2327-9214.1219. eCollection 2016. PMID: 27713904; PMCID: PMC5051582.
Copy Download .nbib Format: NLM
Share it on

EGEMS (Wash DC). 2016 Sep 06;4(1):1219. doi: 10.13063/2327-9214.1219. eCollection 2016.

A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data.

EGEMS (Washington, DC)

Jennifer C Nelson, Robert Wellman, Onchee Yu, Andrea J Cook, Judith C Maro, Rita Ouellet-Hellstrom, Denise Boudreau, James S Floyd, Susan R Heckbert, Simone Pinheiro, Marsha Reichman, Azadeh Shoaibi

Affiliations

  1. Group Health Research Institute; University of Washington.
  2. Group Health Research Institute.
  3. Harvard Medical School; Harvard Pilgrim Health Care Institute.
  4. Food and Drug Administration.
  5. University of Washington.

PMID: 27713904 PMCID: PMC5051582 DOI: 10.13063/2327-9214.1219

Abstract

INTRODUCTION: The large-scale assembly of electronic health care data combined with the use of sequential monitoring has made proactive postmarket drug- and vaccine-safety surveillance possible. Although sequential designs have been used extensively in randomized trials, less attention has been given to methods for applying them in observational electronic health care database settings.

EXISTING METHODS: We review current sequential-surveillance planning methods from randomized trials, and the Vaccine Safety Datalink (VSD) and Mini-Sentinel Pilot projects-two national observational electronic health care database safety monitoring programs.

FUTURE SURVEILLANCE PLANNING: Based on this examination, we suggest three steps for future surveillance planning in health care databases: (1) prespecify the sequential design and analysis plan, using available feasibility data to reduce assumptions and minimize later changes to initial plans; (2) assess existing drug or vaccine uptake, to determine if there is adequate information to proceed with surveillance, before conducting more resource-intensive planning; and (3) statistically evaluate and clearly communicate the sequential design with all those designing and interpreting the safety-surveillance results prior to implementation. Plans should also be flexible enough to accommodate dynamic and often unpredictable changes to the database information made by the health plans for administrative purposes.

CONCLUSIONS: This paper is intended to encourage dialogue about establishing a more systematic, scalable, and transparent sequential design-planning process for medical-product safety-surveillance systems utilizing observational electronic health care databases. Creating such a framework could yield improvements over existing practices, such as designs with increased power to assess serious adverse events.

Keywords: adverse drug reaction reporting systems; drug-related side effects and adverse reactions; electronic health records; product surveillance, postmarketing; sequential analysis; vaccine/adverse effects

References

  1. Vaccine. 2011 Oct 26;29(46):8279-84 - PubMed
  2. Ann Intern Med. 1992 Aug 1;117(3):234-42 - PubMed
  3. Stat Med. 2010 Nov 20;29(26):2698-708 - PubMed
  4. Vaccine. 2014 May 23;32(25):3019-24 - PubMed
  5. Pharmacoepidemiol Drug Saf. 2009 Mar;18(3):226-34 - PubMed
  6. Vaccine. 2012 Mar 2;30(11):2024-31 - PubMed
  7. Biometrics. 1979 Sep;35(3):549-56 - PubMed
  8. Pediatrics. 2011 May;127 Suppl 1:S45-53 - PubMed
  9. Pediatrics. 2010 Jul;126(1):e1-8 - PubMed
  10. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:291-7 - PubMed
  11. Stat Med. 2007 Dec 10;26(28):5047-80 - PubMed
  12. N Engl J Med. 2011 Feb 10;364(6):498-9 - PubMed
  13. Biometrics. 2015 Sep;71(3):851-8 - PubMed
  14. Stat Methods Med Res. 2015 Apr;24(2):177-93 - PubMed
  15. Biometrics. 1987 Mar;43(1):193-9 - PubMed
  16. Vaccine. 2013 May 24;31(22):2578-83 - PubMed
  17. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:62-71 - PubMed
  18. Biometrics. 1999 Sep;55(3):874-82 - PubMed
  19. Pharmacoepidemiol Drug Saf. 2014 Aug;23(8):839-48 - PubMed
  20. Pediatrics. 2011 May;127 Suppl 1:S54-64 - PubMed
  21. Stat Med. 2010 Jan 30;29(2):284-95 - PubMed
  22. Pharmacoepidemiol Drug Saf. 2001 Aug-Sep;10(5):407-10 - PubMed
  23. Pediatr Infect Dis J. 2010 Jan;29(1):1-5 - PubMed
  24. Med Care. 2007 Oct;45(10 Supl 2):S89-95 - PubMed
  25. Am J Epidemiol. 2013 Jan 15;177(2):131-41 - PubMed
  26. Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):583-90 - PubMed
  27. Epidemiology. 2013 Sep;24(5):692-9 - PubMed
  28. Vaccine. 1994 May;12(6):542-50 - PubMed
  29. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:282-90 - PubMed
  30. Am J Prev Med. 2011 Aug;41(2):121-8 - PubMed
  31. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:72-81 - PubMed
  32. Epidemiology. 2005 May;16(3):336-41 - PubMed
  33. Vaccine. 2009 Jul 9;27(32):4257-62 - PubMed

Publication Types

Grant support