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Selecting the Priority Research Topics Addressing Unmet Post-immunization Safety Needs: A Model for Generating Research Proposal and Designing a Questionnaire for the Clinical Experts

설문조사를 통한 전문가 대상 예방접종 후 이상반응 관련 우선순위 연구주제 선정 기준모델 제시

  • 김현정 (성균관대학교 약학대학) ;
  • 이혜성 (성균관대학교 약학대학) ;
  • 김주환 (성균관대학교 약학대학) ;
  • 윤동원 (성균관대학교 약학대학) ;
  • 노윤하 (성균관대학교 약학대학) ;
  • 신주영 (성균관대학교 약학대학)
  • Received : 2019.06.12
  • Accepted : 2019.08.23
  • Published : 2019.09.30

Abstract

Objective: To gather inputs from clinical experts on selecting and prioritizing research topics, to address unmet vaccine safety needs. Methods: A questionnaire containing 15 vaccine safety assessment research proposals was sent to 28 vaccine experts chosen from various domestic medical association boards, and the rationale for each of the proposals was provided by presenting the following information: 1) a brief summary of the clinical safety studies on the vaccine, conducted by the Clinical Immunization Safety Assessment (CISA) project group, supervised by the United States Center for Disease Control (U.S. CDC), and 2) a summary of recently published studies that address vaccine safety issues. The experts were instructed to select and rank 5 topics in the order of preference, and the preference score for each proposed topic was calculated by assigning points on a scale of 1 to 5. Results: All 28 experts responded to the questionnaire, and the following topics were selected according to their calculated preference scores: 1) Human papillomavirus vaccine safety profile in the Korean female adolescents; 2) A signal detection of adverse events following Influenza vaccination: comparison between the US and South Korea; 3) Incidence of anaphylaxis following National Immunization Program vaccines between 2008 and 2017; 4) Safety of quadrivalent influenza vaccines compared to trivalent influenza vaccines; and 5) Pneumococcal vaccine safety profile in the general population. Conclusion: Five research topics addressing vaccine safety were selected, for which well-constructed research protocols need to be promptly developed to address current unmet vaccine safety needs in South Korea.

Keywords

References

  1. Zhou M, Qu S, Zhao L, Kong N, Campy KS, Wang S. Trust collapse caused by the Changsheng vaccine crisis in China. Vaccine 2019;26:3419-25.
  2. Spencer JP, Trondsen Pawlowski RH, Thomas S. Vaccine adverse events: separating myth from reality. Am Fam Physician 2017;95(12):786-94.
  3. Wormsbecker AE, Johnson C, Bourns L, Harris T, Crowcroft NS, Deeks SL. Demonstration of background rates of three conditions of interest for vaccine safety surveillance. PLoS One 2019;14(1):e0210833. https://doi.org/10.1371/journal.pone.0210833
  4. Vaccine Adverse Event Reporting System homepage. Vaccine Adverse Event Reporting System. Available from https://vaers.hhs.gov/about.html. Assessed May 8, 2019.
  5. Centers for Disease Control and Prevention homepage. Vaccine Adverse Event Reporting System. Available from https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html. Assessed May 8, 2019.
  6. Centers for Disease Control and Prevention homepage. The Immunization Safety Office. Available from http://www.cdc.gov/vaccinesafety/Activities/About_ISO.html. Assessed May 8, 2019.
  7. Centers for Disease Control and Prevention homepage. Vaccine Safety Monitoring. Available from http://www.cdc.gov/vaccinesafety/Vaccine_Monitoring/Index.html. Assessed May 9, 2019.
  8. Centers for Disease Control and Prevention homepage. Vaccine Safety Datalink. Available from http://www.cdc.gov/vaccinesafety/Vaccine_Monitoring/Index.html. Assessed May 9, 2019.
  9. CDC homepage. Clinical Immunization Safety Assessment Project. Available from https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html. Assessed May 10, 2019.
  10. Centers for Disease Control and Prevention homepage. Clinical Immunization Safety Assessment Project Publications. Available from https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/publications.html. Assessed May 15, 2019.
  11. LaRussa PS, Edwards KM, Dekker CL, et al. Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network. Pediatrics 2011;127 Suppl 1:S65-73. https://doi.org/10.1542/peds.2010-1722J
  12. Kochhar S, Edwards KM, Ropero Alvarez AM, Moro PL, Ortiz JR. Introduction of new vaccines for immunization in: pregnancy-programmatic, regulatory, safety and ethical considerations. Vaccine 2019;37(25):3267-77. https://doi.org/10.1016/j.vaccine.2019.04.075
  13. Mathian A, Pha M, Amoura Z. Lupus and vaccinations. Curr Opin Rheumatol 2018;30(5):465-70. https://doi.org/10.1097/BOR.0000000000000525
  14. Murdaca G, Orsi A, Spano F, et al. Influenza and pneumococcal vaccinations of patients with systemic lupus erythematosus: current views upon safety and immunogenicity. Autoimmun Rev 2014;13(2):75-84. https://doi.org/10.1016/j.autrev.2013.07.007
  15. Oh M-J. Vaccination in pregnancy. J Korean Med Assoc 2016;59(7):523-8. https://doi.org/10.5124/jkma.2016.59.7.523
  16. Stockwell MS, Cano M, Jakob K, et al. Feasibility of text message influenza vaccine safety monitoring during pregnancy. Am J Prev Med 2017;53(3):282-9. https://doi.org/10.1016/j.amepre.2017.03.014
  17. Jacobson TA, Cheeley MK, Jones PH, et al. The statin adverse treatment experience survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol 2019;13(3):415-24. https://doi.org/10.1016/j.jacl.2019.04.011
  18. Sohn D-E, Ahn Y-W, Park J-S, Ko M-Y. An epidemiological study of temporomandibular disorders patients by screening questionnaire. Journal of Oral Medicine and Pain 2004;29(4):341-51.
  19. Stergiopoulos S, Brown CA, Felix T, Grampp G, Getz KA. A survey of adverse event reporting practices among US healthcare professionals. Drug Saf 2016;39(11):1117-27. https://doi.org/10.1007/s40264-016-0455-4
  20. Herrera Gomez A. Safety and efficacy of influenza vaccine in pregnancy. Rev Enferm 2015;38(2):38-41.
  21. Seo J. Pregnant women will also receive the influenza vaccine for 'free' from this year. Maeil Business Newspaper 2019. Available from https://www.mk.co.kr/news/it/view/2019/03/167369/. Assessed May 28, 2019.