Yih et al. Respond to “Moving From Evidence to Impact for Human Papillomavirus Vaccination”

Yih et al. Respond to “Moving From Evidence to Impact for Human Papillomavirus Vaccination” American Journal of Epidemiology Vol. 187, No. 6 © The Author(s) 2018. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of DOI: 10.1093/aje/kwy022 Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. Advance Access publication: February 23, 2018 Response to Invited Commentary Yih et al. Respond to “Moving From Evidence to Impact for Human Papillomavirus Vaccination” W. Katherine Yih*, Judith C. Maro, and Martin Kulldorff * Correspondence to Dr. W. Katherine Yih, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA 02215-3301 (e-mail: katherine_yih@harvardpilgrim.org). Initially submitted January 24, 2018; accepted for publication January 30, 2018. We agree wholeheartedly with Drs. Rositch and Krakow codes for patients with the same syndrome being dispersed (1) that vaccine safety epidemiologists need to help bridge the among multiple branches of the tree. gap between the generation of evidence on vaccine safety and Ultimately, in order to win and deserve the public’strust in the communication of such evidence to the public. The uptake vaccines, we will need to communicate clearly not only about of human papillomavirus (HPV) vaccines in the United States key safety findings, including those from studies such as this and elsewhere has indeed suffered from parental concerns one that evaluate a whole range of potential adverse events about the risks of HPV vaccination, with millions of teenagers with high statistical power, but also about which kinds of health and young adults foregoing the opportunity to be protected by outcomes have been thoroughly assessed as possible vaccine- these cancer-preventing vaccines. We commend Drs. Rositch and associated adverse events and which have not. Krakow on their 3 well-considered suggestions for how vaccine safety researchers and the public health community as a whole can and should take responsibility for translating research into accessible information and helping disseminate it to the public. ACKNOWLEDGMENTS Our data-mining method for evaluating thousands of poten- Author affiliations: Department of Population Medicine, tially vaccine-related adverse events not previously assessed is Harvard Medical School and Harvard Pilgrim Health Care uniquely comprehensive. In the application described in our Institute, Boston, Massachusetts (W. Katherine Yih, Judith C. paper (2), it had excellent statistical power to detect even small Maro); and Division of Pharmacoepidemiology and excess risks, and thus the finding of only 2 categories of adverse Pharmacoeconomics, Department of Medicine, Harvard events, both consistent with the known safety profile of the Medical School and Brigham and Women’s Hospital, Boston, quadrivalent HPV vaccine, is an important addition to the Massachusetts (Martin Kulldorff). safety record of this vaccine. Such findings indeed need to be Conflict of interest: none declared. better communicated to the public. At the same time, we find it necessary to reiterate 2 possibly important limitations of our evaluation: First, we looked for increased risks of potential adverse events presenting only within the first 42 days after vaccination; thus, potential adverse events with longer latency REFERENCES periods and/or with insidious onset could have been missed. 1. Rositch AF, Krakow M. Invited commentary: moving from Second, the hierarchical tree of diagnoses we used was orga- evidence to impact for human papillomavirus vaccination—the nized by International Classification of Diseases, Ninth Revi- critical role of translation and communication in epidemiology. sion, codes and body system; thus, potential adverse events Am J Epidemiol. 2018;187(6):1277–1280. characterized by physiologically diverse symptoms (e.g., pos- 2. Yih WK, Maro JC, Nguyen M, et al. Assessment of quadrivalent tural orthostatic tachycardia syndrome, which manifests as human papillomavirus vaccine safety using the self-controlled neurological, gastrointestinal, and/or cardiovascular symptoms) tree-temporal scan statistic signal-detection method in the could have been missed due to the possibility of diagnosis Sentinel system. Am J Epidemiol. 2018;187(6):1269–1276. 1281 Am J Epidemiol. 2018;187(6):1281 Downloaded from https://academic.oup.com/aje/article-abstract/187/6/1281/4904163 by Ed 'DeepDyve' Gillespie user on 17 June 2018 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Epidemiology Oxford University Press

Yih et al. Respond to “Moving From Evidence to Impact for Human Papillomavirus Vaccination”

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Publisher
Oxford University Press
Copyright
© The Author(s) 2018. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
ISSN
0002-9262
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1476-6256
D.O.I.
10.1093/aje/kwy022
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Abstract

American Journal of Epidemiology Vol. 187, No. 6 © The Author(s) 2018. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of DOI: 10.1093/aje/kwy022 Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. Advance Access publication: February 23, 2018 Response to Invited Commentary Yih et al. Respond to “Moving From Evidence to Impact for Human Papillomavirus Vaccination” W. Katherine Yih*, Judith C. Maro, and Martin Kulldorff * Correspondence to Dr. W. Katherine Yih, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA 02215-3301 (e-mail: katherine_yih@harvardpilgrim.org). Initially submitted January 24, 2018; accepted for publication January 30, 2018. We agree wholeheartedly with Drs. Rositch and Krakow codes for patients with the same syndrome being dispersed (1) that vaccine safety epidemiologists need to help bridge the among multiple branches of the tree. gap between the generation of evidence on vaccine safety and Ultimately, in order to win and deserve the public’strust in the communication of such evidence to the public. The uptake vaccines, we will need to communicate clearly not only about of human papillomavirus (HPV) vaccines in the United States key safety findings, including those from studies such as this and elsewhere has indeed suffered from parental concerns one that evaluate a whole range of potential adverse events about the risks of HPV vaccination, with millions of teenagers with high statistical power, but also about which kinds of health and young adults foregoing the opportunity to be protected by outcomes have been thoroughly assessed as possible vaccine- these cancer-preventing vaccines. We commend Drs. Rositch and associated adverse events and which have not. Krakow on their 3 well-considered suggestions for how vaccine safety researchers and the public health community as a whole can and should take responsibility for translating research into accessible information and helping disseminate it to the public. ACKNOWLEDGMENTS Our data-mining method for evaluating thousands of poten- Author affiliations: Department of Population Medicine, tially vaccine-related adverse events not previously assessed is Harvard Medical School and Harvard Pilgrim Health Care uniquely comprehensive. In the application described in our Institute, Boston, Massachusetts (W. Katherine Yih, Judith C. paper (2), it had excellent statistical power to detect even small Maro); and Division of Pharmacoepidemiology and excess risks, and thus the finding of only 2 categories of adverse Pharmacoeconomics, Department of Medicine, Harvard events, both consistent with the known safety profile of the Medical School and Brigham and Women’s Hospital, Boston, quadrivalent HPV vaccine, is an important addition to the Massachusetts (Martin Kulldorff). safety record of this vaccine. Such findings indeed need to be Conflict of interest: none declared. better communicated to the public. At the same time, we find it necessary to reiterate 2 possibly important limitations of our evaluation: First, we looked for increased risks of potential adverse events presenting only within the first 42 days after vaccination; thus, potential adverse events with longer latency REFERENCES periods and/or with insidious onset could have been missed. 1. Rositch AF, Krakow M. Invited commentary: moving from Second, the hierarchical tree of diagnoses we used was orga- evidence to impact for human papillomavirus vaccination—the nized by International Classification of Diseases, Ninth Revi- critical role of translation and communication in epidemiology. sion, codes and body system; thus, potential adverse events Am J Epidemiol. 2018;187(6):1277–1280. characterized by physiologically diverse symptoms (e.g., pos- 2. Yih WK, Maro JC, Nguyen M, et al. Assessment of quadrivalent tural orthostatic tachycardia syndrome, which manifests as human papillomavirus vaccine safety using the self-controlled neurological, gastrointestinal, and/or cardiovascular symptoms) tree-temporal scan statistic signal-detection method in the could have been missed due to the possibility of diagnosis Sentinel system. Am J Epidemiol. 2018;187(6):1269–1276. 1281 Am J Epidemiol. 2018;187(6):1281 Downloaded from https://academic.oup.com/aje/article-abstract/187/6/1281/4904163 by Ed 'DeepDyve' Gillespie user on 17 June 2018

Journal

American Journal of EpidemiologyOxford University Press

Published: Feb 23, 2018

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