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Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design

Post-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an over...

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Autores principales: Lai, Lana YH, Arshad, Faaizah, Areia, Carlos, Alshammari, Thamir M., Alghoul, Heba, Casajust, Paula, Li, Xintong, Dawoud, Dalia, Nyberg, Fredrik, Pratt, Nicole, Hripcsak, George, Suchard, Marc A., Prieto-Alhambra, Dani, Ryan, Patrick, Schuemie, Martijn J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8980923/
https://www.ncbi.nlm.nih.gov/pubmed/35392566
http://dx.doi.org/10.3389/fphar.2022.837632
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author Lai, Lana YH
Arshad, Faaizah
Areia, Carlos
Alshammari, Thamir M.
Alghoul, Heba
Casajust, Paula
Li, Xintong
Dawoud, Dalia
Nyberg, Fredrik
Pratt, Nicole
Hripcsak, George
Suchard, Marc A.
Prieto-Alhambra, Dani
Ryan, Patrick
Schuemie, Martijn J.
author_facet Lai, Lana YH
Arshad, Faaizah
Areia, Carlos
Alshammari, Thamir M.
Alghoul, Heba
Casajust, Paula
Li, Xintong
Dawoud, Dalia
Nyberg, Fredrik
Pratt, Nicole
Hripcsak, George
Suchard, Marc A.
Prieto-Alhambra, Dani
Ryan, Patrick
Schuemie, Martijn J.
author_sort Lai, Lana YH
collection PubMed
description Post-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an overview of the strengths, weaknesses, and clinical applications of epidemiologic and analytical methods used in vaccine monitoring, focusing on cohort, case-control and self-controlled designs. These designs are proposed to be evaluated in the EUMAEUS (Evaluating Use of Methods for Adverse Event Under Surveillance–for vaccines) study because of their widespread use and potential utility. Over the past decades, there have been an increasing number of epidemiological study designs used for vaccine safety surveillance. While traditional cohort and case-control study designs remain widely used, newer, novel designs such as the self-controlled case series and self-controlled risk intervals have been developed. Each study design comes with its strengths and limitations, and the most appropriate study design will depend on availability of resources, access to records, number and distribution of cases, and availability of population coverage data. Several assumptions have to be made while using the various study designs, and while the goal is to mitigate any biases, violations of these assumptions are often still present to varying degrees. In our review, we discussed some of the potential biases (i.e., selection bias, misclassification bias and confounding bias), and ways to mitigate them. While the types of epidemiological study designs are well established, a comprehensive comparison of the analytical aspects (including method evaluation and performance metrics) of these study designs are relatively less well studied. We summarized the literature, reporting on two simulation studies, which compared the detection time, empirical power, error rate and risk estimate bias across the above-mentioned study designs. While these simulation studies provided insights on the analytic performance of each of the study designs, its applicability to real-world data remains unclear. To bridge that gap, we provided the rationale of the EUMAEUS study, with a brief description of the study design; and how the use of real-world multi-database networks can provide insights into better methods evaluation and vaccine safety surveillance.
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spelling pubmed-89809232022-04-06 Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design Lai, Lana YH Arshad, Faaizah Areia, Carlos Alshammari, Thamir M. Alghoul, Heba Casajust, Paula Li, Xintong Dawoud, Dalia Nyberg, Fredrik Pratt, Nicole Hripcsak, George Suchard, Marc A. Prieto-Alhambra, Dani Ryan, Patrick Schuemie, Martijn J. Front Pharmacol Pharmacology Post-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an overview of the strengths, weaknesses, and clinical applications of epidemiologic and analytical methods used in vaccine monitoring, focusing on cohort, case-control and self-controlled designs. These designs are proposed to be evaluated in the EUMAEUS (Evaluating Use of Methods for Adverse Event Under Surveillance–for vaccines) study because of their widespread use and potential utility. Over the past decades, there have been an increasing number of epidemiological study designs used for vaccine safety surveillance. While traditional cohort and case-control study designs remain widely used, newer, novel designs such as the self-controlled case series and self-controlled risk intervals have been developed. Each study design comes with its strengths and limitations, and the most appropriate study design will depend on availability of resources, access to records, number and distribution of cases, and availability of population coverage data. Several assumptions have to be made while using the various study designs, and while the goal is to mitigate any biases, violations of these assumptions are often still present to varying degrees. In our review, we discussed some of the potential biases (i.e., selection bias, misclassification bias and confounding bias), and ways to mitigate them. While the types of epidemiological study designs are well established, a comprehensive comparison of the analytical aspects (including method evaluation and performance metrics) of these study designs are relatively less well studied. We summarized the literature, reporting on two simulation studies, which compared the detection time, empirical power, error rate and risk estimate bias across the above-mentioned study designs. While these simulation studies provided insights on the analytic performance of each of the study designs, its applicability to real-world data remains unclear. To bridge that gap, we provided the rationale of the EUMAEUS study, with a brief description of the study design; and how the use of real-world multi-database networks can provide insights into better methods evaluation and vaccine safety surveillance. Frontiers Media S.A. 2022-03-22 /pmc/articles/PMC8980923/ /pubmed/35392566 http://dx.doi.org/10.3389/fphar.2022.837632 Text en Copyright © 2022 Lai, Arshad, Areia, Alshammari, Alghoul, Casajust, Li, Dawoud, Nyberg, Pratt, Hripcsak, Suchard, Prieto-Alhambra, Ryan and Schuemie. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Lai, Lana YH
Arshad, Faaizah
Areia, Carlos
Alshammari, Thamir M.
Alghoul, Heba
Casajust, Paula
Li, Xintong
Dawoud, Dalia
Nyberg, Fredrik
Pratt, Nicole
Hripcsak, George
Suchard, Marc A.
Prieto-Alhambra, Dani
Ryan, Patrick
Schuemie, Martijn J.
Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design
title Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design
title_full Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design
title_fullStr Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design
title_full_unstemmed Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design
title_short Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design
title_sort current approaches to vaccine safety using observational data: a rationale for the eumaeus (evaluating use of methods for adverse events under surveillance-for vaccines) study design
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8980923/
https://www.ncbi.nlm.nih.gov/pubmed/35392566
http://dx.doi.org/10.3389/fphar.2022.837632
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