scholarly journals Vaccine Epidemiology: Observational Vaccine Safety Study Designs

2021 ◽  
Vol 78 (2) ◽  
pp. 219-232
Author(s):  
Can Hüseyin Hekimoğlu
Keyword(s):  
Vaccine Safety ◽  
Safety Study ◽  
Study Designs

scholarly journals Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study

2013 ◽  
Vol 177 (2) ◽  
pp. 131-141 ◽  
Author(s):  
Jennifer C. Nelson ◽  
Onchee Yu ◽  
Clara P. Dominguez-Islas ◽  
Andrea J. Cook ◽  
Do Peterson ◽  
...  
Keyword(s):  
Vaccine Safety ◽  
Safety Study ◽  
Group Sequential ◽  
Sequential Methods ◽  
Safety Surveillance ◽  
Group Sequential Methods

Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice

2011 ◽  
Vol 139 (12) ◽  
pp. 1805-1817 ◽  
Author(s):  
Y. G. WELDESELASSIE ◽  
H. J. WHITAKER ◽  
C. P. FARRINGTON
Keyword(s):  
Adverse Events ◽  
Best Practice ◽  
Good Practice ◽  
Case Series ◽  
Vaccine Safety ◽  
The Self ◽  
Series Method ◽  
Safety Studies ◽  
Definition Of ◽  
Study Designs

SUMMARYThe self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995–2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.

Epidemiological study designs for evaluating vaccine safety

2021 ◽  
pp. 383-404
Author(s):  
Susan Hahné ◽  
Kaatje Bollaerts ◽  
Paddy Farrington
Keyword(s):  
Epidemiological Study ◽  
Vaccine Safety ◽  
Study Designs

Unmasking in an observational vaccine safety study: Using type 2 diabetes mellitus as an example

Vaccine ◽  
2015 ◽  
Vol 33 (46) ◽  
pp. 6224-6226 ◽  
Author(s):  
Bradley K. Ackerson ◽  
Lina S. Sy ◽  
Jeff Slezak ◽  
Chun R. Chao ◽  
Rulin C. Hechter ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Vaccine Safety ◽  
Safety Study

scholarly journals Differential anchoring effects of vaccination comparator selection: characterizing a potential bias due to healthcare utilization in COVID-19 versus influenza

2021 ◽  
Author(s):  
Anna Ostropolets ◽  
Patrick B. Ryan ◽  
Martijn J. Schuemie ◽  
George Hripcsak
Keyword(s):  
Influenza Vaccination ◽  
Large Scale ◽  
Index Date ◽  
Selection Procedure ◽  
Vaccine Safety ◽  
Selection Procedures ◽  
Safety Studies ◽  
Comparison Time ◽  
Baseline Characteristics ◽  
Study Designs

AbstractIntroductionObservational data enables large-scale vaccine safety surveillance but requires careful evaluation of potential sources of bias. One potential source of bias is an index date selection procedure for the unvaccinated cohort or unvaccinated comparison time. Here, we evaluate different index date selection procedures for two vaccines: COVID-19 and influenza.MethodsFor each vaccine, we extracted patient baseline characteristics on the index date and up to 450 days prior and then compared them to the characteristics of the unvaccinated patients indexed on an arbitrary date or indexed on a date of a visit. Additionally, we compared vaccinated patients indexed on the date of vaccination and the same patients indexed on a prior date or visit.ResultsCOVID-19 vaccination and influenza vaccination differ drastically from each other in terms of populations vaccinated and their status on the day of vaccination. When compared to indexing on a visit in unvaccinated population, influenza vaccination had markedly higher covariate proportions and COVID-19 vaccination had lower proportions of most covariates on the index date. In contrast, COVID-19 vaccination had similar covariate proportions when compared to an arbitrary date. These effects attenuated but were still present with a longer lookback period. The effect of day 0 was present even when patients served as their own controls.ConclusionPatient baseline characteristics are sensitive to the choice of the index date. In vaccine safety studies, unexposed index event should represent vaccination settings. Study designs previously used to assess influenza vaccination must be reassessed for COVID-19 to account for a potentially healthier population and lack of medical activity on the day of vaccination.

Differential anchoring effects of vaccination comparator selection: characterizing a potential bias due to healthcare utilization in COVID-19 versus influenza (Preprint)

2021 ◽  
Author(s):  
Anna Ostropolets ◽  
Patrick Ryan ◽  
Martijn Schuemie ◽  
George Hripcsak
Keyword(s):  
Influenza Vaccination ◽  
Large Scale ◽  
Index Date ◽  
Selection Procedure ◽  
Vaccine Safety ◽  
Selection Procedures ◽  
Safety Studies ◽  
Comparison Time ◽  
Baseline Characteristics ◽  
Study Designs

BACKGROUND Observational data enables large-scale vaccine safety surveillance but requires careful evaluation of potential sources of bias. One potential source of bias is an index date selection procedure for the unvaccinated cohort or unvaccinated comparison time. OBJECTIVE Here, we evaluate different index date selection procedures for two vaccines: COVID-19 and influenza. METHODS For each vaccine, we extracted patient baseline characteristics on the index date and up to 450 days prior and then compared them to the characteristics of the unvaccinated patients indexed on an arbitrary date or indexed on a date of a visit. Additionally, we compared vaccinated patients indexed on the date of vaccination and the same patients indexed on a prior date or visit. RESULTS COVID-19 vaccination and influenza vaccination differ drastically from each other in terms of populations vaccinated and their status on the day of vaccination. When compared to indexing on a visit in unvaccinated population, influenza vaccination had markedly higher covariate proportions and COVID-19 vaccination had lower proportions of most covariates on the index date. In contrast, COVID-19 vaccination had similar covariate proportions when compared to an arbitrary date. These effects attenuated but were still present with a longer lookback period. The effect of day 0 was present even when patients served as their own controls. CONCLUSIONS Patient baseline characteristics are sensitive to the choice of the index date. In vaccine safety studies, unexposed index event should represent vaccination settings. Study designs previously used to assess influenza vaccination must be reassessed for COVID-19 to account for a potentially healthier population and lack of medical activity on the day of vaccination.

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