ECDC - Technical Document - Protocol for cohort database studies to measure influenza vaccine effectiveness in the European Union and European Economic Area Member States - 17 July 2009

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Protocol for cohort database studies to measure influenza vaccine effectiveness in the European Union and European Economic Area Member States

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Abbreviations

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iv

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1 Background

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2 Objectives

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2.1 Aim

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2.2 General objective

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2.3 Secondary objectives

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3 Methods

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3.1 Study design

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3.2 Study population and data source

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3.3 Study setting

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3.4 Study period

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Definition of periods

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3.5 Exposure

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3.6 Outcome(s)

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3.7 Sub-groups

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3.8 Confounding factors and effect modifiers

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Presence of chronic diseases

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Previous vaccinations

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Indicators of severity of chronic diseases

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Use of antiviral drugs

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Indicators of healthcare utilisation

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3.9 Miscellaneous confounding factors

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Level of social interaction

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Functional status

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Smoking history

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Indicators of socio-economic status

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Further confounding factors

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3.10 Data collection

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Procedures for database management

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Sample size

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Subsample validation analysis

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Laboratory methods

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Analysis

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Descriptive and univariable analyses

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3.11 Crude VE estimates

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3.12 Stratified analysis

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Multivariable analysis

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Propensity scores

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Sensitivity analysis

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4 Limitations

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4.1 Study population

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4.2 Exposure, vaccination status

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4.3 Outcome

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4.4 Sample size for sub-analysis

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4.5 Negative confounding

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4.6 Positive confounding

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5 Dissemination of results

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6 Ethical approval

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7 Logistical aspects

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8 Budget

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9 Additional studies

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References

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