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ECDC - Technical Document - Protocol for cohort database studies to measure influenza vaccine effectiveness in the European Union and European Economi

Thread starter FrenchieGirl
Start date Jul 17, 2009

FrenchieGirl

Senior Moderator

Jul 17, 2009

#1

[Table of contents below, full content at link]

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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</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0cm 5.4pt; width: 12cm;" valign="top" width="454">

9 Additional studies

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</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0cm 5.4pt; width: 12cm;" valign="top" width="454">

References

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