A Randomised Controlled Trial to Compare Opt-in and Opt-Out Parental Consent for Childhood Vaccine Safety Surveillance Using Data Linkage: Study Protocol
Berry, Jesia G
Braunack-Mayer, Annette J
Duszynski, Katherine M
Gold, Michael S
Trials 2011 January 4; 12: 1
The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods.
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