Social and Behavioral Sciences Commons^™

A Randomised Controlled Trial To Compare Opt-In And Opt-Out Parental Consent For Childhood Vaccine Safety Surveillance Using Data Linkage: Study Protocol, Jesia G. Berry, Philip Ryan, Annette J. Braunack-Mayer, Katherine M. Duszynski, V Xafis, M S. Gold

Faculty of Social Sciences - Papers (Archive)

Background

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.

Methods/Design

Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an …