Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/69150
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Type: Journal article
Title: A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol
Author: Berry, J.
Ryan, P.
Braunack-Mayer, A.
Duszynski, K.
Xafis, V.
Gold, M.
Citation: Trials, 2011; 12(1):1-10
Publisher: BioMed Central Ltd.
Issue Date: 2011
ISSN: 1745-6215
1745-6215
Statement of
Responsibility: 
Jesia G Berry, Philip Ryan, Annette J Braunack-Mayer, Katherine M Duszynski, Vicki Xafis, Michael S Gold, the Vaccine Assessment Using Linked Data (VALiD) Working Group
Abstract: 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 opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion: The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed.
Keywords: Vaccine Assessment Using Linked Data (VALiD) Working Group; Humans; Vaccines; Immunization Schedule; Data Collection; Population Surveillance; Health Care Surveys; Medical Record Linkage; Single-Blind Method; Product Surveillance, Postmarketing; Health Knowledge, Attitudes, Practice; Health Behavior; Parents; Research Design; Parental Consent; Socioeconomic Factors; Infant; Immunization Programs; South Australia
Description: Extent: 10p.
Rights: © 2011 Berry et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited
RMID: 0020102735
DOI: 10.1186/1745-6215-12-1
Published version: http://www.trialsjournal.com.proxy.library.adelaide.edu.au/content/12/1/1
Appears in Collections:Public Health publications

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