Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/69150
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dc.contributor.authorBerry, J.en
dc.contributor.authorRyan, P.en
dc.contributor.authorBraunack-Mayer, A.en
dc.contributor.authorDuszynski, K.en
dc.contributor.authorXafis, V.en
dc.contributor.authorGold, M.en
dc.date.issued2011en
dc.identifier.citationTrials, 2011; 12(1):1-10en
dc.identifier.issn1745-6215en
dc.identifier.issn1745-6215en
dc.identifier.urihttp://hdl.handle.net/2440/69150-
dc.descriptionExtent: 10p.en
dc.description.abstractBackground: 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.en
dc.description.statementofresponsibilityJesia G Berry, Philip Ryan, Annette J Braunack-Mayer, Katherine M Duszynski, Vicki Xafis, Michael S Gold, the Vaccine Assessment Using Linked Data (VALiD) Working Groupen
dc.language.isoenen
dc.publisherBioMed Central Ltd.en
dc.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 citeden
dc.source.urihttp://www.trialsjournal.com.proxy.library.adelaide.edu.au/content/12/1/1en
dc.subjectVaccine 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 Australiaen
dc.titleA randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocolen
dc.typeJournal articleen
dc.identifier.rmid0020102735en
dc.identifier.doi10.1186/1745-6215-12-1en
dc.identifier.pubid32410-
pubs.library.collectionPublic Health publicationsen
pubs.verification-statusVerifieden
pubs.publication-statusPublisheden
dc.identifier.orcidBerry, J. [0000-0002-4446-7927]en
dc.identifier.orcidBraunack-Mayer, A. [0000-0003-4427-0224]en
dc.identifier.orcidXafis, V. [0000-0002-5104-9686]en
dc.identifier.orcidGold, M. [0000-0003-1312-5331]en
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