Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/69150
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dc.contributor.author | Berry, J. | - |
dc.contributor.author | Ryan, P. | - |
dc.contributor.author | Braunack-Mayer, A. | - |
dc.contributor.author | Duszynski, K. | - |
dc.contributor.author | Xafis, V. | - |
dc.contributor.author | Gold, M. | - |
dc.date.issued | 2011 | - |
dc.identifier.citation | Trials, 2011; 12(1):1-10 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | http://hdl.handle.net/2440/69150 | - |
dc.description | Extent: 10p. | - |
dc.description.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. | - |
dc.description.statementofresponsibility | 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 | - |
dc.language.iso | en | - |
dc.publisher | BioMed Central Ltd. | - |
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 cited | - |
dc.source.uri | http://www.trialsjournal.com.proxy.library.adelaide.edu.au/content/12/1/1 | - |
dc.subject | Vaccine Assessment Using Linked Data (VALiD) Working Group | - |
dc.subject | Humans | - |
dc.subject | Vaccines | - |
dc.subject | Immunization Schedule | - |
dc.subject | Data Collection | - |
dc.subject | Population Surveillance | - |
dc.subject | Health Care Surveys | - |
dc.subject | Medical Record Linkage | - |
dc.subject | Single-Blind Method | - |
dc.subject | Product Surveillance, Postmarketing | - |
dc.subject | Health Knowledge, Attitudes, Practice | - |
dc.subject | Health Behavior | - |
dc.subject | Parents | - |
dc.subject | Research Design | - |
dc.subject | Parental Consent | - |
dc.subject | Socioeconomic Factors | - |
dc.subject | Infant | - |
dc.subject | Immunization Programs | - |
dc.subject | South Australia | - |
dc.title | A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1186/1745-6215-12-1 | - |
dc.relation.grant | http://purl.org/au-research/grants/arc/LP0882394 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Berry, J. [0000-0002-4446-7927] | - |
dc.identifier.orcid | Braunack-Mayer, A. [0000-0003-4427-0224] | - |
dc.identifier.orcid | Xafis, V. [0000-0002-5104-9686] | - |
dc.identifier.orcid | Gold, M. [0000-0003-1312-5331] | - |
Appears in Collections: | Aurora harvest Public Health publications |
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