Please use this identifier to cite or link to this item: https://doi.org/10.1186/1745-6215-12-1
Title: A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: Study protocol
Authors: Berry, J.G
Ryan, P
Braunack-Mayer, A.J
Duszynski, K.M
Xafis, V 
Gold, M.S
Keywords: vaccine
vaccine
article
attitude
Australia
childhood
controlled study
e-mail
human
interview
knowledge
major clinical study
mother
outcome assessment
professional practice
randomized controlled trial
single blind procedure
socioeconomics
study design
telephone
tertiary health care
vaccination
attitude to health
Australia
clinical trial
comparative study
controlled clinical trial
health behavior
health care survey
health survey
immunization
infant
information processing
medical record
methodology
parent
parental consent
postmarketing surveillance
preventive health service
psychological aspect
statistics
Data Collection
Health Behavior
Health Care Surveys
Health Knowledge, Attitudes, Practice
Humans
Immunization Programs
Immunization Schedule
Infant
Medical Record Linkage
Parental Consent
Parents
Population Surveillance
Product Surveillance, Postmarketing
Research Design
Single-Blind Method
Socioeconomic Factors
South Australia
Vaccines
Issue Date: 2011
Publisher: BMC
Citation: Berry, J.G, Ryan, P, Braunack-Mayer, A.J, Duszynski, K.M, Xafis, V, Gold, M.S (2011). A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: Study protocol. Trials 12 : 1. ScholarBank@NUS Repository. https://doi.org/10.1186/1745-6215-12-1
Rights: Attribution 4.0 International
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.Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12610000332022. © 2011 Berry et al; licensee BioMed Central Ltd.
Source Title: Trials
URI: https://scholarbank.nus.edu.sg/handle/10635/178183
ISSN: 1745-6215
DOI: 10.1186/1745-6215-12-1
Rights: Attribution 4.0 International
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