Abstract
BackgroundThe 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/DesignSingle-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.DiscussionThe 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000332022
Highlights
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
The VALiD randomised controlled trial (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
Be possible to determine the presence of selection bias in the participation rate, irrespective of whether a subject answered the socio-demographic questions in the interview
Summary
This is the first RCT of opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. The comprehensive list of socio-demographic variables included in the hospital’s patient management system provided basic information on a range of socio-demographics for all mothers: age, marital status, country of birth, Indigenous status, household location (major cities or other) and IRSD It will, be possible to determine the presence of selection bias in the participation rate, irrespective of whether a subject answered the socio-demographic questions in the interview. Parents usually had a good rapport with the hospital as recent recipients of its health services and were willing to participate in the research for altruistic reasons This trial focused on parental attitudes towards using data linkage in one context: childhood vaccine safety surveillance. The findings will have relevance to all stakeholders and policy makers and will stimulate public debate about what it means to protect patients’ interests
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