A Consent Support Resource with Benefits and Harms of Vaccination Does Not Increase Hesitancy in Parents - An Acceptability Study

"It has been argued that engagement, transparency, and parent-centred approaches are key to addressing the global threat of vaccine hesitancy..."

Effective communication is important for preventing and managing vaccine hesitancy. Research has shown that trust and good communication between providers and parents' consultations is key to establishing valid consent for routine childhood vaccination. However, some clinicians may be cautious about providing too much information (e.g., about rare or serious side effects of vaccines) during the consent process, lest they inadvertently alarm parents or dissuade them from vaccinating their children. This study aimed to investigate whether providing parents with information about the benefits and risks of routine childhood vaccination provokes or increases vaccine hesitancy.

The Sharing Knowledge About Immunisation (SKAI) consent support resource, which was used as part of this study, is part of an Australian Government-funded digital platform designed to support parent-provider communication about routine childhood vaccination. Co-designed with parents and providers by a multidisciplinary research team, SKAI is premised on a previously published vaccine communication framework. One of 8 consent support resources included on the SKAI platform, the 3-page fact-sheet titled "What vaccines are recommended for my baby from six weeks?" that was used in this study presents information about childhood vaccination using a question/answer format.

The researchers recruited a convenience sample of parents from the "Parents, Babies and Children's Expo" in Sydney, Australia, in May 2018. The researchers paid for a booth in the exhibition space, branded with the University of Sydney logo and promoted as a survey study about childhood vaccination. Members of the research team invited parents who approached the booth to complete - before and after reading vaccine consent information - an online survey via tablet computers provided or via a link that was emailed on request. Parents were eligible for the study if they were Australian residents who could read and respond in English, were expecting a baby, or were the parent of a child less than 6 months of age.

The scales used to measure primary and secondary outcomes included: the Parent Attitudes about Childhood Vaccines Short Scale (PACV-SS), which measures vaccine hesitancy, the Informed Subscale of the Decisional Conflict Scale (DCS-IS), which measures whether respondents feel adequately informed to make a vaccination decision, the Stage of Decision Making Scale, which measures the strength and nature of parents' vaccination decision-making, as well as a Positive Attitude Assessment, a measure of Side effect and Safety, and an item designed to indicate parents' position within the Vaccine Communication Framework (VCF).

Overall, 416 parents showed no change in vaccine hesitancy (mean PACV-SS score pre = 1.97, post = 1.94). Most indicated they had already made a decision about vaccinating their child at baseline, and there was no significant change after the intervention. Most parents were also categorised at baseline as "accepting" on the VCF, and this also remained unchanged (90.1% pre and 92.0% post, p = 0.1) after exposure to the intervention. However, after reading the consent form, there were some changes: They were more informed (mean DCS-IS score pre = 29.05, post = 7.41; diff = -21.63), more positive towards vaccination (pre = 43.8% post = 50.4%; diff = 6.5%), and less concerned about vaccine safety (pre = 28.5%, post = 23.0%, diff = -5.6%) and side effects (pre = 37.0%, post = 29.0%, diff = -8.0%) - with no change in stage of decision-making or intention to vaccinate.

The majority of parents said the resource had not raised any concerns for them (91.1%). Amongst the 34 (8.2%) respondents who indicated they had some concerns, 6 were related to vaccine safety or side effects, 2 were related to distrust of the Government and the information provided, 2 felt they had been given too much information, 1 wanted more information, 1 reported they wanted to be advised by their doctor before vaccinating their child, and 1 was concerned about new vaccines not being available for free.

In reflecting on the findings, the researchers note that most participants who read the consent form at the expo itself spent less than 1 minute looking at the information. Parents who spent more time reading the consent resource did so at home, "suggesting that these resources should ideally be provided to parents in advance of the vaccination consultation to maximise engagement. This aspect emphasised (as part of the SKAI package) the need to embed the consent resource as a more routine part of the consent process and as the standard of care for parents."

In conclusion: "Providing information about the benefits and risks of routine childhood vaccination increases parents' informed decision-making without increasing vaccine hesitancy."