JMIR Publications

ABSTRACT

Background:

Shared decision-making (SDM) is increasingly valued in pediatric care worldwide; however, its application in Japanese clinical practice is still in the development stage, particularly in areas involving substantial medical uncertainty such as food allergy (FA) management. Although oral immunotherapy (OIT) is a promising option for children with FA, its long-term effectiveness and safety are still being evaluated, leaving families to navigate emotionally complex decisions amid limited evidence. Even in such clinical uncertainty, decision aids (DAs) are beneficial for organizing information and supporting patients and families in value-congruent choices. In addition, involving children in these decisions is increasingly recognized as ethically and developmentally appropriate. DAs clarify treatment options and promote informed, collaborative decisions. However, most DAs target adult users and may not explicitly encourage engagement with children’s views.

Objective:

This study aimed to develop a culturally adapted DA for Japanese parents, considering children’s preferences and perspectives.

Methods:

A paper-based DA was developed through iterative alpha testing and finalized by a multidisciplinary team. Nine parents of children eligible for OIT received this DA as participants in the study. Although intended for parents, the DA was intentionally structured to prompt reflection on children’s involvement in decision-making. Parents completed the structured questionnaires before and 1 week after receiving the DA, assessing uncertainty, anxiety, and the burden of FA management. Meanwhile, four children completed a quality-of-life (QOL) questionnaire. Subsequently, all nine parents and four children participated in semistructured interviews. The parents discussed how they used the DA, their perceptions of its clarity, and their interest in involving their children in decision-making. The children shared their thoughts on participating in decision-making.

Results:

All nine parents read the DA and completed the follow-up assessment (100% retention rate). Among these, four children also participated in the pediatric QOL assessments and interviews. Parents’ decisional conflict scale scores significantly decreased from 58.3 ± 29.9 at baseline to 26.7 ± 24.1 postintervention (t(8) = 2.65, P =.03). The values clarity subscale also significantly declined from 73.1 ± 30.6 to 25.9 ± 26.2 (t(8) = 4.50, P =.002).No significant changes were observed in parental anxiety, parental QOL, or children’s QOL scores. Seven of the nine parents explained treatment options to their child, and six reported actively seeking their child’s feelings. The interview results suggested that the DA associated with a shift in the family dynamic “from protecting to partnering.”

Conclusions:

A culturally adapted DA appears to be practical and acceptable for Japanese families while making pediatric FA treatment choices. Facilitating parent–child dialog, may promote more inclusive decision-making. However, further research with larger samples and longer follow-up is needed to confirm these findings and refine the tool. Clinical Trial: Not registered