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CommuniKIDS: Co-development and dissemination of a tool for communicating trial results in child health research

Submitted by:

Nancy Butcher

Email:

nancy.butcher@sickkids.ca

Author(s)

Nancy Butcher, Ami Baba, Joanne Tay, Cassandra Malandrino, Nicole Pallone, Dawn Richards, Maureen Smith, Shelley Vanderhout, Martin Offringa, Beth Potter

Institution of primary author:

Hospital for Sick Children & University of Toronto

Background:

Advancements in treatments and health outcomes for children are driven by the findings of clinical trials. Efforts in Canada are ongoing to increase family-centered clinical trial design and conduct for pediatric clinical trials. Furthermore, the COVID-19 pandemic is resulting in increased public interest in research and clinical trial results. A critical knowledge gap that remains is how to best communicate trial results with children and their families, whose participation in trials makes them possible. Clinical Trials Ontario (CTO) recently created a generic trial results template using a multi-stakeholder approach that included people who do clinical trials, adult members of the public, patients, and research ethics board (REB) specialists. We hypothesized that children and their caregivers have unique knowledge needs and preferences for receiving trial results. To address this, we launched an initiative to co-develop a freely accessible tool for communicating trial results with youth and families: CommuniKIDS.

Methods:

We developed CommuniKIDS through three main activities: (1) An environmental scan of the literature to identify any available evidence on best practices and considerations for research results communication in child health/disability populations; (2) A series of three virtual workshops with caregivers and youth to characterize their specific informational needs and preferences for receiving trial results using the CTO template as the starting point to co-develop CommuniKIDS; and (3) Pilot-testing and a web-based feedback survey administered to a broad pan-Canadian group of pediatric trialists and REB specialists.

Results:

Our literature search identified diverse recommendations for sharing pediatric trial results, encompassing aspects of content, format, and timing, which were used to inform the development of the workshops; no best-practices or any existing pediatric trial templates were identified. The parent and youth workshops held to date confirmed the importance and value of sharing pediatric trial results with families. Both groups indicated similar preferences for receiving trial results (i.e., directly by email) and content (i.e., overall favourable impressions of the CTO template). Feedback received at the workshops on both the generic CTO template and a populated example of a published pediatric migraine trial led to important modifications to the generic CTO template for youth and families, including the addition of a “summary of results” section at the top of the template, clarification of side effects, and differentiating between short and long-term child health outcomes. The final phase of the project, the survey with trialists and REB experts, is underway; results will be available at the time of presentation. 

Conclusions:

This presentation will mark the launch of a finalized and freely accessible CommuniKIDS tool for communicating trial results, available in both French and English. In the era of the COVID-19 pandemic, sharing trial results freely with the public in a timely and transparent manner is more important than ever. We expect that the availability of this tool will facilitate the sharing of trial results by trialists, and moreover, help create an experience for trial participants and their families that honours their participation by enabling the sharing of knowledge that they themselves generated. 

Nancy Butcher poster

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