Health Literacy Practices Improve Pediatric Assent

Enrolling in a clinical trial can be a very emotional process for adults. That uncertainty is compounded when adults are making those decisions for their children. Yet, just as we need to research the effects of medicines in different ethnicities, races and genders, we also need to study and understand the effects of medicines on children, to ensure we are administering the safest effective dose.

One way we are trying to ease that decision-making burden is by making the process more informative.

In pediatric #clinicaltrials, the parent provides consent on behalf of the child. The child gives assent, where developmentally appropriate. https://t.co/MGmVqeRXZ0

— Lilly Trials (@LillyTrials) February 22, 2017

In pediatric research, the consent is signed by the legally authorized adult. The study is also explained to the child based on their level of understanding. This process is called study assent. This approach assures that both the adult and the child have a chance to understand what they are volunteering for and can have their own questions answered before participation begins.

Recently, we completely reworked our pediatric assent form and measured the impact of those changes on readability and health literacy. Here is what we learned:

1. Use input from patients and other qualified partners. We had input from experts at each step of the way in our revision process. A team at UC-Berkeley’s Health Research for Action Center (HRA) assessed the original documents, helped revise the documents for improved health literacy and coordinated the first review of the revised documents with a group of six children, to assess areas that might still cause confusion. We also worked with the International Children’s Advisory Network (iCAN) in the United States, Scotland and England, to get input directly from kids who have been in research studies.

2. Tailor the content to your audience. Because of the varying levels of literacy and understanding among different age groups, we revised one assent template to be used with younger children ages 7–11 and a second assent template for older children ages 12–16 (see images below).

3. Use validated assessment tools. To ensure we had achieved our goal of making our consents clear and meaningful to children, we used a tool called the Suitability of Assessment Materials (SAM). The SAM rates health information material on readability and comprehension as "superior," "adequate" or "not suitable."

After the revisions and input from youth, the SAM scores for both assent forms improved from "adequate" to "superior."

What’s more: we learned valuable insights from the focus groups with the iCAN youth networks beyond the document alone:

• Youth appreciated efforts to structure the assent in ways that allowed them to better read and understand the information.

• Colorful photographs and images help to make the assent less intimidating and provide natural breaks in reading that aid comprehension.

• Youth thought it was very important to understand who will benefit from the study.

• Youth want to know what to expect if they choose to participate, including what will happen and how often.

• Youth want to be thanked for considering participation even if they decline the study.

Independently of this work on the revised assent forms, we conducted a one-year social media listening project, assessing all publically available data sources from news, forums, blogs, Twitter, Facebook, Google Plus, reviews and comments posted between August 1, 2015 and August 31, 2016. We found that the number of online conversations about pediatric research is relatively low (the average number of online posts per month hovered around 2,000) and the sentiment expressed in these conversations was primarily neutral (79% overall) or negative (18%). To us, that kind of result opens up the possibility for a conversation worth having. We’d like to hear your thoughts on pediatric research—your hopes and your concerns.