To improve your experience on Lilly TrialGuide, please use the latest version of Chrome, Firefox, Safari, or Internet Explorer, with JavaScript enabled.
This website is not optimized for your browser, as configured.
Collaboration

Health Literacy Practices Improve Pediatric Assent

Health Literacy Practices Improve Pediatric Assent Feature Image

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 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.”

Assent After-1024x474

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—so drop us a line on Twitter.

Blog post originally appeared on LillyPad.

Tags: Health Literacy,

Recent Articles

CaringForCaregivers FeatureImage 17Nov2020

Caring for Caregivers

Susan Gilchrist headshot square
Susan Gilchrist
November 18th, 20204 minute read

Read more for services and support groups to make life a bit easier for caregivers - the unsung heroes in the clinical trial process.

YourQuestionsAboutAlzheimersAnswered FeatureImage 21Sept2020

Your questions about Alzheimer’s research, answered

Susan Gilchrist headshot square
Susan Gilchrist
November 17th, 20205 minute read

Considering clinical trial participation may feel overwhelming. Here are some answers to common questions about Alzheimer’s and dementia clinical trials to support you through the learning curve.

ListenToTheYouthVoiceForPatientCentricPediatricDrugDevelopment FeatureImage 21Sept2020-01

Listen to the youth voice for patient-centric pediatric drug development

LTGBlogAuthors LillyGuestAuthorIcon 20July2018
Lilly Guest Author
September 24th, 20204 minute read

The patient voice is critical for successful clinical research, for people of all ages. Learn how Lilly’s partnership with iCAN helps us include that voice in research.

LeapingIntoDecentralizedClinicalTrials FeatureImage 16Sept2020-01

Leaping into Decentralized Clinical Trials

LTGBlogAuthors GuestAuthorIcon 20July2018
Guest Author
September 17th, 20203 minute read

Before starting medical school, Iman Mahoui joined Lilly’s Decentralized Trials team. She reflects on how new approaches to research can help address social justice and health equity issues.

MasterProtocol FeatureImage 14July2020-01

Platform Trials and Master Protocols: A New Approach to Clinical Research

Leigh Anne Naas Headshot
Leigh Anne Naas
August 18th, 20205 minute read

Learn more about platform trials and master protocols, an alternative model to how we conduct clinical research.