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IRBs can help improve health literacy among potential research participants using several tactics, including asking studies to use plain language in informed consent (IC) forms.
“We have a responsibility to make information more clear,” says Sylvia Baedorf Kassis, program manager in the Multi-Regional Clinical Trials Center (MRCT) at Brigham and Women’s Hospital and Harvard in Boston.
IRBs can review informed consent and subject recruitment materials to ensure the study information is clear and adheres to regulatory requirements.
For instance, IRBs can give investigators feedback on the language they use, and suggest they read online resources on health literacy when their materials need improvement, Baedorf Kassis says.
The key is not for IRBs to develop and rely on specific templates, she notes.
“Templates can help, but it’s really a philosophy change,” she adds. “We encourage investigators to understand the needs of their population so the materials being developed are as close to perfect for that community as possible.”
IRBs might ask researchers how they incorporated patient or potential participant feedback into developing their research question, consent form, and recruitment materials, Baedorf Kassis says.
“If you incorporate feedback and use the language of the people you are working with, you are more likely fostering understanding of your concept,” she adds. “It’s a two-way street and an opportunity to learn from and communicate in better ways for people who need the information.”
The MRCT offers a health literacy case study library with examples of how organizations are integrating health literacy into clinical research settings. (The library is accessible at: https://mrctcenter.org/health-literacy/tools/overview/casestudies/.)
Researchers can use these techniques for enhancing health literacy among potential study participants:
• Incorporate plain language. “One of the things that is low-hanging fruit is plain language strategies,” Baedorf Kassis says. “Include fewer technical terms, which is hard to do for science and medicine, but try to explain things in less technical terms.”
IRBs also can use review consent forms, keeping plain language tips in mind. MRCT offers these examples:
- Ensure language is organized logically, and its content flows.
- Determine key concepts and present messages based on what the audience knows.
- Use everyday words, such as “use” instead of “utilize.”
- Simplify terms and definitions, using visuals and word/picture pairings to help explain the concept.
- Use active voice, which leaves less room for error and provides clear instructions.
“A lot of people focus on grade-level material, and it’s not a perfect proxy,” Baedorf Kassis says. “It’s a good check to see where you’re at, but you have to do a little bit more than doing a reading level, saying, ‘It’s at eighth-grade level, so we’re good to go.’”
• Use clear design. IRBs can ask investigators to fix text and presentation through clear design techniques.
For example, they can use design techniques that help present content clearly by breaking down information into short chunks, highlighting important information, eliminating redundant information, and breaking up blocks of text with white space. (Find out more at: https://mrctcenter.org/health-literacy/tools/overview/visualization-design/#visdexamples.)
“It’s not rocket science; it’s a better division of information,” Baedorf Kassis says. “You can divide information with boxes, as needed, providing a more visually appealing section so people can follow information more readily. You can use bullets instead of long sentences.”
Bulleted points help people follow long stretches of information. Graphics also can help make complicated data easier to understand.
“You can integrate a study flow diagram into the process,” Baedorf Kassis says. “You don’t have to be a graphic designer. We can all do some basic things in PowerPoint.”
• Use the teach-back method. The informed consent process includes conversations with participants.
“Even in these times [of the pandemic], when things are done remotely or via online methods, there is still some conversation happening with research professionals to go over the information,” Baedorf Kassis says. “Part of health literacy is a two-way conversation.”
Conversation or interactive techniques are important. The teach-back method can help researchers assess how much participants understand what they just read and heard.
The teach-back method includes these four parts:
- Sharing information: Use simple terms and describe information in a way that is well-received by the target audience.
- Confirming understanding: Ask participants to repeat what they have just learned.
- Rephrasing or clarifying and reconfirming understanding: If the participant does not repeat the key information, demonstrating understanding, then repeat the information differently and ask for teach-back.
- Moving on and repeating: Once the participant demonstrates understanding, move on to the next topic. (Find more information at: https://mrctcenter.org/health-literacy/tools/overview/interactive-techniques/#teachback.)
“IRBs can reinforce for investigators the conversational teach-back techniques, where they ask probing questions about what was just shared,” Baedorf Kassis says. “Have them ask, ‘What are the main things that will happen to you if you get screened for the study?’”
• Try usability testing. Usability testing is evaluating a service or product through testing. It is a way to find out if potential participants understand research communication. (Find out more at: https://mrctcenter.org/health-literacy/tools/overview/usability-testing/.)
“Usability testing can be done at all levels. IRBs can do it with their own templates, and investigators can do it with the content they develop,” Baedorf Kassis says. “It gives you the information you need in order to make the next step in the research decision-making process. Is this document usable to the type of person who will be recruited into your study?”
There is a considerable amount of information available online about these techniques. More resources will be available soon, she notes.
“I’m working with a small group to develop more specific IRB resources and help IRBs to do health literacy training internally,” Baedorf Kassis says. “There is a little guide that I have been working on.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, reports she is on the speakers bureau for AORN and Ethicon USA and is a consultant for Mobile Instrument Service and Repair.