According to the Society of Clinical Trials, most informed consent forms (ICFs) “frequently fall short” of Good Clinical Practice Guidelines, meaning that they are often set at a higher reading level than the general population can understand.
In a new randomized study, which included 334 participants from an AmeriSpeak online survey panel, researchers sought to determine which of three ICFs, each about a stroke-prevention medication, was easiest to understand. The participants were recruited via email and were briefly informed of the importance of ICFs but not of the study’s specific goal.
The first ICF, used in a real 2022 study, was considered the “long” option at 21 pages and was set just below an 11th-grade reading level. The second was a 14-page “medium” ICF. The last was the “short” ICF, consisting of only three pages. The latter two were modified to reach below sixth-grade reading levels, included more graphs and tables, and the researchers ensured they used simpler wording. Respectively, these ICFs usually take about 31 minutes, 17 minutes, and six minutes to read.
The “short” version was based on a recently released FDA two-page summary template set at an eighth-grade reading level and intended to be attached to ICFs. However, researchers found that when a summary is attached to a longer ICF, most participants skip the ICF entirely and read the summary, suggesting that shorter, more concise forms are typically preferred.
The Society of Clinical Trials study oversampled individuals from minority groups and individuals with less than a high school diploma, noting that many previous trials involving ICF improvement studies were underrepresentative of people with lower levels of education, as well as racial and ethnic minority groups.
In this study, 46 Black non-Hispanic individuals comprised 13.8 percent of the total participant sample. White participants made up 58.1 percent, Asian participants 8.7 percent, and Hispanic/Latino participants 17.7 percent.
After reading their assigned informed consent forms, all participants were given a 28-item survey on what they had read. They were not allowed to refer back to the forms.
Overall, the study found that the “medium” ICF scored highest in reading comprehension, with 79.3 percent of questions about the form answered correctly. The “long” ICF scored an average of 65.7 percent, and the ‘short’ received an average of 69.3 percent.
Ninety-six percent of “medium” ICF readers felt “Well Informed” or “Very Well Informed,” compared to 93.2 percent and 95.9 percent of the “long” and “short” readers, respectively. Seventy-nine percent of “medium” readers reported they “Read the ICF Very Carefully” or “Carefully,” compared to 75.7 percent and 74.1 percent of the respective “long” and “short” readers.
When informing participants about clinical trials and other medical information, providers should keep average literacy levels in mind to avoid confusing or misleading participants.
According to 2023 statistics from the National University, the average American reads at a seventh or eighth-grade level. About 28 percent of U.S. adults scored at or below Level 1 on the literacy test. Only 44 percent of U.S. adults scored a Level 3 or above in literacy. Overall, about 130 million U.S. adults read at or below a sixth-grade level.
The National Center for Education Statistics (NCES) reported that Black adults represent 23 percent of the U.S. adults with low literacy ages 16 to 65. White and Hispanic adults make up 35 percent and 34 percent, respectively.
Patients of color have long experienced discrimination and health gaps when it comes to medical care and clinical trials, and ICFs are no exception. Tragedies like the Tuskegee Syphilis study have shown that a Black patient’s experience in clinical trials can be riddled with misinformation or a complete lack of information, paired with severe exploitation. Thus, all patients must be fully aware of a clinical trial’s goals, intentions, and risks at a level commensurate with their literacy levels.
A foundational element of clinical trials, ICFs explain the trial’s goals, processes, estimated length, and potential risks. The purpose of informed consent forms is to educate trial participants about the trial itself, allowing them to grasp the study’s concept and what their involvement will entail. However, if an ICF is at a comprehension and reading level far above the average individual’s capacity, participants may miss important trial factors, like risk and time commitment.
For providers, this study’s findings can illuminate better methods for educating patients on specific clinical trial involvement. If most patients read at a middle school level, prefer summaries and shorter informed consent forms to longer ones, then providers can ensure their correspondence with patients matches that level. Lengthy pages of information at higher reading levels are not recommended for the general population. Using overly medical jargon and multiple pages is more likely to confuse a potential participant, who is putting their time, health, and other life factors at risk.
To ensure your patients thoroughly understand health information, it’s imperative to consider their literacy levels and simplify the language.
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