COVID-19 Vaccine Phase 3 Trial Consent Forms Score Low in Readability

(Reuters Health) – The consent forms used for the Phase 3 COVID-19 vaccine trials were written at a higher reading level than that of the typical American, as well as being crammed with scientific jargon and being overly detailed and long, a new study suggests.

An analysis of the documents, using Microsoft Word tools, found that not one company produced an easily readable form suitable for the general public, a team of researchers reports in the Mayo Clinic Proceedings.

“These were very large trials that sought to enroll people with diverse ages, socioeconomic statuses and education,” said study coauthor, Dr. Gregory Poland, the Mary Lowell Leary Emeritus Professor of Medicine, Infectious Diseases, and Molecular Pharmacology and Experimental Therapeutics and director of the Mayo Vaccine Research Group in Rochester, MN. “There had to be a lot of individuals who did not understand what they read and agreed to.”

“I don’t think the companies in the trials were trying to obfuscate,” Dr. Poland said. “The problem I is the litigious society we live in. Attorneys have designed the forms to shield the companies from any sort of accusation that they didn’t inform or talk about each risk.”

The downside to people not understanding their consent forms is a potential erosion of participant trust if side effects occur that they didn’t expect, Dr. Poland said.

To take a closer look at the readability of the consent forms from five vaccine companies – AstraZeneca, Johnson&Johnson, Moderna, Novavax and Pfizer – used in the phase III COVID-19 vaccine trials, Dr. Poland and his colleagues turned to tools available in Microsoft Word.

The researchers evaluated metrics and readability statistics in each consent form and informational document with three readability formulas: The Flesh Reading Ease score, a scale that predicts readability on a scale of one to 100, with 70 being an appropriate level for the average reader in the U.S. (higher scores indicate better readability); the Flesch-Kincaid Grade Level score, which predicts reading ease of a passage on a scale from one to 12, which indicates the educational level necessary to read the passage; and the Gunning-Fog index, which, like the Flesh-Kincaid Grade Level, is a readability test that scores text from one to 20, with scores based on the number of complex words per sentence in an approximately 100-word passage.

The consent forms averaged 20 pages with a word count of around 8,600, Dr. Poland said. The font size was small, and the average sentence length was a little over 19 words. The average percentage of passive sentences was 33%.

The mean Felsch Reading Score was nearly 50, while the mean Flesch-Kincaid Grade Level was 11. The mean Gunning-Fog Score was 13.3.

“None of the consent forms or informational documents from the recent phase III COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category,” the authors conclude.

“I think that we as a nation have appropriately made it a priority to make vaccines widely available to all of the people in the U.S.,” said Dr. Albert Wu, an internist and a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “From a scientific point of view, it is important that trials also include a diversity of participants so that we can be assured that vaccines are effective for all subgroups of people,” he said.

“Because vaccine trials are not without risk, we have a moral obligation to assure that participants understand what they are getting into,” Dr. Wu said. “From a human point of view, it’s simply the respectful thing to do. We have invested an enormous amount on the development of COVID vaccines in the last 18 months. It would only be appropriate to invest sufficient resources to assure that people who make the sacrifice of participating in trials know what they are getting into.”

“I would also say that in future evaluation, consent forms should be developed in collaboration with groups who are most likely to misunderstand them,” Dr. Wu said. “Future evaluations of readability of informed consent forms would be more informative if also included information directly from those individuals who could talk about what they understood and what they did not.”

SOURCE: Mayo Clinic Proceedings, online June 3, 2021.

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