Research uncovers formula for enhancing informed consent

Combining several comprehension-aiding techniques yields documents that are vastly superior to traditional forms, but legal fears still impede changes that could improve patient understanding.

Informed-consent documents that are shorter and use simpler language, bigger type and graphics lead to dramatically improved understanding of risks and benefits, said a study posted online May 13 in JAMA Pediatrics, formerly Archives of Pediatrics & Adolescent Medicine.

Researchers tested various types of forms — some long and complex, some shorter and simpler, some with graphics and some without — among 640 parents of children scheduled for elective surgery. The forms were designed to deliver the traditional elements of an informed consent-document for the clinical trial of a fictional pain-relieving drug called Painaway. The parents were quizzed after going through the informed-consent process to determine whether they understood what was presented about the risks and benefits of trial participation.

Parents had 50% better odds of understanding documents that included pictures displaying risk information in graphic form. They also were 35% likelier to understand forms with size 14 font and wider margins.

Meanwhile, the odds of comprehension dipped by 75% when forms were written at the 12th-grade reading level compared with documents written at the eighth-grade level. Documents that were just a few pages longer were 71% less likely to be understood than shorter forms, said the study.

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