New study identifies five ways to make consent informed

Xavier Symons
8 Jun 2013
Reproduced with Permission

Health experts have long lamented the complexity of patient consent forms. A new University of Michigan study may provide a solution to this barrier to achieving genuine informed consent.

The study, published in JAMA Paediatrics , was conducted on 640 parents of children scheduled for elective surgery. It involved a fictional trial of the pain relieve drug "Painaway". Parents were randomized to receive information about the trial presented in 1 of 16 consent documents containing different combinations of 5 selected communication strategies (length, readability, processability [formatting], graphical display, and supplemental verbal disclosure).

The trial showed that "positive message attributes " - text written at the eighth-grade reading level, bigger type, graphic display, oral explanations and shorter forms - led to a 75% better understanding risks and benefits of the trial. Parents had 50% better odds of understanding documents that included pictures displaying risk information in graphic form. The odds of comprehension dipped by 75% when forms were written at the 12th-grade reading level. Documents that were just a few pages longer were 71% less likely to be understood than shorter forms.

The research shows it is important to combine as many comprehension-aiding techniques as possible when crafting informed-consent documents, said Alan R. Tait of the University of Michigan Medical School."These are simple things to do. These are not expensive. These are easy fixes, easy to incorporate, and yet they make a big difference."

In an accompanying editorial, Dr Mark Schreiner, of the Children's Hospital of Philadelphia, said that consent forms have been becoming increasingly technical and legalistic. "Instead of brevity, consent forms remain verbose, increasing in length by approximately 1.5 pages per decade, with some well in excess of 20 pages" he said. Many health institutions have been reluctant to shorten and simplify forms due to concerns about increased liability.