Graphical approach helps in pilot trial
A comic-style supplement to the informed consent process can help patients understand more and feel less anxious about coronary angiography and percutaneous coronary intervention (PCI), according to a pilot study in Germany.
Getting an additional packet of graphic illustrations about these procedures -- conveying the same information as the consent form -- led patients to an subjectively better experience compared with standard informed consent (all statistically significant differences):
- Better understanding of coronary angiography and PCI (11.5 vs 9.1 points out of 13 on a quiz)
- Reduced anxiety after informed consent (-3.1 vs +2.0 points on the Spielberger State-Trait Anxiety Inventory)
- Greater satisfaction with the informed consent procedure (27.7 vs 25.2 points on the Client Satisfaction Questionnaire)
- Improved satisfaction after coronary angiography (27.8 vs 25.3 points)
In addition, more of those who got the comics strongly agreed to feeling "well prepared" for cardiac catheterization (71.7% vs 41.0%, P=0.001), according to researchers led by Anna Brand, MD, of Charité-Universitätsmedizin Berlin and the German Centre for Cardiovascular Research, reporting online in the Annals of Internal Medicine.
"Our pilot trial provides novel proof-of-concept data regarding the benefit of medical graphic narratives as supplementary patient information and consent material before coronary angiography," they said.
This kind of informed consent is "way overdue," said Arthur Caplan, PhD, of NYU Langone Health in New York City, who was not involved with the study. Legal liability drives a lot of informed consent, he said. But from an ethics point of view, advancing patient understanding is crucial, Caplan told MedPage Today.
"Getting away from just long wordy printed informed consent forms is the way to go. A lot of people get information visually, not all of them, but many do. They ought to have the option of having the written informed consent supplemented with whatever visual material they find helpful. Others might do better with a short video clip with actors," he suggested.
"[A] short video of the process with the involved physicians in that hospital is much more user-friendly and informative for the patient," commented Roxana Mehran, MD, of Mount Sinai School of Medicine in New York City, who cautioned that the graphics used in the study were "not very realistic and may not give the right flavor of the procedure to the patient."
For the study, the researchers identified 135 consecutive patients who got coronary angiography at Brand's center from October 2016 to January 2018. After excluding those who declined study participation and others for reasons such as cognitive impairment and language barriers, 121 individuals were randomized to informed consent with or without an illustrated supplement.
The same physician performed the consent process in all cases.
The comics eased periprocedural anxiety to a similar extent between the sexes, although women had been markedly more anxious from the start, the authors noted.
Brand's group acknowledged the study's small sample size and that it is based on the experience of just one hospital.
Although the comics are "great" as a supplement to informed consent, they can't replace traditional consent forms just yet, according to Caplan.
Nevertheless, "I think that better strategies for communicating with patients are very important. We have done this in the U.S. and documented similar improvements in patients' experiences," said John Spertus, MD, MPH, of Saint Luke's Mid America Heart Institute in Kansas City, Missouri, who cited his prior work supporting the concept of graphical representations for simpler informed consent.
Brand reported grants from Friede Springer Herz Stiftung.
Annals of Internal Medicine
Source Reference: Brand A, et al "Medical graphic narratives to improve patient comprehension and periprocedural anxiety before coronary angiography and percutaneous coronary intervention: a randomized trial" Ann Intern Med 2019; DOI: 10.7326/M18-2976.
Read the original article on Medpage Today: Comics Improve PCI Informed Consent