Are informed consent forms for organ transplantation and donation too difficult to read?

Informed consent for organ transplantation and donation is an ethical obligation, legally required, and considered as part of the Patient's Rights Condition of Medicare Participation for hospitals. National policy-makers recommend that informed consent forms and patient education materials be written at a low reading level (5th-8th grade level) to facilitate patient comprehension. We assessed reading levels of informed consent forms (CFs) for adult organ transplant recipients and living organ donors across US transplant centers. CFs were analyzed using three measures of reading level: Lexile Measure, Flesch-Kincaid Grade Level, and the Gunning Fog Index. Of active transplant centers contacted (N=209), 75 (36%) sent a total of 332 CFs. CFs were written, on average, at the college level, which is a considerably higher reading level than the standards set by policy-makers. CF reading levels were negatively correlated with transplant center volume (r=-0.119; p<0.03). CFs for intestine transplantation and for evaluation/listing were the easiest to read, while consent forms for liver transplantation/donation and pre-transplant agreements were the most difficult to read. Reducing CFs' reading level may help to increase patient comprehension for adequate informed consent.