Comprehensibility of patient consent forms for radiation therapy of cervical cancer

ObjectiveThe construct of Health Literacy (HL) deals with patients' capacity to understand their health-related instructions, consent forms, and other documents. A significant challenge of providing healthcare to patients with low HL is the complex nature of the disease process, and of requisite treatments. In radiation oncology specifically, the delivery of ionizing radiation is difficult enough to describe; describing radiation toxicity in terms of the underlying physics and biology is daunting. A multimodal analysis of a small sample of patient consent forms was undertaken in order to address this issue more closely, and identify the extent to which such literature contributes to the challenges faced by patients with low HL.MethodsMembers of national cooperative group panels dealing with gynecologic cancer were asked to submit copies of consent forms provided to patients with stage II cervical cancer. Four such forms were submitted and reviewed by a single person with expertise in linguistics using standard tools.ResultsThree of the four consents scored within the lower portion of the “adequate“ range. One consent was not suitable. Consent readability ranged from grades 12.18 to 16.13; this means that they required at least a high school education to interpret, and in two cases required post-graduate coursework.ConclusionThere is significant room for improvement in consent form design and structure. When considering cultural and socioeconomic appropriateness of patient consent forms, input of staff with expertise in linguistics should be sought.

► We study four different consent forms used for stage II cervical cancer patients.
► We perform a multimodal analysis, using a novel combination of standard tools.
► Results demonstrate a consent readability ranging from grade 12.18 to 16.13.
► This research method can aid in best practices for developing new consent forms.
► A signed patient consent may not mean that successful communication was achieved.