title: Comprehensibility of patient consent forms for radiation therapy of cervical cancer.
abstract: OBJECTIVE
  The 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.
  
  
  METHODS
  Members 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.
  
  
  RESULTS
  Three 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.
  
  
  CONCLUSIONS
  There 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.
authors.affiliation: Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Deborah Skinner
authors.initials: DS
authors.lastname: MacDougall
authors.forename: Ulla M
authors.initials: UM
authors.lastname: Connor
authors.forename: Peter A S
authors.initials: PA
authors.lastname: Johnstone
mesh_terms: D001918:Brachytherapy / Q000941:ethics / Q000592:standards; D032962:Consent Forms / Q000941:ethics / Q000592:standards*; D005260:Female; D057220:Health Literacy; D006801:Humans; D009367:Neoplasm Staging; D011878:Radiotherapy / Q000941:ethics / Q000592:standards; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000532:radiotherapy*