title: Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.
abstract: BACKGROUND
  Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms.
  
  
  METHODS
  Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension.
  
  
  RESULTS
  Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials.
  
  
  CONCLUSIONS
  Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.
authors.affiliation: Division of Orthodontics, College of Dentistry, Ohio State University, Columbus, Ohio 43218-2357, USA.
authors.forename: Edith Y
authors.initials: EY
authors.lastname: Kang
authors.forename: Henry W
authors.initials: HW
authors.lastname: Fields
authors.forename: Asuman
authors.initials: A
authors.lastname: Kiyak
authors.forename: F Michael
authors.initials: FM
authors.lastname: Beck
authors.forename: Allen R
authors.initials: AR
authors.lastname: Firestone
mesh_terms: D000293:Adolescent; D000328:Adult; D001741:Black or African American; D001007:Anxiety / Q000503:physiopathology; D001296:Audiovisual Aids; D002648:Child; D032882:Comprehension / Q000502:physiology; D032962:Consent Forms; D003463:Cues; D004522:Educational Status; D005568:Forms and Records Control; D006630:Hispanic or Latino; D006801:Humans; D007182:Income; D011939:Mental Recall / Q000502:physiology; D009971:Orthodontics, Corrective; D010290:Parents; D010347:Patient Care Planning; D010353:Patient Education as Topic; D010358:Patient Participation; D011932:Reading; D012307:Risk Factors; D012647:Self-Assessment; D012959:Socioeconomic Factors; D044465:White People