title: Readability of Invasive Procedure Consent Forms.
abstract: BACKGROUND
  Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information.
  
  
  METHODS
  To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level.
  
  
  RESULTS
  Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001).
  
  
  CONCLUSIONS
  Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions.
authors.affiliation: Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.
authors.forename: Adam E M
authors.initials: AE
authors.lastname: Eltorai
authors.affiliation: Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.
authors.forename: Syed S
authors.initials: SS
authors.lastname: Naqvi
authors.affiliation: Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.
authors.forename: Soha
authors.initials: S
authors.lastname: Ghanian
authors.affiliation: Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.|Department of Orthopaedic Surgery, Rhode Island Hospital, Providence, Rhode Island, USA.
authors.forename: Craig P
authors.initials: CP
authors.lastname: Eberson
authors.affiliation: Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.|Department of Orthopaedic Surgery, Rhode Island Hospital, Providence, Rhode Island, USA.
authors.forename: Arnold-Peter C
authors.initials: AP
authors.lastname: Weiss
authors.affiliation: Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.|Department of Orthopaedic Surgery, Rhode Island Hospital, Providence, Rhode Island, USA.
authors.forename: Christopher T
authors.initials: CT
authors.lastname: Born
authors.affiliation: Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA.|Department of Orthopaedic Surgery, Rhode Island Hospital, Providence, Rhode Island, USA.
authors.forename: Alan H
authors.initials: AH
authors.lastname: Daniels
mesh_terms: D000574:American Medical Association; D032882:Comprehension; D032962:Consent Forms; D057220:Health Literacy; D007258:Informed Consent; D020407:Internet; D009316:National Institutes of Health (U.S.); D011932:Reading; D012237:Rhode Island; D012955:Societies, Medical; D013514:Surgical Procedures, Operative / Q000379:methods; D057170:Translational Research, Biomedical / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards*; D014481:United States
keywords: comprehension; consent form; health literacy; informed consent; readability