title: Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.
abstract: BACKGROUND
  Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.
  
  
  METHODS
  This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed.
  
  
  RESULTS
  Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension.
  
  
  CONCLUSIONS
  Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.
authors.affiliation: University of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Borello
authors.affiliation: Department of Oncology, University of Turin, Section of General Surgery, San Luigi Gonzaga University Hospital, Regione Gonzole 10, 10043 Orbassano, Turin, Italy ,.
authors.forename: Alessia
authors.initials: A
authors.lastname: Ferrarese
authors.affiliation: Città della Salute e della Scienza Hospital, Section of Nuclear Medicine, Turin, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Passera
authors.affiliation: University of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Surace
authors.affiliation: University of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Marola
authors.affiliation: Department of Advanced Biomedical Sciences, Naples, Italy, University "Federico II" of Naples. Via Sergio Pansini 5, 80131, Naples, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Buccelli
authors.affiliation: Department of Advanced Biomedical Sciences, Naples, Italy, University "Federico II" of Naples. Via Sergio Pansini 5, 80131, Naples, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Niola
authors.affiliation: Department of Advanced Biomedical Sciences, Naples, Italy, University "Federico II" of Naples. Via Sergio Pansini 5, 80131, Naples, Italy.
authors.forename: Pierpaolo
authors.initials: P
authors.lastname: Di Lorenzo
authors.affiliation: Department of Neuroscience, Naples, Italy. Fellow in General Surgery at University of Naples, Naples, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Amato
authors.affiliation: Department of Neuroscience, Naples, Italy. Fellow in Anestesiology at University of Naples, Naples, Italy.
authors.forename: Lorenza
authors.initials: L
authors.lastname: Di Domenico
authors.affiliation: University of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Solej
authors.affiliation: University of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
authors.forename: Valter
authors.initials: V
authors.lastname: Martino
keywords: Informed consent; Laparoscopic cholecystectomy