title: A physician-directed intervention: teaching and measuring better informed consent.
abstract: OBJECTIVE
  To improve physician communication with parents using a physician-directed intervention (PDI), emphasizing a sequenced approach to the informed consent conference (ICC) for childhood leukemia clinical trials in which physicians discuss diagnosis, prognosis, and treatment prior to the offer of a clinical trial.
  
  
  METHODS
  Physicians and fellows at the Children's Hospital of Philadelphia and Children's National Medical Center were recruited to participate in Informed Consent Seminars and subsequent half-day booster sessions. Training was followed by a multisite study of informed consent communication. Real-life ICCs were observed and audiotaped, and parents were interviewed after the ICC to ascertain their understanding. Data from the ICC and interview were then coded and analyzed. Trained physician performances were compared with untrained physicians (controls) at two other research sites. Data were collected from 2003 to 2007 at PDI sites and control sites for comparison.
  
  
  RESULTS
  A total of 102 cases were included for initial analyses, with 60 cases from the PDI sites and 42 control cases. Fifty-nine cases were included in the final analysis. Findings revealed that trained physicians followed the sequenced approach more often when compared with controls. Similarly, physicians at the PDI sites tended to elicit parental questions and understanding in an open-ended way and clarify parents' questions more frequently than physicians at the control sites.
  
  
  CONCLUSIONS
  Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs. The "see one, do one, teach one" approach is no longer adequate for informed consent.
authors.affiliation: Children's Hospital Cleveland Clinic, Cleveland, Ohio 44195, USA.
authors.forename: Tsiao Yi
authors.initials: TY
authors.lastname: Yap
authors.forename: Amy
authors.initials: A
authors.lastname: Yamokoski
authors.forename: Robert
authors.initials: R
authors.lastname: Noll
authors.forename: Dennis
authors.initials: D
authors.lastname: Drotar
authors.forename: Steve
authors.initials: S
authors.lastname: Zyzanski
authors.forename: Eric D
authors.initials: ED
authors.lastname: Kodish
mesh_terms: D000328:Adult; D001296:Audiovisual Aids; D016009:Chi-Square Distribution; D002648:Child; D003142:Communication; D005260:Female; D006801:Humans; D007258:Informed Consent; D007318:Inservice Training; D007407:Interviews as Topic; D007938:Leukemia / Q000628:therapy*; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D018579:Patient Selection; D010817:Physician-Patient Relations; D011368:Professional-Family Relations; D016032:Randomized Controlled Trials as Topic