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A Physician-Directed Intervention: Teaching and Measuring Better Informed Consent

Yap, Tsiao Yi MD; Yamokoski, Amy MA; Noll, Robert PhD; Drotar, Dennis PhD; Zyzanski, Steve PhD; Kodish, Eric D. MDon behalf of the Multi-site Intervention Study to Improve Consent Research Team

doi: 10.1097/ACM.0b013e3181acfbcd
Informed Consent

Purpose 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.

Method 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.

Dr. Yap is a third-year pediatric hematology oncology fellow, Children’s Hospital Cleveland Clinic, Cleveland, Ohio.

Ms. Yamokoski is project manager, Multi-site Intervention Study to Improve Consent, Cleveland Clinic, Cleveland, Ohio.

Dr. Noll is director, Division of Developmental and Behavioral Pediatrics, and assistant medical director for behavioral health, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania.

Dr. Drotar is professor, Division of Behavioral Medicine and Clinical Psychology, and director, Center of Adherence and Self Management, Cincinnati Children’s Hospital, Cincinnati, Ohio.

Dr. Zyzanski is professor, Department of Family Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio.

Dr. Kodish is F.J. O’Neill Professor and Chair, Department of Bioethics, Cleveland Clinic, Cleveland, Ohio.

Correspondence should be addressed to Dr. Kodish, Department of Bioethics, Cleveland Clinic, 9500 Euclid Avenue JJ60, Cleveland, Ohio 44195; e-mail: (

© 2009 Association of American Medical Colleges