Education of the Pediatric Resident on Obtaining Valid Informed Consent. Rebecca Fischer, MD Tiffany Lin, MD Children s Hospital of Philadelphia

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1 Education of the Pediatric Resident on Obtaining Valid Informed Consent Rebecca Fischer, MD Tiffany Lin, MD Children s Hospital of Philadelphia

2 Informed Consent The speakers have no relevant financial relationships to disclose or conflicts of interest to resolve Off Label agents: No off label agents or uses will be discussed.

3 Introduction to the problem Residents often are those obtaining consent Obtaining consent involves important skills of effective communication with patients and families Valid informed consent involves specific legal requirements

4 About informed consent.. Disclosure Diagnosis Purpose Risk Alternatives Patient Understanding Competence Patient Decision-Making

5 Background and significance Published work on training residents on informed consent is minimal Training currently is based on the apprenticeship model Reproducibility will be key

6 Hypothesis Pediatric residents with directed training on obtaining consent will be more complete in their consent process and feel more comfortable in their ability to obtain consent.

7 Methods: Implementation Survey sent to participating residents to assess comfort level and perceptions Simulated informed consent situation video taped Video taped sessions are scored using standard rubric Participants watch PowerPoint presentation teaching key elements of consent Repeat simulated consent and original survey to assess intervention

8 Methods: Data collection Survey analysis Knowledge about consent process Comfort assessment Videotape analysis Total time it takes for the process Presence of key elements of informed consent Nonverbal cues and communication skills

9 Our goals Gather data on comfort level of residents with informed consent Provide preliminary information that can form the basis for a larger trial Development of a tool for teaching informed consent Introduce the topic of the importance of teaching informed consent to residents

10 Limitations Survey use Use of simulation Use of single situation Single institution, single group sampling

11 Comments? Suggestions?

12 Acknowledgments Dr. Jim Callahan The program leadership at CHOP CHOP Simulation Center

13 References 1. Angelos P, DaRosa DA, Bentram D, Sherman H. Residents seeking informed consent: Are they adequately knowledgeable? Curr Surg 2002 Jan; 59(1): Chen PW. Treating patients as partners, by way of informed consent. New York Times. July 30, Childers R, Lipsett PA, Pawlik TM. Informed Consent and the Surgeon. J of Am Coll of Surgeons April;208(4): ) 4. Clark PA. What Residents are not learning: Observations in an NICU. Acad Med May;76(5): Coles WH, Wear SE, Bono JJ, Peters AS, Lenkei EJ. Teaching the informed consent process to residents. South Med J Jan; 82(1): Consent: patients and doctors making decisions together. Effective June 2, General Medical Council. 7. Kaushik JS, Narang M, Agarwal N. Informed Consent in Pediatric Practice. Review. Indian Pediatr 2010 Dec. 47(12): Leeper-Majors K, Veale JR, Westbrook TS, Reed K. The effect of standardized patient feedback in teaching surgical residents informed consent: a pilot study. Curr Surg 2003 Nov;60(6): McClean KL, Card SE. Informed consent skills in internal medicine residency: how are residents taught, and what do they learn? Acad Med Feb:79(2): Patel PB, Gilchrist A, Cronan KM, Selbst SM. Adequacy of informed consent for lumbar puncture in pediatric emergency department. Pediatr Emerg Care 2010 Oct; 26(10): Schloendorrf v. Soc y of N.Y. Hospital, 211 N.Y. 125 (N.Y. 1914). 12. Waisel DB, Lamiani G, Sandrock NJ, Pascucci R, Truog RD, Meyer EC. Anesthesiology trainees face ethical, practical, and relational challenges in obtaining informed consent. Anesthesiology 2009 Mar;110(3): Yap TY, Yamokoski A, Noll R et al. A Physician-Directed Intervention: Teaching and Measuring Better Informed Consent. Acad Med August; 84(8):

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