医療人としてのコミュニケーション能力養成プログラムに関する検討 第２報―治験における「同意説明ロールプレイング実習」の質的検討―

Abstract

As part of the practical training curriculum for pharmacy undergraduates,we have introduced a role-playing simulation exercise in obtaining informed consent prior to clinical trials.The exercise has contributed to raising students’awareness of the importance of communication skills and understanding patient anxiety.We conducted the present study to evaluate the outcomes of this exercise.The study targeted 48 junior pharmacy students (21 males,27 females) who attended a one-day training session at the Clinical Research Center in Kitasato Institute Hospital between January and March 2008.Each student played all three roles,i.e.clinical research coordinator (CRC),prospective participant,and observer.We analyzed the role-play sessions of 15 students who had consented to video recording.In addition,the role-plays of professional CRCs for the same scenarios were recorded as a comparative control.The scenario for each session was chosen arbitrarily from the following 5 themes : hyperlipidemia,hay fever,dry eye,low back pain,and athlete’s foot.The average times for the students and the professional CRCs to obtain informed consent were approximately 16 and 36 minutes,respectively.The professional CRCs asked the prospective participants more questions,suggesting that they frequently ensured that the prospective participant had understood their explanation of the clinical trial.While the main objective of introducing the role-playing exercise was initially to verify the effectiveness of participatory training,through repeating it several times,interaction between the CRCs and the prospective participants has become more substantial.Additional qualitative analysis of role-plays should further clarify the significance of communication education.