First use of a video to assist the informed consent process in a randomized controlled trial in Japan

Abstract

Background:In the United States, visual instruction using videos to describe health care services in general, and for acquiring informed consent in randomized controlled trials, is becoming routine. This paper reports the first use of video in a randomized trial in Japan. Methods:A video designed to describe treatment options to patients for prerandomization in a controlled trial for prostate cancer treatments was produced and distributed. Physicians participating in the trial were surveyed by questionnaire regarding the use of the video. Results:Of 47 eligible patients with prostate cancer enrolled in this trial between 1992 and 1994, 20 patients (43%) viewed the video and 27 patients (57%) received all information from the physician. The objective of this study was to determine if viewing the video influenced the patient's desire to express a choice between treatment options. After receiving the information, 11 of 20 patients (55%) who viewed the video, and 22 of 27 patients (81%) who did not view the video, expressed a preference. The difference in expression of a treatment preference between patients in each group was not significant. When the responses of all the patients in the trial are combined, 33 of 47 patients (70%) expressed a treatment preference. Conclusion:The benefits of providing information regarding treatment options in a video format, compared to other means of explanation, remains to be elucidated. However, videos may be a preferable method for acquiring informed consent from patients participating in randomized control trials.Int J Clin Oncol 1997;2:156-160