关键词: 手术知情同意, 知情同意形式, 视频补充知情同意, 纸质补充知情同意

Abstract: In recent years, doctor-patient conflicts has become one of the hottest topics in Chinese society. The imperfection of surgical informed consent is one of the most critical incentives of doctor-patient conflicts. Patients need to be well informed so that they can weigh the advantages and disadvantages of undergoing the surgery and experience better health outcomes. In the present study, we discover a better form of surgical informed consent, and valid its impact on patients’ satisfaction and understanding on surgical informed consent process. We hypothesize that: (a) compared to participants who read the paper, participants who read paper with booklets or paper with video have better understanding on surgical informed consent. (b) compared to videos, booklets are a better way to improve participants’ understanding on surgical informed consent and meet their information needs. One hundred and fifty nine undergraduate students participated in the study. Participants were asked to imagine themselves as patients about to undergo laparoscopic cholecystectomy. Then they were randomly assigned to surgical informed consent paper group, surgical informed consent booklets group and surgical informed consent videos group, and experienced corresponding informed consent process. Participants in the booklets group would first read the surgical informed consent booklet, then read and sign the surgical informed consent paper. Participants in the videos group would first watch the surgical informed consent video, then read and sign the surgical informed consent paper. Participants in the paper group would read and sign the surgical informed consent paper straightly. In order to measure the effects of informed consent procedure, after signing the informed consent paper, participants rated on a 5-point Likert scale, evaluating their satisfaction with informed consent procedure, their perceptions of their understanding on the disease/ treatment/ surgery, and their needs for disease/ treatment/ surgical information. A one-way ANOVA with forms of informed consent as independent variable and patients’ satisfaction with informed consent process as dependent variable revealed a main effect of forms of informed consent. Bonferroni's post-test found that patients’ satisfaction with informed consent process in paper group is significantly lower than those in booklets group. This indicated that add supplementary information to informed consent paper can improve patients’ satisfaction with informed consent process. Moreover, participants perceptions of their understanding of surgical information as well as their scores on surgical information needs in paper group are significantly lower than those in booklets group, too. A one-way ANOVA with patients’ needs for treatment information as independent variable showed a main effect of forms of informed consent. Bonferroni's post-test found that the patients’ scores on treatment information needs in booklets group was significantly higher than those in paper group and those in videos group. What’s more, patients’ scores on surgical information needs in paper group was significantly lower than those in booklets group and those in videos group. In conclusion, supplementary information to surgical informed consent paper can improve patients’ satisfaction with informed consent process, increase patients’ perceptions of their understanding of surgical informed consent paper and meet patients' needs for treatment information. Further, compared to videos, booklets are a better form of informed consent. The practice implications of this study was that current study explore a better form of informed consent, which can be used in future’s medical practice. Future studies can take patients' psychological needs as the dependent variable to explore the impact of supplementary materials on patients' psychological needs. Besides, evaluation indexes such as the recall rate of informed consent content or the correct rate of answering informed consent questions can be used as dependent variables to measure patients’ understanding of informed consent in a more objective way.

Key words: surgical informed consent, forms of informed consent, informed consent videos, informed consent booklet