서면동의에 앞서 제공된 설명문 유형에 따른 대상자의 임상시험에 대한 이해도 = The Effect of Using Photo-novella or Text Form Information on Subjects’ Understanding in the Consent Process: a Randomized, Controlled Design

다국어 초록 (Multilingual Abstract)

This study had two objectives: (a) to compare the level of patients’ understanding in the consent process when information is provided in text-based form with patients’ level of understanding when information is provided in photo-novella form (Wave 1); and (b) to compare the level of patients’ understanding when the routine informed consent process is supplemented with text-based information sheets (Wave 2). Twenty healthy male volunteers were consecutively recruited and randomly allocated to Group A (text-based form) or Group B (photo-novella form). Understanding was measured three times: at Wave 1, at Wave 2, and one week after Wave 2 (Wave 3). The choice type objective understanding (OU) measured at Wave 1, Wave 2, and Wave 3 was significantly higher in Group B than Group A.
Both OU and subjective understanding (SU) increased from Wave 1 to Wave 2, but the changes were not statistically significant between the two groups. In conclusion, OU was higher for the photo-novella group than for the text-based group after receiving the information and remained so up until one week after the routine informed consent process. These results suggest that medical information for informed consent should be provided in photo-novella form.

국문 초록 (Abstract)

본 연구는 서면동의에 앞서 제공된 설명문 유형(텍스트형과 포토노벨라형)에 따라 임상시험에 대한대상자의 이해도에 영향을 주는 지를 파악하기 위한 무작위 대조군 연구이다. 연구대상자는 1상 임상시험에 참여하기로 예정된 20~40세 건강한 남성 100명으로 난수표를 이용하여 A군(텍스트형)과 B군(포토노벨라형)으로 무작위 배정되었다. 대상자의 이해도는 서면동의에 앞서 대상자 스스로 포토노벨라형 또는 텍스트형 설명문을 읽은 후(1차), 텍스트형 설명문을 이용한 일상적인 서면동의과정이 끝난 후(2차), 서면동의 1주 후(3차) 등 총 3회 측정되었다. 연구결과 포토노벨라형 설명문을 이용한 군이 텍스트형 설명문을 이용한 군에 비해 1~3차에 걸친 선택형 객관적 이해도가 유의하게 높았다. 두군 모두 2차 이해도는 1차 이해도보다 유의하게 증가하였으나 두 군 간의 증가의 차이는 통계적으로유의하지 않았다. 결론적으로, 서면동의에 앞서 포토노벨라형 설명문을 읽은 대상자는 텍스트형 설명문을 읽은 대상자에 비해 임상시험에 대한 이해도가 높았으며, 이러한 결과는 일상저인 서면동의 후 1주일까지 유지되었다. 따라서, 포토노벨라형 설명문을 일상적인 서면동의에 앞서 대상자 스스로 임상시험에 대해 선행학습용으로 활용하기를 제언한다.

참고문헌 (Reference)

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