흔히 사용하는 양식과 새로 변경한 양식의 피험자 설명서에 대한 이해도와 선호도의 비교 평가 연구

Backgrounds: The style and contents of information sheet is very important to make the subjects understand appropriately the information provided in the information sheet. However, the conventional forms of information sheets are still mostly difficult to read and understand for the subjects who are mostly unfamiliar to the complex clinical research process. We performed a prospective comparative evaluation of comprehension and preference between a conventional versus a new modified information sheets, in which both styles are different but the contents are same each other. Methods: The 66 participants were divided into two groups. The control group read the conventional information sheet (CIS) and the other test group read the modified information sheet (MIS). After reading the information sheet, both groups answered the questionnaire to evaluate their comprehension on the clinical research presented in the information sheet. By having the control group read MIS and the test group CIS resp., both groups could compare MIS with CIS and expressed their preference one over the other. Results: The population had a mean age of 21.5 years. The average speed of reading MIS (4.13 words/sec) was faster than that of CIS (3.48 words/sec). The score of comprehension on MIS (the percentage of correct answers: 71.4%) was significantly greater than that on CIS (correct answers: 64.3%). The 8 items newly adopted in MIS modified from CIS in this study were 1) bold style and underlining of characters, 2) increasing font size of characters, 3) using diagrams, 4) widening the interval between lines, 5) using colors, 6) inserting a table of contents, 7) using the cover page, and 8) using header symbols. In a preference study, 87.9% of participants preferred MIS to CIS. Conclusions: Improvement of participants' comprehension was observed through using a new modified information sheet over the conventional information sheet, suggesting a new efficient information sheet.