| This study explores possible improvements to the cancer clinical trial informed consent form in order to increase reader comprehension of the information presented. The effect of two design formats, the standard form and a brochure design, were examined. In Addition, three informational ancillary conditions consisting of: no additional material, an informational PowerPoint, and an informational video, were investigated for their effects on reader understanding. Previous literature indicates that a systematic approach to studying this issue is still needed. The study is motivated by two research questions: (1) What significant differences, if any, in comprehension score outcomes exist when individuals are presented with the following cancer clinical trial consent form types as the sole means of communicating the eight elements of research consent? (2) What are the specific areas that are most/least understood when each of the form-types are used?;To examine these questions, the study utilized a simulation administered through a quasi-experimental 2 x 3 block-randomized factorial internet survey. The Quality of Informed Consent (QuIC) instrument was used to measure the comprehension of the 300 respondents. The results of the study indicate that use of an informational PowerPoint in conjunction with an informed consent document has a positive, although limited, effect on comprehension. The most well understood elements were that the research would help others and that it was voluntary. One of the least understood elements was that not all treatments in the clinical trial were standard care. |
