The use of multimedia in the informed consent process.

OBJECTIVE

The goal of the project was to create recommendations and design specifications for a multimedia tool to enhance the informed consent process for clinical trials. The authors focused on the needs of patients with potential cognitive impairment.

DESIGN

The authors first performed a needs assessment using focus groups and interviews with health care researchers, institutional review board members, and three groups of patients (who had depression, breast cancer, or schizophrenia). Their feedback was incorporated into the design of a prototype multimedia tool. The design included general modules with information about clinical trials and informed consent as well as trial-specific modules. The authors then used the resulting prototype multimedia tool for informed consent in follow-up focus groups and interviews to obtain feedback on the feasibility and potential effectiveness of using such a tool routinely for clinical trials.

RESULTS

The authors showed that it was feasible to adapt a structured multimedia informed consent system to a specific clinical trial and to incorporate techniques to improve the understandability of informed consent content. Patients generally felt the prototype system was useful and could replace the paper document. They felt using the system would be less stressful, because they would have a greater sense of control and could proceed at their own pace. They liked the hierarchic and modular approach to providing information and felt that the use of video made information more understandable. Researchers and institutional review board members also found the system to be valuable in these ways but had concerns about how to review the system for potential biases in presentation and about the legal issues associated with replacing the paper document.