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. 1998 May-Jun;5(3):245-56.
doi: 10.1136/jamia.1998.0050245.

The use of multimedia in the informed consent process

H B Jimison  1 , P P Sher, R Appleyard, Y LeVernois
Affiliations

The use of multimedia in the informed consent process

H B Jimison et al. J Am Med Inform Assoc. 1998 May-Jun.

Abstract

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.

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Figures

Figure 1
Figure 1
The five stages of needs assessment for a multimedia informed-consent tool for clinical trial research. The input and feedback in stages II and IV came from focus groups and interviews.
Figure 2
Figure 2
Sample screens from the generic component of the system. Left, A welcome screen. Right, A menu of topics about clinical trials in general.
Figure 3
Figure 3
Sample screens from the trial-specific component of the system. Left, One in a series of screens describing the Seroquel clinical trial, where the text on the screen is supplemented by a video of the physician describing the material. Right, Sample video clips of patient experiences that could be used to communicate possible patient outcomes during a clinical trial. (For the prototype we used kidney dialysis video clips from Lenert's research group at Stanford University.69)
Figure 4
Figure 4
Other trial-specific screens show a list of local resources, such as books and organizations (left) and a sample question from the self-test component (right).
Figure 5
Figure 5
Sample screen from the cognitive test module. The patient is asked to put the pictured activities in order by touching the pictures in sequence. (Based on the Wang and Ennis Cognitive Competency Test.70)
Figure 6
Figure 6
Summary screen describing the main points of the Seroquel study.
Figure 7
Figure 7
These screens show how a patient could use the touch screen to record an electronic signature (left) or to record an audio consent (right).
See this image and copyright information in PMC

References

    1. Kaufmann CL. Informed consent and patient decision making: two decades of research. Soc Sci Med. 1983;17(21): 1657-64. - PubMed
    1. Varricchio CG, Jassak PF. Informed consent: an overview. Semin Oncol Nurs. 1985;5:(2): 95-8. - PubMed
    1. Sloan J. The consent form revisited. Arch Intern Med. 1993; 153: 1170-2. - PubMed
    1. Lidz CW, Meisel A, Osterweis M, Holden JL, Marx JH, Munetz MR. Barriers to informed consent. Ann Intern Med. 1983;99(4): 539-43. - PubMed
    1. Faden R, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press, 1996.

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