Multimedia Informed Consent: Can it help meet subject information needs?

Susan Brink, DrPH
President and CEO, Consent Solutions, Inc.

Informed consent by participants is key in any clinical trial. A successful informed-consent process protects the autonomy and dignity of members of the public, whether healthy volunteers or eligible patients, as they connect to the trial’s the scientific team. It ensures that those who choose to participate in the trial know that they are volunteering for a research project, the purpose of the research, the methods to be used, and the risks and possible benefits of participating. Yet as basic as the consent process is to all research involving human beings, it remains fraught with problems. Candidates scanned pages of well-intended, carefully-written consent material often do not end up informed at all, as judged by any relevant ethical standard. Is this the best we can do?

We are rapidly becoming a society in which most adults gather information from multiple sources other than print and person-to-person speech. These nontraditional sources include television, cell phones, the Internet, audio books, MP3 players, multimedia presentations on CD-ROM, and more. Such profound and widespread changes in information gathering and decision making should be reflected in the ways we deliver information to patients. This includes the consent process, of which a primary goal is to educate the candidate about trial procedures, risks, and benefits. Yet even as learning styles shift and researchers move to electronic data capture for other aspects of clinical trials, the consent process remains stuck in the filing cabinet. That is, the industry standard is still paper-based, as it has been since consent became usual practice in the U.S. and many other countries following the 1979 Belmont Report. Few trials are exploring the uses of non-paper media for engaging potential candidates.

Integration of electronic media into the consent process can further goals important to sponsors and investigators while expanding candidate comprehension. For example, multimedia consent tools can mitigate the differential presentation of material by trial staff based on their perceptions of patients. Not only can this produce a fairer educational outcome, but it allows staff to spend more time addressing areas of special concern to candidates. Human contact will presumably always remain both essential and subject to presenter bias, but the even-handed electronic presentation of basic information across prospective subjects addresses a major drawback of person-to-person education.

On the administrative end, electronic consents for clinical trials offer several benefits to investigators and organizational entities. For example, an electronic consent establishes a substantial audit trail. It can allows automatic monitoring of time spent by each candidate on the material, both overall and section by section, increasing the chances of a meaningful consent process. Besides minimizing the risk of undetected skipping or non-use by candidates, this affords research teams the opportunity to look closely at how the consent document is actually used and to modify its language, structure, or other features accordingly.

New information about a treatment often becomes available during the course of a complex, multi-year trial. Depending on its nature, active trial participants may be asked whether they wish to re-consent. In this situation, electronic consents have an edge because they can be easily amended through highlighting of updated sections and inclusion of additional material. E-mail contact with participants and the use of electronic signatures for participants can also be easily incorporated into an electronic consent system, although this requires the maintenance of strictly up-to-date patient records (always desirable).

While the Belmont Report set forth principles for the ethical conduct of research, it did not dictate the details of the consent process. Consent processes have therefore varied in an ad hoc way from study to study, with mixed results. What is more, paper-based processes have well-known intrinsic shortcomings. Published reports on patient comprehension, recall, and competence to provide informed consent show that many patients have difficulty understanding and remembering clinical-trial information when it is provided in writing, especially when materials have been written with little attention to readability or to the explication of research and medical terminology (Agard et al. 2001; Verheggen et al. 1995; Yuval et al. 2000). In these studies, subjects showed a marked lack of understanding in several areas, including the experimental nature of the treatment, study design and of procedures to be used, level of personal effort required for participation (e.g., number of visits and tests, length of study), and possible alternatives to the trial treatment. Subjects also tended to be unaware of possible side effects of the trial treatment.

Many approaches to increase understanding and retention of information by trial candidates have been suggested. These include subject questionnaires with staff review, lower reading level, layout changes to make reading easier, videos and animated descriptions of procedures, flow charts of trial design, and patient education through brochures, booklets, and web sites. Appropriate use of online multimedia techniques should be particularly helpful in producing truly informed subject consent. The ability of the multimedia approach to inform subjects through both auditory and visual channels—using text, stationary graphics, and video or animation, all with possible voiceover—is its primary strength. Not surprisingly, the addition of audio and visual elements to informed consent materials has been shown to increase subject interest and retention (e.g., Jimison et al. 1999). Patients reported feeling less stress and more in control when using a multimedia informed consent document. They liked the modular presentation and built-in hierarchy of information and reported that video segments made the information easier to understand.

Consider an informed-consent process in which it is necessary to inform candidates about the concept of randomization. In one study of attitudes toward study participation, only 44% of cancer patients would initially agree to participate in a study in which two treatments were randomized (Fallowfield et al. 1998). When patients who refused or were uncertain about participation were given further information about the randomization process, a majority (68%) chose to participate. In such a case, multimedia consent product might allow for fuller education to begin with, enabling the candidate to choose between, say, (a) an animated explanation of randomization in a 2-group clinical trial (followed by a verbal explanation, and (b) a simulation in which they undergo randomization into a hypothetical study. The latter might be followed by questions about their reaction to the outcome: e.g., how does the user feel about being in Group C, the Standard Treatment Group, or the New Treatment Group?

A single multimedia product can also be designed to take into account user-specific reading levels, learning styles, and primary languages. Through the use of embedded review questions, it can offer regular automated assessments and feedback on user comprehension as the trial candidate explores the material.

ConsentSolutions, Inc. has developed a first-generation multimedia consent product that takes advantage of some of these exciting possibilities. Our on-line consent product uses an Institutional Review Board–approved consent document as the basis for the online consent. The document is accessed in sections through a clickable left menu, beginning with an introductory section and continuing to procedures, risks, benefits, and so on through the entire consent. Each section consists primarily of text drawn from the approved language for the trial-specific consent process. The user has the option to hear the entire page read aloud. Numerous hypertext links connect each text page to term definitions, all overvoiced and some animated. An optional self-test is included. The user can generate questions for the study staff and an optional, interactive “To Do or Not to Do” learning tool helps users think about what it means to be in that particular clinical trial. An administrative back-office feature gathers consent-specific statistics about user dwell time on the various pages, which are made available online to those responsible for the consent process.

Advanced features such as variable reading level, adaptive learning style, and simulation games have not been implemented; such developments must wait until their design can be informed by field experience with simpler products.

In a head-to-head test of this online consent document with a paper-based version, adult subjects were asked to review the document as if they were actually considering the trial. Each subject reviewed both the paper and computer document. Regardless of which version was given first, the online multimedia version elicited greater time-on-task, with first-time online consent users spending 28 minutes on the consent process and first-time paper-based consent readers spending 17 minutes. Sixty-six percent stated a preference for the computer version. Subjects expressed perceptions that the online multimedia version was easier to read, more interesting, faster, and provided more information.

Given its many advantages, online consent will probably soon be accepted as a viable alternative to paper-based processes. Increasingly sophisticated and effective electronic consents will be developed that integrate into the consent process and provide wider availability, more effective subject education, and strengthened decision support. However, both attitudinal and technical barriers remain. Sponsors, investigators, and IRB members must be open to new approaches to consent. The organizational entity storing the trial consents must provide Health Insurance Portability and Accountability Act–compliant secure servers for storage of the patient information. To make the best possible use of the electronic informed consent, an electronic signature process must be available. And to assure that all candidates have access to the same quality of information, access to computers must be provided. Once these barriers are overcome by organizations participating in clinical trial research, the advantages cited for electronic consents will probably tip the scale toward widespread adoption.