Informed Consent and Health Literacy Workshop Summary (2015) / Chapter Skim
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5 The Future of Informed Consent
5 The Future of Informed Consent
Pages 75-92
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From page 75... ...
INFORMED CONSENT, CLINICAL TRIALS, AND INFORMATION TECHNOLOGY1 Kenneth Saag University of Alabama at Birmingham As an example of how information technology can improve the informed consent process, Kenneth Saag discussed how he and his colleagues are using an electronic consent platform to address the challenge of obtaining informed consent in the context of pragmatic clinical trials. Pragmatic clinical trials, he explained, measure "real-world" effectiveness 1 This section is based on the presentation by Kenneth Saag, the Jane Knight Lowe Professor of Medicine at the University of Alabama at Birmingham, and the statements are not endorsed or verified by the IOM.
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From page 76... ...
The goals of well-designed and executed pragmatic clinical trials are to involve community physicians and study sites that are not typically included in traditional phase III clinical trials, to create a learning health care environment, and to turn routine clinical care into a potential research encounter (Chalkidou et al., 2012)
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From page 77... ...
Interactions are recorded immediately into a tracking system, creating an audit trail of timed and dated information on the consent process. Saag pointed out that electronic consent can improve security and privacy protections via the ability to upload data to a remote, central site and remove it from the specific device used to collect patient information and consent.
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From page 78... ...
Participants are screened, asked for consent, and randomized using a tablet application. The study design adheres to the principles of pragmatic clinical trials: minimal inclusion and exclusion criteria; limited patient responsibilities and minimal commitment of time for providers; same-day single-visit enrollment; and dynamic randomization performed centrally on the day of that visit.
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From page 79... ...
IVRS (n = 67 pts.) Strongly agree Neither agree Strongly disagree Strongly agree Neither agree Strongly disagree or disagree nor disagree or disagree or disagree nor disagree or disagree The iPAD/phone was easy to use 78 (85.7%)
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From page 80... ...
Saag noted that the tablet consent process took longer than pen and paper. Summarizing what he thinks about the use of electronic consent based on the results of these pilot studies and his reading of the literature, Saag said that informed consent barriers are a particular concern when considering the growing national interest in pragmatic clinical trials.
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From page 81... ...
Saag noted that there has been some research to suggest that mentally ill patients may do better with multimedia consents. When it comes to researchers, his focus has been on community-based physicians who may lack sufficient staff and expertise or the infrastructure to support the consent process associated with clinical trials.
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From page 82... ...
had descriptive guidelines such as "in simple lay language." The mean Flesch-Kincade grade level across all of the templates was 10.6, but in schools with a specified gradelevel standard, only 5 of 61 (8 percent) met their own specific standards All adults 14 22 53 12 Men 16 22 51 11 Women 12 21 55 12 80 60 40 20 0 20 40 60 80 100 Percent Below Basic Percent Basic and above Below Basic Basic Intermediate Proficient FIGURE 5-1 Percentage of U.S.
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From page 83... ...
SOURCE: National Center for Education Statistics, 2003. Figure 5-3 Bitmapped Percent Below Basic Percent Basic and Above FIGURE 5-3 Percentage of U.S.
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From page 84... ...
. On average, the consent forms from those institutions tested at nearly three grade levels higher than the stated standard.
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From page 85... ...
We are telling them to do a better job, but the templates from the organizations themselves are deplorable," said Paasche-Orlow. Reiterating what other speakers had said regarding informed consent being a process, not just a form, Paasche-Orlow said that it would nonetheless be cynical not to do a better job of acting on research that shows that simplifying and shortening informed consent forms improves understanding.
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From page 86... ...
Many research assistants report that they do not get any training at all, so part of the move toward pedagogy will require that everyone involved in the consent process receive adequate training and supervision and that institutions implement quality control metrics to ensure that staffs are properly trained. PaascheOrlow recommended that there be a national survey of training, supervision, and documentation approaches in order to compile best practices that could be relevant to the informed consent process.
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From page 87... ...
Again, a culture change is needed to create an environment that alters the public's perception of why the consent process is important and why patients should truly understand the information they receive during that process. He noted that patients often believe that their physician, whom they trust, would not put them in the placebo arm of a trial, because they misunderstand the research process.
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From page 88... ...
"The professional standard has not been a good guide of where this should be done," said PaascheOrlow. In his opinion, research in health literacy has revealed the risk that the professional standard can lead to racial or cultural bias.
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From page 89... ...
Saag remarked that it is important not to discount the potential for technology to improve the informed consent process just because some physicians are reluctant to overcome the challenges inherent in switching from pen and paper to tablets. For example, Saag said, "I would argue that one size fits none.
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From page 90... ...
Ruth Parker thanked Paasche-Orlow for his recommendations and wondered if there might be another item on that list, that is, to better understand what the public wants and needs to know about various health care–related topics, whether that topic be what various drugs do or what some surgical procedure entails. Similarly, she thought it might be useful to know what pharmaceutical companies, for example, have learned from their own safety and efficacy studies about what patients need to know.
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From page 91... ...
Saag agreed with these ideas but worried about placing yet another burden on primary care physicians, who already have too much to do. "We have to come up with a solution that doesn't involve adding more responsibilities to primary care providers," said Saag, who suggested that pharmacists, nurse educators, and others could take on the added responsibility of agenda setting and better understanding patient desires and needs.
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From page 92... ...
She also stressed the importance of discussion and of the finding that most people, regardless of literacy level, are unable to recall or understand the information presented to them during an informed consent process. George Isham then said that his impression is that many of the people attending the workshop are too close to this issue and are not seeing the forest for the trees.
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