Relevance of Health Literacy to Precision Medicine Proceedings of a Workshop (2016) / Chapter Skim
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4 Health Literacy in Precision Medicine Research
4 Health Literacy in Precision Medicine Research
Pages 23-44
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From page 23... ...
, and Benjamin Solomon, the chief of the division of medical genomics at Inova Translational Medicine Institute, then provided their reactions to the three presentations. Their comments were followed by an open discussion moderated by Laurie Myers, the director of global health literacy at Merck & Co., Inc.
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From page 24... ...
"When you look at those kinds of socioeconomic factors and expected health literacy level," Bakken said, "we know these are individuals who typically have been underrepresented in research in general, let alone research that would include collection of genomic information." Bilingual community health workers were used to collect the data, and snowball sampling -- a non-probability sampling technique in which existing study participants recruit future subjects from among their acquaintances -- was used to take advantage of the social networks of the study subjects and of the community health workers. Bakken said that this was an expensive, but critical way to collect data from those not typically represented in research, and that 90 percent of the data were collected in Spanish.
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From page 25... ...
The lowest level of consent, 53.2 percent, was for long-term storage of biospecimens, which Bakken said was better than expected based on formative work that she and her colleagues had conducted in the community. "We were pleased that by working on building trust with the community, involving the community health workers, using snowball sampling, and other steps we were able to get that level of biospecimen participation," she said.
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From page 26... ...
26 RELEVANCE OF HEALTH LITERACY TO PRECISION MEDICINE FIGURE 4-1 Some test infographics. SOURCES: Bakken slides 13, 14, and 15.
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From page 27... ...
HEALTH LITERACY IN PRECISION MEDICINE RESEARCH 27 FIGURE 4-2 Preferred design for conveying information about blood pressure. SOURCE: Bakken slide 16.
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From page 28... ...
Participants at the town hall meetings had the opportunity to ask questions and were engaged in discussions of WICER in terms of the PMI Cohort. They were also given the opportunity to provide a biospecimen.
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From page 29... ...
This second group of strategies involves community stakeholders in advisory and governance roles, as members of the research team, and in some cases as co-principal investigators. This multi-tiered strategy has been operationalized in a single project organized by the Mid-South Clinical Data Research Network (CDRN)
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From page 30... ...
As Wilkins and her colleagues at Vanderbilt began preparing for what was to become the PMI Cohort Program Pilot, they thought it might be important to understand what their patients and community thought or knew about precision medicine and its importance, and to do so they distributed a survey through the Vanderbilt patient portal. Wilkins explained that the demographics of those who responded to the survey were not representative of the Vanderbilt population, but rather of those who most often used the patient portal.
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From page 31... ...
The survey results also showed that race and levels of health literacy and numeracy all predicted willingness to participate in research, though the numeracy level was the biggest predictor. From these results, Wilkins concluded that it will be important in an era of precision medicine to develop effective methods for communicating risk, probability, and other concepts that depend on numbers rather than just words.
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From page 32... ...
The presumption, she said, is there will be people who are knowledgeable about precision medicine -- some of whom have family histories of genetic conditions and others who are just interested -- and who will immediately want to participate. There will be other groups of people, however, who have no knowledge of precision medicine, who have never participated in research, or who are concerned, distrusting, and weary of the process in general.
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From page 33... ...
MAKING DECISIONS ABOUT REPORTING RESULTS3 One issue with returning the results of gene sequencing to individuals who participate in the PMI Cohort -- and eventually to all patients -- is that a whole-genome sequence has the potential to yield secondary findings about a participant's genetic makeup that may have profound implications, Appelbaum said. Studies of participants' preferences, he noted, have found consistent interest in knowing about these secondary findings, particularly if they are clinically actionable.
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From page 34... ...
Nearly all the researchers mentioned the potential importance of participants sharing information with family members, and some two-thirds of the researchers thought it was important to talk with the participants about how secondary findings with implications for relatives would be handled if the participants became incompetent or died. Other topics the researchers thought should be addressed with participants included the possibility that subsequent studies on banked biospecimens could return secondary findings later in life, data security procedures, and TABLE 4-1 Benefits That Should Be Disclosed from Secondary Findings of Genome Sequencing Researchers Participants (n = 241)
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From page 35... ...
Other issues that researchers suggested should be flagged for participants were possible paternity-related findings or findings of incest and also whether the participant's choices could be overridden in certain circumstances, particularly when those secondary findings turn out to be actionable. More than three-quarters of the researchers believed that participants should give consent at the time of initial participation for potential contact at some future date and also should consent to placing secondary findings into the participant's electronic health record.
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From page 36... ...
The advantages of this model are that it resembles the traditional consent process familiar to the research community, the participant receives all of the information about potential secondary findings prior to deciding whether to participate, and the participant can choose which the types of secondary findings to receive or whether to opt out of receiving these findings. The potential disadvantages of this model are that it adds time and information to an already lengthy and complex process and the participants' preferences may change after the initial consent.
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From page 37... ...
The advantage of this approach is that it simplifies consent at enrollment -- the participant receives information only about selected secondary findings and does not have to choose which findings to receive. This model also clearly defines the researchers' obligations to return predetermined secondary findings, and the participant maintains a degree of choice about whether to participate in the study.
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From page 38... ...
Appelbaum concluded his presentation by noting that many wholegenome sequencing studies will generate some number of secondary findings of clinical or personal significance and that there is a rough consensus among researchers that at least some of these secondary findings should be offered to research participants. The complexity of obtaining informed consent will push the field away from the traditional model, he predicted, but which model becomes dominant -- perhaps a hybrid of two or more of these models or one yet to be developed -- will depend on a mix of practical concerns and normative considerations.
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From page 39... ...
To put his comments into context, Benjamin Solomon first described the precision medicine work his organization has been doing for the past 5 years. He and his colleagues have done whole-genome sequencing on nearly 10,000 people in 3,000 families and have been monitoring the health of these individuals.
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From page 40... ...
Finally Solomon brought up what he said he suspected might be a controversial topic -- the idea that this effort should extend to children and not just adults. "If we are doing precision medicine and want to learn what affects a person's health and well-being, it is challenging if we start in the adult realm," Solomon said.
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From page 41... ...
He said he believes that some combination of technology with dedicated educators and participants who are trained to teach rather than obtain consent could provide a better approach to consent. He noted that a colleague of his at Columbia is leading an effort to develop 3- to 5-minute videos covering discrete topics related to genomic research, including secondary findings.
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From page 42... ...
"We want to have a system in place that allows us to respond to the needs, values, and preferences of everybody who is involved." Jennifer Dillaha from the Arkansas Department of Health commented that she sees a quality consent process as a systems property, not a property based on individual behaviors or on the characteristics of the people in the system. In thinking of relationships with the community as a systems property, the challenge becomes establishing the PMI so that it sustains the quality of relationships and communication regardless of whether certain visionary individuals stay with the initiative.
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From page 43... ...
Wilkins then explained that her institution, in partnership with the University of Miami, was about to launch a center of excellence for precision medicine and population health that will focus on African Americans and Latinos. The planning process for this center included community members
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From page 44... ...
To Michael Villaire from the Institute for Healthcare Advancement one troubling aspect of precision medicine is that it will ultimately place a burden on individuals to contextualize challenging information and use it to make difficult decisions. Given that situation, he wondered if the consent process might have an option of asking participants if they were interested in having another, trusted person present when they receive information to help them make sense of it and make appropriate decisions.
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