5

Messages and Methods for Public Engagement

“The problem of the language used in describing clinical trials is the one problem that is exquisitely fixable.” —Christina Zarcadoolas, CUNY School of Public Health at Hunter College and Mount Sinai School of Medicine

MESSAGES

Engaging vulnerable populations in clinical trials calls for sensitive messaging and wise choice of messengers. According to Carol Horowitz, Mount Sinai School of Medicine, what seems to work best is engaging people in what they perceive (and is truly) a cooperative enterprise. She used a baseball analogy:

What’s the difference between a baseball team and a pickup game? In a team, you know people need you to be there. You know you’re important. You know you matter. We need to build that team—that family mentality—to get (underrepresented) people into our research and to get people into our research community.

In a discussion session of the workshop, this theme reemerged when Ann Bonham, Chief Scientific Officer, Association of American Medical Colleges, suggested that reluctance on the part of the public to participate in clinical trials may be because investigators have not made them feel like partners. Instead, the messages that are delivered (and received) tend to reinforce the gaps in knowledge between scientists and the public, a point effectively made in the following section.



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5 Messages and Methods for Public Engagement “The problem of the language used in describing clinical trials is the one problem that is exquisitely fixable.” —Christina Zarcadoolas, CUNY School of Public Health at Hunter College and Mount Sinai School of Medicine MESSAGES Engaging vulnerable populations in clinical trials calls for sensitive messaging and wise choice of messengers. According to Carol Horowitz, Mount Sinai School of Medicine, what seems to work best is engaging people in what they perceive (and is truly) a cooperative enterprise. She used a baseball analogy: What’s the difference between a baseball team and a pickup game? In a team, you know people need you to be there. You know you’re im- portant. You know you matter. We need to build that team—that family mentality—to get (underrepresented) people into our research and to get people into our research community. In a discussion session of the workshop, this theme reemerged when Ann Bonham, Chief Scientific Officer, Association of American Medical Colleges, suggested that reluctance on the part of the public to participate in clinical trials may be because investigators have not made them feel like partners. Instead, the messages that are delivered (and received) tend to reinforce the gaps in knowledge between scientists and the public, a point effectively made in the following section. 39

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40 PUBLIC ENGAGEMENT AND CLINICAL TRIALS Messages1 After 30 years of research on health literacy, the problem still has not been solved. Half of U.S. adults have low health literacy. That means, in the simplest case, they do not understand how to read a prescription label or what the dosing means, nor do they know what their cancer treatment is, beyond the most general statement. If they do not under- stand these things, they certainly do not understand what a research protocol is. Christine Zarcadoolas, Associate Professor, CUNY School of Public Health at Hunter College and Mount Sinai School of Medicine, defined health literacy as “the wide range of skills and competencies that people develop over their lifetimes to seek out, comprehend, evaluate, and use health information and concepts to make informed choices, reduce health risks, and increase quality of life” (Zarcadoolas et al., 2006). 2 The age group with the lowest level of health literacy is those 65 and older. Disproportionate numbers of racial and ethnic minorities and other underserved populations are health illiterate. The problem of health illiteracy is compounded by the high rate of fundamental illiteracy in the U.S. population, with the average American reading at an 8th-grade level. But even if health information is written at a 5th- or 8th-grade level and people can read and understand it, if they do not use it and cannot apply it in making decisions, they may not have health literacy. Four types of literacy are fundamental literacy (reading, writ - ing, working with numbers), science literacy, civic literacy, and cultural literacy. The general public often does not have science literacy. Even people who have high fundamental literacy may not take their medica - tions correctly, understand their physiology, take actions to protect their health, or distinguish among health advice based on science, pseudo- science, or hope. Clear language is necessary but not sufficient to create understand - ing. Americans generally do not know, or they have great difficulty understanding, the underlying concepts embedded in health informa - 1 This section is based on the presentation by Christina Zarcadoolas, Associate Professor, CUNY School of Public Health at Hunter College and Mount Sinai School of Medicine. 2 An IOM workshop summary report defines health literacy as “the degree to which indi - viduals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions” (Ratzan and Parker, 2000). However, health literacy goes beyond the individual obtaining information. Health literacy emerges when the expectations, preferences, and skills of individuals seeking health information and services meet the expectations, preferences, and skills of those providing information and services. Health literacy arises from a convergence of education, health services, and social and cultural factors (IOM, 2004).

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41 MESSAGES AND METHODS FOR PUBLIC ENGAGEMENT tion. About 20 years ago, researchers in the health literacy field began studying the effectiveness of “simple language” health messages, Zarcadoolas said. The researchers found that, even if the messages were linguistically clear, they often assumed more scientific knowledge than people have. For example, the message not to take an antibiotic when you have a cold may be clearly stated, but it will not make sense unless the target audience also knows that colds are caused by viruses and that antibiotics are ineffective against viruses. According to Zarcadoolas, at least 63 percent of Americans do not know that viruses and bacteria are different. So in this example the language in the delivered message will not be internalized without some underlying scientific understanding. Lack of science understanding has potentially life-threatening conse - quences. For example, in a study of people’s reactions to the H1N1 pandemic of 2009, only 40 percent of Americans understood the risk sufficiently to plan to have their children immunized against H1N1, and almost 30 percent definitely planned not to (30 percent were unsure). Interviews with average New Yorkers found they did not understand why this new virus was so dangerous. Meanwhile, public health mes - sages about the virus described flu in pigs and birds, gene reassortment, and so on—topics of intense interest to influenza researchers, perhaps of academic interest to clinicians, but of no perceived salience to the population at large. The National Science Foundation has assessed public understanding of science for more than 30 years. Between 5 and 15 percent of the U.S. population is considered to be science literate, which is defined as know - ing anything about the scientific process, such as what a research protocol might be or why a protocol is necessary. Even the word “trial,” as in clini - cal trial, is laden with confusing meanings. When Zarcadoolas’s team asks people what they think a “trial” might be, subjects often respond that a trial involves a judge; a trial is what the Lord places upon us; and there’s “trial and error.” To the ordinary person, all meanings of the term “trial” carry a negative connotation. In the clinical trials context, where the underpinning of the whole enterprise is complex and speculative and carries some potential risks, and where many diverse sociocultural factors come into play, effective communication is even more difficult—starting with the fact that consent forms are typically written at the 17th-grade (post-college) level or higher. (In fact, most health information that hospitals and public health depart - ments produce are written at the 10th- or 12th-grade level, which may help perpetuate health illiteracy, Zarcadoolas said.) Zarcadoolas remarked that NIH’s ClinicalTrials.gov should be a major source of information for people asked to participate in a clinical trial. The site has a frequently asked questions (FAQ) section, intended for potential

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42 PUBLIC ENGAGEMENT AND CLINICAL TRIALS trial participants, called “Understanding Clinical Trials,”3 and the first question is, “What Is a Clinical Trial?” The answer, she found: Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators. Zarcadoolas explained that the readability level of this passage is between the 12th- and the 15th-grade level. It is full of science concepts: biomedical, protocol, interventional, observational, subjects, assigned, investigator, intervention, measurement, and outcomes. A health-literacy load analysis reveals many opportunities for misunderstanding; many of the words have other meanings in everyday life. The site also includes a glossary, hyperlinked to the FAQ. Clicking on the word “protocol” displays this definition (excerpt): While in a clinical trial, participants following a protocol are seen regu- larly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Zarcadoolas asked some of the patients she works with, who are generally low-literacy, low health literacy, and underserved, what they believed this statement means. She said that their interpretation was, “you’re in this research project and then they decide if it’s safe for you.” It is possible that researchers’ conscientious attempts to be explicit about the inherent uncertainty of clinical trials are an unintentional source of some of the confusion. In the past two decades, Americans have seen many changes in sci - ence recommendations that have affected their daily lives. Nutrition advice keeps changing. New drugs are developed, then withdrawn. Inter- views with the general public revealed three opinions about the recent market removal of children’s cold medications: • hy can’t they get it right the first time? W • he scientists are just arguing with each other. T • ’m going to do what I think is right for me and my family. I 3 See http://clinicaltrials.gov/ct2/info/understand (accessed October 10, 2011).

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43 MESSAGES AND METHODS FOR PUBLIC ENGAGEMENT Unless people appreciate that science knowledge is a moving target, they see it as providing conflicting advice and no sure guidance. Even the NIH definition of clinical trials starts with ambiguity: “Although there are many definitions of clinical trials.” Much work may be needed in order to create more meaningful pub- lic messages about science, research, and clinical trials, but many of the current problems are fixable. However, they are not fixable by merely simplifying language, Zarcadoolas said. It will take community participa- tion, careful attention to health and science literacy, and using technology to change how and to whom vital information about biomedical research is disseminated. The Love/Avon Army of Women project, among others described during the workshop, demonstrates that demographically diverse Amer- icans will volunteer for clinical trials. It takes high “civic literacy” to understand that such volunteer participation is for the greater good, said Zarcadoolas, and it shows that the American public is altruistic and will contribute to the greater good. But they need to understand the reason for the trial and believe it is being done with and for them and their com - munities, not to them. MESSENGERS4 Even if more meaningful messages about health and participation in clinical trials were devised, much will still depend on the choice of mes - senger. Americans rely predominantly on health professionals for infor- mation on many important aspects of health care: diagnosis, prescription drugs, alternative treatments, and recommendations for a specialist or medical facility (Kuehn, 2011), according to a 2010 Pew Research Center survey. When respondents in a 2010 Capstrat survey were asked who was most influential “the last time you needed information on a health issue,” respondents chose physicians (44 percent) over other health professionals and sources, said Janet Tobias, Ikana Media and Adjunct Assistant Profes - sor, Mount Sinai School of Medicine. The second most influential source of information was a Google search (22 percent), although the survey did not ask about the kinds of resources the search led to (Albritton, 2010). 5 These two surveys also suggest some of the circumstances in which 4 This section is based on the presentation by Janet Tobias, Ikana Media and Adjunct As - sistant Professor, Mount Sinai School of Medicine. 5 The survey was conducted by Capstrat and Public Policy Polling, April 28-29, 2010, and included 678 adults 18 and older; 13 percent of the survey population was African American (approximately 88 individuals).

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44 PUBLIC ENGAGEMENT AND CLINICAL TRIALS people find online guidance most valuable. The primary reason people seek information from online sources is the 24/7 access they offer, and they find the Internet more helpful than professionals when they want to reach out to fellow patients, friends, and family for emotional support or need a quick remedy for a common health problem. Respondents considered health professionals and nonprofessionals equally helpful when seeking “practical advice for coping with day-to-day health situations” (Kuehn, 2011). African American respondents in the Capstrat survey rated Google higher than did the survey population as a whole, with respect to both reli- ability and influence. They also rated physicians less reliable than did the population as a whole (50 percent versus 74 percent overall) and less influ- ential in their search for information (36 percent versus 52 percent overall). Thus, while physicians may still be primary sources of information regarding participation in clinical trials, they are no longer the only one. Online sources of information about clinical trials are increasingly avail - able. But if a curious person searches Google to find information regard- ing “clinical trials,” Tobias asked, what does he or she find, and is it understandable? The information sources that appear on the first page of Google results range from the NIH-sponsored registry of all clinical trials, ClinicalTrials.gov, discussed previously, to nonprofit and for-profit trial matching sites, to a Wikipedia entry, to a Medline resource, to recent news stories, which often focus on problems arising from clinical studies. Even if prospective trial participants choose an authoritative site, they may not understand what they find there, Tobias said. Message Structures6 A person’s decision to participate in a clinical trial is subject to all the individual considerations, vagaries, and complexities of any other decision about behavior. Because behavioral decisions are complex, said Bernadette Boden-Albala, Columbia University, they are best facilitated through structure. Among the professional disciplines that have carefully studied indi - vidual behavior and decision making are the behavioral economists. Richard Thaler, a behavioral economist at the University of Chicago, has said, “There’s no reason to think that markets always drive people to do what’s good for them.” In other words, humans sometimes make biased decisions that run counter to their interests, one of which might be partici- 6 This section is based on the presentation of Bernadette Boden-Albala, Co-Director, Irving Center for Clinical and Translational Research, Community Engagement Core Resource, Columbia University.

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45 MESSAGES AND METHODS FOR PUBLIC ENGAGEMENT pating in a clinical trial, Boden-Albala said. Thaler’s is one explanation for why health-related behavior changes are difficult to achieve, even if they would increase the likelihood of better health and prevention of disease. Another aspect of behavior is “preparedness”—preparedness to take some kind of action or make some decision. Systems and structures can prepare people for a wide array of challenges that may require only short- term skills (e.g., call 911) or long-term training (e.g., undertake a graduate education). For example, preparing people to recognize stroke, treat it as an emergency, and acquire the minimal skills to deal with it (call 911 and navigate to an emergency room) is relatively straightforward, and such preparedness efforts have markedly decreased the time-to-arrival at emergency rooms in communities where they have been implemented. For people to respond adequately to an opportunity to participate in clinical trials also requires preparedness. Part of that preparation will require a better understanding about the nature of clinical trials, in general—the science literacy Zarcadoolas described—and the significance of specific concepts that may be unfamiliar: randomization, placebo, risk. They may still say no, but it should be an informed “no.” Boden-Albala explained that researchers need to consider that their prospective trial participants live in a web of social connections. Partici - pating in trials requires a degree of science literacy on the part not just of potential participants, but their family, friends, and coworkers, who can encourage or discourage them from signing on initially and staying in the trial over its course, said Boden-Albala. Their physicians likewise need information about the specifics of the trial. She cited another University of Chicago behavioral economist, Nobel Laureate Gary Becker, who has said, “It doesn’t matter what you or I do, it’s how the whole group behaves.” Behavioral economics again would suggest that people want to be prudent (eat properly, exercise, contribute to science that might help future generations), but, said Boden-Albala, “They just don’t want to do it right now.” Social scientists have shown large differences in participation in certain programs depending on whether people must opt into the pro- gram or opt out (e.g., organ donation programs or 401[k] plans). If people must take a concrete action to participate (“explicit consent”), they may not get around to doing it. But if they must take an action not to partici- pate (“presumed consent”), they do not get around to that, either (Thaler, 2009).7 Under some circumstances, opt-out rules, or “presumed consent,” for clinical research might be considered, Boden-Albala suggested. Social networks and peer support have been shown to influence 7 A third choice, which Thaler prefers at least with respect to organ donation, is “mandated choice,” in which people are required to indicate their preference, and the process is made as simple as possible (Thaler, 2009).

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46 PUBLIC ENGAGEMENT AND CLINICAL TRIALS BOX 5-1a An Urgent Case for Clear Messaging A clinical study conducted in East Africa to evaluate fluid resuscitation in chil- dren with severe infections (severe malaria, sepsis, or others) and shock came to a surprising conclusion: the treatment—fluid boluses—which has been the standard around the world, actually decreased survival (Maitland et al., 2011). The trial overturned several decades of pediatric recommendations that are taught in pediatric life-support training and followed worldwide. Six clinical centers in Kenya, Tanzania, and Uganda participated in the clinical study. This study faced several messaging challenges from its outset. The study re- quired approval to obtain “emergency consent.” A lengthy consent form read to par- ents holding a critically ill child was neither feasible nor humane. Yet parents needed to understand (and subsequent research shows they did) that they could refuse to participate in the study without jeopardizing their child’s treatment in any way. As the research was being designed, opportunities to involve the community in discussions about the study might have been desirable, but were somewhat lim- ited, inasmuch as the hospitals involved were regional facilities serving dispersed populations and had no real “community.” To help address this, the research team developed and distributed explanatory brochures about the project. Once the trial was stopped, it was important that health care providers not misinterpret the results as suggesting that no intravenous fluids should be given. Children who cannot drink for themselves still must receive sufficient fluids intra- venously to maintain normal levels. Dissemination efforts for the trial results include a paper in the New England Journal of Medicine; a YouTube video about the trial and its findings; and in-person presentations as well as distribution of a DVD about the trial to pediatric societies and academic institutions in East Africa. Finally, an ongoing effort is under way to advise the World Health Organization and other health policymaking bodies to develop poli- cies and guidelines that take into account the results of this important study. a Based on the presentation by Kathryn Maitland, Professor of Medicine, Imperial College. health behavior—in positive and negative ways. As an example of a positive influence on health behavior, if your friends give up smoking or alcohol, you are more likely to do so also (Christakis and Fowler, 2008). Reflecting the influence of social networks and peer support on negative health behavior, if your friends are overweight, you are more likely to become overweight as well (Christakis and Fowler, 2007). It is important to work with the leaders in a social network and help them understand how a particular project benefits the community. Obtaining their support opens doors. See Box 5-1 for an international case study. According to Boden-Albala, examples of how these concepts can be put into practice include the following:

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47 MESSAGES AND METHODS FOR PUBLIC ENGAGEMENT • study attempting to harness the strength of networks for health, A called Families Undergoing Risk Reduction Through Educational Reinforcement (FURRThER), works with the entire family-friends network of a person who has had a stroke. The aim is to help them, collectively, reduce blood pressure—an accomplishment that will benefit each network member’s health and, potentially, that of the patient at the center of the network. • he Washington Heights/Inwood Informatics Infrastructure for T Community-Centered Comparative Effectiveness Research (WICER) study is attempting to enroll 12,000 New York City residents in a registry that can move people quickly into randomized blood pres- sure trials. In eight focus groups, community members advised on study design, suggesting questions, and recommended the reward for registration ($25 in food coupons). As a recruitment strategy, the researchers used “snowball” techniques, asking people who registered to tell their friends and family about the registry. A thou- sand people registered in the first 7 weeks, as a result of contacts made by only 150 people. Social media, such as Facebook, have the potential to serve as social networks in somewhat analogous ways. Although social network partici - pation is heavily skewed toward the younger generation, a 2010 survey showed rapid growth in use among older adults: almost half of people 50 to 64 use social networking sites, as do more than a quarter of those 65 and older (Pew Internet and American Life Project, 2010). Already researchers have used Facebook announcements to advertise clinical tri- als. In addition, there are many websites that are more targeted to health topics or to specific diseases and conditions. An example is the website Patients Like Me (http://www.patients likeme.com/), which has enrolled almost 113,000 patients, collectively having more than 500 conditions. It has developed a clinical trials match - ing tool, conducts surveys of registrants that can be useful in trial design, has a pool of patients for observational studies, and, similar to the Army of Women and 23andMe both discussed in Chapter 4, is committed to publication of results of studies involving its members. Boden-Albala cited the following as challenges to be aware of in using social networks: • voiding coercion in using personal networks A • nsuring reliability of the data and accuracy of self-reports E • he risk of unblinding studies where participants share “too much” T information

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