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v
Risk Communication
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A Mental Mode} Approach to
Risk Communication
M. Granger Morgan
When the word risk is mentioned, many of us first think in terms of a
single value such as the expected number of deaths or injuries. However, a
simple thought experiment can quickly convince us that things are more
complicated. Suppose that we are considering introducing a new product.
After careful market research we have determined that we can sell a number
of them and make a profit, but there will be some net impact, D, on overall
US mortality. What sorts of things do we need to know before we decide
whether we are justified in introducing this product? In addition to the sign
and magnitude of D, most people want to know things such as whether the risk
is immediate or delayed, how equally or unequally it is distributed among
different people, whether those at risk have any control over their exposure,
whether the effects are immediate or delayed, whether there are
intergenerational effects, how well the risk is understood, whether it is similar
to other risks society already accepts, what the product does, who uses it, and
how responsibility and liability will be distributed. As we pursue this simple
question we quickly come to understand that risk is a multi-attribute concept.
We care about more than just some measure of the number of deaths and
. . .
nJurles.
Slovic, Fischhoff and Lichtenstein82 have shown that one can group such
attributes of risk into three broad factors which allow us to reliably sort risks
into a "factor space." People's perceptions of risks, including their beliefs
about the need for regulatory intervention, are a strong Unction of where a risk
falls in this space. Risks posed by such common and well known objects and
activities as skiing, bicycles, and automobiles appear in the lower left corner
82Slovic, P. B Fischhoff and S Lichtenstein (1980). Facts and fears: Understanding perceived
risk, in Schwing, R and W Albers (ed.), Societal Risk Assessment. New York: Plenum.
111
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.
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BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
of the space. In contrast, risks such as those associated with nuclear power,
asbestos, and pesticides lie in the upper right hand comer of the space.
Experimental psychologists have discovered that in making judgments,
such as the number of deaths from a chance event, people use simple mental
rules of thumb called "cognitive heuristics."83 In many day-to-day
circumstances, these serve us very well, but in some instances, they can lead
to biases in the judgments we make. This can be a problem for both laypeople
and for experts. Three such heuristics are particularly common:
Availability: the probability of an event is judged in proportion to the ease
with which people can think of previous occurrences of the event or can
imagine such occurrences.
Anchoring and adjustment: the probability judgment is driven by a
starting value (anchor) from which people typically do not adjust sufficiently
as they consider various relevant factors.
Representiveness: the probability that an object belongs to a particular
class is judged in terms of how much it resembles that class.
The design of effective risk communication requires a recognition of the
multi-attribute nature of risk, an awareness of the psychology of risk
perceptions and judgment under uncertainty, and an analysis of the information
needs of the people for whom the communication is intended.
Developing a risk communication has traditionally been a two-step
process. First, you find some health or safety specialist who knows a lot about
the risk and you ask them what they think people should be told. Then you
find someone who is called a "communications expert," who is usually either
a writer or someone who works in public relations. You give them the
information you got Dom the health or safety specialist and they decide how
they think it should be packaged and delivered.
If you think about it for a while, you will notice that two key things are
missing Mom this traditional approach. First, it doesn't determine
systematically what people already know about the risk. People's knowledge
is important because they interpret anything you tell them in light of what they
already believe. If some of those beliefs happen to be wrong, or misdirected,
your message may be misunderstood. It may even lead people to draw
conclusions that are exactly the opposite from what you intended. Second, the
traditional method doesn't determine systematically the precise information that
people need to make the decisions they face. There are formal methods,
83Kahneman, D, P Slovic and A Tversky (ed.) (1982). Judgment Under Uncertainty:
Heuristics and Biases. New York: Cambridge University Press. Dawes, RM (1988). Rational
Choice in an Uncertain World. Orlando, Florida: Harcourt Brace.
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113
decision analysis, that can provide a precise answer to a question such as
"what is the minimum set of infonnation I need to make the decisions I care
about." Of course, most of us have never heard of decision analysis, and we
don't use it in our daily decision making. For various reasons we typically
require more than the minimum set of information to make the decisions we
face. Yet, when you start reviewing traditional risk communication messages
it is amazing how many of them fail to provide even this minimum set of
information.
Most of us already have some relevant knowledge and beliefs about any
risk that a communication is designed to inform us about. Often we've already
heard some specific things about the risk. If we haven't, we've heard about
other risks which sound pretty similar. In any event, we have a lot of
knowledge about the world around us. We have beliefs about how things work,
and about which things are more and less important. When someone tells us
about a risk we use all our previous knowledge and beliefs, called our "mental
model," in order to interpret what we are being told.
Finding out what someone already knows about a risk means learning
about their "mental model." That's easier said than done. We could
administer a questionnaire, but people aren't stupid. I have to ask questions
about something. As soon as I start putting infonnation in my questions,
people are going to start using that information to make inferences and draw
conclusions. Pretty soon I'm not going to know if the answers I am getting
are telling me about the mental model that the person already had before I
started quizzing them, or the new mental model that the person is building
because of the all the infonnation I am supplying in my questions.
To overcome these and other problems, we have developed a five-step
method for creating, testing and refining risk communication messages: 84
1. Carefully review scientific knowledge about the risk, and summarize
it in terms of a fonnal diagram called an "influence diagram."
2. Conduct open-ended elicitations of people's beliefs about the hazard,
allowing expression of both accurate and inaccurate concepts. Use a "mental
model interview protocol" that has been shaped by the influence diagram.
3. Administer structured questionnaires to a larger set of people in order
to determine the prevalence of the beliefs encountered in the "mental model"
interviews conducted in Step 2.
~ Morgan, MG, B Fischhoff, A Bostrom, ~ Lave, and C Atman (1992). Communicating risk
to the public, Environmental Science & Technology, 26: 2048-2056. Bostrom, A, B Fischhoff and
MG Morgan (1992). Characterizing mental models of hazardous processes: A methodology and
an application to radon, Journal of Social Issues, 48: 85-100.
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BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
4. Develop a draft risk communication message based on both a decision
analytic assessment of what people need to know in order to make informed
decisions and a psychological assessment of their current beliefs.
5. Iteratively test and refine successive versions of the risk communication
message using open-ended interviews, closed-form questionnaires, and various
problem-solving tasks, administered before, during, and after people receive
the message.
Suppose that I want to learn about the mental model that someone has for
a risk such as the safety of the blood supply. In response to a question like
"Tell me about the safety of the blood supply," most people can only talk for
a few sentences before they run out of steam. However, those few sentences
often contain five or ten different ideas. If the interviewer has been trained to
keep track of all the things that are mentioned, they can then go on to ask
questions that follow up on each one. For example, they might say "You
mentioned that screening blood donors can improve safety. Tell me more
about that. . ." By systematically following up on all the concepts that the
subject introduces, a well-trained interviewer can often sustain a conversation
about the risk for 10 to 20 minutes, introducing no new ideas of their own.
Only in a later stage of the interview will the interviewer go on to ask
questions about other key ideas which the subject did not bring up on their
own.
By conducting a number of interviews of this sort, we can begin to build
up some sense of what people know and believe about a risk. Then in step
three of the process, using a closed-form questionnaire, we can determine the
relative frequency with which various beliefs actually occur in the general
public.
Every time that we have conducted mental model interview studies to
crecare a risk communication we have learned surprising and important things
~ ~ _ _
which have had a major effect on the message we developed. Among the
most important insights have come from some of the common misconceptions.
For example, in studies of radon, we learned that a significant number of
Americans believe that once they get radon in their house, the house becomes
permanently contaminated and there is nothing they can do about it. Of
course, this is not true. Radon is a radioactive gas that decays into various
particles which become nonradioactive in a matter of hours. Thus, if the
source of radon gas can be closed off, all of the resulting radioactivity will
soon be gone from the home.
. . .
~.
This is an important part of any risk
communication message, because if you test your home for radon and find
elevated concentrations, you can take various steps to prevent the radon Tom
entering the home and thus reduce or eliminate the risk. How could people
think that a house that has radon is permanently contaminated? Probably they
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115
are extrapolating from other things they know. They have heard about
radioactive waste from power plants and bomb factories that remains
dangerous for 100,000 years. They also may have heard of houses that have
become chemically contaminated when they were sprayed by very long lasting
pesticides. They make a reasonable extrapolation (which in this case happens
to be wrong) that radon is like these other cases. This is the sort of
misconception that it is critical to know about if you are going to design an
effective risk communication. When EPA designed their first Citizen's Guide
to Radon, which was mailed to citizens all over the country, they didn't know
about this common misconception. Their central message was "You should
test your house for radon." However, many people who believe that radon
permanently contaminates a house would probably be inclined to ignore this
message, figuring they are better off not knowing whether their house has a
high concentration of radon. For example, if they don't know, they could sell
their house some time in the future with a clear conscience.
In summary, in order to develop an effective risk communication one
must recognize that risk is a multi-attribute concept. Building on the literature
on risk perception and judgment under uncertainty, one should learn what
people already know about the risk at hand, first through open-ended mental
model interviews, and then through closed-form questionnaires. On the basis
of this, and a careful assessment of the information people need to make on
the decisions they face, a first draft of the communication can be developed.
However, there is no such thing as an expert in risk communication. The only
way to be certain that a message works, that it is understood in the way that
it is intended, is to try it out on real people. By using a variety of methods,
including one-on-one read aloud protocols and focus groups, the message can
be iteratively refined. Test it; refine it; test it again. Don't stop until it works.
DISCUSSION
Henrik Bendixen: How do you know when risk communication works
effectively?
M. Granger Morgan: One strategy is to present people with a hypothetical
situation and ask them what actions they would take. For example, we did a
three-way study with the first version of the EPA Citizen's Guide to Radon
and two brochures we developed from the results of our work. In terms of
simple recall, regurgitating the facts, the three did roughly comparably. Then
we asked participants to respond to a question such as: "You have a neighbor
who has just measured radon levels in their home of 10 picocuries per liter.
What advice do you give them?" The people who read either of the brochures
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1 16 BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
we developed were able to give direct, cogent, and correct advice, but the
people who had read only the EPA brochure had a lot of trouble. They
basically were not able to provide an answer.
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Risk Communication: Building Credibility
Caron Chess
The following true story illustrates the difficulty of relying only on
numbers to explain risk. A high-ranking government official was speaking to
a public meeting of hundreds of people about a proposal for a hazardous waste
incinerator in their neighborhood. The audience was told that the incinerator
would pose only a 1 in 1 million risk of an increased death from cancer. The
crowd's response: "We hope you are the one."8s
If this agency representative had been able to explain more eloquently the
1 in a million risk, would people have said, "Oh, now we understand. We will
graciously accept your incinerator." The answer, of course, is no. Nonetheless,
senior scientists, administrators, and public health officials seek to improve
their explanations of the risk numbers in hopes that the public will yield to
experts' judgments.
These experts are overemphasizing the impact of
explanations of the mortality and morbidity data. I suggest that this and other
environmental communication issues apply to communication about blood
safety. In the following few pages I discuss three myths that scientists and
policy makers believe about explaining risk and propose alternative
approaches.
ROLE OF INFORMATION
One myth is that information changes behavior, while in reality,
information has little association with behavior. Although scientific experts
are very careful to limit extrapolation beyond the data when dealing with their
own disciplines, they tend go beyond the social science data (and sometimes
go where no social scientist has gone before).
85Hance, B.], C Chess, PM Sandman (1988). Improving Dialogue with Communities: ~ Risk
Communication Manual for Government. Trenton: New Jersey Department of Environmental
Protection.
117
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BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
Experts who are not social scientists have in mind a model about the role
of information that is flawed. Many non-social scientists erroneously believe
that if you give people information about risk, they will change their attitudes
and then they will change their behaviors.
However, empirical research
suggests that increased knowledge about technology is not necessarily
associated with support of that technology. For example, in a review of
research on perception of the risks of nuclear energy, about one-half of the
studies show that supporters of nuclear power know more factual knowledge
than opponents. The other studies show that opponents of nuclear power know
more information than supporters or that opponents and supporters have equal
amounts of information. 86
In the health education field there is an evolving consensus that
knowledge has a weak link to behavior. For example, high school kids right
now can pass tests of their AIDS knowledge, but they have not changed their
behavior dramatically. Likewise, women may know that they are at risk for
AIDS if they have unprotected sex with a partner who is HIV infected. That
knowledge does not mean that women will insist that their partners use
condoms.
Advertisers who want to change behavior talk about messages and appeals
rather than information: appeals to status, social approval, sex appeal and so
forth. Similarly, those who attempt to change behavior for the social good,
dubbed social marketing, develop communication strategies and messages
based on what motivates people to change their behavioral For instance,
years ago antismoking campaigns were replete with images of anatomically
explicit photographs of damage to lungs caused by smoking. Somewhat later,
there was a complete change in message, based on research about what
motivates teenagers' behavior: television ads featured Brooke Shields telling
kids that it was uncool to smoke.
When those of you in the blood industry are considering how to increase
the pool of donors, you need to think in terms of social marketing. For
example, the message that donating blood cannot lead to HIV infection, while
a seemingly logical response to public fears, needs to be supported by
empirical research on questions such as: To what extent does fear of HIV
affect those people who have a record of donating blood? Does that fear
largely affect those whose psychological portrait suggests that they would be
donors? Or does it largely affect those who would be unlikely to give blood
under any conditions? If the fear does affect people otherwise likely to give
86Johnson, BB (1993). Advancing understanding of knowledge's role in lay risk perception.
Risk: Issues in Health, Safer, and the Environment, 4: 189-212.
87For example, Rice, RE, CK Atkin (1989). Public Communication Campaigns. Newbury
Park: Sage.
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119
blood, how well is their fear reduced by the message about the lack of
connection between HIV and blood donation?
Some existing empirical research begins to answer this question by
distinguishing the attitudes of those who donate blood from those who do not
donate blood. According to one study, people who give blood tend to
associate blood donation with generosity, civic mindedness, and usefulness as
well as feelings of assurance and relaxation.
Those who do not donate blood connect donation with illness and
discomfort. This study suggests that motivating donors might build on their
positive associations, not merely factual infonnation about the lack of
connection between giving blood and AIDS. Attracting more donors requires
more such research to determine feelings about blood donation, to develop
potential messages based on that research, and to test those messages.
If you want to change behavior, for example, encouraging people to
donate blood or to become repeat donors, you need to understand their
motivations, biases, and beliefs. This same need for understanding is also
essential to discouraging people who continue to donate blood, even though
they know they are HIV-positive or that they may be at risk of HIV infection.
If you are going to communicate with those individuals, you want to know
what their attitudes and beliefs are and what motivates them to behave in this
manner.
When you do provide information, you should consider what your
audience wants to know, not merely what you want to tell them. To provide
this information, you need to know what your audience thinks is
important and knowing your audience requires further research.
THE ROLE OF RISK NUMBERS
Scientific experts tend to subscribe to a second myth: the public is
influenced largely by the risk numbers. However, as the previous discussion
suggests, individuals are influenced by factors other than the risk data. A true
story about a prominent Environmental Protection Agency risk assessor
illustrates the influence of other variables.89 The risk assessor was in the
hospital for tests, including one that had a slight risk of causing kidney failure.
He found that more sophisticated diagnostic equipment, without the potential
risk, existed at a hospital across town. He decided to take an ambulance to the
other hospital to use the more sophisticated diagnostic equipment even
heckler, SJ (1989). Scales for the measurement of attitudes towards blood donation.
Transfusion, 29: 401-404.
89Siegel, B (1987). Managing risks: Sense and science. Los Angeles Times, July 5, I 28.
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BLOOD AND BLOOD PRODUCTS: SAFER AND RISK
One of the classic cases that became notorious involved Chester Southam
from Cornell Medical School, New York Hospital, conducting research at the
Brooklyn Jewish Chronic Disease Hospital.'04 He was interested in the
body's rejection of cancer cells and thought that he could begin to solve some
of the puzzles of cancer. He injected demented senile old men with foreign
cancer cells. When asked why he did this without telling the subjects that he
was going to be injecting them with cancer cells, he said that if he would have
told them that it was cancer cells, they would have become much too
frightened, would have exaggerated the risk, and would have refused to join
the protocol. Because he didn't want to lose his subjects, he did not
communicate to them. At one point he was asked why he didn't also inject
himself, as was frequently the case with researchers. He responded that,
"There aren't enough good cancer investigators." This is one of the problems
of leaving it to the investigator to determine the risks.
It was decided, with NIH as the driving force, that we would no longer
leave risk calculus to the investigator on the grounds that the investigator was
not a neutral figure in this calculation. The investigator's first charge was to
accumulate knowledge. Whether the motive was knowledge, the next grant,
or the prize, investigators as a rule underestimated the risks to which they
exposed their subjects.
The two major functions of the IRB are to calculate the risk-benef~t ratio
and ultimately to insure that the consent process is implemented in a way that
those risks and benefits are clearly communicated to the subject. What we
have done in the area of human experimentation is to require a collective
judgment on the risk by the investigator's peers, with a few other people also
involved. Equally important, the IRB insists that that finding on risk and
benefit be told to the subject, so that the subject has the last word.
The difficulties, the imperfections, and the impossibility of fully informing
the subject are clear and apparent. The question is how far down the
disclosure of risks do you go? When consent in this process was first started
in the early 1970s, you could find spoofs in the major journals. The choice
of subject for the spoof was the deriding of consent hv listing `'v~rv rick acing
. . .
circumcision as the test case
_= ~ __ _^AA ~_ ~_A ~· ^ ~
In the end, we now require communication about risk to the subject, and
we are going about it in a very decentralized way, leaving it to local IRBs, and
to individual patients to calculate the nature of how much risk should be taken.
Were CreutzLeldt-Jakob disease part and parcel of an experimental
protocol, knowing what we know now, would that risk be communicated to the
subject? The answer to that would really depend ultimately on individual
Ibid, pp 77-93.
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IRBs. They might bend over backwards in an experimental protocol and say,
"Yes, that ought to be included." They probably would not rule out an
experiment simply on the basis of that unknown risk being present, but they
might. The key point is that they certainly would want the subject ultimately
to make the decision about the risk.
You are not going to find an existing national body that is going to make
that decision on its own. You will find in elements of risk calculus that we
have accepted informed consent as the basis for approval. We anticipate
through IRB and consent that ultimately we do share risk analysis collectively
and ultimately trust the choice made by the subject. We now tend on the
whole in human experimentation to be risk minimizing. In the area of research
communication of risk, sharing information about risk, and calculating risk
against benefit is not merely standard, it is mandated, and however imperfect
in practice, it is altogether the requirement.
If you look at the clinical setting and allow me my choice of the case of
radical mastectomy versus lumpectomy, you begin to find a second and very
interesting model in teens of risk calculus. The decision in favor of radical
mastectomy as almost the only procedure to be used in all cases of breast
cancer lasted well into the late 1970s and even into the early 1980s. The
ultimate reason was the surgeon's response of risk minimization. The shift
from radical mastectomy to lumpectomy is complicated. Parts of the story
involve radiology and oncology, as well as psychiatry. No roster of
participants who moved us from mastectomy to lumpectomy would be
complete without talking about women and patients' groups themselves. It
would not be an exaggeration to say that although the change certainly was
abetted, encouraged, and finally conclusively established in the territory of
medicine, the role of women activists was absolutely critical.
There the risk calculus shifted the other way as opposed to the
psychological pains and physical pains of a radical mastectomy. Where the
choice turned out to be a realistic one, many women prepared to carry the
additional burden of risk in return for the benefit of not undergoing radical
mastectomy.
That conversation between a surgeon or oncologist and woman patient is
as complicated a conversation medically and emotionally speaking as one can
imagine. The variables that go into the risks of each procedure are very
exquisite. It is very difficult, intellectually and emotionally, to parse out the
risks, and yet it is being done all the time. In this day and age for a breast
surgeon in this country to say, as I recently heard from a physician in Israel,
"This is much too complicated, I am simply going to make the decision and
not involve the woman," would be absurd. It may well be than an older
patient or a patient overwhelmed by the diagnosis may turn to her surgeon and
say, "I don't want to hear about it. Do what you want to do." That certainly
happens. The right to say no to information certainly is to be respected, but
A.,
.. . . .
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BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
the standard is surely to share the information about risk, although it is
complicated. In the area of clinical practice, we have clearly reached the point
where sharing the decision-making about risk after intensive conversation is
standard.
It is fairly apparent that clinically many physicians have great difficulty
communicating risks to their patients. Some are paternalistic. Physicians on
the whole do not do a very good job communicating about risk. There is a
fear that if they tell a patient all the risks, the patient won't be compliant.
Physicians may also be trying to be protective of patients by trying not to
worry them. It seems if you tell the patient there is a side effect, that patient
will call you tomorrow and report the side effect.
In summary, it is easy to spoof risk disclosure and point to the flaws, but
I would suggest on the basis of my two models that the benefits of doing it far
outweigh whatever the problems are. Furthermore, physicians probably don't
have a lot of choice any longer. In experimentation, they certainly don't.
Dealing with women and breast cancer, they don't. The list is going to get
longer, not shorter. You may agree or disagree with one or another of my
arguments, but in the end it is moving in exactly the direction I have
described.
DISCUSSION
Paul Russell: There is no question that we must strive toward informed
consent. There is also no doubt that it is a very flawed process and that we
cannot get to total informed consent. Our responsibility lies with the issue of
diminishing risks as you get out toward the end of the risk curve. It is
difficult, but it is an important thing to do. I am concerned about it. How far
should I go in telling people about risks?
David Rothman: In an experimental setting, I would think you would want
to go further. In a therapeutic setting, the patient gives you cues. I am sure
older patients, or maybe those less educated, might press you less.
Paul Russell: I go as far as the patient wants to go.
David Rothman: You are not going to bludgeon the patient with information,
but if the patient is a long-distance runner and there is a 5 percent risk that this
surgery is going to keep him off the track for the rest of his life, you might
well want to tell him that. If the patient that comes in is rather corpulent, beer
drinking, and poker playing, the 5 percent risk to a running career would be
irrelevant. You will tailor it. You are going to go down the major items and
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147
then, depending on that patient's tolerance for information, you go down below
the normal list to include those that you think would be particularly relevant
for the patient.
Paul Russell: I think that is a helpful guide, but it doesn't get me all the way.
Edward A. Dauer: In those instances in which a patient's perception or
evaluation of a risk is not consonant with its actual quantity, is it the
physician's responsibility to respect the patient's evaluation as it is or to try
to correct that perception and bring it back into line with the actual
quantification?
David Rothman: The answer to that is absolutely yes, you have to bring it
back into line. No patient is going to ever get to exercise informed consent
on his own unless the physician helps him realize it. You have to correct. A
patient may have a fear that is completely out of perspective. You will give
the information. What do you then do when a patient still says, "No thank
you"? You try a second time, but it may not be appropriate to try the fifth
time. That you must make an effort is absolutely clear, but in the end when
you are content that that patient has understood you, then it remains the
patient's choice.
Llewellys Barker: By telling patients what the risks are, the practical
approach is very appropriate. I have been on both sides of this process. In
your mind, does what we tell patients the risks are equate with "these are the
risks we tolerate"?
David Rothman: I have a lot of trouble with "we." Is that the five people
who are sitting in the lab or the five people at an NIH consensus conference?
I might prefer "we" to become "I." The point of my remarks is to personalize
it, individualize it, and communicate it. The "we tolerate" formulation may
make it too easy not to communicate.
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Communication of Risk and
Uncertainly to Patients
Donald Colburn
I wear a lot of hats in the world of hemophilia. I have hemophilia, severe
Factor VIII deficiency. I also have HIV disease, and I happen to be president
and chief executive officer of American Homecare Federation, which is a
company that provides service to people with hemophilia. In addition, I am
currently serving as a member ofthe National Hemophilia Foundation's (NHF)
Blood Products Monitoring Committee, and I am chairing the legislative
campaign for passage of the Ricky Ray Relief Act.
I am going to discuss the general concept of blood safety and take a look
at how we currently educate folks. Having been on the receiving end of that
education, I would say that I have not experienced the inclusion of the patient
in decision making that you have discussed. The attitude of the physicians is
still, "Do what I say. This is good for you. If you don't do it, you will be
more ill."
With respect to blood and blood products, I believe we should be moving
toward a signed informed consent. We can certainly talk about how far we go
in levels of exploring uncertain risks. Unfortunately, the process of sharing the
infonnation necessary to institute informed consent is time-consuming, and, as
we know, the health care system is already operating with a lack of quality
time spent with patients. The challenge we have is to devise a mechanism that
will allow blood bankers, for instance, who are very interested in blood safety
issues to serve a broader role in the process of educating patients.
There has been a great deal of discussion about the pamphlet that is put
out by American ssociation of Blood Banks (AABB) in conjunction with the
Council of Community Blood Centers (CCBC) and the Red Cross. Designed
for recipients of cellular blood products, it is supposed to mimic a package
insert as far as information. To date I have not found one person with
hemophilia or another condition who received this pamphlet at the time of
receiving a cellular product. Even that mechanism isn't being utilized. What
can we do that will allow some "right of information" for that patient? For
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starters, we can provide signed and informed consent with chronic users of
blood products on an annualized basis.
In addition, we first must make information understandable for people
with various levels of education. The second thing that we have to do is to
present the information in an unbiased manner. Then we have to be certain
that patient is up to date with the information when he makes that decision.
Once there has been uncertainty about a particular product, that uncertainty
hinders communication even more, as we experienced with HIV. The patient,
as the blood products' consumer should have the ultimate role in the decision.
Without that type of participation, without informed consent that somebody has
on file somewhere
transmitted.
then the whole thing becomes bogus if a disease is
To sum up, it is important, tremendously important, that we present
materials to people in an unbiased fashion that they can understand. One
would like to think that the patient would have many more questions,
especially in a situation involving chronic use. As far as communicating the
risk of uncertainty, that is a tough one. Blood goes through various processes
which eradicate most diseases most of the time. However, there are many
conditions that are not tested for and that we don't know about. Those are
unknown risks. It is important that we don't panic the person, but that he or
she understands that there will always be risks in any medication. Even
recombinant products have a risk factor. That is part of life. We have to
make a sincere effort to bring the patient into the loop, and in some areas it
works very well. It works really well in discussion groups like this, but when
you get back out into the field you often hear remarks from folks like, "Doe
just said that this is what I should do," remarks which reinforce the continuing
absence of shared information and informed consent. At NHF we are working
very hard to empower our consumers to come back to the medical community
with a lot of questions. We think it is important. We have had a very severe
lesson as a result of our own complacency.
DISCUSSION
Paul Russell: Having the patient specifically sign makes a lot of sense, and
that is really pretty much what we are trying to do throughout. In the case of
transfusion it could be applied a little bit more broadly and repeatedly in the
case of patients like those you are familiar with.
Harvey Klein: Informed consent for blood transfusion has been national
policy since 1986. I don't know whether that is standard of care in the outside
world and whether every institution practices that, but the AABB, for example,
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has had that written form widely disseminated to every one of its members
since 1986. The circular of information, the so-called package insert, was not
really developed for patient use any more than the package inserts in the drugs
that you get. The package inserts were developed to inform the physicians,
whose job it is to infonn the patient who receives a blood transfusion.
Paul Schmidt: There was a study about 3 years ago in which a group of
investigators doing informed consent talked to patients after surgery and then
some months later. The patients didn't remember what had been discussed and
their understanding was different.
Donald Colburn: You are always going to have that obstacle. My emphasis
is on the chronic user of medical services. There the time is importantly spent
because that patient is going to take up a lot of the medical services' time.
The better informed that person is, the better the relationship will be. The
difficulty that we have observed in the hemophilia community is that when
there is a perception that there has not been the opportunity to participate in
the therapeutic regimen decision, then all the other systems become distrusted.
That perceived breach by the individual causes a great deal of hann, even if
the patient would not have remembered everything he or she was told.
Henrik Bendixen: The point is that informed consent is not a freestanding
event but should be part of the continuum of interaction between physician and
patient.
David Rothman: The world wide web on the Internet is becoming a real
player. A colleague of ours talked about the fact that his patients ask where
the newest protocol is. The AIDS community brought us into that
consumer-based knowledge concerning protocol availability. If you don't have
a protocol going they are not coming to your institution. Although I know
those stories about how if you poll the patient 3 months later he doesn't
remember the consent form, there are lots of newer stories about patient groups
that are all on the Interpret communicating with each other in teens of where
the best protocol is.
Harold Sox: At Dartmouth there has been a reverse epidemic of operations
for benign prostatic hypertrophy as a result of Wennberg and Mulley's
work.'05 They developed video disks that convey in an individualized way
~05Kasper, JF, AG Mulley Jr, JE Wennberg (1992). Developing shared decision-making
programs to improve the quality of health care (comments). Qualify Review Bulletin, 18(6):
1 83-190.
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the risks and benefits of a procedure with respect to the various therapeutic
options. As a result patients bring a lot more information to the discussion
with the physician. The process of the discussion is at least enlightened and
may be even truncated somewhat. This might be another instance in which
annual provision of informed consent might be in order.
James Reilly: Whether we are a blood center providing blood to the
transfusion center or a product manufacturer providing products to a treatment
facility, where in your view is the communication breakdown? Is it that we
are not providing enough to the physician or that the physician is not
communicating to the patient?
Donald Colburn: I did ask a number of blood bankers why isn't that circular
used, for instance, because it is supposed to go up with every unit. I started
to probe in that direction and the responses I got were amazing. "When we
first got them we started sending them up, and all of a sudden I got calls from
about five or six different hematologists. 'What the hell are you sending up
to my patients? If I want them to know anything, I will tell them."' The
overall problem is in physician communication to patient. I see it as time
management because it takes a long time to be certain someone is educated.
Frederick Manning: One of the projects I have been involved in here at the
Institute of Medicine involved an experimental drug and the whole question
of informed consent: how much is enough; how much should you tell the
patients. It turned out the drug did not work out all that well. There was a lot
of talk from patients about what they should have been told. In the process
we did a little poll of the committee, who were all relatively eminent clinical
researchers. The question was whether they could recall in their careers ever
having a potential subject in one of their experiments who listened to their
pitch, read the informed consent form, and said, "No, I am not interested." In
fact, none of them could think of a single instance in which that happened.
For the audience today, I would ask you to think back and tell us how many
times have you had a patient leave the office after you described what the risks
were? Maybe there are some inherent limitations about how scared you can
make a patient who has already come to you and decided that he or she is
going to trust you.
Paul Russell: I have certainly had patients decide against surgery after I
explained the risks. We have immensely complicated clinical protocols that
have to be applied to almost every patient we see. When they come in for an
organ transplant they may have to sign about half a dozen consent forms. It
is not uncommon to have one or two of them be inappropriate. Their refusal
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may not be because they are scared, but because it is an immensely
complicated setting. I think you are thinking of a setting with a simple,
straightforward, single question. In the situations that I deal with, there is an
awful lot of experimentation of all kinds, one superimposed on top of another.
There are patients who are in several protocols at once.
David Rothman: There are protocols out there that don't get to enroll
patients. There will be a research team to which the treating physician may
or may not dispatch his or her patient. For example, at our institution the
investigator who really wants to figure out if bone marrow transplantation has
any efficacy in breast cancer cannot get patients to enroll because if you want
it, it is out there to be had, and if you don't want it, you are not going to leave
yourself to a random draw. No one goes into the protocol.
Elaine Eyster: There are two very different types of protocols. One is the
type that has been referred to, in which we have a variety of experimental
studies for persons who are infected with HIV. We present those and patients
may or may not choose to go on that protocol. It doesn't interfere with our
relationship with them, but they have that choice. On the other hand, we have
a routine informed consent that everybody signs and re-signs on some sort of
interim basis saying that they agree to participate in a study in which their
blood can be used for certain purposes. Most patients will accept that as part
of what we do, but others will say, "No, I don't care to do that." That wish
is honored, and they are not included in whatever study that you are doing.
1 ~
William Sherwood: There is also a great deal of informed consent that is
really for comfort. Virtually all hospitals instituted an informed consent for
transfusion, particularly prior to surgery. There are a couple of paragraphs
given to the patient at a time when that patient has a lot of other things to
sign, and the patient is under a good deal of stress having surgery the next day
or the next morning. What we are searching for is just how far to go with
informed consent. An interplay with the patient to try to find out how far to
go was suggested, but I had trouble with that. I would like to be more
uniform. I would like to be able to tell all patients what the potentials are and
what I should be doing. Is there a way to stratify these risks proven,
potential, and theoretical and where should we draw those lines? It is
difficult to handpick something for each patient when you know in the long
run that the patient will be disaffected in some way and later come back and
say, "Why didn't you tell me about that risk?" I cannot come back and say
to them, "I didn't think you needed to know it." We need more guidance on
how deep to go in the risk spectrum in helping patients understand.
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David Rothman: When an institutional review board (IRB) does a risk
assessment for informed consent, it lists the major potential side effects by
percentage; it keeps going down to maybe include some in the 10 percent
range, but it probably doesn't go down to the 1 percent range. I don't know
that all the patients read it, but they are going to certainly read the major
untoward effects. The kinds of complaints that often end up being told to me
are one in which the patient has been given a prescription, but the ordinary
side effect was not mentioned to the patient. The patient experiences it, calls
the physician the next day, and physician says, "Relax, it is one of the side
effects," to which the response is, "So, why didn't you tell me?" We need to
be between the extremes of parsing it out to 1 percent and telling a patient,
"Look, you are going to be taking this. Here are the major side effects."
Donald Colburn: I have signed off on admission to a hospital on a blood
form. What you sign is incredible. If you sit there and challenge the
document, you become a troublesome patient at that point. If you say, "I don't
understand this," the person who is doing the intake to put you into the
hospital is a clerk for the most part and responds, "Sign these forms." You
ask "What happens if I don't sign them?" and the clerk says "We cannot put
you in the hospital." You sign the forms. There is some degree of pressure
that is put on the patient at that stage, in addition to whatever else may have
been tried to have been communicated.
Harvey Klein: Many good hospitals don't consider informed consent a form
given at the time of intake with a clerk. That really isn't informed consent.
David Rothman: Exactly. What could be a worse time? We have some data
on hospitals trying to do advanced directives at the time of admission. Could
there be a worse time to do anything, especially because somebody knows you
are coming.
James Allen: When you talk about listing potential adverse side effects in the
10 percent range, but not the 1 percent range, is that a 10 percent risk of
occurrence versus a 1 percent risk of occurrence? Surely, for serious effects
such as risk of HIV infection post-transfusion, a risk of one in several tens of
thousands is considered highly significant and certainly a"must notify."
David Rothman: You are absolutely right.
Representative terms from entire chapter:
informed consent
