Examples of
Health Risk Communications Perceived Effective
National Cancer
Institute (NCI), National Institutes of Health (NIH)—Improving the Early Diagnosis of Cutaneous Malignant
Melanoma
1.1 Case Description
Beginning in 1976, the intramural
research program of the Environmental Epidemiology
Branch, Division of Cancer Etiology, NCI, indicated that
dysplastic nevi is the precursor lesion for up to 50 percent of
melanomas.
1.2 Characterization of Risk
Because melanomas are uniformly fatal
unless diagnosed and treated early, they require
aggressive and expensive procedures of wide excision,
skin grafting, surgical dissection of draining lymph
nodes, and significant hospitalization and followup. If
the very earliest melanoma stages could be recognized,
localized lesions could be removed by a dermatologist or
surgeon in the office or during a hospital outpatient
procedure, resulting in significant savings in cost as
well as human lives.
1.3 Health Risk Communication
Procedures
A two-pronged approach was taken.
First, the method for clinical diagnosis was refined, and
second, NCI's Office of Cancer Communications developed a
public and professional education program. The program
focused on early detection and the wide dissemination of
clinical criteria for identifying early signs of
melanoma.
Audiovisual and written materials, including pamphlets
containing information on prevention, warning signs, and
treatment, were developed, including free-loan videotapes
for clinicians, pathologists, and patients. Histology
slide sets for professionals were assembled. An average
of 462,000 patient packages and 19,000 professional
packets were distributed annually, with an estimated
58,000 viewers per year.
1.4 Outcomes and Benefits
The impact of this program, as
evaluated by NCI, was estimated in 1987 dollars on the
basis of the 1985 incidence rates by melanoma stage. If
each of 24,351 cases for that year had required the
previously described aggressive surgery and
hospitalization at an estimated cost of $8,484, the
yearly cost would have been $206,593,884. A conservative
estimate of this program's impact is that only 30 percent of the
cases would now require the maximal approach of major
surgery and hospitalization, and some 5 percent could have been
treated in office visits. The average cost for the
combined treatment approaches would then be $4,313 for
each of the 24,351 cases, or $105,025,863.
Therefore, for a cumulative (extramural and intramural)
cost of $17,266,632 (1987 dollars), there was an annual
estimated savings in health care costs of $206,593,884 -
$105,025,863 = $101,568,021, which is believed by NCI to
be a conservative figure.
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National Library of
Medicine (NLM), NIH—Clinical Alerts Online System
2.1 Case Description
On January 18, 1992, the National
Library of Medicine transmitted its first NIH clinical
alert over its MEDLARS network. The alert, unique to NLM's
online system, was a 74-line statement issued by
the National Institute of Child Health and Human
Development regarding the efficacy of a drug used to
treat HIV-infected children.
2.2 Characterization of Risk
The initiation of NIH's new clinical
alert service was prompted by the need to improve the
speed with which highlights of important findings from
clinical trials can be disseminated to the health care
community before they are published in medical journals.
2.3 Health Risk Communication
Procedures
A number of recent instances were
recounted of NIH's special efforts to get clinical
information into the hands of medical practitioners
quickly. The network has the potential to reach more than
40,000 librarians and health professionals in the United
States and abroad with the highlights of important
findings from clinical trials and studies of medications
and new medical procedures.
Various methods of disseminating information to health
care professionals have been used: press conferences,
direct mailings to physicians, media announcements,
telephone conferences, and FAX alerts. The reaction from
the professional community ranged from praise for NIH's
concern with rapid dissemination of clinical findings, to
disappointment that only summary information was
dispensed, to concern that the peer-review publication
process had been short-circuited.
2.4 Outcomes and Benefits
Because of the newness of the project,
no formal evaluation studies have been performed on NLM's
Clinical Alerts Online System.
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National Center for
Environmental Health (NCEH), CDC—Hanford Environmental
Dose Reconstruction Project
3.1 Case Description
The Hanford Environmental Dose
Reconstruction Project is a multiyear scientific study to
estimate the radiation doses of ¹³¹Iodine to the
public living close to the Hanford Nuclear Reservation,
which is in the State of Washington.
3.2 Characterization of Risk
NCEH took a proactive approach to
inform the public about the purpose, process, and results
of the study. Exposure to radioactive materials can cause
adverse health effects, including thyroid cancer. An
estimate of the public's exposure to radionuclides
released from the Hanford facility is an essential first
step in estimating health risk.
3.3 Health Risk Communication
Procedures
Before the ¹³¹Iodine dose
reconstruction report was released, a public handbook was
developed to explain how the study was conducted and how
radiation reaches people. After the report's release,
numerous public meetings and informal discussions were
held in the affected communities. The activities were
intended to: (1) address widespread public concerns and
mistrust of the government; (2) assure that study results
were credible; and (3) lay the groundwork for
communicating the results of the study.
Health risk communication efforts were designed to
explain the scope of the project, the technical work
being conducted, and the uncertainties associated with
the work. Several key activities were planned to build
the trust and credibility needed to communicate with the
public. These activities included the following:
- Ongoing local lecture series
- Small-group work sessions
- Development of printed fact
sheets and educational materials
- Continuously updated mailing
list
- 800 telephone contact number
- Media outreach
- Open meetings of the technical
steering committee (TSC), held five times a year
in the affected communities
3.4 Outcomes and Benefits
Numerous surveys of knowledge and
attitudes were conducted by NCEH at the various settings
where community outreach takes place. Other types of
surveys were sent to individuals on the mailing list, TV
stations, newspapers, and individuals attending the TSC
meetings. These surveys were attempts to gauge the level
of understanding associated with dose reconstruction
science and the use of information gained from dose
reconstructions. Indicative of the building of public
trust has been the growth of public support for the dose
reconstruction project.
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National
Institute of Environmental Health Sciences (NIEHS), NIH—Environmental Health Policy Committee (EHPC) Report on
Fluoride Benefits and Risks
4.1 Case Description
Responding to the findings of a
National Toxicology Program study showing
"equivocal" evidence of sodium fluoride's
carcinogenicity in male rats, the Assistant Secretary for
Health directed EHPC to prepare a report to evaluate
fluoride's overall health benefits and risks.
4.2 Characterization of Risk
Although water fluoridation is known
to be effective in reducing the risk for dental caries,
questions have been raised about the possibility of
adverse effects. Problems potentially associated with
exposure to fluoride include osteosarcoma, bone
fractures, dental fluorosis, and increased caries in
communities where water fluoridation is discontinued.
4.3 Health Risk Communication
PRocedures
EHPC released a report in February
1991 stating that optimal water fluoridation should be
supported because it is safe and very effective in
preventing dental caries. Some public advocacy groups
expressed concern about some of the report's findings,
pointing to possibly harmful health side effects such as
osteosarcoma, a rare bone tumor. Although no conclusive
evidence was found to support an association between
osteosarcoma and water fluoridation, there is evidence
linking a rise in the prevalence of dental fluorosis to
high levels of fluoride exposure. Overall, the report
concluded, "The Public Health Service should
continue to support optimal fluoridation of drinking
water."
In addition to the press releases announcing the EHPC
report's findings, the Assistant Secretary for Health
authored articles in professional medical journals
further emphasizing the importance of the study. A
special issue of CDC's Morbidity and Mortality Weekly
Report was devoted to the EHPC report. Several key
lessons were learned during the public communications
campaign:
- Timing of a report's release
to achieve maximum effectiveness is a critical
consideration. (The EHPC report competed with
news of the Persian Gulf crisis.)
- Message clarity, accuracy, and
balance are important when crafting a message.
The fluoride report and attendant press releases
were clear, as reflected by the accuracy with
which they were reported in the press.
- Commitment at the top of an
organization to a careful and objective response,
and to a fair and open process, and the
development of a clear and balanced message will
greatly assist in risk communication efforts.
- Scientifically and technically
complex reports may result in some messages being
readily understood and acted on, while others may
be lost. Because of this possibility, the need
for additional educational efforts should be
periodically reevaluated.
- Risk communication efforts by
public agencies are facilitated when these public
agencies are perceived as being objective and
acting in the public interest.
4.4 Outcomes and Benefits
In the days and months after the
release of the report, CDC's Division of Oral Health
observed no major disruption of water fluoridation
programs. Informal assessment shows that the EHPC report
was successful in preventing communities from halting
water fluoridation programs. After the report's release,
there was a slow and steady increase in the number of
communities providing fluoride in drinking water. On the
other hand, the EHPC report did not appear to result in a
surge of communities eager to add fluoride to the
drinking water. Overall, the risk communication efforts
were effective in allaying public concern about water
fluoridation and in preventing a cessation in community
water fluoridation programs.
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National Institute of
Mental Health (NIMH), NIH—Reducing HIV Sexual Risk
Behaviors Among Runaway Adolescents
5.1 Case Description (1)
Runaways' sexual behaviors and
intravenous (IV) drug use place them at risk for HIV
infection. The goal of this study was to evaluate an
intervention program targeting the reduction of sexual
risk behaviors among runaway youths in New York City who
are at high risk for contracting HIV.
5.2 Characterization of Risk
Most runaways in New York City are
sexually active, with a median of two sexual partners in
the last 3 months, typically unprotected by condom use.
Unprotected sexual intercourse appears to be the primary
behavior leading to HIV transmission among runaways in
New York City (5.3 percent are seropositive). The high
seropositive rates among runaways exist despite reports
of relatively high knowledge about HIV and the acquired
immunodeficiency syndrome (AIDS) and positive beliefs
about safe acts. Approximately one-fourth of these
runaway adolescents have engaged in trading sex for money
or drugs.
5.3 Health Risk Communication
Procedures
The following intervention activities
were specific to the communication of HIV health risks:
- General knowledge about
HIV/AIDS was addressed primarily by two types of
activities: (1) video and art workshops where
runaways developed soap opera dramatizations,
public service announcements, commercials, and
raps about HIV prevention; and (2) review of
commercial HIV/AIDS prevention videos.
- Training was given in coping
skills that addressed runaways' unrealistic
expectations regarding their emotional and
behavioral responses in high-risk situations.
They were taught to use a Feeling Thermometer to
identify their affective states in situations
with potential risk for HIV transmission and to
identify and practice behavioral and cognitive
coping responses.
- Individual barriers to safer
sex were reviewed in a private counseling session
that targeted dysfunctional attitudes.
5.4 Outcomes and Benefits
The study reported several significant
findings:
- Use of condoms increased and
the percentage of youths reporting a high-risk
pattern of sexual behavior was reduced after the
intervention.
- Participation in an intensive
HIV/AIDS prevention intervention can
significantly reduce sexual risk behaviors.
- The impact of the prevention
program increases as the number of intervention
sessions increases.
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Agency for Toxic
Substances and Disease Registry (ATSDR)—Case Studies
in Environmental Medicine
6.1 Case Description
Studies indicate that the physician is
the most trusted source of information in the community;
however, in regard to environmental issues, physicians
feel that they lack information and resources. A dearth
of information on environmental medicine in the medical
school and residency curricula places the physician at a
distinct disadvantage. Before primary care physicians can
assume a more active role in environmental medicine, they
will require readily available and accurate information.
Recognizing this need, ATSDR has developed Case Studies
in Environmental Medicine, a series of educational
materials for health care professionals to give them a
better understanding of the health risks of certain
hazardous substances in the environment.
6.2 Characterization of Risk
A substantial amount of illness,
injury, and death is attributable to environmental
conditions. For example, environmental conditions may
cause or contribute to asthma, cataracts, immune system
dysfunction, birth defects, various types of cancer, and
heatstroke. Because there are no reporting requirements
for environmentally related disease, estimates of the
impact of such illness are difficult to find.
Furthermore, physicians may not be able to recognize and
diagnose environmental illness. Residents of communities
may rely on health professionals for information about
exposures to hazardous substances, only to find that
their practitioners lack training in this area.
Several factors complicate
communicating the risk of environmental hazards: (1)
public perception of scientific data can be conflicting
and confusing; (2) risk comparison data are sparse and
poorly understood; and (3) competing sources of
information lead to variations in perceptions of risk.
6.3 Health Risk Communication
Procedures
ATSDR designed Case Studies in
Environmental Medicine to enhance physicians' and other
health care professionals' recognition, treatment, and
prevention of illness or injury of persons exposed to
hazardous substances, and to improve their ability to
communicate health information concerning hazardous
substances to their patients and the concerned public.
The Case Studies series is prepared with the assistance
of physicians and other health care professionals who
share a concern for physician education and public and
environmental health. Each case study opens with a list
of specific objectives, a case report concerning a
specific hazardous substance, and the opportunity to
respond to several pretest questions about the case. Each
case study gives a didactic presentation of up-to-date
information about the chemistry, toxicology,
symptomatology, and patient treatment for the toxic
substance of interest. The evaluation consists of a
series of questions that allow practitioners to test
their understanding of the material. Responses to the
questions are provided to assure optimum learning
benefit. After completing the case study, participants
may apply for continuing medical education (CME) credit
and can file the report for future reference.
6.4 Outcomes and Benefits
Reactions from members of the health
care community have been very favorable. Comments
indicate that the Case Studies are timely, well written,
well targeted, and address the concerns of primary care
physicians. Physicians participating in a pilot
evaluation indicated that the documents are particularly
useful because they do not require special equipment such
as computers or videotape players. Other criteria for
evaluating the content and effectiveness of the Case
Studies are (1) number requested; (2) number distributed;
(3) number of CME credits awarded; (4) number of
recipients on mailing list; (5) item analysis; (6)
satisfaction and knowledge posttest; (7) anecdotal
feedback; and (8) costs.
More than 90,000 Case Studies have been distributed, more
than 1,500 CME credits have been awarded, and the mailing
list contains more than 4,000 names. Approximately 10
requests for copies are received daily. Anecdotal
feedback indicates that communication between physician
and patient about the health effects of exposure to
hazardous substances has improved, and some physicians
are reportedly making minor changes in their practice.
Moreover, academic-based physicians report extensive use
of the Case Studies in Environmental Medicine for
teaching medical residents.
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Center for Devices
and Radiological Health, Food and Drug Administration
(FDA)—Bjork Shiley Convexo-Concave (BSCC) Heart Valve
7.1 Case Description
In recent years, FDA has changed its
approach to informing patients of risks associated with
medical devices. Previously, FDA had avoided direct
patient notification through general public media such as
press releases and required the device manufacturer to
inform the physician. FDA's new approach of direct
contact with the public is strongly influenced by two
major concepts: (1) Patients have the right to know about
the possibility of serious harm from problematic medical
devices; and (2) FDA or the manufacturer has a duty to
provide the information directly.
A series of focus tests with consumers, health
professionals, and manufacturers resulted in
recommendations for a two-tiered patient-notification
approach: a letter to the physician, followed by a letter
to the patient 2 weeks later. This case study
represents one of FDA's first attempts to use the
two-tiered system.
7.2 Characterization of Risk
In 1990, FDA was informed by a
manufacturer of heart valves of its intent to conduct a
patient-notification program for an estimated 23,000
surviving BSCC patients in the United States. Statistical
data had shown a higher-than-normal incidence of valve
fractures, generally resulting in patient death. The
manufacturer's response to this unusually high failure
rate was to establish a program for identifying and
locating patients, then advising them to discuss with
their physicians the risks and emergency procedures to
follow in the event of valve fracture. Patients were also
invited to join an implant registry that would facilitate
future notifications. The manufacturer assumed financial
responsibility for the enrollment of all patients in the
registry. FDA participated in the risk communication
effort by reviewing the patient notification letter.
7.3 Health Risk Communication
Procedures
Attempts to identify and notify
patients were undertaken through two methods: (1) media
outreach consisting of press conferences, news releases
through all major wire services, and advertisement in
major medical journals and consumer magazines; and (2)
letters of notification to patients and physicians
describing the problems and risks associated with the
valve failure. Three versions of the patient notification
letter were considered by FDA. Two versions of the
letter, developed by a research group and the
manufacturer, were rejected by FDA for lack of clarity
and overuse of frightening messages. Focus groups of
patients and risk communication experts commented on the
content and format of the synthesized FDA letter. Their
comments formed the basis of the final version.
Additional focus tests involving both patients and
physicians were conducted to evaluate the frightening
word content in the letter. The focus tests revealed that
the letter tended to arouse fears, created ambiguity
about the symptoms, and lacked personal appeal. An
FDA-revised letter was more favorably received, with most
patients agreeing that the tone of the letter was
positive and would motivate them to take the recommended
actions. Physicians also approved the content of the
letter after a period of revision.
7.4 Outcomes and Benefits
Of a possible 23,000 patients, more
than 16,000 have been identified, located, and notified.
The search of hospital records conducted by the
manufacturer was largely successful in identifying and
locating patients. Also contributing to the success of
outreach efforts were the emphasis on focus tests,
incentives to registry enrollment, message design and
clarification, and the solicitation of health
professionals' responses to notification messages. The
mass media campaign was judged to be less successful in
identifying patients only about 32 percent of the total
registered patients were identified through news releases
in the mass media.
An evaluation of notification procedures showed the
letter to be a highly effective risk communication
strategy. According to evaluations conducted by both an
independent evaluation contractor and FDA, 90 percent of the
patients received the letter from the implant registry
and understood the material (FDA figures were 94 percent and
89 percent, respectively). Also, 55 percent of the patients who
received the letter reported feeling relief rather than
irritation upon reading the material. Patients revealed
that they were satisfied with the notification program
and felt the program was appropriate (FDA reported this
rate as 72 percent).
ENDNOTES
(1)
Rotheram-Borus MJ et al. Reducing HIV sexual risk
behaviors among runaway adolescents. JAMA
1991;266:1237-41.
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