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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