Key Point

Currently, self-referred imaging is unregulated with regard to advertising, quality of imaging, and information given to patients. Self-referred imaging raises numerous issues for patient and physician alike.

STANFORD, CALIF—Since the late 1990s, direct-to-consumer advertising has promoted full-body CT and MR scans as a method of early disease detection. However, not only is self-referred imaging unregulated by federal agencies such as the FDA; repeated scans also expose patients to high levels of radiation (often without prior warning) and may give results that are of questionable value.

Commercially driven imaging is a source of frustration among physicians, and even worse, can impair the relationship between a doctor and his or her patient when they disagree about self-referral. “We worry about issues like patient-physician trust and the need for repeated scans and follow-up tests when the self-referred results are positive,” said Judy Illes, PhD, Director of the Program in Neuroethics at Stanford University in California. To evaluate the quality of information that imaging centers use in their promotional materials, Dr. Illes and colleagues analyzed 40 print advertisements and 20 informational brochures. They found a lack of comprehensive, balanced information—a vital component for making informed decisions.¹

GATHERING, EVALUATING, ADVERTISEMENTS

Local, regional, and national newspapers as well as radio and Internet broadcasts were searched for self-referred imaging advertisements. Informational brochures were requested from all centers, and seven thematic categories were identified and designated as targets for comparison. These were¹:

• Health care technology, references to technology, diagnosis, detection, and cure of disease.
• Emotion, empowerment, and assurance (ie, statements directed at the consumer encouraging action in order to benefit from early findings or avoid overt catastrophic health consequences as a result of inaction).
• Incentives such as financing discounts, seasonal promotions, or special offers.
• Limited supporting evidence, including statements made with marginal scientific data, statements not following prior claims or standards, and statements that the investigators considered vague or misleading.
• References to the popularity of screening examinations and their increasingly common use, testimonials, statements about benefits to the public, and mention of celebrities.
• Statistics and numerical data relating to health care, disease, or the examination advertised.
• Images such as pictures of people, specialized text, scans, equipment, and logos.

The investigators analyzed 40 print advertisements from eight different newspapers. Mailed brochures were received from 20 of the 29 scanning companies from which they were requested. The theme of health care technology was present in 93% of advertisements; emotion, empowerment, and assurance statements were found in 98%; incentives were used in 88%; and images were included in 100% of the advertisements. Statistics were used in 23% of advertisements compared to 80% of brochures—this was the largest thematic difference between the two media. Limited supporting evidence was found in 38% of newspaper advertisements and in 25% of brochures.

OFFERING HOPE, PREYING ON FEAR

The themes of technology and emotion, empowerment, and assurance were analyzed in further detail.

Patients were depicted with family members in 62% of advertisements. In one advertisement, a man (presumably one who had not undergone whole-body scanning) was depicted as a ghost, walking arm in arm with apparent surviving family members.

In 100% of the advertisements, messages of happiness and gratitude were employed. Fear-evoking messages were used in 45% of advertisements. This means that 45% of advertisements contained both messages. Three radio advertisements contained information about disease statistics and financing options. Two Internet videos focused on personal testimonials, while a third used no testimonials but instead featured a walk through a cemetery with the narrator talking about diseases and early prevention.

Although nearly all of the advertisements recommended seeking further information by calling the company’s toll-free number or visiting their Web site, almost none suggested secondary sources of information, such as a primary care provider. More important, none mentioned the risks of having a scan.

“The problem is that there are no quality standards,” commented Scott W. Atlas, MD, Professor of Radiology and Chief of Neuroradiology at Stanford. “This means that no one knows the qualifications of the physician (radiologist) interpreting the scan. Moreover,” he continued, “there are no standards regarding the quality of the imaging methods used at the screening centers—these could be low-resolution, essentially inadequate studies, or they may indeed be adequate. No one knows, and there are no standards.”

PATIENTS NOT INFORMED

The authors noted that advertisements for self-referred imaging “do not provide prospective consumers with the information that allows them to be truly autonomous, informed decision makers.”

In the ads, consumers are not made aware of the possibility of false-positive results, nor is the correlation between scan results and actual clinical findings mentioned. About 25% of advertisements claimed (misleadingly) that the technology was FDA approved. The FDA has explicitly stated otherwise, the authors pointed out.

Several advertisements contained negative evaluations of accepted diagnostic tests, including colonoscopy, mammography, and treadmill and cholesterol tests, compared with the undocumented benefits of scanning procedures.

In conventional models of imaging centers, where physicians refer patients for suspected diseases, the standards are related to the quality of imaging, the radiologist’s interpretation, and service as judged by the referring physician, explained Dr. Atlas, who is also a Senior Fellow at Stanford’s Hoover Institution. In the consumer-initiated setting, “the customer is the referring physician. However, in the model of the screening center where no physician has referred the patients and the customer is the ‘normal’ patient, the motivations of the radiology center are subjected to different pressures that may or may not lead to different levels of quality in terms of patient care.”

In an editorial,² Patrick G. O’Malley, MD, MPH, and Allen J. Taylor, MD, pointed out that neither MR nor CT scans have been proven to be cost-effective. They added that the risks accompanying these screening tests need to be examined: specifically, disease labeling, false-positive results, incidental scan findings, psychological effects (such as worry and anxiety), radiation exposure, wasteful costs, and the lower likelihood of insurability.

Now that self-referral for screening has become an accepted practice among the public, what can be done on the part of the medical community? “As a team,” said Dr. Illes, “we are promoting gathering of all stakeholders—physicians, bioethicists, self-referred imaging service providers, policy makers, consumers, and others—to create a framework and some guidelines for best practice standards for this industry, including quality control, scanning frequency for consumers, and advertising.”

Drs. O’Malley and Taylor also called for action by the health care community to “advocate for regulatory control comparable to what is in place for pharmaceutical advertising.”

—Gale Jurasek

References
1. Illes J, Kann D, Karetsky K, et al. Advertising, patient decision making, and self-referral for computed tomographic and magnetic resonance imaging. Arch Intern Med. 2004;164:2415-2419.
2. O’Malley PG, Taylor AJ. Unregulated direct-to-consumer marketing and self-referral for screening imaging services. Arch Intern Med. 2004;164:2406-2408.

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