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Should Whole-Body CT Screening Be Performed with Contrast Media?

¹ Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Rd., Skokie, IL 60076, and Rush Medical College, Chicago, IL.

Received July 16, 2002; accepted after revision July 31, 2002.

 
Case summaries are based on actual events and lawsuits, although certain facts have been omitted or modified by the author. All opinions expressed herein are those of the author and do not necessarily reflect those of the American Journal of Roentgenology or the American Roentgen Ray Society.

Address correspondence to L. Berlin.

The Case

Top The Case Medical—Legal Issues Discussion Contrast Media Summary and Conclusions References

 
While shopping one day in a suburban mall, a 58-year-old woman noticed a radiology imaging center that displayed multicolored posters that invited the public to "Walk in now for a CT screening of your body; no appointment necessary." The patient entered the CT facility and agreed to undergo a body scan immediately. A technologist in the facility took the patient into a waiting area and proceeded to show her a 10-min video that explained the purpose for the scan, how the CT equipment functioned, and the various conditions that could be diagnosed by CT. Toward the end of the video, a radiologist appeared on the television monitor to explain that contrast media would be administered and the reasons for doing so. The radiologist informed the viewers that they were going to be asked to sign a form consenting to the administration of contrast media, but he admonished them to tell the technologist if they had any major allergies or a history of reactions to previously administered contrast media. At the conclusion of the video, the patient signed the consent form and proceeded to undergo the CT examination.

After the noninfusion images had been obtained, a technologist administered IV 100 mL of a nonionic contrast agent. Additional CT images were then obtained, after which the patient was asked to sit up and get off the table. As she stood up and began walking away from the table, the woman suddenly complained that she couldn't breath and then collapsed onto the floor. The radiologist, who had been in another room, came immediately to aid the patient, and paramedics were quickly summoned by telephone. Efforts to resuscitate the patient were initiated by the radiologist and his staff and then continued when paramedics arrived. Nevertheless, the patient died. A later autopsy conducted by the medical examiner attributed the cause of death to "anaphylactic reaction to contrast media."

Eight months later the family of the deceased filed a lawsuit against the radiologist alleging negligence for "inappropriate use of contrast agents."

Medical—Legal Issues

Top The Case Medical—Legal Issues Discussion Contrast Media Summary and Conclusions References

 
The radiologist's professional insurance company appointed an attorney to represent him, and discovery proceedings began. The defendant radiologist and a radiology expert retained by the defense attorney testified during discovery that the anaphylactic reaction had been impossible to predict, but that once it occurred, it had been recognized immediately and treated promptly and appropriately. A radiology expert retained by the plaintiff's attorney acknowledged that the anaphylactic reaction experienced by the patient had been unpredictable and treated appropriately, but the expert asserted that the contrast agent had been "inappropriately administered to begin with." The plaintiff's expert asserted that "the dangers of contrast media are well known," and that "they should be administered only when there are valid medical indications." The plaintiff's expert then went on to claim that there had been no medical reason to administer contrast material in this woman who had been "asymptomatic and who because she saw a poster on a store-front in a shopping mall decided on a whim to get a CT scan." This is "plain, old-fashioned malpractice," exclaimed the plaintiff's expert.

Anticipating that they were not likely to prevail in a jury trial, the defendant radiologist's insurance representative and defense attorney recommended that the lawsuit be settled. A settlement agreement was reached, the terms of which were not disclosed.

Discussion

Top The Case Medical—Legal Issues Discussion Contrast Media Summary and Conclusions References

 
A CT screening craze has descended on the radiology community and seems to be gaining momentum with every passing day. Screening centers seem to be sprouting up in cities all over the nation, and radio, television, newspaper, and magazine advertisements with increasing frequency are urging men and women who are asymptomatic to come in to a nearby radiology facility and undergo CT screening to determine whether they are harboring a small cancer that, if left undetected, would result in the patient's death [1]. Referring to this movement as the "new age of entrepreneurial CT screening," radiologist Michael Brant-Zawadzki [2] attributes its expansion to

...the growing "boomer" population and its associated preoccupation with life span prolongation and wellness...the increased standard of living and the ready access of this generation to medical information through the Internet and other mass media...a sense of medical self-empowerment...[and] consumer-driven medicine.

On center stage of the CT screening phenomenon stands the radiologist who, according to the medical director of a national CT screening enterprise, Craig Bittner [3], is "...in the patient's eye a real doctor...who speaks to patients and makes clinical judgments and recommendations as to course of action." Brant-Zawadzki [2] also places radiologists in pivotal roles, emphasizing that they are

...are well positioned to optimize triage for patients who need further medical care.... Provide reassurance to those anxious healthy individuals whose screening studies are unremarkable, or whose scans show pseudodisease, and guide them in proper health maintenance...

Placing the radiologist in the center of the CT screening phenomenon may at the same time place the radiologist in the center of a medical malpractice maelstrom. Radiologists involved in whole-body CT screening could fall into many potential malpractice pitfalls. The case described in this article focuses on the legal issue of whether contrast media should be administered when whole-body CT screening is performed. A companion article [4] discusses other issues.

Contrast Media

Top The Case Medical—Legal Issues Discussion Contrast Media Summary and Conclusions References

 
The incidence of fatal or serious but non-fatal adverse allergic reactions to iodinated contrast media has been well documented [5, 6]. In addition to allergic reactions, contrast media—induced nephropathy has been reported to occur in as many as 30% of patients with preexisting renal insufficiency [7]. It is not surprising, then, that radiologists are reluctant to administer these potentially life-threatening agents to patients unless there are valid medical indications to do so.

Who has the responsibility of determining whether contrast media should be used in CT examinations? Three standards published by the American College of Radiology (ACR) provide guidance. The ACR Standard for the Performance of Pediatric and Adult Thoracic Computed Tomography (CT), revised in 1998, states [8]:

As with all procedures, the relative benefits and risks of the procedure should be evaluated prior to the performance of thoracic CT with use of iodinated contrast.... The physician shall have the responsibility of reviewing all indications for the examination; specifying the use, dosage, and rate of administration of contrast agents.... The examination may be conducted without contrast, with contrast, or both as clinically indicated.

The ACR Standard for the Performance of Computed Tomography (CT) of the Abdomen and Computed Tomography (CT) of the Pelvis, revised in 2001, states [9]:

As with all procedures, the relative benefits and risk of the procedures should be evaluated prior to the performance of iodinated contrast-enhanced abdominal CT and pelvic CT.... Optimization of the CT examination requires the supervising physician to develop an appropriate CT protocol based on careful review of the patient's history (to include risk factors that might increase the likelihood of adverse reactions to contrast media).

And the ACR Standard for Performing and Interpreting Diagnostic Computed Tomography (CT), 2001, states [10]:

Computed tomography examinations should be performed only for a valid medical reason.... The physician shall have the responsibility for reviewing all indications for the examinations; specifying the use, dosage, and rate of administration of contrast agents.... Policies with respect to contrast...must be administered in accordance with institutional policy as well as state and federal regulations.

Although not formally labeled a standard, the ACR's Digest of Council Actions, 1999 [11], provides additional guidance:

It cannot be emphasized too strongly that each patient undergoing each type of contrast examination requires consideration of the specific situation. In the final analysis, the radiologist (in consultation with the referring physician when necessary) is responsible for that patient and the radiological examination the patient is to undergo, and is in the best position to design the study, properly prepare the patient as indicated by the specific clinical circumstances, and select the appropriate contrast material.... The radiologist should be directly involved in the performance of the procedure, determining its extent, administering and supervising the use of contrast media.... Direct involvement in the performance of scanning procedures requires...determination of the need for contrast media.

It is clear from these statements that the determination of whether contrast media should be used in a CT examination rests primarily with the radiologist. In fact, in the case of a screening CT examination in which the patient has no referring physician, the decision whether to use contrast media rests solely with the radiologist. What is not clear, however, is whether contrast media is or is not indicated in the performance of screening CT. As yet there is a consensus neither in the radiology community nor in any appeals court decision that addresses this issue.

Robert Stanley [12], radiology chair at the University of Alabama, is critical of screening CT performed without contrast material. He has written that images obtained on whole-body CT without the administration of contrast agents are "pretty" and characterized by "remarkable anatomic detail," but "important and fundamental aspects of potentially discovered diseases are not discernible. In other words, the pictures are pretty, but they don't tell enough."

Although generally radiologists involved in CT screening elect not to administer contrast media, some choose to do so. Although acknowledging that the use of contrast media is controversial because of potential risks, Johns Hopkins University radiologists Elliot Fishman and Karen Horton [13] include in their CT screening protocol the IV injection of 120 mL of contrast media.

Medical malpractice litigation alleging improper radiology practice occurs even when consensus exists in the radiology community regarding the parameters of that practice. When consensus is lacking on those parameters, however, such as whether to use contrast media in CT screening, medical malpractice litigation is likely to be initiated with greater frequency. If contrast material is not used and a small carcinoma of an abdominal or pelvic organ is missed, a plaintiff's attorney may well be able to find a well-credentialed radiology expert who will testify that the standard of care requires the use of contrast media in CT screening. In cases in which contrast material is used and a patient dies or sustains serious complication resulting from the contrast material, the plaintiff's attorney may well be able to find a well-credentialed radiology expert who will testify that the standard of care requires that radiologists not administer contrast media when performing CT screening.

Summary and Conclusions

Top The Case Medical—Legal Issues Discussion Contrast Media Summary and Conclusions References

 
Whether contrast media should be administered when whole-body CT screening examinations are performed is controversial. Those standards published by the American College of Radiology that deal with contrast media are based on the assumption that patients undergoing radiologic testing are symptomatic and referred to radiologists by a nonradiologist physician who has examined the patient. As has been shown, the decision of whether to use contrast media when performing these examinations rests primarily with the radiologist. Through training and experience, radiologists have familiarized themselves with indications for the use of contrast media. Having developed a respect for the potential complications of contrast media, radiologists have also learned to refrain from using these agents when appropriate indications do not exist. In the past, there has been little disagreement in the radiology community with regard to the administration of contrast media in the clinical setting. In the screening setting, however, disagreement may well become more commonplace.

The question of whether to use contrast media in CT screening examinations is at present unanswered and will undoubtedly be debated for some time to come. In the mean-time, radiologists participating in CT screening should be mindful of the potential legal pitfalls that contrast media present.

References

Top The Case Medical—Legal Issues Discussion Contrast Media Summary and Conclusions References

 

1. Berlin L. Liability of performing CT screening for coronary artery disease and lung cancer. AJR 2002;179:837 -842[Free Full Text]
2. Brant-Zawadzki M. CT screening: why I do it. AJR 2002;179:319 -326[Free Full Text]
3. Bittner C. CT screening offers new options for radiology. Diagnostic Imaging 2001;23(7):25 , 27-28
4. Berlin L. Potential legal ramifications of whole-body CT screening: taking a peek into Pandora's box. AJR 2003;180:317 -322[Free Full Text]
5. Spring DB, Bettman MA, Barkan HE. Nonfatal adverse reactions to iodinated contrast media: spontaneous reporting to the U. S. Food and Drug Administration, 1978-1994. Radiology 1997;204:325 -332[Abstract/Free Full Text]
6. Spring DB, Bettman MA, Barkan HE. Deaths related to iodinated contrast media reported spontaneously to the U. S. Food and Drug Administration, 1978-1994: effect of the availability of low—osmolarity contrast media. Radiology 1997;204:333 -337[Abstract/Free Full Text]
7. Spinosa DJ, Kaufmann JA, Hartwell GD. Gadolinium chelates in angiography and interventional radiology: a useful alternative to iodinated contrast media for angiography. Radiology 2002;223:319 -325[Abstract/Free Full Text]
8. American College of Radiology. ACR standard for the performance of pediatric and adult thoracic computed tomography (CT). In: Standards 2001-2002. Reston, VA: American College of Radiology, 2001:103 -107
9. American College of Radiology. ACR standard for the performance of computed tomography (CT) of the abdomen and computed tomography (CT) of the pelvis. In: Standards 2001-2002. Reston, VA: American College of Radiology, 2001:179 -181
10. American College of Radiology. ACR standard for performing and interpreting diagnostic computed tomography (CT). In: Standards 2001-2002. Reston, VA: American College of Radiology, 2001: 37-40
11. American College of Radiology. Digest of council actions. II. Criteria for the use of water soluble iodinated contrast agents for intravascular injections. Reston, VA: American College of Radiology, 2000:74,90 -92
12. Stanley RJ. Entrepreneurs are profiting by turning previously healthy people into "patients." Insight on the News, March 13, 2002. Available at: http://archives.insightmag.com/main.ctm/include/detail/storyid/161188.html. Accessed May 8, 2002
13. Fishman EK, Horton KM. Screening strategy joins contrast, noncontrast scans. Diagnostic Imaging 2002;24(6):45 , 47

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