- Email: [email protected]
Medicolegal and ethical issues in radiologic screening
Medicolegal and Ethical Issues in Radiologic Screening Leonard Berlin
N RESPONSE TO an advertisement placed by an imaging center in a local newspaper, a 55-year-old man scheduled a computed tomography (CT) colonography examination. The patient underwent the study in both the supine and prone positions, with images obtained on a 4-row multidetector CT, without incident. One hour after the colonography had been completed, the interpreting radiologist reviewed the study with the patient, reported to him that the examination was normal, and gave the patient a CD-ROM that contained all of the CT images. There was no further contact between the man and the radiologist. One year later, the patient filed a medical malpractice lawsuit against the radiologist and the imaging facility alleging failure to diagnose colon cancer. Subsequent review of the patient' s medical records revealed that 8 months after the colonography examination the patient had noted blood in his stool. The patient's family physician referred the patient to a gastroenterologist, who performed colonoscopy that revealed a 3-cm polypoid lesion in the sigmoid colon. After biopsy confirmed the presence of adenocarcinoma, the patient underwent surgery. Metastases in the adjacent lymph nodes and peritoneum were noted, and the patient received extensive chemotherapy. The patient filed the malpractice lawsuit while still undergoing therapy. During discovery proceedings, the plaintiff's attorney produced an expert radiology witness who testified in deposition that when he reviewed the patient's colonography images that had been retained on the CD ROM, he could identify a 1.5-cm polypoid lesion in the patient's sigmoid colon. The radiology expert went on to state that although the lesion "was not the most obvious one" he had seen, nevertheless, it was his opinion that the defendantradiologist's failure to observe the lesion was a breach of the standard of care. The attorney representing the defendant-radiologist was unable to find a radiology expert who was willing to testify in support of the defendant, for 3 radiologists to whom the defense attorney showed the images responded privately that they too could see the lesion in retrospect. While discovery was continuing, the patient died of metastatic colon cancer. The lawsuit was eventually settled for $1 mllion.
I
Seminars in Roentgenology, Vol 38, No 1 (January), 2003: pp 77-86
A 42-year-old man who heard a radio advertisement by an imaging center extolling the virtues of full-body CT scanning underwent the examination. A radiologist interpreted the study as normal and reported this to the patient. Two years later, after experiencing hematuria, the patient consulted his personal physician. CT at a nearby hospital ordered by the physician disclosed a 4-cm malignant-appearing lesion in the left kidney. After biopsy confirmed renal cell carcinoma, the patient underwent surgery followed by chemotherapy. The patient soon thereafter filed a malpractice lawsuit against the radiologist who had interpreted the initial full-body CT scan, alleging negligence for failing to diagnose the renal carcinoma. On reviewing the original study, the defendantradiologist was adamant that the study was normal. In retrospect, he did notice a lobulation on the lateral aspect of the patient's left kidney where the carcinoma was later discovered, but he insisted the density was a normal dromedary hump. A radiology expert with whom the defense attorney consulted concurred with the defendant-radiologist's interpretation and agreed to testify on behalf of the defendant. The plaintiff's attorney retained as an expert witness a radiologist practicing at a university hospital who was critical of the defendantradiologist for not administering contrast media during the CT screening examination. The plaintiff's expert asserted that he believed there was a "strong probability" that had contrast media been administered as part of the examination, the "lobulation that was thought to be a dromedary hump" by the defendant-radiologist would "almost certainly have been recognized as representing a tumor suspicious for malignancy." The plaintiff's expert went on to contend that administering contrast media "should be a part of every screening
From the Department of Radiology, Rush North Shore Medical Center, Skokie, 1L; and Rush Medical College, Chicago, IL. Address reprint requests to Leonard Berlin, MD, FACR, Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Road, Skokie, 1L 60076. Copyright 2003, Elsevier Science (USA). All rights reserved. 0037-198)(/03/3801-0010530.00/0 do# l O.lO53/sroe.2003.50009 77
78
CT," and that failure to do so constituted negligence. In his deposition, the radiology expert for the defense strongly disagreed with the plaintiff's expert. The defendant-radiologist refused to engage in settlement discussions with the plaintiff and thus the case proceeded to trial. At its conclusion, the jury found in favor of the patient, awarding damages in the amount of $750,000. A 64-year-old man scheduled himself for a full-body CT examination. The radiologist who interpreted the study called the patient into a reading room in which he explained to the patient that the study was normal except for a possible lesion in the liver. The radiologist pointed out a low-density area within the liver and informed the patient that the abnormality could be a cyst, a benign tumor, or a malignant tumor and suggested that the patient consult his private physician. The patient was referred by his private physician to a local hospital for additional radiologic studies. Sonography, CT with infusion, and magnetic resonance studies were obtained, all of which suggested that the nonspecific lesion within the liver was benign, but none indicated benignity with absolute certainty. After consulting with the radiologists in the department, the patient's referring physician told the patient that the radiologists believed "rather strongly" that the lesion was benign, perhaps a hemangioma, and that a follow-up study in 6 months was advised. However, added the physician, if the patient was "really concerned" about the lesion, a radiologist would be asked to perform a needle biopsy. The patient replied that he was "extremely anxious" about the finding and that he wanted to "know what's wrong with me right now." The attending physician arranged to have a needle biopsy performed by one of the radiology department's interventionists. During the procedure, the patient suddenly began to hemorrhage. Suspecting that he had inadvertently lacerated the liver, the radiologist obtained a stat CT that confirmed the laceration. The patient was taken to surgery where the liver injury was repaired, but the patient lost considerable blood. During the next 3 days, the patient experienced numerous complications, including septicemia and recurrent bleeding that required reoperation. Five days after the needle biopsy had been performed, the patient died. Autopsy revealed that the initial liver lesion dis-
LEONARD BERLIN
covered on the screening CT was a benign hemangioma. The patient's family sued the radiologist and the imaging facility at which the screening CT had been obtained, along with the radiologists, attending physician, and surgeon who had been involved with the patient's later care. Radiology experts were retained on both sides. The plaintiff's radiology expert claimed that the benign nature of the lesion should have been obvious and needle biopsy should "never" have been done. The defense experts disagreed, testifying that the lesion, once noted on the initial CT screening, had to be followed up and that once the patient demanded a needle biopsy, the biopsy "had to be done." Eventually the lawsuit was settled for a total of $800,000, the payment of which was shared by all of the codefendants. A 38-year-old woman presented herself at a radiology imaging center for a CT colonography examination. The woman explained that she had heard radio announcements and seen newspaper ads heralding the value of CT colonography and that because her father and her uncle had both died of colon carcinoma, she was concerned enough to want to undergo the CT procedure. The colonography was scheduled and begun. Both supine and prone images were obtained, but before the patient was excused, the technologist came back into the examination room and said that the views had to be repeated because "we need better images." Repeat views were obtained, and the radiologist later interpreted the study as normal. One month later, the woman called the radiologist at the imaging center and explained that she was "somewhat concerned" because she had now discovered that she was 8 weeks pregnant and wondered whether the radiation she had received during the CT examination would be "dangerous to her baby." The radiologist responded that his CT scanner was "low dose" and that the woman should not be worried about any harmful effects. One week later, the patient's obstetrician also called the radiologist to discuss the matter, and the radiologist reiterated his opinion that "there would be no problem." The radiologist heard nothing further from the woman or her obstetrician. One year later, the woman and her newborn child filed a malpractice suit against the radiologist. The plaintiff's lawsuit alleged that the woman carried the pregnancy to term and then delivered a
RADIOLOGIC SCREENING
baby boy with microcephaly and cardiac anomalies. The woman charged that the radiation that she had received during the CT colonoscopy "which had to be repeated because of equipment malfunction" was the cause of the baby's anomalies and that she "should have been warned of the dangers of radiation peculiar to women in the child-bearing age." A radiology expert retained by the plaintiff's attorney was extremely critical of the defendantradiologist for not obtaining a pregnancy test on the patient before the colonography and then for "failing to advise the patient that a voluntary termination of the pregnancy should be strongly considered due to the fact that the CT had to be repeated, resulting in a double dose of radiation." The defendant-radiologist's response was that signs stating, "If you are pregnant ot think you may be pregnant, please notify the technologist or the radiologist" hung in both the patient waiting area and the CT examination room and that it was therefore the patient's responsibility to have told the imaging personnel that she might be pregnant. The defendant-radiologist also added that the dose from the colonography, even though "several views" had to be repeated, was insufficient to cause the fetal anomalies. The plaintiff's attorney demanded $5 million to settle the case, explaining that the newborn would require extensive nursing and other medical care for the rest of the child's life. The lawsuit was eventually settled for $1.5 million. A 47-year old woman who noted a local imaging center's web site on which women were encouraged to undergo full-body CT screening to diagnose very early cancers including ovarian underwent the screening examination at that imaging center. After completion of the examination, a nurse informed the patient that she would be receiving a telephone call from the radiologist who had interpreted the study along with a written report of the findings. Two days later a radiologist telephoned the woman, explaining that an abnormality of the woman's left ovary had been found. The radiologist told the woman that she should see her personal physician, preferably a gynecologist, to follow up on the finding, inasmuch as ovarian cancer was "a possibility." He also added that a written report would be mailed to her. Two weeks later, the woman telephoned the imaging center because she had not received the written report.
79
The secretary answering the telephone responded that a copy of the report would be sent to her again. There was no further contact with the patient. One year later, the patient filed a medical malpractice lawsuit against the radiologist and the imaging center, alleging that they were negligent by "abandoning" her and failing to "adequately inform her of abnormal findings relating to her ovary and arrange competent follow-up care." The insurance company-appointed defense attorney for the radiologist and imaging center reviewed all of the available medical records. Indeed, the woman patient's account of her conversation with the nurse on the day of the examination, and her follow-up telephone call 1 week later, were substantiated in the imaging center's records. A closer review revealed that a clerk in the imaging center had recorded the patient's address incorrectly, apparently explaining the fact that neither the original nor the copy of the written radiology report had ever reached the patient. The defendantradiologist told his attorney that he had spoken with the patient by telephone 2 days after the initial examination and had informed her of the ovarian abnormality and had told her that she should see her private gynecologist. He acknowledged that he had not given specific names of physicians to the patient nor had he in any way followed up by telephone or by mail with the patient. Investigation also disclosed that the imaging center had no formal policy to follow-up abnormal findings on patient examinations. During discovery proceedings, a radiology expert retained by the plaintiff asserted that the defendant-radiologist had violated the principles of both the American Medical Association and American College of Radiology by failing to "properly provide medical care for the patient, care that should include direct notification of test results to the patient and assurance that follow-up would be obtained." The patient testified in deposition that because she had never received the written report from the imaging center and because the radiologist had never followed up his original telephone conversation with her, she "assumed" that her condition "was not that serious." It was not until nearly 1 year later that abdominal pain forced her to visit her personal physician, who then ultimately made the correct diagnosis of ovarian cancer.
80
After much negotiation, the lawsuit was settled for $200,000. A 60-year-old woman underwent a full-body screening CT and was told by the interpreting radiologist that the study was normal. The woman left, and the radiologist had no further contact with her. Two years later, however, the patient sued the radiologist claiming that she had developed adrenal cancer that "had gone undetected because of the radiologist' s negligence in failing to inform her she should have periodic follow-up CT scans." The attorney retained by the defendant-radiologist's insurance company to represent the radiologist reviewed all of the medical records. He found that the woman had been diagnosed as having carcinoma of the left adrenal gland 18 months after the initial CT screening examination. In a later deposition, the woman claimed that before leaving the imaging center at which she had undergone the CT screening, she had asked the radiologist when she should return for a follow-up examination. The woman claimed that the radiologist told her that she "needn't worry about anything for at least 3 or 4 years." The woman went on to claim that the defendant-radiologist's failure to specifically inform her to return for periodic examinations "had the effect of lulling her into a false sense of security into believing that her health was good and would remain so." The defendant-radiologist vehemently disagreed with the patient's account of the conversation that had been held on the day she had undergone the full-body CT. His recollection was that she had indeed asked the question about follow-up, and that he had responded, "If you continue to be concerned about your health, you should return for CT screening at yearly intervals." The defendant-radiologist reviewed the initial CT screening images and found the adrenal glands to be normal. He denied any wrongdoing in the case. The plaintiff's attorney retained a radiology expert witness who testified at deposition that the defendant-radiologist had the duty to discuss "all the pros and cons" of CT screening and should have "emphasized" to the patient that "even though the CT screening was normal, she should continue to be alert for any symptoms that may emerge and should be in touch with her family physician." Refusing all efforts by the plaintiff to settle the case, the defendant-radiologist and his attorney prepared for trial. On the eve of the trial, the plaintiff withdrew the lawsuit.
LEONARD BERLIN
DISCUSSION
None of these cases actually happened, and, in fact, no malpractice lawsuits arising from alleged wrongdoing involving whole-body CT screening have as yet been reported. These 6 scenarios were created to illustrate the potential malpractice pitfalls into which radiologists involved in CT screening could fall. The era of CT screening began to emerge the early 1990s 1 when radio and newspaper advertisements began appearing that exhorted middle-aged men and women to undergo routine CT testing. 2 An abrupt surge in the public's clamor for CT screening occurred on October 2, 2000, the day the test was publicized by television talk-show personality Oprah Winfrey. On the day following the Oprah Winfrey show, scanning companies all over the country were besieged, and in the words of an executive of a CT scanning company, "We had 500-600 phone calls the next d a y . . , it was insane. People went nuts. ''1 As the CT screening movement continues to grow throughout the United States, it is quite possible that malpractice litigation alleging the various acts of radiologic negligence described here will emerge and grow as well, plunging radiologists involved in CT scanning deeper and deeper into the malpractice quagmire. Let us examine more closely the malpractice pitfalls presented. THE FALSE NEGATIVE
The radiologic literature for more than 50 years has been replete with studies showing that errors committed by radiologists when interpreting radiographic examinations are not uncommon. 3 Various researchers 3-6 have found that an average error rate of 30% is prevalent in plain film radiography. Error rates of similar degree have also been documented in virtually all other techniques used in radiologic practice including sonography, v angiography, 8-Io thallium radionuclide heart scanning, lj mammography,12 and magnetic resonance imaging. 13-15 What about the error rate for CT colonography examinations? An article published in 196016 reported that 32% of colon cancers were missed on barium enema examinations. One might speculate that the error rate in detecting colon cancers on CT colonography is lower, but this may not be the case. Although there are studies showing that the overall sensitivity of CT colonography for polyp
RADIOLOGIC SCREENING
detection hovers in the 90% range, I7 no reports measuring actual error rates committed by radiologists interpreting the modality have yet been published• There are, however, many published reports that address the frequency of errors committed in the interpretation of other kinds of CT examinations. One experienced thoracic radiologist, even knowing prospectively that each chest CT in a study group included a missed cancer, was able to identify the missed lesion in less than half the cases. 18 Other researchers 19 found that half of the lung cancers detected on helical CT were present in retrospect on a prior CT examination. Still others 2°-23 have documented miss rates ranging from 13.5% to 37% among radiologists' interpretations of body CT scans. It is likely that error rates in the interpretation of CT colonography and full-body scans will fall into the same range. OVERDIAGNOSIS AND COMPLICATIONS
The term overdiagnosis in the context of screening has been defined as the finding of a tumor or other disease that is not dangerous but nevertheless cannot be distinguished from one that may become lethal, 24 or a preclinical pseudodisease that would not have produced any signs or symptoms before the individual would have died from other causes.25 Among the adverse sequelae of overdiagnosis are complications that may result from diagnostic procedures designed to investigate an apparent abnormality on a CT scan that later turns out to be clinically unimportant. William J. Casarella, MD, Chair of the Department of Radiology at Emory University School of Medicine in Atlanta, GA, has written a firsthand experience of the clinical drama that can follow a screening test. 26 Dr Casarella underwent a CT colonographic examination that was interpreted as normal, but the interpreting radiologists noted lesions in the kidney, liver, and lungs. Contrast material-enhanced CT scan of the abdomen showed the renal mass to be a cyst, but to identify the nature of the liver lesion, a CT-guided liver biopsy was performed. It showed only necrotic tissue, but the findings were not definitive. Finally, a positron emission tomographic scan and a video-aided thoracoscopy were performed, the latter involving 3 wedge resections of the fight lung. A definitive diagnosis of histoplasmosis was finally made. Dr Casarella then goes on to relate that he awoke after the biopsy with a chest tube, a
81
Foley catheter, a subclavian central venous catheter, a nasal oxygen catheter, an epidural catheter, and an arterial catheter all in place• He was also given subcutaneously administered heparin, a constant infusion of prophylactic antibiotics, and analgesia with intravenously administered narcotics. Eventually, after 5 weeks of convalescence and $50,000 in medical expenses, Dr Casarella recovered. Casarella reflected on this experience: High-spatial resolution chest CT is a superb imaging tool. At the moment, it is very sensitive but not specific enough. The pursuit of falsepositive findings in the lungs is at best costly, anxiety producing, and involves 2 years of repeated CT scans. At worse, it will lead to painful, costly, and potentially risky major surgical procedures. Routine screening of the lungs with CT will produce more surgery and certainly more CT scans to monitor change. We as radiologists must understand the consequences to the patient. It is not nihilistic to suggest that more research is needed, and we still need to prove that search for occult lesions will improve the length and quality of life. Addressing the issue of overdiagnosis, the web site of the US Food and Drug Administration contains the following admonition: "If your CT screening result is interpreted as abnormal and there is really nothing significantly wrong with you, then you may be subjected to still further tests or treatments, all of which have their own risks • . . The surprising fact about a CT interpretation of abnormality when there is nothing significant wrong is that it is far more likely to happen to you than the finding of any actual life-threatening disease, since the likelihood that you actually had any deadly disease is so small to begin with. ''27 In its statement on whole-body CT, the American College of Radiology expresses similar sentiments: "The ACR is concerned that [CT screening] will lead to the discovery of numerous findings that will not ultimately affect patients' health but will result in increased patient anxiety, unnecessary follow-up examinations and treatments, and wasted expense."28 Patients who sustain complications and injuries resulting from medical procedures that may not have been indicated to begin with because they were performed because of an abnormality seen on CT screening that later turned out to be insignificant, may well choose to pursue malpractice litigation.
82
LEONARD BERLIN
RADIATION EXPOSURE
Concerns regarding the amount and effect of radiation exposure to CT cannot be ignored. CT scanning systems used in the early 1990s generated an average radiation dose for head scans of 40 to 60 mGy (4-6 rads) and for body scans 10 to 40 mGy (1-4 rads). Radiation doses to patients with multidetector CT are 30% to 50% greater than with older single-slice CT scanners. 29 The question of whether radiation exposure from CT screening will increase the incidence of cancer in the general population is controversial. On a web site, the US Food and Drug Administration, explains the matter this way: " A C T examination may be associated with an increase in the possibility of fatal cancer of approximately 1 chance in 2000. This increase in the possibility of a fatal cancer from radiation can be compared with the natural incidence of fatal cancer in the US population, about 1 chance in 5. In other words, for any one person the risk of radiation-induced cancer is much smaller than the natural risk of cancer. Nevertheless, this small increase in radiation-associated cancer risk for an individual can become a public health concern if large numbers of the population undergo increased numbers of CT screening procedures of uncertain benefit. ''3° The potential damage from CT radiation is greater in children because they are 10 times more sensitive to radiationP 1 The best risk estimates suggest that pediatric CT will result in significantly increased lifetime radiation risk than adult CT. 32 Brant-Zawadzki and Silverman 33 downplay the potential association of carcinogenesis with radiation. They have claimed that objective authentication of the nation's knowledge that low doses of radiation cause cancer simply is not available at this time and may never be. With regard to a woman who is pregnant or who may think she is pregnant, it should be pointed out that radiation-induced teratogenesis is primarily a concern from the 10th to 17th week of gestation. 34 Radiation-induced central nervous system abnormalities and growth retardation most commonly occur in fetuses between 2 and 15 weeks gestation. The radiation dose below which no deleterious effects on the fetus occur even in the most sensitive developmental phase is not known with certainty, but it has been estimated to range from .05 to .15 Gy (5-15 rads). 35 The medical malpractice risks arising from alle-
gations of radiation injury because of CT screening are unknown. Could potential plaintiffs be successful in alleging in a malpractice lawsuit that they developed carcinoma from a screening CT? Could a potential female plaintiff successfully claim that she gave birth to a baby with congenital anomalies caused by the radiation exposure received when she had undergone CT screening at a time when, unbeknownst to her or the radiologist, she was pregnant? These questions cannot be answered at this time. ABANDONING A PATIENT
Radiologists incur certain duties to self-referred patients. The ACR Standard for Communication: Diagnostic Radiology, 2001 revision for the first time included the following provision: "Radiologists should recognize potential obligations in assuming the care and treatment of patients who present themselves for imaging studies on a selfreferred basis. Such obligations may include communicating the results of the imaging studies to the patient and the necessity of appropriate follow-up."36 Historically most radiologists have not thought of themselves as primary care physicians to patients, but the CT screening movement has markedly altered this dynamic. Radiologists who solicit patients to undergo screening radiologic examinations without being referred by a primary care physician will find themselves placed in the position of acting as primary care physician. Once a patient undergoes the screening radiologic examination, a physician-patient relationship between the radiologist and patient is established. The radiologist cannot unilaterally terminate this relationship until or unless the patient is formally notified and arrangements for alternative medical care are made. A radiologist's failure to carry out this duty (and to document it appropriately) could well expose the radiologist to a charge of patient abandonments THE DUTY TO DISCLOSE: LEGAL AND ETHICAL PERSPECTIVES
A physician's legal duty to inform patients of the nature and potential complications of any diagnostic or therapeutic medical procedure and obtain the patient's informed consent before they undertake it is long standingY Radiologists are well acquainted with the need to disclose to pa-
RADIOLOGIC SCREENING
tients the benefits and risks of invasive procedures, alternative measures that might give similar results, and the risks of not performing the procedure. 39 However, in recent years, the informed consent process has been inexorably expanded not only to encompass a growing number of diagnostic radiologic and nonradiologic procedures but also to broaden the content of the disclosures. Courts have begun to impose duties on physicians to disclose to patients such information as physicians' experience, credentials, and personal habits that could affect professional performance?° The advent of CT screening will likely further expand the ground rules for informed consent. By encouraging persons to undergo testing designed to detect early disease, radiologists may be required to assume the responsibility of explaining to these persons the myriad uncertainties that pertain to early detection. For example, it has been accepted by the populace that early detection is a sure-fire way to save lives, and that if one detects a tumor very early, doctors will have the best chance of removing the cancer entirely. But recently, this thesis has been challenged in screening for several types of cancer. 4~ Tests are finding some tumors that would never become dangerous but cannot be distinguished from tumors that could become deadly, thereby subjecting certain patients to the risk of surgery, radiation, or chemotherapy. Patients will have to be explained this by their doctors. To reach a decision about whether to undergo a screening CT, patients will have to be educated by their physicians, and in the case of screening CT the self-referred patient's physician will be the radiologist. Radiologists will have to shed themselves of their personal feelings about the value of CT screening and accept the legal requirement as well as the moral imperative to provide unbiased information to patients about the procedure. The American Medical Association's Principals of Medical Ethics affirm this responsibility: "The patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives. Patients should receive guidance from their physicians as to the optimal course of a c t i o n . . . The patient has the right to make decisions regarding the health care that is recommended by his or her physician. Accordingly, patients may accept or refuse any
83
recommended medical treatment... A physician shall deal honestly with patients and colleagues. ''42 The Principles of Ethics of the American College of Radiology 43 likewise affirm that rendering of a service by a radiologist should be "governed by what is in the best interest of the patient." In February 2002, the US Preventive Services Task Force, an independent panel of experts that reviews research in a wide range of preventive services, issued a statement reaffirming recommendations that women over 40 undergo annual mammography. Included in this statement, however, was the following directive: "Clinicians should inform women about the potential benefits (reduced chance from dying from breast cancer), potential harms (eg, false-positive results, unnecessary biopsies), and limitations of the test that apply to women their a g e . ''44 Although not directly addressing CT screening, the New Jersey Supreme Court nevertheless echoed similar sentiments: "Physicians do not adequately discharge their responsibility by disclosing only treatment alternatives that they recommend . . . Physicians may [not] impose their values on their patients. 45 We do not know how courts will deal with informed consent and duty-to-divulge issues that may arise out of CT-screening lawsuits that may be filed in the future. We do not know how the courts would respond to a potential plaintiff-patient's lawsuit charging a radiologist with misrepresenting the value of a CT screening examination by overemphasizing its accuracy and efficacy while ignoring its potential downside risks. In the hypothetical scenario presented here, the patient alleged that the radiologist was negligent not only by failing to disclose the pitfalls of CT screening but by failing to be specific in giving follow-up recommendations as well. The extent to which a radiologist has a duty to recommend follow-up screening examinations is as yet undetermined. CONTRAST MEDIA
The incidence of fatal or serious but nonfatal adverse allergic reactions to iodinated contrast media has been well documented. 46-47It is thus not surprising that radiologists are reluctant to administer these potentially life-threatening agents to patients unless there are valid medical indications to do so.
84
LEONARD BERLIN
The determination of whether contrast media should be used in a CT examination rests primarily with the radiologist, 484° especially in the case of a screening CT examination in which the patient has no referring physician. However, as yet there is no consensus in the radiologic community that addresses the issue of whether contrast media is or is not indicated in the performance of screening CT. Many radiologists are critical of screening CT performed without administration of contrast, claiming that although images obtained on wholebody CT without contrast agents may be characterized by excellent anatomic detail, nevertheless much of potentially discovered diseases are not discernible. Certainly many tumors could be missed in the absence of contrast infusion. Although most radiologists involved in CT screening elect not to administer contrast media, some do. 51 If contrast media is not used and a small carcinoma of one of the abdominal or pelvic organs is missed, a plaintiff's attorney may well be able to retain 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 whichi contrast media is used and a patient sustains death or other serious complication resulting from the contrast media, the plaintiff's attorney may well be able to retain 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 FUTURE DIRECTIONS
The CT screening "craze" has descended on the radiologic 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 radiologic 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. No one can predict with any degree of certainty whether CT screening will flourish or for that matter even survive over the next decade. However, what can be predicted with reasonable certainty is that if CT screening does continue to grow, the types of allegations of wrongdoing discussed here (along with other allegations not yet
imagined) that have heretofore never hauled radiologists into the nation's courtrooms may well do so in the future. The final judicial disposition of any malpractice lawsuit depends to a great degree on the expert witness retained by the opposing attorneys. Ideally expert radiology witnesses seek the truth, are honest and unbiased, and do not become an advocate or a partisan in a legal proceeding, 52 but opinions rendered by expert radiology witnesses are sometimes slanted or influenced by what that radiologist believes to be "right" or "wrong." Many honest radiologists believe that CT screening is beneficial, whereas many similarly honest radiologists believe that CT screening is of no value. Some, in fact, suggest that the motivation of those who promote screening is not one of patient benefit but rather of personal financial gainP 3 Radiologists encouraging the public to undergo CT screening should be alerted that, in such an environment, a plaintiff's attorney who has filed a malpractice lawsuit against a radiologist claiming negligence involving a CT screening examination probably will have little difficulty in finding a reputable radiologist to testify as an expert witness against the defendant-radiologist. With the development of multirow CT scanners and their use by radiologists in hospitals and imaging centers around the nation, an entire industry in which CT is used for screening purposes has emerged. CT screening examinations to detect early carcinomas and other diseases are now being performed at numerous radiologic facilities in every state, and the number of such examinations appears to be growing exponentially. Unlike conventional radiologic practice in which patients are referred to radiologists by other physicians for radiologic examinations, CT screening studies are usually conducted on patients who refer themselves to radiologists, often because of newspaper and radio solicitations. Many of these solicitations are advertisements containing headlines and texts that explicitly or implicitly infer that the accuracy of the CT is perfect or near perfect and that the detection of early disease or cancer will assure cure of these maladies. Patients who come to expect that CT screening tests will without exception detect all diseases in their earliest stages that they may harbor, and that that
RADIOLOGIC SCREENING
85
disease will be cured, may well respond with a malpractice lawsuit if those expectations are not met. Perhaps an onslaught of malpractice litigation
arising from CT screening will never materialize. On the other hand, perhaps CT screening litigation will be unleashed and haunt radiologists for years to come.
REFERENCES 1. Burton TM: Do CT scans help or hurt patients seeking to prevent heart attacks? The Wall Street Journal, January 7, 2002:A13, A16 2. Chase M: Ads for heart scans prompt wider use of helpful screening. The Wall Street Journal, February 9, 1998:B1 3. Garland LH: On the scientific evaluation of diagnostic procedures. Radiology 52:309-328, 1949 4. Lehr JL, Lodwick GS, Farrell C, et ai: Direct measurement of the effect of film miniaturization on diagnostic accuracy. Radiology 118:257-263, 1976 5. Renfrew DL, Franken EA, Berbaum KS, et al: Error in radiology: Classification and lessons in 182 cases presented at a problem case conference. Radiology 183:145-150, 1992 6. Tsubamoto M, Kuriyama K, Kido S, et al: Detection of lung cancer on chest radiographs: Analysis on the basis of size and extent of ground-glass opacity at thin-section CT. Radiology 224:139-144, 2002 7. Hertzberg BS, Kliewer MA, Panlson EK, et al: PACS in sonography: accuracy of interpretation using film compared with monitor display. Am J Roentgenol 173:1175-1179, 1999 8. Manning WJ, Li W, Adelman RR: A preliminary report comparing magnetic resonance coronary angiography with conventional angiography. N Engl J Med 328:828-832, 1993 9. Van Beek EJR, Bakker AJ, Reekers JA: Pulmonary embolism: lnterobserver agreement in the interpretation of conventional angiographic and DSA images in patients with nondiagnostic lung scan results. Radiology 198:721-724, 1996 10. Diffin DC, Leyendecker JR, Johnson SP, et al: Effect of anatomic distribution of pulmonary emboli on interobserver agreement in the interpretation of pulmonary angiography. Am J RoentgenoI 171:1085-1089, 1998 11. Sigal SL, Soufer R, Fetterman RC, et al: Reproducibility of quantitative planar thallium-201 scintigraphy: quantitative criteria for reversibility of myocardial perfusion defects. J Nucl Med 32:759-765, 1991 12. Burhenne LJW, Wood SA, D'Orsi CJ, et al: Potential contribution of computer-aided detection to the sensitivity of screening mammography. Radiology 215:554-562, 2000 13. Schiebler ML, Yankaskas BC, Tempany BC, et al: MR imaging in adenocarcinoma of the prostate: Interobserver variation and efficacy for determining stage C disease. Am J Roentgenol 158:559-562, 1992 14. Robertson PL, Schweitzer ME, Mitchell DG, et al: Rotator cuff disorders: Interobserver and intraobserver variation in diagnosis with MR imaging. Radiology 194:831-835, 1995 15. Wakeley CJ, Jones AM, Kabala JE, et al: Audit of the value of double reading magnetic resonance imaging films. Br J Radiol 68:358-362, 1995 16. Cooley RN, Agnew CH, Rios G: Diagnostic accuracy of the barium enema study in carcinoma of the colon and rectum. Am J Roentgenol 84:316-331, 1960 17. Yee J, Akerkar GA, Hung RK, et al: Colorectal neoplasia: performance characteristics of CT colonography for detection in 300 patients. Radiology 219:685-692, 2001
18. White CS, Romney BM, Mason AC, et al: Primary carcinoma of the lung overlooked at CT: analysis of findings in 14 patients. Radiology 199:109-115, 1996 19. Kakinuma R, Ohmatsu H, Kaneko M, et al: Detection failures in spiral CT screening for lung cancer: analysis of CT findings. Radiology 212:61-66, 1999 20. Wechsler RJ, Spettell CM, Kurtz AB, et al: Effects of training and experience in interpretation of emergency body CT scans. Radiology 199:717-720, 1996 21. Gollub MJ, Panicek DM, Bach AM, et al: Clinical importance of reinterpretation of body CT scans obtained elsewhere in patients referred for care at a tertiary cancer center. Radiology 210:109-112, 1999 22. Kalbhen CL, Yetter EM, Olson MC, et al: Assessing the resectability of pancreatic carcinoma: The value of reinterpreting abdominal CT performed at other institutions. Am J Roentgenol 171:1571-1576, 1998 23. Siegel CL, Fisher AJ, Bennett HF: lnterobserver variability in determining enhancement of renal masses on helical CT. Am J Roentgenol 172:1207-1212, 1999 24. Kolata G: Test proves fruitless, fueling new debate on cancer screening. The New York Times, April 9, 2002:D1, D4 25. Black WC, Welch HG: Screening for disease. Am J Roentgenol 168:3-11, 1997 26. Casarella WJ: A patient's viewpoint on current controversy. Letter to the Editor. Radiology 224:927, 2002 (letter) 27. Whole-body CT screening--Should I or shouldn't I get one? US Food and Drug Administration, Center for Devices and Radiologic Health. Available at: http://www.fda.gov./cdrh/ct/ screening.html. Accessed July 9, 2002 28. Imaging modalities for screening. ACR Bulletin 57:5657, 2001 29. Hall EJ: Radiobiology for radiologist (ed 5). Philadelphia, PA, Lippincott, Williams & Wilkins, 2000, pp 204-212, 230-233 30. Whole body scanning: What are the radiation risks from CT? US Food and Drug Administration, Center for Devices and Radiologic Health. April 17, 2002. Available at: http://www. fda.gov./cdrh/ct/risks.html. Accessed July 9, 2002 31. Slovis TL: CT and computed radiography: the pictures are great, but is the radiation dose greater than required? Am J Roentgenol 2002;179:39-41, 2002 32. Brenner DJ, Elliston CD, Hall EJ, et al: Estimated risks of radiation-induced fatal cancer from pediatric CT. Am J Roentgenol 178:289-296, 2001 33. Brandt-Zawadzki M, Silverman JM: Cancer risk 'knowledge' may be an assumption. Diagn Imag 24:21-25, 2002 34. Kalbhen CL: Question and answer. Am J Roentgenol 178:1285-1286, 2002 35. Berlin L: Radiation exposure and the pregnant patient. Am J Roentgenol 167:1377-1379, 1996 36. American College of Radiology: ACR standard for communication: diagnostic radiology. Standards 2001-2002. Reston, VA, American College of Radiology, 2001, pp 3-5
86
37. Berlin L: Are radiologists contracted by third party to interpret radiographs liable for not communicating results directly to patients? Am J Roentgenol 178:27-33, 2002 38. Schloendorff v The Society of New York Hosp, 105 NE 92 (NY 1914) 39. Obergfell AM: Law & Ethics in Diagnostic Imaging and Therapeutic Radiology. Philadelphia, PA, Saunders, 1995, pp 85-92 40. Berlin L: The duty to disclose. Am J Roentgenol 171: 1463-1467, 1998 41. Cancer screening and the individual. The New York Times (editorial), April 14, 2002:12 42. American Medical Association Council on Ethical and Judicial Affairs: Principles of medical ethics. Fundamental elements of the patient- physician relationship. Guide to use of annotations. Code of medical ethics: cm~rent opinions with Annotations. Chicago, IL, American Medical Association, 2000, pp xii, xiv, xv 43. American College of Radiology: ACR bylaws 20002001, article XIII, sectionl, principles of ethics. Reston VA, American College of Radiology 2001 44. US preventive services task force (USPSTF). Recommendations and rationale: Screening for breast cancer, February 2002. Available at: http://www.ahrq.gov/clinic/3rduspst/ breastcancer/. Accessed February 22, 2002 45. Matthies v Mastromonaco, 733 A2d 456 (NJ 1999) 46. Spring DB, Bettman MA, Barkan HE: Nonfatal adverse reactions to iodinated contrast media: spontaneous reporting to
LEONARD BERLIN
the U.S. Food and Drug Administration, 1978-1994. Radiology 204:325-332, 1997 47. 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 204: 333-337, 1997 48. American College of Radiology: ACR standard for the performance of pediatric and adult thoracic computed tomography (CT). Standards 2001-2002. Reston, VA: American College of Radiology 2001:103-107 49. American College of Radiology: ACR standard for the performance of computed tomography (CT) of the abdomen and computed tomography (CT) of the pelvis. Standards 20012002. Reston, VA, American College of Radiology, 2001, pp 179-181 50. American College of Radiology: ACR standard for performing and interpreting diagnostic computed tomography (CT). Standards 2001-2002. Reston, VA, American College of Radiology, 2001, pp 37-40 51. Fishman EK, Horton KM: Screening strategy joins contrast, noncontrast scans. Diagn Imag 24:45-47, 2002 52. Lundberg GD: Expert witness for whom? JAMA 252: 251, 1984 53. Stanley RJ: Entrepreneurs are profiting by turning previously healthy people into "patients." Insight on the News. March 13, 2002. Available at: http://archives.insightmag.corrd main.ctm/include/detail/storyid/161188.html. Accessed May 8, 2002
N RESPONSE TO an advertisement placed by an imaging center in a local newspaper, a 55-year-old man scheduled a computed tomography (CT) colonography examination. The patient underwent the study in both the supine and prone positions, with images obtained on a 4-row multidetector CT, without incident. One hour after the colonography had been completed, the interpreting radiologist reviewed the study with the patient, reported to him that the examination was normal, and gave the patient a CD-ROM that contained all of the CT images. There was no further contact between the man and the radiologist. One year later, the patient filed a medical malpractice lawsuit against the radiologist and the imaging facility alleging failure to diagnose colon cancer. Subsequent review of the patient' s medical records revealed that 8 months after the colonography examination the patient had noted blood in his stool. The patient's family physician referred the patient to a gastroenterologist, who performed colonoscopy that revealed a 3-cm polypoid lesion in the sigmoid colon. After biopsy confirmed the presence of adenocarcinoma, the patient underwent surgery. Metastases in the adjacent lymph nodes and peritoneum were noted, and the patient received extensive chemotherapy. The patient filed the malpractice lawsuit while still undergoing therapy. During discovery proceedings, the plaintiff's attorney produced an expert radiology witness who testified in deposition that when he reviewed the patient's colonography images that had been retained on the CD ROM, he could identify a 1.5-cm polypoid lesion in the patient's sigmoid colon. The radiology expert went on to state that although the lesion "was not the most obvious one" he had seen, nevertheless, it was his opinion that the defendantradiologist's failure to observe the lesion was a breach of the standard of care. The attorney representing the defendant-radiologist was unable to find a radiology expert who was willing to testify in support of the defendant, for 3 radiologists to whom the defense attorney showed the images responded privately that they too could see the lesion in retrospect. While discovery was continuing, the patient died of metastatic colon cancer. The lawsuit was eventually settled for $1 mllion.
I
Seminars in Roentgenology, Vol 38, No 1 (January), 2003: pp 77-86
A 42-year-old man who heard a radio advertisement by an imaging center extolling the virtues of full-body CT scanning underwent the examination. A radiologist interpreted the study as normal and reported this to the patient. Two years later, after experiencing hematuria, the patient consulted his personal physician. CT at a nearby hospital ordered by the physician disclosed a 4-cm malignant-appearing lesion in the left kidney. After biopsy confirmed renal cell carcinoma, the patient underwent surgery followed by chemotherapy. The patient soon thereafter filed a malpractice lawsuit against the radiologist who had interpreted the initial full-body CT scan, alleging negligence for failing to diagnose the renal carcinoma. On reviewing the original study, the defendantradiologist was adamant that the study was normal. In retrospect, he did notice a lobulation on the lateral aspect of the patient's left kidney where the carcinoma was later discovered, but he insisted the density was a normal dromedary hump. A radiology expert with whom the defense attorney consulted concurred with the defendant-radiologist's interpretation and agreed to testify on behalf of the defendant. The plaintiff's attorney retained as an expert witness a radiologist practicing at a university hospital who was critical of the defendantradiologist for not administering contrast media during the CT screening examination. The plaintiff's expert asserted that he believed there was a "strong probability" that had contrast media been administered as part of the examination, the "lobulation that was thought to be a dromedary hump" by the defendant-radiologist would "almost certainly have been recognized as representing a tumor suspicious for malignancy." The plaintiff's expert went on to contend that administering contrast media "should be a part of every screening
From the Department of Radiology, Rush North Shore Medical Center, Skokie, 1L; and Rush Medical College, Chicago, IL. Address reprint requests to Leonard Berlin, MD, FACR, Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Road, Skokie, 1L 60076. Copyright 2003, Elsevier Science (USA). All rights reserved. 0037-198)(/03/3801-0010530.00/0 do# l O.lO53/sroe.2003.50009 77
78
CT," and that failure to do so constituted negligence. In his deposition, the radiology expert for the defense strongly disagreed with the plaintiff's expert. The defendant-radiologist refused to engage in settlement discussions with the plaintiff and thus the case proceeded to trial. At its conclusion, the jury found in favor of the patient, awarding damages in the amount of $750,000. A 64-year-old man scheduled himself for a full-body CT examination. The radiologist who interpreted the study called the patient into a reading room in which he explained to the patient that the study was normal except for a possible lesion in the liver. The radiologist pointed out a low-density area within the liver and informed the patient that the abnormality could be a cyst, a benign tumor, or a malignant tumor and suggested that the patient consult his private physician. The patient was referred by his private physician to a local hospital for additional radiologic studies. Sonography, CT with infusion, and magnetic resonance studies were obtained, all of which suggested that the nonspecific lesion within the liver was benign, but none indicated benignity with absolute certainty. After consulting with the radiologists in the department, the patient's referring physician told the patient that the radiologists believed "rather strongly" that the lesion was benign, perhaps a hemangioma, and that a follow-up study in 6 months was advised. However, added the physician, if the patient was "really concerned" about the lesion, a radiologist would be asked to perform a needle biopsy. The patient replied that he was "extremely anxious" about the finding and that he wanted to "know what's wrong with me right now." The attending physician arranged to have a needle biopsy performed by one of the radiology department's interventionists. During the procedure, the patient suddenly began to hemorrhage. Suspecting that he had inadvertently lacerated the liver, the radiologist obtained a stat CT that confirmed the laceration. The patient was taken to surgery where the liver injury was repaired, but the patient lost considerable blood. During the next 3 days, the patient experienced numerous complications, including septicemia and recurrent bleeding that required reoperation. Five days after the needle biopsy had been performed, the patient died. Autopsy revealed that the initial liver lesion dis-
LEONARD BERLIN
covered on the screening CT was a benign hemangioma. The patient's family sued the radiologist and the imaging facility at which the screening CT had been obtained, along with the radiologists, attending physician, and surgeon who had been involved with the patient's later care. Radiology experts were retained on both sides. The plaintiff's radiology expert claimed that the benign nature of the lesion should have been obvious and needle biopsy should "never" have been done. The defense experts disagreed, testifying that the lesion, once noted on the initial CT screening, had to be followed up and that once the patient demanded a needle biopsy, the biopsy "had to be done." Eventually the lawsuit was settled for a total of $800,000, the payment of which was shared by all of the codefendants. A 38-year-old woman presented herself at a radiology imaging center for a CT colonography examination. The woman explained that she had heard radio announcements and seen newspaper ads heralding the value of CT colonography and that because her father and her uncle had both died of colon carcinoma, she was concerned enough to want to undergo the CT procedure. The colonography was scheduled and begun. Both supine and prone images were obtained, but before the patient was excused, the technologist came back into the examination room and said that the views had to be repeated because "we need better images." Repeat views were obtained, and the radiologist later interpreted the study as normal. One month later, the woman called the radiologist at the imaging center and explained that she was "somewhat concerned" because she had now discovered that she was 8 weeks pregnant and wondered whether the radiation she had received during the CT examination would be "dangerous to her baby." The radiologist responded that his CT scanner was "low dose" and that the woman should not be worried about any harmful effects. One week later, the patient's obstetrician also called the radiologist to discuss the matter, and the radiologist reiterated his opinion that "there would be no problem." The radiologist heard nothing further from the woman or her obstetrician. One year later, the woman and her newborn child filed a malpractice suit against the radiologist. The plaintiff's lawsuit alleged that the woman carried the pregnancy to term and then delivered a
RADIOLOGIC SCREENING
baby boy with microcephaly and cardiac anomalies. The woman charged that the radiation that she had received during the CT colonoscopy "which had to be repeated because of equipment malfunction" was the cause of the baby's anomalies and that she "should have been warned of the dangers of radiation peculiar to women in the child-bearing age." A radiology expert retained by the plaintiff's attorney was extremely critical of the defendantradiologist for not obtaining a pregnancy test on the patient before the colonography and then for "failing to advise the patient that a voluntary termination of the pregnancy should be strongly considered due to the fact that the CT had to be repeated, resulting in a double dose of radiation." The defendant-radiologist's response was that signs stating, "If you are pregnant ot think you may be pregnant, please notify the technologist or the radiologist" hung in both the patient waiting area and the CT examination room and that it was therefore the patient's responsibility to have told the imaging personnel that she might be pregnant. The defendant-radiologist also added that the dose from the colonography, even though "several views" had to be repeated, was insufficient to cause the fetal anomalies. The plaintiff's attorney demanded $5 million to settle the case, explaining that the newborn would require extensive nursing and other medical care for the rest of the child's life. The lawsuit was eventually settled for $1.5 million. A 47-year old woman who noted a local imaging center's web site on which women were encouraged to undergo full-body CT screening to diagnose very early cancers including ovarian underwent the screening examination at that imaging center. After completion of the examination, a nurse informed the patient that she would be receiving a telephone call from the radiologist who had interpreted the study along with a written report of the findings. Two days later a radiologist telephoned the woman, explaining that an abnormality of the woman's left ovary had been found. The radiologist told the woman that she should see her personal physician, preferably a gynecologist, to follow up on the finding, inasmuch as ovarian cancer was "a possibility." He also added that a written report would be mailed to her. Two weeks later, the woman telephoned the imaging center because she had not received the written report.
79
The secretary answering the telephone responded that a copy of the report would be sent to her again. There was no further contact with the patient. One year later, the patient filed a medical malpractice lawsuit against the radiologist and the imaging center, alleging that they were negligent by "abandoning" her and failing to "adequately inform her of abnormal findings relating to her ovary and arrange competent follow-up care." The insurance company-appointed defense attorney for the radiologist and imaging center reviewed all of the available medical records. Indeed, the woman patient's account of her conversation with the nurse on the day of the examination, and her follow-up telephone call 1 week later, were substantiated in the imaging center's records. A closer review revealed that a clerk in the imaging center had recorded the patient's address incorrectly, apparently explaining the fact that neither the original nor the copy of the written radiology report had ever reached the patient. The defendantradiologist told his attorney that he had spoken with the patient by telephone 2 days after the initial examination and had informed her of the ovarian abnormality and had told her that she should see her private gynecologist. He acknowledged that he had not given specific names of physicians to the patient nor had he in any way followed up by telephone or by mail with the patient. Investigation also disclosed that the imaging center had no formal policy to follow-up abnormal findings on patient examinations. During discovery proceedings, a radiology expert retained by the plaintiff asserted that the defendant-radiologist had violated the principles of both the American Medical Association and American College of Radiology by failing to "properly provide medical care for the patient, care that should include direct notification of test results to the patient and assurance that follow-up would be obtained." The patient testified in deposition that because she had never received the written report from the imaging center and because the radiologist had never followed up his original telephone conversation with her, she "assumed" that her condition "was not that serious." It was not until nearly 1 year later that abdominal pain forced her to visit her personal physician, who then ultimately made the correct diagnosis of ovarian cancer.
80
After much negotiation, the lawsuit was settled for $200,000. A 60-year-old woman underwent a full-body screening CT and was told by the interpreting radiologist that the study was normal. The woman left, and the radiologist had no further contact with her. Two years later, however, the patient sued the radiologist claiming that she had developed adrenal cancer that "had gone undetected because of the radiologist' s negligence in failing to inform her she should have periodic follow-up CT scans." The attorney retained by the defendant-radiologist's insurance company to represent the radiologist reviewed all of the medical records. He found that the woman had been diagnosed as having carcinoma of the left adrenal gland 18 months after the initial CT screening examination. In a later deposition, the woman claimed that before leaving the imaging center at which she had undergone the CT screening, she had asked the radiologist when she should return for a follow-up examination. The woman claimed that the radiologist told her that she "needn't worry about anything for at least 3 or 4 years." The woman went on to claim that the defendant-radiologist's failure to specifically inform her to return for periodic examinations "had the effect of lulling her into a false sense of security into believing that her health was good and would remain so." The defendant-radiologist vehemently disagreed with the patient's account of the conversation that had been held on the day she had undergone the full-body CT. His recollection was that she had indeed asked the question about follow-up, and that he had responded, "If you continue to be concerned about your health, you should return for CT screening at yearly intervals." The defendant-radiologist reviewed the initial CT screening images and found the adrenal glands to be normal. He denied any wrongdoing in the case. The plaintiff's attorney retained a radiology expert witness who testified at deposition that the defendant-radiologist had the duty to discuss "all the pros and cons" of CT screening and should have "emphasized" to the patient that "even though the CT screening was normal, she should continue to be alert for any symptoms that may emerge and should be in touch with her family physician." Refusing all efforts by the plaintiff to settle the case, the defendant-radiologist and his attorney prepared for trial. On the eve of the trial, the plaintiff withdrew the lawsuit.
LEONARD BERLIN
DISCUSSION
None of these cases actually happened, and, in fact, no malpractice lawsuits arising from alleged wrongdoing involving whole-body CT screening have as yet been reported. These 6 scenarios were created to illustrate the potential malpractice pitfalls into which radiologists involved in CT screening could fall. The era of CT screening began to emerge the early 1990s 1 when radio and newspaper advertisements began appearing that exhorted middle-aged men and women to undergo routine CT testing. 2 An abrupt surge in the public's clamor for CT screening occurred on October 2, 2000, the day the test was publicized by television talk-show personality Oprah Winfrey. On the day following the Oprah Winfrey show, scanning companies all over the country were besieged, and in the words of an executive of a CT scanning company, "We had 500-600 phone calls the next d a y . . , it was insane. People went nuts. ''1 As the CT screening movement continues to grow throughout the United States, it is quite possible that malpractice litigation alleging the various acts of radiologic negligence described here will emerge and grow as well, plunging radiologists involved in CT scanning deeper and deeper into the malpractice quagmire. Let us examine more closely the malpractice pitfalls presented. THE FALSE NEGATIVE
The radiologic literature for more than 50 years has been replete with studies showing that errors committed by radiologists when interpreting radiographic examinations are not uncommon. 3 Various researchers 3-6 have found that an average error rate of 30% is prevalent in plain film radiography. Error rates of similar degree have also been documented in virtually all other techniques used in radiologic practice including sonography, v angiography, 8-Io thallium radionuclide heart scanning, lj mammography,12 and magnetic resonance imaging. 13-15 What about the error rate for CT colonography examinations? An article published in 196016 reported that 32% of colon cancers were missed on barium enema examinations. One might speculate that the error rate in detecting colon cancers on CT colonography is lower, but this may not be the case. Although there are studies showing that the overall sensitivity of CT colonography for polyp
RADIOLOGIC SCREENING
detection hovers in the 90% range, I7 no reports measuring actual error rates committed by radiologists interpreting the modality have yet been published• There are, however, many published reports that address the frequency of errors committed in the interpretation of other kinds of CT examinations. One experienced thoracic radiologist, even knowing prospectively that each chest CT in a study group included a missed cancer, was able to identify the missed lesion in less than half the cases. 18 Other researchers 19 found that half of the lung cancers detected on helical CT were present in retrospect on a prior CT examination. Still others 2°-23 have documented miss rates ranging from 13.5% to 37% among radiologists' interpretations of body CT scans. It is likely that error rates in the interpretation of CT colonography and full-body scans will fall into the same range. OVERDIAGNOSIS AND COMPLICATIONS
The term overdiagnosis in the context of screening has been defined as the finding of a tumor or other disease that is not dangerous but nevertheless cannot be distinguished from one that may become lethal, 24 or a preclinical pseudodisease that would not have produced any signs or symptoms before the individual would have died from other causes.25 Among the adverse sequelae of overdiagnosis are complications that may result from diagnostic procedures designed to investigate an apparent abnormality on a CT scan that later turns out to be clinically unimportant. William J. Casarella, MD, Chair of the Department of Radiology at Emory University School of Medicine in Atlanta, GA, has written a firsthand experience of the clinical drama that can follow a screening test. 26 Dr Casarella underwent a CT colonographic examination that was interpreted as normal, but the interpreting radiologists noted lesions in the kidney, liver, and lungs. Contrast material-enhanced CT scan of the abdomen showed the renal mass to be a cyst, but to identify the nature of the liver lesion, a CT-guided liver biopsy was performed. It showed only necrotic tissue, but the findings were not definitive. Finally, a positron emission tomographic scan and a video-aided thoracoscopy were performed, the latter involving 3 wedge resections of the fight lung. A definitive diagnosis of histoplasmosis was finally made. Dr Casarella then goes on to relate that he awoke after the biopsy with a chest tube, a
81
Foley catheter, a subclavian central venous catheter, a nasal oxygen catheter, an epidural catheter, and an arterial catheter all in place• He was also given subcutaneously administered heparin, a constant infusion of prophylactic antibiotics, and analgesia with intravenously administered narcotics. Eventually, after 5 weeks of convalescence and $50,000 in medical expenses, Dr Casarella recovered. Casarella reflected on this experience: High-spatial resolution chest CT is a superb imaging tool. At the moment, it is very sensitive but not specific enough. The pursuit of falsepositive findings in the lungs is at best costly, anxiety producing, and involves 2 years of repeated CT scans. At worse, it will lead to painful, costly, and potentially risky major surgical procedures. Routine screening of the lungs with CT will produce more surgery and certainly more CT scans to monitor change. We as radiologists must understand the consequences to the patient. It is not nihilistic to suggest that more research is needed, and we still need to prove that search for occult lesions will improve the length and quality of life. Addressing the issue of overdiagnosis, the web site of the US Food and Drug Administration contains the following admonition: "If your CT screening result is interpreted as abnormal and there is really nothing significantly wrong with you, then you may be subjected to still further tests or treatments, all of which have their own risks • . . The surprising fact about a CT interpretation of abnormality when there is nothing significant wrong is that it is far more likely to happen to you than the finding of any actual life-threatening disease, since the likelihood that you actually had any deadly disease is so small to begin with. ''27 In its statement on whole-body CT, the American College of Radiology expresses similar sentiments: "The ACR is concerned that [CT screening] will lead to the discovery of numerous findings that will not ultimately affect patients' health but will result in increased patient anxiety, unnecessary follow-up examinations and treatments, and wasted expense."28 Patients who sustain complications and injuries resulting from medical procedures that may not have been indicated to begin with because they were performed because of an abnormality seen on CT screening that later turned out to be insignificant, may well choose to pursue malpractice litigation.
82
LEONARD BERLIN
RADIATION EXPOSURE
Concerns regarding the amount and effect of radiation exposure to CT cannot be ignored. CT scanning systems used in the early 1990s generated an average radiation dose for head scans of 40 to 60 mGy (4-6 rads) and for body scans 10 to 40 mGy (1-4 rads). Radiation doses to patients with multidetector CT are 30% to 50% greater than with older single-slice CT scanners. 29 The question of whether radiation exposure from CT screening will increase the incidence of cancer in the general population is controversial. On a web site, the US Food and Drug Administration, explains the matter this way: " A C T examination may be associated with an increase in the possibility of fatal cancer of approximately 1 chance in 2000. This increase in the possibility of a fatal cancer from radiation can be compared with the natural incidence of fatal cancer in the US population, about 1 chance in 5. In other words, for any one person the risk of radiation-induced cancer is much smaller than the natural risk of cancer. Nevertheless, this small increase in radiation-associated cancer risk for an individual can become a public health concern if large numbers of the population undergo increased numbers of CT screening procedures of uncertain benefit. ''3° The potential damage from CT radiation is greater in children because they are 10 times more sensitive to radiationP 1 The best risk estimates suggest that pediatric CT will result in significantly increased lifetime radiation risk than adult CT. 32 Brant-Zawadzki and Silverman 33 downplay the potential association of carcinogenesis with radiation. They have claimed that objective authentication of the nation's knowledge that low doses of radiation cause cancer simply is not available at this time and may never be. With regard to a woman who is pregnant or who may think she is pregnant, it should be pointed out that radiation-induced teratogenesis is primarily a concern from the 10th to 17th week of gestation. 34 Radiation-induced central nervous system abnormalities and growth retardation most commonly occur in fetuses between 2 and 15 weeks gestation. The radiation dose below which no deleterious effects on the fetus occur even in the most sensitive developmental phase is not known with certainty, but it has been estimated to range from .05 to .15 Gy (5-15 rads). 35 The medical malpractice risks arising from alle-
gations of radiation injury because of CT screening are unknown. Could potential plaintiffs be successful in alleging in a malpractice lawsuit that they developed carcinoma from a screening CT? Could a potential female plaintiff successfully claim that she gave birth to a baby with congenital anomalies caused by the radiation exposure received when she had undergone CT screening at a time when, unbeknownst to her or the radiologist, she was pregnant? These questions cannot be answered at this time. ABANDONING A PATIENT
Radiologists incur certain duties to self-referred patients. The ACR Standard for Communication: Diagnostic Radiology, 2001 revision for the first time included the following provision: "Radiologists should recognize potential obligations in assuming the care and treatment of patients who present themselves for imaging studies on a selfreferred basis. Such obligations may include communicating the results of the imaging studies to the patient and the necessity of appropriate follow-up."36 Historically most radiologists have not thought of themselves as primary care physicians to patients, but the CT screening movement has markedly altered this dynamic. Radiologists who solicit patients to undergo screening radiologic examinations without being referred by a primary care physician will find themselves placed in the position of acting as primary care physician. Once a patient undergoes the screening radiologic examination, a physician-patient relationship between the radiologist and patient is established. The radiologist cannot unilaterally terminate this relationship until or unless the patient is formally notified and arrangements for alternative medical care are made. A radiologist's failure to carry out this duty (and to document it appropriately) could well expose the radiologist to a charge of patient abandonments THE DUTY TO DISCLOSE: LEGAL AND ETHICAL PERSPECTIVES
A physician's legal duty to inform patients of the nature and potential complications of any diagnostic or therapeutic medical procedure and obtain the patient's informed consent before they undertake it is long standingY Radiologists are well acquainted with the need to disclose to pa-
RADIOLOGIC SCREENING
tients the benefits and risks of invasive procedures, alternative measures that might give similar results, and the risks of not performing the procedure. 39 However, in recent years, the informed consent process has been inexorably expanded not only to encompass a growing number of diagnostic radiologic and nonradiologic procedures but also to broaden the content of the disclosures. Courts have begun to impose duties on physicians to disclose to patients such information as physicians' experience, credentials, and personal habits that could affect professional performance?° The advent of CT screening will likely further expand the ground rules for informed consent. By encouraging persons to undergo testing designed to detect early disease, radiologists may be required to assume the responsibility of explaining to these persons the myriad uncertainties that pertain to early detection. For example, it has been accepted by the populace that early detection is a sure-fire way to save lives, and that if one detects a tumor very early, doctors will have the best chance of removing the cancer entirely. But recently, this thesis has been challenged in screening for several types of cancer. 4~ Tests are finding some tumors that would never become dangerous but cannot be distinguished from tumors that could become deadly, thereby subjecting certain patients to the risk of surgery, radiation, or chemotherapy. Patients will have to be explained this by their doctors. To reach a decision about whether to undergo a screening CT, patients will have to be educated by their physicians, and in the case of screening CT the self-referred patient's physician will be the radiologist. Radiologists will have to shed themselves of their personal feelings about the value of CT screening and accept the legal requirement as well as the moral imperative to provide unbiased information to patients about the procedure. The American Medical Association's Principals of Medical Ethics affirm this responsibility: "The patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives. Patients should receive guidance from their physicians as to the optimal course of a c t i o n . . . The patient has the right to make decisions regarding the health care that is recommended by his or her physician. Accordingly, patients may accept or refuse any
83
recommended medical treatment... A physician shall deal honestly with patients and colleagues. ''42 The Principles of Ethics of the American College of Radiology 43 likewise affirm that rendering of a service by a radiologist should be "governed by what is in the best interest of the patient." In February 2002, the US Preventive Services Task Force, an independent panel of experts that reviews research in a wide range of preventive services, issued a statement reaffirming recommendations that women over 40 undergo annual mammography. Included in this statement, however, was the following directive: "Clinicians should inform women about the potential benefits (reduced chance from dying from breast cancer), potential harms (eg, false-positive results, unnecessary biopsies), and limitations of the test that apply to women their a g e . ''44 Although not directly addressing CT screening, the New Jersey Supreme Court nevertheless echoed similar sentiments: "Physicians do not adequately discharge their responsibility by disclosing only treatment alternatives that they recommend . . . Physicians may [not] impose their values on their patients. 45 We do not know how courts will deal with informed consent and duty-to-divulge issues that may arise out of CT-screening lawsuits that may be filed in the future. We do not know how the courts would respond to a potential plaintiff-patient's lawsuit charging a radiologist with misrepresenting the value of a CT screening examination by overemphasizing its accuracy and efficacy while ignoring its potential downside risks. In the hypothetical scenario presented here, the patient alleged that the radiologist was negligent not only by failing to disclose the pitfalls of CT screening but by failing to be specific in giving follow-up recommendations as well. The extent to which a radiologist has a duty to recommend follow-up screening examinations is as yet undetermined. CONTRAST MEDIA
The incidence of fatal or serious but nonfatal adverse allergic reactions to iodinated contrast media has been well documented. 46-47It is thus not surprising that radiologists are reluctant to administer these potentially life-threatening agents to patients unless there are valid medical indications to do so.
84
LEONARD BERLIN
The determination of whether contrast media should be used in a CT examination rests primarily with the radiologist, 484° especially in the case of a screening CT examination in which the patient has no referring physician. However, as yet there is no consensus in the radiologic community that addresses the issue of whether contrast media is or is not indicated in the performance of screening CT. Many radiologists are critical of screening CT performed without administration of contrast, claiming that although images obtained on wholebody CT without contrast agents may be characterized by excellent anatomic detail, nevertheless much of potentially discovered diseases are not discernible. Certainly many tumors could be missed in the absence of contrast infusion. Although most radiologists involved in CT screening elect not to administer contrast media, some do. 51 If contrast media is not used and a small carcinoma of one of the abdominal or pelvic organs is missed, a plaintiff's attorney may well be able to retain 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 whichi contrast media is used and a patient sustains death or other serious complication resulting from the contrast media, the plaintiff's attorney may well be able to retain 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 FUTURE DIRECTIONS
The CT screening "craze" has descended on the radiologic 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 radiologic 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. No one can predict with any degree of certainty whether CT screening will flourish or for that matter even survive over the next decade. However, what can be predicted with reasonable certainty is that if CT screening does continue to grow, the types of allegations of wrongdoing discussed here (along with other allegations not yet
imagined) that have heretofore never hauled radiologists into the nation's courtrooms may well do so in the future. The final judicial disposition of any malpractice lawsuit depends to a great degree on the expert witness retained by the opposing attorneys. Ideally expert radiology witnesses seek the truth, are honest and unbiased, and do not become an advocate or a partisan in a legal proceeding, 52 but opinions rendered by expert radiology witnesses are sometimes slanted or influenced by what that radiologist believes to be "right" or "wrong." Many honest radiologists believe that CT screening is beneficial, whereas many similarly honest radiologists believe that CT screening is of no value. Some, in fact, suggest that the motivation of those who promote screening is not one of patient benefit but rather of personal financial gainP 3 Radiologists encouraging the public to undergo CT screening should be alerted that, in such an environment, a plaintiff's attorney who has filed a malpractice lawsuit against a radiologist claiming negligence involving a CT screening examination probably will have little difficulty in finding a reputable radiologist to testify as an expert witness against the defendant-radiologist. With the development of multirow CT scanners and their use by radiologists in hospitals and imaging centers around the nation, an entire industry in which CT is used for screening purposes has emerged. CT screening examinations to detect early carcinomas and other diseases are now being performed at numerous radiologic facilities in every state, and the number of such examinations appears to be growing exponentially. Unlike conventional radiologic practice in which patients are referred to radiologists by other physicians for radiologic examinations, CT screening studies are usually conducted on patients who refer themselves to radiologists, often because of newspaper and radio solicitations. Many of these solicitations are advertisements containing headlines and texts that explicitly or implicitly infer that the accuracy of the CT is perfect or near perfect and that the detection of early disease or cancer will assure cure of these maladies. Patients who come to expect that CT screening tests will without exception detect all diseases in their earliest stages that they may harbor, and that that
RADIOLOGIC SCREENING
85
disease will be cured, may well respond with a malpractice lawsuit if those expectations are not met. Perhaps an onslaught of malpractice litigation
arising from CT screening will never materialize. On the other hand, perhaps CT screening litigation will be unleashed and haunt radiologists for years to come.
REFERENCES 1. Burton TM: Do CT scans help or hurt patients seeking to prevent heart attacks? The Wall Street Journal, January 7, 2002:A13, A16 2. Chase M: Ads for heart scans prompt wider use of helpful screening. The Wall Street Journal, February 9, 1998:B1 3. Garland LH: On the scientific evaluation of diagnostic procedures. Radiology 52:309-328, 1949 4. Lehr JL, Lodwick GS, Farrell C, et ai: Direct measurement of the effect of film miniaturization on diagnostic accuracy. Radiology 118:257-263, 1976 5. Renfrew DL, Franken EA, Berbaum KS, et al: Error in radiology: Classification and lessons in 182 cases presented at a problem case conference. Radiology 183:145-150, 1992 6. Tsubamoto M, Kuriyama K, Kido S, et al: Detection of lung cancer on chest radiographs: Analysis on the basis of size and extent of ground-glass opacity at thin-section CT. Radiology 224:139-144, 2002 7. Hertzberg BS, Kliewer MA, Panlson EK, et al: PACS in sonography: accuracy of interpretation using film compared with monitor display. Am J Roentgenol 173:1175-1179, 1999 8. Manning WJ, Li W, Adelman RR: A preliminary report comparing magnetic resonance coronary angiography with conventional angiography. N Engl J Med 328:828-832, 1993 9. Van Beek EJR, Bakker AJ, Reekers JA: Pulmonary embolism: lnterobserver agreement in the interpretation of conventional angiographic and DSA images in patients with nondiagnostic lung scan results. Radiology 198:721-724, 1996 10. Diffin DC, Leyendecker JR, Johnson SP, et al: Effect of anatomic distribution of pulmonary emboli on interobserver agreement in the interpretation of pulmonary angiography. Am J RoentgenoI 171:1085-1089, 1998 11. Sigal SL, Soufer R, Fetterman RC, et al: Reproducibility of quantitative planar thallium-201 scintigraphy: quantitative criteria for reversibility of myocardial perfusion defects. J Nucl Med 32:759-765, 1991 12. Burhenne LJW, Wood SA, D'Orsi CJ, et al: Potential contribution of computer-aided detection to the sensitivity of screening mammography. Radiology 215:554-562, 2000 13. Schiebler ML, Yankaskas BC, Tempany BC, et al: MR imaging in adenocarcinoma of the prostate: Interobserver variation and efficacy for determining stage C disease. Am J Roentgenol 158:559-562, 1992 14. Robertson PL, Schweitzer ME, Mitchell DG, et al: Rotator cuff disorders: Interobserver and intraobserver variation in diagnosis with MR imaging. Radiology 194:831-835, 1995 15. Wakeley CJ, Jones AM, Kabala JE, et al: Audit of the value of double reading magnetic resonance imaging films. Br J Radiol 68:358-362, 1995 16. Cooley RN, Agnew CH, Rios G: Diagnostic accuracy of the barium enema study in carcinoma of the colon and rectum. Am J Roentgenol 84:316-331, 1960 17. Yee J, Akerkar GA, Hung RK, et al: Colorectal neoplasia: performance characteristics of CT colonography for detection in 300 patients. Radiology 219:685-692, 2001
18. White CS, Romney BM, Mason AC, et al: Primary carcinoma of the lung overlooked at CT: analysis of findings in 14 patients. Radiology 199:109-115, 1996 19. Kakinuma R, Ohmatsu H, Kaneko M, et al: Detection failures in spiral CT screening for lung cancer: analysis of CT findings. Radiology 212:61-66, 1999 20. Wechsler RJ, Spettell CM, Kurtz AB, et al: Effects of training and experience in interpretation of emergency body CT scans. Radiology 199:717-720, 1996 21. Gollub MJ, Panicek DM, Bach AM, et al: Clinical importance of reinterpretation of body CT scans obtained elsewhere in patients referred for care at a tertiary cancer center. Radiology 210:109-112, 1999 22. Kalbhen CL, Yetter EM, Olson MC, et al: Assessing the resectability of pancreatic carcinoma: The value of reinterpreting abdominal CT performed at other institutions. Am J Roentgenol 171:1571-1576, 1998 23. Siegel CL, Fisher AJ, Bennett HF: lnterobserver variability in determining enhancement of renal masses on helical CT. Am J Roentgenol 172:1207-1212, 1999 24. Kolata G: Test proves fruitless, fueling new debate on cancer screening. The New York Times, April 9, 2002:D1, D4 25. Black WC, Welch HG: Screening for disease. Am J Roentgenol 168:3-11, 1997 26. Casarella WJ: A patient's viewpoint on current controversy. Letter to the Editor. Radiology 224:927, 2002 (letter) 27. Whole-body CT screening--Should I or shouldn't I get one? US Food and Drug Administration, Center for Devices and Radiologic Health. Available at: http://www.fda.gov./cdrh/ct/ screening.html. Accessed July 9, 2002 28. Imaging modalities for screening. ACR Bulletin 57:5657, 2001 29. Hall EJ: Radiobiology for radiologist (ed 5). Philadelphia, PA, Lippincott, Williams & Wilkins, 2000, pp 204-212, 230-233 30. Whole body scanning: What are the radiation risks from CT? US Food and Drug Administration, Center for Devices and Radiologic Health. April 17, 2002. Available at: http://www. fda.gov./cdrh/ct/risks.html. Accessed July 9, 2002 31. Slovis TL: CT and computed radiography: the pictures are great, but is the radiation dose greater than required? Am J Roentgenol 2002;179:39-41, 2002 32. Brenner DJ, Elliston CD, Hall EJ, et al: Estimated risks of radiation-induced fatal cancer from pediatric CT. Am J Roentgenol 178:289-296, 2001 33. Brandt-Zawadzki M, Silverman JM: Cancer risk 'knowledge' may be an assumption. Diagn Imag 24:21-25, 2002 34. Kalbhen CL: Question and answer. Am J Roentgenol 178:1285-1286, 2002 35. Berlin L: Radiation exposure and the pregnant patient. Am J Roentgenol 167:1377-1379, 1996 36. American College of Radiology: ACR standard for communication: diagnostic radiology. Standards 2001-2002. Reston, VA, American College of Radiology, 2001, pp 3-5
86
37. Berlin L: Are radiologists contracted by third party to interpret radiographs liable for not communicating results directly to patients? Am J Roentgenol 178:27-33, 2002 38. Schloendorff v The Society of New York Hosp, 105 NE 92 (NY 1914) 39. Obergfell AM: Law & Ethics in Diagnostic Imaging and Therapeutic Radiology. Philadelphia, PA, Saunders, 1995, pp 85-92 40. Berlin L: The duty to disclose. Am J Roentgenol 171: 1463-1467, 1998 41. Cancer screening and the individual. The New York Times (editorial), April 14, 2002:12 42. American Medical Association Council on Ethical and Judicial Affairs: Principles of medical ethics. Fundamental elements of the patient- physician relationship. Guide to use of annotations. Code of medical ethics: cm~rent opinions with Annotations. Chicago, IL, American Medical Association, 2000, pp xii, xiv, xv 43. American College of Radiology: ACR bylaws 20002001, article XIII, sectionl, principles of ethics. Reston VA, American College of Radiology 2001 44. US preventive services task force (USPSTF). Recommendations and rationale: Screening for breast cancer, February 2002. Available at: http://www.ahrq.gov/clinic/3rduspst/ breastcancer/. Accessed February 22, 2002 45. Matthies v Mastromonaco, 733 A2d 456 (NJ 1999) 46. Spring DB, Bettman MA, Barkan HE: Nonfatal adverse reactions to iodinated contrast media: spontaneous reporting to
LEONARD BERLIN
the U.S. Food and Drug Administration, 1978-1994. Radiology 204:325-332, 1997 47. 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 204: 333-337, 1997 48. American College of Radiology: ACR standard for the performance of pediatric and adult thoracic computed tomography (CT). Standards 2001-2002. Reston, VA: American College of Radiology 2001:103-107 49. American College of Radiology: ACR standard for the performance of computed tomography (CT) of the abdomen and computed tomography (CT) of the pelvis. Standards 20012002. Reston, VA, American College of Radiology, 2001, pp 179-181 50. American College of Radiology: ACR standard for performing and interpreting diagnostic computed tomography (CT). Standards 2001-2002. Reston, VA, American College of Radiology, 2001, pp 37-40 51. Fishman EK, Horton KM: Screening strategy joins contrast, noncontrast scans. Diagn Imag 24:45-47, 2002 52. Lundberg GD: Expert witness for whom? JAMA 252: 251, 1984 53. Stanley RJ: Entrepreneurs are profiting by turning previously healthy people into "patients." Insight on the News. March 13, 2002. Available at: http://archives.insightmag.corrd main.ctm/include/detail/storyid/161188.html. Accessed May 8, 2002