CHAPTER 34: IMPROVING THE STANDARD OF CARE FOR DIAGNOSIS OF LUNG CANCER


34.1 DEFICIENCIES IN THE STANDARD OF CARE

Over half of lung cancers are diagnosed when the patients have significant symptomotogy indicating advanced cancer. Some could have been saved had they been diagnosed earlier and we need to do a better job of diagnosing lung cancer in the United States. If the notion of saving people has not done the trick, perhaps the threat of legal claims may induce physicians to look at high-risk groups and do the necessary diagnostic work. Thus this chapter deals with improving the standard of care and the filing of malpractice claims for errors.
We can acknowledge that the physician is caught between two conflicting pressures, HMO’s who demand that each test be medically justified, and patients who may sue if they perceive a mistake. While we can sympathize with the physician’s plight, we can say that the goal of saving lives is more important and that if claims bring the medical community closer to seeing matters from the patient’s perspective they have accomplished an important goal. Perhaps such suits will accomplish the goal of establishing that certain diagnostic tests should be performed as a matter of course with high-risk smokers, and eliminate the uncertainty that exposes patients to unnecessary risks and physicians to legal liability. Having a health care system where the number 1 cancer and the second largest cause of death is diagnosed too late is 60% to 70% of cases is not satisfactory.

34.2 ARGUMENTS AGAINST THE BRINGING OF CLAIMS

34.21 Are the Deficiencies in the Standard of Care Rather than the Physicians?

A 55 year old man who smoked a pack a day for 30 years year sees a doctor for a yearly physical. While blood pressure and various other tests are performed, no chest x-ray or other diagnostic test to detect lung cancer is performed. Eighteen months later, he is diagnosed with stage 3B non-small lung cancer. The tumor would probably have been revealed on a chest x-ray, certainly on a CT Scan, with the patient’s prognosis significantly improved in both cases. Should the patient and family suffer for the doctor’s neglect?
In the example above, the doctor is not negligent. There is no standard of care requiring a doctor to arrange a chest x-ray, Ct Scan, or any other diagnostic test even for a smoker at high risk for lung cancer. Thus, the problem is the standard of care not the treatment, and our focus should be to improve the standard, not punish an individual physician.

34.3 TYPES OF CLAIMS

Failure to diagnose lung cancer claims generally involves these scenarios:
1. Failure to take a chest x-ray or Ct Scan when the patients complaints and prior smoking history indicated the test was warranted.
2. Inaccurate interpretations of a chest x-ray- a difficult diagnostic tool.
3. A chest x-ray notes an abnormality, but nothing is done, no follow-up. Sometimes, there is confusion over whose responsibility it was to take action.

34.31 Failure to Take an X-ray

Again we start with the proposition that no physician is required to take an x-ray as part of a yearly or periodic physical, notwithstanding the patient’s smoking history. However, in many cases, the patient will complain of symptoms indicative of lung cancer such as chest pain, shortness of breath, fatigue, or loss of weight. Where the patient’s smoking history and symptomology indicate the possibility of a tumor, it may be a breach of the standard of care for the physician to fail to take or follow up with appropriate diagnostic tests.
Some legal terms to know. Standard of care is that degree of care that a reasonably competent physician would exercise in the same circumstances. The physician is not required to be the best in his area of specialization; he is only required to do what the average or reasonably competent physician would have done. A breach or violation of the standard of care is negligence. Another somewhat more acerbic word for negligence is malpractice.
While it is clear that screening is not required, what exactly is can be a matter of opinion or even surmise. For example, with some complaint of chest pain, is a chest x-ray required? How about fatigue? It is possible in this area for physicians to reach differing conclusions.

34.311 Misinterpretation of a Chest X-ray

This type of claim is relatively common. Indeed, some studies have shown that one quarter of chest x-rays are misinterpreted. We can separate two problems. First, given the difficulty of interpretation and the frequency of error, it is somewhat unfair to impose liability upon the doctor. We think of malpractice as a substantial error but here, one in four physicians could make the same mistake. The solution is clear. Radiologists should be strongly encouraged to take Ct Scans instead of x-rays. The frequency of Ct Scan error is far lower, as the tumor is readily identifiable on a Ct Scan, whereas it is a faint shadow on some x-rays. Where an x-ray is taken particularly of a smoker, the radiologist should recommend a Ct Scan where there is any ambiguity. Trying to ascertain the difference between a shadow due to emphysema as opposed to a lung tumor is a task far too demanding for many radiologists, the stakes too high. and the consequence of delay too significant for an educated guess.
Most attorneys would consider a missed x-ray a solid case. Some physicians would argue that reading chest x-rays is a matter of interpretation that involves not only the x-ray itself, but the patient’s background and complaints, and is an art as much as a science. They would argue that a physician should not be sued for his exercise of discretion and judgment. Nonetheless, in many of these cases, the radiologists not only made an error in reading the x-ray, but missed the chance to recommend Ct Scan followup.
Indeed some clinical studies have examined prior x-rays and found the small shadows which later became serious tumors. These claims are examined in further detail below.

34.32 Follow-up Failures

While chest x-rays are not done for screening, they are frequently done as a part of surgical screening. Going in for an appendectomy, a 60 year old smoker undergoes an x-ray where a small growth is detected. Medically this is an asymptomatic pulmonary nodule. Given the absence of symptomology, it is most likely stage 1 and treatable. Sometimes no followup is done.
The surgeon for the appendicitis is not responsible for his overall care, a general physician may not get the report, and frequently there is no overall doctor. In a time of high-volume medical practice, our diagnostic tools are far more astute, our routine work far worse and records more frequently misplaced. Again, these situations frequently turn into claims.

34.33 Considerations for the Patient

Here are some things you may wish to consider in evaluating whether to pursue a claim:

1. What is your relationship to the physician? Do you believe he did his best notwithstanding the adverse result?
2. How will that affect your treatment? Will you become preoccupied with a claim or feel that you are taking action to right a wrong?
3. Do you see a need to change physician's perspectives in favor of early detection and screening programs?
4. Will you be required to pay any money initially?
5. Is a significant verdict or settlement likely? Will that help pay for any needed treatment or help support your family?

34.4 AVOIDING CLAIMS: ADVICE FOR THE PHYSICIAN

Since some within the medical community may have the opportunity to read this, let me offer some suggestions as to how to avoid claims.

1. On occasion a smoker will avoid a checkup or test for fear of the results. The physician should document that refusal, so the records are clear the test was recommended and even that follow-up was requested and any decision not to undergo tests was by the patient.
2. Given the uncertainty as to the standard of care and the need for early detection, do the maximum. If a chest-xray shows any abnormaltiy, recommend a Ct Scan. You should suggest a Ct Scan if you have a middle-aged smoker with any pulmonary complaints and indeed, discuss the pro-s and cons of screening even for smokers without complaints. Some insurance carriers may not cover the test, but the patient should be given the opportunity to pay for a test on his own.
3. Given the difficulty of interpreting chest x-rays, especially as regard to smaller tumors, have a radiologist interpret the slides and provide a written report. A general physician should not attempt to interpret chest x-rays.

34.5 RADIOLOGICAL MALPRACTICE CLAIMS

An informative study by medical insurers found that radiologists are the chief defendants in medical malpractice cases. Many patients had x-rays taken long before the cancer was diagnosed and a spot or shadow can be seen which at least retrospectively shows the films were not properly read. Since the gap between x-ray and eventual diagnosis may be a number of years, there is a reasonable inference that the patient’s opportunity for long-term survival was adversely affected by the delayed diagnosis.
An x-ray is by its very nature an imprecise instrument- “reading x-ray films, therefore, involves considerable interpretation of the patterns of density of shadows on the film and changes that may have occurred.” Meyer (2). In one study,

“Eighteen radiologists failed to detect 27 potentially resectable bronchogenic carcinomas revealed retrospectively on serial chest radiographs... Six consultant radiologists, who were biased by knowledge that the cases were of missed bronchogenic carcinoma, were individually shown the radiographs in 22 of the cases. Each consultant missed a mean of 26% (5.8 +/- 1.7) of the lesions. At least one of the six consultants missed the lesion in 16 (73%) of the cases.” Radiology (3).

While some tumors are relatively clear, in many instances, trying to devine the difference between pulmonary fibrosis or pneumonia and a small tumor can be difficult.

34.51 What Follow-up is Needed

First, where ambiguities are seen on an x-ray, there should be a clear bias toward recommending further testing. This increases the possibility of early diagnosis, as well as limiting the individual radiologist’s potential liability. If a tumor is misinterpreted as probable scarring from pneumonia, but the radiologist recommends a follow-up CT Scan to make the determination, he has probably eliminated liability notwithstanding the error. Given the large percentage of lung cancer patients whose disease is diagnosed too late, we need to emphasize more frequent use of the available tools to detect the disease. One radiologist routinely adds to his reports, follow-up with additional tests is recommended if the results are inconsistent with other physician and diagnostic findings. While the language is self-protective, it emphasizes the need for continuing inquiry until the cause of disease is clearly identified.
The radiologist may make a life and death determination. He should do that with as much information as possible. The radiologist may want to contact the referring physician. One article states:

“Double reading of radiographs increases the likelihood of detecting pulmonary disease and, accordingly, physicians have an obligation to view the radiographic examinations performed on their patients, either with the radiologist or independently. It is also essential that the radiologist be proved with the clinical findings before he interprets the radiographs, a practice which will result in significant improvement in the accuracy of radiologic reports.” Primary Care (4).

34.52 Referral for CT Scan

There also needs to be a recognition of the inaccuracy of the chest-ray compared with the CT Scan. Using a chest-xray to make or support a diagnosis is a questionable endeavor, as a recent article explained:

“Conventional chest radiography (CXR) is a poor diagnostic tool for detecting lung cancers at a surgically curable stage. To determine the visibility of peripheral small lung cancers on CXR, we retrospectively examined the usefulness of CXR using a consecutive series of 44 cases detected on CT screening and later confirmed by histopathology. All cases had been detected by low dose CT during a population based screening trial for lung cancer.... Of the 42 lung cancers < or = 20 mm, 74% (31/42) were located in the well penetrated lung zones and 71% (22/31) of these were missed on CXR. 26% (11/42) were concealed by hilar vessels, mediastinum, heart or diaphragm, and all (11/11) of these were missed on CXR. 93% (39/42) of the lung cancers < or = 20 mm were adenocarcinomas and 79% (31/39) of these were missed on CXR. 7% (3/42) were epidermoid carcinomas or small cell carcinomas and 66% (2/3) of these were missed on CXR. The overall accuracy of interpretation on CXR for lung cancers was 61%, sensitivity was 23% and specificity 96%.... Thus, CXR was poor at visualizing CT detectable lung cancers of < or = 20 mm diameter, which are usually of very low density, and cannot be relied upon for detection of surgically curable small lung cancer.” British Journal (5).

Thus, chest x-ray failed to detect a number of tumors greater than 20 millimeters. More significantly, it failed in detecting smaller, surgically removable tumors, when timely diagnosis could do the most good. Perhaps, a radiologist cannot recommend a CT Scan in every case referred to him. However, he must recognize that this is a highly imprecise test at best, and using it to base determinations may well cost the patient his life. Where there are smokers, or some type of positive finding on x-ray, Ct Scan should be recommended.

34.6 THE NEED FOR A CLEAR STANDARD AS A WAY TO REDUCE CLAIMS AND SAVE LIVES

Both physicians and patients would benefit from a clear standard regarding diagnostic testing. Today, most patients are diagnosed late, after their cancers have spread, presenting serious questions about long-term survival. Since many of these patients saw physicians before they were diagnosed, we live in a litigious society and the patient’s health may have been compromised by the delay, inevitably claims will be brought. Compensating the patient and/or his family does not solve the basic problem.
Ultimately it would reduce claims and benefit physicians were a clear standard enunciated. Thus, if the American Cancer Society determined that CT Scans were warranted for patients with a heavy smoking history, say 30 pack years (packs per day smoked x years smoked), that would establish a benchmark. Doctors could prescribe Ct Scans for such persons at risk, and a clear demarcation would reduce the incidence of claims.


REFERENCES

1. Hamer, Medical malpractice in diagnostic radiology: claims, compensation and patient injury, Radiology, 1987 Jul;164(1):263-6
2. Meyer, (2) Lung Cancer Chronicles 184 (Rutgers Press 1990).
3. Radiology 1992 Jan;182(1):115-22 .
4. Prim Care 1976 Mar;3(1):107-36.
5. Br J Radiol 2000 Feb;73(866):137-45.