Delayed Diagnosis of Cancer
The Doctors Company continues to see increases in litigation alleging the failure to diagnose cancer at the earliest opportunity. The potential impact of these suits is substantial.
Three primary factors contribute to this heightened awareness and increased litigation:
- Cancer is extraordinarily common in our society. Approximately one in every four Americans will develop cancer, and 60 percent of these cases will prove fatal.
- Few other diagnoses provoke the visceral emotional response that cancer does.
- There has been a major public emphasis on the critical importance of early detection.
The signs and symptoms of the disease are so protean that they form a part of the differential diagnosis of many conditions physicians encounter daily in clinical practice. Unless physicians maintain a high index of suspicion, and exclude the diagnosis with certainty, cases will be missed.
Complaints or Diagnostic Findings
Any physician can readily assemble a long list of presenting complaints or diagnostic findings that might ultimately prove to be cancer-related.
Common examples include:
- Night sweats
- Abdominal pain
- Weight loss
- Skin lesions
- Breast masses
- Heme positive stool
- Increase in blood calcium, alkaline phosphatase, lactic dehydrogenase, and sedimentation rate
Delays in diagnosis can occur for many reasons:
Routine Assumption of Benign Etiology
Examples include the casual attribution of hoarseness or cough to an upper respiratory tract infection or of rectal bleeding to hemorrhoids.
Acceptance of a Sign or Symptom As a Diagnosis
This commonly occurs with anemia and requires investigation of etiology. Even iron-deficiency anemia, which is a diagnosis, is incomplete unless the cause of the iron deficit is identified.
Overreliance on Indirect Means of Diagnosis
This potentially devastating error occurs most frequently when physicians accept x-ray studies as definitive. As many as 17 percent of women with palpable breast abnormalities will have negative mammograms in the presence of cancer.
An axiom of clinical oncology is that a cancer diagnosis requires histologic confirmation. While tissue is not always germane to excluding malignancy, it is mandatory that alternative diagnoses are adequately supported. For example, lymph node biopsy would be unnecessary in a patient with cervical adenopathy and a clinical and laboratory picture of infectious mononucleosis. Conversely, however, cervical adenopathy should not be attributed to mononucleosis in a young patient who simply presents with fever and fatigue unless that diagnosis can be firmly established.
Failure to Mandate Adequate Follow Up
Patients with indeterminate findings should be re-evaluated at short intervals. Follow up will usually clarify whether common problems—such as cough, hoarseness, or borderline lymph node enlargement—are significant. Physicians must arrange for patients to return for definitive evaluation.
Failure to Review Laboratory and X-ray Reports
These oversights can be fatal. Examples include patients with lung cancer whose chest x-ray reports from a year earlier mentioned a coin lesion, or patients with carcinomas of the cervix whose abnormal Pap smear reports are filed in their charts while their physicians are on vacation.
You should personally review the study results you order. It is also appropriate to have consultants telephone you directly concerning unexpected, significant findings on x-rays, laboratory studies, and biopsies. The Doctors Company strongly recommends setting up a system to ensure no laboratory reports or x-rays are filed without your initials or signature signifying you have read them.
Delays in Diagnosis
Representative data helps illuminate this issue. In a series of 100 consecutive cases of colorectal cancer, the median delay from symptom onset to diagnosis was 9.7 months. Thirty of these cases were characterized by severe delay with a median of 18.1 months; 14.7 months was attributed to physician delay and only 3.4 months to patient delay.
A false-negative barium enema and uncritical acceptance of the patient’s symptoms without diagnostic evaluation were the most common explanations. It would be difficult to defend the standard of care given to such a patient who is found later to have advanced disease when the prognosis for early stage colorectal cancer (Duke’s A) is greater than 90 percent while that for Duke’s C falls well below 40 percent.
The point is simple: The physician must identify the source of gastrointestinal bleeding with certainty.
Delayed elucidation of lymphadenopathy is less common, but is always a problem when it occurs. Either the patient or the physician may discover the node, but unless the doctor initiates appropriate study, very long delays can occur before sufficient symptomatology causes the illness to resurface. Malignancy will be found in 75 percent of diagnostic peripheral lymph node biopsies when performed on patients without obvious regional pathology. Of these, more than 50 percent will be lymphoma.
While up to one-third of initial lymph node biopsies will be nonspecific, 20 percent of these patients will evolve specific pathology within the following year. Lymphoma is again the most common etiology. Many issues surround the evaluation of lymphadenopathy:
- The need for head and neck evaluation prior to excision of cervical nodes
- The choice of node for biopsy (Supraclavicular and cervical biopsies have a higher yield than groin or axillary biopsies.)
- Advance preparation may be required for such special studies as electron microscopy, assay for hormone binding studies, and immunocytochemical stains.
Ultimately, the issue is straightforward: Pathologic lymph nodes require attentive follow up until they are resolved or a definitive diagnosis is made.
We could cite many more examples, but all are related to the interface between screening, diagnosis, and management. What constitutes an appropriate annual checkup is controversial and vastly complicated by issues of cost-benefit analysis, lead-time bias, and compliance. Increasingly, however, litigation attempts to place responsibility for screening on the physician.
A careful history and physical examination include most aspects of a cancer-screening process. Though not universally accepted, representative recommendations include:
- Women age 20 and over (or under 20 and sexually active) should have a Pap test every three years after two initial negative tests performed a year apart.
- Women age 20 to 40 should have pelvic exams every three years. Women over 40 should be examined yearly.
- Women age 35 to 40 should have a baseline mammogram.
- Women age 40 to 49 should have a regular mammographic screening every one to two years.
- Women age 50 and over should have an annual mammographic screening.
- Women age 20 to 40 should have clinical breast examinations every three years and then annually after age 40.
- Women over age 20 should practice regular monthly breast exams.
- Men and women over age 50 should have stool guaiacs annually and sigmoidoscopic exams every three to five years after two negative initial exams performed a year apart.
- Men and women over age 40 should have annual rectal examinations.
- Checks for cancer of the thyroid, testes, prostate, lymph nodes, oral region, and skin can be done at the same time.
When you accept responsibility for ongoing care, it is prudent to maintain a regularly updated patient database. Failure to do so occurs easily in specialty practices in which patients make frequent, but narrowly focused visits over a long time period. For example, rheumatologists and cardiologists will seldom have a specific need for stool guaiacs, mammograms, or Pap smears, but they should be certain their patients receive these tests on a timely basis.
Though responsibility for screening remains somewhat undefined, your responsibility for diagnosis is clear. You must adequately elucidate abnormal findings to exclude significant pathology. Cancer is not a subtle disease. Appropriate differential diagnosis and evaluation still provide the best opportunities for timely detection. The mechanics of this process are well known.
About the Author
Richard E. Anderson, M.D., F.A.C.P., a medical oncologist, is chairman and chief executive officer of The Doctors Company. A member of the American Society of Clinical Oncology and a fellow of the American College of Physicians, Dr. Anderson was a clinical professor of medicine at the University of California, San Diego, and is past chairman of the Department of Medicine at Scripps Memorial Hospital, where he served as senior oncologist for 18 years. Dr. Anderson is the editor of a book on medical malpractice, and his commentaries on legal reform and defensive medicine have been widely cited. He is the 2004 recipient of the PLUS Foundation Award for Outstanding Leadership in Healthcare Professional Liability.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.