When it comes to medical malpractice cases alleging missed or delayed diagnosis of cancer in the Harvard medical system, the Number One category is prostate cancer. This accounted for nearly $16 million in incurred losses between the years 2004 and 2008.
In those prostate cancer-related liability cases, 23 physicians, nine organizations, and two nurse practitioners were named as defendants.
Most professional organizations recommend that physicians at least discuss prostate cancer screening with patients over age 50, or younger with risk factors. But the consensus ends there. Uncertainties about the risks and benefits of early detection and treatment of what is often a slow-moving, non-lethal cancer challenge doctors and their patients.
The issues behind screening and diagnosing prostate cancer with a prostate-specific antigen—or PSA—test are complex. Routine PSA testing is controversial because of a high rate of false positives and false negatives and a lack of agreement on the benefit of a test that can lead to treatments with high morbidity and low benefit.
To help primary care physicians navigate these treacherous waters, a Harvard task force has come up with a decision support tool. Dr. Mark Garnick was a member of the task force that developed the tool. Dr. Garnick is a medical oncologist and a clinical professor in the Department of Medicine at Beth Israel Deaconess Medical Center in Boston.
"I think the group of professionals that have the toughest time and have the hardest tasks are the primary care physicians, and one of the patient populations that causes the most angst in the primary care physicians is an individual that has a PSA detected, screened detected cancer that the primary care physician has sent off to surgery for a radical prostatectomy, and the primary care physicians end up questioning themselves whether or not they actually did the right thing by sending the patient off especially if they had, you know, a cancer that had very, very low risk features."
Research into whether or not PSA testing and even early prostate cancer detection improves patient outcomes is contradictory, and the advice from national organizations has been vague or conflicting. In March 2009, studies from two large randomized trials published in the New England Journal of Medicine confused the matter further. One study showed no significant reduction in mortality in control groups given PSA screening, and the other showed a 20 percent reduction in prostate cancer mortality accompanied by a high rate of overdiagnosis and treatment morbidity.
If PSA testing doesn't lead to improved outcomes, elevated values can clearly lead to treatments that increase morbidity for men who choose immediate treatment. Biopsy carries a certain risk of infection, and side effects of radiation or surgery may include incontinence or impotence.
Consensus from professional organizations on the details of PSA testing has been hard to come by. The U.S preventive task force recommends PSA testing not be offered in men over age 74, but has been silent about men under that age, and the American Cancer Society has said it should be offered to every man over age 50, or 45 with risk factors. Dr. Garnick:
"What we are trying to do now is to provide a decision tool for primary care physicians where really the key factors about the issues, the facts that are known, the facts that are controversial, the ambiguous facts about PSA-based screening, are laid out in a fairly concise document so the primary care physician will be in a very, very good position to discuss the aspects, the pros and cons, and have a discussion with the patient about the pros and cons of PSA-based testing in the first place."
The Harvard team came from several different hospitals and represented knowledge from four disciplines closely involved in prostate cancer on a day-to-day basis: general internal medicine, urology, radiation oncology, and medical oncology.
They reached agreement on suggestions for primary care doctors in three key areas: how to communicate with patients about prostate care, when to offer PSA testing, and how to follow-up once a PSA test is done.
"The guideline includes some case studies of physicians that have been the subject of medical malpractice suits based upon PSA-based testing. It provides some general and prostate-specific cancer testing risk management, and the critical thing there is that we believe the important thing for primary care physicians to do is to discuss the pros and cons of PSA-based testing, to document that such a discussion has taken place, and to document that a decision has been made by the patient of whether he does or does not want to get tested."
Dr. Richard Parker is an internist in primary care who reviewed the Harvard decision support tool. Dr. Parker is medical director for the Beth Israel Deaconess Physician Organization in Boston, and has served as an expert witness in numerous medical malpractice cases involving prostate cancer diagnosis.
"I've seen several allegations in the prostate cancer arena. Number One would be the allegation that the doctor never offered the test and the man ended up with prostate cancer and sued. The next would be that the doctor ordered the test, it came back elevated, abnormal, and the doctor or the doctor's office never notified the patient; there was some slip-up in communication. The third one I've seen is a patient put on testosterone therapy where a PSA was never checked, and the patient ended up with prostate cancer, which violates one of the principles that's clear in the guideline."
Agreement does exist about the need to talk about the prostate, and discuss the availability of PSA testing with every male patient between ages 50 and 75, and with males age 45 and over if they have risk factors, such as family history of prostate cancer or African American heritage.
Once PSA testing is initiated for a patient, the ordering physician must have reliable systems in place to ensure that results are assessed in a timely way and repeat testing is done at appropriate intervals.
The Harvard decision support document states that physicians should not simply order the test on all patients over 50 without a consent discussion, in an effort to save time. Dr. Parker says an efficient discussion of PSA testing does not have to be lengthy:
"I think this is one of the myths about informed consent, which is I don't really believe it takes a lot of time. The doctor has to consider the topic and has to introduce it to the male patient, but it really doesn't take more than 2 or 3 minutes to briefly discuss the implications of the test and ask the man whether he would like it or not."
According to Dr. Parker, many physicians mistakenly think they are protecting themselves legally by ordering the test for all their male patients over 50. However, he maintains that the best legal protection is to practice appropriate medicine and document your actions and patient discussions.
As the large randomized trials mature, the data may reveal more conclusively whether PSA testing's benefits outweigh the risks.
In the future, it may be possible to have a way to help determine which prostate cancers will grow quickly and kill a patient without intervention. Dr. Garnick:
"In my own practice, for example, I would say that close to 30% of the patients that I see with newly diagnosed prostate cancer actually opt to have active surveillance with delayed intention to treat, and this is a group of patients that are well defined in terms of what their biopsy scores show, what their Gleason component is, what their PSA value is, what their digital rectal examination shows. And these patients in the past would have been almost universally treated with either surgery or radiation therapy. These patients are actually coming back on a periodic basis—generally every 3-4 months and then getting rebiopsied with sequential prostate biopsies to determine if their cancer is becoming active and whether or not the patient needs treatment at that point."
The CRICO/RMF PSA Decision Support Tool is available online at www.rmf.harvard.edu.
