Safety of care
Prostate cancer medico-legal issues: Diagnosis, communication, and treatment
Originally published December 2013
Prostate cancer is the most common cancer and, according to the Canadian Cancer Society, the third leading cause of cancer death among men in this country.
There is ongoing debate about the value of prostate cancer screening and this can result in conflicting recommendations. Patients may ask for the test and some physicians continue to offer it. Consequently, it is important that the physician discuss with the patient the risks and benefits of prostate cancer screening so the patient can make an informed decision about whether to have this test performed. Once a physician decides to order an investigative test, it is essential to follow up on the results.
The CMPA conducted a review of 69 medico-legal cases that closed between 2008 and 2012 and involved prostate cancer. Civil legal actions and medical regulatory authority (College) cases were almost equal in frequency. In most College matters, issues of communications were identified while legal cases generally pertained to standard of care. Family physicians and urologists were most often involved in these cases, and in a few instances pathologists were identified.
Of the 69 cases, 49 were mostly related to the diagnosis or, in a few instances, the medical treatment of prostate cancer. The remaining 20 cases were related to surgical treatment. Family physicians were more involved in problems with diagnosis, while urologists were more involved in treatment.
The review of the cases looked further at the issues found in each step of the diagnostic process and at the comments of the medical experts who were consulted. It also highlighted the importance of a number of actions physicians can take to increase patient safety and reduce medico-legal risk.
An inadequate assessment was an important diagnostic problem found in these cases. It usually involved a failure to perform a digital rectal exam (DRE) in the presence of symptoms or an abnormal prostate-specific antigen (PSA) level. As well, there were problems with a lack of documentation in the medical record, particularly about ongoing discussions with the patient regarding DRE and PSA testing, or when a patient refused to have a DRE.
Testing and interpretation
Only a few cases had issues with testing and interpretation and these involved pathologists misreading prostate biopsy slides.
The most frequent diagnostic issue was with inadequate follow-up of PSA test results. Experts maintained that if the physician ordered a PSA level, it was important to verify the result. In the cases where the PSA level was elevated or increasing, further investigation was required, such as monitoring the PSA level or referring the patient to a urologist. Some cases also involved situations where the physician failed to discuss test results and available treatment options with the patient, or failed to document when a discussion did occur.
At times, inadequate systems in the physician's office, such as misfiling results or not having a system to flag files that needed review, contributed to the physician's failure to follow up on test results.
Communication is identified as an issue in most College matters while treatment is identified in legal cases.
The following case examples illustrate many of the issues identified in the follow-up management step. PSA levels play a significant role in these cases, and the normal PSA level is generally considered less than or equal to 4 ng/ml, although PSA age-specific reference ranges are also used.
Case 1: Inadequate management and follow-up for persistent rise in PSA levels
A 60-year-old male is referred by his family physician to a urologist for an increasing PSA at 11 despite antibiotic treatment for a presumptive prostatitis. The DRE is normal and the urologist concludes that the increased PSA is secondary to an underlying prostatitis. He orders a repeat PSA which is at 16, but there is no follow-up on the results.
Six months later, the family physician orders a PSA test which comes back at 29. He consults the urologist over the phone who recommends administering antibiotics. Despite treatment, the PSA is measured 3 months later at 79. The urologist reassesses the patient and now describes the prostate gland to be firm at DRE. He does not provide any specific recommendation to the family physician.
The patient consults another urologist 3 months later. The PSA is now 94 and DRE reveals a diffusely nodular and firm prostate. Biopsies are taken and reveal a prostatic cancer which has metastasized to the bones.
A College complaint is filed. The College's experts are critical of the first urologist's patient management and follow-up. The persistent elevation and rise in PSA should have triggered the physician to investigate this patient more thoroughly, namely by arranging prostate biopsies. The urologist was cautioned and a practice inspection was launched.
Case 2: Failure to refer a patient with increasing PSA levels, poor record keeping
A family physician's approach to periodic health examinations includes DRE and PSA testing. For the first time, the PSA of a 60-year-old male patient is measured at 5.8 and the DRE is unremarkable. In subsequent years, the PSA levels increase progressively to 6.5 early in year 2, 8.5 late in year 2, and 12.1 in year 3. The DRE is noted as normal.
In year 4, the patient is seen by another family physician and the DRE remains normal but the PSA level is 20. The patient is promptly notified of this abnormal test result, urgently referred to a urologist, and is diagnosed with prostate cancer.
The patient first complains to the College, which is critical of the first family physician's failure to follow up on abnormal test results. A legal action follows, and the experts in the case are of the opinion that the steady and sometimes rapid increase of the PSA level should have caused concerns for the family physician despite a normal DRE and triggered a referral to urology. Poor record keeping did not help in refuting the patient's allegation that he was never made aware of these abnormal test results. Without expert support, a settlement is paid to the patient by the CMPA on behalf of the family physician.
Case 3: Ineffective office system to monitor test results
A 58-year-old male has a PSA ordered by his family physician and it measures at 11, but the patient is not notified. He comes back 8 years later. His PSA level is now at 40, but the result is filed and neither the physician nor the patient is notified.
One year later, the patient returns. The physician notes the abnormal result from the second test and orders a repeat PSA which comes back at 70. This time the patient is promptly referred to urology and is diagnosed with a locally advanced prostate cancer.
A College complaint results in a caution to the physician. This is followed by a threat of a legal action. An early settlement is paid by the CMPA on behalf of the physician when expert support cannot be obtained, as the physician did not have a system in place to flag abnormal results and relied only on patients showing up for their appointments.
Risk management considerations
Based on the experts' opinions in these medico-legal cases, physicians practising in this area should consider taking the following actions to provide safer care to patients and reduce their own medico-legal risks:
- Be familiar with the current clinical practice guidelines for prostate cancer screening.
- Obtain a thorough medical history from the patient, including risk factors and family history.
- Provide an informed consent discussion with the patient, and as required, include the potential benefits and risks of PSA testing. Document the discussion in the medical records.
- Assess and follow symptomatic patients carefully, and consider referral as appropriate.
- If a PSA is ordered, carefully read the test report and consider if further investigation or referral is needed.
- Follow up on all test results and referrals, documenting these and any further steps taken. A system should be in place to facilitate the timely follow-up of investigations.
- Inform the patient of the test results.
- Speak with the patient about the nature of any proposed treatment, and the related risks and options.