Duties and responsibilities
Medico-legal vulnerabilities in cervical cancer diagnosis
Originally published March 2013
Improved testing methods and greater insight into the natural course of cervical cancer have led to recent changes in screening recommendations.
New Canadian and American guidelines favour doing the first screening at a later age and having longer intervals between screenings for low-risk patients. The aim is to weigh the benefits of detection against the potential harm of overtreatment. At the same time, enhancements to provincially-based screening programs are changing the way routine tests are scheduled and results are managed.
A review of 97 medico-legal cases involving cervical cancer that closed between 2002 and 2011 identified issues in each of the steps in the diagnostic process — assessment, testing and interpretation, and follow-up management. Many cases were complex and showed problems in more than one stage. Absent or infrequent screening was highlighted as an area of concern in a number of the cases.
A recent review of Canadian cervical cancer screening programs found that about 42% of patients diagnosed with invasive cervical cancer had either never been screened or had not been screened in the 5 years or more before the diagnosis.1
Assessment was the step most frequently associated with diagnostic issues. These were linked to a high percentage of unfavourable outcomes for CMPA members. The issues were a failure or a delay in performing a specific examination or procedure when indicated, the most common being pelvic examinations, Pap tests, colposcopies, and biopsies. In the cases where there was a failure to perform a colposcopy or a failure to do a biopsy, it was specialists who failed to perform the procedure as part of their diagnostic process rather than primary care physicians failing to refer a patient to a consultant.
Case example: Appropriate examinations not performed
A 42-year-old woman visited her family physician of 2 years with a complaint of heavy menses with clots and cramping.
Despite the fact that it had been several years since her last Pap test, no examination was performed at this visit as the patient was menstruating. The physician ordered a pelvic ultrasound that found no anomaly. At follow-up he prescribed a 1-month trial of an oral contraceptive to control the bleeding. The patient saw the physician twice during the next 3 months for ongoing lower abdominal pain accompanied by cramping and diarrhea. The physician believed the patient's symptoms were gastrointestinal; however, she did not respond to a trial of GI therapy. She was referred to a gastroenterologist for further evaluation and also to a gynecologist as she continued to have problems with menorrhagia. On examination the gynecologist found a cervical mass that was biopsied and diagnosed as stage IIB invasive squamous cell carcinoma of the cervix. The patient was treated with chemotherapy, radiation, and eventually exenteration surgery. She filed a complaint with the medical regulatory authority (College).
As a result of the ensuing investigation by the College, the physician received a verbal caution. The College acknowledged the physician's care may not have affected the patient's outcome as the cancer may have already been very advanced at the time of her first visit. However, the College was highly critical of the physician for not having performed a pelvic exam and Pap test to investigate the patient's original symptoms and for prescribing an oral contraceptive to control bleeding in this patient without first examining her.
Testing and interpretation
Testing and interpretation issues, which involved the misreading or misinterpretation of test results or pathology slides, represented the smallest group of diagnostic issues in this case series.
Case example: Results misread
The results of a routine Pap test for a 28-year-old showed atypical squamous cells of undetermined significance (ASCUS) and atypical glandular cells (AGC).
The family physician advised her staff to arrange for follow-up in 6 months. When the patient returned 6 months later, the physician discovered that her previous reading of the report was incomplete and she had missed the AGC finding and the pathologist's recommendation to refer for a colposcopy. She repeated the Pap test and referred the patient to a gynecologist for a colposcopy. The patient was found to have cervical cancer and underwent a hysterectomy. She also required psychological treatment to deal with the emotional effects of the treatment and the delayed diagnosis.
The patient filed a complaint with the College. While it was not suggested that the 6-month delay in diagnosis had any effect on the patient's outcome in this case, the physician received educational counsel from the College and subsequently made changes to her practice to improve the management of test results.
Failure to follow up on test results was the second most common diagnostic issue, and it refers specifically to either a failure or delay to follow up on test results, or a failure or delay to refer the patient to a specialist or arrange further testing. In a number of cases, test results were not received or were filed without being seen, while in other cases the physician did not review test results in the context of the patient's history. Some cases also involved situations in which results or treatment plans were not appropriately communicated to patients. In some cases follow-up was complicated by the involvement of multiple physicians. These cases were characterized by inadequate handovers and confusion about which physician was managing the patient's care.
Case example: Patient lost to follow-up
A 31-year-old underwent a routine prenatal Pap test performed by an obstetrician/gynecologist.
The results showed atypical squamous cells of undetermined significance (ASCUS). These results were not followed up. The patient did not return for her scheduled postpartum checkup with the obstetrician/gynecologist, and he assumed she had followed up with her family physician. Three years later, the patient was diagnosed with stage IB squamous cell carcinoma of the cervix and treated with chemotherapy and radiation. The CMPA paid a settlement on behalf of the obstetrician/gynecologist as peer experts could not support the lack of follow-up care.
The analysis also identified a small number of cases in which pregnancy affected patients' clinical outcomes. These cases suggested knowledge gaps, meaning the physician did not know when certain tests could be performed, with respect to testing during pregnancy. The cases also identified the postpartum transfer of care as contributing to the failure to follow up on abnormal test results.
Cervical cancer is considered to be a treatable and often preventable disease in the developed world due to early detection and treatment combined with the latency period of the disease. Currently in Canada, 1 in every 150 women will develop cervical cancer and 1 in 423 will die from it.2 Incidence and mortality have both been steadily declining since 1998,3 and human papilloma virus (HPV) vaccination promises to further improve the clinical outcomes for women.
Managing medico-legal risk
Based on the experts' opinions in the cases reviewed, the following considerations support risk management.
- Being familiar with current guidelines for cervical cancer screening, and with testing protocols during pregnancy.
- Having a system to ensure female patients are scheduled for Pap tests, as appropriate.
- Thoroughly assessing patients with gynecologic symptoms or signs.
- Establishing procedures to enhance the timely receipt and effective review and follow-up of test results.
- Clearly communicating to patients the seriousness of test results and the importance of follow-up.
- Having a procedure to deal with "no-shows."
- When referring the patient to a specialist, checking that all relevant information (e.g. test results, reason for referral, and relevant patient history) has been included in the request for consultation.
- Carefully documenting discussions with patients on abnormal test results and plans for follow-up.
- Canadian Partnership Against Cancer (cpac). Cervical Cancer Screening in Canada: Monitoring Program Performance 2006–2008. 2011. Retrieved November 2012 from: http://www.partnershipagainstcancer.ca
- Public Health Agency of Canada. "Cervical Cancer." 2012. Retrieved on October 25, 2012 from: http://www.phac-aspc.gc.ca
- Canadian Cancer Society's Steering Committee on Cancer Statistics. Canadian Cancer Statistics 2012. Retrieved November 2012 from: http://www.cancer.ca.