OBG Management

Illustration: Kimberly Martens for OBG Management

Advances in cancer genetics are rapidly changing how clinicians assess an individual’s risk for breast cancer. ObGyns counsel many women with a personal or family history of the disease, many of whom can benefit from genetics counseling and testing. As patients with a hereditary predisposition to breast cancer are at higher risk and are younger at diagnosis, it is imperative to identify them early so they can benefit from enhanced surveillance, chemoprevention, and discussions regarding risk-reducing surgeries. ObGyns are uniquely poised to identify young women at risk for hereditary cancer syndromes, and they play a crucial role in screening and prevention over the life span.

CASE Patient with breast cancer history asks about screening for her daughters

A 52-year-old woman presents for her annual examination. She underwent breast cancer treatment 10 years earlier and has done well since then. When asked about family history of breast cancer and ethnicity, she reports her mother had breast cancer later in life, and her mother’s father was of Ashkenazi Jewish ancestry.In addition, a maternal uncle had metastatic prostate cancer. You recall that breast cancer diagnosed before age 50 years and Ashkenazi ancestry are “red flags” for a hereditary cancer syndrome. The patient wonders how her daughters should be screened. What do you do next?

Having a risk assessment plan is crucial

Given increasing demands, limited time, and the abundance of information to be discussed with patients, primary care physicians may find it challenging to assess breast cancer risk, consider genetics testing for appropriate individuals, and counsel patients about risk management options. The process has become even more complex since the expansion in genetics knowledge and the advent of multigene panel testing. Not only is risk assessment crucial for this woman and her daughters, and for other patients, but a delay in diagnosing and treating breast cancer in patients with hereditary and familial cancer risks may represent a worrisome new trend in medical litigation.^1,2 Clinicians must have a process in place for assessing risk in all patients and treating them appropriately.

The American Cancer Society (ACS) estimated that 252,710 cases of breast cancer would be diagnosed in 2017, leading to 40,610 deaths.³ Twelve percent to 14% of breast cancers are thought to be related to hereditary cancer predisposition syndromes.^4–8 This means that, every year, almost 35,000 cases of breast cancer are attributable to hereditary risk. These cases can be detected early with enhanced surveillance, which carries the highest chance for cure, or prevented with risk-reducing surgery in identified genetic mutation carriers. Each child of a person with a genetic mutation predisposing to breast cancer has a 50% chance of inheriting the mutation and having a very high risk of cancer.

In this patient’s case, basic information is collected about her cancer-related personal and family history.

Asking a few key questions can help in stratifying risk:

• Have you or anyone in your family had cancer? What type, and at what age?
• If breast cancer, did it involve both breasts, or was it triple-negative?
• Is there a family history of ovarian cancer?
• Is there a family history of male breast cancer?
• Is there a family history of metastatic prostate cancer?
• Are you of Ashkenazi Jewish ethnicity?
• Have you or anyone in your family ever had genetics testing for cancer?

The hallmarks of hereditary cancer are multiple cancers in an individual or family; young age at diagnosis; and ovarian, pancreatic, or another rare cancer. Metastatic prostate cancer was added as a red flag for hereditary risk after a recent large series found that 11.8% of men with metastatic prostate cancer harbor germline mutations.⁹

CASE Continued

On further questioning, the patient reports she had triple-negative (estrogen receptor–, progesterone receptor–, and human epidermal growth factor receptor 2 [HER2]–negative) breast cancer, a feature of patients with germline BRCA1 (breast cancer susceptibility gene 1) mutations.¹⁰ In addition, her Ashkenazi ancestry is concerning, as there is a 1-in-40 chance of carrying 1 of the 3 Ashkenazi founder BRCA mutations.¹¹ Is a genetics consultation needed?

Read about guidelines for referral and testing.

Guidelines for genetics referral and testing

According to the TABLE, which summarizes national guidelines for genetics referral, maternal and paternal family histories are equally important. Our patient was under age 50 at diagnosis, has a history of triple-negative breast cancer, is of Ashkenazi ancestry, and has a family history of metastatic prostate cancer. She meets the criteria for genetics testing, and screening for her daughters most certainly will depend on the findings of that testing. If she carries a BRCA1 mutation, as might be anticipated, each daughter would have a 50% chance of having inherited the mutation. If they carry the mutation as well, they would begin breast magnetic resonance imaging (MRI) screening at age 25.¹² If they decide against genetics testing, they could still undergo MRI screening as untested first-degree relatives of a BRCA carrier, per ACS recommendations.¹³

Integrating evidence and experience

Over the past 10 to 20 years, other breast cancer susceptibility genes (eg, BRCA2, PALB2, CHEK2) have been identified. More recently, next-generation sequencing has become commercially available. Laboratories can use this newer method to sequence multiple genes rapidly and in parallel, and its cost is similar to that of single-syndrome testing.¹⁴ When more than 1 gene can explain an inherited cancer syndrome, multigene panel testing may be more efficient and cost-effective. Use of multigene panel testing is supported in guidelines issued by the National Comprehensive Cancer Network,¹² the American College of Obstetricians and Gynecologists,¹⁵ and other medical societies.

For our patient, the most logical strategy would be to test for the 3 mutations most common in the Ashkenazi population and then, if no mutation is found, perform multigene panel testing.

Formal genetics counseling can be very helpful for a patient, particularly in the era of multigene panel testing.^16,17 A detailed pedigree (family tree) is elicited, and a genetics specialist determines whether testing is indicated and which test is best for the patient. Possible test findings are explained. The patient may be found to have a pathogenic variant with associated increased cancer risk, a negative test result (informative or uninformative), or a variant of uncertain significance (VUS). VUS is a gene mutation identified with an unknown effect on protein function and an unclear association with cancer risk. A finding of VUS may make the patient anxious,¹⁸ create uncertainty in the treating physician,¹⁹ and lead to harmful overtreatment, excessive surveillance, or unnecessary use of a preventive measure.^19–21 Genetics counseling allows the patient, even the patient with VUS, to make appropriate decisions.²² Counseling may also help a patient or family process emotional responses, such as fear and guilt. In addition, counselors are familiar with relevant laws and regulations, such as the Genetic Information Nondiscrimination Act of 2008 (GINA), which protects patients from insurance and employment discrimination. Many professional guidelines recommend providing genetics counseling in conjunction with genetics testing,^12,23 and some insurance companies and some states require counseling for coverage of testing.

Cost of genetics counseling. If patients are concerned about the cost of genetics testing, they can be reassured with the following information^24–26:

• The Patient Protection and Affordable Care Act (ACA) identifies BRCA testing as a preventive service
• Medicare provides coverage for affected patients with a qualifying personal history
• 97% of commercial insurers and most state Medicaid programs provide coverage for hereditary cancer testing
• Most commercial laboratories have affordability programs that may provide additional support.

If a BRCA mutation is found: Many patients question the value of knowing whether they have a BRCA mutation. What our patient, her daughters, and others may not realize is that, if a BRCA mutation is found, breast MRI screening can begin at age 25. Although contrast-enhanced MRI screening is highly sensitive in detecting breast cancer,^27–29 it lacks specificity and commonly yields false positives.

Some patients also worry about overdiagnosis with this highly sensitive test. Many do not realize that preventively prescribed oral contraceptives can reduce the risk of ovarian cancer by 50%, and cosmetically acceptable risk-reducing breast surgeries can reduce the risk by 90%.

Many are unaware of the associated risks with ovarian, prostate, pancreatic, and other cancers; of risk management options; and of assisted reproduction options, such as preimplantation genetics diagnosis, which can prevent the passing of a genetic mutation to future generations. The guidelines on risk management options are increasingly clear and helpful,^12,30–32 and women often turn to their ObGyns for advice about health and prevention.

ObGyns are often the first-line providers for women with a personal or family history of breast cancer. Identification of at-risk patients begins with taking a careful family history and becoming familiar with the rapidly evolving guidelines in this important field. Identification of appropriate candidates for breast cancer genetics testing is a key step toward prevention, value-based care, and avoidance of legal liability.

CASE Resolved

In this case, testing for the 3 common Ashkenazi BRCA founder mutations was negative, and multigene panel testing was also negative. Her husband is not of Ashkenazi Jewish descent and there is no significant family history of cancer on his side. The daughters are advised to begin high-risk screening at the age of 32, 10 years earlier than their mother was diagnosed, but no genetic testing is indicated for them.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Illustration: Kimberly Martens for OBG Management

Advances in cancer genetics are rapidly changing how clinicians assess an individual’s risk for breast cancer. ObGyns counsel many women with a personal or family history of the disease, many of whom can benefit from genetics counseling and testing. As patients with a hereditary predisposition to breast cancer are at higher risk and are younger at diagnosis, it is imperative to identify them early so they can benefit from enhanced surveillance, chemoprevention, and discussions regarding risk-reducing surgeries. ObGyns are uniquely poised to identify young women at risk for hereditary cancer syndromes, and they play a crucial role in screening and prevention over the life span.

CASE Patient with breast cancer history asks about screening for her daughters

A 52-year-old woman presents for her annual examination. She underwent breast cancer treatment 10 years earlier and has done well since then. When asked about family history of breast cancer and ethnicity, she reports her mother had breast cancer later in life, and her mother’s father was of Ashkenazi Jewish ancestry.In addition, a maternal uncle had metastatic prostate cancer. You recall that breast cancer diagnosed before age 50 years and Ashkenazi ancestry are “red flags” for a hereditary cancer syndrome. The patient wonders how her daughters should be screened. What do you do next?

Having a risk assessment plan is crucial

Given increasing demands, limited time, and the abundance of information to be discussed with patients, primary care physicians may find it challenging to assess breast cancer risk, consider genetics testing for appropriate individuals, and counsel patients about risk management options. The process has become even more complex since the expansion in genetics knowledge and the advent of multigene panel testing. Not only is risk assessment crucial for this woman and her daughters, and for other patients, but a delay in diagnosing and treating breast cancer in patients with hereditary and familial cancer risks may represent a worrisome new trend in medical litigation.^1,2 Clinicians must have a process in place for assessing risk in all patients and treating them appropriately.

The American Cancer Society (ACS) estimated that 252,710 cases of breast cancer would be diagnosed in 2017, leading to 40,610 deaths.³ Twelve percent to 14% of breast cancers are thought to be related to hereditary cancer predisposition syndromes.^4–8 This means that, every year, almost 35,000 cases of breast cancer are attributable to hereditary risk. These cases can be detected early with enhanced surveillance, which carries the highest chance for cure, or prevented with risk-reducing surgery in identified genetic mutation carriers. Each child of a person with a genetic mutation predisposing to breast cancer has a 50% chance of inheriting the mutation and having a very high risk of cancer.

In this patient’s case, basic information is collected about her cancer-related personal and family history.

Asking a few key questions can help in stratifying risk:

• Have you or anyone in your family had cancer? What type, and at what age?
• If breast cancer, did it involve both breasts, or was it triple-negative?
• Is there a family history of ovarian cancer?
• Is there a family history of male breast cancer?
• Is there a family history of metastatic prostate cancer?
• Are you of Ashkenazi Jewish ethnicity?
• Have you or anyone in your family ever had genetics testing for cancer?

The hallmarks of hereditary cancer are multiple cancers in an individual or family; young age at diagnosis; and ovarian, pancreatic, or another rare cancer. Metastatic prostate cancer was added as a red flag for hereditary risk after a recent large series found that 11.8% of men with metastatic prostate cancer harbor germline mutations.⁹

CASE Continued

On further questioning, the patient reports she had triple-negative (estrogen receptor–, progesterone receptor–, and human epidermal growth factor receptor 2 [HER2]–negative) breast cancer, a feature of patients with germline BRCA1 (breast cancer susceptibility gene 1) mutations.¹⁰ In addition, her Ashkenazi ancestry is concerning, as there is a 1-in-40 chance of carrying 1 of the 3 Ashkenazi founder BRCA mutations.¹¹ Is a genetics consultation needed?

Read about guidelines for referral and testing.

Guidelines for genetics referral and testing

According to the TABLE, which summarizes national guidelines for genetics referral, maternal and paternal family histories are equally important. Our patient was under age 50 at diagnosis, has a history of triple-negative breast cancer, is of Ashkenazi ancestry, and has a family history of metastatic prostate cancer. She meets the criteria for genetics testing, and screening for her daughters most certainly will depend on the findings of that testing. If she carries a BRCA1 mutation, as might be anticipated, each daughter would have a 50% chance of having inherited the mutation. If they carry the mutation as well, they would begin breast magnetic resonance imaging (MRI) screening at age 25.¹² If they decide against genetics testing, they could still undergo MRI screening as untested first-degree relatives of a BRCA carrier, per ACS recommendations.¹³

Integrating evidence and experience

Over the past 10 to 20 years, other breast cancer susceptibility genes (eg, BRCA2, PALB2, CHEK2) have been identified. More recently, next-generation sequencing has become commercially available. Laboratories can use this newer method to sequence multiple genes rapidly and in parallel, and its cost is similar to that of single-syndrome testing.¹⁴ When more than 1 gene can explain an inherited cancer syndrome, multigene panel testing may be more efficient and cost-effective. Use of multigene panel testing is supported in guidelines issued by the National Comprehensive Cancer Network,¹² the American College of Obstetricians and Gynecologists,¹⁵ and other medical societies.

For our patient, the most logical strategy would be to test for the 3 mutations most common in the Ashkenazi population and then, if no mutation is found, perform multigene panel testing.

Formal genetics counseling can be very helpful for a patient, particularly in the era of multigene panel testing.^16,17 A detailed pedigree (family tree) is elicited, and a genetics specialist determines whether testing is indicated and which test is best for the patient. Possible test findings are explained. The patient may be found to have a pathogenic variant with associated increased cancer risk, a negative test result (informative or uninformative), or a variant of uncertain significance (VUS). VUS is a gene mutation identified with an unknown effect on protein function and an unclear association with cancer risk. A finding of VUS may make the patient anxious,¹⁸ create uncertainty in the treating physician,¹⁹ and lead to harmful overtreatment, excessive surveillance, or unnecessary use of a preventive measure.^19–21 Genetics counseling allows the patient, even the patient with VUS, to make appropriate decisions.²² Counseling may also help a patient or family process emotional responses, such as fear and guilt. In addition, counselors are familiar with relevant laws and regulations, such as the Genetic Information Nondiscrimination Act of 2008 (GINA), which protects patients from insurance and employment discrimination. Many professional guidelines recommend providing genetics counseling in conjunction with genetics testing,^12,23 and some insurance companies and some states require counseling for coverage of testing.

Cost of genetics counseling. If patients are concerned about the cost of genetics testing, they can be reassured with the following information^24–26:

• The Patient Protection and Affordable Care Act (ACA) identifies BRCA testing as a preventive service
• Medicare provides coverage for affected patients with a qualifying personal history
• 97% of commercial insurers and most state Medicaid programs provide coverage for hereditary cancer testing
• Most commercial laboratories have affordability programs that may provide additional support.

If a BRCA mutation is found: Many patients question the value of knowing whether they have a BRCA mutation. What our patient, her daughters, and others may not realize is that, if a BRCA mutation is found, breast MRI screening can begin at age 25. Although contrast-enhanced MRI screening is highly sensitive in detecting breast cancer,^27–29 it lacks specificity and commonly yields false positives.

Some patients also worry about overdiagnosis with this highly sensitive test. Many do not realize that preventively prescribed oral contraceptives can reduce the risk of ovarian cancer by 50%, and cosmetically acceptable risk-reducing breast surgeries can reduce the risk by 90%.

Many are unaware of the associated risks with ovarian, prostate, pancreatic, and other cancers; of risk management options; and of assisted reproduction options, such as preimplantation genetics diagnosis, which can prevent the passing of a genetic mutation to future generations. The guidelines on risk management options are increasingly clear and helpful,^12,30–32 and women often turn to their ObGyns for advice about health and prevention.

ObGyns are often the first-line providers for women with a personal or family history of breast cancer. Identification of at-risk patients begins with taking a careful family history and becoming familiar with the rapidly evolving guidelines in this important field. Identification of appropriate candidates for breast cancer genetics testing is a key step toward prevention, value-based care, and avoidance of legal liability.

CASE Resolved

In this case, testing for the 3 common Ashkenazi BRCA founder mutations was negative, and multigene panel testing was also negative. Her husband is not of Ashkenazi Jewish descent and there is no significant family history of cancer on his side. The daughters are advised to begin high-risk screening at the age of 32, 10 years earlier than their mother was diagnosed, but no genetic testing is indicated for them.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Illustration: Kimberly Martens for OBG Management

Advances in cancer genetics are rapidly changing how clinicians assess an individual’s risk for breast cancer. ObGyns counsel many women with a personal or family history of the disease, many of whom can benefit from genetics counseling and testing. As patients with a hereditary predisposition to breast cancer are at higher risk and are younger at diagnosis, it is imperative to identify them early so they can benefit from enhanced surveillance, chemoprevention, and discussions regarding risk-reducing surgeries. ObGyns are uniquely poised to identify young women at risk for hereditary cancer syndromes, and they play a crucial role in screening and prevention over the life span.

CASE Patient with breast cancer history asks about screening for her daughters

A 52-year-old woman presents for her annual examination. She underwent breast cancer treatment 10 years earlier and has done well since then. When asked about family history of breast cancer and ethnicity, she reports her mother had breast cancer later in life, and her mother’s father was of Ashkenazi Jewish ancestry.In addition, a maternal uncle had metastatic prostate cancer. You recall that breast cancer diagnosed before age 50 years and Ashkenazi ancestry are “red flags” for a hereditary cancer syndrome. The patient wonders how her daughters should be screened. What do you do next?

Having a risk assessment plan is crucial

Given increasing demands, limited time, and the abundance of information to be discussed with patients, primary care physicians may find it challenging to assess breast cancer risk, consider genetics testing for appropriate individuals, and counsel patients about risk management options. The process has become even more complex since the expansion in genetics knowledge and the advent of multigene panel testing. Not only is risk assessment crucial for this woman and her daughters, and for other patients, but a delay in diagnosing and treating breast cancer in patients with hereditary and familial cancer risks may represent a worrisome new trend in medical litigation.^1,2 Clinicians must have a process in place for assessing risk in all patients and treating them appropriately.

The American Cancer Society (ACS) estimated that 252,710 cases of breast cancer would be diagnosed in 2017, leading to 40,610 deaths.³ Twelve percent to 14% of breast cancers are thought to be related to hereditary cancer predisposition syndromes.^4–8 This means that, every year, almost 35,000 cases of breast cancer are attributable to hereditary risk. These cases can be detected early with enhanced surveillance, which carries the highest chance for cure, or prevented with risk-reducing surgery in identified genetic mutation carriers. Each child of a person with a genetic mutation predisposing to breast cancer has a 50% chance of inheriting the mutation and having a very high risk of cancer.

In this patient’s case, basic information is collected about her cancer-related personal and family history.

Asking a few key questions can help in stratifying risk:

• Have you or anyone in your family had cancer? What type, and at what age?
• If breast cancer, did it involve both breasts, or was it triple-negative?
• Is there a family history of ovarian cancer?
• Is there a family history of male breast cancer?
• Is there a family history of metastatic prostate cancer?
• Are you of Ashkenazi Jewish ethnicity?
• Have you or anyone in your family ever had genetics testing for cancer?

The hallmarks of hereditary cancer are multiple cancers in an individual or family; young age at diagnosis; and ovarian, pancreatic, or another rare cancer. Metastatic prostate cancer was added as a red flag for hereditary risk after a recent large series found that 11.8% of men with metastatic prostate cancer harbor germline mutations.⁹

CASE Continued

On further questioning, the patient reports she had triple-negative (estrogen receptor–, progesterone receptor–, and human epidermal growth factor receptor 2 [HER2]–negative) breast cancer, a feature of patients with germline BRCA1 (breast cancer susceptibility gene 1) mutations.¹⁰ In addition, her Ashkenazi ancestry is concerning, as there is a 1-in-40 chance of carrying 1 of the 3 Ashkenazi founder BRCA mutations.¹¹ Is a genetics consultation needed?

Read about guidelines for referral and testing.

Guidelines for genetics referral and testing

According to the TABLE, which summarizes national guidelines for genetics referral, maternal and paternal family histories are equally important. Our patient was under age 50 at diagnosis, has a history of triple-negative breast cancer, is of Ashkenazi ancestry, and has a family history of metastatic prostate cancer. She meets the criteria for genetics testing, and screening for her daughters most certainly will depend on the findings of that testing. If she carries a BRCA1 mutation, as might be anticipated, each daughter would have a 50% chance of having inherited the mutation. If they carry the mutation as well, they would begin breast magnetic resonance imaging (MRI) screening at age 25.¹² If they decide against genetics testing, they could still undergo MRI screening as untested first-degree relatives of a BRCA carrier, per ACS recommendations.¹³

Integrating evidence and experience

Over the past 10 to 20 years, other breast cancer susceptibility genes (eg, BRCA2, PALB2, CHEK2) have been identified. More recently, next-generation sequencing has become commercially available. Laboratories can use this newer method to sequence multiple genes rapidly and in parallel, and its cost is similar to that of single-syndrome testing.¹⁴ When more than 1 gene can explain an inherited cancer syndrome, multigene panel testing may be more efficient and cost-effective. Use of multigene panel testing is supported in guidelines issued by the National Comprehensive Cancer Network,¹² the American College of Obstetricians and Gynecologists,¹⁵ and other medical societies.

For our patient, the most logical strategy would be to test for the 3 mutations most common in the Ashkenazi population and then, if no mutation is found, perform multigene panel testing.

Formal genetics counseling can be very helpful for a patient, particularly in the era of multigene panel testing.^16,17 A detailed pedigree (family tree) is elicited, and a genetics specialist determines whether testing is indicated and which test is best for the patient. Possible test findings are explained. The patient may be found to have a pathogenic variant with associated increased cancer risk, a negative test result (informative or uninformative), or a variant of uncertain significance (VUS). VUS is a gene mutation identified with an unknown effect on protein function and an unclear association with cancer risk. A finding of VUS may make the patient anxious,¹⁸ create uncertainty in the treating physician,¹⁹ and lead to harmful overtreatment, excessive surveillance, or unnecessary use of a preventive measure.^19–21 Genetics counseling allows the patient, even the patient with VUS, to make appropriate decisions.²² Counseling may also help a patient or family process emotional responses, such as fear and guilt. In addition, counselors are familiar with relevant laws and regulations, such as the Genetic Information Nondiscrimination Act of 2008 (GINA), which protects patients from insurance and employment discrimination. Many professional guidelines recommend providing genetics counseling in conjunction with genetics testing,^12,23 and some insurance companies and some states require counseling for coverage of testing.

Cost of genetics counseling. If patients are concerned about the cost of genetics testing, they can be reassured with the following information^24–26:

• The Patient Protection and Affordable Care Act (ACA) identifies BRCA testing as a preventive service
• Medicare provides coverage for affected patients with a qualifying personal history
• 97% of commercial insurers and most state Medicaid programs provide coverage for hereditary cancer testing
• Most commercial laboratories have affordability programs that may provide additional support.

If a BRCA mutation is found: Many patients question the value of knowing whether they have a BRCA mutation. What our patient, her daughters, and others may not realize is that, if a BRCA mutation is found, breast MRI screening can begin at age 25. Although contrast-enhanced MRI screening is highly sensitive in detecting breast cancer,^27–29 it lacks specificity and commonly yields false positives.

Some patients also worry about overdiagnosis with this highly sensitive test. Many do not realize that preventively prescribed oral contraceptives can reduce the risk of ovarian cancer by 50%, and cosmetically acceptable risk-reducing breast surgeries can reduce the risk by 90%.

Many are unaware of the associated risks with ovarian, prostate, pancreatic, and other cancers; of risk management options; and of assisted reproduction options, such as preimplantation genetics diagnosis, which can prevent the passing of a genetic mutation to future generations. The guidelines on risk management options are increasingly clear and helpful,^12,30–32 and women often turn to their ObGyns for advice about health and prevention.

ObGyns are often the first-line providers for women with a personal or family history of breast cancer. Identification of at-risk patients begins with taking a careful family history and becoming familiar with the rapidly evolving guidelines in this important field. Identification of appropriate candidates for breast cancer genetics testing is a key step toward prevention, value-based care, and avoidance of legal liability.

CASE Resolved

In this case, testing for the 3 common Ashkenazi BRCA founder mutations was negative, and multigene panel testing was also negative. Her husband is not of Ashkenazi Jewish descent and there is no significant family history of cancer on his side. The daughters are advised to begin high-risk screening at the age of 32, 10 years earlier than their mother was diagnosed, but no genetic testing is indicated for them.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Failure to perform cesarean delivery^1–4

A 19-year-old woman (G1P0) received prenatal care at a federally funded health center. Her pregnancy was normal without complications. She presented to the hospital after spontaneous rupture of membranes (SROM). The on-call ObGyn employed by the clinic was offsite when the mother was admitted.

The mother signed a standard consent form for vaginal and cesarean deliveries and any other surgical procedure required during the course of giving birth.

The ObGyn ordered low-dose oxytocin to augment labor in light of her SROM. Oxytocin was started at 9:46 am and labor was uneventful until 1:20 pm when fetal heart monitoring showed deceleration of the baby’s heart rate. At 1:30 pm, oxytocin was discontinued because the fetal heart rate was nonreassuring. When the ObGyn arrived at the patient’s bedside at 1:49 pm, he ordered the oxytocin to be restarted because of irregular contractions. Oxytocin was given from 1:50 pm until delivery at 3:21 pm. During delivery, the ObGyn applied a Kiwi vacuum 3 times. Despite evidence of fetal distress, the ObGyn left the room several times.

Upon delivery, the infant was flaccid and not breathing. His Apgar scores were 2, 3, and 6 at 1, 5, and 10 minutes, respectively, and the cord pH was 7. The neonatal intensive care (NICU) team provided aggressive resuscitation.

At the time of trial, the 18-month-old boy was being fed through a percutaneous endoscopic gastrostomy tube and had a tracheostomy that required periodic suctioning. The child was not able to stand, crawl, or support himself, and will require 24-hour nursing care for the rest of his life.

LAWSUIT. The parents filed a lawsuit in federal court for damages under the Federal Tort Claims Act (see “Notes about this case,”). The mother claimed that she had requested a cesarean delivery early in labor when FHR tracings showed fetal distress, and again prior to vacuum extraction; the ObGyn refused both times.

The ObGyn claimed that when he noted a category III tracing, he recommended cesarean delivery, but the patient refused. He recorded the refusal in the chart some time later, after he had noted the neonate’s appearance.

The parents’ expert testified that restarting oxytocin and using vacuum extraction multiple times were dangerous and gross deviations from acceptable practice. Prolonged and repetitive use of the vacuum extractor caused a large subgaleal hematoma that decreased blood flow to the fetal brain, resulting in irreversible central nervous system (CNS) damage secondary to hypoxic ischemic encephalopathy. An emergency cesarean delivery should have been performed at the first sign of fetal distress.

The defense expert pointed out that the ObGyn discussed the need for cesarean delivery with the patient when fetal distress occurred and that the ObGyn was bedside and monitoring the fetus and the mother. Although the mother consented to a cesarean delivery at time of admission, she refused to allow the procedure.

The labor and delivery (L&D) nurse corroborated the mother’s story that a cesarean delivery was not offered by the ObGyn, and when the patient asked for a cesarean delivery, he refused. The nurse stated that the note added to the records by the ObGyn about the mother’s refusal was a lie. If the mother had refused a cesarean, the nurse would have documented the refusal by completing a Refusal of Treatment form that would have been faxed to the risk manager. No such form was required because nothing was ever offered that the mother refused.

The nurse also testified that during the course of the latter part of labor, the ObGyn left the room several times to assist other patients, deliver another baby, and make an 8-minute phone call to his stockbroker. She reported that the ObGyn was out of the room when delivery occurred.

WHAT’S THE VERDICT?

Read about the verdict and medical considerations.

WHAT’S THE VERDICT?

The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.⁴

Medical considerations

Refusal of medical care

Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.⁵ There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.⁵ The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”⁵ There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate⁵:

• reliability and validity of evidence-based medicine
• severity of the prospective outcome
• degree of risk or burden placed on the patient
• patient understanding of the gravity of the situation and risks
• degree of urgency.

Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”⁶

Complications from vacuum-assisted vaginal delivery

Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.⁷

A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.⁸

Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.⁷ Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.⁹ Up to one-quarter of babies who require NICU admission for this condition die.¹⁰ This injury seldom occurs with forceps.

Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.¹¹

Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).¹²

Cerebral palsy (CP) is defined as “a chronic neuromuscular disability characterized by aberrant control of movement or posture appearing early in life and not the result of recognized progressive disease.”^13,14

The Collaborative Perinatal Project concluded that birth trauma plays a minimal role in development of CP.¹⁵ Arrested labor, use of oxytocin, or prolonged labor did not play a role. CP can develop following significant cerebral or posterior fossa hemorrhage in term infants.¹⁶

Perinatal asphyxia is a poor and imprecise term and use of the expression should be abandoned. Overall, 90% of children with CP do not have birth asphyxia as the underlying etiology.¹⁴

Prognostic assessment can be made, in part, by using the Sarnat classification system (classification scale for hypoxic-ischemic encephalopathy of the newborn) or an electroencephalogram to stratify the severity of neonatal encephalopathy.¹² Such tests are not stand-alone but a segment of assessment. At this point “a better understanding of the processes leading to neonatal encephalopathy and associated outcomes” appear to be required to understand and associate outcomes.¹² “More accurate and reliable tools (are required) for prognostic forecasting.”¹²

Hypoxic-ischemic encephalopathy involves multisystem organ failure including renal, hepatic, hematologic, cardiac, gastrointestinal, and metabolic abnormalities. There is no correlation between the degree of CNS injury and level of other organ abnormalities.¹²

Differential diagnosis

When events such as those described in this case occur, develop a differential diagnosis by considering the following¹²:

• uterine rupture
• severe placental abruption
• umbilical cord prolapse
• amniotic fluid embolus
• maternal cardiovascular collapse
• fetal exsanguination.

Read about the legal considerations.

Legal considerations

Although ObGyns are among the specialties most likely to experience malpractice claims,¹⁷ a verdict of more than $33 million is unusual.¹⁸ Despite the failure of adequate care, and the enormous damages, the ObGyn involved probably will not be responsible for paying the verdict (see “Notes about this case”). The case presents a number of important lessons and reminders for anyone practicing obstetrics.

Very large verdict

The extraordinary size of this verdict ($33 million without any punitive damages) is a reminder that in obstetrics, mistakes can have catastrophic consequences and very high costs.¹⁹ This fact is reflected in malpractice insurance rates.

A substantial amount of this case’s award will provide around-the-clock care for the child. This verdict was not the result of a runaway jury—it was a judge’s decision. It is also noteworthy to report that a small percentage of physicians (1%) appear responsible for a significant number (about one-third) of paid claims.²⁰

Although the size of the verdict is unusual, the case is a fairly straightforward negligence tort. The judge found that the ObGyn had breached the duty of care for his patient. The actions that fell below the standard of care included restarting the oxytocin, using the Kiwi vacuum device 3 times, and failing to perform a cesarean delivery in light of obvious fetal distress. That negligence caused injury to the infant (and his parents).²¹ The judge determined that the 4 elements of negligence were present: 1) duty of care, 2) breach of that duty, 3) injury, and 4) a causal link between the breach of duty and the injury. The failure to adhere to good practice standards practically defines breach of duty.²²

Multitasking

One important lesson is that multitasking, absence, and inattention can look terrible when things go wrong. Known as “hindsight bias,” the awareness that there was a disastrous result makes it easier to attribute the outcome to small mistakes that otherwise might seem trivial. This ObGyn was in and out of the room during a difficult labor. Perhaps that was understandable if it were unavoidable because of another delivery, but being absent frequently and not present for the delivery now looks very significant.²³ And, of course, the 8-minute phone call to the stockbroker shines as a heartless, self-centered act of inattention.

Manipulating the record

Another lesson of this case: Do not manipulate the record. The ObGyn recorded that the patient had refused the cesarean delivery he recommended. Had that been the truth, it would have substantially improved his case. But apparently it was not the truth. Although there was circumstantial evidence (the charting of the patient’s refusal only after the newborn’s condition was obvious, failure to complete appropriate hospital forms), the most damning evidence was the direct testimony of the L&D nurse. She reported that, contrary to what the ObGyn put in the chart, the patient requested a cesarean delivery. In truth, it was the ObGyn who had refused.

A physician who is dishonest with charting—making false statements or going back or “correcting” a chart later—loses credibility and the presumption of acting in good faith. That is disastrous for the physician.²⁴

A hidden lesson

Another lesson, more human than legal, is that it matters how patients are treated when things go wrong. According to press reports, the parents felt that the ObGyn had not recognized that he had made any errors, did not apologize, and had even blamed the mother for the outcome. It does not require graduate work in psychology to expect that this approach would make the parents angry enough to pursue legal action. True regret, respect, and apologies are not panaceas, but they are important.²⁵ Who gets sued and why is a key question that is part of a larger risk management plan. In this case, the magnitude of the injuries made a suit very likely, which is not the case with all bad outcomes.²⁶ Honest communication with patients in the face of bad results remains the goal.²⁷

Pulling it all together

Clinicians must always remain cognizant that the patient comes first and of the importance of working as a team with nursing staff and other allied health professionals. Excellent communication and support staff interaction in good times and bad can make a difference in patient outcomes and, indeed, in medical malpractice verdicts.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Failure to perform cesarean delivery^1–4

A 19-year-old woman (G1P0) received prenatal care at a federally funded health center. Her pregnancy was normal without complications. She presented to the hospital after spontaneous rupture of membranes (SROM). The on-call ObGyn employed by the clinic was offsite when the mother was admitted.

The mother signed a standard consent form for vaginal and cesarean deliveries and any other surgical procedure required during the course of giving birth.

The ObGyn ordered low-dose oxytocin to augment labor in light of her SROM. Oxytocin was started at 9:46 am and labor was uneventful until 1:20 pm when fetal heart monitoring showed deceleration of the baby’s heart rate. At 1:30 pm, oxytocin was discontinued because the fetal heart rate was nonreassuring. When the ObGyn arrived at the patient’s bedside at 1:49 pm, he ordered the oxytocin to be restarted because of irregular contractions. Oxytocin was given from 1:50 pm until delivery at 3:21 pm. During delivery, the ObGyn applied a Kiwi vacuum 3 times. Despite evidence of fetal distress, the ObGyn left the room several times.

Upon delivery, the infant was flaccid and not breathing. His Apgar scores were 2, 3, and 6 at 1, 5, and 10 minutes, respectively, and the cord pH was 7. The neonatal intensive care (NICU) team provided aggressive resuscitation.

At the time of trial, the 18-month-old boy was being fed through a percutaneous endoscopic gastrostomy tube and had a tracheostomy that required periodic suctioning. The child was not able to stand, crawl, or support himself, and will require 24-hour nursing care for the rest of his life.

LAWSUIT. The parents filed a lawsuit in federal court for damages under the Federal Tort Claims Act (see “Notes about this case,”). The mother claimed that she had requested a cesarean delivery early in labor when FHR tracings showed fetal distress, and again prior to vacuum extraction; the ObGyn refused both times.

The ObGyn claimed that when he noted a category III tracing, he recommended cesarean delivery, but the patient refused. He recorded the refusal in the chart some time later, after he had noted the neonate’s appearance.

The parents’ expert testified that restarting oxytocin and using vacuum extraction multiple times were dangerous and gross deviations from acceptable practice. Prolonged and repetitive use of the vacuum extractor caused a large subgaleal hematoma that decreased blood flow to the fetal brain, resulting in irreversible central nervous system (CNS) damage secondary to hypoxic ischemic encephalopathy. An emergency cesarean delivery should have been performed at the first sign of fetal distress.

The defense expert pointed out that the ObGyn discussed the need for cesarean delivery with the patient when fetal distress occurred and that the ObGyn was bedside and monitoring the fetus and the mother. Although the mother consented to a cesarean delivery at time of admission, she refused to allow the procedure.

The labor and delivery (L&D) nurse corroborated the mother’s story that a cesarean delivery was not offered by the ObGyn, and when the patient asked for a cesarean delivery, he refused. The nurse stated that the note added to the records by the ObGyn about the mother’s refusal was a lie. If the mother had refused a cesarean, the nurse would have documented the refusal by completing a Refusal of Treatment form that would have been faxed to the risk manager. No such form was required because nothing was ever offered that the mother refused.

The nurse also testified that during the course of the latter part of labor, the ObGyn left the room several times to assist other patients, deliver another baby, and make an 8-minute phone call to his stockbroker. She reported that the ObGyn was out of the room when delivery occurred.

WHAT’S THE VERDICT?

Read about the verdict and medical considerations.

WHAT’S THE VERDICT?

The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.⁴

Medical considerations

Refusal of medical care

Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.⁵ There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.⁵ The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”⁵ There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate⁵:

• reliability and validity of evidence-based medicine
• severity of the prospective outcome
• degree of risk or burden placed on the patient
• patient understanding of the gravity of the situation and risks
• degree of urgency.

Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”⁶

Complications from vacuum-assisted vaginal delivery

Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.⁷

A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.⁸

Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.⁷ Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.⁹ Up to one-quarter of babies who require NICU admission for this condition die.¹⁰ This injury seldom occurs with forceps.

Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.¹¹

Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).¹²

Cerebral palsy (CP) is defined as “a chronic neuromuscular disability characterized by aberrant control of movement or posture appearing early in life and not the result of recognized progressive disease.”^13,14

The Collaborative Perinatal Project concluded that birth trauma plays a minimal role in development of CP.¹⁵ Arrested labor, use of oxytocin, or prolonged labor did not play a role. CP can develop following significant cerebral or posterior fossa hemorrhage in term infants.¹⁶

Perinatal asphyxia is a poor and imprecise term and use of the expression should be abandoned. Overall, 90% of children with CP do not have birth asphyxia as the underlying etiology.¹⁴

Prognostic assessment can be made, in part, by using the Sarnat classification system (classification scale for hypoxic-ischemic encephalopathy of the newborn) or an electroencephalogram to stratify the severity of neonatal encephalopathy.¹² Such tests are not stand-alone but a segment of assessment. At this point “a better understanding of the processes leading to neonatal encephalopathy and associated outcomes” appear to be required to understand and associate outcomes.¹² “More accurate and reliable tools (are required) for prognostic forecasting.”¹²

Hypoxic-ischemic encephalopathy involves multisystem organ failure including renal, hepatic, hematologic, cardiac, gastrointestinal, and metabolic abnormalities. There is no correlation between the degree of CNS injury and level of other organ abnormalities.¹²

Differential diagnosis

When events such as those described in this case occur, develop a differential diagnosis by considering the following¹²:

• uterine rupture
• severe placental abruption
• umbilical cord prolapse
• amniotic fluid embolus
• maternal cardiovascular collapse
• fetal exsanguination.

Read about the legal considerations.

Legal considerations

Although ObGyns are among the specialties most likely to experience malpractice claims,¹⁷ a verdict of more than $33 million is unusual.¹⁸ Despite the failure of adequate care, and the enormous damages, the ObGyn involved probably will not be responsible for paying the verdict (see “Notes about this case”). The case presents a number of important lessons and reminders for anyone practicing obstetrics.

Very large verdict

The extraordinary size of this verdict ($33 million without any punitive damages) is a reminder that in obstetrics, mistakes can have catastrophic consequences and very high costs.¹⁹ This fact is reflected in malpractice insurance rates.

A substantial amount of this case’s award will provide around-the-clock care for the child. This verdict was not the result of a runaway jury—it was a judge’s decision. It is also noteworthy to report that a small percentage of physicians (1%) appear responsible for a significant number (about one-third) of paid claims.²⁰

Although the size of the verdict is unusual, the case is a fairly straightforward negligence tort. The judge found that the ObGyn had breached the duty of care for his patient. The actions that fell below the standard of care included restarting the oxytocin, using the Kiwi vacuum device 3 times, and failing to perform a cesarean delivery in light of obvious fetal distress. That negligence caused injury to the infant (and his parents).²¹ The judge determined that the 4 elements of negligence were present: 1) duty of care, 2) breach of that duty, 3) injury, and 4) a causal link between the breach of duty and the injury. The failure to adhere to good practice standards practically defines breach of duty.²²

Multitasking

One important lesson is that multitasking, absence, and inattention can look terrible when things go wrong. Known as “hindsight bias,” the awareness that there was a disastrous result makes it easier to attribute the outcome to small mistakes that otherwise might seem trivial. This ObGyn was in and out of the room during a difficult labor. Perhaps that was understandable if it were unavoidable because of another delivery, but being absent frequently and not present for the delivery now looks very significant.²³ And, of course, the 8-minute phone call to the stockbroker shines as a heartless, self-centered act of inattention.

Manipulating the record

Another lesson of this case: Do not manipulate the record. The ObGyn recorded that the patient had refused the cesarean delivery he recommended. Had that been the truth, it would have substantially improved his case. But apparently it was not the truth. Although there was circumstantial evidence (the charting of the patient’s refusal only after the newborn’s condition was obvious, failure to complete appropriate hospital forms), the most damning evidence was the direct testimony of the L&D nurse. She reported that, contrary to what the ObGyn put in the chart, the patient requested a cesarean delivery. In truth, it was the ObGyn who had refused.

A physician who is dishonest with charting—making false statements or going back or “correcting” a chart later—loses credibility and the presumption of acting in good faith. That is disastrous for the physician.²⁴

A hidden lesson

Another lesson, more human than legal, is that it matters how patients are treated when things go wrong. According to press reports, the parents felt that the ObGyn had not recognized that he had made any errors, did not apologize, and had even blamed the mother for the outcome. It does not require graduate work in psychology to expect that this approach would make the parents angry enough to pursue legal action. True regret, respect, and apologies are not panaceas, but they are important.²⁵ Who gets sued and why is a key question that is part of a larger risk management plan. In this case, the magnitude of the injuries made a suit very likely, which is not the case with all bad outcomes.²⁶ Honest communication with patients in the face of bad results remains the goal.²⁷

Pulling it all together

Clinicians must always remain cognizant that the patient comes first and of the importance of working as a team with nursing staff and other allied health professionals. Excellent communication and support staff interaction in good times and bad can make a difference in patient outcomes and, indeed, in medical malpractice verdicts.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Failure to perform cesarean delivery^1–4

A 19-year-old woman (G1P0) received prenatal care at a federally funded health center. Her pregnancy was normal without complications. She presented to the hospital after spontaneous rupture of membranes (SROM). The on-call ObGyn employed by the clinic was offsite when the mother was admitted.

The mother signed a standard consent form for vaginal and cesarean deliveries and any other surgical procedure required during the course of giving birth.

The ObGyn ordered low-dose oxytocin to augment labor in light of her SROM. Oxytocin was started at 9:46 am and labor was uneventful until 1:20 pm when fetal heart monitoring showed deceleration of the baby’s heart rate. At 1:30 pm, oxytocin was discontinued because the fetal heart rate was nonreassuring. When the ObGyn arrived at the patient’s bedside at 1:49 pm, he ordered the oxytocin to be restarted because of irregular contractions. Oxytocin was given from 1:50 pm until delivery at 3:21 pm. During delivery, the ObGyn applied a Kiwi vacuum 3 times. Despite evidence of fetal distress, the ObGyn left the room several times.

Upon delivery, the infant was flaccid and not breathing. His Apgar scores were 2, 3, and 6 at 1, 5, and 10 minutes, respectively, and the cord pH was 7. The neonatal intensive care (NICU) team provided aggressive resuscitation.

At the time of trial, the 18-month-old boy was being fed through a percutaneous endoscopic gastrostomy tube and had a tracheostomy that required periodic suctioning. The child was not able to stand, crawl, or support himself, and will require 24-hour nursing care for the rest of his life.

LAWSUIT. The parents filed a lawsuit in federal court for damages under the Federal Tort Claims Act (see “Notes about this case,”). The mother claimed that she had requested a cesarean delivery early in labor when FHR tracings showed fetal distress, and again prior to vacuum extraction; the ObGyn refused both times.

The ObGyn claimed that when he noted a category III tracing, he recommended cesarean delivery, but the patient refused. He recorded the refusal in the chart some time later, after he had noted the neonate’s appearance.

The parents’ expert testified that restarting oxytocin and using vacuum extraction multiple times were dangerous and gross deviations from acceptable practice. Prolonged and repetitive use of the vacuum extractor caused a large subgaleal hematoma that decreased blood flow to the fetal brain, resulting in irreversible central nervous system (CNS) damage secondary to hypoxic ischemic encephalopathy. An emergency cesarean delivery should have been performed at the first sign of fetal distress.

The defense expert pointed out that the ObGyn discussed the need for cesarean delivery with the patient when fetal distress occurred and that the ObGyn was bedside and monitoring the fetus and the mother. Although the mother consented to a cesarean delivery at time of admission, she refused to allow the procedure.

The labor and delivery (L&D) nurse corroborated the mother’s story that a cesarean delivery was not offered by the ObGyn, and when the patient asked for a cesarean delivery, he refused. The nurse stated that the note added to the records by the ObGyn about the mother’s refusal was a lie. If the mother had refused a cesarean, the nurse would have documented the refusal by completing a Refusal of Treatment form that would have been faxed to the risk manager. No such form was required because nothing was ever offered that the mother refused.

The nurse also testified that during the course of the latter part of labor, the ObGyn left the room several times to assist other patients, deliver another baby, and make an 8-minute phone call to his stockbroker. She reported that the ObGyn was out of the room when delivery occurred.

WHAT’S THE VERDICT?

Read about the verdict and medical considerations.

WHAT’S THE VERDICT?

The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.⁴

Medical considerations

Refusal of medical care

Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.⁵ There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.⁵ The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”⁵ There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate⁵:

• reliability and validity of evidence-based medicine
• severity of the prospective outcome
• degree of risk or burden placed on the patient
• patient understanding of the gravity of the situation and risks
• degree of urgency.

Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”⁶

Complications from vacuum-assisted vaginal delivery

Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.⁷

A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.⁸

Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.⁷ Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.⁹ Up to one-quarter of babies who require NICU admission for this condition die.¹⁰ This injury seldom occurs with forceps.

Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.¹¹

Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).¹²

Cerebral palsy (CP) is defined as “a chronic neuromuscular disability characterized by aberrant control of movement or posture appearing early in life and not the result of recognized progressive disease.”^13,14

The Collaborative Perinatal Project concluded that birth trauma plays a minimal role in development of CP.¹⁵ Arrested labor, use of oxytocin, or prolonged labor did not play a role. CP can develop following significant cerebral or posterior fossa hemorrhage in term infants.¹⁶

Perinatal asphyxia is a poor and imprecise term and use of the expression should be abandoned. Overall, 90% of children with CP do not have birth asphyxia as the underlying etiology.¹⁴

Prognostic assessment can be made, in part, by using the Sarnat classification system (classification scale for hypoxic-ischemic encephalopathy of the newborn) or an electroencephalogram to stratify the severity of neonatal encephalopathy.¹² Such tests are not stand-alone but a segment of assessment. At this point “a better understanding of the processes leading to neonatal encephalopathy and associated outcomes” appear to be required to understand and associate outcomes.¹² “More accurate and reliable tools (are required) for prognostic forecasting.”¹²

Hypoxic-ischemic encephalopathy involves multisystem organ failure including renal, hepatic, hematologic, cardiac, gastrointestinal, and metabolic abnormalities. There is no correlation between the degree of CNS injury and level of other organ abnormalities.¹²

Differential diagnosis

When events such as those described in this case occur, develop a differential diagnosis by considering the following¹²:

• uterine rupture
• severe placental abruption
• umbilical cord prolapse
• amniotic fluid embolus
• maternal cardiovascular collapse
• fetal exsanguination.

Read about the legal considerations.

Legal considerations

Although ObGyns are among the specialties most likely to experience malpractice claims,¹⁷ a verdict of more than $33 million is unusual.¹⁸ Despite the failure of adequate care, and the enormous damages, the ObGyn involved probably will not be responsible for paying the verdict (see “Notes about this case”). The case presents a number of important lessons and reminders for anyone practicing obstetrics.

Very large verdict

The extraordinary size of this verdict ($33 million without any punitive damages) is a reminder that in obstetrics, mistakes can have catastrophic consequences and very high costs.¹⁹ This fact is reflected in malpractice insurance rates.

A substantial amount of this case’s award will provide around-the-clock care for the child. This verdict was not the result of a runaway jury—it was a judge’s decision. It is also noteworthy to report that a small percentage of physicians (1%) appear responsible for a significant number (about one-third) of paid claims.²⁰

Although the size of the verdict is unusual, the case is a fairly straightforward negligence tort. The judge found that the ObGyn had breached the duty of care for his patient. The actions that fell below the standard of care included restarting the oxytocin, using the Kiwi vacuum device 3 times, and failing to perform a cesarean delivery in light of obvious fetal distress. That negligence caused injury to the infant (and his parents).²¹ The judge determined that the 4 elements of negligence were present: 1) duty of care, 2) breach of that duty, 3) injury, and 4) a causal link between the breach of duty and the injury. The failure to adhere to good practice standards practically defines breach of duty.²²

Multitasking

One important lesson is that multitasking, absence, and inattention can look terrible when things go wrong. Known as “hindsight bias,” the awareness that there was a disastrous result makes it easier to attribute the outcome to small mistakes that otherwise might seem trivial. This ObGyn was in and out of the room during a difficult labor. Perhaps that was understandable if it were unavoidable because of another delivery, but being absent frequently and not present for the delivery now looks very significant.²³ And, of course, the 8-minute phone call to the stockbroker shines as a heartless, self-centered act of inattention.

Manipulating the record

Another lesson of this case: Do not manipulate the record. The ObGyn recorded that the patient had refused the cesarean delivery he recommended. Had that been the truth, it would have substantially improved his case. But apparently it was not the truth. Although there was circumstantial evidence (the charting of the patient’s refusal only after the newborn’s condition was obvious, failure to complete appropriate hospital forms), the most damning evidence was the direct testimony of the L&D nurse. She reported that, contrary to what the ObGyn put in the chart, the patient requested a cesarean delivery. In truth, it was the ObGyn who had refused.

A physician who is dishonest with charting—making false statements or going back or “correcting” a chart later—loses credibility and the presumption of acting in good faith. That is disastrous for the physician.²⁴

A hidden lesson

Another lesson, more human than legal, is that it matters how patients are treated when things go wrong. According to press reports, the parents felt that the ObGyn had not recognized that he had made any errors, did not apologize, and had even blamed the mother for the outcome. It does not require graduate work in psychology to expect that this approach would make the parents angry enough to pursue legal action. True regret, respect, and apologies are not panaceas, but they are important.²⁵ Who gets sued and why is a key question that is part of a larger risk management plan. In this case, the magnitude of the injuries made a suit very likely, which is not the case with all bad outcomes.²⁶ Honest communication with patients in the face of bad results remains the goal.²⁷

Pulling it all together

Clinicians must always remain cognizant that the patient comes first and of the importance of working as a team with nursing staff and other allied health professionals. Excellent communication and support staff interaction in good times and bad can make a difference in patient outcomes and, indeed, in medical malpractice verdicts.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A meaningful evolution has occurred over the past 30 years in the evaluation of ovarian tumors. In the 1980s, any palpable ovarian tumor was recommended for surgical removal.¹ In the early 2000s, studies showed that unilocular cysts were at very low risk for malignancy, and surveillance was recommended.² In the following decade, septate cysts were added to the list of ovarian tumors unlikely to be malignant, and nonsurgical therapy was suggested.³ It is estimated that 10% of women will undergo surgery for an adnexal mass in their lifetime, despite the fact that only 1 in 6 (13%–21%) of these masses is found to be malignant.^4,5

A comprehensive, morphology-based pelvic ultrasonography is the first and most important step in evaluating an ovarian tumor’s risk of malignancy to determine whether surgery or surveillance is required.

Ovarian cancer continues to be the leading cause of gynecologic cancer death. Despite achieving superior surgical and cancer outcomes, a gynecologic oncologist performs only 40% of the initial ovarian cancer surgeries.⁶ Premenopausal and menopausal ovarian tumors are different in cause and consequence. Only 15% of premenopausal tumors are malignant, most commonly germ cell tumors, borderline ovarian tumors, and epithelial ovarian cancers. Tumors in menopausal women are less common but are more likely to be malignant. In actuality, up to 50% of tumors in this population are malignant. The most common of these malignancies are epithelial ovarian cancers, cancers metastatic to the ovary, and malignant stromal tumors.

Effective and evidence-based preoperative evaluations are available to help the clinician estimate a tumor’s risk of malignancy and determine which tumors are appropriate for referral to a specialist for surgery.

The actual incidence and prevalence of ovarian tumors are not known. From a review of almost 40,000 ultrasonography scans performed in the University of Kentucky Ovarian Cancer Screening Program, the estimated incidence and prevalence of ovarian abnormalities are 8.2 per 100 women annuallyand 17%, respectively.⁷ Seventy percent of these abnormalities have a unilocular or simple septate morphology and are at low risk for malignancy.⁷ The remaining 30% of abnormalities are high risk, although this represents only 9% of the total population evaluated. Since the vast majority of these abnormalities are expected to be asymptomatic, most will go unrecognized in the general population. For women who have an ovarian abnormality on ultrasonography, the majority will be at low risk for malignancy and will not require surgery.

Ovarian ultrasonography plus morphologic scoring comprise a comprehensive approach

The recently published recommendations of the First International Consensus Conference report on adnexal masses are summarized in TABLE 1.⁸ The expert panel reviewed the evidence and concluded that effective ultrasonography strategies exist and are well validated, and that low-risk asymptomatic ovarian cysts do not require surgical removal.

While no single ultrasonographic findingcan differentiate a benign from a malignant mass, morphologic scoring systems improve our ability to estimate a tumor’s malignant potential. In the United States, most practitioners in women’s health have ready access to gynecologic ultrasonography, but individual training and proficiency vary. Since not everyone is an expert sonographer, it is useful to employ an objective strategy when evaluating an ovarian tumor. The focus of a comprehensive ovarian ultrasonography is to recognize morphologic patterns that reflect a tumor’s malignant potential. While tumor volume is useful, tumor morphology is the most prognostic feature.

International Ovarian Tumor Analysis group

The International Ovarian Tumor Analysis (IOTA) group has published extensively on sonographic definitions and patterns that categorize tumors based on appearance.⁹ Simple rules and the ADNEX risk model are 2 of the group’s approaches (FIGURE 1).^10,11 Both methods have been validated as effective for differentiating benign from malignant ovarian tumors, but neither has been used to study serial changes in ovarian morphology.

Regardless of the strategy employed, 25% of ovarian ultrasonography evaluations will be interpreted as “indeterminate” or “risk unknown.”¹⁰ The IOTA strategies have been successfully used in Europe for years, but they have not yet been studied or adopted in the United States.

Kentucky morphology index

The morphology index (MI) from the University of Kentucky is an ultrasonography-based scoring system that combines tumor volume and tumor structure into a simple and effective index with a score ranging from 0 to 10 (FIGURE 2).¹² A rising Kentucky MI score has a linear and predictable increase in the risk of ovarian malignancy. In a review of almost 40,000 sonograms, 85% of the malignancies had an MI score of 5 or greater (TABLE 2).¹² Using this as a cutoff, the sensitivity and specificity for predicting malignancy was 86% and 98%, respectively.¹²

When comparing the ADNEX risk model with the Kentucky MI, investigators reviewed 45,000 ultrasound results and found that the majority of cancers were categorized by the ADNEX model in the lowest 4 of the 10 risk-of-malignancy groups, compared with only 15% for the MI.¹³ This clustering or skew is potentially problematic, since we expect higher scores to be more predictive of cancer than lower scores. It also infers that the ADNEX model may not be useful in serial surveillance strategies. Moreover, the ADNEX model identified only 30% of early stage cancers compared with identification of 80% with use of the MI.¹³

Serial ultrasonography

Serial ultrasonography is a concept similar to any longitudinal biomarker evaluation. In the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) program, the Risk of Ovarian Cancer Algorithm (ROCA) employs serial measurements of cancer antigen 125 (CA 125) to improve cancer detection. Serial ultrasonography similarly can be applied to better characterize a tumor’s physiology as well as its morphology. Over time, malignant ovarian tumors grow naturally in volume and complexity, and they do so at a rate faster than nonmalignant tumors. If this physical change can be measured objectively with ultrasonography, then serial sonography becomes a valuable diagnostic aid.

In comparing serial MI scores with clinical outcomes, studies have shown that malignant tumors exhibit a rapid increase, nonmalignant tumors have a stable or gradual rise, and resolving cysts show a decrease in MI score over time (FIGURE 3).¹² An increase in the MI score of 1 or more per month (≥1 per month) is concerning for malignancy, and surgical removal should be considered. If the MI score of an asymptomatic ovarian tumor does not increase by 1 per month, it can be surveilled with intermittent ultrasonography.

Read about evaluating with serum biomarkers and sonography.

Serum biomarkers useful for determining risk, need for referral

Serum biomarkers can be used to complement an ultrasonographic evaluation. They are particularly useful when surgery is recommended but the sonographic evaluation is indeterminate for malignancy risk. Many serum biomarkers are commonly used for the preoperative evaluation of an ovarian tumor or for surveillance of a malignancy following diagnosis (TABLE 3).

CA 125 is the most commonly ordered serum biomarker test for ovarian cancer. It is estimated that three‐quarters of CA 125 tests are ordered for preoperative use, which is not the US Food and Drug Administration (FDA) approved indication. Despite our clinical reliance on CA 125 as a diagnostic test prior to surgery, its utility is limited because of a low sensitivity for predicting cancer in premenopausal women and early stage disease.^14,15 CA 125 specificity also varies widely, depending on patient age and other clinical factors, ranging from as low as 26% in premenopausal women to as high as 100% in postmenopausal women.¹⁶ Because CA 125 often is negative when early stage cancer is present, or positive when cancer is not, it is not recommended for preoperative use for determining whether an ovarian tumor is malignant or whether surgery is indicated. CA 125 should be used to monitor patients with a known ovarian malignancy.

The new triage serum biomarkers, Overa, Ova1, and ROMA (Risk of Ovarian Malignancy Algorithm), are FDA cleared for preoperative use to help determine whether a woman needing surgery for an ovarian mass should be referred to a gynecologic oncologist.^17–20 These tests should not be used to decide if surgery is indicated, but rather should be considered when the decision for surgery has already been made but the malignancy risk is unknown. A woman with a “high risk” result should be referred to a gynecologic oncologist, while one with a “low risk” score is very unlikely to have a malignancy and referral to a specialist is not necessary. TABLE 4 lists a comparison of the relative performance of these serum biomarkers.^{14,15,17–20} There are no published data on the use of serial triage biomarkers.

How to evaluate an ovarian tumor

Approximately 65% of the time, ovarian cystic tumors can be identified accurately as low risk based on the initial sonographic evaluation (TABLE 5). In this scenario, the risk of malignancy is very low (<1%), no secondary testing is needed, and no surgery is recommended.^1,3,21

About 10% of tumors are expected to have a high-risk morphology on ultrasonography, where the risk of malignancy exceeds 25% and referral to a gynecologic oncologist is required.

The remaining 25% of tumors cannot be accurately classified with a single ultrasonographic evaluation and are considered indeterminate.²² Indeterminate tumors require secondary testing to ascertain whether surgery is indicated. Secondary testing may consist of serial ultrasonography, magnetic resonance imaging (MRI), or serum triage biomarker testing if the decision for surgery has been made.

A 2-step process is recommended for evaluating an ovarian tumor.

Step 1. Perform a detailed ultrasonography study using a morphology-based system. Classify the tumor as:

• low risk (65%): unilocular, simple septate, no flow on color Doppler

• simple rules: benign
• MI score 0–3
• no secondary testing; no referral is recommended

• high risk (10%): irregular, mostly solid, papillary projections, very strong flow on color Doppler

• simple rules: malignant
• MI score ≥5
• no secondary testing; refer to a gynecologic oncologist

• indeterminate (25%): partly solid, small wall abnormalities, minimal or moderate flow on color Doppler

• simple rules: both M and B rules apply or no rule applies
• MI score usually 4–6
• perform secondary testing (step 2).

Step 2. Perform secondary testing as follows:

• serum triage biomarkers if surgery is planned (Ova1, ROMA, Overa), or
• MRI, or
• serial sonography.

The 3 case scenarios that follow illustrate how the ovarian tumor evaluation process may be applied in clinical practice, with referral to a gynecologic oncologist as appropriate.

CASE 1 Postmenopausal woman with urinary symptoms and pelvic pressure

A 61-year-old woman is referred with a newly identified ovarian tumor. She has had 1 month of urinary urgency, frequency, and pelvic pressure, but she denies vaginal bleeding or fever. She has no family history of cancer. The referring physician included results of a serum CA 125 (48 U/mL; normal, ≤35 U/mL). A pelvic examination reveals a palpable, irregular mass in the anterior pelvis with limited mobility.

What would be your next step in the evaluation of this patient?

Start with ultrasonography

Step 1. Perform pelvic ultrasonography. In this patient, transvaginal sonography revealed a 6-cm (volume, 89 mL) mostly solid tumor (FIGURE 4). The maximum solid diameter of the tumor was 4.0 cm. There was a 20-mL pocket of pelvic ascites.

Results of morphology-based classification were as follows:

• simple rules: M1 and M5 positive; B rules: negative (malignant; high risk)
• ADNEX: 51.6% risk of malignancy (high risk)
• MI: 7 (high risk).

Step 2. Consider secondary testing. In this case, no secondary testing was recommended. Treatment plan. The patient was referred to a gynecologic oncologist for surgery and was found to have a stage IIA serous ovarian carcinoma.

CASE 2 Woman with history of pelvic symptoms and worsening pain

A 46-year-old woman presents with worsening pelvic pain over the last month. She has a long-standing history of pelvic pain, dysmenorrhea, and dyspareunia from suspected endometriosis. She has no family history of cancer. The referring physician included the following serum biomarker results: CA 125, 48 U/mL (normal, ≤35 U/mL), and HE4, 60 pM (normal, ≤150 pM). On pelvic examination, there is a palpable mass with limited mobility in the posterior cul-de-sac.

Based on the patient’s available history, physical examination, and biomarker information, how would you proceed?

Follow the 2-step process

Step 1. Perform pelvic ultrasonography. Transvaginal sonography revealed a 6-cm (volume, 89 mL) partly solid tumor with regular internal borders (FIGURE 5). The maximum solid diameter of the tumor was 4.5 cm. There was no pelvic ascites.

Morphology classification was as follows:

• simple rules: M5 equivocal; B4 positive (indeterminate risk)
• ADNEX: 42.7% risk of malignancy (high risk)
• MI: 6 (indeterminate risk).

Step 2. Secondary testing was recommended for this patient. Test results were:

• repeat ultrasonography in 4 weeks with MI of 7 (volume score increase from 2 to 3, structure score unchanged at 4). Change in MI score +1 per month (high risk)
• Overa: 5.2 (high risk)
• ROMA: 11.8% (low risk).

Treatment plan. The patient was referred to a gynecologic oncologist because of an increasing MI score on serial sonography. Surgery revealed a stage IA grade 2 endometrioid adenocarcinoma of the ovary with surrounding endometriosis.

Read about treating a woman with postmenstrual bleeding.

CASE 3 Woman with postmenopausal bleeding seeks medical care

A 62-year-old woman is referred with new-onset postmenopausal spotting for 1 month. She was recently prescribed antibiotics for diverticulitis. She has no family history of cancer. The referring physician included the results of a serum CA 125, which was 48 U/mL (normal, ≤35 U/mL). On pelvic examination, a mobile cystic mass is noted in the posterior cul-de-sac.

Use the stepwise protocol to sort out findings

Step 1. Pelvic ultrasonography. Transvaginal sonography suggested the presence of an endometrial polyp and revealed a 6-cm (volume, 89 mL) septate ovarian cyst (FIGURE 6).

Based on morphology classification, risk was categorized as:

• simple rules: M rules negative; B2, B4, B5 positive (benign; low risk)
• ADNEX: 2.9% risk of malignancy (low risk)
• MI: 2 (low risk).

Step 2. No secondary testing was recommended in this case.

Treatment plan. The patient’s gynecologist performed a hysteroscopic polypectomy that revealed no cancer. Serial monitoring was recommended for the low-risk ovarian cyst. The next ultrasonography scan, at 6 months, was unchanged; a subsequent scan was ordered for 12 months later, and at that time the cyst had resolved.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A meaningful evolution has occurred over the past 30 years in the evaluation of ovarian tumors. In the 1980s, any palpable ovarian tumor was recommended for surgical removal.¹ In the early 2000s, studies showed that unilocular cysts were at very low risk for malignancy, and surveillance was recommended.² In the following decade, septate cysts were added to the list of ovarian tumors unlikely to be malignant, and nonsurgical therapy was suggested.³ It is estimated that 10% of women will undergo surgery for an adnexal mass in their lifetime, despite the fact that only 1 in 6 (13%–21%) of these masses is found to be malignant.^4,5

A comprehensive, morphology-based pelvic ultrasonography is the first and most important step in evaluating an ovarian tumor’s risk of malignancy to determine whether surgery or surveillance is required.

Ovarian cancer continues to be the leading cause of gynecologic cancer death. Despite achieving superior surgical and cancer outcomes, a gynecologic oncologist performs only 40% of the initial ovarian cancer surgeries.⁶ Premenopausal and menopausal ovarian tumors are different in cause and consequence. Only 15% of premenopausal tumors are malignant, most commonly germ cell tumors, borderline ovarian tumors, and epithelial ovarian cancers. Tumors in menopausal women are less common but are more likely to be malignant. In actuality, up to 50% of tumors in this population are malignant. The most common of these malignancies are epithelial ovarian cancers, cancers metastatic to the ovary, and malignant stromal tumors.

Effective and evidence-based preoperative evaluations are available to help the clinician estimate a tumor’s risk of malignancy and determine which tumors are appropriate for referral to a specialist for surgery.

The actual incidence and prevalence of ovarian tumors are not known. From a review of almost 40,000 ultrasonography scans performed in the University of Kentucky Ovarian Cancer Screening Program, the estimated incidence and prevalence of ovarian abnormalities are 8.2 per 100 women annuallyand 17%, respectively.⁷ Seventy percent of these abnormalities have a unilocular or simple septate morphology and are at low risk for malignancy.⁷ The remaining 30% of abnormalities are high risk, although this represents only 9% of the total population evaluated. Since the vast majority of these abnormalities are expected to be asymptomatic, most will go unrecognized in the general population. For women who have an ovarian abnormality on ultrasonography, the majority will be at low risk for malignancy and will not require surgery.

Ovarian ultrasonography plus morphologic scoring comprise a comprehensive approach

The recently published recommendations of the First International Consensus Conference report on adnexal masses are summarized in TABLE 1.⁸ The expert panel reviewed the evidence and concluded that effective ultrasonography strategies exist and are well validated, and that low-risk asymptomatic ovarian cysts do not require surgical removal.

While no single ultrasonographic findingcan differentiate a benign from a malignant mass, morphologic scoring systems improve our ability to estimate a tumor’s malignant potential. In the United States, most practitioners in women’s health have ready access to gynecologic ultrasonography, but individual training and proficiency vary. Since not everyone is an expert sonographer, it is useful to employ an objective strategy when evaluating an ovarian tumor. The focus of a comprehensive ovarian ultrasonography is to recognize morphologic patterns that reflect a tumor’s malignant potential. While tumor volume is useful, tumor morphology is the most prognostic feature.

International Ovarian Tumor Analysis group

The International Ovarian Tumor Analysis (IOTA) group has published extensively on sonographic definitions and patterns that categorize tumors based on appearance.⁹ Simple rules and the ADNEX risk model are 2 of the group’s approaches (FIGURE 1).^10,11 Both methods have been validated as effective for differentiating benign from malignant ovarian tumors, but neither has been used to study serial changes in ovarian morphology.

Regardless of the strategy employed, 25% of ovarian ultrasonography evaluations will be interpreted as “indeterminate” or “risk unknown.”¹⁰ The IOTA strategies have been successfully used in Europe for years, but they have not yet been studied or adopted in the United States.

Kentucky morphology index

The morphology index (MI) from the University of Kentucky is an ultrasonography-based scoring system that combines tumor volume and tumor structure into a simple and effective index with a score ranging from 0 to 10 (FIGURE 2).¹² A rising Kentucky MI score has a linear and predictable increase in the risk of ovarian malignancy. In a review of almost 40,000 sonograms, 85% of the malignancies had an MI score of 5 or greater (TABLE 2).¹² Using this as a cutoff, the sensitivity and specificity for predicting malignancy was 86% and 98%, respectively.¹²

When comparing the ADNEX risk model with the Kentucky MI, investigators reviewed 45,000 ultrasound results and found that the majority of cancers were categorized by the ADNEX model in the lowest 4 of the 10 risk-of-malignancy groups, compared with only 15% for the MI.¹³ This clustering or skew is potentially problematic, since we expect higher scores to be more predictive of cancer than lower scores. It also infers that the ADNEX model may not be useful in serial surveillance strategies. Moreover, the ADNEX model identified only 30% of early stage cancers compared with identification of 80% with use of the MI.¹³

Serial ultrasonography

Serial ultrasonography is a concept similar to any longitudinal biomarker evaluation. In the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) program, the Risk of Ovarian Cancer Algorithm (ROCA) employs serial measurements of cancer antigen 125 (CA 125) to improve cancer detection. Serial ultrasonography similarly can be applied to better characterize a tumor’s physiology as well as its morphology. Over time, malignant ovarian tumors grow naturally in volume and complexity, and they do so at a rate faster than nonmalignant tumors. If this physical change can be measured objectively with ultrasonography, then serial sonography becomes a valuable diagnostic aid.

In comparing serial MI scores with clinical outcomes, studies have shown that malignant tumors exhibit a rapid increase, nonmalignant tumors have a stable or gradual rise, and resolving cysts show a decrease in MI score over time (FIGURE 3).¹² An increase in the MI score of 1 or more per month (≥1 per month) is concerning for malignancy, and surgical removal should be considered. If the MI score of an asymptomatic ovarian tumor does not increase by 1 per month, it can be surveilled with intermittent ultrasonography.

Read about evaluating with serum biomarkers and sonography.

Serum biomarkers useful for determining risk, need for referral

Serum biomarkers can be used to complement an ultrasonographic evaluation. They are particularly useful when surgery is recommended but the sonographic evaluation is indeterminate for malignancy risk. Many serum biomarkers are commonly used for the preoperative evaluation of an ovarian tumor or for surveillance of a malignancy following diagnosis (TABLE 3).

CA 125 is the most commonly ordered serum biomarker test for ovarian cancer. It is estimated that three‐quarters of CA 125 tests are ordered for preoperative use, which is not the US Food and Drug Administration (FDA) approved indication. Despite our clinical reliance on CA 125 as a diagnostic test prior to surgery, its utility is limited because of a low sensitivity for predicting cancer in premenopausal women and early stage disease.^14,15 CA 125 specificity also varies widely, depending on patient age and other clinical factors, ranging from as low as 26% in premenopausal women to as high as 100% in postmenopausal women.¹⁶ Because CA 125 often is negative when early stage cancer is present, or positive when cancer is not, it is not recommended for preoperative use for determining whether an ovarian tumor is malignant or whether surgery is indicated. CA 125 should be used to monitor patients with a known ovarian malignancy.

The new triage serum biomarkers, Overa, Ova1, and ROMA (Risk of Ovarian Malignancy Algorithm), are FDA cleared for preoperative use to help determine whether a woman needing surgery for an ovarian mass should be referred to a gynecologic oncologist.^17–20 These tests should not be used to decide if surgery is indicated, but rather should be considered when the decision for surgery has already been made but the malignancy risk is unknown. A woman with a “high risk” result should be referred to a gynecologic oncologist, while one with a “low risk” score is very unlikely to have a malignancy and referral to a specialist is not necessary. TABLE 4 lists a comparison of the relative performance of these serum biomarkers.^{14,15,17–20} There are no published data on the use of serial triage biomarkers.

How to evaluate an ovarian tumor

Approximately 65% of the time, ovarian cystic tumors can be identified accurately as low risk based on the initial sonographic evaluation (TABLE 5). In this scenario, the risk of malignancy is very low (<1%), no secondary testing is needed, and no surgery is recommended.^1,3,21

About 10% of tumors are expected to have a high-risk morphology on ultrasonography, where the risk of malignancy exceeds 25% and referral to a gynecologic oncologist is required.

The remaining 25% of tumors cannot be accurately classified with a single ultrasonographic evaluation and are considered indeterminate.²² Indeterminate tumors require secondary testing to ascertain whether surgery is indicated. Secondary testing may consist of serial ultrasonography, magnetic resonance imaging (MRI), or serum triage biomarker testing if the decision for surgery has been made.

A 2-step process is recommended for evaluating an ovarian tumor.

Step 1. Perform a detailed ultrasonography study using a morphology-based system. Classify the tumor as:

• low risk (65%): unilocular, simple septate, no flow on color Doppler

• simple rules: benign
• MI score 0–3
• no secondary testing; no referral is recommended

• high risk (10%): irregular, mostly solid, papillary projections, very strong flow on color Doppler

• simple rules: malignant
• MI score ≥5
• no secondary testing; refer to a gynecologic oncologist

• indeterminate (25%): partly solid, small wall abnormalities, minimal or moderate flow on color Doppler

• simple rules: both M and B rules apply or no rule applies
• MI score usually 4–6
• perform secondary testing (step 2).

Step 2. Perform secondary testing as follows:

• serum triage biomarkers if surgery is planned (Ova1, ROMA, Overa), or
• MRI, or
• serial sonography.

The 3 case scenarios that follow illustrate how the ovarian tumor evaluation process may be applied in clinical practice, with referral to a gynecologic oncologist as appropriate.

CASE 1 Postmenopausal woman with urinary symptoms and pelvic pressure

A 61-year-old woman is referred with a newly identified ovarian tumor. She has had 1 month of urinary urgency, frequency, and pelvic pressure, but she denies vaginal bleeding or fever. She has no family history of cancer. The referring physician included results of a serum CA 125 (48 U/mL; normal, ≤35 U/mL). A pelvic examination reveals a palpable, irregular mass in the anterior pelvis with limited mobility.

What would be your next step in the evaluation of this patient?

Start with ultrasonography

Step 1. Perform pelvic ultrasonography. In this patient, transvaginal sonography revealed a 6-cm (volume, 89 mL) mostly solid tumor (FIGURE 4). The maximum solid diameter of the tumor was 4.0 cm. There was a 20-mL pocket of pelvic ascites.

Results of morphology-based classification were as follows:

• simple rules: M1 and M5 positive; B rules: negative (malignant; high risk)
• ADNEX: 51.6% risk of malignancy (high risk)
• MI: 7 (high risk).

Step 2. Consider secondary testing. In this case, no secondary testing was recommended. Treatment plan. The patient was referred to a gynecologic oncologist for surgery and was found to have a stage IIA serous ovarian carcinoma.

CASE 2 Woman with history of pelvic symptoms and worsening pain

A 46-year-old woman presents with worsening pelvic pain over the last month. She has a long-standing history of pelvic pain, dysmenorrhea, and dyspareunia from suspected endometriosis. She has no family history of cancer. The referring physician included the following serum biomarker results: CA 125, 48 U/mL (normal, ≤35 U/mL), and HE4, 60 pM (normal, ≤150 pM). On pelvic examination, there is a palpable mass with limited mobility in the posterior cul-de-sac.

Based on the patient’s available history, physical examination, and biomarker information, how would you proceed?

Follow the 2-step process

Step 1. Perform pelvic ultrasonography. Transvaginal sonography revealed a 6-cm (volume, 89 mL) partly solid tumor with regular internal borders (FIGURE 5). The maximum solid diameter of the tumor was 4.5 cm. There was no pelvic ascites.

Morphology classification was as follows:

• simple rules: M5 equivocal; B4 positive (indeterminate risk)
• ADNEX: 42.7% risk of malignancy (high risk)
• MI: 6 (indeterminate risk).

Step 2. Secondary testing was recommended for this patient. Test results were:

• repeat ultrasonography in 4 weeks with MI of 7 (volume score increase from 2 to 3, structure score unchanged at 4). Change in MI score +1 per month (high risk)
• Overa: 5.2 (high risk)
• ROMA: 11.8% (low risk).

Treatment plan. The patient was referred to a gynecologic oncologist because of an increasing MI score on serial sonography. Surgery revealed a stage IA grade 2 endometrioid adenocarcinoma of the ovary with surrounding endometriosis.

Read about treating a woman with postmenstrual bleeding.

CASE 3 Woman with postmenopausal bleeding seeks medical care

A 62-year-old woman is referred with new-onset postmenopausal spotting for 1 month. She was recently prescribed antibiotics for diverticulitis. She has no family history of cancer. The referring physician included the results of a serum CA 125, which was 48 U/mL (normal, ≤35 U/mL). On pelvic examination, a mobile cystic mass is noted in the posterior cul-de-sac.

Use the stepwise protocol to sort out findings

Step 1. Pelvic ultrasonography. Transvaginal sonography suggested the presence of an endometrial polyp and revealed a 6-cm (volume, 89 mL) septate ovarian cyst (FIGURE 6).

Based on morphology classification, risk was categorized as:

• simple rules: M rules negative; B2, B4, B5 positive (benign; low risk)
• ADNEX: 2.9% risk of malignancy (low risk)
• MI: 2 (low risk).

Step 2. No secondary testing was recommended in this case.

Treatment plan. The patient’s gynecologist performed a hysteroscopic polypectomy that revealed no cancer. Serial monitoring was recommended for the low-risk ovarian cyst. The next ultrasonography scan, at 6 months, was unchanged; a subsequent scan was ordered for 12 months later, and at that time the cyst had resolved.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A meaningful evolution has occurred over the past 30 years in the evaluation of ovarian tumors. In the 1980s, any palpable ovarian tumor was recommended for surgical removal.¹ In the early 2000s, studies showed that unilocular cysts were at very low risk for malignancy, and surveillance was recommended.² In the following decade, septate cysts were added to the list of ovarian tumors unlikely to be malignant, and nonsurgical therapy was suggested.³ It is estimated that 10% of women will undergo surgery for an adnexal mass in their lifetime, despite the fact that only 1 in 6 (13%–21%) of these masses is found to be malignant.^4,5

A comprehensive, morphology-based pelvic ultrasonography is the first and most important step in evaluating an ovarian tumor’s risk of malignancy to determine whether surgery or surveillance is required.

Ovarian cancer continues to be the leading cause of gynecologic cancer death. Despite achieving superior surgical and cancer outcomes, a gynecologic oncologist performs only 40% of the initial ovarian cancer surgeries.⁶ Premenopausal and menopausal ovarian tumors are different in cause and consequence. Only 15% of premenopausal tumors are malignant, most commonly germ cell tumors, borderline ovarian tumors, and epithelial ovarian cancers. Tumors in menopausal women are less common but are more likely to be malignant. In actuality, up to 50% of tumors in this population are malignant. The most common of these malignancies are epithelial ovarian cancers, cancers metastatic to the ovary, and malignant stromal tumors.

Effective and evidence-based preoperative evaluations are available to help the clinician estimate a tumor’s risk of malignancy and determine which tumors are appropriate for referral to a specialist for surgery.

The actual incidence and prevalence of ovarian tumors are not known. From a review of almost 40,000 ultrasonography scans performed in the University of Kentucky Ovarian Cancer Screening Program, the estimated incidence and prevalence of ovarian abnormalities are 8.2 per 100 women annuallyand 17%, respectively.⁷ Seventy percent of these abnormalities have a unilocular or simple septate morphology and are at low risk for malignancy.⁷ The remaining 30% of abnormalities are high risk, although this represents only 9% of the total population evaluated. Since the vast majority of these abnormalities are expected to be asymptomatic, most will go unrecognized in the general population. For women who have an ovarian abnormality on ultrasonography, the majority will be at low risk for malignancy and will not require surgery.

Ovarian ultrasonography plus morphologic scoring comprise a comprehensive approach

The recently published recommendations of the First International Consensus Conference report on adnexal masses are summarized in TABLE 1.⁸ The expert panel reviewed the evidence and concluded that effective ultrasonography strategies exist and are well validated, and that low-risk asymptomatic ovarian cysts do not require surgical removal.

While no single ultrasonographic findingcan differentiate a benign from a malignant mass, morphologic scoring systems improve our ability to estimate a tumor’s malignant potential. In the United States, most practitioners in women’s health have ready access to gynecologic ultrasonography, but individual training and proficiency vary. Since not everyone is an expert sonographer, it is useful to employ an objective strategy when evaluating an ovarian tumor. The focus of a comprehensive ovarian ultrasonography is to recognize morphologic patterns that reflect a tumor’s malignant potential. While tumor volume is useful, tumor morphology is the most prognostic feature.

International Ovarian Tumor Analysis group

The International Ovarian Tumor Analysis (IOTA) group has published extensively on sonographic definitions and patterns that categorize tumors based on appearance.⁹ Simple rules and the ADNEX risk model are 2 of the group’s approaches (FIGURE 1).^10,11 Both methods have been validated as effective for differentiating benign from malignant ovarian tumors, but neither has been used to study serial changes in ovarian morphology.

Regardless of the strategy employed, 25% of ovarian ultrasonography evaluations will be interpreted as “indeterminate” or “risk unknown.”¹⁰ The IOTA strategies have been successfully used in Europe for years, but they have not yet been studied or adopted in the United States.

Kentucky morphology index

The morphology index (MI) from the University of Kentucky is an ultrasonography-based scoring system that combines tumor volume and tumor structure into a simple and effective index with a score ranging from 0 to 10 (FIGURE 2).¹² A rising Kentucky MI score has a linear and predictable increase in the risk of ovarian malignancy. In a review of almost 40,000 sonograms, 85% of the malignancies had an MI score of 5 or greater (TABLE 2).¹² Using this as a cutoff, the sensitivity and specificity for predicting malignancy was 86% and 98%, respectively.¹²

When comparing the ADNEX risk model with the Kentucky MI, investigators reviewed 45,000 ultrasound results and found that the majority of cancers were categorized by the ADNEX model in the lowest 4 of the 10 risk-of-malignancy groups, compared with only 15% for the MI.¹³ This clustering or skew is potentially problematic, since we expect higher scores to be more predictive of cancer than lower scores. It also infers that the ADNEX model may not be useful in serial surveillance strategies. Moreover, the ADNEX model identified only 30% of early stage cancers compared with identification of 80% with use of the MI.¹³

Serial ultrasonography

Serial ultrasonography is a concept similar to any longitudinal biomarker evaluation. In the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) program, the Risk of Ovarian Cancer Algorithm (ROCA) employs serial measurements of cancer antigen 125 (CA 125) to improve cancer detection. Serial ultrasonography similarly can be applied to better characterize a tumor’s physiology as well as its morphology. Over time, malignant ovarian tumors grow naturally in volume and complexity, and they do so at a rate faster than nonmalignant tumors. If this physical change can be measured objectively with ultrasonography, then serial sonography becomes a valuable diagnostic aid.

In comparing serial MI scores with clinical outcomes, studies have shown that malignant tumors exhibit a rapid increase, nonmalignant tumors have a stable or gradual rise, and resolving cysts show a decrease in MI score over time (FIGURE 3).¹² An increase in the MI score of 1 or more per month (≥1 per month) is concerning for malignancy, and surgical removal should be considered. If the MI score of an asymptomatic ovarian tumor does not increase by 1 per month, it can be surveilled with intermittent ultrasonography.

Read about evaluating with serum biomarkers and sonography.

Serum biomarkers useful for determining risk, need for referral

Serum biomarkers can be used to complement an ultrasonographic evaluation. They are particularly useful when surgery is recommended but the sonographic evaluation is indeterminate for malignancy risk. Many serum biomarkers are commonly used for the preoperative evaluation of an ovarian tumor or for surveillance of a malignancy following diagnosis (TABLE 3).

CA 125 is the most commonly ordered serum biomarker test for ovarian cancer. It is estimated that three‐quarters of CA 125 tests are ordered for preoperative use, which is not the US Food and Drug Administration (FDA) approved indication. Despite our clinical reliance on CA 125 as a diagnostic test prior to surgery, its utility is limited because of a low sensitivity for predicting cancer in premenopausal women and early stage disease.^14,15 CA 125 specificity also varies widely, depending on patient age and other clinical factors, ranging from as low as 26% in premenopausal women to as high as 100% in postmenopausal women.¹⁶ Because CA 125 often is negative when early stage cancer is present, or positive when cancer is not, it is not recommended for preoperative use for determining whether an ovarian tumor is malignant or whether surgery is indicated. CA 125 should be used to monitor patients with a known ovarian malignancy.

The new triage serum biomarkers, Overa, Ova1, and ROMA (Risk of Ovarian Malignancy Algorithm), are FDA cleared for preoperative use to help determine whether a woman needing surgery for an ovarian mass should be referred to a gynecologic oncologist.^17–20 These tests should not be used to decide if surgery is indicated, but rather should be considered when the decision for surgery has already been made but the malignancy risk is unknown. A woman with a “high risk” result should be referred to a gynecologic oncologist, while one with a “low risk” score is very unlikely to have a malignancy and referral to a specialist is not necessary. TABLE 4 lists a comparison of the relative performance of these serum biomarkers.^{14,15,17–20} There are no published data on the use of serial triage biomarkers.

How to evaluate an ovarian tumor

Approximately 65% of the time, ovarian cystic tumors can be identified accurately as low risk based on the initial sonographic evaluation (TABLE 5). In this scenario, the risk of malignancy is very low (<1%), no secondary testing is needed, and no surgery is recommended.^1,3,21

About 10% of tumors are expected to have a high-risk morphology on ultrasonography, where the risk of malignancy exceeds 25% and referral to a gynecologic oncologist is required.

The remaining 25% of tumors cannot be accurately classified with a single ultrasonographic evaluation and are considered indeterminate.²² Indeterminate tumors require secondary testing to ascertain whether surgery is indicated. Secondary testing may consist of serial ultrasonography, magnetic resonance imaging (MRI), or serum triage biomarker testing if the decision for surgery has been made.

A 2-step process is recommended for evaluating an ovarian tumor.

Step 1. Perform a detailed ultrasonography study using a morphology-based system. Classify the tumor as:

• low risk (65%): unilocular, simple septate, no flow on color Doppler

• simple rules: benign
• MI score 0–3
• no secondary testing; no referral is recommended

• high risk (10%): irregular, mostly solid, papillary projections, very strong flow on color Doppler

• simple rules: malignant
• MI score ≥5
• no secondary testing; refer to a gynecologic oncologist

• indeterminate (25%): partly solid, small wall abnormalities, minimal or moderate flow on color Doppler

• simple rules: both M and B rules apply or no rule applies
• MI score usually 4–6
• perform secondary testing (step 2).

Step 2. Perform secondary testing as follows:

• serum triage biomarkers if surgery is planned (Ova1, ROMA, Overa), or
• MRI, or
• serial sonography.

The 3 case scenarios that follow illustrate how the ovarian tumor evaluation process may be applied in clinical practice, with referral to a gynecologic oncologist as appropriate.

CASE 1 Postmenopausal woman with urinary symptoms and pelvic pressure

A 61-year-old woman is referred with a newly identified ovarian tumor. She has had 1 month of urinary urgency, frequency, and pelvic pressure, but she denies vaginal bleeding or fever. She has no family history of cancer. The referring physician included results of a serum CA 125 (48 U/mL; normal, ≤35 U/mL). A pelvic examination reveals a palpable, irregular mass in the anterior pelvis with limited mobility.

What would be your next step in the evaluation of this patient?

Start with ultrasonography

Step 1. Perform pelvic ultrasonography. In this patient, transvaginal sonography revealed a 6-cm (volume, 89 mL) mostly solid tumor (FIGURE 4). The maximum solid diameter of the tumor was 4.0 cm. There was a 20-mL pocket of pelvic ascites.

Results of morphology-based classification were as follows:

• simple rules: M1 and M5 positive; B rules: negative (malignant; high risk)
• ADNEX: 51.6% risk of malignancy (high risk)
• MI: 7 (high risk).

Step 2. Consider secondary testing. In this case, no secondary testing was recommended. Treatment plan. The patient was referred to a gynecologic oncologist for surgery and was found to have a stage IIA serous ovarian carcinoma.

CASE 2 Woman with history of pelvic symptoms and worsening pain

A 46-year-old woman presents with worsening pelvic pain over the last month. She has a long-standing history of pelvic pain, dysmenorrhea, and dyspareunia from suspected endometriosis. She has no family history of cancer. The referring physician included the following serum biomarker results: CA 125, 48 U/mL (normal, ≤35 U/mL), and HE4, 60 pM (normal, ≤150 pM). On pelvic examination, there is a palpable mass with limited mobility in the posterior cul-de-sac.

Based on the patient’s available history, physical examination, and biomarker information, how would you proceed?

Follow the 2-step process

Step 1. Perform pelvic ultrasonography. Transvaginal sonography revealed a 6-cm (volume, 89 mL) partly solid tumor with regular internal borders (FIGURE 5). The maximum solid diameter of the tumor was 4.5 cm. There was no pelvic ascites.

Morphology classification was as follows:

• simple rules: M5 equivocal; B4 positive (indeterminate risk)
• ADNEX: 42.7% risk of malignancy (high risk)
• MI: 6 (indeterminate risk).

Step 2. Secondary testing was recommended for this patient. Test results were:

• repeat ultrasonography in 4 weeks with MI of 7 (volume score increase from 2 to 3, structure score unchanged at 4). Change in MI score +1 per month (high risk)
• Overa: 5.2 (high risk)
• ROMA: 11.8% (low risk).

Treatment plan. The patient was referred to a gynecologic oncologist because of an increasing MI score on serial sonography. Surgery revealed a stage IA grade 2 endometrioid adenocarcinoma of the ovary with surrounding endometriosis.

Read about treating a woman with postmenstrual bleeding.

CASE 3 Woman with postmenopausal bleeding seeks medical care

A 62-year-old woman is referred with new-onset postmenopausal spotting for 1 month. She was recently prescribed antibiotics for diverticulitis. She has no family history of cancer. The referring physician included the results of a serum CA 125, which was 48 U/mL (normal, ≤35 U/mL). On pelvic examination, a mobile cystic mass is noted in the posterior cul-de-sac.

Use the stepwise protocol to sort out findings

Step 1. Pelvic ultrasonography. Transvaginal sonography suggested the presence of an endometrial polyp and revealed a 6-cm (volume, 89 mL) septate ovarian cyst (FIGURE 6).

Based on morphology classification, risk was categorized as:

• simple rules: M rules negative; B2, B4, B5 positive (benign; low risk)
• ADNEX: 2.9% risk of malignancy (low risk)
• MI: 2 (low risk).

Step 2. No secondary testing was recommended in this case.

Treatment plan. The patient’s gynecologist performed a hysteroscopic polypectomy that revealed no cancer. Serial monitoring was recommended for the low-risk ovarian cyst. The next ultrasonography scan, at 6 months, was unchanged; a subsequent scan was ordered for 12 months later, and at that time the cyst had resolved.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Breast cancer screening is an important aspect of women’s preventative health care, with proven mortality benefits.^1,2 Different recommendations have been made for the age at initiation and the frequency of breast cancer screening in an effort to maximize benefit while minimizing unnecessary health care costs and harms of screening.

The American College of Obstetricians and Gynecologists (ACOG) and the National Comprehensive Cancer Network (NCCN) recommend initiating mammography screening at age 40, with annual screening (although ACOG offers deferral of screening to age 50 and biennial screening through shared decision making).^3,4 The American Cancer Society (ACS) recommends offering annual mammography at ages 40 to 44 and recommends routinely starting annual mammography from 45 to 54, followed by either annual or biennial screening for women 55 and older.¹ Finally, the US Preventive Services Task Force (USPSTF) recommends biennial mammography screening starting at age 50.⁵ No organization alters screening recommendations based on a woman’s race/ethnicity.

Details of the study

Stapleton and colleagues recently performed a retrospective population-based cohort study using the Surveillance, Epidemiology, and End Results (SEER) Program database to evaluate the age and stage at breast cancer diagnosis across different racial groups in the United States.⁶ The study (timeframe, January 1, 1973 to December 31, 2010) included 747,763 women, with a racial/ethnic distribution of 77.0% white, 9.3% black, 7.0% Hispanic, and 6.2% Asian.

The investigators found 2 distinct age distributions of breast cancer based on race. Among nonwhite women, the highest peak of breast cancer diagnoses occurred between 45 and 50 years (FIGURE). By contrast, breast cancer diagnoses peaked at 60 to 65 years in white women.

Similarly, a higher proportion of nonwhite women were diagnosed with their breast cancer prior to age 50 compared with white women. While one-quarter of white women with breast cancer develop disease prior to age 50, approximately one-third of black, Asian, and Hispanic women with breast cancer will be diagnosed before age 50 (TABLE).

These data suggest that the peak proportion of breast cancer diagnoses in nonwhite women occurs prior to the age of initiation of screening recommended by the USPSTF. Based on these results, Stapleton and colleagues recommend reconsideration of the current USPSTF guidelines to incorporate race/ethnicity–based differences. To diagnose the same proportion of breast cancer cases among nonwhite women as is currently possible among white women at age 50, initiation of breast cancer screening would need to be adjusted to age 47 for black women, age 46 for Hispanic women, and age 47 for Asian women.

Study strengths and weaknesses

This is a unique study that uses the SEER database to capture a large cross section of the American population. The SEER database is a valuable tool because it gathers data from numerous major US metropolitan areas, creating a diverse representative population that minimizes confounding from geographical trends. Nevertheless, any study utilizing a large database is limited by the accuracy and completeness of the data collected at the level of the individual cancer registry. Furthermore, information regarding medical comorbidities and access and adherence to breast cancer screening is lacking in the SEER database; this provides an opportunity for confounding.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Breast cancer screening is an important aspect of women’s preventative health care, with proven mortality benefits.^1,2 Different recommendations have been made for the age at initiation and the frequency of breast cancer screening in an effort to maximize benefit while minimizing unnecessary health care costs and harms of screening.

The American College of Obstetricians and Gynecologists (ACOG) and the National Comprehensive Cancer Network (NCCN) recommend initiating mammography screening at age 40, with annual screening (although ACOG offers deferral of screening to age 50 and biennial screening through shared decision making).^3,4 The American Cancer Society (ACS) recommends offering annual mammography at ages 40 to 44 and recommends routinely starting annual mammography from 45 to 54, followed by either annual or biennial screening for women 55 and older.¹ Finally, the US Preventive Services Task Force (USPSTF) recommends biennial mammography screening starting at age 50.⁵ No organization alters screening recommendations based on a woman’s race/ethnicity.

Details of the study

Stapleton and colleagues recently performed a retrospective population-based cohort study using the Surveillance, Epidemiology, and End Results (SEER) Program database to evaluate the age and stage at breast cancer diagnosis across different racial groups in the United States.⁶ The study (timeframe, January 1, 1973 to December 31, 2010) included 747,763 women, with a racial/ethnic distribution of 77.0% white, 9.3% black, 7.0% Hispanic, and 6.2% Asian.

The investigators found 2 distinct age distributions of breast cancer based on race. Among nonwhite women, the highest peak of breast cancer diagnoses occurred between 45 and 50 years (FIGURE). By contrast, breast cancer diagnoses peaked at 60 to 65 years in white women.

Similarly, a higher proportion of nonwhite women were diagnosed with their breast cancer prior to age 50 compared with white women. While one-quarter of white women with breast cancer develop disease prior to age 50, approximately one-third of black, Asian, and Hispanic women with breast cancer will be diagnosed before age 50 (TABLE).

These data suggest that the peak proportion of breast cancer diagnoses in nonwhite women occurs prior to the age of initiation of screening recommended by the USPSTF. Based on these results, Stapleton and colleagues recommend reconsideration of the current USPSTF guidelines to incorporate race/ethnicity–based differences. To diagnose the same proportion of breast cancer cases among nonwhite women as is currently possible among white women at age 50, initiation of breast cancer screening would need to be adjusted to age 47 for black women, age 46 for Hispanic women, and age 47 for Asian women.

Study strengths and weaknesses

This is a unique study that uses the SEER database to capture a large cross section of the American population. The SEER database is a valuable tool because it gathers data from numerous major US metropolitan areas, creating a diverse representative population that minimizes confounding from geographical trends. Nevertheless, any study utilizing a large database is limited by the accuracy and completeness of the data collected at the level of the individual cancer registry. Furthermore, information regarding medical comorbidities and access and adherence to breast cancer screening is lacking in the SEER database; this provides an opportunity for confounding.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

Breast cancer screening is an important aspect of women’s preventative health care, with proven mortality benefits.^1,2 Different recommendations have been made for the age at initiation and the frequency of breast cancer screening in an effort to maximize benefit while minimizing unnecessary health care costs and harms of screening.

The American College of Obstetricians and Gynecologists (ACOG) and the National Comprehensive Cancer Network (NCCN) recommend initiating mammography screening at age 40, with annual screening (although ACOG offers deferral of screening to age 50 and biennial screening through shared decision making).^3,4 The American Cancer Society (ACS) recommends offering annual mammography at ages 40 to 44 and recommends routinely starting annual mammography from 45 to 54, followed by either annual or biennial screening for women 55 and older.¹ Finally, the US Preventive Services Task Force (USPSTF) recommends biennial mammography screening starting at age 50.⁵ No organization alters screening recommendations based on a woman’s race/ethnicity.

Details of the study

Stapleton and colleagues recently performed a retrospective population-based cohort study using the Surveillance, Epidemiology, and End Results (SEER) Program database to evaluate the age and stage at breast cancer diagnosis across different racial groups in the United States.⁶ The study (timeframe, January 1, 1973 to December 31, 2010) included 747,763 women, with a racial/ethnic distribution of 77.0% white, 9.3% black, 7.0% Hispanic, and 6.2% Asian.

The investigators found 2 distinct age distributions of breast cancer based on race. Among nonwhite women, the highest peak of breast cancer diagnoses occurred between 45 and 50 years (FIGURE). By contrast, breast cancer diagnoses peaked at 60 to 65 years in white women.

Similarly, a higher proportion of nonwhite women were diagnosed with their breast cancer prior to age 50 compared with white women. While one-quarter of white women with breast cancer develop disease prior to age 50, approximately one-third of black, Asian, and Hispanic women with breast cancer will be diagnosed before age 50 (TABLE).

These data suggest that the peak proportion of breast cancer diagnoses in nonwhite women occurs prior to the age of initiation of screening recommended by the USPSTF. Based on these results, Stapleton and colleagues recommend reconsideration of the current USPSTF guidelines to incorporate race/ethnicity–based differences. To diagnose the same proportion of breast cancer cases among nonwhite women as is currently possible among white women at age 50, initiation of breast cancer screening would need to be adjusted to age 47 for black women, age 46 for Hispanic women, and age 47 for Asian women.

Study strengths and weaknesses

This is a unique study that uses the SEER database to capture a large cross section of the American population. The SEER database is a valuable tool because it gathers data from numerous major US metropolitan areas, creating a diverse representative population that minimizes confounding from geographical trends. Nevertheless, any study utilizing a large database is limited by the accuracy and completeness of the data collected at the level of the individual cancer registry. Furthermore, information regarding medical comorbidities and access and adherence to breast cancer screening is lacking in the SEER database; this provides an opportunity for confounding.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Obstetrics is a field filled with joyful experiences highlighted by pregnancy, childbirth, and the growth of healthy families. The field is also filled with many experiences that are sorrowful, including failure to conceive after infertility treatment, miscarriage, ultrasound-detected fetal anomalies, fetuses with genetic problems, fetal and neonatal demise, extremely premature birth, and birth injury. For decades oncologists have evolved their approach to discussing bad news with cancer patients. In the distant past, oncologists often kept a cancer diagnosis from the patient, preferring to spare them the stress of the news. In the modern era of transparency, however, oncologists now uniformly strive to keep patients informed of their situation and have adopted structured approaches to delivering bad news. An adverse pregnancy outcome such as a miscarriage or fetal loss may trigger emotional responses as intense as those experienced by a person hearing about a cancer diagnosis. Women who have recently experienced a miscarriage report emotional responses ranging from “a little disappointed” to “in shock” and “for it to be taken away was crushing.”¹ As obstetricians, we can advance our practice by adopting a structured approach to delivering bad news, building on the lessons from cancer medicine. Improving the quality of our communication about adverse pregnancy events will reduce emotional distress and enable patients and families to more effectively cope with challenging situations.

Photo: Shutterstock

Communicating bad news: The facts, the emotional response, and the impact on identity

Clinicians need to be cognizant that a conversation about bad news is 3 interwoven conversations that involve facts, emotional responses, and an altered self-identity. In addition to communicating the facts of the event in clear language, clinicians need to simultaneously monitor and manage the emotional responses to the adverse event and the impact on the participants’ sense of self.² Clinicians are steeped in scientific tradition and method, and as experts we are naturally drawn to a discussion of the facts.

However, a discussion about bad news is highly likely to trigger an emotional response in the patient and the clinician. For example, when a clinician tells the patient about delivery events that resulted in an unexpected newborn injury, the patient may become angry and the clinician may be fearful, anxious, and defensive. Managing the emotions of all participants in the conversation is important for an optimal outcome.

An adverse event also may cause those involved to think about their self-identity. A key feature of bad news is that it alters patients’ expectations about their future, juxtaposing the reality of their outcome with the preferable outcome that may have been. Following a stillbirth during her first pregnancy the patient may be wondering, “Will I ever be a mother?”, “Did I cause the loss?”, and “Does all life end in death?” A traumatic event also may impact the self-identity of the clinician. Following a delivery where the newborn was injured, the clinician may be wondering, “Am I a good or bad clinician?”, “Did I do something wrong?”, “Is it time for me to retire from obstetrical practice?”

Following an adverse pregnancy outcome some patients are consumed with intense grief. This may require the patient and her family to move through a series of emotions (similar to those who receive a new diagnosis of cancer), including denial, anger, bargaining, depression, and acceptance.

Responses to grief

Kubler-Ross identified these 5 psychological coping mechanisms that are often used by people experiencing grief: denial, anger, bargaining, depression, and acceptance.³ The goal of the clinician is to help grieving patients move through these stages in an appropriate fashion and not get stuck in the stages of denial, anger, and/or depression. Following a difficult pregnancy some patients and their family members become stuck in a state dominated by anger, rage, and resentment. This is fertile ground for the growth of a professional liability case. Denial and anger are adaptive short-term defenses to protecting self-identity. In time, most people engage in more constructive responses, accept the adverse event, and plan for the future. Kubler-Ross observed that hope helps people survive through a time of great suffering and is present throughout the response to grief. Clinicians can play an important role in ensuring that a flame of hope is kept burning throughout the process of responding to and grieving bad outcomes.

A structured approach to delivering bad news: SPIKES

Dr. Robert Buckman, an oncologist, has proposed using a structured approach, SPIKES, to guide conversations focused on delivering bad news.^4–6 SPIKES is focused on trying to deeply understand the patient’s level of knowledge, emotions, and perspective before providing medical information and support. SPIKES consists of 6 key steps.

1. Setting up and starting. Mentally rehearse and arrange for privacy. Make sure the patient’s support people are present. Sit down, use open body language, eye contact, and/or touch to make a connection with the patient. Create room for a dialogue by using open-ended questions, silent pauses, listening first, and encouraging the patient to provide their perspective.

2. Perception. Elicit the patient’s perspective. Assess what the patient believes and feels. Assess vocabulary and comprehension.

3. Invitation. Ask the patient what they would like to know. Obtain permission to share knowledge.

4. Knowledge. Provide information in small pieces, always checking back on the patient’s understanding. Use plain language that aligns with the patient’s vocabulary and understanding.

5. Emotions. Explore, explicitly recognize, and empathize with the patient’s emotions.

6. Strategy and summary. Set out a medical plan of action. Express a commitment to be available for the patient as she embarks on the care plan. Arrange for a follow-up conversation.

Some studies have indicated that having a protocol such as SPIKES for delivering bad news helps clinicians to navigate this challenging process, which in turn improves patient satisfaction with disclosure.⁷ Simulation training focused on communicating bad news could be better utilized to help clinicians practice this skill, similar to the simulation exercises used to practice common clinical problems like hemorrhage and shoulder dystocia.^8,9

Physician responses to bad outcomes

Over a career in clinical practice, physicians experience many bad outcomes that expose them to the contagion of sadness and grief. Despite this vicarious trauma, they must always present a professional persona, placing the patient’s needs above their own pain. Due to these experiences, clinicians may become isolated, depressed, and burned out. Drs. Michael and Enid Balint recognized the adverse effect of a lifetime of exposure to suffering and pain. They proposed that physicians could mitigate the trauma of these experiences by participating in small group meetings with a trained leader to discuss their most difficult clinical experiences in a confidential and supportive environment.^10,11 By sharing clinical experiences, feelings, and stories with trusted colleagues, physicians can channel painful experiences into a greater understanding of the empathy and compassion needed to care for themselves, their colleagues, and patients. Clinical practice is invariably punctuated by occasional adverse outcomes necessitating that we effectively manage the process of delivering bad news, simultaneously caring for ourselves and our patients.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Obstetrics is a field filled with joyful experiences highlighted by pregnancy, childbirth, and the growth of healthy families. The field is also filled with many experiences that are sorrowful, including failure to conceive after infertility treatment, miscarriage, ultrasound-detected fetal anomalies, fetuses with genetic problems, fetal and neonatal demise, extremely premature birth, and birth injury. For decades oncologists have evolved their approach to discussing bad news with cancer patients. In the distant past, oncologists often kept a cancer diagnosis from the patient, preferring to spare them the stress of the news. In the modern era of transparency, however, oncologists now uniformly strive to keep patients informed of their situation and have adopted structured approaches to delivering bad news. An adverse pregnancy outcome such as a miscarriage or fetal loss may trigger emotional responses as intense as those experienced by a person hearing about a cancer diagnosis. Women who have recently experienced a miscarriage report emotional responses ranging from “a little disappointed” to “in shock” and “for it to be taken away was crushing.”¹ As obstetricians, we can advance our practice by adopting a structured approach to delivering bad news, building on the lessons from cancer medicine. Improving the quality of our communication about adverse pregnancy events will reduce emotional distress and enable patients and families to more effectively cope with challenging situations.

Photo: Shutterstock

Communicating bad news: The facts, the emotional response, and the impact on identity

Clinicians need to be cognizant that a conversation about bad news is 3 interwoven conversations that involve facts, emotional responses, and an altered self-identity. In addition to communicating the facts of the event in clear language, clinicians need to simultaneously monitor and manage the emotional responses to the adverse event and the impact on the participants’ sense of self.² Clinicians are steeped in scientific tradition and method, and as experts we are naturally drawn to a discussion of the facts.

However, a discussion about bad news is highly likely to trigger an emotional response in the patient and the clinician. For example, when a clinician tells the patient about delivery events that resulted in an unexpected newborn injury, the patient may become angry and the clinician may be fearful, anxious, and defensive. Managing the emotions of all participants in the conversation is important for an optimal outcome.

An adverse event also may cause those involved to think about their self-identity. A key feature of bad news is that it alters patients’ expectations about their future, juxtaposing the reality of their outcome with the preferable outcome that may have been. Following a stillbirth during her first pregnancy the patient may be wondering, “Will I ever be a mother?”, “Did I cause the loss?”, and “Does all life end in death?” A traumatic event also may impact the self-identity of the clinician. Following a delivery where the newborn was injured, the clinician may be wondering, “Am I a good or bad clinician?”, “Did I do something wrong?”, “Is it time for me to retire from obstetrical practice?”

Following an adverse pregnancy outcome some patients are consumed with intense grief. This may require the patient and her family to move through a series of emotions (similar to those who receive a new diagnosis of cancer), including denial, anger, bargaining, depression, and acceptance.

Responses to grief

Kubler-Ross identified these 5 psychological coping mechanisms that are often used by people experiencing grief: denial, anger, bargaining, depression, and acceptance.³ The goal of the clinician is to help grieving patients move through these stages in an appropriate fashion and not get stuck in the stages of denial, anger, and/or depression. Following a difficult pregnancy some patients and their family members become stuck in a state dominated by anger, rage, and resentment. This is fertile ground for the growth of a professional liability case. Denial and anger are adaptive short-term defenses to protecting self-identity. In time, most people engage in more constructive responses, accept the adverse event, and plan for the future. Kubler-Ross observed that hope helps people survive through a time of great suffering and is present throughout the response to grief. Clinicians can play an important role in ensuring that a flame of hope is kept burning throughout the process of responding to and grieving bad outcomes.

A structured approach to delivering bad news: SPIKES

Dr. Robert Buckman, an oncologist, has proposed using a structured approach, SPIKES, to guide conversations focused on delivering bad news.^4–6 SPIKES is focused on trying to deeply understand the patient’s level of knowledge, emotions, and perspective before providing medical information and support. SPIKES consists of 6 key steps.