TORONTO – Implementation of a simple screening tool improved the influenza vaccination status of hospitalized children, results from a single-center study showed.

“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.

Doug Brunk/MDedge News

“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.

In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.

Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.

“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”

The researchers reported having no financial disclosures.

[email protected]

TORONTO – Implementation of a simple screening tool improved the influenza vaccination status of hospitalized children, results from a single-center study showed.

“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.

Doug Brunk/MDedge News

“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.

In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.

Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.

“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”

The researchers reported having no financial disclosures.

[email protected]

TORONTO – Implementation of a simple screening tool improved the influenza vaccination status of hospitalized children, results from a single-center study showed.

“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.

Doug Brunk/MDedge News

“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.

In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.

Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.

“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”

The researchers reported having no financial disclosures.

[email protected]

In light of changing clinical practice guidelines and changing provider attitudes, endocrinologists have the opportunity to step up and become community experts on transgender health care, according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.

“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

MDedge News

For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.

A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.

Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.

It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.

“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”

In light of changing clinical practice guidelines and changing provider attitudes, endocrinologists have the opportunity to step up and become community experts on transgender health care, according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.

“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

MDedge News

For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.

A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.

Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.

It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.

“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”

In light of changing clinical practice guidelines and changing provider attitudes, endocrinologists have the opportunity to step up and become community experts on transgender health care, according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.

“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

MDedge News

For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.

A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.

Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.

It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.

“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”

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.

NASHVILLE—Single-nucleotide polymorphisms (SNPs) in the CYP2J2 region of chromosome 1 may be associated with an increased risk of multiple sclerosis (MS) and higher levels of prolactin, according to research presented at the 2018 CMSC Annual Meeting. “To our knowledge, this is the first report to show an association between genetic variants within this region and either MS status or the level of serum prolactin,” said Samantha Jack, Research Coordinator at Saunders Medical Center in Wahoo, Nebraska, and colleagues.

Although the cause of MS is unknown, a combination of genetic, environmental, and infectious risk factors may contribute to its pathogenesis, said Ms. Jack and colleagues. Vitamin D has been suggested as the most attractive environmental factor. In addition, the CYP2J2 gene has been identified as having a role in serum vitamin D levels in cattle, and the CYP2J2-containing region on bovine chromosome 3 is syntenic with that on human chromosome 1, the researchers said.

Evaluating SNPs in the CYP2J2 Region

Ms. Jack and colleagues conducted a study to determine whether associations exist between variations in the genomic region of CYP2J2 and MS status or levels of serum markers associated with vitamin D and calcium metabolism such as prolactin, vitamin D, vitamin D–binding protein, alkaline phosphatase, and calcium.

Participants were recruited from Nebraska, Iowa, and Kansas between October 2014 and December 2016 to participate in a single blood draw.

Ms. Jack and colleagues collected blood samples from 220 patients with MS and 238 age- and sex-matched controls. DNA from blood samples was genotyped for 94 SNPs in a 255,348 base-pair region of chromosome 1 that included CYP2J2 and C1orf87. Researchers analyzed serum samples to quantify concentrations of vitamin D, vitamin D–binding protein, alkaline phosphatase, and prolactin. Almost all participants with MS took supplemental vitamin D.

The 458 participants in the study were predominately Caucasian and had an average age of about 50, said Ms. Jack.

SNPs in the CYP2J2 region were associated with an increased risk of MS. These associations were not significant following Bonferroni correction. Several other SNPs in the CYP2J2 region were associated with prolactin levels, but the associations were not significant following the Bonferroni correction. No SNPs in this region showed significant associations between levels of vitamin D, vitamin D–binding protein, calcium, or alkaline phosphatase, but vitamin D levels may have been skewed since many patients with MS were taking vitamin D supplements, said the researchers.

Overall, SNPs downstream of CYP2J2 in the C1orf87 gene were associated with prolactin levels, and SNPs in the intergenic region between CYP212 and C1orf87 may be associated with MS, said the researchers.

Study Limitations and Future Directions

Study limitations include that the study population was homogeneous (ie, middle-aged and white from the Midwest) and that samples were not always taken in the morning after fasting, which may have affected prolactin levels, said Ms. Jack.

“We are in the process of undertaking a genome-wide association study to continue this work,” Ms. Jack said. “We are currently enrolling more subjects to have a well-powered study, and we hope to have a small subset of people who have not taken vitamin D supplementation so that we will be able to analyze those values.”

—Erica Tricarico

NASHVILLE—Single-nucleotide polymorphisms (SNPs) in the CYP2J2 region of chromosome 1 may be associated with an increased risk of multiple sclerosis (MS) and higher levels of prolactin, according to research presented at the 2018 CMSC Annual Meeting. “To our knowledge, this is the first report to show an association between genetic variants within this region and either MS status or the level of serum prolactin,” said Samantha Jack, Research Coordinator at Saunders Medical Center in Wahoo, Nebraska, and colleagues.

Although the cause of MS is unknown, a combination of genetic, environmental, and infectious risk factors may contribute to its pathogenesis, said Ms. Jack and colleagues. Vitamin D has been suggested as the most attractive environmental factor. In addition, the CYP2J2 gene has been identified as having a role in serum vitamin D levels in cattle, and the CYP2J2-containing region on bovine chromosome 3 is syntenic with that on human chromosome 1, the researchers said.

Evaluating SNPs in the CYP2J2 Region

Ms. Jack and colleagues conducted a study to determine whether associations exist between variations in the genomic region of CYP2J2 and MS status or levels of serum markers associated with vitamin D and calcium metabolism such as prolactin, vitamin D, vitamin D–binding protein, alkaline phosphatase, and calcium.

Participants were recruited from Nebraska, Iowa, and Kansas between October 2014 and December 2016 to participate in a single blood draw.

Ms. Jack and colleagues collected blood samples from 220 patients with MS and 238 age- and sex-matched controls. DNA from blood samples was genotyped for 94 SNPs in a 255,348 base-pair region of chromosome 1 that included CYP2J2 and C1orf87. Researchers analyzed serum samples to quantify concentrations of vitamin D, vitamin D–binding protein, alkaline phosphatase, and prolactin. Almost all participants with MS took supplemental vitamin D.

The 458 participants in the study were predominately Caucasian and had an average age of about 50, said Ms. Jack.

SNPs in the CYP2J2 region were associated with an increased risk of MS. These associations were not significant following Bonferroni correction. Several other SNPs in the CYP2J2 region were associated with prolactin levels, but the associations were not significant following the Bonferroni correction. No SNPs in this region showed significant associations between levels of vitamin D, vitamin D–binding protein, calcium, or alkaline phosphatase, but vitamin D levels may have been skewed since many patients with MS were taking vitamin D supplements, said the researchers.

Overall, SNPs downstream of CYP2J2 in the C1orf87 gene were associated with prolactin levels, and SNPs in the intergenic region between CYP212 and C1orf87 may be associated with MS, said the researchers.

Study Limitations and Future Directions

Study limitations include that the study population was homogeneous (ie, middle-aged and white from the Midwest) and that samples were not always taken in the morning after fasting, which may have affected prolactin levels, said Ms. Jack.

“We are in the process of undertaking a genome-wide association study to continue this work,” Ms. Jack said. “We are currently enrolling more subjects to have a well-powered study, and we hope to have a small subset of people who have not taken vitamin D supplementation so that we will be able to analyze those values.”

—Erica Tricarico

NASHVILLE—Single-nucleotide polymorphisms (SNPs) in the CYP2J2 region of chromosome 1 may be associated with an increased risk of multiple sclerosis (MS) and higher levels of prolactin, according to research presented at the 2018 CMSC Annual Meeting. “To our knowledge, this is the first report to show an association between genetic variants within this region and either MS status or the level of serum prolactin,” said Samantha Jack, Research Coordinator at Saunders Medical Center in Wahoo, Nebraska, and colleagues.

Although the cause of MS is unknown, a combination of genetic, environmental, and infectious risk factors may contribute to its pathogenesis, said Ms. Jack and colleagues. Vitamin D has been suggested as the most attractive environmental factor. In addition, the CYP2J2 gene has been identified as having a role in serum vitamin D levels in cattle, and the CYP2J2-containing region on bovine chromosome 3 is syntenic with that on human chromosome 1, the researchers said.

Evaluating SNPs in the CYP2J2 Region

Ms. Jack and colleagues conducted a study to determine whether associations exist between variations in the genomic region of CYP2J2 and MS status or levels of serum markers associated with vitamin D and calcium metabolism such as prolactin, vitamin D, vitamin D–binding protein, alkaline phosphatase, and calcium.

Participants were recruited from Nebraska, Iowa, and Kansas between October 2014 and December 2016 to participate in a single blood draw.

Ms. Jack and colleagues collected blood samples from 220 patients with MS and 238 age- and sex-matched controls. DNA from blood samples was genotyped for 94 SNPs in a 255,348 base-pair region of chromosome 1 that included CYP2J2 and C1orf87. Researchers analyzed serum samples to quantify concentrations of vitamin D, vitamin D–binding protein, alkaline phosphatase, and prolactin. Almost all participants with MS took supplemental vitamin D.

The 458 participants in the study were predominately Caucasian and had an average age of about 50, said Ms. Jack.

SNPs in the CYP2J2 region were associated with an increased risk of MS. These associations were not significant following Bonferroni correction. Several other SNPs in the CYP2J2 region were associated with prolactin levels, but the associations were not significant following the Bonferroni correction. No SNPs in this region showed significant associations between levels of vitamin D, vitamin D–binding protein, calcium, or alkaline phosphatase, but vitamin D levels may have been skewed since many patients with MS were taking vitamin D supplements, said the researchers.

Overall, SNPs downstream of CYP2J2 in the C1orf87 gene were associated with prolactin levels, and SNPs in the intergenic region between CYP212 and C1orf87 may be associated with MS, said the researchers.

Study Limitations and Future Directions

Study limitations include that the study population was homogeneous (ie, middle-aged and white from the Midwest) and that samples were not always taken in the morning after fasting, which may have affected prolactin levels, said Ms. Jack.

“We are in the process of undertaking a genome-wide association study to continue this work,” Ms. Jack said. “We are currently enrolling more subjects to have a well-powered study, and we hope to have a small subset of people who have not taken vitamin D supplementation so that we will be able to analyze those values.”

—Erica Tricarico

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.

NASHVILLE, Tenn. – Recent research into comorbidities in multiple sclerosis – including head-scratching findings about lower cancer rates – is shedding light on the links between the disease and other illnesses, according to an epidemiologist specializing in MS.

“People should be mindful that if they look at having a positive impact on those comorbidities, they may have the ability to benefit patients in context of their MS,” Helen Tremlett, PhD, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. She is the Canada Research Chair in Neuroepidemiology and Multiple Sclerosis at the University of British Columbia, Vancouver.

In recent years, research into comorbidities in MS has risen dramatically. Dr. Tremlett found that the number of papers per year in PubMed that address MS and comorbidity has risen from roughly 30 in 2007 to about 80 in 2015, although the numbers dipped to about 50 and 60, respectively, in 2016 and 2017.

A 2015 systematic review of research into MS and comorbidities reported that while “findings were inconsistent overall,” studies suggested that “meningiomas and possibly urinary system cancers, inflammatory bowel disease, irritable bowel syndrome, epilepsy, depression, anxiety, bipolar disorder, early cataracts, and restless legs syndrome were more common than expected in the MS population.” (Mult Scler. 2015 Mar;21[3]:263-81).

Notably, most cancers are missing from this list. In fact, Dr. Tremlett cowrote a 2012 study that found lower risks of all cancers and several specific types of cancer – breast, lung, colorectal, prostate, and melanoma – in MS patients, compared with age- and gender-matched controls (Brain. 2012 Oct;135[Pt 10]:2973-9).

According to Dr. Tremlett, there are several theories about the apparent lower cancer risk in patients with MS. Perhaps their immune systems are hypervigilant, or maybe MS diagnoses inspire healthier lifestyles.

Researchers have been intrigued by another possibility – that cancer diagnoses are being delayed in patients with MS. Indeed, the 2012 study found that tumor sizes at diagnosis in patients with MS were larger than expected in breast, prostate, lung, and colorectal cancer (P = .04).

“We couldn’t record why that’s the case, but there may be some so-called ‘diagnostic neglect,’ ” she said. “You could imagine a scenario where a typical person with MS goes to see their physician and says, ‘I’m tired. I have fatigue,’ and the physician says, ‘Yes, you have MS, that’s what you should expect.’ Someone in the general population might get additional investigation, get blood work done, and their cancer might be found earlier.”

It’s also possible, she said, that cancer isn’t picked up earlier because it can be difficult to screen people with disabilities. “It’s only recently that physicians can offer the Pap smear to women in a wheelchair.”

On another front, there’s evidence linking comorbidities to worsening MS. A 2018 study coauthored by Dr. Tremlett found that patients with more comorbidities had more disability. Specifically, ischemic heart disease and epilepsy were associated with greater Expanded Disability Status Scale scores (Neurology. 2018 Jan 3. doi: 10.1212/WNL.0000000000004885).

Other research coauthored by Dr. Tremlett has linked comorbidities in MS – specifically, hyperlipidemia, migraine, and three or more comorbidities – to higher risk of MS relapse (Neurology. 2017 Dec 12;89[24]:2455-61).

Dr. Tremlett reported having no relevant disclosures.

NASHVILLE, Tenn. – Recent research into comorbidities in multiple sclerosis – including head-scratching findings about lower cancer rates – is shedding light on the links between the disease and other illnesses, according to an epidemiologist specializing in MS.

“People should be mindful that if they look at having a positive impact on those comorbidities, they may have the ability to benefit patients in context of their MS,” Helen Tremlett, PhD, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. She is the Canada Research Chair in Neuroepidemiology and Multiple Sclerosis at the University of British Columbia, Vancouver.

In recent years, research into comorbidities in MS has risen dramatically. Dr. Tremlett found that the number of papers per year in PubMed that address MS and comorbidity has risen from roughly 30 in 2007 to about 80 in 2015, although the numbers dipped to about 50 and 60, respectively, in 2016 and 2017.

A 2015 systematic review of research into MS and comorbidities reported that while “findings were inconsistent overall,” studies suggested that “meningiomas and possibly urinary system cancers, inflammatory bowel disease, irritable bowel syndrome, epilepsy, depression, anxiety, bipolar disorder, early cataracts, and restless legs syndrome were more common than expected in the MS population.” (Mult Scler. 2015 Mar;21[3]:263-81).

Notably, most cancers are missing from this list. In fact, Dr. Tremlett cowrote a 2012 study that found lower risks of all cancers and several specific types of cancer – breast, lung, colorectal, prostate, and melanoma – in MS patients, compared with age- and gender-matched controls (Brain. 2012 Oct;135[Pt 10]:2973-9).

According to Dr. Tremlett, there are several theories about the apparent lower cancer risk in patients with MS. Perhaps their immune systems are hypervigilant, or maybe MS diagnoses inspire healthier lifestyles.

Researchers have been intrigued by another possibility – that cancer diagnoses are being delayed in patients with MS. Indeed, the 2012 study found that tumor sizes at diagnosis in patients with MS were larger than expected in breast, prostate, lung, and colorectal cancer (P = .04).

“We couldn’t record why that’s the case, but there may be some so-called ‘diagnostic neglect,’ ” she said. “You could imagine a scenario where a typical person with MS goes to see their physician and says, ‘I’m tired. I have fatigue,’ and the physician says, ‘Yes, you have MS, that’s what you should expect.’ Someone in the general population might get additional investigation, get blood work done, and their cancer might be found earlier.”

It’s also possible, she said, that cancer isn’t picked up earlier because it can be difficult to screen people with disabilities. “It’s only recently that physicians can offer the Pap smear to women in a wheelchair.”

On another front, there’s evidence linking comorbidities to worsening MS. A 2018 study coauthored by Dr. Tremlett found that patients with more comorbidities had more disability. Specifically, ischemic heart disease and epilepsy were associated with greater Expanded Disability Status Scale scores (Neurology. 2018 Jan 3. doi: 10.1212/WNL.0000000000004885).

Other research coauthored by Dr. Tremlett has linked comorbidities in MS – specifically, hyperlipidemia, migraine, and three or more comorbidities – to higher risk of MS relapse (Neurology. 2017 Dec 12;89[24]:2455-61).

Dr. Tremlett reported having no relevant disclosures.

NASHVILLE, Tenn. – Recent research into comorbidities in multiple sclerosis – including head-scratching findings about lower cancer rates – is shedding light on the links between the disease and other illnesses, according to an epidemiologist specializing in MS.

“People should be mindful that if they look at having a positive impact on those comorbidities, they may have the ability to benefit patients in context of their MS,” Helen Tremlett, PhD, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. She is the Canada Research Chair in Neuroepidemiology and Multiple Sclerosis at the University of British Columbia, Vancouver.

In recent years, research into comorbidities in MS has risen dramatically. Dr. Tremlett found that the number of papers per year in PubMed that address MS and comorbidity has risen from roughly 30 in 2007 to about 80 in 2015, although the numbers dipped to about 50 and 60, respectively, in 2016 and 2017.

A 2015 systematic review of research into MS and comorbidities reported that while “findings were inconsistent overall,” studies suggested that “meningiomas and possibly urinary system cancers, inflammatory bowel disease, irritable bowel syndrome, epilepsy, depression, anxiety, bipolar disorder, early cataracts, and restless legs syndrome were more common than expected in the MS population.” (Mult Scler. 2015 Mar;21[3]:263-81).

Notably, most cancers are missing from this list. In fact, Dr. Tremlett cowrote a 2012 study that found lower risks of all cancers and several specific types of cancer – breast, lung, colorectal, prostate, and melanoma – in MS patients, compared with age- and gender-matched controls (Brain. 2012 Oct;135[Pt 10]:2973-9).

According to Dr. Tremlett, there are several theories about the apparent lower cancer risk in patients with MS. Perhaps their immune systems are hypervigilant, or maybe MS diagnoses inspire healthier lifestyles.

Researchers have been intrigued by another possibility – that cancer diagnoses are being delayed in patients with MS. Indeed, the 2012 study found that tumor sizes at diagnosis in patients with MS were larger than expected in breast, prostate, lung, and colorectal cancer (P = .04).

“We couldn’t record why that’s the case, but there may be some so-called ‘diagnostic neglect,’ ” she said. “You could imagine a scenario where a typical person with MS goes to see their physician and says, ‘I’m tired. I have fatigue,’ and the physician says, ‘Yes, you have MS, that’s what you should expect.’ Someone in the general population might get additional investigation, get blood work done, and their cancer might be found earlier.”

It’s also possible, she said, that cancer isn’t picked up earlier because it can be difficult to screen people with disabilities. “It’s only recently that physicians can offer the Pap smear to women in a wheelchair.”

On another front, there’s evidence linking comorbidities to worsening MS. A 2018 study coauthored by Dr. Tremlett found that patients with more comorbidities had more disability. Specifically, ischemic heart disease and epilepsy were associated with greater Expanded Disability Status Scale scores (Neurology. 2018 Jan 3. doi: 10.1212/WNL.0000000000004885).

Other research coauthored by Dr. Tremlett has linked comorbidities in MS – specifically, hyperlipidemia, migraine, and three or more comorbidities – to higher risk of MS relapse (Neurology. 2017 Dec 12;89[24]:2455-61).

Dr. Tremlett reported having no relevant disclosures.

Clinical question: Is there a difference in the ordering of laboratory tests between teaching and nonteaching hospitals?

Background: There is a general impression that trainees at teaching hospitals order more unnecessary laboratory testing, compared with those at nonteaching hospitals, but there are not enough data to support this generalization. In addition, there may be factors at teaching hospitals that influence these results.

Study design: Cross-sectional study.

Setting: Teaching and nonteaching hospitals.

Synopsis: Investigators used the Texas Inpatient Public Use Data file to examine hospital discharges from both teaching and nonteaching hospitals with a discharge diagnosis of cellulitis or pneumonia. There were a greater number of laboratory tests ordered at teaching hospitals, compared with nonteaching hospitals. For pneumonia, there were an additional 3.6 tests ordered per day, and for cellulitis, there were an additional 2.6 tests ordered per day. This finding was statistically significant, even when adjusted for illness severity, length of stay, and patient demographics.

This study did not account for confounding diagnoses that may have influenced ordering or the prescribing habits of different practitioner groups (such as residents, attending physicians, or advanced practice providers).

Bottom line: There is an increase in laboratory test orders in teaching versus nonteaching hospitals for pneumonia and cellulitis.

Citation: Valencia V et al. A comparison of laboratory testing in teaching vs nonteaching hospitals for 2 common medical conditions. JAMA Intern Med. 2018 Jan 1;178(1):39-47.

Dr. Shaffie is a hospitalist at Denver Health Medical Center and an assistant professor of medicine at the University of Colorado at Denver, Aurora.

Clinical question: Is there a difference in the ordering of laboratory tests between teaching and nonteaching hospitals?

Background: There is a general impression that trainees at teaching hospitals order more unnecessary laboratory testing, compared with those at nonteaching hospitals, but there are not enough data to support this generalization. In addition, there may be factors at teaching hospitals that influence these results.

Study design: Cross-sectional study.

Setting: Teaching and nonteaching hospitals.

Synopsis: Investigators used the Texas Inpatient Public Use Data file to examine hospital discharges from both teaching and nonteaching hospitals with a discharge diagnosis of cellulitis or pneumonia. There were a greater number of laboratory tests ordered at teaching hospitals, compared with nonteaching hospitals. For pneumonia, there were an additional 3.6 tests ordered per day, and for cellulitis, there were an additional 2.6 tests ordered per day. This finding was statistically significant, even when adjusted for illness severity, length of stay, and patient demographics.

This study did not account for confounding diagnoses that may have influenced ordering or the prescribing habits of different practitioner groups (such as residents, attending physicians, or advanced practice providers).

Bottom line: There is an increase in laboratory test orders in teaching versus nonteaching hospitals for pneumonia and cellulitis.

Citation: Valencia V et al. A comparison of laboratory testing in teaching vs nonteaching hospitals for 2 common medical conditions. JAMA Intern Med. 2018 Jan 1;178(1):39-47.

Dr. Shaffie is a hospitalist at Denver Health Medical Center and an assistant professor of medicine at the University of Colorado at Denver, Aurora.

Clinical question: Is there a difference in the ordering of laboratory tests between teaching and nonteaching hospitals?

Background: There is a general impression that trainees at teaching hospitals order more unnecessary laboratory testing, compared with those at nonteaching hospitals, but there are not enough data to support this generalization. In addition, there may be factors at teaching hospitals that influence these results.

Study design: Cross-sectional study.

Setting: Teaching and nonteaching hospitals.

Synopsis: Investigators used the Texas Inpatient Public Use Data file to examine hospital discharges from both teaching and nonteaching hospitals with a discharge diagnosis of cellulitis or pneumonia. There were a greater number of laboratory tests ordered at teaching hospitals, compared with nonteaching hospitals. For pneumonia, there were an additional 3.6 tests ordered per day, and for cellulitis, there were an additional 2.6 tests ordered per day. This finding was statistically significant, even when adjusted for illness severity, length of stay, and patient demographics.

This study did not account for confounding diagnoses that may have influenced ordering or the prescribing habits of different practitioner groups (such as residents, attending physicians, or advanced practice providers).

Bottom line: There is an increase in laboratory test orders in teaching versus nonteaching hospitals for pneumonia and cellulitis.

Citation: Valencia V et al. A comparison of laboratory testing in teaching vs nonteaching hospitals for 2 common medical conditions. JAMA Intern Med. 2018 Jan 1;178(1):39-47.

Dr. Shaffie is a hospitalist at Denver Health Medical Center and an assistant professor of medicine at the University of Colorado at Denver, Aurora.

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.

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.

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.

NASHVILLE, TENN. – Jeffrey B. English, MD, of the MS Center of Atlanta, knows which quality measures physicians and their patients with multiple sclerosis think are important. After all, he and his colleagues have surveyed them about that very topic.

But he has little time to monitor these measures since he’s too busy with a more overwhelming task: keeping track of unrelated quality measures as required by the federal government.

“When they developed quality measures under the MACRA law, they were not thinking about MS people in general. They were very primary care based,” Dr. English said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers.

In terms of MS, he said, “no one really knows what the correct outcome measures are.”

Dr. English knows more than most about quality measures preferred by neurologists and patients. At the annual CMSC meeting last year, he presented results from a survey of 11 physicians and 423 patients about the measures of care they consider most important. The patient survey asked about several measures recommended by the American Academy of Neurology plus other measures recommended by the physicians.

The two groups – physicians and patients – agreed on the top four measures: change observed via MRI, change observed via exam, quality of life, and fatigue. However, they disagreed on the ranking within the top four spots.

The least important measures for patients were exercise levels, depression, medication compliance, and relapses.

Dr. English wants to “be able to follow what the patients want me to follow.” However, he hasn’t been able to do so since “25% of my time with patients, in between patients and after hours, is spent trying to comply with outcome measures from the new health care system that are of no benefit to the patient,” he said.

He’s referring to the quality measures that many physicians are tracking to get reimbursed by Medicare and Medicaid.

Value-based care posts other challenges for MS physicians, he said, since MS care is especially expensive. Accountable Care Organizations are looking at cost savings in closed systems, he said, and that could spell trouble because patients with MS cost more.

As a 2015 report noted, first-generation disease-modifying therapies (DMTs) for MS cost about $60,000, and “costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs” (Neurology. 2015 May 26;84[21]:2185-92).

“If I’m in an ACO, and I’m taking care of a lot of MS patients, I’ll already lose money for the accountable care system,” Dr. English said. “They may not necessarily want an MS center inside an ACO.”

What can doctors do? “Advocacy efforts are pretty difficult for physicians,” Dr. English said. “Our hope is that the CMSC will be a clearinghouse for doctors who have ideas and efforts and advocacy, and somehow channel that into the actual provision of care. You have people advocating for medications and for research and for patients, but there’s nobody advocating for the actual care that’s going on, the boots-on-the-ground care. That’s where CMSC should play a big role.”

Dr. English disclosed that he has served as a consultant for multiple pharmaceutical companies.

NASHVILLE, TENN. – Jeffrey B. English, MD, of the MS Center of Atlanta, knows which quality measures physicians and their patients with multiple sclerosis think are important. After all, he and his colleagues have surveyed them about that very topic.

But he has little time to monitor these measures since he’s too busy with a more overwhelming task: keeping track of unrelated quality measures as required by the federal government.

“When they developed quality measures under the MACRA law, they were not thinking about MS people in general. They were very primary care based,” Dr. English said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers.

In terms of MS, he said, “no one really knows what the correct outcome measures are.”

Dr. English knows more than most about quality measures preferred by neurologists and patients. At the annual CMSC meeting last year, he presented results from a survey of 11 physicians and 423 patients about the measures of care they consider most important. The patient survey asked about several measures recommended by the American Academy of Neurology plus other measures recommended by the physicians.

The two groups – physicians and patients – agreed on the top four measures: change observed via MRI, change observed via exam, quality of life, and fatigue. However, they disagreed on the ranking within the top four spots.

The least important measures for patients were exercise levels, depression, medication compliance, and relapses.

Dr. English wants to “be able to follow what the patients want me to follow.” However, he hasn’t been able to do so since “25% of my time with patients, in between patients and after hours, is spent trying to comply with outcome measures from the new health care system that are of no benefit to the patient,” he said.

He’s referring to the quality measures that many physicians are tracking to get reimbursed by Medicare and Medicaid.

Value-based care posts other challenges for MS physicians, he said, since MS care is especially expensive. Accountable Care Organizations are looking at cost savings in closed systems, he said, and that could spell trouble because patients with MS cost more.

As a 2015 report noted, first-generation disease-modifying therapies (DMTs) for MS cost about $60,000, and “costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs” (Neurology. 2015 May 26;84[21]:2185-92).

“If I’m in an ACO, and I’m taking care of a lot of MS patients, I’ll already lose money for the accountable care system,” Dr. English said. “They may not necessarily want an MS center inside an ACO.”

What can doctors do? “Advocacy efforts are pretty difficult for physicians,” Dr. English said. “Our hope is that the CMSC will be a clearinghouse for doctors who have ideas and efforts and advocacy, and somehow channel that into the actual provision of care. You have people advocating for medications and for research and for patients, but there’s nobody advocating for the actual care that’s going on, the boots-on-the-ground care. That’s where CMSC should play a big role.”

Dr. English disclosed that he has served as a consultant for multiple pharmaceutical companies.

NASHVILLE, TENN. – Jeffrey B. English, MD, of the MS Center of Atlanta, knows which quality measures physicians and their patients with multiple sclerosis think are important. After all, he and his colleagues have surveyed them about that very topic.

But he has little time to monitor these measures since he’s too busy with a more overwhelming task: keeping track of unrelated quality measures as required by the federal government.

“When they developed quality measures under the MACRA law, they were not thinking about MS people in general. They were very primary care based,” Dr. English said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers.

In terms of MS, he said, “no one really knows what the correct outcome measures are.”

Dr. English knows more than most about quality measures preferred by neurologists and patients. At the annual CMSC meeting last year, he presented results from a survey of 11 physicians and 423 patients about the measures of care they consider most important. The patient survey asked about several measures recommended by the American Academy of Neurology plus other measures recommended by the physicians.

The two groups – physicians and patients – agreed on the top four measures: change observed via MRI, change observed via exam, quality of life, and fatigue. However, they disagreed on the ranking within the top four spots.

The least important measures for patients were exercise levels, depression, medication compliance, and relapses.

Dr. English wants to “be able to follow what the patients want me to follow.” However, he hasn’t been able to do so since “25% of my time with patients, in between patients and after hours, is spent trying to comply with outcome measures from the new health care system that are of no benefit to the patient,” he said.

He’s referring to the quality measures that many physicians are tracking to get reimbursed by Medicare and Medicaid.

Value-based care posts other challenges for MS physicians, he said, since MS care is especially expensive. Accountable Care Organizations are looking at cost savings in closed systems, he said, and that could spell trouble because patients with MS cost more.

As a 2015 report noted, first-generation disease-modifying therapies (DMTs) for MS cost about $60,000, and “costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs” (Neurology. 2015 May 26;84[21]:2185-92).

“If I’m in an ACO, and I’m taking care of a lot of MS patients, I’ll already lose money for the accountable care system,” Dr. English said. “They may not necessarily want an MS center inside an ACO.”

What can doctors do? “Advocacy efforts are pretty difficult for physicians,” Dr. English said. “Our hope is that the CMSC will be a clearinghouse for doctors who have ideas and efforts and advocacy, and somehow channel that into the actual provision of care. You have people advocating for medications and for research and for patients, but there’s nobody advocating for the actual care that’s going on, the boots-on-the-ground care. That’s where CMSC should play a big role.”

Dr. English disclosed that he has served as a consultant for multiple pharmaceutical companies.

By Guilherme Piovezani Ramos, MD, Seth Sweetser, MD, and John B. Kisiel, MD

Recurrent SBO owing to contained perforation after accidental ingestion of a metal bristle of a barbecue grill brush 
 
SBO may be caused by a variety of intrinsic or extrinsic lesions. Postoperative adhesions (60%) and malignant tumors (20%) are responsible for the majority of cases in the United States. CD accounts for approximately 5% of all SBOs.¹ The unusual root cause of our patient's SBO was unintentional ingestion of a foreign body.

By Guilherme Piovezani Ramos, MD, Seth Sweetser, MD, and John B. Kisiel, MD

Recurrent SBO owing to contained perforation after accidental ingestion of a metal bristle of a barbecue grill brush 
 
SBO may be caused by a variety of intrinsic or extrinsic lesions. Postoperative adhesions (60%) and malignant tumors (20%) are responsible for the majority of cases in the United States. CD accounts for approximately 5% of all SBOs.¹ The unusual root cause of our patient's SBO was unintentional ingestion of a foreign body.

By Guilherme Piovezani Ramos, MD, Seth Sweetser, MD, and John B. Kisiel, MD

Recurrent SBO owing to contained perforation after accidental ingestion of a metal bristle of a barbecue grill brush 
 
SBO may be caused by a variety of intrinsic or extrinsic lesions. Postoperative adhesions (60%) and malignant tumors (20%) are responsible for the majority of cases in the United States. CD accounts for approximately 5% of all SBOs.¹ The unusual root cause of our patient's SBO was unintentional ingestion of a foreign body.