Janelle Yates

Several small studies have suggested that endometriosis—which affects about 10% of women of reproductive age—is a risk factor for epithelial ovarian cancer. Now, a study published online in Lancet Oncology provides definitive evidence of this link and highlights the risk of specific subtypes of ovarian cancer.¹

In the study, a team from the Ovarian Cancer Association Consortium calculated the size of the association between endometriosis and each of the five major ovarian cancer histologic subtypes:

• high-grade serous (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.97–1.32; P = .13)
• low-grade serous (OR, 2.11; 95% CI, 1.39–3.20; P < .0001)
• clear-cell (OR, 3.05; 95% CI, 2.43–3.84; P < .0001)
• endometrioid (OR, 2.04; 95% CI, 1.67–2.48; P < .0001)
• mucinous carcinomas (OR, 1.02; 95% CI, 0.69–1.50; P = .93).

The study consisted of a pooled analysis of 13 case-control studies, which included data from more than 23,000 women (13,326 controls; 7,911 women who had invasive ovarian cancer; and 1,907 women who had borderline cancer).

A history of endometriosis more than tripled the risk of clear-cell ovarian cancer and more than doubled the risk of endometrioid tumors. It also doubled the risk of low-grade serous ovarian cancers.

A link was not found between endometriosis and high-grade serous, mucinous, serous borderline, or mucinous borderline ovarian cancers.

The authors of the published report of the study characterize their findings as a “breakthrough” that “could lead to better identification of women at increased risk of ovarian cancer and could provide a basis for increased cancer surveillance of the relevant population, allowing better individualization of prevention and early detection approaches such as risk-reduction surgery and screening,” according to Celeste Leigh Pearce from the University of Southern California, Los Angeles, the lead author.

But the authors were quick to offer a caution: “Although we have reported strong associations between endometriosis and risk of clear-cell, endometrioid, and low-grade serous ovarian cancers, most women with endometriosis do not develop ovarian cancer. However, health-care providers should be alert to the increased risk of specific subtypes of ovarian cancer in women with a history of endometriosis.”

We want to hear from you! Tell us what you think.

Several small studies have suggested that endometriosis—which affects about 10% of women of reproductive age—is a risk factor for epithelial ovarian cancer. Now, a study published online in Lancet Oncology provides definitive evidence of this link and highlights the risk of specific subtypes of ovarian cancer.¹

In the study, a team from the Ovarian Cancer Association Consortium calculated the size of the association between endometriosis and each of the five major ovarian cancer histologic subtypes:

• high-grade serous (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.97–1.32; P = .13)
• low-grade serous (OR, 2.11; 95% CI, 1.39–3.20; P < .0001)
• clear-cell (OR, 3.05; 95% CI, 2.43–3.84; P < .0001)
• endometrioid (OR, 2.04; 95% CI, 1.67–2.48; P < .0001)
• mucinous carcinomas (OR, 1.02; 95% CI, 0.69–1.50; P = .93).

The study consisted of a pooled analysis of 13 case-control studies, which included data from more than 23,000 women (13,326 controls; 7,911 women who had invasive ovarian cancer; and 1,907 women who had borderline cancer).

A history of endometriosis more than tripled the risk of clear-cell ovarian cancer and more than doubled the risk of endometrioid tumors. It also doubled the risk of low-grade serous ovarian cancers.

A link was not found between endometriosis and high-grade serous, mucinous, serous borderline, or mucinous borderline ovarian cancers.

The authors of the published report of the study characterize their findings as a “breakthrough” that “could lead to better identification of women at increased risk of ovarian cancer and could provide a basis for increased cancer surveillance of the relevant population, allowing better individualization of prevention and early detection approaches such as risk-reduction surgery and screening,” according to Celeste Leigh Pearce from the University of Southern California, Los Angeles, the lead author.

But the authors were quick to offer a caution: “Although we have reported strong associations between endometriosis and risk of clear-cell, endometrioid, and low-grade serous ovarian cancers, most women with endometriosis do not develop ovarian cancer. However, health-care providers should be alert to the increased risk of specific subtypes of ovarian cancer in women with a history of endometriosis.”

We want to hear from you! Tell us what you think.

Several small studies have suggested that endometriosis—which affects about 10% of women of reproductive age—is a risk factor for epithelial ovarian cancer. Now, a study published online in Lancet Oncology provides definitive evidence of this link and highlights the risk of specific subtypes of ovarian cancer.¹

In the study, a team from the Ovarian Cancer Association Consortium calculated the size of the association between endometriosis and each of the five major ovarian cancer histologic subtypes:

• high-grade serous (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.97–1.32; P = .13)
• low-grade serous (OR, 2.11; 95% CI, 1.39–3.20; P < .0001)
• clear-cell (OR, 3.05; 95% CI, 2.43–3.84; P < .0001)
• endometrioid (OR, 2.04; 95% CI, 1.67–2.48; P < .0001)
• mucinous carcinomas (OR, 1.02; 95% CI, 0.69–1.50; P = .93).

The study consisted of a pooled analysis of 13 case-control studies, which included data from more than 23,000 women (13,326 controls; 7,911 women who had invasive ovarian cancer; and 1,907 women who had borderline cancer).

A history of endometriosis more than tripled the risk of clear-cell ovarian cancer and more than doubled the risk of endometrioid tumors. It also doubled the risk of low-grade serous ovarian cancers.

A link was not found between endometriosis and high-grade serous, mucinous, serous borderline, or mucinous borderline ovarian cancers.

The authors of the published report of the study characterize their findings as a “breakthrough” that “could lead to better identification of women at increased risk of ovarian cancer and could provide a basis for increased cancer surveillance of the relevant population, allowing better individualization of prevention and early detection approaches such as risk-reduction surgery and screening,” according to Celeste Leigh Pearce from the University of Southern California, Los Angeles, the lead author.

But the authors were quick to offer a caution: “Although we have reported strong associations between endometriosis and risk of clear-cell, endometrioid, and low-grade serous ovarian cancers, most women with endometriosis do not develop ovarian cancer. However, health-care providers should be alert to the increased risk of specific subtypes of ovarian cancer in women with a history of endometriosis.”

We want to hear from you! Tell us what you think.

A study of antiviral therapy to treat herpes simplex virus type 2 (HSV-2) demonstrated that the virus can reactivate in “breakthrough episodes” even when doses of antiviral therapy are high.

The study, published last month in The Lancet, combined three trials:

• In Trial 1, participants were randomized to standard-dose aciclovir (Zovirax, Zovir, etc.) (400 mg twice daily) or no medication for 4 weeks, followed by a 1-week wash-out period and crossover to the opposite group for another 4 weeks.
• In Trial 2, participants were randomized to standard-dose valaciclovir (Valtrex) (500 mg daily) or high-dose aciclovir (800 mg three times daily) for 7 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 7 additional weeks.
• In Trial 3, subjects were randomized to standard-dose valaciclovir or high-dose valaciclovir (1 g three times daily) for 5 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 5 additional weeks.¹

All three trials demonstrated that short episodes of subclinical shedding persist with both standard-dose and high-dose aciclovir and valaciclovir. Although shedding of HSV-2 decreased 50% in participants who took the highest dose of valaciclovir, compared with standard-dose valaciclovir, the rate of breakthrough shedding did not change—about 16 to 20 episodes every year.

“Despite the increased use of antiviral therapy in the past two decades,” the authors observe, “the prevalence of, and complications from, HSV-2 infection have changed little.”

“Daily antiviral therapy,” they go on to say, “reduces genital lesions and suppresses detection of HSV on genital mucosal surfaces (shedding),” but daily valaciclovir reduces the risk of sexual transmission by only 48%. Furthermore, aciclovir does not reduce the risk of HIV transmission or acquisition, which is heightened in people who have HSV-2.

“The discrepancy between potent suppression of clinical symptoms and failure of antiviral agents to fully prevent HSV transmission is not well understood. Intensive genital secretion collection shows that HSV shedding episodes are three times more frequent than was previously realized.”

We want to hear from you! Tell us what you think.

A study of antiviral therapy to treat herpes simplex virus type 2 (HSV-2) demonstrated that the virus can reactivate in “breakthrough episodes” even when doses of antiviral therapy are high.

The study, published last month in The Lancet, combined three trials:

• In Trial 1, participants were randomized to standard-dose aciclovir (Zovirax, Zovir, etc.) (400 mg twice daily) or no medication for 4 weeks, followed by a 1-week wash-out period and crossover to the opposite group for another 4 weeks.
• In Trial 2, participants were randomized to standard-dose valaciclovir (Valtrex) (500 mg daily) or high-dose aciclovir (800 mg three times daily) for 7 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 7 additional weeks.
• In Trial 3, subjects were randomized to standard-dose valaciclovir or high-dose valaciclovir (1 g three times daily) for 5 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 5 additional weeks.¹

All three trials demonstrated that short episodes of subclinical shedding persist with both standard-dose and high-dose aciclovir and valaciclovir. Although shedding of HSV-2 decreased 50% in participants who took the highest dose of valaciclovir, compared with standard-dose valaciclovir, the rate of breakthrough shedding did not change—about 16 to 20 episodes every year.

“Despite the increased use of antiviral therapy in the past two decades,” the authors observe, “the prevalence of, and complications from, HSV-2 infection have changed little.”

“Daily antiviral therapy,” they go on to say, “reduces genital lesions and suppresses detection of HSV on genital mucosal surfaces (shedding),” but daily valaciclovir reduces the risk of sexual transmission by only 48%. Furthermore, aciclovir does not reduce the risk of HIV transmission or acquisition, which is heightened in people who have HSV-2.

“The discrepancy between potent suppression of clinical symptoms and failure of antiviral agents to fully prevent HSV transmission is not well understood. Intensive genital secretion collection shows that HSV shedding episodes are three times more frequent than was previously realized.”

We want to hear from you! Tell us what you think.

A study of antiviral therapy to treat herpes simplex virus type 2 (HSV-2) demonstrated that the virus can reactivate in “breakthrough episodes” even when doses of antiviral therapy are high.

The study, published last month in The Lancet, combined three trials:

• In Trial 1, participants were randomized to standard-dose aciclovir (Zovirax, Zovir, etc.) (400 mg twice daily) or no medication for 4 weeks, followed by a 1-week wash-out period and crossover to the opposite group for another 4 weeks.
• In Trial 2, participants were randomized to standard-dose valaciclovir (Valtrex) (500 mg daily) or high-dose aciclovir (800 mg three times daily) for 7 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 7 additional weeks.
• In Trial 3, subjects were randomized to standard-dose valaciclovir or high-dose valaciclovir (1 g three times daily) for 5 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 5 additional weeks.¹

All three trials demonstrated that short episodes of subclinical shedding persist with both standard-dose and high-dose aciclovir and valaciclovir. Although shedding of HSV-2 decreased 50% in participants who took the highest dose of valaciclovir, compared with standard-dose valaciclovir, the rate of breakthrough shedding did not change—about 16 to 20 episodes every year.

“Despite the increased use of antiviral therapy in the past two decades,” the authors observe, “the prevalence of, and complications from, HSV-2 infection have changed little.”

“Daily antiviral therapy,” they go on to say, “reduces genital lesions and suppresses detection of HSV on genital mucosal surfaces (shedding),” but daily valaciclovir reduces the risk of sexual transmission by only 48%. Furthermore, aciclovir does not reduce the risk of HIV transmission or acquisition, which is heightened in people who have HSV-2.

“The discrepancy between potent suppression of clinical symptoms and failure of antiviral agents to fully prevent HSV transmission is not well understood. Intensive genital secretion collection shows that HSV shedding episodes are three times more frequent than was previously realized.”

We want to hear from you! Tell us what you think.

Good news on the medical liability front, Doctor!

Yes, that’s right, good news.

According to data from the Physician Insurers Association of America (PIAA), the number of claims that were paid in the ObGyn category between 2006 and 2011 was 44% lower than the number of claims paid between 1986 and 1991.

The percentage of claims that were paid also decreased over the same quarter century. During 1986–1990, 37.25% of all claims were paid in the ObGyn category, compared with 31.73% during 2006–2010.¹

And when claims for both periods are calculated in 2010 dollars, the amount paid also declined—by more than $138 million!

These are three of the findings that reflect “significant improvement” in obstetrics and gynecology in medical liability, says John B. Stanchfield, MD, an endocrinologist who, for 25 years, was medical director of the Utah Medical Insurance Association (UMIA)—a member company of PIAA. PIAA is the insurance industry trade association.

PIAA member companies in the United States “include large national insurance companies, mid-size regional writers, single-state insurers, and specialty companies that serve specific health care–provider niche markets. Collectively, these companies provide insurance protection to more than 60% of America’s private practice physicians and write approximately 46%, or $5.2 billion, of the total industry premium.”²

The improvement in ObGyn comes as no surprise to Dr. Stanchfield because the specialty was “the first group that got ‘risk-managed’ almost universally across the country,” he says. “In our little company out here in Utah, in 1985, we were told that if we didn’t do something [about lawsuits in obstetrics and gynecology], we weren’t going to be able to insure that class anymore because we wouldn’t be able to collect enough money. That’s what the actuaries told us, but it wasn’t unique to us—it was a nationwide problem.”

Why was the ObGyn specialty, in particular, in need of aggressive risk management? What made ObGyn claims unique?

“It’s infant injury,” says Dr. Stanchfield. “It’s injury to the baby. Those claims, you start talking at a million dollars.”

Another reason may be that some claims in this specialty category involve doctors other than ObGyns who provide obstetric care—for example, family practice physicians.

A risk manager’s perspective

After receiving the warning about ObGyn claims, UMIA got busy. First, it formed a committee comprising perinatologists, ObGyns, family practice physicians, claims specialists, and attorneys. “We analyzed all claims that were paid, looking for common denominators,” says Dr. Stanchfield. Improvement was clearly needed in about 10 areas, so “we basically created a risk-management program and then mandated it.” In the process, the organization published a booklet entitled Insurance Recommendations for Obstetrical Practice, of which Dr. Stanchfield was the editor.³

The booklet offers guidance on 10 potential “problem” areas:

• antepartum testing
• hypertension and pregnancy
• operative vaginal delivery
• breech delivery
• oxytocin administration
• vaginal birth after cesarean
• use of misoprostol
• shoulder dystocia
• preterm labor
• hospital standards.

Fewer claims and more physicians

The declining number and percentage of paid claims in obstetrics and gynecology over 25 years may be even more impressive than the figures suggest, says Dr. Stanchfield.

“Gestalt tells me that through the years there are more practicing physicians rather than fewer,” so the denominator is increasing even as these claims are declining—making the decrease “even more powerful.”

The numbers haven’t improved to the same degree in other specialties, Dr. Stanchfield says. “If you look at global data, the decrease in paid claims might have been 10% to 15%. In ObGyn, if you compare the last 5-year block of data with the first 5-year block, the number of paid claims is almost cut in half.”

What brought about this improvement?

“There weren’t any groundbreaking medical or surgical technological advances during this period. It was just doing it better. And the main push to doing it better in this country, in my opinion, is risk management.”

Slicing the data

Now for the not-so-great news: In 2010 alone, more than $55 million was paid out in the ObGyn category for 10 patient conditions. Topping the list were “pregnancy” and “brain-damaged infant.” The $55 million figure represents the money paid for the top 10 most commonly cited conditions in cases closed during 2010 (TABLE 1).

TABLE 1

Claims categorized under the rather broad category of pregnancy usually were placed there because a more appropriate category was lacking, says Dr. Stanchfield. These claims typically involve “things that happen—usually to the baby—that result in a lawsuit other than brain damage per se.” For example, a claim that involved skull fracture without brain damage might fall into this zone, he says.

Problematic procedures

Slicing the data a different way, problems related to the 10 most commonly cited ObGyn procedures cost PIAA companies more than $120 million dollars in 2010—and that figure is only for the top 10.¹ The top three procedures, in terms of number of claims closed in 2010, were operative procedures on the uterus, manually assisted delivery, and cesarean delivery (TABLE 2).

TABLE 2

Manually assisted delivery does not include vacuum extraction or forceps delivery, notes Dr. Stanchfield. “Manually assisted delivery is basically standing there like a quarterback and catching the baby.”

Top 10 “medical misadventures”

And another slice of data reveals the 10 most prevalent medical misadventures in the ObGyn specialty in 2010 (TABLE 3):

• improper performance of a procedure
• no medical misadventure (i.e., no misadventure was identifiable)
• errors in diagnosis
• failure to supervise or monitor a case
• delay in performance of a procedure
• failure to recognize a complication
• surgical foreign body left in a patient after a procedure
• necessary treatment or management was “not performed”
• failure to instruct or communicate with a patient
• medication errors.

The total indemnity paid for these so-called misadventures was more than $136 million.¹

TABLE 3

Putting the dollars in perspective

PIAA also collects data on the number of claims reported, and indemnity dollars paid, for other specialties.

“Of the 28 specialty groups included in the database, ObGyn ranks second”—behind internal medicine—“in the number of claims closed between 1985 and 2010,” a PIAA report notes. The ObGyn specialty also ranks second—behind dentists—in the percentage (35%) of those claims that were paid (for dentists, the figure was 46%). Obstetrics and gynecology was also responsible for the single largest indemnity payment—$13,000,000.¹

Medical liability: A national disaster?

According to figures from the PIAA Data Sharing Project, an ongoing claim study that includes 22 PIAA member companies, $19.7 billion in losses (total indemnity plus expenses) were reported during the period from 1985 through 2008. Those losses represented approximately 25% of the physicians who were practicing during that time.

“So if you multiply that $19.7 billion figure by four”—to extrapolate it to the full spectrum of physicians practicing between 1985 and 2008—“you’ve got almost $80 billion coming out of the pockets of the doctors in this country,” says Dr. Stanchfield. If you compare that $80 billion figure to the World Trade Center disaster, which involved approximately $42 billion in losses, the need for federal tort reform is highlighted, he says. In 24 years, the physicians “in this country have paid for almost two World Trade Center disasters. That’s an incredible dollar cost.”

From Dr. Stanchfield’s perspective as a risk manager, the best thing physicians can do to protect themselves is to practice medicine wisely.

“One of our speakers used to say, ‘Look, just practice good, middle-of-the-road medicine. Don’t get yourself out on the fringes where you’re doing something questionable. Just practice rock-solid, conservative, safe medicine.’”

We want to hear from you! Tell us what you think.

Good news on the medical liability front, Doctor!

Yes, that’s right, good news.

According to data from the Physician Insurers Association of America (PIAA), the number of claims that were paid in the ObGyn category between 2006 and 2011 was 44% lower than the number of claims paid between 1986 and 1991.

The percentage of claims that were paid also decreased over the same quarter century. During 1986–1990, 37.25% of all claims were paid in the ObGyn category, compared with 31.73% during 2006–2010.¹

And when claims for both periods are calculated in 2010 dollars, the amount paid also declined—by more than $138 million!

These are three of the findings that reflect “significant improvement” in obstetrics and gynecology in medical liability, says John B. Stanchfield, MD, an endocrinologist who, for 25 years, was medical director of the Utah Medical Insurance Association (UMIA)—a member company of PIAA. PIAA is the insurance industry trade association.

PIAA member companies in the United States “include large national insurance companies, mid-size regional writers, single-state insurers, and specialty companies that serve specific health care–provider niche markets. Collectively, these companies provide insurance protection to more than 60% of America’s private practice physicians and write approximately 46%, or $5.2 billion, of the total industry premium.”²

The improvement in ObGyn comes as no surprise to Dr. Stanchfield because the specialty was “the first group that got ‘risk-managed’ almost universally across the country,” he says. “In our little company out here in Utah, in 1985, we were told that if we didn’t do something [about lawsuits in obstetrics and gynecology], we weren’t going to be able to insure that class anymore because we wouldn’t be able to collect enough money. That’s what the actuaries told us, but it wasn’t unique to us—it was a nationwide problem.”

Why was the ObGyn specialty, in particular, in need of aggressive risk management? What made ObGyn claims unique?

“It’s infant injury,” says Dr. Stanchfield. “It’s injury to the baby. Those claims, you start talking at a million dollars.”

Another reason may be that some claims in this specialty category involve doctors other than ObGyns who provide obstetric care—for example, family practice physicians.

A risk manager’s perspective

After receiving the warning about ObGyn claims, UMIA got busy. First, it formed a committee comprising perinatologists, ObGyns, family practice physicians, claims specialists, and attorneys. “We analyzed all claims that were paid, looking for common denominators,” says Dr. Stanchfield. Improvement was clearly needed in about 10 areas, so “we basically created a risk-management program and then mandated it.” In the process, the organization published a booklet entitled Insurance Recommendations for Obstetrical Practice, of which Dr. Stanchfield was the editor.³

The booklet offers guidance on 10 potential “problem” areas:

• antepartum testing
• hypertension and pregnancy
• operative vaginal delivery
• breech delivery
• oxytocin administration
• vaginal birth after cesarean
• use of misoprostol
• shoulder dystocia
• preterm labor
• hospital standards.

Fewer claims and more physicians

The declining number and percentage of paid claims in obstetrics and gynecology over 25 years may be even more impressive than the figures suggest, says Dr. Stanchfield.

“Gestalt tells me that through the years there are more practicing physicians rather than fewer,” so the denominator is increasing even as these claims are declining—making the decrease “even more powerful.”

The numbers haven’t improved to the same degree in other specialties, Dr. Stanchfield says. “If you look at global data, the decrease in paid claims might have been 10% to 15%. In ObGyn, if you compare the last 5-year block of data with the first 5-year block, the number of paid claims is almost cut in half.”

What brought about this improvement?

“There weren’t any groundbreaking medical or surgical technological advances during this period. It was just doing it better. And the main push to doing it better in this country, in my opinion, is risk management.”

Slicing the data

Now for the not-so-great news: In 2010 alone, more than $55 million was paid out in the ObGyn category for 10 patient conditions. Topping the list were “pregnancy” and “brain-damaged infant.” The $55 million figure represents the money paid for the top 10 most commonly cited conditions in cases closed during 2010 (TABLE 1).

TABLE 1

Claims categorized under the rather broad category of pregnancy usually were placed there because a more appropriate category was lacking, says Dr. Stanchfield. These claims typically involve “things that happen—usually to the baby—that result in a lawsuit other than brain damage per se.” For example, a claim that involved skull fracture without brain damage might fall into this zone, he says.

Problematic procedures

Slicing the data a different way, problems related to the 10 most commonly cited ObGyn procedures cost PIAA companies more than $120 million dollars in 2010—and that figure is only for the top 10.¹ The top three procedures, in terms of number of claims closed in 2010, were operative procedures on the uterus, manually assisted delivery, and cesarean delivery (TABLE 2).

TABLE 2

Manually assisted delivery does not include vacuum extraction or forceps delivery, notes Dr. Stanchfield. “Manually assisted delivery is basically standing there like a quarterback and catching the baby.”

Top 10 “medical misadventures”

And another slice of data reveals the 10 most prevalent medical misadventures in the ObGyn specialty in 2010 (TABLE 3):

• improper performance of a procedure
• no medical misadventure (i.e., no misadventure was identifiable)
• errors in diagnosis
• failure to supervise or monitor a case
• delay in performance of a procedure
• failure to recognize a complication
• surgical foreign body left in a patient after a procedure
• necessary treatment or management was “not performed”
• failure to instruct or communicate with a patient
• medication errors.

The total indemnity paid for these so-called misadventures was more than $136 million.¹

TABLE 3

Putting the dollars in perspective

PIAA also collects data on the number of claims reported, and indemnity dollars paid, for other specialties.

“Of the 28 specialty groups included in the database, ObGyn ranks second”—behind internal medicine—“in the number of claims closed between 1985 and 2010,” a PIAA report notes. The ObGyn specialty also ranks second—behind dentists—in the percentage (35%) of those claims that were paid (for dentists, the figure was 46%). Obstetrics and gynecology was also responsible for the single largest indemnity payment—$13,000,000.¹

Medical liability: A national disaster?

According to figures from the PIAA Data Sharing Project, an ongoing claim study that includes 22 PIAA member companies, $19.7 billion in losses (total indemnity plus expenses) were reported during the period from 1985 through 2008. Those losses represented approximately 25% of the physicians who were practicing during that time.

“So if you multiply that $19.7 billion figure by four”—to extrapolate it to the full spectrum of physicians practicing between 1985 and 2008—“you’ve got almost $80 billion coming out of the pockets of the doctors in this country,” says Dr. Stanchfield. If you compare that $80 billion figure to the World Trade Center disaster, which involved approximately $42 billion in losses, the need for federal tort reform is highlighted, he says. In 24 years, the physicians “in this country have paid for almost two World Trade Center disasters. That’s an incredible dollar cost.”

From Dr. Stanchfield’s perspective as a risk manager, the best thing physicians can do to protect themselves is to practice medicine wisely.

“One of our speakers used to say, ‘Look, just practice good, middle-of-the-road medicine. Don’t get yourself out on the fringes where you’re doing something questionable. Just practice rock-solid, conservative, safe medicine.’”

We want to hear from you! Tell us what you think.

Good news on the medical liability front, Doctor!

Yes, that’s right, good news.

According to data from the Physician Insurers Association of America (PIAA), the number of claims that were paid in the ObGyn category between 2006 and 2011 was 44% lower than the number of claims paid between 1986 and 1991.

The percentage of claims that were paid also decreased over the same quarter century. During 1986–1990, 37.25% of all claims were paid in the ObGyn category, compared with 31.73% during 2006–2010.¹

And when claims for both periods are calculated in 2010 dollars, the amount paid also declined—by more than $138 million!

These are three of the findings that reflect “significant improvement” in obstetrics and gynecology in medical liability, says John B. Stanchfield, MD, an endocrinologist who, for 25 years, was medical director of the Utah Medical Insurance Association (UMIA)—a member company of PIAA. PIAA is the insurance industry trade association.

PIAA member companies in the United States “include large national insurance companies, mid-size regional writers, single-state insurers, and specialty companies that serve specific health care–provider niche markets. Collectively, these companies provide insurance protection to more than 60% of America’s private practice physicians and write approximately 46%, or $5.2 billion, of the total industry premium.”²

The improvement in ObGyn comes as no surprise to Dr. Stanchfield because the specialty was “the first group that got ‘risk-managed’ almost universally across the country,” he says. “In our little company out here in Utah, in 1985, we were told that if we didn’t do something [about lawsuits in obstetrics and gynecology], we weren’t going to be able to insure that class anymore because we wouldn’t be able to collect enough money. That’s what the actuaries told us, but it wasn’t unique to us—it was a nationwide problem.”

Why was the ObGyn specialty, in particular, in need of aggressive risk management? What made ObGyn claims unique?

“It’s infant injury,” says Dr. Stanchfield. “It’s injury to the baby. Those claims, you start talking at a million dollars.”

Another reason may be that some claims in this specialty category involve doctors other than ObGyns who provide obstetric care—for example, family practice physicians.

A risk manager’s perspective

After receiving the warning about ObGyn claims, UMIA got busy. First, it formed a committee comprising perinatologists, ObGyns, family practice physicians, claims specialists, and attorneys. “We analyzed all claims that were paid, looking for common denominators,” says Dr. Stanchfield. Improvement was clearly needed in about 10 areas, so “we basically created a risk-management program and then mandated it.” In the process, the organization published a booklet entitled Insurance Recommendations for Obstetrical Practice, of which Dr. Stanchfield was the editor.³

The booklet offers guidance on 10 potential “problem” areas:

• antepartum testing
• hypertension and pregnancy
• operative vaginal delivery
• breech delivery
• oxytocin administration
• vaginal birth after cesarean
• use of misoprostol
• shoulder dystocia
• preterm labor
• hospital standards.

Fewer claims and more physicians

The declining number and percentage of paid claims in obstetrics and gynecology over 25 years may be even more impressive than the figures suggest, says Dr. Stanchfield.

“Gestalt tells me that through the years there are more practicing physicians rather than fewer,” so the denominator is increasing even as these claims are declining—making the decrease “even more powerful.”

The numbers haven’t improved to the same degree in other specialties, Dr. Stanchfield says. “If you look at global data, the decrease in paid claims might have been 10% to 15%. In ObGyn, if you compare the last 5-year block of data with the first 5-year block, the number of paid claims is almost cut in half.”

What brought about this improvement?

“There weren’t any groundbreaking medical or surgical technological advances during this period. It was just doing it better. And the main push to doing it better in this country, in my opinion, is risk management.”

Slicing the data

Now for the not-so-great news: In 2010 alone, more than $55 million was paid out in the ObGyn category for 10 patient conditions. Topping the list were “pregnancy” and “brain-damaged infant.” The $55 million figure represents the money paid for the top 10 most commonly cited conditions in cases closed during 2010 (TABLE 1).

TABLE 1

Claims categorized under the rather broad category of pregnancy usually were placed there because a more appropriate category was lacking, says Dr. Stanchfield. These claims typically involve “things that happen—usually to the baby—that result in a lawsuit other than brain damage per se.” For example, a claim that involved skull fracture without brain damage might fall into this zone, he says.

Problematic procedures

Slicing the data a different way, problems related to the 10 most commonly cited ObGyn procedures cost PIAA companies more than $120 million dollars in 2010—and that figure is only for the top 10.¹ The top three procedures, in terms of number of claims closed in 2010, were operative procedures on the uterus, manually assisted delivery, and cesarean delivery (TABLE 2).

TABLE 2

Manually assisted delivery does not include vacuum extraction or forceps delivery, notes Dr. Stanchfield. “Manually assisted delivery is basically standing there like a quarterback and catching the baby.”

Top 10 “medical misadventures”

And another slice of data reveals the 10 most prevalent medical misadventures in the ObGyn specialty in 2010 (TABLE 3):

• improper performance of a procedure
• no medical misadventure (i.e., no misadventure was identifiable)
• errors in diagnosis
• failure to supervise or monitor a case
• delay in performance of a procedure
• failure to recognize a complication
• surgical foreign body left in a patient after a procedure
• necessary treatment or management was “not performed”
• failure to instruct or communicate with a patient
• medication errors.

The total indemnity paid for these so-called misadventures was more than $136 million.¹

TABLE 3

Putting the dollars in perspective

PIAA also collects data on the number of claims reported, and indemnity dollars paid, for other specialties.

“Of the 28 specialty groups included in the database, ObGyn ranks second”—behind internal medicine—“in the number of claims closed between 1985 and 2010,” a PIAA report notes. The ObGyn specialty also ranks second—behind dentists—in the percentage (35%) of those claims that were paid (for dentists, the figure was 46%). Obstetrics and gynecology was also responsible for the single largest indemnity payment—$13,000,000.¹

Medical liability: A national disaster?

According to figures from the PIAA Data Sharing Project, an ongoing claim study that includes 22 PIAA member companies, $19.7 billion in losses (total indemnity plus expenses) were reported during the period from 1985 through 2008. Those losses represented approximately 25% of the physicians who were practicing during that time.

“So if you multiply that $19.7 billion figure by four”—to extrapolate it to the full spectrum of physicians practicing between 1985 and 2008—“you’ve got almost $80 billion coming out of the pockets of the doctors in this country,” says Dr. Stanchfield. If you compare that $80 billion figure to the World Trade Center disaster, which involved approximately $42 billion in losses, the need for federal tort reform is highlighted, he says. In 24 years, the physicians “in this country have paid for almost two World Trade Center disasters. That’s an incredible dollar cost.”

From Dr. Stanchfield’s perspective as a risk manager, the best thing physicians can do to protect themselves is to practice medicine wisely.

“One of our speakers used to say, ‘Look, just practice good, middle-of-the-road medicine. Don’t get yourself out on the fringes where you’re doing something questionable. Just practice rock-solid, conservative, safe medicine.’”

We want to hear from you! Tell us what you think.

The final results of the Population-Based Screening Study Amsterdam (POBASCAM), published online in The Lancet Oncology, provide the strongest evidence to date in support of HPV testing as a cervical cancer screening strategy, according to Rijkaart and colleagues, authors of the study.¹

The POBASCAM trial involved nearly 45,000 women 29 to 56 years old who attended routine cervical screening in the Netherlands. Investigators examined whether HPV testing was associated with fewer high-grade cervical lesions and cervical cancer in the second round of screening because of earlier detection and treatment of lesions. They also sought to determine the most appropriate age to initiate HPV testing.

At the start of the study, women were randomly assigned to cotesting with HPV DNA and Pap testing or to cytology alone. At the second screening round 5 years later, HPV and cytology testing were performed on all women.

In the first screen, the arm that included HPV testing identified significantly more cancer precursors (cervical intraepithelial neoplasia [CIN] grade 2 or worse) than cytology alone. Five years later, significantly fewer women had CIN 3 or worse and cervical cancer in the HPV group than in the group that underwent cytology alone (88 of 19,579 women in the HPV group vs 122 of 19,731 women in the control group [relative risk, 0.73; 95% confidence interval (CI), 0.55–0.96; P=.023]). Cervical cancer was also less common in the HPV group than in the control group (4 of 19,579 women in the HPV group vs 14 of 19,731 women in the control group [relative risk, 0.29; 95% CI, 0.10–0.87; P=.031]).

“Implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant CIN grade 2 or worse, which, when adequately treated, improves protection against CIN grade 3 or worse and cervical cancer,” the investigators concluded.

Improved protection against CIN 3 and worse in the HPV group was largely due to early detection of high-grade cervical lesions caused by HPV 16, which, along with HPV 18, is responsible for more than 70% of cervical cancers. This finding indicates that HPV testing could, eventually, lead to a reduction in the rate of cancer-related illness and death.

When data from both screening rounds were combined, the cumulative detection of CIN 2+ and CIN 3+ did not differ between women 29 to 33 years old and women older than 33 years, indicating that HPV testing did not lead to overdiagnosis of regressive CIN 2+ lesions in younger women.

“Our results…lend support to the implementation of HPV DNA testing in programmed cervical screening starting at age 30 years,” the investigators write.

The authors of an accompanying commentary observe that the “POBASCAM trial shows that 5-year screening intervals are safe, and that conservative management of HPV-positive women can control excess CIN grade 2 or 3 while preventing cervical cancer. However, how the POBASCAM protocol would perform in other populations that have different baseline cancer rates, compliance, and management infrastructure, is unclear.”²

The final results of the Population-Based Screening Study Amsterdam (POBASCAM), published online in The Lancet Oncology, provide the strongest evidence to date in support of HPV testing as a cervical cancer screening strategy, according to Rijkaart and colleagues, authors of the study.¹

The POBASCAM trial involved nearly 45,000 women 29 to 56 years old who attended routine cervical screening in the Netherlands. Investigators examined whether HPV testing was associated with fewer high-grade cervical lesions and cervical cancer in the second round of screening because of earlier detection and treatment of lesions. They also sought to determine the most appropriate age to initiate HPV testing.

At the start of the study, women were randomly assigned to cotesting with HPV DNA and Pap testing or to cytology alone. At the second screening round 5 years later, HPV and cytology testing were performed on all women.

In the first screen, the arm that included HPV testing identified significantly more cancer precursors (cervical intraepithelial neoplasia [CIN] grade 2 or worse) than cytology alone. Five years later, significantly fewer women had CIN 3 or worse and cervical cancer in the HPV group than in the group that underwent cytology alone (88 of 19,579 women in the HPV group vs 122 of 19,731 women in the control group [relative risk, 0.73; 95% confidence interval (CI), 0.55–0.96; P=.023]). Cervical cancer was also less common in the HPV group than in the control group (4 of 19,579 women in the HPV group vs 14 of 19,731 women in the control group [relative risk, 0.29; 95% CI, 0.10–0.87; P=.031]).

“Implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant CIN grade 2 or worse, which, when adequately treated, improves protection against CIN grade 3 or worse and cervical cancer,” the investigators concluded.

Improved protection against CIN 3 and worse in the HPV group was largely due to early detection of high-grade cervical lesions caused by HPV 16, which, along with HPV 18, is responsible for more than 70% of cervical cancers. This finding indicates that HPV testing could, eventually, lead to a reduction in the rate of cancer-related illness and death.

When data from both screening rounds were combined, the cumulative detection of CIN 2+ and CIN 3+ did not differ between women 29 to 33 years old and women older than 33 years, indicating that HPV testing did not lead to overdiagnosis of regressive CIN 2+ lesions in younger women.

“Our results…lend support to the implementation of HPV DNA testing in programmed cervical screening starting at age 30 years,” the investigators write.

The authors of an accompanying commentary observe that the “POBASCAM trial shows that 5-year screening intervals are safe, and that conservative management of HPV-positive women can control excess CIN grade 2 or 3 while preventing cervical cancer. However, how the POBASCAM protocol would perform in other populations that have different baseline cancer rates, compliance, and management infrastructure, is unclear.”²

The final results of the Population-Based Screening Study Amsterdam (POBASCAM), published online in The Lancet Oncology, provide the strongest evidence to date in support of HPV testing as a cervical cancer screening strategy, according to Rijkaart and colleagues, authors of the study.¹

The POBASCAM trial involved nearly 45,000 women 29 to 56 years old who attended routine cervical screening in the Netherlands. Investigators examined whether HPV testing was associated with fewer high-grade cervical lesions and cervical cancer in the second round of screening because of earlier detection and treatment of lesions. They also sought to determine the most appropriate age to initiate HPV testing.

At the start of the study, women were randomly assigned to cotesting with HPV DNA and Pap testing or to cytology alone. At the second screening round 5 years later, HPV and cytology testing were performed on all women.

In the first screen, the arm that included HPV testing identified significantly more cancer precursors (cervical intraepithelial neoplasia [CIN] grade 2 or worse) than cytology alone. Five years later, significantly fewer women had CIN 3 or worse and cervical cancer in the HPV group than in the group that underwent cytology alone (88 of 19,579 women in the HPV group vs 122 of 19,731 women in the control group [relative risk, 0.73; 95% confidence interval (CI), 0.55–0.96; P=.023]). Cervical cancer was also less common in the HPV group than in the control group (4 of 19,579 women in the HPV group vs 14 of 19,731 women in the control group [relative risk, 0.29; 95% CI, 0.10–0.87; P=.031]).

“Implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant CIN grade 2 or worse, which, when adequately treated, improves protection against CIN grade 3 or worse and cervical cancer,” the investigators concluded.

Improved protection against CIN 3 and worse in the HPV group was largely due to early detection of high-grade cervical lesions caused by HPV 16, which, along with HPV 18, is responsible for more than 70% of cervical cancers. This finding indicates that HPV testing could, eventually, lead to a reduction in the rate of cancer-related illness and death.

When data from both screening rounds were combined, the cumulative detection of CIN 2+ and CIN 3+ did not differ between women 29 to 33 years old and women older than 33 years, indicating that HPV testing did not lead to overdiagnosis of regressive CIN 2+ lesions in younger women.

“Our results…lend support to the implementation of HPV DNA testing in programmed cervical screening starting at age 30 years,” the investigators write.

The authors of an accompanying commentary observe that the “POBASCAM trial shows that 5-year screening intervals are safe, and that conservative management of HPV-positive women can control excess CIN grade 2 or 3 while preventing cervical cancer. However, how the POBASCAM protocol would perform in other populations that have different baseline cancer rates, compliance, and management infrastructure, is unclear.”²

The birth rate among US teens 15 to 19 years old was 34.3 births for every 1,000 teenagers in 2010—a 9% decline from 2009 and the lowest rate ever recorded in nearly seven decades of collecting data, according to a report released November 17, 2011, by the Centers for Disease Control and Prevention (CDC).

The report, Births: Preliminary Data for 2010, from the CDC’s National Center for Health Statistics, is based on an analysis of nearly 100% of birth records collected in the 50 states, the District of Columbia, and US territories.

The birth rate for teenagers 15 to 19 years old has declined for the past 3 years and 17 of the past 19 years. Birth rates for younger and older teenagers and for all race and ethnic groups reached historic lows in 2010.

Other findings:

• The rate of cesarean delivery declined for the first time since 1996. In 2010, it was 32.8%, down from 32.9% in 2009
• Total births declined 3%, from 4,130,665 in 2009 to 4,000,279 in 2010
• The overall fertility rate fell 3%, from 66.2 births for every 1,000 females 15 to 44 years old in 2009 to 64.1 in 2010. This is the third straight decline for overall fertility in the United States.
• The total number of births to unmarried mothers declined for the second year in a row, to 1,633,785, down from 1,693,685 in 2009. Similarly, the birth rate for unmarried mothers declined to 47.7 for every 1,000 women in 2010, compared with 49.9 in 2009. The percentage of births to unmarried mothers also declined slightly in 2010, to 40.8%, compared with 41% in 2009.
• The birth rate for women in their early 20s fell 6% in 2010. The rates also fell for women in their late 20s and 30s. However, the birth rate for women in their early 40s increased to 10.2 per 1,000 women in 2010, compared with 10.0 in 2009, making it the highest birth rate for this age group since 1967
• The preterm birth rate declined for the fourth straight year in 2010, to just under 12% of all births (11.99%)—a 6% drop from 2006
• The rate of low birth-weight infants remained essentially unchanged between 2009 and 2010 at less than 8.2%, but is down slightly from the record high of 8.3 in 2006.

The full report is available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_02.pdf.

We want to hear from you! Tell us what you think.

The birth rate among US teens 15 to 19 years old was 34.3 births for every 1,000 teenagers in 2010—a 9% decline from 2009 and the lowest rate ever recorded in nearly seven decades of collecting data, according to a report released November 17, 2011, by the Centers for Disease Control and Prevention (CDC).

The report, Births: Preliminary Data for 2010, from the CDC’s National Center for Health Statistics, is based on an analysis of nearly 100% of birth records collected in the 50 states, the District of Columbia, and US territories.

The birth rate for teenagers 15 to 19 years old has declined for the past 3 years and 17 of the past 19 years. Birth rates for younger and older teenagers and for all race and ethnic groups reached historic lows in 2010.

Other findings:

• The rate of cesarean delivery declined for the first time since 1996. In 2010, it was 32.8%, down from 32.9% in 2009
• Total births declined 3%, from 4,130,665 in 2009 to 4,000,279 in 2010
• The overall fertility rate fell 3%, from 66.2 births for every 1,000 females 15 to 44 years old in 2009 to 64.1 in 2010. This is the third straight decline for overall fertility in the United States.
• The total number of births to unmarried mothers declined for the second year in a row, to 1,633,785, down from 1,693,685 in 2009. Similarly, the birth rate for unmarried mothers declined to 47.7 for every 1,000 women in 2010, compared with 49.9 in 2009. The percentage of births to unmarried mothers also declined slightly in 2010, to 40.8%, compared with 41% in 2009.
• The birth rate for women in their early 20s fell 6% in 2010. The rates also fell for women in their late 20s and 30s. However, the birth rate for women in their early 40s increased to 10.2 per 1,000 women in 2010, compared with 10.0 in 2009, making it the highest birth rate for this age group since 1967
• The preterm birth rate declined for the fourth straight year in 2010, to just under 12% of all births (11.99%)—a 6% drop from 2006
• The rate of low birth-weight infants remained essentially unchanged between 2009 and 2010 at less than 8.2%, but is down slightly from the record high of 8.3 in 2006.

The full report is available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_02.pdf.

We want to hear from you! Tell us what you think.

The birth rate among US teens 15 to 19 years old was 34.3 births for every 1,000 teenagers in 2010—a 9% decline from 2009 and the lowest rate ever recorded in nearly seven decades of collecting data, according to a report released November 17, 2011, by the Centers for Disease Control and Prevention (CDC).

The report, Births: Preliminary Data for 2010, from the CDC’s National Center for Health Statistics, is based on an analysis of nearly 100% of birth records collected in the 50 states, the District of Columbia, and US territories.

The birth rate for teenagers 15 to 19 years old has declined for the past 3 years and 17 of the past 19 years. Birth rates for younger and older teenagers and for all race and ethnic groups reached historic lows in 2010.

Other findings:

• The rate of cesarean delivery declined for the first time since 1996. In 2010, it was 32.8%, down from 32.9% in 2009
• Total births declined 3%, from 4,130,665 in 2009 to 4,000,279 in 2010
• The overall fertility rate fell 3%, from 66.2 births for every 1,000 females 15 to 44 years old in 2009 to 64.1 in 2010. This is the third straight decline for overall fertility in the United States.
• The total number of births to unmarried mothers declined for the second year in a row, to 1,633,785, down from 1,693,685 in 2009. Similarly, the birth rate for unmarried mothers declined to 47.7 for every 1,000 women in 2010, compared with 49.9 in 2009. The percentage of births to unmarried mothers also declined slightly in 2010, to 40.8%, compared with 41% in 2009.
• The birth rate for women in their early 20s fell 6% in 2010. The rates also fell for women in their late 20s and 30s. However, the birth rate for women in their early 40s increased to 10.2 per 1,000 women in 2010, compared with 10.0 in 2009, making it the highest birth rate for this age group since 1967
• The preterm birth rate declined for the fourth straight year in 2010, to just under 12% of all births (11.99%)—a 6% drop from 2006
• The rate of low birth-weight infants remained essentially unchanged between 2009 and 2010 at less than 8.2%, but is down slightly from the record high of 8.3 in 2006.

The full report is available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_02.pdf.

We want to hear from you! Tell us what you think.

The use of magnetic resonance imaging (MRI) for breast cancer screening and to guide treatment decisions is increasing—with little evidence that it is beneficial in those settings, according to the findings of a recent study.¹ Although MRI was shown to be a valuable tool for screening women who are at genetically high risk of breast cancer, the investigation produced limited support for its 1) use in screening women in the general population and 2) routine use before breast-conserving surgery to guide patient selection, reduce surgical procedures, or lower the risk of local recurrence.

Morrow and colleagues from Memorial Sloan-Kettering Cancer Center reviewed research from the past decade to determine whether the increased sensitivity of MRI in the detection of cancer actually improves outcomes. Over recent years, MRI has been widely incorporated into clinical practice because of its heightened sensitivity.

There is sufficient evidence that MRI is a beneficial tool for screening women at high risk of breast cancer because of their family history or a known gene mutation. The modality can accurately identify tumors missed by mammography and ultrasonographic imaging. However, little is known about whether this improved detection has an impact on survival.

Morrow and colleagues conclude that the existing data “do not support the idea that MRI improves patient selection for breast-conserving surgery or that it increases the likelihood of obtaining negative margins at the initial surgical excision.”

Furthermore, the impact of MRI on longer-term outcomes, such as the incidence of contralateral cancer or the recurrence of ipsilateral cancer, cannot be established because of the limited number of trials, many of which are of low quality.

Research does suggest, however, that MRI is more reliable than traditional examinations (i.e., physical examination, mammography, and ultrasonography) at assessing the extent of residual disease after preoperative chemotherapy, as well as the response to preoperative chemotherapy. But whether this improves the surgeon’s ability to select patients suitable for breast-conserving therapy is unclear.

“Ultimately, the true value of MRI might lie in its ability to predict biological behavior, rather than to quantitate low-volume disease,” the investigators conclude. “Very early changes in intracellular metabolism that are detectable by magnetic resonance spectroscopy seem to be predictive of the response to treatment, and, if validated in larger studies, could avoid the toxicity and expense of continuing a chemotherapy regimen that will not be beneficial.”

We want to hear from you! Tell us what you think.

The use of magnetic resonance imaging (MRI) for breast cancer screening and to guide treatment decisions is increasing—with little evidence that it is beneficial in those settings, according to the findings of a recent study.¹ Although MRI was shown to be a valuable tool for screening women who are at genetically high risk of breast cancer, the investigation produced limited support for its 1) use in screening women in the general population and 2) routine use before breast-conserving surgery to guide patient selection, reduce surgical procedures, or lower the risk of local recurrence.

Morrow and colleagues from Memorial Sloan-Kettering Cancer Center reviewed research from the past decade to determine whether the increased sensitivity of MRI in the detection of cancer actually improves outcomes. Over recent years, MRI has been widely incorporated into clinical practice because of its heightened sensitivity.

There is sufficient evidence that MRI is a beneficial tool for screening women at high risk of breast cancer because of their family history or a known gene mutation. The modality can accurately identify tumors missed by mammography and ultrasonographic imaging. However, little is known about whether this improved detection has an impact on survival.

Morrow and colleagues conclude that the existing data “do not support the idea that MRI improves patient selection for breast-conserving surgery or that it increases the likelihood of obtaining negative margins at the initial surgical excision.”

Furthermore, the impact of MRI on longer-term outcomes, such as the incidence of contralateral cancer or the recurrence of ipsilateral cancer, cannot be established because of the limited number of trials, many of which are of low quality.

Research does suggest, however, that MRI is more reliable than traditional examinations (i.e., physical examination, mammography, and ultrasonography) at assessing the extent of residual disease after preoperative chemotherapy, as well as the response to preoperative chemotherapy. But whether this improves the surgeon’s ability to select patients suitable for breast-conserving therapy is unclear.

“Ultimately, the true value of MRI might lie in its ability to predict biological behavior, rather than to quantitate low-volume disease,” the investigators conclude. “Very early changes in intracellular metabolism that are detectable by magnetic resonance spectroscopy seem to be predictive of the response to treatment, and, if validated in larger studies, could avoid the toxicity and expense of continuing a chemotherapy regimen that will not be beneficial.”

We want to hear from you! Tell us what you think.

The use of magnetic resonance imaging (MRI) for breast cancer screening and to guide treatment decisions is increasing—with little evidence that it is beneficial in those settings, according to the findings of a recent study.¹ Although MRI was shown to be a valuable tool for screening women who are at genetically high risk of breast cancer, the investigation produced limited support for its 1) use in screening women in the general population and 2) routine use before breast-conserving surgery to guide patient selection, reduce surgical procedures, or lower the risk of local recurrence.

Morrow and colleagues from Memorial Sloan-Kettering Cancer Center reviewed research from the past decade to determine whether the increased sensitivity of MRI in the detection of cancer actually improves outcomes. Over recent years, MRI has been widely incorporated into clinical practice because of its heightened sensitivity.

There is sufficient evidence that MRI is a beneficial tool for screening women at high risk of breast cancer because of their family history or a known gene mutation. The modality can accurately identify tumors missed by mammography and ultrasonographic imaging. However, little is known about whether this improved detection has an impact on survival.

Morrow and colleagues conclude that the existing data “do not support the idea that MRI improves patient selection for breast-conserving surgery or that it increases the likelihood of obtaining negative margins at the initial surgical excision.”

Furthermore, the impact of MRI on longer-term outcomes, such as the incidence of contralateral cancer or the recurrence of ipsilateral cancer, cannot be established because of the limited number of trials, many of which are of low quality.

Research does suggest, however, that MRI is more reliable than traditional examinations (i.e., physical examination, mammography, and ultrasonography) at assessing the extent of residual disease after preoperative chemotherapy, as well as the response to preoperative chemotherapy. But whether this improves the surgeon’s ability to select patients suitable for breast-conserving therapy is unclear.

“Ultimately, the true value of MRI might lie in its ability to predict biological behavior, rather than to quantitate low-volume disease,” the investigators conclude. “Very early changes in intracellular metabolism that are detectable by magnetic resonance spectroscopy seem to be predictive of the response to treatment, and, if validated in larger studies, could avoid the toxicity and expense of continuing a chemotherapy regimen that will not be beneficial.”

We want to hear from you! Tell us what you think.

Women who undergo radiotherapy to the conserved breast after breast-conserving cancer surgery can expect a reduction in the rate of recurrence (locoregional or distant) of approximately 50% and a reduction in the rate of death from breast cancer of about one sixth. Those are the latest findings from the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), published online in The Lancet.¹

The EBCTCG report updates earlier analyses of individual patient data from randomized trials of radiotherapy after breast-conserving therapy. It adds follow-up data from nine of 10 trials analyzed earlier. It also includes information from seven new trials (six of them in low-risk women). Overall, it boosts the total number of women analyzed by almost 50%.¹

The EBCTCG performed a meta-analysis using individual patient data from 10,801 women in 17 randomized trials of radiotherapy versus no radiotherapy after breast-conserving surgery. Of these women, 8,337 had pathologically confirmed lymph node status (7,287 with negative nodes and 1,050 with positive nodes).

Among the findings:

• Women randomized to radiotherapy had an average annual rate of any first recurrence 50% lower than the women who underwent surgery alone (rate ratio, 0.52; 95% confidence interval [CI], 0.48–0.56), with the greatest reduction seen in the first year after treatment (rate ratio, 0.31; 95% CI, 0.26–0.37). The reduction in the rate of recurrence persisted during years 5–9 (rate ratio, 0.59; 95% CI, 0.50–0.70).
• Women allocated to radiotherapy had a reduction in the risk of death from breast cancer of about 17% (rate ratio, 0.82; 95% CI, 0.75–0.90).
• Women who had negative nodes experienced a reduction in the average annual recurrence rate of about 50% during the first decade (rate ratio, 0.46; 95% CI, 0.41–0.51), lowering the 10-year-risk of any first recurrence from 31.0% to 15.6%, an absolute reduction of 15.4% (95% CI, 13.2–17.6; 2p<.00001).
• For women who had positive nodes, randomization to radiotherapy reduced the 1-year risk of recurrence from 26.0% to 5.1%, a fivefold reduction (rate ratio, 0.20; 95% CI, 0.14–0.29)
• Overall, one breast cancer death was avoided by year 15 for every four recurrences avoided by year 10.

“The overall findings from these trials show that radiotherapy after breast-conserving surgery not only substantially reduces the risk of recurrence but also moderately reduces the risk of death from breast cancer,” the investigators write. “These results suggest that killing microscopic tumor foci in the conserved breast with radiotherapy reduces the potential for both local recurrence and distant metastasis.”

We want to hear from you!  Tell us what you think.

Women who undergo radiotherapy to the conserved breast after breast-conserving cancer surgery can expect a reduction in the rate of recurrence (locoregional or distant) of approximately 50% and a reduction in the rate of death from breast cancer of about one sixth. Those are the latest findings from the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), published online in The Lancet.¹

The EBCTCG report updates earlier analyses of individual patient data from randomized trials of radiotherapy after breast-conserving therapy. It adds follow-up data from nine of 10 trials analyzed earlier. It also includes information from seven new trials (six of them in low-risk women). Overall, it boosts the total number of women analyzed by almost 50%.¹

The EBCTCG performed a meta-analysis using individual patient data from 10,801 women in 17 randomized trials of radiotherapy versus no radiotherapy after breast-conserving surgery. Of these women, 8,337 had pathologically confirmed lymph node status (7,287 with negative nodes and 1,050 with positive nodes).

Among the findings:

• Women randomized to radiotherapy had an average annual rate of any first recurrence 50% lower than the women who underwent surgery alone (rate ratio, 0.52; 95% confidence interval [CI], 0.48–0.56), with the greatest reduction seen in the first year after treatment (rate ratio, 0.31; 95% CI, 0.26–0.37). The reduction in the rate of recurrence persisted during years 5–9 (rate ratio, 0.59; 95% CI, 0.50–0.70).
• Women allocated to radiotherapy had a reduction in the risk of death from breast cancer of about 17% (rate ratio, 0.82; 95% CI, 0.75–0.90).
• Women who had negative nodes experienced a reduction in the average annual recurrence rate of about 50% during the first decade (rate ratio, 0.46; 95% CI, 0.41–0.51), lowering the 10-year-risk of any first recurrence from 31.0% to 15.6%, an absolute reduction of 15.4% (95% CI, 13.2–17.6; 2p<.00001).
• For women who had positive nodes, randomization to radiotherapy reduced the 1-year risk of recurrence from 26.0% to 5.1%, a fivefold reduction (rate ratio, 0.20; 95% CI, 0.14–0.29)
• Overall, one breast cancer death was avoided by year 15 for every four recurrences avoided by year 10.

“The overall findings from these trials show that radiotherapy after breast-conserving surgery not only substantially reduces the risk of recurrence but also moderately reduces the risk of death from breast cancer,” the investigators write. “These results suggest that killing microscopic tumor foci in the conserved breast with radiotherapy reduces the potential for both local recurrence and distant metastasis.”

We want to hear from you!  Tell us what you think.

Women who undergo radiotherapy to the conserved breast after breast-conserving cancer surgery can expect a reduction in the rate of recurrence (locoregional or distant) of approximately 50% and a reduction in the rate of death from breast cancer of about one sixth. Those are the latest findings from the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), published online in The Lancet.¹

The EBCTCG report updates earlier analyses of individual patient data from randomized trials of radiotherapy after breast-conserving therapy. It adds follow-up data from nine of 10 trials analyzed earlier. It also includes information from seven new trials (six of them in low-risk women). Overall, it boosts the total number of women analyzed by almost 50%.¹

The EBCTCG performed a meta-analysis using individual patient data from 10,801 women in 17 randomized trials of radiotherapy versus no radiotherapy after breast-conserving surgery. Of these women, 8,337 had pathologically confirmed lymph node status (7,287 with negative nodes and 1,050 with positive nodes).

Among the findings:

• Women randomized to radiotherapy had an average annual rate of any first recurrence 50% lower than the women who underwent surgery alone (rate ratio, 0.52; 95% confidence interval [CI], 0.48–0.56), with the greatest reduction seen in the first year after treatment (rate ratio, 0.31; 95% CI, 0.26–0.37). The reduction in the rate of recurrence persisted during years 5–9 (rate ratio, 0.59; 95% CI, 0.50–0.70).
• Women allocated to radiotherapy had a reduction in the risk of death from breast cancer of about 17% (rate ratio, 0.82; 95% CI, 0.75–0.90).
• Women who had negative nodes experienced a reduction in the average annual recurrence rate of about 50% during the first decade (rate ratio, 0.46; 95% CI, 0.41–0.51), lowering the 10-year-risk of any first recurrence from 31.0% to 15.6%, an absolute reduction of 15.4% (95% CI, 13.2–17.6; 2p<.00001).
• For women who had positive nodes, randomization to radiotherapy reduced the 1-year risk of recurrence from 26.0% to 5.1%, a fivefold reduction (rate ratio, 0.20; 95% CI, 0.14–0.29)
• Overall, one breast cancer death was avoided by year 15 for every four recurrences avoided by year 10.

“The overall findings from these trials show that radiotherapy after breast-conserving surgery not only substantially reduces the risk of recurrence but also moderately reduces the risk of death from breast cancer,” the investigators write. “These results suggest that killing microscopic tumor foci in the conserved breast with radiotherapy reduces the potential for both local recurrence and distant metastasis.”

We want to hear from you!  Tell us what you think.

The Foley catheter is one of the oldest mechanical methods used for inducing labor. New data show that it produces a vaginal delivery rate similar to that of prostaglandin E₂ gel, the current treatment of choice in the United States and United Kingdom—but carries fewer side effects.¹

The newly published PROBAAT trial suggests that a mechanical approach to induction of labor could reduce complications; it also challenges the belief that mechanical methods increase the risk of infection for mothers and newborns.¹

In the open-label trial of 824 women in 12 hospitals in the Netherlands, women who had a singleton gestation in cephalic presentation, with intact membranes and an unfavorable cervix, were randomized to induction of labor with a 30-mL Foley catheter (n=412) or vaginal prostaglandin E₂ gel (n=412). The rate of cesarean delivery was similar between groups (23% for the Foley catheter vs 20% for prostaglandin gel; risk ratio, 1.13; 95% confidence interval [CI], 0.87–1.47). Two serious maternal adverse events were recorded in the prostaglandin group—one uterine perforation after insertion of a uterine pressure catheter and one uterine rupture during augmentation with oxytocin—versus none in the Foley-catheter group, though this difference was not statistically significant.¹

In addition, the women randomized to the Foley catheter had a lower rate of operative delivery for suspected fetal distress, fewer mothers required intrapartum antibiotics, and fewer newborns were admitted to the NICU. However, the time from the start of induction of labor to birth was longer with the Foley catheter (median of 29 versus 18 hours; relative risk, 1.66; 95% CI, 1.34-1.61; P < .0001).

A meta-analysis that included these new data was then conducted by the researchers; it confirmed that induction of labor with the Foley catheter produces a vaginal delivery rate similar to that of prostaglandin E₂ gel and significantly reduces the rates of uterine hyperstimulation and postpartum hemorrhage. This finding is in line with another recent meta-analysis.²

In a commentary accompanying the study, Jane Norman and Sarah Stock of the University of Edinburgh in Edinburgh, Scotland, conclude: “These data should prompt a revision of the recommendation that ‘mechanical procedures (balloon catheters and laminaria tents) should not be used routinely for induction of [labor].’”³

The authors of the study itself conclude: “We think that a Foley catheter should at least be considered for induction of labor in women with an unfavorable cervix at term.”

We want to hear from you! Tell us what you think.

The Foley catheter is one of the oldest mechanical methods used for inducing labor. New data show that it produces a vaginal delivery rate similar to that of prostaglandin E₂ gel, the current treatment of choice in the United States and United Kingdom—but carries fewer side effects.¹

The newly published PROBAAT trial suggests that a mechanical approach to induction of labor could reduce complications; it also challenges the belief that mechanical methods increase the risk of infection for mothers and newborns.¹

In the open-label trial of 824 women in 12 hospitals in the Netherlands, women who had a singleton gestation in cephalic presentation, with intact membranes and an unfavorable cervix, were randomized to induction of labor with a 30-mL Foley catheter (n=412) or vaginal prostaglandin E₂ gel (n=412). The rate of cesarean delivery was similar between groups (23% for the Foley catheter vs 20% for prostaglandin gel; risk ratio, 1.13; 95% confidence interval [CI], 0.87–1.47). Two serious maternal adverse events were recorded in the prostaglandin group—one uterine perforation after insertion of a uterine pressure catheter and one uterine rupture during augmentation with oxytocin—versus none in the Foley-catheter group, though this difference was not statistically significant.¹

In addition, the women randomized to the Foley catheter had a lower rate of operative delivery for suspected fetal distress, fewer mothers required intrapartum antibiotics, and fewer newborns were admitted to the NICU. However, the time from the start of induction of labor to birth was longer with the Foley catheter (median of 29 versus 18 hours; relative risk, 1.66; 95% CI, 1.34-1.61; P < .0001).

A meta-analysis that included these new data was then conducted by the researchers; it confirmed that induction of labor with the Foley catheter produces a vaginal delivery rate similar to that of prostaglandin E₂ gel and significantly reduces the rates of uterine hyperstimulation and postpartum hemorrhage. This finding is in line with another recent meta-analysis.²

In a commentary accompanying the study, Jane Norman and Sarah Stock of the University of Edinburgh in Edinburgh, Scotland, conclude: “These data should prompt a revision of the recommendation that ‘mechanical procedures (balloon catheters and laminaria tents) should not be used routinely for induction of [labor].’”³

The authors of the study itself conclude: “We think that a Foley catheter should at least be considered for induction of labor in women with an unfavorable cervix at term.”

We want to hear from you! Tell us what you think.

The Foley catheter is one of the oldest mechanical methods used for inducing labor. New data show that it produces a vaginal delivery rate similar to that of prostaglandin E₂ gel, the current treatment of choice in the United States and United Kingdom—but carries fewer side effects.¹

The newly published PROBAAT trial suggests that a mechanical approach to induction of labor could reduce complications; it also challenges the belief that mechanical methods increase the risk of infection for mothers and newborns.¹

In the open-label trial of 824 women in 12 hospitals in the Netherlands, women who had a singleton gestation in cephalic presentation, with intact membranes and an unfavorable cervix, were randomized to induction of labor with a 30-mL Foley catheter (n=412) or vaginal prostaglandin E₂ gel (n=412). The rate of cesarean delivery was similar between groups (23% for the Foley catheter vs 20% for prostaglandin gel; risk ratio, 1.13; 95% confidence interval [CI], 0.87–1.47). Two serious maternal adverse events were recorded in the prostaglandin group—one uterine perforation after insertion of a uterine pressure catheter and one uterine rupture during augmentation with oxytocin—versus none in the Foley-catheter group, though this difference was not statistically significant.¹

In addition, the women randomized to the Foley catheter had a lower rate of operative delivery for suspected fetal distress, fewer mothers required intrapartum antibiotics, and fewer newborns were admitted to the NICU. However, the time from the start of induction of labor to birth was longer with the Foley catheter (median of 29 versus 18 hours; relative risk, 1.66; 95% CI, 1.34-1.61; P < .0001).

A meta-analysis that included these new data was then conducted by the researchers; it confirmed that induction of labor with the Foley catheter produces a vaginal delivery rate similar to that of prostaglandin E₂ gel and significantly reduces the rates of uterine hyperstimulation and postpartum hemorrhage. This finding is in line with another recent meta-analysis.²

In a commentary accompanying the study, Jane Norman and Sarah Stock of the University of Edinburgh in Edinburgh, Scotland, conclude: “These data should prompt a revision of the recommendation that ‘mechanical procedures (balloon catheters and laminaria tents) should not be used routinely for induction of [labor].’”³

The authors of the study itself conclude: “We think that a Foley catheter should at least be considered for induction of labor in women with an unfavorable cervix at term.”

We want to hear from you! Tell us what you think.

The first noninvasive maternal blood test for Down syndrome is available to physicians on request in 20 major metropolitan regions in the United States, with more widespread availability planned in the coming months.

According to manufacturer Sequenom, Inc., the MaterniT21 assay is indicated for use in pregnant women at “high risk” of carrying a fetus with Down syndrome and can accurately test maternal blood as early as 10 weeks of gestation.

The test is based on the presence of cell-free fetal nucleic acids in maternal plasma. The health provider draws a small sample of whole blood from a pregnant woman and ships the sample to the Sequenom Center for Molecular Medicine in San Diego, California, where massively parallel sequencing (MPS) is used to measure a possible overabundance of chromosome 21, or Trisomy 21 (Down syndrome).

Down syndrome affects approximately 6,000 infants or 1 in every 691 pregnancies each year in the United States.¹

Currently, identification of Trisomy 21 requires assessment of several maternal serum screening markers and sonographic measurement of nuchal translucency. If these tests identify a high risk of Trisomy 21, chorionic villus sampling (CVS) or amniocentesis follows. First-trimester screening identifies as many as 90% of all cases of Down syndrome, with a false-positive rate of 2%.¹ Because CVS and amniocentesis are invasive, however, they carry a small risk of pregnancy loss.

All MaterniT21 tests must be interpreted at one of the manufacturer’s laboratories. Approximate cost: $1,900—roughly equivalent to the cost of amniocentesis. Sequenom expects the out-of-pocket cost for patients with insurance to be no more than $235.

The test is not approved by the US Food and Drug Administration, which does not regulate tests when only one laboratory is involved.

Similar tests for Down syndrome are reportedly being developed by other laboratories.

Data on the new test

MaterniT21 was evaluated in a validation study of 4,664 women who had a high risk of Down syndrome.² Fetal karyotyping was compared with the MaterniT21 test in 212 cases of Down syndrome and 1,484 matched euploid cases. The Down syndrome detection rate for the MaterniT21 test was 98.6% (209 of 212 cases); the false-positive rate was 0.20% (three of 1,471 cases); and testing failed in 13 pregnancies (0.8%), all of which were euploid. Researchers concluded that the new test “can substantially reduce the need for invasive diagnostic procedures and attendant procedure-related fetal losses.”²

“The results of this large clinical validation study are extremely promising,” said Allan T. Bombard, MD, laboratory director of Sequenom Center for Molecular Medicine and one of the authors of the study. “We believe perinatal specialists and obstetricians will appreciate the introduction of a test that is noninvasive and highly specific.”

The manufacturer is planning outreach to clinicians through its sales force, medical science liaisons, managed care team, and genetic counselors.

Is the test ready for widespread use?

“I certainly think this test needs to be confirmed by other studies before it becomes ready for prime time,” says Jeffrey A. Kuller, MD, a maternal-fetal medicine specialist and clinical geneticist at Duke University Medical Center in Durham, NC. Dr. Kuller notes that the MaterniT21 test detects only Trisomy 21, whereas conventional first-trimester screening assesses Trisomy 18 and, usually, Trisomy 13 as well. Dr. Kuller is professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke.

“Another big question mark is what does one do with an abnormal result? We have a pretty standardized algorithm for what we do if a patient has an abnormal first-trimester screen,” he points out—”they’re offered invasive testing.” But it’s unclear whether this test is intended to be diagnostic if it detects Trisomy 21.

“Can we essentially tell a patient, ‘You’re carrying a fetus with Down syndrome?’ Or do we need to do invasive testing like we do right now?”

Another unresolved issue is whether the test can be used reliably in a “low-risk” population. The creators of the MaterniT21 assay tested the product only in a “high-risk” population, Dr. Kuller notes. “I don’t think we know whether this would be a reasonable test for all patients.”

These three issues remain unresolved, says Dr. Kuller:

• confirmation of the test’s efficacy in additional studies
• clarification of whether it is diagnostic of Down syndrome
• evaluation of the test in a population at low risk of Trisomy 21.

Panel offers recommendations for genetic counseling

The International Society for Prenatal Diagnosis (ISPD) issued a “rapid response statement” on the new test on October 24: “At this time, individual women who might be considering the MPS test need to receive detailed genetic counseling that explains the benefits and limitations of the test. Testing should only be provided after an informed consent.”³

The ISPD recommends that the following information be conveyed to the patient:

• The test identifies only Down syndrome, or only “about half of the fetal aneuploidy that would be identified through amniocentesis or CVS”.
• The test is not perfect; that is, it does not identify all cases of fetal Down syndrome.
• Because false-positive results are possible, women who test positive still need the result confirmed by amniocentesis or CVS.
• If a woman tests positive for Down syndrome on the MPS test, the waiting period for the results of confirmatory testing may be “highly stressful”.
• The MPS test may not be informative in all cases.
• Women who have an elevated risk of having a child with a “prenatally diagnosable disorder with Mendelian pattern of inheritance, microdeletion syndrome, or some other conditions” still need to undergo amniocentesis or CVS.³

We want to hear from you! Tell us what you think.

The first noninvasive maternal blood test for Down syndrome is available to physicians on request in 20 major metropolitan regions in the United States, with more widespread availability planned in the coming months.

According to manufacturer Sequenom, Inc., the MaterniT21 assay is indicated for use in pregnant women at “high risk” of carrying a fetus with Down syndrome and can accurately test maternal blood as early as 10 weeks of gestation.

The test is based on the presence of cell-free fetal nucleic acids in maternal plasma. The health provider draws a small sample of whole blood from a pregnant woman and ships the sample to the Sequenom Center for Molecular Medicine in San Diego, California, where massively parallel sequencing (MPS) is used to measure a possible overabundance of chromosome 21, or Trisomy 21 (Down syndrome).

Down syndrome affects approximately 6,000 infants or 1 in every 691 pregnancies each year in the United States.¹

Currently, identification of Trisomy 21 requires assessment of several maternal serum screening markers and sonographic measurement of nuchal translucency. If these tests identify a high risk of Trisomy 21, chorionic villus sampling (CVS) or amniocentesis follows. First-trimester screening identifies as many as 90% of all cases of Down syndrome, with a false-positive rate of 2%.¹ Because CVS and amniocentesis are invasive, however, they carry a small risk of pregnancy loss.

All MaterniT21 tests must be interpreted at one of the manufacturer’s laboratories. Approximate cost: $1,900—roughly equivalent to the cost of amniocentesis. Sequenom expects the out-of-pocket cost for patients with insurance to be no more than $235.

The test is not approved by the US Food and Drug Administration, which does not regulate tests when only one laboratory is involved.

Similar tests for Down syndrome are reportedly being developed by other laboratories.

Data on the new test

MaterniT21 was evaluated in a validation study of 4,664 women who had a high risk of Down syndrome.² Fetal karyotyping was compared with the MaterniT21 test in 212 cases of Down syndrome and 1,484 matched euploid cases. The Down syndrome detection rate for the MaterniT21 test was 98.6% (209 of 212 cases); the false-positive rate was 0.20% (three of 1,471 cases); and testing failed in 13 pregnancies (0.8%), all of which were euploid. Researchers concluded that the new test “can substantially reduce the need for invasive diagnostic procedures and attendant procedure-related fetal losses.”²

“The results of this large clinical validation study are extremely promising,” said Allan T. Bombard, MD, laboratory director of Sequenom Center for Molecular Medicine and one of the authors of the study. “We believe perinatal specialists and obstetricians will appreciate the introduction of a test that is noninvasive and highly specific.”

The manufacturer is planning outreach to clinicians through its sales force, medical science liaisons, managed care team, and genetic counselors.

Is the test ready for widespread use?

“I certainly think this test needs to be confirmed by other studies before it becomes ready for prime time,” says Jeffrey A. Kuller, MD, a maternal-fetal medicine specialist and clinical geneticist at Duke University Medical Center in Durham, NC. Dr. Kuller notes that the MaterniT21 test detects only Trisomy 21, whereas conventional first-trimester screening assesses Trisomy 18 and, usually, Trisomy 13 as well. Dr. Kuller is professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke.

“Another big question mark is what does one do with an abnormal result? We have a pretty standardized algorithm for what we do if a patient has an abnormal first-trimester screen,” he points out—”they’re offered invasive testing.” But it’s unclear whether this test is intended to be diagnostic if it detects Trisomy 21.

“Can we essentially tell a patient, ‘You’re carrying a fetus with Down syndrome?’ Or do we need to do invasive testing like we do right now?”

Another unresolved issue is whether the test can be used reliably in a “low-risk” population. The creators of the MaterniT21 assay tested the product only in a “high-risk” population, Dr. Kuller notes. “I don’t think we know whether this would be a reasonable test for all patients.”

These three issues remain unresolved, says Dr. Kuller:

• confirmation of the test’s efficacy in additional studies
• clarification of whether it is diagnostic of Down syndrome
• evaluation of the test in a population at low risk of Trisomy 21.

Panel offers recommendations for genetic counseling

The International Society for Prenatal Diagnosis (ISPD) issued a “rapid response statement” on the new test on October 24: “At this time, individual women who might be considering the MPS test need to receive detailed genetic counseling that explains the benefits and limitations of the test. Testing should only be provided after an informed consent.”³

The ISPD recommends that the following information be conveyed to the patient:

• The test identifies only Down syndrome, or only “about half of the fetal aneuploidy that would be identified through amniocentesis or CVS”.
• The test is not perfect; that is, it does not identify all cases of fetal Down syndrome.
• Because false-positive results are possible, women who test positive still need the result confirmed by amniocentesis or CVS.
• If a woman tests positive for Down syndrome on the MPS test, the waiting period for the results of confirmatory testing may be “highly stressful”.
• The MPS test may not be informative in all cases.
• Women who have an elevated risk of having a child with a “prenatally diagnosable disorder with Mendelian pattern of inheritance, microdeletion syndrome, or some other conditions” still need to undergo amniocentesis or CVS.³

We want to hear from you! Tell us what you think.

The first noninvasive maternal blood test for Down syndrome is available to physicians on request in 20 major metropolitan regions in the United States, with more widespread availability planned in the coming months.

According to manufacturer Sequenom, Inc., the MaterniT21 assay is indicated for use in pregnant women at “high risk” of carrying a fetus with Down syndrome and can accurately test maternal blood as early as 10 weeks of gestation.

The test is based on the presence of cell-free fetal nucleic acids in maternal plasma. The health provider draws a small sample of whole blood from a pregnant woman and ships the sample to the Sequenom Center for Molecular Medicine in San Diego, California, where massively parallel sequencing (MPS) is used to measure a possible overabundance of chromosome 21, or Trisomy 21 (Down syndrome).

Down syndrome affects approximately 6,000 infants or 1 in every 691 pregnancies each year in the United States.¹

Currently, identification of Trisomy 21 requires assessment of several maternal serum screening markers and sonographic measurement of nuchal translucency. If these tests identify a high risk of Trisomy 21, chorionic villus sampling (CVS) or amniocentesis follows. First-trimester screening identifies as many as 90% of all cases of Down syndrome, with a false-positive rate of 2%.¹ Because CVS and amniocentesis are invasive, however, they carry a small risk of pregnancy loss.

All MaterniT21 tests must be interpreted at one of the manufacturer’s laboratories. Approximate cost: $1,900—roughly equivalent to the cost of amniocentesis. Sequenom expects the out-of-pocket cost for patients with insurance to be no more than $235.

The test is not approved by the US Food and Drug Administration, which does not regulate tests when only one laboratory is involved.

Similar tests for Down syndrome are reportedly being developed by other laboratories.

Data on the new test

MaterniT21 was evaluated in a validation study of 4,664 women who had a high risk of Down syndrome.² Fetal karyotyping was compared with the MaterniT21 test in 212 cases of Down syndrome and 1,484 matched euploid cases. The Down syndrome detection rate for the MaterniT21 test was 98.6% (209 of 212 cases); the false-positive rate was 0.20% (three of 1,471 cases); and testing failed in 13 pregnancies (0.8%), all of which were euploid. Researchers concluded that the new test “can substantially reduce the need for invasive diagnostic procedures and attendant procedure-related fetal losses.”²

“The results of this large clinical validation study are extremely promising,” said Allan T. Bombard, MD, laboratory director of Sequenom Center for Molecular Medicine and one of the authors of the study. “We believe perinatal specialists and obstetricians will appreciate the introduction of a test that is noninvasive and highly specific.”

The manufacturer is planning outreach to clinicians through its sales force, medical science liaisons, managed care team, and genetic counselors.

Is the test ready for widespread use?

“I certainly think this test needs to be confirmed by other studies before it becomes ready for prime time,” says Jeffrey A. Kuller, MD, a maternal-fetal medicine specialist and clinical geneticist at Duke University Medical Center in Durham, NC. Dr. Kuller notes that the MaterniT21 test detects only Trisomy 21, whereas conventional first-trimester screening assesses Trisomy 18 and, usually, Trisomy 13 as well. Dr. Kuller is professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke.

“Another big question mark is what does one do with an abnormal result? We have a pretty standardized algorithm for what we do if a patient has an abnormal first-trimester screen,” he points out—”they’re offered invasive testing.” But it’s unclear whether this test is intended to be diagnostic if it detects Trisomy 21.

“Can we essentially tell a patient, ‘You’re carrying a fetus with Down syndrome?’ Or do we need to do invasive testing like we do right now?”

Another unresolved issue is whether the test can be used reliably in a “low-risk” population. The creators of the MaterniT21 assay tested the product only in a “high-risk” population, Dr. Kuller notes. “I don’t think we know whether this would be a reasonable test for all patients.”

These three issues remain unresolved, says Dr. Kuller:

• confirmation of the test’s efficacy in additional studies
• clarification of whether it is diagnostic of Down syndrome
• evaluation of the test in a population at low risk of Trisomy 21.

Panel offers recommendations for genetic counseling

The International Society for Prenatal Diagnosis (ISPD) issued a “rapid response statement” on the new test on October 24: “At this time, individual women who might be considering the MPS test need to receive detailed genetic counseling that explains the benefits and limitations of the test. Testing should only be provided after an informed consent.”³

The ISPD recommends that the following information be conveyed to the patient:

• The test identifies only Down syndrome, or only “about half of the fetal aneuploidy that would be identified through amniocentesis or CVS”.
• The test is not perfect; that is, it does not identify all cases of fetal Down syndrome.
• Because false-positive results are possible, women who test positive still need the result confirmed by amniocentesis or CVS.
• If a woman tests positive for Down syndrome on the MPS test, the waiting period for the results of confirmatory testing may be “highly stressful”.
• The MPS test may not be informative in all cases.
• Women who have an elevated risk of having a child with a “prenatally diagnosable disorder with Mendelian pattern of inheritance, microdeletion syndrome, or some other conditions” still need to undergo amniocentesis or CVS.³

We want to hear from you! Tell us what you think.

Stroke may be an unusual event in pregnancy, but it’s becoming less of a rarity, according to a new study.¹ Hospitalizations related to stroke in pregnancy increased 54% over the past dozen years, from 4,085 in 1994–95 to 6,293 in 2006–07.

Researchers from the Centers for Disease Control and Prevention (CDC) analyzed a large national database of 5 to 8 million discharges from 1,000 hospitals and compared the rates of stroke from 1994–95 with the rates from 2006–07 in women who were pregnant, delivering a baby, and who had recently given birth.

In women who were pregnant, the rate of hospitalization for stroke rose 47%. The rate during the 12 weeks after delivery rose 83%. The rate remained stable for hospitalizations that occurred during the time immediately surrounding childbirth.

“I am surprised at the magnitude of the increase, which is substantial,” said Elena V. Kuklina, MD, PhD, lead author of the study and senior service fellow and epidemiologist at the CDC’s Division for Heart Disease and Stroke Prevention in Atlanta, Ga. “Our results indicate an urgent need to take a closer look. Stroke is such a debilitating condition. We need to put more effort into prevention.”

“Now more and more women entering pregnancy already have some type of risk factor for stroke, such as obesity, chronic hypertension, diabetes, or congenital heart disease. Since pregnancy by itself is a risk factor, if you have one of these other stroke risk factors, it doubles the risk.”

Not surprisingly, the prevalence of high blood pressure also rose over the 12-year period. In 1994–95, the rate was:

• 11.3% in antepartum women
• 23.4% in women at or near delivery
• 27.8% in women within 12 weeks after delivery.

In 2006–07, the rate was:

• 17% in antepartum women
• 28.5% in women at or near delivery
• 40.9% in women within 12 weeks after delivery.

“It’s best for women to enter pregnancy with ideal cardiovascular health, without additional risk factors,” Kuklina said. She recommends development of a comprehensive, multidisciplinary plan that gives doctors and patients guidelines for appropriate monitoring and care before, during, and after childbirth.

We want to hear from you! Tell us what you think.

Stroke may be an unusual event in pregnancy, but it’s becoming less of a rarity, according to a new study.¹ Hospitalizations related to stroke in pregnancy increased 54% over the past dozen years, from 4,085 in 1994–95 to 6,293 in 2006–07.

Researchers from the Centers for Disease Control and Prevention (CDC) analyzed a large national database of 5 to 8 million discharges from 1,000 hospitals and compared the rates of stroke from 1994–95 with the rates from 2006–07 in women who were pregnant, delivering a baby, and who had recently given birth.

In women who were pregnant, the rate of hospitalization for stroke rose 47%. The rate during the 12 weeks after delivery rose 83%. The rate remained stable for hospitalizations that occurred during the time immediately surrounding childbirth.

“I am surprised at the magnitude of the increase, which is substantial,” said Elena V. Kuklina, MD, PhD, lead author of the study and senior service fellow and epidemiologist at the CDC’s Division for Heart Disease and Stroke Prevention in Atlanta, Ga. “Our results indicate an urgent need to take a closer look. Stroke is such a debilitating condition. We need to put more effort into prevention.”

“Now more and more women entering pregnancy already have some type of risk factor for stroke, such as obesity, chronic hypertension, diabetes, or congenital heart disease. Since pregnancy by itself is a risk factor, if you have one of these other stroke risk factors, it doubles the risk.”

Not surprisingly, the prevalence of high blood pressure also rose over the 12-year period. In 1994–95, the rate was:

• 11.3% in antepartum women
• 23.4% in women at or near delivery
• 27.8% in women within 12 weeks after delivery.

In 2006–07, the rate was:

• 17% in antepartum women
• 28.5% in women at or near delivery
• 40.9% in women within 12 weeks after delivery.

“It’s best for women to enter pregnancy with ideal cardiovascular health, without additional risk factors,” Kuklina said. She recommends development of a comprehensive, multidisciplinary plan that gives doctors and patients guidelines for appropriate monitoring and care before, during, and after childbirth.

We want to hear from you! Tell us what you think.

Stroke may be an unusual event in pregnancy, but it’s becoming less of a rarity, according to a new study.¹ Hospitalizations related to stroke in pregnancy increased 54% over the past dozen years, from 4,085 in 1994–95 to 6,293 in 2006–07.

Researchers from the Centers for Disease Control and Prevention (CDC) analyzed a large national database of 5 to 8 million discharges from 1,000 hospitals and compared the rates of stroke from 1994–95 with the rates from 2006–07 in women who were pregnant, delivering a baby, and who had recently given birth.

In women who were pregnant, the rate of hospitalization for stroke rose 47%. The rate during the 12 weeks after delivery rose 83%. The rate remained stable for hospitalizations that occurred during the time immediately surrounding childbirth.

“I am surprised at the magnitude of the increase, which is substantial,” said Elena V. Kuklina, MD, PhD, lead author of the study and senior service fellow and epidemiologist at the CDC’s Division for Heart Disease and Stroke Prevention in Atlanta, Ga. “Our results indicate an urgent need to take a closer look. Stroke is such a debilitating condition. We need to put more effort into prevention.”

“Now more and more women entering pregnancy already have some type of risk factor for stroke, such as obesity, chronic hypertension, diabetes, or congenital heart disease. Since pregnancy by itself is a risk factor, if you have one of these other stroke risk factors, it doubles the risk.”

Not surprisingly, the prevalence of high blood pressure also rose over the 12-year period. In 1994–95, the rate was:

• 11.3% in antepartum women
• 23.4% in women at or near delivery
• 27.8% in women within 12 weeks after delivery.

In 2006–07, the rate was:

• 17% in antepartum women
• 28.5% in women at or near delivery
• 40.9% in women within 12 weeks after delivery.

“It’s best for women to enter pregnancy with ideal cardiovascular health, without additional risk factors,” Kuklina said. She recommends development of a comprehensive, multidisciplinary plan that gives doctors and patients guidelines for appropriate monitoring and care before, during, and after childbirth.

We want to hear from you! Tell us what you think.