Obstetrics

Unintended pregnancy remains a serious problem in the United States, and the rate continues to increase. Currently, the unintended pregnancy rate is at an all-time high, estimated at 51% of all pregnancies.¹ Sobering statistics reveal that the United States has a significantly higher rate of unintended pregnancy than any other developed country.^2,3

So the question remains: If we have been introducing new contraceptive methods, why do unintended pregnancy rates keep rising in the United States?

The answer: Key barriers prevent women from attaining their desired contraceptive—foremost among them, cost.

The unintended pregnancy rate is highest among women who are poor, young (aged 18–24 years), minorities, or cohabitating.¹ The unintended pregnancy rate among poor women (income below the federal poverty level) of reproductive age has increased over the past few decades, whereas the rate among high-income women (more than twice the federal poverty level) has declined.¹ The unintended pregnancy rate discrepancy between poor women and those with means has increased 77%, from a threefold difference in 1995 to a difference of more than fivefold in 2008 (TABLE 1).^1,4

These data indicate that we are doing well providing contraception to women of means. However, as a society, we need to improve how we deliver contraceptives—especially highly effective methods—to poor women. As one might expect, given these numbers, low-income women have rates of abortion and unplanned birth that are nearly 6 times higher than their higher-income counterparts.¹ The resultant cost to society is substantial, with 68% of unplanned births paid for by public insurance programs such as Medicaid, compared with 38% of planned births.⁵

As women’s health providers, we must work to improve these numbers and advocate for our patients to help them gain access to the contraceptives they need in accordance with their reproductive life plan. In this article, we hope to put this information in context as we:

National and state snapshots reveal shifting proportions of intended, unintended pregnancies
Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001–2008. Am J Public Health. 2014;104(suppl 1):s43–s48.

Kost K. Unintended pregnancy rates at the state level: estimates for 2010 and trends since 2002. Guttmacher Institute. https://www.guttmacher.org/pubs/StateUP10.pdf. Published January 2015. Accessed June 29, 2015.

Recent studies have demonstrated trends in unplanned pregnancy over the past 2 decades on both a national and statewide level. Data from the National Survey of Family Growth have highlighted trends in abortion and miscarriage, and data from the National Center for Health Statistics have shed light on birth trends. Of 6 million births in 2008, 51% were unintended.¹ Unintended pregnancy was defined as a gestation that was mistimed or unwanted. Intended pregnancy was defined as one that was desired at the time it occurred or sooner.

2008 data focus on the national level
Although the overall pregnancy rate for US women aged 15 to 44 years is relatively unchanged, there is a small change in whether or not the pregnancy was intended. For 2008, as the rate of intended pregnancy dropped slightly, from 54 to 51 pregnancies per 1,000 women, the unintended pregnancy rate increased by 10%, from 49 to 54 pregnancies per 1,000 women. Proportionally, unintended pregnancies that resulted in abortion declined from 47% to 40%, whereas the rate of unintended pregnancies ending in birth increased to 27 births per 1,000 women.¹

2010 data focus on individual states
We now have state-specific data on trends in unintended pregnancy rates from 2002 to 2010 in the United States.⁶ In 28 of 50 states, more than half of all pregnancies were unintended, with rates ranging from 36% to 62%. The median rate was 47 unintended pregnancies per 1,000 women aged 15 to 44, with the lowest unintended pregnancy rate in New Hampshire at 32 per 1,000 women and highest rates in Delaware, Hawaii, and New York at 61 to 62 unintended pregnancies per 1,000 women.⁶

Between 2002 and 2010, unintended pregnancy rates fell 5% or more in 18 states and rose 5% or more in 4 states. In the remaining 12 states for which there are data, unintended pregnancy rates remained unchanged.

Interestingly, 16 states had increases in unintended pregnancy rates of 5% or more between 2002 and 2006. The trend reversed between 2006 and 2010, during which 28 of 41 states with available data experienced decreases of 5% or more and only 1 state experienced an increase of 5% or more. These latest numbers suggest we may be making some progress in reducing the overall rate of unintended pregnancy.

What this EVIDENCE means for practice
Although the rate of unintended pregnancy is declining in some states, the national rate is still increasing. This information emphasizes the need for all providers to consider initiating discussions about pregnancy intentions—a step that may be as important as obtaining blood pressure and weight. When women are seen for any health visit, they should be asked about their reproductive plans. The Centers for Disease Control and Prevention (CDC) has issued a helpful set of questions to guide the discussion of timing and planning pregnancy. It also provides useful information on ways to increase utilization of long-acting reversible contraceptives (LARCs) to help realize the goal of fewer unintended pregnancies. (For more on this discussion, see “How to motivate your patient to create a reproductive life plan,” below.)

How Colorado broke down barriers to highly effective contraception—and saved $42.5 million in 1 year
Ricketts S, Klinger G, Schwalberg R. Game change in Colorado: widespread use of long-acting reversible contraceptives and rapid decline of births among young, low-income women. Perspect Sexual Reprod Health. 2014;46(3):125–132.

The Contraceptive CHOICE Project in St. Louis County, Missouri, is an incredible success story. In it, clinicians made highly effective LARCs readily available and free of charge. When a large percentage of women chose a LARC method, the unintended pregnancy and abortion rates declined.⁷ In Colorado, providers put this study into practice, creating a successful statewide initiative to reduce the unintended pregnancy rate.⁸

The data behind LARC methods
LARC methods are backed by endorsements from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the CDC, and the World Health Organization, which recommend them for adolescents because of their superiority to shorter-acting methods. With LARCs, failure rates are lower and compliance is greater, making them ideal for adolescents, who have high unintended pregnancy rates.¹

However, based on 2011 data, only 2% of LARC users nationwide are aged 20 or younger. A number of barriers prevent young women from obtaining LARCs, including lack of education, limited access to and availability of the contraceptives, and, importantly, cost. Many state plans have adopted ­Medicaid expansions to reduce barriers to LARCs. However, this benefit is still not available in many states, Colorado being 1 of them.

How the Colorado initiative worked
In 2005, 40% of Colorado’s births were ­unintended, and 60% of those unintended births occurred in women aged 15 to 24 years. About three-quarters of women who were using a contraceptive method at the time of unintended pregnancy reported that it was a low-cost, high-failure method such as condoms or withdrawal.

In response, Colorado’s Department of Public Health and Environment and the ­Colorado Family Planning Initiative (CFPI) used private funds from an anonymous foundation to provide LARC products at no cost to the Title X–funded clinics in the state.

The initiative began in 2009 in clinics that served 95% of the state’s total population. The funding provided the products ­themselves (intrauterine device [IUD], implant), as well as training for providers and staff.

Before the initiative began, 52,645 clients received services in these clinics annually. In the third year of the initiative, that number had increased to 64,928 annually. About 55% of clients receiving services both preinitiative and postinitiative were younger than 25 years, and most (92% in 2011) had income below the poverty level.

LARC use increased fourfold over the 3 years of the funded program, from less than 4.5% to 19.4% in the third year. Contraceptive implant use increased tenfold, and IUD use increased by almost threefold. At the same time, oral contraceptive use declined 13%. Before the initiative, only 620 young, low-income women used a LARC method; afterward, 8,435 did.

These changes in contraceptive practice triggered a significant decline in pregnancy rates (TABLE 2) and abortion rates (TABLE 3). Abortion rates increased 8% among 20- to 24-year-olds who were not enrolled in the initiative and decreased 18% among those who were. The proportion of high-risk births (births to unmarried, low-income women with less than a high school education) dropped 24% after the initiative began. The proportion of high-risk births in counties not receiving CFPI funds stayed the same at 7%.

Colorado program saved $42.5 million in public funds
This Colorado program demonstrated that the CHOICE Project can be translated to a statewide initiative. Whereas CHOICE enrolled 9,256 women over 4 years, the Colorado initiative included more than 50,000 clients annually over 3 years. Colorado did not use any state funds for this project, which resulted in significant decreases in the unintended birth rate, abortion rate, and rate of high-risk births.

The Colorado governor’s office estimates that the CFPI saved $5.68 in Medicaid costs for Colorado for every dollar spent on contraceptives. In just 1 year (2010), the program saved approximately $42.5 million in public funds.

Ironically, despite the success of this project, the Colorado legislature denied further funding once the initial financial support ceased.
 

What this EVIDENCE means for practice
The Colorado program demonstrates that we all can provide LARC methods in practice, especially to young women. In this population, use of highly effective contraception resulted in fewer unintended pregnancies, births, and abortions statewide.

We also need to advocate for our patients, particularly those who have less means and rely on public assistance. Public funding of LARC methods clearly improves outcomes at an individual and population level.

A new, more affordable IUD enters the market
Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015;92(1):10–16.

Programs such as the Contraceptive CHOICE Project and the Colorado Family Planning Initiative relied on private foundations for financial support, largely because of the high cost of the IUDs and implants currently available in the United States. Even with the Affordable Care Act (ACA) reducing the costs of LARC products and other contraceptives for patients, there are still many women not covered by these programs. For example, “grandfathered” health insurance plans do not need to follow some aspects of the ACA.

Just as important, the high cost of LARC products takes a toll on providers and clinics that must finance the cost per unit to have stock on hand and then wait for months for reimbursement by insurance companies. As a result, some providers do not stock IUDs and implants and only order them as they are needed and approved by insurance for a particular patient. These barriers limit access to LARC methods and reduce the number of women who receive the products.⁸

Liletta is less expensive than other IUDs
Enter Liletta, a new levonorgestrel-releasing, 52-mg intrauterine system (IUS) that has been in clinical trials since 2009.⁹ ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an Intrauterine System) was initiated by Medicines360, a unique nonprofit pharmaceutical company committed to ensuring access to reproductive health products for all women (private and public sector).

ACCESS IUS is the largest IUD approval study ever performed exclusively in the United States. The Phase 3, open-label clinical trial was conducted at 29 sites around the United States, enrolling healthy, nonpregnant, sexually active women aged 16 to 45 years with regular menstrual cycles. Both nulliparous and parous women were included, with no weight or body mass index (BMI) restrictions applied. The study is ongoing and will continue for as long as 7 years. Eisenberg and colleagues published the data used for initial approval for 3 years of use in the United States and Europe.⁹

Details of the trial
A total of 1,600 women aged 16 to 35 years comprised the group in which efficacy was evaluated. An additional 151 women aged 36 to 45 years were evaluated for safety only. Of the enrolled women, 1,011 (58%) were nulliparous, making ACCESS IUS the largest product approval study of nulliparous women. In addition, 438 women (25.1%) were obese, and 5% of these women had a BMI greater than 40 kg/m².

Liletta was placed successfully in 1,714 women (97.9%). Fifteen women did not have placement attempted due to uterine factors (the uterus could not be sounded, or the sound was <5.5 cm) or factors unrelated to the product or inserter. In women in whom placement was attempted, the success rate was 98.7%.

The first-year Pearl index for Liletta was 0.15. Life-table pregnancy rates were 0.14 through year 1 and 0.55 through year 3. Four of the 6 pregnancies reported through 3 years of use were ectopic. Adverse events and their incidence, occurring in more than 2% of users, were acne (6%), expulsion (3.5%), dyspareunia (2.8%), and mastalgia (2.0%). The most common adverse events leading to discontinuation were expulsion (3.5%), bleeding complaints (1.5%), acne (1.3%), and mood swings (1.3%).

Uterine perforation with Liletta was diagnosed in 2 participants (0.11%). Expulsion occurred in 62 users (3.5%) and was more frequent among parous than nulliparous women (5.6% vs 2.0%, respectively; P<.001). Most (80.6%) of the expulsions were reported in the first year of product use. Pelvic infection was reported in 10 participants (0.6%), and all cases resolved with outpatient antibiotic treatment.⁹

Keep in mind that this is an ongoing study—not all women have reached a full 3 years of use. Updates on efficacy and adverse events will be published in the future. This current publication demonstrates the high efficacy and safety of the product through 3 years of use, permitting its approval for contraception in the United States.

In Europe, the product is approved for both contraception and the treatment of heavy menstrual bleeding, based on a European study.¹⁰

What this EVIDENCE means for practice
Liletta is a branded product (not generic) designed to be similar to Mirena, with the same size, frame, hormone content, and hormone release rate.¹¹ Medicines360 has entered a groundbreaking marketing partnership with Actavis to make Liletta widely available and affordable. For most public sector providers and clinics in the United States, Liletta costs only $50, significantly less than other LARC methods available in the United States. Actavis also has a program that ensures that any woman lacking insurance coverage for an IUD and not receiving care at a public sector clinic will not be charged more than $75 for her IUD. However, the price of the device is only one aspect of its overall cost, as women still need to pay for any office visit or insertion fees.

For society, this unique business partnership has to include providers and patients as well. Sales of Liletta in the private sector will support the very low price in the public sector. As a health care community, even if we do not directly care for women in public-sector settings, we can all help poor women access very affordable highly effective contraception.

For providers, Liletta is a lower-cost alternative to currently available hormonal IUDs and should perform well over the long term. The highly successful use of Liletta in nulliparous women demonstrates its safety in this population. The 3-year approval is the first step, as the Phase 3 study continues. In the future, Liletta is expected to be approved for 5 years or longer.

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

Unintended pregnancy remains a serious problem in the United States, and the rate continues to increase. Currently, the unintended pregnancy rate is at an all-time high, estimated at 51% of all pregnancies.¹ Sobering statistics reveal that the United States has a significantly higher rate of unintended pregnancy than any other developed country.^2,3

So the question remains: If we have been introducing new contraceptive methods, why do unintended pregnancy rates keep rising in the United States?

The answer: Key barriers prevent women from attaining their desired contraceptive—foremost among them, cost.

The unintended pregnancy rate is highest among women who are poor, young (aged 18–24 years), minorities, or cohabitating.¹ The unintended pregnancy rate among poor women (income below the federal poverty level) of reproductive age has increased over the past few decades, whereas the rate among high-income women (more than twice the federal poverty level) has declined.¹ The unintended pregnancy rate discrepancy between poor women and those with means has increased 77%, from a threefold difference in 1995 to a difference of more than fivefold in 2008 (TABLE 1).^1,4

These data indicate that we are doing well providing contraception to women of means. However, as a society, we need to improve how we deliver contraceptives—especially highly effective methods—to poor women. As one might expect, given these numbers, low-income women have rates of abortion and unplanned birth that are nearly 6 times higher than their higher-income counterparts.¹ The resultant cost to society is substantial, with 68% of unplanned births paid for by public insurance programs such as Medicaid, compared with 38% of planned births.⁵

As women’s health providers, we must work to improve these numbers and advocate for our patients to help them gain access to the contraceptives they need in accordance with their reproductive life plan. In this article, we hope to put this information in context as we:

National and state snapshots reveal shifting proportions of intended, unintended pregnancies
Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001–2008. Am J Public Health. 2014;104(suppl 1):s43–s48.

Kost K. Unintended pregnancy rates at the state level: estimates for 2010 and trends since 2002. Guttmacher Institute. https://www.guttmacher.org/pubs/StateUP10.pdf. Published January 2015. Accessed June 29, 2015.

Recent studies have demonstrated trends in unplanned pregnancy over the past 2 decades on both a national and statewide level. Data from the National Survey of Family Growth have highlighted trends in abortion and miscarriage, and data from the National Center for Health Statistics have shed light on birth trends. Of 6 million births in 2008, 51% were unintended.¹ Unintended pregnancy was defined as a gestation that was mistimed or unwanted. Intended pregnancy was defined as one that was desired at the time it occurred or sooner.

2008 data focus on the national level
Although the overall pregnancy rate for US women aged 15 to 44 years is relatively unchanged, there is a small change in whether or not the pregnancy was intended. For 2008, as the rate of intended pregnancy dropped slightly, from 54 to 51 pregnancies per 1,000 women, the unintended pregnancy rate increased by 10%, from 49 to 54 pregnancies per 1,000 women. Proportionally, unintended pregnancies that resulted in abortion declined from 47% to 40%, whereas the rate of unintended pregnancies ending in birth increased to 27 births per 1,000 women.¹

2010 data focus on individual states
We now have state-specific data on trends in unintended pregnancy rates from 2002 to 2010 in the United States.⁶ In 28 of 50 states, more than half of all pregnancies were unintended, with rates ranging from 36% to 62%. The median rate was 47 unintended pregnancies per 1,000 women aged 15 to 44, with the lowest unintended pregnancy rate in New Hampshire at 32 per 1,000 women and highest rates in Delaware, Hawaii, and New York at 61 to 62 unintended pregnancies per 1,000 women.⁶

Between 2002 and 2010, unintended pregnancy rates fell 5% or more in 18 states and rose 5% or more in 4 states. In the remaining 12 states for which there are data, unintended pregnancy rates remained unchanged.

Interestingly, 16 states had increases in unintended pregnancy rates of 5% or more between 2002 and 2006. The trend reversed between 2006 and 2010, during which 28 of 41 states with available data experienced decreases of 5% or more and only 1 state experienced an increase of 5% or more. These latest numbers suggest we may be making some progress in reducing the overall rate of unintended pregnancy.

What this EVIDENCE means for practice
Although the rate of unintended pregnancy is declining in some states, the national rate is still increasing. This information emphasizes the need for all providers to consider initiating discussions about pregnancy intentions—a step that may be as important as obtaining blood pressure and weight. When women are seen for any health visit, they should be asked about their reproductive plans. The Centers for Disease Control and Prevention (CDC) has issued a helpful set of questions to guide the discussion of timing and planning pregnancy. It also provides useful information on ways to increase utilization of long-acting reversible contraceptives (LARCs) to help realize the goal of fewer unintended pregnancies. (For more on this discussion, see “How to motivate your patient to create a reproductive life plan,” below.)

How Colorado broke down barriers to highly effective contraception—and saved $42.5 million in 1 year
Ricketts S, Klinger G, Schwalberg R. Game change in Colorado: widespread use of long-acting reversible contraceptives and rapid decline of births among young, low-income women. Perspect Sexual Reprod Health. 2014;46(3):125–132.

The Contraceptive CHOICE Project in St. Louis County, Missouri, is an incredible success story. In it, clinicians made highly effective LARCs readily available and free of charge. When a large percentage of women chose a LARC method, the unintended pregnancy and abortion rates declined.⁷ In Colorado, providers put this study into practice, creating a successful statewide initiative to reduce the unintended pregnancy rate.⁸

The data behind LARC methods
LARC methods are backed by endorsements from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the CDC, and the World Health Organization, which recommend them for adolescents because of their superiority to shorter-acting methods. With LARCs, failure rates are lower and compliance is greater, making them ideal for adolescents, who have high unintended pregnancy rates.¹

However, based on 2011 data, only 2% of LARC users nationwide are aged 20 or younger. A number of barriers prevent young women from obtaining LARCs, including lack of education, limited access to and availability of the contraceptives, and, importantly, cost. Many state plans have adopted ­Medicaid expansions to reduce barriers to LARCs. However, this benefit is still not available in many states, Colorado being 1 of them.

How the Colorado initiative worked
In 2005, 40% of Colorado’s births were ­unintended, and 60% of those unintended births occurred in women aged 15 to 24 years. About three-quarters of women who were using a contraceptive method at the time of unintended pregnancy reported that it was a low-cost, high-failure method such as condoms or withdrawal.

In response, Colorado’s Department of Public Health and Environment and the ­Colorado Family Planning Initiative (CFPI) used private funds from an anonymous foundation to provide LARC products at no cost to the Title X–funded clinics in the state.

The initiative began in 2009 in clinics that served 95% of the state’s total population. The funding provided the products ­themselves (intrauterine device [IUD], implant), as well as training for providers and staff.

Before the initiative began, 52,645 clients received services in these clinics annually. In the third year of the initiative, that number had increased to 64,928 annually. About 55% of clients receiving services both preinitiative and postinitiative were younger than 25 years, and most (92% in 2011) had income below the poverty level.

LARC use increased fourfold over the 3 years of the funded program, from less than 4.5% to 19.4% in the third year. Contraceptive implant use increased tenfold, and IUD use increased by almost threefold. At the same time, oral contraceptive use declined 13%. Before the initiative, only 620 young, low-income women used a LARC method; afterward, 8,435 did.

These changes in contraceptive practice triggered a significant decline in pregnancy rates (TABLE 2) and abortion rates (TABLE 3). Abortion rates increased 8% among 20- to 24-year-olds who were not enrolled in the initiative and decreased 18% among those who were. The proportion of high-risk births (births to unmarried, low-income women with less than a high school education) dropped 24% after the initiative began. The proportion of high-risk births in counties not receiving CFPI funds stayed the same at 7%.

Colorado program saved $42.5 million in public funds
This Colorado program demonstrated that the CHOICE Project can be translated to a statewide initiative. Whereas CHOICE enrolled 9,256 women over 4 years, the Colorado initiative included more than 50,000 clients annually over 3 years. Colorado did not use any state funds for this project, which resulted in significant decreases in the unintended birth rate, abortion rate, and rate of high-risk births.

The Colorado governor’s office estimates that the CFPI saved $5.68 in Medicaid costs for Colorado for every dollar spent on contraceptives. In just 1 year (2010), the program saved approximately $42.5 million in public funds.

Ironically, despite the success of this project, the Colorado legislature denied further funding once the initial financial support ceased.
 

What this EVIDENCE means for practice
The Colorado program demonstrates that we all can provide LARC methods in practice, especially to young women. In this population, use of highly effective contraception resulted in fewer unintended pregnancies, births, and abortions statewide.

We also need to advocate for our patients, particularly those who have less means and rely on public assistance. Public funding of LARC methods clearly improves outcomes at an individual and population level.

A new, more affordable IUD enters the market
Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015;92(1):10–16.

Programs such as the Contraceptive CHOICE Project and the Colorado Family Planning Initiative relied on private foundations for financial support, largely because of the high cost of the IUDs and implants currently available in the United States. Even with the Affordable Care Act (ACA) reducing the costs of LARC products and other contraceptives for patients, there are still many women not covered by these programs. For example, “grandfathered” health insurance plans do not need to follow some aspects of the ACA.

Just as important, the high cost of LARC products takes a toll on providers and clinics that must finance the cost per unit to have stock on hand and then wait for months for reimbursement by insurance companies. As a result, some providers do not stock IUDs and implants and only order them as they are needed and approved by insurance for a particular patient. These barriers limit access to LARC methods and reduce the number of women who receive the products.⁸

Liletta is less expensive than other IUDs
Enter Liletta, a new levonorgestrel-releasing, 52-mg intrauterine system (IUS) that has been in clinical trials since 2009.⁹ ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an Intrauterine System) was initiated by Medicines360, a unique nonprofit pharmaceutical company committed to ensuring access to reproductive health products for all women (private and public sector).

ACCESS IUS is the largest IUD approval study ever performed exclusively in the United States. The Phase 3, open-label clinical trial was conducted at 29 sites around the United States, enrolling healthy, nonpregnant, sexually active women aged 16 to 45 years with regular menstrual cycles. Both nulliparous and parous women were included, with no weight or body mass index (BMI) restrictions applied. The study is ongoing and will continue for as long as 7 years. Eisenberg and colleagues published the data used for initial approval for 3 years of use in the United States and Europe.⁹

Details of the trial
A total of 1,600 women aged 16 to 35 years comprised the group in which efficacy was evaluated. An additional 151 women aged 36 to 45 years were evaluated for safety only. Of the enrolled women, 1,011 (58%) were nulliparous, making ACCESS IUS the largest product approval study of nulliparous women. In addition, 438 women (25.1%) were obese, and 5% of these women had a BMI greater than 40 kg/m².

Liletta was placed successfully in 1,714 women (97.9%). Fifteen women did not have placement attempted due to uterine factors (the uterus could not be sounded, or the sound was <5.5 cm) or factors unrelated to the product or inserter. In women in whom placement was attempted, the success rate was 98.7%.

The first-year Pearl index for Liletta was 0.15. Life-table pregnancy rates were 0.14 through year 1 and 0.55 through year 3. Four of the 6 pregnancies reported through 3 years of use were ectopic. Adverse events and their incidence, occurring in more than 2% of users, were acne (6%), expulsion (3.5%), dyspareunia (2.8%), and mastalgia (2.0%). The most common adverse events leading to discontinuation were expulsion (3.5%), bleeding complaints (1.5%), acne (1.3%), and mood swings (1.3%).

Uterine perforation with Liletta was diagnosed in 2 participants (0.11%). Expulsion occurred in 62 users (3.5%) and was more frequent among parous than nulliparous women (5.6% vs 2.0%, respectively; P<.001). Most (80.6%) of the expulsions were reported in the first year of product use. Pelvic infection was reported in 10 participants (0.6%), and all cases resolved with outpatient antibiotic treatment.⁹

Keep in mind that this is an ongoing study—not all women have reached a full 3 years of use. Updates on efficacy and adverse events will be published in the future. This current publication demonstrates the high efficacy and safety of the product through 3 years of use, permitting its approval for contraception in the United States.

In Europe, the product is approved for both contraception and the treatment of heavy menstrual bleeding, based on a European study.¹⁰

What this EVIDENCE means for practice
Liletta is a branded product (not generic) designed to be similar to Mirena, with the same size, frame, hormone content, and hormone release rate.¹¹ Medicines360 has entered a groundbreaking marketing partnership with Actavis to make Liletta widely available and affordable. For most public sector providers and clinics in the United States, Liletta costs only $50, significantly less than other LARC methods available in the United States. Actavis also has a program that ensures that any woman lacking insurance coverage for an IUD and not receiving care at a public sector clinic will not be charged more than $75 for her IUD. However, the price of the device is only one aspect of its overall cost, as women still need to pay for any office visit or insertion fees.

For society, this unique business partnership has to include providers and patients as well. Sales of Liletta in the private sector will support the very low price in the public sector. As a health care community, even if we do not directly care for women in public-sector settings, we can all help poor women access very affordable highly effective contraception.

For providers, Liletta is a lower-cost alternative to currently available hormonal IUDs and should perform well over the long term. The highly successful use of Liletta in nulliparous women demonstrates its safety in this population. The 3-year approval is the first step, as the Phase 3 study continues. In the future, Liletta is expected to be approved for 5 years or longer.

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

Unintended pregnancy remains a serious problem in the United States, and the rate continues to increase. Currently, the unintended pregnancy rate is at an all-time high, estimated at 51% of all pregnancies.¹ Sobering statistics reveal that the United States has a significantly higher rate of unintended pregnancy than any other developed country.^2,3

So the question remains: If we have been introducing new contraceptive methods, why do unintended pregnancy rates keep rising in the United States?

The answer: Key barriers prevent women from attaining their desired contraceptive—foremost among them, cost.

The unintended pregnancy rate is highest among women who are poor, young (aged 18–24 years), minorities, or cohabitating.¹ The unintended pregnancy rate among poor women (income below the federal poverty level) of reproductive age has increased over the past few decades, whereas the rate among high-income women (more than twice the federal poverty level) has declined.¹ The unintended pregnancy rate discrepancy between poor women and those with means has increased 77%, from a threefold difference in 1995 to a difference of more than fivefold in 2008 (TABLE 1).^1,4

These data indicate that we are doing well providing contraception to women of means. However, as a society, we need to improve how we deliver contraceptives—especially highly effective methods—to poor women. As one might expect, given these numbers, low-income women have rates of abortion and unplanned birth that are nearly 6 times higher than their higher-income counterparts.¹ The resultant cost to society is substantial, with 68% of unplanned births paid for by public insurance programs such as Medicaid, compared with 38% of planned births.⁵

As women’s health providers, we must work to improve these numbers and advocate for our patients to help them gain access to the contraceptives they need in accordance with their reproductive life plan. In this article, we hope to put this information in context as we:

National and state snapshots reveal shifting proportions of intended, unintended pregnancies
Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001–2008. Am J Public Health. 2014;104(suppl 1):s43–s48.

Kost K. Unintended pregnancy rates at the state level: estimates for 2010 and trends since 2002. Guttmacher Institute. https://www.guttmacher.org/pubs/StateUP10.pdf. Published January 2015. Accessed June 29, 2015.

Recent studies have demonstrated trends in unplanned pregnancy over the past 2 decades on both a national and statewide level. Data from the National Survey of Family Growth have highlighted trends in abortion and miscarriage, and data from the National Center for Health Statistics have shed light on birth trends. Of 6 million births in 2008, 51% were unintended.¹ Unintended pregnancy was defined as a gestation that was mistimed or unwanted. Intended pregnancy was defined as one that was desired at the time it occurred or sooner.

2008 data focus on the national level
Although the overall pregnancy rate for US women aged 15 to 44 years is relatively unchanged, there is a small change in whether or not the pregnancy was intended. For 2008, as the rate of intended pregnancy dropped slightly, from 54 to 51 pregnancies per 1,000 women, the unintended pregnancy rate increased by 10%, from 49 to 54 pregnancies per 1,000 women. Proportionally, unintended pregnancies that resulted in abortion declined from 47% to 40%, whereas the rate of unintended pregnancies ending in birth increased to 27 births per 1,000 women.¹

2010 data focus on individual states
We now have state-specific data on trends in unintended pregnancy rates from 2002 to 2010 in the United States.⁶ In 28 of 50 states, more than half of all pregnancies were unintended, with rates ranging from 36% to 62%. The median rate was 47 unintended pregnancies per 1,000 women aged 15 to 44, with the lowest unintended pregnancy rate in New Hampshire at 32 per 1,000 women and highest rates in Delaware, Hawaii, and New York at 61 to 62 unintended pregnancies per 1,000 women.⁶

Between 2002 and 2010, unintended pregnancy rates fell 5% or more in 18 states and rose 5% or more in 4 states. In the remaining 12 states for which there are data, unintended pregnancy rates remained unchanged.

Interestingly, 16 states had increases in unintended pregnancy rates of 5% or more between 2002 and 2006. The trend reversed between 2006 and 2010, during which 28 of 41 states with available data experienced decreases of 5% or more and only 1 state experienced an increase of 5% or more. These latest numbers suggest we may be making some progress in reducing the overall rate of unintended pregnancy.

What this EVIDENCE means for practice
Although the rate of unintended pregnancy is declining in some states, the national rate is still increasing. This information emphasizes the need for all providers to consider initiating discussions about pregnancy intentions—a step that may be as important as obtaining blood pressure and weight. When women are seen for any health visit, they should be asked about their reproductive plans. The Centers for Disease Control and Prevention (CDC) has issued a helpful set of questions to guide the discussion of timing and planning pregnancy. It also provides useful information on ways to increase utilization of long-acting reversible contraceptives (LARCs) to help realize the goal of fewer unintended pregnancies. (For more on this discussion, see “How to motivate your patient to create a reproductive life plan,” below.)

How Colorado broke down barriers to highly effective contraception—and saved $42.5 million in 1 year
Ricketts S, Klinger G, Schwalberg R. Game change in Colorado: widespread use of long-acting reversible contraceptives and rapid decline of births among young, low-income women. Perspect Sexual Reprod Health. 2014;46(3):125–132.

The Contraceptive CHOICE Project in St. Louis County, Missouri, is an incredible success story. In it, clinicians made highly effective LARCs readily available and free of charge. When a large percentage of women chose a LARC method, the unintended pregnancy and abortion rates declined.⁷ In Colorado, providers put this study into practice, creating a successful statewide initiative to reduce the unintended pregnancy rate.⁸

The data behind LARC methods
LARC methods are backed by endorsements from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the CDC, and the World Health Organization, which recommend them for adolescents because of their superiority to shorter-acting methods. With LARCs, failure rates are lower and compliance is greater, making them ideal for adolescents, who have high unintended pregnancy rates.¹

However, based on 2011 data, only 2% of LARC users nationwide are aged 20 or younger. A number of barriers prevent young women from obtaining LARCs, including lack of education, limited access to and availability of the contraceptives, and, importantly, cost. Many state plans have adopted ­Medicaid expansions to reduce barriers to LARCs. However, this benefit is still not available in many states, Colorado being 1 of them.

How the Colorado initiative worked
In 2005, 40% of Colorado’s births were ­unintended, and 60% of those unintended births occurred in women aged 15 to 24 years. About three-quarters of women who were using a contraceptive method at the time of unintended pregnancy reported that it was a low-cost, high-failure method such as condoms or withdrawal.

In response, Colorado’s Department of Public Health and Environment and the ­Colorado Family Planning Initiative (CFPI) used private funds from an anonymous foundation to provide LARC products at no cost to the Title X–funded clinics in the state.

The initiative began in 2009 in clinics that served 95% of the state’s total population. The funding provided the products ­themselves (intrauterine device [IUD], implant), as well as training for providers and staff.

Before the initiative began, 52,645 clients received services in these clinics annually. In the third year of the initiative, that number had increased to 64,928 annually. About 55% of clients receiving services both preinitiative and postinitiative were younger than 25 years, and most (92% in 2011) had income below the poverty level.

LARC use increased fourfold over the 3 years of the funded program, from less than 4.5% to 19.4% in the third year. Contraceptive implant use increased tenfold, and IUD use increased by almost threefold. At the same time, oral contraceptive use declined 13%. Before the initiative, only 620 young, low-income women used a LARC method; afterward, 8,435 did.

These changes in contraceptive practice triggered a significant decline in pregnancy rates (TABLE 2) and abortion rates (TABLE 3). Abortion rates increased 8% among 20- to 24-year-olds who were not enrolled in the initiative and decreased 18% among those who were. The proportion of high-risk births (births to unmarried, low-income women with less than a high school education) dropped 24% after the initiative began. The proportion of high-risk births in counties not receiving CFPI funds stayed the same at 7%.

Colorado program saved $42.5 million in public funds
This Colorado program demonstrated that the CHOICE Project can be translated to a statewide initiative. Whereas CHOICE enrolled 9,256 women over 4 years, the Colorado initiative included more than 50,000 clients annually over 3 years. Colorado did not use any state funds for this project, which resulted in significant decreases in the unintended birth rate, abortion rate, and rate of high-risk births.

The Colorado governor’s office estimates that the CFPI saved $5.68 in Medicaid costs for Colorado for every dollar spent on contraceptives. In just 1 year (2010), the program saved approximately $42.5 million in public funds.

Ironically, despite the success of this project, the Colorado legislature denied further funding once the initial financial support ceased.
 

What this EVIDENCE means for practice
The Colorado program demonstrates that we all can provide LARC methods in practice, especially to young women. In this population, use of highly effective contraception resulted in fewer unintended pregnancies, births, and abortions statewide.

We also need to advocate for our patients, particularly those who have less means and rely on public assistance. Public funding of LARC methods clearly improves outcomes at an individual and population level.

A new, more affordable IUD enters the market
Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015;92(1):10–16.

Programs such as the Contraceptive CHOICE Project and the Colorado Family Planning Initiative relied on private foundations for financial support, largely because of the high cost of the IUDs and implants currently available in the United States. Even with the Affordable Care Act (ACA) reducing the costs of LARC products and other contraceptives for patients, there are still many women not covered by these programs. For example, “grandfathered” health insurance plans do not need to follow some aspects of the ACA.

Just as important, the high cost of LARC products takes a toll on providers and clinics that must finance the cost per unit to have stock on hand and then wait for months for reimbursement by insurance companies. As a result, some providers do not stock IUDs and implants and only order them as they are needed and approved by insurance for a particular patient. These barriers limit access to LARC methods and reduce the number of women who receive the products.⁸

Liletta is less expensive than other IUDs
Enter Liletta, a new levonorgestrel-releasing, 52-mg intrauterine system (IUS) that has been in clinical trials since 2009.⁹ ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an Intrauterine System) was initiated by Medicines360, a unique nonprofit pharmaceutical company committed to ensuring access to reproductive health products for all women (private and public sector).

ACCESS IUS is the largest IUD approval study ever performed exclusively in the United States. The Phase 3, open-label clinical trial was conducted at 29 sites around the United States, enrolling healthy, nonpregnant, sexually active women aged 16 to 45 years with regular menstrual cycles. Both nulliparous and parous women were included, with no weight or body mass index (BMI) restrictions applied. The study is ongoing and will continue for as long as 7 years. Eisenberg and colleagues published the data used for initial approval for 3 years of use in the United States and Europe.⁹

Details of the trial
A total of 1,600 women aged 16 to 35 years comprised the group in which efficacy was evaluated. An additional 151 women aged 36 to 45 years were evaluated for safety only. Of the enrolled women, 1,011 (58%) were nulliparous, making ACCESS IUS the largest product approval study of nulliparous women. In addition, 438 women (25.1%) were obese, and 5% of these women had a BMI greater than 40 kg/m².

Liletta was placed successfully in 1,714 women (97.9%). Fifteen women did not have placement attempted due to uterine factors (the uterus could not be sounded, or the sound was <5.5 cm) or factors unrelated to the product or inserter. In women in whom placement was attempted, the success rate was 98.7%.

The first-year Pearl index for Liletta was 0.15. Life-table pregnancy rates were 0.14 through year 1 and 0.55 through year 3. Four of the 6 pregnancies reported through 3 years of use were ectopic. Adverse events and their incidence, occurring in more than 2% of users, were acne (6%), expulsion (3.5%), dyspareunia (2.8%), and mastalgia (2.0%). The most common adverse events leading to discontinuation were expulsion (3.5%), bleeding complaints (1.5%), acne (1.3%), and mood swings (1.3%).

Uterine perforation with Liletta was diagnosed in 2 participants (0.11%). Expulsion occurred in 62 users (3.5%) and was more frequent among parous than nulliparous women (5.6% vs 2.0%, respectively; P<.001). Most (80.6%) of the expulsions were reported in the first year of product use. Pelvic infection was reported in 10 participants (0.6%), and all cases resolved with outpatient antibiotic treatment.⁹

Keep in mind that this is an ongoing study—not all women have reached a full 3 years of use. Updates on efficacy and adverse events will be published in the future. This current publication demonstrates the high efficacy and safety of the product through 3 years of use, permitting its approval for contraception in the United States.

In Europe, the product is approved for both contraception and the treatment of heavy menstrual bleeding, based on a European study.¹⁰

What this EVIDENCE means for practice
Liletta is a branded product (not generic) designed to be similar to Mirena, with the same size, frame, hormone content, and hormone release rate.¹¹ Medicines360 has entered a groundbreaking marketing partnership with Actavis to make Liletta widely available and affordable. For most public sector providers and clinics in the United States, Liletta costs only $50, significantly less than other LARC methods available in the United States. Actavis also has a program that ensures that any woman lacking insurance coverage for an IUD and not receiving care at a public sector clinic will not be charged more than $75 for her IUD. However, the price of the device is only one aspect of its overall cost, as women still need to pay for any office visit or insertion fees.

For society, this unique business partnership has to include providers and patients as well. Sales of Liletta in the private sector will support the very low price in the public sector. As a health care community, even if we do not directly care for women in public-sector settings, we can all help poor women access very affordable highly effective contraception.

For providers, Liletta is a lower-cost alternative to currently available hormonal IUDs and should perform well over the long term. The highly successful use of Liletta in nulliparous women demonstrates its safety in this population. The 3-year approval is the first step, as the Phase 3 study continues. In the future, Liletta is expected to be approved for 5 years or longer.

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

Past research into outcomes for induction of labor for women attempting trial of labor after cesarean (TOLAC) has compared labor induction with spontaneous labor. This comparison may be biased against induction, say Lappen and colleagues, who conducted this recent study with the goal of characterizing the likelihood of failed TOLAC with induction and assessing maternal and neonatal outcomes of induction, compared with expectant management, by week of gestation (between 37 and 40 completed weeks).

Details of the study
The researchers analyzed data from the Consortium on Safe Labor,¹ excluding women who had:

Their final, primary cohort included 6,033 women undergoing TOLAC (1,626 underwent induction of labor; 4,407 did not). For this group, induction of labor was defined to include all medically indicated and elective inductions.

They also analyzed a secondary cohort, for which they redefined the induction group to only include those inductions that were nonmedically indicated. This was a “low risk” cohort (n = 500) that excluded women with chronic conditions (hypertension, gestational diabetes, etc) that could result in medically indicated induction.

Induction of labor still associated with failed TOLAC
Comparing induction of labor with expectant management, the frequency of failed TOLAC was higher at each week of gestation, but not at 40 weeks. The adjusted odds ratios were:

Induction was associated with an increased risk of composite maternal morbidity at 39 weeks’ gestation. The authors attributed this to a statistically significant increase in the risk of transfusion. Induction was not associated with increased neonatal morbidity.

The authors point out that, since their data set collection, ACOG recommended against nonmedically indicated inductions before 39 weeks’ gestation, but argue that their results remain generalizable and clinically pertinent because medically indicated early-term inductions remain common.

What this evidence means for practice
The authors identified a significant increase in risk of failed TOLAC with induction of labor. These findings are consistent with prior work describing the favorable relationship between TOLAC success and spontaneous labor and thus should not alter current obstetric practice. The study authors used a large, reliable database for the analysis and controlled for maternal age, body mass index, and history of any prior vaginal birth. However, as the authors point out, the study was limited by a lack of data on obstetric factors that have been identified in prior studies to be pertinent to the likelihood of success of TOLAC, such as Bishop score, indication for prior cesarean delivery, and history of any successful vaginal birth after cesarean. Clinicians should consider each patient’s predictors for successful TOLAC individually and provide appropriate counseling. An induction of labor remains appropriate in well-selected patients attempting TOLAC.
— Janine S. Rhoades, MD, and Alison G. Cahill, MD

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

Past research into outcomes for induction of labor for women attempting trial of labor after cesarean (TOLAC) has compared labor induction with spontaneous labor. This comparison may be biased against induction, say Lappen and colleagues, who conducted this recent study with the goal of characterizing the likelihood of failed TOLAC with induction and assessing maternal and neonatal outcomes of induction, compared with expectant management, by week of gestation (between 37 and 40 completed weeks).

Details of the study
The researchers analyzed data from the Consortium on Safe Labor,¹ excluding women who had:

Their final, primary cohort included 6,033 women undergoing TOLAC (1,626 underwent induction of labor; 4,407 did not). For this group, induction of labor was defined to include all medically indicated and elective inductions.

They also analyzed a secondary cohort, for which they redefined the induction group to only include those inductions that were nonmedically indicated. This was a “low risk” cohort (n = 500) that excluded women with chronic conditions (hypertension, gestational diabetes, etc) that could result in medically indicated induction.

Induction of labor still associated with failed TOLAC
Comparing induction of labor with expectant management, the frequency of failed TOLAC was higher at each week of gestation, but not at 40 weeks. The adjusted odds ratios were:

Induction was associated with an increased risk of composite maternal morbidity at 39 weeks’ gestation. The authors attributed this to a statistically significant increase in the risk of transfusion. Induction was not associated with increased neonatal morbidity.

The authors point out that, since their data set collection, ACOG recommended against nonmedically indicated inductions before 39 weeks’ gestation, but argue that their results remain generalizable and clinically pertinent because medically indicated early-term inductions remain common.

What this evidence means for practice
The authors identified a significant increase in risk of failed TOLAC with induction of labor. These findings are consistent with prior work describing the favorable relationship between TOLAC success and spontaneous labor and thus should not alter current obstetric practice. The study authors used a large, reliable database for the analysis and controlled for maternal age, body mass index, and history of any prior vaginal birth. However, as the authors point out, the study was limited by a lack of data on obstetric factors that have been identified in prior studies to be pertinent to the likelihood of success of TOLAC, such as Bishop score, indication for prior cesarean delivery, and history of any successful vaginal birth after cesarean. Clinicians should consider each patient’s predictors for successful TOLAC individually and provide appropriate counseling. An induction of labor remains appropriate in well-selected patients attempting TOLAC.
— Janine S. Rhoades, MD, and Alison G. Cahill, MD

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

Past research into outcomes for induction of labor for women attempting trial of labor after cesarean (TOLAC) has compared labor induction with spontaneous labor. This comparison may be biased against induction, say Lappen and colleagues, who conducted this recent study with the goal of characterizing the likelihood of failed TOLAC with induction and assessing maternal and neonatal outcomes of induction, compared with expectant management, by week of gestation (between 37 and 40 completed weeks).

Details of the study
The researchers analyzed data from the Consortium on Safe Labor,¹ excluding women who had:

Their final, primary cohort included 6,033 women undergoing TOLAC (1,626 underwent induction of labor; 4,407 did not). For this group, induction of labor was defined to include all medically indicated and elective inductions.

They also analyzed a secondary cohort, for which they redefined the induction group to only include those inductions that were nonmedically indicated. This was a “low risk” cohort (n = 500) that excluded women with chronic conditions (hypertension, gestational diabetes, etc) that could result in medically indicated induction.

Induction of labor still associated with failed TOLAC
Comparing induction of labor with expectant management, the frequency of failed TOLAC was higher at each week of gestation, but not at 40 weeks. The adjusted odds ratios were:

Induction was associated with an increased risk of composite maternal morbidity at 39 weeks’ gestation. The authors attributed this to a statistically significant increase in the risk of transfusion. Induction was not associated with increased neonatal morbidity.

The authors point out that, since their data set collection, ACOG recommended against nonmedically indicated inductions before 39 weeks’ gestation, but argue that their results remain generalizable and clinically pertinent because medically indicated early-term inductions remain common.

What this evidence means for practice
The authors identified a significant increase in risk of failed TOLAC with induction of labor. These findings are consistent with prior work describing the favorable relationship between TOLAC success and spontaneous labor and thus should not alter current obstetric practice. The study authors used a large, reliable database for the analysis and controlled for maternal age, body mass index, and history of any prior vaginal birth. However, as the authors point out, the study was limited by a lack of data on obstetric factors that have been identified in prior studies to be pertinent to the likelihood of success of TOLAC, such as Bishop score, indication for prior cesarean delivery, and history of any successful vaginal birth after cesarean. Clinicians should consider each patient’s predictors for successful TOLAC individually and provide appropriate counseling. An induction of labor remains appropriate in well-selected patients attempting TOLAC.
— Janine S. Rhoades, MD, and Alison G. Cahill, MD

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

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection¹:

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD
Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD
Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,¹ not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.² Bats also have been identified as a reservoir for the Marburg virus.³ However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.⁴

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD
Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.¹ In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.¹ It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD

Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD
Pleasanton, California

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

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection¹:

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD
Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD
Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,¹ not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.² Bats also have been identified as a reservoir for the Marburg virus.³ However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.⁴

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD
Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.¹ In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.¹ It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD

Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD
Pleasanton, California

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

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection¹:

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD
Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD
Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,¹ not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.² Bats also have been identified as a reservoir for the Marburg virus.³ However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.⁴

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD
Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.¹ In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.¹ It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD

Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD
Pleasanton, California

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

The U.S. Preventive Services Task Force has issued a draft grade B recommendation endorsing depression screening in the general adult population, the group announced July 28.

The draft is an update to the 2009 USPSTF recommendation, which suggested screening only when staff-assisted depression care supports are in place.

© Stuart Jenner/Thinkstock

“In recognition that such support is now much more widely available and accepted as part of mental health care, the current recommendation statement has omitted the recommendation regarding selective screening, as it is no longer representative of current clinical practice,” the USPSTF said in a statement.

In addition, the new recommendation supports screening for depression in pregnant and postpartum women, groups that were not reviewed for the 2009 recommendation.

About 7% of the U.S. population met the criteria for a current depressive disorder from 2009 to 2012, according to the National Survey on Drug Use and Health and the National Health and Nutrition Examination Survey, the USPSTF noted.

“Major depressive disorder is a common and significant health care problem,” the statement said. “It is the leading cause of disability among adults in high-income countries and is associated with increased mortality due to suicide and impaired ability to manage other health issues.”

A USPSTF review of clinical trials found that adult patients reported a 46% remission rate with antidepressants and a 48% remission rate with psychotherapy after 10-16 weeks. A separate review concluded that older adults who received antidepressants were twice as likely to achieve remission as older adults who received placebo (odds ratio, 2.03), the task force reported.

In addition, a review of clinical trials that evaluated the effect of screening in pregnant and postpartum women showed 28%-59% reductions in risk of depression at follow-up, compared with usual care. Another trial, which evaluated screening plus provider support, found that 45% of intervention participants reported a 5-point or greater reduction in Patient Health Questionnaire-9 scores, compared with 35% of usual care participants (OR, 1.74), the report said.

Data from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions reported depression prevalence of 9.1% in pregnant women, 10.2% in postpartum women, and 13.1% in women in childbearing age who were not in the postpartum period.

“For pregnant and postpartum women, there is at least moderate certainty that the net benefit of screening for depression is moderate based on the evidence of benefits and harms when [cognitive behavioral therapy] or other evidence-based counseling is available,” the USPSTF reported.

The draft recommendation is open for public comment on the USPSTF website until Aug. 24.

The U.S. Preventive Services Task Force has issued a draft grade B recommendation endorsing depression screening in the general adult population, the group announced July 28.

The draft is an update to the 2009 USPSTF recommendation, which suggested screening only when staff-assisted depression care supports are in place.

© Stuart Jenner/Thinkstock

“In recognition that such support is now much more widely available and accepted as part of mental health care, the current recommendation statement has omitted the recommendation regarding selective screening, as it is no longer representative of current clinical practice,” the USPSTF said in a statement.

In addition, the new recommendation supports screening for depression in pregnant and postpartum women, groups that were not reviewed for the 2009 recommendation.

About 7% of the U.S. population met the criteria for a current depressive disorder from 2009 to 2012, according to the National Survey on Drug Use and Health and the National Health and Nutrition Examination Survey, the USPSTF noted.

“Major depressive disorder is a common and significant health care problem,” the statement said. “It is the leading cause of disability among adults in high-income countries and is associated with increased mortality due to suicide and impaired ability to manage other health issues.”

A USPSTF review of clinical trials found that adult patients reported a 46% remission rate with antidepressants and a 48% remission rate with psychotherapy after 10-16 weeks. A separate review concluded that older adults who received antidepressants were twice as likely to achieve remission as older adults who received placebo (odds ratio, 2.03), the task force reported.

In addition, a review of clinical trials that evaluated the effect of screening in pregnant and postpartum women showed 28%-59% reductions in risk of depression at follow-up, compared with usual care. Another trial, which evaluated screening plus provider support, found that 45% of intervention participants reported a 5-point or greater reduction in Patient Health Questionnaire-9 scores, compared with 35% of usual care participants (OR, 1.74), the report said.

Data from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions reported depression prevalence of 9.1% in pregnant women, 10.2% in postpartum women, and 13.1% in women in childbearing age who were not in the postpartum period.

“For pregnant and postpartum women, there is at least moderate certainty that the net benefit of screening for depression is moderate based on the evidence of benefits and harms when [cognitive behavioral therapy] or other evidence-based counseling is available,” the USPSTF reported.

The draft recommendation is open for public comment on the USPSTF website until Aug. 24.

The U.S. Preventive Services Task Force has issued a draft grade B recommendation endorsing depression screening in the general adult population, the group announced July 28.

The draft is an update to the 2009 USPSTF recommendation, which suggested screening only when staff-assisted depression care supports are in place.

© Stuart Jenner/Thinkstock

“In recognition that such support is now much more widely available and accepted as part of mental health care, the current recommendation statement has omitted the recommendation regarding selective screening, as it is no longer representative of current clinical practice,” the USPSTF said in a statement.

In addition, the new recommendation supports screening for depression in pregnant and postpartum women, groups that were not reviewed for the 2009 recommendation.

About 7% of the U.S. population met the criteria for a current depressive disorder from 2009 to 2012, according to the National Survey on Drug Use and Health and the National Health and Nutrition Examination Survey, the USPSTF noted.

“Major depressive disorder is a common and significant health care problem,” the statement said. “It is the leading cause of disability among adults in high-income countries and is associated with increased mortality due to suicide and impaired ability to manage other health issues.”

A USPSTF review of clinical trials found that adult patients reported a 46% remission rate with antidepressants and a 48% remission rate with psychotherapy after 10-16 weeks. A separate review concluded that older adults who received antidepressants were twice as likely to achieve remission as older adults who received placebo (odds ratio, 2.03), the task force reported.

In addition, a review of clinical trials that evaluated the effect of screening in pregnant and postpartum women showed 28%-59% reductions in risk of depression at follow-up, compared with usual care. Another trial, which evaluated screening plus provider support, found that 45% of intervention participants reported a 5-point or greater reduction in Patient Health Questionnaire-9 scores, compared with 35% of usual care participants (OR, 1.74), the report said.

Data from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions reported depression prevalence of 9.1% in pregnant women, 10.2% in postpartum women, and 13.1% in women in childbearing age who were not in the postpartum period.

“For pregnant and postpartum women, there is at least moderate certainty that the net benefit of screening for depression is moderate based on the evidence of benefits and harms when [cognitive behavioral therapy] or other evidence-based counseling is available,” the USPSTF reported.

The draft recommendation is open for public comment on the USPSTF website until Aug. 24.

Joint Commission-accredited health care organizations looking to up their perinatal care credentials now can, thanks to a new Perinatal Care Certification program.

The program was developed by the Joint Commission in response to data from the World Health Organization that shows at least 1,200 American women die during pregnancy or in childbirth annually. An additional 60,000 women in the U.S. suffer near-fatal perinatal complications.

© Cameron Whitman/Thinkstock

“The certification will give providers an unparalleled advantage when it comes to preparing mothers for labor and delivery, while helping mothers and newborns if complications arise,” Wendi Roberts, executive director of The Joint Commission’s Certification Program, said in a statement.

The certification program, which covers prenatal care through postpartum care, requires early identification of high-risk pregnancies and births, transfers for women and babies who require a higher level of care, and ongoing quality improvement processes.

The program is aimed at reducing maternal and infant mortality and complications, unnecessary induction of labor, elective deliveries, and prematurity rates.

Along with improving patient outcomes, the program could also drive down the cost of maternity care, which the Joint Commission said reached $60 billion in 2012 the United States alone. Hospitals may be able to reduce costs associated with longer length of stay due to complications, according to the Joint Commission.

[email protected]

On Twitter @whitneymcknight

Joint Commission-accredited health care organizations looking to up their perinatal care credentials now can, thanks to a new Perinatal Care Certification program.

The program was developed by the Joint Commission in response to data from the World Health Organization that shows at least 1,200 American women die during pregnancy or in childbirth annually. An additional 60,000 women in the U.S. suffer near-fatal perinatal complications.

© Cameron Whitman/Thinkstock

“The certification will give providers an unparalleled advantage when it comes to preparing mothers for labor and delivery, while helping mothers and newborns if complications arise,” Wendi Roberts, executive director of The Joint Commission’s Certification Program, said in a statement.

The certification program, which covers prenatal care through postpartum care, requires early identification of high-risk pregnancies and births, transfers for women and babies who require a higher level of care, and ongoing quality improvement processes.

The program is aimed at reducing maternal and infant mortality and complications, unnecessary induction of labor, elective deliveries, and prematurity rates.

Along with improving patient outcomes, the program could also drive down the cost of maternity care, which the Joint Commission said reached $60 billion in 2012 the United States alone. Hospitals may be able to reduce costs associated with longer length of stay due to complications, according to the Joint Commission.

[email protected]

On Twitter @whitneymcknight

Joint Commission-accredited health care organizations looking to up their perinatal care credentials now can, thanks to a new Perinatal Care Certification program.

The program was developed by the Joint Commission in response to data from the World Health Organization that shows at least 1,200 American women die during pregnancy or in childbirth annually. An additional 60,000 women in the U.S. suffer near-fatal perinatal complications.

© Cameron Whitman/Thinkstock

“The certification will give providers an unparalleled advantage when it comes to preparing mothers for labor and delivery, while helping mothers and newborns if complications arise,” Wendi Roberts, executive director of The Joint Commission’s Certification Program, said in a statement.

The certification program, which covers prenatal care through postpartum care, requires early identification of high-risk pregnancies and births, transfers for women and babies who require a higher level of care, and ongoing quality improvement processes.

The program is aimed at reducing maternal and infant mortality and complications, unnecessary induction of labor, elective deliveries, and prematurity rates.

Along with improving patient outcomes, the program could also drive down the cost of maternity care, which the Joint Commission said reached $60 billion in 2012 the United States alone. Hospitals may be able to reduce costs associated with longer length of stay due to complications, according to the Joint Commission.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – The high trisomy 21 detection rate is among the selling points of noninvasive prenatal testing using cell-free DNA screening, though the test detects only a small number of abnormalities, Dr. Mary Norton said at the International Conference on Prenatal Diagnosis and Therapy.

During a symposium on introducing cfDNA screening into routine prenatal care, Dr. Norton, professor of obstetrics and gynecology at the University of California, San Francisco, said physicians are debating not only whether the cfDNA test should be used to screen low- versus high-risk women, but also whether cfDNA screening is appropriate as a primary screen for all pregnant women.

The use of noninvasive prenatal testing (NIPT) is growing in popularity, but its usefulness is narrow, focusing on three chromosomal abnormalities (trisomy 13, 21, and 18), while traditional diagnostic tests provide a broad screen for a wide array of abnormalities, she said.

Dr. Richard Feldmann/National Cancer Institute

One of the pros of using cfDNA as a primary screen is that “there’s no question” the detection rate for Down syndrome is better than with other methods, she said.

Other benefits include a lower false positive rate and a reduction in diagnostic tests.

In a prospective, international study published earlier this year that compared cfDNA testing to standard screening for trisomy 21, cfDNA testing identified trisomy 21 in all 38 women with the abnormality, compared to 30 of 38 with standard screening.

In the cfDNA group, the false positive rate was significantly lower (0.06% vs. 5.4%), and the positive predictive value was significantly higher (almost 81% vs. 3.4%) when compared with standard screening, according to Dr. Norton, who was the lead author of the study (N. Engl. J. Med. 2015;372:1589-97).

Another issue is positive predictive value, which is driven by prevalence of the abnormality screened, with lower prevalence corresponding to a lower PPV, she said. In a study of about 1,900 low-risk women whose mean maternal age was 30 years, cfDNA testing detected all cases of trisomy 21. The PPV for trisomy 21 was 45.5% compared with 4.2% with standard screening (N. Engl. J. Med. 2014;370:799-808).

But there are downsides to using the NIPT. For instance, cfDNA testing does not detect many other chromosome abnormalities.

In a study of more than 1.3 million women who had traditional prenatal screening between 2009 and 2012, about 17% of chromosome abnormalities identified were not detectable by current NIPT methods (Obset. Gynecol. 2014;124:979-86).

Other issues include test failure, which can occur because of a low fetal fraction (the amount of cfDNA in the maternal blood of fetal origin), as well as providers who offer cfDNA testing without a full understanding about the implications of positive results, Dr. Norton said.

In many communities, general ob.gyns. are confused about the meaning of the results, she said.

She pointed to a December 2014 investigative report on NIPT in the Boston Globe that said some women have terminated their pregnancies based on NIPT screening results without having a confirmatory diagnostic test.

And when using cfDNA screening, about 3% of samples do not provide a result, which can be associated with aneuploidy and cannot be ignored, Dr. Norton said.

The cfDNA testing is also expensive, Dr. Norton said. For patients who are young with a low risk for Down syndrome but higher risk for other abnormalities, it could be argued that a screening test should be “cheap and broad,” she said.

In the United States, there are many different ways serum and ultrasound screening is currently practiced, and cfDNA screening is being “integrated in very different ways in different settings,” she noted.

A recent American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine statement on cfDNA screening states that considering the performance of conventional screening methods, “the limitations of cell-free DNA screening performance, and the limited data on cost-effectiveness in the low-risk obstetric population, conventional screening methods remain the most appropriate choice for first line screening for most women in the general obstetric population.”

The statement also notes that while any patient, regardless of her risk, can choose cfDNA testing, she should understand the “limitations and benefits of this screening paradigm” in the context of alternative screening and diagnostic options.

The ACOG/SMFM opinion adds that the cfDNA technology for prenatal aneuploidy screening is rapidly changing, and that “any recommendations regarding its use in screening also will likely evolve quickly.”

Dr. Norton disclosed having received research support from Natera and Ariosa.

[email protected]

WASHINGTON – The high trisomy 21 detection rate is among the selling points of noninvasive prenatal testing using cell-free DNA screening, though the test detects only a small number of abnormalities, Dr. Mary Norton said at the International Conference on Prenatal Diagnosis and Therapy.

During a symposium on introducing cfDNA screening into routine prenatal care, Dr. Norton, professor of obstetrics and gynecology at the University of California, San Francisco, said physicians are debating not only whether the cfDNA test should be used to screen low- versus high-risk women, but also whether cfDNA screening is appropriate as a primary screen for all pregnant women.

The use of noninvasive prenatal testing (NIPT) is growing in popularity, but its usefulness is narrow, focusing on three chromosomal abnormalities (trisomy 13, 21, and 18), while traditional diagnostic tests provide a broad screen for a wide array of abnormalities, she said.

Dr. Richard Feldmann/National Cancer Institute

One of the pros of using cfDNA as a primary screen is that “there’s no question” the detection rate for Down syndrome is better than with other methods, she said.

Other benefits include a lower false positive rate and a reduction in diagnostic tests.

In a prospective, international study published earlier this year that compared cfDNA testing to standard screening for trisomy 21, cfDNA testing identified trisomy 21 in all 38 women with the abnormality, compared to 30 of 38 with standard screening.

In the cfDNA group, the false positive rate was significantly lower (0.06% vs. 5.4%), and the positive predictive value was significantly higher (almost 81% vs. 3.4%) when compared with standard screening, according to Dr. Norton, who was the lead author of the study (N. Engl. J. Med. 2015;372:1589-97).

Another issue is positive predictive value, which is driven by prevalence of the abnormality screened, with lower prevalence corresponding to a lower PPV, she said. In a study of about 1,900 low-risk women whose mean maternal age was 30 years, cfDNA testing detected all cases of trisomy 21. The PPV for trisomy 21 was 45.5% compared with 4.2% with standard screening (N. Engl. J. Med. 2014;370:799-808).

But there are downsides to using the NIPT. For instance, cfDNA testing does not detect many other chromosome abnormalities.

In a study of more than 1.3 million women who had traditional prenatal screening between 2009 and 2012, about 17% of chromosome abnormalities identified were not detectable by current NIPT methods (Obset. Gynecol. 2014;124:979-86).

Other issues include test failure, which can occur because of a low fetal fraction (the amount of cfDNA in the maternal blood of fetal origin), as well as providers who offer cfDNA testing without a full understanding about the implications of positive results, Dr. Norton said.

In many communities, general ob.gyns. are confused about the meaning of the results, she said.

She pointed to a December 2014 investigative report on NIPT in the Boston Globe that said some women have terminated their pregnancies based on NIPT screening results without having a confirmatory diagnostic test.

And when using cfDNA screening, about 3% of samples do not provide a result, which can be associated with aneuploidy and cannot be ignored, Dr. Norton said.

The cfDNA testing is also expensive, Dr. Norton said. For patients who are young with a low risk for Down syndrome but higher risk for other abnormalities, it could be argued that a screening test should be “cheap and broad,” she said.

In the United States, there are many different ways serum and ultrasound screening is currently practiced, and cfDNA screening is being “integrated in very different ways in different settings,” she noted.

A recent American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine statement on cfDNA screening states that considering the performance of conventional screening methods, “the limitations of cell-free DNA screening performance, and the limited data on cost-effectiveness in the low-risk obstetric population, conventional screening methods remain the most appropriate choice for first line screening for most women in the general obstetric population.”

The statement also notes that while any patient, regardless of her risk, can choose cfDNA testing, she should understand the “limitations and benefits of this screening paradigm” in the context of alternative screening and diagnostic options.

The ACOG/SMFM opinion adds that the cfDNA technology for prenatal aneuploidy screening is rapidly changing, and that “any recommendations regarding its use in screening also will likely evolve quickly.”

Dr. Norton disclosed having received research support from Natera and Ariosa.

[email protected]

WASHINGTON – The high trisomy 21 detection rate is among the selling points of noninvasive prenatal testing using cell-free DNA screening, though the test detects only a small number of abnormalities, Dr. Mary Norton said at the International Conference on Prenatal Diagnosis and Therapy.

During a symposium on introducing cfDNA screening into routine prenatal care, Dr. Norton, professor of obstetrics and gynecology at the University of California, San Francisco, said physicians are debating not only whether the cfDNA test should be used to screen low- versus high-risk women, but also whether cfDNA screening is appropriate as a primary screen for all pregnant women.

The use of noninvasive prenatal testing (NIPT) is growing in popularity, but its usefulness is narrow, focusing on three chromosomal abnormalities (trisomy 13, 21, and 18), while traditional diagnostic tests provide a broad screen for a wide array of abnormalities, she said.

Dr. Richard Feldmann/National Cancer Institute

One of the pros of using cfDNA as a primary screen is that “there’s no question” the detection rate for Down syndrome is better than with other methods, she said.

Other benefits include a lower false positive rate and a reduction in diagnostic tests.

In a prospective, international study published earlier this year that compared cfDNA testing to standard screening for trisomy 21, cfDNA testing identified trisomy 21 in all 38 women with the abnormality, compared to 30 of 38 with standard screening.

In the cfDNA group, the false positive rate was significantly lower (0.06% vs. 5.4%), and the positive predictive value was significantly higher (almost 81% vs. 3.4%) when compared with standard screening, according to Dr. Norton, who was the lead author of the study (N. Engl. J. Med. 2015;372:1589-97).

Another issue is positive predictive value, which is driven by prevalence of the abnormality screened, with lower prevalence corresponding to a lower PPV, she said. In a study of about 1,900 low-risk women whose mean maternal age was 30 years, cfDNA testing detected all cases of trisomy 21. The PPV for trisomy 21 was 45.5% compared with 4.2% with standard screening (N. Engl. J. Med. 2014;370:799-808).

But there are downsides to using the NIPT. For instance, cfDNA testing does not detect many other chromosome abnormalities.

In a study of more than 1.3 million women who had traditional prenatal screening between 2009 and 2012, about 17% of chromosome abnormalities identified were not detectable by current NIPT methods (Obset. Gynecol. 2014;124:979-86).

Other issues include test failure, which can occur because of a low fetal fraction (the amount of cfDNA in the maternal blood of fetal origin), as well as providers who offer cfDNA testing without a full understanding about the implications of positive results, Dr. Norton said.

In many communities, general ob.gyns. are confused about the meaning of the results, she said.

She pointed to a December 2014 investigative report on NIPT in the Boston Globe that said some women have terminated their pregnancies based on NIPT screening results without having a confirmatory diagnostic test.

And when using cfDNA screening, about 3% of samples do not provide a result, which can be associated with aneuploidy and cannot be ignored, Dr. Norton said.

The cfDNA testing is also expensive, Dr. Norton said. For patients who are young with a low risk for Down syndrome but higher risk for other abnormalities, it could be argued that a screening test should be “cheap and broad,” she said.

In the United States, there are many different ways serum and ultrasound screening is currently practiced, and cfDNA screening is being “integrated in very different ways in different settings,” she noted.

A recent American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine statement on cfDNA screening states that considering the performance of conventional screening methods, “the limitations of cell-free DNA screening performance, and the limited data on cost-effectiveness in the low-risk obstetric population, conventional screening methods remain the most appropriate choice for first line screening for most women in the general obstetric population.”

The statement also notes that while any patient, regardless of her risk, can choose cfDNA testing, she should understand the “limitations and benefits of this screening paradigm” in the context of alternative screening and diagnostic options.

The ACOG/SMFM opinion adds that the cfDNA technology for prenatal aneuploidy screening is rapidly changing, and that “any recommendations regarding its use in screening also will likely evolve quickly.”

Dr. Norton disclosed having received research support from Natera and Ariosa.

[email protected]

For the 7th straight year, the rate of preterm births in the United States has decreased, with 11.4% of babies being born preterm in 2013, compared with 11.5% in 2012, according to a new federal report.

The report, America’s Children: Key National Indicators of Well-Being, 2015, was compiled by the Federal Interagency Forum on Child and Family Statistics, and includes participants from 23 federal agencies. The report attempts to quantify children’s well-being based on key indicators in seven domains: family and social environment, economic circumstances, health care, physical environment and safety, behavior, education, and health.

The percentage of preterm births – babies born before 37 weeks’ gestation – along with low-birth-weight infants had been rising for several decades, but the latest report shows progress in both areas. The preterm birth rate fell from a high of 12.8% in 2006 to 11.4% in 2013; the percentage of infants born with low birth weight (less than 5 pounds 8 ounces) was 8.0% in 2013, compared with 8.3% in 2006.

In addition, in 2013, the teen birth rate hit 12/1,000 adolescents aged 15-17 years, a record low, according to the report. In 2007, the teen birth rate was more than 40% higher at 22 births/1,000 adolescents.

But major depressive disorder among adolescents is on the rise, with 11% of youth aged 12-17 years experiencing a major depressive episode in 2013, compared with 9% in 2004. And only 38% of young adults in 2013 received treatment for such an episode, compared to 40% in 2004.

[email protected]

For the 7th straight year, the rate of preterm births in the United States has decreased, with 11.4% of babies being born preterm in 2013, compared with 11.5% in 2012, according to a new federal report.

The report, America’s Children: Key National Indicators of Well-Being, 2015, was compiled by the Federal Interagency Forum on Child and Family Statistics, and includes participants from 23 federal agencies. The report attempts to quantify children’s well-being based on key indicators in seven domains: family and social environment, economic circumstances, health care, physical environment and safety, behavior, education, and health.

The percentage of preterm births – babies born before 37 weeks’ gestation – along with low-birth-weight infants had been rising for several decades, but the latest report shows progress in both areas. The preterm birth rate fell from a high of 12.8% in 2006 to 11.4% in 2013; the percentage of infants born with low birth weight (less than 5 pounds 8 ounces) was 8.0% in 2013, compared with 8.3% in 2006.

In addition, in 2013, the teen birth rate hit 12/1,000 adolescents aged 15-17 years, a record low, according to the report. In 2007, the teen birth rate was more than 40% higher at 22 births/1,000 adolescents.

But major depressive disorder among adolescents is on the rise, with 11% of youth aged 12-17 years experiencing a major depressive episode in 2013, compared with 9% in 2004. And only 38% of young adults in 2013 received treatment for such an episode, compared to 40% in 2004.

[email protected]

For the 7th straight year, the rate of preterm births in the United States has decreased, with 11.4% of babies being born preterm in 2013, compared with 11.5% in 2012, according to a new federal report.

The report, America’s Children: Key National Indicators of Well-Being, 2015, was compiled by the Federal Interagency Forum on Child and Family Statistics, and includes participants from 23 federal agencies. The report attempts to quantify children’s well-being based on key indicators in seven domains: family and social environment, economic circumstances, health care, physical environment and safety, behavior, education, and health.

The percentage of preterm births – babies born before 37 weeks’ gestation – along with low-birth-weight infants had been rising for several decades, but the latest report shows progress in both areas. The preterm birth rate fell from a high of 12.8% in 2006 to 11.4% in 2013; the percentage of infants born with low birth weight (less than 5 pounds 8 ounces) was 8.0% in 2013, compared with 8.3% in 2006.

In addition, in 2013, the teen birth rate hit 12/1,000 adolescents aged 15-17 years, a record low, according to the report. In 2007, the teen birth rate was more than 40% higher at 22 births/1,000 adolescents.

But major depressive disorder among adolescents is on the rise, with 11% of youth aged 12-17 years experiencing a major depressive episode in 2013, compared with 9% in 2004. And only 38% of young adults in 2013 received treatment for such an episode, compared to 40% in 2004.

[email protected]