Obstetrics

Prenatal care has long included carrier screening for genetic diseases, such as cystic fibrosis and Tay-Sachs disease. Recently, advances in genetics technologies led to the development of multiplex panels that can be used to test for hundreds of genetic disorders simultaneously, and can be used to assess carrier status for expectant couples or those planning a pregnancy. Although such screening covers many more conditions than those recommended in traditional guidelines, the benefit of expanded carrier screening (ECS) over standard gene-by-gene testing is not clear.

In this Update, I review recent ECS research that can be helpful to those who practice reproductive endocrinology and infertility medicine, maternal–fetal medicine, and general ObGyn. This research considered some of the many complexities of ECS:

• number and type of severe autosomal recessive conditions identified by an ECS panel, or by panethnic screening for 3 common conditions (cystic fibrosis, fragile X syndrome, spinal muscular atrophy)
• whether the disorders covered by ECS panels meet recommended criteria regarding severity, prevalence, and test accuracy
• women’s thoughts and perspectives on ECS
• whether the marketing materials disseminated by commercial providers of ECS are accurate and balanced.

Genetic diseases identified by expanded carrier screening

Haque IS, Lazarin GA, Kang HP, Evans EA, Goldberg JD, Wapner RJ. Modeled fetal risk of genetic diseases identified by expanded carrier screening. JAMA. 2016;316(7):734-742.

Screening during pregnancy to determine if one or both parents are carriers of genetic disorders historically has involved testing for a limited number of conditions, such as cystic fibrosis, hemoglobinopathies, and Tay-Sachs disease. Patients usually are offered testing for 1 or 2 disorders, with test choices primarily based on patient race and ethnicity. Unfortunately, ancestry-based screening may result in inequitable distribution of genetic testing and resources, as it has significant limitations in our increasingly multicultural society, which includes many people of uncertain or mixed race and ethnicity.

Advantages of expanded carrier screening

Several commercial laboratories now offer ECS. Haque and colleagues used data from one of these laboratories and modeled the predicted number of potentially affected fetuses that would be identified with traditional, ethnicity-based screening as compared with ECS. In one of their hypothetical cohorts, of Northern European couples, traditional screening would identify 55 affected fetuses per 100,000 (1 in 1,800), and ECS would identify 159 per 100,000 (almost 3 times more). The numbers identified with ECS varied with race or ethnicity and ranged from 94 per 100,000 (about 1 in 1,000) for Hispanic couples to 392 per 100,000 (about 1 in 250) for Ashkenazi Jewish couples.

In Australia, Archibald and colleagues conducted a similar study, of panethnic screening of 12,000 women for cystic fibrosis, fragile X syndrome, and spinal muscular atrophy.¹ The number of affected fetuses identified was about 1 per 1,000 screened couples--not much different from the ECS number, though comparison is difficult given the likely very different racial and ethnic backgrounds of the 2 cohorts.

Although these data suggest ECS increases detection of genetic disorders, and it seems almost self-evident that more screening is better, there are concerns about ECS.² Traditional carrier screening methods focus on conditions that significantly affect quality of life--owing to cognitive or physical disabilities or required lifelong medical therapies--and that have a fetal, neonatal, or early-childhood onset and well-defined phenotype. In ECS panels, additional conditions may vary significantly in severity or age of onset. Although some genetic variants on ECS panels have a consistent phenotype, the natural history of others is less well understood. Panels often include conditions for which carrier screening of the general population is not recommended by current guidelines--for example, hemochromatosis and factor V Leiden. Moreover, almost by definition, ECS panels include rare conditions for which the natural history may not be well understood, and the carrier frequency as well as the proportion of condition-causing variants that can be detected may be unclear, leaving the residual risk unknown.

Read about the ideal expanded carrier screening panel.

The ideal expanded carrier screening panel

Stevens B, Krstic N, Jones M, Murphy L, Hoskovec J. Finding middle ground in constructing a clinically useful expanded carrier screening panel. Obstet Gynecol. 2017;130(2):279-284.

Both the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics and Genomics (ACMG) have proposed criteria for including specific disorders on ECS panels.^3,4 These criteria consider disorder characteristics, such as carrier prevalence, which should be at least 1 in 100; severity; early-childhood onset; and complete penetrance. In addition, they consider test characteristics, such as sensitivity, which should be at least 70%.

Details of the study

Stevens and colleagues evaluated the ECS panels offered by 6 commercial laboratories in the United States. They found that only 27% of included conditions met the recommended criteria, and concluded that these panels are putting patients at risk for undue anxiety, and that time and money are being spent on follow-up testing for rare and mild conditions for which the benefits of testing are unclear or unlikely. The potential benefits of the extra screening should be weighed against the significant resulting harms.

Across the 6 ECS panels, 96 conditions met the criteria. As some laboratories allow providers to customize their panels, members of my practice, after reviewing this thought-provoking article, agreed we should create a custom panel that includes only these 96 conditions. Unfortunately, no commercial laboratory includes all 96 conditions, so it is not feasible to create an "ideal" panel at this time.

Arguments favoring ECS include its low cost and the efficiency of screening with multigene panels. In a 2013 study, however, 24% of patients were identified as carriers, and in most cases this finding led to screening for the reproductive partner as well.⁵ If the rate of detection of the disorder is low, the utility of screening with the same panel may be limited, and couples may require more extensive testing, such as gene sequencing, which is far more expensive. These findings and the additional testing also will increase the need for genetic counseling, and may lead to invasive prenatal diagnostic testing with further increases in costs. If counseling and prenatal testing yield improved outcomes--increased detection of important findings--the benefit will justify the higher costs. However, if the increased costs are largely generated chasing down and explaining findings that are not important to patients or providers, the costs may be incurred without benefit.

Read about the pregnant women’s perspectives on ECS.

Pregnant women's perspectives on expanded carrier screening

Propst L, Connor G, Hinton M, Poorvu T, Dungan J. Pregnant women's perspectives on expanded carrier screening [published online February 23, 2018]. J Genet Couns. doi:10.1007/s10897-018-0232-x.

Although several authors have discussed ECS detection rates, less has been reported on how women perceive ECS or how they elect or decline screening. Studies have found that the decision to undergo screening for cystic fibrosis is influenced by factors that include age, sex, ethnicity, socioeconomic status, lack of family history, cost, fear of a blood test, lack of knowledge about the condition, already having children, wanting to avoid having a disabled child, abortion preferences, and feeling pressured by health care providers.^6,7 Propst and colleagues asked women for their perspectives on ECS, on electing or declining screening, and on any anxiety associated with their decision.

Details of the study

Women who declined ECS said they did so because they:

• had no family history
• knew there was a very small chance their partner carried the same condition  
• would not change the course of their pregnancy on the basis of the test results.

Women who elected ECS said they did so because they wanted to:

• know their risk of having a child with a genetic condition
• have all available information about their genetic risks
• be able to make decisions about continuing or terminating their pregnancy.

Women also were asked what they would do if they discovered their fetus had a genetic disorder. About 42% said they were unsure what they would do, 34% said they would continue their pregnancy and prepare for the birth of an affected child, and 24% said they likely would terminate their pregnancy.

The most common reason women gave for declining ECS was that they had no family history. However, ECS is not a good option for women with a positive family history, as they need genetic counseling and specific consideration of their own risks and what testing should be done. The majority of couples who have a child with a genetic disease have no other family history of the disorder. In a study of reproductive carrier screening in Australia, 88% of carriers had no family history.¹ Careful pretest counseling is needed to explain the distinction between, on one hand, genetic counseling and testing for those with a family history of genetic disease and, on the other hand, population screening performed to identify unsuspecting individuals who are healthy carriers of genetic disorders.

Another crucial point about carrier screening is the need to consider how its results will be used, and what options the carrier couple will have. For women who are pregnant when a risk is identified, options include expectant management, with diagnosis after birth, or prenatal diagnosis with termination of an affected fetus, out-adoption of an affected fetus, or expectant management with preparation for caring for an affected child. For women who are not pregnant when they have ECS, additional options include use of a gamete (ovum or sperm) donor to achieve pregnancy, or preimplantation genetic diagnosis with implantation of only unaffected embryos.

Read about the marketing of ECS.

Marketing of expanded carrier screening

Chokoshvili D, Borry P, Vears DF. A systematic analysis of online marketing materials used by providers of expanded carrier screening [published online December 14, 2017]. Genet Med. doi:10.1038/gim.2017.222.

Prenatal carrier screening can be helpful to women and their families, but it is also a high-volume, lucrative business, with many commercial laboratories competing for the growing ECS market. Professional medical societies recommend making all screening candidates aware of the purpose, characteristics, and limitations of the tests, and of the potential significance of their results. As becoming familiar and comfortable with the tests and explaining them to each patient can be time-consuming, and daunting, many busy clinicians have started relying on marketing materials and other information from the commercial laboratories. Therefore analysis of the accuracy of such materials is in order.

Details of the study

Chokoshvili and colleagues performed a systematic analysis of the quality and accuracy of online marketing materials for ECS. They identified 18 providers: 16 commercial laboratories and 2 medical services providers. All described ECS as a useful tool for family planning, and some were very directive in stating that this testing is "one of the most important steps in preparing for parenthood." In their materials, most of the companies cover some limitations, such as residual risk, but none of the commercial laboratories indicate that ECS can overestimate risk (many variants have incomplete penetrance, meaning that some individuals with a positive test result may in fact be asymptomatic throughout their lifetime).

In addition, whereas a large amount of the marketing materials implies the test was developed in line with professional recommendations, none in fact complies with ACOG and ACMG guidance. Finally, though some of the online information provided by laboratories can be helpful, it is important for clinicians to remember that reproductive genetic counseling should be nondirective and balanced. Carrier testing should be based on patient (not provider) values regarding reproductive autonomy.

Summary

ECS increasingly is being adopted into clinical practice. According to ACOG, traditional ethnicity-based screening, panethnic screening (the same limited panel of tests for all patients), and ECS are all acceptable alternatives for prenatal carrier screening.³ For providers who offer ECS, it is important to have a good understanding of each selected test and its limitations. Providers should have a plan for following up patients who have positive test results; this plan may include having genetic counseling and prenatal genetic diagnostic testing in place. Although treatment is available for a few genetic conditions, for the large majority, prenatal screening has not been proved to lead to improved therapeutic options. Providers should try to make sure that patients do not have unrealistic expectations of the outcomes of carrier screening.

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.

Prenatal care has long included carrier screening for genetic diseases, such as cystic fibrosis and Tay-Sachs disease. Recently, advances in genetics technologies led to the development of multiplex panels that can be used to test for hundreds of genetic disorders simultaneously, and can be used to assess carrier status for expectant couples or those planning a pregnancy. Although such screening covers many more conditions than those recommended in traditional guidelines, the benefit of expanded carrier screening (ECS) over standard gene-by-gene testing is not clear.

In this Update, I review recent ECS research that can be helpful to those who practice reproductive endocrinology and infertility medicine, maternal–fetal medicine, and general ObGyn. This research considered some of the many complexities of ECS:

• number and type of severe autosomal recessive conditions identified by an ECS panel, or by panethnic screening for 3 common conditions (cystic fibrosis, fragile X syndrome, spinal muscular atrophy)
• whether the disorders covered by ECS panels meet recommended criteria regarding severity, prevalence, and test accuracy
• women’s thoughts and perspectives on ECS
• whether the marketing materials disseminated by commercial providers of ECS are accurate and balanced.

Genetic diseases identified by expanded carrier screening

Haque IS, Lazarin GA, Kang HP, Evans EA, Goldberg JD, Wapner RJ. Modeled fetal risk of genetic diseases identified by expanded carrier screening. JAMA. 2016;316(7):734-742.

Screening during pregnancy to determine if one or both parents are carriers of genetic disorders historically has involved testing for a limited number of conditions, such as cystic fibrosis, hemoglobinopathies, and Tay-Sachs disease. Patients usually are offered testing for 1 or 2 disorders, with test choices primarily based on patient race and ethnicity. Unfortunately, ancestry-based screening may result in inequitable distribution of genetic testing and resources, as it has significant limitations in our increasingly multicultural society, which includes many people of uncertain or mixed race and ethnicity.

Advantages of expanded carrier screening

Several commercial laboratories now offer ECS. Haque and colleagues used data from one of these laboratories and modeled the predicted number of potentially affected fetuses that would be identified with traditional, ethnicity-based screening as compared with ECS. In one of their hypothetical cohorts, of Northern European couples, traditional screening would identify 55 affected fetuses per 100,000 (1 in 1,800), and ECS would identify 159 per 100,000 (almost 3 times more). The numbers identified with ECS varied with race or ethnicity and ranged from 94 per 100,000 (about 1 in 1,000) for Hispanic couples to 392 per 100,000 (about 1 in 250) for Ashkenazi Jewish couples.

In Australia, Archibald and colleagues conducted a similar study, of panethnic screening of 12,000 women for cystic fibrosis, fragile X syndrome, and spinal muscular atrophy.¹ The number of affected fetuses identified was about 1 per 1,000 screened couples--not much different from the ECS number, though comparison is difficult given the likely very different racial and ethnic backgrounds of the 2 cohorts.

Although these data suggest ECS increases detection of genetic disorders, and it seems almost self-evident that more screening is better, there are concerns about ECS.² Traditional carrier screening methods focus on conditions that significantly affect quality of life--owing to cognitive or physical disabilities or required lifelong medical therapies--and that have a fetal, neonatal, or early-childhood onset and well-defined phenotype. In ECS panels, additional conditions may vary significantly in severity or age of onset. Although some genetic variants on ECS panels have a consistent phenotype, the natural history of others is less well understood. Panels often include conditions for which carrier screening of the general population is not recommended by current guidelines--for example, hemochromatosis and factor V Leiden. Moreover, almost by definition, ECS panels include rare conditions for which the natural history may not be well understood, and the carrier frequency as well as the proportion of condition-causing variants that can be detected may be unclear, leaving the residual risk unknown.

Read about the ideal expanded carrier screening panel.

The ideal expanded carrier screening panel

Stevens B, Krstic N, Jones M, Murphy L, Hoskovec J. Finding middle ground in constructing a clinically useful expanded carrier screening panel. Obstet Gynecol. 2017;130(2):279-284.

Both the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics and Genomics (ACMG) have proposed criteria for including specific disorders on ECS panels.^3,4 These criteria consider disorder characteristics, such as carrier prevalence, which should be at least 1 in 100; severity; early-childhood onset; and complete penetrance. In addition, they consider test characteristics, such as sensitivity, which should be at least 70%.

Details of the study

Stevens and colleagues evaluated the ECS panels offered by 6 commercial laboratories in the United States. They found that only 27% of included conditions met the recommended criteria, and concluded that these panels are putting patients at risk for undue anxiety, and that time and money are being spent on follow-up testing for rare and mild conditions for which the benefits of testing are unclear or unlikely. The potential benefits of the extra screening should be weighed against the significant resulting harms.

Across the 6 ECS panels, 96 conditions met the criteria. As some laboratories allow providers to customize their panels, members of my practice, after reviewing this thought-provoking article, agreed we should create a custom panel that includes only these 96 conditions. Unfortunately, no commercial laboratory includes all 96 conditions, so it is not feasible to create an "ideal" panel at this time.

Arguments favoring ECS include its low cost and the efficiency of screening with multigene panels. In a 2013 study, however, 24% of patients were identified as carriers, and in most cases this finding led to screening for the reproductive partner as well.⁵ If the rate of detection of the disorder is low, the utility of screening with the same panel may be limited, and couples may require more extensive testing, such as gene sequencing, which is far more expensive. These findings and the additional testing also will increase the need for genetic counseling, and may lead to invasive prenatal diagnostic testing with further increases in costs. If counseling and prenatal testing yield improved outcomes--increased detection of important findings--the benefit will justify the higher costs. However, if the increased costs are largely generated chasing down and explaining findings that are not important to patients or providers, the costs may be incurred without benefit.

Read about the pregnant women’s perspectives on ECS.

Pregnant women's perspectives on expanded carrier screening

Propst L, Connor G, Hinton M, Poorvu T, Dungan J. Pregnant women's perspectives on expanded carrier screening [published online February 23, 2018]. J Genet Couns. doi:10.1007/s10897-018-0232-x.

Although several authors have discussed ECS detection rates, less has been reported on how women perceive ECS or how they elect or decline screening. Studies have found that the decision to undergo screening for cystic fibrosis is influenced by factors that include age, sex, ethnicity, socioeconomic status, lack of family history, cost, fear of a blood test, lack of knowledge about the condition, already having children, wanting to avoid having a disabled child, abortion preferences, and feeling pressured by health care providers.^6,7 Propst and colleagues asked women for their perspectives on ECS, on electing or declining screening, and on any anxiety associated with their decision.

Details of the study

Women who declined ECS said they did so because they:

• had no family history
• knew there was a very small chance their partner carried the same condition  
• would not change the course of their pregnancy on the basis of the test results.

Women who elected ECS said they did so because they wanted to:

• know their risk of having a child with a genetic condition
• have all available information about their genetic risks
• be able to make decisions about continuing or terminating their pregnancy.

Women also were asked what they would do if they discovered their fetus had a genetic disorder. About 42% said they were unsure what they would do, 34% said they would continue their pregnancy and prepare for the birth of an affected child, and 24% said they likely would terminate their pregnancy.

The most common reason women gave for declining ECS was that they had no family history. However, ECS is not a good option for women with a positive family history, as they need genetic counseling and specific consideration of their own risks and what testing should be done. The majority of couples who have a child with a genetic disease have no other family history of the disorder. In a study of reproductive carrier screening in Australia, 88% of carriers had no family history.¹ Careful pretest counseling is needed to explain the distinction between, on one hand, genetic counseling and testing for those with a family history of genetic disease and, on the other hand, population screening performed to identify unsuspecting individuals who are healthy carriers of genetic disorders.

Another crucial point about carrier screening is the need to consider how its results will be used, and what options the carrier couple will have. For women who are pregnant when a risk is identified, options include expectant management, with diagnosis after birth, or prenatal diagnosis with termination of an affected fetus, out-adoption of an affected fetus, or expectant management with preparation for caring for an affected child. For women who are not pregnant when they have ECS, additional options include use of a gamete (ovum or sperm) donor to achieve pregnancy, or preimplantation genetic diagnosis with implantation of only unaffected embryos.

Read about the marketing of ECS.

Marketing of expanded carrier screening

Chokoshvili D, Borry P, Vears DF. A systematic analysis of online marketing materials used by providers of expanded carrier screening [published online December 14, 2017]. Genet Med. doi:10.1038/gim.2017.222.

Prenatal carrier screening can be helpful to women and their families, but it is also a high-volume, lucrative business, with many commercial laboratories competing for the growing ECS market. Professional medical societies recommend making all screening candidates aware of the purpose, characteristics, and limitations of the tests, and of the potential significance of their results. As becoming familiar and comfortable with the tests and explaining them to each patient can be time-consuming, and daunting, many busy clinicians have started relying on marketing materials and other information from the commercial laboratories. Therefore analysis of the accuracy of such materials is in order.

Details of the study

Chokoshvili and colleagues performed a systematic analysis of the quality and accuracy of online marketing materials for ECS. They identified 18 providers: 16 commercial laboratories and 2 medical services providers. All described ECS as a useful tool for family planning, and some were very directive in stating that this testing is "one of the most important steps in preparing for parenthood." In their materials, most of the companies cover some limitations, such as residual risk, but none of the commercial laboratories indicate that ECS can overestimate risk (many variants have incomplete penetrance, meaning that some individuals with a positive test result may in fact be asymptomatic throughout their lifetime).

In addition, whereas a large amount of the marketing materials implies the test was developed in line with professional recommendations, none in fact complies with ACOG and ACMG guidance. Finally, though some of the online information provided by laboratories can be helpful, it is important for clinicians to remember that reproductive genetic counseling should be nondirective and balanced. Carrier testing should be based on patient (not provider) values regarding reproductive autonomy.

Summary

ECS increasingly is being adopted into clinical practice. According to ACOG, traditional ethnicity-based screening, panethnic screening (the same limited panel of tests for all patients), and ECS are all acceptable alternatives for prenatal carrier screening.³ For providers who offer ECS, it is important to have a good understanding of each selected test and its limitations. Providers should have a plan for following up patients who have positive test results; this plan may include having genetic counseling and prenatal genetic diagnostic testing in place. Although treatment is available for a few genetic conditions, for the large majority, prenatal screening has not been proved to lead to improved therapeutic options. Providers should try to make sure that patients do not have unrealistic expectations of the outcomes of carrier screening.

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.

Prenatal care has long included carrier screening for genetic diseases, such as cystic fibrosis and Tay-Sachs disease. Recently, advances in genetics technologies led to the development of multiplex panels that can be used to test for hundreds of genetic disorders simultaneously, and can be used to assess carrier status for expectant couples or those planning a pregnancy. Although such screening covers many more conditions than those recommended in traditional guidelines, the benefit of expanded carrier screening (ECS) over standard gene-by-gene testing is not clear.

In this Update, I review recent ECS research that can be helpful to those who practice reproductive endocrinology and infertility medicine, maternal–fetal medicine, and general ObGyn. This research considered some of the many complexities of ECS:

• number and type of severe autosomal recessive conditions identified by an ECS panel, or by panethnic screening for 3 common conditions (cystic fibrosis, fragile X syndrome, spinal muscular atrophy)
• whether the disorders covered by ECS panels meet recommended criteria regarding severity, prevalence, and test accuracy
• women’s thoughts and perspectives on ECS
• whether the marketing materials disseminated by commercial providers of ECS are accurate and balanced.

Genetic diseases identified by expanded carrier screening

Haque IS, Lazarin GA, Kang HP, Evans EA, Goldberg JD, Wapner RJ. Modeled fetal risk of genetic diseases identified by expanded carrier screening. JAMA. 2016;316(7):734-742.

Screening during pregnancy to determine if one or both parents are carriers of genetic disorders historically has involved testing for a limited number of conditions, such as cystic fibrosis, hemoglobinopathies, and Tay-Sachs disease. Patients usually are offered testing for 1 or 2 disorders, with test choices primarily based on patient race and ethnicity. Unfortunately, ancestry-based screening may result in inequitable distribution of genetic testing and resources, as it has significant limitations in our increasingly multicultural society, which includes many people of uncertain or mixed race and ethnicity.

Advantages of expanded carrier screening

Several commercial laboratories now offer ECS. Haque and colleagues used data from one of these laboratories and modeled the predicted number of potentially affected fetuses that would be identified with traditional, ethnicity-based screening as compared with ECS. In one of their hypothetical cohorts, of Northern European couples, traditional screening would identify 55 affected fetuses per 100,000 (1 in 1,800), and ECS would identify 159 per 100,000 (almost 3 times more). The numbers identified with ECS varied with race or ethnicity and ranged from 94 per 100,000 (about 1 in 1,000) for Hispanic couples to 392 per 100,000 (about 1 in 250) for Ashkenazi Jewish couples.

In Australia, Archibald and colleagues conducted a similar study, of panethnic screening of 12,000 women for cystic fibrosis, fragile X syndrome, and spinal muscular atrophy.¹ The number of affected fetuses identified was about 1 per 1,000 screened couples--not much different from the ECS number, though comparison is difficult given the likely very different racial and ethnic backgrounds of the 2 cohorts.

Although these data suggest ECS increases detection of genetic disorders, and it seems almost self-evident that more screening is better, there are concerns about ECS.² Traditional carrier screening methods focus on conditions that significantly affect quality of life--owing to cognitive or physical disabilities or required lifelong medical therapies--and that have a fetal, neonatal, or early-childhood onset and well-defined phenotype. In ECS panels, additional conditions may vary significantly in severity or age of onset. Although some genetic variants on ECS panels have a consistent phenotype, the natural history of others is less well understood. Panels often include conditions for which carrier screening of the general population is not recommended by current guidelines--for example, hemochromatosis and factor V Leiden. Moreover, almost by definition, ECS panels include rare conditions for which the natural history may not be well understood, and the carrier frequency as well as the proportion of condition-causing variants that can be detected may be unclear, leaving the residual risk unknown.

Read about the ideal expanded carrier screening panel.

The ideal expanded carrier screening panel

Stevens B, Krstic N, Jones M, Murphy L, Hoskovec J. Finding middle ground in constructing a clinically useful expanded carrier screening panel. Obstet Gynecol. 2017;130(2):279-284.

Both the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics and Genomics (ACMG) have proposed criteria for including specific disorders on ECS panels.^3,4 These criteria consider disorder characteristics, such as carrier prevalence, which should be at least 1 in 100; severity; early-childhood onset; and complete penetrance. In addition, they consider test characteristics, such as sensitivity, which should be at least 70%.

Details of the study

Stevens and colleagues evaluated the ECS panels offered by 6 commercial laboratories in the United States. They found that only 27% of included conditions met the recommended criteria, and concluded that these panels are putting patients at risk for undue anxiety, and that time and money are being spent on follow-up testing for rare and mild conditions for which the benefits of testing are unclear or unlikely. The potential benefits of the extra screening should be weighed against the significant resulting harms.

Across the 6 ECS panels, 96 conditions met the criteria. As some laboratories allow providers to customize their panels, members of my practice, after reviewing this thought-provoking article, agreed we should create a custom panel that includes only these 96 conditions. Unfortunately, no commercial laboratory includes all 96 conditions, so it is not feasible to create an "ideal" panel at this time.

Arguments favoring ECS include its low cost and the efficiency of screening with multigene panels. In a 2013 study, however, 24% of patients were identified as carriers, and in most cases this finding led to screening for the reproductive partner as well.⁵ If the rate of detection of the disorder is low, the utility of screening with the same panel may be limited, and couples may require more extensive testing, such as gene sequencing, which is far more expensive. These findings and the additional testing also will increase the need for genetic counseling, and may lead to invasive prenatal diagnostic testing with further increases in costs. If counseling and prenatal testing yield improved outcomes--increased detection of important findings--the benefit will justify the higher costs. However, if the increased costs are largely generated chasing down and explaining findings that are not important to patients or providers, the costs may be incurred without benefit.

Read about the pregnant women’s perspectives on ECS.

Pregnant women's perspectives on expanded carrier screening

Propst L, Connor G, Hinton M, Poorvu T, Dungan J. Pregnant women's perspectives on expanded carrier screening [published online February 23, 2018]. J Genet Couns. doi:10.1007/s10897-018-0232-x.

Although several authors have discussed ECS detection rates, less has been reported on how women perceive ECS or how they elect or decline screening. Studies have found that the decision to undergo screening for cystic fibrosis is influenced by factors that include age, sex, ethnicity, socioeconomic status, lack of family history, cost, fear of a blood test, lack of knowledge about the condition, already having children, wanting to avoid having a disabled child, abortion preferences, and feeling pressured by health care providers.^6,7 Propst and colleagues asked women for their perspectives on ECS, on electing or declining screening, and on any anxiety associated with their decision.

Details of the study

Women who declined ECS said they did so because they:

• had no family history
• knew there was a very small chance their partner carried the same condition  
• would not change the course of their pregnancy on the basis of the test results.

Women who elected ECS said they did so because they wanted to:

• know their risk of having a child with a genetic condition
• have all available information about their genetic risks
• be able to make decisions about continuing or terminating their pregnancy.

Women also were asked what they would do if they discovered their fetus had a genetic disorder. About 42% said they were unsure what they would do, 34% said they would continue their pregnancy and prepare for the birth of an affected child, and 24% said they likely would terminate their pregnancy.

The most common reason women gave for declining ECS was that they had no family history. However, ECS is not a good option for women with a positive family history, as they need genetic counseling and specific consideration of their own risks and what testing should be done. The majority of couples who have a child with a genetic disease have no other family history of the disorder. In a study of reproductive carrier screening in Australia, 88% of carriers had no family history.¹ Careful pretest counseling is needed to explain the distinction between, on one hand, genetic counseling and testing for those with a family history of genetic disease and, on the other hand, population screening performed to identify unsuspecting individuals who are healthy carriers of genetic disorders.

Another crucial point about carrier screening is the need to consider how its results will be used, and what options the carrier couple will have. For women who are pregnant when a risk is identified, options include expectant management, with diagnosis after birth, or prenatal diagnosis with termination of an affected fetus, out-adoption of an affected fetus, or expectant management with preparation for caring for an affected child. For women who are not pregnant when they have ECS, additional options include use of a gamete (ovum or sperm) donor to achieve pregnancy, or preimplantation genetic diagnosis with implantation of only unaffected embryos.

Read about the marketing of ECS.

Marketing of expanded carrier screening

Chokoshvili D, Borry P, Vears DF. A systematic analysis of online marketing materials used by providers of expanded carrier screening [published online December 14, 2017]. Genet Med. doi:10.1038/gim.2017.222.

Prenatal carrier screening can be helpful to women and their families, but it is also a high-volume, lucrative business, with many commercial laboratories competing for the growing ECS market. Professional medical societies recommend making all screening candidates aware of the purpose, characteristics, and limitations of the tests, and of the potential significance of their results. As becoming familiar and comfortable with the tests and explaining them to each patient can be time-consuming, and daunting, many busy clinicians have started relying on marketing materials and other information from the commercial laboratories. Therefore analysis of the accuracy of such materials is in order.

Details of the study

Chokoshvili and colleagues performed a systematic analysis of the quality and accuracy of online marketing materials for ECS. They identified 18 providers: 16 commercial laboratories and 2 medical services providers. All described ECS as a useful tool for family planning, and some were very directive in stating that this testing is "one of the most important steps in preparing for parenthood." In their materials, most of the companies cover some limitations, such as residual risk, but none of the commercial laboratories indicate that ECS can overestimate risk (many variants have incomplete penetrance, meaning that some individuals with a positive test result may in fact be asymptomatic throughout their lifetime).

In addition, whereas a large amount of the marketing materials implies the test was developed in line with professional recommendations, none in fact complies with ACOG and ACMG guidance. Finally, though some of the online information provided by laboratories can be helpful, it is important for clinicians to remember that reproductive genetic counseling should be nondirective and balanced. Carrier testing should be based on patient (not provider) values regarding reproductive autonomy.

Summary

ECS increasingly is being adopted into clinical practice. According to ACOG, traditional ethnicity-based screening, panethnic screening (the same limited panel of tests for all patients), and ECS are all acceptable alternatives for prenatal carrier screening.³ For providers who offer ECS, it is important to have a good understanding of each selected test and its limitations. Providers should have a plan for following up patients who have positive test results; this plan may include having genetic counseling and prenatal genetic diagnostic testing in place. Although treatment is available for a few genetic conditions, for the large majority, prenatal screening has not been proved to lead to improved therapeutic options. Providers should try to make sure that patients do not have unrealistic expectations of the outcomes of carrier screening.

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.

CHICAGO – When women with polycystic ovary syndrome (PCOS) took metformin during pregnancy, preterm births and late miscarriages were reduced, but researchers saw no effect on blood glucose levels or other diabetes-related maternal outcomes.

A Nordic study of pregnant women, dubbed PregMet 2, followed the course of 487 women with PCOS who were randomized to take 2,000 mg of metformin or placebo daily during pregnancy.

Kari Oakes/MDedge News

[email protected]

CHICAGO – When women with polycystic ovary syndrome (PCOS) took metformin during pregnancy, preterm births and late miscarriages were reduced, but researchers saw no effect on blood glucose levels or other diabetes-related maternal outcomes.

A Nordic study of pregnant women, dubbed PregMet 2, followed the course of 487 women with PCOS who were randomized to take 2,000 mg of metformin or placebo daily during pregnancy.

Kari Oakes/MDedge News

[email protected]

CHICAGO – When women with polycystic ovary syndrome (PCOS) took metformin during pregnancy, preterm births and late miscarriages were reduced, but researchers saw no effect on blood glucose levels or other diabetes-related maternal outcomes.

A Nordic study of pregnant women, dubbed PregMet 2, followed the course of 487 women with PCOS who were randomized to take 2,000 mg of metformin or placebo daily during pregnancy.

Kari Oakes/MDedge News

[email protected]

High preconception blood pressure is associated with a greater risk of pregnancy loss, according to analysis of data from a randomized clinical trial of aspirin and pregnancy outcomes.

Researchers in the EAGeR (Effects of Aspirin on Gestational and Reproduction) trial analyzed data from 1,228 women attempting pregnancy with a history of pregnancy loss. After researchers adjusted for treatment assignment, body mass index (BMI), race, marital status, smoking, parity, and time from last pregnancy loss, an increase in all blood pressure measures was associated with a 17% increase in the risk of pregnancy loss (Hypertension. doi: 10.1161/hypertensionaha.117.10705).

thodonal/Thinkstock

[email protected]

SOURCE: Nobles CJ et al. Hypertension. 2018 Apr 2;71. doi: 10.1161/hypertensionaha.117.10705.

High preconception blood pressure is associated with a greater risk of pregnancy loss, according to analysis of data from a randomized clinical trial of aspirin and pregnancy outcomes.

Researchers in the EAGeR (Effects of Aspirin on Gestational and Reproduction) trial analyzed data from 1,228 women attempting pregnancy with a history of pregnancy loss. After researchers adjusted for treatment assignment, body mass index (BMI), race, marital status, smoking, parity, and time from last pregnancy loss, an increase in all blood pressure measures was associated with a 17% increase in the risk of pregnancy loss (Hypertension. doi: 10.1161/hypertensionaha.117.10705).

thodonal/Thinkstock

[email protected]

SOURCE: Nobles CJ et al. Hypertension. 2018 Apr 2;71. doi: 10.1161/hypertensionaha.117.10705.

High preconception blood pressure is associated with a greater risk of pregnancy loss, according to analysis of data from a randomized clinical trial of aspirin and pregnancy outcomes.

Researchers in the EAGeR (Effects of Aspirin on Gestational and Reproduction) trial analyzed data from 1,228 women attempting pregnancy with a history of pregnancy loss. After researchers adjusted for treatment assignment, body mass index (BMI), race, marital status, smoking, parity, and time from last pregnancy loss, an increase in all blood pressure measures was associated with a 17% increase in the risk of pregnancy loss (Hypertension. doi: 10.1161/hypertensionaha.117.10705).

thodonal/Thinkstock

[email protected]

SOURCE: Nobles CJ et al. Hypertension. 2018 Apr 2;71. doi: 10.1161/hypertensionaha.117.10705.

Fetal pathology exam performed without consent: $500,000 verdict

At 12 to 15 weeks' gestation, a fetus was found to have died. An ObGyn stimulated uterine contractions with misoprostol and the fetus was delivered.

The parents requested chromosomal testing to determine the cause of death. The ObGyn took samples of the baby's skin near the umbilical cord and from the placenta. He told the parents that the tests might come back as inconclusive, and that it may be necessary to take further samples. The couple was also told that, under hospital policy, the fetus must go to the pathology department before being taken to a funeral home. The parents told the ObGyn that they did not want further samples taken for any reason, and that nothing else should be done to their child before funeral preparations. The placenta, umbilical cord, and fetus were placed in 2 separate containers. The container with the placenta and umbilical cord had an anatomic pathology requisition form, indicating that a surgical pathology exam was to be performed. The container with the fetus did not have a requisition form. When the father accompanied the nurse who carried the containers to the pathology department, he told a general technologist that no additional tissue samples were to be taken from the fetus.

The next day, the pathologist made an incision on the fetus' left side and took a sample to create a slide for microscopic analysis. The parents discovered the incision at the funeral home.

PARENTS' CLAIM: The parents sued the hospital and pathologist. The pathologist was negligent in performing a surgical pathology examination without consent. The hospital had a duty to communicate the parents' desires to the pathologist.

According to hospital protocol, the nurse who attended the delivery was to fill out the proper forms and ensure that they were available to the pathologist. The container with the fetus should have had its own requisition form that instructed the pathologist to not perform any further testing. Every specimen that goes to pathology should have a requisition form, per guidelines from the College of American Pathologists (CAP). Without a form, the pathologist should not do anything with the sample.

The parents' verbal instructions not to take additional samples from the fetus were never relayed to the pathologist.

DEFENDANTS' DEFENSE: The hospital and pathologist denied negligence. A single requisition form was appropriate; the containers' labeling and the form made it clear that the placenta, umbilical cord, and fetus were from the same patient. CAP guidelines do not require separate forms. The remains were in the gross room at pathology, which is where specimens are taken for review and analysis. Therefore, the pathologist assumed he was to perform a standard pathology exam on both containers. The technologist with whom the father had spoken met the accepted standard of care.

VERDICT: A $500,000 Maine verdict was returned. The pathologist (through insurance) and the hospital equally shared payment of the award.

When should delivery have occurred? $4M verdict

Concerned that her fetus had stopped moving, a mother presented to the ED. Results of fetal heart-rate (FHR) monitoring ordered by the attending ObGyn (Dr. A) were nonreassuring. A second ObGyn (Dr. B) ordered a fetal biophysical profile (BPP); the score was 2 points. Although a low score usually results in immediate delivery, Dr. B consulted a maternal-fetal medicine (MFM) specialist. After another fetal BPP scored 8 points, the mother was discharged.

The next day, the mother called her ObGyn (Dr. C), who told her to immediately come to his office. A fetal BPP scored 4 points, with nonreassuring fetal heart sounds.

The mother was transported to the hospital for emergency cesarean delivery. At birth, the baby was blue, not breathing, and had meconium in his lungs. After 6 minutes' resuscitation, he began breathing. The child has an hypoxic brain injury.

PARENTS' CLAIM: Based on the nonreassuring FHR readings when the mother first reported lack of fetal movement, and a BPP of 2 points, an immediate cesarean delivery should have been performed. If the child had been delivered in a timely manner, he would have escaped a brain injury. At the very least, the mother should have been kept in the hospital for monitoring.

DEFENDANTS' DEFENSE: Drs. A and B and the hospital claimed that the child did not have a hypoxic injury; he had gastroschisis. 

VERDICT: A $4,098,266 New York verdict was returned.

Second twin's birth delayed; brain damage: $1.5M settlement

A 35-year-old woman was 30 weeks' pregnant with twins when she was admitted to a hospital at high risk. At 36 weeks' gestation, she went into labor. A resident called the ObGyn to report that the patient was ready to deliver and waiting to push. The ObGyn advised that he was tied up in another procedure and for the mother to wait until he could get there.

Forty minutes later, the ObGyn arrived and the mother was allowed to push. A first-year resident delivered the first twin without incident. The second twin shifted from a cephalic presentation to a double foot- ling breech presentation and his FHR reflected severe bradycardia. Under the supervision of the ObGyn, a fourth-year resident managed the delivery, which took 28 minutes. The second twin's Apgar scores were low. He was intubated and transferred to a children's hospital for brain cooling.

PARENTS' CLAIM: Although excellent care following the birth reduced the degree of brain damage, the delay caused by the ObGyn's late arrival was responsible for the child's injuries.

PHYSICIAN'S DEFENSE: In pretrial findings, a panel of physicians reported that the child did not have a qualifying injury. However, the case settled before the trial began.

VERDICT: A $1.5 million Virginia settlement was reached.

Pregnant mother prepares for child's congenital heart disorder

A mother was told that her fetus had tricuspid atresia, a congenital defect. The mother and pediatric cardiologist developed a treatment plan to perform a balloon heart procedure at birth then transfer the baby to a specialized hospital.

After birth at a local hospital, the child was also found to have a lung disorder. He was promptly placed on a respirator. The hospital's pediatric cardiologist decided that the baby was too fragile to undergo the balloon procedure, and that the procedure could wait until the child was more stable. The baby died on his third day of life. 

The neonatologists involved in treating the baby determined that the cause of death was tricuspid atresia. A pathologist reported that the death was due to a combination of congenital heart and lung disorders. 

ESTATE'S CLAIM: The hospital team was sued for not following the prenatal plan. The baby's condition was serious but survivable if treated properly. 

DEFENDANTS' DEFENSE: The hospital team made the correct decision to stabilize the baby's lung conditions before performing the balloon repair. The baby died because both his heart and lungs were compromised. The child's chance of survival was very small.

VERDICT: A Mississippi defense verdict was returned.

Severe uterine atony and PPH: hysterectomy

A 35-year-old woman at 41 weeks' gestation was admitted to the hospital in active labor at 5:45 am on July 26. At 2:45 pm, an ObGyn noted that she was 8+ cm dilated, 90% effaced, and that the baby's head was at -1 station. At 6:00 pm, the membranes were artificially ruptured. At 7:45 pm, examination revealed no change in her cervix. The ObGyn reviewed the options with the mother, including offering an epidural and cesarean delivery. At 8:30 pm, an intrauterine pressure catheter was placed. The ObGyn noted an inadequate labor pattern and ordered augmentation with oxytocin. On July 27 at 12:50 am, examination revealed that the cervix was completely dilated and the baby's head was at +1 station. At 2:30 am, oxytocin was infusing at 12 mU/m. At 2:30 am, the patient began to push. By 4:30 am, oxytocin was running at 14 mU/m and the patient continued to push. At 5:00 am, the ObGyn noted no further progression of labor and recommended a cesarean delivery, but the mother wanted to push a little longer. At 6:00 am, with no further progress, the decision was made to perform cesarean delivery. At 6:40 am, the patient was transferred to the operating room and delivery occurred at 7:08 am. The baby weighed 9.5 lb.

The mother's uterus was closed and hemostasis was reached. However, uterine atony was persistent and did not respond to multiple doses of medication or uterine massage. Persistent atony led to postpartum hemorrhaging (PPH). The ObGyn used conservative methods to control the hemorrhage, including medications and sutures. He then called for assistance from another ObGyn, and performed ligation of the utero-ovarian ligaments and additional suturing, which had no effect on the bleeding. They attempted an ovarian artery ligation and placed additional sutures, but the PPH continued. The ObGyn recommended a hysterectomy to the patient and her husband, who agreed. A supracervical hysterectomy was performed. During the procedure, the left ovary tore and was removed. 

PARENTS' CLAIM: The patient and her husband spoke at trial of their intention to have more than one child. They sued the ObGyn, her practice, and the hospital. The ObGyn was negligent in allowing labor to continue for too long, for using oxytocin to stimulate contractions, and for allowing the patient to push for several hours, given that the baby was large. Oxytocin stimulation for so many hours without labor progression created an unacceptably high risk of uterine atony. This led to a nonreversible atonic state after delivery, which caused the patient to lose her uterus, left ovary, and her ability to reproduce.

DEFENDANTS' DEFENSE: The ObGyn was not negligent. The ObGyn met the standard of care in the management of labor and delivery. She was attentive, present at appropriate intervals, and there was no point at which a different decision should have been made. The ObGyn allowed the patient to have input in the decision-making process, as long as the ObGyn was comfortable that the decision was not compromising the safety of mother and baby. The length of labor and size of the fetus increased the risk of atony. However, in most cases, this does not occur; it can occur without those risk factors. PPH is a serious but frequently unavoidable complication of childbirth. The ObGyn's management was appropriate and prevented the patient's death. 

VERDICT: A Pennsylvania defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Fetal pathology exam performed without consent: $500,000 verdict

At 12 to 15 weeks' gestation, a fetus was found to have died. An ObGyn stimulated uterine contractions with misoprostol and the fetus was delivered.

The parents requested chromosomal testing to determine the cause of death. The ObGyn took samples of the baby's skin near the umbilical cord and from the placenta. He told the parents that the tests might come back as inconclusive, and that it may be necessary to take further samples. The couple was also told that, under hospital policy, the fetus must go to the pathology department before being taken to a funeral home. The parents told the ObGyn that they did not want further samples taken for any reason, and that nothing else should be done to their child before funeral preparations. The placenta, umbilical cord, and fetus were placed in 2 separate containers. The container with the placenta and umbilical cord had an anatomic pathology requisition form, indicating that a surgical pathology exam was to be performed. The container with the fetus did not have a requisition form. When the father accompanied the nurse who carried the containers to the pathology department, he told a general technologist that no additional tissue samples were to be taken from the fetus.

The next day, the pathologist made an incision on the fetus' left side and took a sample to create a slide for microscopic analysis. The parents discovered the incision at the funeral home.

PARENTS' CLAIM: The parents sued the hospital and pathologist. The pathologist was negligent in performing a surgical pathology examination without consent. The hospital had a duty to communicate the parents' desires to the pathologist.

According to hospital protocol, the nurse who attended the delivery was to fill out the proper forms and ensure that they were available to the pathologist. The container with the fetus should have had its own requisition form that instructed the pathologist to not perform any further testing. Every specimen that goes to pathology should have a requisition form, per guidelines from the College of American Pathologists (CAP). Without a form, the pathologist should not do anything with the sample.

The parents' verbal instructions not to take additional samples from the fetus were never relayed to the pathologist.

DEFENDANTS' DEFENSE: The hospital and pathologist denied negligence. A single requisition form was appropriate; the containers' labeling and the form made it clear that the placenta, umbilical cord, and fetus were from the same patient. CAP guidelines do not require separate forms. The remains were in the gross room at pathology, which is where specimens are taken for review and analysis. Therefore, the pathologist assumed he was to perform a standard pathology exam on both containers. The technologist with whom the father had spoken met the accepted standard of care.

VERDICT: A $500,000 Maine verdict was returned. The pathologist (through insurance) and the hospital equally shared payment of the award.

When should delivery have occurred? $4M verdict

Concerned that her fetus had stopped moving, a mother presented to the ED. Results of fetal heart-rate (FHR) monitoring ordered by the attending ObGyn (Dr. A) were nonreassuring. A second ObGyn (Dr. B) ordered a fetal biophysical profile (BPP); the score was 2 points. Although a low score usually results in immediate delivery, Dr. B consulted a maternal-fetal medicine (MFM) specialist. After another fetal BPP scored 8 points, the mother was discharged.

The next day, the mother called her ObGyn (Dr. C), who told her to immediately come to his office. A fetal BPP scored 4 points, with nonreassuring fetal heart sounds.

The mother was transported to the hospital for emergency cesarean delivery. At birth, the baby was blue, not breathing, and had meconium in his lungs. After 6 minutes' resuscitation, he began breathing. The child has an hypoxic brain injury.

PARENTS' CLAIM: Based on the nonreassuring FHR readings when the mother first reported lack of fetal movement, and a BPP of 2 points, an immediate cesarean delivery should have been performed. If the child had been delivered in a timely manner, he would have escaped a brain injury. At the very least, the mother should have been kept in the hospital for monitoring.

DEFENDANTS' DEFENSE: Drs. A and B and the hospital claimed that the child did not have a hypoxic injury; he had gastroschisis. 

VERDICT: A $4,098,266 New York verdict was returned.

Second twin's birth delayed; brain damage: $1.5M settlement

A 35-year-old woman was 30 weeks' pregnant with twins when she was admitted to a hospital at high risk. At 36 weeks' gestation, she went into labor. A resident called the ObGyn to report that the patient was ready to deliver and waiting to push. The ObGyn advised that he was tied up in another procedure and for the mother to wait until he could get there.

Forty minutes later, the ObGyn arrived and the mother was allowed to push. A first-year resident delivered the first twin without incident. The second twin shifted from a cephalic presentation to a double foot- ling breech presentation and his FHR reflected severe bradycardia. Under the supervision of the ObGyn, a fourth-year resident managed the delivery, which took 28 minutes. The second twin's Apgar scores were low. He was intubated and transferred to a children's hospital for brain cooling.

PARENTS' CLAIM: Although excellent care following the birth reduced the degree of brain damage, the delay caused by the ObGyn's late arrival was responsible for the child's injuries.

PHYSICIAN'S DEFENSE: In pretrial findings, a panel of physicians reported that the child did not have a qualifying injury. However, the case settled before the trial began.

VERDICT: A $1.5 million Virginia settlement was reached.

Pregnant mother prepares for child's congenital heart disorder

A mother was told that her fetus had tricuspid atresia, a congenital defect. The mother and pediatric cardiologist developed a treatment plan to perform a balloon heart procedure at birth then transfer the baby to a specialized hospital.

After birth at a local hospital, the child was also found to have a lung disorder. He was promptly placed on a respirator. The hospital's pediatric cardiologist decided that the baby was too fragile to undergo the balloon procedure, and that the procedure could wait until the child was more stable. The baby died on his third day of life. 

The neonatologists involved in treating the baby determined that the cause of death was tricuspid atresia. A pathologist reported that the death was due to a combination of congenital heart and lung disorders. 

ESTATE'S CLAIM: The hospital team was sued for not following the prenatal plan. The baby's condition was serious but survivable if treated properly. 

DEFENDANTS' DEFENSE: The hospital team made the correct decision to stabilize the baby's lung conditions before performing the balloon repair. The baby died because both his heart and lungs were compromised. The child's chance of survival was very small.

VERDICT: A Mississippi defense verdict was returned.

Severe uterine atony and PPH: hysterectomy

A 35-year-old woman at 41 weeks' gestation was admitted to the hospital in active labor at 5:45 am on July 26. At 2:45 pm, an ObGyn noted that she was 8+ cm dilated, 90% effaced, and that the baby's head was at -1 station. At 6:00 pm, the membranes were artificially ruptured. At 7:45 pm, examination revealed no change in her cervix. The ObGyn reviewed the options with the mother, including offering an epidural and cesarean delivery. At 8:30 pm, an intrauterine pressure catheter was placed. The ObGyn noted an inadequate labor pattern and ordered augmentation with oxytocin. On July 27 at 12:50 am, examination revealed that the cervix was completely dilated and the baby's head was at +1 station. At 2:30 am, oxytocin was infusing at 12 mU/m. At 2:30 am, the patient began to push. By 4:30 am, oxytocin was running at 14 mU/m and the patient continued to push. At 5:00 am, the ObGyn noted no further progression of labor and recommended a cesarean delivery, but the mother wanted to push a little longer. At 6:00 am, with no further progress, the decision was made to perform cesarean delivery. At 6:40 am, the patient was transferred to the operating room and delivery occurred at 7:08 am. The baby weighed 9.5 lb.

The mother's uterus was closed and hemostasis was reached. However, uterine atony was persistent and did not respond to multiple doses of medication or uterine massage. Persistent atony led to postpartum hemorrhaging (PPH). The ObGyn used conservative methods to control the hemorrhage, including medications and sutures. He then called for assistance from another ObGyn, and performed ligation of the utero-ovarian ligaments and additional suturing, which had no effect on the bleeding. They attempted an ovarian artery ligation and placed additional sutures, but the PPH continued. The ObGyn recommended a hysterectomy to the patient and her husband, who agreed. A supracervical hysterectomy was performed. During the procedure, the left ovary tore and was removed. 

PARENTS' CLAIM: The patient and her husband spoke at trial of their intention to have more than one child. They sued the ObGyn, her practice, and the hospital. The ObGyn was negligent in allowing labor to continue for too long, for using oxytocin to stimulate contractions, and for allowing the patient to push for several hours, given that the baby was large. Oxytocin stimulation for so many hours without labor progression created an unacceptably high risk of uterine atony. This led to a nonreversible atonic state after delivery, which caused the patient to lose her uterus, left ovary, and her ability to reproduce.

DEFENDANTS' DEFENSE: The ObGyn was not negligent. The ObGyn met the standard of care in the management of labor and delivery. She was attentive, present at appropriate intervals, and there was no point at which a different decision should have been made. The ObGyn allowed the patient to have input in the decision-making process, as long as the ObGyn was comfortable that the decision was not compromising the safety of mother and baby. The length of labor and size of the fetus increased the risk of atony. However, in most cases, this does not occur; it can occur without those risk factors. PPH is a serious but frequently unavoidable complication of childbirth. The ObGyn's management was appropriate and prevented the patient's death. 

VERDICT: A Pennsylvania defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Fetal pathology exam performed without consent: $500,000 verdict

At 12 to 15 weeks' gestation, a fetus was found to have died. An ObGyn stimulated uterine contractions with misoprostol and the fetus was delivered.

The parents requested chromosomal testing to determine the cause of death. The ObGyn took samples of the baby's skin near the umbilical cord and from the placenta. He told the parents that the tests might come back as inconclusive, and that it may be necessary to take further samples. The couple was also told that, under hospital policy, the fetus must go to the pathology department before being taken to a funeral home. The parents told the ObGyn that they did not want further samples taken for any reason, and that nothing else should be done to their child before funeral preparations. The placenta, umbilical cord, and fetus were placed in 2 separate containers. The container with the placenta and umbilical cord had an anatomic pathology requisition form, indicating that a surgical pathology exam was to be performed. The container with the fetus did not have a requisition form. When the father accompanied the nurse who carried the containers to the pathology department, he told a general technologist that no additional tissue samples were to be taken from the fetus.

The next day, the pathologist made an incision on the fetus' left side and took a sample to create a slide for microscopic analysis. The parents discovered the incision at the funeral home.

PARENTS' CLAIM: The parents sued the hospital and pathologist. The pathologist was negligent in performing a surgical pathology examination without consent. The hospital had a duty to communicate the parents' desires to the pathologist.

According to hospital protocol, the nurse who attended the delivery was to fill out the proper forms and ensure that they were available to the pathologist. The container with the fetus should have had its own requisition form that instructed the pathologist to not perform any further testing. Every specimen that goes to pathology should have a requisition form, per guidelines from the College of American Pathologists (CAP). Without a form, the pathologist should not do anything with the sample.

The parents' verbal instructions not to take additional samples from the fetus were never relayed to the pathologist.

DEFENDANTS' DEFENSE: The hospital and pathologist denied negligence. A single requisition form was appropriate; the containers' labeling and the form made it clear that the placenta, umbilical cord, and fetus were from the same patient. CAP guidelines do not require separate forms. The remains were in the gross room at pathology, which is where specimens are taken for review and analysis. Therefore, the pathologist assumed he was to perform a standard pathology exam on both containers. The technologist with whom the father had spoken met the accepted standard of care.

VERDICT: A $500,000 Maine verdict was returned. The pathologist (through insurance) and the hospital equally shared payment of the award.

When should delivery have occurred? $4M verdict

Concerned that her fetus had stopped moving, a mother presented to the ED. Results of fetal heart-rate (FHR) monitoring ordered by the attending ObGyn (Dr. A) were nonreassuring. A second ObGyn (Dr. B) ordered a fetal biophysical profile (BPP); the score was 2 points. Although a low score usually results in immediate delivery, Dr. B consulted a maternal-fetal medicine (MFM) specialist. After another fetal BPP scored 8 points, the mother was discharged.

The next day, the mother called her ObGyn (Dr. C), who told her to immediately come to his office. A fetal BPP scored 4 points, with nonreassuring fetal heart sounds.

The mother was transported to the hospital for emergency cesarean delivery. At birth, the baby was blue, not breathing, and had meconium in his lungs. After 6 minutes' resuscitation, he began breathing. The child has an hypoxic brain injury.

PARENTS' CLAIM: Based on the nonreassuring FHR readings when the mother first reported lack of fetal movement, and a BPP of 2 points, an immediate cesarean delivery should have been performed. If the child had been delivered in a timely manner, he would have escaped a brain injury. At the very least, the mother should have been kept in the hospital for monitoring.

DEFENDANTS' DEFENSE: Drs. A and B and the hospital claimed that the child did not have a hypoxic injury; he had gastroschisis. 

VERDICT: A $4,098,266 New York verdict was returned.

Second twin's birth delayed; brain damage: $1.5M settlement

A 35-year-old woman was 30 weeks' pregnant with twins when she was admitted to a hospital at high risk. At 36 weeks' gestation, she went into labor. A resident called the ObGyn to report that the patient was ready to deliver and waiting to push. The ObGyn advised that he was tied up in another procedure and for the mother to wait until he could get there.

Forty minutes later, the ObGyn arrived and the mother was allowed to push. A first-year resident delivered the first twin without incident. The second twin shifted from a cephalic presentation to a double foot- ling breech presentation and his FHR reflected severe bradycardia. Under the supervision of the ObGyn, a fourth-year resident managed the delivery, which took 28 minutes. The second twin's Apgar scores were low. He was intubated and transferred to a children's hospital for brain cooling.

PARENTS' CLAIM: Although excellent care following the birth reduced the degree of brain damage, the delay caused by the ObGyn's late arrival was responsible for the child's injuries.

PHYSICIAN'S DEFENSE: In pretrial findings, a panel of physicians reported that the child did not have a qualifying injury. However, the case settled before the trial began.

VERDICT: A $1.5 million Virginia settlement was reached.

Pregnant mother prepares for child's congenital heart disorder

A mother was told that her fetus had tricuspid atresia, a congenital defect. The mother and pediatric cardiologist developed a treatment plan to perform a balloon heart procedure at birth then transfer the baby to a specialized hospital.

After birth at a local hospital, the child was also found to have a lung disorder. He was promptly placed on a respirator. The hospital's pediatric cardiologist decided that the baby was too fragile to undergo the balloon procedure, and that the procedure could wait until the child was more stable. The baby died on his third day of life. 

The neonatologists involved in treating the baby determined that the cause of death was tricuspid atresia. A pathologist reported that the death was due to a combination of congenital heart and lung disorders. 

ESTATE'S CLAIM: The hospital team was sued for not following the prenatal plan. The baby's condition was serious but survivable if treated properly. 

DEFENDANTS' DEFENSE: The hospital team made the correct decision to stabilize the baby's lung conditions before performing the balloon repair. The baby died because both his heart and lungs were compromised. The child's chance of survival was very small.

VERDICT: A Mississippi defense verdict was returned.

Severe uterine atony and PPH: hysterectomy

A 35-year-old woman at 41 weeks' gestation was admitted to the hospital in active labor at 5:45 am on July 26. At 2:45 pm, an ObGyn noted that she was 8+ cm dilated, 90% effaced, and that the baby's head was at -1 station. At 6:00 pm, the membranes were artificially ruptured. At 7:45 pm, examination revealed no change in her cervix. The ObGyn reviewed the options with the mother, including offering an epidural and cesarean delivery. At 8:30 pm, an intrauterine pressure catheter was placed. The ObGyn noted an inadequate labor pattern and ordered augmentation with oxytocin. On July 27 at 12:50 am, examination revealed that the cervix was completely dilated and the baby's head was at +1 station. At 2:30 am, oxytocin was infusing at 12 mU/m. At 2:30 am, the patient began to push. By 4:30 am, oxytocin was running at 14 mU/m and the patient continued to push. At 5:00 am, the ObGyn noted no further progression of labor and recommended a cesarean delivery, but the mother wanted to push a little longer. At 6:00 am, with no further progress, the decision was made to perform cesarean delivery. At 6:40 am, the patient was transferred to the operating room and delivery occurred at 7:08 am. The baby weighed 9.5 lb.

The mother's uterus was closed and hemostasis was reached. However, uterine atony was persistent and did not respond to multiple doses of medication or uterine massage. Persistent atony led to postpartum hemorrhaging (PPH). The ObGyn used conservative methods to control the hemorrhage, including medications and sutures. He then called for assistance from another ObGyn, and performed ligation of the utero-ovarian ligaments and additional suturing, which had no effect on the bleeding. They attempted an ovarian artery ligation and placed additional sutures, but the PPH continued. The ObGyn recommended a hysterectomy to the patient and her husband, who agreed. A supracervical hysterectomy was performed. During the procedure, the left ovary tore and was removed. 

PARENTS' CLAIM: The patient and her husband spoke at trial of their intention to have more than one child. They sued the ObGyn, her practice, and the hospital. The ObGyn was negligent in allowing labor to continue for too long, for using oxytocin to stimulate contractions, and for allowing the patient to push for several hours, given that the baby was large. Oxytocin stimulation for so many hours without labor progression created an unacceptably high risk of uterine atony. This led to a nonreversible atonic state after delivery, which caused the patient to lose her uterus, left ovary, and her ability to reproduce.

DEFENDANTS' DEFENSE: The ObGyn was not negligent. The ObGyn met the standard of care in the management of labor and delivery. She was attentive, present at appropriate intervals, and there was no point at which a different decision should have been made. The ObGyn allowed the patient to have input in the decision-making process, as long as the ObGyn was comfortable that the decision was not compromising the safety of mother and baby. The length of labor and size of the fetus increased the risk of atony. However, in most cases, this does not occur; it can occur without those risk factors. PPH is a serious but frequently unavoidable complication of childbirth. The ObGyn's management was appropriate and prevented the patient's death. 

VERDICT: A Pennsylvania defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

“Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.¹ Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes²:

• effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
• efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
• equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
• patient-centeredness: meeting patient needs and preferences and providing education and support
• safety: actual or potential bodily harm
• timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

• patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
• health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
• society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.³

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.⁴

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.⁵ When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.⁶ This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”⁷

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

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.

“Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.¹ Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes²:

• effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
• efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
• equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
• patient-centeredness: meeting patient needs and preferences and providing education and support
• safety: actual or potential bodily harm
• timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

• patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
• health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
• society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.³

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.⁴

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.⁵ When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.⁶ This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”⁷

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

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.

“Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.¹ Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes²:

• effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
• efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
• equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
• patient-centeredness: meeting patient needs and preferences and providing education and support
• safety: actual or potential bodily harm
• timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

• patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
• health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
• society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.³

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.⁴

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.⁵ When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.⁶ This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”⁷

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

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.

Halsted’s surgical principles

Dr. William Steward Halsted, the first chief of surgery at Johns Hopkins Hospital, articulated a set of surgical principles that included strict aseptic technique, gentle tissue handling, meticulous hemostasis, minimum tension on tissue, accurate tissue apposition, preservation of blood supply, and obliteration of dead space where appropriate. These principles of “safe surgery” are believed to improve surgical outcomes and reduce the risk of surgical site infection.¹

Preoperative antibiotics

All obstetricians who perform cesarean delivery know the importance of administering a narrow-spectrum antibiotic, such as cefazolin or ampicillin, prior to the skin incision, but not more than 60 minutes before the incision, to help reduce the risk of wound infection and endometritis. In a meta-analysis of 82 studies involving more than 13,000 women the administration of a preoperative antibiotic compared with placebo reduced the risk of wound infection (relative risk [RR], 0.40; 95% confidence interval [CI], 0.35–0.46) and endometritis (RR, 0.38; 95% CI, 0.34–0.42).²

Cefazolin 3 g versus 2 g for obese patients

There are no data from randomized trials of cesarean delivery that directly compare the efficacy of preoperative cefazolin at doses of 2 g and 3 g to reduce the risk of infection. However, based on the observation that, for any given dose of cefazolin, circulating levels are reduced in obese patients, many authorities recommend that if the patient weighs ≥120 kg that 3 g of cefazolin should be administered.³

Extended-spectrum preoperative antibiotics

Some experts recommend that, for women in labor and for women with more than 4 hours of ruptured membranes, IV azithromycin 500 mg be added to the standard narrow-spectrum cefazolin regimen to reduce the rate of postoperative infection. In one trial, 2,013 women who were in labor or had more than 4 hours of ruptured membranes were randomly assigned to IV cefazolin alone or IV cefazolin plus azithromycin 500 mg prior to cesarean delivery.⁴ The cefazolin dose was reported to be weight-based utilizing the BMI at the time of delivery. The rates of endometritis (3.8% vs 6.1%) and wound infection (2.4% vs 6.6%) were lower in the women receiving extended-spectrum antibiotics versus cefazolin monotherapy.

Concerns have been raised about the impact of extended-spectrum antibiotics on the newborn microbiome and risk of accelerating the emergence of bacteria resistant to available antibiotics. Limiting the use of azithromycin to those cesarean delivery cases in which the patient is immunosuppressed, diabetic, obese, in labor and/or with prolonged ruptured membranes would reduce the number of women and newborns exposed to the drug and achieve the immediate health goal of reducing surgical infection.

Preoperative vaginal preparation

Many authorities recommend the use of a preoperative povidone- iodine vaginal scrub for 30 seconds prior to cesarean delivery for women in labor and women with ruptured membranes. In a meta-analysis of 16 trials involving 4,837 women, the women who received vaginal cleansing before cesarean delivery had a significantly lower incidence of endometritis (4.5% vs 8.8%) and postoperative fever (9.4% vs 14.9%) compared with those who did not have vaginal cleansing.⁵ Most of the benefit in reducing the risk of endometritis was confined to women in labor before the cesarean delivery (8.1% vs 13.8%) and women with ruptured membranes (4.3% vs 20.1%).⁵

Metronidazole gel 5 g also has been reported to be effective in reducing the rate of endometritis associated with cesarean delivery. In one study, 224 women having a cesarean delivery for various indications were randomly assigned to preoperative treatment with vaginally administered metronidazole gel 5 g or placebo gel. All women also received one dose of preoperative intravenous antibiotics. The rates of endometritis were 7% and 17% in the metronidazole and placebo groups, respectively.⁶

Povidone-iodine is approved for vaginal surgical site cleansing. For women with allergies to iodine or povidone-iodine, the options for vaginal cleansing are limited. The American College of Obstetricians and Gynecologists has noted the chlorhexidine gluconate solutions with a high concentration of alcohol should not be used for vaginal cleansing because the alcohol can irritate the mucosal epithelium. However, although not US Food and Drug Administration–approved for vaginal cleansing, solutions of chlorhexidine with a low alcohol content (Hibiclens, chlorhexidine with 4% alcohol concentration) are thought to be safe and may be considered for off-label use in vaginal cleansing.⁷

Preoperative abdominal preparation with chlorhexidine

Some authorities recommend skin preparation with chlorhexidine rather than povidone-iodine prior to cesarean delivery. Two recent randomized trials in women undergoing cesarean delivery^8,9 and one trial in patients undergoing general surgery operations¹⁰ reported a reduction in surgical site infection with chlorhexidine. However, other trials have reported no difference in the rate of surgical site infection with these two skin preparation methods.^11,12

Changing gloves and equipment after delivery of the newborn

Currently there is no high-quality evidence that changing gloves after delivery of the newborn or using new surgical instruments for closure reduces the risk of postcesarean infection. Two small clinical trials reported that changing gloves after delivery of the newborn did not reduce the rate of postcesarean infection.^13,14

Postoperative antibiotics (a heretical challenge to the central dogma of antibiotic prophylaxis in surgery)

The central dogma of antibiotic prevention of postoperative infection is that antibiotics administered just before skin incision are effective, and postoperative antibiotics to prevent surgical infection generally are not useful. For the case of cesarean delivery, where the rate of postcesarean infection is very high, that dogma is being questioned. In a recent clinical trial, 403 women with a prepregnancy BMI ≥30 kg/m² were randomly assigned to postcesarean treatment with oral cephalexin plus metronidazole (500 mg of each medication every 8 hours for 6 doses) or placebo pills.¹⁵ All women received preoperative IV cefazolin 2 g, indicating that the dosing was probably not weight-based. The surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 6.4% and 15.4%, respectively (RR, 0.41; 95% CI, 0.22–0.77; P = .01). In a subgroup analysis based on the presence or absence of ruptured membranes, postoperative oral cephalexin plus metronidazole was most beneficial for the women with ruptured membranes. Among women with ruptured membranes the surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 9.5% and 30.2%, respectively. Among women with intact membranes the surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 5% and 8.7%, respectively.

Given that these findings are not consistent with current dogma, clinicians should be cautious about using postcesarean antibiotics and await confirmation in additional trials. Of relevance, a randomized study of women with chorioamnionitis who were treated precesarean delivery with ampicillin, gentamicin, and clindamycin did not benefit from the administration of additional postoperative antibiotics (one additional dose of gentamicin and clindamycin) compared with no postdelivery antibiotics.¹⁶

Does suture selection matter?

In one randomized trial comparing two suture types, 550 women undergoing nonemergent cesarean delivery were randomly assigned to subcuticular skin closure with polyglactin 910 (Vicryl) or poliglecaprone 25 (Monocryl) suture. The poliglecaprone 25 suture was associated with a lower rate of wound complications (8.8% vs 14.4%; 95% CI, 0.37–99; P = .04).¹⁷ However, a post-hoc analysis of a randomized trial of skin preparation did not observe a difference in wound complications between the use of polyglactinor poliglecaprone suture for skin closure.¹⁸

Prophylactic negative-pressure wound therapy: An evolving best practice?

A meta-analysis of 6 randomized trials and 3 cohort studies reported that in high-risk obese women the use of prophylactic negative-pressure wound therapy compared with standard wound dressing resulted in a decrease in surgical site infection (RR, 0.45; 95% CI, 0.31–0.66).¹⁹ The number needed to treat was 17. In one recent study, the wound outcomes following cesarean delivery among women with a BMI ≥40 kg/m² were compared in 234 women who received and 233 women who did not receive negative-pressure wound therapy.²⁰ Wound infection was observed in 5.6% and 9.9% of the treated and untreated women, respectively.²⁰ However, another meta-analysis of prophylactic negative-pressure wound therapy for obese women undergoing cesarean delivery did not report any benefit.²¹

Let’s work on continuous improvement

Cesarean delivery is a common major operation and is associated with wound infections and endometritis at rates much greater than those observed after vaginal delivery or other major intra-abdominal operations. As obstetricians, we can do more to guide practice toward continuous improvement in surgical outcomes. Systematically using a bundle of evidence-based interventions, including proper antibiotic selection, timing, and dosing; use of hair removal with clippers; use of chlorhexidine abdominal prep; removal of the placenta with gentle traction; and closure of the subcutaneous layer if tissue depth is ≥2 cm, will reduce the rate of postcesarean infection.²² Although aspirational, we may, someday, achieve a post‑cesarean infection rate less than 1%!

CASE Conclusion
The patient was noted to be at high risk for postcesarean infection because she had both an elevated BMI and ruptured membranes. The surgeon astutely decided to administer cefazolin 3 g and azithromycin 500 mg, cleanse the vagina with povidone-iodine, use chlorhexidine for the abdominal prep, use poliglecaprone 25 subcuticular skin closure, and did not use postoperative antibiotics or prophylactic wound vacuum. Following an uneventful cesarean delivery, the patient was discharged without an infection on postoperative day 4.

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.

Halsted’s surgical principles

Dr. William Steward Halsted, the first chief of surgery at Johns Hopkins Hospital, articulated a set of surgical principles that included strict aseptic technique, gentle tissue handling, meticulous hemostasis, minimum tension on tissue, accurate tissue apposition, preservation of blood supply, and obliteration of dead space where appropriate. These principles of “safe surgery” are believed to improve surgical outcomes and reduce the risk of surgical site infection.¹

Preoperative antibiotics

All obstetricians who perform cesarean delivery know the importance of administering a narrow-spectrum antibiotic, such as cefazolin or ampicillin, prior to the skin incision, but not more than 60 minutes before the incision, to help reduce the risk of wound infection and endometritis. In a meta-analysis of 82 studies involving more than 13,000 women the administration of a preoperative antibiotic compared with placebo reduced the risk of wound infection (relative risk [RR], 0.40; 95% confidence interval [CI], 0.35–0.46) and endometritis (RR, 0.38; 95% CI, 0.34–0.42).²

Cefazolin 3 g versus 2 g for obese patients

There are no data from randomized trials of cesarean delivery that directly compare the efficacy of preoperative cefazolin at doses of 2 g and 3 g to reduce the risk of infection. However, based on the observation that, for any given dose of cefazolin, circulating levels are reduced in obese patients, many authorities recommend that if the patient weighs ≥120 kg that 3 g of cefazolin should be administered.³

Extended-spectrum preoperative antibiotics

Some experts recommend that, for women in labor and for women with more than 4 hours of ruptured membranes, IV azithromycin 500 mg be added to the standard narrow-spectrum cefazolin regimen to reduce the rate of postoperative infection. In one trial, 2,013 women who were in labor or had more than 4 hours of ruptured membranes were randomly assigned to IV cefazolin alone or IV cefazolin plus azithromycin 500 mg prior to cesarean delivery.⁴ The cefazolin dose was reported to be weight-based utilizing the BMI at the time of delivery. The rates of endometritis (3.8% vs 6.1%) and wound infection (2.4% vs 6.6%) were lower in the women receiving extended-spectrum antibiotics versus cefazolin monotherapy.

Concerns have been raised about the impact of extended-spectrum antibiotics on the newborn microbiome and risk of accelerating the emergence of bacteria resistant to available antibiotics. Limiting the use of azithromycin to those cesarean delivery cases in which the patient is immunosuppressed, diabetic, obese, in labor and/or with prolonged ruptured membranes would reduce the number of women and newborns exposed to the drug and achieve the immediate health goal of reducing surgical infection.

Preoperative vaginal preparation

Many authorities recommend the use of a preoperative povidone- iodine vaginal scrub for 30 seconds prior to cesarean delivery for women in labor and women with ruptured membranes. In a meta-analysis of 16 trials involving 4,837 women, the women who received vaginal cleansing before cesarean delivery had a significantly lower incidence of endometritis (4.5% vs 8.8%) and postoperative fever (9.4% vs 14.9%) compared with those who did not have vaginal cleansing.⁵ Most of the benefit in reducing the risk of endometritis was confined to women in labor before the cesarean delivery (8.1% vs 13.8%) and women with ruptured membranes (4.3% vs 20.1%).⁵

Metronidazole gel 5 g also has been reported to be effective in reducing the rate of endometritis associated with cesarean delivery. In one study, 224 women having a cesarean delivery for various indications were randomly assigned to preoperative treatment with vaginally administered metronidazole gel 5 g or placebo gel. All women also received one dose of preoperative intravenous antibiotics. The rates of endometritis were 7% and 17% in the metronidazole and placebo groups, respectively.⁶

Povidone-iodine is approved for vaginal surgical site cleansing. For women with allergies to iodine or povidone-iodine, the options for vaginal cleansing are limited. The American College of Obstetricians and Gynecologists has noted the chlorhexidine gluconate solutions with a high concentration of alcohol should not be used for vaginal cleansing because the alcohol can irritate the mucosal epithelium. However, although not US Food and Drug Administration–approved for vaginal cleansing, solutions of chlorhexidine with a low alcohol content (Hibiclens, chlorhexidine with 4% alcohol concentration) are thought to be safe and may be considered for off-label use in vaginal cleansing.⁷

Preoperative abdominal preparation with chlorhexidine

Some authorities recommend skin preparation with chlorhexidine rather than povidone-iodine prior to cesarean delivery. Two recent randomized trials in women undergoing cesarean delivery^8,9 and one trial in patients undergoing general surgery operations¹⁰ reported a reduction in surgical site infection with chlorhexidine. However, other trials have reported no difference in the rate of surgical site infection with these two skin preparation methods.^11,12

Changing gloves and equipment after delivery of the newborn

Currently there is no high-quality evidence that changing gloves after delivery of the newborn or using new surgical instruments for closure reduces the risk of postcesarean infection. Two small clinical trials reported that changing gloves after delivery of the newborn did not reduce the rate of postcesarean infection.^13,14

Postoperative antibiotics (a heretical challenge to the central dogma of antibiotic prophylaxis in surgery)

The central dogma of antibiotic prevention of postoperative infection is that antibiotics administered just before skin incision are effective, and postoperative antibiotics to prevent surgical infection generally are not useful. For the case of cesarean delivery, where the rate of postcesarean infection is very high, that dogma is being questioned. In a recent clinical trial, 403 women with a prepregnancy BMI ≥30 kg/m² were randomly assigned to postcesarean treatment with oral cephalexin plus metronidazole (500 mg of each medication every 8 hours for 6 doses) or placebo pills.¹⁵ All women received preoperative IV cefazolin 2 g, indicating that the dosing was probably not weight-based. The surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 6.4% and 15.4%, respectively (RR, 0.41; 95% CI, 0.22–0.77; P = .01). In a subgroup analysis based on the presence or absence of ruptured membranes, postoperative oral cephalexin plus metronidazole was most beneficial for the women with ruptured membranes. Among women with ruptured membranes the surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 9.5% and 30.2%, respectively. Among women with intact membranes the surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 5% and 8.7%, respectively.

Given that these findings are not consistent with current dogma, clinicians should be cautious about using postcesarean antibiotics and await confirmation in additional trials. Of relevance, a randomized study of women with chorioamnionitis who were treated precesarean delivery with ampicillin, gentamicin, and clindamycin did not benefit from the administration of additional postoperative antibiotics (one additional dose of gentamicin and clindamycin) compared with no postdelivery antibiotics.¹⁶

Does suture selection matter?

In one randomized trial comparing two suture types, 550 women undergoing nonemergent cesarean delivery were randomly assigned to subcuticular skin closure with polyglactin 910 (Vicryl) or poliglecaprone 25 (Monocryl) suture. The poliglecaprone 25 suture was associated with a lower rate of wound complications (8.8% vs 14.4%; 95% CI, 0.37–99; P = .04).¹⁷ However, a post-hoc analysis of a randomized trial of skin preparation did not observe a difference in wound complications between the use of polyglactinor poliglecaprone suture for skin closure.¹⁸

Prophylactic negative-pressure wound therapy: An evolving best practice?

A meta-analysis of 6 randomized trials and 3 cohort studies reported that in high-risk obese women the use of prophylactic negative-pressure wound therapy compared with standard wound dressing resulted in a decrease in surgical site infection (RR, 0.45; 95% CI, 0.31–0.66).¹⁹ The number needed to treat was 17. In one recent study, the wound outcomes following cesarean delivery among women with a BMI ≥40 kg/m² were compared in 234 women who received and 233 women who did not receive negative-pressure wound therapy.²⁰ Wound infection was observed in 5.6% and 9.9% of the treated and untreated women, respectively.²⁰ However, another meta-analysis of prophylactic negative-pressure wound therapy for obese women undergoing cesarean delivery did not report any benefit.²¹

Let’s work on continuous improvement

Cesarean delivery is a common major operation and is associated with wound infections and endometritis at rates much greater than those observed after vaginal delivery or other major intra-abdominal operations. As obstetricians, we can do more to guide practice toward continuous improvement in surgical outcomes. Systematically using a bundle of evidence-based interventions, including proper antibiotic selection, timing, and dosing; use of hair removal with clippers; use of chlorhexidine abdominal prep; removal of the placenta with gentle traction; and closure of the subcutaneous layer if tissue depth is ≥2 cm, will reduce the rate of postcesarean infection.²² Although aspirational, we may, someday, achieve a post‑cesarean infection rate less than 1%!

CASE Conclusion
The patient was noted to be at high risk for postcesarean infection because she had both an elevated BMI and ruptured membranes. The surgeon astutely decided to administer cefazolin 3 g and azithromycin 500 mg, cleanse the vagina with povidone-iodine, use chlorhexidine for the abdominal prep, use poliglecaprone 25 subcuticular skin closure, and did not use postoperative antibiotics or prophylactic wound vacuum. Following an uneventful cesarean delivery, the patient was discharged without an infection on postoperative day 4.

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.

Halsted’s surgical principles

Dr. William Steward Halsted, the first chief of surgery at Johns Hopkins Hospital, articulated a set of surgical principles that included strict aseptic technique, gentle tissue handling, meticulous hemostasis, minimum tension on tissue, accurate tissue apposition, preservation of blood supply, and obliteration of dead space where appropriate. These principles of “safe surgery” are believed to improve surgical outcomes and reduce the risk of surgical site infection.¹

Preoperative antibiotics

All obstetricians who perform cesarean delivery know the importance of administering a narrow-spectrum antibiotic, such as cefazolin or ampicillin, prior to the skin incision, but not more than 60 minutes before the incision, to help reduce the risk of wound infection and endometritis. In a meta-analysis of 82 studies involving more than 13,000 women the administration of a preoperative antibiotic compared with placebo reduced the risk of wound infection (relative risk [RR], 0.40; 95% confidence interval [CI], 0.35–0.46) and endometritis (RR, 0.38; 95% CI, 0.34–0.42).²

Cefazolin 3 g versus 2 g for obese patients

There are no data from randomized trials of cesarean delivery that directly compare the efficacy of preoperative cefazolin at doses of 2 g and 3 g to reduce the risk of infection. However, based on the observation that, for any given dose of cefazolin, circulating levels are reduced in obese patients, many authorities recommend that if the patient weighs ≥120 kg that 3 g of cefazolin should be administered.³

Extended-spectrum preoperative antibiotics

Some experts recommend that, for women in labor and for women with more than 4 hours of ruptured membranes, IV azithromycin 500 mg be added to the standard narrow-spectrum cefazolin regimen to reduce the rate of postoperative infection. In one trial, 2,013 women who were in labor or had more than 4 hours of ruptured membranes were randomly assigned to IV cefazolin alone or IV cefazolin plus azithromycin 500 mg prior to cesarean delivery.⁴ The cefazolin dose was reported to be weight-based utilizing the BMI at the time of delivery. The rates of endometritis (3.8% vs 6.1%) and wound infection (2.4% vs 6.6%) were lower in the women receiving extended-spectrum antibiotics versus cefazolin monotherapy.

Concerns have been raised about the impact of extended-spectrum antibiotics on the newborn microbiome and risk of accelerating the emergence of bacteria resistant to available antibiotics. Limiting the use of azithromycin to those cesarean delivery cases in which the patient is immunosuppressed, diabetic, obese, in labor and/or with prolonged ruptured membranes would reduce the number of women and newborns exposed to the drug and achieve the immediate health goal of reducing surgical infection.

Preoperative vaginal preparation

Many authorities recommend the use of a preoperative povidone- iodine vaginal scrub for 30 seconds prior to cesarean delivery for women in labor and women with ruptured membranes. In a meta-analysis of 16 trials involving 4,837 women, the women who received vaginal cleansing before cesarean delivery had a significantly lower incidence of endometritis (4.5% vs 8.8%) and postoperative fever (9.4% vs 14.9%) compared with those who did not have vaginal cleansing.⁵ Most of the benefit in reducing the risk of endometritis was confined to women in labor before the cesarean delivery (8.1% vs 13.8%) and women with ruptured membranes (4.3% vs 20.1%).⁵

Metronidazole gel 5 g also has been reported to be effective in reducing the rate of endometritis associated with cesarean delivery. In one study, 224 women having a cesarean delivery for various indications were randomly assigned to preoperative treatment with vaginally administered metronidazole gel 5 g or placebo gel. All women also received one dose of preoperative intravenous antibiotics. The rates of endometritis were 7% and 17% in the metronidazole and placebo groups, respectively.⁶

Povidone-iodine is approved for vaginal surgical site cleansing. For women with allergies to iodine or povidone-iodine, the options for vaginal cleansing are limited. The American College of Obstetricians and Gynecologists has noted the chlorhexidine gluconate solutions with a high concentration of alcohol should not be used for vaginal cleansing because the alcohol can irritate the mucosal epithelium. However, although not US Food and Drug Administration–approved for vaginal cleansing, solutions of chlorhexidine with a low alcohol content (Hibiclens, chlorhexidine with 4% alcohol concentration) are thought to be safe and may be considered for off-label use in vaginal cleansing.⁷

Preoperative abdominal preparation with chlorhexidine

Some authorities recommend skin preparation with chlorhexidine rather than povidone-iodine prior to cesarean delivery. Two recent randomized trials in women undergoing cesarean delivery^8,9 and one trial in patients undergoing general surgery operations¹⁰ reported a reduction in surgical site infection with chlorhexidine. However, other trials have reported no difference in the rate of surgical site infection with these two skin preparation methods.^11,12

Changing gloves and equipment after delivery of the newborn

Currently there is no high-quality evidence that changing gloves after delivery of the newborn or using new surgical instruments for closure reduces the risk of postcesarean infection. Two small clinical trials reported that changing gloves after delivery of the newborn did not reduce the rate of postcesarean infection.^13,14

Postoperative antibiotics (a heretical challenge to the central dogma of antibiotic prophylaxis in surgery)

The central dogma of antibiotic prevention of postoperative infection is that antibiotics administered just before skin incision are effective, and postoperative antibiotics to prevent surgical infection generally are not useful. For the case of cesarean delivery, where the rate of postcesarean infection is very high, that dogma is being questioned. In a recent clinical trial, 403 women with a prepregnancy BMI ≥30 kg/m² were randomly assigned to postcesarean treatment with oral cephalexin plus metronidazole (500 mg of each medication every 8 hours for 6 doses) or placebo pills.¹⁵ All women received preoperative IV cefazolin 2 g, indicating that the dosing was probably not weight-based. The surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 6.4% and 15.4%, respectively (RR, 0.41; 95% CI, 0.22–0.77; P = .01). In a subgroup analysis based on the presence or absence of ruptured membranes, postoperative oral cephalexin plus metronidazole was most beneficial for the women with ruptured membranes. Among women with ruptured membranes the surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 9.5% and 30.2%, respectively. Among women with intact membranes the surgical site infection rates in the cephalexin plus metronidazole and placebo groups were 5% and 8.7%, respectively.

Given that these findings are not consistent with current dogma, clinicians should be cautious about using postcesarean antibiotics and await confirmation in additional trials. Of relevance, a randomized study of women with chorioamnionitis who were treated precesarean delivery with ampicillin, gentamicin, and clindamycin did not benefit from the administration of additional postoperative antibiotics (one additional dose of gentamicin and clindamycin) compared with no postdelivery antibiotics.¹⁶

Does suture selection matter?

In one randomized trial comparing two suture types, 550 women undergoing nonemergent cesarean delivery were randomly assigned to subcuticular skin closure with polyglactin 910 (Vicryl) or poliglecaprone 25 (Monocryl) suture. The poliglecaprone 25 suture was associated with a lower rate of wound complications (8.8% vs 14.4%; 95% CI, 0.37–99; P = .04).¹⁷ However, a post-hoc analysis of a randomized trial of skin preparation did not observe a difference in wound complications between the use of polyglactinor poliglecaprone suture for skin closure.¹⁸

Prophylactic negative-pressure wound therapy: An evolving best practice?

A meta-analysis of 6 randomized trials and 3 cohort studies reported that in high-risk obese women the use of prophylactic negative-pressure wound therapy compared with standard wound dressing resulted in a decrease in surgical site infection (RR, 0.45; 95% CI, 0.31–0.66).¹⁹ The number needed to treat was 17. In one recent study, the wound outcomes following cesarean delivery among women with a BMI ≥40 kg/m² were compared in 234 women who received and 233 women who did not receive negative-pressure wound therapy.²⁰ Wound infection was observed in 5.6% and 9.9% of the treated and untreated women, respectively.²⁰ However, another meta-analysis of prophylactic negative-pressure wound therapy for obese women undergoing cesarean delivery did not report any benefit.²¹

Let’s work on continuous improvement

Cesarean delivery is a common major operation and is associated with wound infections and endometritis at rates much greater than those observed after vaginal delivery or other major intra-abdominal operations. As obstetricians, we can do more to guide practice toward continuous improvement in surgical outcomes. Systematically using a bundle of evidence-based interventions, including proper antibiotic selection, timing, and dosing; use of hair removal with clippers; use of chlorhexidine abdominal prep; removal of the placenta with gentle traction; and closure of the subcutaneous layer if tissue depth is ≥2 cm, will reduce the rate of postcesarean infection.²² Although aspirational, we may, someday, achieve a post‑cesarean infection rate less than 1%!

CASE Conclusion
The patient was noted to be at high risk for postcesarean infection because she had both an elevated BMI and ruptured membranes. The surgeon astutely decided to administer cefazolin 3 g and azithromycin 500 mg, cleanse the vagina with povidone-iodine, use chlorhexidine for the abdominal prep, use poliglecaprone 25 subcuticular skin closure, and did not use postoperative antibiotics or prophylactic wound vacuum. Following an uneventful cesarean delivery, the patient was discharged without an infection on postoperative day 4.

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.

Why most heart failure may be preventable. Statins miss the mark in familial high cholesterol. Why mumps outbreaks are on the rise. And how using epileptic drugs in pregnancy affects school test scores.

Listen to the MDedge Daily News podcast for all the details on today’s top news.
 

Why most heart failure may be preventable. Statins miss the mark in familial high cholesterol. Why mumps outbreaks are on the rise. And how using epileptic drugs in pregnancy affects school test scores.

Listen to the MDedge Daily News podcast for all the details on today’s top news.
 

Why most heart failure may be preventable. Statins miss the mark in familial high cholesterol. Why mumps outbreaks are on the rise. And how using epileptic drugs in pregnancy affects school test scores.

Listen to the MDedge Daily News podcast for all the details on today’s top news.
 

Axial spondyloarthritis (axSpA) disease activity in pregnant women appears to remain mostly stable, with slight worsening in the second trimester, according to results of a prospective study.

“In the largest prospective study to date exploring disease activity during pregnancy in women with axSpA, we found that the majority experienced stable, low disease activity,” Kristin Ursin, MD, of the Trondheim (Norway) University Hospital and her associates wrote in Rheumatology. “In accordance with two previous studies, we found a small increase in disease activity in the second trimester.”

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SOURCE: Ursin K et al. Rheumatology. 2018 Mar 14. doi: 10.1093/rheumatology/key047.

Axial spondyloarthritis (axSpA) disease activity in pregnant women appears to remain mostly stable, with slight worsening in the second trimester, according to results of a prospective study.

“In the largest prospective study to date exploring disease activity during pregnancy in women with axSpA, we found that the majority experienced stable, low disease activity,” Kristin Ursin, MD, of the Trondheim (Norway) University Hospital and her associates wrote in Rheumatology. “In accordance with two previous studies, we found a small increase in disease activity in the second trimester.”

Jupiterimages/Thinkstock

[email protected]

SOURCE: Ursin K et al. Rheumatology. 2018 Mar 14. doi: 10.1093/rheumatology/key047.

Axial spondyloarthritis (axSpA) disease activity in pregnant women appears to remain mostly stable, with slight worsening in the second trimester, according to results of a prospective study.

“In the largest prospective study to date exploring disease activity during pregnancy in women with axSpA, we found that the majority experienced stable, low disease activity,” Kristin Ursin, MD, of the Trondheim (Norway) University Hospital and her associates wrote in Rheumatology. “In accordance with two previous studies, we found a small increase in disease activity in the second trimester.”

Jupiterimages/Thinkstock

[email protected]

SOURCE: Ursin K et al. Rheumatology. 2018 Mar 14. doi: 10.1093/rheumatology/key047.

The incidence of neonatal abstinence syndrome (NAS) and the corresponding costs to Medicaid are unlikely to decline unless interventions focus on stopping opioid use by low-income mothers, said Tyler N.A. Winkelman, MD, of Hennepin County Medical Center, Minneapolis, and his associates.

Zoonar RF/Thinkstock

[email protected]

SOURCE: Winkelman TNA et al. Pediatrics. 2018;141(4):e20173520.

The incidence of neonatal abstinence syndrome (NAS) and the corresponding costs to Medicaid are unlikely to decline unless interventions focus on stopping opioid use by low-income mothers, said Tyler N.A. Winkelman, MD, of Hennepin County Medical Center, Minneapolis, and his associates.

Zoonar RF/Thinkstock

[email protected]

SOURCE: Winkelman TNA et al. Pediatrics. 2018;141(4):e20173520.

The incidence of neonatal abstinence syndrome (NAS) and the corresponding costs to Medicaid are unlikely to decline unless interventions focus on stopping opioid use by low-income mothers, said Tyler N.A. Winkelman, MD, of Hennepin County Medical Center, Minneapolis, and his associates.

Zoonar RF/Thinkstock

[email protected]

SOURCE: Winkelman TNA et al. Pediatrics. 2018;141(4):e20173520.