OBG Management

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.

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.

Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania 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.

Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania 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.

Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania 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.

My pager went off 20 minutes into my case. The circulating nurse announced that it was the chief of staff’s office, and as I migrated over to the phone, everyone was wondering what I had done to warrant a call from the boss. The nurse held the phone to my ear and Dr. Joe Hahn, a neurosurgeon and second-in-command at Cleveland Clinic, congratulated me: “You’re it,” he said. I thanked him and went back to work. My scrub tech wanted to know what happened. I told him I was just appointed chief experience officer at Cleveland Clinic. With a befuddled look, he asked what that meant. I said I wasn’t sure.

Jim gets a fast lesson on how to lead patient experience

Patient experience was a signature issue for Dr. Toby Cosgrove, our then president and chief executive officer. Although the Clinic was revered for its high-quality care, patients did not always like going there. Dr. Cosgrove passionately believed that providing a high-quality experience was as important as the best medical care, and that the experience at the Clinic needed to be improved. Another physician had held the role of chief experience officer before me, but she came from outside the system and was not practicing, which proved to be a challenge in the Clinic’s physician-dominated culture. Dr. Cosgrove wanted a physician who “grew up” in the organization to lead this initiative.

When I left my initial interview with Dr. Cosgrove, I could not define patient experience, did not know what HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) was—at the time were in the 10th percentile—and frankly had no idea how I would move a culture of 45,000 people, including 3,000 employed physicians, to embrace patient-centricity. By the time I left the Clinic in 2015, however, we had pushed our experience scores to the top quartile, realigned our culture, and had become world renown for patient experience.¹

I knew intuitively that improving the patient experience was the right thing to do. In 2004, my father had died at the Clinic from surgical complications; his experience had been terrible. At that time, we did not use the term experience, but based on the items that hospitals are graded on today, my father would have failed us on all of them.

What is patient experience?

Patient experience is not about making people happy. Fundamentally, it is about delivering safe, high-quality, patient-centric care. A 2017 Press Ganey analysis of publicly reported data from the Centers for Medicaid and Medicare demonstrated that when performance on experience measures is high, safety and quality also are high.² Similarly, in 2015, JAMA published an article using data from the National Surgical Quality Improvement Project demonstrating a significant association between patient experience scores and several objective measures of surgical quality, including mortality and complications.³

In my new role, I mercilessly told my father’s story, changed the narrative to include safety and quality, and asked my physician colleagues for their help to improve patient experience. People in health care pay very close attention to what physicians do and say, and I needed the doctors to “own it” if we were going to implement the desired change.

I also had to convince them to see themselves on the “other side.” It was not just a matter of “treating patients the way you would want to be treated.” It was about putting yourself in your patients’ shoes—having empathy for what they are experiencing and recognizing that you or a family member could be sitting in that bed. Before my father was ill, I had never been on the other side so intimately, and it was an eye-opening experience.

Retooling communication competency

For the physicians, we zeroed in on helping them improve how they communicate with patients. Communication is a high-value target for experience improvement, and it directly influences safety and quality. We produced a physician-centric communication guide that provided useful tips (see “Practical tips to help physicians improve communication with patients”). We made communication scores transparent. In addition, working with the American Academy on Communication in Healthcare (AACH), we developed a program specifically designed to help physicians improve their communication skills and practice management.⁴ The outcome was not only better scores but also higher physician engagement and lower burnout.⁵

Keeping it real

Being married to another member of the medical staff—a strong-willed and opinionated one at that—ensured that my strategic approach to improving patient experience was grounded. It gave me a safe place to test ideas and concepts, which in turn allowed me to keep my instincts framed and relevant to the needs of key stakeholders, particularly the physicians.

Read what the ObGyn wife has to say.

The ObGyn wife tells her side

When my husband was appointed chief experience officer, I naturally was happy for his accomplishment but admitted that I was not sure exactly what it meant. What was he going to be doing? Would he give up surgery, which he loved?

The experience “thing” always had been fuzzy to me. I equated experience with satisfaction, and I saw my primary role as taking care of patients, not making them happy. I believed that I had great patient relationships, so what else did I need to know to contribute to this work? The connection to safety and quality did resonate with me, though, and it made talking about patient experience more tangible.

When Jim started teasing apart what steps needed to be taken, improving the culture seemed like an obvious focus. One thing was clear: He would need to get the physicians on board by helping them to see the practical importance of this work. It could not be gimmicky or too touchy-feely. The work had to be relevant and tangible to their everyday practice. One thing he said struck a chord: “Everyone comes to health care to help people, and we all believe we are the best we can be, but clearly there are opportunities to improve, and evolve our skills.” I started to consider specific circumstances in which that made sense.

Practice to be a better communicator

Improving physician communication was a top priority. I believed that I was a very good communicator, so I was not sure I would learn much from participating in a required day-long session designed by the AACH.

For this program we convened in small groups of 8 to 10 physicians, and each person paired with a partner. The course provided an important framework that would help us to better organize the patient encounter, an approach that no one had ever taught me. It showed me how to leverage the patient’s chief complaint to empower her to set the agenda. This would avoid unnecessary and inefficient conversational tangents, such as the doorknob question—when the patient brings up the real reason for the visit as you are leaving the exam room.

The course also taught me that while I was a good communicator, I was not efficient. I learned how to listen more effectively. Notably, how we manage patients and how we communicate are learned skills, just like mastering a new surgical procedure. High performance requires thoughtful review and practice.

Work on relationship skills

I had professional colleagues who were difficult to work with or, as I knew from covering for them, had terrible relationships with patients. These interactions made my job harder and directly influenced patient care. I always found it distasteful to hear, “Dr. X treats people very poorly, but he or she is such a great doctor.” Should not doctors be both excellent at their work and excel at the human relationship side of the business? Maybe we did need to work on certain things.

An early Cleveland Clinic initiative was to immerse every employee, including physicians, in a half-day appreciative-inquiry exercise. This entailed sitting around a table with other randomly selected caregivers—a nurse, valet, environmental service worker, administrator—and discussing various topics, such as our role in the organization, teamwork, and the servant-leader philosophy. Going into this exercise, I was skeptical. But going through it fostered a deeper understanding of how we all need to work better together to drive safe, high-quality patient care. It made me reflect on what patients go through every day and the critical contribution each team member makes. The program made me think about what we do and created greater appreciation and mindfulness of our work.

Think empathy

One of the most impactful efforts was getting people to understand and appreciate being on the other side of health care. The patient experience team crafted an empathy video that showcased people—patients, families, caregivers, physicians—and their thoughts as they experienced the other side of health care. The video frames what they are thinking about in the moment and is a powerful reminder that each person has something happening in their life that affects their daily experiences. The empathy video has been viewed by millions around the world. (See “Empathy: The human connection to patient care,” at https://www.youtube.com/watch?v=cDDWvj_q-o8.)

Together we embraced the work

Amy and I shared a unique perspective on this work as the leader of the experience improvement initiative, married to a person experiencing it. We both came to realize that we did not know all there is to know about how to deliver high-quality patient care. Improving experience is both complex and highly nuanced, and it is a vital component of what we do as physicians. The Clinic’s efforts moved the organization to high performance, and everyone played a role. However, we would not have succeeded without the engagement of physician leaders.

Making patients and families happy was never part of the equation. It is about reducing patient suffering and delivering safe, high-quality care in an environment where people feel cared for. That is what the people we serve desire, and it is what we want for ourselves. Although there will always be doubters, especially among physicians, of the importance of patient experience, we must never lose sight that this is the right thing to do for our patients, our families, and ourselves.

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.

My pager went off 20 minutes into my case. The circulating nurse announced that it was the chief of staff’s office, and as I migrated over to the phone, everyone was wondering what I had done to warrant a call from the boss. The nurse held the phone to my ear and Dr. Joe Hahn, a neurosurgeon and second-in-command at Cleveland Clinic, congratulated me: “You’re it,” he said. I thanked him and went back to work. My scrub tech wanted to know what happened. I told him I was just appointed chief experience officer at Cleveland Clinic. With a befuddled look, he asked what that meant. I said I wasn’t sure.

Jim gets a fast lesson on how to lead patient experience

Patient experience was a signature issue for Dr. Toby Cosgrove, our then president and chief executive officer. Although the Clinic was revered for its high-quality care, patients did not always like going there. Dr. Cosgrove passionately believed that providing a high-quality experience was as important as the best medical care, and that the experience at the Clinic needed to be improved. Another physician had held the role of chief experience officer before me, but she came from outside the system and was not practicing, which proved to be a challenge in the Clinic’s physician-dominated culture. Dr. Cosgrove wanted a physician who “grew up” in the organization to lead this initiative.

When I left my initial interview with Dr. Cosgrove, I could not define patient experience, did not know what HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) was—at the time were in the 10th percentile—and frankly had no idea how I would move a culture of 45,000 people, including 3,000 employed physicians, to embrace patient-centricity. By the time I left the Clinic in 2015, however, we had pushed our experience scores to the top quartile, realigned our culture, and had become world renown for patient experience.¹

I knew intuitively that improving the patient experience was the right thing to do. In 2004, my father had died at the Clinic from surgical complications; his experience had been terrible. At that time, we did not use the term experience, but based on the items that hospitals are graded on today, my father would have failed us on all of them.

What is patient experience?

Patient experience is not about making people happy. Fundamentally, it is about delivering safe, high-quality, patient-centric care. A 2017 Press Ganey analysis of publicly reported data from the Centers for Medicaid and Medicare demonstrated that when performance on experience measures is high, safety and quality also are high.² Similarly, in 2015, JAMA published an article using data from the National Surgical Quality Improvement Project demonstrating a significant association between patient experience scores and several objective measures of surgical quality, including mortality and complications.³

In my new role, I mercilessly told my father’s story, changed the narrative to include safety and quality, and asked my physician colleagues for their help to improve patient experience. People in health care pay very close attention to what physicians do and say, and I needed the doctors to “own it” if we were going to implement the desired change.

I also had to convince them to see themselves on the “other side.” It was not just a matter of “treating patients the way you would want to be treated.” It was about putting yourself in your patients’ shoes—having empathy for what they are experiencing and recognizing that you or a family member could be sitting in that bed. Before my father was ill, I had never been on the other side so intimately, and it was an eye-opening experience.

Retooling communication competency

For the physicians, we zeroed in on helping them improve how they communicate with patients. Communication is a high-value target for experience improvement, and it directly influences safety and quality. We produced a physician-centric communication guide that provided useful tips (see “Practical tips to help physicians improve communication with patients”). We made communication scores transparent. In addition, working with the American Academy on Communication in Healthcare (AACH), we developed a program specifically designed to help physicians improve their communication skills and practice management.⁴ The outcome was not only better scores but also higher physician engagement and lower burnout.⁵

Keeping it real

Being married to another member of the medical staff—a strong-willed and opinionated one at that—ensured that my strategic approach to improving patient experience was grounded. It gave me a safe place to test ideas and concepts, which in turn allowed me to keep my instincts framed and relevant to the needs of key stakeholders, particularly the physicians.

Read what the ObGyn wife has to say.

The ObGyn wife tells her side

When my husband was appointed chief experience officer, I naturally was happy for his accomplishment but admitted that I was not sure exactly what it meant. What was he going to be doing? Would he give up surgery, which he loved?

The experience “thing” always had been fuzzy to me. I equated experience with satisfaction, and I saw my primary role as taking care of patients, not making them happy. I believed that I had great patient relationships, so what else did I need to know to contribute to this work? The connection to safety and quality did resonate with me, though, and it made talking about patient experience more tangible.

When Jim started teasing apart what steps needed to be taken, improving the culture seemed like an obvious focus. One thing was clear: He would need to get the physicians on board by helping them to see the practical importance of this work. It could not be gimmicky or too touchy-feely. The work had to be relevant and tangible to their everyday practice. One thing he said struck a chord: “Everyone comes to health care to help people, and we all believe we are the best we can be, but clearly there are opportunities to improve, and evolve our skills.” I started to consider specific circumstances in which that made sense.

Practice to be a better communicator

Improving physician communication was a top priority. I believed that I was a very good communicator, so I was not sure I would learn much from participating in a required day-long session designed by the AACH.

For this program we convened in small groups of 8 to 10 physicians, and each person paired with a partner. The course provided an important framework that would help us to better organize the patient encounter, an approach that no one had ever taught me. It showed me how to leverage the patient’s chief complaint to empower her to set the agenda. This would avoid unnecessary and inefficient conversational tangents, such as the doorknob question—when the patient brings up the real reason for the visit as you are leaving the exam room.

The course also taught me that while I was a good communicator, I was not efficient. I learned how to listen more effectively. Notably, how we manage patients and how we communicate are learned skills, just like mastering a new surgical procedure. High performance requires thoughtful review and practice.

Work on relationship skills

I had professional colleagues who were difficult to work with or, as I knew from covering for them, had terrible relationships with patients. These interactions made my job harder and directly influenced patient care. I always found it distasteful to hear, “Dr. X treats people very poorly, but he or she is such a great doctor.” Should not doctors be both excellent at their work and excel at the human relationship side of the business? Maybe we did need to work on certain things.

An early Cleveland Clinic initiative was to immerse every employee, including physicians, in a half-day appreciative-inquiry exercise. This entailed sitting around a table with other randomly selected caregivers—a nurse, valet, environmental service worker, administrator—and discussing various topics, such as our role in the organization, teamwork, and the servant-leader philosophy. Going into this exercise, I was skeptical. But going through it fostered a deeper understanding of how we all need to work better together to drive safe, high-quality patient care. It made me reflect on what patients go through every day and the critical contribution each team member makes. The program made me think about what we do and created greater appreciation and mindfulness of our work.

Think empathy

One of the most impactful efforts was getting people to understand and appreciate being on the other side of health care. The patient experience team crafted an empathy video that showcased people—patients, families, caregivers, physicians—and their thoughts as they experienced the other side of health care. The video frames what they are thinking about in the moment and is a powerful reminder that each person has something happening in their life that affects their daily experiences. The empathy video has been viewed by millions around the world. (See “Empathy: The human connection to patient care,” at https://www.youtube.com/watch?v=cDDWvj_q-o8.)

Together we embraced the work

Amy and I shared a unique perspective on this work as the leader of the experience improvement initiative, married to a person experiencing it. We both came to realize that we did not know all there is to know about how to deliver high-quality patient care. Improving experience is both complex and highly nuanced, and it is a vital component of what we do as physicians. The Clinic’s efforts moved the organization to high performance, and everyone played a role. However, we would not have succeeded without the engagement of physician leaders.

Making patients and families happy was never part of the equation. It is about reducing patient suffering and delivering safe, high-quality care in an environment where people feel cared for. That is what the people we serve desire, and it is what we want for ourselves. Although there will always be doubters, especially among physicians, of the importance of patient experience, we must never lose sight that this is the right thing to do for our patients, our families, and ourselves.

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.

My pager went off 20 minutes into my case. The circulating nurse announced that it was the chief of staff’s office, and as I migrated over to the phone, everyone was wondering what I had done to warrant a call from the boss. The nurse held the phone to my ear and Dr. Joe Hahn, a neurosurgeon and second-in-command at Cleveland Clinic, congratulated me: “You’re it,” he said. I thanked him and went back to work. My scrub tech wanted to know what happened. I told him I was just appointed chief experience officer at Cleveland Clinic. With a befuddled look, he asked what that meant. I said I wasn’t sure.

Jim gets a fast lesson on how to lead patient experience

Patient experience was a signature issue for Dr. Toby Cosgrove, our then president and chief executive officer. Although the Clinic was revered for its high-quality care, patients did not always like going there. Dr. Cosgrove passionately believed that providing a high-quality experience was as important as the best medical care, and that the experience at the Clinic needed to be improved. Another physician had held the role of chief experience officer before me, but she came from outside the system and was not practicing, which proved to be a challenge in the Clinic’s physician-dominated culture. Dr. Cosgrove wanted a physician who “grew up” in the organization to lead this initiative.

When I left my initial interview with Dr. Cosgrove, I could not define patient experience, did not know what HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) was—at the time were in the 10th percentile—and frankly had no idea how I would move a culture of 45,000 people, including 3,000 employed physicians, to embrace patient-centricity. By the time I left the Clinic in 2015, however, we had pushed our experience scores to the top quartile, realigned our culture, and had become world renown for patient experience.¹

I knew intuitively that improving the patient experience was the right thing to do. In 2004, my father had died at the Clinic from surgical complications; his experience had been terrible. At that time, we did not use the term experience, but based on the items that hospitals are graded on today, my father would have failed us on all of them.

What is patient experience?

Patient experience is not about making people happy. Fundamentally, it is about delivering safe, high-quality, patient-centric care. A 2017 Press Ganey analysis of publicly reported data from the Centers for Medicaid and Medicare demonstrated that when performance on experience measures is high, safety and quality also are high.² Similarly, in 2015, JAMA published an article using data from the National Surgical Quality Improvement Project demonstrating a significant association between patient experience scores and several objective measures of surgical quality, including mortality and complications.³

In my new role, I mercilessly told my father’s story, changed the narrative to include safety and quality, and asked my physician colleagues for their help to improve patient experience. People in health care pay very close attention to what physicians do and say, and I needed the doctors to “own it” if we were going to implement the desired change.

I also had to convince them to see themselves on the “other side.” It was not just a matter of “treating patients the way you would want to be treated.” It was about putting yourself in your patients’ shoes—having empathy for what they are experiencing and recognizing that you or a family member could be sitting in that bed. Before my father was ill, I had never been on the other side so intimately, and it was an eye-opening experience.

Retooling communication competency

For the physicians, we zeroed in on helping them improve how they communicate with patients. Communication is a high-value target for experience improvement, and it directly influences safety and quality. We produced a physician-centric communication guide that provided useful tips (see “Practical tips to help physicians improve communication with patients”). We made communication scores transparent. In addition, working with the American Academy on Communication in Healthcare (AACH), we developed a program specifically designed to help physicians improve their communication skills and practice management.⁴ The outcome was not only better scores but also higher physician engagement and lower burnout.⁵

Keeping it real

Being married to another member of the medical staff—a strong-willed and opinionated one at that—ensured that my strategic approach to improving patient experience was grounded. It gave me a safe place to test ideas and concepts, which in turn allowed me to keep my instincts framed and relevant to the needs of key stakeholders, particularly the physicians.

Read what the ObGyn wife has to say.

The ObGyn wife tells her side

When my husband was appointed chief experience officer, I naturally was happy for his accomplishment but admitted that I was not sure exactly what it meant. What was he going to be doing? Would he give up surgery, which he loved?

The experience “thing” always had been fuzzy to me. I equated experience with satisfaction, and I saw my primary role as taking care of patients, not making them happy. I believed that I had great patient relationships, so what else did I need to know to contribute to this work? The connection to safety and quality did resonate with me, though, and it made talking about patient experience more tangible.

When Jim started teasing apart what steps needed to be taken, improving the culture seemed like an obvious focus. One thing was clear: He would need to get the physicians on board by helping them to see the practical importance of this work. It could not be gimmicky or too touchy-feely. The work had to be relevant and tangible to their everyday practice. One thing he said struck a chord: “Everyone comes to health care to help people, and we all believe we are the best we can be, but clearly there are opportunities to improve, and evolve our skills.” I started to consider specific circumstances in which that made sense.

Practice to be a better communicator

Improving physician communication was a top priority. I believed that I was a very good communicator, so I was not sure I would learn much from participating in a required day-long session designed by the AACH.

For this program we convened in small groups of 8 to 10 physicians, and each person paired with a partner. The course provided an important framework that would help us to better organize the patient encounter, an approach that no one had ever taught me. It showed me how to leverage the patient’s chief complaint to empower her to set the agenda. This would avoid unnecessary and inefficient conversational tangents, such as the doorknob question—when the patient brings up the real reason for the visit as you are leaving the exam room.

The course also taught me that while I was a good communicator, I was not efficient. I learned how to listen more effectively. Notably, how we manage patients and how we communicate are learned skills, just like mastering a new surgical procedure. High performance requires thoughtful review and practice.

Work on relationship skills

I had professional colleagues who were difficult to work with or, as I knew from covering for them, had terrible relationships with patients. These interactions made my job harder and directly influenced patient care. I always found it distasteful to hear, “Dr. X treats people very poorly, but he or she is such a great doctor.” Should not doctors be both excellent at their work and excel at the human relationship side of the business? Maybe we did need to work on certain things.

An early Cleveland Clinic initiative was to immerse every employee, including physicians, in a half-day appreciative-inquiry exercise. This entailed sitting around a table with other randomly selected caregivers—a nurse, valet, environmental service worker, administrator—and discussing various topics, such as our role in the organization, teamwork, and the servant-leader philosophy. Going into this exercise, I was skeptical. But going through it fostered a deeper understanding of how we all need to work better together to drive safe, high-quality patient care. It made me reflect on what patients go through every day and the critical contribution each team member makes. The program made me think about what we do and created greater appreciation and mindfulness of our work.

Think empathy

One of the most impactful efforts was getting people to understand and appreciate being on the other side of health care. The patient experience team crafted an empathy video that showcased people—patients, families, caregivers, physicians—and their thoughts as they experienced the other side of health care. The video frames what they are thinking about in the moment and is a powerful reminder that each person has something happening in their life that affects their daily experiences. The empathy video has been viewed by millions around the world. (See “Empathy: The human connection to patient care,” at https://www.youtube.com/watch?v=cDDWvj_q-o8.)

Together we embraced the work

Amy and I shared a unique perspective on this work as the leader of the experience improvement initiative, married to a person experiencing it. We both came to realize that we did not know all there is to know about how to deliver high-quality patient care. Improving experience is both complex and highly nuanced, and it is a vital component of what we do as physicians. The Clinic’s efforts moved the organization to high performance, and everyone played a role. However, we would not have succeeded without the engagement of physician leaders.

Making patients and families happy was never part of the equation. It is about reducing patient suffering and delivering safe, high-quality care in an environment where people feel cared for. That is what the people we serve desire, and it is what we want for ourselves. Although there will always be doubters, especially among physicians, of the importance of patient experience, we must never lose sight that this is the right thing to do for our patients, our families, and ourselves.

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.

Effective surgical management of advanced pelvic organ prolapse (POP) depends on prolapse location and stage, presence of urinary incontinence, need for hysterectomy, the patient’s desire to maintain sexual function, type of surgery, and the surgeon’s skill and experience, among other factors. For these reasons, POP repair is not a one-size-fits all procedure.

In this article, experts in minimally invasive prolapse repair offer their perspectives on 3 surgical approaches: use of native tissue (Drs. White, Aguilar, and Rogers), abdominal sacrocolpopexy (Drs. Huber and Culligan), and transvaginal mesh (Drs. Lucente and Ton). They evaluate the evidence on these procedures and provide recommendations based on their experience of best practices for achieving surgical success and minimizing adverse events.

Using native tissue for vaginal anatomy repair

Amanda White, MD; Vivian Aguilar, MD; and Rebecca G. Rogers, MD
Dr. Rogers reports that she receives royalties from UpToDate. Drs. White and Aguilar report no financial relationships relevant to this article.

Surgical therapy is the mainstay of treatment for POP, and 20% of US women will undergo prolapse and/or stress incontinence surgery by age 80.¹ Prolapse surgery either restores the vaginal anatomy (reconstructive surgery) or obliterates the vaginal canal (obliterative surgery). Vaginal reconstruction can be performed  using the patient's native tissue or mesh. Because of concerns associated with mesh use, native tissue repairs continue to be commonly performed.

Unfortunately, not all prolapse surgeries result in prolapse cure, and recurrent prolapse that necessitates repeat operation is not rare, regardless of whether or not mesh is used.^2,3 Native tissue repairs are most commonly performed through the vaginal route, the first minimally invasive approach to prolapse surgery. Restoration of the vaginal apex has been identified as critically important in these surgeries. Apical native tissue repairs include reconstructive procedures, such as sacrospinous ligament suspension (SSLS) or uterosacral ligament suspension (USLS), and obliterative procedures, such as colpocleisis.

In this discussion, we present 2 case vignettes that highlight surgical decision making for repair of stage 3 or 4 pelvic organ prolapse utilizing these techniques.  

CASE 1 Active woman with prolapse
A 65-year-old woman (G2P2) presents with stage 3 prolapse, with the anterior compartment at +3 and the cervix at the hymen with straining. She is sexually active and desires to retain coital function. A trial of pessary has failed.

What surgical options can be considered for this patient?

Reconstruction procedures for prolapse

This patient presents with a typical configuration of prolapse; the anterior and apical compartments are the most likely to prolapse.⁴ Importantly, conservative management of her prolapse has failed. While it is not required that women have a trial with pessary prior to undergoing surgery, all women should be offered conservative management of prolapse, according to the American Urogynecologic Society (AUGS) and the American College of Obstetricians and Gynecologists (ACOG).^4,5

Apical suspension
Since this patient desires to retain coital function, her gynecologist recommends a reconstructive procedure. The combination of apical and anterior vaginal wall prolapse will require an apical suspension procedure (FIGURES 1 and 2). If suspension of the apex does not correct the anterior wall prolapse, the patient also may require anterior compartment reconstruction.

SOURCE: Siddiqui NY, Edenfield AL. Clinical challenges in the management of vaginal prolapse. Int J Womens Health. 2014;6:83–94. Used with permission.

SOURCE: Siddiqui NY, Edenfield AL. Clinical challenges in the management of vaginal prolapse. Int J Womens Health. 2014;6:83–94. Used with permission.

The 2 most commonly performed native tissue apical suspension procedures, SSLS and USLS, have equivalent outcomes at 2 years, according to a multicenter randomized trial.⁶ Therefore, the choice of procedure is at the surgeon's discretion. USLS is most commonly performed at the time of hysterectomy via an intraperitoneal approach, while SSLS is often selected for posthysterectomy vault prolapse, given its extraperitoneal location.

Suture type. Whether to use permanent suture at the time of SSLS or USLS is controversial. Some data suggest that permanent suture provides greater long-term success compared with delayed absorbable suture.⁷ However, permanent suture has been reported to be associated with higher rates of suture complications--up to 44% in USLS and 36% in SSLS--compared with a 3.5% complication rate in a USLS cohort treated with absorbable suture.^8-10

Hysterectomy versus hysteropexy. Considerable debate exists regarding whether a patient requires hysterectomy at the time of prolapse repair. In a randomized trial at 12 months' follow-up, uterine preservation by sacrospinous hysteropexy was noninferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment.¹¹ A recent meta-analysis found that apical failure rates after sacrospinous hysteropexy versus vaginal hysterectomy were not different.¹² Repeat surgery rates for prolapse also were not different between groups. The most significant disadvantage of uterine-preservation prolapse surgery, when compared with hysterectomy, is the lack of prevention and diagnosis of uterine malignancy.¹² From 2002 to 2012, rates of hysteropexy significantly increased in the United States, although rates remain low.¹³

Sling procedure pros and cons. This case patient did not report urinary incontinence, but she may develop incontinence with reduction of the anterior wall prolapse. A large randomized controlled trial that included 337 women compared sling with no sling procedures among women with prolapse undergoing transvaginal prolapse repair.¹⁴ Management with a prophylactic sling resulted in less incontinence (27.3% and 43.0%, respectively, at 12 months postoperatively) but higher rates of urinary tract infection (31.0% vs 18.3%), major bleeding complications (3.1% vs 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs 0%) (P≤.05 for all).¹⁴

CASE 1 Recommendations for this patient
For this case, we would offer the patient a transvaginal hysterectomy and USLS. At the time of repair, we would assess whether she needed an anterior repair as well. We would offer a prophylactic sling procedure and also would discuss the risks and benefits of concomitant versus interval incontinence procedures.

CASE 2 Elderly woman with severe prolapse
An 85-year-old woman (G3P3) presents with procidentia, or complete eversion of the vagina, with the cervix 10 cm outside of the hymen. She has difficulty voiding, and the prolapse is uncomfortable when walking. A trial of pessary has failed. The patient denies vaginal bleeding. She is not sexually active and does not desire to retain coital function.

What treatment options would be appropriate for this patient?

Obliterative surgery

This elderly patient presents with advanced pelvic organ prolapse, and conservative management has failed. She is not sexually active and does not desire coital function in the future, so an obliterative procedure is indicated. Colpocleisis is a minimally invasive procedure that has cure rates ranging from 91% to 100%.¹⁵ It is likely that this patient's voiding dysfunction will improve after surgery and that she will be highly satisfied with the surgery.¹⁶

The question of hysterectomy with colpocleisis
The role of hysterectomy at the time of colpocleisis is controversial. LeFort colpocleisis preserves the uterus, with the anterior and posterior vaginal walls sutured together (FIGURE 3). Hysterectomy at the time of vaginal closure increases the operative time and blood loss.¹⁵ On the other hand, closure without hysterectomy prohibits future endometrial or cervical cancer screening.

SOURCE: Baggish MS, Karram MM. Atlas of pelvic anatomy and gynecologic surgery. 3rd ed. St Louis, MO: Elsevier Saunders; 2011. Used with permission.

In a recent review using the American College of Surgeons National Surgical Quality Improvement Program database, investigators compared women who underwent colopocleisis alone with those who underwent colpocleisis with hysterectomy.¹⁷ They found that the incidence of major complications was greater among women who underwent concomitant hysterectomy, and they concluded that hysterectomy should not be performed routinely at the time of colpocleisis.¹⁷

Among 322 urogynecologists who responded to a web-based survey, only 18% routinely performed hysterectomy at the time of colpocleisis.¹⁸ Further, in a decision analysis model, the utility for colpocleisis without hysterectomy was higher in women older than age 40, suggesting that hysterectomy should be performed only in special circumstances.¹⁹

Evaluating the endometrium. If the uterus remains in situ, should endometrial evaluation be performed? If so, should ultrasonography or endometrial biopsy be used? Authors of a decision analysis model found that among women at low risk for cancer and without abnormal uterine bleeding, endometrial biopsy was not favored until the probability of cancer reached 64%.²⁰ Specifically, no evaluation or evaluation by transvaginal ultrasonography is adequate in the majority of cases.²⁰ When screened by transvaginal ultrasonography, the high, 99% negative predictive value for endometrial disease, using a cutoff value of 5 mm for endometrial stripe width, will allow most patients to avoid unnecessary tissue sampling.

Stress incontinence. It is likely that this patient's voiding dysfunction will resolve with reduction of the prolapse, and she may develop stress incontinence symptoms. In up to 68% of women, occult stress incontinence will be revealed with reduction of stage 3 or stage 4 prolapse.²¹ If the patient demonstrates stress incontinence, a midurethral sling is likely to treat her incontinence effectively, with little added risk from the procedure.²² Even among women who have an elevated postvoid residual urine volume, the incidence of sling revision is low.¹⁵

CASE 2 Procedure recommendation for this patient
For this case, we would perform a LeFort colpocleisis and discuss whether or not the patient would prefer a midurethral sling if stress incontinence was demonstrated on examination. We would not perform endometrial evaluation in this patient, as she has not been bleeding and her risk for endometrial cancer is low.

Weighing the benefits of native tissue repair

Native tissue repair when performed transvaginally is a minimally invasive approach to prolapse repair. In a multicenter randomized trial, anatomic success was reported to be 64.5% at 2 years.⁶ Long-term follow up of patients undergoing mesh sacrocolpopexy shows a similar anatomic failure rate, with up to one-third of patients meeting the definition of composite failure.³ Unlike mesh-augmented repairs, however, adverse events, including bowel obstruction, mesh exposure, and thromboembolism, are more likely to occur in the mesh sacrocolpopexy group.²³

Obliterative procedures have the highest success rates of all prolapse repairs and carry with them low morbidity. However, women must forego the ability for coitus in the future. For all native tissue vaginal repairs, the surgeon and patient must weigh the risks and benefits of concomitant anti-incontinence procedures.

Read about using abdominal sacrocolpopexy for apical prolapse repair.

Abdominal sacrocolpopexy: A tried-and-true approach for apical prolapse repair

Sarah Huber, MD, and Patrick Culligan, MD

Dr. Culligan reports that he is a shareholder in Oragami Surgical LLC and a consultant and speaker for Coloplast and Intuitive Surgical Inc. Dr. Huber reports no financial relationships relevant to this article.

CASE Woman with advanced prolapse desires surgical repair
A 55-year-old woman (G2P2) presents to her gynecologist's office reporting a vaginal bulge and pressure that has been worsening for the past year. She describes a nontender ball of tissue the size of an orange protruding past the introitus that worsens with ambulating and lifting heavy objects. She reports some urinary urgency and increased frequency and at times feels as though her bladder does not empty completely with voiding. She denies any urinary incontinence. The patient has regular bowel movements but does report some difficulty with stool evacuation. She has a history of 2 vaginal deliveries and is sexually active. She is postmenopausal, with the last menses about 4 years ago. She is active and exercises regularly.

The patient's Pap smears, mammograms, and colonoscopy are up to date and test results have been normal. She has no significant medical or surgical history and no significant family history of cancer. On examination, her body mass index is normal, as is the cardiopulmonary exam. Her pelvic organ prolapse quantification system (POP-Q) score is Aa +3, Ba +3, C +4, GH 3, PB 3, TVL 10, Ap +2, Bp +2, and D +2. The patient is interested in surgical management.

What urodynamic tests would be appropriate for this patient, and what treatment options would you recommend?  

Additional tests needed

Patients with advanced-stage pelvic organ prolapse are at an increased risk for stress urinary incontinence that may be masked by urethral "kinking" due to anatomic distortion of the periurethral support mechanism. Based on recommendations from the American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), we routinely perform a postvoid residual urine volume measurement, urinalysis, urine culture, and a prolapse reduction stress test.²⁴ If the urinalysis is positive for blood, then a preoperative cystoscopy would be indicated.

If stress incontinence is confirmed by reduction stress testing, the patient should be offered an anti-incontinence procedure, such as a mesh midurethral sling.

This patient's overactive bladder symptoms warrant investigation via complex urodynamic testing to allow for comprehensive counseling about her postoperative expectations.

Counseling the patient on the sacrocolpopexy option

Abdominal sacrocolpopexy initially was described in 1962 by Lane as a technique to affix the vaginal apex to the sacral promontory using a graft. Although the procedure has been modified over the years, the principles of using an implanted strengthening material to permanently attach the apex to the anterior longitudinal ligament at the sacrum has proven to be a highly effective and safe treatment, establishing it as the gold standard for apical prolapse repair.^25,26

Compared with other methods of apical prolapse repair, sacrocolpopexy via any approach is superior to vaginal surgery in terms of subjective and objective outcomes. In a recent systematic review comparing apical prolapse repairs, patients who underwent a vaginal approach were more likely to report awareness of their prolapse after surgery, undergo repeat surgery, have objective recurrent prolapse, and were at increased risk for postoperative stress urinary incontinence and dyspareunia.²⁶ Prospective studies within our practice have shown 1-year composite subjective and objective cure rates of 94% to 95%.^27,28

Selecting a route for sacrocolpopexy

Although sacrocolpopexy can be approached via laparotomy or conventional laparoscopy, we routinely use a robot-assisted approach, as it has been shown to be especially beneficial for complex situations, such as in patients with prior pelvic surgery, a foreshortened vagina, or obesity.^29,30

Potential complications
Sacrocolpopexy complications are rare, especially when a minimally invasive approach is used.³¹ Reported complications of minimally invasive sacrocolpopexy include gastrointestinal or genitourinary injury, bowel obstruction or ileus, incisional hernia, vascular injury, discitis or osteomyelitis, conversion to open procedure, and mesh exposure.

Vaginal mesh exposure is rare following sacrocolpopexy, but it can occur at any time following surgery.³¹ Some risk factors include mesh material selection (specifically polytetrafluoroethylene [PTFE] mesh), concurrent total hysterectomy, vaginal atrophy, and smoking.^32,33 As a result, recent recommendations have advised the use of polypropylene mesh with uterine preservation or supracervical hysterectomy at the time of sacrocolpopexy.³⁴ In fact, supracervical hysterectomy alone appears to cut down or eliminate the risk of mesh exposure in laparoscopic sacrocolpopexy.³⁵

In our practice, avoiding split-thickness vaginal dissection, employing supracervical hysterectomy techniques, and using ultralightweight mesh has resulted in mesh exposure rates approaching zero.²⁸

For atrophic vaginal tissue, one can consider prescribing preoperative vaginal estrogen for 4 to 6 weeks, but this is not essential and should not routinely delay pelvic reconstructive surgery.

What type of implant material is best?
While various materials have been used as the fixation media in sacrocolpopexy, loosely knitted synthetic type I macroporous polypropylene mesh is the best choice due to its efficacy, availability, and low adverse effect profile. We recommend a lightweight mesh with a maximum weight of 25 g/m². Two such products currently available are the UPsylon Y-Mesh (Boston Scientific, Marlborough, Massachusetts) and Restorelle Y mesh (Coloplast, Minneapolis, Minnesota). Lightweight mesh has been proven to maintain integrity, guaranteeing a successful outcome, while reducing the "mesh load" on the attached tissue.^27,28

Comparative studies with fascia lata or cross-linked porcine dermal grafts demonstrated inferior outcomes versus synthetic mesh, and currently the only biologic material on the market indicated for prolapse repair augmentation, ACell Pelvic Floor Matrix (ACell, Columbia, Maryland), has not been extensively tested in sacrocolpopexy.^36-38

Vaginal anatomy restored by sacrocolpopexy

Abdominal sacrocolpopexy, specifically via a minimally invasive approach, is an effective and long-lasting treatment that should be offered to women with advanced-stage prolapse.

Using the surgical techniques described below, including attachment of the mesh along the lengths of the anterior and posterior vaginal walls and gathering up excess tissue with mesh attachment, can provide women with adequate support for the entire vagina with restoration of normal vaginal anatomy and caliber.

Step-by-step tips for surgical efficiency

Robotic port placement

• Place the trocars in a "W" layout for the da Vinci Si Surgical System (FIGURE 4, VIDEO 1) or in a linear layout for the da Vinci Xi Surgical System (Intuitive Surgical, Sunnyvale, California). Both Si and Xi port placement includes a 3- to 5-mm assistant port in the right upper quadrant of the abdomen.

Supracervical hysterectomy, if indicated

• Maneuver the uterus with the robotic tenaculum, which obviates the need for a uterine manipulator during the hysterectomy (VIDEO 2).
• Create the bladder flap just above the upper edge of the bladder to facilitate the upcoming anterior wall dissection. This helps to prevent the development of a split-thickness dissection plane.
• 1.5 to 2 cm of cervix should be left in place, and conization should be avoided.

Anterior vaginal wall dissection

• The key to a good full-thickness dissection is sustained tissue traction and countertraction. The bedside assistant pulls the anterior peritoneal cut edge anteriorly for "gross" traction, and further "fine" traction can be created by pulling the areolar tissue with robotic forceps. The cervix is grasped with the tenaculum, which applies a constant midline cephalad countertraction (VIDEO 3).
• Sharp dissection with cold scissors allows for creation of the dissection plane, while cautery is judiciously applied only for hemostasis. If bleeding is encountered, this usually indicates that a split thickness of the vaginal wall has been created, and the surgeon should correct to the proper dissection plane.
• Dissection is made easier by taking down the bladder pillars before advancing down toward the bladder neck.
• The anterior dissection is always carried down to level of the trigone, confirmed by visualization of the Foley bulb (FIGURE 5).

Posterior vaginal wall dissection

• Begin dissection just above the rectal reflection, leaving peritoneum on the posterior cervix (VIDEO 4).
• Extend the incision bilaterally to the uterosacral ligaments only after the correct dissection plane is confirmed by visualization of the areolar tissue.
• Apply cervical traction using the tenaculum in a cephalad midline direction, and place traction on the cut edge of the posterior peritoneum using the bipolar forceps. The tenaculum wrist must be turned away from the working instruments to avoid internal clashing.
• Completely transect the right uterosacral ligament to better facilitate the creation of a contiguous peritoneal opening for burying the mesh. The remainder of the opening will be created later.
• While it is important to avoid split-thickness dissection, the vaginal plane must be "clean" (that is, without fat or adventitia) to allow for robust suturing.
• Dissection at least halfway down the posterior vaginal wall is recommended but proceeding down to the perineal body provides the most optimal support (FIGURE 6).  

Sacral dissection

• Use a noncrushing instrument to laterally sweep the bowel to the left side, effectively "plastering" the peritoneum over the sacral promontory (FIGURE 7; VIDEO 5).
• Extend the superficial peritoneal incision down the right paracolic gutter halfway between the ureter and colon until it communicates with the incised posterior peritoneal edge created during the posterior dissection.
• Identify the middle sacral artery to avoid vascular injury, but there is no need to prophylactically coagulate it.  

Vaginal mesh attachment

• Cut a lightweight Y-mesh to a length of 6 to 8 cm anteriorly and 8 to 11 cm posteriorly and place it into the surgical field (FIGURE 8; VIDEO 6). The length is determined based on the preoperative office examination and examination under anesthesia prior to starting the procedure.
• Attach the mesh securely and evenly to the anterior and posterior vaginal walls using multiple interrupted monofilament sutures. We aim to place sutures that provide mesh stability without excess vaginal wall incorporation to avoid "through-and-through" suturing.
• The posterior wall suturing is performed first, starting at the perineal body and continuing cephalad (VIDEO 7). We find it easiest to tie the knots between the mesh and the vagina in this space.
• Suture the crotch of the Y-mesh to the cervix so that no gap exists between tissue and mesh.
• For advanced-stage prolapse with significant anterior prolapse, the stretched out vaginal epithelium can be systematically gathered up to reconfigure the tissue to conform to the desired mesh dimensions (VIDEO 8). This tissue remodeling is evident even at the 2- to 4-week postoperative visit.

Peritoneal closure: Step 1

• Reapproximate the cut edges of peritoneum surrounding the vagina and cervix using a continuous purse-string suture of 0 Monocryl (poliglecaprone 25) on an SH needle (Ethicon, Somerville, New Jersey) with a fisherman's knot tied at the end (VIDEO 9). The needle passes are placed close together and close to the incised edge of the cut peritoneum.
• We typically start our peritoneal suture at the 5 o'clock position of the posterior peritoneum, extending in a clockwise direction and ultimately jumping anteriorly around the sacral arm of the mesh.
• Place the mesh within the paracolic peritoneal canal, and secure the needle for later use.

Sacral mesh attachment

• The mesh is tensioned so that a vaginal examination confirms adequate support of all the walls without excess tension or tissue banding. Some laxity of the anterior vaginal wall consistent with a mild cystocele is appropriate.
• Place 2 permanent PTFE sutures along the slope of the sacral promontory into the anterior longitudinal ligament (VIDEO 10). This avoids injury to the disc space that sits at the edge of the promontory. We do not advise the use of bone anchors as they increase the risk for discitis and osteomyelitis.
• Secure the mesh to the anterior longitudinal ligament without any tension. This is facilitated by  creating mesh slack via cephalad pressure from a vaginal probe.

Peritoneal closure: Step 2

• Close the remaining paracolic peritoneal incision, completely burying the mesh within the created canal (FIGURE 9).  
• At the end of the procedure, perform a repeat vaginal exam, rectal exam, and cystoscopy.

Technique with prior total hysterectomy  

• In patients with a prior total hysterectomy, place a 13 x 3.5 cm Breisky vaginal retractor and/or coated nonconductive stent (Marina Medical, Sunrise, Florida) into the vagina to delineate the anterior and posterior walls at the vaginal apex during dissection.
• Some surgeons may opt to retrograde fill the bladder to better identify its location.
• We routinely leave a segment of peritoneum attached to the dome of the vaginal apex for added tissue integrity to prevent erosion.

Read about using transvaginal mesh for POP repair.

Transvaginal mesh: An effective, durable option for POP repair

Vincent R. Lucente, MD, MBA, and Jessica B. Ton, MD

Dr. Lucente reports that he has received grant or research support from Advanced Tactile Imaging, Boston Scientific, Coloplast, and Valencia; is a consultant to Coloplast; is a speaker for Allergan, Boston Scientific, Coloplast, and Shionogi; and serves as an expert witness for American Medical Systems and C.R. Bard. Dr. Ton reports no financial relationships relevant to this article.

As baseline health in the elderly population continues to improve, the number of women in the United States with symptomatic POP will increase by approximately 50% by 2050.³⁹ Unfortunately, after native tissue repair (NTR) the rate of prolapse recurrence is extremely high: approximately 40% regardless of approach, as demonstrated in the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial by Barber and colleagues.⁶ The authors of that clinical trial recently revealed that at the 5-year follow-up, these failure rates progressed to 70% for sacrospinous ligament fixation and 61% for uterosacral ligament suspension (data presented at the Society of Gynecologic Surgeons Annual Scientific Meeting 2018, Orlando, Florida). This establishes that NTR is not durable enough to meet the increasing physical demands of this age group and that mesh augmentation must be considered.

For patients at increased risk of prolapse recurrence, using transvaginal mesh (TVM) is the most minimally invasive approach and is an excellent option for mesh augmentation. Avoiding adverse events during placement of TVM depends largely on optimal surgical technique.⁴⁰ (VIDEO: “Demonstration of an anterior vaginal wall dissection into the true vesicovaginal space”)

The evidence on TVM versus NTR

Several studies have examined whether TVM has a measurable benefit over NTR.

A 2016 Cochrane review by Maher and colleagues included 37 randomized trials (4,023 women) that compared TVM and biologic grafts with NTR.⁴¹ Three primary outcomes were defined: awareness of prolapse, recurrence, and repeat surgery. Compared with women treated with NTR, those treated with synthetic nonabsorbable TVM exhibited a greater reduction in awareness of prolapse (risk ratio [RR], 0.66; 95% confidence interval [CI], 0.54-0.81), decreased recurrence in the anterior compartment (RR, 0.33; 95% CI, 0.26-0.40), and decreased reoperation for prolapse (RR, 0.53; 95% CI, 0.31-0.88). The overall calculated exposure rate was 12%, with a range of 3.2% to 20.8%.⁴¹ As we will discuss, this wide range most likely is attributed to a suboptimal, split-thickness dissection. There were no differences in other key secondary outcomes, including dyspareunia, operating time, and estimated blood loss.⁴¹

Longitudinal studies are emerging as almost 2 decades have passed since TVM was introduced. In a study of 5-year follow-up after TVM placement, Meyer and colleagues reported that patients had continued significant improvements in both subjective and objective outcomes.⁴² The mesh exposure rate was 6%, attributed to severe vaginal atrophy.⁴² A 10-year observational study by Weintraub and colleagues demonstrated a recurrence rate of only 2.6% in the anterior compartment, 7.6% in the posterior (nonaugmented) compartment, and no exposures or extrusions after anterior TVM placement.⁴³

In contrast to the Cochrane review, in the 2017 multicenter PROSPECT (Prolapse surgery: Pragmatic evaluation and randomized controlled trials) trial, Glazener and colleagues found no difference in desired outcomes with TVM compared with NTR.⁴⁴ There was an overall 6% to 7% exposure rate over 2 years.⁴⁴ To reflect "real-world" practice, however, this study was intentionally designed without rigorous standardization of surgical technique. The authors reported that "appropriately experienced surgeons" performed the procedure, but it is unclear how experience was determined given that 20% of the cases were performed by "registrars," the equivalent of US residents or fellows.⁴⁵

The PROSPECT study protocol described the TVM procedure as "a standard repair with a nonabsorbable mesh inlay to support the stitches," implying that there was no apical attachment of the mesh to the sacrospinous ligament.⁴⁵ This is a suboptimal use of TVM because it does not address a detachment-type defect common in advanced prolapse. The PROSPECT study reinforces the need for better surgical training and standardization of the TVM procedure.⁴⁴

How TVM compares with sacrocolpopexy

When comparing the use of TVM with sacrocolpopexy, our experience has been that TVM yields similar outcomes to sacrocolpopexy with additional benefits. We completed a 1-year retrospective cohort study comparing robot-assisted laparoscopic sacrocolpopexy (RALS) with TVM in a total of 86 patients, with both approaches performed by the same surgeon. Both treatment groups showed statistically significant improvements in nearly all functional and quality-of-life measures, including urinary symptoms, sexual function, and POP-Q scores.⁴⁰  In particular, points Aa and Ba on the POP-Q score were significantly improved with TVM as compared to RALS. This suggests that TVM can achieve both lateral and apical support, where sacrocolpopexy addresses only the apex.⁴⁰ This has clinical significance when considering DeLancey and colleagues' dynamic magnetic resonance imaging study, which demonstrated advanced prolapse results from both lateral and apical detachment.⁴⁶ In addition, TVM placement also was considerably faster than RALS by approximately 96 minutes and could be performed using regional anesthesia. Only 1 mesh exposure in each study arm was reported.⁴⁰

Finally, as with other vaginal procedures, patients who undergo TVM placement require minimal to no pain medication postoperatively and report faster return to daily activities. Almost none of our patients require narcotics, which is a significant benefit in the face of the ongoing national opioid crisis.

Gutman and colleagues compared laparoscopic mesh hysteropexy with TVM; they demonstrated comparable cure rates and, again, significantly longer operative times for the laparoscopic approach (174 vs 64 minutes; P<.0001).⁴⁷ This multicenter study reported mesh exposure rates of 2.7% for laparoscopy and 6.6% for TVM,⁴⁷ again likely due to a split-thickness dissection.

Safety of TVM depends on the surgeon factor

Because of the reported complications associated with TVM, in 2011 the US Food and Drug Administration (FDA) issued an update on the safety and efficacy of TVM augmentation and mandated postmarket studies.⁴⁸ While we do not dispute that the mesh exposure rates were accurate at the time the FDA document was issued, we recognize that exposure has been erroneously attributed to inherent properties of the mesh.

Mesh exposure rates reported in the literature vary widely, ranging from 0% to 30%, even when surgeons used identical mesh products.⁴⁹ This clearly establishes that the main contributing variable is surgical technique. It is critically important to recognize the "surgeon factor" as a confounder in trials that compare surgical procedures.⁵⁰ Studies on TVM have shown that low-volume surgeons had significantly higher reoperation rates, while high-volume surgeons achieved a 41% reduction in reoperations.^51,52 When TVM is performed by expert surgeons, the reported mesh exposure rates for TVM are noticeably lower.^{40,42,43,53,54}

Decreasing mesh exposure rates would reduce the most common adverse event associated with TVM, thus improving its safety. The critical step to successful TVM placement is the initial dissection. Gynecologists traditionally have performed a split-thickness, colporrhaphy-style dissection to place the mesh within the layers of the vaginal wall.⁵⁵ Placement within these planes, however, is too superficial and increases the risk of exposure. By contrast, by consistently performing a full-thickness vaginal wall dissection (FIGURE 10) and placing the mesh in the true vesicovaginal space,⁵⁶ we have achieved a TVM exposure rate as low as 0% to 3%.^40,54 If we can standardize the dissection component across our subspecialty, the rate of mesh exposure undoubtedly will decrease.

The PROSPECT investigators readily admitted what the study was not: a trial conducted "exclusively by the most experienced surgeons in the highest volume centres¬with a highly protocolised technique."⁴⁴ In reality, that is the kind of rigorous study on TVM that our subspecialty demands. We must hold ourselves accountable and ensure that only the most qualified surgeons are placing TVM.

Keep the mesh option available

We support the position of the American Urogynecologic Society in opposing an outright ban of TVM because such a restriction would deny our patients access to an effective, durable, and minimally invasive approach for prolapse repair.⁵⁷

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.

Effective surgical management of advanced pelvic organ prolapse (POP) depends on prolapse location and stage, presence of urinary incontinence, need for hysterectomy, the patient’s desire to maintain sexual function, type of surgery, and the surgeon’s skill and experience, among other factors. For these reasons, POP repair is not a one-size-fits all procedure.

In this article, experts in minimally invasive prolapse repair offer their perspectives on 3 surgical approaches: use of native tissue (Drs. White, Aguilar, and Rogers), abdominal sacrocolpopexy (Drs. Huber and Culligan), and transvaginal mesh (Drs. Lucente and Ton). They evaluate the evidence on these procedures and provide recommendations based on their experience of best practices for achieving surgical success and minimizing adverse events.

Using native tissue for vaginal anatomy repair

Amanda White, MD; Vivian Aguilar, MD; and Rebecca G. Rogers, MD
Dr. Rogers reports that she receives royalties from UpToDate. Drs. White and Aguilar report no financial relationships relevant to this article.

Surgical therapy is the mainstay of treatment for POP, and 20% of US women will undergo prolapse and/or stress incontinence surgery by age 80.¹ Prolapse surgery either restores the vaginal anatomy (reconstructive surgery) or obliterates the vaginal canal (obliterative surgery). Vaginal reconstruction can be performed  using the patient's native tissue or mesh. Because of concerns associated with mesh use, native tissue repairs continue to be commonly performed.

Unfortunately, not all prolapse surgeries result in prolapse cure, and recurrent prolapse that necessitates repeat operation is not rare, regardless of whether or not mesh is used.^2,3 Native tissue repairs are most commonly performed through the vaginal route, the first minimally invasive approach to prolapse surgery. Restoration of the vaginal apex has been identified as critically important in these surgeries. Apical native tissue repairs include reconstructive procedures, such as sacrospinous ligament suspension (SSLS) or uterosacral ligament suspension (USLS), and obliterative procedures, such as colpocleisis.

In this discussion, we present 2 case vignettes that highlight surgical decision making for repair of stage 3 or 4 pelvic organ prolapse utilizing these techniques.  

CASE 1 Active woman with prolapse
A 65-year-old woman (G2P2) presents with stage 3 prolapse, with the anterior compartment at +3 and the cervix at the hymen with straining. She is sexually active and desires to retain coital function. A trial of pessary has failed.

What surgical options can be considered for this patient?

Reconstruction procedures for prolapse

This patient presents with a typical configuration of prolapse; the anterior and apical compartments are the most likely to prolapse.⁴ Importantly, conservative management of her prolapse has failed. While it is not required that women have a trial with pessary prior to undergoing surgery, all women should be offered conservative management of prolapse, according to the American Urogynecologic Society (AUGS) and the American College of Obstetricians and Gynecologists (ACOG).^4,5

Apical suspension
Since this patient desires to retain coital function, her gynecologist recommends a reconstructive procedure. The combination of apical and anterior vaginal wall prolapse will require an apical suspension procedure (FIGURES 1 and 2). If suspension of the apex does not correct the anterior wall prolapse, the patient also may require anterior compartment reconstruction.

SOURCE: Siddiqui NY, Edenfield AL. Clinical challenges in the management of vaginal prolapse. Int J Womens Health. 2014;6:83–94. Used with permission.

SOURCE: Siddiqui NY, Edenfield AL. Clinical challenges in the management of vaginal prolapse. Int J Womens Health. 2014;6:83–94. Used with permission.

The 2 most commonly performed native tissue apical suspension procedures, SSLS and USLS, have equivalent outcomes at 2 years, according to a multicenter randomized trial.⁶ Therefore, the choice of procedure is at the surgeon's discretion. USLS is most commonly performed at the time of hysterectomy via an intraperitoneal approach, while SSLS is often selected for posthysterectomy vault prolapse, given its extraperitoneal location.

Suture type. Whether to use permanent suture at the time of SSLS or USLS is controversial. Some data suggest that permanent suture provides greater long-term success compared with delayed absorbable suture.⁷ However, permanent suture has been reported to be associated with higher rates of suture complications--up to 44% in USLS and 36% in SSLS--compared with a 3.5% complication rate in a USLS cohort treated with absorbable suture.^8-10

Hysterectomy versus hysteropexy. Considerable debate exists regarding whether a patient requires hysterectomy at the time of prolapse repair. In a randomized trial at 12 months' follow-up, uterine preservation by sacrospinous hysteropexy was noninferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment.¹¹ A recent meta-analysis found that apical failure rates after sacrospinous hysteropexy versus vaginal hysterectomy were not different.¹² Repeat surgery rates for prolapse also were not different between groups. The most significant disadvantage of uterine-preservation prolapse surgery, when compared with hysterectomy, is the lack of prevention and diagnosis of uterine malignancy.¹² From 2002 to 2012, rates of hysteropexy significantly increased in the United States, although rates remain low.¹³

Sling procedure pros and cons. This case patient did not report urinary incontinence, but she may develop incontinence with reduction of the anterior wall prolapse. A large randomized controlled trial that included 337 women compared sling with no sling procedures among women with prolapse undergoing transvaginal prolapse repair.¹⁴ Management with a prophylactic sling resulted in less incontinence (27.3% and 43.0%, respectively, at 12 months postoperatively) but higher rates of urinary tract infection (31.0% vs 18.3%), major bleeding complications (3.1% vs 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs 0%) (P≤.05 for all).¹⁴

CASE 1 Recommendations for this patient
For this case, we would offer the patient a transvaginal hysterectomy and USLS. At the time of repair, we would assess whether she needed an anterior repair as well. We would offer a prophylactic sling procedure and also would discuss the risks and benefits of concomitant versus interval incontinence procedures.

CASE 2 Elderly woman with severe prolapse
An 85-year-old woman (G3P3) presents with procidentia, or complete eversion of the vagina, with the cervix 10 cm outside of the hymen. She has difficulty voiding, and the prolapse is uncomfortable when walking. A trial of pessary has failed. The patient denies vaginal bleeding. She is not sexually active and does not desire to retain coital function.

What treatment options would be appropriate for this patient?

Obliterative surgery

This elderly patient presents with advanced pelvic organ prolapse, and conservative management has failed. She is not sexually active and does not desire coital function in the future, so an obliterative procedure is indicated. Colpocleisis is a minimally invasive procedure that has cure rates ranging from 91% to 100%.¹⁵ It is likely that this patient's voiding dysfunction will improve after surgery and that she will be highly satisfied with the surgery.¹⁶

The question of hysterectomy with colpocleisis
The role of hysterectomy at the time of colpocleisis is controversial. LeFort colpocleisis preserves the uterus, with the anterior and posterior vaginal walls sutured together (FIGURE 3). Hysterectomy at the time of vaginal closure increases the operative time and blood loss.¹⁵ On the other hand, closure without hysterectomy prohibits future endometrial or cervical cancer screening.

SOURCE: Baggish MS, Karram MM. Atlas of pelvic anatomy and gynecologic surgery. 3rd ed. St Louis, MO: Elsevier Saunders; 2011. Used with permission.

In a recent review using the American College of Surgeons National Surgical Quality Improvement Program database, investigators compared women who underwent colopocleisis alone with those who underwent colpocleisis with hysterectomy.¹⁷ They found that the incidence of major complications was greater among women who underwent concomitant hysterectomy, and they concluded that hysterectomy should not be performed routinely at the time of colpocleisis.¹⁷

Among 322 urogynecologists who responded to a web-based survey, only 18% routinely performed hysterectomy at the time of colpocleisis.¹⁸ Further, in a decision analysis model, the utility for colpocleisis without hysterectomy was higher in women older than age 40, suggesting that hysterectomy should be performed only in special circumstances.¹⁹

Evaluating the endometrium. If the uterus remains in situ, should endometrial evaluation be performed? If so, should ultrasonography or endometrial biopsy be used? Authors of a decision analysis model found that among women at low risk for cancer and without abnormal uterine bleeding, endometrial biopsy was not favored until the probability of cancer reached 64%.²⁰ Specifically, no evaluation or evaluation by transvaginal ultrasonography is adequate in the majority of cases.²⁰ When screened by transvaginal ultrasonography, the high, 99% negative predictive value for endometrial disease, using a cutoff value of 5 mm for endometrial stripe width, will allow most patients to avoid unnecessary tissue sampling.

Stress incontinence. It is likely that this patient's voiding dysfunction will resolve with reduction of the prolapse, and she may develop stress incontinence symptoms. In up to 68% of women, occult stress incontinence will be revealed with reduction of stage 3 or stage 4 prolapse.²¹ If the patient demonstrates stress incontinence, a midurethral sling is likely to treat her incontinence effectively, with little added risk from the procedure.²² Even among women who have an elevated postvoid residual urine volume, the incidence of sling revision is low.¹⁵

CASE 2 Procedure recommendation for this patient
For this case, we would perform a LeFort colpocleisis and discuss whether or not the patient would prefer a midurethral sling if stress incontinence was demonstrated on examination. We would not perform endometrial evaluation in this patient, as she has not been bleeding and her risk for endometrial cancer is low.

Weighing the benefits of native tissue repair

Native tissue repair when performed transvaginally is a minimally invasive approach to prolapse repair. In a multicenter randomized trial, anatomic success was reported to be 64.5% at 2 years.⁶ Long-term follow up of patients undergoing mesh sacrocolpopexy shows a similar anatomic failure rate, with up to one-third of patients meeting the definition of composite failure.³ Unlike mesh-augmented repairs, however, adverse events, including bowel obstruction, mesh exposure, and thromboembolism, are more likely to occur in the mesh sacrocolpopexy group.²³

Obliterative procedures have the highest success rates of all prolapse repairs and carry with them low morbidity. However, women must forego the ability for coitus in the future. For all native tissue vaginal repairs, the surgeon and patient must weigh the risks and benefits of concomitant anti-incontinence procedures.

Read about using abdominal sacrocolpopexy for apical prolapse repair.

Abdominal sacrocolpopexy: A tried-and-true approach for apical prolapse repair

Sarah Huber, MD, and Patrick Culligan, MD

Dr. Culligan reports that he is a shareholder in Oragami Surgical LLC and a consultant and speaker for Coloplast and Intuitive Surgical Inc. Dr. Huber reports no financial relationships relevant to this article.

CASE Woman with advanced prolapse desires surgical repair
A 55-year-old woman (G2P2) presents to her gynecologist's office reporting a vaginal bulge and pressure that has been worsening for the past year. She describes a nontender ball of tissue the size of an orange protruding past the introitus that worsens with ambulating and lifting heavy objects. She reports some urinary urgency and increased frequency and at times feels as though her bladder does not empty completely with voiding. She denies any urinary incontinence. The patient has regular bowel movements but does report some difficulty with stool evacuation. She has a history of 2 vaginal deliveries and is sexually active. She is postmenopausal, with the last menses about 4 years ago. She is active and exercises regularly.

The patient's Pap smears, mammograms, and colonoscopy are up to date and test results have been normal. She has no significant medical or surgical history and no significant family history of cancer. On examination, her body mass index is normal, as is the cardiopulmonary exam. Her pelvic organ prolapse quantification system (POP-Q) score is Aa +3, Ba +3, C +4, GH 3, PB 3, TVL 10, Ap +2, Bp +2, and D +2. The patient is interested in surgical management.

What urodynamic tests would be appropriate for this patient, and what treatment options would you recommend?  

Additional tests needed

Patients with advanced-stage pelvic organ prolapse are at an increased risk for stress urinary incontinence that may be masked by urethral "kinking" due to anatomic distortion of the periurethral support mechanism. Based on recommendations from the American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), we routinely perform a postvoid residual urine volume measurement, urinalysis, urine culture, and a prolapse reduction stress test.²⁴ If the urinalysis is positive for blood, then a preoperative cystoscopy would be indicated.

If stress incontinence is confirmed by reduction stress testing, the patient should be offered an anti-incontinence procedure, such as a mesh midurethral sling.

This patient's overactive bladder symptoms warrant investigation via complex urodynamic testing to allow for comprehensive counseling about her postoperative expectations.

Counseling the patient on the sacrocolpopexy option

Abdominal sacrocolpopexy initially was described in 1962 by Lane as a technique to affix the vaginal apex to the sacral promontory using a graft. Although the procedure has been modified over the years, the principles of using an implanted strengthening material to permanently attach the apex to the anterior longitudinal ligament at the sacrum has proven to be a highly effective and safe treatment, establishing it as the gold standard for apical prolapse repair.^25,26

Compared with other methods of apical prolapse repair, sacrocolpopexy via any approach is superior to vaginal surgery in terms of subjective and objective outcomes. In a recent systematic review comparing apical prolapse repairs, patients who underwent a vaginal approach were more likely to report awareness of their prolapse after surgery, undergo repeat surgery, have objective recurrent prolapse, and were at increased risk for postoperative stress urinary incontinence and dyspareunia.²⁶ Prospective studies within our practice have shown 1-year composite subjective and objective cure rates of 94% to 95%.^27,28

Selecting a route for sacrocolpopexy

Although sacrocolpopexy can be approached via laparotomy or conventional laparoscopy, we routinely use a robot-assisted approach, as it has been shown to be especially beneficial for complex situations, such as in patients with prior pelvic surgery, a foreshortened vagina, or obesity.^29,30

Potential complications
Sacrocolpopexy complications are rare, especially when a minimally invasive approach is used.³¹ Reported complications of minimally invasive sacrocolpopexy include gastrointestinal or genitourinary injury, bowel obstruction or ileus, incisional hernia, vascular injury, discitis or osteomyelitis, conversion to open procedure, and mesh exposure.

Vaginal mesh exposure is rare following sacrocolpopexy, but it can occur at any time following surgery.³¹ Some risk factors include mesh material selection (specifically polytetrafluoroethylene [PTFE] mesh), concurrent total hysterectomy, vaginal atrophy, and smoking.^32,33 As a result, recent recommendations have advised the use of polypropylene mesh with uterine preservation or supracervical hysterectomy at the time of sacrocolpopexy.³⁴ In fact, supracervical hysterectomy alone appears to cut down or eliminate the risk of mesh exposure in laparoscopic sacrocolpopexy.³⁵

In our practice, avoiding split-thickness vaginal dissection, employing supracervical hysterectomy techniques, and using ultralightweight mesh has resulted in mesh exposure rates approaching zero.²⁸

For atrophic vaginal tissue, one can consider prescribing preoperative vaginal estrogen for 4 to 6 weeks, but this is not essential and should not routinely delay pelvic reconstructive surgery.

What type of implant material is best?
While various materials have been used as the fixation media in sacrocolpopexy, loosely knitted synthetic type I macroporous polypropylene mesh is the best choice due to its efficacy, availability, and low adverse effect profile. We recommend a lightweight mesh with a maximum weight of 25 g/m². Two such products currently available are the UPsylon Y-Mesh (Boston Scientific, Marlborough, Massachusetts) and Restorelle Y mesh (Coloplast, Minneapolis, Minnesota). Lightweight mesh has been proven to maintain integrity, guaranteeing a successful outcome, while reducing the "mesh load" on the attached tissue.^27,28

Comparative studies with fascia lata or cross-linked porcine dermal grafts demonstrated inferior outcomes versus synthetic mesh, and currently the only biologic material on the market indicated for prolapse repair augmentation, ACell Pelvic Floor Matrix (ACell, Columbia, Maryland), has not been extensively tested in sacrocolpopexy.^36-38

Vaginal anatomy restored by sacrocolpopexy

Abdominal sacrocolpopexy, specifically via a minimally invasive approach, is an effective and long-lasting treatment that should be offered to women with advanced-stage prolapse.

Using the surgical techniques described below, including attachment of the mesh along the lengths of the anterior and posterior vaginal walls and gathering up excess tissue with mesh attachment, can provide women with adequate support for the entire vagina with restoration of normal vaginal anatomy and caliber.

Step-by-step tips for surgical efficiency

Robotic port placement

• Place the trocars in a "W" layout for the da Vinci Si Surgical System (FIGURE 4, VIDEO 1) or in a linear layout for the da Vinci Xi Surgical System (Intuitive Surgical, Sunnyvale, California). Both Si and Xi port placement includes a 3- to 5-mm assistant port in the right upper quadrant of the abdomen.

Supracervical hysterectomy, if indicated

• Maneuver the uterus with the robotic tenaculum, which obviates the need for a uterine manipulator during the hysterectomy (VIDEO 2).
• Create the bladder flap just above the upper edge of the bladder to facilitate the upcoming anterior wall dissection. This helps to prevent the development of a split-thickness dissection plane.
• 1.5 to 2 cm of cervix should be left in place, and conization should be avoided.