OBG Management

In this Update we discuss several exciting new recommendations for preventive treatments in pregnancy and prenatal diagnostic tests. Our A-to-Z coverage includes:

• antenatal steroids in late preterm pregnancy
• expanded list of high-risk conditions warranting low-dose aspirin for preeclampsia prevention
• chromosomal microarray analysis versus karyotype for specific clinical situations
• Zika virus infection evolving information.

Next: New recommendation for timing of late preterm antenatal steroids

New recommendation offered for timing of late preterm antenatal steroids

Gyamfi-Bannerman C, Thom EA, Blackwell SC, et al; for the NICHD Maternal-Fetal Medicine Units Network. Antenatal betamethasone for women at risk for late preterm delivery. N Engl J Med. 2016;374(14):1311-1320.

American College of Obstetricians and Gynecologists. Committee Opinion No. 677. Antenatal corticosteroidtherapy for fetal maturation. Obstet Gynecol. 2016;128(4):e187-e194.

Kamath-Rayne BD, Rozance PJ, Goldenberg RL, Jobe AH. Antenatal corticosteroids beyond 34 weeks gestation: what do we do now? Am J Obstet Gynecol. 2016;215(4):423-430.

A dramatic recommendation for obstetric practice change occurred in 2016: the option of administering antenatal steroids for fetal lung maturity after 34 weeks. In the Antenatal Late Preterm Steroids (ALPS) trial of betamethasone in the late preterm period in patients at "high risk" of imminent delivery, Gyamfi-Bannerman and colleagues demonstrated that the treated group had a significant decrease in the rate of neonatal respiratory complications.

The primary outcome, a composite of respiratory morbidities (including transient tachypnea of the newborn, surfactant use, and need for resuscitation at birth) within the first 72 hours of life, had significant differences between groups, occurring in 165 of 1,427 infants (11.6%) in the betamethasone-treated group and 202 of 1,400 (14.4%) in the placebo group (relative risk in the betamethasone group, 0.80; 95% confidence interval, 0.66-0.97; P = .02). However, there was no statistically significant difference in respiratory distress syndrome, apnea, or pneumonia between groups, and the significant difference noted in bronchopulmonary dysplasia was based on a total number of 11 cases.

In response to these findings, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) released practice advisories and interim updates, culminating in a final recommendation for a single course of betamethasone in patients at high risk of preterm delivery between 34 and 36 6/7 weeks who have not received a previous course.

Related article:
When could use of antenatal corticosteroids in the late preterm birth period be beneficial?

In a thorough review of the literature on antenatal steroid use, Kamath-Rayne and colleagues highlighted several factors that should be considered before adopting universal use of steroids at >34 weeks. These include:   

• The definition of "high risk of imminent delivery" as preterm labor with at least 3-cm dilation or 75% effacement, or spontaneous rupture of membranes. The effect of less stringent inclusion criteria in real-world clinical practice is not known, and many patients who will go on to deliver at term will receive steroids unnecessarily.
• Multiple gestation, patients with pre-existing diabetes, women who had previously received a course of steroids, and fetuses with anomalies were excluded from the ALPS study. Use of antenatal steroids in these groups at >34 weeks should be evaluated before universal adoption.

Related article:
What is the ideal gestational age for twin delivery to minimize perinatal deaths?

• The incidence of neonatal hypoglycemia in the treated group was significantly increased. This affects our colleagues in pediatrics considerably from a systems standpoint (need for changes to newborn protocols and communication between services).
• The long-term outcomes of patients exposed to steroids in the late preterm period are yet to be delineated, specifically, the potential neurodevelopmental effects of a medication known to alter preterm brain development as well as cardiovascular and metabolic consequences.

Next: Low-dose aspirin for reducing preeclampsia risk

Low-dose aspirin clearly is effective for reducing the risk of preeclampsia

American College of Obstetricians and Gynecologists. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131.

Henderson JT, Whitlock EP, O'Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the US Preventive Services Task Force. Ann Intern Med. 2014;160(10):695-703.

LeFevre ML; US Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(11):819-826.

American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Published July 11, 2016. Accessed December 6, 2016.

In the 2013 ACOG Task Force on Hypertension in Pregnancy report, low-dose aspirin (60-80 mg) was recommended to be initiated in the late first trimester to reduce preeclampsia risk for women with:

• prior early onset preeclampsia with preterm delivery at <34 weeks' gestation, or
• preeclampsia in more than one prior pregnancy.  

This recommendation was based on several meta-analyses that demonstrated a 10% to 17% reduction in risk with no increase in bleeding, placental abruption, or other adverse events.

In 2014, the US Preventive Services Task Force (USPSTF) conducted a systematic evidence review of low-dose aspirin use for prevention of morbidity and mortality from preeclampsia. That report revealed a 24% risk reduction of preeclampsia in high-risk women treated with low-dose aspirin, as well as a 14% reduction in preterm birth and a 20% reduction in fetal growth restriction. A final statement from the USPSTF in 2014 recommended low-dose aspirin (60-150 mg) starting between 12 and 28 weeks' gestation for women at "high" risk who have:

• a history of preeclampsia, especially if accompanied by an adverse outcome
• multifetal gestation
• chronic hypertension
• diabetes (type 1 or type 2)
• renal disease
• autoimmune disease (such as systematic lupus erythematosus, antiphospholipid syndrome).

Related article:
Start offering aspirin to pregnant women at high risk for preeclampsia

As of July 11, 2016, ACOG supports this expanded list of high-risk conditions. Additionally, the USPSTF identified a "moderate" risk group in which low-dose aspirin may be considered if a patient has several risk factors, such as obesity, nulliparity, family history of preeclampsia, age 35 years or older, or another poor pregnancy outcome. ACOG notes, however, that the evidence supporting this practice is uncertain and does not make a recommendation regarding aspirin use in this population. Further study should be conducted to determine the benefit of low-dose aspirin in these patients as well as the long-term effects of treatment on maternal and child outcomes.

Next: CMA for prenatal genetic diagnosis

Chromosomal microarray analysis is preferable to karyotype in certain situations  

Pauli JM, Repke JT. Update on obstetrics. OBG Manag. 2013;25(1):28-32.

Society for Maternal-Fetal Medicine (SMFM), Dugoff L, Norton ME, Kuller JA. The use of chromosomal microarray for prenatal diagnosis. Am J Obstet Gynecol. 2016;215(4):B2-B9.

American College of Obstetricians and Gynecologists. Committee Opinion No. 682. Microarrays and next- generation sequencing technology: the use of advanced genetic diagnostic tools in obstetrics and gynecology.Obstet  Gynecol. 2016;128(6):e262-e268.

We previously addressed the use of chromosomal microarray analysis (CMA) for prenatal diagnosis in our 2013 "Update on obstetrics," specifically, the question of whether CMA could replace karyotype. The main differences between karyotype and CMA are that 1) only karyotype can detect balanced translocations/inversions and 2) only CMA can detect copy number variants (CNV). There are some differences in the technology and capabilities of the 2 types of CMA currently available as well.

In our 2013 article we concluded that "The total costs of such an approach--test, interpretation, counseling, and long-term follow-up of uncertain results--are unknown at this time and may prove to be unaffordable on a population-wide basis." Today, the cost of CMA is still higher than karyotype, but it is expected to decrease and insurance coverage for this test is expected to increase.

Related article:
Cell-free DNA screening for women at low risk for fetal aneuploidy

Both SMFM and ACOG released recommendations in 2016 regarding the use of CMA in prenatal genetic diagnosis, summarized as follows:  

• CMA is recommended over karyotype for fetuses with structural abnormalities on ultrasound
  • The detection rate for clinically relevant abnormal CNVs in this population is about 6%
• CMA is recommended for diagnosis for stillbirth specimens
  • CMA does not require dividing cells and may be a quicker and more reliable test in this population
• Karotype or fluorescence in situ hybridization (FISH) is recommended for fetuses with ultrasound findings suggestive of aneuploidy
  • If it is negative, then CMA is recommended
• Karyotype or CMA is recommended for patients desiring prenatal diagnostic testing with a normal fetal ultrasound
  • The detection rate for clinically relevant CNVs in this population (advanced maternal age, abnormal serum screening, prior aneuploidy, parental anxiety) is about 1%
• Pretest and posttest counseling about the limitations of CMA and a 2% risk of detection of variants of unknown significance (VUS) should be performed by a provider who has expertise in CMA and who has access to databases with genotype/phenotype information for VUS
  • This counseling should also include the possibility of diagnosis of nonpaternity, consanguinity, and adult-onset disease
• Karyotype is recommended for couples with recurrent pregnancy loss
  • The identification of balanced translocations in this population is most relevant in this patient population
• Prenatal diagnosis with routine use of whole-genome or whole-exome sequencing is not recommended.

Next: Zika virus: Check for updates

Zika virus infection: Check often for the latest updates

American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. Practice advisory on Zika virus. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Interim-Guidance-for-Care-of-Obstetric-Patients- During-a-Zika-Virus-Outbreak. Published December 5, 2016. Accessed December 6, 2016.

Centers for Disease Control and Prevention. Zika virus. http://www.cdc.gov/zika/pregnancy/index.html. Updated August 22, 2016. Accessed December 6, 2016.

Petersen EE, Meaney-Delman D, Neblett-Fanfair R, et al. Update: interim guidance for preconception counseling and prevention of sexual transmission of Zika virus for persons with possible Zika virus exposure--United States, September 2016. MMWR Morbid Mortal Wkly Rep. 2016;65(39):1077-1081.

A yearly update on obstetrics would be remiss without mention of the Zika virus and its impact on pregnancy and reproduction. That being said, any recommendations we offer may be out of date by the time this article is published given the rapidly changing picture of Zika virus since it first dominated the headlines in 2016. Here are the basics as summarized from ACOG and the Centers for Disease Control and Prevention (CDC):

Viral spread. Zika virus may be spread in several ways: by an infected Aedes species mosquito, mother to fetus, sexual contact, blood transfusion, or laboratory exposure.

Symptoms of infection include conjunctivitis, fever, rash, and arthralgia, but most patients (4/5) are asymptomatic.

Sequelae. Zika virus infection during pregnancy is believed to cause fetal and neonatal microcephaly, intracranial calcifications, and brain and eye abnormalities. The rate of these findings in infected individuals, as well as the rate of vertical transmission, is not known.

Travel advisory. Pregnant women should not travel to areas with active Zika infection (the CDC website regularly updates these restricted areas).

Preventive measures. If traveling to an area of active Zika infection, pregnant women should take preventative measures day and night against mosquito bites, such as use of insect repellents approved by the Environmental Protection Agency, clothing that covers exposed skin, and staying indoors.

Safe sex. Abstinence or consistent condom use is recommended for pregnant women with partners who travel to or live in areas of active Zika infection.

Delay conception. Conception should be postponed for at least 6 months in men with Zika infection and at least 8 weeks in women with Zika infection.

Testing recommendations. Pregnant women with Zika virus exposure should be tested, regardless of symptoms. Symptomatic exposed nonpregnant women and all men should be tested.

Prenatal surveillance. High-risk consultation and serial ultrasounds for fetal anatomy and growth should be considered in patients with Zika virus infection during pregnancy. Amniocentesis can be considered on a case-by-case basis.

Related article:
Zika virus update: A rapidly moving target

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In this Update we discuss several exciting new recommendations for preventive treatments in pregnancy and prenatal diagnostic tests. Our A-to-Z coverage includes:

• antenatal steroids in late preterm pregnancy
• expanded list of high-risk conditions warranting low-dose aspirin for preeclampsia prevention
• chromosomal microarray analysis versus karyotype for specific clinical situations
• Zika virus infection evolving information.

Next: New recommendation for timing of late preterm antenatal steroids

New recommendation offered for timing of late preterm antenatal steroids

Gyamfi-Bannerman C, Thom EA, Blackwell SC, et al; for the NICHD Maternal-Fetal Medicine Units Network. Antenatal betamethasone for women at risk for late preterm delivery. N Engl J Med. 2016;374(14):1311-1320.

American College of Obstetricians and Gynecologists. Committee Opinion No. 677. Antenatal corticosteroidtherapy for fetal maturation. Obstet Gynecol. 2016;128(4):e187-e194.

Kamath-Rayne BD, Rozance PJ, Goldenberg RL, Jobe AH. Antenatal corticosteroids beyond 34 weeks gestation: what do we do now? Am J Obstet Gynecol. 2016;215(4):423-430.

A dramatic recommendation for obstetric practice change occurred in 2016: the option of administering antenatal steroids for fetal lung maturity after 34 weeks. In the Antenatal Late Preterm Steroids (ALPS) trial of betamethasone in the late preterm period in patients at "high risk" of imminent delivery, Gyamfi-Bannerman and colleagues demonstrated that the treated group had a significant decrease in the rate of neonatal respiratory complications.

The primary outcome, a composite of respiratory morbidities (including transient tachypnea of the newborn, surfactant use, and need for resuscitation at birth) within the first 72 hours of life, had significant differences between groups, occurring in 165 of 1,427 infants (11.6%) in the betamethasone-treated group and 202 of 1,400 (14.4%) in the placebo group (relative risk in the betamethasone group, 0.80; 95% confidence interval, 0.66-0.97; P = .02). However, there was no statistically significant difference in respiratory distress syndrome, apnea, or pneumonia between groups, and the significant difference noted in bronchopulmonary dysplasia was based on a total number of 11 cases.

In response to these findings, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) released practice advisories and interim updates, culminating in a final recommendation for a single course of betamethasone in patients at high risk of preterm delivery between 34 and 36 6/7 weeks who have not received a previous course.

Related article:
When could use of antenatal corticosteroids in the late preterm birth period be beneficial?

In a thorough review of the literature on antenatal steroid use, Kamath-Rayne and colleagues highlighted several factors that should be considered before adopting universal use of steroids at >34 weeks. These include:   

• The definition of "high risk of imminent delivery" as preterm labor with at least 3-cm dilation or 75% effacement, or spontaneous rupture of membranes. The effect of less stringent inclusion criteria in real-world clinical practice is not known, and many patients who will go on to deliver at term will receive steroids unnecessarily.
• Multiple gestation, patients with pre-existing diabetes, women who had previously received a course of steroids, and fetuses with anomalies were excluded from the ALPS study. Use of antenatal steroids in these groups at >34 weeks should be evaluated before universal adoption.

Related article:
What is the ideal gestational age for twin delivery to minimize perinatal deaths?

• The incidence of neonatal hypoglycemia in the treated group was significantly increased. This affects our colleagues in pediatrics considerably from a systems standpoint (need for changes to newborn protocols and communication between services).
• The long-term outcomes of patients exposed to steroids in the late preterm period are yet to be delineated, specifically, the potential neurodevelopmental effects of a medication known to alter preterm brain development as well as cardiovascular and metabolic consequences.

Next: Low-dose aspirin for reducing preeclampsia risk

Low-dose aspirin clearly is effective for reducing the risk of preeclampsia

American College of Obstetricians and Gynecologists. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131.

Henderson JT, Whitlock EP, O'Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the US Preventive Services Task Force. Ann Intern Med. 2014;160(10):695-703.

LeFevre ML; US Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(11):819-826.

American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Published July 11, 2016. Accessed December 6, 2016.

In the 2013 ACOG Task Force on Hypertension in Pregnancy report, low-dose aspirin (60-80 mg) was recommended to be initiated in the late first trimester to reduce preeclampsia risk for women with:

• prior early onset preeclampsia with preterm delivery at <34 weeks' gestation, or
• preeclampsia in more than one prior pregnancy.  

This recommendation was based on several meta-analyses that demonstrated a 10% to 17% reduction in risk with no increase in bleeding, placental abruption, or other adverse events.

In 2014, the US Preventive Services Task Force (USPSTF) conducted a systematic evidence review of low-dose aspirin use for prevention of morbidity and mortality from preeclampsia. That report revealed a 24% risk reduction of preeclampsia in high-risk women treated with low-dose aspirin, as well as a 14% reduction in preterm birth and a 20% reduction in fetal growth restriction. A final statement from the USPSTF in 2014 recommended low-dose aspirin (60-150 mg) starting between 12 and 28 weeks' gestation for women at "high" risk who have:

• a history of preeclampsia, especially if accompanied by an adverse outcome
• multifetal gestation
• chronic hypertension
• diabetes (type 1 or type 2)
• renal disease
• autoimmune disease (such as systematic lupus erythematosus, antiphospholipid syndrome).

Related article:
Start offering aspirin to pregnant women at high risk for preeclampsia

As of July 11, 2016, ACOG supports this expanded list of high-risk conditions. Additionally, the USPSTF identified a "moderate" risk group in which low-dose aspirin may be considered if a patient has several risk factors, such as obesity, nulliparity, family history of preeclampsia, age 35 years or older, or another poor pregnancy outcome. ACOG notes, however, that the evidence supporting this practice is uncertain and does not make a recommendation regarding aspirin use in this population. Further study should be conducted to determine the benefit of low-dose aspirin in these patients as well as the long-term effects of treatment on maternal and child outcomes.

Next: CMA for prenatal genetic diagnosis

Chromosomal microarray analysis is preferable to karyotype in certain situations  

Pauli JM, Repke JT. Update on obstetrics. OBG Manag. 2013;25(1):28-32.

Society for Maternal-Fetal Medicine (SMFM), Dugoff L, Norton ME, Kuller JA. The use of chromosomal microarray for prenatal diagnosis. Am J Obstet Gynecol. 2016;215(4):B2-B9.

American College of Obstetricians and Gynecologists. Committee Opinion No. 682. Microarrays and next- generation sequencing technology: the use of advanced genetic diagnostic tools in obstetrics and gynecology.Obstet  Gynecol. 2016;128(6):e262-e268.

We previously addressed the use of chromosomal microarray analysis (CMA) for prenatal diagnosis in our 2013 "Update on obstetrics," specifically, the question of whether CMA could replace karyotype. The main differences between karyotype and CMA are that 1) only karyotype can detect balanced translocations/inversions and 2) only CMA can detect copy number variants (CNV). There are some differences in the technology and capabilities of the 2 types of CMA currently available as well.

In our 2013 article we concluded that "The total costs of such an approach--test, interpretation, counseling, and long-term follow-up of uncertain results--are unknown at this time and may prove to be unaffordable on a population-wide basis." Today, the cost of CMA is still higher than karyotype, but it is expected to decrease and insurance coverage for this test is expected to increase.

Related article:
Cell-free DNA screening for women at low risk for fetal aneuploidy

Both SMFM and ACOG released recommendations in 2016 regarding the use of CMA in prenatal genetic diagnosis, summarized as follows:  

• CMA is recommended over karyotype for fetuses with structural abnormalities on ultrasound
  • The detection rate for clinically relevant abnormal CNVs in this population is about 6%
• CMA is recommended for diagnosis for stillbirth specimens
  • CMA does not require dividing cells and may be a quicker and more reliable test in this population
• Karotype or fluorescence in situ hybridization (FISH) is recommended for fetuses with ultrasound findings suggestive of aneuploidy
  • If it is negative, then CMA is recommended
• Karyotype or CMA is recommended for patients desiring prenatal diagnostic testing with a normal fetal ultrasound
  • The detection rate for clinically relevant CNVs in this population (advanced maternal age, abnormal serum screening, prior aneuploidy, parental anxiety) is about 1%
• Pretest and posttest counseling about the limitations of CMA and a 2% risk of detection of variants of unknown significance (VUS) should be performed by a provider who has expertise in CMA and who has access to databases with genotype/phenotype information for VUS
  • This counseling should also include the possibility of diagnosis of nonpaternity, consanguinity, and adult-onset disease
• Karyotype is recommended for couples with recurrent pregnancy loss
  • The identification of balanced translocations in this population is most relevant in this patient population
• Prenatal diagnosis with routine use of whole-genome or whole-exome sequencing is not recommended.

Next: Zika virus: Check for updates

Zika virus infection: Check often for the latest updates

American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. Practice advisory on Zika virus. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Interim-Guidance-for-Care-of-Obstetric-Patients- During-a-Zika-Virus-Outbreak. Published December 5, 2016. Accessed December 6, 2016.

Centers for Disease Control and Prevention. Zika virus. http://www.cdc.gov/zika/pregnancy/index.html. Updated August 22, 2016. Accessed December 6, 2016.

Petersen EE, Meaney-Delman D, Neblett-Fanfair R, et al. Update: interim guidance for preconception counseling and prevention of sexual transmission of Zika virus for persons with possible Zika virus exposure--United States, September 2016. MMWR Morbid Mortal Wkly Rep. 2016;65(39):1077-1081.

A yearly update on obstetrics would be remiss without mention of the Zika virus and its impact on pregnancy and reproduction. That being said, any recommendations we offer may be out of date by the time this article is published given the rapidly changing picture of Zika virus since it first dominated the headlines in 2016. Here are the basics as summarized from ACOG and the Centers for Disease Control and Prevention (CDC):

Viral spread. Zika virus may be spread in several ways: by an infected Aedes species mosquito, mother to fetus, sexual contact, blood transfusion, or laboratory exposure.

Symptoms of infection include conjunctivitis, fever, rash, and arthralgia, but most patients (4/5) are asymptomatic.

Sequelae. Zika virus infection during pregnancy is believed to cause fetal and neonatal microcephaly, intracranial calcifications, and brain and eye abnormalities. The rate of these findings in infected individuals, as well as the rate of vertical transmission, is not known.

Travel advisory. Pregnant women should not travel to areas with active Zika infection (the CDC website regularly updates these restricted areas).

Preventive measures. If traveling to an area of active Zika infection, pregnant women should take preventative measures day and night against mosquito bites, such as use of insect repellents approved by the Environmental Protection Agency, clothing that covers exposed skin, and staying indoors.

Safe sex. Abstinence or consistent condom use is recommended for pregnant women with partners who travel to or live in areas of active Zika infection.

Delay conception. Conception should be postponed for at least 6 months in men with Zika infection and at least 8 weeks in women with Zika infection.

Testing recommendations. Pregnant women with Zika virus exposure should be tested, regardless of symptoms. Symptomatic exposed nonpregnant women and all men should be tested.

Prenatal surveillance. High-risk consultation and serial ultrasounds for fetal anatomy and growth should be considered in patients with Zika virus infection during pregnancy. Amniocentesis can be considered on a case-by-case basis.

Related article:
Zika virus update: A rapidly moving target

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In this Update we discuss several exciting new recommendations for preventive treatments in pregnancy and prenatal diagnostic tests. Our A-to-Z coverage includes:

• antenatal steroids in late preterm pregnancy
• expanded list of high-risk conditions warranting low-dose aspirin for preeclampsia prevention
• chromosomal microarray analysis versus karyotype for specific clinical situations
• Zika virus infection evolving information.

Next: New recommendation for timing of late preterm antenatal steroids

New recommendation offered for timing of late preterm antenatal steroids

Gyamfi-Bannerman C, Thom EA, Blackwell SC, et al; for the NICHD Maternal-Fetal Medicine Units Network. Antenatal betamethasone for women at risk for late preterm delivery. N Engl J Med. 2016;374(14):1311-1320.

American College of Obstetricians and Gynecologists. Committee Opinion No. 677. Antenatal corticosteroidtherapy for fetal maturation. Obstet Gynecol. 2016;128(4):e187-e194.

Kamath-Rayne BD, Rozance PJ, Goldenberg RL, Jobe AH. Antenatal corticosteroids beyond 34 weeks gestation: what do we do now? Am J Obstet Gynecol. 2016;215(4):423-430.

A dramatic recommendation for obstetric practice change occurred in 2016: the option of administering antenatal steroids for fetal lung maturity after 34 weeks. In the Antenatal Late Preterm Steroids (ALPS) trial of betamethasone in the late preterm period in patients at "high risk" of imminent delivery, Gyamfi-Bannerman and colleagues demonstrated that the treated group had a significant decrease in the rate of neonatal respiratory complications.

The primary outcome, a composite of respiratory morbidities (including transient tachypnea of the newborn, surfactant use, and need for resuscitation at birth) within the first 72 hours of life, had significant differences between groups, occurring in 165 of 1,427 infants (11.6%) in the betamethasone-treated group and 202 of 1,400 (14.4%) in the placebo group (relative risk in the betamethasone group, 0.80; 95% confidence interval, 0.66-0.97; P = .02). However, there was no statistically significant difference in respiratory distress syndrome, apnea, or pneumonia between groups, and the significant difference noted in bronchopulmonary dysplasia was based on a total number of 11 cases.

In response to these findings, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) released practice advisories and interim updates, culminating in a final recommendation for a single course of betamethasone in patients at high risk of preterm delivery between 34 and 36 6/7 weeks who have not received a previous course.

Related article:
When could use of antenatal corticosteroids in the late preterm birth period be beneficial?

In a thorough review of the literature on antenatal steroid use, Kamath-Rayne and colleagues highlighted several factors that should be considered before adopting universal use of steroids at >34 weeks. These include:   

• The definition of "high risk of imminent delivery" as preterm labor with at least 3-cm dilation or 75% effacement, or spontaneous rupture of membranes. The effect of less stringent inclusion criteria in real-world clinical practice is not known, and many patients who will go on to deliver at term will receive steroids unnecessarily.
• Multiple gestation, patients with pre-existing diabetes, women who had previously received a course of steroids, and fetuses with anomalies were excluded from the ALPS study. Use of antenatal steroids in these groups at >34 weeks should be evaluated before universal adoption.

Related article:
What is the ideal gestational age for twin delivery to minimize perinatal deaths?

• The incidence of neonatal hypoglycemia in the treated group was significantly increased. This affects our colleagues in pediatrics considerably from a systems standpoint (need for changes to newborn protocols and communication between services).
• The long-term outcomes of patients exposed to steroids in the late preterm period are yet to be delineated, specifically, the potential neurodevelopmental effects of a medication known to alter preterm brain development as well as cardiovascular and metabolic consequences.

Next: Low-dose aspirin for reducing preeclampsia risk

Low-dose aspirin clearly is effective for reducing the risk of preeclampsia

American College of Obstetricians and Gynecologists. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131.

Henderson JT, Whitlock EP, O'Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the US Preventive Services Task Force. Ann Intern Med. 2014;160(10):695-703.

LeFevre ML; US Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(11):819-826.

American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Published July 11, 2016. Accessed December 6, 2016.

In the 2013 ACOG Task Force on Hypertension in Pregnancy report, low-dose aspirin (60-80 mg) was recommended to be initiated in the late first trimester to reduce preeclampsia risk for women with:

• prior early onset preeclampsia with preterm delivery at <34 weeks' gestation, or
• preeclampsia in more than one prior pregnancy.  

This recommendation was based on several meta-analyses that demonstrated a 10% to 17% reduction in risk with no increase in bleeding, placental abruption, or other adverse events.

In 2014, the US Preventive Services Task Force (USPSTF) conducted a systematic evidence review of low-dose aspirin use for prevention of morbidity and mortality from preeclampsia. That report revealed a 24% risk reduction of preeclampsia in high-risk women treated with low-dose aspirin, as well as a 14% reduction in preterm birth and a 20% reduction in fetal growth restriction. A final statement from the USPSTF in 2014 recommended low-dose aspirin (60-150 mg) starting between 12 and 28 weeks' gestation for women at "high" risk who have:

• a history of preeclampsia, especially if accompanied by an adverse outcome
• multifetal gestation
• chronic hypertension
• diabetes (type 1 or type 2)
• renal disease
• autoimmune disease (such as systematic lupus erythematosus, antiphospholipid syndrome).

Related article:
Start offering aspirin to pregnant women at high risk for preeclampsia

As of July 11, 2016, ACOG supports this expanded list of high-risk conditions. Additionally, the USPSTF identified a "moderate" risk group in which low-dose aspirin may be considered if a patient has several risk factors, such as obesity, nulliparity, family history of preeclampsia, age 35 years or older, or another poor pregnancy outcome. ACOG notes, however, that the evidence supporting this practice is uncertain and does not make a recommendation regarding aspirin use in this population. Further study should be conducted to determine the benefit of low-dose aspirin in these patients as well as the long-term effects of treatment on maternal and child outcomes.

Next: CMA for prenatal genetic diagnosis

Chromosomal microarray analysis is preferable to karyotype in certain situations  

Pauli JM, Repke JT. Update on obstetrics. OBG Manag. 2013;25(1):28-32.

Society for Maternal-Fetal Medicine (SMFM), Dugoff L, Norton ME, Kuller JA. The use of chromosomal microarray for prenatal diagnosis. Am J Obstet Gynecol. 2016;215(4):B2-B9.

American College of Obstetricians and Gynecologists. Committee Opinion No. 682. Microarrays and next- generation sequencing technology: the use of advanced genetic diagnostic tools in obstetrics and gynecology.Obstet  Gynecol. 2016;128(6):e262-e268.

We previously addressed the use of chromosomal microarray analysis (CMA) for prenatal diagnosis in our 2013 "Update on obstetrics," specifically, the question of whether CMA could replace karyotype. The main differences between karyotype and CMA are that 1) only karyotype can detect balanced translocations/inversions and 2) only CMA can detect copy number variants (CNV). There are some differences in the technology and capabilities of the 2 types of CMA currently available as well.

In our 2013 article we concluded that "The total costs of such an approach--test, interpretation, counseling, and long-term follow-up of uncertain results--are unknown at this time and may prove to be unaffordable on a population-wide basis." Today, the cost of CMA is still higher than karyotype, but it is expected to decrease and insurance coverage for this test is expected to increase.

Related article:
Cell-free DNA screening for women at low risk for fetal aneuploidy

Both SMFM and ACOG released recommendations in 2016 regarding the use of CMA in prenatal genetic diagnosis, summarized as follows:  

• CMA is recommended over karyotype for fetuses with structural abnormalities on ultrasound
  • The detection rate for clinically relevant abnormal CNVs in this population is about 6%
• CMA is recommended for diagnosis for stillbirth specimens
  • CMA does not require dividing cells and may be a quicker and more reliable test in this population
• Karotype or fluorescence in situ hybridization (FISH) is recommended for fetuses with ultrasound findings suggestive of aneuploidy
  • If it is negative, then CMA is recommended
• Karyotype or CMA is recommended for patients desiring prenatal diagnostic testing with a normal fetal ultrasound
  • The detection rate for clinically relevant CNVs in this population (advanced maternal age, abnormal serum screening, prior aneuploidy, parental anxiety) is about 1%
• Pretest and posttest counseling about the limitations of CMA and a 2% risk of detection of variants of unknown significance (VUS) should be performed by a provider who has expertise in CMA and who has access to databases with genotype/phenotype information for VUS
  • This counseling should also include the possibility of diagnosis of nonpaternity, consanguinity, and adult-onset disease
• Karyotype is recommended for couples with recurrent pregnancy loss
  • The identification of balanced translocations in this population is most relevant in this patient population
• Prenatal diagnosis with routine use of whole-genome or whole-exome sequencing is not recommended.

Next: Zika virus: Check for updates

Zika virus infection: Check often for the latest updates

American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. Practice advisory on Zika virus. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Interim-Guidance-for-Care-of-Obstetric-Patients- During-a-Zika-Virus-Outbreak. Published December 5, 2016. Accessed December 6, 2016.

Centers for Disease Control and Prevention. Zika virus. http://www.cdc.gov/zika/pregnancy/index.html. Updated August 22, 2016. Accessed December 6, 2016.

Petersen EE, Meaney-Delman D, Neblett-Fanfair R, et al. Update: interim guidance for preconception counseling and prevention of sexual transmission of Zika virus for persons with possible Zika virus exposure--United States, September 2016. MMWR Morbid Mortal Wkly Rep. 2016;65(39):1077-1081.

A yearly update on obstetrics would be remiss without mention of the Zika virus and its impact on pregnancy and reproduction. That being said, any recommendations we offer may be out of date by the time this article is published given the rapidly changing picture of Zika virus since it first dominated the headlines in 2016. Here are the basics as summarized from ACOG and the Centers for Disease Control and Prevention (CDC):

Viral spread. Zika virus may be spread in several ways: by an infected Aedes species mosquito, mother to fetus, sexual contact, blood transfusion, or laboratory exposure.

Symptoms of infection include conjunctivitis, fever, rash, and arthralgia, but most patients (4/5) are asymptomatic.

Sequelae. Zika virus infection during pregnancy is believed to cause fetal and neonatal microcephaly, intracranial calcifications, and brain and eye abnormalities. The rate of these findings in infected individuals, as well as the rate of vertical transmission, is not known.

Travel advisory. Pregnant women should not travel to areas with active Zika infection (the CDC website regularly updates these restricted areas).

Preventive measures. If traveling to an area of active Zika infection, pregnant women should take preventative measures day and night against mosquito bites, such as use of insect repellents approved by the Environmental Protection Agency, clothing that covers exposed skin, and staying indoors.

Safe sex. Abstinence or consistent condom use is recommended for pregnant women with partners who travel to or live in areas of active Zika infection.

Delay conception. Conception should be postponed for at least 6 months in men with Zika infection and at least 8 weeks in women with Zika infection.

Testing recommendations. Pregnant women with Zika virus exposure should be tested, regardless of symptoms. Symptomatic exposed nonpregnant women and all men should be tested.

Prenatal surveillance. High-risk consultation and serial ultrasounds for fetal anatomy and growth should be considered in patients with Zika virus infection during pregnancy. Amniocentesis can be considered on a case-by-case basis.

Related article:
Zika virus update: A rapidly moving target

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As estrogen levels decline, postmenopausal women commonly experience uncomfortable and distressing symptoms of genital atrophy, or genitourinary syndrome of menopause (GSM). Moreover, aromatase inhibitors (AIs), increasingly used as adjuvant therapy by menopausal breast cancer survivors, contribute to vaginal dryness and sexual pain. This discussion focuses on studies of several local vaginal treatments (including a recently approved agent) that ameliorate GSM symptoms but do not appreciably raise serum sex steroid levels—reassuring data for certain patient populations.

EXPERT COMMENTARY

Andrew M. Kaunitz, MD, is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is the  Medical  Director  and  Director  of  Menopause  and  Gynecologic  Ultrasound  Services,  UF  Women’s  Health Specialists–Emerson. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that in 2015 he served on a contraception advisory board for Pfizer, which markets the low-dose estradiol vaginal ring.

Read expert commentary from Dr. Kaunitz

For women with early-stage breast cancer receiving an AI, is a vaginal estradiol ring or testosterone cream safe for genital atrophy?

Yes, according to results of a randomized, noncomparative short-term trial that found both agents improved vaginal dryness and sexual dysfunction and had little tendency to persistently elevate serum estradiol levels

Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer: a randomized clinical trial [published online ahead of print November 10, 2016]. JAMA Oncol. doi: 10.1001/jamaoncol.2016.3904.

Long-term adjuvant AI therapy, which often causes vaginal dryness and sexual dysfunction, is recommended for postmenopausal women with hormone receptor-positive breast cancer. Although use of a vaginally administered low-dose 3-month estradiol ring as well as compounded testosterone cream is known to improve menopausal genital atrophy and sexual symptoms, little data address these agents' impact on serum estradiol levels in women using AIs.

In a safety evaluation study of these treatments performed at an academic US cancer center, Melisko and colleagues randomly assigned postmenopausal women with hormone receptor-positive breast cancer who reported vaginal dryness, sexual pain, or reduced sexual desire to 12 weeks of off-label treatment with an estradiol vaginal ring or intravaginal testosterone cream.

Related article:
Does extending aromatase-inhibitor use from 5 to 10 years benefit menopausal women with hormone-positive breast cancer?

Details of the study

Among 68 evaluable women (mean age, 56 years), mean baseline estradiol levels were 20 pg/mL (range, <2 to 127 pg/mL); estradiol levels were above the postmenopausal range (>10 pg/mL) in 37% of participants. During the 12-week trial, transient and persistent estradiol levels above this threshold were noted, respectively, in 4 and 0 women treated with the vaginal ring and in 4 and 4 women treated with testosterone cream. Estradiol levels assessed using commercially available (liquid chromatography and mass spectrometry) and research laboratory (radioimmune assay) methodology yielded similar results. In the testosterone cream group, persistent elevations above the normal postmenopausal range were common.

Atrophic vaginal changes, sexual desire, and sexual dysfunction improved in both treatment groups based on gynecologic examinations and sexual quality-of-life questionnaires completed at baseline and week 12.

Read on for Dr. Kaunitz’s comments on a new dyspareunia treatment

What's new for the treatment of dyspareunia associated with GSM?

Intrarosa, a once-daily vaginal insert containing prasterone as the active ingredient, was recently approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause

FDA approves Intrarosa for postmenopausal women experiencing pain during sex [news release]. Silver Spring, MD: US Food and Drug Administration; November 17, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm. Accessed December 19, 2017.

Intrarosa [package insert]. Quebec City, Canada: Endoceutics Inc; 2016.

On November 17, 2016, the US Food and Drug Administration (FDA) approved Intrarosa, vaginal dehydroepiandrosterone (DHEA)--also known as prasterone--for women experiencing moderate to severe pain during sexual intercourse due to menopause-related genital atrophy, or GSM. In clinical trials, daily treatment with a 6.5-mg vaginal ovule of DHEA was found effective in reducing symptoms of atrophy. Vaginal discharge was the most common adverse effect.

After menopause, DHEA, which is produced largely by the adrenal glands, represents the dominant source of all sex steroids. DHEA is enzymatically transformed at the intracellular level into estrogens. Because estradiol is inactivated at the site of its synthesis, use of vaginal DHEA causes little if any rise in serum estradiol levels.^1,2

Related article:
2014 Update on Fertility

Details of 2 studies

A pivotal randomized, double-blind, placebo-controlled phase 3 trial of intravaginal DHEA (6.5 mg daily) for treating postmenopausal dyspareunia in women with vulvovaginal atrophy was conducted over 12 weeks.1 The trial included 325 women treated with DHEA and 157 who received placebo.

All 4 coprimary objectives measured improved with treatment compared with mean baseline levels: percentage of parabasal cells in treated participants decreased by 27.7% over placebo (P<.0001); percentage of superficial cells increased by 8.44% over placebo (P<.0001); vaginal pH decreased by 0.66 pH unit over placebo (P<.0001); and pain with sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = .0002). In addition, participant-reported moderate to severe vaginal dryness (present in 84% of women at baseline) improved considerably at 12 weeks, and gynecologic evaluation revealed improvements in vaginal secretions, epithelial integrity and surface thickness, and color.1

About 6% of participants reported vaginal discharge as an adverse effect. Levels of serum steroids remained within the normal range for postmenopausal women.¹

Another study, in which authors integrated data from four phase 3 clinical trials of postmenopausal women with vulvovaginal atrophy treated with vaginal DHEA (n = 723)  or placebo (n = 266) for 12 weeks, analyzed serum steroid levels measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry.²

At 12 weeks' treatment, mean levels of the most relevant sex steroid, serum estradiol, was noted to be 3.36 pg/mL, 19% below the normal postmenopausal value of 4.17 pg/mL.The mean level of estrone sulfate was noted to be 209 pg/mL, lower than the normal 220 pg/mL level in postmenopausal women. Further, androsterone glucuronide, the primary metabolite of androgens, also remained well within normal postmenopausal values.²

The authors concluded that the study data demonstrate that a daily 6.5-mg dose of intravaginal DHEA in postmenopausal women achieves the desired local efficacy (ie, amelioration of vulvovaginal atrophy symptoms) without systemic sex steroid exposure.²

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As estrogen levels decline, postmenopausal women commonly experience uncomfortable and distressing symptoms of genital atrophy, or genitourinary syndrome of menopause (GSM). Moreover, aromatase inhibitors (AIs), increasingly used as adjuvant therapy by menopausal breast cancer survivors, contribute to vaginal dryness and sexual pain. This discussion focuses on studies of several local vaginal treatments (including a recently approved agent) that ameliorate GSM symptoms but do not appreciably raise serum sex steroid levels—reassuring data for certain patient populations.

EXPERT COMMENTARY

Andrew M. Kaunitz, MD, is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is the  Medical  Director  and  Director  of  Menopause  and  Gynecologic  Ultrasound  Services,  UF  Women’s  Health Specialists–Emerson. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that in 2015 he served on a contraception advisory board for Pfizer, which markets the low-dose estradiol vaginal ring.

Read expert commentary from Dr. Kaunitz

For women with early-stage breast cancer receiving an AI, is a vaginal estradiol ring or testosterone cream safe for genital atrophy?

Yes, according to results of a randomized, noncomparative short-term trial that found both agents improved vaginal dryness and sexual dysfunction and had little tendency to persistently elevate serum estradiol levels

Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer: a randomized clinical trial [published online ahead of print November 10, 2016]. JAMA Oncol. doi: 10.1001/jamaoncol.2016.3904.

Long-term adjuvant AI therapy, which often causes vaginal dryness and sexual dysfunction, is recommended for postmenopausal women with hormone receptor-positive breast cancer. Although use of a vaginally administered low-dose 3-month estradiol ring as well as compounded testosterone cream is known to improve menopausal genital atrophy and sexual symptoms, little data address these agents' impact on serum estradiol levels in women using AIs.

In a safety evaluation study of these treatments performed at an academic US cancer center, Melisko and colleagues randomly assigned postmenopausal women with hormone receptor-positive breast cancer who reported vaginal dryness, sexual pain, or reduced sexual desire to 12 weeks of off-label treatment with an estradiol vaginal ring or intravaginal testosterone cream.

Related article:
Does extending aromatase-inhibitor use from 5 to 10 years benefit menopausal women with hormone-positive breast cancer?

Details of the study

Among 68 evaluable women (mean age, 56 years), mean baseline estradiol levels were 20 pg/mL (range, <2 to 127 pg/mL); estradiol levels were above the postmenopausal range (>10 pg/mL) in 37% of participants. During the 12-week trial, transient and persistent estradiol levels above this threshold were noted, respectively, in 4 and 0 women treated with the vaginal ring and in 4 and 4 women treated with testosterone cream. Estradiol levels assessed using commercially available (liquid chromatography and mass spectrometry) and research laboratory (radioimmune assay) methodology yielded similar results. In the testosterone cream group, persistent elevations above the normal postmenopausal range were common.

Atrophic vaginal changes, sexual desire, and sexual dysfunction improved in both treatment groups based on gynecologic examinations and sexual quality-of-life questionnaires completed at baseline and week 12.

Read on for Dr. Kaunitz’s comments on a new dyspareunia treatment

What's new for the treatment of dyspareunia associated with GSM?

Intrarosa, a once-daily vaginal insert containing prasterone as the active ingredient, was recently approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause

FDA approves Intrarosa for postmenopausal women experiencing pain during sex [news release]. Silver Spring, MD: US Food and Drug Administration; November 17, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm. Accessed December 19, 2017.

Intrarosa [package insert]. Quebec City, Canada: Endoceutics Inc; 2016.

On November 17, 2016, the US Food and Drug Administration (FDA) approved Intrarosa, vaginal dehydroepiandrosterone (DHEA)--also known as prasterone--for women experiencing moderate to severe pain during sexual intercourse due to menopause-related genital atrophy, or GSM. In clinical trials, daily treatment with a 6.5-mg vaginal ovule of DHEA was found effective in reducing symptoms of atrophy. Vaginal discharge was the most common adverse effect.

After menopause, DHEA, which is produced largely by the adrenal glands, represents the dominant source of all sex steroids. DHEA is enzymatically transformed at the intracellular level into estrogens. Because estradiol is inactivated at the site of its synthesis, use of vaginal DHEA causes little if any rise in serum estradiol levels.^1,2

Related article:
2014 Update on Fertility

Details of 2 studies

A pivotal randomized, double-blind, placebo-controlled phase 3 trial of intravaginal DHEA (6.5 mg daily) for treating postmenopausal dyspareunia in women with vulvovaginal atrophy was conducted over 12 weeks.1 The trial included 325 women treated with DHEA and 157 who received placebo.

All 4 coprimary objectives measured improved with treatment compared with mean baseline levels: percentage of parabasal cells in treated participants decreased by 27.7% over placebo (P<.0001); percentage of superficial cells increased by 8.44% over placebo (P<.0001); vaginal pH decreased by 0.66 pH unit over placebo (P<.0001); and pain with sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = .0002). In addition, participant-reported moderate to severe vaginal dryness (present in 84% of women at baseline) improved considerably at 12 weeks, and gynecologic evaluation revealed improvements in vaginal secretions, epithelial integrity and surface thickness, and color.1

About 6% of participants reported vaginal discharge as an adverse effect. Levels of serum steroids remained within the normal range for postmenopausal women.¹

Another study, in which authors integrated data from four phase 3 clinical trials of postmenopausal women with vulvovaginal atrophy treated with vaginal DHEA (n = 723)  or placebo (n = 266) for 12 weeks, analyzed serum steroid levels measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry.²

At 12 weeks' treatment, mean levels of the most relevant sex steroid, serum estradiol, was noted to be 3.36 pg/mL, 19% below the normal postmenopausal value of 4.17 pg/mL.The mean level of estrone sulfate was noted to be 209 pg/mL, lower than the normal 220 pg/mL level in postmenopausal women. Further, androsterone glucuronide, the primary metabolite of androgens, also remained well within normal postmenopausal values.²

The authors concluded that the study data demonstrate that a daily 6.5-mg dose of intravaginal DHEA in postmenopausal women achieves the desired local efficacy (ie, amelioration of vulvovaginal atrophy symptoms) without systemic sex steroid exposure.²

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As estrogen levels decline, postmenopausal women commonly experience uncomfortable and distressing symptoms of genital atrophy, or genitourinary syndrome of menopause (GSM). Moreover, aromatase inhibitors (AIs), increasingly used as adjuvant therapy by menopausal breast cancer survivors, contribute to vaginal dryness and sexual pain. This discussion focuses on studies of several local vaginal treatments (including a recently approved agent) that ameliorate GSM symptoms but do not appreciably raise serum sex steroid levels—reassuring data for certain patient populations.

EXPERT COMMENTARY

Andrew M. Kaunitz, MD, is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is the  Medical  Director  and  Director  of  Menopause  and  Gynecologic  Ultrasound  Services,  UF  Women’s  Health Specialists–Emerson. Dr. Kaunitz serves on the OBG Management Board of Editors.

Dr. Kaunitz reports that in 2015 he served on a contraception advisory board for Pfizer, which markets the low-dose estradiol vaginal ring.

Read expert commentary from Dr. Kaunitz

For women with early-stage breast cancer receiving an AI, is a vaginal estradiol ring or testosterone cream safe for genital atrophy?

Yes, according to results of a randomized, noncomparative short-term trial that found both agents improved vaginal dryness and sexual dysfunction and had little tendency to persistently elevate serum estradiol levels

Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer: a randomized clinical trial [published online ahead of print November 10, 2016]. JAMA Oncol. doi: 10.1001/jamaoncol.2016.3904.

Long-term adjuvant AI therapy, which often causes vaginal dryness and sexual dysfunction, is recommended for postmenopausal women with hormone receptor-positive breast cancer. Although use of a vaginally administered low-dose 3-month estradiol ring as well as compounded testosterone cream is known to improve menopausal genital atrophy and sexual symptoms, little data address these agents' impact on serum estradiol levels in women using AIs.

In a safety evaluation study of these treatments performed at an academic US cancer center, Melisko and colleagues randomly assigned postmenopausal women with hormone receptor-positive breast cancer who reported vaginal dryness, sexual pain, or reduced sexual desire to 12 weeks of off-label treatment with an estradiol vaginal ring or intravaginal testosterone cream.

Related article:
Does extending aromatase-inhibitor use from 5 to 10 years benefit menopausal women with hormone-positive breast cancer?

Details of the study

Among 68 evaluable women (mean age, 56 years), mean baseline estradiol levels were 20 pg/mL (range, <2 to 127 pg/mL); estradiol levels were above the postmenopausal range (>10 pg/mL) in 37% of participants. During the 12-week trial, transient and persistent estradiol levels above this threshold were noted, respectively, in 4 and 0 women treated with the vaginal ring and in 4 and 4 women treated with testosterone cream. Estradiol levels assessed using commercially available (liquid chromatography and mass spectrometry) and research laboratory (radioimmune assay) methodology yielded similar results. In the testosterone cream group, persistent elevations above the normal postmenopausal range were common.

Atrophic vaginal changes, sexual desire, and sexual dysfunction improved in both treatment groups based on gynecologic examinations and sexual quality-of-life questionnaires completed at baseline and week 12.

Read on for Dr. Kaunitz’s comments on a new dyspareunia treatment

What's new for the treatment of dyspareunia associated with GSM?

Intrarosa, a once-daily vaginal insert containing prasterone as the active ingredient, was recently approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause

FDA approves Intrarosa for postmenopausal women experiencing pain during sex [news release]. Silver Spring, MD: US Food and Drug Administration; November 17, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm. Accessed December 19, 2017.

Intrarosa [package insert]. Quebec City, Canada: Endoceutics Inc; 2016.

On November 17, 2016, the US Food and Drug Administration (FDA) approved Intrarosa, vaginal dehydroepiandrosterone (DHEA)--also known as prasterone--for women experiencing moderate to severe pain during sexual intercourse due to menopause-related genital atrophy, or GSM. In clinical trials, daily treatment with a 6.5-mg vaginal ovule of DHEA was found effective in reducing symptoms of atrophy. Vaginal discharge was the most common adverse effect.

After menopause, DHEA, which is produced largely by the adrenal glands, represents the dominant source of all sex steroids. DHEA is enzymatically transformed at the intracellular level into estrogens. Because estradiol is inactivated at the site of its synthesis, use of vaginal DHEA causes little if any rise in serum estradiol levels.^1,2

Related article:
2014 Update on Fertility

Details of 2 studies

A pivotal randomized, double-blind, placebo-controlled phase 3 trial of intravaginal DHEA (6.5 mg daily) for treating postmenopausal dyspareunia in women with vulvovaginal atrophy was conducted over 12 weeks.1 The trial included 325 women treated with DHEA and 157 who received placebo.

All 4 coprimary objectives measured improved with treatment compared with mean baseline levels: percentage of parabasal cells in treated participants decreased by 27.7% over placebo (P<.0001); percentage of superficial cells increased by 8.44% over placebo (P<.0001); vaginal pH decreased by 0.66 pH unit over placebo (P<.0001); and pain with sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = .0002). In addition, participant-reported moderate to severe vaginal dryness (present in 84% of women at baseline) improved considerably at 12 weeks, and gynecologic evaluation revealed improvements in vaginal secretions, epithelial integrity and surface thickness, and color.1

About 6% of participants reported vaginal discharge as an adverse effect. Levels of serum steroids remained within the normal range for postmenopausal women.¹

Another study, in which authors integrated data from four phase 3 clinical trials of postmenopausal women with vulvovaginal atrophy treated with vaginal DHEA (n = 723)  or placebo (n = 266) for 12 weeks, analyzed serum steroid levels measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry.²

At 12 weeks' treatment, mean levels of the most relevant sex steroid, serum estradiol, was noted to be 3.36 pg/mL, 19% below the normal postmenopausal value of 4.17 pg/mL.The mean level of estrone sulfate was noted to be 209 pg/mL, lower than the normal 220 pg/mL level in postmenopausal women. Further, androsterone glucuronide, the primary metabolite of androgens, also remained well within normal postmenopausal values.²

The authors concluded that the study data demonstrate that a daily 6.5-mg dose of intravaginal DHEA in postmenopausal women achieves the desired local efficacy (ie, amelioration of vulvovaginal atrophy symptoms) without systemic sex steroid exposure.²

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The use of long-acting reversible contraceptive (LARC) methods has shown a steady increase in the United States. The major factors for increasing acceptance include high efficacy, ease of use, and an acceptable adverse effect profile. Since these methods require placement under the skin (implantable device) or into the uterus (intrauterine devices [IUDs]), unique management issues arise during their usage. Recently, the American College of Obstetricians and Gynecologists (ACOG) released a committee opinion addressing several of these clinical challenges—among them: pain with insertion, what to do when the IUD strings are not visualized, and the plan of action for a nonpalpable IUD or contraceptive implant.¹ In this article we present 7 cases, and successful management approaches, that reflect ACOG’s recent recommendations and our extensive clinical experience.

Read the first CHALLENGE: Pain with IUD insertion

CHALLENGE 1: Pain with IUD insertion

CASE First-time, nulliparous IUD user apprehensive about insertion pain

A 21-year-old woman (G0) presents for placement of a 52-mg levonorgestrel IUD for contraception and treatment of dysmenorrhea. Her medical and surgical histories are unremarkable. She has heard that IUD insertion “is more painful if you haven’t had a baby yet” and she asks what treatments are available to aid in pain relief.

What can you offer her?

A number of approaches have been used to reduce IUD insertion pain, including:

• placing lidocaine gel into or on the cervix
• lidocaine paracervical block
• preinsertion use of misoprostol or nonsteroidal anti-inflammatory drugs.

Authors of a recent Cochrane review² indicated that none of these approaches were particularly effective at reducing insertion pain for nulliparous women. Naproxen sodium 550 mg or tramadol 50 mg taken 1 hour prior to IUD insertion have been found to decrease IUD insertion pain in multiparous patients.³ Misoprostol, apart from being ineffective in reducing insertion pain, also requires use for a number of hours before insertion and can cause painful uterine cramping, upset stomach, and diarrhea.² Some studies do suggest that use of a paracervical block does reduce the pain associated with tenaculum placement but not the IUD insertion itself.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement
 

A reasonable pain management strategy for nulliparous patients. Given these data, there is not an evidence-based IUD insertion pain management strategy that can be used for the nulliparous case patient. A practical approach for nulliparous patients is to offer naproxen sodium or tramadol, which have been found to be beneficial in multiparous patients, to a nulliparous patient. Additionally, lidocaine gel applied to the cervix or tenaculum-site injection can be considered for tenaculum-associated pain, although it does not appear to help significantly with IUD insertion pain. Misoprostol should be avoided as it does not alleviate the pain of insertion and it can cause bothersome adverse effects.

Read CHALLENGE 2: IUD strings not visualized

CHALLENGE 2: IUD strings not visualized

CASE No strings palpated 6 weeks after postpartum IUD placement

A 26-year-old woman (G2P2) presents to your office for a postpartum visit 6 weeks after an uncomplicated cesarean delivery at term. She had requested that a 52-mg levonorgestrel IUD be placed at the time of delivery, and the delivery report describes an uneventful placement. The patient has not been able to feel the IUD strings using her fingers and you do not find them on examination. She does not remember the IUD falling out.

What are the next steps in her management?

Failure to palpate the IUD strings by the user or failure to visualize the strings is a fairly common occurrence. This is especially true when an IUD is placed immediatelypostpartum, as in this patient’s case.

When the strings cannot be palpated, it is important to exclude pregnancy and recommend a form of backup contraception, such as condoms and emergency contraception if appropriate, until evaluation can be completed.

Steps to locate a device. In the office setting, the strings often can be located by inserting a cytobrush into the endocervical canal to extract them. If that maneuver fails to locate them, an ultrasound should be completed to determine if the device is in the uterus. If the ultrasound does not detect the device in the uterus, obtain an anteroposterior (AP) x-ray encompassing the entire abdomen and pelvis. All IUDs used in the United States are radiopaque and will be observed on x-ray if present. If the IUD is identified, operative removal is indicated.

Related article:
How to identify and localize IUDs on ultrasound
 

Intraperitoneal location. If an IUD is found in this location, it is usually the result of a perforation that occurred at the time of insertion. In general, the device can be removed via laparoscopy. Occasionally, laparotomy is needed if there is significant pelvic infection, possible bowel perforation, or if there is an inability to locate the device at laparoscopy.⁴ The copper IUD is more inflammatory than the levonorgestrel IUDs.

Abdominal location. No matter the IUD type, operative removal of intra-abdominal IUDs should take place expeditiously after they are discovered.

In the case of expulsion. If the IUD is not seen on x-ray, expulsion is the likely cause. Expulsion tends to be more common among⁵:

• parous users
• those younger than age 20
• placements that immediately follow a delivery or second-trimester abortion.

Nulliparity and type of device are not associated with increased risk of expulsion.

Read CHALLENGE 3: Difficult IUD removal

CHALLENGE 3: Difficult IUD removal

CASE Strings not palpated in a patient with history of LEEP

A 37-year-old woman (G3P2) presents to your office for IUD removal. She underwent a loop electrosurgical excision procedure 2 years ago for cervical intraepithelial neoplasia (CIN) 2 and since then has not been able to feel the IUD strings. On pelvic examination, you do not palpate or visualize the IUD strings after speculum placement.

How can you achieve IUD removal for your patient?

When a patient requests that her IUD be removed, but the strings are not visible and the woman is not pregnant, employ ultrasonography to confirm the IUD remains intrauterine and to rule out expulsion or perforation.

Employ alligator forceps or an IUD hook. Once intrauterine position is confirmed, use an alligator forceps of suitable length and with a small diameter to extract the device (FIGURE 1). It is useful to utilize ultrasonography for guidance during the removal procedure. The alligator forceps will grasp both the IUD device itself and IUD strings well, so either can be targeted during removal.

A second useful tool for IUD removal is an IUD hook (FIGURE 2). In a similar way that a curette is used for endometrial sampling, IUD hooks can be used to drag the IUD from the uterus.

Anesthesia is not usually necessary for IUD removal with alligator forceps or an IUD hook, although it may be appropriate in select patients. Data are limited with regard to the utility of paracervical blocks in this situation.

Related article:
Surgical removal of malpositioned IUDs
 

Hysteroscopy is an option. If removal with an alligator forceps or IUD hook is unsuccessful, or if preferred by the clinician, hysteroscopic-guided removal is a management option. Hysteroscopic removal may be required if the IUD has become embedded in the uterine wall.

Read CHALLENGE 4: Nonfundal IUD location

CHALLENGE 4: Nonfundal IUD location

CASE Copper IUD found in lower uterine segment

A 31-year-old woman (G1P1) calls your office to report that she thinks her copper IUD strings are longer than before. Office examination confirms that the strings are noticeably longer than is typical. Pelvic ultrasonography shows the copper IUD in the lower uterine segment.

What is the appropriate course of action?

Occasionally, IUDs are noted to be located in the lower uterine segment (FIGURE 3) or cervix. With malposition, users may be experiencing cramping or abnormal bleeding.

Cervical malposition calls for removal. ACOG advises that, regardless of a patient’s presenting symptoms, clinicians should remove IUDs located in the cervix (ie, the stem below the internal os) due to an increased risk of pregnancy and address the woman’s contraceptive needs.

Related article:
STOP relying on 2D ultrasound for IUD localization
 

Lower-uterine-segment malposition man‑agement less clear. If the patient is symptomatic, remove the device and initiate some form of contraception. If the woman is asymptomatic, the woman should be given the option of having the device removed or left in place. The mechanisms of action of both the copper and levonorgestrel-releasing IUDs suggest that this lower location is unlikely to be associated with a significant decrease in efficacy.

Unfortunately, it is difficult to estimate the risk of pregnancy for a patient whose device is located in the lower uterine segment. Braaten and Goldberg discussed case-controlled data in their 2012 article that suggest malposition may be more important to the efficacy of copper IUDs than of levonorgestrel IUDs.^6,7 As unintended pregnancy is an important risk to avoid, ultimately, it is the woman’s decision as to whether she wants removal or continued IUD use.

Read CHALLENGE 5: Pregnancy in an IUD user

CHALLENGE 5: Pregnancy in an IUD user

CASE 3-year copper IUD user with positive pregnancy test

A 25-year-old woman (G3P2) presents to your office because of missed menses and a positive home pregnancy test. Her last menstrual period was 6 weeks ago. She has had a copper IUD in place for 3 years and can feel the strings herself. She has experienced light cramping but no bleeding. Office examination is notable for the IUD stem present at the external cervical os. While the pregnancy is unplanned, the patient desires that it continue.

Should you remove the IUD?

The pregnancy rate among IUD users is less than 1%—a rate that is equivalent to that experienced by women undergoing tubal sterilization. Although there is an overall low risk of pregnancy, a higher proportion of pregnancies among IUD users compared with nonusers are ectopic. Therefore, subsequent management of pregnancy in an IUD user needs to be determined by, using ultrasound, both the location of the pregnancy and whether the IUD is in place.

If an ectopic pregnancy is found, it may be managed medically or surgically with the IUD left in place if desired. If you find an intrauterine pregnancy that is undesired, the IUD can be removed at the time of a surgical abortion or before the initiation of a medical abortion.

If you fail to locate the IUD either before or after the abortion procedure, use an AP x-ray of the entire abdomen and pelvis to determine whether the IUD is in the peritoneal cavity or whether it was likely expelled prior to the pregnancy.

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

With a desired pregnancy, if the strings are visible, remove the IUD with gentle traction. If the IUD is left in place, the risk of spontaneous abortion is significantly increased. If the strings are not seen, but the device was noted to be in the cervix by ultrasound, remove the device if the stem is below the internal cervical os. For IUDs that are located above the cervix, removal should not be attempted; counsel the patient about the increased risk of spontaneous abortion, infection, and preterm delivery.

Read CHALLENGE 6: Pregnancy in an implant user

CHALLENGE 6: Pregnancy in an implant user

CASE 3-week implant user with positive pregnancy test

Your 21-year-old patient who received a contraceptive implant 3 weeks earlier now pre‑sents with nausea and abdominal cramping. Her last menstrual period was 6 weeks ago. She has regular cycles that are 28 days in length. Results of urine pregnancy testing are positive. Prior to using the implant, the patient inconsistently used condoms.

How should you counsel your patient?

The rate of pregnancy among implant users is very low; it is estimated at 5 pregnancies per 10,000 implant users per year.⁸ As in this case, apparent “failures” of the contraceptive implant actually may represent placements that occurred before a very early pregnancy was recognized. Similar to IUDs, the proportion of pregnancies that are ectopic among implant users compared to nonusers may be higher.

With a pregnancy that is ectopic or that is intrauterine and undesired, the device may be left in and use continued after the pregnancy has been terminated. Although the effectiveness of medication abortion with pre-existing contraceptive implant in situ is not well known, researchers have demonstrated that medication abortion initiated at the same time as contraceptive implant insertion does not influence success of the medication abortion.⁹

Related article:
2016 Update on contraception

For women with desired intrauterine pregnancies, remove the device as soon as feasible and counsel the woman that there is no known teratogenic risk associated with the contraceptive implant.

Read CHALLENGE 7: Nonpalpable contraceptive implant

CHALLENGE 7: Nonpalpable contraceptive implant

CASE Patient requests device removal to attempt conception

A 30-year-old woman (G2P2) presents for contraceptive implant removal because she would like to have another child. The device was placed 30 months ago in the patient’s left arm. The insertion note in the patient’s medical record is unremarkable, and standard insertion technique was used. On physical examination, you cannot palpate the device.

What is your next course of action?

Nonpalpable implants, particularly if removal is desired, present a significant clinical challenge. Do not attempt removing a nonpalpable implant before trying to locate the device through past medical records or radiography. Records that describe the original insertion, particularly the location and type of device, are helpful.

Related article:
2015 Update on contraception
 

Appropriate imaging assistance. Ultrasonography with a high frequency linear array transducer (10 MHz or greater) may allow an experienced radiologist to identify the implant—including earlier versions without barium (Implanon) and later ones with barium (Nexplanon). Magnetic resonance imaging (MRI), computed tomography scan, or plain x-ray also can be used to detect a barium-containing device; MRI can be used to locate a non−barium-containing implant.

Carry out removal using ultrasonographic guidance. If a deep insertion is felt to be close to a neurovascular bundle, device removal should be carried out in an operating room by a surgeon familiar with the anatomy of the upper arm.

When an implant cannot be located despite radiography. This is an infrequent occurrence. Merck, the manufacturer of the etonorgestrel implant, provides advice and support in this circumstance. (Visit https://www.merckconnect.com/nexplanon/over view.html.)

Recently, published case reports detail episodes of implants inserted into the venous system with migration to the heart or lungs.¹⁰ While this phenomenon is considered rare, the manufacturer has recommended that insertion of the contraceptive implant avoid the sulcus between the biceps and triceps muscles.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The use of long-acting reversible contraceptive (LARC) methods has shown a steady increase in the United States. The major factors for increasing acceptance include high efficacy, ease of use, and an acceptable adverse effect profile. Since these methods require placement under the skin (implantable device) or into the uterus (intrauterine devices [IUDs]), unique management issues arise during their usage. Recently, the American College of Obstetricians and Gynecologists (ACOG) released a committee opinion addressing several of these clinical challenges—among them: pain with insertion, what to do when the IUD strings are not visualized, and the plan of action for a nonpalpable IUD or contraceptive implant.¹ In this article we present 7 cases, and successful management approaches, that reflect ACOG’s recent recommendations and our extensive clinical experience.

Read the first CHALLENGE: Pain with IUD insertion

CHALLENGE 1: Pain with IUD insertion

CASE First-time, nulliparous IUD user apprehensive about insertion pain

A 21-year-old woman (G0) presents for placement of a 52-mg levonorgestrel IUD for contraception and treatment of dysmenorrhea. Her medical and surgical histories are unremarkable. She has heard that IUD insertion “is more painful if you haven’t had a baby yet” and she asks what treatments are available to aid in pain relief.

What can you offer her?

A number of approaches have been used to reduce IUD insertion pain, including:

• placing lidocaine gel into or on the cervix
• lidocaine paracervical block
• preinsertion use of misoprostol or nonsteroidal anti-inflammatory drugs.

Authors of a recent Cochrane review² indicated that none of these approaches were particularly effective at reducing insertion pain for nulliparous women. Naproxen sodium 550 mg or tramadol 50 mg taken 1 hour prior to IUD insertion have been found to decrease IUD insertion pain in multiparous patients.³ Misoprostol, apart from being ineffective in reducing insertion pain, also requires use for a number of hours before insertion and can cause painful uterine cramping, upset stomach, and diarrhea.² Some studies do suggest that use of a paracervical block does reduce the pain associated with tenaculum placement but not the IUD insertion itself.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement
 

A reasonable pain management strategy for nulliparous patients. Given these data, there is not an evidence-based IUD insertion pain management strategy that can be used for the nulliparous case patient. A practical approach for nulliparous patients is to offer naproxen sodium or tramadol, which have been found to be beneficial in multiparous patients, to a nulliparous patient. Additionally, lidocaine gel applied to the cervix or tenaculum-site injection can be considered for tenaculum-associated pain, although it does not appear to help significantly with IUD insertion pain. Misoprostol should be avoided as it does not alleviate the pain of insertion and it can cause bothersome adverse effects.

Read CHALLENGE 2: IUD strings not visualized

CHALLENGE 2: IUD strings not visualized

CASE No strings palpated 6 weeks after postpartum IUD placement

A 26-year-old woman (G2P2) presents to your office for a postpartum visit 6 weeks after an uncomplicated cesarean delivery at term. She had requested that a 52-mg levonorgestrel IUD be placed at the time of delivery, and the delivery report describes an uneventful placement. The patient has not been able to feel the IUD strings using her fingers and you do not find them on examination. She does not remember the IUD falling out.

What are the next steps in her management?

Failure to palpate the IUD strings by the user or failure to visualize the strings is a fairly common occurrence. This is especially true when an IUD is placed immediatelypostpartum, as in this patient’s case.

When the strings cannot be palpated, it is important to exclude pregnancy and recommend a form of backup contraception, such as condoms and emergency contraception if appropriate, until evaluation can be completed.

Steps to locate a device. In the office setting, the strings often can be located by inserting a cytobrush into the endocervical canal to extract them. If that maneuver fails to locate them, an ultrasound should be completed to determine if the device is in the uterus. If the ultrasound does not detect the device in the uterus, obtain an anteroposterior (AP) x-ray encompassing the entire abdomen and pelvis. All IUDs used in the United States are radiopaque and will be observed on x-ray if present. If the IUD is identified, operative removal is indicated.

Related article:
How to identify and localize IUDs on ultrasound
 

Intraperitoneal location. If an IUD is found in this location, it is usually the result of a perforation that occurred at the time of insertion. In general, the device can be removed via laparoscopy. Occasionally, laparotomy is needed if there is significant pelvic infection, possible bowel perforation, or if there is an inability to locate the device at laparoscopy.⁴ The copper IUD is more inflammatory than the levonorgestrel IUDs.

Abdominal location. No matter the IUD type, operative removal of intra-abdominal IUDs should take place expeditiously after they are discovered.

In the case of expulsion. If the IUD is not seen on x-ray, expulsion is the likely cause. Expulsion tends to be more common among⁵:

• parous users
• those younger than age 20
• placements that immediately follow a delivery or second-trimester abortion.

Nulliparity and type of device are not associated with increased risk of expulsion.

Read CHALLENGE 3: Difficult IUD removal

CHALLENGE 3: Difficult IUD removal

CASE Strings not palpated in a patient with history of LEEP

A 37-year-old woman (G3P2) presents to your office for IUD removal. She underwent a loop electrosurgical excision procedure 2 years ago for cervical intraepithelial neoplasia (CIN) 2 and since then has not been able to feel the IUD strings. On pelvic examination, you do not palpate or visualize the IUD strings after speculum placement.

How can you achieve IUD removal for your patient?

When a patient requests that her IUD be removed, but the strings are not visible and the woman is not pregnant, employ ultrasonography to confirm the IUD remains intrauterine and to rule out expulsion or perforation.

Employ alligator forceps or an IUD hook. Once intrauterine position is confirmed, use an alligator forceps of suitable length and with a small diameter to extract the device (FIGURE 1). It is useful to utilize ultrasonography for guidance during the removal procedure. The alligator forceps will grasp both the IUD device itself and IUD strings well, so either can be targeted during removal.

A second useful tool for IUD removal is an IUD hook (FIGURE 2). In a similar way that a curette is used for endometrial sampling, IUD hooks can be used to drag the IUD from the uterus.

Anesthesia is not usually necessary for IUD removal with alligator forceps or an IUD hook, although it may be appropriate in select patients. Data are limited with regard to the utility of paracervical blocks in this situation.

Related article:
Surgical removal of malpositioned IUDs
 

Hysteroscopy is an option. If removal with an alligator forceps or IUD hook is unsuccessful, or if preferred by the clinician, hysteroscopic-guided removal is a management option. Hysteroscopic removal may be required if the IUD has become embedded in the uterine wall.

Read CHALLENGE 4: Nonfundal IUD location

CHALLENGE 4: Nonfundal IUD location

CASE Copper IUD found in lower uterine segment

A 31-year-old woman (G1P1) calls your office to report that she thinks her copper IUD strings are longer than before. Office examination confirms that the strings are noticeably longer than is typical. Pelvic ultrasonography shows the copper IUD in the lower uterine segment.

What is the appropriate course of action?

Occasionally, IUDs are noted to be located in the lower uterine segment (FIGURE 3) or cervix. With malposition, users may be experiencing cramping or abnormal bleeding.

Cervical malposition calls for removal. ACOG advises that, regardless of a patient’s presenting symptoms, clinicians should remove IUDs located in the cervix (ie, the stem below the internal os) due to an increased risk of pregnancy and address the woman’s contraceptive needs.

Related article:
STOP relying on 2D ultrasound for IUD localization
 

Lower-uterine-segment malposition man‑agement less clear. If the patient is symptomatic, remove the device and initiate some form of contraception. If the woman is asymptomatic, the woman should be given the option of having the device removed or left in place. The mechanisms of action of both the copper and levonorgestrel-releasing IUDs suggest that this lower location is unlikely to be associated with a significant decrease in efficacy.

Unfortunately, it is difficult to estimate the risk of pregnancy for a patient whose device is located in the lower uterine segment. Braaten and Goldberg discussed case-controlled data in their 2012 article that suggest malposition may be more important to the efficacy of copper IUDs than of levonorgestrel IUDs.^6,7 As unintended pregnancy is an important risk to avoid, ultimately, it is the woman’s decision as to whether she wants removal or continued IUD use.

Read CHALLENGE 5: Pregnancy in an IUD user

CHALLENGE 5: Pregnancy in an IUD user

CASE 3-year copper IUD user with positive pregnancy test

A 25-year-old woman (G3P2) presents to your office because of missed menses and a positive home pregnancy test. Her last menstrual period was 6 weeks ago. She has had a copper IUD in place for 3 years and can feel the strings herself. She has experienced light cramping but no bleeding. Office examination is notable for the IUD stem present at the external cervical os. While the pregnancy is unplanned, the patient desires that it continue.

Should you remove the IUD?

The pregnancy rate among IUD users is less than 1%—a rate that is equivalent to that experienced by women undergoing tubal sterilization. Although there is an overall low risk of pregnancy, a higher proportion of pregnancies among IUD users compared with nonusers are ectopic. Therefore, subsequent management of pregnancy in an IUD user needs to be determined by, using ultrasound, both the location of the pregnancy and whether the IUD is in place.

If an ectopic pregnancy is found, it may be managed medically or surgically with the IUD left in place if desired. If you find an intrauterine pregnancy that is undesired, the IUD can be removed at the time of a surgical abortion or before the initiation of a medical abortion.

If you fail to locate the IUD either before or after the abortion procedure, use an AP x-ray of the entire abdomen and pelvis to determine whether the IUD is in the peritoneal cavity or whether it was likely expelled prior to the pregnancy.

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

With a desired pregnancy, if the strings are visible, remove the IUD with gentle traction. If the IUD is left in place, the risk of spontaneous abortion is significantly increased. If the strings are not seen, but the device was noted to be in the cervix by ultrasound, remove the device if the stem is below the internal cervical os. For IUDs that are located above the cervix, removal should not be attempted; counsel the patient about the increased risk of spontaneous abortion, infection, and preterm delivery.

Read CHALLENGE 6: Pregnancy in an implant user

CHALLENGE 6: Pregnancy in an implant user

CASE 3-week implant user with positive pregnancy test

Your 21-year-old patient who received a contraceptive implant 3 weeks earlier now pre‑sents with nausea and abdominal cramping. Her last menstrual period was 6 weeks ago. She has regular cycles that are 28 days in length. Results of urine pregnancy testing are positive. Prior to using the implant, the patient inconsistently used condoms.

How should you counsel your patient?

The rate of pregnancy among implant users is very low; it is estimated at 5 pregnancies per 10,000 implant users per year.⁸ As in this case, apparent “failures” of the contraceptive implant actually may represent placements that occurred before a very early pregnancy was recognized. Similar to IUDs, the proportion of pregnancies that are ectopic among implant users compared to nonusers may be higher.

With a pregnancy that is ectopic or that is intrauterine and undesired, the device may be left in and use continued after the pregnancy has been terminated. Although the effectiveness of medication abortion with pre-existing contraceptive implant in situ is not well known, researchers have demonstrated that medication abortion initiated at the same time as contraceptive implant insertion does not influence success of the medication abortion.⁹

Related article:
2016 Update on contraception

For women with desired intrauterine pregnancies, remove the device as soon as feasible and counsel the woman that there is no known teratogenic risk associated with the contraceptive implant.

Read CHALLENGE 7: Nonpalpable contraceptive implant

CHALLENGE 7: Nonpalpable contraceptive implant

CASE Patient requests device removal to attempt conception

A 30-year-old woman (G2P2) presents for contraceptive implant removal because she would like to have another child. The device was placed 30 months ago in the patient’s left arm. The insertion note in the patient’s medical record is unremarkable, and standard insertion technique was used. On physical examination, you cannot palpate the device.

What is your next course of action?

Nonpalpable implants, particularly if removal is desired, present a significant clinical challenge. Do not attempt removing a nonpalpable implant before trying to locate the device through past medical records or radiography. Records that describe the original insertion, particularly the location and type of device, are helpful.

Related article:
2015 Update on contraception
 

Appropriate imaging assistance. Ultrasonography with a high frequency linear array transducer (10 MHz or greater) may allow an experienced radiologist to identify the implant—including earlier versions without barium (Implanon) and later ones with barium (Nexplanon). Magnetic resonance imaging (MRI), computed tomography scan, or plain x-ray also can be used to detect a barium-containing device; MRI can be used to locate a non−barium-containing implant.

Carry out removal using ultrasonographic guidance. If a deep insertion is felt to be close to a neurovascular bundle, device removal should be carried out in an operating room by a surgeon familiar with the anatomy of the upper arm.

When an implant cannot be located despite radiography. This is an infrequent occurrence. Merck, the manufacturer of the etonorgestrel implant, provides advice and support in this circumstance. (Visit https://www.merckconnect.com/nexplanon/over view.html.)

Recently, published case reports detail episodes of implants inserted into the venous system with migration to the heart or lungs.¹⁰ While this phenomenon is considered rare, the manufacturer has recommended that insertion of the contraceptive implant avoid the sulcus between the biceps and triceps muscles.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The use of long-acting reversible contraceptive (LARC) methods has shown a steady increase in the United States. The major factors for increasing acceptance include high efficacy, ease of use, and an acceptable adverse effect profile. Since these methods require placement under the skin (implantable device) or into the uterus (intrauterine devices [IUDs]), unique management issues arise during their usage. Recently, the American College of Obstetricians and Gynecologists (ACOG) released a committee opinion addressing several of these clinical challenges—among them: pain with insertion, what to do when the IUD strings are not visualized, and the plan of action for a nonpalpable IUD or contraceptive implant.¹ In this article we present 7 cases, and successful management approaches, that reflect ACOG’s recent recommendations and our extensive clinical experience.

Read the first CHALLENGE: Pain with IUD insertion

CHALLENGE 1: Pain with IUD insertion

CASE First-time, nulliparous IUD user apprehensive about insertion pain

A 21-year-old woman (G0) presents for placement of a 52-mg levonorgestrel IUD for contraception and treatment of dysmenorrhea. Her medical and surgical histories are unremarkable. She has heard that IUD insertion “is more painful if you haven’t had a baby yet” and she asks what treatments are available to aid in pain relief.

What can you offer her?

A number of approaches have been used to reduce IUD insertion pain, including:

• placing lidocaine gel into or on the cervix
• lidocaine paracervical block
• preinsertion use of misoprostol or nonsteroidal anti-inflammatory drugs.

Authors of a recent Cochrane review² indicated that none of these approaches were particularly effective at reducing insertion pain for nulliparous women. Naproxen sodium 550 mg or tramadol 50 mg taken 1 hour prior to IUD insertion have been found to decrease IUD insertion pain in multiparous patients.³ Misoprostol, apart from being ineffective in reducing insertion pain, also requires use for a number of hours before insertion and can cause painful uterine cramping, upset stomach, and diarrhea.² Some studies do suggest that use of a paracervical block does reduce the pain associated with tenaculum placement but not the IUD insertion itself.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement
 

A reasonable pain management strategy for nulliparous patients. Given these data, there is not an evidence-based IUD insertion pain management strategy that can be used for the nulliparous case patient. A practical approach for nulliparous patients is to offer naproxen sodium or tramadol, which have been found to be beneficial in multiparous patients, to a nulliparous patient. Additionally, lidocaine gel applied to the cervix or tenaculum-site injection can be considered for tenaculum-associated pain, although it does not appear to help significantly with IUD insertion pain. Misoprostol should be avoided as it does not alleviate the pain of insertion and it can cause bothersome adverse effects.

Read CHALLENGE 2: IUD strings not visualized

CHALLENGE 2: IUD strings not visualized

CASE No strings palpated 6 weeks after postpartum IUD placement

A 26-year-old woman (G2P2) presents to your office for a postpartum visit 6 weeks after an uncomplicated cesarean delivery at term. She had requested that a 52-mg levonorgestrel IUD be placed at the time of delivery, and the delivery report describes an uneventful placement. The patient has not been able to feel the IUD strings using her fingers and you do not find them on examination. She does not remember the IUD falling out.

What are the next steps in her management?

Failure to palpate the IUD strings by the user or failure to visualize the strings is a fairly common occurrence. This is especially true when an IUD is placed immediatelypostpartum, as in this patient’s case.

When the strings cannot be palpated, it is important to exclude pregnancy and recommend a form of backup contraception, such as condoms and emergency contraception if appropriate, until evaluation can be completed.

Steps to locate a device. In the office setting, the strings often can be located by inserting a cytobrush into the endocervical canal to extract them. If that maneuver fails to locate them, an ultrasound should be completed to determine if the device is in the uterus. If the ultrasound does not detect the device in the uterus, obtain an anteroposterior (AP) x-ray encompassing the entire abdomen and pelvis. All IUDs used in the United States are radiopaque and will be observed on x-ray if present. If the IUD is identified, operative removal is indicated.

Related article:
How to identify and localize IUDs on ultrasound
 

Intraperitoneal location. If an IUD is found in this location, it is usually the result of a perforation that occurred at the time of insertion. In general, the device can be removed via laparoscopy. Occasionally, laparotomy is needed if there is significant pelvic infection, possible bowel perforation, or if there is an inability to locate the device at laparoscopy.⁴ The copper IUD is more inflammatory than the levonorgestrel IUDs.

Abdominal location. No matter the IUD type, operative removal of intra-abdominal IUDs should take place expeditiously after they are discovered.

In the case of expulsion. If the IUD is not seen on x-ray, expulsion is the likely cause. Expulsion tends to be more common among⁵:

• parous users
• those younger than age 20
• placements that immediately follow a delivery or second-trimester abortion.

Nulliparity and type of device are not associated with increased risk of expulsion.

Read CHALLENGE 3: Difficult IUD removal

CHALLENGE 3: Difficult IUD removal

CASE Strings not palpated in a patient with history of LEEP

A 37-year-old woman (G3P2) presents to your office for IUD removal. She underwent a loop electrosurgical excision procedure 2 years ago for cervical intraepithelial neoplasia (CIN) 2 and since then has not been able to feel the IUD strings. On pelvic examination, you do not palpate or visualize the IUD strings after speculum placement.

How can you achieve IUD removal for your patient?

When a patient requests that her IUD be removed, but the strings are not visible and the woman is not pregnant, employ ultrasonography to confirm the IUD remains intrauterine and to rule out expulsion or perforation.

Employ alligator forceps or an IUD hook. Once intrauterine position is confirmed, use an alligator forceps of suitable length and with a small diameter to extract the device (FIGURE 1). It is useful to utilize ultrasonography for guidance during the removal procedure. The alligator forceps will grasp both the IUD device itself and IUD strings well, so either can be targeted during removal.

A second useful tool for IUD removal is an IUD hook (FIGURE 2). In a similar way that a curette is used for endometrial sampling, IUD hooks can be used to drag the IUD from the uterus.

Anesthesia is not usually necessary for IUD removal with alligator forceps or an IUD hook, although it may be appropriate in select patients. Data are limited with regard to the utility of paracervical blocks in this situation.

Related article:
Surgical removal of malpositioned IUDs
 

Hysteroscopy is an option. If removal with an alligator forceps or IUD hook is unsuccessful, or if preferred by the clinician, hysteroscopic-guided removal is a management option. Hysteroscopic removal may be required if the IUD has become embedded in the uterine wall.

Read CHALLENGE 4: Nonfundal IUD location

CHALLENGE 4: Nonfundal IUD location

CASE Copper IUD found in lower uterine segment

A 31-year-old woman (G1P1) calls your office to report that she thinks her copper IUD strings are longer than before. Office examination confirms that the strings are noticeably longer than is typical. Pelvic ultrasonography shows the copper IUD in the lower uterine segment.

What is the appropriate course of action?

Occasionally, IUDs are noted to be located in the lower uterine segment (FIGURE 3) or cervix. With malposition, users may be experiencing cramping or abnormal bleeding.

Cervical malposition calls for removal. ACOG advises that, regardless of a patient’s presenting symptoms, clinicians should remove IUDs located in the cervix (ie, the stem below the internal os) due to an increased risk of pregnancy and address the woman’s contraceptive needs.

Related article:
STOP relying on 2D ultrasound for IUD localization
 

Lower-uterine-segment malposition man‑agement less clear. If the patient is symptomatic, remove the device and initiate some form of contraception. If the woman is asymptomatic, the woman should be given the option of having the device removed or left in place. The mechanisms of action of both the copper and levonorgestrel-releasing IUDs suggest that this lower location is unlikely to be associated with a significant decrease in efficacy.

Unfortunately, it is difficult to estimate the risk of pregnancy for a patient whose device is located in the lower uterine segment. Braaten and Goldberg discussed case-controlled data in their 2012 article that suggest malposition may be more important to the efficacy of copper IUDs than of levonorgestrel IUDs.^6,7 As unintended pregnancy is an important risk to avoid, ultimately, it is the woman’s decision as to whether she wants removal or continued IUD use.

Read CHALLENGE 5: Pregnancy in an IUD user

CHALLENGE 5: Pregnancy in an IUD user

CASE 3-year copper IUD user with positive pregnancy test

A 25-year-old woman (G3P2) presents to your office because of missed menses and a positive home pregnancy test. Her last menstrual period was 6 weeks ago. She has had a copper IUD in place for 3 years and can feel the strings herself. She has experienced light cramping but no bleeding. Office examination is notable for the IUD stem present at the external cervical os. While the pregnancy is unplanned, the patient desires that it continue.

Should you remove the IUD?

The pregnancy rate among IUD users is less than 1%—a rate that is equivalent to that experienced by women undergoing tubal sterilization. Although there is an overall low risk of pregnancy, a higher proportion of pregnancies among IUD users compared with nonusers are ectopic. Therefore, subsequent management of pregnancy in an IUD user needs to be determined by, using ultrasound, both the location of the pregnancy and whether the IUD is in place.

If an ectopic pregnancy is found, it may be managed medically or surgically with the IUD left in place if desired. If you find an intrauterine pregnancy that is undesired, the IUD can be removed at the time of a surgical abortion or before the initiation of a medical abortion.

If you fail to locate the IUD either before or after the abortion procedure, use an AP x-ray of the entire abdomen and pelvis to determine whether the IUD is in the peritoneal cavity or whether it was likely expelled prior to the pregnancy.

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

With a desired pregnancy, if the strings are visible, remove the IUD with gentle traction. If the IUD is left in place, the risk of spontaneous abortion is significantly increased. If the strings are not seen, but the device was noted to be in the cervix by ultrasound, remove the device if the stem is below the internal cervical os. For IUDs that are located above the cervix, removal should not be attempted; counsel the patient about the increased risk of spontaneous abortion, infection, and preterm delivery.

Read CHALLENGE 6: Pregnancy in an implant user

CHALLENGE 6: Pregnancy in an implant user

CASE 3-week implant user with positive pregnancy test

Your 21-year-old patient who received a contraceptive implant 3 weeks earlier now pre‑sents with nausea and abdominal cramping. Her last menstrual period was 6 weeks ago. She has regular cycles that are 28 days in length. Results of urine pregnancy testing are positive. Prior to using the implant, the patient inconsistently used condoms.

How should you counsel your patient?

The rate of pregnancy among implant users is very low; it is estimated at 5 pregnancies per 10,000 implant users per year.⁸ As in this case, apparent “failures” of the contraceptive implant actually may represent placements that occurred before a very early pregnancy was recognized. Similar to IUDs, the proportion of pregnancies that are ectopic among implant users compared to nonusers may be higher.

With a pregnancy that is ectopic or that is intrauterine and undesired, the device may be left in and use continued after the pregnancy has been terminated. Although the effectiveness of medication abortion with pre-existing contraceptive implant in situ is not well known, researchers have demonstrated that medication abortion initiated at the same time as contraceptive implant insertion does not influence success of the medication abortion.⁹

Related article:
2016 Update on contraception

For women with desired intrauterine pregnancies, remove the device as soon as feasible and counsel the woman that there is no known teratogenic risk associated with the contraceptive implant.

Read CHALLENGE 7: Nonpalpable contraceptive implant

CHALLENGE 7: Nonpalpable contraceptive implant

CASE Patient requests device removal to attempt conception

A 30-year-old woman (G2P2) presents for contraceptive implant removal because she would like to have another child. The device was placed 30 months ago in the patient’s left arm. The insertion note in the patient’s medical record is unremarkable, and standard insertion technique was used. On physical examination, you cannot palpate the device.

What is your next course of action?

Nonpalpable implants, particularly if removal is desired, present a significant clinical challenge. Do not attempt removing a nonpalpable implant before trying to locate the device through past medical records or radiography. Records that describe the original insertion, particularly the location and type of device, are helpful.

Related article:
2015 Update on contraception
 

Appropriate imaging assistance. Ultrasonography with a high frequency linear array transducer (10 MHz or greater) may allow an experienced radiologist to identify the implant—including earlier versions without barium (Implanon) and later ones with barium (Nexplanon). Magnetic resonance imaging (MRI), computed tomography scan, or plain x-ray also can be used to detect a barium-containing device; MRI can be used to locate a non−barium-containing implant.

Carry out removal using ultrasonographic guidance. If a deep insertion is felt to be close to a neurovascular bundle, device removal should be carried out in an operating room by a surgeon familiar with the anatomy of the upper arm.

When an implant cannot be located despite radiography. This is an infrequent occurrence. Merck, the manufacturer of the etonorgestrel implant, provides advice and support in this circumstance. (Visit https://www.merckconnect.com/nexplanon/over view.html.)

Recently, published case reports detail episodes of implants inserted into the venous system with migration to the heart or lungs.¹⁰ While this phenomenon is considered rare, the manufacturer has recommended that insertion of the contraceptive implant avoid the sulcus between the biceps and triceps muscles.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

An estimated 98,000 Americans die each year due to medical errors. This is an attention-grabbing statistic—from the year 2000.¹ A recent study (published in 2016) reported that medical errors are the third leading cause of death in the United States, ranking just behind heart disease and cancer.²

As expected, much has been done to reduce medical errors and improve patient safety as a result of these publications. Quality, safety, and outcomes are paramount, as evidenced by the Institute of Health Care Improvement’s “triple aim”: reduce cost of care, improve quality of care, and improve patient outcomes.³

While these 3 aims are of paramount importance, this article seeks to portray the “quadruple aim,” with an additional focus on physician well-being. Patients and their families (first victims) are not the only ones affected by medical errors. Clinicians are, too, and these effects can be devastating. Here I offer concrete strategies to support providers involved in medical errors, including tips on developing a formal support program. First, however, I describe the devastating effects medical errors can have on providers and the signs of a second victim.

Related article:
Medical errors: Caring for the second victim (you)

The scope of the problem

In 2000, it was Dr. Albert Wu’s publication in The British Medical Journal titled “Medical Error: The Second Victim” (the doctor who makes mistakes needs help too), that first addressed this important topic.⁴ In his article he shared a case of another house officer who missed signs of a pericardial tamponade and was judged incompetent by peers due to his mistake.

As physicians, we do not intrinsically support colleagues who have experienced a medical error. We all have taken, with pride and commitment, our Hippocratic Oath of “do no harm,” yet we are often held to standards of perfection by society, peers, and, above all, ourselves. Have technologic wonders and precise laboratory tests supplanted the adage “doctors are only human”? Dr. Wu also points out in this landmark essay his observation and dismay at the lack of empathy, sympathy, and compassion shown by peers when medical errors occur. All of these elements are needed for the healing of those involved to take place. If they are not provided, dysfunctional coping mechanisms ensue.⁴

Incidence of medical errors

Despite the Institute of Medicine report from 2000¹ and the recent study from Johns Hopkins,² determining the exact number of errors and incidents is not easy. Most data reporting is sparse. A prospective longitudinal study of perceived medical errors and resident distress estimated medical errors to be between 5% and 10% in hospitalized patients, but that it could be up to 50%.⁵ According to a 2005 study, approximately one-third of internal medicine residents report at least 1 major medical error during their 3 years of training, while 18% of multidisciplinary residents report an adverse event under their care in the previous week.⁶

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

Who is at risk of becoming a second victim?

Any and all clinicians can become a second victim, and the state can be realized at varying points in the process of an experienced medical error. The circumstances of the initial error and the severity of the effect on the patient and/or the damaged physician−patient relationship can affect whether or not there is a second victim. A second victim also can emerge as a result of peers’ or colleagues’ comments and lack of empathy or support. Certainly a lawsuit can produce a second victim.⁷

How often do physicians become second victims?

The prevalence of second victims has a large variation in estimates. A 2006 study estimates a prevalence of 10.4%.⁸ In 2010, the estimate was 30%, and a prevalence of 43.3% was reported in 2000.^9,10 Regarding emotional distress within a year of a major adverse event, 30% of almost 900 providers reported these feelings.¹¹ Other studies note 50% of health care workers reported feelings consistent with those of a second victim.⁷

Next: What are the symptoms of a second victim?

The signs of, and long-lasting risks for, a second victim

Second victims are at risk for several well-documented symptoms, regardless of their stage of training, including⁶:

• depression (in fact, they have a 3-fold risk)
• decrease in overall quality of life
• increase in burnout
• increase in feelings of distress, guilt, and shame, which may be long lasting.

Health care providers as second victims also may experience shock and hopelessness, sleep disturbance, social avoidance, intrusive thoughts and nightmares, and poor memory and concentration. Interestingly, these emotions and reactions are indistinguishable from posttraumatic stress disorder. These continued symptoms can have short- and long-term implications for physicians, patients, and the health care organization.¹²

Next: How to support those affected by a medical error

How to support all of those affected by a medical error

Over the past decade or so, much attention has been paid to creating safer health systems, improving outcomes and patient satisfaction, and recognizing the needs of patients and families of first victims when medical errors occur. Much less has been done to acknowledge and address the needs of struggling clinicians.

Provide nurturing discussions and sympathy

Hospital systems do have embedded processes to review outcomes and medical errors, including, among others, peer review, quality improvement, morbidity and mortality review, and root cause analysis. Unfortunately, often a “name, blame, shame game” can result from the overall process, with certain individuals or groups of individuals singled out, and only worsen the incidence and effects of the second victim. Ideally, system processes for addressing medical errors should allow for an environment more focused on nurturing discussions to prevent error and recognize all the factors contributing to an error.

Of course in any outcome or error investigation, the goal is to identify what happened, what factors contributed to the incident, and what can be done to prevent future occurrences. The concern for the family as priority is understandable, as is the desire to prevent a lawsuit. The lack of attention and sympathy to the health care provider involved contributes to the second victim.⁷

It is all too easy to blame, even in a Just Culture. Deficiencies in sympathy and attention can occur without a system whose culture is focused on “name, blame, shame.” A Just Culture, as defined by the Institute for Healthcare Improvement, is one in which individuals come forward with a mistake without fear of punishment. Such a culture balances the need to learn from our mistakes and the need to have disciplinary action.¹³

David Marx, an outcomes engineer and author of “Whack a Mole: The Price We Pay for Expecting Perfection,” touts a Just Culture as one having the following sets of beliefs:

• recognition that professionals will make mistakes
• recognition that even professionals will develop unhealthy norms
• a fierce intolerance for reckless conduct.

He strongly asserts that human error be consoled while reckless behavior be punished.¹⁴ Punishing human error is a setup for the second victim.

Read on for tips to develop a coping program

Tips for developing a coping program

In 2009, Scott and colleagues described 6 stages of a second victim. These are:

• Stage 1: Chaos and event repair
• Stage 2: Intrusive thoughts, “what if”
• Stage 3: Restoring personal identity
• Stage 4: Enduring the inquisition
• Stage 5: Obtaining emotional first aid
• Stage 6: Moving on or dropping out; surviving and/or thriving

Throughout the stages, second victims look for support and share their experience of the medical error event, as well as their personal and professional impact of the error.¹⁵

A 2007 study that examined the emotional impact of medical errors on physicians revealed some startling data. A full 82% of physicians expressed interest in counseling to help cope with their distress. And 90% felt there was inadequate support at their hospitals or health care organizations for this distress.¹⁶

Use The Joint Commission’s toolkit

Unfortunately, there are only a few well-documented second-victim support programs in the United States, despite the growing evidence of the emotional distress that second victims experience. Many hospitals do not know how to develop or implement such a support system. Recognizing this challenge, The Joint Commission developed a toolkit to assist health care organizations in developing a second-victim program. The toolkit consists of 10 modules (TABLE) designed to assist organizations not only to implement a second-victim support process but also to customize it to their specific institutional culture. This toolkit can be downloaded for free or used online. Within the first year of its availability, over 6,000 people visited the website and there were more than 700 requests for a download.¹⁷

Follow forYOU’s example

An example and well-recognized second-victim support program is the “forYOU” team at the University of Missouri. The program is free to employees, confidential, and available 24-7. Its purpose is “providing care and support to our staff,” by helping members understand the phenomenon of the second victim and quickly returning members to a satisfying professional practice.¹⁸

The “forYOU” team was created in 2007 under the direction of the University of Missouri Health Care’s Office of Clinical Effectiveness with the goals of increasing institutional awareness, providing a second victim with a “safe zone,” and allowing for the expression of emotions and reactions in a confidential setting. Team members are multidisciplinary and include physicians, nurses, respiratory therapists, social workers, and chaplains. They strive to normalize the feelings and thoughts second victims experience after a stressful outcome or event. Team members are highly trained in second-victim responses and the stages of coping. The program has established institutional actions to each of the 6 stages (FIGURE).¹⁹

Read on to learn how peer mentors are crucial to a support program

Establish TRUST

At the Carilion Clinic in Roanoke, Virginia, we too have developed a second-victim support program for all of our employees: TRUST. In the beginning stages, we quickly reaffirmed the challenges in developing such a program.

Initial challenges you will face. First, education on what a second victim is needs to be recognized. The fact that not everyone experiences second-victim emotions needs to be validated. Administrators and staff must be convinced that needing support is not a sign of weakness. And the program must ensure confidentiality and recruit mentors. These are just a few of the obstacles we faced on our path to program realization. Our journey to develop our second-victim program was approximately 5 years and required participation, affirmation, and support from all levels of the organization.

Our program name embodies its inherent purpose and goals. TRUST stands for:

• Treatment that is just. Second victims deserve the right of a presumption that their intentions were good, and should be able to depend on organizational leaders for integrity, fairness, just treatment, and shared accountability for outcomes.
• Respect. Second victims deserve respect and common decency and should not be blamed and shamed for human fallibility.
• Understanding and compassion. Second victims need compassionate help to grieve and heal.
• Supportive care. Second victims are entitled to psychological and support services that are delivered in a professional and organized way.
• Transparency and opportunity to contribute. Second victims have a right to participate in the learning gathered from the event, to share important causal information with the organization, and to be provided with an opportunity to heal by contributing to the prevention of future events.

Employ peer mentors, who serve a vital role

We have identified the need to develop a more direct and active approach to the TRUST program’s recruitment and established a subcommittee to begin this process. We began by asking leaders to nominate potential peer mentors and spoke about the program and asked for volunteers at various hospital committees. Once we had most disciplines represented, leaders were asked to take an assessment for emotional intelligence.

Other than the initial training for the TRUST program, the time requirement for participation for peer mentors is likely less than an hour per month. The dedicated time certainly is dependent on how much support the second victim is requiring, however, and varies. We encourage the peer supporters to be aware of their time constraints and establish parameters for the relationship in a direct but supportive way.

Since the inception of the TRUST Team in September 2014, we have trained 12 peer mentors, 10 of whom currently still serve in that capacity. We have 3 additional peers awaiting training. To date, The TRUST team has supported 19 clinicians/staff, including 3 ACPs, 9 nurses, 6 physicians, and 1 other (pharmacist). Of those 10, 3 are still actively receiving support so closing data have yet to be collected. Of the 16 who have been closed, 6 were referred for ongoing support and 10 were able to return to baseline with TRUST Team Supports.

Related article:
Who is liable when a surgical error occurs?

Just surviving the medical error is not the goal

Medical errors are inevitable, and the effects on providers can be devastating. It is important that physicians and institutions are aware of the signs and symptoms of a second victim as well as provide support to them. Institutions must have a just culture in which all members of the health care team can come forward with medical errors without the fear of punishment. Ideally, these institutions also have a second-victim support system that identifies those who need assistance and assist all health care clinicians not only to survive the effects of medical errors but also to thrive after receiving the necessary support.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

An estimated 98,000 Americans die each year due to medical errors. This is an attention-grabbing statistic—from the year 2000.¹ A recent study (published in 2016) reported that medical errors are the third leading cause of death in the United States, ranking just behind heart disease and cancer.²

As expected, much has been done to reduce medical errors and improve patient safety as a result of these publications. Quality, safety, and outcomes are paramount, as evidenced by the Institute of Health Care Improvement’s “triple aim”: reduce cost of care, improve quality of care, and improve patient outcomes.³

While these 3 aims are of paramount importance, this article seeks to portray the “quadruple aim,” with an additional focus on physician well-being. Patients and their families (first victims) are not the only ones affected by medical errors. Clinicians are, too, and these effects can be devastating. Here I offer concrete strategies to support providers involved in medical errors, including tips on developing a formal support program. First, however, I describe the devastating effects medical errors can have on providers and the signs of a second victim.

Related article:
Medical errors: Caring for the second victim (you)

The scope of the problem

In 2000, it was Dr. Albert Wu’s publication in The British Medical Journal titled “Medical Error: The Second Victim” (the doctor who makes mistakes needs help too), that first addressed this important topic.⁴ In his article he shared a case of another house officer who missed signs of a pericardial tamponade and was judged incompetent by peers due to his mistake.

As physicians, we do not intrinsically support colleagues who have experienced a medical error. We all have taken, with pride and commitment, our Hippocratic Oath of “do no harm,” yet we are often held to standards of perfection by society, peers, and, above all, ourselves. Have technologic wonders and precise laboratory tests supplanted the adage “doctors are only human”? Dr. Wu also points out in this landmark essay his observation and dismay at the lack of empathy, sympathy, and compassion shown by peers when medical errors occur. All of these elements are needed for the healing of those involved to take place. If they are not provided, dysfunctional coping mechanisms ensue.⁴

Incidence of medical errors

Despite the Institute of Medicine report from 2000¹ and the recent study from Johns Hopkins,² determining the exact number of errors and incidents is not easy. Most data reporting is sparse. A prospective longitudinal study of perceived medical errors and resident distress estimated medical errors to be between 5% and 10% in hospitalized patients, but that it could be up to 50%.⁵ According to a 2005 study, approximately one-third of internal medicine residents report at least 1 major medical error during their 3 years of training, while 18% of multidisciplinary residents report an adverse event under their care in the previous week.⁶

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

Who is at risk of becoming a second victim?

Any and all clinicians can become a second victim, and the state can be realized at varying points in the process of an experienced medical error. The circumstances of the initial error and the severity of the effect on the patient and/or the damaged physician−patient relationship can affect whether or not there is a second victim. A second victim also can emerge as a result of peers’ or colleagues’ comments and lack of empathy or support. Certainly a lawsuit can produce a second victim.⁷

How often do physicians become second victims?

The prevalence of second victims has a large variation in estimates. A 2006 study estimates a prevalence of 10.4%.⁸ In 2010, the estimate was 30%, and a prevalence of 43.3% was reported in 2000.^9,10 Regarding emotional distress within a year of a major adverse event, 30% of almost 900 providers reported these feelings.¹¹ Other studies note 50% of health care workers reported feelings consistent with those of a second victim.⁷

Next: What are the symptoms of a second victim?

The signs of, and long-lasting risks for, a second victim

Second victims are at risk for several well-documented symptoms, regardless of their stage of training, including⁶:

• depression (in fact, they have a 3-fold risk)
• decrease in overall quality of life
• increase in burnout
• increase in feelings of distress, guilt, and shame, which may be long lasting.

Health care providers as second victims also may experience shock and hopelessness, sleep disturbance, social avoidance, intrusive thoughts and nightmares, and poor memory and concentration. Interestingly, these emotions and reactions are indistinguishable from posttraumatic stress disorder. These continued symptoms can have short- and long-term implications for physicians, patients, and the health care organization.¹²

Next: How to support those affected by a medical error

How to support all of those affected by a medical error

Over the past decade or so, much attention has been paid to creating safer health systems, improving outcomes and patient satisfaction, and recognizing the needs of patients and families of first victims when medical errors occur. Much less has been done to acknowledge and address the needs of struggling clinicians.

Provide nurturing discussions and sympathy

Hospital systems do have embedded processes to review outcomes and medical errors, including, among others, peer review, quality improvement, morbidity and mortality review, and root cause analysis. Unfortunately, often a “name, blame, shame game” can result from the overall process, with certain individuals or groups of individuals singled out, and only worsen the incidence and effects of the second victim. Ideally, system processes for addressing medical errors should allow for an environment more focused on nurturing discussions to prevent error and recognize all the factors contributing to an error.

Of course in any outcome or error investigation, the goal is to identify what happened, what factors contributed to the incident, and what can be done to prevent future occurrences. The concern for the family as priority is understandable, as is the desire to prevent a lawsuit. The lack of attention and sympathy to the health care provider involved contributes to the second victim.⁷

It is all too easy to blame, even in a Just Culture. Deficiencies in sympathy and attention can occur without a system whose culture is focused on “name, blame, shame.” A Just Culture, as defined by the Institute for Healthcare Improvement, is one in which individuals come forward with a mistake without fear of punishment. Such a culture balances the need to learn from our mistakes and the need to have disciplinary action.¹³

David Marx, an outcomes engineer and author of “Whack a Mole: The Price We Pay for Expecting Perfection,” touts a Just Culture as one having the following sets of beliefs:

• recognition that professionals will make mistakes
• recognition that even professionals will develop unhealthy norms
• a fierce intolerance for reckless conduct.

He strongly asserts that human error be consoled while reckless behavior be punished.¹⁴ Punishing human error is a setup for the second victim.

Read on for tips to develop a coping program

Tips for developing a coping program

In 2009, Scott and colleagues described 6 stages of a second victim. These are:

• Stage 1: Chaos and event repair
• Stage 2: Intrusive thoughts, “what if”
• Stage 3: Restoring personal identity
• Stage 4: Enduring the inquisition
• Stage 5: Obtaining emotional first aid
• Stage 6: Moving on or dropping out; surviving and/or thriving

Throughout the stages, second victims look for support and share their experience of the medical error event, as well as their personal and professional impact of the error.¹⁵

A 2007 study that examined the emotional impact of medical errors on physicians revealed some startling data. A full 82% of physicians expressed interest in counseling to help cope with their distress. And 90% felt there was inadequate support at their hospitals or health care organizations for this distress.¹⁶

Use The Joint Commission’s toolkit

Unfortunately, there are only a few well-documented second-victim support programs in the United States, despite the growing evidence of the emotional distress that second victims experience. Many hospitals do not know how to develop or implement such a support system. Recognizing this challenge, The Joint Commission developed a toolkit to assist health care organizations in developing a second-victim program. The toolkit consists of 10 modules (TABLE) designed to assist organizations not only to implement a second-victim support process but also to customize it to their specific institutional culture. This toolkit can be downloaded for free or used online. Within the first year of its availability, over 6,000 people visited the website and there were more than 700 requests for a download.¹⁷

Follow forYOU’s example

An example and well-recognized second-victim support program is the “forYOU” team at the University of Missouri. The program is free to employees, confidential, and available 24-7. Its purpose is “providing care and support to our staff,” by helping members understand the phenomenon of the second victim and quickly returning members to a satisfying professional practice.¹⁸

The “forYOU” team was created in 2007 under the direction of the University of Missouri Health Care’s Office of Clinical Effectiveness with the goals of increasing institutional awareness, providing a second victim with a “safe zone,” and allowing for the expression of emotions and reactions in a confidential setting. Team members are multidisciplinary and include physicians, nurses, respiratory therapists, social workers, and chaplains. They strive to normalize the feelings and thoughts second victims experience after a stressful outcome or event. Team members are highly trained in second-victim responses and the stages of coping. The program has established institutional actions to each of the 6 stages (FIGURE).¹⁹

Read on to learn how peer mentors are crucial to a support program

Establish TRUST

At the Carilion Clinic in Roanoke, Virginia, we too have developed a second-victim support program for all of our employees: TRUST. In the beginning stages, we quickly reaffirmed the challenges in developing such a program.

Initial challenges you will face. First, education on what a second victim is needs to be recognized. The fact that not everyone experiences second-victim emotions needs to be validated. Administrators and staff must be convinced that needing support is not a sign of weakness. And the program must ensure confidentiality and recruit mentors. These are just a few of the obstacles we faced on our path to program realization. Our journey to develop our second-victim program was approximately 5 years and required participation, affirmation, and support from all levels of the organization.

Our program name embodies its inherent purpose and goals. TRUST stands for:

• Treatment that is just. Second victims deserve the right of a presumption that their intentions were good, and should be able to depend on organizational leaders for integrity, fairness, just treatment, and shared accountability for outcomes.
• Respect. Second victims deserve respect and common decency and should not be blamed and shamed for human fallibility.
• Understanding and compassion. Second victims need compassionate help to grieve and heal.
• Supportive care. Second victims are entitled to psychological and support services that are delivered in a professional and organized way.
• Transparency and opportunity to contribute. Second victims have a right to participate in the learning gathered from the event, to share important causal information with the organization, and to be provided with an opportunity to heal by contributing to the prevention of future events.

Employ peer mentors, who serve a vital role

We have identified the need to develop a more direct and active approach to the TRUST program’s recruitment and established a subcommittee to begin this process. We began by asking leaders to nominate potential peer mentors and spoke about the program and asked for volunteers at various hospital committees. Once we had most disciplines represented, leaders were asked to take an assessment for emotional intelligence.

Other than the initial training for the TRUST program, the time requirement for participation for peer mentors is likely less than an hour per month. The dedicated time certainly is dependent on how much support the second victim is requiring, however, and varies. We encourage the peer supporters to be aware of their time constraints and establish parameters for the relationship in a direct but supportive way.

Since the inception of the TRUST Team in September 2014, we have trained 12 peer mentors, 10 of whom currently still serve in that capacity. We have 3 additional peers awaiting training. To date, The TRUST team has supported 19 clinicians/staff, including 3 ACPs, 9 nurses, 6 physicians, and 1 other (pharmacist). Of those 10, 3 are still actively receiving support so closing data have yet to be collected. Of the 16 who have been closed, 6 were referred for ongoing support and 10 were able to return to baseline with TRUST Team Supports.

Related article:
Who is liable when a surgical error occurs?

Just surviving the medical error is not the goal

Medical errors are inevitable, and the effects on providers can be devastating. It is important that physicians and institutions are aware of the signs and symptoms of a second victim as well as provide support to them. Institutions must have a just culture in which all members of the health care team can come forward with medical errors without the fear of punishment. Ideally, these institutions also have a second-victim support system that identifies those who need assistance and assist all health care clinicians not only to survive the effects of medical errors but also to thrive after receiving the necessary support.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

An estimated 98,000 Americans die each year due to medical errors. This is an attention-grabbing statistic—from the year 2000.¹ A recent study (published in 2016) reported that medical errors are the third leading cause of death in the United States, ranking just behind heart disease and cancer.²

As expected, much has been done to reduce medical errors and improve patient safety as a result of these publications. Quality, safety, and outcomes are paramount, as evidenced by the Institute of Health Care Improvement’s “triple aim”: reduce cost of care, improve quality of care, and improve patient outcomes.³

While these 3 aims are of paramount importance, this article seeks to portray the “quadruple aim,” with an additional focus on physician well-being. Patients and their families (first victims) are not the only ones affected by medical errors. Clinicians are, too, and these effects can be devastating. Here I offer concrete strategies to support providers involved in medical errors, including tips on developing a formal support program. First, however, I describe the devastating effects medical errors can have on providers and the signs of a second victim.

Related article:
Medical errors: Caring for the second victim (you)

The scope of the problem

In 2000, it was Dr. Albert Wu’s publication in The British Medical Journal titled “Medical Error: The Second Victim” (the doctor who makes mistakes needs help too), that first addressed this important topic.⁴ In his article he shared a case of another house officer who missed signs of a pericardial tamponade and was judged incompetent by peers due to his mistake.

As physicians, we do not intrinsically support colleagues who have experienced a medical error. We all have taken, with pride and commitment, our Hippocratic Oath of “do no harm,” yet we are often held to standards of perfection by society, peers, and, above all, ourselves. Have technologic wonders and precise laboratory tests supplanted the adage “doctors are only human”? Dr. Wu also points out in this landmark essay his observation and dismay at the lack of empathy, sympathy, and compassion shown by peers when medical errors occur. All of these elements are needed for the healing of those involved to take place. If they are not provided, dysfunctional coping mechanisms ensue.⁴

Incidence of medical errors

Despite the Institute of Medicine report from 2000¹ and the recent study from Johns Hopkins,² determining the exact number of errors and incidents is not easy. Most data reporting is sparse. A prospective longitudinal study of perceived medical errors and resident distress estimated medical errors to be between 5% and 10% in hospitalized patients, but that it could be up to 50%.⁵ According to a 2005 study, approximately one-third of internal medicine residents report at least 1 major medical error during their 3 years of training, while 18% of multidisciplinary residents report an adverse event under their care in the previous week.⁶

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

Who is at risk of becoming a second victim?

Any and all clinicians can become a second victim, and the state can be realized at varying points in the process of an experienced medical error. The circumstances of the initial error and the severity of the effect on the patient and/or the damaged physician−patient relationship can affect whether or not there is a second victim. A second victim also can emerge as a result of peers’ or colleagues’ comments and lack of empathy or support. Certainly a lawsuit can produce a second victim.⁷

How often do physicians become second victims?

The prevalence of second victims has a large variation in estimates. A 2006 study estimates a prevalence of 10.4%.⁸ In 2010, the estimate was 30%, and a prevalence of 43.3% was reported in 2000.^9,10 Regarding emotional distress within a year of a major adverse event, 30% of almost 900 providers reported these feelings.¹¹ Other studies note 50% of health care workers reported feelings consistent with those of a second victim.⁷

Next: What are the symptoms of a second victim?

The signs of, and long-lasting risks for, a second victim

Second victims are at risk for several well-documented symptoms, regardless of their stage of training, including⁶:

• depression (in fact, they have a 3-fold risk)
• decrease in overall quality of life
• increase in burnout
• increase in feelings of distress, guilt, and shame, which may be long lasting.

Health care providers as second victims also may experience shock and hopelessness, sleep disturbance, social avoidance, intrusive thoughts and nightmares, and poor memory and concentration. Interestingly, these emotions and reactions are indistinguishable from posttraumatic stress disorder. These continued symptoms can have short- and long-term implications for physicians, patients, and the health care organization.¹²

Next: How to support those affected by a medical error

How to support all of those affected by a medical error

Over the past decade or so, much attention has been paid to creating safer health systems, improving outcomes and patient satisfaction, and recognizing the needs of patients and families of first victims when medical errors occur. Much less has been done to acknowledge and address the needs of struggling clinicians.

Provide nurturing discussions and sympathy

Hospital systems do have embedded processes to review outcomes and medical errors, including, among others, peer review, quality improvement, morbidity and mortality review, and root cause analysis. Unfortunately, often a “name, blame, shame game” can result from the overall process, with certain individuals or groups of individuals singled out, and only worsen the incidence and effects of the second victim. Ideally, system processes for addressing medical errors should allow for an environment more focused on nurturing discussions to prevent error and recognize all the factors contributing to an error.

Of course in any outcome or error investigation, the goal is to identify what happened, what factors contributed to the incident, and what can be done to prevent future occurrences. The concern for the family as priority is understandable, as is the desire to prevent a lawsuit. The lack of attention and sympathy to the health care provider involved contributes to the second victim.⁷

It is all too easy to blame, even in a Just Culture. Deficiencies in sympathy and attention can occur without a system whose culture is focused on “name, blame, shame.” A Just Culture, as defined by the Institute for Healthcare Improvement, is one in which individuals come forward with a mistake without fear of punishment. Such a culture balances the need to learn from our mistakes and the need to have disciplinary action.¹³

David Marx, an outcomes engineer and author of “Whack a Mole: The Price We Pay for Expecting Perfection,” touts a Just Culture as one having the following sets of beliefs:

• recognition that professionals will make mistakes
• recognition that even professionals will develop unhealthy norms
• a fierce intolerance for reckless conduct.

He strongly asserts that human error be consoled while reckless behavior be punished.¹⁴ Punishing human error is a setup for the second victim.

Read on for tips to develop a coping program

Tips for developing a coping program

In 2009, Scott and colleagues described 6 stages of a second victim. These are:

• Stage 1: Chaos and event repair
• Stage 2: Intrusive thoughts, “what if”
• Stage 3: Restoring personal identity
• Stage 4: Enduring the inquisition
• Stage 5: Obtaining emotional first aid
• Stage 6: Moving on or dropping out; surviving and/or thriving

Throughout the stages, second victims look for support and share their experience of the medical error event, as well as their personal and professional impact of the error.¹⁵

A 2007 study that examined the emotional impact of medical errors on physicians revealed some startling data. A full 82% of physicians expressed interest in counseling to help cope with their distress. And 90% felt there was inadequate support at their hospitals or health care organizations for this distress.¹⁶

Use The Joint Commission’s toolkit

Unfortunately, there are only a few well-documented second-victim support programs in the United States, despite the growing evidence of the emotional distress that second victims experience. Many hospitals do not know how to develop or implement such a support system. Recognizing this challenge, The Joint Commission developed a toolkit to assist health care organizations in developing a second-victim program. The toolkit consists of 10 modules (TABLE) designed to assist organizations not only to implement a second-victim support process but also to customize it to their specific institutional culture. This toolkit can be downloaded for free or used online. Within the first year of its availability, over 6,000 people visited the website and there were more than 700 requests for a download.¹⁷

Follow forYOU’s example

An example and well-recognized second-victim support program is the “forYOU” team at the University of Missouri. The program is free to employees, confidential, and available 24-7. Its purpose is “providing care and support to our staff,” by helping members understand the phenomenon of the second victim and quickly returning members to a satisfying professional practice.¹⁸

The “forYOU” team was created in 2007 under the direction of the University of Missouri Health Care’s Office of Clinical Effectiveness with the goals of increasing institutional awareness, providing a second victim with a “safe zone,” and allowing for the expression of emotions and reactions in a confidential setting. Team members are multidisciplinary and include physicians, nurses, respiratory therapists, social workers, and chaplains. They strive to normalize the feelings and thoughts second victims experience after a stressful outcome or event. Team members are highly trained in second-victim responses and the stages of coping. The program has established institutional actions to each of the 6 stages (FIGURE).¹⁹

Read on to learn how peer mentors are crucial to a support program

Establish TRUST

At the Carilion Clinic in Roanoke, Virginia, we too have developed a second-victim support program for all of our employees: TRUST. In the beginning stages, we quickly reaffirmed the challenges in developing such a program.

Initial challenges you will face. First, education on what a second victim is needs to be recognized. The fact that not everyone experiences second-victim emotions needs to be validated. Administrators and staff must be convinced that needing support is not a sign of weakness. And the program must ensure confidentiality and recruit mentors. These are just a few of the obstacles we faced on our path to program realization. Our journey to develop our second-victim program was approximately 5 years and required participation, affirmation, and support from all levels of the organization.

Our program name embodies its inherent purpose and goals. TRUST stands for:

• Treatment that is just. Second victims deserve the right of a presumption that their intentions were good, and should be able to depend on organizational leaders for integrity, fairness, just treatment, and shared accountability for outcomes.
• Respect. Second victims deserve respect and common decency and should not be blamed and shamed for human fallibility.
• Understanding and compassion. Second victims need compassionate help to grieve and heal.
• Supportive care. Second victims are entitled to psychological and support services that are delivered in a professional and organized way.
• Transparency and opportunity to contribute. Second victims have a right to participate in the learning gathered from the event, to share important causal information with the organization, and to be provided with an opportunity to heal by contributing to the prevention of future events.

Employ peer mentors, who serve a vital role

We have identified the need to develop a more direct and active approach to the TRUST program’s recruitment and established a subcommittee to begin this process. We began by asking leaders to nominate potential peer mentors and spoke about the program and asked for volunteers at various hospital committees. Once we had most disciplines represented, leaders were asked to take an assessment for emotional intelligence.

Other than the initial training for the TRUST program, the time requirement for participation for peer mentors is likely less than an hour per month. The dedicated time certainly is dependent on how much support the second victim is requiring, however, and varies. We encourage the peer supporters to be aware of their time constraints and establish parameters for the relationship in a direct but supportive way.

Since the inception of the TRUST Team in September 2014, we have trained 12 peer mentors, 10 of whom currently still serve in that capacity. We have 3 additional peers awaiting training. To date, The TRUST team has supported 19 clinicians/staff, including 3 ACPs, 9 nurses, 6 physicians, and 1 other (pharmacist). Of those 10, 3 are still actively receiving support so closing data have yet to be collected. Of the 16 who have been closed, 6 were referred for ongoing support and 10 were able to return to baseline with TRUST Team Supports.

Related article:
Who is liable when a surgical error occurs?

Just surviving the medical error is not the goal

Medical errors are inevitable, and the effects on providers can be devastating. It is important that physicians and institutions are aware of the signs and symptoms of a second victim as well as provide support to them. Institutions must have a just culture in which all members of the health care team can come forward with medical errors without the fear of punishment. Ideally, these institutions also have a second-victim support system that identifies those who need assistance and assist all health care clinicians not only to survive the effects of medical errors but also to thrive after receiving the necessary support.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Technology has changed--and continues to change--the practice of medicine. Health care providers access word processing programs, e-mail, and electronic medical records using desktop and laptop computers. Now, providers are accessing these same tools with handheld devices such as smartphones, tablets, and "phablets" (a class of mobile devices designed to combine the form of a smartphone and a tablet).

Critical to the popularity and functionality of handheld devices are mobile applications, also known as "apps." An app is a self-contained program or piece of software designed to run on handheld devices to perform a specific purpose. App overload and app inaccuracy, however, are major problems. Health care providers do not have the time to search through thousands of medical apps in app stores to find specialty-related apps that might be useful in their practice--or to check the accuracy of those apps.

Vetted apps for ObGyns

My team's research has focused on identifying apps for ObGyns to use in clinical practice.¹ In the process, we have developed the APPLICATIONS scoring system, which contains objective and subjective components to help differentiate among the accurate apps.² This new quarterly "App review" series in OBG Management will showcase recommended apps for the busy ObGyn in the hope of improving work efficiency and the provider-patient relationship.

First up: Apps for calculating the date of delivery. This first app review focuses on pregnancy wheels, or due date calculators. Calculator apps are preferred over other types of apps such as procedure/case documentation apps, as providers use smartphones at point of care to allow rapid decision making.³ Calculating the estimated date of delivery (EDD) and gestational age (GA) is an important, vital task for providers of obstetric care. In fact, new guidelines for calculating EDD were recently developed by the American College of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine (AIUM), and the Society for Maternal-Fetal Medicine (SMFM).⁴ Notably, pregnancy wheel apps are more accurate than paper wheels.5 My team checked the accuracy of the pregnancy wheel apps by applying strict criteria to ensure the correct EDD and GA and then scored them in a systematic, nonbiased, conflict-of-interest-free manner.²

Related article:
Elective induction of labor at 39 (vs 41) weeks: Caveats and considerations
 

The TABLE below lists the top 3 recommended pregnancy wheel or due date calculator apps vetted by our research. The apps are listed alphabetically, and details for each app are provided based on a shortened version of the APPLICATIONS scoring system, APPLI--app comprehensiveness, price, platform, literature use, and important special features.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Technology has changed--and continues to change--the practice of medicine. Health care providers access word processing programs, e-mail, and electronic medical records using desktop and laptop computers. Now, providers are accessing these same tools with handheld devices such as smartphones, tablets, and "phablets" (a class of mobile devices designed to combine the form of a smartphone and a tablet).

Critical to the popularity and functionality of handheld devices are mobile applications, also known as "apps." An app is a self-contained program or piece of software designed to run on handheld devices to perform a specific purpose. App overload and app inaccuracy, however, are major problems. Health care providers do not have the time to search through thousands of medical apps in app stores to find specialty-related apps that might be useful in their practice--or to check the accuracy of those apps.

Vetted apps for ObGyns

My team's research has focused on identifying apps for ObGyns to use in clinical practice.¹ In the process, we have developed the APPLICATIONS scoring system, which contains objective and subjective components to help differentiate among the accurate apps.² This new quarterly "App review" series in OBG Management will showcase recommended apps for the busy ObGyn in the hope of improving work efficiency and the provider-patient relationship.

First up: Apps for calculating the date of delivery. This first app review focuses on pregnancy wheels, or due date calculators. Calculator apps are preferred over other types of apps such as procedure/case documentation apps, as providers use smartphones at point of care to allow rapid decision making.³ Calculating the estimated date of delivery (EDD) and gestational age (GA) is an important, vital task for providers of obstetric care. In fact, new guidelines for calculating EDD were recently developed by the American College of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine (AIUM), and the Society for Maternal-Fetal Medicine (SMFM).⁴ Notably, pregnancy wheel apps are more accurate than paper wheels.5 My team checked the accuracy of the pregnancy wheel apps by applying strict criteria to ensure the correct EDD and GA and then scored them in a systematic, nonbiased, conflict-of-interest-free manner.²

Related article:
Elective induction of labor at 39 (vs 41) weeks: Caveats and considerations
 

The TABLE below lists the top 3 recommended pregnancy wheel or due date calculator apps vetted by our research. The apps are listed alphabetically, and details for each app are provided based on a shortened version of the APPLICATIONS scoring system, APPLI--app comprehensiveness, price, platform, literature use, and important special features.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Technology has changed--and continues to change--the practice of medicine. Health care providers access word processing programs, e-mail, and electronic medical records using desktop and laptop computers. Now, providers are accessing these same tools with handheld devices such as smartphones, tablets, and "phablets" (a class of mobile devices designed to combine the form of a smartphone and a tablet).

Critical to the popularity and functionality of handheld devices are mobile applications, also known as "apps." An app is a self-contained program or piece of software designed to run on handheld devices to perform a specific purpose. App overload and app inaccuracy, however, are major problems. Health care providers do not have the time to search through thousands of medical apps in app stores to find specialty-related apps that might be useful in their practice--or to check the accuracy of those apps.

Vetted apps for ObGyns

My team's research has focused on identifying apps for ObGyns to use in clinical practice.¹ In the process, we have developed the APPLICATIONS scoring system, which contains objective and subjective components to help differentiate among the accurate apps.² This new quarterly "App review" series in OBG Management will showcase recommended apps for the busy ObGyn in the hope of improving work efficiency and the provider-patient relationship.

First up: Apps for calculating the date of delivery. This first app review focuses on pregnancy wheels, or due date calculators. Calculator apps are preferred over other types of apps such as procedure/case documentation apps, as providers use smartphones at point of care to allow rapid decision making.³ Calculating the estimated date of delivery (EDD) and gestational age (GA) is an important, vital task for providers of obstetric care. In fact, new guidelines for calculating EDD were recently developed by the American College of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine (AIUM), and the Society for Maternal-Fetal Medicine (SMFM).⁴ Notably, pregnancy wheel apps are more accurate than paper wheels.5 My team checked the accuracy of the pregnancy wheel apps by applying strict criteria to ensure the correct EDD and GA and then scored them in a systematic, nonbiased, conflict-of-interest-free manner.²

Related article:
Elective induction of labor at 39 (vs 41) weeks: Caveats and considerations
 

The TABLE below lists the top 3 recommended pregnancy wheel or due date calculator apps vetted by our research. The apps are listed alphabetically, and details for each app are provided based on a shortened version of the APPLICATIONS scoring system, APPLI--app comprehensiveness, price, platform, literature use, and important special features.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.