Opinion

Cervical dysplasia is a condition commonly encountered by the gynecologist. It is either treated (with excision or ablation) or monitored, depending on the lesion grade, cytologic history, medical history, and reproductive goals. Cervical dysplasia commonly arises in women of reproductive age. Therefore, consider reproductive effects when deciding whether to treat or monitor, as well as when choosing the treatment modality.

Background

Approximately two-thirds of human papillomavirus infections resolve within a year, and more than 90% resolve within 2 years. Similarly, low-grade cervical intraepithelial neoplasia (CIN 1) lesions frequently resolve. High-grade (CIN 2 and CIN 3) lesions regress less commonly, with 5% and 12%-40% progressing to invasive cancer, respectively. Therefore, treatment is typically recommended.

Obstetric implications

Potential obstetric risks of treatment for CIN include infertility, spontaneous abortion, preterm premature rupture of membranes (PPROM), preterm delivery, and perinatal/neonatal mortality. These risks are discussed individually below. Mechanisms that have been suggested for such complications include decreased cervical mucous, cervical scarring impeding conception or dilation, loss of cervical volume, collagen breakdown, and immunologic processes due to decreased physical defenses or microbiome shifts.

Fertility

Studies have shown that treatment does not appear to impede conception. The overall pregnancy rate is higher among treated women than untreated women. Pregnancy rates are not different among women intending to conceive or among women attempting conception for more than 12 months, with the caveat being that these studies are heterogenous.^2,3

Miscarriage

No difference has been observed in total (less than 24 weeks) miscarriage rate or first trimester (less than 12 weeks) miscarriage rate among treated and untreated women. However, the second trimester miscarriage rate is significantly higher among treated women (risk ratio, 2.60).² This risk is most notable following laser conization or LEEP.⁴ There may also be an association between ablation and pregnancy loss.

Preterm birth and PPROM

Several studies and meta-analyses show an association between preterm birth and treatment for CIN using LEEP or CKC. There is an increased risk of severe preterm delivery (relative risk, 2.78), extreme preterm delivery (relative risk, 5.33), and low birth weight (relative risk, 2.86) with CKC.⁵ LEEP is associated with the same outcomes, albeit the risk is lower than with CKC.⁶ The risk of preterm birth is even lower for ablation.⁷

Other complications

Ectopic pregnancy and termination rates may be higher in treated women, compared with untreated women.² However, there does not appear to be an increased risk for perinatal/neonatal mortality, cesarean section, or neonatal intensive care unit admission among women treated with excisional procedures.⁶

Pointers for practice

• Due to the potential for adverse obstetric complications following excisional procedures for cervical dysplasia, gynecologists should closely adhere to the American Society for Colposcopy and Cervical Pathology guidelines when determining the appropriateness of dysplasia interventions. The decision to treat, versus monitor, dysplasia in a woman who plans future childbearing should be made with the patient after thorough discussion of the risks and benefits of each path.
• Women younger than age 30 years should not be screened for high-risk human papillomavirus because of both its high incidence and its high rate of spontaneous resolution.
• For reproductive-aged women with CIN 2 and adequate colposcopy, the American Society for Colposcopy and Cervical Pathology supports either monitoring with cytology and colposcopy every 6 months for a year or excisional treatment. However, women with CIN 3, inadequate colposcopy, prior cervical cancer, diethylstilbestrol exposure, or decreased immunity should undergo excisional treatment.
• When selecting an excisional method (LEEP or CKC), surgeons should choose the most appropriate technique for the patient’s pathology but should acknowledge the observed higher rates of PPROM, preterm birth, and low-birth-weight infants among those receiving CKC, and tailor the size of the excision to the specific lesion.
• Consider recommending a 12-month interval between treatment and pregnancy to ensure resolution of high-grade dysplasia. Furthermore, obstetric risk may be increased within 12 months following treatment.

Dr. Robbins is a resident in the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC, Chapel Hill. They reported having no relevant financial disclosures.

References

1. Am J Obstet Gynecol. 2011 Jul;205(1):19-27.

2. Cochrane Database Syst Rev. 2015 Sep 29;(9):CD008478.

3. BMJ. 2014 Oct 28;349:g6192.

4. Obstet Gynecol. 2016 Dec;128(6):1265-73.

5. BMJ. 2008 Sep 18;337:a1284.

6. Arch Gynecol Obstet. 2014 Jan;289(1):85-99.

7. BJOG. 2011 Aug;118(9):1031-41.

8. Obstet Gynecol. 2013 May;121(5):1063-8.

9. Lancet. 2006 Feb 11;367(9509):489-98.

10. Gynecol Obstet Invest. 2014;77(4):240-4.

Cervical dysplasia is a condition commonly encountered by the gynecologist. It is either treated (with excision or ablation) or monitored, depending on the lesion grade, cytologic history, medical history, and reproductive goals. Cervical dysplasia commonly arises in women of reproductive age. Therefore, consider reproductive effects when deciding whether to treat or monitor, as well as when choosing the treatment modality.

Background

Approximately two-thirds of human papillomavirus infections resolve within a year, and more than 90% resolve within 2 years. Similarly, low-grade cervical intraepithelial neoplasia (CIN 1) lesions frequently resolve. High-grade (CIN 2 and CIN 3) lesions regress less commonly, with 5% and 12%-40% progressing to invasive cancer, respectively. Therefore, treatment is typically recommended.

Obstetric implications

Potential obstetric risks of treatment for CIN include infertility, spontaneous abortion, preterm premature rupture of membranes (PPROM), preterm delivery, and perinatal/neonatal mortality. These risks are discussed individually below. Mechanisms that have been suggested for such complications include decreased cervical mucous, cervical scarring impeding conception or dilation, loss of cervical volume, collagen breakdown, and immunologic processes due to decreased physical defenses or microbiome shifts.

Fertility

Studies have shown that treatment does not appear to impede conception. The overall pregnancy rate is higher among treated women than untreated women. Pregnancy rates are not different among women intending to conceive or among women attempting conception for more than 12 months, with the caveat being that these studies are heterogenous.^2,3

Miscarriage

No difference has been observed in total (less than 24 weeks) miscarriage rate or first trimester (less than 12 weeks) miscarriage rate among treated and untreated women. However, the second trimester miscarriage rate is significantly higher among treated women (risk ratio, 2.60).² This risk is most notable following laser conization or LEEP.⁴ There may also be an association between ablation and pregnancy loss.

Preterm birth and PPROM

Several studies and meta-analyses show an association between preterm birth and treatment for CIN using LEEP or CKC. There is an increased risk of severe preterm delivery (relative risk, 2.78), extreme preterm delivery (relative risk, 5.33), and low birth weight (relative risk, 2.86) with CKC.⁵ LEEP is associated with the same outcomes, albeit the risk is lower than with CKC.⁶ The risk of preterm birth is even lower for ablation.⁷

Other complications

Ectopic pregnancy and termination rates may be higher in treated women, compared with untreated women.² However, there does not appear to be an increased risk for perinatal/neonatal mortality, cesarean section, or neonatal intensive care unit admission among women treated with excisional procedures.⁶

Pointers for practice

• Due to the potential for adverse obstetric complications following excisional procedures for cervical dysplasia, gynecologists should closely adhere to the American Society for Colposcopy and Cervical Pathology guidelines when determining the appropriateness of dysplasia interventions. The decision to treat, versus monitor, dysplasia in a woman who plans future childbearing should be made with the patient after thorough discussion of the risks and benefits of each path.
• Women younger than age 30 years should not be screened for high-risk human papillomavirus because of both its high incidence and its high rate of spontaneous resolution.
• For reproductive-aged women with CIN 2 and adequate colposcopy, the American Society for Colposcopy and Cervical Pathology supports either monitoring with cytology and colposcopy every 6 months for a year or excisional treatment. However, women with CIN 3, inadequate colposcopy, prior cervical cancer, diethylstilbestrol exposure, or decreased immunity should undergo excisional treatment.
• When selecting an excisional method (LEEP or CKC), surgeons should choose the most appropriate technique for the patient’s pathology but should acknowledge the observed higher rates of PPROM, preterm birth, and low-birth-weight infants among those receiving CKC, and tailor the size of the excision to the specific lesion.
• Consider recommending a 12-month interval between treatment and pregnancy to ensure resolution of high-grade dysplasia. Furthermore, obstetric risk may be increased within 12 months following treatment.

Dr. Robbins is a resident in the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC, Chapel Hill. They reported having no relevant financial disclosures.

References

1. Am J Obstet Gynecol. 2011 Jul;205(1):19-27.

2. Cochrane Database Syst Rev. 2015 Sep 29;(9):CD008478.

3. BMJ. 2014 Oct 28;349:g6192.

4. Obstet Gynecol. 2016 Dec;128(6):1265-73.

5. BMJ. 2008 Sep 18;337:a1284.

6. Arch Gynecol Obstet. 2014 Jan;289(1):85-99.

7. BJOG. 2011 Aug;118(9):1031-41.

8. Obstet Gynecol. 2013 May;121(5):1063-8.

9. Lancet. 2006 Feb 11;367(9509):489-98.

10. Gynecol Obstet Invest. 2014;77(4):240-4.

Cervical dysplasia is a condition commonly encountered by the gynecologist. It is either treated (with excision or ablation) or monitored, depending on the lesion grade, cytologic history, medical history, and reproductive goals. Cervical dysplasia commonly arises in women of reproductive age. Therefore, consider reproductive effects when deciding whether to treat or monitor, as well as when choosing the treatment modality.

Background

Approximately two-thirds of human papillomavirus infections resolve within a year, and more than 90% resolve within 2 years. Similarly, low-grade cervical intraepithelial neoplasia (CIN 1) lesions frequently resolve. High-grade (CIN 2 and CIN 3) lesions regress less commonly, with 5% and 12%-40% progressing to invasive cancer, respectively. Therefore, treatment is typically recommended.

Obstetric implications

Potential obstetric risks of treatment for CIN include infertility, spontaneous abortion, preterm premature rupture of membranes (PPROM), preterm delivery, and perinatal/neonatal mortality. These risks are discussed individually below. Mechanisms that have been suggested for such complications include decreased cervical mucous, cervical scarring impeding conception or dilation, loss of cervical volume, collagen breakdown, and immunologic processes due to decreased physical defenses or microbiome shifts.

Fertility

Studies have shown that treatment does not appear to impede conception. The overall pregnancy rate is higher among treated women than untreated women. Pregnancy rates are not different among women intending to conceive or among women attempting conception for more than 12 months, with the caveat being that these studies are heterogenous.^2,3

Miscarriage

No difference has been observed in total (less than 24 weeks) miscarriage rate or first trimester (less than 12 weeks) miscarriage rate among treated and untreated women. However, the second trimester miscarriage rate is significantly higher among treated women (risk ratio, 2.60).² This risk is most notable following laser conization or LEEP.⁴ There may also be an association between ablation and pregnancy loss.

Preterm birth and PPROM

Several studies and meta-analyses show an association between preterm birth and treatment for CIN using LEEP or CKC. There is an increased risk of severe preterm delivery (relative risk, 2.78), extreme preterm delivery (relative risk, 5.33), and low birth weight (relative risk, 2.86) with CKC.⁵ LEEP is associated with the same outcomes, albeit the risk is lower than with CKC.⁶ The risk of preterm birth is even lower for ablation.⁷

Other complications

Ectopic pregnancy and termination rates may be higher in treated women, compared with untreated women.² However, there does not appear to be an increased risk for perinatal/neonatal mortality, cesarean section, or neonatal intensive care unit admission among women treated with excisional procedures.⁶

Pointers for practice

• Due to the potential for adverse obstetric complications following excisional procedures for cervical dysplasia, gynecologists should closely adhere to the American Society for Colposcopy and Cervical Pathology guidelines when determining the appropriateness of dysplasia interventions. The decision to treat, versus monitor, dysplasia in a woman who plans future childbearing should be made with the patient after thorough discussion of the risks and benefits of each path.
• Women younger than age 30 years should not be screened for high-risk human papillomavirus because of both its high incidence and its high rate of spontaneous resolution.
• For reproductive-aged women with CIN 2 and adequate colposcopy, the American Society for Colposcopy and Cervical Pathology supports either monitoring with cytology and colposcopy every 6 months for a year or excisional treatment. However, women with CIN 3, inadequate colposcopy, prior cervical cancer, diethylstilbestrol exposure, or decreased immunity should undergo excisional treatment.
• When selecting an excisional method (LEEP or CKC), surgeons should choose the most appropriate technique for the patient’s pathology but should acknowledge the observed higher rates of PPROM, preterm birth, and low-birth-weight infants among those receiving CKC, and tailor the size of the excision to the specific lesion.
• Consider recommending a 12-month interval between treatment and pregnancy to ensure resolution of high-grade dysplasia. Furthermore, obstetric risk may be increased within 12 months following treatment.

Dr. Robbins is a resident in the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC, Chapel Hill. They reported having no relevant financial disclosures.

References

1. Am J Obstet Gynecol. 2011 Jul;205(1):19-27.

2. Cochrane Database Syst Rev. 2015 Sep 29;(9):CD008478.

3. BMJ. 2014 Oct 28;349:g6192.

4. Obstet Gynecol. 2016 Dec;128(6):1265-73.

5. BMJ. 2008 Sep 18;337:a1284.

6. Arch Gynecol Obstet. 2014 Jan;289(1):85-99.

7. BJOG. 2011 Aug;118(9):1031-41.

8. Obstet Gynecol. 2013 May;121(5):1063-8.

9. Lancet. 2006 Feb 11;367(9509):489-98.

10. Gynecol Obstet Invest. 2014;77(4):240-4.

Electronic fetal monitoring (EFM) is the most commonly used instrument in obstetrics and is the perceived standard of care. However, the U.S. Preventive Services Task Force recommended against its use in low-risk women in 1996 (a “D” rating) – signifying the lack of evidence for benefit and the potential for harm – and said there was insufficient evidence to recommend for or against its use in high-risk women (a “C” rating).

Today, available data still suggest that EFM does not reduce overall perinatal mortality or the risk of cerebral palsy. Moreover, its use is associated with increased operative vaginal deliveries and cesarean deliveries.

Emerging research

An abnormal or indeterminate fetal heart rate tracing is the second most common indication for primary cesarean, after labor arrest, according to a study published in 2011 of more than 32,000 live births. Given the rarity of category III tracings (“abnormal”), it is likely that category II tracings (“indeterminate”) account for most of the cesarean deliveries performed out of concern for fetal acidemia (Obstet Gynecol. 2011 Jul;118[1]:29-38).

Until recently, we’ve known very little about the patterns contained within category II of our current three-tier system for categorizing fetal heart rate patterns. The system was defined by the 2008 consensus workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (Obstet Gynecol. 2008 Sep;112[3]:661-6).

We have reasonable data to know that the vast majority of patients with category I fetal heart rate tracings will have a normal pH. We also have reasonable data showing us that patients with category III tracings have a high risk of acidemia and morbidity. However, the majority of tracings we see during labor at term fall into category II, with no clear indication of risk and characterized most often by the presence of decelerations.

As we’ve delved more deeply into the highly variable and complex category II tracings defined in 2008, we’ve begun to demonstrate that tracings can have different meanings for different patients, and that particular clinical factors can make EFM patterns more informative and predictive. In other words, EFM patterns may require different interpretations based on a priori risk and clinical factors.

One of these factors may be the presence of meconium. In a prospective cohort of more than 3,000 women with category II tracings, the presence of meconium – especially thick meconium – was associated with a higher risk of acidemia and neonatal morbidity than when meconium was absent. Interestingly, the negative predictive value was higher than the overall predictive ability in this cohort, which suggests that the absence of meconium in the setting of a category II tracing can be considered a reassuring feature (Am J Obstet Gynecol. 2014;211:644.e1-8).

We have also found through retrospective cohort studies that magnesium sulfate can impact fetal heart rate tracings, causing a transient decrease in variability (Obstet Gynecol. 2012 Jun;119[6]:1129-36 and Am J Perinatol. 2014 Nov;31[10]:869-74). In addition, intrauterine growth restricted fetuses have a higher risk of decelerations without a commensurate higher risk of morbidity (Am J Perinatol. 2015 Jul;32[9]:873-8).

Such findings need to be reproduced, expanded, and further analyzed to show us how the risk of acidemia can be better predicted. For now, just as we increasingly appreciate that tracings have a transient nature and should be considered with two lenses – one looking back in time and one looking forward – we have a growing sense that EFM should not be interpreted without consideration of clinical factors.

Research at our institution and others has shown that acidemia is more significantly associated with non-NICHD measures of fetal heart rate deceleration than with each of the main deceleration types defined by the 2008 NICHD system (i.e., repetitive variable, repetitive late, and repetitive prolonged).

For instance, Emily Hamilton, MD, and her colleagues at PeriGen, a perinatal software company, found that only prolonged decelerations, in addition to the variability within the deceleration and a depth below 60 beats per minute for more than 60 seconds, could discriminate between cases of metabolic acidosis and those with normal umbilical artery gases (J Matern Fetal Neonatal Med. 2012 Jun;25[6]:648-53).

In a 4-year retrospective cohort study of nearly 5,340 consecutive singleton, term, nonanomalous gestations, we found acidemia was most significantly associated with a calculation of the “total deceleration area” – the sum of the estimates of area within all the decelerations. This measure accounted for the frequency, depth, and duration of all decelerations in the final 30 minutes of EFM.

Each of the NICHD deceleration types was associated in our study with acidemia after adjustment for fever, obesity, prolonged first stage, and nulliparity. However, total deceleration area had superior predictive ability. After the same adjustments were made, an abnormal total deceleration area (greater than the 95th percentile) was significantly associated with an increased risk for acidemia (odds ratio, 3.79) (Am J Obstet Gynecol. 2012 Sep;207[3]:206.e1-8).

Pathophysiologically, it seems logical that the total area is most predictive, as it captures both the temporal and dose effect of decelerations. At this point, however, we can only apply this concept crudely at the bedside. There is more work to do to translate such findings into software-driven bedside tools.

Gaining reassurance

Although efforts to manage intrapartum fetal heart rate tracings focus largely on attempting to better predict who is at greatest risk for acidemia, it is important and worthwhile that we also attempt to determine whether a fetus with a category II tracing is not acidotic.

Research has consistently shown that the presence of accelerations, whether spontaneous or stimulated, is a highly reliable indicator of normal neonatal umbilical cord pH. It is therefore reasonable, when faced with indeterminate tracings (e.g., minimal variability), to consider scalp stimulation to elicit fetal heart rate acceleration. Scalp stimulation is the easiest noninvasive tool to employ to quickly secure clinical reassurance – within a couple of minutes – that the fetus is not acidotic.

For guidance on managing repetitive variable decelerations, amnioinfusion with normal saline is similarly worthy of consideration. It has been demonstrated (Level A evidence) to resolve variable fetal heart rate decelerations and reduce the incidence of cesarean delivery for nonreassuring fetal heart rate patterns. Both amnioinfusion and scalp stimulation are recommended in the 2014 ACOG/SMFM consensus statement on “Safe Prevention of the Primary Cesarean Delivery” (Obstet Gynecol. 2014 Mar;123[3]:693-711).

Oxygen administration, on the other hand, is ingrained in practice and is included in the American College of Obstetricians and Gynecologists’ practice bulletin on managing intrapartum fetal rate tracings. It is listed as a possible resuscitative measure for category II or III tracings, despite the fact that there are extremely limited data for its effectiveness or safety in labor.

Maureen S. Hamel, MD, and her colleagues at the Warren Albert Medical School at Brown University reviewed the literature and concluded that the only two randomized trials investigating the use of maternal oxygen supplementation in laboring women do not support the idea that supplementation may benefit the fetus. Moreover, they contended that oxygen supplementation may even be harmful (Am J Obstet Gynecol. 2014 Aug;211[2]:124-7).

If supplemental oxygen were a medication, we would want to know the dose, as well as the length and duration of administration before fetal heart rate tracing improved. We don’t know the answers to these questions.

There is research ongoing, both observational studies and at least one registered randomized clinical trial, that should provide more information and guidance on the impact of supplemental oxygen in the setting of category II fetal heart rate patterns. I do not expect these findings to resolve all the questions. We’re going to need a thorough body of work to provide us with definitive answers.
 

Dr. Cahill is the chief of the division of maternal-fetal medicine at Washington University in St. Louis. She reported having no financial disclosures relevant to this Master Class.

Electronic fetal monitoring (EFM) is the most commonly used instrument in obstetrics and is the perceived standard of care. However, the U.S. Preventive Services Task Force recommended against its use in low-risk women in 1996 (a “D” rating) – signifying the lack of evidence for benefit and the potential for harm – and said there was insufficient evidence to recommend for or against its use in high-risk women (a “C” rating).

Today, available data still suggest that EFM does not reduce overall perinatal mortality or the risk of cerebral palsy. Moreover, its use is associated with increased operative vaginal deliveries and cesarean deliveries.

Emerging research

An abnormal or indeterminate fetal heart rate tracing is the second most common indication for primary cesarean, after labor arrest, according to a study published in 2011 of more than 32,000 live births. Given the rarity of category III tracings (“abnormal”), it is likely that category II tracings (“indeterminate”) account for most of the cesarean deliveries performed out of concern for fetal acidemia (Obstet Gynecol. 2011 Jul;118[1]:29-38).

Until recently, we’ve known very little about the patterns contained within category II of our current three-tier system for categorizing fetal heart rate patterns. The system was defined by the 2008 consensus workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (Obstet Gynecol. 2008 Sep;112[3]:661-6).

We have reasonable data to know that the vast majority of patients with category I fetal heart rate tracings will have a normal pH. We also have reasonable data showing us that patients with category III tracings have a high risk of acidemia and morbidity. However, the majority of tracings we see during labor at term fall into category II, with no clear indication of risk and characterized most often by the presence of decelerations.

As we’ve delved more deeply into the highly variable and complex category II tracings defined in 2008, we’ve begun to demonstrate that tracings can have different meanings for different patients, and that particular clinical factors can make EFM patterns more informative and predictive. In other words, EFM patterns may require different interpretations based on a priori risk and clinical factors.

One of these factors may be the presence of meconium. In a prospective cohort of more than 3,000 women with category II tracings, the presence of meconium – especially thick meconium – was associated with a higher risk of acidemia and neonatal morbidity than when meconium was absent. Interestingly, the negative predictive value was higher than the overall predictive ability in this cohort, which suggests that the absence of meconium in the setting of a category II tracing can be considered a reassuring feature (Am J Obstet Gynecol. 2014;211:644.e1-8).

We have also found through retrospective cohort studies that magnesium sulfate can impact fetal heart rate tracings, causing a transient decrease in variability (Obstet Gynecol. 2012 Jun;119[6]:1129-36 and Am J Perinatol. 2014 Nov;31[10]:869-74). In addition, intrauterine growth restricted fetuses have a higher risk of decelerations without a commensurate higher risk of morbidity (Am J Perinatol. 2015 Jul;32[9]:873-8).

Such findings need to be reproduced, expanded, and further analyzed to show us how the risk of acidemia can be better predicted. For now, just as we increasingly appreciate that tracings have a transient nature and should be considered with two lenses – one looking back in time and one looking forward – we have a growing sense that EFM should not be interpreted without consideration of clinical factors.

Research at our institution and others has shown that acidemia is more significantly associated with non-NICHD measures of fetal heart rate deceleration than with each of the main deceleration types defined by the 2008 NICHD system (i.e., repetitive variable, repetitive late, and repetitive prolonged).

For instance, Emily Hamilton, MD, and her colleagues at PeriGen, a perinatal software company, found that only prolonged decelerations, in addition to the variability within the deceleration and a depth below 60 beats per minute for more than 60 seconds, could discriminate between cases of metabolic acidosis and those with normal umbilical artery gases (J Matern Fetal Neonatal Med. 2012 Jun;25[6]:648-53).

In a 4-year retrospective cohort study of nearly 5,340 consecutive singleton, term, nonanomalous gestations, we found acidemia was most significantly associated with a calculation of the “total deceleration area” – the sum of the estimates of area within all the decelerations. This measure accounted for the frequency, depth, and duration of all decelerations in the final 30 minutes of EFM.

Each of the NICHD deceleration types was associated in our study with acidemia after adjustment for fever, obesity, prolonged first stage, and nulliparity. However, total deceleration area had superior predictive ability. After the same adjustments were made, an abnormal total deceleration area (greater than the 95th percentile) was significantly associated with an increased risk for acidemia (odds ratio, 3.79) (Am J Obstet Gynecol. 2012 Sep;207[3]:206.e1-8).

Pathophysiologically, it seems logical that the total area is most predictive, as it captures both the temporal and dose effect of decelerations. At this point, however, we can only apply this concept crudely at the bedside. There is more work to do to translate such findings into software-driven bedside tools.

Gaining reassurance

Although efforts to manage intrapartum fetal heart rate tracings focus largely on attempting to better predict who is at greatest risk for acidemia, it is important and worthwhile that we also attempt to determine whether a fetus with a category II tracing is not acidotic.

Research has consistently shown that the presence of accelerations, whether spontaneous or stimulated, is a highly reliable indicator of normal neonatal umbilical cord pH. It is therefore reasonable, when faced with indeterminate tracings (e.g., minimal variability), to consider scalp stimulation to elicit fetal heart rate acceleration. Scalp stimulation is the easiest noninvasive tool to employ to quickly secure clinical reassurance – within a couple of minutes – that the fetus is not acidotic.

For guidance on managing repetitive variable decelerations, amnioinfusion with normal saline is similarly worthy of consideration. It has been demonstrated (Level A evidence) to resolve variable fetal heart rate decelerations and reduce the incidence of cesarean delivery for nonreassuring fetal heart rate patterns. Both amnioinfusion and scalp stimulation are recommended in the 2014 ACOG/SMFM consensus statement on “Safe Prevention of the Primary Cesarean Delivery” (Obstet Gynecol. 2014 Mar;123[3]:693-711).

Oxygen administration, on the other hand, is ingrained in practice and is included in the American College of Obstetricians and Gynecologists’ practice bulletin on managing intrapartum fetal rate tracings. It is listed as a possible resuscitative measure for category II or III tracings, despite the fact that there are extremely limited data for its effectiveness or safety in labor.

Maureen S. Hamel, MD, and her colleagues at the Warren Albert Medical School at Brown University reviewed the literature and concluded that the only two randomized trials investigating the use of maternal oxygen supplementation in laboring women do not support the idea that supplementation may benefit the fetus. Moreover, they contended that oxygen supplementation may even be harmful (Am J Obstet Gynecol. 2014 Aug;211[2]:124-7).

If supplemental oxygen were a medication, we would want to know the dose, as well as the length and duration of administration before fetal heart rate tracing improved. We don’t know the answers to these questions.

There is research ongoing, both observational studies and at least one registered randomized clinical trial, that should provide more information and guidance on the impact of supplemental oxygen in the setting of category II fetal heart rate patterns. I do not expect these findings to resolve all the questions. We’re going to need a thorough body of work to provide us with definitive answers.
 

Dr. Cahill is the chief of the division of maternal-fetal medicine at Washington University in St. Louis. She reported having no financial disclosures relevant to this Master Class.

Electronic fetal monitoring (EFM) is the most commonly used instrument in obstetrics and is the perceived standard of care. However, the U.S. Preventive Services Task Force recommended against its use in low-risk women in 1996 (a “D” rating) – signifying the lack of evidence for benefit and the potential for harm – and said there was insufficient evidence to recommend for or against its use in high-risk women (a “C” rating).

Today, available data still suggest that EFM does not reduce overall perinatal mortality or the risk of cerebral palsy. Moreover, its use is associated with increased operative vaginal deliveries and cesarean deliveries.

Emerging research

An abnormal or indeterminate fetal heart rate tracing is the second most common indication for primary cesarean, after labor arrest, according to a study published in 2011 of more than 32,000 live births. Given the rarity of category III tracings (“abnormal”), it is likely that category II tracings (“indeterminate”) account for most of the cesarean deliveries performed out of concern for fetal acidemia (Obstet Gynecol. 2011 Jul;118[1]:29-38).

Until recently, we’ve known very little about the patterns contained within category II of our current three-tier system for categorizing fetal heart rate patterns. The system was defined by the 2008 consensus workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (Obstet Gynecol. 2008 Sep;112[3]:661-6).

We have reasonable data to know that the vast majority of patients with category I fetal heart rate tracings will have a normal pH. We also have reasonable data showing us that patients with category III tracings have a high risk of acidemia and morbidity. However, the majority of tracings we see during labor at term fall into category II, with no clear indication of risk and characterized most often by the presence of decelerations.

As we’ve delved more deeply into the highly variable and complex category II tracings defined in 2008, we’ve begun to demonstrate that tracings can have different meanings for different patients, and that particular clinical factors can make EFM patterns more informative and predictive. In other words, EFM patterns may require different interpretations based on a priori risk and clinical factors.

One of these factors may be the presence of meconium. In a prospective cohort of more than 3,000 women with category II tracings, the presence of meconium – especially thick meconium – was associated with a higher risk of acidemia and neonatal morbidity than when meconium was absent. Interestingly, the negative predictive value was higher than the overall predictive ability in this cohort, which suggests that the absence of meconium in the setting of a category II tracing can be considered a reassuring feature (Am J Obstet Gynecol. 2014;211:644.e1-8).

We have also found through retrospective cohort studies that magnesium sulfate can impact fetal heart rate tracings, causing a transient decrease in variability (Obstet Gynecol. 2012 Jun;119[6]:1129-36 and Am J Perinatol. 2014 Nov;31[10]:869-74). In addition, intrauterine growth restricted fetuses have a higher risk of decelerations without a commensurate higher risk of morbidity (Am J Perinatol. 2015 Jul;32[9]:873-8).

Such findings need to be reproduced, expanded, and further analyzed to show us how the risk of acidemia can be better predicted. For now, just as we increasingly appreciate that tracings have a transient nature and should be considered with two lenses – one looking back in time and one looking forward – we have a growing sense that EFM should not be interpreted without consideration of clinical factors.

Research at our institution and others has shown that acidemia is more significantly associated with non-NICHD measures of fetal heart rate deceleration than with each of the main deceleration types defined by the 2008 NICHD system (i.e., repetitive variable, repetitive late, and repetitive prolonged).

For instance, Emily Hamilton, MD, and her colleagues at PeriGen, a perinatal software company, found that only prolonged decelerations, in addition to the variability within the deceleration and a depth below 60 beats per minute for more than 60 seconds, could discriminate between cases of metabolic acidosis and those with normal umbilical artery gases (J Matern Fetal Neonatal Med. 2012 Jun;25[6]:648-53).

In a 4-year retrospective cohort study of nearly 5,340 consecutive singleton, term, nonanomalous gestations, we found acidemia was most significantly associated with a calculation of the “total deceleration area” – the sum of the estimates of area within all the decelerations. This measure accounted for the frequency, depth, and duration of all decelerations in the final 30 minutes of EFM.

Each of the NICHD deceleration types was associated in our study with acidemia after adjustment for fever, obesity, prolonged first stage, and nulliparity. However, total deceleration area had superior predictive ability. After the same adjustments were made, an abnormal total deceleration area (greater than the 95th percentile) was significantly associated with an increased risk for acidemia (odds ratio, 3.79) (Am J Obstet Gynecol. 2012 Sep;207[3]:206.e1-8).

Pathophysiologically, it seems logical that the total area is most predictive, as it captures both the temporal and dose effect of decelerations. At this point, however, we can only apply this concept crudely at the bedside. There is more work to do to translate such findings into software-driven bedside tools.

Gaining reassurance

Although efforts to manage intrapartum fetal heart rate tracings focus largely on attempting to better predict who is at greatest risk for acidemia, it is important and worthwhile that we also attempt to determine whether a fetus with a category II tracing is not acidotic.

Research has consistently shown that the presence of accelerations, whether spontaneous or stimulated, is a highly reliable indicator of normal neonatal umbilical cord pH. It is therefore reasonable, when faced with indeterminate tracings (e.g., minimal variability), to consider scalp stimulation to elicit fetal heart rate acceleration. Scalp stimulation is the easiest noninvasive tool to employ to quickly secure clinical reassurance – within a couple of minutes – that the fetus is not acidotic.

For guidance on managing repetitive variable decelerations, amnioinfusion with normal saline is similarly worthy of consideration. It has been demonstrated (Level A evidence) to resolve variable fetal heart rate decelerations and reduce the incidence of cesarean delivery for nonreassuring fetal heart rate patterns. Both amnioinfusion and scalp stimulation are recommended in the 2014 ACOG/SMFM consensus statement on “Safe Prevention of the Primary Cesarean Delivery” (Obstet Gynecol. 2014 Mar;123[3]:693-711).

Oxygen administration, on the other hand, is ingrained in practice and is included in the American College of Obstetricians and Gynecologists’ practice bulletin on managing intrapartum fetal rate tracings. It is listed as a possible resuscitative measure for category II or III tracings, despite the fact that there are extremely limited data for its effectiveness or safety in labor.

Maureen S. Hamel, MD, and her colleagues at the Warren Albert Medical School at Brown University reviewed the literature and concluded that the only two randomized trials investigating the use of maternal oxygen supplementation in laboring women do not support the idea that supplementation may benefit the fetus. Moreover, they contended that oxygen supplementation may even be harmful (Am J Obstet Gynecol. 2014 Aug;211[2]:124-7).

If supplemental oxygen were a medication, we would want to know the dose, as well as the length and duration of administration before fetal heart rate tracing improved. We don’t know the answers to these questions.

There is research ongoing, both observational studies and at least one registered randomized clinical trial, that should provide more information and guidance on the impact of supplemental oxygen in the setting of category II fetal heart rate patterns. I do not expect these findings to resolve all the questions. We’re going to need a thorough body of work to provide us with definitive answers.
 

Dr. Cahill is the chief of the division of maternal-fetal medicine at Washington University in St. Louis. She reported having no financial disclosures relevant to this Master Class.

There is no question that we are living in the information age where “big data” isn’t just reserved for scientists but is accessible to everyone. Wearable devices have revolutionized when and how often we exercise. Smartphones have changed the way in which we consume news, watch television, take photographs, and record home movies. Online video chatting has allowed people who live miles – or even countries – away to connect on a whole new level. Today’s 7-year-olds have never lived in a world without iPhones and don’t know what life is like without iPads. Technology has improved our daily lives in countless ways. However, is “too much of a good thing” ever just too much?

Last year, we looked back over the preceding 5 decades of ob.gyn. practice. This retrospective analysis demonstrated that today’s practitioners have infinitely more tools at their disposal than many of their mentors did to ensure the best pregnancy outcomes. From prenatal diagnostic approaches, such as ultrasonography and genetic screening, to in utero surgical interventions, our discipline has advanced in leaps and bounds, all over the course of one person’s lifetime.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at obnews@frontlinemedcom.com.

There is no question that we are living in the information age where “big data” isn’t just reserved for scientists but is accessible to everyone. Wearable devices have revolutionized when and how often we exercise. Smartphones have changed the way in which we consume news, watch television, take photographs, and record home movies. Online video chatting has allowed people who live miles – or even countries – away to connect on a whole new level. Today’s 7-year-olds have never lived in a world without iPhones and don’t know what life is like without iPads. Technology has improved our daily lives in countless ways. However, is “too much of a good thing” ever just too much?

Last year, we looked back over the preceding 5 decades of ob.gyn. practice. This retrospective analysis demonstrated that today’s practitioners have infinitely more tools at their disposal than many of their mentors did to ensure the best pregnancy outcomes. From prenatal diagnostic approaches, such as ultrasonography and genetic screening, to in utero surgical interventions, our discipline has advanced in leaps and bounds, all over the course of one person’s lifetime.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at obnews@frontlinemedcom.com.

There is no question that we are living in the information age where “big data” isn’t just reserved for scientists but is accessible to everyone. Wearable devices have revolutionized when and how often we exercise. Smartphones have changed the way in which we consume news, watch television, take photographs, and record home movies. Online video chatting has allowed people who live miles – or even countries – away to connect on a whole new level. Today’s 7-year-olds have never lived in a world without iPhones and don’t know what life is like without iPads. Technology has improved our daily lives in countless ways. However, is “too much of a good thing” ever just too much?

Last year, we looked back over the preceding 5 decades of ob.gyn. practice. This retrospective analysis demonstrated that today’s practitioners have infinitely more tools at their disposal than many of their mentors did to ensure the best pregnancy outcomes. From prenatal diagnostic approaches, such as ultrasonography and genetic screening, to in utero surgical interventions, our discipline has advanced in leaps and bounds, all over the course of one person’s lifetime.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at obnews@frontlinemedcom.com.

The Food and Drug Administration approved 22 new drug products in 12 pharmacologic classes in 2016. Additionally, daclizumab (Zenapax), which was approved several years ago for prophylaxis of acute organ rejection in patients receiving renal transplants, was approved for multiple sclerosis treatment (Zinbryta) last year, and sofosbuvir (Sovaldi), which was approved in 2013 for the treatment of hepatitis C virus, is now combined with velpatasvir (Epclusa) to treat all six major forms of hepatitis C.

There are 22 drugs that can be considered novel drugs. As defined by the FDA, novel drugs have never been approved for human use. There are no human pregnancy data for any of the newly approved drugs or drug combinations. As such, it is important to consider that high molecular weight drugs that probably do not cross the placenta in the first half of pregnancy may do so in late pregnancy.

Antineoplastics

Atezolizumab (Tecentriq) is a programmed death ligand–blocking antibody that is indicated for locally advanced or metastatic urothelial carcinoma and metastatic nonsmall cell lung cancer following platinum-containing chemotherapy. Animal reproduction studies have not been conducted, but, based on its mechanism of action, fetal exposure may increase the risk of developing immune-mediated disorders or altering the normal immune response. The molecular weight is high (145,000) and the terminal half-life is long (27 days).

Olaratumab (Lartruvo) is a platelet-derived growth factor receptor– alpha-blocking antibody. It is indicated, in combination with doxorubicin, for the treatment of soft tissue sarcoma. Although the estimated elimination half-life is long (about 11 days with a range of 6-24 days), the high molecular weight (about 154,000) should limit fetal exposure, at least in the first half of pregnancy. The drug should be avoided in pregnancy, however, based on the animal data, the mechanism of action, and its combination with doxorubicin.

Rucaparib (Rubraca) is a poly (adenosine diphosphate–ribose) polymerase inhibitor indicated for the treatment of ovarian cancer. The drug could cause human fetal harm based on the animal data, mechanism of action, relatively low molecular weight (about 556), and terminal half-life (17 hours).

Venetoclax (Venclexta) is a B-cell lymphoma 2 inhibitor indicated for the treatment of chronic lymphocytic leukemia. Although the animal data, molecular weight (about 868), and elimination half-life (about 26 hours) suggest embryo-fetal risk, the high plasma protein binding (99.9%) should limit the amount crossing the placenta.

Anti-infectives

There are two new monoclonal antibodies in this class. Bezlotoxumab (Zinplava) is used to reduce recurrence of Clostridium difficile. Animal reproduction studies have not been conducted. As the molecular weight is about 148,000, the drug will not cross the placenta, at least not in the first half of pregnancy. However, the drug has a long elimination half-life (about 19 days), so, depending on when it was given, it could cross in late pregnancy. Obiltoxaximab (Anthim), administered as a single IV dose, is indicated for the treatment of inhaled anthrax due to Bacillus anthracis. No fetal harm was observed in animal reproduction studies. The high molecular weight (about 148,000) suggests that the drug will not cross to the embryo and/or fetus, at least not in the first part of pregnancy.

Elbasvir/Grazoprevir (Zepatier) is indicated for the treatment of chronic hepatitis C virus genotype 1 or 4. Animal reproduction studies found no evidence of adverse developmental outcomes. The molecular weights of the two components are about 882 and 767, respectively. Both are extensively bound to plasma proteins, 99.9% and 98.8%, respectively, and the terminal half-lives are 24 and 31 hours. Thus, the product appears to be low risk if used in human pregnancy. However, it is contraindicated if given with ribavirin.

moodboard/Thinkstock

Central nervous system agents

Brivaracetam (Briviact) is an anticonvulsant used to treat partial-onset seizures. Animal reproduction studies suggest moderate risk. The molecular weight (about 212), low plasma protein binding (less than or equal to 20%), and terminal plasma half-life of about 9 hours suggest that the drug will cross the placenta. The manufacturer recommends that the drug should be used in pregnancy only if the potential benefit justifies the potential risk to the embryo/fetus.

Pimavanserin (Nuplazid) is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Reproduction studies in animals suggest low risk. The molecular weight of the free base (about 428) and the long mean plasma half-lives of the parent drug and active metabolite (57 and 200 hours) suggest that the drug will cross the placenta. However, the high plasma protein binding (about 95%) may limit the exposure. Nevertheless, avoiding the period of organogenesis appears to be best.

Dermatologic agents

Crisaborole (Eucrisa) is indicated for topical treatment of mild to moderate atopic dermatitis. In 33 pediatric subjects (aged 2-17 years) who applied the ointment twice daily for 8 days, low amounts were absorbed systemically with plasma concentrations in the nanogram/milliliter range. Plasma protein binding was 97%. With oral formulations of the drug, animal reproduction studies suggest low risk. Taken in sum, the human pregnancy risk appears to be low.

Ixekizumab (Taltz) is a humanized interleukin-17A antagonist, administered subcutaneously, that is indicated for the treatment of adults with moderate to severe plaque psoriasis. The drug did not cause developmental toxicity in monkeys. The molecular weight for the drug’s protein backbone is 146,158, and the mean elimination half-life was 13 days. The human embryo-fetal risk in the first half of pregnancy appears to be low.

Diagnostic agents

Fluciclovine F 18 (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography imaging in men with suspected prostate cancer. Since the agent is only used in men, there are no human or animal pregnancy data.

Gallium GA 68 dotatate injection, a diagnostic imaging agent to detect rare neuroendocrine tumors, is not yet on the market.

Endocrine/metabolic agents

Lixisenatide (Adlyxin) is a glucagon-like–peptide-1 receptor agonist that is administered subcutaneously. It is indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes. The drug was teratogenic in two animal species. The molecular weight is about 4,859, and the mean terminal half-life was about 3 hours. Since tight control of glucose levels in type 2 diabetes is required during pregnancy, insulin is the treatment of choice. Consequently, lixisenatide should not be used during pregnancy.

Gastrointestinal agents

Obeticholic acid (Ocaliva) is a farnesoid X receptor agonist that is given orally for the treatment of primary biliary cholangitis, in combination with ursodiol, or ursodeoxycholic acid. I have classified ursodiol as compatible in pregnancy in the 10th edition of “Drugs in Pregnancy and Lactation” (2011: Wolters Kluwer Health). The animal reproduction data for both drugs suggest low risk. Based on the molecular weight of obeticholic (about 421), the drug will probably cross to the embryo/fetus, but the high plasma protein binding (greater than 99%) may limit exposure. The elimination half-life is apparently unknown.

Hematologic agents

Defibrotide sodium (Defitelio), given as an intravenous infusion, is an oligonucleotide mixture. It is indicated for the treatment of hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation. Animal reproduction studies in two species suggest risk. The mean molecular weight is 13,000-20,000. Plasma protein binding is an average 93%, and the elimination half-life is less than 2 hours. It is doubtful if the drug crosses the placenta, especially in the first half of pregnancy. If possible, avoid the drug in the second half of pregnancy.

Immunologics

Two indications have been approved for daclizumab. The first was in 2005 for the prophylaxis of acute organ rejection of renal transplants (Zenapax), and the second was in 2016 for the treatment of relapsing forms of multiple sclerosis (Zinbryta). Reproduction studies in monkeys with Zinbryta can be classified as low risk. The molecular weight (about 144,000) suggests that the drug will not cross the placenta, at least in the first half of pregnancy. However, depending on when the drug is given, the long elimination half-life of 21 days might allow the drug to cross in late pregnancy. Regardless, if the perceived maternal benefit exceeds the potential embryo-fetal risk, the drug should not be withheld because of pregnancy.

Muscular disorder agents

Eteplirsen (Exondys 51) is an antisense oligonucleotide that is given intravenously. It is indicated for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the related gene, which is amenable to exon 51 skipping. There are no animal reproduction data. The molecular weight is about 10,306. This suggests that the drug will not cross the placenta, at least in the first half of pregnancy. The elimination half-life is 3-4 hours, and the plasma concentration 24 hours after a dose was 0.07% of the peak plasma concentration. The drug is given once weekly, and waiting for 24 hours or slightly longer after a dose should reduce the exposure, if any, of the embryo-fetus during the first half of pregnancy.

Nusinersen (Spinraza), a survival motor neuron 2 directed–antisense oligonucleotide, is given as an intrathecal dose. It is indicated for the treatment of spinal muscular atrophy. Subcutaneous doses in two animal species caused no developmental toxicity. The molecular weight of 7,501 suggests that the drug will not cross the human placenta, at least not in the first half of pregnancy. The mean terminal elimination half-life in cerebrospinal fluid was 135-177 days and 63-87 days in plasma.

Ophthalmic agents

Lifitegrast (Xiidra) is an ophthalmic solution of a lymphocyte function-associated–antigen-1 antagonist. It is indicated for the treatment of the signs and symptoms of dry eye disease. The animal reproduction data suggest low risk. The molecular weight is about 616, suggesting that the drug would cross the placenta. However, in a Phase III trial conducted before FDA approval, 47 patients with dry eye disease were given 1 drop twice daily for periods up to 360 days. Nine patients (19%) had plasma predose (trough) concentrations above 0.5 ng/mL, the lower limit of quantitation. Trough plasma concentrations in these patients ranged from 0.55 ng/mL to 3.74 ng/mL. These amounts do not appear to represent an embryo-fetal risk.

Respiratory agents

Reslizumab (Cinqair), an interleukin-5 antagonist monoclonal antibody, is given intravenously. It is indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype. Animal data in two species suggest low risk. The molecular weight is about 147,000, and the elimination half-life is about 24 days. This suggests that exposure of the embryo and fetus will be minimal, at least in the first half of pregnancy. The maternal benefit appears to outweigh the unknown embryo-fetal risk.

Lactation

None of the above drugs have been studied during breastfeeding. Many drugs, regardless of their molecular weight, will cross into milk in small amounts during the first postpartum week. The effects of this exposure on a nursing infant are unknown. Based on the potential for nursing infant harm, the drugs that probably should not be given during breastfeeding include the four antineoplastics, the atypical antipsychotic pimavanserin, and the diabetes injection lixisenatide.

Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, and at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation,” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.

The Food and Drug Administration approved 22 new drug products in 12 pharmacologic classes in 2016. Additionally, daclizumab (Zenapax), which was approved several years ago for prophylaxis of acute organ rejection in patients receiving renal transplants, was approved for multiple sclerosis treatment (Zinbryta) last year, and sofosbuvir (Sovaldi), which was approved in 2013 for the treatment of hepatitis C virus, is now combined with velpatasvir (Epclusa) to treat all six major forms of hepatitis C.

There are 22 drugs that can be considered novel drugs. As defined by the FDA, novel drugs have never been approved for human use. There are no human pregnancy data for any of the newly approved drugs or drug combinations. As such, it is important to consider that high molecular weight drugs that probably do not cross the placenta in the first half of pregnancy may do so in late pregnancy.

Antineoplastics

Atezolizumab (Tecentriq) is a programmed death ligand–blocking antibody that is indicated for locally advanced or metastatic urothelial carcinoma and metastatic nonsmall cell lung cancer following platinum-containing chemotherapy. Animal reproduction studies have not been conducted, but, based on its mechanism of action, fetal exposure may increase the risk of developing immune-mediated disorders or altering the normal immune response. The molecular weight is high (145,000) and the terminal half-life is long (27 days).

Olaratumab (Lartruvo) is a platelet-derived growth factor receptor– alpha-blocking antibody. It is indicated, in combination with doxorubicin, for the treatment of soft tissue sarcoma. Although the estimated elimination half-life is long (about 11 days with a range of 6-24 days), the high molecular weight (about 154,000) should limit fetal exposure, at least in the first half of pregnancy. The drug should be avoided in pregnancy, however, based on the animal data, the mechanism of action, and its combination with doxorubicin.

Rucaparib (Rubraca) is a poly (adenosine diphosphate–ribose) polymerase inhibitor indicated for the treatment of ovarian cancer. The drug could cause human fetal harm based on the animal data, mechanism of action, relatively low molecular weight (about 556), and terminal half-life (17 hours).

Venetoclax (Venclexta) is a B-cell lymphoma 2 inhibitor indicated for the treatment of chronic lymphocytic leukemia. Although the animal data, molecular weight (about 868), and elimination half-life (about 26 hours) suggest embryo-fetal risk, the high plasma protein binding (99.9%) should limit the amount crossing the placenta.

Anti-infectives

There are two new monoclonal antibodies in this class. Bezlotoxumab (Zinplava) is used to reduce recurrence of Clostridium difficile. Animal reproduction studies have not been conducted. As the molecular weight is about 148,000, the drug will not cross the placenta, at least not in the first half of pregnancy. However, the drug has a long elimination half-life (about 19 days), so, depending on when it was given, it could cross in late pregnancy. Obiltoxaximab (Anthim), administered as a single IV dose, is indicated for the treatment of inhaled anthrax due to Bacillus anthracis. No fetal harm was observed in animal reproduction studies. The high molecular weight (about 148,000) suggests that the drug will not cross to the embryo and/or fetus, at least not in the first part of pregnancy.

Elbasvir/Grazoprevir (Zepatier) is indicated for the treatment of chronic hepatitis C virus genotype 1 or 4. Animal reproduction studies found no evidence of adverse developmental outcomes. The molecular weights of the two components are about 882 and 767, respectively. Both are extensively bound to plasma proteins, 99.9% and 98.8%, respectively, and the terminal half-lives are 24 and 31 hours. Thus, the product appears to be low risk if used in human pregnancy. However, it is contraindicated if given with ribavirin.

moodboard/Thinkstock

Central nervous system agents

Brivaracetam (Briviact) is an anticonvulsant used to treat partial-onset seizures. Animal reproduction studies suggest moderate risk. The molecular weight (about 212), low plasma protein binding (less than or equal to 20%), and terminal plasma half-life of about 9 hours suggest that the drug will cross the placenta. The manufacturer recommends that the drug should be used in pregnancy only if the potential benefit justifies the potential risk to the embryo/fetus.

Pimavanserin (Nuplazid) is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Reproduction studies in animals suggest low risk. The molecular weight of the free base (about 428) and the long mean plasma half-lives of the parent drug and active metabolite (57 and 200 hours) suggest that the drug will cross the placenta. However, the high plasma protein binding (about 95%) may limit the exposure. Nevertheless, avoiding the period of organogenesis appears to be best.

Dermatologic agents

Crisaborole (Eucrisa) is indicated for topical treatment of mild to moderate atopic dermatitis. In 33 pediatric subjects (aged 2-17 years) who applied the ointment twice daily for 8 days, low amounts were absorbed systemically with plasma concentrations in the nanogram/milliliter range. Plasma protein binding was 97%. With oral formulations of the drug, animal reproduction studies suggest low risk. Taken in sum, the human pregnancy risk appears to be low.

Ixekizumab (Taltz) is a humanized interleukin-17A antagonist, administered subcutaneously, that is indicated for the treatment of adults with moderate to severe plaque psoriasis. The drug did not cause developmental toxicity in monkeys. The molecular weight for the drug’s protein backbone is 146,158, and the mean elimination half-life was 13 days. The human embryo-fetal risk in the first half of pregnancy appears to be low.

Diagnostic agents

Fluciclovine F 18 (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography imaging in men with suspected prostate cancer. Since the agent is only used in men, there are no human or animal pregnancy data.

Gallium GA 68 dotatate injection, a diagnostic imaging agent to detect rare neuroendocrine tumors, is not yet on the market.

Endocrine/metabolic agents

Lixisenatide (Adlyxin) is a glucagon-like–peptide-1 receptor agonist that is administered subcutaneously. It is indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes. The drug was teratogenic in two animal species. The molecular weight is about 4,859, and the mean terminal half-life was about 3 hours. Since tight control of glucose levels in type 2 diabetes is required during pregnancy, insulin is the treatment of choice. Consequently, lixisenatide should not be used during pregnancy.

Gastrointestinal agents

Obeticholic acid (Ocaliva) is a farnesoid X receptor agonist that is given orally for the treatment of primary biliary cholangitis, in combination with ursodiol, or ursodeoxycholic acid. I have classified ursodiol as compatible in pregnancy in the 10th edition of “Drugs in Pregnancy and Lactation” (2011: Wolters Kluwer Health). The animal reproduction data for both drugs suggest low risk. Based on the molecular weight of obeticholic (about 421), the drug will probably cross to the embryo/fetus, but the high plasma protein binding (greater than 99%) may limit exposure. The elimination half-life is apparently unknown.

Hematologic agents

Defibrotide sodium (Defitelio), given as an intravenous infusion, is an oligonucleotide mixture. It is indicated for the treatment of hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation. Animal reproduction studies in two species suggest risk. The mean molecular weight is 13,000-20,000. Plasma protein binding is an average 93%, and the elimination half-life is less than 2 hours. It is doubtful if the drug crosses the placenta, especially in the first half of pregnancy. If possible, avoid the drug in the second half of pregnancy.

Immunologics

Two indications have been approved for daclizumab. The first was in 2005 for the prophylaxis of acute organ rejection of renal transplants (Zenapax), and the second was in 2016 for the treatment of relapsing forms of multiple sclerosis (Zinbryta). Reproduction studies in monkeys with Zinbryta can be classified as low risk. The molecular weight (about 144,000) suggests that the drug will not cross the placenta, at least in the first half of pregnancy. However, depending on when the drug is given, the long elimination half-life of 21 days might allow the drug to cross in late pregnancy. Regardless, if the perceived maternal benefit exceeds the potential embryo-fetal risk, the drug should not be withheld because of pregnancy.

Muscular disorder agents

Eteplirsen (Exondys 51) is an antisense oligonucleotide that is given intravenously. It is indicated for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the related gene, which is amenable to exon 51 skipping. There are no animal reproduction data. The molecular weight is about 10,306. This suggests that the drug will not cross the placenta, at least in the first half of pregnancy. The elimination half-life is 3-4 hours, and the plasma concentration 24 hours after a dose was 0.07% of the peak plasma concentration. The drug is given once weekly, and waiting for 24 hours or slightly longer after a dose should reduce the exposure, if any, of the embryo-fetus during the first half of pregnancy.

Nusinersen (Spinraza), a survival motor neuron 2 directed–antisense oligonucleotide, is given as an intrathecal dose. It is indicated for the treatment of spinal muscular atrophy. Subcutaneous doses in two animal species caused no developmental toxicity. The molecular weight of 7,501 suggests that the drug will not cross the human placenta, at least not in the first half of pregnancy. The mean terminal elimination half-life in cerebrospinal fluid was 135-177 days and 63-87 days in plasma.

Ophthalmic agents

Lifitegrast (Xiidra) is an ophthalmic solution of a lymphocyte function-associated–antigen-1 antagonist. It is indicated for the treatment of the signs and symptoms of dry eye disease. The animal reproduction data suggest low risk. The molecular weight is about 616, suggesting that the drug would cross the placenta. However, in a Phase III trial conducted before FDA approval, 47 patients with dry eye disease were given 1 drop twice daily for periods up to 360 days. Nine patients (19%) had plasma predose (trough) concentrations above 0.5 ng/mL, the lower limit of quantitation. Trough plasma concentrations in these patients ranged from 0.55 ng/mL to 3.74 ng/mL. These amounts do not appear to represent an embryo-fetal risk.

Respiratory agents

Reslizumab (Cinqair), an interleukin-5 antagonist monoclonal antibody, is given intravenously. It is indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype. Animal data in two species suggest low risk. The molecular weight is about 147,000, and the elimination half-life is about 24 days. This suggests that exposure of the embryo and fetus will be minimal, at least in the first half of pregnancy. The maternal benefit appears to outweigh the unknown embryo-fetal risk.

Lactation

None of the above drugs have been studied during breastfeeding. Many drugs, regardless of their molecular weight, will cross into milk in small amounts during the first postpartum week. The effects of this exposure on a nursing infant are unknown. Based on the potential for nursing infant harm, the drugs that probably should not be given during breastfeeding include the four antineoplastics, the atypical antipsychotic pimavanserin, and the diabetes injection lixisenatide.

Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, and at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation,” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.

The Food and Drug Administration approved 22 new drug products in 12 pharmacologic classes in 2016. Additionally, daclizumab (Zenapax), which was approved several years ago for prophylaxis of acute organ rejection in patients receiving renal transplants, was approved for multiple sclerosis treatment (Zinbryta) last year, and sofosbuvir (Sovaldi), which was approved in 2013 for the treatment of hepatitis C virus, is now combined with velpatasvir (Epclusa) to treat all six major forms of hepatitis C.

There are 22 drugs that can be considered novel drugs. As defined by the FDA, novel drugs have never been approved for human use. There are no human pregnancy data for any of the newly approved drugs or drug combinations. As such, it is important to consider that high molecular weight drugs that probably do not cross the placenta in the first half of pregnancy may do so in late pregnancy.

Antineoplastics

Atezolizumab (Tecentriq) is a programmed death ligand–blocking antibody that is indicated for locally advanced or metastatic urothelial carcinoma and metastatic nonsmall cell lung cancer following platinum-containing chemotherapy. Animal reproduction studies have not been conducted, but, based on its mechanism of action, fetal exposure may increase the risk of developing immune-mediated disorders or altering the normal immune response. The molecular weight is high (145,000) and the terminal half-life is long (27 days).

Olaratumab (Lartruvo) is a platelet-derived growth factor receptor– alpha-blocking antibody. It is indicated, in combination with doxorubicin, for the treatment of soft tissue sarcoma. Although the estimated elimination half-life is long (about 11 days with a range of 6-24 days), the high molecular weight (about 154,000) should limit fetal exposure, at least in the first half of pregnancy. The drug should be avoided in pregnancy, however, based on the animal data, the mechanism of action, and its combination with doxorubicin.

Rucaparib (Rubraca) is a poly (adenosine diphosphate–ribose) polymerase inhibitor indicated for the treatment of ovarian cancer. The drug could cause human fetal harm based on the animal data, mechanism of action, relatively low molecular weight (about 556), and terminal half-life (17 hours).

Venetoclax (Venclexta) is a B-cell lymphoma 2 inhibitor indicated for the treatment of chronic lymphocytic leukemia. Although the animal data, molecular weight (about 868), and elimination half-life (about 26 hours) suggest embryo-fetal risk, the high plasma protein binding (99.9%) should limit the amount crossing the placenta.

Anti-infectives

There are two new monoclonal antibodies in this class. Bezlotoxumab (Zinplava) is used to reduce recurrence of Clostridium difficile. Animal reproduction studies have not been conducted. As the molecular weight is about 148,000, the drug will not cross the placenta, at least not in the first half of pregnancy. However, the drug has a long elimination half-life (about 19 days), so, depending on when it was given, it could cross in late pregnancy. Obiltoxaximab (Anthim), administered as a single IV dose, is indicated for the treatment of inhaled anthrax due to Bacillus anthracis. No fetal harm was observed in animal reproduction studies. The high molecular weight (about 148,000) suggests that the drug will not cross to the embryo and/or fetus, at least not in the first part of pregnancy.

Elbasvir/Grazoprevir (Zepatier) is indicated for the treatment of chronic hepatitis C virus genotype 1 or 4. Animal reproduction studies found no evidence of adverse developmental outcomes. The molecular weights of the two components are about 882 and 767, respectively. Both are extensively bound to plasma proteins, 99.9% and 98.8%, respectively, and the terminal half-lives are 24 and 31 hours. Thus, the product appears to be low risk if used in human pregnancy. However, it is contraindicated if given with ribavirin.

moodboard/Thinkstock

Central nervous system agents

Brivaracetam (Briviact) is an anticonvulsant used to treat partial-onset seizures. Animal reproduction studies suggest moderate risk. The molecular weight (about 212), low plasma protein binding (less than or equal to 20%), and terminal plasma half-life of about 9 hours suggest that the drug will cross the placenta. The manufacturer recommends that the drug should be used in pregnancy only if the potential benefit justifies the potential risk to the embryo/fetus.

Pimavanserin (Nuplazid) is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Reproduction studies in animals suggest low risk. The molecular weight of the free base (about 428) and the long mean plasma half-lives of the parent drug and active metabolite (57 and 200 hours) suggest that the drug will cross the placenta. However, the high plasma protein binding (about 95%) may limit the exposure. Nevertheless, avoiding the period of organogenesis appears to be best.

Dermatologic agents

Crisaborole (Eucrisa) is indicated for topical treatment of mild to moderate atopic dermatitis. In 33 pediatric subjects (aged 2-17 years) who applied the ointment twice daily for 8 days, low amounts were absorbed systemically with plasma concentrations in the nanogram/milliliter range. Plasma protein binding was 97%. With oral formulations of the drug, animal reproduction studies suggest low risk. Taken in sum, the human pregnancy risk appears to be low.

Ixekizumab (Taltz) is a humanized interleukin-17A antagonist, administered subcutaneously, that is indicated for the treatment of adults with moderate to severe plaque psoriasis. The drug did not cause developmental toxicity in monkeys. The molecular weight for the drug’s protein backbone is 146,158, and the mean elimination half-life was 13 days. The human embryo-fetal risk in the first half of pregnancy appears to be low.

Diagnostic agents

Fluciclovine F 18 (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography imaging in men with suspected prostate cancer. Since the agent is only used in men, there are no human or animal pregnancy data.

Gallium GA 68 dotatate injection, a diagnostic imaging agent to detect rare neuroendocrine tumors, is not yet on the market.

Endocrine/metabolic agents

Lixisenatide (Adlyxin) is a glucagon-like–peptide-1 receptor agonist that is administered subcutaneously. It is indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes. The drug was teratogenic in two animal species. The molecular weight is about 4,859, and the mean terminal half-life was about 3 hours. Since tight control of glucose levels in type 2 diabetes is required during pregnancy, insulin is the treatment of choice. Consequently, lixisenatide should not be used during pregnancy.

Gastrointestinal agents

Obeticholic acid (Ocaliva) is a farnesoid X receptor agonist that is given orally for the treatment of primary biliary cholangitis, in combination with ursodiol, or ursodeoxycholic acid. I have classified ursodiol as compatible in pregnancy in the 10th edition of “Drugs in Pregnancy and Lactation” (2011: Wolters Kluwer Health). The animal reproduction data for both drugs suggest low risk. Based on the molecular weight of obeticholic (about 421), the drug will probably cross to the embryo/fetus, but the high plasma protein binding (greater than 99%) may limit exposure. The elimination half-life is apparently unknown.

Hematologic agents

Defibrotide sodium (Defitelio), given as an intravenous infusion, is an oligonucleotide mixture. It is indicated for the treatment of hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation. Animal reproduction studies in two species suggest risk. The mean molecular weight is 13,000-20,000. Plasma protein binding is an average 93%, and the elimination half-life is less than 2 hours. It is doubtful if the drug crosses the placenta, especially in the first half of pregnancy. If possible, avoid the drug in the second half of pregnancy.

Immunologics

Two indications have been approved for daclizumab. The first was in 2005 for the prophylaxis of acute organ rejection of renal transplants (Zenapax), and the second was in 2016 for the treatment of relapsing forms of multiple sclerosis (Zinbryta). Reproduction studies in monkeys with Zinbryta can be classified as low risk. The molecular weight (about 144,000) suggests that the drug will not cross the placenta, at least in the first half of pregnancy. However, depending on when the drug is given, the long elimination half-life of 21 days might allow the drug to cross in late pregnancy. Regardless, if the perceived maternal benefit exceeds the potential embryo-fetal risk, the drug should not be withheld because of pregnancy.

Muscular disorder agents

Eteplirsen (Exondys 51) is an antisense oligonucleotide that is given intravenously. It is indicated for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the related gene, which is amenable to exon 51 skipping. There are no animal reproduction data. The molecular weight is about 10,306. This suggests that the drug will not cross the placenta, at least in the first half of pregnancy. The elimination half-life is 3-4 hours, and the plasma concentration 24 hours after a dose was 0.07% of the peak plasma concentration. The drug is given once weekly, and waiting for 24 hours or slightly longer after a dose should reduce the exposure, if any, of the embryo-fetus during the first half of pregnancy.

Nusinersen (Spinraza), a survival motor neuron 2 directed–antisense oligonucleotide, is given as an intrathecal dose. It is indicated for the treatment of spinal muscular atrophy. Subcutaneous doses in two animal species caused no developmental toxicity. The molecular weight of 7,501 suggests that the drug will not cross the human placenta, at least not in the first half of pregnancy. The mean terminal elimination half-life in cerebrospinal fluid was 135-177 days and 63-87 days in plasma.

Ophthalmic agents

Lifitegrast (Xiidra) is an ophthalmic solution of a lymphocyte function-associated–antigen-1 antagonist. It is indicated for the treatment of the signs and symptoms of dry eye disease. The animal reproduction data suggest low risk. The molecular weight is about 616, suggesting that the drug would cross the placenta. However, in a Phase III trial conducted before FDA approval, 47 patients with dry eye disease were given 1 drop twice daily for periods up to 360 days. Nine patients (19%) had plasma predose (trough) concentrations above 0.5 ng/mL, the lower limit of quantitation. Trough plasma concentrations in these patients ranged from 0.55 ng/mL to 3.74 ng/mL. These amounts do not appear to represent an embryo-fetal risk.

Respiratory agents

Reslizumab (Cinqair), an interleukin-5 antagonist monoclonal antibody, is given intravenously. It is indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype. Animal data in two species suggest low risk. The molecular weight is about 147,000, and the elimination half-life is about 24 days. This suggests that exposure of the embryo and fetus will be minimal, at least in the first half of pregnancy. The maternal benefit appears to outweigh the unknown embryo-fetal risk.

Lactation

None of the above drugs have been studied during breastfeeding. Many drugs, regardless of their molecular weight, will cross into milk in small amounts during the first postpartum week. The effects of this exposure on a nursing infant are unknown. Based on the potential for nursing infant harm, the drugs that probably should not be given during breastfeeding include the four antineoplastics, the atypical antipsychotic pimavanserin, and the diabetes injection lixisenatide.

Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, and at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation,” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.

Editor’s note: “Everything We Say and Do” is an informational series developed by the Society of Hospital Medicine’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experiences of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

What I say and do

I empower all of my patients by giving them the opportunity to consider advance care planning.

Why I do it

Everyone deserves advance care planning, and every health care encounter, including a hospitalization, is an opportunity to better identify and document patients’ wishes for care should they become unable to express them. If we wait for patients to develop serious advanced illness before having advance care planning conversations, we risk depriving them of the care they would want in these situations. Additionally, we place a huge burden on family members who may struggle with excruciatingly difficult decisions in the absence of guidance about their loved one’s wishes.

How I do it

I start by identifying which components of advance care planning each patient needs, using a simple algorithm (see figure). All of my patients are queried about code status, and I give them the opportunity to better understand the value of having a healthcare proxy and advance directives, if they are not already in place.

To introduce the concept of a health care proxy and advance directives, I ask, “Have you ever thought about who you might choose to make medical decisions on your behalf if you became too sick to make those decisions yourself?” Then, finally, I share the following information, usually referring to the blank advance directives document they received in their admission packet: “There is a valuable way to put your wishes about specific care options in writing so others will know your wishes if you’re unable to communicate with them. Would you like to talk about that right now?” Again, this gives the patient control of the situation and an opportunity to decline the conversation if they are not interested or comfortable at that time.

It’s important to document the nature and outcome of these conversations. Keep in mind, advance care planning discussions need not occur at the time of admission. In fact, admission may be the worst time for some patients, further underscoring the importance of documentation so that subsequent providers can see whether advance care planning has been addressed during the hospital stay.

Note: For useful educational resources that address goals-of-care conversations in patients toward the end of life, the Center to Advance Palliative Care (www.capc.org) has a number of educational courses that address these important communication skills.
 

Dr. Rudolph is vice president of physician development and patient experience for Sound Physicians, Tacoma, Wash. and chair of the SHM Patient Experience Committee .

Reference

1. Moss, A.H., Ganjoo, J, Sharma S, et al. Utility of the “Surprise” Question to Identify Dialysis Patients with High Mortality. Clinical Journal of the American Society of Nephrology: CJASN. 2008;3(5):1379-84. doi:10.2215/CJN.00940208.




 

Editor’s note: “Everything We Say and Do” is an informational series developed by the Society of Hospital Medicine’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experiences of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

What I say and do

I empower all of my patients by giving them the opportunity to consider advance care planning.

Why I do it

Everyone deserves advance care planning, and every health care encounter, including a hospitalization, is an opportunity to better identify and document patients’ wishes for care should they become unable to express them. If we wait for patients to develop serious advanced illness before having advance care planning conversations, we risk depriving them of the care they would want in these situations. Additionally, we place a huge burden on family members who may struggle with excruciatingly difficult decisions in the absence of guidance about their loved one’s wishes.

How I do it

I start by identifying which components of advance care planning each patient needs, using a simple algorithm (see figure). All of my patients are queried about code status, and I give them the opportunity to better understand the value of having a healthcare proxy and advance directives, if they are not already in place.

To introduce the concept of a health care proxy and advance directives, I ask, “Have you ever thought about who you might choose to make medical decisions on your behalf if you became too sick to make those decisions yourself?” Then, finally, I share the following information, usually referring to the blank advance directives document they received in their admission packet: “There is a valuable way to put your wishes about specific care options in writing so others will know your wishes if you’re unable to communicate with them. Would you like to talk about that right now?” Again, this gives the patient control of the situation and an opportunity to decline the conversation if they are not interested or comfortable at that time.

It’s important to document the nature and outcome of these conversations. Keep in mind, advance care planning discussions need not occur at the time of admission. In fact, admission may be the worst time for some patients, further underscoring the importance of documentation so that subsequent providers can see whether advance care planning has been addressed during the hospital stay.

Note: For useful educational resources that address goals-of-care conversations in patients toward the end of life, the Center to Advance Palliative Care (www.capc.org) has a number of educational courses that address these important communication skills.
 

Dr. Rudolph is vice president of physician development and patient experience for Sound Physicians, Tacoma, Wash. and chair of the SHM Patient Experience Committee .

Reference

1. Moss, A.H., Ganjoo, J, Sharma S, et al. Utility of the “Surprise” Question to Identify Dialysis Patients with High Mortality. Clinical Journal of the American Society of Nephrology: CJASN. 2008;3(5):1379-84. doi:10.2215/CJN.00940208.




 

Editor’s note: “Everything We Say and Do” is an informational series developed by the Society of Hospital Medicine’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experiences of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

What I say and do

I empower all of my patients by giving them the opportunity to consider advance care planning.

Why I do it

Everyone deserves advance care planning, and every health care encounter, including a hospitalization, is an opportunity to better identify and document patients’ wishes for care should they become unable to express them. If we wait for patients to develop serious advanced illness before having advance care planning conversations, we risk depriving them of the care they would want in these situations. Additionally, we place a huge burden on family members who may struggle with excruciatingly difficult decisions in the absence of guidance about their loved one’s wishes.

How I do it

I start by identifying which components of advance care planning each patient needs, using a simple algorithm (see figure). All of my patients are queried about code status, and I give them the opportunity to better understand the value of having a healthcare proxy and advance directives, if they are not already in place.

To introduce the concept of a health care proxy and advance directives, I ask, “Have you ever thought about who you might choose to make medical decisions on your behalf if you became too sick to make those decisions yourself?” Then, finally, I share the following information, usually referring to the blank advance directives document they received in their admission packet: “There is a valuable way to put your wishes about specific care options in writing so others will know your wishes if you’re unable to communicate with them. Would you like to talk about that right now?” Again, this gives the patient control of the situation and an opportunity to decline the conversation if they are not interested or comfortable at that time.

It’s important to document the nature and outcome of these conversations. Keep in mind, advance care planning discussions need not occur at the time of admission. In fact, admission may be the worst time for some patients, further underscoring the importance of documentation so that subsequent providers can see whether advance care planning has been addressed during the hospital stay.

Note: For useful educational resources that address goals-of-care conversations in patients toward the end of life, the Center to Advance Palliative Care (www.capc.org) has a number of educational courses that address these important communication skills.
 

Dr. Rudolph is vice president of physician development and patient experience for Sound Physicians, Tacoma, Wash. and chair of the SHM Patient Experience Committee .

Reference

1. Moss, A.H., Ganjoo, J, Sharma S, et al. Utility of the “Surprise” Question to Identify Dialysis Patients with High Mortality. Clinical Journal of the American Society of Nephrology: CJASN. 2008;3(5):1379-84. doi:10.2215/CJN.00940208.




 

I recently had the good fortune to read a commentary written by Dr. Peter Angelos in ACS Surgery News entitled, The Right Choice? Surgeons, confidence, and humility (2017, February, p. 11). The essay touches on the philosophy, psychology, and attitudes that surgeons adopt and express in their daily interactions with the public.

The article refers to “the balance between lack of confidence and overconfidence, and between thoughtful introspection and paralyzing fear of future complications.” This is a critically important struggle in the mind of the surgeon. I would like to propose an exercise to bolster self-esteem in the psyche of the surgeon, particularly in the formative stages of one’s career, without fostering false or pathological bravado.

Dr. Chuback is a vascular surgeon in private practice in Paramus, N.J.

I recently had the good fortune to read a commentary written by Dr. Peter Angelos in ACS Surgery News entitled, The Right Choice? Surgeons, confidence, and humility (2017, February, p. 11). The essay touches on the philosophy, psychology, and attitudes that surgeons adopt and express in their daily interactions with the public.

The article refers to “the balance between lack of confidence and overconfidence, and between thoughtful introspection and paralyzing fear of future complications.” This is a critically important struggle in the mind of the surgeon. I would like to propose an exercise to bolster self-esteem in the psyche of the surgeon, particularly in the formative stages of one’s career, without fostering false or pathological bravado.

Dr. Chuback is a vascular surgeon in private practice in Paramus, N.J.

I recently had the good fortune to read a commentary written by Dr. Peter Angelos in ACS Surgery News entitled, The Right Choice? Surgeons, confidence, and humility (2017, February, p. 11). The essay touches on the philosophy, psychology, and attitudes that surgeons adopt and express in their daily interactions with the public.

The article refers to “the balance between lack of confidence and overconfidence, and between thoughtful introspection and paralyzing fear of future complications.” This is a critically important struggle in the mind of the surgeon. I would like to propose an exercise to bolster self-esteem in the psyche of the surgeon, particularly in the formative stages of one’s career, without fostering false or pathological bravado.

Dr. Chuback is a vascular surgeon in private practice in Paramus, N.J.

I’ve never been to a patient’s funeral, though I know plenty of other doctors who have.

I suppose this is a highly personal decision. Some feel they should go out of respect to the patient, or if they had a particularly strong or longstanding relationship with them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

[polldaddy:9711658]

I’ve never been to a patient’s funeral, though I know plenty of other doctors who have.

I suppose this is a highly personal decision. Some feel they should go out of respect to the patient, or if they had a particularly strong or longstanding relationship with them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

[polldaddy:9711658]

I’ve never been to a patient’s funeral, though I know plenty of other doctors who have.

I suppose this is a highly personal decision. Some feel they should go out of respect to the patient, or if they had a particularly strong or longstanding relationship with them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

[polldaddy:9711658]

[polldaddy:9711250]

[polldaddy:9711250]

[polldaddy:9711250]

“Often, innovation is a product of desperation. I have seen too many of my patients die from opioid overdoses, and I’ve decided to create something that can stop this.”

This is the opening description of an innovative idea that Joseph Insler, MD, an early–career psychiatrist in Boston, pitched to the judges last October.

As one of the judges, this is how I described the item: “It’s like a Fitbit for people addicted to opioids, who are at risk of overdose. But, instead of tracking your footsteps and your sleep movements, it tracks your blood oxygen level, heart rate, and lack of movement. Based on an algorithm tuned to identify signs of an overdose, the Opioid Overdose Recovery Bracelet would give you a shot of medicine in your wrist. If you have accidentally overdosed, it will give you a premeasured dose of naloxone from its reservoir, likely saving your life.”

Courtesy Dr. Steven R. Daviss

New lab will set records

On May 21, at the APA annual meeting in San Diego, the third Innovation Lab event will take place with record sponsorship and funding. More than $30,000 in prizes will be awarded to winning teams in the following categories: Grand Prize, Audience Choice, Outstanding Progress, Most Promising Innovation, and Most Disruptive Innovation. New this year, the Accelerator Prize will be awarded to the alumni team that has made the most progress since its participation in a previous Innovation Lab. A special prize from Google, worth $20,000, will be given to the innovation that best uses the potential of Cloud services, including Web applications, software, and machine learning.

Courtesy Dr. Steven R. Daviss

Dr. Daviss is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology.

Psychiatry Innovation Lab alumni

Entrepreneurs from the October 2016 competition created products that addressed addiction, autism, Alzheimer’s, posttraumatic stress disorder, and other mental disorders.

Finalists

• Overdose Recovery Bracelet – “A novel solution to the opioid epidemic” – Joseph Insler
• Spectrum – “An app to encourage facial processing and emotion recognition in autism spectrum disorder” – Swathi Krishna
• Spring – “Enabling personalized behavioral healthcare using machine learning and big data” – April Koh
• Alzhelp – “Using augmented reality and intelligent personal assistant software to keep Alzheimer’s patients safe” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• MiHelper – “Identifying patterns of distress and determining optimal periods for real time mental health interventions” – Kammarauche Isuzu and Mackenzie Drazan
• WEmbrace – “A mobile application for foreign-background psychiatric patients to effectively provide critical care” – Ellen Oh

Semifinalists

• Broadleaf Mental Health –“Reaching school-aged children in the rural eastern Himalayas” – Michael Matergia
• TechLink – “Connecting students and tech” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• Beacon – “Smarter therapy. Together” – Shrenik Jain and Ravi Shah
• Muse – “Assisted meditation in mental health” – Graeme Moffat
• MiResource – “Helping adolescents find the right therapeutic fit” – Gabriela Asturias and Mackenzie Drazen
• BraVe Reality – “Virtual treatment for PTSD patients” – Monica Kullar
• SKNR – “A user-centric psychotherapy tool for the digital age” – Hyun-Hee Kim
• We2Link – “Connect better” – Michael Malone PRISM – “Helping patients gain insight through digital art mobile app” – Kenechi Ejebe and Whitney McFadden

SOURCE: Dr. Daviss

“Often, innovation is a product of desperation. I have seen too many of my patients die from opioid overdoses, and I’ve decided to create something that can stop this.”

This is the opening description of an innovative idea that Joseph Insler, MD, an early–career psychiatrist in Boston, pitched to the judges last October.

As one of the judges, this is how I described the item: “It’s like a Fitbit for people addicted to opioids, who are at risk of overdose. But, instead of tracking your footsteps and your sleep movements, it tracks your blood oxygen level, heart rate, and lack of movement. Based on an algorithm tuned to identify signs of an overdose, the Opioid Overdose Recovery Bracelet would give you a shot of medicine in your wrist. If you have accidentally overdosed, it will give you a premeasured dose of naloxone from its reservoir, likely saving your life.”

Courtesy Dr. Steven R. Daviss

New lab will set records

On May 21, at the APA annual meeting in San Diego, the third Innovation Lab event will take place with record sponsorship and funding. More than $30,000 in prizes will be awarded to winning teams in the following categories: Grand Prize, Audience Choice, Outstanding Progress, Most Promising Innovation, and Most Disruptive Innovation. New this year, the Accelerator Prize will be awarded to the alumni team that has made the most progress since its participation in a previous Innovation Lab. A special prize from Google, worth $20,000, will be given to the innovation that best uses the potential of Cloud services, including Web applications, software, and machine learning.

Courtesy Dr. Steven R. Daviss

Dr. Daviss is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology.

Psychiatry Innovation Lab alumni

Entrepreneurs from the October 2016 competition created products that addressed addiction, autism, Alzheimer’s, posttraumatic stress disorder, and other mental disorders.

Finalists

• Overdose Recovery Bracelet – “A novel solution to the opioid epidemic” – Joseph Insler
• Spectrum – “An app to encourage facial processing and emotion recognition in autism spectrum disorder” – Swathi Krishna
• Spring – “Enabling personalized behavioral healthcare using machine learning and big data” – April Koh
• Alzhelp – “Using augmented reality and intelligent personal assistant software to keep Alzheimer’s patients safe” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• MiHelper – “Identifying patterns of distress and determining optimal periods for real time mental health interventions” – Kammarauche Isuzu and Mackenzie Drazan
• WEmbrace – “A mobile application for foreign-background psychiatric patients to effectively provide critical care” – Ellen Oh

Semifinalists

• Broadleaf Mental Health –“Reaching school-aged children in the rural eastern Himalayas” – Michael Matergia
• TechLink – “Connecting students and tech” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• Beacon – “Smarter therapy. Together” – Shrenik Jain and Ravi Shah
• Muse – “Assisted meditation in mental health” – Graeme Moffat
• MiResource – “Helping adolescents find the right therapeutic fit” – Gabriela Asturias and Mackenzie Drazen
• BraVe Reality – “Virtual treatment for PTSD patients” – Monica Kullar
• SKNR – “A user-centric psychotherapy tool for the digital age” – Hyun-Hee Kim
• We2Link – “Connect better” – Michael Malone PRISM – “Helping patients gain insight through digital art mobile app” – Kenechi Ejebe and Whitney McFadden

SOURCE: Dr. Daviss

“Often, innovation is a product of desperation. I have seen too many of my patients die from opioid overdoses, and I’ve decided to create something that can stop this.”

This is the opening description of an innovative idea that Joseph Insler, MD, an early–career psychiatrist in Boston, pitched to the judges last October.

As one of the judges, this is how I described the item: “It’s like a Fitbit for people addicted to opioids, who are at risk of overdose. But, instead of tracking your footsteps and your sleep movements, it tracks your blood oxygen level, heart rate, and lack of movement. Based on an algorithm tuned to identify signs of an overdose, the Opioid Overdose Recovery Bracelet would give you a shot of medicine in your wrist. If you have accidentally overdosed, it will give you a premeasured dose of naloxone from its reservoir, likely saving your life.”

Courtesy Dr. Steven R. Daviss

New lab will set records

On May 21, at the APA annual meeting in San Diego, the third Innovation Lab event will take place with record sponsorship and funding. More than $30,000 in prizes will be awarded to winning teams in the following categories: Grand Prize, Audience Choice, Outstanding Progress, Most Promising Innovation, and Most Disruptive Innovation. New this year, the Accelerator Prize will be awarded to the alumni team that has made the most progress since its participation in a previous Innovation Lab. A special prize from Google, worth $20,000, will be given to the innovation that best uses the potential of Cloud services, including Web applications, software, and machine learning.

Courtesy Dr. Steven R. Daviss

Dr. Daviss is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology.

Psychiatry Innovation Lab alumni

Entrepreneurs from the October 2016 competition created products that addressed addiction, autism, Alzheimer’s, posttraumatic stress disorder, and other mental disorders.

Finalists

• Overdose Recovery Bracelet – “A novel solution to the opioid epidemic” – Joseph Insler
• Spectrum – “An app to encourage facial processing and emotion recognition in autism spectrum disorder” – Swathi Krishna
• Spring – “Enabling personalized behavioral healthcare using machine learning and big data” – April Koh
• Alzhelp – “Using augmented reality and intelligent personal assistant software to keep Alzheimer’s patients safe” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• MiHelper – “Identifying patterns of distress and determining optimal periods for real time mental health interventions” – Kammarauche Isuzu and Mackenzie Drazan
• WEmbrace – “A mobile application for foreign-background psychiatric patients to effectively provide critical care” – Ellen Oh

Semifinalists

• Broadleaf Mental Health –“Reaching school-aged children in the rural eastern Himalayas” – Michael Matergia
• TechLink – “Connecting students and tech” – Akanksha Jain, Michelle Koh, and Priscilla Siow
• Beacon – “Smarter therapy. Together” – Shrenik Jain and Ravi Shah
• Muse – “Assisted meditation in mental health” – Graeme Moffat
• MiResource – “Helping adolescents find the right therapeutic fit” – Gabriela Asturias and Mackenzie Drazen
• BraVe Reality – “Virtual treatment for PTSD patients” – Monica Kullar
• SKNR – “A user-centric psychotherapy tool for the digital age” – Hyun-Hee Kim
• We2Link – “Connect better” – Michael Malone PRISM – “Helping patients gain insight through digital art mobile app” – Kenechi Ejebe and Whitney McFadden

SOURCE: Dr. Daviss

Lesbian, gay, bisexual, transgender, and questioning or queer (LGBTQ) youth face bias and discrimination within the health care setting and experience disparities in health, compared with their heterosexual cisgender peers. This is an area that is receiving increasing attention and study as health care providers and researchers work to achieve health equity within these populations.

Studies focusing specifically on the health of bisexual youth and adults are lacking. The few that do exist suggest that the experiences of people who identify as bisexual may be different from those who identify as lesbian or gay. Myths and misconceptions about bisexual, pansexual, queer, and fluid identities may in some cases put these populations at increased risks. Common myths include that bisexuality is just a phase or that youth who identify as bisexual are just confused. Studies suggest that bisexual youth account for almost half of youth who identify as LGBTQ. Understanding more about some of the challenges bisexual youth and adults may face can help us better care for all of our patients and families.

• Bisexual adults are more likely to engage in self-harming behaviors, attempt suicide, or think about suicide than heterosexual adults, lesbian women, or gay men.¹

• Bisexual women have higher rates of high blood pressure, compared with heterosexual and lesbian women.²

• Bisexual women have higher rates of alcohol-related disorders than lesbian and heterosexual women.¹

Some disparities appear to be related to lack of preventive care. A survey by the Williams Institute found that 39% of bisexual men and 33% of bisexual women did not disclose their sexual orientation, compared with 13% of gay men and 10% of lesbian women.¹ The effect of intersecting identities also must be considered when discussing these health disparities. More than 40% of LGBTQ people of color identify as bisexual, and almost half of transgender people describe their sexual orientation as bisexual or queer.¹ These individuals may be especially vulnerable to health disparities as they may experience a combination of racism, transphobia, and biphobia.

Risk factors for these disparities may develop early in life. A 2012 survey of LGBTQ youth found that:³

• Bisexual youth were less likely than lesbian and gay youth to report having supportive adults who they could turn to if they were sad.

• Only 5% of bisexual youth reported being very happy, compared with 8% of gay and lesbian youth and 21% of non-LGBT youth.

• Bisexual youth reported higher rates of experimentation with drugs and alcohol, compared with their lesbian, gay, and heterosexual peers.

• Bisexual youth reported lower levels of family acceptance and knowledge of social support systems in their communities than lesbian and gay youth. Both family acceptance and knowledge of social support systems have been identified as protective factors in the development of youth.

• Bisexual youth are less likely to be out to their friends, families, and communities.

As health care providers, recognizing, respecting, and supporting the identities of our bisexual patients is important. A few simple things we can do in practice are as follows:

• Don’t mislabel patients as lesbian, gay, or straight when they have disclosed a bisexual identity.

• Don’t assume that bisexuality is just a phase or that youths are confused when they disclose their identity.

• Don’t assume you know a patient’s sexual orientation or behaviors on the basis of the sex of the current partner or current behaviors.

• Do ask open and nonjudgmental questions about sexual attraction and behaviors, and be familiar with the terms bisexual, queer, questioning, and pansexual in addition to lesbian, gay, and straight.

• Do use inclusive terms like LGBT when referring to the community rather than gay rights.

• Do recognize potential biases and assumptions regarding sexuality and bisexuality and work to change them.

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus.

Terms and definitions:

Bisexual – A person who can be attracted to more than one sex, gender, or gender identity. “Bi” is often used as an abbreviation.

Biphobia – Prejudice, fear, or hatred directed toward bisexual people.

Queer – A term people often use to express fluid identities and orientations. Historically considered a pejorative term, but used by many youth to describe their identity.

Pansexual – A person who can be attracted to any sex, gender, or gender identity.

References:
 

1. ”Health Disparities Among Bisexual People,” brief by the Human Rights Campaign Foundation.

2. “New Mexico’s Progress in Collecting Lesbian, Gay, Bisexual, and Transgender Health Data and Its Implications for Addressing Health Disparities,” New Mexico Department of Health, April 2010.

3. “Supporting and Caring for Our Bisexual Youth,” the Human Rights Campaign Foundation, 2014.

Lesbian, gay, bisexual, transgender, and questioning or queer (LGBTQ) youth face bias and discrimination within the health care setting and experience disparities in health, compared with their heterosexual cisgender peers. This is an area that is receiving increasing attention and study as health care providers and researchers work to achieve health equity within these populations.

Studies focusing specifically on the health of bisexual youth and adults are lacking. The few that do exist suggest that the experiences of people who identify as bisexual may be different from those who identify as lesbian or gay. Myths and misconceptions about bisexual, pansexual, queer, and fluid identities may in some cases put these populations at increased risks. Common myths include that bisexuality is just a phase or that youth who identify as bisexual are just confused. Studies suggest that bisexual youth account for almost half of youth who identify as LGBTQ. Understanding more about some of the challenges bisexual youth and adults may face can help us better care for all of our patients and families.

• Bisexual adults are more likely to engage in self-harming behaviors, attempt suicide, or think about suicide than heterosexual adults, lesbian women, or gay men.¹

• Bisexual women have higher rates of high blood pressure, compared with heterosexual and lesbian women.²

• Bisexual women have higher rates of alcohol-related disorders than lesbian and heterosexual women.¹

Some disparities appear to be related to lack of preventive care. A survey by the Williams Institute found that 39% of bisexual men and 33% of bisexual women did not disclose their sexual orientation, compared with 13% of gay men and 10% of lesbian women.¹ The effect of intersecting identities also must be considered when discussing these health disparities. More than 40% of LGBTQ people of color identify as bisexual, and almost half of transgender people describe their sexual orientation as bisexual or queer.¹ These individuals may be especially vulnerable to health disparities as they may experience a combination of racism, transphobia, and biphobia.

Risk factors for these disparities may develop early in life. A 2012 survey of LGBTQ youth found that:³

• Bisexual youth were less likely than lesbian and gay youth to report having supportive adults who they could turn to if they were sad.

• Only 5% of bisexual youth reported being very happy, compared with 8% of gay and lesbian youth and 21% of non-LGBT youth.

• Bisexual youth reported higher rates of experimentation with drugs and alcohol, compared with their lesbian, gay, and heterosexual peers.

• Bisexual youth reported lower levels of family acceptance and knowledge of social support systems in their communities than lesbian and gay youth. Both family acceptance and knowledge of social support systems have been identified as protective factors in the development of youth.

• Bisexual youth are less likely to be out to their friends, families, and communities.

As health care providers, recognizing, respecting, and supporting the identities of our bisexual patients is important. A few simple things we can do in practice are as follows:

• Don’t mislabel patients as lesbian, gay, or straight when they have disclosed a bisexual identity.

• Don’t assume that bisexuality is just a phase or that youths are confused when they disclose their identity.

• Don’t assume you know a patient’s sexual orientation or behaviors on the basis of the sex of the current partner or current behaviors.

• Do ask open and nonjudgmental questions about sexual attraction and behaviors, and be familiar with the terms bisexual, queer, questioning, and pansexual in addition to lesbian, gay, and straight.

• Do use inclusive terms like LGBT when referring to the community rather than gay rights.

• Do recognize potential biases and assumptions regarding sexuality and bisexuality and work to change them.

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus.

Terms and definitions:

Bisexual – A person who can be attracted to more than one sex, gender, or gender identity. “Bi” is often used as an abbreviation.

Biphobia – Prejudice, fear, or hatred directed toward bisexual people.

Queer – A term people often use to express fluid identities and orientations. Historically considered a pejorative term, but used by many youth to describe their identity.

Pansexual – A person who can be attracted to any sex, gender, or gender identity.

References:
 

1. ”Health Disparities Among Bisexual People,” brief by the Human Rights Campaign Foundation.

2. “New Mexico’s Progress in Collecting Lesbian, Gay, Bisexual, and Transgender Health Data and Its Implications for Addressing Health Disparities,” New Mexico Department of Health, April 2010.

3. “Supporting and Caring for Our Bisexual Youth,” the Human Rights Campaign Foundation, 2014.

Lesbian, gay, bisexual, transgender, and questioning or queer (LGBTQ) youth face bias and discrimination within the health care setting and experience disparities in health, compared with their heterosexual cisgender peers. This is an area that is receiving increasing attention and study as health care providers and researchers work to achieve health equity within these populations.

Studies focusing specifically on the health of bisexual youth and adults are lacking. The few that do exist suggest that the experiences of people who identify as bisexual may be different from those who identify as lesbian or gay. Myths and misconceptions about bisexual, pansexual, queer, and fluid identities may in some cases put these populations at increased risks. Common myths include that bisexuality is just a phase or that youth who identify as bisexual are just confused. Studies suggest that bisexual youth account for almost half of youth who identify as LGBTQ. Understanding more about some of the challenges bisexual youth and adults may face can help us better care for all of our patients and families.

• Bisexual adults are more likely to engage in self-harming behaviors, attempt suicide, or think about suicide than heterosexual adults, lesbian women, or gay men.¹

• Bisexual women have higher rates of high blood pressure, compared with heterosexual and lesbian women.²

• Bisexual women have higher rates of alcohol-related disorders than lesbian and heterosexual women.¹

Some disparities appear to be related to lack of preventive care. A survey by the Williams Institute found that 39% of bisexual men and 33% of bisexual women did not disclose their sexual orientation, compared with 13% of gay men and 10% of lesbian women.¹ The effect of intersecting identities also must be considered when discussing these health disparities. More than 40% of LGBTQ people of color identify as bisexual, and almost half of transgender people describe their sexual orientation as bisexual or queer.¹ These individuals may be especially vulnerable to health disparities as they may experience a combination of racism, transphobia, and biphobia.

Risk factors for these disparities may develop early in life. A 2012 survey of LGBTQ youth found that:³

• Bisexual youth were less likely than lesbian and gay youth to report having supportive adults who they could turn to if they were sad.

• Only 5% of bisexual youth reported being very happy, compared with 8% of gay and lesbian youth and 21% of non-LGBT youth.

• Bisexual youth reported higher rates of experimentation with drugs and alcohol, compared with their lesbian, gay, and heterosexual peers.

• Bisexual youth reported lower levels of family acceptance and knowledge of social support systems in their communities than lesbian and gay youth. Both family acceptance and knowledge of social support systems have been identified as protective factors in the development of youth.

• Bisexual youth are less likely to be out to their friends, families, and communities.

As health care providers, recognizing, respecting, and supporting the identities of our bisexual patients is important. A few simple things we can do in practice are as follows:

• Don’t mislabel patients as lesbian, gay, or straight when they have disclosed a bisexual identity.

• Don’t assume that bisexuality is just a phase or that youths are confused when they disclose their identity.

• Don’t assume you know a patient’s sexual orientation or behaviors on the basis of the sex of the current partner or current behaviors.

• Do ask open and nonjudgmental questions about sexual attraction and behaviors, and be familiar with the terms bisexual, queer, questioning, and pansexual in addition to lesbian, gay, and straight.

• Do use inclusive terms like LGBT when referring to the community rather than gay rights.

• Do recognize potential biases and assumptions regarding sexuality and bisexuality and work to change them.

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at the Ohio State University, both in Columbus.

Terms and definitions:

Bisexual – A person who can be attracted to more than one sex, gender, or gender identity. “Bi” is often used as an abbreviation.

Biphobia – Prejudice, fear, or hatred directed toward bisexual people.

Queer – A term people often use to express fluid identities and orientations. Historically considered a pejorative term, but used by many youth to describe their identity.

Pansexual – A person who can be attracted to any sex, gender, or gender identity.

References:
 

1. ”Health Disparities Among Bisexual People,” brief by the Human Rights Campaign Foundation.

2. “New Mexico’s Progress in Collecting Lesbian, Gay, Bisexual, and Transgender Health Data and Its Implications for Addressing Health Disparities,” New Mexico Department of Health, April 2010.

3. “Supporting and Caring for Our Bisexual Youth,” the Human Rights Campaign Foundation, 2014.