MDedge ObGyn

In the musical Hamilton, there is a line from the song “The Election of 1800” in which, after a tumultuous time, Thomas Jefferson pleads for a sense of normalcy with, “Can we get back to politics?”

Trying to get back to “normal,” whatever that is, characterized the year 2022. Peeking out from under the constant shadow of the COVID-19 pandemic (not really gone, definitely not forgotten) were some blockbuster obstetrical headlines, including those on the CHAP (Chronic Hypertension and Pregnancy) trial and the impact of the Dobbs v Jackson Supreme Court decision. As these have been extensively covered in both OBG Management and other publications, in this Update we simply ask, “Can we get back to obstetrics?” as we focus on some straightforward patient care guidelines.

Thus, we offer updated information on the use of progesterone for preterm birth prevention, management of pregnancies that result from in vitro fertilization (IVF), and headache management in pregnant and postpartum patients.

Society guidance and FDA  advisement on the use of  progesterone for the prevention  of spontaneous preterm birth

American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth. ACOG practice bulletin no. 234. Obstet Gynecol. 2021;138:e65-e90.

EPPPIC Group. Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials. Lancet. 2021;397:1183-1194.

This is not déjà vu! Progesterone and spontaneous preterm birth (sPTB) is a hot topic again. If you wonder what to tell your patients, you are not alone. Preterm birth (PTB) continues to pose a challenge in obstetrics, with a most recently reported overall rate of 10.49%¹ in the United States—a 4% increase from 2019. Preterm birth accounts for approximately 75% of perinatal mortality and more than half of neonatal morbidity.²

What has not changed

A recent practice bulletin from the American College of Obstetricians and Gynecologists (ACOG) notes that some risk factors and screening assessments for PTB remain unchanged, including²:

• A history of PTB increases the risk for subsequent PTB. Risk increases with the number of prior preterm deliveries.
• A short cervix (<25 mm between 16 and  24 weeks’ gestation) is a risk factor for sPTB.
• The cervix should be visualized during the anatomy ultrasound exam (18 0/7 to 22 6/7 weeks’ gestation) in all pregnant patients regardless of prior birth history. If the cervix length (CL) appears shortened on transabdominal imaging, transvaginal (TV) imaging should be performed.
• Patients with a current singleton pregnancy and history of sPTB should have serial TV cervical measurements between 16 0/7 and 24 0/7 weeks’ gestation.²

EPPPIC changes and key takeaway points

In a meta-analysis of data from 31 randomized controlled trials, the EPPPIC (Evaluating Progestogens for Preventing Preterm birth International Collaborative) investigators compared vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate  (17-OHPC), or oral progesterone with control or with each other in women at risk for PTB.³ Outcomes included PTB and the associated adverse neonatal and maternal outcomes.

The EPPPIC study’s main findings were:

• Singleton pregnancies at high risk for PTB due to prior sPTB or short cervix who received 17-OHPC or vaginal progesterone were less likely to deliver before  34 weeks’ gestation compared with those who received no treatment.
• There is a benefit to both 17-OHPC and vaginal progesterone in reducing the risk of PTB, with no clear evidence to support one intervention’s effectiveness over the other.
• There is benefit to either 17-OHPC or vaginal progesterone for CL less than 25 mm. The shorter the CL, the greater the absolute risk reduction on PTB.
• In multifetal pregnancies, use of 17-OHPC, when compared with placebo, was shown to increase the risk of preterm premature rupture of membranes. Neither 17-OHPC nor vaginal progesterone was found to reduce the risk of sPTB in multifetal pregnancies.³

What continues to change

While the March 30, 2021, statement from the Society for Maternal-Fetal Medicine (SMFM), “Response to EPPPIC and consideration for the use of progestogens for the prevention of preterm birth” (https://www .smfm.org/publications/383-smfm-stat ement-response-to-epppic-and-consider ations-of-the-use-of-progestogens-for-the -prevention-of-preterm-birth), stands, ACOG has withdrawn its accompanying Practice Advisory on guidance for integrating the EPPPIC findings.

In August 2022, the US Food and Drug Administration (FDA) granted a hearing on the Center for Drug Evaluation and Research’s proposal to withdraw approval for Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) on the basis that available evidence does not demonstrate that it is effective for its approved indication to reduce the risk of PTB in women with a singleton pregnancy with a history of singleton sPTB.⁴

The key takeaway points from the FDA hearing (October 17–19, 2022) were:

• A better designed randomized controlled confirmatory trial is needed in the most at-risk patients to determine if Makena is effective for its approved indication.
• Makena and its approved generic equivalents remain on the market until the FDA makes its final decision regarding approval.⁴

Continue to: Managing pregnancies that result from IVF...

Society for Maternal-Fetal Medicine (SMFM); Ghidini A, Gandhi M, McCoy J, et al; Publications Committee. Society for Maternal-Fetal Medicine consult series #60: management of pregnancies resulting from in vitro fertilization. Am J Obstet Gynecol. 2022;226:B2-B12.

Assisted reproductive technology contributes to 1.6% of all infant births, and although most pregnancies are uncomplicated, some specific risks alter management.^5–7 For example, IVF is associated with increased rates of prematurity and its complications, fetal growth restriction, low birth weight, congenital anomalies, genetic abnormalities, and placental abnormalities. In addition, there is doubling of the risk of morbidities to the pregnant IVF patient, including but not limited to hypertensive disorders and diabetes. These complications are thought to be related to both the process of IVF itself as well as to conditions that contribute to subfertility and infertility in the first place.

Genetic screening and diagnostic testing options

IVF pregnancies have a documented increase in chromosomal abnormalities compared with spontaneously conceived pregnancies due to the following factors:

• karyotypic abnormalities in couples with infertility
• microdeletions on the Y chromosome in patients with oligospermia or azoospermia
• de novo chromosomal abnormalities in IVF pregnancies that utilize intracytoplasmic sperm injection (ICSI)
• fragile X mutations in patients with reduced ovarian reserve
• imprinting disorders in patients with fertility issues.

A common misconception is that preimplantation genetic testing renders prenatal genetic screening or testing unnecessary. However, preimplantation testing can be anywhere from 43% to 84% concordant with prenatal diagnostic testing due to biologic and technical factors. Therefore, all pregnancies should be offered the same options of aneuploidy screening as well as diagnostic testing. Pretest counseling should include an increased risk in IVF pregnancies of false-positives for the first-trimester screen and “no-call” results for cell-free fetal DNA. Additionally, diagnostic testing is recommended specifically in cases where mosaic embryos are transferred when euploid embryos are not available.

Counseling on fetal reduction for multifetal pregnancies

The risks of multifetal pregnancies (particularly higher order multiples) are significant and well documented for both the patient and the fetuses. It is therefore recommended that the option of multifetal pregnancy reduction be discussed, including the risks and benefits of reduction versus pregnancy continuation, timing, procedural considerations, and genetic testing options.^5,8

Detailed anatomic survey and fetal echocardiogram are indicated

Fetal anomalies, including congenital cardiac defects, occur at a higher rate in IVF pregnancies compared with spontaneously conceived pregnancies (475/10,000 live births vs 317/10,000 live births). Placental anomalies (such as placenta previa, vasa previa, and velamentous cord insertion) are also more common in this population. A detailed anatomic survey is therefore recommended for all IVF pregnancies and it is suggested that a fetal echocardiogram is offered these patients as well.

Pregnancy management and delivery considerations

Despite an increased risk of preterm birth, preeclampsia, and fetal growth restriction in IVF pregnancies (odds ratios range, 1.4–2), serial cervical lengths, serial growth ultrasound exams, and low-dose aspirin are not recommended for the sole indication of IVF. Due to lack of data on the utility of serial exams, a single screening cervical length at the time of anatomic survey and a third-trimester growth assessment are recommended. For aspirin, IVF qualifies as a “moderate” risk factor for preeclampsia; it is therefore recommended if another moderate risk factor is present (for example, nulliparity, obesity, or family history of preeclampsia).⁹

There is a 2- to 3-fold increased risk of stillbirth in IVF pregnancies; therefore, antenatal surveillance in the third trimester is recommended (weekly starting at 36 weeks for the sole indication of IVF).¹⁰ As no specific studies have evaluated the timing of delivery in IVF pregnancies, delivery recommendations include the option of 39-week delivery with shared decision-making with the patient.

Continue to: Evaluating and treating headaches in pregnancy and postpartum...

Evaluating and treating headaches in pregnancy and postpartum

American College of Obstetricians and Gynecologists. Clinical practice guideline no. 3: headaches in pregnancy and postpartum. Obstet Gynecol. 2022;139:944-972.

For obstetricians, headaches are a common and often frustrating condition to treat, as many of the available diagnostic tools and medications are either not recommended or have no data on use in pregnancy and lactation. Additionally, a headache is not always just a headache but could be a sign of a time-sensitive serious complication. An updated guideline from the American College of Obstetricians and Gynecologists approaches the topic of headaches in a stepwise algorithm that promotes efficiency and efficacy in diagnosis  and treatment.¹¹

Types of headaches

The primary headache types—migraine, cluster, and tension—are distinguished from each other by patient characteristics, quality, duration, location, and related symptoms. Reassuringly, headache frequency decreases by 30% to 80% during pregnancy, which allows for the option to decrease, change, or stop current medications, ideally prior to pregnancy. Prevention via use of calcium channel blockers, antihistamines, or β-blockers is recommended, as requiring acute treatments more than 2 days per week increases the risk of medication overuse headaches.

Treating acute headache

For patients who present with an acute headache consistent with their usual type, treatment starts with known medications that are compatible with pregnancy and proceeds in a stepwise fashion:

1. Acetaminophen 1,000 mg orally with or without caffeine 130 mg orally (maximum dose, acetaminophen < 3.25–4 g per day, caffeine 200 mg per day)

2. Metoclopramide 10 mg intravenously with or without diphenhydramine 25 mg intravenously (for nausea and to counteract restlessness and offer sedation)

3. If headache continues after steps 1 and 2, consider the following secondary treatment options: magnesium sulfate 1–2 g intravenously, sumatriptan 6 mg subcutaneously or 20-mg nasal spray, ibuprofen 600 mg orally once, or ketorolac 30 mg intravenously once (second trimester only)

4. If continued treatment and/or hospitalization is required after step 3, steroids can be used: prednisone 20 mg 4 times a day for 2 days or methylprednisolone 4-mg dose pack over 6 days

5. Do not use butalbital, opioids, or ergotamines due to lack of efficacy in providing additional pain relief, potential for addiction, risk of medication overuse headaches, and association with fetal/ pregnancy abnormalities.

Consider secondary headache

An acute headache discordant from the patient’s usual type or with concerning symptoms (“red flags”) requires consideration of secondary headaches as well as a comprehensive symptom evaluation, imaging, and consultation as needed. While secondary headaches postpartum are most likely musculoskeletal in nature, the following symptoms need to be evaluated immediately:

• rapid onset/change from baseline
• “thunderclap” nature
• hypertension
• fever
• focal neurologic deficits (blurry vision or blindness, confusion, seizures)
• altered consciousness
• laboratory abnormalities.

The differential diagnosis includes preeclampsia, reversible cerebral vasoconstriction syndrome (RCVS), posterior reversible encephalopathy syndrome (PRES), infection, cerebral venous sinus thrombosis (CVST), post–dural puncture (PDP) headache, idiopathic intracranial hypertension (IIH), and less likely, carotid dissection, subarachnoid hemorrhage, intracranial hemorrhage, pituitary apoplexy, or neoplasm.

Treatment. Individualized treatment depends on the diagnosis. Preeclampsia with severe features is treated with antihypertensive medication, magnesium sulfate, and delivery planning. PDP headache is treated with epidural blood patch, sphenopalatine block, or occipital block with an anesthesiology consultation. If preeclampsia and PDP are ruled out, or if there are more concerning neurologic features, imaging is essential, as 25% of pregnant patients with acute headaches will have a secondary etiology. Magnetic resonance imaging without contrast is preferred due to concerns about gadolinium crossing the placenta and the lack of data on long-term accumulation in fetal  tissues. Once diagnosed on imaging, PRES and RCVS are treated with antihypertensives and delivery. CVST is treated with anticoagulation and a thrombophilia workup. IIH may be treated with acetazolamide after 20 weeks or serial lumbar punctures. Intracranial vascular abnormalities may be treated with endoscopic resection and steroids. ●

In the musical Hamilton, there is a line from the song “The Election of 1800” in which, after a tumultuous time, Thomas Jefferson pleads for a sense of normalcy with, “Can we get back to politics?”

Trying to get back to “normal,” whatever that is, characterized the year 2022. Peeking out from under the constant shadow of the COVID-19 pandemic (not really gone, definitely not forgotten) were some blockbuster obstetrical headlines, including those on the CHAP (Chronic Hypertension and Pregnancy) trial and the impact of the Dobbs v Jackson Supreme Court decision. As these have been extensively covered in both OBG Management and other publications, in this Update we simply ask, “Can we get back to obstetrics?” as we focus on some straightforward patient care guidelines.

Thus, we offer updated information on the use of progesterone for preterm birth prevention, management of pregnancies that result from in vitro fertilization (IVF), and headache management in pregnant and postpartum patients.

Society guidance and FDA  advisement on the use of  progesterone for the prevention  of spontaneous preterm birth

American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth. ACOG practice bulletin no. 234. Obstet Gynecol. 2021;138:e65-e90.

EPPPIC Group. Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials. Lancet. 2021;397:1183-1194.

This is not déjà vu! Progesterone and spontaneous preterm birth (sPTB) is a hot topic again. If you wonder what to tell your patients, you are not alone. Preterm birth (PTB) continues to pose a challenge in obstetrics, with a most recently reported overall rate of 10.49%¹ in the United States—a 4% increase from 2019. Preterm birth accounts for approximately 75% of perinatal mortality and more than half of neonatal morbidity.²

What has not changed

A recent practice bulletin from the American College of Obstetricians and Gynecologists (ACOG) notes that some risk factors and screening assessments for PTB remain unchanged, including²:

• A history of PTB increases the risk for subsequent PTB. Risk increases with the number of prior preterm deliveries.
• A short cervix (<25 mm between 16 and  24 weeks’ gestation) is a risk factor for sPTB.
• The cervix should be visualized during the anatomy ultrasound exam (18 0/7 to 22 6/7 weeks’ gestation) in all pregnant patients regardless of prior birth history. If the cervix length (CL) appears shortened on transabdominal imaging, transvaginal (TV) imaging should be performed.
• Patients with a current singleton pregnancy and history of sPTB should have serial TV cervical measurements between 16 0/7 and 24 0/7 weeks’ gestation.²

EPPPIC changes and key takeaway points

In a meta-analysis of data from 31 randomized controlled trials, the EPPPIC (Evaluating Progestogens for Preventing Preterm birth International Collaborative) investigators compared vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate  (17-OHPC), or oral progesterone with control or with each other in women at risk for PTB.³ Outcomes included PTB and the associated adverse neonatal and maternal outcomes.

The EPPPIC study’s main findings were:

• Singleton pregnancies at high risk for PTB due to prior sPTB or short cervix who received 17-OHPC or vaginal progesterone were less likely to deliver before  34 weeks’ gestation compared with those who received no treatment.
• There is a benefit to both 17-OHPC and vaginal progesterone in reducing the risk of PTB, with no clear evidence to support one intervention’s effectiveness over the other.
• There is benefit to either 17-OHPC or vaginal progesterone for CL less than 25 mm. The shorter the CL, the greater the absolute risk reduction on PTB.
• In multifetal pregnancies, use of 17-OHPC, when compared with placebo, was shown to increase the risk of preterm premature rupture of membranes. Neither 17-OHPC nor vaginal progesterone was found to reduce the risk of sPTB in multifetal pregnancies.³

What continues to change

While the March 30, 2021, statement from the Society for Maternal-Fetal Medicine (SMFM), “Response to EPPPIC and consideration for the use of progestogens for the prevention of preterm birth” (https://www .smfm.org/publications/383-smfm-stat ement-response-to-epppic-and-consider ations-of-the-use-of-progestogens-for-the -prevention-of-preterm-birth), stands, ACOG has withdrawn its accompanying Practice Advisory on guidance for integrating the EPPPIC findings.

In August 2022, the US Food and Drug Administration (FDA) granted a hearing on the Center for Drug Evaluation and Research’s proposal to withdraw approval for Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) on the basis that available evidence does not demonstrate that it is effective for its approved indication to reduce the risk of PTB in women with a singleton pregnancy with a history of singleton sPTB.⁴

The key takeaway points from the FDA hearing (October 17–19, 2022) were:

• A better designed randomized controlled confirmatory trial is needed in the most at-risk patients to determine if Makena is effective for its approved indication.
• Makena and its approved generic equivalents remain on the market until the FDA makes its final decision regarding approval.⁴

Continue to: Managing pregnancies that result from IVF...

Society for Maternal-Fetal Medicine (SMFM); Ghidini A, Gandhi M, McCoy J, et al; Publications Committee. Society for Maternal-Fetal Medicine consult series #60: management of pregnancies resulting from in vitro fertilization. Am J Obstet Gynecol. 2022;226:B2-B12.

Assisted reproductive technology contributes to 1.6% of all infant births, and although most pregnancies are uncomplicated, some specific risks alter management.^5–7 For example, IVF is associated with increased rates of prematurity and its complications, fetal growth restriction, low birth weight, congenital anomalies, genetic abnormalities, and placental abnormalities. In addition, there is doubling of the risk of morbidities to the pregnant IVF patient, including but not limited to hypertensive disorders and diabetes. These complications are thought to be related to both the process of IVF itself as well as to conditions that contribute to subfertility and infertility in the first place.

Genetic screening and diagnostic testing options

IVF pregnancies have a documented increase in chromosomal abnormalities compared with spontaneously conceived pregnancies due to the following factors:

• karyotypic abnormalities in couples with infertility
• microdeletions on the Y chromosome in patients with oligospermia or azoospermia
• de novo chromosomal abnormalities in IVF pregnancies that utilize intracytoplasmic sperm injection (ICSI)
• fragile X mutations in patients with reduced ovarian reserve
• imprinting disorders in patients with fertility issues.

A common misconception is that preimplantation genetic testing renders prenatal genetic screening or testing unnecessary. However, preimplantation testing can be anywhere from 43% to 84% concordant with prenatal diagnostic testing due to biologic and technical factors. Therefore, all pregnancies should be offered the same options of aneuploidy screening as well as diagnostic testing. Pretest counseling should include an increased risk in IVF pregnancies of false-positives for the first-trimester screen and “no-call” results for cell-free fetal DNA. Additionally, diagnostic testing is recommended specifically in cases where mosaic embryos are transferred when euploid embryos are not available.

Counseling on fetal reduction for multifetal pregnancies

The risks of multifetal pregnancies (particularly higher order multiples) are significant and well documented for both the patient and the fetuses. It is therefore recommended that the option of multifetal pregnancy reduction be discussed, including the risks and benefits of reduction versus pregnancy continuation, timing, procedural considerations, and genetic testing options.^5,8

Detailed anatomic survey and fetal echocardiogram are indicated

Fetal anomalies, including congenital cardiac defects, occur at a higher rate in IVF pregnancies compared with spontaneously conceived pregnancies (475/10,000 live births vs 317/10,000 live births). Placental anomalies (such as placenta previa, vasa previa, and velamentous cord insertion) are also more common in this population. A detailed anatomic survey is therefore recommended for all IVF pregnancies and it is suggested that a fetal echocardiogram is offered these patients as well.

Pregnancy management and delivery considerations

Despite an increased risk of preterm birth, preeclampsia, and fetal growth restriction in IVF pregnancies (odds ratios range, 1.4–2), serial cervical lengths, serial growth ultrasound exams, and low-dose aspirin are not recommended for the sole indication of IVF. Due to lack of data on the utility of serial exams, a single screening cervical length at the time of anatomic survey and a third-trimester growth assessment are recommended. For aspirin, IVF qualifies as a “moderate” risk factor for preeclampsia; it is therefore recommended if another moderate risk factor is present (for example, nulliparity, obesity, or family history of preeclampsia).⁹

There is a 2- to 3-fold increased risk of stillbirth in IVF pregnancies; therefore, antenatal surveillance in the third trimester is recommended (weekly starting at 36 weeks for the sole indication of IVF).¹⁰ As no specific studies have evaluated the timing of delivery in IVF pregnancies, delivery recommendations include the option of 39-week delivery with shared decision-making with the patient.

Continue to: Evaluating and treating headaches in pregnancy and postpartum...

Evaluating and treating headaches in pregnancy and postpartum

American College of Obstetricians and Gynecologists. Clinical practice guideline no. 3: headaches in pregnancy and postpartum. Obstet Gynecol. 2022;139:944-972.

For obstetricians, headaches are a common and often frustrating condition to treat, as many of the available diagnostic tools and medications are either not recommended or have no data on use in pregnancy and lactation. Additionally, a headache is not always just a headache but could be a sign of a time-sensitive serious complication. An updated guideline from the American College of Obstetricians and Gynecologists approaches the topic of headaches in a stepwise algorithm that promotes efficiency and efficacy in diagnosis  and treatment.¹¹

Types of headaches

The primary headache types—migraine, cluster, and tension—are distinguished from each other by patient characteristics, quality, duration, location, and related symptoms. Reassuringly, headache frequency decreases by 30% to 80% during pregnancy, which allows for the option to decrease, change, or stop current medications, ideally prior to pregnancy. Prevention via use of calcium channel blockers, antihistamines, or β-blockers is recommended, as requiring acute treatments more than 2 days per week increases the risk of medication overuse headaches.

Treating acute headache

For patients who present with an acute headache consistent with their usual type, treatment starts with known medications that are compatible with pregnancy and proceeds in a stepwise fashion:

1. Acetaminophen 1,000 mg orally with or without caffeine 130 mg orally (maximum dose, acetaminophen < 3.25–4 g per day, caffeine 200 mg per day)

2. Metoclopramide 10 mg intravenously with or without diphenhydramine 25 mg intravenously (for nausea and to counteract restlessness and offer sedation)

3. If headache continues after steps 1 and 2, consider the following secondary treatment options: magnesium sulfate 1–2 g intravenously, sumatriptan 6 mg subcutaneously or 20-mg nasal spray, ibuprofen 600 mg orally once, or ketorolac 30 mg intravenously once (second trimester only)

4. If continued treatment and/or hospitalization is required after step 3, steroids can be used: prednisone 20 mg 4 times a day for 2 days or methylprednisolone 4-mg dose pack over 6 days

5. Do not use butalbital, opioids, or ergotamines due to lack of efficacy in providing additional pain relief, potential for addiction, risk of medication overuse headaches, and association with fetal/ pregnancy abnormalities.

Consider secondary headache

An acute headache discordant from the patient’s usual type or with concerning symptoms (“red flags”) requires consideration of secondary headaches as well as a comprehensive symptom evaluation, imaging, and consultation as needed. While secondary headaches postpartum are most likely musculoskeletal in nature, the following symptoms need to be evaluated immediately:

• rapid onset/change from baseline
• “thunderclap” nature
• hypertension
• fever
• focal neurologic deficits (blurry vision or blindness, confusion, seizures)
• altered consciousness
• laboratory abnormalities.

The differential diagnosis includes preeclampsia, reversible cerebral vasoconstriction syndrome (RCVS), posterior reversible encephalopathy syndrome (PRES), infection, cerebral venous sinus thrombosis (CVST), post–dural puncture (PDP) headache, idiopathic intracranial hypertension (IIH), and less likely, carotid dissection, subarachnoid hemorrhage, intracranial hemorrhage, pituitary apoplexy, or neoplasm.

Treatment. Individualized treatment depends on the diagnosis. Preeclampsia with severe features is treated with antihypertensive medication, magnesium sulfate, and delivery planning. PDP headache is treated with epidural blood patch, sphenopalatine block, or occipital block with an anesthesiology consultation. If preeclampsia and PDP are ruled out, or if there are more concerning neurologic features, imaging is essential, as 25% of pregnant patients with acute headaches will have a secondary etiology. Magnetic resonance imaging without contrast is preferred due to concerns about gadolinium crossing the placenta and the lack of data on long-term accumulation in fetal  tissues. Once diagnosed on imaging, PRES and RCVS are treated with antihypertensives and delivery. CVST is treated with anticoagulation and a thrombophilia workup. IIH may be treated with acetazolamide after 20 weeks or serial lumbar punctures. Intracranial vascular abnormalities may be treated with endoscopic resection and steroids. ●

In the musical Hamilton, there is a line from the song “The Election of 1800” in which, after a tumultuous time, Thomas Jefferson pleads for a sense of normalcy with, “Can we get back to politics?”

Trying to get back to “normal,” whatever that is, characterized the year 2022. Peeking out from under the constant shadow of the COVID-19 pandemic (not really gone, definitely not forgotten) were some blockbuster obstetrical headlines, including those on the CHAP (Chronic Hypertension and Pregnancy) trial and the impact of the Dobbs v Jackson Supreme Court decision. As these have been extensively covered in both OBG Management and other publications, in this Update we simply ask, “Can we get back to obstetrics?” as we focus on some straightforward patient care guidelines.

Thus, we offer updated information on the use of progesterone for preterm birth prevention, management of pregnancies that result from in vitro fertilization (IVF), and headache management in pregnant and postpartum patients.

Society guidance and FDA  advisement on the use of  progesterone for the prevention  of spontaneous preterm birth

American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth. ACOG practice bulletin no. 234. Obstet Gynecol. 2021;138:e65-e90.

EPPPIC Group. Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials. Lancet. 2021;397:1183-1194.

This is not déjà vu! Progesterone and spontaneous preterm birth (sPTB) is a hot topic again. If you wonder what to tell your patients, you are not alone. Preterm birth (PTB) continues to pose a challenge in obstetrics, with a most recently reported overall rate of 10.49%¹ in the United States—a 4% increase from 2019. Preterm birth accounts for approximately 75% of perinatal mortality and more than half of neonatal morbidity.²

What has not changed

A recent practice bulletin from the American College of Obstetricians and Gynecologists (ACOG) notes that some risk factors and screening assessments for PTB remain unchanged, including²:

• A history of PTB increases the risk for subsequent PTB. Risk increases with the number of prior preterm deliveries.
• A short cervix (<25 mm between 16 and  24 weeks’ gestation) is a risk factor for sPTB.
• The cervix should be visualized during the anatomy ultrasound exam (18 0/7 to 22 6/7 weeks’ gestation) in all pregnant patients regardless of prior birth history. If the cervix length (CL) appears shortened on transabdominal imaging, transvaginal (TV) imaging should be performed.
• Patients with a current singleton pregnancy and history of sPTB should have serial TV cervical measurements between 16 0/7 and 24 0/7 weeks’ gestation.²

EPPPIC changes and key takeaway points

In a meta-analysis of data from 31 randomized controlled trials, the EPPPIC (Evaluating Progestogens for Preventing Preterm birth International Collaborative) investigators compared vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate  (17-OHPC), or oral progesterone with control or with each other in women at risk for PTB.³ Outcomes included PTB and the associated adverse neonatal and maternal outcomes.

The EPPPIC study’s main findings were:

• Singleton pregnancies at high risk for PTB due to prior sPTB or short cervix who received 17-OHPC or vaginal progesterone were less likely to deliver before  34 weeks’ gestation compared with those who received no treatment.
• There is a benefit to both 17-OHPC and vaginal progesterone in reducing the risk of PTB, with no clear evidence to support one intervention’s effectiveness over the other.
• There is benefit to either 17-OHPC or vaginal progesterone for CL less than 25 mm. The shorter the CL, the greater the absolute risk reduction on PTB.
• In multifetal pregnancies, use of 17-OHPC, when compared with placebo, was shown to increase the risk of preterm premature rupture of membranes. Neither 17-OHPC nor vaginal progesterone was found to reduce the risk of sPTB in multifetal pregnancies.³

What continues to change

While the March 30, 2021, statement from the Society for Maternal-Fetal Medicine (SMFM), “Response to EPPPIC and consideration for the use of progestogens for the prevention of preterm birth” (https://www .smfm.org/publications/383-smfm-stat ement-response-to-epppic-and-consider ations-of-the-use-of-progestogens-for-the -prevention-of-preterm-birth), stands, ACOG has withdrawn its accompanying Practice Advisory on guidance for integrating the EPPPIC findings.

In August 2022, the US Food and Drug Administration (FDA) granted a hearing on the Center for Drug Evaluation and Research’s proposal to withdraw approval for Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) on the basis that available evidence does not demonstrate that it is effective for its approved indication to reduce the risk of PTB in women with a singleton pregnancy with a history of singleton sPTB.⁴

The key takeaway points from the FDA hearing (October 17–19, 2022) were:

• A better designed randomized controlled confirmatory trial is needed in the most at-risk patients to determine if Makena is effective for its approved indication.
• Makena and its approved generic equivalents remain on the market until the FDA makes its final decision regarding approval.⁴

Continue to: Managing pregnancies that result from IVF...

Society for Maternal-Fetal Medicine (SMFM); Ghidini A, Gandhi M, McCoy J, et al; Publications Committee. Society for Maternal-Fetal Medicine consult series #60: management of pregnancies resulting from in vitro fertilization. Am J Obstet Gynecol. 2022;226:B2-B12.

Assisted reproductive technology contributes to 1.6% of all infant births, and although most pregnancies are uncomplicated, some specific risks alter management.^5–7 For example, IVF is associated with increased rates of prematurity and its complications, fetal growth restriction, low birth weight, congenital anomalies, genetic abnormalities, and placental abnormalities. In addition, there is doubling of the risk of morbidities to the pregnant IVF patient, including but not limited to hypertensive disorders and diabetes. These complications are thought to be related to both the process of IVF itself as well as to conditions that contribute to subfertility and infertility in the first place.

Genetic screening and diagnostic testing options

IVF pregnancies have a documented increase in chromosomal abnormalities compared with spontaneously conceived pregnancies due to the following factors:

• karyotypic abnormalities in couples with infertility
• microdeletions on the Y chromosome in patients with oligospermia or azoospermia
• de novo chromosomal abnormalities in IVF pregnancies that utilize intracytoplasmic sperm injection (ICSI)
• fragile X mutations in patients with reduced ovarian reserve
• imprinting disorders in patients with fertility issues.

A common misconception is that preimplantation genetic testing renders prenatal genetic screening or testing unnecessary. However, preimplantation testing can be anywhere from 43% to 84% concordant with prenatal diagnostic testing due to biologic and technical factors. Therefore, all pregnancies should be offered the same options of aneuploidy screening as well as diagnostic testing. Pretest counseling should include an increased risk in IVF pregnancies of false-positives for the first-trimester screen and “no-call” results for cell-free fetal DNA. Additionally, diagnostic testing is recommended specifically in cases where mosaic embryos are transferred when euploid embryos are not available.

Counseling on fetal reduction for multifetal pregnancies

The risks of multifetal pregnancies (particularly higher order multiples) are significant and well documented for both the patient and the fetuses. It is therefore recommended that the option of multifetal pregnancy reduction be discussed, including the risks and benefits of reduction versus pregnancy continuation, timing, procedural considerations, and genetic testing options.^5,8

Detailed anatomic survey and fetal echocardiogram are indicated

Fetal anomalies, including congenital cardiac defects, occur at a higher rate in IVF pregnancies compared with spontaneously conceived pregnancies (475/10,000 live births vs 317/10,000 live births). Placental anomalies (such as placenta previa, vasa previa, and velamentous cord insertion) are also more common in this population. A detailed anatomic survey is therefore recommended for all IVF pregnancies and it is suggested that a fetal echocardiogram is offered these patients as well.

Pregnancy management and delivery considerations

Despite an increased risk of preterm birth, preeclampsia, and fetal growth restriction in IVF pregnancies (odds ratios range, 1.4–2), serial cervical lengths, serial growth ultrasound exams, and low-dose aspirin are not recommended for the sole indication of IVF. Due to lack of data on the utility of serial exams, a single screening cervical length at the time of anatomic survey and a third-trimester growth assessment are recommended. For aspirin, IVF qualifies as a “moderate” risk factor for preeclampsia; it is therefore recommended if another moderate risk factor is present (for example, nulliparity, obesity, or family history of preeclampsia).⁹

There is a 2- to 3-fold increased risk of stillbirth in IVF pregnancies; therefore, antenatal surveillance in the third trimester is recommended (weekly starting at 36 weeks for the sole indication of IVF).¹⁰ As no specific studies have evaluated the timing of delivery in IVF pregnancies, delivery recommendations include the option of 39-week delivery with shared decision-making with the patient.

Continue to: Evaluating and treating headaches in pregnancy and postpartum...

Evaluating and treating headaches in pregnancy and postpartum

American College of Obstetricians and Gynecologists. Clinical practice guideline no. 3: headaches in pregnancy and postpartum. Obstet Gynecol. 2022;139:944-972.

For obstetricians, headaches are a common and often frustrating condition to treat, as many of the available diagnostic tools and medications are either not recommended or have no data on use in pregnancy and lactation. Additionally, a headache is not always just a headache but could be a sign of a time-sensitive serious complication. An updated guideline from the American College of Obstetricians and Gynecologists approaches the topic of headaches in a stepwise algorithm that promotes efficiency and efficacy in diagnosis  and treatment.¹¹

Types of headaches

The primary headache types—migraine, cluster, and tension—are distinguished from each other by patient characteristics, quality, duration, location, and related symptoms. Reassuringly, headache frequency decreases by 30% to 80% during pregnancy, which allows for the option to decrease, change, or stop current medications, ideally prior to pregnancy. Prevention via use of calcium channel blockers, antihistamines, or β-blockers is recommended, as requiring acute treatments more than 2 days per week increases the risk of medication overuse headaches.

Treating acute headache

For patients who present with an acute headache consistent with their usual type, treatment starts with known medications that are compatible with pregnancy and proceeds in a stepwise fashion:

1. Acetaminophen 1,000 mg orally with or without caffeine 130 mg orally (maximum dose, acetaminophen < 3.25–4 g per day, caffeine 200 mg per day)

2. Metoclopramide 10 mg intravenously with or without diphenhydramine 25 mg intravenously (for nausea and to counteract restlessness and offer sedation)

3. If headache continues after steps 1 and 2, consider the following secondary treatment options: magnesium sulfate 1–2 g intravenously, sumatriptan 6 mg subcutaneously or 20-mg nasal spray, ibuprofen 600 mg orally once, or ketorolac 30 mg intravenously once (second trimester only)

4. If continued treatment and/or hospitalization is required after step 3, steroids can be used: prednisone 20 mg 4 times a day for 2 days or methylprednisolone 4-mg dose pack over 6 days

5. Do not use butalbital, opioids, or ergotamines due to lack of efficacy in providing additional pain relief, potential for addiction, risk of medication overuse headaches, and association with fetal/ pregnancy abnormalities.

Consider secondary headache

An acute headache discordant from the patient’s usual type or with concerning symptoms (“red flags”) requires consideration of secondary headaches as well as a comprehensive symptom evaluation, imaging, and consultation as needed. While secondary headaches postpartum are most likely musculoskeletal in nature, the following symptoms need to be evaluated immediately:

• rapid onset/change from baseline
• “thunderclap” nature
• hypertension
• fever
• focal neurologic deficits (blurry vision or blindness, confusion, seizures)
• altered consciousness
• laboratory abnormalities.

The differential diagnosis includes preeclampsia, reversible cerebral vasoconstriction syndrome (RCVS), posterior reversible encephalopathy syndrome (PRES), infection, cerebral venous sinus thrombosis (CVST), post–dural puncture (PDP) headache, idiopathic intracranial hypertension (IIH), and less likely, carotid dissection, subarachnoid hemorrhage, intracranial hemorrhage, pituitary apoplexy, or neoplasm.

Treatment. Individualized treatment depends on the diagnosis. Preeclampsia with severe features is treated with antihypertensive medication, magnesium sulfate, and delivery planning. PDP headache is treated with epidural blood patch, sphenopalatine block, or occipital block with an anesthesiology consultation. If preeclampsia and PDP are ruled out, or if there are more concerning neurologic features, imaging is essential, as 25% of pregnant patients with acute headaches will have a secondary etiology. Magnetic resonance imaging without contrast is preferred due to concerns about gadolinium crossing the placenta and the lack of data on long-term accumulation in fetal  tissues. Once diagnosed on imaging, PRES and RCVS are treated with antihypertensives and delivery. CVST is treated with anticoagulation and a thrombophilia workup. IIH may be treated with acetazolamide after 20 weeks or serial lumbar punctures. Intracranial vascular abnormalities may be treated with endoscopic resection and steroids. ●

This article discusses updates in geriatrics from studies published in 2022 to early 2023. The topics covered include vitamin D supplementation and incident fractures, the association of social isolation and dementia, and the release of lecanemab, the second disease-modifying therapy for mild Alzheimer dementia.

Vitamin D supplementation and incident fractures

Vitamin D supplementation is a commonly recommended intervention for bone health, but data to support its impact on reducing fracture risk has been variable.

A study in the New England Journal of Medicine by LeBoff and colleagues has garnered much attention since its publication in July 2022.¹ In the ancillary study of the Vitamin D and Omega-3-Trial (VITAL), the authors examined the impact of vitamin D supplementation versus placebo on incident fractures. The study found that vitamin D supplementation, as compared with placebo, led to no significant difference in the incidence of total, nonvertebral, and hip fractures in midlife and older adults over the 5-year period of follow-up.

The generalizability of these findings has been raised as a concern as the study does not describe adults at higher risk for fracture. The authors of the study specified in their conclusion that vitamin D supplementation does not reduce fracture risk in “generally healthy midlife and older adults who were not selected for vitamin D deficiency, low bone mass or osteoporosis.”

With a mean participant age of 67 and exclusion of participants with a history of cardiovascular disease, stroke, cirrhosis and other serious illnesses, the study does not reflect the multimorbid older adult population that geriatricians typically care for. Furthermore, efficacy of vitamin D supplementation on fracture risk may be the most impactful in those with osteoporosis and with severe vitamin D deficiency (defined by vitamin D 25[OH]D level less than 12 ng/mL).

In post hoc analyses, there was no significant difference in fracture risk in these subgroups, however the authors acknowledged that the findings may be limited by the small percentage of participants with severe vitamin D deficiency (2.4%) and osteoporosis included in the study (5%).
 

Lecanemab for mild cognitive impairment and early Alzheimer’s dementia

On Jan. 6, 2023, the Food and Drug Administration approved lecanemab, the second-ever disease-modifying treatment for Alzheimer’s dementia following the approval of aducanumab in 2021. Lecanemab is a monoclonal antibody targeting larger amyloid-beta oligomers, which has been shown in vitro to have higher affinity for amyloid-beta, compared with aducanumab. FDA approval followed shortly after the publication of the CLARITY-AD trial, which investigated the effect of lecanemab versus placebo on cognitive decline and burden of amyloid in adults with mild cognitive impairment and mild Alzheimer’s dementia. Over an 18-month period, the study found that participants who received lecanemab, compared with placebo, had a significantly smaller decline in cognition and function, and reduction in amyloid burden on PET CT.²

The clinical significance of these findings, however, is unclear. As noted by an editorial published in the Lancet in 2022, the difference in Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale between the treatment and placebo groups was 0.45. On an 18-point scale, prior research has noted that a minimal clinically significance difference of 0.98 is necessary in those with mild cognitive impairment and 1.63 in mild Alzheimer dementia.³

Additionally, the CLARITY-AD trial reported that lecanemab resulted in infusion reactions in 26.4% of participants and brain edema (an amyloid-related imaging abnormality referred to as ARIA-E) in 12.6% of participants. This finding highlights concerns for safety and the need for close monitoring, as well as ongoing implications of economic feasibility and equitable access for all those who qualify for treatment.²

Social isolation and dementia risk

There is growing awareness of the impact of social isolation on health outcomes, particularly among older adults. Prior research has reported that one in four older adults are considered socially isolated and that social isolation increases risk of premature death, dementia, depression, and cardiovascular disease.⁴

A study by Huang and colleagues is the first nationally representative cohort study examining the association between social isolation and incident dementia for older adults in community dwelling settings. A cohort of 5,022 older adults participating in the National Health and Aging Trends Study was followed from 2011 to 2020. When adjusting for demographic and health factors, including race, level of education, and number of chronic health conditions, socially isolated adults had a greater risk of developing dementia, compared with adults who were not socially isolated (hazard ratio, 1.27; 95% confidence interval, 1.08-1.49). Potential mechanisms to explain this association include the increased risk of cardiovascular disease and depression in older adults who are socially isolated, thereby increasing dementia risk.

Decreased cognitive activity/engagement and access to resources such as caregiving and health care may also be linked to the increased risk of dementia in socially isolated older adults.⁵

Another observational cohort study from the National Health and Aging Trends Study investigated whether access and use of technology can lower the risk of social isolation. The study found that older adults who used email or text messaging had a lower risk of social isolation than older adults who did not use technology (incidence rate ratio, 0.64; 95% CI, 0.51-0.80).⁶ These findings highlight the importance of addressing social isolation as an important modifiable health risk factor, and the need for providing equitable access to technology in vulnerable populations as health intervention.

Dr. Mengru “Ruru” Wang is a geriatrician and internist at the University of Washington, Seattle. She practices full-spectrum medicine, seeing patients in primary care, nursing homes, and acute care. Dr. Wang has no disclosures related to this piece.

References

1. LeBoff MS et al. Supplemental vitamin D and incident fractures in midlife and older adults. N Engl J Med. 2022;387(4):299-30.

2. van Dyck CH et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21.

3. The Lancet. Lecanemab for Alzheimer’s disease: tempering hype and hope. Lancet. 2022; 400:1899.

4. National Academies of Sciences, Engineering, and Medicine. Social Isolation and Loneliness in Older Adults: Opportunities for the Health Care System. Washington, DC: 2020, The National Academies Press.

5. Huang, AR et al. Social isolation and 9-year dementia risk in community dwelling Medicare beneficiaries in the United States. J Am Geriatr Soc. 2023 Jan 11. doi: 10.1111/jgs18140.

6. Umoh ME etal. Impact of technology on social isolation: Longitudinal analysis from the National Health Aging Trends Study. J Am Geriatr Soc. 2022 Dec 15. doi 10.1111/jgs.18179.

This article discusses updates in geriatrics from studies published in 2022 to early 2023. The topics covered include vitamin D supplementation and incident fractures, the association of social isolation and dementia, and the release of lecanemab, the second disease-modifying therapy for mild Alzheimer dementia.

Vitamin D supplementation and incident fractures

Vitamin D supplementation is a commonly recommended intervention for bone health, but data to support its impact on reducing fracture risk has been variable.

A study in the New England Journal of Medicine by LeBoff and colleagues has garnered much attention since its publication in July 2022.¹ In the ancillary study of the Vitamin D and Omega-3-Trial (VITAL), the authors examined the impact of vitamin D supplementation versus placebo on incident fractures. The study found that vitamin D supplementation, as compared with placebo, led to no significant difference in the incidence of total, nonvertebral, and hip fractures in midlife and older adults over the 5-year period of follow-up.

The generalizability of these findings has been raised as a concern as the study does not describe adults at higher risk for fracture. The authors of the study specified in their conclusion that vitamin D supplementation does not reduce fracture risk in “generally healthy midlife and older adults who were not selected for vitamin D deficiency, low bone mass or osteoporosis.”

With a mean participant age of 67 and exclusion of participants with a history of cardiovascular disease, stroke, cirrhosis and other serious illnesses, the study does not reflect the multimorbid older adult population that geriatricians typically care for. Furthermore, efficacy of vitamin D supplementation on fracture risk may be the most impactful in those with osteoporosis and with severe vitamin D deficiency (defined by vitamin D 25[OH]D level less than 12 ng/mL).

In post hoc analyses, there was no significant difference in fracture risk in these subgroups, however the authors acknowledged that the findings may be limited by the small percentage of participants with severe vitamin D deficiency (2.4%) and osteoporosis included in the study (5%).
 

Lecanemab for mild cognitive impairment and early Alzheimer’s dementia

On Jan. 6, 2023, the Food and Drug Administration approved lecanemab, the second-ever disease-modifying treatment for Alzheimer’s dementia following the approval of aducanumab in 2021. Lecanemab is a monoclonal antibody targeting larger amyloid-beta oligomers, which has been shown in vitro to have higher affinity for amyloid-beta, compared with aducanumab. FDA approval followed shortly after the publication of the CLARITY-AD trial, which investigated the effect of lecanemab versus placebo on cognitive decline and burden of amyloid in adults with mild cognitive impairment and mild Alzheimer’s dementia. Over an 18-month period, the study found that participants who received lecanemab, compared with placebo, had a significantly smaller decline in cognition and function, and reduction in amyloid burden on PET CT.²

The clinical significance of these findings, however, is unclear. As noted by an editorial published in the Lancet in 2022, the difference in Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale between the treatment and placebo groups was 0.45. On an 18-point scale, prior research has noted that a minimal clinically significance difference of 0.98 is necessary in those with mild cognitive impairment and 1.63 in mild Alzheimer dementia.³

Additionally, the CLARITY-AD trial reported that lecanemab resulted in infusion reactions in 26.4% of participants and brain edema (an amyloid-related imaging abnormality referred to as ARIA-E) in 12.6% of participants. This finding highlights concerns for safety and the need for close monitoring, as well as ongoing implications of economic feasibility and equitable access for all those who qualify for treatment.²

Social isolation and dementia risk

There is growing awareness of the impact of social isolation on health outcomes, particularly among older adults. Prior research has reported that one in four older adults are considered socially isolated and that social isolation increases risk of premature death, dementia, depression, and cardiovascular disease.⁴

A study by Huang and colleagues is the first nationally representative cohort study examining the association between social isolation and incident dementia for older adults in community dwelling settings. A cohort of 5,022 older adults participating in the National Health and Aging Trends Study was followed from 2011 to 2020. When adjusting for demographic and health factors, including race, level of education, and number of chronic health conditions, socially isolated adults had a greater risk of developing dementia, compared with adults who were not socially isolated (hazard ratio, 1.27; 95% confidence interval, 1.08-1.49). Potential mechanisms to explain this association include the increased risk of cardiovascular disease and depression in older adults who are socially isolated, thereby increasing dementia risk.

Decreased cognitive activity/engagement and access to resources such as caregiving and health care may also be linked to the increased risk of dementia in socially isolated older adults.⁵

Another observational cohort study from the National Health and Aging Trends Study investigated whether access and use of technology can lower the risk of social isolation. The study found that older adults who used email or text messaging had a lower risk of social isolation than older adults who did not use technology (incidence rate ratio, 0.64; 95% CI, 0.51-0.80).⁶ These findings highlight the importance of addressing social isolation as an important modifiable health risk factor, and the need for providing equitable access to technology in vulnerable populations as health intervention.

Dr. Mengru “Ruru” Wang is a geriatrician and internist at the University of Washington, Seattle. She practices full-spectrum medicine, seeing patients in primary care, nursing homes, and acute care. Dr. Wang has no disclosures related to this piece.

References

1. LeBoff MS et al. Supplemental vitamin D and incident fractures in midlife and older adults. N Engl J Med. 2022;387(4):299-30.

2. van Dyck CH et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21.

3. The Lancet. Lecanemab for Alzheimer’s disease: tempering hype and hope. Lancet. 2022; 400:1899.

4. National Academies of Sciences, Engineering, and Medicine. Social Isolation and Loneliness in Older Adults: Opportunities for the Health Care System. Washington, DC: 2020, The National Academies Press.

5. Huang, AR et al. Social isolation and 9-year dementia risk in community dwelling Medicare beneficiaries in the United States. J Am Geriatr Soc. 2023 Jan 11. doi: 10.1111/jgs18140.

6. Umoh ME etal. Impact of technology on social isolation: Longitudinal analysis from the National Health Aging Trends Study. J Am Geriatr Soc. 2022 Dec 15. doi 10.1111/jgs.18179.

This article discusses updates in geriatrics from studies published in 2022 to early 2023. The topics covered include vitamin D supplementation and incident fractures, the association of social isolation and dementia, and the release of lecanemab, the second disease-modifying therapy for mild Alzheimer dementia.

Vitamin D supplementation and incident fractures

Vitamin D supplementation is a commonly recommended intervention for bone health, but data to support its impact on reducing fracture risk has been variable.

A study in the New England Journal of Medicine by LeBoff and colleagues has garnered much attention since its publication in July 2022.¹ In the ancillary study of the Vitamin D and Omega-3-Trial (VITAL), the authors examined the impact of vitamin D supplementation versus placebo on incident fractures. The study found that vitamin D supplementation, as compared with placebo, led to no significant difference in the incidence of total, nonvertebral, and hip fractures in midlife and older adults over the 5-year period of follow-up.

The generalizability of these findings has been raised as a concern as the study does not describe adults at higher risk for fracture. The authors of the study specified in their conclusion that vitamin D supplementation does not reduce fracture risk in “generally healthy midlife and older adults who were not selected for vitamin D deficiency, low bone mass or osteoporosis.”

With a mean participant age of 67 and exclusion of participants with a history of cardiovascular disease, stroke, cirrhosis and other serious illnesses, the study does not reflect the multimorbid older adult population that geriatricians typically care for. Furthermore, efficacy of vitamin D supplementation on fracture risk may be the most impactful in those with osteoporosis and with severe vitamin D deficiency (defined by vitamin D 25[OH]D level less than 12 ng/mL).

In post hoc analyses, there was no significant difference in fracture risk in these subgroups, however the authors acknowledged that the findings may be limited by the small percentage of participants with severe vitamin D deficiency (2.4%) and osteoporosis included in the study (5%).
 

Lecanemab for mild cognitive impairment and early Alzheimer’s dementia

On Jan. 6, 2023, the Food and Drug Administration approved lecanemab, the second-ever disease-modifying treatment for Alzheimer’s dementia following the approval of aducanumab in 2021. Lecanemab is a monoclonal antibody targeting larger amyloid-beta oligomers, which has been shown in vitro to have higher affinity for amyloid-beta, compared with aducanumab. FDA approval followed shortly after the publication of the CLARITY-AD trial, which investigated the effect of lecanemab versus placebo on cognitive decline and burden of amyloid in adults with mild cognitive impairment and mild Alzheimer’s dementia. Over an 18-month period, the study found that participants who received lecanemab, compared with placebo, had a significantly smaller decline in cognition and function, and reduction in amyloid burden on PET CT.²

The clinical significance of these findings, however, is unclear. As noted by an editorial published in the Lancet in 2022, the difference in Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale between the treatment and placebo groups was 0.45. On an 18-point scale, prior research has noted that a minimal clinically significance difference of 0.98 is necessary in those with mild cognitive impairment and 1.63 in mild Alzheimer dementia.³

Additionally, the CLARITY-AD trial reported that lecanemab resulted in infusion reactions in 26.4% of participants and brain edema (an amyloid-related imaging abnormality referred to as ARIA-E) in 12.6% of participants. This finding highlights concerns for safety and the need for close monitoring, as well as ongoing implications of economic feasibility and equitable access for all those who qualify for treatment.²

Social isolation and dementia risk

There is growing awareness of the impact of social isolation on health outcomes, particularly among older adults. Prior research has reported that one in four older adults are considered socially isolated and that social isolation increases risk of premature death, dementia, depression, and cardiovascular disease.⁴

A study by Huang and colleagues is the first nationally representative cohort study examining the association between social isolation and incident dementia for older adults in community dwelling settings. A cohort of 5,022 older adults participating in the National Health and Aging Trends Study was followed from 2011 to 2020. When adjusting for demographic and health factors, including race, level of education, and number of chronic health conditions, socially isolated adults had a greater risk of developing dementia, compared with adults who were not socially isolated (hazard ratio, 1.27; 95% confidence interval, 1.08-1.49). Potential mechanisms to explain this association include the increased risk of cardiovascular disease and depression in older adults who are socially isolated, thereby increasing dementia risk.

Decreased cognitive activity/engagement and access to resources such as caregiving and health care may also be linked to the increased risk of dementia in socially isolated older adults.⁵

Another observational cohort study from the National Health and Aging Trends Study investigated whether access and use of technology can lower the risk of social isolation. The study found that older adults who used email or text messaging had a lower risk of social isolation than older adults who did not use technology (incidence rate ratio, 0.64; 95% CI, 0.51-0.80).⁶ These findings highlight the importance of addressing social isolation as an important modifiable health risk factor, and the need for providing equitable access to technology in vulnerable populations as health intervention.

Dr. Mengru “Ruru” Wang is a geriatrician and internist at the University of Washington, Seattle. She practices full-spectrum medicine, seeing patients in primary care, nursing homes, and acute care. Dr. Wang has no disclosures related to this piece.

References

1. LeBoff MS et al. Supplemental vitamin D and incident fractures in midlife and older adults. N Engl J Med. 2022;387(4):299-30.

2. van Dyck CH et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21.

3. The Lancet. Lecanemab for Alzheimer’s disease: tempering hype and hope. Lancet. 2022; 400:1899.

4. National Academies of Sciences, Engineering, and Medicine. Social Isolation and Loneliness in Older Adults: Opportunities for the Health Care System. Washington, DC: 2020, The National Academies Press.

5. Huang, AR et al. Social isolation and 9-year dementia risk in community dwelling Medicare beneficiaries in the United States. J Am Geriatr Soc. 2023 Jan 11. doi: 10.1111/jgs18140.

6. Umoh ME etal. Impact of technology on social isolation: Longitudinal analysis from the National Health Aging Trends Study. J Am Geriatr Soc. 2022 Dec 15. doi 10.1111/jgs.18179.

“When I walk in to see a patient, I always introduce myself with, ‘Hello, my name is Cyndy, I’m the PA working with the doctor today,’ ” says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”

“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”

Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.

With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.

A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.

But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.

“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
 

Education starts in your practice

Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.

Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.

Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”

The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.

“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.

Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room. 

“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”

Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.

“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
 

Not everyone is a doctor

Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”

“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”

Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.

“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.

NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.

An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.

“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”

When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.

A version of this article first appeared on Medscape.com.

“When I walk in to see a patient, I always introduce myself with, ‘Hello, my name is Cyndy, I’m the PA working with the doctor today,’ ” says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”

“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”

Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.

With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.

A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.

But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.

“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
 

Education starts in your practice

Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.

Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.

Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”

The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.

“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.

Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room. 

“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”

Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.

“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
 

Not everyone is a doctor

Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”

“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”

Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.

“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.

NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.

An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.

“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”

When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.

A version of this article first appeared on Medscape.com.

“When I walk in to see a patient, I always introduce myself with, ‘Hello, my name is Cyndy, I’m the PA working with the doctor today,’ ” says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”

“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”

Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.

With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.

A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.

But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.

“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
 

Education starts in your practice

Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.

Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.

Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”

The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.

“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.

Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room. 

“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”

Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.

“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
 

Not everyone is a doctor

Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”

“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”

Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.

“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.

NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.

An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.

“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”

When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.

A version of this article first appeared on Medscape.com.

Postpartum/perinatal depression (PPD) remains the most common complication in modern obstetrics, with a prevalence of 10%-15% based on multiple studies over the last 2 decades. Over those same 2 decades, there has been growing interest and motivation across the country – from small community hospitals to major academic centers – to promote screening. Such screening is integrated into obstetrical practices, typically using the Edinburgh Postnatal Depression Scale (EPDS), the most widely used validated screen for PPD globally.

As mentioned in previous columns, the U.S. Preventive Services Task Force recommended screening for PPD in 2016, which includes screening women at highest risk, and both acutely treating and preventing PPD.

Since then, screening women for a common clinical problem like PPD has been widely adopted by clinicians representing a broad spectrum of interdisciplinary care. Providers who are engaged in the treatment of postpartum women – obstetricians, psychiatrists, doulas, lactation consultants, facilitators of postpartum support groups, and advocacy groups among others – are included.

An open question and one of great concern recently to our group and others has been what happens after screening. It is clear that identification of PPD per se is not necessarily a challenge, and we have multiple effective treatments from antidepressants to mindfulness-based cognitive therapy to cognitive-behavioral interventions. There is also a growing number of digital applications aimed at mitigation of depressive symptoms in women with postpartum major depressive disorder. One unanswered question is how to engage women after identification of PPD and how to facilitate access to care in a way that maximizes the likelihood that women who actually are suffering from PPD get adequate treatment.

The “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression. This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well?

With that backdrop, it is surprising that the Canadian Task Force on Preventive Health Care has recently recommended against screening with systematic questionnaires, noting that benefits were unclear and not a particular advantage relative to standard practice. The recommendation carries an assumption that standard practice involves queries about mental health. While the task force continues to recommend screening for PPD, their recommendation against screening with a standardized questionnaire represents a bold, sweeping, if not myopic view.

While the Canadian Task Force on Preventive Health Care made their recommendation based on a single randomized controlled trial with the assumption that women were getting mental health counseling, and that women liked getting mental health engagement around their depression, that is not a uniform part of practice. Thus, it is puzzling why the task force would make the recommendation based on such sparse data.

The way to optimize access to care and referral systems for women who are suffering from PPD is not to remove a part of the system that’s already working. Well-validated questionnaires such as the EPDS are easy to administer and are routinely integrated into the electronic health systems records of both small and large centers. These questionnaires are an inexpensive way to increase the likelihood that women get identified and referred for a spectrum of potentially helpful interventions.

PPD is also easy to treat with medications and a wide spectrum of nonpharmacologic interventions. Novel interventions are also being explored to maximize access for women with postpartum mood and anxiety disorders such as peer-delivered behavioral activation and cognitive-behavioral therapy, which could be community based and implemented from urban to rural settings across the United States.

What may need the greatest study is the path to accessing effective treatments and resources for these women and this problem has prompted our group to explore these issues in our more recent investigations. Better understanding of those factors that limit access to mental health providers with expertise in perinatal mental health to the logistical issues of navigating the health care system for sleep-deprived new moms and their families demands greater attention and clearer answers.

The whole field has an obligation to postpartum women to figure out the amalgam of practitioners, resources, and platforms that need to be used to engage women so that they get effective treatment – because we have effective treatments. But the solution to improving perinatal mental health outcomes, unlike the approach of our colleagues in Canada, is not to be found in abandoning questionnaire-based screening, but in identifying the best ways to prevent PPD and to maximize access to care.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Postpartum/perinatal depression (PPD) remains the most common complication in modern obstetrics, with a prevalence of 10%-15% based on multiple studies over the last 2 decades. Over those same 2 decades, there has been growing interest and motivation across the country – from small community hospitals to major academic centers – to promote screening. Such screening is integrated into obstetrical practices, typically using the Edinburgh Postnatal Depression Scale (EPDS), the most widely used validated screen for PPD globally.

As mentioned in previous columns, the U.S. Preventive Services Task Force recommended screening for PPD in 2016, which includes screening women at highest risk, and both acutely treating and preventing PPD.

Since then, screening women for a common clinical problem like PPD has been widely adopted by clinicians representing a broad spectrum of interdisciplinary care. Providers who are engaged in the treatment of postpartum women – obstetricians, psychiatrists, doulas, lactation consultants, facilitators of postpartum support groups, and advocacy groups among others – are included.

An open question and one of great concern recently to our group and others has been what happens after screening. It is clear that identification of PPD per se is not necessarily a challenge, and we have multiple effective treatments from antidepressants to mindfulness-based cognitive therapy to cognitive-behavioral interventions. There is also a growing number of digital applications aimed at mitigation of depressive symptoms in women with postpartum major depressive disorder. One unanswered question is how to engage women after identification of PPD and how to facilitate access to care in a way that maximizes the likelihood that women who actually are suffering from PPD get adequate treatment.

The “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression. This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well?

With that backdrop, it is surprising that the Canadian Task Force on Preventive Health Care has recently recommended against screening with systematic questionnaires, noting that benefits were unclear and not a particular advantage relative to standard practice. The recommendation carries an assumption that standard practice involves queries about mental health. While the task force continues to recommend screening for PPD, their recommendation against screening with a standardized questionnaire represents a bold, sweeping, if not myopic view.

While the Canadian Task Force on Preventive Health Care made their recommendation based on a single randomized controlled trial with the assumption that women were getting mental health counseling, and that women liked getting mental health engagement around their depression, that is not a uniform part of practice. Thus, it is puzzling why the task force would make the recommendation based on such sparse data.

The way to optimize access to care and referral systems for women who are suffering from PPD is not to remove a part of the system that’s already working. Well-validated questionnaires such as the EPDS are easy to administer and are routinely integrated into the electronic health systems records of both small and large centers. These questionnaires are an inexpensive way to increase the likelihood that women get identified and referred for a spectrum of potentially helpful interventions.

PPD is also easy to treat with medications and a wide spectrum of nonpharmacologic interventions. Novel interventions are also being explored to maximize access for women with postpartum mood and anxiety disorders such as peer-delivered behavioral activation and cognitive-behavioral therapy, which could be community based and implemented from urban to rural settings across the United States.

What may need the greatest study is the path to accessing effective treatments and resources for these women and this problem has prompted our group to explore these issues in our more recent investigations. Better understanding of those factors that limit access to mental health providers with expertise in perinatal mental health to the logistical issues of navigating the health care system for sleep-deprived new moms and their families demands greater attention and clearer answers.

The whole field has an obligation to postpartum women to figure out the amalgam of practitioners, resources, and platforms that need to be used to engage women so that they get effective treatment – because we have effective treatments. But the solution to improving perinatal mental health outcomes, unlike the approach of our colleagues in Canada, is not to be found in abandoning questionnaire-based screening, but in identifying the best ways to prevent PPD and to maximize access to care.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Postpartum/perinatal depression (PPD) remains the most common complication in modern obstetrics, with a prevalence of 10%-15% based on multiple studies over the last 2 decades. Over those same 2 decades, there has been growing interest and motivation across the country – from small community hospitals to major academic centers – to promote screening. Such screening is integrated into obstetrical practices, typically using the Edinburgh Postnatal Depression Scale (EPDS), the most widely used validated screen for PPD globally.

As mentioned in previous columns, the U.S. Preventive Services Task Force recommended screening for PPD in 2016, which includes screening women at highest risk, and both acutely treating and preventing PPD.

Since then, screening women for a common clinical problem like PPD has been widely adopted by clinicians representing a broad spectrum of interdisciplinary care. Providers who are engaged in the treatment of postpartum women – obstetricians, psychiatrists, doulas, lactation consultants, facilitators of postpartum support groups, and advocacy groups among others – are included.

An open question and one of great concern recently to our group and others has been what happens after screening. It is clear that identification of PPD per se is not necessarily a challenge, and we have multiple effective treatments from antidepressants to mindfulness-based cognitive therapy to cognitive-behavioral interventions. There is also a growing number of digital applications aimed at mitigation of depressive symptoms in women with postpartum major depressive disorder. One unanswered question is how to engage women after identification of PPD and how to facilitate access to care in a way that maximizes the likelihood that women who actually are suffering from PPD get adequate treatment.

The “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression. This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well?

With that backdrop, it is surprising that the Canadian Task Force on Preventive Health Care has recently recommended against screening with systematic questionnaires, noting that benefits were unclear and not a particular advantage relative to standard practice. The recommendation carries an assumption that standard practice involves queries about mental health. While the task force continues to recommend screening for PPD, their recommendation against screening with a standardized questionnaire represents a bold, sweeping, if not myopic view.

While the Canadian Task Force on Preventive Health Care made their recommendation based on a single randomized controlled trial with the assumption that women were getting mental health counseling, and that women liked getting mental health engagement around their depression, that is not a uniform part of practice. Thus, it is puzzling why the task force would make the recommendation based on such sparse data.

The way to optimize access to care and referral systems for women who are suffering from PPD is not to remove a part of the system that’s already working. Well-validated questionnaires such as the EPDS are easy to administer and are routinely integrated into the electronic health systems records of both small and large centers. These questionnaires are an inexpensive way to increase the likelihood that women get identified and referred for a spectrum of potentially helpful interventions.

PPD is also easy to treat with medications and a wide spectrum of nonpharmacologic interventions. Novel interventions are also being explored to maximize access for women with postpartum mood and anxiety disorders such as peer-delivered behavioral activation and cognitive-behavioral therapy, which could be community based and implemented from urban to rural settings across the United States.

What may need the greatest study is the path to accessing effective treatments and resources for these women and this problem has prompted our group to explore these issues in our more recent investigations. Better understanding of those factors that limit access to mental health providers with expertise in perinatal mental health to the logistical issues of navigating the health care system for sleep-deprived new moms and their families demands greater attention and clearer answers.

The whole field has an obligation to postpartum women to figure out the amalgam of practitioners, resources, and platforms that need to be used to engage women so that they get effective treatment – because we have effective treatments. But the solution to improving perinatal mental health outcomes, unlike the approach of our colleagues in Canada, is not to be found in abandoning questionnaire-based screening, but in identifying the best ways to prevent PPD and to maximize access to care.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

A version of this article first appeared on WebMD.com.

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

A version of this article first appeared on WebMD.com.

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

A version of this article first appeared on WebMD.com.

If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

A version of this article first appeared on Medscape.com.

If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

A version of this article first appeared on Medscape.com.

If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.

The AMA, however, accused her of vote trading. Now, the Baltimore internist and AMA trustee has sued the organization for defamation and conspiracy.

The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.

“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.

The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.

Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.

As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
 

‘Quid pro quo’ alleged

In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.

According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.

Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.

The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”

On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.

Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.

Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.

Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.

The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.

Dr. Edwards was given a short opportunity to speak, in which she denied any violations.

According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”

The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”

Dr. Edwards lost the election.
 

AMA: Nothing more to add

The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.

In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”

The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.

The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”

He added that there “is no official transcript of the Speaker’s report.”

A version of this article first appeared on Medscape.com.

Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.

The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.

Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.

The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.

The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.

These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.

Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.

“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”

The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”

Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.

However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.

When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”

Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”

The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.

At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.

This means that a physician needs to rely on the patient’s memory.

This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”

Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.

“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”

Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.

The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.

Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.

The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.

The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.

These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.

Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.

“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”

The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”

Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.

However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.

When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”

Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”

The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.

At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.

This means that a physician needs to rely on the patient’s memory.

This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”

Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.

“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”

Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.

The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.

Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.

The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.

The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.

These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.

Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.

“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”

The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”

Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.

However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.

When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”

Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”

The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.

At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.

This means that a physician needs to rely on the patient’s memory.

This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”

Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.

“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”

Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.

Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.

Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.

“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.

Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.

Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.

Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.

“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”

The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.

Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.

Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.

Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.

The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.

“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.

Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.

The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.

Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.

A version of this article first appeared on Medscape.com.

Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.

Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.

Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.

“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.

Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.

Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.

Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.

“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”

The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.

Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.

Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.

Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.

The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.

“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.

Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.

The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.

Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.

A version of this article first appeared on Medscape.com.

Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.

Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.

Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.

“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.

Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.

Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.

Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.

“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”

The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.

Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.

Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.

Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.

The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.

“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.

Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.

The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.

Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.

A version of this article first appeared on Medscape.com.

The approach to hysterectomy has been debated, with the need for individualization case by case stressed, and the expertise of the operating surgeon considered.

CASE Was surgeon experience a factor in case complications?

VM is a 46-year-old woman (G5 P4014) reporting persistent uterine bleeding that is refractory to medical therapy. The patient has uterine fibroids, 6 weeks in size on examination, with “mild” prolapse noted. Additional medical diagnoses included vulvitis, ovarian cyst in the past, cystic mastopathy, and prior evidence of pelvic adhesion, noted at the time of ovarian cystectomy. Prior surgical records were not obtained by the operating surgeon, although her obstetric history includes 2 prior vaginal deliveries and 2 cesarean deliveries (CDs). The patient had an umbilical herniorraphy a number of years ago. Her medications include hormonal therapy, for presumed menopause, and medication for depression (she reported “doing well” on medication). She reported smoking 1 PPD and had a prior tubal ligation.

VM was previously evaluated for Lynch Syndrome and informed of the potential for increased risks of colon, endometrial, and several other cancers. She did not have cancer as of the time of planned surgery.

The patient underwent robotic-assisted total laparoscopic hysterectomy and bilateral salpingo-oophorectomy. The operating surgeon did not have a lot of experience with robotic hysterectomies but told the patient preoperatively “I have done a few.” Perioperatively, blood loss was minimal, urine output was recorded as 25 mL, and according to the operative report there were extensive pelvic adhesions and no complications. The “ureters were identified” when the broad ligament was opened at the time of skeletonization of the uterine vessels and documented accordingly. The intraoperative Foley was discontinued at the end of the procedure. The pathology report noted diffuse adenomyosis and uterine fibroids; the uterus weighed 250 g. In addition, a “large hemorrhagic corpus luteum cyst” was noted on the right ovary.

The patient presented for a postoperative visit reporting “leaking” serosanguinous fluid that began 2.5 weeks postoperatively and required her to wear 3 to 4 “Depends” every day. She also reported constipation since beginning her prescribed pain medication. She requested a copy of her medical records and said she was dissatisfied with the care she had received related to the hysterectomy; she was “seeking a second opinion from a urologist.” The urologist suggested evaluation of the “leaking,” and a Foley catheter was placed. When she stood up, however, there was leaking around the catheter, and she reported a “yellowish-green,” foul smelling discharge. She called the urologist’s office, stating, “I think I have a bowel obstruction.” The patient was instructed to proceed to the emergency department at her local hospital. She was released with a diagnosis of constipation. Upon follow-up urologic evaluation, a vulvovaginal fistula was noted. Management was a “simple fistula repair,” and the patient did well subsequently.

The patient brought suit against the hospital and operating gynecologist. In part the hospital records noted, “relatively inexperienced robotic surgeon.” The hospital was taken to task for granting privileges to an individual that had prior privilege “problems.”

PHOTO: GETTY IMAGES LL28

Continue to: Medical opinion...

Medical opinion

This case demonstrates a number of issues. (We will discuss the credentials for the surgeon and hospital privileges in the legal considerations section.) From the medical perspective, the rate of urologic injury associated with all hysterectomies is 0.87%.¹ Robotic hysterectomy has been reported at 0.92% in a series published from Henry Ford Hospital.¹ The lowest rate of urologic injury is associated with vaginal hysterectomy, reported at 0.2%.² Reported rates of urologic injury by approach to hysterectomy are¹:

• robotic, 0.92%
• laparoscopic, 0.90%
• vaginal, 0.33%
• abdominal, 0.96%.

Complications by surgeon type also have been addressed, and the percent of total urologic complications are reported as¹:

• ObGyn, 47%
• gyn oncologist, 47%
• urogynecologist, 6%.

Intraoperative conversion to laparotomy from initial robotic approach has been addressed in a retrospective study over a 2-year period, with operative times ranging from 1 hr, 50 min to 9 hrs of surgical time.¹ The vast majority of intraoperative complications in a series reported from Finland were managed “within minutes,” and in the series of 83 patients, 5 (6%) required conversion to laparotomy.² Intraoperative complications reported include failed entry, vascular injury, nerve injury, visceral injury, solid organ injury, tumor fragmentation, and anesthetic-related complications.³ Of note, the vascular injuries included inferior vena cava, common iliac, and external iliac.

Mortality rates in association with benign laparoscopic and robotic procedures have been addressed and noted to be 1:6,456 cases based upon a meta-analysis.⁴ The analysis included 124,216 patients. Laparoscopic versus robotic mortality rates were not statistically different. Mortality was more common among cases of undiagnosed rare colorectal injury. This mortality is on par with complications from Roux-en-Y gastric bypass procedures. Procedures such as sacrocolpopexy are equated with higher mortality (1:1,246) in comparison with benign hysterectomy.⁵

Infectious complications following either laparoscopic or robotic hysterectomy were reported at less than 1% and not statistically different for either approach.⁶ The series authored by Marra et al evaluated 176,016 patients.

Overall, robotic-assisted gynecologic complications are rare. One series was focused on gynecological oncologic cases.⁷ Specific categories of complications included⁷:

• patient positioning and pneumoperitoneum
• injury to surrounding organs
• bowel injury
• port site metastasis
• surgical emphysema
• vaginal cuff dehiscence
• anesthesia-related problems.

The authors concluded, “robotic assisted surgery in gynecological oncology is safe and the incidence of complications is low.”⁷ The major cause of death related to robotic surgery is vascular injury–related. The authors emphasized the importance of knowledge of anatomy, basic principles of “traction and counter-traction” and proper dissection along tissue planes as key to minimizing complications. Consider placement of stents for ureter identification, as appropriate. Barbed-suturing does not prevent dehiscence.

Continue to: Legal considerations...

Robotic surgery presents many legal issues and promises to raise many more in the future. The law must control new technology while encouraging productive uses, and provide new remedies for harms while respecting traditional legal principles.⁸ There is no shortage of good ideas about controlling surgical robots,⁹ automated devices more generally,¹⁰ and artificial intelligence.¹¹ Those issues will be important, and watching them unfold will be intriguing.

In the meantime, physicians and other health care professionals, health care facilities, technology companies, and patients must work within current legal structures in implementing and using robotic surgery. These are extraordinarily complex issues, so it is possible only to review the current landscape and speculate what the near future may hold.

Regulating surgical robots

The US Food and Drug Administration (FDA) is the primary regulator of robots used in medicine.¹² It has the authority to regulate surgical devices, including surgical robots—which it refers to as “robotically-assisted surgical devices,” or RASD. In 2000, it approved Intuitive Surgical’s daVinci system for use in surgery. In 2017, the FDA expanded its clearance to include the Senhance System of TransEnterix Surgical Inc. for minimally invasive gynecologic surgery.¹³ In 2021, the FDA cleared the Hominis Surgical System for transvaginal hysterectomy “in certain patients.” However, the FDA emphasized that this clearance is for benign hysterectomy with salpingo-oophorectomy.¹⁴ (The FDA has cleared various robotic devices for several other areas of surgical practice, including neurosurgery, orthopedics, and urology.)

The use of robots in cancer surgery is limited. The FDA approved specific RASDs in some “surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy.”¹⁵ However, it cautioned that this clearance was based only on a 30-day patient follow up. More specifically, the FDA “has not evaluated the safety or effectiveness of RASD devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”¹⁵

The FDA has clearly warned physicians and patients that the agency has not granted the use of RASDs “for any cancer-related surgery marketing authorization, and therefore the survival benefits to patients compared to traditional surgery have not been established.”¹⁵ (This did not apply to the hysterectomy surgery as noted above. More specifically, that clearance did not apply to anything other than 30-day results, nor to the efficacy related to cancer survival.)

States also have some authority to regulate medical practice within their borders.⁹ When the FDA has approved a device as safe and effective, however, there are limits on what states can do to regulate or impose liability on the approved product. The Supreme Court held that the FDA approval “pre-empted” some state action regarding approved devices.¹⁶

Hospitals, of course, regulate what is allowed within the hospital. For example, it may require training before a physician is permitted to use equipment, limit the conditions for which the equipment may be used, or decline to obtain equipment for use in the hospitals.¹⁷ In the case of RASDs, however, the high cost of equipment may provide an incentive for hospitals to urge the wide use of the latest robotic acquisition.¹⁸

Regulation aims primarily to protect patients, usually from injury or inadequate treatment. Some robotic surgery is likely to be more expensive than the same surgery without robotic assistance. The cost to the patient is not usually part of the FDA’s consideration. Insurance companies (including Medicare and Medicaid), however, do care about costs and will set or negotiate how much the reimbursement will be for a procedure. Third-party payers may decline to cover the additional cost when there is no apparent benefit from using the robot.¹⁹ For some institutions, the public perception that it offers “the most modern technology” is an important public message and a strong incentive to have the equipment.²⁰

There are inconsistent studies about the advantages and disadvantages of RADS in gynecologic procedures, although there are few randomized studies.²¹ The demonstrated advantages are generally identified as somewhat shorter recovery time.²² The ultimate goal will be to minimize risks while maximizing the many potential benefits of robotic surgery.²³

Continue to: Liability...

Liability

A recent study by De Ravin and colleagues of robotic surgery liability found a 250% increase in the total number of robotic surgery–related malpractice claims reported in 7 recent years (2014-2021), compared with the prior 7 (2006-2013).²⁴ However, the number of cases varied considerably from year to year. ObGyn had the most significant gain (from 19% to 49% of all claims). During the same time, urology claims declined from 56% to 16%. (The limitations of the study’s data are discussed later in this article.)

De Ravin et al reported the legal bases for the claims, but the specific legal claim was unclear in many cases.²⁴ For example, the vast majority were classified as “negligent surgery.” Many cases made more than 1 legal claim for liability, so the total percentages were greater than 100%. Of the specific claims, many appear unrelated to robotic surgery (misdiagnosis, delayed treatment, or infection). However, there were a significant number of cases that raised issues that were related to robotic surgery. The following are those claims that probably relate to the “robotic” surgery, along with the percentage of cases making such a claim as reported²⁴:

• “Patient not a candidate for surgery performed” appeared in about 13% of the cases.²⁴ Such claims could include that the surgeon should have performed the surgery with traditional laparoscopy or open technique, but instead using a robot led to the injury. Physicians may feel pressure from patients or hospitals, because of the equipment’s cost, to use robotic surgery as it seems to be the modern approach (and therefore better). Neither reason is sufficient for using robotic assistance unless it will benefit the patient.
• “Failure to calibrate or operate robot” was in 11% of the claims.²⁴ Physicians must properly calibrate and otherwise ensure that surgical equipment is operating correctly. In addition, the hospitals supplying the equipment must ensure that the equipment is maintained correctly. Finally, the equipment manufacturer may be liable through “products liability” if the equipment is defective.²⁵ The expanding use of artificial intelligence in medical equipment (including surgical robots) is increasing the complexity of determining what “defective” means.¹¹
• “Training deficiencies or credentialing” liability is a common problem with new technology. Physicians using new technology should be thoroughly trained and, where appropriate, certified in the use of the new technology.²⁶ Early adopters of the technology should be especially cautious because good training may be challenging to obtain. In the study, the claims of inadequate training were particularly high during the early 7 years (35%), but dropped during the later time (4%).²⁴
• “Improper positioning” of the patient or device or patient was raised in 7% of the cases.²⁴
• “Manufacturing problems” were claimed in a small number of cases—13% in 2006-2013, but 2% in 2014-2021.²⁴ These cases raise the complex question of products liability for robotic surgery and artificial intelligence (AI). Products liability has been part of surgical practice for many years. There usually will be liability if there are “defects” in a product, whether or not resulting from negligence. What a “defect” in a computer program means is a complicated issue that will be significant in future liability cases.²⁷

Several other cases reported in the De Ravin study were probably related to robotic surgery. For example, Informed Consent and Failure to Monitor each appeared in more than 30%, of 2014-2021 cases, and Failure to Refer in 16% of the cases.^24,27

The outcomes of the reported cases were mostly verdicts (or trial-related settlements) for defendants (doctors and hospitals). The defense prevailed 69% of the time in the early period and 78% of the time in 2014-2021. However, there were substantial damages in some cases. The range of damages in 2006-2013 was $95,000 to $6 million (mean, $2.5 million); in 2014-2021, it was $10,000 to $5 million (mean, $1.3 million).²⁴

An earlier study looked at reported cases against Intuitive Surgical, maker of the daVinci system, from 2000-2017.²⁸ Of the 108 claims in the study, 62% were gynecologic surgeries. Of these claims, 35% were dismissed, but “no other information regarding settlements or trial outcomes was available.” The study did not report the basis for the lawsuits involving gynecologic surgeries.

We should exercise caution in reviewing these studies. Although the studies were of considerable value, the authors note significant limitations of the databases available. The database was Westlaw in the first study discussed (“Robotic surgery: the impact”²⁴) and Bloomberg in the second (“Robotic urologic”²⁸). For example, the “impact” study was based on “jury verdict reports” excluding settlements, and the latter excluded class actions and cases settled. Thus the studies undoubtedly understated the number of claims made (those that resulted in settlement before a lawsuit was filed), cases filed but abandoned, and settlements made before trial.

Despite these limitations, the studies provide valuable insights into current malpractice risks and future directions. It is worth remembering that these cases nearly all involved a single robot, the daVinci, produced by Intuitive Surgical. It is not a “smart” robot and is commonly referred to as a “master-slave” machine. With much more intelligent and independent machines, the future will raise more complex problems in the FDA approval process and malpractice and product liability claims when things go wrong.

Continue to: What’s the verdict?...

The case of VM and operating surgeon Dr. G illustrates several important legal aspects of using surgical robots. It also demonstrates that the presence of the robot assist still requires the surgeon’s careful attention to issues of informed consent, adequate specific training, and thorough follow up. In the following discussion, we divide the case review into the elements of negligence-malpractice (duty and breach, causation, and damages) and conclude with a thought about how to proceed when things have gone wrong.

Dr. G’s statement, “I’ve done a few,” is indefinite, but it may suggest that Dr. G. had not received full, supervised training in the robotic assist he was planning to use. That problem was underlined by the conclusion that Dr. G was a “relatively inexperienced robotic surgeon.” If so, that failure could constitute a breach of the duty of care to the patient. In addition, if it is inaccurate or did not provide information VM reasonably needed in consenting to Dr. G proceeding with the surgery, there could be an issue of whether there was a partial failure of fully informed consent.

The hospital also may have potential liability. It was “taken to task for granting privileges to an individual that had prior privilege ‘problems,’” suggesting that it had not performed adequate review before granting hospital privileges. Furthermore, if Dr. G was not sufficiently practiced or supervised in robotic surgery, the hospital, which allowed Dr. G to proceed, might also be negligent.

VM had a series of problems postsurgery that ultimately resulted in additional care and “simple fistula repair.” Assuming that there was negligence, the next question is whether that failure caused the injury. Causation may be the most difficult part of the case for VM to prove. It would require expert testimony that the inadequate surgery (inappropriate use of robotic surgery or other error during surgery) and follow up resulted in the formation or increase in the likelihood of the fistula.

VM would also have to prove damages. Damages are those costs (the economic value) of injuries that would not have occurred but for negligence. Damages would include most of the cost of the follow-up medical care and any related additional future care required, plus costs that were a consequence of the negligence (such as lost work). In addition, damages would include pain and suffering that resulted from the negligence, subject to caps in some states.

When the patient was dissatisfied and reported a postsurgical problem, the hospital and Dr. G may have had an opportunity to avoid further dissatisfaction, complaints, and ultimately a lawsuit. Effective approaches for dealing with such dissatisfaction may serve the institution’s and physician’s values and financial best interests.

The jury verdict was in favor of the plaintiff. Jurors felt the operating surgeon should have conveyed his experience with robotic surgery more clearly as part of the informed consent process.

“Hey Siri! Perform a type 3 hysterectomy. Please watch out for the ureter!”²⁹

Medicine is still at the frontier of surgical robots. Over future decades, the number and sophistication of these machines will increase substantially. They likely will become much more like robots, guided by AI, and make independent judgments. These have the potential for significant medical progress that improves the treatment of patients. At the same time, the last 20 years suggest that robotic innovation will challenge medicine, the FDA and other regulators, lawmakers, and courts. In the future, regulators and patients should embrace genuine advances in robotic surgery but not be dazzled by these new machines’ luster (or potential for considerable profits).³⁰

The public may be wildly optimistic about the benefits without balancing the risks. The AI that runs them will be essentially invisible and constantly changing. Physicians and regulators must develop new techniques for assessing and controlling the software. Real surgical robots require rigorous testing, cautious promotion, disciplined use, and perpetual review. ●

The approach to hysterectomy has been debated, with the need for individualization case by case stressed, and the expertise of the operating surgeon considered.

CASE Was surgeon experience a factor in case complications?

VM is a 46-year-old woman (G5 P4014) reporting persistent uterine bleeding that is refractory to medical therapy. The patient has uterine fibroids, 6 weeks in size on examination, with “mild” prolapse noted. Additional medical diagnoses included vulvitis, ovarian cyst in the past, cystic mastopathy, and prior evidence of pelvic adhesion, noted at the time of ovarian cystectomy. Prior surgical records were not obtained by the operating surgeon, although her obstetric history includes 2 prior vaginal deliveries and 2 cesarean deliveries (CDs). The patient had an umbilical herniorraphy a number of years ago. Her medications include hormonal therapy, for presumed menopause, and medication for depression (she reported “doing well” on medication). She reported smoking 1 PPD and had a prior tubal ligation.

VM was previously evaluated for Lynch Syndrome and informed of the potential for increased risks of colon, endometrial, and several other cancers. She did not have cancer as of the time of planned surgery.

The patient underwent robotic-assisted total laparoscopic hysterectomy and bilateral salpingo-oophorectomy. The operating surgeon did not have a lot of experience with robotic hysterectomies but told the patient preoperatively “I have done a few.” Perioperatively, blood loss was minimal, urine output was recorded as 25 mL, and according to the operative report there were extensive pelvic adhesions and no complications. The “ureters were identified” when the broad ligament was opened at the time of skeletonization of the uterine vessels and documented accordingly. The intraoperative Foley was discontinued at the end of the procedure. The pathology report noted diffuse adenomyosis and uterine fibroids; the uterus weighed 250 g. In addition, a “large hemorrhagic corpus luteum cyst” was noted on the right ovary.

The patient presented for a postoperative visit reporting “leaking” serosanguinous fluid that began 2.5 weeks postoperatively and required her to wear 3 to 4 “Depends” every day. She also reported constipation since beginning her prescribed pain medication. She requested a copy of her medical records and said she was dissatisfied with the care she had received related to the hysterectomy; she was “seeking a second opinion from a urologist.” The urologist suggested evaluation of the “leaking,” and a Foley catheter was placed. When she stood up, however, there was leaking around the catheter, and she reported a “yellowish-green,” foul smelling discharge. She called the urologist’s office, stating, “I think I have a bowel obstruction.” The patient was instructed to proceed to the emergency department at her local hospital. She was released with a diagnosis of constipation. Upon follow-up urologic evaluation, a vulvovaginal fistula was noted. Management was a “simple fistula repair,” and the patient did well subsequently.

The patient brought suit against the hospital and operating gynecologist. In part the hospital records noted, “relatively inexperienced robotic surgeon.” The hospital was taken to task for granting privileges to an individual that had prior privilege “problems.”

PHOTO: GETTY IMAGES LL28

Continue to: Medical opinion...

Medical opinion

This case demonstrates a number of issues. (We will discuss the credentials for the surgeon and hospital privileges in the legal considerations section.) From the medical perspective, the rate of urologic injury associated with all hysterectomies is 0.87%.¹ Robotic hysterectomy has been reported at 0.92% in a series published from Henry Ford Hospital.¹ The lowest rate of urologic injury is associated with vaginal hysterectomy, reported at 0.2%.² Reported rates of urologic injury by approach to hysterectomy are¹:

• robotic, 0.92%
• laparoscopic, 0.90%
• vaginal, 0.33%
• abdominal, 0.96%.

Complications by surgeon type also have been addressed, and the percent of total urologic complications are reported as¹:

• ObGyn, 47%
• gyn oncologist, 47%
• urogynecologist, 6%.

Intraoperative conversion to laparotomy from initial robotic approach has been addressed in a retrospective study over a 2-year period, with operative times ranging from 1 hr, 50 min to 9 hrs of surgical time.¹ The vast majority of intraoperative complications in a series reported from Finland were managed “within minutes,” and in the series of 83 patients, 5 (6%) required conversion to laparotomy.² Intraoperative complications reported include failed entry, vascular injury, nerve injury, visceral injury, solid organ injury, tumor fragmentation, and anesthetic-related complications.³ Of note, the vascular injuries included inferior vena cava, common iliac, and external iliac.

Mortality rates in association with benign laparoscopic and robotic procedures have been addressed and noted to be 1:6,456 cases based upon a meta-analysis.⁴ The analysis included 124,216 patients. Laparoscopic versus robotic mortality rates were not statistically different. Mortality was more common among cases of undiagnosed rare colorectal injury. This mortality is on par with complications from Roux-en-Y gastric bypass procedures. Procedures such as sacrocolpopexy are equated with higher mortality (1:1,246) in comparison with benign hysterectomy.⁵

Infectious complications following either laparoscopic or robotic hysterectomy were reported at less than 1% and not statistically different for either approach.⁶ The series authored by Marra et al evaluated 176,016 patients.

Overall, robotic-assisted gynecologic complications are rare. One series was focused on gynecological oncologic cases.⁷ Specific categories of complications included⁷:

• patient positioning and pneumoperitoneum
• injury to surrounding organs
• bowel injury
• port site metastasis
• surgical emphysema
• vaginal cuff dehiscence
• anesthesia-related problems.

The authors concluded, “robotic assisted surgery in gynecological oncology is safe and the incidence of complications is low.”⁷ The major cause of death related to robotic surgery is vascular injury–related. The authors emphasized the importance of knowledge of anatomy, basic principles of “traction and counter-traction” and proper dissection along tissue planes as key to minimizing complications. Consider placement of stents for ureter identification, as appropriate. Barbed-suturing does not prevent dehiscence.

Continue to: Legal considerations...

Robotic surgery presents many legal issues and promises to raise many more in the future. The law must control new technology while encouraging productive uses, and provide new remedies for harms while respecting traditional legal principles.⁸ There is no shortage of good ideas about controlling surgical robots,⁹ automated devices more generally,¹⁰ and artificial intelligence.¹¹ Those issues will be important, and watching them unfold will be intriguing.

In the meantime, physicians and other health care professionals, health care facilities, technology companies, and patients must work within current legal structures in implementing and using robotic surgery. These are extraordinarily complex issues, so it is possible only to review the current landscape and speculate what the near future may hold.

Regulating surgical robots

The US Food and Drug Administration (FDA) is the primary regulator of robots used in medicine.¹² It has the authority to regulate surgical devices, including surgical robots—which it refers to as “robotically-assisted surgical devices,” or RASD. In 2000, it approved Intuitive Surgical’s daVinci system for use in surgery. In 2017, the FDA expanded its clearance to include the Senhance System of TransEnterix Surgical Inc. for minimally invasive gynecologic surgery.¹³ In 2021, the FDA cleared the Hominis Surgical System for transvaginal hysterectomy “in certain patients.” However, the FDA emphasized that this clearance is for benign hysterectomy with salpingo-oophorectomy.¹⁴ (The FDA has cleared various robotic devices for several other areas of surgical practice, including neurosurgery, orthopedics, and urology.)

The use of robots in cancer surgery is limited. The FDA approved specific RASDs in some “surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy.”¹⁵ However, it cautioned that this clearance was based only on a 30-day patient follow up. More specifically, the FDA “has not evaluated the safety or effectiveness of RASD devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”¹⁵

The FDA has clearly warned physicians and patients that the agency has not granted the use of RASDs “for any cancer-related surgery marketing authorization, and therefore the survival benefits to patients compared to traditional surgery have not been established.”¹⁵ (This did not apply to the hysterectomy surgery as noted above. More specifically, that clearance did not apply to anything other than 30-day results, nor to the efficacy related to cancer survival.)

States also have some authority to regulate medical practice within their borders.⁹ When the FDA has approved a device as safe and effective, however, there are limits on what states can do to regulate or impose liability on the approved product. The Supreme Court held that the FDA approval “pre-empted” some state action regarding approved devices.¹⁶

Hospitals, of course, regulate what is allowed within the hospital. For example, it may require training before a physician is permitted to use equipment, limit the conditions for which the equipment may be used, or decline to obtain equipment for use in the hospitals.¹⁷ In the case of RASDs, however, the high cost of equipment may provide an incentive for hospitals to urge the wide use of the latest robotic acquisition.¹⁸

Regulation aims primarily to protect patients, usually from injury or inadequate treatment. Some robotic surgery is likely to be more expensive than the same surgery without robotic assistance. The cost to the patient is not usually part of the FDA’s consideration. Insurance companies (including Medicare and Medicaid), however, do care about costs and will set or negotiate how much the reimbursement will be for a procedure. Third-party payers may decline to cover the additional cost when there is no apparent benefit from using the robot.¹⁹ For some institutions, the public perception that it offers “the most modern technology” is an important public message and a strong incentive to have the equipment.²⁰

There are inconsistent studies about the advantages and disadvantages of RADS in gynecologic procedures, although there are few randomized studies.²¹ The demonstrated advantages are generally identified as somewhat shorter recovery time.²² The ultimate goal will be to minimize risks while maximizing the many potential benefits of robotic surgery.²³

Continue to: Liability...

Liability

A recent study by De Ravin and colleagues of robotic surgery liability found a 250% increase in the total number of robotic surgery–related malpractice claims reported in 7 recent years (2014-2021), compared with the prior 7 (2006-2013).²⁴ However, the number of cases varied considerably from year to year. ObGyn had the most significant gain (from 19% to 49% of all claims). During the same time, urology claims declined from 56% to 16%. (The limitations of the study’s data are discussed later in this article.)

De Ravin et al reported the legal bases for the claims, but the specific legal claim was unclear in many cases.²⁴ For example, the vast majority were classified as “negligent surgery.” Many cases made more than 1 legal claim for liability, so the total percentages were greater than 100%. Of the specific claims, many appear unrelated to robotic surgery (misdiagnosis, delayed treatment, or infection). However, there were a significant number of cases that raised issues that were related to robotic surgery. The following are those claims that probably relate to the “robotic” surgery, along with the percentage of cases making such a claim as reported²⁴:

• “Patient not a candidate for surgery performed” appeared in about 13% of the cases.²⁴ Such claims could include that the surgeon should have performed the surgery with traditional laparoscopy or open technique, but instead using a robot led to the injury. Physicians may feel pressure from patients or hospitals, because of the equipment’s cost, to use robotic surgery as it seems to be the modern approach (and therefore better). Neither reason is sufficient for using robotic assistance unless it will benefit the patient.
• “Failure to calibrate or operate robot” was in 11% of the claims.²⁴ Physicians must properly calibrate and otherwise ensure that surgical equipment is operating correctly. In addition, the hospitals supplying the equipment must ensure that the equipment is maintained correctly. Finally, the equipment manufacturer may be liable through “products liability” if the equipment is defective.²⁵ The expanding use of artificial intelligence in medical equipment (including surgical robots) is increasing the complexity of determining what “defective” means.¹¹
• “Training deficiencies or credentialing” liability is a common problem with new technology. Physicians using new technology should be thoroughly trained and, where appropriate, certified in the use of the new technology.²⁶ Early adopters of the technology should be especially cautious because good training may be challenging to obtain. In the study, the claims of inadequate training were particularly high during the early 7 years (35%), but dropped during the later time (4%).²⁴
• “Improper positioning” of the patient or device or patient was raised in 7% of the cases.²⁴
• “Manufacturing problems” were claimed in a small number of cases—13% in 2006-2013, but 2% in 2014-2021.²⁴ These cases raise the complex question of products liability for robotic surgery and artificial intelligence (AI). Products liability has been part of surgical practice for many years. There usually will be liability if there are “defects” in a product, whether or not resulting from negligence. What a “defect” in a computer program means is a complicated issue that will be significant in future liability cases.²⁷

Several other cases reported in the De Ravin study were probably related to robotic surgery. For example, Informed Consent and Failure to Monitor each appeared in more than 30%, of 2014-2021 cases, and Failure to Refer in 16% of the cases.^24,27

The outcomes of the reported cases were mostly verdicts (or trial-related settlements) for defendants (doctors and hospitals). The defense prevailed 69% of the time in the early period and 78% of the time in 2014-2021. However, there were substantial damages in some cases. The range of damages in 2006-2013 was $95,000 to $6 million (mean, $2.5 million); in 2014-2021, it was $10,000 to $5 million (mean, $1.3 million).²⁴

An earlier study looked at reported cases against Intuitive Surgical, maker of the daVinci system, from 2000-2017.²⁸ Of the 108 claims in the study, 62% were gynecologic surgeries. Of these claims, 35% were dismissed, but “no other information regarding settlements or trial outcomes was available.” The study did not report the basis for the lawsuits involving gynecologic surgeries.

We should exercise caution in reviewing these studies. Although the studies were of considerable value, the authors note significant limitations of the databases available. The database was Westlaw in the first study discussed (“Robotic surgery: the impact”²⁴) and Bloomberg in the second (“Robotic urologic”²⁸). For example, the “impact” study was based on “jury verdict reports” excluding settlements, and the latter excluded class actions and cases settled. Thus the studies undoubtedly understated the number of claims made (those that resulted in settlement before a lawsuit was filed), cases filed but abandoned, and settlements made before trial.

Despite these limitations, the studies provide valuable insights into current malpractice risks and future directions. It is worth remembering that these cases nearly all involved a single robot, the daVinci, produced by Intuitive Surgical. It is not a “smart” robot and is commonly referred to as a “master-slave” machine. With much more intelligent and independent machines, the future will raise more complex problems in the FDA approval process and malpractice and product liability claims when things go wrong.

Continue to: What’s the verdict?...

The case of VM and operating surgeon Dr. G illustrates several important legal aspects of using surgical robots. It also demonstrates that the presence of the robot assist still requires the surgeon’s careful attention to issues of informed consent, adequate specific training, and thorough follow up. In the following discussion, we divide the case review into the elements of negligence-malpractice (duty and breach, causation, and damages) and conclude with a thought about how to proceed when things have gone wrong.

Dr. G’s statement, “I’ve done a few,” is indefinite, but it may suggest that Dr. G. had not received full, supervised training in the robotic assist he was planning to use. That problem was underlined by the conclusion that Dr. G was a “relatively inexperienced robotic surgeon.” If so, that failure could constitute a breach of the duty of care to the patient. In addition, if it is inaccurate or did not provide information VM reasonably needed in consenting to Dr. G proceeding with the surgery, there could be an issue of whether there was a partial failure of fully informed consent.

The hospital also may have potential liability. It was “taken to task for granting privileges to an individual that had prior privilege ‘problems,’” suggesting that it had not performed adequate review before granting hospital privileges. Furthermore, if Dr. G was not sufficiently practiced or supervised in robotic surgery, the hospital, which allowed Dr. G to proceed, might also be negligent.

VM had a series of problems postsurgery that ultimately resulted in additional care and “simple fistula repair.” Assuming that there was negligence, the next question is whether that failure caused the injury. Causation may be the most difficult part of the case for VM to prove. It would require expert testimony that the inadequate surgery (inappropriate use of robotic surgery or other error during surgery) and follow up resulted in the formation or increase in the likelihood of the fistula.

VM would also have to prove damages. Damages are those costs (the economic value) of injuries that would not have occurred but for negligence. Damages would include most of the cost of the follow-up medical care and any related additional future care required, plus costs that were a consequence of the negligence (such as lost work). In addition, damages would include pain and suffering that resulted from the negligence, subject to caps in some states.

When the patient was dissatisfied and reported a postsurgical problem, the hospital and Dr. G may have had an opportunity to avoid further dissatisfaction, complaints, and ultimately a lawsuit. Effective approaches for dealing with such dissatisfaction may serve the institution’s and physician’s values and financial best interests.

The jury verdict was in favor of the plaintiff. Jurors felt the operating surgeon should have conveyed his experience with robotic surgery more clearly as part of the informed consent process.

“Hey Siri! Perform a type 3 hysterectomy. Please watch out for the ureter!”²⁹

Medicine is still at the frontier of surgical robots. Over future decades, the number and sophistication of these machines will increase substantially. They likely will become much more like robots, guided by AI, and make independent judgments. These have the potential for significant medical progress that improves the treatment of patients. At the same time, the last 20 years suggest that robotic innovation will challenge medicine, the FDA and other regulators, lawmakers, and courts. In the future, regulators and patients should embrace genuine advances in robotic surgery but not be dazzled by these new machines’ luster (or potential for considerable profits).³⁰

The public may be wildly optimistic about the benefits without balancing the risks. The AI that runs them will be essentially invisible and constantly changing. Physicians and regulators must develop new techniques for assessing and controlling the software. Real surgical robots require rigorous testing, cautious promotion, disciplined use, and perpetual review. ●

The approach to hysterectomy has been debated, with the need for individualization case by case stressed, and the expertise of the operating surgeon considered.

CASE Was surgeon experience a factor in case complications?

VM is a 46-year-old woman (G5 P4014) reporting persistent uterine bleeding that is refractory to medical therapy. The patient has uterine fibroids, 6 weeks in size on examination, with “mild” prolapse noted. Additional medical diagnoses included vulvitis, ovarian cyst in the past, cystic mastopathy, and prior evidence of pelvic adhesion, noted at the time of ovarian cystectomy. Prior surgical records were not obtained by the operating surgeon, although her obstetric history includes 2 prior vaginal deliveries and 2 cesarean deliveries (CDs). The patient had an umbilical herniorraphy a number of years ago. Her medications include hormonal therapy, for presumed menopause, and medication for depression (she reported “doing well” on medication). She reported smoking 1 PPD and had a prior tubal ligation.

VM was previously evaluated for Lynch Syndrome and informed of the potential for increased risks of colon, endometrial, and several other cancers. She did not have cancer as of the time of planned surgery.

The patient underwent robotic-assisted total laparoscopic hysterectomy and bilateral salpingo-oophorectomy. The operating surgeon did not have a lot of experience with robotic hysterectomies but told the patient preoperatively “I have done a few.” Perioperatively, blood loss was minimal, urine output was recorded as 25 mL, and according to the operative report there were extensive pelvic adhesions and no complications. The “ureters were identified” when the broad ligament was opened at the time of skeletonization of the uterine vessels and documented accordingly. The intraoperative Foley was discontinued at the end of the procedure. The pathology report noted diffuse adenomyosis and uterine fibroids; the uterus weighed 250 g. In addition, a “large hemorrhagic corpus luteum cyst” was noted on the right ovary.

The patient presented for a postoperative visit reporting “leaking” serosanguinous fluid that began 2.5 weeks postoperatively and required her to wear 3 to 4 “Depends” every day. She also reported constipation since beginning her prescribed pain medication. She requested a copy of her medical records and said she was dissatisfied with the care she had received related to the hysterectomy; she was “seeking a second opinion from a urologist.” The urologist suggested evaluation of the “leaking,” and a Foley catheter was placed. When she stood up, however, there was leaking around the catheter, and she reported a “yellowish-green,” foul smelling discharge. She called the urologist’s office, stating, “I think I have a bowel obstruction.” The patient was instructed to proceed to the emergency department at her local hospital. She was released with a diagnosis of constipation. Upon follow-up urologic evaluation, a vulvovaginal fistula was noted. Management was a “simple fistula repair,” and the patient did well subsequently.

The patient brought suit against the hospital and operating gynecologist. In part the hospital records noted, “relatively inexperienced robotic surgeon.” The hospital was taken to task for granting privileges to an individual that had prior privilege “problems.”

PHOTO: GETTY IMAGES LL28

Continue to: Medical opinion...

Medical opinion

This case demonstrates a number of issues. (We will discuss the credentials for the surgeon and hospital privileges in the legal considerations section.) From the medical perspective, the rate of urologic injury associated with all hysterectomies is 0.87%.¹ Robotic hysterectomy has been reported at 0.92% in a series published from Henry Ford Hospital.¹ The lowest rate of urologic injury is associated with vaginal hysterectomy, reported at 0.2%.² Reported rates of urologic injury by approach to hysterectomy are¹:

• robotic, 0.92%
• laparoscopic, 0.90%
• vaginal, 0.33%
• abdominal, 0.96%.

Complications by surgeon type also have been addressed, and the percent of total urologic complications are reported as¹:

• ObGyn, 47%
• gyn oncologist, 47%
• urogynecologist, 6%.

Intraoperative conversion to laparotomy from initial robotic approach has been addressed in a retrospective study over a 2-year period, with operative times ranging from 1 hr, 50 min to 9 hrs of surgical time.¹ The vast majority of intraoperative complications in a series reported from Finland were managed “within minutes,” and in the series of 83 patients, 5 (6%) required conversion to laparotomy.² Intraoperative complications reported include failed entry, vascular injury, nerve injury, visceral injury, solid organ injury, tumor fragmentation, and anesthetic-related complications.³ Of note, the vascular injuries included inferior vena cava, common iliac, and external iliac.

Mortality rates in association with benign laparoscopic and robotic procedures have been addressed and noted to be 1:6,456 cases based upon a meta-analysis.⁴ The analysis included 124,216 patients. Laparoscopic versus robotic mortality rates were not statistically different. Mortality was more common among cases of undiagnosed rare colorectal injury. This mortality is on par with complications from Roux-en-Y gastric bypass procedures. Procedures such as sacrocolpopexy are equated with higher mortality (1:1,246) in comparison with benign hysterectomy.⁵

Infectious complications following either laparoscopic or robotic hysterectomy were reported at less than 1% and not statistically different for either approach.⁶ The series authored by Marra et al evaluated 176,016 patients.

Overall, robotic-assisted gynecologic complications are rare. One series was focused on gynecological oncologic cases.⁷ Specific categories of complications included⁷:

• patient positioning and pneumoperitoneum
• injury to surrounding organs
• bowel injury
• port site metastasis
• surgical emphysema
• vaginal cuff dehiscence
• anesthesia-related problems.

The authors concluded, “robotic assisted surgery in gynecological oncology is safe and the incidence of complications is low.”⁷ The major cause of death related to robotic surgery is vascular injury–related. The authors emphasized the importance of knowledge of anatomy, basic principles of “traction and counter-traction” and proper dissection along tissue planes as key to minimizing complications. Consider placement of stents for ureter identification, as appropriate. Barbed-suturing does not prevent dehiscence.

Continue to: Legal considerations...

Robotic surgery presents many legal issues and promises to raise many more in the future. The law must control new technology while encouraging productive uses, and provide new remedies for harms while respecting traditional legal principles.⁸ There is no shortage of good ideas about controlling surgical robots,⁹ automated devices more generally,¹⁰ and artificial intelligence.¹¹ Those issues will be important, and watching them unfold will be intriguing.

In the meantime, physicians and other health care professionals, health care facilities, technology companies, and patients must work within current legal structures in implementing and using robotic surgery. These are extraordinarily complex issues, so it is possible only to review the current landscape and speculate what the near future may hold.

Regulating surgical robots

The US Food and Drug Administration (FDA) is the primary regulator of robots used in medicine.¹² It has the authority to regulate surgical devices, including surgical robots—which it refers to as “robotically-assisted surgical devices,” or RASD. In 2000, it approved Intuitive Surgical’s daVinci system for use in surgery. In 2017, the FDA expanded its clearance to include the Senhance System of TransEnterix Surgical Inc. for minimally invasive gynecologic surgery.¹³ In 2021, the FDA cleared the Hominis Surgical System for transvaginal hysterectomy “in certain patients.” However, the FDA emphasized that this clearance is for benign hysterectomy with salpingo-oophorectomy.¹⁴ (The FDA has cleared various robotic devices for several other areas of surgical practice, including neurosurgery, orthopedics, and urology.)

The use of robots in cancer surgery is limited. The FDA approved specific RASDs in some “surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy.”¹⁵ However, it cautioned that this clearance was based only on a 30-day patient follow up. More specifically, the FDA “has not evaluated the safety or effectiveness of RASD devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”¹⁵

The FDA has clearly warned physicians and patients that the agency has not granted the use of RASDs “for any cancer-related surgery marketing authorization, and therefore the survival benefits to patients compared to traditional surgery have not been established.”¹⁵ (This did not apply to the hysterectomy surgery as noted above. More specifically, that clearance did not apply to anything other than 30-day results, nor to the efficacy related to cancer survival.)

States also have some authority to regulate medical practice within their borders.⁹ When the FDA has approved a device as safe and effective, however, there are limits on what states can do to regulate or impose liability on the approved product. The Supreme Court held that the FDA approval “pre-empted” some state action regarding approved devices.¹⁶

Hospitals, of course, regulate what is allowed within the hospital. For example, it may require training before a physician is permitted to use equipment, limit the conditions for which the equipment may be used, or decline to obtain equipment for use in the hospitals.¹⁷ In the case of RASDs, however, the high cost of equipment may provide an incentive for hospitals to urge the wide use of the latest robotic acquisition.¹⁸

Regulation aims primarily to protect patients, usually from injury or inadequate treatment. Some robotic surgery is likely to be more expensive than the same surgery without robotic assistance. The cost to the patient is not usually part of the FDA’s consideration. Insurance companies (including Medicare and Medicaid), however, do care about costs and will set or negotiate how much the reimbursement will be for a procedure. Third-party payers may decline to cover the additional cost when there is no apparent benefit from using the robot.¹⁹ For some institutions, the public perception that it offers “the most modern technology” is an important public message and a strong incentive to have the equipment.²⁰

There are inconsistent studies about the advantages and disadvantages of RADS in gynecologic procedures, although there are few randomized studies.²¹ The demonstrated advantages are generally identified as somewhat shorter recovery time.²² The ultimate goal will be to minimize risks while maximizing the many potential benefits of robotic surgery.²³

Continue to: Liability...

Liability

A recent study by De Ravin and colleagues of robotic surgery liability found a 250% increase in the total number of robotic surgery–related malpractice claims reported in 7 recent years (2014-2021), compared with the prior 7 (2006-2013).²⁴ However, the number of cases varied considerably from year to year. ObGyn had the most significant gain (from 19% to 49% of all claims). During the same time, urology claims declined from 56% to 16%. (The limitations of the study’s data are discussed later in this article.)

De Ravin et al reported the legal bases for the claims, but the specific legal claim was unclear in many cases.²⁴ For example, the vast majority were classified as “negligent surgery.” Many cases made more than 1 legal claim for liability, so the total percentages were greater than 100%. Of the specific claims, many appear unrelated to robotic surgery (misdiagnosis, delayed treatment, or infection). However, there were a significant number of cases that raised issues that were related to robotic surgery. The following are those claims that probably relate to the “robotic” surgery, along with the percentage of cases making such a claim as reported²⁴:

• “Patient not a candidate for surgery performed” appeared in about 13% of the cases.²⁴ Such claims could include that the surgeon should have performed the surgery with traditional laparoscopy or open technique, but instead using a robot led to the injury. Physicians may feel pressure from patients or hospitals, because of the equipment’s cost, to use robotic surgery as it seems to be the modern approach (and therefore better). Neither reason is sufficient for using robotic assistance unless it will benefit the patient.
• “Failure to calibrate or operate robot” was in 11% of the claims.²⁴ Physicians must properly calibrate and otherwise ensure that surgical equipment is operating correctly. In addition, the hospitals supplying the equipment must ensure that the equipment is maintained correctly. Finally, the equipment manufacturer may be liable through “products liability” if the equipment is defective.²⁵ The expanding use of artificial intelligence in medical equipment (including surgical robots) is increasing the complexity of determining what “defective” means.¹¹
• “Training deficiencies or credentialing” liability is a common problem with new technology. Physicians using new technology should be thoroughly trained and, where appropriate, certified in the use of the new technology.²⁶ Early adopters of the technology should be especially cautious because good training may be challenging to obtain. In the study, the claims of inadequate training were particularly high during the early 7 years (35%), but dropped during the later time (4%).²⁴
• “Improper positioning” of the patient or device or patient was raised in 7% of the cases.²⁴
• “Manufacturing problems” were claimed in a small number of cases—13% in 2006-2013, but 2% in 2014-2021.²⁴ These cases raise the complex question of products liability for robotic surgery and artificial intelligence (AI). Products liability has been part of surgical practice for many years. There usually will be liability if there are “defects” in a product, whether or not resulting from negligence. What a “defect” in a computer program means is a complicated issue that will be significant in future liability cases.²⁷

Several other cases reported in the De Ravin study were probably related to robotic surgery. For example, Informed Consent and Failure to Monitor each appeared in more than 30%, of 2014-2021 cases, and Failure to Refer in 16% of the cases.^24,27

The outcomes of the reported cases were mostly verdicts (or trial-related settlements) for defendants (doctors and hospitals). The defense prevailed 69% of the time in the early period and 78% of the time in 2014-2021. However, there were substantial damages in some cases. The range of damages in 2006-2013 was $95,000 to $6 million (mean, $2.5 million); in 2014-2021, it was $10,000 to $5 million (mean, $1.3 million).²⁴

An earlier study looked at reported cases against Intuitive Surgical, maker of the daVinci system, from 2000-2017.²⁸ Of the 108 claims in the study, 62% were gynecologic surgeries. Of these claims, 35% were dismissed, but “no other information regarding settlements or trial outcomes was available.” The study did not report the basis for the lawsuits involving gynecologic surgeries.

We should exercise caution in reviewing these studies. Although the studies were of considerable value, the authors note significant limitations of the databases available. The database was Westlaw in the first study discussed (“Robotic surgery: the impact”²⁴) and Bloomberg in the second (“Robotic urologic”²⁸). For example, the “impact” study was based on “jury verdict reports” excluding settlements, and the latter excluded class actions and cases settled. Thus the studies undoubtedly understated the number of claims made (those that resulted in settlement before a lawsuit was filed), cases filed but abandoned, and settlements made before trial.

Despite these limitations, the studies provide valuable insights into current malpractice risks and future directions. It is worth remembering that these cases nearly all involved a single robot, the daVinci, produced by Intuitive Surgical. It is not a “smart” robot and is commonly referred to as a “master-slave” machine. With much more intelligent and independent machines, the future will raise more complex problems in the FDA approval process and malpractice and product liability claims when things go wrong.

Continue to: What’s the verdict?...

The case of VM and operating surgeon Dr. G illustrates several important legal aspects of using surgical robots. It also demonstrates that the presence of the robot assist still requires the surgeon’s careful attention to issues of informed consent, adequate specific training, and thorough follow up. In the following discussion, we divide the case review into the elements of negligence-malpractice (duty and breach, causation, and damages) and conclude with a thought about how to proceed when things have gone wrong.

Dr. G’s statement, “I’ve done a few,” is indefinite, but it may suggest that Dr. G. had not received full, supervised training in the robotic assist he was planning to use. That problem was underlined by the conclusion that Dr. G was a “relatively inexperienced robotic surgeon.” If so, that failure could constitute a breach of the duty of care to the patient. In addition, if it is inaccurate or did not provide information VM reasonably needed in consenting to Dr. G proceeding with the surgery, there could be an issue of whether there was a partial failure of fully informed consent.

The hospital also may have potential liability. It was “taken to task for granting privileges to an individual that had prior privilege ‘problems,’” suggesting that it had not performed adequate review before granting hospital privileges. Furthermore, if Dr. G was not sufficiently practiced or supervised in robotic surgery, the hospital, which allowed Dr. G to proceed, might also be negligent.

VM had a series of problems postsurgery that ultimately resulted in additional care and “simple fistula repair.” Assuming that there was negligence, the next question is whether that failure caused the injury. Causation may be the most difficult part of the case for VM to prove. It would require expert testimony that the inadequate surgery (inappropriate use of robotic surgery or other error during surgery) and follow up resulted in the formation or increase in the likelihood of the fistula.

VM would also have to prove damages. Damages are those costs (the economic value) of injuries that would not have occurred but for negligence. Damages would include most of the cost of the follow-up medical care and any related additional future care required, plus costs that were a consequence of the negligence (such as lost work). In addition, damages would include pain and suffering that resulted from the negligence, subject to caps in some states.

When the patient was dissatisfied and reported a postsurgical problem, the hospital and Dr. G may have had an opportunity to avoid further dissatisfaction, complaints, and ultimately a lawsuit. Effective approaches for dealing with such dissatisfaction may serve the institution’s and physician’s values and financial best interests.

The jury verdict was in favor of the plaintiff. Jurors felt the operating surgeon should have conveyed his experience with robotic surgery more clearly as part of the informed consent process.

“Hey Siri! Perform a type 3 hysterectomy. Please watch out for the ureter!”²⁹

Medicine is still at the frontier of surgical robots. Over future decades, the number and sophistication of these machines will increase substantially. They likely will become much more like robots, guided by AI, and make independent judgments. These have the potential for significant medical progress that improves the treatment of patients. At the same time, the last 20 years suggest that robotic innovation will challenge medicine, the FDA and other regulators, lawmakers, and courts. In the future, regulators and patients should embrace genuine advances in robotic surgery but not be dazzled by these new machines’ luster (or potential for considerable profits).³⁰

The public may be wildly optimistic about the benefits without balancing the risks. The AI that runs them will be essentially invisible and constantly changing. Physicians and regulators must develop new techniques for assessing and controlling the software. Real surgical robots require rigorous testing, cautious promotion, disciplined use, and perpetual review. ●

My desk looks nothing like my grandfather’s. It stands about mid-abdomen high and has a small surface, perhaps just enough for the monitor and a mug. Yes, I can move it up and down (thank you 21st century), but it has no drawers. It is lean and immaculate, but it has no soul.

My grandfather sat at a large oak desk with three drawers on each side. Each was so heavy you had to be at least 6 years old to pull one open for exploring the contents inside. The desk surface was vast and although immobile, it had a greenish leather blotter for writing. Alongside his pile of correspondences was a treasure for those of us tall enough to get it: A heavy brass letter opener. It came, I believe, with a secretary who would open his letters and stack them neatly before placing this sometimes-pirate’s-sword far enough away from the edge for us to not reach it.

Kind Regards, 

Pat

I sat down, my desk nearly at eye level now, and felt the paper in my hand. It was white, college ruled paper and a blue ink pen. She carefully looped her “y’s” and crossed her “t’s.” Not one cross out. She thought about each sentence before transcribing it. The paper once sat on her desk, touched her fingers and the envelope sealed with her saliva. It was not filled with trifling requests or complaints. It was not efficient, but it was more than just communication. She took the time to choose the words to capture her emotion and express her gratitude. It was respectful, dignified, decidedly nondigital. For a brief moment I thought I might write back, but quickly realized that was impractical. I knew I wouldn’t make the time to do so. I wish I had. 

Having no drawers to save it, I held it up with just a corner of the page resting on my desk and scribbled in black ink “Reviewed. Please scan to media file. 12/8/22. JAB”

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

My desk looks nothing like my grandfather’s. It stands about mid-abdomen high and has a small surface, perhaps just enough for the monitor and a mug. Yes, I can move it up and down (thank you 21st century), but it has no drawers. It is lean and immaculate, but it has no soul.

My grandfather sat at a large oak desk with three drawers on each side. Each was so heavy you had to be at least 6 years old to pull one open for exploring the contents inside. The desk surface was vast and although immobile, it had a greenish leather blotter for writing. Alongside his pile of correspondences was a treasure for those of us tall enough to get it: A heavy brass letter opener. It came, I believe, with a secretary who would open his letters and stack them neatly before placing this sometimes-pirate’s-sword far enough away from the edge for us to not reach it.

Kind Regards, 

Pat

I sat down, my desk nearly at eye level now, and felt the paper in my hand. It was white, college ruled paper and a blue ink pen. She carefully looped her “y’s” and crossed her “t’s.” Not one cross out. She thought about each sentence before transcribing it. The paper once sat on her desk, touched her fingers and the envelope sealed with her saliva. It was not filled with trifling requests or complaints. It was not efficient, but it was more than just communication. She took the time to choose the words to capture her emotion and express her gratitude. It was respectful, dignified, decidedly nondigital. For a brief moment I thought I might write back, but quickly realized that was impractical. I knew I wouldn’t make the time to do so. I wish I had. 

Having no drawers to save it, I held it up with just a corner of the page resting on my desk and scribbled in black ink “Reviewed. Please scan to media file. 12/8/22. JAB”

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

My desk looks nothing like my grandfather’s. It stands about mid-abdomen high and has a small surface, perhaps just enough for the monitor and a mug. Yes, I can move it up and down (thank you 21st century), but it has no drawers. It is lean and immaculate, but it has no soul.

My grandfather sat at a large oak desk with three drawers on each side. Each was so heavy you had to be at least 6 years old to pull one open for exploring the contents inside. The desk surface was vast and although immobile, it had a greenish leather blotter for writing. Alongside his pile of correspondences was a treasure for those of us tall enough to get it: A heavy brass letter opener. It came, I believe, with a secretary who would open his letters and stack them neatly before placing this sometimes-pirate’s-sword far enough away from the edge for us to not reach it.

Kind Regards, 

Pat

I sat down, my desk nearly at eye level now, and felt the paper in my hand. It was white, college ruled paper and a blue ink pen. She carefully looped her “y’s” and crossed her “t’s.” Not one cross out. She thought about each sentence before transcribing it. The paper once sat on her desk, touched her fingers and the envelope sealed with her saliva. It was not filled with trifling requests or complaints. It was not efficient, but it was more than just communication. She took the time to choose the words to capture her emotion and express her gratitude. It was respectful, dignified, decidedly nondigital. For a brief moment I thought I might write back, but quickly realized that was impractical. I knew I wouldn’t make the time to do so. I wish I had. 

Having no drawers to save it, I held it up with just a corner of the page resting on my desk and scribbled in black ink “Reviewed. Please scan to media file. 12/8/22. JAB”

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].