A Massachusetts hospital must pay $20 million to a man who lost his left leg after a blood clot was misdiagnosed as sciatica, according to a story posted on boston.com, the news site of The Boston Globe.

On March 7, 2015, Steven Luppold, at the time a construction worker, went to the emergency department at Lowell General Hospital, in Lowell, Mass. He had a long history of sciatica. The pain often radiated down his left leg. This time, though, his discomfort in his left foot felt different.

At the ED, Mr. Luppold was initially examined by two nurses, who wrote in the patient’s chart that his foot was turning purple and felt cool to the touch. He was next examined by a physician assistant, Charles Loucraft, who made a diagnosis of worsening sciatica and sent the patient home. Court records suggest Mr. Loucraft made this diagnosis without having read the patient’s chart.

Six days later, Mr. Luppold returned to the ED with severe pain – a 9 on a scale of 10, as he reported at the time. Again, he was seen by two nurses, one of whom had examined him the previous week. He was then examined by Carlos Flores, a nurse practitioner, who reiterated the PA’s initial diagnosis of sciatica. Once more, Mr. Luppold was sent home.

Four days later, on March 17, Mr. Luppold placed a call to his primary care physician (PCP), who worked at Lahey Hospital and Medical Center, in Burlington, Mass., about 18 miles south of Lowell.

The PCP administered an ultrasound and diagnosed the patient as having a deep-vein thrombosis and an arterial thrombosis in his left leg. Mr. Luppold was taken immediately to the Lahey Hospital ED. A vascular surgeon ordered a CT scan, which indicated that the tissue in the patient’s left leg was necrotic. The following day, with few options open to them, surgeons amputated the patient’s left leg above the knee.

At some point after the surgery, Mr. Luppold filed a medical malpractice suit that named the PA, NP, and their physician-group employer, Merrimack Valley Emergency Associates, in Lowell. Also named in the suit were the three ED nurses who had examined him.

“Honestly, the reason this happened was because the communication ... in the emergency department between the nurses and providers was nonexistent,” says Robert M. Higgins, a partner at Lubin & Meyer, in Boston, who represented the plaintiff. Had providers ordered “a simple ultrasound” during either of Mr. Luppold’s visits to the ED, Mr. Higgins added, his leg could have been saved.

The jury agreed. It awarded Mr. Luppold $10 million for pain and suffering and another $10 million in compensatory damages.

At press time, there was no word on whether the defendants planned to appeal.
 

Doctors at risk for providing trans care to minors

Arkansas doctors who “perform a gender transition procedure” for persons younger than 18 years could be in legal jeopardy for well beyond the date of treatment, reports a story in the Arkansas Advocate, among other news sites.

That prospect is the result of a bill signed into law in March by Arkansas Gov. Sarah Huckabee Sanders. Under the law, slated to take effect this summer, a doctor who provides gender-affirming care to a minor can be sued for a period of up to 15 years after that patient turns 18. (Under current state law, plaintiffs must file a med-mal claim within 2 years of an injury.)

A federal judge is considering whether to strike down a similar measure that was signed into law by Gov. Sanders’s predecessor, Asa Hutchinson, in 2021. That statute prohibits doctors from providing or from referring a minor to someone who would provide gender-affirming hormone or puberty blockers. (Minors in the state do not qualify for gender-related surgery.)

Opponents of such care are hopeful that the 2021 statute will survive judicial review. Even if it doesn’t, though, they believe the new med-mal law will have a similar effect: to dissuade Arkansas doctors from treating minors seeking gender-related treatment.

It’s possible that the new law could itself be subject to a court review. But at least one of the bill’s sponsors, Sen. Gary Stubblefield, a Republican member of the Arkansas senate, is cautiously optimistic: “I know what we did was what we thought was best for our children.”

Opponents argue, though, that the new law will end up harming children who identify as transgender.

“You might not understand what it means to be gay or trans or a member of the LGBTQ community,” explained House Minority Leader Tippi McCullough during debate over the bill in the GOP-led chamber. “I get that, but I’m standing here as the only member of that community in the entire General Assembly, a caucus of one, telling you ... [the bill] denies trans kids the most affirming care they may ever receive in their lives, and that’s cruel.”
 

Appeals court slashes jury award

A Pennsylvania doctor who faced paying a $2.7 million award has had it cut nearly in half by a three-judge Superior Court panel, as a story in the Claims Journal reports.

The underlying case stems from a suit brought by the estate of a man who died in 2018. At the time of his death, he had been diagnosed with advanced prostate cancer and liver cancer. The suit by the family estate was initially centered on the doctor’s alleged negligence in treating the man’s prostate cancer. At some point during the 2021 trial, though, the suit was amended to include a second claim – an allegation that the doctor had also been negligent in treating the patient’s liver cancer, which had been belatedly diagnosed. The doctor’s medical practice was also a named defendant in the suit.

On March 2, 2022, a jury sided with the plaintiffs, awarding them compensatory damages of $1.5 million for the prostate cancer claim and $1.2 million for the liver cancer claim.

The doctor and other defendants appealed, arguing two essential points: first, the liver cancer claim amounted to a new cause of action, one for which they had not been given adequate notice.

Second, and more significantly, plaintiff action relating to this second claim had only begun in earnest on July 6, 2021, when an expert report was first filed with the court. But this filing was nearly a full year beyond the state’s 2-year statute of limitations, which, given the patient’s death in 2018, was at the very limit, said defendants. For these reasons, they argued, the appeals court should forthwith order a new trial.

That court, however, ended up walking a middle road. Although the court found that the liver claim was “time-barred,” since it had exceeded the 2-year statute of limitations, the court denied the defendants’ motion for a new trial.

Instead, the court cut $1.2 million from the portion of the jury award that applied to the liver cancer claim but left intact the $1.5 million that related to the cause of action regarding prostate cancer.

It was a Solomonic decision that undoubtedly displeased both sides equally.

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

A Massachusetts hospital must pay $20 million to a man who lost his left leg after a blood clot was misdiagnosed as sciatica, according to a story posted on boston.com, the news site of The Boston Globe.

On March 7, 2015, Steven Luppold, at the time a construction worker, went to the emergency department at Lowell General Hospital, in Lowell, Mass. He had a long history of sciatica. The pain often radiated down his left leg. This time, though, his discomfort in his left foot felt different.

At the ED, Mr. Luppold was initially examined by two nurses, who wrote in the patient’s chart that his foot was turning purple and felt cool to the touch. He was next examined by a physician assistant, Charles Loucraft, who made a diagnosis of worsening sciatica and sent the patient home. Court records suggest Mr. Loucraft made this diagnosis without having read the patient’s chart.

Six days later, Mr. Luppold returned to the ED with severe pain – a 9 on a scale of 10, as he reported at the time. Again, he was seen by two nurses, one of whom had examined him the previous week. He was then examined by Carlos Flores, a nurse practitioner, who reiterated the PA’s initial diagnosis of sciatica. Once more, Mr. Luppold was sent home.

Four days later, on March 17, Mr. Luppold placed a call to his primary care physician (PCP), who worked at Lahey Hospital and Medical Center, in Burlington, Mass., about 18 miles south of Lowell.

The PCP administered an ultrasound and diagnosed the patient as having a deep-vein thrombosis and an arterial thrombosis in his left leg. Mr. Luppold was taken immediately to the Lahey Hospital ED. A vascular surgeon ordered a CT scan, which indicated that the tissue in the patient’s left leg was necrotic. The following day, with few options open to them, surgeons amputated the patient’s left leg above the knee.

At some point after the surgery, Mr. Luppold filed a medical malpractice suit that named the PA, NP, and their physician-group employer, Merrimack Valley Emergency Associates, in Lowell. Also named in the suit were the three ED nurses who had examined him.

“Honestly, the reason this happened was because the communication ... in the emergency department between the nurses and providers was nonexistent,” says Robert M. Higgins, a partner at Lubin & Meyer, in Boston, who represented the plaintiff. Had providers ordered “a simple ultrasound” during either of Mr. Luppold’s visits to the ED, Mr. Higgins added, his leg could have been saved.

The jury agreed. It awarded Mr. Luppold $10 million for pain and suffering and another $10 million in compensatory damages.

At press time, there was no word on whether the defendants planned to appeal.
 

Doctors at risk for providing trans care to minors

Arkansas doctors who “perform a gender transition procedure” for persons younger than 18 years could be in legal jeopardy for well beyond the date of treatment, reports a story in the Arkansas Advocate, among other news sites.

That prospect is the result of a bill signed into law in March by Arkansas Gov. Sarah Huckabee Sanders. Under the law, slated to take effect this summer, a doctor who provides gender-affirming care to a minor can be sued for a period of up to 15 years after that patient turns 18. (Under current state law, plaintiffs must file a med-mal claim within 2 years of an injury.)

A federal judge is considering whether to strike down a similar measure that was signed into law by Gov. Sanders’s predecessor, Asa Hutchinson, in 2021. That statute prohibits doctors from providing or from referring a minor to someone who would provide gender-affirming hormone or puberty blockers. (Minors in the state do not qualify for gender-related surgery.)

Opponents of such care are hopeful that the 2021 statute will survive judicial review. Even if it doesn’t, though, they believe the new med-mal law will have a similar effect: to dissuade Arkansas doctors from treating minors seeking gender-related treatment.

It’s possible that the new law could itself be subject to a court review. But at least one of the bill’s sponsors, Sen. Gary Stubblefield, a Republican member of the Arkansas senate, is cautiously optimistic: “I know what we did was what we thought was best for our children.”

Opponents argue, though, that the new law will end up harming children who identify as transgender.

“You might not understand what it means to be gay or trans or a member of the LGBTQ community,” explained House Minority Leader Tippi McCullough during debate over the bill in the GOP-led chamber. “I get that, but I’m standing here as the only member of that community in the entire General Assembly, a caucus of one, telling you ... [the bill] denies trans kids the most affirming care they may ever receive in their lives, and that’s cruel.”
 

Appeals court slashes jury award

A Pennsylvania doctor who faced paying a $2.7 million award has had it cut nearly in half by a three-judge Superior Court panel, as a story in the Claims Journal reports.

The underlying case stems from a suit brought by the estate of a man who died in 2018. At the time of his death, he had been diagnosed with advanced prostate cancer and liver cancer. The suit by the family estate was initially centered on the doctor’s alleged negligence in treating the man’s prostate cancer. At some point during the 2021 trial, though, the suit was amended to include a second claim – an allegation that the doctor had also been negligent in treating the patient’s liver cancer, which had been belatedly diagnosed. The doctor’s medical practice was also a named defendant in the suit.

On March 2, 2022, a jury sided with the plaintiffs, awarding them compensatory damages of $1.5 million for the prostate cancer claim and $1.2 million for the liver cancer claim.

The doctor and other defendants appealed, arguing two essential points: first, the liver cancer claim amounted to a new cause of action, one for which they had not been given adequate notice.

Second, and more significantly, plaintiff action relating to this second claim had only begun in earnest on July 6, 2021, when an expert report was first filed with the court. But this filing was nearly a full year beyond the state’s 2-year statute of limitations, which, given the patient’s death in 2018, was at the very limit, said defendants. For these reasons, they argued, the appeals court should forthwith order a new trial.

That court, however, ended up walking a middle road. Although the court found that the liver claim was “time-barred,” since it had exceeded the 2-year statute of limitations, the court denied the defendants’ motion for a new trial.

Instead, the court cut $1.2 million from the portion of the jury award that applied to the liver cancer claim but left intact the $1.5 million that related to the cause of action regarding prostate cancer.

It was a Solomonic decision that undoubtedly displeased both sides equally.

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

A Massachusetts hospital must pay $20 million to a man who lost his left leg after a blood clot was misdiagnosed as sciatica, according to a story posted on boston.com, the news site of The Boston Globe.

On March 7, 2015, Steven Luppold, at the time a construction worker, went to the emergency department at Lowell General Hospital, in Lowell, Mass. He had a long history of sciatica. The pain often radiated down his left leg. This time, though, his discomfort in his left foot felt different.

At the ED, Mr. Luppold was initially examined by two nurses, who wrote in the patient’s chart that his foot was turning purple and felt cool to the touch. He was next examined by a physician assistant, Charles Loucraft, who made a diagnosis of worsening sciatica and sent the patient home. Court records suggest Mr. Loucraft made this diagnosis without having read the patient’s chart.

Six days later, Mr. Luppold returned to the ED with severe pain – a 9 on a scale of 10, as he reported at the time. Again, he was seen by two nurses, one of whom had examined him the previous week. He was then examined by Carlos Flores, a nurse practitioner, who reiterated the PA’s initial diagnosis of sciatica. Once more, Mr. Luppold was sent home.

Four days later, on March 17, Mr. Luppold placed a call to his primary care physician (PCP), who worked at Lahey Hospital and Medical Center, in Burlington, Mass., about 18 miles south of Lowell.

The PCP administered an ultrasound and diagnosed the patient as having a deep-vein thrombosis and an arterial thrombosis in his left leg. Mr. Luppold was taken immediately to the Lahey Hospital ED. A vascular surgeon ordered a CT scan, which indicated that the tissue in the patient’s left leg was necrotic. The following day, with few options open to them, surgeons amputated the patient’s left leg above the knee.

At some point after the surgery, Mr. Luppold filed a medical malpractice suit that named the PA, NP, and their physician-group employer, Merrimack Valley Emergency Associates, in Lowell. Also named in the suit were the three ED nurses who had examined him.

“Honestly, the reason this happened was because the communication ... in the emergency department between the nurses and providers was nonexistent,” says Robert M. Higgins, a partner at Lubin & Meyer, in Boston, who represented the plaintiff. Had providers ordered “a simple ultrasound” during either of Mr. Luppold’s visits to the ED, Mr. Higgins added, his leg could have been saved.

The jury agreed. It awarded Mr. Luppold $10 million for pain and suffering and another $10 million in compensatory damages.

At press time, there was no word on whether the defendants planned to appeal.
 

Doctors at risk for providing trans care to minors

Arkansas doctors who “perform a gender transition procedure” for persons younger than 18 years could be in legal jeopardy for well beyond the date of treatment, reports a story in the Arkansas Advocate, among other news sites.

That prospect is the result of a bill signed into law in March by Arkansas Gov. Sarah Huckabee Sanders. Under the law, slated to take effect this summer, a doctor who provides gender-affirming care to a minor can be sued for a period of up to 15 years after that patient turns 18. (Under current state law, plaintiffs must file a med-mal claim within 2 years of an injury.)

A federal judge is considering whether to strike down a similar measure that was signed into law by Gov. Sanders’s predecessor, Asa Hutchinson, in 2021. That statute prohibits doctors from providing or from referring a minor to someone who would provide gender-affirming hormone or puberty blockers. (Minors in the state do not qualify for gender-related surgery.)

Opponents of such care are hopeful that the 2021 statute will survive judicial review. Even if it doesn’t, though, they believe the new med-mal law will have a similar effect: to dissuade Arkansas doctors from treating minors seeking gender-related treatment.

It’s possible that the new law could itself be subject to a court review. But at least one of the bill’s sponsors, Sen. Gary Stubblefield, a Republican member of the Arkansas senate, is cautiously optimistic: “I know what we did was what we thought was best for our children.”

Opponents argue, though, that the new law will end up harming children who identify as transgender.

“You might not understand what it means to be gay or trans or a member of the LGBTQ community,” explained House Minority Leader Tippi McCullough during debate over the bill in the GOP-led chamber. “I get that, but I’m standing here as the only member of that community in the entire General Assembly, a caucus of one, telling you ... [the bill] denies trans kids the most affirming care they may ever receive in their lives, and that’s cruel.”
 

Appeals court slashes jury award

A Pennsylvania doctor who faced paying a $2.7 million award has had it cut nearly in half by a three-judge Superior Court panel, as a story in the Claims Journal reports.

The underlying case stems from a suit brought by the estate of a man who died in 2018. At the time of his death, he had been diagnosed with advanced prostate cancer and liver cancer. The suit by the family estate was initially centered on the doctor’s alleged negligence in treating the man’s prostate cancer. At some point during the 2021 trial, though, the suit was amended to include a second claim – an allegation that the doctor had also been negligent in treating the patient’s liver cancer, which had been belatedly diagnosed. The doctor’s medical practice was also a named defendant in the suit.

On March 2, 2022, a jury sided with the plaintiffs, awarding them compensatory damages of $1.5 million for the prostate cancer claim and $1.2 million for the liver cancer claim.

The doctor and other defendants appealed, arguing two essential points: first, the liver cancer claim amounted to a new cause of action, one for which they had not been given adequate notice.

Second, and more significantly, plaintiff action relating to this second claim had only begun in earnest on July 6, 2021, when an expert report was first filed with the court. But this filing was nearly a full year beyond the state’s 2-year statute of limitations, which, given the patient’s death in 2018, was at the very limit, said defendants. For these reasons, they argued, the appeals court should forthwith order a new trial.

That court, however, ended up walking a middle road. Although the court found that the liver claim was “time-barred,” since it had exceeded the 2-year statute of limitations, the court denied the defendants’ motion for a new trial.

Instead, the court cut $1.2 million from the portion of the jury award that applied to the liver cancer claim but left intact the $1.5 million that related to the cause of action regarding prostate cancer.

It was a Solomonic decision that undoubtedly displeased both sides equally.

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

AIRWAYS DISORDERS NETWORK

Asthma & COPD Section

The 2023 GOLD committee proposed changes in nomenclature and therapy for various subgroups of patients with COPD. The 2023 GOLD committee changed the ABCD group classification to ABE (for exacerbations), which highlights the importance of the number and severity of exacerbations irrespective of daily symptoms.

The mainstay of initial treatment for symptomatic COPD should include combination LABA/LAMA bronchodilators in a single inhaler. For patients with features of concomitant asthma or eosinophils greater than or equal to 300 cells/microliter, an ICS/LABA/LAMA combination inhaler is recommended.

People with “young COPD” develop respiratory symptoms and meet spirometric criteria for COPD between the ages of 25 and 50 years old. Other terminology changes center around those with functional and/or structural changes suggesting COPD, but who do not meet the post-bronchodilator spirometric criteria to confirm the COPD diagnosis.

Those with “pre-COPD” have normal spirometry, including the FEV₁ and FEV₁/FVC ratio, but have functional and/or structural changes concerning for COPD. Functional changes include air trapping and/or hyperinflation on PFTs, low diffusion capacity, and/or decline in FEV₁ of >40 mL per year.

Structural changes include emphysematous changes and/or bronchial wall changes on CT scans. “PRISm” stands for preserved ratio with impaired spirometry, where the postbronchodilator FEV₁/FVC is greater than or equal to 0.70, but FEV₁ is < 80% predicted with similar functional and/or structural changes to those with “pre-COPD.” People with PRISm have increased all-cause mortality. Not all people with pre-COPD or PRISm progress clinically and spiro-metrically to COPD; however, they should be treated because they have symptoms as well as functional and/or structural abnormalities. Despite increasing data regarding pre-COPD and PRISm, many gaps remain regarding optimal management.

Maria Ashar, MD, MBBS
Section Fellow-in-Training

Max J. Martin, MD
Section Fellow-in-Training

Sandra G. Adams, MD, MS, FCCP
Section Member-at-Large

REFERENCE

Global strategy for prevention, diagnosis and management of COPD: 2023 report; https://goldcopd.org. Accessed March 13, 2023.

AIRWAYS DISORDERS NETWORK

Asthma & COPD Section

The 2023 GOLD committee proposed changes in nomenclature and therapy for various subgroups of patients with COPD. The 2023 GOLD committee changed the ABCD group classification to ABE (for exacerbations), which highlights the importance of the number and severity of exacerbations irrespective of daily symptoms.

The mainstay of initial treatment for symptomatic COPD should include combination LABA/LAMA bronchodilators in a single inhaler. For patients with features of concomitant asthma or eosinophils greater than or equal to 300 cells/microliter, an ICS/LABA/LAMA combination inhaler is recommended.

People with “young COPD” develop respiratory symptoms and meet spirometric criteria for COPD between the ages of 25 and 50 years old. Other terminology changes center around those with functional and/or structural changes suggesting COPD, but who do not meet the post-bronchodilator spirometric criteria to confirm the COPD diagnosis.

Those with “pre-COPD” have normal spirometry, including the FEV₁ and FEV₁/FVC ratio, but have functional and/or structural changes concerning for COPD. Functional changes include air trapping and/or hyperinflation on PFTs, low diffusion capacity, and/or decline in FEV₁ of >40 mL per year.

Structural changes include emphysematous changes and/or bronchial wall changes on CT scans. “PRISm” stands for preserved ratio with impaired spirometry, where the postbronchodilator FEV₁/FVC is greater than or equal to 0.70, but FEV₁ is < 80% predicted with similar functional and/or structural changes to those with “pre-COPD.” People with PRISm have increased all-cause mortality. Not all people with pre-COPD or PRISm progress clinically and spiro-metrically to COPD; however, they should be treated because they have symptoms as well as functional and/or structural abnormalities. Despite increasing data regarding pre-COPD and PRISm, many gaps remain regarding optimal management.

Maria Ashar, MD, MBBS
Section Fellow-in-Training

Max J. Martin, MD
Section Fellow-in-Training

Sandra G. Adams, MD, MS, FCCP
Section Member-at-Large

REFERENCE

Global strategy for prevention, diagnosis and management of COPD: 2023 report; https://goldcopd.org. Accessed March 13, 2023.

AIRWAYS DISORDERS NETWORK

Asthma & COPD Section

The 2023 GOLD committee proposed changes in nomenclature and therapy for various subgroups of patients with COPD. The 2023 GOLD committee changed the ABCD group classification to ABE (for exacerbations), which highlights the importance of the number and severity of exacerbations irrespective of daily symptoms.

The mainstay of initial treatment for symptomatic COPD should include combination LABA/LAMA bronchodilators in a single inhaler. For patients with features of concomitant asthma or eosinophils greater than or equal to 300 cells/microliter, an ICS/LABA/LAMA combination inhaler is recommended.

People with “young COPD” develop respiratory symptoms and meet spirometric criteria for COPD between the ages of 25 and 50 years old. Other terminology changes center around those with functional and/or structural changes suggesting COPD, but who do not meet the post-bronchodilator spirometric criteria to confirm the COPD diagnosis.

Those with “pre-COPD” have normal spirometry, including the FEV₁ and FEV₁/FVC ratio, but have functional and/or structural changes concerning for COPD. Functional changes include air trapping and/or hyperinflation on PFTs, low diffusion capacity, and/or decline in FEV₁ of >40 mL per year.

Structural changes include emphysematous changes and/or bronchial wall changes on CT scans. “PRISm” stands for preserved ratio with impaired spirometry, where the postbronchodilator FEV₁/FVC is greater than or equal to 0.70, but FEV₁ is < 80% predicted with similar functional and/or structural changes to those with “pre-COPD.” People with PRISm have increased all-cause mortality. Not all people with pre-COPD or PRISm progress clinically and spiro-metrically to COPD; however, they should be treated because they have symptoms as well as functional and/or structural abnormalities. Despite increasing data regarding pre-COPD and PRISm, many gaps remain regarding optimal management.

Maria Ashar, MD, MBBS
Section Fellow-in-Training

Max J. Martin, MD
Section Fellow-in-Training

Sandra G. Adams, MD, MS, FCCP
Section Member-at-Large

REFERENCE

Global strategy for prevention, diagnosis and management of COPD: 2023 report; https://goldcopd.org. Accessed March 13, 2023.

Studies indicate that physical activity improves glucose metabolism in patients with type 2 diabetes. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

In the consensus report “Management of Hyperglycemia in Type 2 Diabetes, 2022,” the American Diabetes Association and the European Association for the Study of Diabetes, therefore, recommend at least 150 minutes per week of moderate- to vigorous-intensity aerobic activity, supplemented with two to three resistance, flexibility, or balance training sessions per week.

But even when such recommendations are integrated into a therapeutic education program, adherence is often transient or partial.

In this context, Michael Joubert, MD, PhD, and his team at Caen (France) University Hospital wondered about neuromuscular electrical stimulation (NMES), a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. Could NMES improve glycemic control in patients with type 2 diabetes, and thus, be an alternative to traditional physical activity?

To answer this question, they conducted a crossover randomized controlled trial called ELECTRODIAB2. The results were presented at the 2023 Congress of the Francophone Diabetes Society.

A few small pilot studies found that NMES improved insulin sensitivity and glycemic control; therefore, it could indeed be an alternative. The metabolic effect of NMES, however, has not been widely studied.

A total of 40 patients were enrolled in ELECTRODIAB2. Of these participants, 35 were randomly assigned to one of three groups: 6 weeks without NMES (control, no intervention), electrostimulation on 3 days per week for 6 weeks (20-minute ambulatory biquadricipital electrostimulation sessions) (NMES3), and electrostimulation on 5 days per week for 6 weeks (20-minutes ambulatory biquadricipital electrostimulation sessions) (NMES5). The goal was to assess the glucose levels of sedentary patients with type 2 diabetes during these periods. At each session, NMES was applied at the maximum-tolerated intensity.

Data from 32 participants were analyzed. Mean age was 58 ± 10 years, and body mass index was 33.0 ± 4.3 kg/m². Duration of diabetes was 8.6 ± 5.9 years. Regarding diabetes treatments, 47%, 31%, 9%, and 13% of the patients were taking 0, 1, 2, and 3 oral hypoglycemic agents or glucagonlike peptide–1 agonists, respectively.

No significant differences in glucose levels were observed between the three groups. The primary outcome was mean glucose level based on a 6-day continuous glucose monitoring (CGM) recording. Those levels were 181.4 ± 42.5 mg/dL (control, no intervention), 180.6 ± 45.8 mg/dL (NMES3), and 181.1 ± 48.9 mg/dL (NMES5).

Furthermore, secondary outcomes (rates of hyperglycemia and hypoglycemia) did not differ between the three groups.

The researchers concluded that, “with regard to the CGM criteria, this crossover randomized controlled trial did not show that the 6-week biquadricipital NMES sessions had any benefit. This finding conflicts with the results of preliminary pilot studies but it does not encourage further research on NMES in this population of patients with early-stage diabetes.”

Therefore, at this point, it does not look like NMES can be recommended as an alternative to physical activity for sedentary patients with type 2 diabetes.

This article was translated from the Medscape French edition. A version appeared on Medscape.com.

Studies indicate that physical activity improves glucose metabolism in patients with type 2 diabetes. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

In the consensus report “Management of Hyperglycemia in Type 2 Diabetes, 2022,” the American Diabetes Association and the European Association for the Study of Diabetes, therefore, recommend at least 150 minutes per week of moderate- to vigorous-intensity aerobic activity, supplemented with two to three resistance, flexibility, or balance training sessions per week.

But even when such recommendations are integrated into a therapeutic education program, adherence is often transient or partial.

In this context, Michael Joubert, MD, PhD, and his team at Caen (France) University Hospital wondered about neuromuscular electrical stimulation (NMES), a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. Could NMES improve glycemic control in patients with type 2 diabetes, and thus, be an alternative to traditional physical activity?

To answer this question, they conducted a crossover randomized controlled trial called ELECTRODIAB2. The results were presented at the 2023 Congress of the Francophone Diabetes Society.

A few small pilot studies found that NMES improved insulin sensitivity and glycemic control; therefore, it could indeed be an alternative. The metabolic effect of NMES, however, has not been widely studied.

A total of 40 patients were enrolled in ELECTRODIAB2. Of these participants, 35 were randomly assigned to one of three groups: 6 weeks without NMES (control, no intervention), electrostimulation on 3 days per week for 6 weeks (20-minute ambulatory biquadricipital electrostimulation sessions) (NMES3), and electrostimulation on 5 days per week for 6 weeks (20-minutes ambulatory biquadricipital electrostimulation sessions) (NMES5). The goal was to assess the glucose levels of sedentary patients with type 2 diabetes during these periods. At each session, NMES was applied at the maximum-tolerated intensity.

Data from 32 participants were analyzed. Mean age was 58 ± 10 years, and body mass index was 33.0 ± 4.3 kg/m². Duration of diabetes was 8.6 ± 5.9 years. Regarding diabetes treatments, 47%, 31%, 9%, and 13% of the patients were taking 0, 1, 2, and 3 oral hypoglycemic agents or glucagonlike peptide–1 agonists, respectively.

No significant differences in glucose levels were observed between the three groups. The primary outcome was mean glucose level based on a 6-day continuous glucose monitoring (CGM) recording. Those levels were 181.4 ± 42.5 mg/dL (control, no intervention), 180.6 ± 45.8 mg/dL (NMES3), and 181.1 ± 48.9 mg/dL (NMES5).

Furthermore, secondary outcomes (rates of hyperglycemia and hypoglycemia) did not differ between the three groups.

The researchers concluded that, “with regard to the CGM criteria, this crossover randomized controlled trial did not show that the 6-week biquadricipital NMES sessions had any benefit. This finding conflicts with the results of preliminary pilot studies but it does not encourage further research on NMES in this population of patients with early-stage diabetes.”

Therefore, at this point, it does not look like NMES can be recommended as an alternative to physical activity for sedentary patients with type 2 diabetes.

This article was translated from the Medscape French edition. A version appeared on Medscape.com.

Studies indicate that physical activity improves glucose metabolism in patients with type 2 diabetes. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

In the consensus report “Management of Hyperglycemia in Type 2 Diabetes, 2022,” the American Diabetes Association and the European Association for the Study of Diabetes, therefore, recommend at least 150 minutes per week of moderate- to vigorous-intensity aerobic activity, supplemented with two to three resistance, flexibility, or balance training sessions per week.

But even when such recommendations are integrated into a therapeutic education program, adherence is often transient or partial.

In this context, Michael Joubert, MD, PhD, and his team at Caen (France) University Hospital wondered about neuromuscular electrical stimulation (NMES), a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. Could NMES improve glycemic control in patients with type 2 diabetes, and thus, be an alternative to traditional physical activity?

To answer this question, they conducted a crossover randomized controlled trial called ELECTRODIAB2. The results were presented at the 2023 Congress of the Francophone Diabetes Society.

A few small pilot studies found that NMES improved insulin sensitivity and glycemic control; therefore, it could indeed be an alternative. The metabolic effect of NMES, however, has not been widely studied.

A total of 40 patients were enrolled in ELECTRODIAB2. Of these participants, 35 were randomly assigned to one of three groups: 6 weeks without NMES (control, no intervention), electrostimulation on 3 days per week for 6 weeks (20-minute ambulatory biquadricipital electrostimulation sessions) (NMES3), and electrostimulation on 5 days per week for 6 weeks (20-minutes ambulatory biquadricipital electrostimulation sessions) (NMES5). The goal was to assess the glucose levels of sedentary patients with type 2 diabetes during these periods. At each session, NMES was applied at the maximum-tolerated intensity.

Data from 32 participants were analyzed. Mean age was 58 ± 10 years, and body mass index was 33.0 ± 4.3 kg/m². Duration of diabetes was 8.6 ± 5.9 years. Regarding diabetes treatments, 47%, 31%, 9%, and 13% of the patients were taking 0, 1, 2, and 3 oral hypoglycemic agents or glucagonlike peptide–1 agonists, respectively.

No significant differences in glucose levels were observed between the three groups. The primary outcome was mean glucose level based on a 6-day continuous glucose monitoring (CGM) recording. Those levels were 181.4 ± 42.5 mg/dL (control, no intervention), 180.6 ± 45.8 mg/dL (NMES3), and 181.1 ± 48.9 mg/dL (NMES5).

Furthermore, secondary outcomes (rates of hyperglycemia and hypoglycemia) did not differ between the three groups.

The researchers concluded that, “with regard to the CGM criteria, this crossover randomized controlled trial did not show that the 6-week biquadricipital NMES sessions had any benefit. This finding conflicts with the results of preliminary pilot studies but it does not encourage further research on NMES in this population of patients with early-stage diabetes.”

Therefore, at this point, it does not look like NMES can be recommended as an alternative to physical activity for sedentary patients with type 2 diabetes.

This article was translated from the Medscape French edition. A version appeared on Medscape.com.

STAT recently published an article on a new aspect of managed medical care.

They found that some Medicare Advantage plans are using artificial intelligence algorithms to make decisions on how long patients should (or shouldn’t) be in hospitals and receive treatments.

That’s ... kind of scary.

Certainly, computers aren’t bad things. In 2023 America you can’t practice medicine without them. They aren’t malicious. They can analyze a lot of data faster than we can (for the record, the average memory capacity of a human brain is 1 petabyte, so we’re still ahead of the average desktop in that regard).

Computers, though, are pretty uniform. I’m a Mac person, and I can go into any Apple store and buy one. Right off the shelf I know how to work it, how it will run a given program, and can predict how it will handle different commands and such. They’re pretty much the same.

People are not quite as easy. Anatomically and chemically we’re similar, but that’s not the same. There are immune, genetic, and multiple other factors that put a lot of variables into the equation. Part of our training is knowing that and taking it into account when making treatment plans.

Algorithms, and artificial intelligence, can only do so much of that. If they were right all the time sports betting wouldn’t exist. But it does, because sports depends on the participants, who are people (or horses), and they’re not exactly alike ... for that matter how they’ll perform varies from day to day for the same individual.

But medical care isn’t a sport (even though hospital call can seem like a marathon). The data we give computers to use is generally based on averages – a rehab stay of 16.6 days for an 85-year-old woman with a broken shoulder (per the above article). But they don’t realize that averages are actually a collection of data on a bell-shaped curve. An insurance company will be only too happy when one person completes their rehabilitation in 11.6 days, and then feel it’s unreasonable when another takes 21.6.

That said, many of the companies involved say the final decisions are made by humans and that the algorithms are just guidelines.

Maybe so, but the STAT article suggests they’re putting too much credence in what the computer says, and not the specific circumstances of the individual involved.

That ain’t good, at least not for the patients.

Medicine, for better or worse, is a business. In an ideal world it probably wouldn’t be, but we don’t live in one.

But it’s unlike any other business out there, and shouldn’t be run like one. A car repair shop knows what parts to order and generally how long repairs will take. Once they’re done the car should be ready to roll out of the shop.

People aren’t like that.

I understand the need to prevent abuse and overbilling for unnecessary days and services. Medicine, unfortunately, has plenty of opportunities for the dishonest to take advantage of.

It’s a thin line, but, at least today, turning treatment decisions over to algorithms and computers is a bad idea for the people we’re supposed to be caring for.

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

STAT recently published an article on a new aspect of managed medical care.

They found that some Medicare Advantage plans are using artificial intelligence algorithms to make decisions on how long patients should (or shouldn’t) be in hospitals and receive treatments.

That’s ... kind of scary.

Certainly, computers aren’t bad things. In 2023 America you can’t practice medicine without them. They aren’t malicious. They can analyze a lot of data faster than we can (for the record, the average memory capacity of a human brain is 1 petabyte, so we’re still ahead of the average desktop in that regard).

Computers, though, are pretty uniform. I’m a Mac person, and I can go into any Apple store and buy one. Right off the shelf I know how to work it, how it will run a given program, and can predict how it will handle different commands and such. They’re pretty much the same.

People are not quite as easy. Anatomically and chemically we’re similar, but that’s not the same. There are immune, genetic, and multiple other factors that put a lot of variables into the equation. Part of our training is knowing that and taking it into account when making treatment plans.

Algorithms, and artificial intelligence, can only do so much of that. If they were right all the time sports betting wouldn’t exist. But it does, because sports depends on the participants, who are people (or horses), and they’re not exactly alike ... for that matter how they’ll perform varies from day to day for the same individual.

But medical care isn’t a sport (even though hospital call can seem like a marathon). The data we give computers to use is generally based on averages – a rehab stay of 16.6 days for an 85-year-old woman with a broken shoulder (per the above article). But they don’t realize that averages are actually a collection of data on a bell-shaped curve. An insurance company will be only too happy when one person completes their rehabilitation in 11.6 days, and then feel it’s unreasonable when another takes 21.6.

That said, many of the companies involved say the final decisions are made by humans and that the algorithms are just guidelines.

Maybe so, but the STAT article suggests they’re putting too much credence in what the computer says, and not the specific circumstances of the individual involved.

That ain’t good, at least not for the patients.

Medicine, for better or worse, is a business. In an ideal world it probably wouldn’t be, but we don’t live in one.

But it’s unlike any other business out there, and shouldn’t be run like one. A car repair shop knows what parts to order and generally how long repairs will take. Once they’re done the car should be ready to roll out of the shop.

People aren’t like that.

I understand the need to prevent abuse and overbilling for unnecessary days and services. Medicine, unfortunately, has plenty of opportunities for the dishonest to take advantage of.

It’s a thin line, but, at least today, turning treatment decisions over to algorithms and computers is a bad idea for the people we’re supposed to be caring for.

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

STAT recently published an article on a new aspect of managed medical care.

They found that some Medicare Advantage plans are using artificial intelligence algorithms to make decisions on how long patients should (or shouldn’t) be in hospitals and receive treatments.

That’s ... kind of scary.

Certainly, computers aren’t bad things. In 2023 America you can’t practice medicine without them. They aren’t malicious. They can analyze a lot of data faster than we can (for the record, the average memory capacity of a human brain is 1 petabyte, so we’re still ahead of the average desktop in that regard).

Computers, though, are pretty uniform. I’m a Mac person, and I can go into any Apple store and buy one. Right off the shelf I know how to work it, how it will run a given program, and can predict how it will handle different commands and such. They’re pretty much the same.

People are not quite as easy. Anatomically and chemically we’re similar, but that’s not the same. There are immune, genetic, and multiple other factors that put a lot of variables into the equation. Part of our training is knowing that and taking it into account when making treatment plans.

Algorithms, and artificial intelligence, can only do so much of that. If they were right all the time sports betting wouldn’t exist. But it does, because sports depends on the participants, who are people (or horses), and they’re not exactly alike ... for that matter how they’ll perform varies from day to day for the same individual.

But medical care isn’t a sport (even though hospital call can seem like a marathon). The data we give computers to use is generally based on averages – a rehab stay of 16.6 days for an 85-year-old woman with a broken shoulder (per the above article). But they don’t realize that averages are actually a collection of data on a bell-shaped curve. An insurance company will be only too happy when one person completes their rehabilitation in 11.6 days, and then feel it’s unreasonable when another takes 21.6.

That said, many of the companies involved say the final decisions are made by humans and that the algorithms are just guidelines.

Maybe so, but the STAT article suggests they’re putting too much credence in what the computer says, and not the specific circumstances of the individual involved.

That ain’t good, at least not for the patients.

Medicine, for better or worse, is a business. In an ideal world it probably wouldn’t be, but we don’t live in one.

But it’s unlike any other business out there, and shouldn’t be run like one. A car repair shop knows what parts to order and generally how long repairs will take. Once they’re done the car should be ready to roll out of the shop.

People aren’t like that.

I understand the need to prevent abuse and overbilling for unnecessary days and services. Medicine, unfortunately, has plenty of opportunities for the dishonest to take advantage of.

It’s a thin line, but, at least today, turning treatment decisions over to algorithms and computers is a bad idea for the people we’re supposed to be caring for.

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

Cases of the sexually transmitted disease syphilis soared in 2021 to the highest total in more than 70 years, a new report says.

Earlier in 2023, the Centers for Disease Control and Prevention issued preliminary projections that syphilis rates had made a startling jump from 2020 to 2021. But now that health officials have finalized all of the 2021 data, the increase is worse than what was announced back in March.

In just a 1-year period, from 2020 to 2021, cases increased by 32%, to 176,713, according to newly finalized data from the CDC. That is the highest total number of syphilis cases the U.S. has seen since 1950.

The total number of STD cases in the U.S. in 2021 was 2.5 million, including 1.6 million cases of chlamydia, which was up 4% over the year prior. 

A CDC official labeled the situation an epidemic.

“The reasons for the ongoing increases are multifaceted – and so are the solutions,” said Leandro Mena, MD, MPH, director of the CDC’s STD prevention division, in a statement. “It will take many of us working together to effectively use new and existing tools to increase access to quality sexual health care services for more people and to encourage ongoing innovation and prioritization of STI prevention and treatment in this country.”

Syphilis causes sores and rashes and, left untreated over a long period of time, can cause severe problems in organs, the brain, and the nervous system. Untreated congenital syphilis can lead to stillbirth. The treatment for syphilis is antibiotics.

The CDC called a 32% increase from 2020 to 2021 of congenital syphilis cases “alarming,” reporting that it resulted in 220 stillbirths and infant deaths in 2021.

The rise in STDs during the pandemic has been attributed to decreased attention and resources devoted to sexual health. Opioid use is also considered a contributing factor.

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

Cases of the sexually transmitted disease syphilis soared in 2021 to the highest total in more than 70 years, a new report says.

Earlier in 2023, the Centers for Disease Control and Prevention issued preliminary projections that syphilis rates had made a startling jump from 2020 to 2021. But now that health officials have finalized all of the 2021 data, the increase is worse than what was announced back in March.

In just a 1-year period, from 2020 to 2021, cases increased by 32%, to 176,713, according to newly finalized data from the CDC. That is the highest total number of syphilis cases the U.S. has seen since 1950.

The total number of STD cases in the U.S. in 2021 was 2.5 million, including 1.6 million cases of chlamydia, which was up 4% over the year prior. 

A CDC official labeled the situation an epidemic.

“The reasons for the ongoing increases are multifaceted – and so are the solutions,” said Leandro Mena, MD, MPH, director of the CDC’s STD prevention division, in a statement. “It will take many of us working together to effectively use new and existing tools to increase access to quality sexual health care services for more people and to encourage ongoing innovation and prioritization of STI prevention and treatment in this country.”

Syphilis causes sores and rashes and, left untreated over a long period of time, can cause severe problems in organs, the brain, and the nervous system. Untreated congenital syphilis can lead to stillbirth. The treatment for syphilis is antibiotics.

The CDC called a 32% increase from 2020 to 2021 of congenital syphilis cases “alarming,” reporting that it resulted in 220 stillbirths and infant deaths in 2021.

The rise in STDs during the pandemic has been attributed to decreased attention and resources devoted to sexual health. Opioid use is also considered a contributing factor.

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

Cases of the sexually transmitted disease syphilis soared in 2021 to the highest total in more than 70 years, a new report says.

Earlier in 2023, the Centers for Disease Control and Prevention issued preliminary projections that syphilis rates had made a startling jump from 2020 to 2021. But now that health officials have finalized all of the 2021 data, the increase is worse than what was announced back in March.

In just a 1-year period, from 2020 to 2021, cases increased by 32%, to 176,713, according to newly finalized data from the CDC. That is the highest total number of syphilis cases the U.S. has seen since 1950.

The total number of STD cases in the U.S. in 2021 was 2.5 million, including 1.6 million cases of chlamydia, which was up 4% over the year prior. 

A CDC official labeled the situation an epidemic.

“The reasons for the ongoing increases are multifaceted – and so are the solutions,” said Leandro Mena, MD, MPH, director of the CDC’s STD prevention division, in a statement. “It will take many of us working together to effectively use new and existing tools to increase access to quality sexual health care services for more people and to encourage ongoing innovation and prioritization of STI prevention and treatment in this country.”

Syphilis causes sores and rashes and, left untreated over a long period of time, can cause severe problems in organs, the brain, and the nervous system. Untreated congenital syphilis can lead to stillbirth. The treatment for syphilis is antibiotics.

The CDC called a 32% increase from 2020 to 2021 of congenital syphilis cases “alarming,” reporting that it resulted in 220 stillbirths and infant deaths in 2021.

The rise in STDs during the pandemic has been attributed to decreased attention and resources devoted to sexual health. Opioid use is also considered a contributing factor.

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

PULMONARY VASCULAR & CARDIOVASCULAR NETWORK

Cardiovascular Medicine & Surgery Section

Over the recent decades, the cardiovascular intensive care unit (CICU) has seen a significant transformation. Not only has the acuity of cardiac conditions evolved, but the prevalence of noncardiac critical illness has multiplied (Yuriditsky E, et al. ATS Sch. 2022;3[4]):522).

The tradition of general cardiologists managing CICUs was believed to be an unsustainable model and, in 2012, the American Heart Association (AHA) published a scientific statement detailing pathways to train cardiologists in critical care medicine (CCM) (Morrow DA, et al. Circulation. 2012;126:1408).

However, fewer than 15% of modern CICUs are staffed by physicians dual-boarded in cardiology and CCM; most believe that CCM training is necessary to effectively practice in the CICU (van Diepen S, et al. Circ Cardiovasc Qual Outcomes. 2017;10:e003864).

How best do we develop future cardiac intensivists to manage complex decompensated cardiovascular disease with compounded medical critical illness?

Multiple training pathways leading to board eligibility and dual certification have been outlined (Geller BJ, et al. J Am Coll Cardiol. 2018;72:1171). A commonly elected path requires the completion of a 1-year CCM fellowship following a 3-year general cardiology fellowship.

As few programs exist, limited guidance is available surrounding CCM fellowship design for the cardiologist; however, proposed curricula have been published (Yuriditsky E, et al. ATS Sch. 2022;3[4]:522).

Developing such programs requires collaboration between cardiologists and intensivists to secure funding, develop infrastructure, obtain accreditation, and to recruit candidates.

Having completed dual training, I not only saw my skillset flourish, but the partnership between CCM and cardiology strengthen. As interest in this field grows, we eagerly await to see program adaptation and innovative curriculum design.

Eugene Yuriditsky, MD
Section Fellow-in-Training

PULMONARY VASCULAR & CARDIOVASCULAR NETWORK

Cardiovascular Medicine & Surgery Section

Over the recent decades, the cardiovascular intensive care unit (CICU) has seen a significant transformation. Not only has the acuity of cardiac conditions evolved, but the prevalence of noncardiac critical illness has multiplied (Yuriditsky E, et al. ATS Sch. 2022;3[4]):522).

The tradition of general cardiologists managing CICUs was believed to be an unsustainable model and, in 2012, the American Heart Association (AHA) published a scientific statement detailing pathways to train cardiologists in critical care medicine (CCM) (Morrow DA, et al. Circulation. 2012;126:1408).

However, fewer than 15% of modern CICUs are staffed by physicians dual-boarded in cardiology and CCM; most believe that CCM training is necessary to effectively practice in the CICU (van Diepen S, et al. Circ Cardiovasc Qual Outcomes. 2017;10:e003864).

How best do we develop future cardiac intensivists to manage complex decompensated cardiovascular disease with compounded medical critical illness?

Multiple training pathways leading to board eligibility and dual certification have been outlined (Geller BJ, et al. J Am Coll Cardiol. 2018;72:1171). A commonly elected path requires the completion of a 1-year CCM fellowship following a 3-year general cardiology fellowship.

As few programs exist, limited guidance is available surrounding CCM fellowship design for the cardiologist; however, proposed curricula have been published (Yuriditsky E, et al. ATS Sch. 2022;3[4]:522).

Developing such programs requires collaboration between cardiologists and intensivists to secure funding, develop infrastructure, obtain accreditation, and to recruit candidates.

Having completed dual training, I not only saw my skillset flourish, but the partnership between CCM and cardiology strengthen. As interest in this field grows, we eagerly await to see program adaptation and innovative curriculum design.

Eugene Yuriditsky, MD
Section Fellow-in-Training

PULMONARY VASCULAR & CARDIOVASCULAR NETWORK

Cardiovascular Medicine & Surgery Section

Over the recent decades, the cardiovascular intensive care unit (CICU) has seen a significant transformation. Not only has the acuity of cardiac conditions evolved, but the prevalence of noncardiac critical illness has multiplied (Yuriditsky E, et al. ATS Sch. 2022;3[4]):522).

The tradition of general cardiologists managing CICUs was believed to be an unsustainable model and, in 2012, the American Heart Association (AHA) published a scientific statement detailing pathways to train cardiologists in critical care medicine (CCM) (Morrow DA, et al. Circulation. 2012;126:1408).

However, fewer than 15% of modern CICUs are staffed by physicians dual-boarded in cardiology and CCM; most believe that CCM training is necessary to effectively practice in the CICU (van Diepen S, et al. Circ Cardiovasc Qual Outcomes. 2017;10:e003864).

How best do we develop future cardiac intensivists to manage complex decompensated cardiovascular disease with compounded medical critical illness?

Multiple training pathways leading to board eligibility and dual certification have been outlined (Geller BJ, et al. J Am Coll Cardiol. 2018;72:1171). A commonly elected path requires the completion of a 1-year CCM fellowship following a 3-year general cardiology fellowship.

As few programs exist, limited guidance is available surrounding CCM fellowship design for the cardiologist; however, proposed curricula have been published (Yuriditsky E, et al. ATS Sch. 2022;3[4]:522).

Developing such programs requires collaboration between cardiologists and intensivists to secure funding, develop infrastructure, obtain accreditation, and to recruit candidates.

Having completed dual training, I not only saw my skillset flourish, but the partnership between CCM and cardiology strengthen. As interest in this field grows, we eagerly await to see program adaptation and innovative curriculum design.

Eugene Yuriditsky, MD
Section Fellow-in-Training

Nasal damage from cocaine use can be misdiagnosed as a rare, nonthreatening nasal disease, according to researchers from the United Kingdom.

Granulomatosis with polyangiitis (GPA), a disorder which causes inflammation in the nose, sinuses, throat, lungs, and kidneys, can have similar symptoms to cocaine-induced vasculitis, the researchers wrote. Drug testing can help identify patients who have cocaine-induced disease, they argued.

“Patients with destructive nasal lesions, especially young patients, should have urine toxicology performed for cocaine before diagnosing GPA and considering immunosuppressive therapy,” the authors wrote.

The paper was published in Rheumatology Advances in Practice.

Cocaine is the second-most popular drug in the United Kingdom, with 2.0% of people aged 16-59 years reporting using the drug in the past year. In the United States, about 1.7% of people aged 12 years and older (about 4.8 million people) used cocaine in the last 12 months, according to the 2021 National Survey on Drug Use and Health. The drug can cause midline destructive lesions, skin rash, and other vascular problems, and it can also trigger the production of antineutrophil cytoplasmic antibodies (ANCA) that lead to a clinical presentation that mimics GPA, which can make diagnosis more difficult. Treating cocaine-induced disease with immunosuppressant medication can be ineffective if the patient does not stop using the drug, and can have dangerous side effects, previous case studies suggest.

To better understand cocaine-induced disease, researchers conducted a review of patients who visited vasculitis clinics at Queen Elizabeth Hospital in Birmingham, England, and at the Royal Free Hospital in London between 2016 and 2021. They identified 42 patients with GPA-like symptoms who disclosed cocaine use or tested positive for the drug in urine toxicology test. The study included 23 men, 18 women, and 1 individual who did not identify with either gender. The median age was 41 years, and most patients were white.

Of those who underwent drug testing, more than 85% were positive. Nine patients who denied ever using cocaine were positive for the drug and 11 patients who said they were ex-users also tested positive via urine analysis. During clinical examinations, 30 patients had evidence of septal perforation, of which 6 had oronasal fistulas. Most patients’ symptoms were limited to the upper respiratory tract, though 12 did have other systemic symptoms, including skin lesions, joint pain, breathlessness, fatigue, and diplopia. Of the patients who received blood tests for ANCA, 87.5% tested positive for the antibodies.

The researchers noted that patients who continued cocaine use did not see improvement of symptoms, even if they were treated with immunosuppressant drugs.

“The experience in our two different centers suggests that discontinuation of cocaine is required to manage patients and that symptoms will persist despite immunosuppression if there is ongoing cocaine use,” the authors wrote.

“It can feel like chasing your tail at times if you’re trying to treat the inflammation but the real culprit – what’s driving the inflammation – is persistent,” Lindsay S. Lally, MD, a rheumatologist at the Hospital for Special Surgery in New York, said in an interview. She was not involved with the work.

Dr. Lally said the paper had a decent-sized cohort, and “helps us recognize that cocaine use is probably an under-recognized mimic of GPA, even though it’s something we all learn about and talk about.” She added that routine toxicology screening for patients deserves some consideration, though asking patients to complete a drug test could also undermine trust in the doctor-patient relationship. Patients who deny cocaine use may leave the office without providing a urine sample.

If Dr. Lally does suspect cocaine may be the cause of a patient’s systems, having a candid conversation with the patient may have a better chance at getting a patient to open up about their potential drug use. In practice, this means explaining “why it’s so important for me as their partner in this treatment to understand what factors are at play, and how dangerous it could potentially be if I was giving strong immunosuppressive medications [for a condition] that is being induced by a drug,” she said. “I do think that partnership and talking to the patients, at least in many patients, is more helpful than sort of the ‘gotcha’ moment” that can happen with drug testing.

The study authors disclosed no relevant financial relationships. Dr. Lally reported receiving consulting fees from Amgen.

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

Nasal damage from cocaine use can be misdiagnosed as a rare, nonthreatening nasal disease, according to researchers from the United Kingdom.

Granulomatosis with polyangiitis (GPA), a disorder which causes inflammation in the nose, sinuses, throat, lungs, and kidneys, can have similar symptoms to cocaine-induced vasculitis, the researchers wrote. Drug testing can help identify patients who have cocaine-induced disease, they argued.

“Patients with destructive nasal lesions, especially young patients, should have urine toxicology performed for cocaine before diagnosing GPA and considering immunosuppressive therapy,” the authors wrote.

The paper was published in Rheumatology Advances in Practice.

Cocaine is the second-most popular drug in the United Kingdom, with 2.0% of people aged 16-59 years reporting using the drug in the past year. In the United States, about 1.7% of people aged 12 years and older (about 4.8 million people) used cocaine in the last 12 months, according to the 2021 National Survey on Drug Use and Health. The drug can cause midline destructive lesions, skin rash, and other vascular problems, and it can also trigger the production of antineutrophil cytoplasmic antibodies (ANCA) that lead to a clinical presentation that mimics GPA, which can make diagnosis more difficult. Treating cocaine-induced disease with immunosuppressant medication can be ineffective if the patient does not stop using the drug, and can have dangerous side effects, previous case studies suggest.

To better understand cocaine-induced disease, researchers conducted a review of patients who visited vasculitis clinics at Queen Elizabeth Hospital in Birmingham, England, and at the Royal Free Hospital in London between 2016 and 2021. They identified 42 patients with GPA-like symptoms who disclosed cocaine use or tested positive for the drug in urine toxicology test. The study included 23 men, 18 women, and 1 individual who did not identify with either gender. The median age was 41 years, and most patients were white.

Of those who underwent drug testing, more than 85% were positive. Nine patients who denied ever using cocaine were positive for the drug and 11 patients who said they were ex-users also tested positive via urine analysis. During clinical examinations, 30 patients had evidence of septal perforation, of which 6 had oronasal fistulas. Most patients’ symptoms were limited to the upper respiratory tract, though 12 did have other systemic symptoms, including skin lesions, joint pain, breathlessness, fatigue, and diplopia. Of the patients who received blood tests for ANCA, 87.5% tested positive for the antibodies.

The researchers noted that patients who continued cocaine use did not see improvement of symptoms, even if they were treated with immunosuppressant drugs.

“The experience in our two different centers suggests that discontinuation of cocaine is required to manage patients and that symptoms will persist despite immunosuppression if there is ongoing cocaine use,” the authors wrote.

“It can feel like chasing your tail at times if you’re trying to treat the inflammation but the real culprit – what’s driving the inflammation – is persistent,” Lindsay S. Lally, MD, a rheumatologist at the Hospital for Special Surgery in New York, said in an interview. She was not involved with the work.

Dr. Lally said the paper had a decent-sized cohort, and “helps us recognize that cocaine use is probably an under-recognized mimic of GPA, even though it’s something we all learn about and talk about.” She added that routine toxicology screening for patients deserves some consideration, though asking patients to complete a drug test could also undermine trust in the doctor-patient relationship. Patients who deny cocaine use may leave the office without providing a urine sample.

If Dr. Lally does suspect cocaine may be the cause of a patient’s systems, having a candid conversation with the patient may have a better chance at getting a patient to open up about their potential drug use. In practice, this means explaining “why it’s so important for me as their partner in this treatment to understand what factors are at play, and how dangerous it could potentially be if I was giving strong immunosuppressive medications [for a condition] that is being induced by a drug,” she said. “I do think that partnership and talking to the patients, at least in many patients, is more helpful than sort of the ‘gotcha’ moment” that can happen with drug testing.

The study authors disclosed no relevant financial relationships. Dr. Lally reported receiving consulting fees from Amgen.

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

Nasal damage from cocaine use can be misdiagnosed as a rare, nonthreatening nasal disease, according to researchers from the United Kingdom.

Granulomatosis with polyangiitis (GPA), a disorder which causes inflammation in the nose, sinuses, throat, lungs, and kidneys, can have similar symptoms to cocaine-induced vasculitis, the researchers wrote. Drug testing can help identify patients who have cocaine-induced disease, they argued.

“Patients with destructive nasal lesions, especially young patients, should have urine toxicology performed for cocaine before diagnosing GPA and considering immunosuppressive therapy,” the authors wrote.

The paper was published in Rheumatology Advances in Practice.

Cocaine is the second-most popular drug in the United Kingdom, with 2.0% of people aged 16-59 years reporting using the drug in the past year. In the United States, about 1.7% of people aged 12 years and older (about 4.8 million people) used cocaine in the last 12 months, according to the 2021 National Survey on Drug Use and Health. The drug can cause midline destructive lesions, skin rash, and other vascular problems, and it can also trigger the production of antineutrophil cytoplasmic antibodies (ANCA) that lead to a clinical presentation that mimics GPA, which can make diagnosis more difficult. Treating cocaine-induced disease with immunosuppressant medication can be ineffective if the patient does not stop using the drug, and can have dangerous side effects, previous case studies suggest.

To better understand cocaine-induced disease, researchers conducted a review of patients who visited vasculitis clinics at Queen Elizabeth Hospital in Birmingham, England, and at the Royal Free Hospital in London between 2016 and 2021. They identified 42 patients with GPA-like symptoms who disclosed cocaine use or tested positive for the drug in urine toxicology test. The study included 23 men, 18 women, and 1 individual who did not identify with either gender. The median age was 41 years, and most patients were white.

Of those who underwent drug testing, more than 85% were positive. Nine patients who denied ever using cocaine were positive for the drug and 11 patients who said they were ex-users also tested positive via urine analysis. During clinical examinations, 30 patients had evidence of septal perforation, of which 6 had oronasal fistulas. Most patients’ symptoms were limited to the upper respiratory tract, though 12 did have other systemic symptoms, including skin lesions, joint pain, breathlessness, fatigue, and diplopia. Of the patients who received blood tests for ANCA, 87.5% tested positive for the antibodies.

The researchers noted that patients who continued cocaine use did not see improvement of symptoms, even if they were treated with immunosuppressant drugs.

“The experience in our two different centers suggests that discontinuation of cocaine is required to manage patients and that symptoms will persist despite immunosuppression if there is ongoing cocaine use,” the authors wrote.

“It can feel like chasing your tail at times if you’re trying to treat the inflammation but the real culprit – what’s driving the inflammation – is persistent,” Lindsay S. Lally, MD, a rheumatologist at the Hospital for Special Surgery in New York, said in an interview. She was not involved with the work.

Dr. Lally said the paper had a decent-sized cohort, and “helps us recognize that cocaine use is probably an under-recognized mimic of GPA, even though it’s something we all learn about and talk about.” She added that routine toxicology screening for patients deserves some consideration, though asking patients to complete a drug test could also undermine trust in the doctor-patient relationship. Patients who deny cocaine use may leave the office without providing a urine sample.

If Dr. Lally does suspect cocaine may be the cause of a patient’s systems, having a candid conversation with the patient may have a better chance at getting a patient to open up about their potential drug use. In practice, this means explaining “why it’s so important for me as their partner in this treatment to understand what factors are at play, and how dangerous it could potentially be if I was giving strong immunosuppressive medications [for a condition] that is being induced by a drug,” she said. “I do think that partnership and talking to the patients, at least in many patients, is more helpful than sort of the ‘gotcha’ moment” that can happen with drug testing.

The study authors disclosed no relevant financial relationships. Dr. Lally reported receiving consulting fees from Amgen.

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

Photo: Shutterstock

Tita ATN, Carlo WA, McClure EM, et al; for the A-PLUS Trial Group. Azithromycin to prevent sepsis or death in women planning a vaginal birth. N Engl J Med. 2023;388:1161-1170. doi:10:1056/NEJMoa2212111.

EXPERT COMMENTARY

Maternal peripartum infection is 1 of the top 5 causes of maternal death, accounting for about 10% of cases of maternal mortality. Cesarean delivery (CD), of course, is the most important risk factor for puerperal infection. However, even vaginal delivery, particularly in low- to middle-resource countries, where deliveries often occur under less-than-optimal conditions, may be associated with a surprisingly high frequency of both maternal and neonatal infections. The beneficial effect of prophylactic antibiotics for CD is well established. An important remaining question is whether similar benefit can be achieved with prophylaxis for women planning to have a vaginal birth.

In 2017, Oluwalana and colleagues conducted a prospective, randomized, double-blind, placebo-controlled trial of a single 2-g oral dose of azithromycin in Gambian women undergoing labor.¹ During the 8 weeks after delivery, maternal infections were lower in the azithromycin group, 3.6% versus 9.2% (relative risk [RR], 0.40; 95% confidence interval [CI], 0.22–0.71; P=.002). Infections also were lower in the newborns, 18.1% versus 23.8% (RR, 0.76; 95% CI, 0.58–0.99; P=.052), delivered to mothers who received azithromycin. The greatest impact on neonatal infections was the reduced frequency of skin infections.

In 2021, Subramaniam and colleagues evaluated the effect of a single dose of oral azithromycin with, or without, amoxicillin on the prevalence of peripartum infection in laboring women in Cameroon.² Patients and their newborns were followed for 6 weeks after delivery. Unlike the previous investigation, the authors were unable to show a protective effect of prophylaxis on either maternal or neonatal infection.

Against this backdrop, Tita and colleagues conducted a remarkably large, well-designed, randomized, placebo-controlled study of azithromycin prophylaxis in women at 8 different sites in 7 low- or middle-income countries (the A-PLUS investigation).³

Details of the study

The investigators randomly assigned 29,278 patients at or beyond 28 weeks’ gestation to receive either a 2-g oral dose of azithromycin or placebo during labor. This particular drug was chosen because it is readily available, inexpensive, well tolerated, and has a broad range of activity against many important pelvic pathogens, including genital mycoplasmas. Some patients also received other antibiotics, for example, for group B streptococcal (GBS) prophylaxis or for CD prophylaxis if abdominal delivery was indicated.

The 2 primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis within 4 weeks of delivery. Secondary outcomes included individual components of the primary outcomes.

Results. The results of the investigation were compelling, and the data safety monitoring committee recommended stopping the trial early because of clear maternal benefit. The groups were well balanced with respect to important characteristics, such as incidence of CD, receipt of other prophylactic antibiotics, and median time between randomization and delivery.

The incidence of maternal sepsis or death was lower in the azithromycin group (1.6% vs 2.4%; RR, 0.67; 95% CI, 0.56–0.79; P<.001). The key effect was on the frequency of maternal sepsis because the incidence of maternal death was very low in both groups, 0.1%. With respect to secondary outcomes, prophylaxis was effective in reducing the frequency of endometritis (RR, 0.66; 95% CI, 0.55–0.79) and perineal and incisional infection (RR, 0.71; 95% CI, 0.56–0.85).

There was no difference in the frequency of neonatal sepsis or death. There also was no difference in the frequency of adverse drug effects in either group. Of note, more cases of neonatal pyloric stenosis were observed in the azithromycin group, but the overall incidence was lower than the expected background rate. This possible “signal” is important because this effect has been noted with increased frequency in neonates who received this antibiotic. ●

Photo: Shutterstock

Tita ATN, Carlo WA, McClure EM, et al; for the A-PLUS Trial Group. Azithromycin to prevent sepsis or death in women planning a vaginal birth. N Engl J Med. 2023;388:1161-1170. doi:10:1056/NEJMoa2212111.

EXPERT COMMENTARY

Maternal peripartum infection is 1 of the top 5 causes of maternal death, accounting for about 10% of cases of maternal mortality. Cesarean delivery (CD), of course, is the most important risk factor for puerperal infection. However, even vaginal delivery, particularly in low- to middle-resource countries, where deliveries often occur under less-than-optimal conditions, may be associated with a surprisingly high frequency of both maternal and neonatal infections. The beneficial effect of prophylactic antibiotics for CD is well established. An important remaining question is whether similar benefit can be achieved with prophylaxis for women planning to have a vaginal birth.

In 2017, Oluwalana and colleagues conducted a prospective, randomized, double-blind, placebo-controlled trial of a single 2-g oral dose of azithromycin in Gambian women undergoing labor.¹ During the 8 weeks after delivery, maternal infections were lower in the azithromycin group, 3.6% versus 9.2% (relative risk [RR], 0.40; 95% confidence interval [CI], 0.22–0.71; P=.002). Infections also were lower in the newborns, 18.1% versus 23.8% (RR, 0.76; 95% CI, 0.58–0.99; P=.052), delivered to mothers who received azithromycin. The greatest impact on neonatal infections was the reduced frequency of skin infections.

In 2021, Subramaniam and colleagues evaluated the effect of a single dose of oral azithromycin with, or without, amoxicillin on the prevalence of peripartum infection in laboring women in Cameroon.² Patients and their newborns were followed for 6 weeks after delivery. Unlike the previous investigation, the authors were unable to show a protective effect of prophylaxis on either maternal or neonatal infection.

Against this backdrop, Tita and colleagues conducted a remarkably large, well-designed, randomized, placebo-controlled study of azithromycin prophylaxis in women at 8 different sites in 7 low- or middle-income countries (the A-PLUS investigation).³

Details of the study

The investigators randomly assigned 29,278 patients at or beyond 28 weeks’ gestation to receive either a 2-g oral dose of azithromycin or placebo during labor. This particular drug was chosen because it is readily available, inexpensive, well tolerated, and has a broad range of activity against many important pelvic pathogens, including genital mycoplasmas. Some patients also received other antibiotics, for example, for group B streptococcal (GBS) prophylaxis or for CD prophylaxis if abdominal delivery was indicated.

The 2 primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis within 4 weeks of delivery. Secondary outcomes included individual components of the primary outcomes.

Results. The results of the investigation were compelling, and the data safety monitoring committee recommended stopping the trial early because of clear maternal benefit. The groups were well balanced with respect to important characteristics, such as incidence of CD, receipt of other prophylactic antibiotics, and median time between randomization and delivery.

The incidence of maternal sepsis or death was lower in the azithromycin group (1.6% vs 2.4%; RR, 0.67; 95% CI, 0.56–0.79; P<.001). The key effect was on the frequency of maternal sepsis because the incidence of maternal death was very low in both groups, 0.1%. With respect to secondary outcomes, prophylaxis was effective in reducing the frequency of endometritis (RR, 0.66; 95% CI, 0.55–0.79) and perineal and incisional infection (RR, 0.71; 95% CI, 0.56–0.85).

There was no difference in the frequency of neonatal sepsis or death. There also was no difference in the frequency of adverse drug effects in either group. Of note, more cases of neonatal pyloric stenosis were observed in the azithromycin group, but the overall incidence was lower than the expected background rate. This possible “signal” is important because this effect has been noted with increased frequency in neonates who received this antibiotic. ●

Photo: Shutterstock

Tita ATN, Carlo WA, McClure EM, et al; for the A-PLUS Trial Group. Azithromycin to prevent sepsis or death in women planning a vaginal birth. N Engl J Med. 2023;388:1161-1170. doi:10:1056/NEJMoa2212111.

EXPERT COMMENTARY

Maternal peripartum infection is 1 of the top 5 causes of maternal death, accounting for about 10% of cases of maternal mortality. Cesarean delivery (CD), of course, is the most important risk factor for puerperal infection. However, even vaginal delivery, particularly in low- to middle-resource countries, where deliveries often occur under less-than-optimal conditions, may be associated with a surprisingly high frequency of both maternal and neonatal infections. The beneficial effect of prophylactic antibiotics for CD is well established. An important remaining question is whether similar benefit can be achieved with prophylaxis for women planning to have a vaginal birth.

In 2017, Oluwalana and colleagues conducted a prospective, randomized, double-blind, placebo-controlled trial of a single 2-g oral dose of azithromycin in Gambian women undergoing labor.¹ During the 8 weeks after delivery, maternal infections were lower in the azithromycin group, 3.6% versus 9.2% (relative risk [RR], 0.40; 95% confidence interval [CI], 0.22–0.71; P=.002). Infections also were lower in the newborns, 18.1% versus 23.8% (RR, 0.76; 95% CI, 0.58–0.99; P=.052), delivered to mothers who received azithromycin. The greatest impact on neonatal infections was the reduced frequency of skin infections.

In 2021, Subramaniam and colleagues evaluated the effect of a single dose of oral azithromycin with, or without, amoxicillin on the prevalence of peripartum infection in laboring women in Cameroon.² Patients and their newborns were followed for 6 weeks after delivery. Unlike the previous investigation, the authors were unable to show a protective effect of prophylaxis on either maternal or neonatal infection.

Against this backdrop, Tita and colleagues conducted a remarkably large, well-designed, randomized, placebo-controlled study of azithromycin prophylaxis in women at 8 different sites in 7 low- or middle-income countries (the A-PLUS investigation).³

Details of the study

The investigators randomly assigned 29,278 patients at or beyond 28 weeks’ gestation to receive either a 2-g oral dose of azithromycin or placebo during labor. This particular drug was chosen because it is readily available, inexpensive, well tolerated, and has a broad range of activity against many important pelvic pathogens, including genital mycoplasmas. Some patients also received other antibiotics, for example, for group B streptococcal (GBS) prophylaxis or for CD prophylaxis if abdominal delivery was indicated.

The 2 primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis within 4 weeks of delivery. Secondary outcomes included individual components of the primary outcomes.

Results. The results of the investigation were compelling, and the data safety monitoring committee recommended stopping the trial early because of clear maternal benefit. The groups were well balanced with respect to important characteristics, such as incidence of CD, receipt of other prophylactic antibiotics, and median time between randomization and delivery.

The incidence of maternal sepsis or death was lower in the azithromycin group (1.6% vs 2.4%; RR, 0.67; 95% CI, 0.56–0.79; P<.001). The key effect was on the frequency of maternal sepsis because the incidence of maternal death was very low in both groups, 0.1%. With respect to secondary outcomes, prophylaxis was effective in reducing the frequency of endometritis (RR, 0.66; 95% CI, 0.55–0.79) and perineal and incisional infection (RR, 0.71; 95% CI, 0.56–0.85).

There was no difference in the frequency of neonatal sepsis or death. There also was no difference in the frequency of adverse drug effects in either group. Of note, more cases of neonatal pyloric stenosis were observed in the azithromycin group, but the overall incidence was lower than the expected background rate. This possible “signal” is important because this effect has been noted with increased frequency in neonates who received this antibiotic. ●

First trimester miscarriage, the presence of a nonviable intrauterine pregnancy before 13 weeks’ gestation, is a common complication occurring in approximately 15% of clinical pregnancies.^1,2 The goals for the holistic management of first-trimester miscarriage are to 1) reduce the risk of complications such as excessive bleeding and infection, 2) ensure that the patient is supported during a time of great distress, and 3) optimally counsel the patient about treatment options and elicit the patient’s preferences for care.³ To resolve a miscarriage, the intrauterine pregnancy tissue must be expelled, restoring normal reproductive function.

The options for the management of a nonviable intrauterine pregnancy include expectant management, medication treatment with mifepristone plus misoprostol or misoprostol-alone, or uterine aspiration. In the absence of uterine hemorrhage, infection, or another severe complication of miscarriage, the patient’s preferences should guide the choice of treatment. Many patients with miscarriage prioritize avoiding medical interventions and may prefer expectant management. A patient who prefers rapid and reliable completion of the pregnancy loss process may prefer uterine aspiration. If the patient prefers to avoid uterine aspiration but desires control over the time and location of the expulsion process, medication treatment may be optimal. Many other factors influence a patient’s choice of miscarriage treatment, including balancing work and childcare issues and the ease of scheduling a uterine aspiration. In counseling patients about the options for miscarriage treatment it is helpful to know the success rate of each treatment option.⁴ This editorial reviews miscarriage treatment outcomes as summarized in a recent Cochrane network meta-analysis.⁵

Uterine aspiration versus mifepristone-misoprostol

In 2 clinical trials that included 899 patients with miscarriage, successful treatment with uterine aspira-tion versus mifepristone-misoprostolwas reported in 95% and 66% of cases, respectively.^6,7

In the largest clinical trial comparing uterine aspiration to mifepristone-misoprostol, 801 patients with first-trimester miscarriage were randomly assigned to uterine aspiration or mifepristone-misoprostol.⁶ Uterine aspiration and mifepristone-misoprostol were associated with successful miscarriage treatment in 95% and 64% of cases, respectively. In the uterine aspiration group, a second uterine aspiration occurred in 5% of patients. Two patients in the uterine aspiration group needed a third uterine aspiration to resolve the miscarriage. In the mifepristone-misoprostol group, 36% of patients had a uterine aspiration. It should be noted that the trial protocol guided patients having a medication abortion to uterine aspiration if expulsion of miscarriage tissue had not occurred within 8 hours of receiving misoprostol. If the trial protocol permitted 1 to 4 weeks of monitoring after mifepristone-misoprostol treatment, the success rate with medication treatment would be greater. Six to 8 weeks following miscarriage treatment, patient-reported anxiety and depression symptoms were similar in both groups.⁶

Uterine aspiration versus misoprostol

Among 3 clinical trials that limited enrollment to patients with missed miscarriage, involving 308 patients, the success rates for uterine aspiration and misoprostol treatment was 95% and 62%, respectively.⁵

In a study sponsored by the National Institutes of Health, 652 patients with missed miscarriage or incomplete miscarriage were randomly assigned in a 1:3 ratioto uterine aspiration or misoprostol treatment (800 µg vaginally). After 8 days of follow-up, successful treatment rates among the patients treated with uterine evacuation or misoprostol was 97% and 84%, respectively.⁸ Of note, with misoprostol treatment the success rate increased from day 3 to day 8 of follow-up—from 71% to 84%.⁸

Continue to: Mifepristone-misoprostol versus misoprostol...

The combined results of 7 clinical trials of medication management of missed miscarriage that included 1,812 patients showed that successful treatment with mifepristone-misoprostol or misoprostol alone occurred in 80% and 70% of cases, respectively.⁵

Schreiber and colleagues⁹ reported a study of 300 patients with an anembryonic gestation or embryonic demise that were between 5 and 12 completed weeks of gestation and randomly assigned to treatment with mifepristone (200 mg) plus vaginal misoprostol (800 µg) administered 24 to 48 hours after mifepristone or vaginal misoprostol (800 µg) alone. Ultrasonography was performed 1 to 4 days after misoprostol administration. Successful treatment was defined as expulsion of the gestational sac plus no additional surgical or medical intervention within 30 days after treatment. In this study, the dual-medication regimen of mifepristone-misoprostol was more successful than misoprostol alone in resolving the miscarriage, 84% and 67%, respectively (relative risk [RR], 1.25; 95% CI, 1.09–1.43). Surgical evacuation of the uterus occurred less often with mifepristone-misoprostol treatment (9%) than with misoprostol monotherapy (24%) (RR, 0.37; 95% CI, 0.21 ̶ 0.68). Pelvic infection occurred in 2 patients (1.3%) in each group. Uterine bleeding managed with blood transfusion occurred in 3 patients who received mifepristone-misoprostol and 1 patient who received misoprostol alone. In this study, clinical factors, including active bleeding, parity, and gestational age did not influence treatment success with the mifepristone-misoprostol regimen.¹⁰ The mifepristone-misoprostol regimen was reported to be more cost-effective than misoprostol alone.¹¹Chu and colleagues¹² reporteda study of medication treatmentof missed miscarriage that included more than 700 patients randomly assigned to treatment with mifepristone-misoprostol or placebo-misoprostol. Missed miscarriage was diagnosed by an ultrasound demonstrating a gestational sac and a nonviable pregnancy. The doses of mifepristone and misoprostol were 200 mg and 800 µg, respectively. In this study, the misoprostol was administered 48 hours following mifepristone or placebo using a vaginal, oral, or buccal route; 90% of patients used the vaginal route. Treatment was considered successful if the patient passed the gestational sac as determined by an ultrasound performed 7 days after entry into the study. If the gestational sac was passed, the patients were asked to do a urine pregnancy test 3 weeks after entering the study to conclude their care episode. If patients did not pass the gestational sac, they were offered a second dose of misoprostol or surgical evacuation. At 7 days of follow-up, the success rates in the mifepristone-misoprostol and misoprostol-alone groups were 83% and 76%, respectively. Surgical intervention was performed in 25% of patients treated with placebo-misoprostol and 17% of patients treated with mifepristone-misoprostol (RR, 0.73; 95% CI, 0.53 ̶ 0.95; P=.021).¹² A cost-effectiveness analysis of the trial results reported that the combination of mifepristone-misoprostol was less costly than misoprostolalone for the management of missed miscarriages.¹³

Photo: Getty Images

Expectant management versus uterine aspiration

The combined results of 7 clinical trials that included a total of 1,693 patients showed that successful treatment of miscarriage with expectant management or uterine aspiration occurred in 68% and 93% of cases, respectively.⁵ In one study, 700 patients with miscarriage were randomly assigned to expectant management or uterine aspiration. Treatment was successful for 56% and 95% of patients in the expectant management and uterine aspiration groups, respectively.⁶

The Cochrane network meta-analysis concluded that cervical preparation followed by uterine aspiration may be more effective than expectant management, with a reported risk ratio (RR) of 2.12 (95% CI, 1.41–3.20) with low-certainty evidence.⁵ In addition, uterine aspiration compared with expectant management may reduce the risk of serious complications (RR, 0.55; 95% CI, 0.23–1.32), with a wide range of treatment effects in reported trials and low-certainty evidence.⁵

In the treatment of miscarriage, the efficacy of expectant management may vary by the type of miscarriage. In one study, following the identification of a miscarriage, the percent of patients who have completed the expulsion of pregnancy tissue by 14 days was reported to be 84% for incomplete miscarriage, 59% for pregnancy loss with no expulsion of tissue, and 52% with ultrasound detection of a nonviable pregnancy with a gestational sac.¹⁴

Expectant management versus mifepristone-misoprostol

Aggregated data from 3 clinical trials that included a total of 910 patients showed that successful treatment with expectant management or mifepristone-misoprostol was reported in 48% and 68% of cases, respectively.⁵ The Cochrane network meta-analysis concluded that mifepristone-misoprostol may be more effective than expectant management, with a risk ratio of 1.42 (95% CI, 1.22–1.66) with low-certainty evidence. In addition, mifepristone-misoprostol compared with expectant management may reduce the risk for serious complications (RR, 0.76; 95% CI, 0.31–1.84) with wide range of treatment effects and low-certainty evidence.⁵

Continue to: Expectant management versus misoprostol...

The combined results of 10 clinical trials that included a total of 838 patients with miscarriage, showed that successful treatment with expectant management or misoprostol-alone occurred in 44% and 75% of cases, respectively.⁵ Among 3 studies limiting enrollment to patients with missed miscarriage, successful treatment with expectant management or misoprostol-alone occurred in 32% and 70%, respectively.⁵

The Cochrane analysis concluded that misoprostol-alone may be more effective than expectant management, with a reported risk ratio of 1.30 (95% CI, 1.16–1.46) with low-certainty evidence. In addition, misoprostol-alone compared with expectant management may reduce the risk of serious complications (RR, 0.50; 95% CI, 0.22–1.15) with a wide range of treatment effects and low-certainty evidence.⁵

Patient experience of miscarriage care

Pregnancy loss is often a distressing experience, which is associated with grief, anxiety, depression, and guilt, lasting up to 2 years for some patients.^15,16 Patient dissatisfaction with miscarriage care often focuses on 4 issues: a perceived lack of emotional support, failure to elicit patient preferences for treatment, insufficient provision of information, and inconsistent posttreatment follow-up.^17-19 When caring for patients with miscarriage, key goals are to communicate medical information with empathy and to provide emotional support. In the setting of a miscarriage, it is easy for patients to perceive that the clinician is insensitive and cold.¹⁵ Expressions of sympathy, compassion, and condolence help build an emotional connection and improve trust with the patient. Communications that may be helpful include: “I am sorry for your loss,” “I wish the outcome could be different,” “Our clinical team wants to provide you the best care possible,” and “May I ask how you are feeling?” Many patients report that they would like to have been offered mental health services as part of their miscarriage care.¹⁵

The Cochrane network meta-analysis of miscarriage concluded that uterine aspiration, misoprostol-mifepristone, and misoprostol-alone were likely more effective in resolving a miscarriage than expectant management.⁵ The strength of the conclusion was limited because of significant heterogeneity among studies, including different inclusion criteria, definition of success, and length of follow-up. Clinical trials with follow-up intervals more than 7 days generally reported greater success rates with expectant¹⁴ and medication management⁸ than studies with short follow-up intervals. Generally, expectant or medication management treatment is more likely to be successful in cases of incomplete abortion than in cases of missed miscarriage.⁵

In a rank analysis of treatment efficacy, uterine aspiration was top-ranked, followed by medication management. Expectant management had the greatest probability of being associated with unplanned uterine aspiration. Based on my analysis of available miscarriage studies, I estimate that the treatment success rates are approximately:

• uterine aspiration (93% to 99%)
• misoprostol-mifepristone (66% to 84%)
• misoprostol-alone (62% to 76%)
• expectant management (32% to 68%).

Although there may be significant differences in efficacy among the treatment options, offering patients all available approaches to treatment, providing information about the relative success of each approach, and eliciting the patient preference for care ensures an optimal patient experience during a major life event. ●
 

First trimester miscarriage, the presence of a nonviable intrauterine pregnancy before 13 weeks’ gestation, is a common complication occurring in approximately 15% of clinical pregnancies.^1,2 The goals for the holistic management of first-trimester miscarriage are to 1) reduce the risk of complications such as excessive bleeding and infection, 2) ensure that the patient is supported during a time of great distress, and 3) optimally counsel the patient about treatment options and elicit the patient’s preferences for care.³ To resolve a miscarriage, the intrauterine pregnancy tissue must be expelled, restoring normal reproductive function.

The options for the management of a nonviable intrauterine pregnancy include expectant management, medication treatment with mifepristone plus misoprostol or misoprostol-alone, or uterine aspiration. In the absence of uterine hemorrhage, infection, or another severe complication of miscarriage, the patient’s preferences should guide the choice of treatment. Many patients with miscarriage prioritize avoiding medical interventions and may prefer expectant management. A patient who prefers rapid and reliable completion of the pregnancy loss process may prefer uterine aspiration. If the patient prefers to avoid uterine aspiration but desires control over the time and location of the expulsion process, medication treatment may be optimal. Many other factors influence a patient’s choice of miscarriage treatment, including balancing work and childcare issues and the ease of scheduling a uterine aspiration. In counseling patients about the options for miscarriage treatment it is helpful to know the success rate of each treatment option.⁴ This editorial reviews miscarriage treatment outcomes as summarized in a recent Cochrane network meta-analysis.⁵

Uterine aspiration versus mifepristone-misoprostol

In 2 clinical trials that included 899 patients with miscarriage, successful treatment with uterine aspira-tion versus mifepristone-misoprostolwas reported in 95% and 66% of cases, respectively.^6,7

In the largest clinical trial comparing uterine aspiration to mifepristone-misoprostol, 801 patients with first-trimester miscarriage were randomly assigned to uterine aspiration or mifepristone-misoprostol.⁶ Uterine aspiration and mifepristone-misoprostol were associated with successful miscarriage treatment in 95% and 64% of cases, respectively. In the uterine aspiration group, a second uterine aspiration occurred in 5% of patients. Two patients in the uterine aspiration group needed a third uterine aspiration to resolve the miscarriage. In the mifepristone-misoprostol group, 36% of patients had a uterine aspiration. It should be noted that the trial protocol guided patients having a medication abortion to uterine aspiration if expulsion of miscarriage tissue had not occurred within 8 hours of receiving misoprostol. If the trial protocol permitted 1 to 4 weeks of monitoring after mifepristone-misoprostol treatment, the success rate with medication treatment would be greater. Six to 8 weeks following miscarriage treatment, patient-reported anxiety and depression symptoms were similar in both groups.⁶

Uterine aspiration versus misoprostol

Among 3 clinical trials that limited enrollment to patients with missed miscarriage, involving 308 patients, the success rates for uterine aspiration and misoprostol treatment was 95% and 62%, respectively.⁵

In a study sponsored by the National Institutes of Health, 652 patients with missed miscarriage or incomplete miscarriage were randomly assigned in a 1:3 ratioto uterine aspiration or misoprostol treatment (800 µg vaginally). After 8 days of follow-up, successful treatment rates among the patients treated with uterine evacuation or misoprostol was 97% and 84%, respectively.⁸ Of note, with misoprostol treatment the success rate increased from day 3 to day 8 of follow-up—from 71% to 84%.⁸

Continue to: Mifepristone-misoprostol versus misoprostol...

The combined results of 7 clinical trials of medication management of missed miscarriage that included 1,812 patients showed that successful treatment with mifepristone-misoprostol or misoprostol alone occurred in 80% and 70% of cases, respectively.⁵

Schreiber and colleagues⁹ reported a study of 300 patients with an anembryonic gestation or embryonic demise that were between 5 and 12 completed weeks of gestation and randomly assigned to treatment with mifepristone (200 mg) plus vaginal misoprostol (800 µg) administered 24 to 48 hours after mifepristone or vaginal misoprostol (800 µg) alone. Ultrasonography was performed 1 to 4 days after misoprostol administration. Successful treatment was defined as expulsion of the gestational sac plus no additional surgical or medical intervention within 30 days after treatment. In this study, the dual-medication regimen of mifepristone-misoprostol was more successful than misoprostol alone in resolving the miscarriage, 84% and 67%, respectively (relative risk [RR], 1.25; 95% CI, 1.09–1.43). Surgical evacuation of the uterus occurred less often with mifepristone-misoprostol treatment (9%) than with misoprostol monotherapy (24%) (RR, 0.37; 95% CI, 0.21 ̶ 0.68). Pelvic infection occurred in 2 patients (1.3%) in each group. Uterine bleeding managed with blood transfusion occurred in 3 patients who received mifepristone-misoprostol and 1 patient who received misoprostol alone. In this study, clinical factors, including active bleeding, parity, and gestational age did not influence treatment success with the mifepristone-misoprostol regimen.¹⁰ The mifepristone-misoprostol regimen was reported to be more cost-effective than misoprostol alone.¹¹Chu and colleagues¹² reporteda study of medication treatmentof missed miscarriage that included more than 700 patients randomly assigned to treatment with mifepristone-misoprostol or placebo-misoprostol. Missed miscarriage was diagnosed by an ultrasound demonstrating a gestational sac and a nonviable pregnancy. The doses of mifepristone and misoprostol were 200 mg and 800 µg, respectively. In this study, the misoprostol was administered 48 hours following mifepristone or placebo using a vaginal, oral, or buccal route; 90% of patients used the vaginal route. Treatment was considered successful if the patient passed the gestational sac as determined by an ultrasound performed 7 days after entry into the study. If the gestational sac was passed, the patients were asked to do a urine pregnancy test 3 weeks after entering the study to conclude their care episode. If patients did not pass the gestational sac, they were offered a second dose of misoprostol or surgical evacuation. At 7 days of follow-up, the success rates in the mifepristone-misoprostol and misoprostol-alone groups were 83% and 76%, respectively. Surgical intervention was performed in 25% of patients treated with placebo-misoprostol and 17% of patients treated with mifepristone-misoprostol (RR, 0.73; 95% CI, 0.53 ̶ 0.95; P=.021).¹² A cost-effectiveness analysis of the trial results reported that the combination of mifepristone-misoprostol was less costly than misoprostolalone for the management of missed miscarriages.¹³

Photo: Getty Images

Expectant management versus uterine aspiration

The combined results of 7 clinical trials that included a total of 1,693 patients showed that successful treatment of miscarriage with expectant management or uterine aspiration occurred in 68% and 93% of cases, respectively.⁵ In one study, 700 patients with miscarriage were randomly assigned to expectant management or uterine aspiration. Treatment was successful for 56% and 95% of patients in the expectant management and uterine aspiration groups, respectively.⁶

The Cochrane network meta-analysis concluded that cervical preparation followed by uterine aspiration may be more effective than expectant management, with a reported risk ratio (RR) of 2.12 (95% CI, 1.41–3.20) with low-certainty evidence.⁵ In addition, uterine aspiration compared with expectant management may reduce the risk of serious complications (RR, 0.55; 95% CI, 0.23–1.32), with a wide range of treatment effects in reported trials and low-certainty evidence.⁵

In the treatment of miscarriage, the efficacy of expectant management may vary by the type of miscarriage. In one study, following the identification of a miscarriage, the percent of patients who have completed the expulsion of pregnancy tissue by 14 days was reported to be 84% for incomplete miscarriage, 59% for pregnancy loss with no expulsion of tissue, and 52% with ultrasound detection of a nonviable pregnancy with a gestational sac.¹⁴

Expectant management versus mifepristone-misoprostol

Aggregated data from 3 clinical trials that included a total of 910 patients showed that successful treatment with expectant management or mifepristone-misoprostol was reported in 48% and 68% of cases, respectively.⁵ The Cochrane network meta-analysis concluded that mifepristone-misoprostol may be more effective than expectant management, with a risk ratio of 1.42 (95% CI, 1.22–1.66) with low-certainty evidence. In addition, mifepristone-misoprostol compared with expectant management may reduce the risk for serious complications (RR, 0.76; 95% CI, 0.31–1.84) with wide range of treatment effects and low-certainty evidence.⁵

Continue to: Expectant management versus misoprostol...

The combined results of 10 clinical trials that included a total of 838 patients with miscarriage, showed that successful treatment with expectant management or misoprostol-alone occurred in 44% and 75% of cases, respectively.⁵ Among 3 studies limiting enrollment to patients with missed miscarriage, successful treatment with expectant management or misoprostol-alone occurred in 32% and 70%, respectively.⁵

The Cochrane analysis concluded that misoprostol-alone may be more effective than expectant management, with a reported risk ratio of 1.30 (95% CI, 1.16–1.46) with low-certainty evidence. In addition, misoprostol-alone compared with expectant management may reduce the risk of serious complications (RR, 0.50; 95% CI, 0.22–1.15) with a wide range of treatment effects and low-certainty evidence.⁵

Patient experience of miscarriage care

Pregnancy loss is often a distressing experience, which is associated with grief, anxiety, depression, and guilt, lasting up to 2 years for some patients.^15,16 Patient dissatisfaction with miscarriage care often focuses on 4 issues: a perceived lack of emotional support, failure to elicit patient preferences for treatment, insufficient provision of information, and inconsistent posttreatment follow-up.^17-19 When caring for patients with miscarriage, key goals are to communicate medical information with empathy and to provide emotional support. In the setting of a miscarriage, it is easy for patients to perceive that the clinician is insensitive and cold.¹⁵ Expressions of sympathy, compassion, and condolence help build an emotional connection and improve trust with the patient. Communications that may be helpful include: “I am sorry for your loss,” “I wish the outcome could be different,” “Our clinical team wants to provide you the best care possible,” and “May I ask how you are feeling?” Many patients report that they would like to have been offered mental health services as part of their miscarriage care.¹⁵

The Cochrane network meta-analysis of miscarriage concluded that uterine aspiration, misoprostol-mifepristone, and misoprostol-alone were likely more effective in resolving a miscarriage than expectant management.⁵ The strength of the conclusion was limited because of significant heterogeneity among studies, including different inclusion criteria, definition of success, and length of follow-up. Clinical trials with follow-up intervals more than 7 days generally reported greater success rates with expectant¹⁴ and medication management⁸ than studies with short follow-up intervals. Generally, expectant or medication management treatment is more likely to be successful in cases of incomplete abortion than in cases of missed miscarriage.⁵

In a rank analysis of treatment efficacy, uterine aspiration was top-ranked, followed by medication management. Expectant management had the greatest probability of being associated with unplanned uterine aspiration. Based on my analysis of available miscarriage studies, I estimate that the treatment success rates are approximately:

• uterine aspiration (93% to 99%)
• misoprostol-mifepristone (66% to 84%)
• misoprostol-alone (62% to 76%)
• expectant management (32% to 68%).

Although there may be significant differences in efficacy among the treatment options, offering patients all available approaches to treatment, providing information about the relative success of each approach, and eliciting the patient preference for care ensures an optimal patient experience during a major life event. ●
 

First trimester miscarriage, the presence of a nonviable intrauterine pregnancy before 13 weeks’ gestation, is a common complication occurring in approximately 15% of clinical pregnancies.^1,2 The goals for the holistic management of first-trimester miscarriage are to 1) reduce the risk of complications such as excessive bleeding and infection, 2) ensure that the patient is supported during a time of great distress, and 3) optimally counsel the patient about treatment options and elicit the patient’s preferences for care.³ To resolve a miscarriage, the intrauterine pregnancy tissue must be expelled, restoring normal reproductive function.

The options for the management of a nonviable intrauterine pregnancy include expectant management, medication treatment with mifepristone plus misoprostol or misoprostol-alone, or uterine aspiration. In the absence of uterine hemorrhage, infection, or another severe complication of miscarriage, the patient’s preferences should guide the choice of treatment. Many patients with miscarriage prioritize avoiding medical interventions and may prefer expectant management. A patient who prefers rapid and reliable completion of the pregnancy loss process may prefer uterine aspiration. If the patient prefers to avoid uterine aspiration but desires control over the time and location of the expulsion process, medication treatment may be optimal. Many other factors influence a patient’s choice of miscarriage treatment, including balancing work and childcare issues and the ease of scheduling a uterine aspiration. In counseling patients about the options for miscarriage treatment it is helpful to know the success rate of each treatment option.⁴ This editorial reviews miscarriage treatment outcomes as summarized in a recent Cochrane network meta-analysis.⁵

Uterine aspiration versus mifepristone-misoprostol

In 2 clinical trials that included 899 patients with miscarriage, successful treatment with uterine aspira-tion versus mifepristone-misoprostolwas reported in 95% and 66% of cases, respectively.^6,7

In the largest clinical trial comparing uterine aspiration to mifepristone-misoprostol, 801 patients with first-trimester miscarriage were randomly assigned to uterine aspiration or mifepristone-misoprostol.⁶ Uterine aspiration and mifepristone-misoprostol were associated with successful miscarriage treatment in 95% and 64% of cases, respectively. In the uterine aspiration group, a second uterine aspiration occurred in 5% of patients. Two patients in the uterine aspiration group needed a third uterine aspiration to resolve the miscarriage. In the mifepristone-misoprostol group, 36% of patients had a uterine aspiration. It should be noted that the trial protocol guided patients having a medication abortion to uterine aspiration if expulsion of miscarriage tissue had not occurred within 8 hours of receiving misoprostol. If the trial protocol permitted 1 to 4 weeks of monitoring after mifepristone-misoprostol treatment, the success rate with medication treatment would be greater. Six to 8 weeks following miscarriage treatment, patient-reported anxiety and depression symptoms were similar in both groups.⁶

Uterine aspiration versus misoprostol

Among 3 clinical trials that limited enrollment to patients with missed miscarriage, involving 308 patients, the success rates for uterine aspiration and misoprostol treatment was 95% and 62%, respectively.⁵

In a study sponsored by the National Institutes of Health, 652 patients with missed miscarriage or incomplete miscarriage were randomly assigned in a 1:3 ratioto uterine aspiration or misoprostol treatment (800 µg vaginally). After 8 days of follow-up, successful treatment rates among the patients treated with uterine evacuation or misoprostol was 97% and 84%, respectively.⁸ Of note, with misoprostol treatment the success rate increased from day 3 to day 8 of follow-up—from 71% to 84%.⁸

Continue to: Mifepristone-misoprostol versus misoprostol...

The combined results of 7 clinical trials of medication management of missed miscarriage that included 1,812 patients showed that successful treatment with mifepristone-misoprostol or misoprostol alone occurred in 80% and 70% of cases, respectively.⁵

Schreiber and colleagues⁹ reported a study of 300 patients with an anembryonic gestation or embryonic demise that were between 5 and 12 completed weeks of gestation and randomly assigned to treatment with mifepristone (200 mg) plus vaginal misoprostol (800 µg) administered 24 to 48 hours after mifepristone or vaginal misoprostol (800 µg) alone. Ultrasonography was performed 1 to 4 days after misoprostol administration. Successful treatment was defined as expulsion of the gestational sac plus no additional surgical or medical intervention within 30 days after treatment. In this study, the dual-medication regimen of mifepristone-misoprostol was more successful than misoprostol alone in resolving the miscarriage, 84% and 67%, respectively (relative risk [RR], 1.25; 95% CI, 1.09–1.43). Surgical evacuation of the uterus occurred less often with mifepristone-misoprostol treatment (9%) than with misoprostol monotherapy (24%) (RR, 0.37; 95% CI, 0.21 ̶ 0.68). Pelvic infection occurred in 2 patients (1.3%) in each group. Uterine bleeding managed with blood transfusion occurred in 3 patients who received mifepristone-misoprostol and 1 patient who received misoprostol alone. In this study, clinical factors, including active bleeding, parity, and gestational age did not influence treatment success with the mifepristone-misoprostol regimen.¹⁰ The mifepristone-misoprostol regimen was reported to be more cost-effective than misoprostol alone.¹¹Chu and colleagues¹² reporteda study of medication treatmentof missed miscarriage that included more than 700 patients randomly assigned to treatment with mifepristone-misoprostol or placebo-misoprostol. Missed miscarriage was diagnosed by an ultrasound demonstrating a gestational sac and a nonviable pregnancy. The doses of mifepristone and misoprostol were 200 mg and 800 µg, respectively. In this study, the misoprostol was administered 48 hours following mifepristone or placebo using a vaginal, oral, or buccal route; 90% of patients used the vaginal route. Treatment was considered successful if the patient passed the gestational sac as determined by an ultrasound performed 7 days after entry into the study. If the gestational sac was passed, the patients were asked to do a urine pregnancy test 3 weeks after entering the study to conclude their care episode. If patients did not pass the gestational sac, they were offered a second dose of misoprostol or surgical evacuation. At 7 days of follow-up, the success rates in the mifepristone-misoprostol and misoprostol-alone groups were 83% and 76%, respectively. Surgical intervention was performed in 25% of patients treated with placebo-misoprostol and 17% of patients treated with mifepristone-misoprostol (RR, 0.73; 95% CI, 0.53 ̶ 0.95; P=.021).¹² A cost-effectiveness analysis of the trial results reported that the combination of mifepristone-misoprostol was less costly than misoprostolalone for the management of missed miscarriages.¹³

Photo: Getty Images

Expectant management versus uterine aspiration

The combined results of 7 clinical trials that included a total of 1,693 patients showed that successful treatment of miscarriage with expectant management or uterine aspiration occurred in 68% and 93% of cases, respectively.⁵ In one study, 700 patients with miscarriage were randomly assigned to expectant management or uterine aspiration. Treatment was successful for 56% and 95% of patients in the expectant management and uterine aspiration groups, respectively.⁶

The Cochrane network meta-analysis concluded that cervical preparation followed by uterine aspiration may be more effective than expectant management, with a reported risk ratio (RR) of 2.12 (95% CI, 1.41–3.20) with low-certainty evidence.⁵ In addition, uterine aspiration compared with expectant management may reduce the risk of serious complications (RR, 0.55; 95% CI, 0.23–1.32), with a wide range of treatment effects in reported trials and low-certainty evidence.⁵

In the treatment of miscarriage, the efficacy of expectant management may vary by the type of miscarriage. In one study, following the identification of a miscarriage, the percent of patients who have completed the expulsion of pregnancy tissue by 14 days was reported to be 84% for incomplete miscarriage, 59% for pregnancy loss with no expulsion of tissue, and 52% with ultrasound detection of a nonviable pregnancy with a gestational sac.¹⁴

Expectant management versus mifepristone-misoprostol

Aggregated data from 3 clinical trials that included a total of 910 patients showed that successful treatment with expectant management or mifepristone-misoprostol was reported in 48% and 68% of cases, respectively.⁵ The Cochrane network meta-analysis concluded that mifepristone-misoprostol may be more effective than expectant management, with a risk ratio of 1.42 (95% CI, 1.22–1.66) with low-certainty evidence. In addition, mifepristone-misoprostol compared with expectant management may reduce the risk for serious complications (RR, 0.76; 95% CI, 0.31–1.84) with wide range of treatment effects and low-certainty evidence.⁵

Continue to: Expectant management versus misoprostol...

The combined results of 10 clinical trials that included a total of 838 patients with miscarriage, showed that successful treatment with expectant management or misoprostol-alone occurred in 44% and 75% of cases, respectively.⁵ Among 3 studies limiting enrollment to patients with missed miscarriage, successful treatment with expectant management or misoprostol-alone occurred in 32% and 70%, respectively.⁵

The Cochrane analysis concluded that misoprostol-alone may be more effective than expectant management, with a reported risk ratio of 1.30 (95% CI, 1.16–1.46) with low-certainty evidence. In addition, misoprostol-alone compared with expectant management may reduce the risk of serious complications (RR, 0.50; 95% CI, 0.22–1.15) with a wide range of treatment effects and low-certainty evidence.⁵

Patient experience of miscarriage care

Pregnancy loss is often a distressing experience, which is associated with grief, anxiety, depression, and guilt, lasting up to 2 years for some patients.^15,16 Patient dissatisfaction with miscarriage care often focuses on 4 issues: a perceived lack of emotional support, failure to elicit patient preferences for treatment, insufficient provision of information, and inconsistent posttreatment follow-up.^17-19 When caring for patients with miscarriage, key goals are to communicate medical information with empathy and to provide emotional support. In the setting of a miscarriage, it is easy for patients to perceive that the clinician is insensitive and cold.¹⁵ Expressions of sympathy, compassion, and condolence help build an emotional connection and improve trust with the patient. Communications that may be helpful include: “I am sorry for your loss,” “I wish the outcome could be different,” “Our clinical team wants to provide you the best care possible,” and “May I ask how you are feeling?” Many patients report that they would like to have been offered mental health services as part of their miscarriage care.¹⁵

The Cochrane network meta-analysis of miscarriage concluded that uterine aspiration, misoprostol-mifepristone, and misoprostol-alone were likely more effective in resolving a miscarriage than expectant management.⁵ The strength of the conclusion was limited because of significant heterogeneity among studies, including different inclusion criteria, definition of success, and length of follow-up. Clinical trials with follow-up intervals more than 7 days generally reported greater success rates with expectant¹⁴ and medication management⁸ than studies with short follow-up intervals. Generally, expectant or medication management treatment is more likely to be successful in cases of incomplete abortion than in cases of missed miscarriage.⁵

In a rank analysis of treatment efficacy, uterine aspiration was top-ranked, followed by medication management. Expectant management had the greatest probability of being associated with unplanned uterine aspiration. Based on my analysis of available miscarriage studies, I estimate that the treatment success rates are approximately:

• uterine aspiration (93% to 99%)
• misoprostol-mifepristone (66% to 84%)
• misoprostol-alone (62% to 76%)
• expectant management (32% to 68%).

Although there may be significant differences in efficacy among the treatment options, offering patients all available approaches to treatment, providing information about the relative success of each approach, and eliciting the patient preference for care ensures an optimal patient experience during a major life event. ●