OBG Management

CASE Patient has urine leakage that worsens with exercise

At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.

What nonsurgical treatment options are available for this patient?

Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.¹ This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence^.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.⁴ The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.

Types of UI

The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.

Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.⁵ In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).⁶

In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.⁵

Making a diagnosis

A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.⁷

During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).⁸ This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.

The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).⁹ It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.¹⁰ Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.

Continue to: Primary therapies for UI...

Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.

Lifestyle and behavioral modifications

Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.¹¹ Information gained from a 3-day bladder diary (FIGURE 2)¹² can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.

Weight loss

Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m² increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.¹³

Reducing fluid intake and bladder irritants

Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).¹⁴

Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).¹⁵ Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.^5,16

Continue to: Pelvic floor muscle training...

Pelvic floor muscle training

An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.¹⁷ The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.

Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.

Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.^18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.¹⁷

Vaginal pessaries

Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).

The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.

UUI-specific nonsurgical treatments

Drug therapy

All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.

A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).²¹

Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.²²

Continue to: UUI office-based procedure treatments...

UUI office-based procedure treatments

If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.

Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.²⁴

OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.

In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.²⁵ The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.

Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.

SUI-specific nonsurgical treatments

Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.

Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).²⁶

The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.

CASE Symptom presentation guides treatment plan

Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●

CASE Patient has urine leakage that worsens with exercise

At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.

What nonsurgical treatment options are available for this patient?

Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.¹ This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence^.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.⁴ The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.

Types of UI

The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.

Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.⁵ In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).⁶

In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.⁵

Making a diagnosis

A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.⁷

During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).⁸ This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.

The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).⁹ It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.¹⁰ Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.

Continue to: Primary therapies for UI...

Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.

Lifestyle and behavioral modifications

Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.¹¹ Information gained from a 3-day bladder diary (FIGURE 2)¹² can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.

Weight loss

Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m² increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.¹³

Reducing fluid intake and bladder irritants

Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).¹⁴

Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).¹⁵ Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.^5,16

Continue to: Pelvic floor muscle training...

Pelvic floor muscle training

An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.¹⁷ The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.

Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.

Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.^18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.¹⁷

Vaginal pessaries

Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).

The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.

UUI-specific nonsurgical treatments

Drug therapy

All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.

A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).²¹

Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.²²

Continue to: UUI office-based procedure treatments...

UUI office-based procedure treatments

If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.

Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.²⁴

OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.

In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.²⁵ The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.

Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.

SUI-specific nonsurgical treatments

Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.

Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).²⁶

The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.

CASE Symptom presentation guides treatment plan

Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●

CASE Patient has urine leakage that worsens with exercise

At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.

What nonsurgical treatment options are available for this patient?

Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.¹ This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence^.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.⁴ The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.

Types of UI

The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.

Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.⁵ In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).⁶

In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.⁵

Making a diagnosis

A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.⁷

During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).⁸ This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.

The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).⁹ It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.¹⁰ Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.

Continue to: Primary therapies for UI...

Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.

Lifestyle and behavioral modifications

Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.¹¹ Information gained from a 3-day bladder diary (FIGURE 2)¹² can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.

Weight loss

Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m² increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.¹³

Reducing fluid intake and bladder irritants

Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).¹⁴

Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).¹⁵ Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.^5,16

Continue to: Pelvic floor muscle training...

Pelvic floor muscle training

An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.¹⁷ The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.

Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.

Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.^18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.¹⁷

Vaginal pessaries

Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).

The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.

UUI-specific nonsurgical treatments

Drug therapy

All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.

A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).²¹

Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.²²

Continue to: UUI office-based procedure treatments...

UUI office-based procedure treatments

If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.

Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.²⁴

OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.

In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.²⁵ The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.

Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.

SUI-specific nonsurgical treatments

Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.

Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).²⁶

The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.

CASE Symptom presentation guides treatment plan

Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●

In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.

COVID-19 vaccination had minimal effects on menstrual cycle length

Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.

Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,^1,2 as the menstrual cycle is often considered a sign of health and fertility.

To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.³ Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.

The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the  2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)

Increase in cycle length clinically negligible

The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).

An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.

Counseling takeaway

This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.

Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...

Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel

Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.

A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as  combined oral contraceptives (COCs).

Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG)  0.075 mg, which is commonly used in Europe.⁴ Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.

Top reasons for stopping a POP

The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.

New oral contraception option

This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.

Continue to: Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy...

Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy

Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.

Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.

Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.⁵ These included 4 retrospective cohort studies with control groups,  2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.

Promising results  for combined therapy

Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first  6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.

The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an  LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.

Bottom line

The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.

 Continue to: LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...

LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows

van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.

To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.⁶

Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.

Cost-effectiveness and noninferiority assessed

A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.

At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.

Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).

Key takeaway

Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial  ablation. ●

In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.

COVID-19 vaccination had minimal effects on menstrual cycle length

Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.

Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,^1,2 as the menstrual cycle is often considered a sign of health and fertility.

To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.³ Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.

The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the  2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)

Increase in cycle length clinically negligible

The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).

An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.

Counseling takeaway

This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.

Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...

Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel

Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.

A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as  combined oral contraceptives (COCs).

Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG)  0.075 mg, which is commonly used in Europe.⁴ Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.

Top reasons for stopping a POP

The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.

New oral contraception option

This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.

Continue to: Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy...

Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy

Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.

Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.

Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.⁵ These included 4 retrospective cohort studies with control groups,  2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.

Promising results  for combined therapy

Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first  6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.

The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an  LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.

Bottom line

The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.

 Continue to: LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...

LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows

van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.

To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.⁶

Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.

Cost-effectiveness and noninferiority assessed

A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.

At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.

Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).

Key takeaway

Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial  ablation. ●

In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.

COVID-19 vaccination had minimal effects on menstrual cycle length

Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.

Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,^1,2 as the menstrual cycle is often considered a sign of health and fertility.

To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.³ Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.

The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the  2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)

Increase in cycle length clinically negligible

The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).

An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.

Counseling takeaway

This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.

Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...

Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel

Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.

A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as  combined oral contraceptives (COCs).

Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG)  0.075 mg, which is commonly used in Europe.⁴ Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.

Top reasons for stopping a POP

The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.

New oral contraception option

This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.

Continue to: Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy...

Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy

Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.

Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.

Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.⁵ These included 4 retrospective cohort studies with control groups,  2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.

Promising results  for combined therapy

Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first  6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.

The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an  LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.

Bottom line

The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.

 Continue to: LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...

LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows

van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.

To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.⁶

Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.

Cost-effectiveness and noninferiority assessed

A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.

At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.

Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).

Key takeaway

Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial  ablation. ●

The 2021–2022 US Supreme Court Term was a blockbuster medical Term. The bookends of the Term were COVID-19 vaccinations and abortion rights. Between the bookends were Medicare reimbursement, criminal liability for prescribing controlled substances, gun control, and carbon dioxide emissions. In this article, we focus on the significant medical issues, briefly note other important decisions, and consider the implications of this Term.

Abortion decisions

Dobbs v Jackson Women’s Health Organization¹ was the most controversial decision and, for ObGyns, perhaps the most important decision in decades. The basic holding of the case can be stated simply: Roe v Wade² and Planned Parenthood of Southeastern Pennsylvania v Casey³ (which essentially created a constitutional right to abortion) are overruled. The law related to abortion is for the states and Congress to determine, not federal courts. (For a review of earlier reproductive freedom cases in the Court, see our previous article, “The Supreme Court and reproductive rights.”⁴)

Dobbs arose from a Mississippi statute that made it illegal to perform abortions after 15 weeks of gestation, well before viability. Six members of the Court held that the Mississippi law was constitutional and 3 would have struck down the state law. There were 5 opinions, covering a total of 213 pages in the U.S. Reports. The Court fell into 4 camps, ranging from the most to the least protective of abortion rights, as follows:

• Three justices (Breyer, Kagan, and Sotomayor) voted to strike down the Mississippi statute and uphold Roe and Casey and wrote a joint dissent. They believe the Constitution makes abortion an issue “off limits to majority rule.” They also warned that other areas of “substantive due process” (discussed below), including contraception and same-sex marriage, might be under threat.
• The Chief Justice voted to uphold the statute but wanted an incremental approach; that is, not to overturn Roe and Casey entirely in this case because the Dobbs case required the Court only to determine the more limited question of whether the 15-week limit on abortion was constitutional. He found that the viability standard did not make sense, but he suggested that the Court “leave for another day” whether to overturn Roe.
• Five justices joined the opinion to uphold the statute and overturn Roe. Justice Alito wrote the decision joined by Justices Thomas, Kavanaugh, Gorsuch, and Barrett. They found that a right to abortion was not “deeply rooted in our Nation’s history,” as evidenced by the fact that when the 14th Amendment was adopted, abortion was a criminal offense in most states and not a protected right in any state. In 2 lengthy appendices, the Court reviewed the criminalization of abortion in the states in 1868 and in the territories that later became states. Even when Roe was decided in 1973, abortion was not “deeply rooted” because it was not generally legal in the states. Justice Kavanaugh joined this opinion and wrote separately to emphasize that the majority opinion does not outlaw abortion, but rather leaves the issue to “the people and their representatives.” He also emphasized that the case did not overturn all of the substantive due process cases.
• Justice Thomas would have gone further and abandoned “substantive due process” completely.

The constitutional issue

The majority said that the issue before the Court was not whether the law should permit or prohibit abortions—that is a question for the political branches. Rather, the question was only whether the Constitution precludes the political branches from allowing abortions. There is no mention of abortion in the Constitution and no specific reference to a right to privacy that includes medical decisions. A central constitutional question has been to identify where exactly in the Constitution the right to privacy resides. The Court has generally used “substantive due process” to locate privacy rights. The 14th Amendment provides, in part, that no state may “deprive any person of life, liberty, or property, without due process of law.” “Process” generally refers to procedural protections, but the Court sometimes has used it to encompass substantive rights (for example, privacy)—hence, “substantive due process.”

Over the decades, the legitimacy of substantive due process has remained controversial. Justice Thomas called it an “oxymoron” to turn “process” into substantive rights. And its use has a somewhat checkered history. For nearly 50 years (1890–1937), it was used to preclude states from protecting employees (for example, hour and wage laws violated “the right to contract”) and was discredited. More recently the Court has used substantive due process to protect contraception access, abortion, and same-sex marriages.

A critical question is knowing what rights substantive due process protects. The Court sometimes has said that it protects rights “deeply rooted in the Nation’s history and traditions” and “implicit in the concept of ordered liberty,”⁵ although in other cases suggested a more ambiguous definition.⁶ The next constitutional question is how to state or define the right to be protected. For example, is it the right to intimately personal decisions, bodily integrity, reproductive choice, abortion, or late-term abortion? Some of those may be deeply rooted in history and traditions (intimate decisions), and others not so much (late-term abortion). Finally, a question is whether a substantive right is defined at the time the 14th Amendment was adopted (1868) or now—is it a “living Constitution” that, without much guidance, means whatever 5 justices believe at the moment, or is it a Constitution grounded in the distant past?

The future of substantive due process is uncertain following Dobbs. Although the majority said it was not disclaiming substantive due process, the dissent said it doubted that claim because other rights are “part of the same constitutional fabric” (substantive due process). The Court might, in future cases, find some other constitutional provision in which to ground rights. The source of those rights might be the 9th Amendment (in addition to the Constitution’s enumerated rights, there are “others retained by the people”) or another provision of the 14th (“No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States…”). Each of these possibilities has its problems, many of which are similar to substantive due process, but they avoid the “oxymoron” issue.

Continue to: ObGyn briefs in the case...

ObGyn briefs in the case

The medical profession filed several amicus curiae briefs in the Dobbs case. (These are “friends of the court” briefs filed by nonparties to the litigation. The purpose is to give a court a perspective on the case not presented by the parties.) The American College of Obstetricians and Gynecologists (ACOG) took the lead in filing an amicus brief.⁷ Nearly 2 dozen other medical organizations joined the brief, including the American Academy of Pediatrics, American College of Osteopathic Obstetricians and Gynecologists, American Gynecological and Obstetrical Society, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics and Gynecology, North American Society for Pediatric and Adolescent Gynecology, Society for Academic Specialists in General Obstetrics and Gynecology, Society of Gynecologic Oncology, and Society of OB/GYN Hospitalists.

The brief argued that abortion is a safe procedure, an abortion ban would harm the health of pregnant patients, and it would undermine the physician-patient relationship and interfere with patient autonomy. It also discussed the issue of fetal pain,⁸ telling the Court that “Every major medical organization that has examined the issue of fetal pain and peer-reviewed studies on the matter have consistently concluded that pre-viability abortion does not result in fetal pain perception.”⁹ The brief was cited in the dissent for the fact that “About 18 percent of pregnancies in this country end in abortion, and about one-quarter of American women will have an abortion before the age of 45.”¹⁰

The Court received a different view from an amicus brief filed by the American Association of Pro-Life Obstetricians and Gynecologists.¹¹ It told the Court that abortion, especially later-term, poses health risks: the abortion process itself may injure the woman, abortion puts women at risk for future preterm births, later-term abortion raises a woman’s risk of developing breast cancer, and abortions (especially those later in the pregnancy) are linked to a greater risk of psychological harm.¹² The brief also noted that 93% of obstetrician-gynecologists do not perform abortions, and “abortion has been deemed contrary to sound medicine for thousands of years” (citing the Hippocratic oath).¹³ The brief was not cited by the Court.

Many other medical and pro-life medical groups presented amicus briefs. A list of and links to all the briefs is available on the SCOTUSblog website at https://www.scotusblog.com/case-files/cases/dobbs-v-jackson-womens-health-organization/.

Ramifications

The Court decision does not make abortion illegal but allows states (and possibly Congress) to decide whether, when, and how abortions may be performed. Some states may ban most abortions (making it illegal to have or to perform abortions). Thirteen states had “trigger laws” to go into effect limiting abortion if the Court permitted such limitations. Most of those states were almost immediately entangled in lawsuits challenging the state laws. Some states, for example, have privacy provisions in their state constitution that state courts could interpret as allowing abortion, thereby voiding the state statutes prohibiting abortion.

At least a few states have abortion laws still on the books that were passed decades ago (perhaps before Roe) and were never repealed. Those laws may once again be valid, although state courts might hold that those statutes were repealed by Roe and must be passed again to be valid. Some experts anticipate that 28 states will eventually have significant limitations on abortion.

The Guttmacher Institute maintains a frequently updated table on the abortion laws in each state.¹⁴ According to one estimate, 29 states are hostile to abortion rights (or lean that way), with about 40 million women aged 13 to 44 (58% of the United States) living in states with some hostility to abortion.¹⁵ Congress may pass some national abortion laws, but that seems unlikely and there may be some limits on its ability to control private medical practice within states.

An additional legal issue will arise from medication-induced abortions, generally through the use of mifepristone and misoprostol. They now account for the majority of abortions. These medications might be used for abortion, up to about 9 weeks of pregnancy, in states prohibiting abortion. The drugs once were available only with an in-person visit, but now the US Food and Drug Administration (FDA) permits mail-order delivery. The potential exists, therefore, to circumvent states’ prohibition on abortion through mail-order postal shipments. The FDA controls the licensing of pharmaceuticals in interstate commerce, but not the practice of medicine within a state. Therefore the ability of individuals (within a state) to possess or use drugs is unclear.

The abortion wars of the last 50 years gave rise to state laws related to abortion, including consent by minors, information to parents, special informed consent, and facilities requirements. If these laws were once struck down because they were inconsistent with Roe, but were never formally repealed, they may now become legal requirements.

In the foreseeable future, abortion laws generally will not be determined by federal courts but by state law, generally legislatures. In legislative hearings, town hall meetings, and conversations with lawmakers, ObGyns should engage the topic of abortion with scientific expertise, reason, openness, and humility. It will be impossible for the profession to speak with a single voice, as the briefs filed this Term demonstrate. Where there are honest differences in science, the reasons for the different interpretations should be explainable to lay decision makers. The profession, who are not being pseudo-lobbyists, can contribute a great deal to the rational consideration of this emotional topic.

Continue to: What is a practitioner to do?...

What is a practitioner to do?

For many practitioners, the Dobbs decision will have little effect because their state laws are consistent with Roe, and the legislature is not going to change the law. They may, of course, see an influx of patients from other states (that restrict abortion) seeking treatment. At the other extreme, in some states, most abortions will become prohibited. State courts may ease the restrictions. In many states, there will be an ongoing battle over when abortion is legal and when it is not, resulting in shifting laws and regulations. Keeping up with the shifts that affect practice will be a challenge.

All states are likely to permit abortions “to save the life of the mother,” and many will have a version of “to preserve the health of the mother.” Other exceptions may be for pregnancy resulting from rape or incest or in the case of serious fetal abnormality. ObGyns, of course, will be called on to certify that one of these exceptions exists. Determining that pregnancy resulted from rape or incest, of course, can be challenging. Before Roe, there was a cottage industry opining that pregnancy seriously affected the health of the mother, which often involved physical manifestations of mental health. ObGyns in some states may be asked once again to make such determinations.

Laws not directly related to abortions will, in some states, be changed as a way of discouraging abortion. For example, child abuse reporting laws may be modified to require reporting of any known or suspected abortion or attempted abortion, and medical licensing standards may make it a violation to participate in or facilitate abortion in any way.

Particularly in states where the rules keep shifting, practitioners must keep up with the current law. Professional organizations can help with that, but there is no substitute for practitioners having an ongoing professional relationship with an attorney who has expertise in health law.

Other abortion decisions this Term

In other abortion decisions this Term, the Court refused to suspend a Texas law that prohibited abortions after a fetal heartbeat could be detected.¹⁶ The law has remarkable enforcement mechanisms that preclude state officers from enforcing it; instead, it creates what amounts to a private attorney general (PAG) provision that allows private citizens to file suit against anyone performing or assisting in performing abortions. This PAG made pre-enforcement challenges to the law difficult.¹⁷

In a Kentucky case, the Court allowed the Kentucky attorney general to intervene in a case that challenged a Kentucky law that prohibits physicians from using dilation and evacuation procedures to end second-trimester pregnancies.¹⁸

Criminal convictions for physicians’ overprescription of controlled substances

Perhaps the least sympathetic of the physicians involved with the Court this Term were the 2 in Ruan v U.S.¹⁹ Their trials indicate that Dr. Ruan’s clinic issued more than 300,000 controlled substance prescriptions over 4 years and was one of the most frequent prescribers of fentanyl. Dr. Kahn prescribed controlled substances without an examination, falsified notes, and sold controlled substances for cash and guns.²⁰

Both physicians were convicted of “knowingly or intentionally” dispensing a controlled substance without authorization.²¹ They were authorized to prescribe drugs, but only “for a legitimate medical purpose.”²² Appeals to their respective Circuit courts confirmed their convictions. The Supreme Court, however, held that to convict them, the government must prove that they knowingly or intentionally acted in an unauthorized manner. That proof can be by circumstantial evidence, but it must be beyond a reasonable doubt.

Health care reimbursement

Hospitals won one and lost one Medicare-Medicaid reimbursement case that involved payments for low-income patients.

In the loss, the Court held that the US Department of Health and Human Services (HHS) properly calculated the disproportionate share adjustments (DSH), or Medicare fraction,²³ that provides a supplemental payment for hospitals with a large proportion of low-income patients. The lower DSH payments calculated by HHS were upheld, thereby reducing the number of hospitals receiving DSH payments and decreasing the amounts others will receive.

The win involved payments for prescription drugs that hospitals provide to outpatients in safety-net hospitals.²⁴ HHS determined that it was overpaying hospitals for drugs and cut the reimbursement rate. The Court held that before HHS can change the drug rate, it must conduct a survey of hospitals regarding actual costs. It had not done that, so the rate reduction was not permitted by the law.

An accidental disincentive to (some) malpractice suits

Medicaid requires states to obtain part of a tort recovery that recipients obtain if Medicaid is covering medical expenses related to their injuries. In implementing that law, a state may provide a disincentive for injured beneficiaries to file malpractice cases. At issue was a Florida law that provided the Medicaid state would take 37.5% of the beneficiary’s total tort recovery (being one-half of the recovery after deducting 25% for attorney’s fees and costs). In a 7-2 decision, the Court upheld the Florida law.²⁵

The disincentive to filing a lawsuit is that the state is taking 37.5%, plus contingency fee attorneys will typically take 33.3% (and there will be some fees). This is especially true when there is a state cap on noneconomic damages. In the case the Court decided, the plaintiff received a settlement of $850,000. If we assume a typical contingency fee, less the state’s Medicaid claim of $300,000, the plaintiff possibly received $266,667. That is not trivial, but it is only 31% of the settlement.

The Medicaid expectation of reimbursement and the Florida approach, however, impose heavy burdens on severely injured beneficiaries. The plaintiff had catastrophic injuries and was in a vegetative state. There are some things Medicaid does not pay for, as well as nonmedical expenses. The amount left for such expenses is likely well below what the family will need.

Continue to: COVID-19 vaccinations...

COVID-19 vaccinations

Had it not been for the abortion decisions, 2021–2022 might have been “the COVID Term.” Two of the most anticipated decisions involved mandatory vaccinations (or masking/testing instead). The question in each of these cases was whether Congress had authorized 2 federal agencies to issue the emergency regulations requiring vaccination. Emergency regulations are held to higher standards because they bypass the usual protections of the Administrative Procedure Act.

One case involved a regulation issued by the Occupational Safety and Health Administration (OSHA) that employers (with more than 100 employees) must require their employees to be vaccinated. In a 6-3 decision, the Court held that OSHA did not have the authority to enforce this as an emergency regulation. The other case was a regulation issued by HHS that health care institutions receiving Medicare and Medicaid funding must require all staff to be vaccinated.²⁶ In a 5-4 decision, the Court upheld this emergency regulation because of the very broad authority Congress had given HHS to ensure the safety of patients and the quality of Medicare- and Medicaid-funded programs.²⁷

In another case, in the shadow docket (orders and opinions in cases without full arguments), the Court struck down the Centers for Disease Control and Prevention’s eviction moratorium.²⁸ The Court said the government claimed “a breathtaking amount of authority” that Congress did not intend. In other shadow docket cases, the Court refused to hold unconstitutional state laws that require COVID-19 vaccination but did not have religious exemptions.²⁹

Analysis of this Term

It was an extraordinary Term. The Court decided 66 cases (excluding most cases in the shadow docket), a low number historically. Not only were there many seminal cases but also the Court appears to be shifting toward a new direction. That direction may be oriented more toward the original understanding of the words of the Constitution and statutes and less toward policy; Congress rather than administrative agencies; racial nondiscrimination rather than preferences; and the free exercise rather than the establishment of religion. Whether there is such a shift or not, of course, only time will tell.

Chief Justice Roberts and Justice Kavanaugh were in the majority most often (95% of the cases), followed by Justices Barrett (90%), Alito (85%), Thomas (80%), and Gorsuch (75%). Justices Kagan (69%) and Breyer (68%) were not far behind. Justice Sotomayor was in the majority 58%. The Court was unanimous 29% of the time, well below the decade average (43%), and 6-3 accounted for 30% of the decisions.

A major, potentially scarring, event this Term was the leak of an early draft of the majority opinion in Dobbs. Although leaks have occurred before, the early leak of an opinion was unprecedented. It will almost inevitably change the openness and candor within the Court and the justices’ clerks. Although not unprecedented, the attempt on the life of Justice Kavanaugh and the organized efforts to harass some justices in their homes are likely to have lasting impact. Almost certainly it means that justices and their families will have constant security and their movements and connection with the general public will become less frequent, which is sad for the justices and our democracy.

Looking toward the next Term

When the Court next convenes, Justice Ketanji Brown Jackson will take her seat on the left end of the Court (the traditional seat for a new justice, not a commentary on judicial philosophy). The Court has already taken many cases, including issues about university affirmative action programs, web designers and same-sex couples, redistricting and voting rights, DNA testing in criminal cases, and overtime pay for someone making over $200,000 per year. It begins Monday, October 3, and promises to be another interesting Term. ●

The 2021–2022 US Supreme Court Term was a blockbuster medical Term. The bookends of the Term were COVID-19 vaccinations and abortion rights. Between the bookends were Medicare reimbursement, criminal liability for prescribing controlled substances, gun control, and carbon dioxide emissions. In this article, we focus on the significant medical issues, briefly note other important decisions, and consider the implications of this Term.

Abortion decisions

Dobbs v Jackson Women’s Health Organization¹ was the most controversial decision and, for ObGyns, perhaps the most important decision in decades. The basic holding of the case can be stated simply: Roe v Wade² and Planned Parenthood of Southeastern Pennsylvania v Casey³ (which essentially created a constitutional right to abortion) are overruled. The law related to abortion is for the states and Congress to determine, not federal courts. (For a review of earlier reproductive freedom cases in the Court, see our previous article, “The Supreme Court and reproductive rights.”⁴)

Dobbs arose from a Mississippi statute that made it illegal to perform abortions after 15 weeks of gestation, well before viability. Six members of the Court held that the Mississippi law was constitutional and 3 would have struck down the state law. There were 5 opinions, covering a total of 213 pages in the U.S. Reports. The Court fell into 4 camps, ranging from the most to the least protective of abortion rights, as follows:

• Three justices (Breyer, Kagan, and Sotomayor) voted to strike down the Mississippi statute and uphold Roe and Casey and wrote a joint dissent. They believe the Constitution makes abortion an issue “off limits to majority rule.” They also warned that other areas of “substantive due process” (discussed below), including contraception and same-sex marriage, might be under threat.
• The Chief Justice voted to uphold the statute but wanted an incremental approach; that is, not to overturn Roe and Casey entirely in this case because the Dobbs case required the Court only to determine the more limited question of whether the 15-week limit on abortion was constitutional. He found that the viability standard did not make sense, but he suggested that the Court “leave for another day” whether to overturn Roe.
• Five justices joined the opinion to uphold the statute and overturn Roe. Justice Alito wrote the decision joined by Justices Thomas, Kavanaugh, Gorsuch, and Barrett. They found that a right to abortion was not “deeply rooted in our Nation’s history,” as evidenced by the fact that when the 14th Amendment was adopted, abortion was a criminal offense in most states and not a protected right in any state. In 2 lengthy appendices, the Court reviewed the criminalization of abortion in the states in 1868 and in the territories that later became states. Even when Roe was decided in 1973, abortion was not “deeply rooted” because it was not generally legal in the states. Justice Kavanaugh joined this opinion and wrote separately to emphasize that the majority opinion does not outlaw abortion, but rather leaves the issue to “the people and their representatives.” He also emphasized that the case did not overturn all of the substantive due process cases.
• Justice Thomas would have gone further and abandoned “substantive due process” completely.

The constitutional issue

The majority said that the issue before the Court was not whether the law should permit or prohibit abortions—that is a question for the political branches. Rather, the question was only whether the Constitution precludes the political branches from allowing abortions. There is no mention of abortion in the Constitution and no specific reference to a right to privacy that includes medical decisions. A central constitutional question has been to identify where exactly in the Constitution the right to privacy resides. The Court has generally used “substantive due process” to locate privacy rights. The 14th Amendment provides, in part, that no state may “deprive any person of life, liberty, or property, without due process of law.” “Process” generally refers to procedural protections, but the Court sometimes has used it to encompass substantive rights (for example, privacy)—hence, “substantive due process.”

Over the decades, the legitimacy of substantive due process has remained controversial. Justice Thomas called it an “oxymoron” to turn “process” into substantive rights. And its use has a somewhat checkered history. For nearly 50 years (1890–1937), it was used to preclude states from protecting employees (for example, hour and wage laws violated “the right to contract”) and was discredited. More recently the Court has used substantive due process to protect contraception access, abortion, and same-sex marriages.

A critical question is knowing what rights substantive due process protects. The Court sometimes has said that it protects rights “deeply rooted in the Nation’s history and traditions” and “implicit in the concept of ordered liberty,”⁵ although in other cases suggested a more ambiguous definition.⁶ The next constitutional question is how to state or define the right to be protected. For example, is it the right to intimately personal decisions, bodily integrity, reproductive choice, abortion, or late-term abortion? Some of those may be deeply rooted in history and traditions (intimate decisions), and others not so much (late-term abortion). Finally, a question is whether a substantive right is defined at the time the 14th Amendment was adopted (1868) or now—is it a “living Constitution” that, without much guidance, means whatever 5 justices believe at the moment, or is it a Constitution grounded in the distant past?

The future of substantive due process is uncertain following Dobbs. Although the majority said it was not disclaiming substantive due process, the dissent said it doubted that claim because other rights are “part of the same constitutional fabric” (substantive due process). The Court might, in future cases, find some other constitutional provision in which to ground rights. The source of those rights might be the 9th Amendment (in addition to the Constitution’s enumerated rights, there are “others retained by the people”) or another provision of the 14th (“No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States…”). Each of these possibilities has its problems, many of which are similar to substantive due process, but they avoid the “oxymoron” issue.

Continue to: ObGyn briefs in the case...

ObGyn briefs in the case

The medical profession filed several amicus curiae briefs in the Dobbs case. (These are “friends of the court” briefs filed by nonparties to the litigation. The purpose is to give a court a perspective on the case not presented by the parties.) The American College of Obstetricians and Gynecologists (ACOG) took the lead in filing an amicus brief.⁷ Nearly 2 dozen other medical organizations joined the brief, including the American Academy of Pediatrics, American College of Osteopathic Obstetricians and Gynecologists, American Gynecological and Obstetrical Society, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics and Gynecology, North American Society for Pediatric and Adolescent Gynecology, Society for Academic Specialists in General Obstetrics and Gynecology, Society of Gynecologic Oncology, and Society of OB/GYN Hospitalists.

The brief argued that abortion is a safe procedure, an abortion ban would harm the health of pregnant patients, and it would undermine the physician-patient relationship and interfere with patient autonomy. It also discussed the issue of fetal pain,⁸ telling the Court that “Every major medical organization that has examined the issue of fetal pain and peer-reviewed studies on the matter have consistently concluded that pre-viability abortion does not result in fetal pain perception.”⁹ The brief was cited in the dissent for the fact that “About 18 percent of pregnancies in this country end in abortion, and about one-quarter of American women will have an abortion before the age of 45.”¹⁰

The Court received a different view from an amicus brief filed by the American Association of Pro-Life Obstetricians and Gynecologists.¹¹ It told the Court that abortion, especially later-term, poses health risks: the abortion process itself may injure the woman, abortion puts women at risk for future preterm births, later-term abortion raises a woman’s risk of developing breast cancer, and abortions (especially those later in the pregnancy) are linked to a greater risk of psychological harm.¹² The brief also noted that 93% of obstetrician-gynecologists do not perform abortions, and “abortion has been deemed contrary to sound medicine for thousands of years” (citing the Hippocratic oath).¹³ The brief was not cited by the Court.

Many other medical and pro-life medical groups presented amicus briefs. A list of and links to all the briefs is available on the SCOTUSblog website at https://www.scotusblog.com/case-files/cases/dobbs-v-jackson-womens-health-organization/.

Ramifications

The Court decision does not make abortion illegal but allows states (and possibly Congress) to decide whether, when, and how abortions may be performed. Some states may ban most abortions (making it illegal to have or to perform abortions). Thirteen states had “trigger laws” to go into effect limiting abortion if the Court permitted such limitations. Most of those states were almost immediately entangled in lawsuits challenging the state laws. Some states, for example, have privacy provisions in their state constitution that state courts could interpret as allowing abortion, thereby voiding the state statutes prohibiting abortion.

At least a few states have abortion laws still on the books that were passed decades ago (perhaps before Roe) and were never repealed. Those laws may once again be valid, although state courts might hold that those statutes were repealed by Roe and must be passed again to be valid. Some experts anticipate that 28 states will eventually have significant limitations on abortion.

The Guttmacher Institute maintains a frequently updated table on the abortion laws in each state.¹⁴ According to one estimate, 29 states are hostile to abortion rights (or lean that way), with about 40 million women aged 13 to 44 (58% of the United States) living in states with some hostility to abortion.¹⁵ Congress may pass some national abortion laws, but that seems unlikely and there may be some limits on its ability to control private medical practice within states.

An additional legal issue will arise from medication-induced abortions, generally through the use of mifepristone and misoprostol. They now account for the majority of abortions. These medications might be used for abortion, up to about 9 weeks of pregnancy, in states prohibiting abortion. The drugs once were available only with an in-person visit, but now the US Food and Drug Administration (FDA) permits mail-order delivery. The potential exists, therefore, to circumvent states’ prohibition on abortion through mail-order postal shipments. The FDA controls the licensing of pharmaceuticals in interstate commerce, but not the practice of medicine within a state. Therefore the ability of individuals (within a state) to possess or use drugs is unclear.

The abortion wars of the last 50 years gave rise to state laws related to abortion, including consent by minors, information to parents, special informed consent, and facilities requirements. If these laws were once struck down because they were inconsistent with Roe, but were never formally repealed, they may now become legal requirements.

In the foreseeable future, abortion laws generally will not be determined by federal courts but by state law, generally legislatures. In legislative hearings, town hall meetings, and conversations with lawmakers, ObGyns should engage the topic of abortion with scientific expertise, reason, openness, and humility. It will be impossible for the profession to speak with a single voice, as the briefs filed this Term demonstrate. Where there are honest differences in science, the reasons for the different interpretations should be explainable to lay decision makers. The profession, who are not being pseudo-lobbyists, can contribute a great deal to the rational consideration of this emotional topic.

Continue to: What is a practitioner to do?...

What is a practitioner to do?

For many practitioners, the Dobbs decision will have little effect because their state laws are consistent with Roe, and the legislature is not going to change the law. They may, of course, see an influx of patients from other states (that restrict abortion) seeking treatment. At the other extreme, in some states, most abortions will become prohibited. State courts may ease the restrictions. In many states, there will be an ongoing battle over when abortion is legal and when it is not, resulting in shifting laws and regulations. Keeping up with the shifts that affect practice will be a challenge.

All states are likely to permit abortions “to save the life of the mother,” and many will have a version of “to preserve the health of the mother.” Other exceptions may be for pregnancy resulting from rape or incest or in the case of serious fetal abnormality. ObGyns, of course, will be called on to certify that one of these exceptions exists. Determining that pregnancy resulted from rape or incest, of course, can be challenging. Before Roe, there was a cottage industry opining that pregnancy seriously affected the health of the mother, which often involved physical manifestations of mental health. ObGyns in some states may be asked once again to make such determinations.

Laws not directly related to abortions will, in some states, be changed as a way of discouraging abortion. For example, child abuse reporting laws may be modified to require reporting of any known or suspected abortion or attempted abortion, and medical licensing standards may make it a violation to participate in or facilitate abortion in any way.

Particularly in states where the rules keep shifting, practitioners must keep up with the current law. Professional organizations can help with that, but there is no substitute for practitioners having an ongoing professional relationship with an attorney who has expertise in health law.

Other abortion decisions this Term

In other abortion decisions this Term, the Court refused to suspend a Texas law that prohibited abortions after a fetal heartbeat could be detected.¹⁶ The law has remarkable enforcement mechanisms that preclude state officers from enforcing it; instead, it creates what amounts to a private attorney general (PAG) provision that allows private citizens to file suit against anyone performing or assisting in performing abortions. This PAG made pre-enforcement challenges to the law difficult.¹⁷

In a Kentucky case, the Court allowed the Kentucky attorney general to intervene in a case that challenged a Kentucky law that prohibits physicians from using dilation and evacuation procedures to end second-trimester pregnancies.¹⁸

Criminal convictions for physicians’ overprescription of controlled substances

Perhaps the least sympathetic of the physicians involved with the Court this Term were the 2 in Ruan v U.S.¹⁹ Their trials indicate that Dr. Ruan’s clinic issued more than 300,000 controlled substance prescriptions over 4 years and was one of the most frequent prescribers of fentanyl. Dr. Kahn prescribed controlled substances without an examination, falsified notes, and sold controlled substances for cash and guns.²⁰

Both physicians were convicted of “knowingly or intentionally” dispensing a controlled substance without authorization.²¹ They were authorized to prescribe drugs, but only “for a legitimate medical purpose.”²² Appeals to their respective Circuit courts confirmed their convictions. The Supreme Court, however, held that to convict them, the government must prove that they knowingly or intentionally acted in an unauthorized manner. That proof can be by circumstantial evidence, but it must be beyond a reasonable doubt.

Health care reimbursement

Hospitals won one and lost one Medicare-Medicaid reimbursement case that involved payments for low-income patients.

In the loss, the Court held that the US Department of Health and Human Services (HHS) properly calculated the disproportionate share adjustments (DSH), or Medicare fraction,²³ that provides a supplemental payment for hospitals with a large proportion of low-income patients. The lower DSH payments calculated by HHS were upheld, thereby reducing the number of hospitals receiving DSH payments and decreasing the amounts others will receive.

The win involved payments for prescription drugs that hospitals provide to outpatients in safety-net hospitals.²⁴ HHS determined that it was overpaying hospitals for drugs and cut the reimbursement rate. The Court held that before HHS can change the drug rate, it must conduct a survey of hospitals regarding actual costs. It had not done that, so the rate reduction was not permitted by the law.

An accidental disincentive to (some) malpractice suits

Medicaid requires states to obtain part of a tort recovery that recipients obtain if Medicaid is covering medical expenses related to their injuries. In implementing that law, a state may provide a disincentive for injured beneficiaries to file malpractice cases. At issue was a Florida law that provided the Medicaid state would take 37.5% of the beneficiary’s total tort recovery (being one-half of the recovery after deducting 25% for attorney’s fees and costs). In a 7-2 decision, the Court upheld the Florida law.²⁵

The disincentive to filing a lawsuit is that the state is taking 37.5%, plus contingency fee attorneys will typically take 33.3% (and there will be some fees). This is especially true when there is a state cap on noneconomic damages. In the case the Court decided, the plaintiff received a settlement of $850,000. If we assume a typical contingency fee, less the state’s Medicaid claim of $300,000, the plaintiff possibly received $266,667. That is not trivial, but it is only 31% of the settlement.

The Medicaid expectation of reimbursement and the Florida approach, however, impose heavy burdens on severely injured beneficiaries. The plaintiff had catastrophic injuries and was in a vegetative state. There are some things Medicaid does not pay for, as well as nonmedical expenses. The amount left for such expenses is likely well below what the family will need.

Continue to: COVID-19 vaccinations...

COVID-19 vaccinations

Had it not been for the abortion decisions, 2021–2022 might have been “the COVID Term.” Two of the most anticipated decisions involved mandatory vaccinations (or masking/testing instead). The question in each of these cases was whether Congress had authorized 2 federal agencies to issue the emergency regulations requiring vaccination. Emergency regulations are held to higher standards because they bypass the usual protections of the Administrative Procedure Act.

One case involved a regulation issued by the Occupational Safety and Health Administration (OSHA) that employers (with more than 100 employees) must require their employees to be vaccinated. In a 6-3 decision, the Court held that OSHA did not have the authority to enforce this as an emergency regulation. The other case was a regulation issued by HHS that health care institutions receiving Medicare and Medicaid funding must require all staff to be vaccinated.²⁶ In a 5-4 decision, the Court upheld this emergency regulation because of the very broad authority Congress had given HHS to ensure the safety of patients and the quality of Medicare- and Medicaid-funded programs.²⁷

In another case, in the shadow docket (orders and opinions in cases without full arguments), the Court struck down the Centers for Disease Control and Prevention’s eviction moratorium.²⁸ The Court said the government claimed “a breathtaking amount of authority” that Congress did not intend. In other shadow docket cases, the Court refused to hold unconstitutional state laws that require COVID-19 vaccination but did not have religious exemptions.²⁹

Analysis of this Term

It was an extraordinary Term. The Court decided 66 cases (excluding most cases in the shadow docket), a low number historically. Not only were there many seminal cases but also the Court appears to be shifting toward a new direction. That direction may be oriented more toward the original understanding of the words of the Constitution and statutes and less toward policy; Congress rather than administrative agencies; racial nondiscrimination rather than preferences; and the free exercise rather than the establishment of religion. Whether there is such a shift or not, of course, only time will tell.

Chief Justice Roberts and Justice Kavanaugh were in the majority most often (95% of the cases), followed by Justices Barrett (90%), Alito (85%), Thomas (80%), and Gorsuch (75%). Justices Kagan (69%) and Breyer (68%) were not far behind. Justice Sotomayor was in the majority 58%. The Court was unanimous 29% of the time, well below the decade average (43%), and 6-3 accounted for 30% of the decisions.

A major, potentially scarring, event this Term was the leak of an early draft of the majority opinion in Dobbs. Although leaks have occurred before, the early leak of an opinion was unprecedented. It will almost inevitably change the openness and candor within the Court and the justices’ clerks. Although not unprecedented, the attempt on the life of Justice Kavanaugh and the organized efforts to harass some justices in their homes are likely to have lasting impact. Almost certainly it means that justices and their families will have constant security and their movements and connection with the general public will become less frequent, which is sad for the justices and our democracy.

Looking toward the next Term

When the Court next convenes, Justice Ketanji Brown Jackson will take her seat on the left end of the Court (the traditional seat for a new justice, not a commentary on judicial philosophy). The Court has already taken many cases, including issues about university affirmative action programs, web designers and same-sex couples, redistricting and voting rights, DNA testing in criminal cases, and overtime pay for someone making over $200,000 per year. It begins Monday, October 3, and promises to be another interesting Term. ●

The 2021–2022 US Supreme Court Term was a blockbuster medical Term. The bookends of the Term were COVID-19 vaccinations and abortion rights. Between the bookends were Medicare reimbursement, criminal liability for prescribing controlled substances, gun control, and carbon dioxide emissions. In this article, we focus on the significant medical issues, briefly note other important decisions, and consider the implications of this Term.

Abortion decisions

Dobbs v Jackson Women’s Health Organization¹ was the most controversial decision and, for ObGyns, perhaps the most important decision in decades. The basic holding of the case can be stated simply: Roe v Wade² and Planned Parenthood of Southeastern Pennsylvania v Casey³ (which essentially created a constitutional right to abortion) are overruled. The law related to abortion is for the states and Congress to determine, not federal courts. (For a review of earlier reproductive freedom cases in the Court, see our previous article, “The Supreme Court and reproductive rights.”⁴)

Dobbs arose from a Mississippi statute that made it illegal to perform abortions after 15 weeks of gestation, well before viability. Six members of the Court held that the Mississippi law was constitutional and 3 would have struck down the state law. There were 5 opinions, covering a total of 213 pages in the U.S. Reports. The Court fell into 4 camps, ranging from the most to the least protective of abortion rights, as follows:

• Three justices (Breyer, Kagan, and Sotomayor) voted to strike down the Mississippi statute and uphold Roe and Casey and wrote a joint dissent. They believe the Constitution makes abortion an issue “off limits to majority rule.” They also warned that other areas of “substantive due process” (discussed below), including contraception and same-sex marriage, might be under threat.
• The Chief Justice voted to uphold the statute but wanted an incremental approach; that is, not to overturn Roe and Casey entirely in this case because the Dobbs case required the Court only to determine the more limited question of whether the 15-week limit on abortion was constitutional. He found that the viability standard did not make sense, but he suggested that the Court “leave for another day” whether to overturn Roe.
• Five justices joined the opinion to uphold the statute and overturn Roe. Justice Alito wrote the decision joined by Justices Thomas, Kavanaugh, Gorsuch, and Barrett. They found that a right to abortion was not “deeply rooted in our Nation’s history,” as evidenced by the fact that when the 14th Amendment was adopted, abortion was a criminal offense in most states and not a protected right in any state. In 2 lengthy appendices, the Court reviewed the criminalization of abortion in the states in 1868 and in the territories that later became states. Even when Roe was decided in 1973, abortion was not “deeply rooted” because it was not generally legal in the states. Justice Kavanaugh joined this opinion and wrote separately to emphasize that the majority opinion does not outlaw abortion, but rather leaves the issue to “the people and their representatives.” He also emphasized that the case did not overturn all of the substantive due process cases.
• Justice Thomas would have gone further and abandoned “substantive due process” completely.

The constitutional issue

The majority said that the issue before the Court was not whether the law should permit or prohibit abortions—that is a question for the political branches. Rather, the question was only whether the Constitution precludes the political branches from allowing abortions. There is no mention of abortion in the Constitution and no specific reference to a right to privacy that includes medical decisions. A central constitutional question has been to identify where exactly in the Constitution the right to privacy resides. The Court has generally used “substantive due process” to locate privacy rights. The 14th Amendment provides, in part, that no state may “deprive any person of life, liberty, or property, without due process of law.” “Process” generally refers to procedural protections, but the Court sometimes has used it to encompass substantive rights (for example, privacy)—hence, “substantive due process.”

Over the decades, the legitimacy of substantive due process has remained controversial. Justice Thomas called it an “oxymoron” to turn “process” into substantive rights. And its use has a somewhat checkered history. For nearly 50 years (1890–1937), it was used to preclude states from protecting employees (for example, hour and wage laws violated “the right to contract”) and was discredited. More recently the Court has used substantive due process to protect contraception access, abortion, and same-sex marriages.

A critical question is knowing what rights substantive due process protects. The Court sometimes has said that it protects rights “deeply rooted in the Nation’s history and traditions” and “implicit in the concept of ordered liberty,”⁵ although in other cases suggested a more ambiguous definition.⁶ The next constitutional question is how to state or define the right to be protected. For example, is it the right to intimately personal decisions, bodily integrity, reproductive choice, abortion, or late-term abortion? Some of those may be deeply rooted in history and traditions (intimate decisions), and others not so much (late-term abortion). Finally, a question is whether a substantive right is defined at the time the 14th Amendment was adopted (1868) or now—is it a “living Constitution” that, without much guidance, means whatever 5 justices believe at the moment, or is it a Constitution grounded in the distant past?

The future of substantive due process is uncertain following Dobbs. Although the majority said it was not disclaiming substantive due process, the dissent said it doubted that claim because other rights are “part of the same constitutional fabric” (substantive due process). The Court might, in future cases, find some other constitutional provision in which to ground rights. The source of those rights might be the 9th Amendment (in addition to the Constitution’s enumerated rights, there are “others retained by the people”) or another provision of the 14th (“No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States…”). Each of these possibilities has its problems, many of which are similar to substantive due process, but they avoid the “oxymoron” issue.

Continue to: ObGyn briefs in the case...

ObGyn briefs in the case

The medical profession filed several amicus curiae briefs in the Dobbs case. (These are “friends of the court” briefs filed by nonparties to the litigation. The purpose is to give a court a perspective on the case not presented by the parties.) The American College of Obstetricians and Gynecologists (ACOG) took the lead in filing an amicus brief.⁷ Nearly 2 dozen other medical organizations joined the brief, including the American Academy of Pediatrics, American College of Osteopathic Obstetricians and Gynecologists, American Gynecological and Obstetrical Society, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics and Gynecology, North American Society for Pediatric and Adolescent Gynecology, Society for Academic Specialists in General Obstetrics and Gynecology, Society of Gynecologic Oncology, and Society of OB/GYN Hospitalists.

The brief argued that abortion is a safe procedure, an abortion ban would harm the health of pregnant patients, and it would undermine the physician-patient relationship and interfere with patient autonomy. It also discussed the issue of fetal pain,⁸ telling the Court that “Every major medical organization that has examined the issue of fetal pain and peer-reviewed studies on the matter have consistently concluded that pre-viability abortion does not result in fetal pain perception.”⁹ The brief was cited in the dissent for the fact that “About 18 percent of pregnancies in this country end in abortion, and about one-quarter of American women will have an abortion before the age of 45.”¹⁰

The Court received a different view from an amicus brief filed by the American Association of Pro-Life Obstetricians and Gynecologists.¹¹ It told the Court that abortion, especially later-term, poses health risks: the abortion process itself may injure the woman, abortion puts women at risk for future preterm births, later-term abortion raises a woman’s risk of developing breast cancer, and abortions (especially those later in the pregnancy) are linked to a greater risk of psychological harm.¹² The brief also noted that 93% of obstetrician-gynecologists do not perform abortions, and “abortion has been deemed contrary to sound medicine for thousands of years” (citing the Hippocratic oath).¹³ The brief was not cited by the Court.

Many other medical and pro-life medical groups presented amicus briefs. A list of and links to all the briefs is available on the SCOTUSblog website at https://www.scotusblog.com/case-files/cases/dobbs-v-jackson-womens-health-organization/.

Ramifications

The Court decision does not make abortion illegal but allows states (and possibly Congress) to decide whether, when, and how abortions may be performed. Some states may ban most abortions (making it illegal to have or to perform abortions). Thirteen states had “trigger laws” to go into effect limiting abortion if the Court permitted such limitations. Most of those states were almost immediately entangled in lawsuits challenging the state laws. Some states, for example, have privacy provisions in their state constitution that state courts could interpret as allowing abortion, thereby voiding the state statutes prohibiting abortion.

At least a few states have abortion laws still on the books that were passed decades ago (perhaps before Roe) and were never repealed. Those laws may once again be valid, although state courts might hold that those statutes were repealed by Roe and must be passed again to be valid. Some experts anticipate that 28 states will eventually have significant limitations on abortion.

The Guttmacher Institute maintains a frequently updated table on the abortion laws in each state.¹⁴ According to one estimate, 29 states are hostile to abortion rights (or lean that way), with about 40 million women aged 13 to 44 (58% of the United States) living in states with some hostility to abortion.¹⁵ Congress may pass some national abortion laws, but that seems unlikely and there may be some limits on its ability to control private medical practice within states.

An additional legal issue will arise from medication-induced abortions, generally through the use of mifepristone and misoprostol. They now account for the majority of abortions. These medications might be used for abortion, up to about 9 weeks of pregnancy, in states prohibiting abortion. The drugs once were available only with an in-person visit, but now the US Food and Drug Administration (FDA) permits mail-order delivery. The potential exists, therefore, to circumvent states’ prohibition on abortion through mail-order postal shipments. The FDA controls the licensing of pharmaceuticals in interstate commerce, but not the practice of medicine within a state. Therefore the ability of individuals (within a state) to possess or use drugs is unclear.

The abortion wars of the last 50 years gave rise to state laws related to abortion, including consent by minors, information to parents, special informed consent, and facilities requirements. If these laws were once struck down because they were inconsistent with Roe, but were never formally repealed, they may now become legal requirements.

In the foreseeable future, abortion laws generally will not be determined by federal courts but by state law, generally legislatures. In legislative hearings, town hall meetings, and conversations with lawmakers, ObGyns should engage the topic of abortion with scientific expertise, reason, openness, and humility. It will be impossible for the profession to speak with a single voice, as the briefs filed this Term demonstrate. Where there are honest differences in science, the reasons for the different interpretations should be explainable to lay decision makers. The profession, who are not being pseudo-lobbyists, can contribute a great deal to the rational consideration of this emotional topic.

Continue to: What is a practitioner to do?...

What is a practitioner to do?

For many practitioners, the Dobbs decision will have little effect because their state laws are consistent with Roe, and the legislature is not going to change the law. They may, of course, see an influx of patients from other states (that restrict abortion) seeking treatment. At the other extreme, in some states, most abortions will become prohibited. State courts may ease the restrictions. In many states, there will be an ongoing battle over when abortion is legal and when it is not, resulting in shifting laws and regulations. Keeping up with the shifts that affect practice will be a challenge.

All states are likely to permit abortions “to save the life of the mother,” and many will have a version of “to preserve the health of the mother.” Other exceptions may be for pregnancy resulting from rape or incest or in the case of serious fetal abnormality. ObGyns, of course, will be called on to certify that one of these exceptions exists. Determining that pregnancy resulted from rape or incest, of course, can be challenging. Before Roe, there was a cottage industry opining that pregnancy seriously affected the health of the mother, which often involved physical manifestations of mental health. ObGyns in some states may be asked once again to make such determinations.

Laws not directly related to abortions will, in some states, be changed as a way of discouraging abortion. For example, child abuse reporting laws may be modified to require reporting of any known or suspected abortion or attempted abortion, and medical licensing standards may make it a violation to participate in or facilitate abortion in any way.

Particularly in states where the rules keep shifting, practitioners must keep up with the current law. Professional organizations can help with that, but there is no substitute for practitioners having an ongoing professional relationship with an attorney who has expertise in health law.

Other abortion decisions this Term

In other abortion decisions this Term, the Court refused to suspend a Texas law that prohibited abortions after a fetal heartbeat could be detected.¹⁶ The law has remarkable enforcement mechanisms that preclude state officers from enforcing it; instead, it creates what amounts to a private attorney general (PAG) provision that allows private citizens to file suit against anyone performing or assisting in performing abortions. This PAG made pre-enforcement challenges to the law difficult.¹⁷

In a Kentucky case, the Court allowed the Kentucky attorney general to intervene in a case that challenged a Kentucky law that prohibits physicians from using dilation and evacuation procedures to end second-trimester pregnancies.¹⁸

Criminal convictions for physicians’ overprescription of controlled substances

Perhaps the least sympathetic of the physicians involved with the Court this Term were the 2 in Ruan v U.S.¹⁹ Their trials indicate that Dr. Ruan’s clinic issued more than 300,000 controlled substance prescriptions over 4 years and was one of the most frequent prescribers of fentanyl. Dr. Kahn prescribed controlled substances without an examination, falsified notes, and sold controlled substances for cash and guns.²⁰

Both physicians were convicted of “knowingly or intentionally” dispensing a controlled substance without authorization.²¹ They were authorized to prescribe drugs, but only “for a legitimate medical purpose.”²² Appeals to their respective Circuit courts confirmed their convictions. The Supreme Court, however, held that to convict them, the government must prove that they knowingly or intentionally acted in an unauthorized manner. That proof can be by circumstantial evidence, but it must be beyond a reasonable doubt.

Health care reimbursement

Hospitals won one and lost one Medicare-Medicaid reimbursement case that involved payments for low-income patients.

In the loss, the Court held that the US Department of Health and Human Services (HHS) properly calculated the disproportionate share adjustments (DSH), or Medicare fraction,²³ that provides a supplemental payment for hospitals with a large proportion of low-income patients. The lower DSH payments calculated by HHS were upheld, thereby reducing the number of hospitals receiving DSH payments and decreasing the amounts others will receive.

The win involved payments for prescription drugs that hospitals provide to outpatients in safety-net hospitals.²⁴ HHS determined that it was overpaying hospitals for drugs and cut the reimbursement rate. The Court held that before HHS can change the drug rate, it must conduct a survey of hospitals regarding actual costs. It had not done that, so the rate reduction was not permitted by the law.

An accidental disincentive to (some) malpractice suits

Medicaid requires states to obtain part of a tort recovery that recipients obtain if Medicaid is covering medical expenses related to their injuries. In implementing that law, a state may provide a disincentive for injured beneficiaries to file malpractice cases. At issue was a Florida law that provided the Medicaid state would take 37.5% of the beneficiary’s total tort recovery (being one-half of the recovery after deducting 25% for attorney’s fees and costs). In a 7-2 decision, the Court upheld the Florida law.²⁵

The disincentive to filing a lawsuit is that the state is taking 37.5%, plus contingency fee attorneys will typically take 33.3% (and there will be some fees). This is especially true when there is a state cap on noneconomic damages. In the case the Court decided, the plaintiff received a settlement of $850,000. If we assume a typical contingency fee, less the state’s Medicaid claim of $300,000, the plaintiff possibly received $266,667. That is not trivial, but it is only 31% of the settlement.

The Medicaid expectation of reimbursement and the Florida approach, however, impose heavy burdens on severely injured beneficiaries. The plaintiff had catastrophic injuries and was in a vegetative state. There are some things Medicaid does not pay for, as well as nonmedical expenses. The amount left for such expenses is likely well below what the family will need.

Continue to: COVID-19 vaccinations...

COVID-19 vaccinations

Had it not been for the abortion decisions, 2021–2022 might have been “the COVID Term.” Two of the most anticipated decisions involved mandatory vaccinations (or masking/testing instead). The question in each of these cases was whether Congress had authorized 2 federal agencies to issue the emergency regulations requiring vaccination. Emergency regulations are held to higher standards because they bypass the usual protections of the Administrative Procedure Act.

One case involved a regulation issued by the Occupational Safety and Health Administration (OSHA) that employers (with more than 100 employees) must require their employees to be vaccinated. In a 6-3 decision, the Court held that OSHA did not have the authority to enforce this as an emergency regulation. The other case was a regulation issued by HHS that health care institutions receiving Medicare and Medicaid funding must require all staff to be vaccinated.²⁶ In a 5-4 decision, the Court upheld this emergency regulation because of the very broad authority Congress had given HHS to ensure the safety of patients and the quality of Medicare- and Medicaid-funded programs.²⁷

In another case, in the shadow docket (orders and opinions in cases without full arguments), the Court struck down the Centers for Disease Control and Prevention’s eviction moratorium.²⁸ The Court said the government claimed “a breathtaking amount of authority” that Congress did not intend. In other shadow docket cases, the Court refused to hold unconstitutional state laws that require COVID-19 vaccination but did not have religious exemptions.²⁹

Analysis of this Term

It was an extraordinary Term. The Court decided 66 cases (excluding most cases in the shadow docket), a low number historically. Not only were there many seminal cases but also the Court appears to be shifting toward a new direction. That direction may be oriented more toward the original understanding of the words of the Constitution and statutes and less toward policy; Congress rather than administrative agencies; racial nondiscrimination rather than preferences; and the free exercise rather than the establishment of religion. Whether there is such a shift or not, of course, only time will tell.

Chief Justice Roberts and Justice Kavanaugh were in the majority most often (95% of the cases), followed by Justices Barrett (90%), Alito (85%), Thomas (80%), and Gorsuch (75%). Justices Kagan (69%) and Breyer (68%) were not far behind. Justice Sotomayor was in the majority 58%. The Court was unanimous 29% of the time, well below the decade average (43%), and 6-3 accounted for 30% of the decisions.

A major, potentially scarring, event this Term was the leak of an early draft of the majority opinion in Dobbs. Although leaks have occurred before, the early leak of an opinion was unprecedented. It will almost inevitably change the openness and candor within the Court and the justices’ clerks. Although not unprecedented, the attempt on the life of Justice Kavanaugh and the organized efforts to harass some justices in their homes are likely to have lasting impact. Almost certainly it means that justices and their families will have constant security and their movements and connection with the general public will become less frequent, which is sad for the justices and our democracy.

Looking toward the next Term

When the Court next convenes, Justice Ketanji Brown Jackson will take her seat on the left end of the Court (the traditional seat for a new justice, not a commentary on judicial philosophy). The Court has already taken many cases, including issues about university affirmative action programs, web designers and same-sex couples, redistricting and voting rights, DNA testing in criminal cases, and overtime pay for someone making over $200,000 per year. It begins Monday, October 3, and promises to be another interesting Term. ●

The nation’s population is quickly diversifying, making racial/ethnic disparities in health care outcomes even more apparent. Minority and non-English-speaking populations have grown and may become a majority in the next generation.¹ A proposed strategy to reduce disparities in health care is to recruit more practitioners who better reflect the patient populations.² Improved access to care with racial concordance between physicians and patients has been reported.³

Being increasingly aware of access-to-care data, more patients are advocating and asking for physicians of color to be their providers.⁴ Despite progress (ie, more women entering the medical profession), the proportion of physicians who are underrepresented in medicine (URiM—eg, Black, Hispanic, and Native American) still lags US population demographics.³

Why diversity in medicine matters

In addition to improving access to care, diversity in medicine offers other benefits. Working within diverse learning environments has demonstrated educational advantages.^5,6 Medical students and residents from diverse backgrounds are less likely to report depression symptoms, regardless of their race. Diversity may accelerate advancements in health care as well, since it is well-established that diverse teams outperform nondiverse teams when it comes to innovation and productivity.⁷ Finally, as a profession committed to equity, advocacy, and justice, physicians are positioned to lead the way toward racial equity.

Overall, racial and gender diversity in all clinical specialties is improving, but not at the same pace. While the diversity of US medical students and residents by sex and race/ethnicity is greater than among faculty, change in racial diversity has been slow for all 3 groups.⁸ During the past 40 years the number of full-time faculty has increased 6-fold for females and more than tripled for males.⁸ However, this rise has not favored URiM faculty, because their proportion is still underrepresented relative to their group in the general population. Clinical departments that are making the most progress in recruiting URiM residents and faculty are often primary or preventive care specialties rather than surgical or service or hospital-based specialties.^8,9 ObGyn has consistently had a proportion of URiM residents (18%) that is highest in the surgical specialties and comparable to family medicine and pediatrics.¹⁰

When examining physician workforce diversity, it is important to “drill down” to individual specialties to obtain a clearer understanding of trends. The continued need for increased resident and faculty diversity prompted us to examine ObGyn departments. The most recent nationwide data were gathered about full-time faculty from the 2021 AAMC Faculty Roster, residents from the 2021 Accreditation Counsel for Graduate Medical Education (ACGME) Data Resource Book, medical student matriculants from 2021 AAMC, and US adult women (defined arbitrarily as 15 years or older) from the 2019 American Community Survey.^11-13

Increase in female faculty and residents

The expanding numbers of faculty and residents over a 40-year period (from 1973 to 2012) led to more women and underrepresented minorities in ObGyn than in other major clinical departments.^14,15 Women now constitute two-thirds of all ObGyn faculty and are more likely to be junior rather than senior faculty.⁹ When looking at junior faculty, a higher proportion of junior faculty who are URiM are female. While more junior faculty and residents are female, male faculty are also racially and ethnically diverse.⁹

Continue to: Growth of URiM physicians in ObGyn...

Growth of URiM physicians in ObGyn

The distribution of racial/ethnic groups in 2021 were compared between senior and junior ObGyn faculty and residents with the US adult female population.⁹ As shown in the FIGURE, the proportion of ObGyn faculty who are White approximates the White US adult female population. The most rapidly growing racial/ethnic group in the US population is Hispanic. Although Hispanic is the best represented ethnicity among junior faculty, the proportions of Hispanics among faculty and residents lag well behind the US population. The proportion of ObGyn faculty who are Black has consistently been less than in the US adult female population. ObGyns who are Asian constitute higher proportions of faculty and residents than in the US adult female population. This finding about Asians is consistent across all clinical specialties.⁷

Recruiting URiM students into ObGyn is important. Racial and ethnic representation in surgical and nonsurgical residency programs has not substantially improved in the past decade and continues to lag the changing demographics of the US population.¹⁰ More students than residents and faculty are Hispanic, which represents a much-needed opportunity for recruitment. By contrast, junior ObGyn faculty are more likely to be Black than residents and students. Native Americans constitute less than 1% of all faculty, residents, students, and US adult females.⁹ Lastly, race/ethnicity being self-reported as “other” or “unknown” is most common among students and residents, which perhaps represents greater diversity.

Looking back

Increasing diversity in medicine and in ObGyn has not happened by accident. Transformational change requires rectifying any factors that detrimentally affect the racial/ethnic diversity of our medical students, residents, and faculty. For example, biases inherent in key residency application metrics are being recognized, and use of holistic review is increasing. Change is also accelerated by an explicit and public commitment from national organizations. In 2009, the Liaison Committee of Medical Education (LCME) mandated that medical schools engage in practices that focus on recruitment and retention of a diverse workforce. Increases in Black and Hispanic medical students were noted after implementation of this new mandate.¹⁶ The ACGME followed suit with similar guidelines in 2019.¹⁰

Diversity is one of the foundational strengths of the ObGyn specialty. Important aspects of the specialty are built upon the contributions of women of color, some voluntary and some not. One example is the knowledge of gynecology that was gained through the involuntary and nonanesthetized surgeries performed on Anarcha Westcott.¹⁷ Beyond that painful legacy, several Black physicians re-shaped our specialty, including Helen Octavia Dickens, MD, the first Black woman to receive ObGyn board certification, and Georgia Rooks Dwelled, MD, who established the first obstetrical “lying-in” hospital for African American women in Atlanta.¹⁸ Similarly, Helen Rodriguez-Trias, MD, was one of the most important advocates for the passage of the 1973 national guideline that established the requirement for a woman’s written consent for sterilization.¹⁸ Guarding and enhancing the legacy of diversity in ObGyn will require intentionality on all our parts.

Moving forward

Advancing diversity in ObGyn offers advantages: better representation of patient populations, improving public health by better access to care, enhancing learning in medical education, building more comprehensive research agendas, and driving institutional excellence. While progress has been made, significant work is still to be done. We must continue to critically examine the role of biases and structural racism that are embedded in evaluating medical students, screening of residency applicants, and selecting and retaining faculty. In future work, we should explore the hypothesis that continued change in racial/ethnic diversity of faculty will only occur once more URiM students, especially the growing number of Hispanics, are admitted into medical schools and recruited for residency positions. We should also examine whether further diversity improves patient outcomes.

It is encouraging to realize that ObGyn departments are leaders in racial/ethnic diversity at US medical schools. It is also critical that the specialty commits to the progress that still needs to be made, including increasing diversity among faculty and institutional leadership. To maintain diversity that mirrors the US adult female population, the specialty of ObGyn will require active surveillance and continued recruitment of Black and, especially Hispanic, faculty and residents.¹⁹ The national strategies aimed at building medical student and residency diversity are beginning to yield results. For those gains to help faculty diversity, institutional and departmental leaders will need to implement best practices for recruiting, retaining, and advancing URiM faculty.¹⁹ Those practices would include making workforce diversity an explicit priority, building diverse applicant pools, and establishing infrastructure and mentorship to advance URiM faculty to senior leadership positions.²⁰

In conclusion

Building a physician workforce that is more representative of the US population should aid in addressing inequalities in health and health care. Significant strides have been made in racial/ethnic diversity in ObGyn. This has resulted in a specialty that is among the most diverse in academic medicine. At the same time, there is more work to be done. For example, the specialty is far from reaching racial equity for Hispanic physicians. Also, continued efforts are necessary to advance URiM faculty to leadership positions. The legacy of racial/ethnic diversity in ObGyn did not happen by accident and will not be maintained without intention. ●

The nation’s population is quickly diversifying, making racial/ethnic disparities in health care outcomes even more apparent. Minority and non-English-speaking populations have grown and may become a majority in the next generation.¹ A proposed strategy to reduce disparities in health care is to recruit more practitioners who better reflect the patient populations.² Improved access to care with racial concordance between physicians and patients has been reported.³

Being increasingly aware of access-to-care data, more patients are advocating and asking for physicians of color to be their providers.⁴ Despite progress (ie, more women entering the medical profession), the proportion of physicians who are underrepresented in medicine (URiM—eg, Black, Hispanic, and Native American) still lags US population demographics.³

Why diversity in medicine matters

In addition to improving access to care, diversity in medicine offers other benefits. Working within diverse learning environments has demonstrated educational advantages.^5,6 Medical students and residents from diverse backgrounds are less likely to report depression symptoms, regardless of their race. Diversity may accelerate advancements in health care as well, since it is well-established that diverse teams outperform nondiverse teams when it comes to innovation and productivity.⁷ Finally, as a profession committed to equity, advocacy, and justice, physicians are positioned to lead the way toward racial equity.

Overall, racial and gender diversity in all clinical specialties is improving, but not at the same pace. While the diversity of US medical students and residents by sex and race/ethnicity is greater than among faculty, change in racial diversity has been slow for all 3 groups.⁸ During the past 40 years the number of full-time faculty has increased 6-fold for females and more than tripled for males.⁸ However, this rise has not favored URiM faculty, because their proportion is still underrepresented relative to their group in the general population. Clinical departments that are making the most progress in recruiting URiM residents and faculty are often primary or preventive care specialties rather than surgical or service or hospital-based specialties.^8,9 ObGyn has consistently had a proportion of URiM residents (18%) that is highest in the surgical specialties and comparable to family medicine and pediatrics.¹⁰

When examining physician workforce diversity, it is important to “drill down” to individual specialties to obtain a clearer understanding of trends. The continued need for increased resident and faculty diversity prompted us to examine ObGyn departments. The most recent nationwide data were gathered about full-time faculty from the 2021 AAMC Faculty Roster, residents from the 2021 Accreditation Counsel for Graduate Medical Education (ACGME) Data Resource Book, medical student matriculants from 2021 AAMC, and US adult women (defined arbitrarily as 15 years or older) from the 2019 American Community Survey.^11-13

Increase in female faculty and residents

The expanding numbers of faculty and residents over a 40-year period (from 1973 to 2012) led to more women and underrepresented minorities in ObGyn than in other major clinical departments.^14,15 Women now constitute two-thirds of all ObGyn faculty and are more likely to be junior rather than senior faculty.⁹ When looking at junior faculty, a higher proportion of junior faculty who are URiM are female. While more junior faculty and residents are female, male faculty are also racially and ethnically diverse.⁹

Continue to: Growth of URiM physicians in ObGyn...

Growth of URiM physicians in ObGyn

The distribution of racial/ethnic groups in 2021 were compared between senior and junior ObGyn faculty and residents with the US adult female population.⁹ As shown in the FIGURE, the proportion of ObGyn faculty who are White approximates the White US adult female population. The most rapidly growing racial/ethnic group in the US population is Hispanic. Although Hispanic is the best represented ethnicity among junior faculty, the proportions of Hispanics among faculty and residents lag well behind the US population. The proportion of ObGyn faculty who are Black has consistently been less than in the US adult female population. ObGyns who are Asian constitute higher proportions of faculty and residents than in the US adult female population. This finding about Asians is consistent across all clinical specialties.⁷

Recruiting URiM students into ObGyn is important. Racial and ethnic representation in surgical and nonsurgical residency programs has not substantially improved in the past decade and continues to lag the changing demographics of the US population.¹⁰ More students than residents and faculty are Hispanic, which represents a much-needed opportunity for recruitment. By contrast, junior ObGyn faculty are more likely to be Black than residents and students. Native Americans constitute less than 1% of all faculty, residents, students, and US adult females.⁹ Lastly, race/ethnicity being self-reported as “other” or “unknown” is most common among students and residents, which perhaps represents greater diversity.

Looking back

Increasing diversity in medicine and in ObGyn has not happened by accident. Transformational change requires rectifying any factors that detrimentally affect the racial/ethnic diversity of our medical students, residents, and faculty. For example, biases inherent in key residency application metrics are being recognized, and use of holistic review is increasing. Change is also accelerated by an explicit and public commitment from national organizations. In 2009, the Liaison Committee of Medical Education (LCME) mandated that medical schools engage in practices that focus on recruitment and retention of a diverse workforce. Increases in Black and Hispanic medical students were noted after implementation of this new mandate.¹⁶ The ACGME followed suit with similar guidelines in 2019.¹⁰

Diversity is one of the foundational strengths of the ObGyn specialty. Important aspects of the specialty are built upon the contributions of women of color, some voluntary and some not. One example is the knowledge of gynecology that was gained through the involuntary and nonanesthetized surgeries performed on Anarcha Westcott.¹⁷ Beyond that painful legacy, several Black physicians re-shaped our specialty, including Helen Octavia Dickens, MD, the first Black woman to receive ObGyn board certification, and Georgia Rooks Dwelled, MD, who established the first obstetrical “lying-in” hospital for African American women in Atlanta.¹⁸ Similarly, Helen Rodriguez-Trias, MD, was one of the most important advocates for the passage of the 1973 national guideline that established the requirement for a woman’s written consent for sterilization.¹⁸ Guarding and enhancing the legacy of diversity in ObGyn will require intentionality on all our parts.

Moving forward

Advancing diversity in ObGyn offers advantages: better representation of patient populations, improving public health by better access to care, enhancing learning in medical education, building more comprehensive research agendas, and driving institutional excellence. While progress has been made, significant work is still to be done. We must continue to critically examine the role of biases and structural racism that are embedded in evaluating medical students, screening of residency applicants, and selecting and retaining faculty. In future work, we should explore the hypothesis that continued change in racial/ethnic diversity of faculty will only occur once more URiM students, especially the growing number of Hispanics, are admitted into medical schools and recruited for residency positions. We should also examine whether further diversity improves patient outcomes.

It is encouraging to realize that ObGyn departments are leaders in racial/ethnic diversity at US medical schools. It is also critical that the specialty commits to the progress that still needs to be made, including increasing diversity among faculty and institutional leadership. To maintain diversity that mirrors the US adult female population, the specialty of ObGyn will require active surveillance and continued recruitment of Black and, especially Hispanic, faculty and residents.¹⁹ The national strategies aimed at building medical student and residency diversity are beginning to yield results. For those gains to help faculty diversity, institutional and departmental leaders will need to implement best practices for recruiting, retaining, and advancing URiM faculty.¹⁹ Those practices would include making workforce diversity an explicit priority, building diverse applicant pools, and establishing infrastructure and mentorship to advance URiM faculty to senior leadership positions.²⁰

In conclusion

Building a physician workforce that is more representative of the US population should aid in addressing inequalities in health and health care. Significant strides have been made in racial/ethnic diversity in ObGyn. This has resulted in a specialty that is among the most diverse in academic medicine. At the same time, there is more work to be done. For example, the specialty is far from reaching racial equity for Hispanic physicians. Also, continued efforts are necessary to advance URiM faculty to leadership positions. The legacy of racial/ethnic diversity in ObGyn did not happen by accident and will not be maintained without intention. ●

The nation’s population is quickly diversifying, making racial/ethnic disparities in health care outcomes even more apparent. Minority and non-English-speaking populations have grown and may become a majority in the next generation.¹ A proposed strategy to reduce disparities in health care is to recruit more practitioners who better reflect the patient populations.² Improved access to care with racial concordance between physicians and patients has been reported.³

Being increasingly aware of access-to-care data, more patients are advocating and asking for physicians of color to be their providers.⁴ Despite progress (ie, more women entering the medical profession), the proportion of physicians who are underrepresented in medicine (URiM—eg, Black, Hispanic, and Native American) still lags US population demographics.³

Why diversity in medicine matters

In addition to improving access to care, diversity in medicine offers other benefits. Working within diverse learning environments has demonstrated educational advantages.^5,6 Medical students and residents from diverse backgrounds are less likely to report depression symptoms, regardless of their race. Diversity may accelerate advancements in health care as well, since it is well-established that diverse teams outperform nondiverse teams when it comes to innovation and productivity.⁷ Finally, as a profession committed to equity, advocacy, and justice, physicians are positioned to lead the way toward racial equity.

Overall, racial and gender diversity in all clinical specialties is improving, but not at the same pace. While the diversity of US medical students and residents by sex and race/ethnicity is greater than among faculty, change in racial diversity has been slow for all 3 groups.⁸ During the past 40 years the number of full-time faculty has increased 6-fold for females and more than tripled for males.⁸ However, this rise has not favored URiM faculty, because their proportion is still underrepresented relative to their group in the general population. Clinical departments that are making the most progress in recruiting URiM residents and faculty are often primary or preventive care specialties rather than surgical or service or hospital-based specialties.^8,9 ObGyn has consistently had a proportion of URiM residents (18%) that is highest in the surgical specialties and comparable to family medicine and pediatrics.¹⁰

When examining physician workforce diversity, it is important to “drill down” to individual specialties to obtain a clearer understanding of trends. The continued need for increased resident and faculty diversity prompted us to examine ObGyn departments. The most recent nationwide data were gathered about full-time faculty from the 2021 AAMC Faculty Roster, residents from the 2021 Accreditation Counsel for Graduate Medical Education (ACGME) Data Resource Book, medical student matriculants from 2021 AAMC, and US adult women (defined arbitrarily as 15 years or older) from the 2019 American Community Survey.^11-13

Increase in female faculty and residents

The expanding numbers of faculty and residents over a 40-year period (from 1973 to 2012) led to more women and underrepresented minorities in ObGyn than in other major clinical departments.^14,15 Women now constitute two-thirds of all ObGyn faculty and are more likely to be junior rather than senior faculty.⁹ When looking at junior faculty, a higher proportion of junior faculty who are URiM are female. While more junior faculty and residents are female, male faculty are also racially and ethnically diverse.⁹

Continue to: Growth of URiM physicians in ObGyn...

Growth of URiM physicians in ObGyn

The distribution of racial/ethnic groups in 2021 were compared between senior and junior ObGyn faculty and residents with the US adult female population.⁹ As shown in the FIGURE, the proportion of ObGyn faculty who are White approximates the White US adult female population. The most rapidly growing racial/ethnic group in the US population is Hispanic. Although Hispanic is the best represented ethnicity among junior faculty, the proportions of Hispanics among faculty and residents lag well behind the US population. The proportion of ObGyn faculty who are Black has consistently been less than in the US adult female population. ObGyns who are Asian constitute higher proportions of faculty and residents than in the US adult female population. This finding about Asians is consistent across all clinical specialties.⁷

Recruiting URiM students into ObGyn is important. Racial and ethnic representation in surgical and nonsurgical residency programs has not substantially improved in the past decade and continues to lag the changing demographics of the US population.¹⁰ More students than residents and faculty are Hispanic, which represents a much-needed opportunity for recruitment. By contrast, junior ObGyn faculty are more likely to be Black than residents and students. Native Americans constitute less than 1% of all faculty, residents, students, and US adult females.⁹ Lastly, race/ethnicity being self-reported as “other” or “unknown” is most common among students and residents, which perhaps represents greater diversity.

Looking back

Increasing diversity in medicine and in ObGyn has not happened by accident. Transformational change requires rectifying any factors that detrimentally affect the racial/ethnic diversity of our medical students, residents, and faculty. For example, biases inherent in key residency application metrics are being recognized, and use of holistic review is increasing. Change is also accelerated by an explicit and public commitment from national organizations. In 2009, the Liaison Committee of Medical Education (LCME) mandated that medical schools engage in practices that focus on recruitment and retention of a diverse workforce. Increases in Black and Hispanic medical students were noted after implementation of this new mandate.¹⁶ The ACGME followed suit with similar guidelines in 2019.¹⁰

Diversity is one of the foundational strengths of the ObGyn specialty. Important aspects of the specialty are built upon the contributions of women of color, some voluntary and some not. One example is the knowledge of gynecology that was gained through the involuntary and nonanesthetized surgeries performed on Anarcha Westcott.¹⁷ Beyond that painful legacy, several Black physicians re-shaped our specialty, including Helen Octavia Dickens, MD, the first Black woman to receive ObGyn board certification, and Georgia Rooks Dwelled, MD, who established the first obstetrical “lying-in” hospital for African American women in Atlanta.¹⁸ Similarly, Helen Rodriguez-Trias, MD, was one of the most important advocates for the passage of the 1973 national guideline that established the requirement for a woman’s written consent for sterilization.¹⁸ Guarding and enhancing the legacy of diversity in ObGyn will require intentionality on all our parts.

Moving forward

Advancing diversity in ObGyn offers advantages: better representation of patient populations, improving public health by better access to care, enhancing learning in medical education, building more comprehensive research agendas, and driving institutional excellence. While progress has been made, significant work is still to be done. We must continue to critically examine the role of biases and structural racism that are embedded in evaluating medical students, screening of residency applicants, and selecting and retaining faculty. In future work, we should explore the hypothesis that continued change in racial/ethnic diversity of faculty will only occur once more URiM students, especially the growing number of Hispanics, are admitted into medical schools and recruited for residency positions. We should also examine whether further diversity improves patient outcomes.

It is encouraging to realize that ObGyn departments are leaders in racial/ethnic diversity at US medical schools. It is also critical that the specialty commits to the progress that still needs to be made, including increasing diversity among faculty and institutional leadership. To maintain diversity that mirrors the US adult female population, the specialty of ObGyn will require active surveillance and continued recruitment of Black and, especially Hispanic, faculty and residents.¹⁹ The national strategies aimed at building medical student and residency diversity are beginning to yield results. For those gains to help faculty diversity, institutional and departmental leaders will need to implement best practices for recruiting, retaining, and advancing URiM faculty.¹⁹ Those practices would include making workforce diversity an explicit priority, building diverse applicant pools, and establishing infrastructure and mentorship to advance URiM faculty to senior leadership positions.²⁰

In conclusion

Building a physician workforce that is more representative of the US population should aid in addressing inequalities in health and health care. Significant strides have been made in racial/ethnic diversity in ObGyn. This has resulted in a specialty that is among the most diverse in academic medicine. At the same time, there is more work to be done. For example, the specialty is far from reaching racial equity for Hispanic physicians. Also, continued efforts are necessary to advance URiM faculty to leadership positions. The legacy of racial/ethnic diversity in ObGyn did not happen by accident and will not be maintained without intention. ●

Ashbrook M, et al. Management of complicated appendicitis during pregnancy in the US. JAMA Network Open. 2022;5:e227555. doi:10.1001/jamanetworkopen.2022.7555.

Expert Commentary

Over the last decade, the management of acute appendicitis in the nonpregnant adult has evolved such that some authorities favor first-line nonoperative therapy in the appropriate candidate, including some individuals with complicated appendicitis. While the conventional teaching regarding appendicitis in pregnancy has always been immediate surgery, favorable outcomes from nonoperative management in the nonpregnant population have led to an increasing application of conservative therapy in pregnancy, particularly among patients with uncomplicated appendicitis. However, optimal management of complicated appendicitis in pregnancy is unclear, as the risks of both operative and nonoperative management can be significant.

Details about the study

This retrospective cohort study using data from the National Inpatient Sample (NIS) focuses on outcomes of various management options among pregnant women with complicated appendicitis from January 2003 to September 2015. Complicated appendicitis refers to individuals with appendiceal perforation with peritonitis (a free perforation) or phlegmon/abscess (a walled-off perforation). Women included in the study were identified using ICD-9 codes for both pregnancy and complicated appendicitis; they were categorized into 3 groups: immediate operative management, successful nonoperative management, and failed nonoperative management (defined as surgical intervention >1 day after admission). The clinical and other outcomes of interest included maternal death, preterm labor/delivery or pregnancy loss, amniotic infection, sepsis, pneumonia, antenatal hemorrhage, and premature rupture of membranes. Outcomes included are those that occurred during the hospitalization for appendicitis; outcomes that may have occurred between discharge from the appendicitis hospitalization to the delivery hospitalization are not included in this study.

A total of 8,087 pregnant women with complicated appendicitis were included in this study, of whom 954 (11.8%) had successful nonoperative management, 2,646 (32.7%) had failed nonoperative management, and 4,487 (55.5%) had immediate operative management. First, when comparing successful nonoperative management to immediate operative management, there were no differences in preterm labor/delivery or pregnancy loss, or antenatal hemorrhage; however, successful nonoperative management was also associated with higher risks of maternal infectious complications, including risks of amniotic infection, pneumonia, and sepsis. When comparing failed nonoperative management (women who required surgical intervention during the index hospitalization) to immediate operative management, failed conservative management was associated with higher risks of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, amniotic infection, pneumonia, and sepsis. For every 1 day that surgery was delayed in the group of women who failed nonoperative management, the odds of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, sepsis, amniotic infection, and pneumonia increased.

Study strengths and weaknesses

Database studies have inherent limitations that are overcome with strength in numbers. In this study, our understanding of outcomes associated with management of complicated appendicitis assumes that women were correctly identified as both being pregnant and having complicated appendicitis (as opposed to uncomplicated appendicitis but miscoded). Clinical data that may have led to selection of one management strategy over another, or specific clinical management decisions, are not possible to extract from the NIS. For instance, did nonoperative management systematically include percutaneous guided drainage if an abscess was noted, and appropriately targeted antibiotic therapy? If delayed operative intervention with IV antibiotics to allow for “cooling off” of the abdomen prior to surgery was planned, this strategy would have been included in the failed nonoperative management group, when in fact nonoperative management was never the plan. Whether gestational age (which is not known in this study), or any other clinical data contributed to the initially chosen management strategy is not known.

The treating clinicians, obstetricians and surgeons alike, would like to know the pregnancy outcome when considering the various management strategies for complicated appendicitis. However, this study only provides insight into the outcomes for the hospitalization for appendicitis. Whether or not women categorized as successful nonoperative management go on to require surgery or have preterm labor in the future, or whether women with successful immediate surgical management might be readmitted with complications, is not known. This is a significant limitation of the database, which does not allow for linking of individual hospitalizations, and rather can provide only a snapshot in time.

This study includes a fairly long timespan–2003 to 2015–during which the management of complicated appendicitis was actively evolving. Early in this time frame, nonoperative management outside of pregnancy was uncommon, and nonoperative management may have been even rarer and perhaps reserved for the most ill of pregnant women on presentation (for whom surgery may have been considered too risky without a short time with IV antibiotics to “cool off” the abdomen). As time progressed over the study span, nonoperative management was likely offered with greater frequency and among women with lesser degrees of illness. However, the year of presentation was not controlled for in this study.

Finally, given the differences noted in management strategy by race/ethnicity and type of hospital, it is not clear how this bias influences the findings from this study. ●

Ashbrook M, et al. Management of complicated appendicitis during pregnancy in the US. JAMA Network Open. 2022;5:e227555. doi:10.1001/jamanetworkopen.2022.7555.

Expert Commentary

Over the last decade, the management of acute appendicitis in the nonpregnant adult has evolved such that some authorities favor first-line nonoperative therapy in the appropriate candidate, including some individuals with complicated appendicitis. While the conventional teaching regarding appendicitis in pregnancy has always been immediate surgery, favorable outcomes from nonoperative management in the nonpregnant population have led to an increasing application of conservative therapy in pregnancy, particularly among patients with uncomplicated appendicitis. However, optimal management of complicated appendicitis in pregnancy is unclear, as the risks of both operative and nonoperative management can be significant.

Details about the study

This retrospective cohort study using data from the National Inpatient Sample (NIS) focuses on outcomes of various management options among pregnant women with complicated appendicitis from January 2003 to September 2015. Complicated appendicitis refers to individuals with appendiceal perforation with peritonitis (a free perforation) or phlegmon/abscess (a walled-off perforation). Women included in the study were identified using ICD-9 codes for both pregnancy and complicated appendicitis; they were categorized into 3 groups: immediate operative management, successful nonoperative management, and failed nonoperative management (defined as surgical intervention >1 day after admission). The clinical and other outcomes of interest included maternal death, preterm labor/delivery or pregnancy loss, amniotic infection, sepsis, pneumonia, antenatal hemorrhage, and premature rupture of membranes. Outcomes included are those that occurred during the hospitalization for appendicitis; outcomes that may have occurred between discharge from the appendicitis hospitalization to the delivery hospitalization are not included in this study.

A total of 8,087 pregnant women with complicated appendicitis were included in this study, of whom 954 (11.8%) had successful nonoperative management, 2,646 (32.7%) had failed nonoperative management, and 4,487 (55.5%) had immediate operative management. First, when comparing successful nonoperative management to immediate operative management, there were no differences in preterm labor/delivery or pregnancy loss, or antenatal hemorrhage; however, successful nonoperative management was also associated with higher risks of maternal infectious complications, including risks of amniotic infection, pneumonia, and sepsis. When comparing failed nonoperative management (women who required surgical intervention during the index hospitalization) to immediate operative management, failed conservative management was associated with higher risks of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, amniotic infection, pneumonia, and sepsis. For every 1 day that surgery was delayed in the group of women who failed nonoperative management, the odds of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, sepsis, amniotic infection, and pneumonia increased.

Study strengths and weaknesses

Database studies have inherent limitations that are overcome with strength in numbers. In this study, our understanding of outcomes associated with management of complicated appendicitis assumes that women were correctly identified as both being pregnant and having complicated appendicitis (as opposed to uncomplicated appendicitis but miscoded). Clinical data that may have led to selection of one management strategy over another, or specific clinical management decisions, are not possible to extract from the NIS. For instance, did nonoperative management systematically include percutaneous guided drainage if an abscess was noted, and appropriately targeted antibiotic therapy? If delayed operative intervention with IV antibiotics to allow for “cooling off” of the abdomen prior to surgery was planned, this strategy would have been included in the failed nonoperative management group, when in fact nonoperative management was never the plan. Whether gestational age (which is not known in this study), or any other clinical data contributed to the initially chosen management strategy is not known.

The treating clinicians, obstetricians and surgeons alike, would like to know the pregnancy outcome when considering the various management strategies for complicated appendicitis. However, this study only provides insight into the outcomes for the hospitalization for appendicitis. Whether or not women categorized as successful nonoperative management go on to require surgery or have preterm labor in the future, or whether women with successful immediate surgical management might be readmitted with complications, is not known. This is a significant limitation of the database, which does not allow for linking of individual hospitalizations, and rather can provide only a snapshot in time.

This study includes a fairly long timespan–2003 to 2015–during which the management of complicated appendicitis was actively evolving. Early in this time frame, nonoperative management outside of pregnancy was uncommon, and nonoperative management may have been even rarer and perhaps reserved for the most ill of pregnant women on presentation (for whom surgery may have been considered too risky without a short time with IV antibiotics to “cool off” the abdomen). As time progressed over the study span, nonoperative management was likely offered with greater frequency and among women with lesser degrees of illness. However, the year of presentation was not controlled for in this study.

Finally, given the differences noted in management strategy by race/ethnicity and type of hospital, it is not clear how this bias influences the findings from this study. ●

Ashbrook M, et al. Management of complicated appendicitis during pregnancy in the US. JAMA Network Open. 2022;5:e227555. doi:10.1001/jamanetworkopen.2022.7555.

Expert Commentary

Over the last decade, the management of acute appendicitis in the nonpregnant adult has evolved such that some authorities favor first-line nonoperative therapy in the appropriate candidate, including some individuals with complicated appendicitis. While the conventional teaching regarding appendicitis in pregnancy has always been immediate surgery, favorable outcomes from nonoperative management in the nonpregnant population have led to an increasing application of conservative therapy in pregnancy, particularly among patients with uncomplicated appendicitis. However, optimal management of complicated appendicitis in pregnancy is unclear, as the risks of both operative and nonoperative management can be significant.

Details about the study

This retrospective cohort study using data from the National Inpatient Sample (NIS) focuses on outcomes of various management options among pregnant women with complicated appendicitis from January 2003 to September 2015. Complicated appendicitis refers to individuals with appendiceal perforation with peritonitis (a free perforation) or phlegmon/abscess (a walled-off perforation). Women included in the study were identified using ICD-9 codes for both pregnancy and complicated appendicitis; they were categorized into 3 groups: immediate operative management, successful nonoperative management, and failed nonoperative management (defined as surgical intervention >1 day after admission). The clinical and other outcomes of interest included maternal death, preterm labor/delivery or pregnancy loss, amniotic infection, sepsis, pneumonia, antenatal hemorrhage, and premature rupture of membranes. Outcomes included are those that occurred during the hospitalization for appendicitis; outcomes that may have occurred between discharge from the appendicitis hospitalization to the delivery hospitalization are not included in this study.

A total of 8,087 pregnant women with complicated appendicitis were included in this study, of whom 954 (11.8%) had successful nonoperative management, 2,646 (32.7%) had failed nonoperative management, and 4,487 (55.5%) had immediate operative management. First, when comparing successful nonoperative management to immediate operative management, there were no differences in preterm labor/delivery or pregnancy loss, or antenatal hemorrhage; however, successful nonoperative management was also associated with higher risks of maternal infectious complications, including risks of amniotic infection, pneumonia, and sepsis. When comparing failed nonoperative management (women who required surgical intervention during the index hospitalization) to immediate operative management, failed conservative management was associated with higher risks of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, amniotic infection, pneumonia, and sepsis. For every 1 day that surgery was delayed in the group of women who failed nonoperative management, the odds of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, sepsis, amniotic infection, and pneumonia increased.

Study strengths and weaknesses

Database studies have inherent limitations that are overcome with strength in numbers. In this study, our understanding of outcomes associated with management of complicated appendicitis assumes that women were correctly identified as both being pregnant and having complicated appendicitis (as opposed to uncomplicated appendicitis but miscoded). Clinical data that may have led to selection of one management strategy over another, or specific clinical management decisions, are not possible to extract from the NIS. For instance, did nonoperative management systematically include percutaneous guided drainage if an abscess was noted, and appropriately targeted antibiotic therapy? If delayed operative intervention with IV antibiotics to allow for “cooling off” of the abdomen prior to surgery was planned, this strategy would have been included in the failed nonoperative management group, when in fact nonoperative management was never the plan. Whether gestational age (which is not known in this study), or any other clinical data contributed to the initially chosen management strategy is not known.

The treating clinicians, obstetricians and surgeons alike, would like to know the pregnancy outcome when considering the various management strategies for complicated appendicitis. However, this study only provides insight into the outcomes for the hospitalization for appendicitis. Whether or not women categorized as successful nonoperative management go on to require surgery or have preterm labor in the future, or whether women with successful immediate surgical management might be readmitted with complications, is not known. This is a significant limitation of the database, which does not allow for linking of individual hospitalizations, and rather can provide only a snapshot in time.

This study includes a fairly long timespan–2003 to 2015–during which the management of complicated appendicitis was actively evolving. Early in this time frame, nonoperative management outside of pregnancy was uncommon, and nonoperative management may have been even rarer and perhaps reserved for the most ill of pregnant women on presentation (for whom surgery may have been considered too risky without a short time with IV antibiotics to “cool off” the abdomen). As time progressed over the study span, nonoperative management was likely offered with greater frequency and among women with lesser degrees of illness. However, the year of presentation was not controlled for in this study.

Finally, given the differences noted in management strategy by race/ethnicity and type of hospital, it is not clear how this bias influences the findings from this study. ●