When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.

While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.

Case

A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?

A. Obtain lipids with her other blood work now.

B. Have her return tomorrow to obtain fasting labs.

In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.

Studies of fasting vs. nonfasting lipids

Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.¹ They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.

Mora and colleagues performed a post hoc prospective follow-up of a randomized control

trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.² Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.

Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.³ Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).³

Benefits of nonfasting lipid labs

There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.

For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.

Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
 

Summary

Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.

Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.⁴
 

Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Rahman F et al. Curr Atheroscler Rep. 2018;20(3):14. Published 2018 Feb 17.

2. Mora S et al. JAMA Intern Med. 2019;179(7):898-905.

3. Sidhu D and Naugler C. Arch Intern Med. 2012;172(22):1707-10.

4. Hoover LE. Am Fam Physician. 2019 May 1;99(9):589-91.

When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.

While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.

Case

A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?

A. Obtain lipids with her other blood work now.

B. Have her return tomorrow to obtain fasting labs.

In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.

Studies of fasting vs. nonfasting lipids

Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.¹ They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.

Mora and colleagues performed a post hoc prospective follow-up of a randomized control

trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.² Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.

Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.³ Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).³

Benefits of nonfasting lipid labs

There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.

For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.

Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
 

Summary

Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.

Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.⁴
 

Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Rahman F et al. Curr Atheroscler Rep. 2018;20(3):14. Published 2018 Feb 17.

2. Mora S et al. JAMA Intern Med. 2019;179(7):898-905.

3. Sidhu D and Naugler C. Arch Intern Med. 2012;172(22):1707-10.

4. Hoover LE. Am Fam Physician. 2019 May 1;99(9):589-91.

When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.

While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.

Case

A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?

A. Obtain lipids with her other blood work now.

B. Have her return tomorrow to obtain fasting labs.

In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.

Studies of fasting vs. nonfasting lipids

Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.¹ They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.

Mora and colleagues performed a post hoc prospective follow-up of a randomized control

trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.² Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.

Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.³ Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).³

Benefits of nonfasting lipid labs

There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.

For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.

Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
 

Summary

Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.

Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.⁴
 

Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Rahman F et al. Curr Atheroscler Rep. 2018;20(3):14. Published 2018 Feb 17.

2. Mora S et al. JAMA Intern Med. 2019;179(7):898-905.

3. Sidhu D and Naugler C. Arch Intern Med. 2012;172(22):1707-10.

4. Hoover LE. Am Fam Physician. 2019 May 1;99(9):589-91.

Takeaway

• Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
• Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.

Why this matters

• Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.

Study design

• A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
• Funding: Gender and Prevention Grant from ZonMw and other.

Key results

• During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
• A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
• Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
• –Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
• –Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).

• The risk of new-onset AF was significantly higher in women who experienced menopause:
• –At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
• –Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
• –At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
• Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.

Limitations

• Observational design.

A version of this article first appeared on Medscape UK.

Reference

Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.

Takeaway

• Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
• Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.

Why this matters

• Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.

Study design

• A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
• Funding: Gender and Prevention Grant from ZonMw and other.

Key results

• During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
• A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
• Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
• –Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
• –Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).

• The risk of new-onset AF was significantly higher in women who experienced menopause:
• –At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
• –Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
• –At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
• Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.

Limitations

• Observational design.

A version of this article first appeared on Medscape UK.

Reference

Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.

Takeaway

• Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
• Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.

Why this matters

• Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.

Study design

• A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
• Funding: Gender and Prevention Grant from ZonMw and other.

Key results

• During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
• A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
• Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
• –Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
• –Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).

• The risk of new-onset AF was significantly higher in women who experienced menopause:
• –At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
• –Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
• –At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
• Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.

Limitations

• Observational design.

A version of this article first appeared on Medscape UK.

Reference

Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.

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. ●

Do you want to support the AGA Research Foundation, but feel overwhelmed by everyday living costs, such as the latest home repair, food expenses, and escalating gas prices?

There’s a solution that doesn’t involve writing a check. You can designate a gift in your estate plan. There are two main benefits to this meaningful step:

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The easiest and most popular way to support the AGA Research Foundation while putting your current financial needs first is to include a gift in your will or revocable living trust. It takes as little as one sentence to complete your gift.

Best of all, you have the option to leave a percentage of your estate or an asset so that no matter how the size of your estate changes, gifts to your family and nonprofits remain proportional.

Your gift directly supports the talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.

Do you want to support the AGA Research Foundation, but feel overwhelmed by everyday living costs, such as the latest home repair, food expenses, and escalating gas prices?

There’s a solution that doesn’t involve writing a check. You can designate a gift in your estate plan. There are two main benefits to this meaningful step:

• Your current income or assets remain the same.
• You can change your mind at any time.

The easiest and most popular way to support the AGA Research Foundation while putting your current financial needs first is to include a gift in your will or revocable living trust. It takes as little as one sentence to complete your gift.

Best of all, you have the option to leave a percentage of your estate or an asset so that no matter how the size of your estate changes, gifts to your family and nonprofits remain proportional.

Your gift directly supports the talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.

Do you want to support the AGA Research Foundation, but feel overwhelmed by everyday living costs, such as the latest home repair, food expenses, and escalating gas prices?

There’s a solution that doesn’t involve writing a check. You can designate a gift in your estate plan. There are two main benefits to this meaningful step:

• Your current income or assets remain the same.
• You can change your mind at any time.

The easiest and most popular way to support the AGA Research Foundation while putting your current financial needs first is to include a gift in your will or revocable living trust. It takes as little as one sentence to complete your gift.

Best of all, you have the option to leave a percentage of your estate or an asset so that no matter how the size of your estate changes, gifts to your family and nonprofits remain proportional.

Your gift directly supports the talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.

STOCKHOLM – New evidence continues to show that alternative measures of adiposity than body mass index, such as waist-to-hip ratio, work better for predicting the risk a person with overweight or obesity faces from their excess weight.

A direct comparison of waist-to-hip ratio (WHR), body mass index (BMI), and fat mass index (FMI) in a total of more than 380,000 United Kingdom residents included in the UK Biobank showed that WHR had the strongest and most consistent relationship to all-cause death, compared with the other two measures, indicating that clinicians should pay more attention to adiposity distribution than they do to BMI when prioritizing obesity interventions, Irfan Khan said at the annual meeting of the European Association for the Study of Diabetes.

MDedge News/Mitchel L. Zoler

Moving away from BMI-centric obesity

“This is a timely topic, because guidelines for treating people with obesity have depended so much on BMI. We want to go from a BMI-centric view to a view of obesity that depends more on disease burden,” commented Matthias Blüher, MD, professor of molecular endocrinology and head of the Obesity Outpatient Clinic for Adults at the University of Leipzig (Germany).

MDedge News/Mitchel L. Zoler

For example, the 2016 obesity management guidelines from the American Association of Clinical Endocrinologists and the American College of Endocrinology called for a “complications-centric” approach to assessing and intervening in people with obesity rather than a “BMI-centric” approach.

But Dr. Blüher went a step further in an interview, adding that “waist-to-hip ratio is now outdated,” with adjusted measures of WHR such as waist-to-height ratio “considered a better proxy for all-cause death.” He also gave high marks to the Edmonton Obesity Staging System, which independently added to BMI as well as to a diagnosis of metabolic syndrome for predicting mortality in a sample from the U.S. National Health and Nutrition Examination Survey (NHANES). The Edmonton System also surpassed BMI for disease-severity staging using data from more than 23,000 Canadians with a BMI that denoted obesity.
 

1 standard deviation increase in WHR linked with a 41% increased mortality

The study reported by Mr. Khan used both epidemiologic and Mendelian randomization analyses on data collected from more than 380,000 U.K. residents included in the UK Biobank database to examine the statistical associations between BMI, FMI, and WHR and all-cause death. This showed that while BMI and FMI both had significant, independent associations with all-cause mortality, with hazard ratios of 1.14 for each 1 standard deviation increase in BMI and of 1.17 for each standard deviation increase in FMI, the link was a stronger 1.41 per standard deviation increase in WHR, he said.

Another analysis that divided the entire UK Biobank study cohort into 20 roughly similar subgroups by their BMI showed that WHR had the most consistent association across the BMI spectrum.

Further analyses showed that WHR also strongly and significantly linked with cardiovascular disease death and with other causes of death that were not cardiovascular, cancer-related, or associated with respiratory diseases. And the WHR link to all-cause mortality was strongest in men, and much less robust in women, likely because visceral adiposity is much more common among men, even compared with the postmenopausal women who predominate in the UK Biobank cohort.

One more feature of WHR that makes it an attractive metric is its relative ease of measurement, about as easy as BMI, Mr. Khan said.

The study received no commercial funding, and Mr. Khan had no disclosures. Dr. Blüher has been a consultant to or speaker on behalf of Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, Novartis, Novo Nordisk, and Sanofi.

[email protected]

STOCKHOLM – New evidence continues to show that alternative measures of adiposity than body mass index, such as waist-to-hip ratio, work better for predicting the risk a person with overweight or obesity faces from their excess weight.

A direct comparison of waist-to-hip ratio (WHR), body mass index (BMI), and fat mass index (FMI) in a total of more than 380,000 United Kingdom residents included in the UK Biobank showed that WHR had the strongest and most consistent relationship to all-cause death, compared with the other two measures, indicating that clinicians should pay more attention to adiposity distribution than they do to BMI when prioritizing obesity interventions, Irfan Khan said at the annual meeting of the European Association for the Study of Diabetes.

MDedge News/Mitchel L. Zoler

Moving away from BMI-centric obesity

“This is a timely topic, because guidelines for treating people with obesity have depended so much on BMI. We want to go from a BMI-centric view to a view of obesity that depends more on disease burden,” commented Matthias Blüher, MD, professor of molecular endocrinology and head of the Obesity Outpatient Clinic for Adults at the University of Leipzig (Germany).

MDedge News/Mitchel L. Zoler

For example, the 2016 obesity management guidelines from the American Association of Clinical Endocrinologists and the American College of Endocrinology called for a “complications-centric” approach to assessing and intervening in people with obesity rather than a “BMI-centric” approach.

But Dr. Blüher went a step further in an interview, adding that “waist-to-hip ratio is now outdated,” with adjusted measures of WHR such as waist-to-height ratio “considered a better proxy for all-cause death.” He also gave high marks to the Edmonton Obesity Staging System, which independently added to BMI as well as to a diagnosis of metabolic syndrome for predicting mortality in a sample from the U.S. National Health and Nutrition Examination Survey (NHANES). The Edmonton System also surpassed BMI for disease-severity staging using data from more than 23,000 Canadians with a BMI that denoted obesity.
 

1 standard deviation increase in WHR linked with a 41% increased mortality

The study reported by Mr. Khan used both epidemiologic and Mendelian randomization analyses on data collected from more than 380,000 U.K. residents included in the UK Biobank database to examine the statistical associations between BMI, FMI, and WHR and all-cause death. This showed that while BMI and FMI both had significant, independent associations with all-cause mortality, with hazard ratios of 1.14 for each 1 standard deviation increase in BMI and of 1.17 for each standard deviation increase in FMI, the link was a stronger 1.41 per standard deviation increase in WHR, he said.

Another analysis that divided the entire UK Biobank study cohort into 20 roughly similar subgroups by their BMI showed that WHR had the most consistent association across the BMI spectrum.

Further analyses showed that WHR also strongly and significantly linked with cardiovascular disease death and with other causes of death that were not cardiovascular, cancer-related, or associated with respiratory diseases. And the WHR link to all-cause mortality was strongest in men, and much less robust in women, likely because visceral adiposity is much more common among men, even compared with the postmenopausal women who predominate in the UK Biobank cohort.

One more feature of WHR that makes it an attractive metric is its relative ease of measurement, about as easy as BMI, Mr. Khan said.

The study received no commercial funding, and Mr. Khan had no disclosures. Dr. Blüher has been a consultant to or speaker on behalf of Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, Novartis, Novo Nordisk, and Sanofi.

[email protected]

STOCKHOLM – New evidence continues to show that alternative measures of adiposity than body mass index, such as waist-to-hip ratio, work better for predicting the risk a person with overweight or obesity faces from their excess weight.

A direct comparison of waist-to-hip ratio (WHR), body mass index (BMI), and fat mass index (FMI) in a total of more than 380,000 United Kingdom residents included in the UK Biobank showed that WHR had the strongest and most consistent relationship to all-cause death, compared with the other two measures, indicating that clinicians should pay more attention to adiposity distribution than they do to BMI when prioritizing obesity interventions, Irfan Khan said at the annual meeting of the European Association for the Study of Diabetes.

MDedge News/Mitchel L. Zoler

Moving away from BMI-centric obesity

“This is a timely topic, because guidelines for treating people with obesity have depended so much on BMI. We want to go from a BMI-centric view to a view of obesity that depends more on disease burden,” commented Matthias Blüher, MD, professor of molecular endocrinology and head of the Obesity Outpatient Clinic for Adults at the University of Leipzig (Germany).

MDedge News/Mitchel L. Zoler

For example, the 2016 obesity management guidelines from the American Association of Clinical Endocrinologists and the American College of Endocrinology called for a “complications-centric” approach to assessing and intervening in people with obesity rather than a “BMI-centric” approach.

But Dr. Blüher went a step further in an interview, adding that “waist-to-hip ratio is now outdated,” with adjusted measures of WHR such as waist-to-height ratio “considered a better proxy for all-cause death.” He also gave high marks to the Edmonton Obesity Staging System, which independently added to BMI as well as to a diagnosis of metabolic syndrome for predicting mortality in a sample from the U.S. National Health and Nutrition Examination Survey (NHANES). The Edmonton System also surpassed BMI for disease-severity staging using data from more than 23,000 Canadians with a BMI that denoted obesity.
 

1 standard deviation increase in WHR linked with a 41% increased mortality

The study reported by Mr. Khan used both epidemiologic and Mendelian randomization analyses on data collected from more than 380,000 U.K. residents included in the UK Biobank database to examine the statistical associations between BMI, FMI, and WHR and all-cause death. This showed that while BMI and FMI both had significant, independent associations with all-cause mortality, with hazard ratios of 1.14 for each 1 standard deviation increase in BMI and of 1.17 for each standard deviation increase in FMI, the link was a stronger 1.41 per standard deviation increase in WHR, he said.

Another analysis that divided the entire UK Biobank study cohort into 20 roughly similar subgroups by their BMI showed that WHR had the most consistent association across the BMI spectrum.

Further analyses showed that WHR also strongly and significantly linked with cardiovascular disease death and with other causes of death that were not cardiovascular, cancer-related, or associated with respiratory diseases. And the WHR link to all-cause mortality was strongest in men, and much less robust in women, likely because visceral adiposity is much more common among men, even compared with the postmenopausal women who predominate in the UK Biobank cohort.

One more feature of WHR that makes it an attractive metric is its relative ease of measurement, about as easy as BMI, Mr. Khan said.

The study received no commercial funding, and Mr. Khan had no disclosures. Dr. Blüher has been a consultant to or speaker on behalf of Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, Novartis, Novo Nordisk, and Sanofi.

[email protected]

Obesity currently affects more than 40% of the U.S. population. It is the second-leading preventable cause of mortality behind smoking with an estimated 300,000 deaths per year.^1,2 Weight loss can reduce the risk of metabolic comorbidities such as diabetes, heart disease, and stroke. However, 5%-10% total body weight loss (TBWL) is required for risk reduction.³ Sustained weight loss involves dietary alterations and physical activity, although it is difficult to maintain long term with lifestyle changes alone. Less than 10% of Americans with a BMI greater than 30 kg/m² will achieve 5% TBWL each year, and nearly 80% of people will regain the weight within 5 years, a phenomenon known as “weight cycling.”^4,5 Not only can these weight fluctuations make future weight-loss efforts more difficult, but they can also negatively impact cardiometabolic health in the long term.⁵ Thus, additional therapies are typically needed in conjunction with lifestyle interventions to treat obesity.

Current guidelines recommend bariatric surgery for patients unable to achieve or maintain weight loss through lifestyle changes.⁶ Surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy lead to improvements in morbidity and mortality from metabolic diseases but are often only approved for select patients with a BMI of at least 40 or at least 35 with obesity-related comorbidities.⁷ These restrictions exclude patients at lower BMIs who may have early metabolic disease. Furthermore, only a small proportion of eligible patients are referred or willing to undergo surgery because of access issues, socioeconomic barriers, and concerns about adverse events.^8,9 Endoscopic bariatric therapy and antiobesity medications (AOMs) have blossomed because of the need for other less-invasive options to stimulate weight loss.
 

Minimally invasive and noninvasive therapies in obesity

Endoscopic bariatric and metabolic therapies

Endoscopic bariatric and metabolic therapies (EBMTs) are used for the treatment of obesity in patients with a BMI of 30 kg/m², a cohort that may be ineligible for bariatric surgery.^10,11 EBMTs involve three categories: space-occupying devices (intragastric balloons [IGBs], transpyloric shuttle [TPS]), aspiration therapy, and gastric remodeling (endoscopic sleeve gastroplasty [ESG]).^21,13 Presently, TPS and aspiration therapy are not commercially available in the United States. There are three types of IGB approved by the Food and Drug Administration, and Apollo ESGTM recently received de novo marketing authorization for the treatment of obesity. TBWL with EBMTs is promising at 12 months post procedure. Ranges include 7%-12% TBWL for IGBs and 15%-19% for ESG, with low rates of serious adverse events (AEs).^13-18 Weight loss often reaches or exceeds the 10% TBWL needed to improve or completely reverse metabolic complications.

Obesity pharmacotherapy

Multiple professional societies support the use of obesity pharmacotherapy as an effective adjunct to lifestyle interventions.¹⁹ AOMs are classified as peripherally-acting to prevent nutrition absorption (e.g. orlistat), centrally acting to suppress appetite and/or cravings (e.g., phentermine/topiramate or naltrexone/bupropion), or incretin mimetics such as glucagonlike peptide–1 agonists (e.g., liraglutide, semaglutide).²⁰ With the exception of orlistat, most agents have some effects on the hypothalamus to suppress appetite.²¹ Obesity medications tend to lead to a minimum weight loss of 3-10 kg after 12 months of treatment, and newer medications have even greater efficacy.²² Despite these results, discontinuation rates of the popular GLP-1 agonists can be as high as 47.7% and 70.1% at 12 and 24 months, respectively, because of the high cost of medications, gastrointestinal side effects, and poor tolerance.^23,24

An ongoing challenge for patients is maintaining weight loss following cessation of pharmacotherapy when weight loss goals have been achieved. In this context, the combination of obesity pharmacotherapy and EBMTs can be utilized for long-term weight loss and weight maintenance given the chronic, relapsing, and complex nature of obesity.²⁵

Advantages of less-invasive therapies in obesity management

The advantages of both pharmacologic and endoscopic weight-loss therapies are numerous. Pharmacotherapies are noninvasive, and their multiple mechanisms allow for combined use to synergistically promote weight reduction.^26,27 Medications can be used in both the short- and long-term management of obesity, allowing for flexibility in use for patients pending fluctuations in weight. Furthermore, medications can improve markers of cardiovascular health including total cholesterol, LDL cholesterol, blood pressure, and glycemic control.²⁸

As minimally invasive therapies, EBMTs have less morbidity and mortality, compared with bariatric surgeries.²⁹ The most common side effects of IGBs or ESG include abdominal pain, nausea, and worsening of acid reflux symptoms, which can be medically managed unlike some of the AEs associated with surgery, such as bowel obstruction, anastomotic dehiscence, fistulization, and postoperative infections.³⁰ Long-term AEs from surgery also include malabsorption, nutritional deficiencies, cholelithiasis, and anastomotic stenosis.³¹ Even with improvement in surgical techniques, the rate of perioperative and postoperative mortality in Roux-en-Y gastric bypass is estimated to be 0.4% and 0.7%, respectively, compared with only 0.08% with IGBs.^30,32

In addition, EBMTs are also more cost effective than surgery, as they are often same-day outpatient procedures, leading to decreased length of stay (LOS) for patients. In ongoing research conducted by Sharaiha and colleagues, it was found that patients undergoing ESG had an average LOS of only 0.13 days, compared with 3.09 days for laparoscopic sleeve gastrectomy and 1.68 for laparoscopic gastric banding. The cost for ESG was approximately $12,000, compared with $15,000-$22,000 for laparoscopic bariatric surgeries.³³ With their availability to patients with lower BMIs and their less-invasive nature, EBMTs and pharmacotherapy can be utilized on the spectrum of obesity care as bridge therapies both before and after surgery.

Our clinical approach

In 2015, the first Veterans Affairs hospital-based endoscopic bariatric program was established at the VA New York Harbor Healthcare System utilizing IGBs and weight loss pharmacotherapy in conjunction with the VA MOVE! Program to treat obesity and metabolic comorbidities in veterans. Since then, EBMTs have expanded to include ESG and novel medications. Our treatment algorithm accounts for the chronic nature of obesity, the risk of weight regain after any intervention, and the need for longitudinal patient care.

Patients undergo work-up by a multidisciplinary team (MD team) with a nutritionist, psychologist, primary care physician, gastroenterologist, and endocrinologist to determine the optimal treatment plan (Fig. 1).²⁹

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Patients are required to attend multiple information sessions, where all weight-loss methods are presented, including surgery, bariatric endoscopy, and pharmacotherapy. Other specialists also help manage comorbid conditions. Prior to selecting an initial intervention, patients undergo intensive lifestyle and behavioral therapy (Fig. 2 and 3). Depending on the selected therapy, initial treatment lasts between 3 and 12 months with ongoing support from the MD team.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

If patients do not achieve their targeted weight loss after initial treatment, a new strategy is selected. This includes a different EBMT such as ESG, alternate pharmacotherapy, or surgery until the weight and health goals of the patient are achieved and sustained (Fig. 3). From the start, patients are informed that our program is a long-term intervention and that active participation in the MOVE! Program, as well as follow-up with the MD team are keys to success. EBMTs and medications are presented as effective tools that only work to enhance the effects of lifestyle changes.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Our multidisciplinary approach provides flexibility for patients to trial different options depending on their progress. Research on long-term outcomes with weight loss and metabolic parameters is ongoing, though early results are promising. Thus far, we have observed that patients undergoing a combination therapy of EBMTs and AOMs have greater weight loss than patients on a single therapeutic approach with either EBMT or AOMs alone.³⁴ Racial and socioeconomic disparities in referrals to bariatric surgery are yet another barrier for patients to access weight reduction and improvement in cardiovascular health.³⁵ EBMTs and pharmacotherapy are no longer just on the horizon; they are here as accessible, effective, and long-term treatments for all patients with obesity. More expansive insurance coverage is needed for EBMTs and AOMs in order to prevent progression of obesity-related comorbidities, reduce high costs, and ensure more equitable access to these effective therapies.
 

Dr. Young and Dr. Zenger are resident physicians in the department of internal medicine at New York University. Dr. Holzwanger is an advanced endoscopy fellow in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. Dr. Popov is director of bariatric endoscopy at VA New York Harbor Healthcare System, and assistant professor of medicine at New York University. Dr. Popov reported relationships with Obalon, Microtech, and Spatz, but the remaining authors reported no competing interests.

References

1. Ward ZJ et al. N Engl J Med. 2019;381(25):2440-50.

2. Stein CJ and Colditz GA. J Clin Endocrinol Metab. 2004;89(6):2522-5.

3. Ryan DH and Yockey SR. Curr Obes Rep. 2017;6(2):187-94.

4. Fildes A et al. Am J Public Health. 2015;105(9):e54-9.

5. Rhee E-J. J Obes Metab Syndr. 2017;26(4):237-42.

6. American College of Cardiology/American Heart Association Task Force on Practice Guidelines OEP. Obesity (Silver Spring). 2014;22 Suppl 2:S5-39.

7. Adams TD et al. N Engl J Med. 2018;378(1):93-6.

8. Wharton S et al. Clin Obes. 2016;6(2):154-60.

9. Iuzzolino E and Kim Y. Obes Res Clin Pract. 2020;14(4):310-20.

10. Goyal D, Watson RR. Endoscopic Bariatric Therapies. Curr Gastroenterol Rep. 2016;18(6):26.

11. Ali MR et al. Surg Obes Relat Dis. 2016;12(3):462-467.

12. Turkeltaub JA, Edmundowicz SA. Curr Treat Options Gastroenterol. 2019;17(2):187-201.
 

13. Reja D et al. Transl Gastroenterol Hepatol. 2022;7:21.

14. Force ABET et al. Gastrointest Endosc. 2015;82(3):425-38e5.

15. Thompson CC et al. Am J Gastroenterol. 2017;112(3):447-57.

16. Nystrom M et al. Obes Surg. 2018;28(7):1860-8.

17. Abu Dayyeh BK et al. Surg Obes Relat Dis. 2019;15(8):1423-4.

18. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2017;15(4):504-10.

19. Apovian CM et al. J Clin Endocrinol Metab. 2015;100(2):342-62.

20. Son JW and Kim S. Diabetes Metab J. 2020;44(6):802-18.

21. Holst JJ. Int J Obes (Lond). Int J Obes (Lond). 2013;37(9):1161-8.

22. Joo JK and Lee KS. J Menopausal Med. 2014;20(3):90-6.

23. Weiss T et al. Patient Prefer Adherence. 2020;14:2337-45.

24. Sikirica MV et al. Diabetes Metab Syndr Obes. 2017;10:403-12.

25. Kahan S et al. Tech Innov Gastrointest Endosc. 2020;22(3):154-8.

26. Bhat SP and Sharma A. Curr Drug Targets. 2017;18(8):983-93.

27. Pendse J et al. Obesity (Silver Spring). 2021;29(2):308-16.

28. Rucker D et al. BMJ. 2007;335(7631):1194-9.

29. Jirapinyo P and Thompson CC. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

30. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81(5):1073-86.

31. Schulman AR and Thompson CC. Am J Gastroenterol. 2017;112(11):1640-55.

32. Ma IT and Madura JA, 2nd. Gastroenterol Hepatol (NY). 2015;11(8):526-35.

33. Sharaiha RZ. Endoscopic sleeve gastroplasty as a nonsurgical weight loss alternative. Digestive Disease Week, oral presentation. 2017.

34. Young S et al. Long-term efficacy of a multidisciplinary minimally invasive approach to weight management compared to single endoscopic therapy: A cohort study. P0865. American College of Gastroenterology Meeting, Abstract P0865. 2021.

35. Johnson-Mann C et al. Surg Obes Relat Dis. 2019;15(4):615-20.
 

Obesity currently affects more than 40% of the U.S. population. It is the second-leading preventable cause of mortality behind smoking with an estimated 300,000 deaths per year.^1,2 Weight loss can reduce the risk of metabolic comorbidities such as diabetes, heart disease, and stroke. However, 5%-10% total body weight loss (TBWL) is required for risk reduction.³ Sustained weight loss involves dietary alterations and physical activity, although it is difficult to maintain long term with lifestyle changes alone. Less than 10% of Americans with a BMI greater than 30 kg/m² will achieve 5% TBWL each year, and nearly 80% of people will regain the weight within 5 years, a phenomenon known as “weight cycling.”^4,5 Not only can these weight fluctuations make future weight-loss efforts more difficult, but they can also negatively impact cardiometabolic health in the long term.⁵ Thus, additional therapies are typically needed in conjunction with lifestyle interventions to treat obesity.

Current guidelines recommend bariatric surgery for patients unable to achieve or maintain weight loss through lifestyle changes.⁶ Surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy lead to improvements in morbidity and mortality from metabolic diseases but are often only approved for select patients with a BMI of at least 40 or at least 35 with obesity-related comorbidities.⁷ These restrictions exclude patients at lower BMIs who may have early metabolic disease. Furthermore, only a small proportion of eligible patients are referred or willing to undergo surgery because of access issues, socioeconomic barriers, and concerns about adverse events.^8,9 Endoscopic bariatric therapy and antiobesity medications (AOMs) have blossomed because of the need for other less-invasive options to stimulate weight loss.
 

Minimally invasive and noninvasive therapies in obesity

Endoscopic bariatric and metabolic therapies

Endoscopic bariatric and metabolic therapies (EBMTs) are used for the treatment of obesity in patients with a BMI of 30 kg/m², a cohort that may be ineligible for bariatric surgery.^10,11 EBMTs involve three categories: space-occupying devices (intragastric balloons [IGBs], transpyloric shuttle [TPS]), aspiration therapy, and gastric remodeling (endoscopic sleeve gastroplasty [ESG]).^21,13 Presently, TPS and aspiration therapy are not commercially available in the United States. There are three types of IGB approved by the Food and Drug Administration, and Apollo ESGTM recently received de novo marketing authorization for the treatment of obesity. TBWL with EBMTs is promising at 12 months post procedure. Ranges include 7%-12% TBWL for IGBs and 15%-19% for ESG, with low rates of serious adverse events (AEs).^13-18 Weight loss often reaches or exceeds the 10% TBWL needed to improve or completely reverse metabolic complications.

Obesity pharmacotherapy

Multiple professional societies support the use of obesity pharmacotherapy as an effective adjunct to lifestyle interventions.¹⁹ AOMs are classified as peripherally-acting to prevent nutrition absorption (e.g. orlistat), centrally acting to suppress appetite and/or cravings (e.g., phentermine/topiramate or naltrexone/bupropion), or incretin mimetics such as glucagonlike peptide–1 agonists (e.g., liraglutide, semaglutide).²⁰ With the exception of orlistat, most agents have some effects on the hypothalamus to suppress appetite.²¹ Obesity medications tend to lead to a minimum weight loss of 3-10 kg after 12 months of treatment, and newer medications have even greater efficacy.²² Despite these results, discontinuation rates of the popular GLP-1 agonists can be as high as 47.7% and 70.1% at 12 and 24 months, respectively, because of the high cost of medications, gastrointestinal side effects, and poor tolerance.^23,24

An ongoing challenge for patients is maintaining weight loss following cessation of pharmacotherapy when weight loss goals have been achieved. In this context, the combination of obesity pharmacotherapy and EBMTs can be utilized for long-term weight loss and weight maintenance given the chronic, relapsing, and complex nature of obesity.²⁵

Advantages of less-invasive therapies in obesity management

The advantages of both pharmacologic and endoscopic weight-loss therapies are numerous. Pharmacotherapies are noninvasive, and their multiple mechanisms allow for combined use to synergistically promote weight reduction.^26,27 Medications can be used in both the short- and long-term management of obesity, allowing for flexibility in use for patients pending fluctuations in weight. Furthermore, medications can improve markers of cardiovascular health including total cholesterol, LDL cholesterol, blood pressure, and glycemic control.²⁸

As minimally invasive therapies, EBMTs have less morbidity and mortality, compared with bariatric surgeries.²⁹ The most common side effects of IGBs or ESG include abdominal pain, nausea, and worsening of acid reflux symptoms, which can be medically managed unlike some of the AEs associated with surgery, such as bowel obstruction, anastomotic dehiscence, fistulization, and postoperative infections.³⁰ Long-term AEs from surgery also include malabsorption, nutritional deficiencies, cholelithiasis, and anastomotic stenosis.³¹ Even with improvement in surgical techniques, the rate of perioperative and postoperative mortality in Roux-en-Y gastric bypass is estimated to be 0.4% and 0.7%, respectively, compared with only 0.08% with IGBs.^30,32

In addition, EBMTs are also more cost effective than surgery, as they are often same-day outpatient procedures, leading to decreased length of stay (LOS) for patients. In ongoing research conducted by Sharaiha and colleagues, it was found that patients undergoing ESG had an average LOS of only 0.13 days, compared with 3.09 days for laparoscopic sleeve gastrectomy and 1.68 for laparoscopic gastric banding. The cost for ESG was approximately $12,000, compared with $15,000-$22,000 for laparoscopic bariatric surgeries.³³ With their availability to patients with lower BMIs and their less-invasive nature, EBMTs and pharmacotherapy can be utilized on the spectrum of obesity care as bridge therapies both before and after surgery.

Our clinical approach

In 2015, the first Veterans Affairs hospital-based endoscopic bariatric program was established at the VA New York Harbor Healthcare System utilizing IGBs and weight loss pharmacotherapy in conjunction with the VA MOVE! Program to treat obesity and metabolic comorbidities in veterans. Since then, EBMTs have expanded to include ESG and novel medications. Our treatment algorithm accounts for the chronic nature of obesity, the risk of weight regain after any intervention, and the need for longitudinal patient care.

Patients undergo work-up by a multidisciplinary team (MD team) with a nutritionist, psychologist, primary care physician, gastroenterologist, and endocrinologist to determine the optimal treatment plan (Fig. 1).²⁹

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Patients are required to attend multiple information sessions, where all weight-loss methods are presented, including surgery, bariatric endoscopy, and pharmacotherapy. Other specialists also help manage comorbid conditions. Prior to selecting an initial intervention, patients undergo intensive lifestyle and behavioral therapy (Fig. 2 and 3). Depending on the selected therapy, initial treatment lasts between 3 and 12 months with ongoing support from the MD team.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

If patients do not achieve their targeted weight loss after initial treatment, a new strategy is selected. This includes a different EBMT such as ESG, alternate pharmacotherapy, or surgery until the weight and health goals of the patient are achieved and sustained (Fig. 3). From the start, patients are informed that our program is a long-term intervention and that active participation in the MOVE! Program, as well as follow-up with the MD team are keys to success. EBMTs and medications are presented as effective tools that only work to enhance the effects of lifestyle changes.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Our multidisciplinary approach provides flexibility for patients to trial different options depending on their progress. Research on long-term outcomes with weight loss and metabolic parameters is ongoing, though early results are promising. Thus far, we have observed that patients undergoing a combination therapy of EBMTs and AOMs have greater weight loss than patients on a single therapeutic approach with either EBMT or AOMs alone.³⁴ Racial and socioeconomic disparities in referrals to bariatric surgery are yet another barrier for patients to access weight reduction and improvement in cardiovascular health.³⁵ EBMTs and pharmacotherapy are no longer just on the horizon; they are here as accessible, effective, and long-term treatments for all patients with obesity. More expansive insurance coverage is needed for EBMTs and AOMs in order to prevent progression of obesity-related comorbidities, reduce high costs, and ensure more equitable access to these effective therapies.
 

Dr. Young and Dr. Zenger are resident physicians in the department of internal medicine at New York University. Dr. Holzwanger is an advanced endoscopy fellow in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. Dr. Popov is director of bariatric endoscopy at VA New York Harbor Healthcare System, and assistant professor of medicine at New York University. Dr. Popov reported relationships with Obalon, Microtech, and Spatz, but the remaining authors reported no competing interests.

References

1. Ward ZJ et al. N Engl J Med. 2019;381(25):2440-50.

2. Stein CJ and Colditz GA. J Clin Endocrinol Metab. 2004;89(6):2522-5.

3. Ryan DH and Yockey SR. Curr Obes Rep. 2017;6(2):187-94.

4. Fildes A et al. Am J Public Health. 2015;105(9):e54-9.

5. Rhee E-J. J Obes Metab Syndr. 2017;26(4):237-42.

6. American College of Cardiology/American Heart Association Task Force on Practice Guidelines OEP. Obesity (Silver Spring). 2014;22 Suppl 2:S5-39.

7. Adams TD et al. N Engl J Med. 2018;378(1):93-6.

8. Wharton S et al. Clin Obes. 2016;6(2):154-60.

9. Iuzzolino E and Kim Y. Obes Res Clin Pract. 2020;14(4):310-20.

10. Goyal D, Watson RR. Endoscopic Bariatric Therapies. Curr Gastroenterol Rep. 2016;18(6):26.

11. Ali MR et al. Surg Obes Relat Dis. 2016;12(3):462-467.

12. Turkeltaub JA, Edmundowicz SA. Curr Treat Options Gastroenterol. 2019;17(2):187-201.
 

13. Reja D et al. Transl Gastroenterol Hepatol. 2022;7:21.

14. Force ABET et al. Gastrointest Endosc. 2015;82(3):425-38e5.

15. Thompson CC et al. Am J Gastroenterol. 2017;112(3):447-57.

16. Nystrom M et al. Obes Surg. 2018;28(7):1860-8.

17. Abu Dayyeh BK et al. Surg Obes Relat Dis. 2019;15(8):1423-4.

18. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2017;15(4):504-10.

19. Apovian CM et al. J Clin Endocrinol Metab. 2015;100(2):342-62.

20. Son JW and Kim S. Diabetes Metab J. 2020;44(6):802-18.

21. Holst JJ. Int J Obes (Lond). Int J Obes (Lond). 2013;37(9):1161-8.

22. Joo JK and Lee KS. J Menopausal Med. 2014;20(3):90-6.

23. Weiss T et al. Patient Prefer Adherence. 2020;14:2337-45.

24. Sikirica MV et al. Diabetes Metab Syndr Obes. 2017;10:403-12.

25. Kahan S et al. Tech Innov Gastrointest Endosc. 2020;22(3):154-8.

26. Bhat SP and Sharma A. Curr Drug Targets. 2017;18(8):983-93.

27. Pendse J et al. Obesity (Silver Spring). 2021;29(2):308-16.

28. Rucker D et al. BMJ. 2007;335(7631):1194-9.

29. Jirapinyo P and Thompson CC. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

30. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81(5):1073-86.

31. Schulman AR and Thompson CC. Am J Gastroenterol. 2017;112(11):1640-55.

32. Ma IT and Madura JA, 2nd. Gastroenterol Hepatol (NY). 2015;11(8):526-35.

33. Sharaiha RZ. Endoscopic sleeve gastroplasty as a nonsurgical weight loss alternative. Digestive Disease Week, oral presentation. 2017.

34. Young S et al. Long-term efficacy of a multidisciplinary minimally invasive approach to weight management compared to single endoscopic therapy: A cohort study. P0865. American College of Gastroenterology Meeting, Abstract P0865. 2021.

35. Johnson-Mann C et al. Surg Obes Relat Dis. 2019;15(4):615-20.
 

Obesity currently affects more than 40% of the U.S. population. It is the second-leading preventable cause of mortality behind smoking with an estimated 300,000 deaths per year.^1,2 Weight loss can reduce the risk of metabolic comorbidities such as diabetes, heart disease, and stroke. However, 5%-10% total body weight loss (TBWL) is required for risk reduction.³ Sustained weight loss involves dietary alterations and physical activity, although it is difficult to maintain long term with lifestyle changes alone. Less than 10% of Americans with a BMI greater than 30 kg/m² will achieve 5% TBWL each year, and nearly 80% of people will regain the weight within 5 years, a phenomenon known as “weight cycling.”^4,5 Not only can these weight fluctuations make future weight-loss efforts more difficult, but they can also negatively impact cardiometabolic health in the long term.⁵ Thus, additional therapies are typically needed in conjunction with lifestyle interventions to treat obesity.

Current guidelines recommend bariatric surgery for patients unable to achieve or maintain weight loss through lifestyle changes.⁶ Surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy lead to improvements in morbidity and mortality from metabolic diseases but are often only approved for select patients with a BMI of at least 40 or at least 35 with obesity-related comorbidities.⁷ These restrictions exclude patients at lower BMIs who may have early metabolic disease. Furthermore, only a small proportion of eligible patients are referred or willing to undergo surgery because of access issues, socioeconomic barriers, and concerns about adverse events.^8,9 Endoscopic bariatric therapy and antiobesity medications (AOMs) have blossomed because of the need for other less-invasive options to stimulate weight loss.
 

Minimally invasive and noninvasive therapies in obesity

Endoscopic bariatric and metabolic therapies

Endoscopic bariatric and metabolic therapies (EBMTs) are used for the treatment of obesity in patients with a BMI of 30 kg/m², a cohort that may be ineligible for bariatric surgery.^10,11 EBMTs involve three categories: space-occupying devices (intragastric balloons [IGBs], transpyloric shuttle [TPS]), aspiration therapy, and gastric remodeling (endoscopic sleeve gastroplasty [ESG]).^21,13 Presently, TPS and aspiration therapy are not commercially available in the United States. There are three types of IGB approved by the Food and Drug Administration, and Apollo ESGTM recently received de novo marketing authorization for the treatment of obesity. TBWL with EBMTs is promising at 12 months post procedure. Ranges include 7%-12% TBWL for IGBs and 15%-19% for ESG, with low rates of serious adverse events (AEs).^13-18 Weight loss often reaches or exceeds the 10% TBWL needed to improve or completely reverse metabolic complications.

Obesity pharmacotherapy

Multiple professional societies support the use of obesity pharmacotherapy as an effective adjunct to lifestyle interventions.¹⁹ AOMs are classified as peripherally-acting to prevent nutrition absorption (e.g. orlistat), centrally acting to suppress appetite and/or cravings (e.g., phentermine/topiramate or naltrexone/bupropion), or incretin mimetics such as glucagonlike peptide–1 agonists (e.g., liraglutide, semaglutide).²⁰ With the exception of orlistat, most agents have some effects on the hypothalamus to suppress appetite.²¹ Obesity medications tend to lead to a minimum weight loss of 3-10 kg after 12 months of treatment, and newer medications have even greater efficacy.²² Despite these results, discontinuation rates of the popular GLP-1 agonists can be as high as 47.7% and 70.1% at 12 and 24 months, respectively, because of the high cost of medications, gastrointestinal side effects, and poor tolerance.^23,24

An ongoing challenge for patients is maintaining weight loss following cessation of pharmacotherapy when weight loss goals have been achieved. In this context, the combination of obesity pharmacotherapy and EBMTs can be utilized for long-term weight loss and weight maintenance given the chronic, relapsing, and complex nature of obesity.²⁵

Advantages of less-invasive therapies in obesity management

The advantages of both pharmacologic and endoscopic weight-loss therapies are numerous. Pharmacotherapies are noninvasive, and their multiple mechanisms allow for combined use to synergistically promote weight reduction.^26,27 Medications can be used in both the short- and long-term management of obesity, allowing for flexibility in use for patients pending fluctuations in weight. Furthermore, medications can improve markers of cardiovascular health including total cholesterol, LDL cholesterol, blood pressure, and glycemic control.²⁸

As minimally invasive therapies, EBMTs have less morbidity and mortality, compared with bariatric surgeries.²⁹ The most common side effects of IGBs or ESG include abdominal pain, nausea, and worsening of acid reflux symptoms, which can be medically managed unlike some of the AEs associated with surgery, such as bowel obstruction, anastomotic dehiscence, fistulization, and postoperative infections.³⁰ Long-term AEs from surgery also include malabsorption, nutritional deficiencies, cholelithiasis, and anastomotic stenosis.³¹ Even with improvement in surgical techniques, the rate of perioperative and postoperative mortality in Roux-en-Y gastric bypass is estimated to be 0.4% and 0.7%, respectively, compared with only 0.08% with IGBs.^30,32

In addition, EBMTs are also more cost effective than surgery, as they are often same-day outpatient procedures, leading to decreased length of stay (LOS) for patients. In ongoing research conducted by Sharaiha and colleagues, it was found that patients undergoing ESG had an average LOS of only 0.13 days, compared with 3.09 days for laparoscopic sleeve gastrectomy and 1.68 for laparoscopic gastric banding. The cost for ESG was approximately $12,000, compared with $15,000-$22,000 for laparoscopic bariatric surgeries.³³ With their availability to patients with lower BMIs and their less-invasive nature, EBMTs and pharmacotherapy can be utilized on the spectrum of obesity care as bridge therapies both before and after surgery.

Our clinical approach

In 2015, the first Veterans Affairs hospital-based endoscopic bariatric program was established at the VA New York Harbor Healthcare System utilizing IGBs and weight loss pharmacotherapy in conjunction with the VA MOVE! Program to treat obesity and metabolic comorbidities in veterans. Since then, EBMTs have expanded to include ESG and novel medications. Our treatment algorithm accounts for the chronic nature of obesity, the risk of weight regain after any intervention, and the need for longitudinal patient care.

Patients undergo work-up by a multidisciplinary team (MD team) with a nutritionist, psychologist, primary care physician, gastroenterologist, and endocrinologist to determine the optimal treatment plan (Fig. 1).²⁹

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Patients are required to attend multiple information sessions, where all weight-loss methods are presented, including surgery, bariatric endoscopy, and pharmacotherapy. Other specialists also help manage comorbid conditions. Prior to selecting an initial intervention, patients undergo intensive lifestyle and behavioral therapy (Fig. 2 and 3). Depending on the selected therapy, initial treatment lasts between 3 and 12 months with ongoing support from the MD team.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

If patients do not achieve their targeted weight loss after initial treatment, a new strategy is selected. This includes a different EBMT such as ESG, alternate pharmacotherapy, or surgery until the weight and health goals of the patient are achieved and sustained (Fig. 3). From the start, patients are informed that our program is a long-term intervention and that active participation in the MOVE! Program, as well as follow-up with the MD team are keys to success. EBMTs and medications are presented as effective tools that only work to enhance the effects of lifestyle changes.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Our multidisciplinary approach provides flexibility for patients to trial different options depending on their progress. Research on long-term outcomes with weight loss and metabolic parameters is ongoing, though early results are promising. Thus far, we have observed that patients undergoing a combination therapy of EBMTs and AOMs have greater weight loss than patients on a single therapeutic approach with either EBMT or AOMs alone.³⁴ Racial and socioeconomic disparities in referrals to bariatric surgery are yet another barrier for patients to access weight reduction and improvement in cardiovascular health.³⁵ EBMTs and pharmacotherapy are no longer just on the horizon; they are here as accessible, effective, and long-term treatments for all patients with obesity. More expansive insurance coverage is needed for EBMTs and AOMs in order to prevent progression of obesity-related comorbidities, reduce high costs, and ensure more equitable access to these effective therapies.
 

Dr. Young and Dr. Zenger are resident physicians in the department of internal medicine at New York University. Dr. Holzwanger is an advanced endoscopy fellow in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. Dr. Popov is director of bariatric endoscopy at VA New York Harbor Healthcare System, and assistant professor of medicine at New York University. Dr. Popov reported relationships with Obalon, Microtech, and Spatz, but the remaining authors reported no competing interests.

References

1. Ward ZJ et al. N Engl J Med. 2019;381(25):2440-50.

2. Stein CJ and Colditz GA. J Clin Endocrinol Metab. 2004;89(6):2522-5.

3. Ryan DH and Yockey SR. Curr Obes Rep. 2017;6(2):187-94.

4. Fildes A et al. Am J Public Health. 2015;105(9):e54-9.

5. Rhee E-J. J Obes Metab Syndr. 2017;26(4):237-42.

6. American College of Cardiology/American Heart Association Task Force on Practice Guidelines OEP. Obesity (Silver Spring). 2014;22 Suppl 2:S5-39.

7. Adams TD et al. N Engl J Med. 2018;378(1):93-6.

8. Wharton S et al. Clin Obes. 2016;6(2):154-60.

9. Iuzzolino E and Kim Y. Obes Res Clin Pract. 2020;14(4):310-20.

10. Goyal D, Watson RR. Endoscopic Bariatric Therapies. Curr Gastroenterol Rep. 2016;18(6):26.

11. Ali MR et al. Surg Obes Relat Dis. 2016;12(3):462-467.

12. Turkeltaub JA, Edmundowicz SA. Curr Treat Options Gastroenterol. 2019;17(2):187-201.
 

13. Reja D et al. Transl Gastroenterol Hepatol. 2022;7:21.

14. Force ABET et al. Gastrointest Endosc. 2015;82(3):425-38e5.

15. Thompson CC et al. Am J Gastroenterol. 2017;112(3):447-57.

16. Nystrom M et al. Obes Surg. 2018;28(7):1860-8.

17. Abu Dayyeh BK et al. Surg Obes Relat Dis. 2019;15(8):1423-4.

18. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2017;15(4):504-10.

19. Apovian CM et al. J Clin Endocrinol Metab. 2015;100(2):342-62.

20. Son JW and Kim S. Diabetes Metab J. 2020;44(6):802-18.

21. Holst JJ. Int J Obes (Lond). Int J Obes (Lond). 2013;37(9):1161-8.

22. Joo JK and Lee KS. J Menopausal Med. 2014;20(3):90-6.

23. Weiss T et al. Patient Prefer Adherence. 2020;14:2337-45.

24. Sikirica MV et al. Diabetes Metab Syndr Obes. 2017;10:403-12.

25. Kahan S et al. Tech Innov Gastrointest Endosc. 2020;22(3):154-8.

26. Bhat SP and Sharma A. Curr Drug Targets. 2017;18(8):983-93.

27. Pendse J et al. Obesity (Silver Spring). 2021;29(2):308-16.

28. Rucker D et al. BMJ. 2007;335(7631):1194-9.

29. Jirapinyo P and Thompson CC. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

30. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81(5):1073-86.

31. Schulman AR and Thompson CC. Am J Gastroenterol. 2017;112(11):1640-55.

32. Ma IT and Madura JA, 2nd. Gastroenterol Hepatol (NY). 2015;11(8):526-35.

33. Sharaiha RZ. Endoscopic sleeve gastroplasty as a nonsurgical weight loss alternative. Digestive Disease Week, oral presentation. 2017.

34. Young S et al. Long-term efficacy of a multidisciplinary minimally invasive approach to weight management compared to single endoscopic therapy: A cohort study. P0865. American College of Gastroenterology Meeting, Abstract P0865. 2021.

35. Johnson-Mann C et al. Surg Obes Relat Dis. 2019;15(4):615-20.
 

I don’t think I heard the term “passive income” until I was already an attending gastroenterologist.

That was no surprise. Why would I as a gastroenterologist with a focus in inflammatory bowel diseases be even remotely interested in that term?

Like most physicians, I went into medicine to take care of patients. That was my entire dream. It was a pleasant surprise to hear that gastroenterologists were relatively well paid compared to many other internal medicine specialties.

That was a bonus. I was not practicing medicine for the money. I was here to do good, only. Money was the evil one. It’s no surprise money remained a taboo topic amongst physicians.

This is reflected in the lack of financial education in our training.

I went through all my medical training without getting any financial education. In my last year of training, I wondered how I was going to not end up being a burned out, overworked physician mom. I knew I was going to work in a large hospital-based practice or academic center. I was already aware that employed physicians had a higher burnout rate compared to independent physicians. My desperation to avoid what looked like the natural history of most physicians in medicine was what led me to my financial awakening, as you could call it.

I became curious about where my money was going as it hit my bank account. Where was I investing? How was I going to ensure that I wasn’t putting all my financial eggs in one basket by relying solely on my clinical income? This road led me into a world that I didn’t know existed. It was the world of physician entrepreneurs.

I began thinking more critically of how I was spending my time outside of the hospital. As a busy physician mom, there already were a lot of competing needs and demands on the 24 hours that I was limited to within a day. How could I get things done and increase my earnability without needing to exchange more time for money in a one-to-one ratio?

Passive income!

First of all, what exactly is passive income?

It refers to money earned that does not require you to physically and actively pump in time in order to get money out. For instance, seeing patients clinically is not passive. Performing procedures is not passive.
 

What are some examples of passive income?

• Dividend paying stocks or funds

• Investing through retirement accounts

• Passive real estate investment through syndications, crowdfunding, REITs

• Book writing

• Business partnership or ownership such as surgery center co-ownership

• Peer-to-peer lending

• Affiliate marketing

• House hacking

• Rent out your car

• Rent out your backyard/ swimming pool

• Invention with royalty payment

• Podcasting

There are some myths about passive income that are worth exploring

1. Passive income is completely passive: This is relative passivity, meaning that for every investment, there is a phase of learning, acquiring knowledge, vetting, and possibly researching that is not passive. After the initial phase of set up, most passive sources of income may require some monitoring or checking in. However, what makes an investment passive is the absence of that one-to-one ratio of input to output that would normally exist in a more active income source.

2. Making passive income is lazy: If you are a physician, you are probably not lazy. Yes, we have a high standard of expectation for ourselves, but anyone that is able to withstand the rigors of medical training, residency, and fellowship is not lazy in my books. Burnout can present in various ways, including apathy. Let’s not confuse that as lazy because, if we do, that would qualify as gaslighting and self-splaining. As someone that teaches physicians how to have money, here is my opinion: In order to make money ethically, there has to be exchange in value. One person gives value, the other gives money as a thank you. Value can be physical as seen in clinical work. Value can also be monetary. For example, I could give $100,000 to a start-up company that needs that money to execute their brilliant idea, and, in return for my investment, they could give me a 15% return per year. Is that lazy? Without this, their brilliant idea may not see daylight. Value exchange is the key. Giving value comes in different ways.

3. Finding ideas for passive income is hard: Many of us are invested in the stock market, most commonly through retirement accounts. This would qualify as passive income. Typically, we have simply elected that the growth in our investment or dividends be reinvested as we are choosing to use this money long term. In other words, if you have a retirement account, you already have passive income. The question now is how you can find additional passive ways to invest.

What are the benefits to passive income as a gastroenterologist?

1. Changing landscape of medicine: Over the last few decades, we have seen a growing shift in the landscape of medicine. There has been an increase in administrations surpassing the increase in physicians. There seem to be more and more growing bodies that are wedging between physicians and patients. This has led to increasing dissatisfaction for patients and physicians alike. In order to respond to these changes and create lasting changes, there is a need for a change in the leadership. It is fair to say that when you have a more diversified source of income, there is less pressure on a single source of income to provide “food and shelter” for your family. Physician leaders that are liberated have to have a sense of financial liberation.

2. Not putting eggs in one basket: At the beginning of the COVID-19 pandemic, there was significant fear of the unknown. Elective procedures were canceled, leading to financial strain for physicians. Gastroenterologists were not spared. When your income source is diverse, it provides more peace of mind.

3. Mental resourcefulness: This is an understated benefit of passive income and diversified income. As physicians, we went through a lot of hard work to get to where we are today. An average incoming medical student has had extensive demonstration of activity, volunteerism, and problem solving. Yet, as attending physicians, because of the burden of everyday clinical responsibilities and endless paperwork, as well as the platform and “warehouse” and “administrative-type involvement” in medicine, the average physician isn’t creating avenues to expend their cognitive abilities in a way that is diverse outside of the clinical setting. Having passive income opportunities creates a gym for mental resourcefulness that increases work satisfaction and may positively impact burnout.

4. Relationship building: As physicians, we tend to stick with our own. After working 60-80 hours per week, it is no surprise that most of your social network may end up being those that you work with. Passive income opportunities expose physicians to networking and social opportunities that may be critical for relationship building. This may improve mental wellness and overall sense of well-being.

5. Longevity in medicine: As more physicians elect to be employed by larger organizations outside of academics, sabbaticals are becoming less and less available. Having passive sources of income may permit a physician who would otherwise not be able to suffer loss of income the opportunity to take a leave of absence in the short term that may provide long-term longevity in medicine, while promoting wellness.

6. Wealth building: Wealth has had a negative reputation in the world. We seem to equate wealth as bad and being the source of evil. We forget that money is simply a tool that takes the shape of the container you place it in. If you are good, money becomes a tool for more good. Having passive income can help accelerate the journey to wealth building. This can be a great resource as physicians can support unique lifesaving, community-building, and environment-protecting initiatives, as well as support political candidates who will have a positive effect on patient care and the future of medicine.

I hope you are convinced that, with weighing the benefits and the myths associated with passive income, it is of value for gastroenterologists to equip themselves financially so we can be positioned to be a critical part of the changing platform in medicine. Gastroenterologists have to do their due diligence to ensure that their finances are future proof to the best of their abilities.
 

Dr. Alli-Akintade, a gastroenterologist with Kaiser Permanente South Sacramento (Calif.) Medical Center, is founder of The MoneyFitMD and creator of The MoneyFitMD podcast (www.moneyfitmd.com).

I don’t think I heard the term “passive income” until I was already an attending gastroenterologist.

That was no surprise. Why would I as a gastroenterologist with a focus in inflammatory bowel diseases be even remotely interested in that term?

Like most physicians, I went into medicine to take care of patients. That was my entire dream. It was a pleasant surprise to hear that gastroenterologists were relatively well paid compared to many other internal medicine specialties.

That was a bonus. I was not practicing medicine for the money. I was here to do good, only. Money was the evil one. It’s no surprise money remained a taboo topic amongst physicians.

This is reflected in the lack of financial education in our training.

I went through all my medical training without getting any financial education. In my last year of training, I wondered how I was going to not end up being a burned out, overworked physician mom. I knew I was going to work in a large hospital-based practice or academic center. I was already aware that employed physicians had a higher burnout rate compared to independent physicians. My desperation to avoid what looked like the natural history of most physicians in medicine was what led me to my financial awakening, as you could call it.

I became curious about where my money was going as it hit my bank account. Where was I investing? How was I going to ensure that I wasn’t putting all my financial eggs in one basket by relying solely on my clinical income? This road led me into a world that I didn’t know existed. It was the world of physician entrepreneurs.

I began thinking more critically of how I was spending my time outside of the hospital. As a busy physician mom, there already were a lot of competing needs and demands on the 24 hours that I was limited to within a day. How could I get things done and increase my earnability without needing to exchange more time for money in a one-to-one ratio?

Passive income!

First of all, what exactly is passive income?

It refers to money earned that does not require you to physically and actively pump in time in order to get money out. For instance, seeing patients clinically is not passive. Performing procedures is not passive.
 

What are some examples of passive income?

• Dividend paying stocks or funds

• Investing through retirement accounts

• Passive real estate investment through syndications, crowdfunding, REITs

• Book writing

• Business partnership or ownership such as surgery center co-ownership

• Peer-to-peer lending

• Affiliate marketing

• House hacking

• Rent out your car

• Rent out your backyard/ swimming pool

• Invention with royalty payment

• Podcasting

There are some myths about passive income that are worth exploring

1. Passive income is completely passive: This is relative passivity, meaning that for every investment, there is a phase of learning, acquiring knowledge, vetting, and possibly researching that is not passive. After the initial phase of set up, most passive sources of income may require some monitoring or checking in. However, what makes an investment passive is the absence of that one-to-one ratio of input to output that would normally exist in a more active income source.

2. Making passive income is lazy: If you are a physician, you are probably not lazy. Yes, we have a high standard of expectation for ourselves, but anyone that is able to withstand the rigors of medical training, residency, and fellowship is not lazy in my books. Burnout can present in various ways, including apathy. Let’s not confuse that as lazy because, if we do, that would qualify as gaslighting and self-splaining. As someone that teaches physicians how to have money, here is my opinion: In order to make money ethically, there has to be exchange in value. One person gives value, the other gives money as a thank you. Value can be physical as seen in clinical work. Value can also be monetary. For example, I could give $100,000 to a start-up company that needs that money to execute their brilliant idea, and, in return for my investment, they could give me a 15% return per year. Is that lazy? Without this, their brilliant idea may not see daylight. Value exchange is the key. Giving value comes in different ways.

3. Finding ideas for passive income is hard: Many of us are invested in the stock market, most commonly through retirement accounts. This would qualify as passive income. Typically, we have simply elected that the growth in our investment or dividends be reinvested as we are choosing to use this money long term. In other words, if you have a retirement account, you already have passive income. The question now is how you can find additional passive ways to invest.

What are the benefits to passive income as a gastroenterologist?

1. Changing landscape of medicine: Over the last few decades, we have seen a growing shift in the landscape of medicine. There has been an increase in administrations surpassing the increase in physicians. There seem to be more and more growing bodies that are wedging between physicians and patients. This has led to increasing dissatisfaction for patients and physicians alike. In order to respond to these changes and create lasting changes, there is a need for a change in the leadership. It is fair to say that when you have a more diversified source of income, there is less pressure on a single source of income to provide “food and shelter” for your family. Physician leaders that are liberated have to have a sense of financial liberation.

2. Not putting eggs in one basket: At the beginning of the COVID-19 pandemic, there was significant fear of the unknown. Elective procedures were canceled, leading to financial strain for physicians. Gastroenterologists were not spared. When your income source is diverse, it provides more peace of mind.

3. Mental resourcefulness: This is an understated benefit of passive income and diversified income. As physicians, we went through a lot of hard work to get to where we are today. An average incoming medical student has had extensive demonstration of activity, volunteerism, and problem solving. Yet, as attending physicians, because of the burden of everyday clinical responsibilities and endless paperwork, as well as the platform and “warehouse” and “administrative-type involvement” in medicine, the average physician isn’t creating avenues to expend their cognitive abilities in a way that is diverse outside of the clinical setting. Having passive income opportunities creates a gym for mental resourcefulness that increases work satisfaction and may positively impact burnout.

4. Relationship building: As physicians, we tend to stick with our own. After working 60-80 hours per week, it is no surprise that most of your social network may end up being those that you work with. Passive income opportunities expose physicians to networking and social opportunities that may be critical for relationship building. This may improve mental wellness and overall sense of well-being.

5. Longevity in medicine: As more physicians elect to be employed by larger organizations outside of academics, sabbaticals are becoming less and less available. Having passive sources of income may permit a physician who would otherwise not be able to suffer loss of income the opportunity to take a leave of absence in the short term that may provide long-term longevity in medicine, while promoting wellness.

6. Wealth building: Wealth has had a negative reputation in the world. We seem to equate wealth as bad and being the source of evil. We forget that money is simply a tool that takes the shape of the container you place it in. If you are good, money becomes a tool for more good. Having passive income can help accelerate the journey to wealth building. This can be a great resource as physicians can support unique lifesaving, community-building, and environment-protecting initiatives, as well as support political candidates who will have a positive effect on patient care and the future of medicine.

I hope you are convinced that, with weighing the benefits and the myths associated with passive income, it is of value for gastroenterologists to equip themselves financially so we can be positioned to be a critical part of the changing platform in medicine. Gastroenterologists have to do their due diligence to ensure that their finances are future proof to the best of their abilities.
 

Dr. Alli-Akintade, a gastroenterologist with Kaiser Permanente South Sacramento (Calif.) Medical Center, is founder of The MoneyFitMD and creator of The MoneyFitMD podcast (www.moneyfitmd.com).

I don’t think I heard the term “passive income” until I was already an attending gastroenterologist.

That was no surprise. Why would I as a gastroenterologist with a focus in inflammatory bowel diseases be even remotely interested in that term?

Like most physicians, I went into medicine to take care of patients. That was my entire dream. It was a pleasant surprise to hear that gastroenterologists were relatively well paid compared to many other internal medicine specialties.

That was a bonus. I was not practicing medicine for the money. I was here to do good, only. Money was the evil one. It’s no surprise money remained a taboo topic amongst physicians.

This is reflected in the lack of financial education in our training.

I went through all my medical training without getting any financial education. In my last year of training, I wondered how I was going to not end up being a burned out, overworked physician mom. I knew I was going to work in a large hospital-based practice or academic center. I was already aware that employed physicians had a higher burnout rate compared to independent physicians. My desperation to avoid what looked like the natural history of most physicians in medicine was what led me to my financial awakening, as you could call it.

I became curious about where my money was going as it hit my bank account. Where was I investing? How was I going to ensure that I wasn’t putting all my financial eggs in one basket by relying solely on my clinical income? This road led me into a world that I didn’t know existed. It was the world of physician entrepreneurs.

I began thinking more critically of how I was spending my time outside of the hospital. As a busy physician mom, there already were a lot of competing needs and demands on the 24 hours that I was limited to within a day. How could I get things done and increase my earnability without needing to exchange more time for money in a one-to-one ratio?

Passive income!

First of all, what exactly is passive income?

It refers to money earned that does not require you to physically and actively pump in time in order to get money out. For instance, seeing patients clinically is not passive. Performing procedures is not passive.
 

What are some examples of passive income?

• Dividend paying stocks or funds

• Investing through retirement accounts

• Passive real estate investment through syndications, crowdfunding, REITs

• Book writing

• Business partnership or ownership such as surgery center co-ownership

• Peer-to-peer lending

• Affiliate marketing

• House hacking

• Rent out your car

• Rent out your backyard/ swimming pool

• Invention with royalty payment

• Podcasting

There are some myths about passive income that are worth exploring

1. Passive income is completely passive: This is relative passivity, meaning that for every investment, there is a phase of learning, acquiring knowledge, vetting, and possibly researching that is not passive. After the initial phase of set up, most passive sources of income may require some monitoring or checking in. However, what makes an investment passive is the absence of that one-to-one ratio of input to output that would normally exist in a more active income source.

2. Making passive income is lazy: If you are a physician, you are probably not lazy. Yes, we have a high standard of expectation for ourselves, but anyone that is able to withstand the rigors of medical training, residency, and fellowship is not lazy in my books. Burnout can present in various ways, including apathy. Let’s not confuse that as lazy because, if we do, that would qualify as gaslighting and self-splaining. As someone that teaches physicians how to have money, here is my opinion: In order to make money ethically, there has to be exchange in value. One person gives value, the other gives money as a thank you. Value can be physical as seen in clinical work. Value can also be monetary. For example, I could give $100,000 to a start-up company that needs that money to execute their brilliant idea, and, in return for my investment, they could give me a 15% return per year. Is that lazy? Without this, their brilliant idea may not see daylight. Value exchange is the key. Giving value comes in different ways.

3. Finding ideas for passive income is hard: Many of us are invested in the stock market, most commonly through retirement accounts. This would qualify as passive income. Typically, we have simply elected that the growth in our investment or dividends be reinvested as we are choosing to use this money long term. In other words, if you have a retirement account, you already have passive income. The question now is how you can find additional passive ways to invest.

What are the benefits to passive income as a gastroenterologist?

1. Changing landscape of medicine: Over the last few decades, we have seen a growing shift in the landscape of medicine. There has been an increase in administrations surpassing the increase in physicians. There seem to be more and more growing bodies that are wedging between physicians and patients. This has led to increasing dissatisfaction for patients and physicians alike. In order to respond to these changes and create lasting changes, there is a need for a change in the leadership. It is fair to say that when you have a more diversified source of income, there is less pressure on a single source of income to provide “food and shelter” for your family. Physician leaders that are liberated have to have a sense of financial liberation.

2. Not putting eggs in one basket: At the beginning of the COVID-19 pandemic, there was significant fear of the unknown. Elective procedures were canceled, leading to financial strain for physicians. Gastroenterologists were not spared. When your income source is diverse, it provides more peace of mind.

3. Mental resourcefulness: This is an understated benefit of passive income and diversified income. As physicians, we went through a lot of hard work to get to where we are today. An average incoming medical student has had extensive demonstration of activity, volunteerism, and problem solving. Yet, as attending physicians, because of the burden of everyday clinical responsibilities and endless paperwork, as well as the platform and “warehouse” and “administrative-type involvement” in medicine, the average physician isn’t creating avenues to expend their cognitive abilities in a way that is diverse outside of the clinical setting. Having passive income opportunities creates a gym for mental resourcefulness that increases work satisfaction and may positively impact burnout.

4. Relationship building: As physicians, we tend to stick with our own. After working 60-80 hours per week, it is no surprise that most of your social network may end up being those that you work with. Passive income opportunities expose physicians to networking and social opportunities that may be critical for relationship building. This may improve mental wellness and overall sense of well-being.

5. Longevity in medicine: As more physicians elect to be employed by larger organizations outside of academics, sabbaticals are becoming less and less available. Having passive sources of income may permit a physician who would otherwise not be able to suffer loss of income the opportunity to take a leave of absence in the short term that may provide long-term longevity in medicine, while promoting wellness.

6. Wealth building: Wealth has had a negative reputation in the world. We seem to equate wealth as bad and being the source of evil. We forget that money is simply a tool that takes the shape of the container you place it in. If you are good, money becomes a tool for more good. Having passive income can help accelerate the journey to wealth building. This can be a great resource as physicians can support unique lifesaving, community-building, and environment-protecting initiatives, as well as support political candidates who will have a positive effect on patient care and the future of medicine.

I hope you are convinced that, with weighing the benefits and the myths associated with passive income, it is of value for gastroenterologists to equip themselves financially so we can be positioned to be a critical part of the changing platform in medicine. Gastroenterologists have to do their due diligence to ensure that their finances are future proof to the best of their abilities.
 

Dr. Alli-Akintade, a gastroenterologist with Kaiser Permanente South Sacramento (Calif.) Medical Center, is founder of The MoneyFitMD and creator of The MoneyFitMD podcast (www.moneyfitmd.com).

A hefty decline in new COVID-19 cases among children resulted in the lowest weekly total since late April, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 60,300 new COVID cases reported during the week of Sept. 9-15 were down by almost 28%, compared with the previous week’s 83,000, making for 2 consecutive weeks of declines after almost 91,000 cases were recorded for the week ending Sept. 1, the AAP and CHA said in their latest COVID report of state-level data.

The last time the weekly count was under 60,000 came during the week of April 22-28, when 53,000 were reported by state and territorial health departments in the midst of a 7-week stretch of rising cases. Since that streak ended in mid-May, however, “reported weekly cases have plateaued, fluctuating between a low, now of 60,300 cases and a high of about 112,000,” the AAP noted.

Emergency department visits and hospital admissions, which showed less fluctuation over the summer and more steady rise and fall, have both dropped in recent weeks and are now approaching late May/early June rates, according to data from the Centers for Disease Control and Prevention.

On Sept. 15, for example, ED visits for children under 12 years with diagnosed COVID were just 2.2% of all visits, lower than at any time since May 19 and down from a summer high of 6.8% in late July. Hospital admissions for children aged 0-17 years also rose steadily through June and July, reaching 0.46 per 100,000 population on July 30, but have since slipped to 0.29 per 100,000 as of Sept. 17, the CDC said on its COVID Data Tracker.
 

Vaccination continues to be a tough sell

Vaccination activity among the most recently eligible age group, in the meantime, remains tepid. Just 6.0% of children under age 5 had received at least one dose of COVID-19 vaccine as of Sept. 13, about 3 months since its final approval in June, and 1.6% were fully vaccinated. For the two older groups of children with separate vaccine approvals, 31.5% of those aged 5-11 years and 43.3% of those aged 12-15 had received at least one dose 3 months after their vaccinations began, the CDC data show.

In the 2 weeks ending Sept. 14, almost 59,000 children under age 5 received their initial COVID-19 vaccine dose, as did 28,000 5- to 11-year-olds and 14,000 children aged 12-17. Children under age 5 years represented almost 20% of all Americans getting a first dose during Sept. 1-14, compared with 9.7% for those aged 5-11 and 4.8% for the 12- to 17-year-olds, the CDC said.

At the state level, children under age 5 years in the District of Columbia, where 28% have received at least one dose, and Vermont, at 24%, are the most likely to be vaccinated. The states with the lowest rates in this age group are Alabama, Louisiana, and Mississippi, all of which are at 2%. Vermont and D.C. have the highest rates for ages 5-11 at 70% each, and Alabama (17%) is the lowest, while D.C. (100%), Rhode Island (99%), and Massachusetts (99%) are highest for children aged 12-17 years and Wyoming (41%) is the lowest, the AAP said in a separate report.

A hefty decline in new COVID-19 cases among children resulted in the lowest weekly total since late April, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 60,300 new COVID cases reported during the week of Sept. 9-15 were down by almost 28%, compared with the previous week’s 83,000, making for 2 consecutive weeks of declines after almost 91,000 cases were recorded for the week ending Sept. 1, the AAP and CHA said in their latest COVID report of state-level data.

The last time the weekly count was under 60,000 came during the week of April 22-28, when 53,000 were reported by state and territorial health departments in the midst of a 7-week stretch of rising cases. Since that streak ended in mid-May, however, “reported weekly cases have plateaued, fluctuating between a low, now of 60,300 cases and a high of about 112,000,” the AAP noted.

Emergency department visits and hospital admissions, which showed less fluctuation over the summer and more steady rise and fall, have both dropped in recent weeks and are now approaching late May/early June rates, according to data from the Centers for Disease Control and Prevention.

On Sept. 15, for example, ED visits for children under 12 years with diagnosed COVID were just 2.2% of all visits, lower than at any time since May 19 and down from a summer high of 6.8% in late July. Hospital admissions for children aged 0-17 years also rose steadily through June and July, reaching 0.46 per 100,000 population on July 30, but have since slipped to 0.29 per 100,000 as of Sept. 17, the CDC said on its COVID Data Tracker.
 

Vaccination continues to be a tough sell

Vaccination activity among the most recently eligible age group, in the meantime, remains tepid. Just 6.0% of children under age 5 had received at least one dose of COVID-19 vaccine as of Sept. 13, about 3 months since its final approval in June, and 1.6% were fully vaccinated. For the two older groups of children with separate vaccine approvals, 31.5% of those aged 5-11 years and 43.3% of those aged 12-15 had received at least one dose 3 months after their vaccinations began, the CDC data show.

In the 2 weeks ending Sept. 14, almost 59,000 children under age 5 received their initial COVID-19 vaccine dose, as did 28,000 5- to 11-year-olds and 14,000 children aged 12-17. Children under age 5 years represented almost 20% of all Americans getting a first dose during Sept. 1-14, compared with 9.7% for those aged 5-11 and 4.8% for the 12- to 17-year-olds, the CDC said.

At the state level, children under age 5 years in the District of Columbia, where 28% have received at least one dose, and Vermont, at 24%, are the most likely to be vaccinated. The states with the lowest rates in this age group are Alabama, Louisiana, and Mississippi, all of which are at 2%. Vermont and D.C. have the highest rates for ages 5-11 at 70% each, and Alabama (17%) is the lowest, while D.C. (100%), Rhode Island (99%), and Massachusetts (99%) are highest for children aged 12-17 years and Wyoming (41%) is the lowest, the AAP said in a separate report.

A hefty decline in new COVID-19 cases among children resulted in the lowest weekly total since late April, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 60,300 new COVID cases reported during the week of Sept. 9-15 were down by almost 28%, compared with the previous week’s 83,000, making for 2 consecutive weeks of declines after almost 91,000 cases were recorded for the week ending Sept. 1, the AAP and CHA said in their latest COVID report of state-level data.

The last time the weekly count was under 60,000 came during the week of April 22-28, when 53,000 were reported by state and territorial health departments in the midst of a 7-week stretch of rising cases. Since that streak ended in mid-May, however, “reported weekly cases have plateaued, fluctuating between a low, now of 60,300 cases and a high of about 112,000,” the AAP noted.

Emergency department visits and hospital admissions, which showed less fluctuation over the summer and more steady rise and fall, have both dropped in recent weeks and are now approaching late May/early June rates, according to data from the Centers for Disease Control and Prevention.

On Sept. 15, for example, ED visits for children under 12 years with diagnosed COVID were just 2.2% of all visits, lower than at any time since May 19 and down from a summer high of 6.8% in late July. Hospital admissions for children aged 0-17 years also rose steadily through June and July, reaching 0.46 per 100,000 population on July 30, but have since slipped to 0.29 per 100,000 as of Sept. 17, the CDC said on its COVID Data Tracker.
 

Vaccination continues to be a tough sell

Vaccination activity among the most recently eligible age group, in the meantime, remains tepid. Just 6.0% of children under age 5 had received at least one dose of COVID-19 vaccine as of Sept. 13, about 3 months since its final approval in June, and 1.6% were fully vaccinated. For the two older groups of children with separate vaccine approvals, 31.5% of those aged 5-11 years and 43.3% of those aged 12-15 had received at least one dose 3 months after their vaccinations began, the CDC data show.

In the 2 weeks ending Sept. 14, almost 59,000 children under age 5 received their initial COVID-19 vaccine dose, as did 28,000 5- to 11-year-olds and 14,000 children aged 12-17. Children under age 5 years represented almost 20% of all Americans getting a first dose during Sept. 1-14, compared with 9.7% for those aged 5-11 and 4.8% for the 12- to 17-year-olds, the CDC said.

At the state level, children under age 5 years in the District of Columbia, where 28% have received at least one dose, and Vermont, at 24%, are the most likely to be vaccinated. The states with the lowest rates in this age group are Alabama, Louisiana, and Mississippi, all of which are at 2%. Vermont and D.C. have the highest rates for ages 5-11 at 70% each, and Alabama (17%) is the lowest, while D.C. (100%), Rhode Island (99%), and Massachusetts (99%) are highest for children aged 12-17 years and Wyoming (41%) is the lowest, the AAP said in a separate report.