The current standard for breast cancer screening (for non–high-risk patients) is an annual or semiannual mammogram for women aged 40 and older.¹ However, mammography-based screening can give false-positive or false-negative results. This can lead to excessive use of invasive tissue biopsies and unnecessary exposure to ionizing radiation—which can also become expensive and time-consuming for patients.²

Both normal and cancerous cells shed cell-free DNA (cfDNA) into the blood circulation.³ Circulating tumor DNA (ctDNA) are fragments of DNA derived from tumor cells that circulate in the blood together with cfDNA. The ctDNA originates directly from a tumor or from circulating tumor cells (and carries information from the tumor cell genome), whereas cfDNA enters the bloodstream after apoptosis or necrosis and carries genome-wide DNA information. The amount of ctDNA in the blood has been shown to be elevated in patients with cancer.³ Different cancers release varying levels of ctDNA; the amount of ctDNA released depends on the number of tumor cells that are in senescence vs undergoing apoptosis.⁴ 

The possibility of incorporating this biomarker obtained from a “liquid biopsy” is currently being studied and will hopefully become a standard of care for breast cancer screening and monitoring. The liquid biopsy detects ctDNA that has been released into the bloodstream from tumor regions and helps identify intratumoral heterogeneity and clonal        evolution.⁵ Additionally, sequencing tumor DNA has opened new possibilities for precision oncology.⁶ Detection of somatic gene mutations, amplifications, and gene fusions helps to deliver targeted therapies.⁶ Analysis of potential somatic mutations in ctDNA, in combination with cfDNA levels, can help capture clinically relevant information beyond single genetic alterations and tumor fraction, potentially improving the accuracy of early detection and screening for breast cancer.

Recent advances in ctDNA testing technology have made it more accurate and reliable. ctDNA testing has several benefits, including early detection of cancer (detecting ctDNA at low levels⁾⁷; monitoring of tumor dynamics, therapeutic response, and residual disease⁸; as well as analysis of the evolution of genetic or epigenetic alterations characterizing the tumor.⁹ Its noninvasiveness, rapidity, and low cost allow for longitudinal monitoring of cancer in real time, potentially capturing tumor heterogeneity.^10,11 

The liquid biopsy potentially can give more options for therapeutic monitoring for breast cancer and may mirror clinically relevant genetic alterations that occur in all tumor tissues. Liquid biopsy offers many advantages. It allows for the detection of minimal residual disease and micrometastatic disease that may be difficult to detect with a traditional tissue biopsy.¹² Liquid biopsy detects ctDNA that has been released into the bloodstream from multiple tumor regions and allows the possibility of identifying intratumoral heterogeneity and  clonal evolution.⁵ It can also detect small quantitative variations within the blood, enabling real-time surveillance.

The liquid biopsy can offer earlier and easier access to some tumor-based genetic information at any given timepoint and can replace a tumor tissue biopsy in some cases, helping to avoid delays and complications of a solid tumor invasive biopsy procedure. This is especially relevant in the metastatic setting, in which ctDNA might be the only available genetic material from tumors.¹³ Tissue biopsy can only provide a static and spatially limited view of the disease at the time of sampling; ctDNA analysis could potentially reflect the genetic alterations that occur in all metastatic breast cancer sites over time.^14,15 Furthermore, machine learning of multi-gene signatures, obtained from ctDNA, can possibly identify complex biological features, including measures of tumor proliferation and estrogen receptor signaling, similar to direct tumor tissue DNA or RNA profiling.¹⁶

ctDNA testing is currently being studied to monitor patients who have been diagnosed with breast cancer. Small retrospective studies have shown that detection of ctDNA in plasma, after patients have completed therapy for early-stage breast cancer, is associated with a very high risk of relapse.¹⁷

Ongoing studies are examining the tailoring of adjuvant treatment based on ctDNA. If these trials are successful, certain aspects of adjuvant treatment could be lessened, or omitted, for patients who have undetectable ctDNA or intensified for patients who have detectable ctDNA after definitive treatments. This could personalize treatment specifically to the patient.

The detection and persistence of ctDNA in the middle of neoadjuvant systemic therapy may have the potential to negatively predict response to treatment and identify patients who will not achieve pathologic complete response. This may have the potential to aid in clinical decision-making for treatment escalation in these nonresponders.¹⁸ 

Despite these distinct characteristics, the low levels of ctDNA found in early-stage disease, along with the lack of ctDNA shedding from some tumors, can further complicate or impede detection of recurrence in early-stage breast cancer. Testing is further complicated by hematologic genetic alterations.⁵ The limitation of ctDNA approaches is that these techniques only detect known mutations in certain genes, so patients without these mutations could be overlooked, limiting the application of this technology.¹⁹

Overall, ctDNA testing represents a promising area of research for the diagnosis, treatment, and monitoring of breast cancer. While more research is needed to fully understand its potential, the advances in this technology are certainly exciting and could lead to significant improvements in patient outcomes. It is hopeful that in the near future, ctDNA testing from liquid biopsy could become a standard of care in breast cancer screening, ultimately helping clinicians to personalize treatment therapies and improve patient outcomes when treating patients with breast cancer.

The current standard for breast cancer screening (for non–high-risk patients) is an annual or semiannual mammogram for women aged 40 and older.¹ However, mammography-based screening can give false-positive or false-negative results. This can lead to excessive use of invasive tissue biopsies and unnecessary exposure to ionizing radiation—which can also become expensive and time-consuming for patients.²

Both normal and cancerous cells shed cell-free DNA (cfDNA) into the blood circulation.³ Circulating tumor DNA (ctDNA) are fragments of DNA derived from tumor cells that circulate in the blood together with cfDNA. The ctDNA originates directly from a tumor or from circulating tumor cells (and carries information from the tumor cell genome), whereas cfDNA enters the bloodstream after apoptosis or necrosis and carries genome-wide DNA information. The amount of ctDNA in the blood has been shown to be elevated in patients with cancer.³ Different cancers release varying levels of ctDNA; the amount of ctDNA released depends on the number of tumor cells that are in senescence vs undergoing apoptosis.⁴ 

The possibility of incorporating this biomarker obtained from a “liquid biopsy” is currently being studied and will hopefully become a standard of care for breast cancer screening and monitoring. The liquid biopsy detects ctDNA that has been released into the bloodstream from tumor regions and helps identify intratumoral heterogeneity and clonal        evolution.⁵ Additionally, sequencing tumor DNA has opened new possibilities for precision oncology.⁶ Detection of somatic gene mutations, amplifications, and gene fusions helps to deliver targeted therapies.⁶ Analysis of potential somatic mutations in ctDNA, in combination with cfDNA levels, can help capture clinically relevant information beyond single genetic alterations and tumor fraction, potentially improving the accuracy of early detection and screening for breast cancer.

Recent advances in ctDNA testing technology have made it more accurate and reliable. ctDNA testing has several benefits, including early detection of cancer (detecting ctDNA at low levels⁾⁷; monitoring of tumor dynamics, therapeutic response, and residual disease⁸; as well as analysis of the evolution of genetic or epigenetic alterations characterizing the tumor.⁹ Its noninvasiveness, rapidity, and low cost allow for longitudinal monitoring of cancer in real time, potentially capturing tumor heterogeneity.^10,11 

The liquid biopsy potentially can give more options for therapeutic monitoring for breast cancer and may mirror clinically relevant genetic alterations that occur in all tumor tissues. Liquid biopsy offers many advantages. It allows for the detection of minimal residual disease and micrometastatic disease that may be difficult to detect with a traditional tissue biopsy.¹² Liquid biopsy detects ctDNA that has been released into the bloodstream from multiple tumor regions and allows the possibility of identifying intratumoral heterogeneity and  clonal evolution.⁵ It can also detect small quantitative variations within the blood, enabling real-time surveillance.

The liquid biopsy can offer earlier and easier access to some tumor-based genetic information at any given timepoint and can replace a tumor tissue biopsy in some cases, helping to avoid delays and complications of a solid tumor invasive biopsy procedure. This is especially relevant in the metastatic setting, in which ctDNA might be the only available genetic material from tumors.¹³ Tissue biopsy can only provide a static and spatially limited view of the disease at the time of sampling; ctDNA analysis could potentially reflect the genetic alterations that occur in all metastatic breast cancer sites over time.^14,15 Furthermore, machine learning of multi-gene signatures, obtained from ctDNA, can possibly identify complex biological features, including measures of tumor proliferation and estrogen receptor signaling, similar to direct tumor tissue DNA or RNA profiling.¹⁶

ctDNA testing is currently being studied to monitor patients who have been diagnosed with breast cancer. Small retrospective studies have shown that detection of ctDNA in plasma, after patients have completed therapy for early-stage breast cancer, is associated with a very high risk of relapse.¹⁷

Ongoing studies are examining the tailoring of adjuvant treatment based on ctDNA. If these trials are successful, certain aspects of adjuvant treatment could be lessened, or omitted, for patients who have undetectable ctDNA or intensified for patients who have detectable ctDNA after definitive treatments. This could personalize treatment specifically to the patient.

The detection and persistence of ctDNA in the middle of neoadjuvant systemic therapy may have the potential to negatively predict response to treatment and identify patients who will not achieve pathologic complete response. This may have the potential to aid in clinical decision-making for treatment escalation in these nonresponders.¹⁸ 

Despite these distinct characteristics, the low levels of ctDNA found in early-stage disease, along with the lack of ctDNA shedding from some tumors, can further complicate or impede detection of recurrence in early-stage breast cancer. Testing is further complicated by hematologic genetic alterations.⁵ The limitation of ctDNA approaches is that these techniques only detect known mutations in certain genes, so patients without these mutations could be overlooked, limiting the application of this technology.¹⁹

Overall, ctDNA testing represents a promising area of research for the diagnosis, treatment, and monitoring of breast cancer. While more research is needed to fully understand its potential, the advances in this technology are certainly exciting and could lead to significant improvements in patient outcomes. It is hopeful that in the near future, ctDNA testing from liquid biopsy could become a standard of care in breast cancer screening, ultimately helping clinicians to personalize treatment therapies and improve patient outcomes when treating patients with breast cancer.

The current standard for breast cancer screening (for non–high-risk patients) is an annual or semiannual mammogram for women aged 40 and older.¹ However, mammography-based screening can give false-positive or false-negative results. This can lead to excessive use of invasive tissue biopsies and unnecessary exposure to ionizing radiation—which can also become expensive and time-consuming for patients.²

Both normal and cancerous cells shed cell-free DNA (cfDNA) into the blood circulation.³ Circulating tumor DNA (ctDNA) are fragments of DNA derived from tumor cells that circulate in the blood together with cfDNA. The ctDNA originates directly from a tumor or from circulating tumor cells (and carries information from the tumor cell genome), whereas cfDNA enters the bloodstream after apoptosis or necrosis and carries genome-wide DNA information. The amount of ctDNA in the blood has been shown to be elevated in patients with cancer.³ Different cancers release varying levels of ctDNA; the amount of ctDNA released depends on the number of tumor cells that are in senescence vs undergoing apoptosis.⁴ 

The possibility of incorporating this biomarker obtained from a “liquid biopsy” is currently being studied and will hopefully become a standard of care for breast cancer screening and monitoring. The liquid biopsy detects ctDNA that has been released into the bloodstream from tumor regions and helps identify intratumoral heterogeneity and clonal        evolution.⁵ Additionally, sequencing tumor DNA has opened new possibilities for precision oncology.⁶ Detection of somatic gene mutations, amplifications, and gene fusions helps to deliver targeted therapies.⁶ Analysis of potential somatic mutations in ctDNA, in combination with cfDNA levels, can help capture clinically relevant information beyond single genetic alterations and tumor fraction, potentially improving the accuracy of early detection and screening for breast cancer.

Recent advances in ctDNA testing technology have made it more accurate and reliable. ctDNA testing has several benefits, including early detection of cancer (detecting ctDNA at low levels⁾⁷; monitoring of tumor dynamics, therapeutic response, and residual disease⁸; as well as analysis of the evolution of genetic or epigenetic alterations characterizing the tumor.⁹ Its noninvasiveness, rapidity, and low cost allow for longitudinal monitoring of cancer in real time, potentially capturing tumor heterogeneity.^10,11 

The liquid biopsy potentially can give more options for therapeutic monitoring for breast cancer and may mirror clinically relevant genetic alterations that occur in all tumor tissues. Liquid biopsy offers many advantages. It allows for the detection of minimal residual disease and micrometastatic disease that may be difficult to detect with a traditional tissue biopsy.¹² Liquid biopsy detects ctDNA that has been released into the bloodstream from multiple tumor regions and allows the possibility of identifying intratumoral heterogeneity and  clonal evolution.⁵ It can also detect small quantitative variations within the blood, enabling real-time surveillance.

The liquid biopsy can offer earlier and easier access to some tumor-based genetic information at any given timepoint and can replace a tumor tissue biopsy in some cases, helping to avoid delays and complications of a solid tumor invasive biopsy procedure. This is especially relevant in the metastatic setting, in which ctDNA might be the only available genetic material from tumors.¹³ Tissue biopsy can only provide a static and spatially limited view of the disease at the time of sampling; ctDNA analysis could potentially reflect the genetic alterations that occur in all metastatic breast cancer sites over time.^14,15 Furthermore, machine learning of multi-gene signatures, obtained from ctDNA, can possibly identify complex biological features, including measures of tumor proliferation and estrogen receptor signaling, similar to direct tumor tissue DNA or RNA profiling.¹⁶

ctDNA testing is currently being studied to monitor patients who have been diagnosed with breast cancer. Small retrospective studies have shown that detection of ctDNA in plasma, after patients have completed therapy for early-stage breast cancer, is associated with a very high risk of relapse.¹⁷

Ongoing studies are examining the tailoring of adjuvant treatment based on ctDNA. If these trials are successful, certain aspects of adjuvant treatment could be lessened, or omitted, for patients who have undetectable ctDNA or intensified for patients who have detectable ctDNA after definitive treatments. This could personalize treatment specifically to the patient.

The detection and persistence of ctDNA in the middle of neoadjuvant systemic therapy may have the potential to negatively predict response to treatment and identify patients who will not achieve pathologic complete response. This may have the potential to aid in clinical decision-making for treatment escalation in these nonresponders.¹⁸ 

Despite these distinct characteristics, the low levels of ctDNA found in early-stage disease, along with the lack of ctDNA shedding from some tumors, can further complicate or impede detection of recurrence in early-stage breast cancer. Testing is further complicated by hematologic genetic alterations.⁵ The limitation of ctDNA approaches is that these techniques only detect known mutations in certain genes, so patients without these mutations could be overlooked, limiting the application of this technology.¹⁹

Overall, ctDNA testing represents a promising area of research for the diagnosis, treatment, and monitoring of breast cancer. While more research is needed to fully understand its potential, the advances in this technology are certainly exciting and could lead to significant improvements in patient outcomes. It is hopeful that in the near future, ctDNA testing from liquid biopsy could become a standard of care in breast cancer screening, ultimately helping clinicians to personalize treatment therapies and improve patient outcomes when treating patients with breast cancer.

Obesity is a major health problem in the United States. The Centers for Disease Control and Prevention (CDC) defines the problem as weight that is higher than what is healthy for a given height, with quantitative definitions of overweight and obesity as body mass indices (BMIs) of 25 to 29.9 kg/m² and ≥ 30 kg/m², respectively.¹ The prevalence of obesity among adults in 2017 ̶ 2018 was reported by the CDC to be 42.4%.² Among women, the reported prevalence of obesity was lowest among Asian individuals (17.2%) and greatest among non-Hispanic Black individuals (56.9%), with White (39.8%) and Hispanic individuals (43.7%) having rates in between.² In a meta-analysis of prospective studies that included 4 million people who were never smokers and had no chronic disease at baseline, age- and sex-adjusted mortality rates were studied over a median of 14 years of follow-up.³ Compared with those with a BMI of 20 to 25 kg/m², people with a BMI of 30 to 34.9 kg/m² or a BMI of 35 to 39.9 kg/m² had increased risks of death of 46% and 94%, respectively, demonstrating that obesity increases this risk.³

The increased risk of death associated with obesity is caused by obesity-related diseases that cause early mortality, including diabetes mellitus (DM), dyslipidemia, hypertension, coronary heart disease, heart failure, atrial fibrillation, stroke, and venous thromboembolic events.⁴ Obesity is also associated with an increased risk of many cancers, including cancer of the endometrium, kidney, esophagus, stomach, colon, rectum, gallbladder, pancreas, liver, and breast.⁵ With regard to gynecologic disease, obesity is associated with an increased risk of fibroids and heavy menstrual bleeding.⁶ For pregnant patients, obesity is associated with increased risks of⁷:

• miscarriage and stillbirth
• preeclampsia and gestational hypertension
• gestational diabetes
• severe maternal morbidity
• postterm pregnancy
• venous thromboembolism
• endometritis.

For obese patients, weight loss can normalize blood pressure, reduce the risk of cardiovascular events, decrease the risk of cancer, and cure type 2 DM.⁸

Bariatric surgery: The gold standard treatment for reliable and sustained weight loss

All patients with obesity should be counseled to reduce caloric intake and increase physical activity. Dietary counseling provided by a nutritionist may help reinforce advice given by a provider. However, lifestyle interventions are associated with modest weight loss (<5% of bodyweight; FIGURE).⁹ The gold standard treatment for reliable and sustained weight loss is bariatric surgery.

In the Swedish Obese Subjects study, involving 2,010 people, following bariatric surgery the mean decrease in bodyweight was 23% at 2 years, with a slow increase in weight thereafter, resulting in a sustained mean weight loss of 18% at 10 years.⁸ In this study, people in the diet and exercise control group had no change in bodyweight over 10 years of follow-up.⁸ Not all eligible obese patients want to undergo bariatric surgery because it is an arduous sequential process involving 6 months of intensive preoperative preparation, bariatric surgery, recovery, and intensive postoperative follow-up. The perioperative mortality rate is 0.03% to 0.2%.¹⁰ Following bariatric surgery, additional operations may be necessary for more than 10% of patients.¹⁰ With recent breakthroughs in the medication management of obesity, patients who do not want bariatric surgery can achieve reliable weight loss of greater than 10% of body weight with glucagon-like peptide -1 (GLP-1) agonists.

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

GLP-1 agonist analogues: Practice-changing breakthrough in medication treatment

GLP-1, a 30 amino acid peptide, is produced by intestinal enteroendocrine cells and neurons in the medulla and hypothalamus.¹¹ GLP-1 reduces hunger cravings and causes satiety, reducing daily food intake.¹² GLP-1 also enhances the secretion of insulin, making GLP-1 agonists an effective treatment for type 2 DM. In humans and experimental animals, the administration of exogenous GLP-1 agonists decreases hunger cravings and causes satiety, reducing food intake, resulting in weight loss.¹² The synthetic GLP-1 agonists, liraglutide (Saxenda) and semaglutide (Wegovy) are approved by the US Food and Drug Administration (FDA) as anti-obesity medications.

Native GLP-1 has a short circulating half-life of approximately 2 minutes. The synthetic GLP-1 agonist medications liraglutide and semaglutide are modified to significantly increase their half-life. Liraglutide is a modified version of GLP-1 with a palmitic acid side chain and an amino acid spacer resulting in reduced degradation and a 15-hour half-life, necessitating daily administration. Semaglutide has a steric acid diacid at Lys26, a large synthetic spacer, a modification of amino acid 8 with the addition of α-aminobutyric acid and a 165-hour half-life, permitting weekly administration.¹³ For weight loss, liraglutide and semaglultide are administered by subcutaneous injection. Tirzepatide (Mounjaro) is a novel GLP-1 agonist. It is also a gastric inhibitory peptide, is FDA approved to treat type 2 DM, and is awaiting FDA approval as a weight loss medication.Tirzepatide causes substantial weight loss, similar to the effect of semaglutide.¹⁴

Semaglutide and weight loss

Semaglutide is approved by the FDA for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in adults with a BMI ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of a weight-related comorbidity. It is also FDA approved to treat type 2 DM.

In a weight loss trial, 1,961 overweight and obese patients with a mean BMI of 38 kg/m², were randomly assigned to semaglutide or placebo treatment for 68 weeks. All the participants were following a regimen that included a calorie-reduced diet and increased physical activity. The mean changes in body weight for the patients in the semaglutide and placebo treatment groups were -14.9% and -2.4%, respectively. The treatment difference was -12.4% (95% confidence interval [CI], -13.4% to -11.5%; P <.001). In this study, compared with placebo, semaglutide treatment resulted in a greater decrease in waist circumference, -5.3 in versus -1.6 in.¹⁵ A network meta-analysis of the efficacy of weight loss medicines indicates that semaglutide is the most effective medication currently FDA approved for weight loss, reliably producing substantial weight loss (FIGURE).⁹

In one randomized clinical trial, investigators directly compared the efficacy of semaglutide and liraglutide in achieving weight loss. In this trial, 338 patients were assigned randomly to treatment with semaglutide 2.4 mg weekly subcutaneous injection, liraglutide 3.0 mg daily subcutaneous injection, or placebo. All the participants were following a regimen that included a calorie-reduced diet and increased physical activity.¹⁶ After 68 weeks of treatment, the mean weight changes were -15.8%, -6.4%, and -1.9% in the semaglutide, liraglutide, and placebo groups, respectively. The difference between the semaglutide and liraglutide groups was -9.4% (95% CI, -12% to -6.8%; P <.001).¹⁶

Continue to: Semaglutide dose-escalation and contraindications...

For weight loss, the target dose of semaglutide is 2.4 mg once weekly subcutaneous injection achieved by sequential dose escalation. To give patients time to adjust to adverse effects caused by the medication, a standardized dose-escalation regimen is recommended. The FDA-approved escalation regimen for semaglutide treatment begins with a weekly subcutaneous dose of 0.25 mg for 4 weeks, followed by an increase in the weekly dosage every 4 weeks: 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg.¹⁷ To support the dose-escalation process there are 5 unique autoinjectors that deliver the appropriate dose for the current step.

Semaglutide is contraindicated if the patient has an allergy to the medication or if there is a personal or family history of medullary thyroid cancer.¹⁷ In animal toxicology studies, semaglutide at clinically relevant dosing was associated with an increased risk of developing medullary thyroid cancer. Patients with a personal history of multiple endocrine neoplasia syndrome type 2, (medullary thyroid cancer, pheochromocytoma, and primary hyperparathyroidism) should not take semaglutide. Semaglutide may cause fetal harm and the FDA recommends discontinuing semaglutide at least 2 months before pregnancy.¹⁷ According to the FDA, the safety of semaglutide during breastfeeding has not been established. In Canada, breastfeeding is a contraindication to semaglutide treatment.¹⁸

Limitations of medication treatment of obesity

There are important limitations to semaglutide treatment of obesity, including:

• weight gain after stopping treatment
• limited medical insurance supportfor an expensive medication treatment
• bothersome adverse effects.

Weight gain posttreatment. After stopping medication treatment of obesity, weight gain occurs in most patients. However, patients may remain below baseline weight for a long time after stopping medication therapy. In one trial of 803 patients, after 20 weeks of semaglutide treatment (16-week dose-escalation phase, followed by 4 weeks on a weekly dose of 2.4 mg), the participants were randomized to 48 additional weeks of semaglutide or placebo.¹⁹ All the participants were following a regimen that included a calorie-reduced diet and increased physical activity. At the initial 20 weeks of treatment time point the mean weight change was -10.6%. Over the following 48 weeks, the patients treated with semaglutidehad an additional mean weight change of -7.9%, while the mean weight change for the placebo group was +6.9%.

Medical insurance coverage. A major barrier to semaglutide treatment of obesity is the medication’s cost. At the website GoodRx (https://www.goodrx.com/), the estimated price for a 1-month supply of semaglutide (Wegovy) is $1,350.²⁰ By contrast, a 1-month supply of phentermine-topiramate (Qsymia) is approximately $205. Currently, many medical insurance plans do not cover the cost of semaglutide treatment for weight loss. Patent protection for liraglutide may expire in the next few years, permitting the marketing of a lower-cost generic formulation, increasing the availability of the medication. However, as noted above, compared with liraglutide, semaglutide treatment results in much greater weight loss.

The most common adverse effects associated with semaglutide treatment are nausea, vomiting, diarrhea, and constipation. In one randomized clinical trial involving 1,961 patients, the frequency of adverse effects reported by patients taking semaglutide incrementally above the frequency of the same adverse effect reported by patients on placebo was: nausea (27%), vomiting (18%), diarrhea (16%), constipation (14%), dyspepsia (7%), and abdominal pain (5%).¹⁵ In this study, treatment was discontinued due to adverse effects in 7% and 3% of the patients in the semaglutide and placebo groups, respectively. Experts believe that adverse effects can be minimized by increasing the dose slowly and decreasing the dose if adverse effects are bothersome to the patient.

Measuring the benefits of semaglutide weight loss

Overweight and obesity are prevalent problems with many adverse consequences, including an increased risk of death. In population studies, weight loss following bariatric surgery is associated with a substantial reduction in mortality, cancer, and heart disease compared with conventional therapy.²¹ Over the next few years, the effect of semaglutide-induced weight loss on the rate of cancer and heart disease should become clear. If semaglutide treatment of obesity is associated with a reduction in cancer and heart disease, it would be a truly breakthrough medication. ●

Obesity is a major health problem in the United States. The Centers for Disease Control and Prevention (CDC) defines the problem as weight that is higher than what is healthy for a given height, with quantitative definitions of overweight and obesity as body mass indices (BMIs) of 25 to 29.9 kg/m² and ≥ 30 kg/m², respectively.¹ The prevalence of obesity among adults in 2017 ̶ 2018 was reported by the CDC to be 42.4%.² Among women, the reported prevalence of obesity was lowest among Asian individuals (17.2%) and greatest among non-Hispanic Black individuals (56.9%), with White (39.8%) and Hispanic individuals (43.7%) having rates in between.² In a meta-analysis of prospective studies that included 4 million people who were never smokers and had no chronic disease at baseline, age- and sex-adjusted mortality rates were studied over a median of 14 years of follow-up.³ Compared with those with a BMI of 20 to 25 kg/m², people with a BMI of 30 to 34.9 kg/m² or a BMI of 35 to 39.9 kg/m² had increased risks of death of 46% and 94%, respectively, demonstrating that obesity increases this risk.³

The increased risk of death associated with obesity is caused by obesity-related diseases that cause early mortality, including diabetes mellitus (DM), dyslipidemia, hypertension, coronary heart disease, heart failure, atrial fibrillation, stroke, and venous thromboembolic events.⁴ Obesity is also associated with an increased risk of many cancers, including cancer of the endometrium, kidney, esophagus, stomach, colon, rectum, gallbladder, pancreas, liver, and breast.⁵ With regard to gynecologic disease, obesity is associated with an increased risk of fibroids and heavy menstrual bleeding.⁶ For pregnant patients, obesity is associated with increased risks of⁷:

• miscarriage and stillbirth
• preeclampsia and gestational hypertension
• gestational diabetes
• severe maternal morbidity
• postterm pregnancy
• venous thromboembolism
• endometritis.

For obese patients, weight loss can normalize blood pressure, reduce the risk of cardiovascular events, decrease the risk of cancer, and cure type 2 DM.⁸

Bariatric surgery: The gold standard treatment for reliable and sustained weight loss

All patients with obesity should be counseled to reduce caloric intake and increase physical activity. Dietary counseling provided by a nutritionist may help reinforce advice given by a provider. However, lifestyle interventions are associated with modest weight loss (<5% of bodyweight; FIGURE).⁹ The gold standard treatment for reliable and sustained weight loss is bariatric surgery.

In the Swedish Obese Subjects study, involving 2,010 people, following bariatric surgery the mean decrease in bodyweight was 23% at 2 years, with a slow increase in weight thereafter, resulting in a sustained mean weight loss of 18% at 10 years.⁸ In this study, people in the diet and exercise control group had no change in bodyweight over 10 years of follow-up.⁸ Not all eligible obese patients want to undergo bariatric surgery because it is an arduous sequential process involving 6 months of intensive preoperative preparation, bariatric surgery, recovery, and intensive postoperative follow-up. The perioperative mortality rate is 0.03% to 0.2%.¹⁰ Following bariatric surgery, additional operations may be necessary for more than 10% of patients.¹⁰ With recent breakthroughs in the medication management of obesity, patients who do not want bariatric surgery can achieve reliable weight loss of greater than 10% of body weight with glucagon-like peptide -1 (GLP-1) agonists.

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

GLP-1 agonist analogues: Practice-changing breakthrough in medication treatment

GLP-1, a 30 amino acid peptide, is produced by intestinal enteroendocrine cells and neurons in the medulla and hypothalamus.¹¹ GLP-1 reduces hunger cravings and causes satiety, reducing daily food intake.¹² GLP-1 also enhances the secretion of insulin, making GLP-1 agonists an effective treatment for type 2 DM. In humans and experimental animals, the administration of exogenous GLP-1 agonists decreases hunger cravings and causes satiety, reducing food intake, resulting in weight loss.¹² The synthetic GLP-1 agonists, liraglutide (Saxenda) and semaglutide (Wegovy) are approved by the US Food and Drug Administration (FDA) as anti-obesity medications.

Native GLP-1 has a short circulating half-life of approximately 2 minutes. The synthetic GLP-1 agonist medications liraglutide and semaglutide are modified to significantly increase their half-life. Liraglutide is a modified version of GLP-1 with a palmitic acid side chain and an amino acid spacer resulting in reduced degradation and a 15-hour half-life, necessitating daily administration. Semaglutide has a steric acid diacid at Lys26, a large synthetic spacer, a modification of amino acid 8 with the addition of α-aminobutyric acid and a 165-hour half-life, permitting weekly administration.¹³ For weight loss, liraglutide and semaglultide are administered by subcutaneous injection. Tirzepatide (Mounjaro) is a novel GLP-1 agonist. It is also a gastric inhibitory peptide, is FDA approved to treat type 2 DM, and is awaiting FDA approval as a weight loss medication.Tirzepatide causes substantial weight loss, similar to the effect of semaglutide.¹⁴

Semaglutide and weight loss

Semaglutide is approved by the FDA for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in adults with a BMI ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of a weight-related comorbidity. It is also FDA approved to treat type 2 DM.

In a weight loss trial, 1,961 overweight and obese patients with a mean BMI of 38 kg/m², were randomly assigned to semaglutide or placebo treatment for 68 weeks. All the participants were following a regimen that included a calorie-reduced diet and increased physical activity. The mean changes in body weight for the patients in the semaglutide and placebo treatment groups were -14.9% and -2.4%, respectively. The treatment difference was -12.4% (95% confidence interval [CI], -13.4% to -11.5%; P <.001). In this study, compared with placebo, semaglutide treatment resulted in a greater decrease in waist circumference, -5.3 in versus -1.6 in.¹⁵ A network meta-analysis of the efficacy of weight loss medicines indicates that semaglutide is the most effective medication currently FDA approved for weight loss, reliably producing substantial weight loss (FIGURE).⁹

In one randomized clinical trial, investigators directly compared the efficacy of semaglutide and liraglutide in achieving weight loss. In this trial, 338 patients were assigned randomly to treatment with semaglutide 2.4 mg weekly subcutaneous injection, liraglutide 3.0 mg daily subcutaneous injection, or placebo. All the participants were following a regimen that included a calorie-reduced diet and increased physical activity.¹⁶ After 68 weeks of treatment, the mean weight changes were -15.8%, -6.4%, and -1.9% in the semaglutide, liraglutide, and placebo groups, respectively. The difference between the semaglutide and liraglutide groups was -9.4% (95% CI, -12% to -6.8%; P <.001).¹⁶

Continue to: Semaglutide dose-escalation and contraindications...

For weight loss, the target dose of semaglutide is 2.4 mg once weekly subcutaneous injection achieved by sequential dose escalation. To give patients time to adjust to adverse effects caused by the medication, a standardized dose-escalation regimen is recommended. The FDA-approved escalation regimen for semaglutide treatment begins with a weekly subcutaneous dose of 0.25 mg for 4 weeks, followed by an increase in the weekly dosage every 4 weeks: 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg.¹⁷ To support the dose-escalation process there are 5 unique autoinjectors that deliver the appropriate dose for the current step.

Semaglutide is contraindicated if the patient has an allergy to the medication or if there is a personal or family history of medullary thyroid cancer.¹⁷ In animal toxicology studies, semaglutide at clinically relevant dosing was associated with an increased risk of developing medullary thyroid cancer. Patients with a personal history of multiple endocrine neoplasia syndrome type 2, (medullary thyroid cancer, pheochromocytoma, and primary hyperparathyroidism) should not take semaglutide. Semaglutide may cause fetal harm and the FDA recommends discontinuing semaglutide at least 2 months before pregnancy.¹⁷ According to the FDA, the safety of semaglutide during breastfeeding has not been established. In Canada, breastfeeding is a contraindication to semaglutide treatment.¹⁸

Limitations of medication treatment of obesity

There are important limitations to semaglutide treatment of obesity, including:

• weight gain after stopping treatment
• limited medical insurance supportfor an expensive medication treatment
• bothersome adverse effects.

Weight gain posttreatment. After stopping medication treatment of obesity, weight gain occurs in most patients. However, patients may remain below baseline weight for a long time after stopping medication therapy. In one trial of 803 patients, after 20 weeks of semaglutide treatment (16-week dose-escalation phase, followed by 4 weeks on a weekly dose of 2.4 mg), the participants were randomized to 48 additional weeks of semaglutide or placebo.¹⁹ All the participants were following a regimen that included a calorie-reduced diet and increased physical activity. At the initial 20 weeks of treatment time point the mean weight change was -10.6%. Over the following 48 weeks, the patients treated with semaglutidehad an additional mean weight change of -7.9%, while the mean weight change for the placebo group was +6.9%.

Medical insurance coverage. A major barrier to semaglutide treatment of obesity is the medication’s cost. At the website GoodRx (https://www.goodrx.com/), the estimated price for a 1-month supply of semaglutide (Wegovy) is $1,350.²⁰ By contrast, a 1-month supply of phentermine-topiramate (Qsymia) is approximately $205. Currently, many medical insurance plans do not cover the cost of semaglutide treatment for weight loss. Patent protection for liraglutide may expire in the next few years, permitting the marketing of a lower-cost generic formulation, increasing the availability of the medication. However, as noted above, compared with liraglutide, semaglutide treatment results in much greater weight loss.

The most common adverse effects associated with semaglutide treatment are nausea, vomiting, diarrhea, and constipation. In one randomized clinical trial involving 1,961 patients, the frequency of adverse effects reported by patients taking semaglutide incrementally above the frequency of the same adverse effect reported by patients on placebo was: nausea (27%), vomiting (18%), diarrhea (16%), constipation (14%), dyspepsia (7%), and abdominal pain (5%).¹⁵ In this study, treatment was discontinued due to adverse effects in 7% and 3% of the patients in the semaglutide and placebo groups, respectively. Experts believe that adverse effects can be minimized by increasing the dose slowly and decreasing the dose if adverse effects are bothersome to the patient.

Measuring the benefits of semaglutide weight loss

Overweight and obesity are prevalent problems with many adverse consequences, including an increased risk of death. In population studies, weight loss following bariatric surgery is associated with a substantial reduction in mortality, cancer, and heart disease compared with conventional therapy.²¹ Over the next few years, the effect of semaglutide-induced weight loss on the rate of cancer and heart disease should become clear. If semaglutide treatment of obesity is associated with a reduction in cancer and heart disease, it would be a truly breakthrough medication. ●

Obesity is a major health problem in the United States. The Centers for Disease Control and Prevention (CDC) defines the problem as weight that is higher than what is healthy for a given height, with quantitative definitions of overweight and obesity as body mass indices (BMIs) of 25 to 29.9 kg/m² and ≥ 30 kg/m², respectively.¹ The prevalence of obesity among adults in 2017 ̶ 2018 was reported by the CDC to be 42.4%.² Among women, the reported prevalence of obesity was lowest among Asian individuals (17.2%) and greatest among non-Hispanic Black individuals (56.9%), with White (39.8%) and Hispanic individuals (43.7%) having rates in between.² In a meta-analysis of prospective studies that included 4 million people who were never smokers and had no chronic disease at baseline, age- and sex-adjusted mortality rates were studied over a median of 14 years of follow-up.³ Compared with those with a BMI of 20 to 25 kg/m², people with a BMI of 30 to 34.9 kg/m² or a BMI of 35 to 39.9 kg/m² had increased risks of death of 46% and 94%, respectively, demonstrating that obesity increases this risk.³

The increased risk of death associated with obesity is caused by obesity-related diseases that cause early mortality, including diabetes mellitus (DM), dyslipidemia, hypertension, coronary heart disease, heart failure, atrial fibrillation, stroke, and venous thromboembolic events.⁴ Obesity is also associated with an increased risk of many cancers, including cancer of the endometrium, kidney, esophagus, stomach, colon, rectum, gallbladder, pancreas, liver, and breast.⁵ With regard to gynecologic disease, obesity is associated with an increased risk of fibroids and heavy menstrual bleeding.⁶ For pregnant patients, obesity is associated with increased risks of⁷:

• miscarriage and stillbirth
• preeclampsia and gestational hypertension
• gestational diabetes
• severe maternal morbidity
• postterm pregnancy
• venous thromboembolism
• endometritis.

For obese patients, weight loss can normalize blood pressure, reduce the risk of cardiovascular events, decrease the risk of cancer, and cure type 2 DM.⁸

Bariatric surgery: The gold standard treatment for reliable and sustained weight loss

All patients with obesity should be counseled to reduce caloric intake and increase physical activity. Dietary counseling provided by a nutritionist may help reinforce advice given by a provider. However, lifestyle interventions are associated with modest weight loss (<5% of bodyweight; FIGURE).⁹ The gold standard treatment for reliable and sustained weight loss is bariatric surgery.

In the Swedish Obese Subjects study, involving 2,010 people, following bariatric surgery the mean decrease in bodyweight was 23% at 2 years, with a slow increase in weight thereafter, resulting in a sustained mean weight loss of 18% at 10 years.⁸ In this study, people in the diet and exercise control group had no change in bodyweight over 10 years of follow-up.⁸ Not all eligible obese patients want to undergo bariatric surgery because it is an arduous sequential process involving 6 months of intensive preoperative preparation, bariatric surgery, recovery, and intensive postoperative follow-up. The perioperative mortality rate is 0.03% to 0.2%.¹⁰ Following bariatric surgery, additional operations may be necessary for more than 10% of patients.¹⁰ With recent breakthroughs in the medication management of obesity, patients who do not want bariatric surgery can achieve reliable weight loss of greater than 10% of body weight with glucagon-like peptide -1 (GLP-1) agonists.

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

GLP-1 agonist analogues: Practice-changing breakthrough in medication treatment

GLP-1, a 30 amino acid peptide, is produced by intestinal enteroendocrine cells and neurons in the medulla and hypothalamus.¹¹ GLP-1 reduces hunger cravings and causes satiety, reducing daily food intake.¹² GLP-1 also enhances the secretion of insulin, making GLP-1 agonists an effective treatment for type 2 DM. In humans and experimental animals, the administration of exogenous GLP-1 agonists decreases hunger cravings and causes satiety, reducing food intake, resulting in weight loss.¹² The synthetic GLP-1 agonists, liraglutide (Saxenda) and semaglutide (Wegovy) are approved by the US Food and Drug Administration (FDA) as anti-obesity medications.

Native GLP-1 has a short circulating half-life of approximately 2 minutes. The synthetic GLP-1 agonist medications liraglutide and semaglutide are modified to significantly increase their half-life. Liraglutide is a modified version of GLP-1 with a palmitic acid side chain and an amino acid spacer resulting in reduced degradation and a 15-hour half-life, necessitating daily administration. Semaglutide has a steric acid diacid at Lys26, a large synthetic spacer, a modification of amino acid 8 with the addition of α-aminobutyric acid and a 165-hour half-life, permitting weekly administration.¹³ For weight loss, liraglutide and semaglultide are administered by subcutaneous injection. Tirzepatide (Mounjaro) is a novel GLP-1 agonist. It is also a gastric inhibitory peptide, is FDA approved to treat type 2 DM, and is awaiting FDA approval as a weight loss medication.Tirzepatide causes substantial weight loss, similar to the effect of semaglutide.¹⁴

Semaglutide and weight loss

Semaglutide is approved by the FDA for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in adults with a BMI ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of a weight-related comorbidity. It is also FDA approved to treat type 2 DM.

In a weight loss trial, 1,961 overweight and obese patients with a mean BMI of 38 kg/m², were randomly assigned to semaglutide or placebo treatment for 68 weeks. All the participants were following a regimen that included a calorie-reduced diet and increased physical activity. The mean changes in body weight for the patients in the semaglutide and placebo treatment groups were -14.9% and -2.4%, respectively. The treatment difference was -12.4% (95% confidence interval [CI], -13.4% to -11.5%; P <.001). In this study, compared with placebo, semaglutide treatment resulted in a greater decrease in waist circumference, -5.3 in versus -1.6 in.¹⁵ A network meta-analysis of the efficacy of weight loss medicines indicates that semaglutide is the most effective medication currently FDA approved for weight loss, reliably producing substantial weight loss (FIGURE).⁹

In one randomized clinical trial, investigators directly compared the efficacy of semaglutide and liraglutide in achieving weight loss. In this trial, 338 patients were assigned randomly to treatment with semaglutide 2.4 mg weekly subcutaneous injection, liraglutide 3.0 mg daily subcutaneous injection, or placebo. All the participants were following a regimen that included a calorie-reduced diet and increased physical activity.¹⁶ After 68 weeks of treatment, the mean weight changes were -15.8%, -6.4%, and -1.9% in the semaglutide, liraglutide, and placebo groups, respectively. The difference between the semaglutide and liraglutide groups was -9.4% (95% CI, -12% to -6.8%; P <.001).¹⁶

Continue to: Semaglutide dose-escalation and contraindications...

For weight loss, the target dose of semaglutide is 2.4 mg once weekly subcutaneous injection achieved by sequential dose escalation. To give patients time to adjust to adverse effects caused by the medication, a standardized dose-escalation regimen is recommended. The FDA-approved escalation regimen for semaglutide treatment begins with a weekly subcutaneous dose of 0.25 mg for 4 weeks, followed by an increase in the weekly dosage every 4 weeks: 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg.¹⁷ To support the dose-escalation process there are 5 unique autoinjectors that deliver the appropriate dose for the current step.

Semaglutide is contraindicated if the patient has an allergy to the medication or if there is a personal or family history of medullary thyroid cancer.¹⁷ In animal toxicology studies, semaglutide at clinically relevant dosing was associated with an increased risk of developing medullary thyroid cancer. Patients with a personal history of multiple endocrine neoplasia syndrome type 2, (medullary thyroid cancer, pheochromocytoma, and primary hyperparathyroidism) should not take semaglutide. Semaglutide may cause fetal harm and the FDA recommends discontinuing semaglutide at least 2 months before pregnancy.¹⁷ According to the FDA, the safety of semaglutide during breastfeeding has not been established. In Canada, breastfeeding is a contraindication to semaglutide treatment.¹⁸

Limitations of medication treatment of obesity

There are important limitations to semaglutide treatment of obesity, including:

• weight gain after stopping treatment
• limited medical insurance supportfor an expensive medication treatment
• bothersome adverse effects.

Weight gain posttreatment. After stopping medication treatment of obesity, weight gain occurs in most patients. However, patients may remain below baseline weight for a long time after stopping medication therapy. In one trial of 803 patients, after 20 weeks of semaglutide treatment (16-week dose-escalation phase, followed by 4 weeks on a weekly dose of 2.4 mg), the participants were randomized to 48 additional weeks of semaglutide or placebo.¹⁹ All the participants were following a regimen that included a calorie-reduced diet and increased physical activity. At the initial 20 weeks of treatment time point the mean weight change was -10.6%. Over the following 48 weeks, the patients treated with semaglutidehad an additional mean weight change of -7.9%, while the mean weight change for the placebo group was +6.9%.

Medical insurance coverage. A major barrier to semaglutide treatment of obesity is the medication’s cost. At the website GoodRx (https://www.goodrx.com/), the estimated price for a 1-month supply of semaglutide (Wegovy) is $1,350.²⁰ By contrast, a 1-month supply of phentermine-topiramate (Qsymia) is approximately $205. Currently, many medical insurance plans do not cover the cost of semaglutide treatment for weight loss. Patent protection for liraglutide may expire in the next few years, permitting the marketing of a lower-cost generic formulation, increasing the availability of the medication. However, as noted above, compared with liraglutide, semaglutide treatment results in much greater weight loss.

The most common adverse effects associated with semaglutide treatment are nausea, vomiting, diarrhea, and constipation. In one randomized clinical trial involving 1,961 patients, the frequency of adverse effects reported by patients taking semaglutide incrementally above the frequency of the same adverse effect reported by patients on placebo was: nausea (27%), vomiting (18%), diarrhea (16%), constipation (14%), dyspepsia (7%), and abdominal pain (5%).¹⁵ In this study, treatment was discontinued due to adverse effects in 7% and 3% of the patients in the semaglutide and placebo groups, respectively. Experts believe that adverse effects can be minimized by increasing the dose slowly and decreasing the dose if adverse effects are bothersome to the patient.

Measuring the benefits of semaglutide weight loss

Overweight and obesity are prevalent problems with many adverse consequences, including an increased risk of death. In population studies, weight loss following bariatric surgery is associated with a substantial reduction in mortality, cancer, and heart disease compared with conventional therapy.²¹ Over the next few years, the effect of semaglutide-induced weight loss on the rate of cancer and heart disease should become clear. If semaglutide treatment of obesity is associated with a reduction in cancer and heart disease, it would be a truly breakthrough medication. ●

McElwee ER, Oliver EA, McFarling K, et al. Risk of stillbirth in pregnancies complicated by diabetes, stratified by fetal growth. Obstet Gynecol. 2023;141:801-809. doi:10.1097/AOG.0000000000005102.

EXPERT COMMENTARY 

Stillbirth is defined as intrauterine demise at or beyond 20 weeks’ gestation. Pregestational DM and GDM significantly increase the risk of stillbirth. Both fetal growth restriction and macrosomia are common complications of pregnancies affected by diabetes, and they further increase the risk of stillbirth. While maternal variables such as glycemic control and medication requirement are currently used to assess the risks of expectant management and inform delivery timing, abnormal fetal growth is not.

Investigators sought to evaluate the stillbirth rates per week of expectant management during the late third trimester stratified by birth weight (as a surrogate for fetal growth) in pregnancies complicated by PG-DM or GDM.

Details of the study

McElwee and colleagues used the US National Vital Statistics System to identify nonanomalous singleton pregnancies complicated by PG-DM or GDM from 2014 to 2017.¹ Pregnancies were stratified by birth weight and categorized as being LGA (birth weight > 90th percentile for gestational age), SGA (birth weight < 10th percentile for gestational age), or AGA. Stillbirths were identified from 34 0/7 through 39 6/7 weeks of gestation, and conditional stillbirth rates per 10,000 pregnancies were calculated for each week of gestation.

Results. Among 834,631 pregnancies complicated by PG-DM (13.1%) or GDM (86.9%), there were 3,033 stillbirths, of which 61% were in pregnancies with PG-DM. Stillbirth rates increased with advancing gestational age for both PG-DM and GDM regardless of birth weight. In pregnancies with PG-DM, fetuses that were LGA or SGA had a higher relative risk of stillbirth compared with their AGA counterparts at each gestational age. This stillbirth risk was highest in pregnancies with PG-DM that were LGA. At 39 weeks, the stillbirth rate in this population was 96.9/10,000 ongoing pregnancies and was 5 times higher than pregnancies with PG-DM that were AGA. When the GDM-related AGA group was selected as the referent (as the lowest-risk comparison group), pregnancies with PG-DM that were LGA had a 21-times higher relative risk of stillbirth at 37 and 38 weeks of gestation.

Study strengths and limitations

Decisions on the optimal timing of delivery seek to strike a balance between the increased neonatal morbidity with delivery before 39 weeks’ gestation and the increased risk of stillbirth with expectant management. In pregnancies complicated by diabetes, current guidelines from the American College of Obstetricians and Gynecologists recommend consideration of maternal variables, such as medication requirement, glycemic control, and vascular sequelae, to inform decisions on delivery timing, as these factors have been postulated to influence the risk of stillbirth with pregnancy prolongation.² These recommendations are based largely on expert opinion and retrospective data.

The question of how fetal growth abnormalities factor into this complicated decision making is also an area of low-quality evidence despite studies that demonstrate that both SGA and LGA fetuses in pregnancies complicated by diabetes are at increased risk of stillbirth.³

The large population-based study design by McElwee and colleagues allowed the investigators to examine a rare event (stillbirth) with multiple stratification levels and sufficient statistical power and to contribute to this literature.

Significant limitations, however, must be considered before generalizing these results. The data were restricted to variables available on birth and death certificates, and more granular information—such as the type of DM, level of glycemic control, frequency of antenatal testing, and stillbirth work-up—could not be assessed. Ultrasonographic estimations of fetal weight also were not included. Birth weight data were used as a proxy, although we know that these variables do not always correlate well given the limited accuracy of ultrasonography in assessing projected birth weight, particularly later in pregnancy. The authors also did not control for highly prevalent variables (for example, hypertension, obesity) that are likely associated with abnormal fetal growth and stillbirth in these populations. ●

McElwee ER, Oliver EA, McFarling K, et al. Risk of stillbirth in pregnancies complicated by diabetes, stratified by fetal growth. Obstet Gynecol. 2023;141:801-809. doi:10.1097/AOG.0000000000005102.

EXPERT COMMENTARY 

Stillbirth is defined as intrauterine demise at or beyond 20 weeks’ gestation. Pregestational DM and GDM significantly increase the risk of stillbirth. Both fetal growth restriction and macrosomia are common complications of pregnancies affected by diabetes, and they further increase the risk of stillbirth. While maternal variables such as glycemic control and medication requirement are currently used to assess the risks of expectant management and inform delivery timing, abnormal fetal growth is not.

Investigators sought to evaluate the stillbirth rates per week of expectant management during the late third trimester stratified by birth weight (as a surrogate for fetal growth) in pregnancies complicated by PG-DM or GDM.

Details of the study

McElwee and colleagues used the US National Vital Statistics System to identify nonanomalous singleton pregnancies complicated by PG-DM or GDM from 2014 to 2017.¹ Pregnancies were stratified by birth weight and categorized as being LGA (birth weight > 90th percentile for gestational age), SGA (birth weight < 10th percentile for gestational age), or AGA. Stillbirths were identified from 34 0/7 through 39 6/7 weeks of gestation, and conditional stillbirth rates per 10,000 pregnancies were calculated for each week of gestation.

Results. Among 834,631 pregnancies complicated by PG-DM (13.1%) or GDM (86.9%), there were 3,033 stillbirths, of which 61% were in pregnancies with PG-DM. Stillbirth rates increased with advancing gestational age for both PG-DM and GDM regardless of birth weight. In pregnancies with PG-DM, fetuses that were LGA or SGA had a higher relative risk of stillbirth compared with their AGA counterparts at each gestational age. This stillbirth risk was highest in pregnancies with PG-DM that were LGA. At 39 weeks, the stillbirth rate in this population was 96.9/10,000 ongoing pregnancies and was 5 times higher than pregnancies with PG-DM that were AGA. When the GDM-related AGA group was selected as the referent (as the lowest-risk comparison group), pregnancies with PG-DM that were LGA had a 21-times higher relative risk of stillbirth at 37 and 38 weeks of gestation.

Study strengths and limitations

Decisions on the optimal timing of delivery seek to strike a balance between the increased neonatal morbidity with delivery before 39 weeks’ gestation and the increased risk of stillbirth with expectant management. In pregnancies complicated by diabetes, current guidelines from the American College of Obstetricians and Gynecologists recommend consideration of maternal variables, such as medication requirement, glycemic control, and vascular sequelae, to inform decisions on delivery timing, as these factors have been postulated to influence the risk of stillbirth with pregnancy prolongation.² These recommendations are based largely on expert opinion and retrospective data.

The question of how fetal growth abnormalities factor into this complicated decision making is also an area of low-quality evidence despite studies that demonstrate that both SGA and LGA fetuses in pregnancies complicated by diabetes are at increased risk of stillbirth.³

The large population-based study design by McElwee and colleagues allowed the investigators to examine a rare event (stillbirth) with multiple stratification levels and sufficient statistical power and to contribute to this literature.

Significant limitations, however, must be considered before generalizing these results. The data were restricted to variables available on birth and death certificates, and more granular information—such as the type of DM, level of glycemic control, frequency of antenatal testing, and stillbirth work-up—could not be assessed. Ultrasonographic estimations of fetal weight also were not included. Birth weight data were used as a proxy, although we know that these variables do not always correlate well given the limited accuracy of ultrasonography in assessing projected birth weight, particularly later in pregnancy. The authors also did not control for highly prevalent variables (for example, hypertension, obesity) that are likely associated with abnormal fetal growth and stillbirth in these populations. ●

McElwee ER, Oliver EA, McFarling K, et al. Risk of stillbirth in pregnancies complicated by diabetes, stratified by fetal growth. Obstet Gynecol. 2023;141:801-809. doi:10.1097/AOG.0000000000005102.

EXPERT COMMENTARY 

Stillbirth is defined as intrauterine demise at or beyond 20 weeks’ gestation. Pregestational DM and GDM significantly increase the risk of stillbirth. Both fetal growth restriction and macrosomia are common complications of pregnancies affected by diabetes, and they further increase the risk of stillbirth. While maternal variables such as glycemic control and medication requirement are currently used to assess the risks of expectant management and inform delivery timing, abnormal fetal growth is not.

Investigators sought to evaluate the stillbirth rates per week of expectant management during the late third trimester stratified by birth weight (as a surrogate for fetal growth) in pregnancies complicated by PG-DM or GDM.

Details of the study

McElwee and colleagues used the US National Vital Statistics System to identify nonanomalous singleton pregnancies complicated by PG-DM or GDM from 2014 to 2017.¹ Pregnancies were stratified by birth weight and categorized as being LGA (birth weight > 90th percentile for gestational age), SGA (birth weight < 10th percentile for gestational age), or AGA. Stillbirths were identified from 34 0/7 through 39 6/7 weeks of gestation, and conditional stillbirth rates per 10,000 pregnancies were calculated for each week of gestation.

Results. Among 834,631 pregnancies complicated by PG-DM (13.1%) or GDM (86.9%), there were 3,033 stillbirths, of which 61% were in pregnancies with PG-DM. Stillbirth rates increased with advancing gestational age for both PG-DM and GDM regardless of birth weight. In pregnancies with PG-DM, fetuses that were LGA or SGA had a higher relative risk of stillbirth compared with their AGA counterparts at each gestational age. This stillbirth risk was highest in pregnancies with PG-DM that were LGA. At 39 weeks, the stillbirth rate in this population was 96.9/10,000 ongoing pregnancies and was 5 times higher than pregnancies with PG-DM that were AGA. When the GDM-related AGA group was selected as the referent (as the lowest-risk comparison group), pregnancies with PG-DM that were LGA had a 21-times higher relative risk of stillbirth at 37 and 38 weeks of gestation.

Study strengths and limitations

Decisions on the optimal timing of delivery seek to strike a balance between the increased neonatal morbidity with delivery before 39 weeks’ gestation and the increased risk of stillbirth with expectant management. In pregnancies complicated by diabetes, current guidelines from the American College of Obstetricians and Gynecologists recommend consideration of maternal variables, such as medication requirement, glycemic control, and vascular sequelae, to inform decisions on delivery timing, as these factors have been postulated to influence the risk of stillbirth with pregnancy prolongation.² These recommendations are based largely on expert opinion and retrospective data.

The question of how fetal growth abnormalities factor into this complicated decision making is also an area of low-quality evidence despite studies that demonstrate that both SGA and LGA fetuses in pregnancies complicated by diabetes are at increased risk of stillbirth.³

The large population-based study design by McElwee and colleagues allowed the investigators to examine a rare event (stillbirth) with multiple stratification levels and sufficient statistical power and to contribute to this literature.

Significant limitations, however, must be considered before generalizing these results. The data were restricted to variables available on birth and death certificates, and more granular information—such as the type of DM, level of glycemic control, frequency of antenatal testing, and stillbirth work-up—could not be assessed. Ultrasonographic estimations of fetal weight also were not included. Birth weight data were used as a proxy, although we know that these variables do not always correlate well given the limited accuracy of ultrasonography in assessing projected birth weight, particularly later in pregnancy. The authors also did not control for highly prevalent variables (for example, hypertension, obesity) that are likely associated with abnormal fetal growth and stillbirth in these populations. ●

Topline

A new study provides early evidence of sex differences in rapid effects of stress systems on the cognitive control of negative emotions.

Methodology

• The study included 80 healthy participants, mean age 24 years.
• Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
• Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
• Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
• Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.

Takeaway

• In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
• In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
• Direct stress effects on ER were smaller than expected.

In practice

The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.

Source

The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.

Limitations

The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.

Disclosures

The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.

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

Topline

A new study provides early evidence of sex differences in rapid effects of stress systems on the cognitive control of negative emotions.

Methodology

• The study included 80 healthy participants, mean age 24 years.
• Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
• Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
• Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
• Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.

Takeaway

• In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
• In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
• Direct stress effects on ER were smaller than expected.

In practice

The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.

Source

The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.

Limitations

The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.

Disclosures

The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.

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

Topline

A new study provides early evidence of sex differences in rapid effects of stress systems on the cognitive control of negative emotions.

Methodology

• The study included 80 healthy participants, mean age 24 years.
• Half the subjects immersed their nondominant hand (including the wrist) in ice water for up to 3 minutes; the other half, which served as the control group, immersed their hand in warm water for 3 minutes.
• Participants were asked to deliberately downregulate emotional responses to high-intensity negative pictures.
• Participants regularly provided saliva samples to check cortisol levels and were monitored for cardiovascular activity.
• Researchers assessed pupil dilation, which along with subject ratings of their affective state served as emotion regulation (ER) outcome measures.

Takeaway

• In men, stress rapidly improved the ability to downregulate emotional arousal via distraction that was fully mediated by cortisol.
• In women, sympathetic nervous system (SNS) reactivity was linked to decreased regulatory performances.
• Direct stress effects on ER were smaller than expected.

In practice

The study contributes to a “better understanding of the neuroendocrinological mechanisms of stress effects on ER that may help to develop adequate preventive and curative interventions of stress- and emotion-related disorders,” the researchers write.

Source

The study was conducted by Katja Langer, Valerie Jentsch, and Oliver Wolf from the Department of Cognitive Psychology, Ruhr University Bochum (Germany). It was published in the May 2023 issue of Psychoneuroendocrinology.

Limitations

The results have some inconsistencies. The ER paradigm is somewhat artificial and not fully comparable with emotional trigger and regulatory requirements in everyday life. The study did not directly assess levels of catecholamines such as adrenaline and noradrenaline.

Disclosures

The study received support from the German Research Foundation (DFG). The authors have no reported conflicts of interest.

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

It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.

The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.

While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.

AGA

“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.

The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.

AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.

UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”

“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”

However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.

The advance notification policy comes despite immense pressure from physicians, patients, lawmakers, and regulators to crack down on prior authorization policies. “AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
 

How advance notification works

Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.

The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.

Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.

Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.

UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”

The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.

Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.

“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.

For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.

It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.

The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.

While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.

AGA

“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.

The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.

AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.

UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”

“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”

However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.

The advance notification policy comes despite immense pressure from physicians, patients, lawmakers, and regulators to crack down on prior authorization policies. “AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
 

How advance notification works

Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.

The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.

Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.

Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.

UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”

The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.

Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.

“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.

For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.

It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.

The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.

While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.

AGA

“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.

The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.

AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.

UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”

“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”

However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.

The advance notification policy comes despite immense pressure from physicians, patients, lawmakers, and regulators to crack down on prior authorization policies. “AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
 

How advance notification works

Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.

The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.

Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.

Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.

UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”

The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.

Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.

“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.

For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

Changes in movement detected passively by smartwatches can help flag Parkinson’s disease (PD) years before symptom onset, new research shows.

An analysis of wearable motion-tracking data from UK Biobank participants showed a strong correlation between reduced daytime movement over 1 week and a clinical diagnosis of PD up to 7 years later.

“Smartwatch data is easily accessible and low cost. By using this type of data, we would potentially be able to identify individuals in the very early stages of Parkinson’s disease within the general population,” lead researcher Cynthia Sandor, PhD, from Cardiff (Wales) University, said in a statement.

“We have shown here that a single week of data captured can predict events up to 7 years in the future. With these results we could develop a valuable screening tool to aid in the early detection of Parkinson’s,” she added.

“This has implications both for research, in improving recruitment into clinical trials, and in clinical practice, in allowing patients to access treatments at an earlier stage, in future when such treatments become available,” said Dr. Sandor.

The study was published online in Nature Medicine.
 

Novel biomarker for PD

Using machine learning, the researchers analyzed accelerometry data from 103,712 UK Biobank participants who wore a medical-grade smartwatch for a 7-day period during 2013-2016.

At the time of or within 2 years after accelerometry data collection, 273 participants were diagnosed with PD. An additional 196 individuals received a new PD diagnosis more than 2 years after accelerometry data collection (the prodromal group).

The patients with prodromal symptoms of PD and those who were diagnosed with PD showed a significantly reduced daytime acceleration profile up to 7 years before diagnosis, compared with age- and sex-matched healthy control persons, the researchers found.

The reduction in acceleration both before and following diagnosis was unique to patients with PD, “suggesting this measure to be disease specific with potential for use in early identification of individuals likely to be diagnosed with PD,” they wrote.

Accelerometry data proved more accurate than other risk factors (lifestyle, genetics, blood chemistry) or recognized prodromal symptoms of PD in predicting whether an individual would develop PD.

“Our results suggest that accelerometry collected with wearable devices in the general population could be used to identify those at elevated risk for PD on an unprecedented scale and, importantly, individuals who will likely convert within the next few years can be included in studies for neuroprotective treatments,” the researchers conclude in their article.

High-quality research

In a statement from the U.K.-based nonprofit Science Media Centre, José López Barneo, MD, PhD, with the University of Seville (Spain), said this “good quality” study “fits well with current knowledge.”

Dr. Barneo noted that other investigators have also observed that slowness of movement is a characteristic feature of some people who subsequently develop PD.

But these studies involved preselected cohorts of persons at risk of developing PD, or they were carried out in a hospital that required healthcare staff to conduct the movement analysis. In contrast, the current study was conducted in a very large cohort from the general U.K. population.

Also weighing in, José Luis Lanciego, MD, PhD, with the University of Navarra (Spain), said the “main value of this study is that it has demonstrated that accelerometry measurements obtained using wearable devices (such as a smartwatch or other similar devices) are more useful than the assessment of any other potentially prodromal symptom in identifying which people in the [general] population are at increased risk of developing Parkinson’s disease in the future, as well as being able to estimate how many years it will take to start suffering from this neurodegenerative process.

“In these diseases, early diagnosis is to some extent questionable, as early diagnosis is of little use if neuroprotective treatment is not available,” Dr. Lanciego noted.

“However, it is of great importance for use in clinical trials aimed at evaluating the efficacy of new potentially neuroprotective treatments whose main objective is to slow down – and, ideally, even halt ― the clinical progression that typically characterizes Parkinson’s disease,” Dr. Lanciego added.

The study was funded by the UK Dementia Research Institute, the Welsh government, and Cardiff University. Dr. Sandor, Dr. Barneo, and Dr. Lanciego have no relevant disclosures.

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

Changes in movement detected passively by smartwatches can help flag Parkinson’s disease (PD) years before symptom onset, new research shows.

An analysis of wearable motion-tracking data from UK Biobank participants showed a strong correlation between reduced daytime movement over 1 week and a clinical diagnosis of PD up to 7 years later.

“Smartwatch data is easily accessible and low cost. By using this type of data, we would potentially be able to identify individuals in the very early stages of Parkinson’s disease within the general population,” lead researcher Cynthia Sandor, PhD, from Cardiff (Wales) University, said in a statement.

“We have shown here that a single week of data captured can predict events up to 7 years in the future. With these results we could develop a valuable screening tool to aid in the early detection of Parkinson’s,” she added.

“This has implications both for research, in improving recruitment into clinical trials, and in clinical practice, in allowing patients to access treatments at an earlier stage, in future when such treatments become available,” said Dr. Sandor.

The study was published online in Nature Medicine.
 

Novel biomarker for PD

Using machine learning, the researchers analyzed accelerometry data from 103,712 UK Biobank participants who wore a medical-grade smartwatch for a 7-day period during 2013-2016.

At the time of or within 2 years after accelerometry data collection, 273 participants were diagnosed with PD. An additional 196 individuals received a new PD diagnosis more than 2 years after accelerometry data collection (the prodromal group).

The patients with prodromal symptoms of PD and those who were diagnosed with PD showed a significantly reduced daytime acceleration profile up to 7 years before diagnosis, compared with age- and sex-matched healthy control persons, the researchers found.

The reduction in acceleration both before and following diagnosis was unique to patients with PD, “suggesting this measure to be disease specific with potential for use in early identification of individuals likely to be diagnosed with PD,” they wrote.

Accelerometry data proved more accurate than other risk factors (lifestyle, genetics, blood chemistry) or recognized prodromal symptoms of PD in predicting whether an individual would develop PD.

“Our results suggest that accelerometry collected with wearable devices in the general population could be used to identify those at elevated risk for PD on an unprecedented scale and, importantly, individuals who will likely convert within the next few years can be included in studies for neuroprotective treatments,” the researchers conclude in their article.

High-quality research

In a statement from the U.K.-based nonprofit Science Media Centre, José López Barneo, MD, PhD, with the University of Seville (Spain), said this “good quality” study “fits well with current knowledge.”

Dr. Barneo noted that other investigators have also observed that slowness of movement is a characteristic feature of some people who subsequently develop PD.

But these studies involved preselected cohorts of persons at risk of developing PD, or they were carried out in a hospital that required healthcare staff to conduct the movement analysis. In contrast, the current study was conducted in a very large cohort from the general U.K. population.

Also weighing in, José Luis Lanciego, MD, PhD, with the University of Navarra (Spain), said the “main value of this study is that it has demonstrated that accelerometry measurements obtained using wearable devices (such as a smartwatch or other similar devices) are more useful than the assessment of any other potentially prodromal symptom in identifying which people in the [general] population are at increased risk of developing Parkinson’s disease in the future, as well as being able to estimate how many years it will take to start suffering from this neurodegenerative process.

“In these diseases, early diagnosis is to some extent questionable, as early diagnosis is of little use if neuroprotective treatment is not available,” Dr. Lanciego noted.

“However, it is of great importance for use in clinical trials aimed at evaluating the efficacy of new potentially neuroprotective treatments whose main objective is to slow down – and, ideally, even halt ― the clinical progression that typically characterizes Parkinson’s disease,” Dr. Lanciego added.

The study was funded by the UK Dementia Research Institute, the Welsh government, and Cardiff University. Dr. Sandor, Dr. Barneo, and Dr. Lanciego have no relevant disclosures.

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

Changes in movement detected passively by smartwatches can help flag Parkinson’s disease (PD) years before symptom onset, new research shows.

An analysis of wearable motion-tracking data from UK Biobank participants showed a strong correlation between reduced daytime movement over 1 week and a clinical diagnosis of PD up to 7 years later.

“Smartwatch data is easily accessible and low cost. By using this type of data, we would potentially be able to identify individuals in the very early stages of Parkinson’s disease within the general population,” lead researcher Cynthia Sandor, PhD, from Cardiff (Wales) University, said in a statement.

“We have shown here that a single week of data captured can predict events up to 7 years in the future. With these results we could develop a valuable screening tool to aid in the early detection of Parkinson’s,” she added.

“This has implications both for research, in improving recruitment into clinical trials, and in clinical practice, in allowing patients to access treatments at an earlier stage, in future when such treatments become available,” said Dr. Sandor.

The study was published online in Nature Medicine.
 

Novel biomarker for PD

Using machine learning, the researchers analyzed accelerometry data from 103,712 UK Biobank participants who wore a medical-grade smartwatch for a 7-day period during 2013-2016.

At the time of or within 2 years after accelerometry data collection, 273 participants were diagnosed with PD. An additional 196 individuals received a new PD diagnosis more than 2 years after accelerometry data collection (the prodromal group).

The patients with prodromal symptoms of PD and those who were diagnosed with PD showed a significantly reduced daytime acceleration profile up to 7 years before diagnosis, compared with age- and sex-matched healthy control persons, the researchers found.

The reduction in acceleration both before and following diagnosis was unique to patients with PD, “suggesting this measure to be disease specific with potential for use in early identification of individuals likely to be diagnosed with PD,” they wrote.

Accelerometry data proved more accurate than other risk factors (lifestyle, genetics, blood chemistry) or recognized prodromal symptoms of PD in predicting whether an individual would develop PD.

“Our results suggest that accelerometry collected with wearable devices in the general population could be used to identify those at elevated risk for PD on an unprecedented scale and, importantly, individuals who will likely convert within the next few years can be included in studies for neuroprotective treatments,” the researchers conclude in their article.

High-quality research

In a statement from the U.K.-based nonprofit Science Media Centre, José López Barneo, MD, PhD, with the University of Seville (Spain), said this “good quality” study “fits well with current knowledge.”

Dr. Barneo noted that other investigators have also observed that slowness of movement is a characteristic feature of some people who subsequently develop PD.

But these studies involved preselected cohorts of persons at risk of developing PD, or they were carried out in a hospital that required healthcare staff to conduct the movement analysis. In contrast, the current study was conducted in a very large cohort from the general U.K. population.

Also weighing in, José Luis Lanciego, MD, PhD, with the University of Navarra (Spain), said the “main value of this study is that it has demonstrated that accelerometry measurements obtained using wearable devices (such as a smartwatch or other similar devices) are more useful than the assessment of any other potentially prodromal symptom in identifying which people in the [general] population are at increased risk of developing Parkinson’s disease in the future, as well as being able to estimate how many years it will take to start suffering from this neurodegenerative process.

“In these diseases, early diagnosis is to some extent questionable, as early diagnosis is of little use if neuroprotective treatment is not available,” Dr. Lanciego noted.

“However, it is of great importance for use in clinical trials aimed at evaluating the efficacy of new potentially neuroprotective treatments whose main objective is to slow down – and, ideally, even halt ― the clinical progression that typically characterizes Parkinson’s disease,” Dr. Lanciego added.

The study was funded by the UK Dementia Research Institute, the Welsh government, and Cardiff University. Dr. Sandor, Dr. Barneo, and Dr. Lanciego have no relevant disclosures.

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

In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.

Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).

Dr. Amos Grunebaum

“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.

But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.

“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”

Propagating ‘race-based medicine’

Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.

“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”

Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”

In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.

Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.

Dr. Sara E. Edwards

“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.

And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.

Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.

But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.

In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.

“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
 

Bias ‘creeping in’ to neonatal care

Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.

Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.

“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.

This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.

Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.

The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
 

New scoring system needed

Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.

Emma Gillette

“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”

That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”

Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.

In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”

Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.

In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.

Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).

Dr. Amos Grunebaum

“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.

But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.

“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”

Propagating ‘race-based medicine’

Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.

“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”

Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”

In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.

Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.

Dr. Sara E. Edwards

“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.

And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.

Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.

But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.

In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.

“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
 

Bias ‘creeping in’ to neonatal care

Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.

Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.

“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.

This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.

Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.

The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
 

New scoring system needed

Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.

Emma Gillette

“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”

That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”

Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.

In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”

Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.

In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.

Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).

Dr. Amos Grunebaum

“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.

But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.

“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”

Propagating ‘race-based medicine’

Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.

“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”

Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”

In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.

Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.

Dr. Sara E. Edwards

“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.

And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.

Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.

But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.

In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.

“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
 

Bias ‘creeping in’ to neonatal care

Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.

Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.

“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.

This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.

Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.

The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
 

New scoring system needed

Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.

Emma Gillette

“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”

That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”

Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.

In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”

Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.

In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.

The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.

APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.

The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.

Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.

The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.  

“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.

Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”

“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.

Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.

The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”

The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.

While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.

In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.

Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.

A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.

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

In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.

The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.

APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.

The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.

Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.

The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.  

“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.

Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”

“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.

Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.

The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”

The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.

While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.

In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.

Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.

A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.

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

In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.

The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.

APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.

The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.

Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.

The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.  

“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.

Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”

“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.

Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.

The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”

The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.

While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.

In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.

Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.

A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.

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

Nearly one in five people in the United States had never been infected with COVID-19 as of the end of 2022, according to a new estimate.

The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.

Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.

In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.

As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.

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

Nearly one in five people in the United States had never been infected with COVID-19 as of the end of 2022, according to a new estimate.

The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.

Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.

In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.

As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.

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

Nearly one in five people in the United States had never been infected with COVID-19 as of the end of 2022, according to a new estimate.

The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.

Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.

In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.

As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.

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