Summer heat is notorious for making the strain of pregnancy worse. But for many pregnant people, sweltering temperatures are much worse than a sweaty annoyance.

New research shows that the risk of miscarriage rises sharply as the mercury climbs. In late August, for example, the risk of losing a pregnancy is 44% higher than in February, according to the findings.

“One of our hypotheses is that heat may trigger miscarriage, which is something that we are now exploring further,” says Amelia Wesselink, PhD, an assistant professor of epidemiology at Boston University School of Public Health, who led the study team. “Our next step is to dig into drivers of this seasonal pattern.”

She and her colleagues analyzed seasonal differences and pregnancy outcomes for over 12,000 women. Spontaneous abortion rates peaked in late August, especially for those living in the southern and midwestern United States.

Spontaneous abortion was defined as miscarriage, chemical pregnancy (a very early miscarriage where the embryo stops growing), or blighted ovum (the embryo stops developing or never develops).

From 2013 to 2020, 12,197 women living in the United States and Canada were followed for up to 1 year using Pregnancy Study Online (PRESTO), an internet-based fertility study from the Boston University School of Public Health. Those in the study answered questions about their income, education, race/ethnicity, and lifestyle, as well as follow-up questions about their pregnancy and/or loss of pregnancy.

Most of the people studied were non-Hispanic White (86%) and had at least a college degree (79%). Almost half earned more than $100,000 annually (47%). Those seeking fertility treatments were excluded from the study.

Half of the women (6,104) said they conceived in the first 12 months of trying to get pregnant, and almost one in five (19.5%) of those who conceived miscarried.

The risk of miscarriage was 44% higher in late August than it was in late February, the month with the lowest rate of lost pregnancies. This trend was almost exclusively seen for pregnancies in their first 8 weeks. The risk of miscarriage increased 31% in late August for pregnancies at any stage.

The link between miscarriage and extreme heat was strongest in the South and Midwest, with peaks in late August and early September, respectively.

“We know so little about the causes of miscarriage that it’s difficult to tie seasonal variation in risk to any particular cause,” says David Savitz, PhD, a professor of epidemiology and obstetrics, gynecology & pediatrics at Brown University, Providence, R.I., who helped conduct the study. “Exposures vary by summer, including a lower risk of respiratory infection in the warm season, changes in diet and physical activity, and physical factors such as temperature and sunlight.”

But another expert warned that extreme heat may not be the only culprit in summer’s observed miscarriage rates.

“You need to be careful when linking summer months to miscarriage, as women may pursue more outdoor activities during summer,” says Saifuddin Ahmed PhD, a researcher at Johns Hopkins Bloomberg School of Public Health, Baltimore.

Although the paper suggested physical activity may play a role in miscarriage frequency, no analysis supported this claim, Dr. Ahmed says.

Also, participants in the study were mostly White and tended to be wealthier than the general population, so the findings may not apply to everyone, Dr. Wesselink says. Although the researchers saw some similarities between participants with income above $100,000 a year and those who earned less, socioeconomic status plays an important role in environmental exposures – including heat – so the results may not hold among lower-income populations, Dr. Wesselink says.

Dr. Wesselink and her colleagues published their findings in the journal Epidemiology.

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

Summer heat is notorious for making the strain of pregnancy worse. But for many pregnant people, sweltering temperatures are much worse than a sweaty annoyance.

New research shows that the risk of miscarriage rises sharply as the mercury climbs. In late August, for example, the risk of losing a pregnancy is 44% higher than in February, according to the findings.

“One of our hypotheses is that heat may trigger miscarriage, which is something that we are now exploring further,” says Amelia Wesselink, PhD, an assistant professor of epidemiology at Boston University School of Public Health, who led the study team. “Our next step is to dig into drivers of this seasonal pattern.”

She and her colleagues analyzed seasonal differences and pregnancy outcomes for over 12,000 women. Spontaneous abortion rates peaked in late August, especially for those living in the southern and midwestern United States.

Spontaneous abortion was defined as miscarriage, chemical pregnancy (a very early miscarriage where the embryo stops growing), or blighted ovum (the embryo stops developing or never develops).

From 2013 to 2020, 12,197 women living in the United States and Canada were followed for up to 1 year using Pregnancy Study Online (PRESTO), an internet-based fertility study from the Boston University School of Public Health. Those in the study answered questions about their income, education, race/ethnicity, and lifestyle, as well as follow-up questions about their pregnancy and/or loss of pregnancy.

Most of the people studied were non-Hispanic White (86%) and had at least a college degree (79%). Almost half earned more than $100,000 annually (47%). Those seeking fertility treatments were excluded from the study.

Half of the women (6,104) said they conceived in the first 12 months of trying to get pregnant, and almost one in five (19.5%) of those who conceived miscarried.

The risk of miscarriage was 44% higher in late August than it was in late February, the month with the lowest rate of lost pregnancies. This trend was almost exclusively seen for pregnancies in their first 8 weeks. The risk of miscarriage increased 31% in late August for pregnancies at any stage.

The link between miscarriage and extreme heat was strongest in the South and Midwest, with peaks in late August and early September, respectively.

“We know so little about the causes of miscarriage that it’s difficult to tie seasonal variation in risk to any particular cause,” says David Savitz, PhD, a professor of epidemiology and obstetrics, gynecology & pediatrics at Brown University, Providence, R.I., who helped conduct the study. “Exposures vary by summer, including a lower risk of respiratory infection in the warm season, changes in diet and physical activity, and physical factors such as temperature and sunlight.”

But another expert warned that extreme heat may not be the only culprit in summer’s observed miscarriage rates.

“You need to be careful when linking summer months to miscarriage, as women may pursue more outdoor activities during summer,” says Saifuddin Ahmed PhD, a researcher at Johns Hopkins Bloomberg School of Public Health, Baltimore.

Although the paper suggested physical activity may play a role in miscarriage frequency, no analysis supported this claim, Dr. Ahmed says.

Also, participants in the study were mostly White and tended to be wealthier than the general population, so the findings may not apply to everyone, Dr. Wesselink says. Although the researchers saw some similarities between participants with income above $100,000 a year and those who earned less, socioeconomic status plays an important role in environmental exposures – including heat – so the results may not hold among lower-income populations, Dr. Wesselink says.

Dr. Wesselink and her colleagues published their findings in the journal Epidemiology.

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

Summer heat is notorious for making the strain of pregnancy worse. But for many pregnant people, sweltering temperatures are much worse than a sweaty annoyance.

New research shows that the risk of miscarriage rises sharply as the mercury climbs. In late August, for example, the risk of losing a pregnancy is 44% higher than in February, according to the findings.

“One of our hypotheses is that heat may trigger miscarriage, which is something that we are now exploring further,” says Amelia Wesselink, PhD, an assistant professor of epidemiology at Boston University School of Public Health, who led the study team. “Our next step is to dig into drivers of this seasonal pattern.”

She and her colleagues analyzed seasonal differences and pregnancy outcomes for over 12,000 women. Spontaneous abortion rates peaked in late August, especially for those living in the southern and midwestern United States.

Spontaneous abortion was defined as miscarriage, chemical pregnancy (a very early miscarriage where the embryo stops growing), or blighted ovum (the embryo stops developing or never develops).

From 2013 to 2020, 12,197 women living in the United States and Canada were followed for up to 1 year using Pregnancy Study Online (PRESTO), an internet-based fertility study from the Boston University School of Public Health. Those in the study answered questions about their income, education, race/ethnicity, and lifestyle, as well as follow-up questions about their pregnancy and/or loss of pregnancy.

Most of the people studied were non-Hispanic White (86%) and had at least a college degree (79%). Almost half earned more than $100,000 annually (47%). Those seeking fertility treatments were excluded from the study.

Half of the women (6,104) said they conceived in the first 12 months of trying to get pregnant, and almost one in five (19.5%) of those who conceived miscarried.

The risk of miscarriage was 44% higher in late August than it was in late February, the month with the lowest rate of lost pregnancies. This trend was almost exclusively seen for pregnancies in their first 8 weeks. The risk of miscarriage increased 31% in late August for pregnancies at any stage.

The link between miscarriage and extreme heat was strongest in the South and Midwest, with peaks in late August and early September, respectively.

“We know so little about the causes of miscarriage that it’s difficult to tie seasonal variation in risk to any particular cause,” says David Savitz, PhD, a professor of epidemiology and obstetrics, gynecology & pediatrics at Brown University, Providence, R.I., who helped conduct the study. “Exposures vary by summer, including a lower risk of respiratory infection in the warm season, changes in diet and physical activity, and physical factors such as temperature and sunlight.”

But another expert warned that extreme heat may not be the only culprit in summer’s observed miscarriage rates.

“You need to be careful when linking summer months to miscarriage, as women may pursue more outdoor activities during summer,” says Saifuddin Ahmed PhD, a researcher at Johns Hopkins Bloomberg School of Public Health, Baltimore.

Although the paper suggested physical activity may play a role in miscarriage frequency, no analysis supported this claim, Dr. Ahmed says.

Also, participants in the study were mostly White and tended to be wealthier than the general population, so the findings may not apply to everyone, Dr. Wesselink says. Although the researchers saw some similarities between participants with income above $100,000 a year and those who earned less, socioeconomic status plays an important role in environmental exposures – including heat – so the results may not hold among lower-income populations, Dr. Wesselink says.

Dr. Wesselink and her colleagues published their findings in the journal Epidemiology.

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

Amazon is working with the Fred Hutchinson Cancer Research Center to develop cancer vaccines in a new clinical trial.

The trial is aimed at finding “personalized vaccines” to treat breast cancer and melanoma. The phase 1 trial is recruiting 20 people over the age of 18 to study the safety of the vaccines, according to CNBC.

The Fred Hutchinson Cancer Research Center and University of Washington Cancer Consortium are listed as the researchers of the clinical trial, and Amazon is listed as a collaborator, according to a filing on the ClinicalTrials.gov database.

“Amazon is contributing scientific and machine learning expertise to a partnership with Fred Hutch to explore the development of a personalized treatment for certain forms of cancer,” an Amazon spokesperson told CNBC.

“It’s very early, but Fred Hutch recently received permission from the U.S. Food and Drug Administration to proceed with a phase 1 clinical trial, and it’s unclear whether it will be successful,” the spokesperson said. “This will be a long, multiyear process – should it progress, we would be open to working with other organizations in health care and life sciences that might also be interested in similar efforts.”

In recent years, Amazon has grown its presence in the health care industry, CNBC reported. The company launched an online pharmacy in 2020, developed a telehealth service called Amazon Care, and released its own COVID-19 test during the pandemic.

A research and development group inside Amazon, known as Grand Challenge, oversaw the company’s early cancer vaccine effort, according to Business Insider. It’s now under the purview of a cancer research team that reports to Robert Williams, the company’s vice president of devices.

The study was first posted on ClinicalTrials.gov in October 2021 and began recruiting patients on June 9, according to the filing. The phase 1 trial is expected to run through November 2023.

The phase 1 trial will study the safety of personalized vaccines to treat patients with late-stage melanoma or hormone receptor-positive HER2-negative breast cancer which has either spread to other parts of the body or doesn’t respond to treatment.

More information about the study can be found on ClinicalTrials.gov under the identifier NCT05098210.

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

Amazon is working with the Fred Hutchinson Cancer Research Center to develop cancer vaccines in a new clinical trial.

The trial is aimed at finding “personalized vaccines” to treat breast cancer and melanoma. The phase 1 trial is recruiting 20 people over the age of 18 to study the safety of the vaccines, according to CNBC.

The Fred Hutchinson Cancer Research Center and University of Washington Cancer Consortium are listed as the researchers of the clinical trial, and Amazon is listed as a collaborator, according to a filing on the ClinicalTrials.gov database.

“Amazon is contributing scientific and machine learning expertise to a partnership with Fred Hutch to explore the development of a personalized treatment for certain forms of cancer,” an Amazon spokesperson told CNBC.

“It’s very early, but Fred Hutch recently received permission from the U.S. Food and Drug Administration to proceed with a phase 1 clinical trial, and it’s unclear whether it will be successful,” the spokesperson said. “This will be a long, multiyear process – should it progress, we would be open to working with other organizations in health care and life sciences that might also be interested in similar efforts.”

In recent years, Amazon has grown its presence in the health care industry, CNBC reported. The company launched an online pharmacy in 2020, developed a telehealth service called Amazon Care, and released its own COVID-19 test during the pandemic.

A research and development group inside Amazon, known as Grand Challenge, oversaw the company’s early cancer vaccine effort, according to Business Insider. It’s now under the purview of a cancer research team that reports to Robert Williams, the company’s vice president of devices.

The study was first posted on ClinicalTrials.gov in October 2021 and began recruiting patients on June 9, according to the filing. The phase 1 trial is expected to run through November 2023.

The phase 1 trial will study the safety of personalized vaccines to treat patients with late-stage melanoma or hormone receptor-positive HER2-negative breast cancer which has either spread to other parts of the body or doesn’t respond to treatment.

More information about the study can be found on ClinicalTrials.gov under the identifier NCT05098210.

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

Amazon is working with the Fred Hutchinson Cancer Research Center to develop cancer vaccines in a new clinical trial.

The trial is aimed at finding “personalized vaccines” to treat breast cancer and melanoma. The phase 1 trial is recruiting 20 people over the age of 18 to study the safety of the vaccines, according to CNBC.

The Fred Hutchinson Cancer Research Center and University of Washington Cancer Consortium are listed as the researchers of the clinical trial, and Amazon is listed as a collaborator, according to a filing on the ClinicalTrials.gov database.

“Amazon is contributing scientific and machine learning expertise to a partnership with Fred Hutch to explore the development of a personalized treatment for certain forms of cancer,” an Amazon spokesperson told CNBC.

“It’s very early, but Fred Hutch recently received permission from the U.S. Food and Drug Administration to proceed with a phase 1 clinical trial, and it’s unclear whether it will be successful,” the spokesperson said. “This will be a long, multiyear process – should it progress, we would be open to working with other organizations in health care and life sciences that might also be interested in similar efforts.”

In recent years, Amazon has grown its presence in the health care industry, CNBC reported. The company launched an online pharmacy in 2020, developed a telehealth service called Amazon Care, and released its own COVID-19 test during the pandemic.

A research and development group inside Amazon, known as Grand Challenge, oversaw the company’s early cancer vaccine effort, according to Business Insider. It’s now under the purview of a cancer research team that reports to Robert Williams, the company’s vice president of devices.

The study was first posted on ClinicalTrials.gov in October 2021 and began recruiting patients on June 9, according to the filing. The phase 1 trial is expected to run through November 2023.

The phase 1 trial will study the safety of personalized vaccines to treat patients with late-stage melanoma or hormone receptor-positive HER2-negative breast cancer which has either spread to other parts of the body or doesn’t respond to treatment.

More information about the study can be found on ClinicalTrials.gov under the identifier NCT05098210.

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

A cost-saving, stepwise approach to treating diabetic macular edema was as effective and at least as safe as what’s been the standard approach, which jumps straight to the costlier treatment, in a head-to-head, multicenter, U.S. randomized trial of the two regimens that included 312 eyes in 270 adults with type 1 or type 2 diabetes.

The findings validate a treatment regimen for diabetic macular edema that’s already common in U.S. practice based on requirements by many health insurance providers because of the money it saves.

The step-therapy approach studied involves starting off-label treatment with the relatively inexpensive agent bevacizumab (Avastin), followed by a switch to the much pricier aflibercept (Eylea) when patients don’t adequately respond, following a prespecified algorithm that applies four criteria to determine when patients need to change agents.

These new findings build on a 2016 study that compared aflibercept monotherapy with bevacizumab monotherapy and showed that after 2 years of treatment aflibercept produced clearly better outcomes.

The new trial findings “are particularly relevant given the increasing frequency of insurers mandating step therapy with bevacizumab before the use of other drugs” such as aflibercept, noted Chirag D. Jhaveri, MD, and colleagues in the study published online in the New England Journal of Medicine.
 

Opportunity for ‘substantial cost reductions’

Jhaveri, a retina surgeon in Austin, Texas, and associates note that, based on Medicare reimbursement rates of $1,830 for a single dose of aflibercept and $70 for one dose of bevacizumab, starting treatment with bevacizumab could produce “substantial cost reductions for the health care system.”

The authors of an accompanying editorial agree. Step therapy that starts with bevacizumab would probably result in “substantial” cost savings, and the findings document “similar outcomes” from the two tested regimens based on improvements in visual acuity and changes in the thickness measurement of the central retina during the 2-year trial, write David C. Musch, PhD, and Emily Y. Chew, MD.

Dr. Musch, a professor and ophthalmology epidemiologist at the University of Michigan in Ann Arbor, and Dr. Chew, director of the Division of Epidemiology and Clinical Applications at the National Eye Institute in Bethesda, Md., also laud the “rigorous” study for its design and conduct that was “beyond reproach,” and for producing evidence that “applies well to clinical practice.”

The only potential drawback to the step-therapy approach, they write, is that people with diabetes often have “numerous coexisting conditions that make it more difficult for them to adhere to frequent follow-up visits,” a key element of the tested step-care protocol, which mandated follow-up visits every 4 weeks during the first year and every 4-16 weeks during the second year.
 

312 eyes of 270 patients

The new trial, organized by the DRCR Retinal Network and the Jaeb Center for Health Research in Tampa, Fla., ran at 54 U.S. sites from December 2017 to November 2019. The study randomized 158 eyes in 137 patients to aflibercept monotherapy, and 154 eyes in 133 patients to the step-care regimen (both eyes were treated in several patients in each group, with each eye receiving a different regimen). Participants were around 60 years old, 48% were women, and 95% had type 2 diabetes.

To be eligible for enrollment, patients had at least one eye with a best-corrected visual-acuity letter score of 24-69 on an Electronic Early Treatment Diabetic Retinopathy Study chart (ranges from 0 to 100, with higher values indicating better visual acuity), which corresponds to Snellen chart values of 20/320-20/50, readings that encompass most patients with diabetic macular edema, noted study authors Adam R. Glassman and Jennifer K. Sun, MD, in an interview.

“Very few patients with diabetic macular edema have vision due to this alone that is worse than 20/320, which meets criteria for legal blindness,” said Dr. Glassman, who is executive director of the Jaeb Center for Health Research, and Dr. Sun, who is chief of the center for clinical eye research and trials at the Joslin Diabetes Center in Boston and chair of the DRCR Retinal Network.

The primary outcome was time-averaged change in visual-acuity letter score from baseline to 2 years, which improved by an average of 15.0 letters in the aflibercept monotherapy group and an average of 14.0 letters in the step-therapy group, an adjusted difference of 0.8 letters, which was not significant. An improvement from baseline of at least 15 letters occurred in 53% of the eyes in the aflibercept monotherapy group and in 58% of those who had step therapy, and 77% of eyes in both groups had improvements of at least 10 letters.  

Central retinal thickness dropped from baseline by an average of 192 mcm with aflibercept monotherapy and 198 mcm with step therapy. The average number of total treatments (by intravitreous injection) was 14.6 in the aflibercept monotherapy group and 16.1 in the step-therapy group. After the first 24 weeks of the study, 39% of eyes in the step-therapy group had switched from bevacizumab to aflibercept injections; after 1 year, 60% of eyes had switched; and by study end, after 2 years, 70% had changed.

The bevacizumab-first group also showed at least comparable if not better safety, with similar rates of prespecified ocular events in both groups, but with a significantly lower rate of serious systemic adverse events, which occurred in 52% of the eyes treated with aflibercept only and 36% of eyes that began treatment on bevacizumab. Serious systemic adverse events occurred in 43% of patients who had two eyes treated as part of the trial.
 

‘Bevacizumab first was noninferior’

The team that designed the trial opted for a superiority design rather than a noninferiority trial and powered the study based on the presumption that aflibercept monotherapy would prove superior, said Dr. Glassman and Dr. Sun. “We feel that the clinical interpretation of these results will be similar to the interpretation if we had conducted a noninferiority study, and we found that bevacizumab first was noninferior to aflibercept monotherapy,” they maintained in an interview.

Dr. Glassman and Dr. Sun said they and their coauthors are now analyzing the results to try to find patient characteristics that could identify eyes most likely to respond to the bevacizumab-first approach. “It would be clinically valuable” to use the results to identify characteristics that could help guide clinicians’ treatment approach and enhance patient counseling, they said.

The study received funding from the National Institutes of Health. Dr. Jhaveri has reported being a consultant for Genentech, Novartis, and Regenxbio. Dr. Glassman has reported receiving grants from Genentech and Regeneron. Dr. Sun has reported receiving grants from Boehringer Ingelheim, Janssen Biotech, KalVista, Optovue, and Physical Sciences, grants and travel support from Novartis and Novo Nordisk, travel support from Merck, writing support from Genentech, and equipment supplied by Adaptive Sensory and Boston Micromachines. Dr. Musch and Dr. Chew have reported no relevant financial relationships.

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

A cost-saving, stepwise approach to treating diabetic macular edema was as effective and at least as safe as what’s been the standard approach, which jumps straight to the costlier treatment, in a head-to-head, multicenter, U.S. randomized trial of the two regimens that included 312 eyes in 270 adults with type 1 or type 2 diabetes.

The findings validate a treatment regimen for diabetic macular edema that’s already common in U.S. practice based on requirements by many health insurance providers because of the money it saves.

The step-therapy approach studied involves starting off-label treatment with the relatively inexpensive agent bevacizumab (Avastin), followed by a switch to the much pricier aflibercept (Eylea) when patients don’t adequately respond, following a prespecified algorithm that applies four criteria to determine when patients need to change agents.

These new findings build on a 2016 study that compared aflibercept monotherapy with bevacizumab monotherapy and showed that after 2 years of treatment aflibercept produced clearly better outcomes.

The new trial findings “are particularly relevant given the increasing frequency of insurers mandating step therapy with bevacizumab before the use of other drugs” such as aflibercept, noted Chirag D. Jhaveri, MD, and colleagues in the study published online in the New England Journal of Medicine.
 

Opportunity for ‘substantial cost reductions’

Jhaveri, a retina surgeon in Austin, Texas, and associates note that, based on Medicare reimbursement rates of $1,830 for a single dose of aflibercept and $70 for one dose of bevacizumab, starting treatment with bevacizumab could produce “substantial cost reductions for the health care system.”

The authors of an accompanying editorial agree. Step therapy that starts with bevacizumab would probably result in “substantial” cost savings, and the findings document “similar outcomes” from the two tested regimens based on improvements in visual acuity and changes in the thickness measurement of the central retina during the 2-year trial, write David C. Musch, PhD, and Emily Y. Chew, MD.

Dr. Musch, a professor and ophthalmology epidemiologist at the University of Michigan in Ann Arbor, and Dr. Chew, director of the Division of Epidemiology and Clinical Applications at the National Eye Institute in Bethesda, Md., also laud the “rigorous” study for its design and conduct that was “beyond reproach,” and for producing evidence that “applies well to clinical practice.”

The only potential drawback to the step-therapy approach, they write, is that people with diabetes often have “numerous coexisting conditions that make it more difficult for them to adhere to frequent follow-up visits,” a key element of the tested step-care protocol, which mandated follow-up visits every 4 weeks during the first year and every 4-16 weeks during the second year.
 

312 eyes of 270 patients

The new trial, organized by the DRCR Retinal Network and the Jaeb Center for Health Research in Tampa, Fla., ran at 54 U.S. sites from December 2017 to November 2019. The study randomized 158 eyes in 137 patients to aflibercept monotherapy, and 154 eyes in 133 patients to the step-care regimen (both eyes were treated in several patients in each group, with each eye receiving a different regimen). Participants were around 60 years old, 48% were women, and 95% had type 2 diabetes.

To be eligible for enrollment, patients had at least one eye with a best-corrected visual-acuity letter score of 24-69 on an Electronic Early Treatment Diabetic Retinopathy Study chart (ranges from 0 to 100, with higher values indicating better visual acuity), which corresponds to Snellen chart values of 20/320-20/50, readings that encompass most patients with diabetic macular edema, noted study authors Adam R. Glassman and Jennifer K. Sun, MD, in an interview.

“Very few patients with diabetic macular edema have vision due to this alone that is worse than 20/320, which meets criteria for legal blindness,” said Dr. Glassman, who is executive director of the Jaeb Center for Health Research, and Dr. Sun, who is chief of the center for clinical eye research and trials at the Joslin Diabetes Center in Boston and chair of the DRCR Retinal Network.

The primary outcome was time-averaged change in visual-acuity letter score from baseline to 2 years, which improved by an average of 15.0 letters in the aflibercept monotherapy group and an average of 14.0 letters in the step-therapy group, an adjusted difference of 0.8 letters, which was not significant. An improvement from baseline of at least 15 letters occurred in 53% of the eyes in the aflibercept monotherapy group and in 58% of those who had step therapy, and 77% of eyes in both groups had improvements of at least 10 letters.  

Central retinal thickness dropped from baseline by an average of 192 mcm with aflibercept monotherapy and 198 mcm with step therapy. The average number of total treatments (by intravitreous injection) was 14.6 in the aflibercept monotherapy group and 16.1 in the step-therapy group. After the first 24 weeks of the study, 39% of eyes in the step-therapy group had switched from bevacizumab to aflibercept injections; after 1 year, 60% of eyes had switched; and by study end, after 2 years, 70% had changed.

The bevacizumab-first group also showed at least comparable if not better safety, with similar rates of prespecified ocular events in both groups, but with a significantly lower rate of serious systemic adverse events, which occurred in 52% of the eyes treated with aflibercept only and 36% of eyes that began treatment on bevacizumab. Serious systemic adverse events occurred in 43% of patients who had two eyes treated as part of the trial.
 

‘Bevacizumab first was noninferior’

The team that designed the trial opted for a superiority design rather than a noninferiority trial and powered the study based on the presumption that aflibercept monotherapy would prove superior, said Dr. Glassman and Dr. Sun. “We feel that the clinical interpretation of these results will be similar to the interpretation if we had conducted a noninferiority study, and we found that bevacizumab first was noninferior to aflibercept monotherapy,” they maintained in an interview.

Dr. Glassman and Dr. Sun said they and their coauthors are now analyzing the results to try to find patient characteristics that could identify eyes most likely to respond to the bevacizumab-first approach. “It would be clinically valuable” to use the results to identify characteristics that could help guide clinicians’ treatment approach and enhance patient counseling, they said.

The study received funding from the National Institutes of Health. Dr. Jhaveri has reported being a consultant for Genentech, Novartis, and Regenxbio. Dr. Glassman has reported receiving grants from Genentech and Regeneron. Dr. Sun has reported receiving grants from Boehringer Ingelheim, Janssen Biotech, KalVista, Optovue, and Physical Sciences, grants and travel support from Novartis and Novo Nordisk, travel support from Merck, writing support from Genentech, and equipment supplied by Adaptive Sensory and Boston Micromachines. Dr. Musch and Dr. Chew have reported no relevant financial relationships.

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

A cost-saving, stepwise approach to treating diabetic macular edema was as effective and at least as safe as what’s been the standard approach, which jumps straight to the costlier treatment, in a head-to-head, multicenter, U.S. randomized trial of the two regimens that included 312 eyes in 270 adults with type 1 or type 2 diabetes.

The findings validate a treatment regimen for diabetic macular edema that’s already common in U.S. practice based on requirements by many health insurance providers because of the money it saves.

The step-therapy approach studied involves starting off-label treatment with the relatively inexpensive agent bevacizumab (Avastin), followed by a switch to the much pricier aflibercept (Eylea) when patients don’t adequately respond, following a prespecified algorithm that applies four criteria to determine when patients need to change agents.

These new findings build on a 2016 study that compared aflibercept monotherapy with bevacizumab monotherapy and showed that after 2 years of treatment aflibercept produced clearly better outcomes.

The new trial findings “are particularly relevant given the increasing frequency of insurers mandating step therapy with bevacizumab before the use of other drugs” such as aflibercept, noted Chirag D. Jhaveri, MD, and colleagues in the study published online in the New England Journal of Medicine.
 

Opportunity for ‘substantial cost reductions’

Jhaveri, a retina surgeon in Austin, Texas, and associates note that, based on Medicare reimbursement rates of $1,830 for a single dose of aflibercept and $70 for one dose of bevacizumab, starting treatment with bevacizumab could produce “substantial cost reductions for the health care system.”

The authors of an accompanying editorial agree. Step therapy that starts with bevacizumab would probably result in “substantial” cost savings, and the findings document “similar outcomes” from the two tested regimens based on improvements in visual acuity and changes in the thickness measurement of the central retina during the 2-year trial, write David C. Musch, PhD, and Emily Y. Chew, MD.

Dr. Musch, a professor and ophthalmology epidemiologist at the University of Michigan in Ann Arbor, and Dr. Chew, director of the Division of Epidemiology and Clinical Applications at the National Eye Institute in Bethesda, Md., also laud the “rigorous” study for its design and conduct that was “beyond reproach,” and for producing evidence that “applies well to clinical practice.”

The only potential drawback to the step-therapy approach, they write, is that people with diabetes often have “numerous coexisting conditions that make it more difficult for them to adhere to frequent follow-up visits,” a key element of the tested step-care protocol, which mandated follow-up visits every 4 weeks during the first year and every 4-16 weeks during the second year.
 

312 eyes of 270 patients

The new trial, organized by the DRCR Retinal Network and the Jaeb Center for Health Research in Tampa, Fla., ran at 54 U.S. sites from December 2017 to November 2019. The study randomized 158 eyes in 137 patients to aflibercept monotherapy, and 154 eyes in 133 patients to the step-care regimen (both eyes were treated in several patients in each group, with each eye receiving a different regimen). Participants were around 60 years old, 48% were women, and 95% had type 2 diabetes.

To be eligible for enrollment, patients had at least one eye with a best-corrected visual-acuity letter score of 24-69 on an Electronic Early Treatment Diabetic Retinopathy Study chart (ranges from 0 to 100, with higher values indicating better visual acuity), which corresponds to Snellen chart values of 20/320-20/50, readings that encompass most patients with diabetic macular edema, noted study authors Adam R. Glassman and Jennifer K. Sun, MD, in an interview.

“Very few patients with diabetic macular edema have vision due to this alone that is worse than 20/320, which meets criteria for legal blindness,” said Dr. Glassman, who is executive director of the Jaeb Center for Health Research, and Dr. Sun, who is chief of the center for clinical eye research and trials at the Joslin Diabetes Center in Boston and chair of the DRCR Retinal Network.

The primary outcome was time-averaged change in visual-acuity letter score from baseline to 2 years, which improved by an average of 15.0 letters in the aflibercept monotherapy group and an average of 14.0 letters in the step-therapy group, an adjusted difference of 0.8 letters, which was not significant. An improvement from baseline of at least 15 letters occurred in 53% of the eyes in the aflibercept monotherapy group and in 58% of those who had step therapy, and 77% of eyes in both groups had improvements of at least 10 letters.  

Central retinal thickness dropped from baseline by an average of 192 mcm with aflibercept monotherapy and 198 mcm with step therapy. The average number of total treatments (by intravitreous injection) was 14.6 in the aflibercept monotherapy group and 16.1 in the step-therapy group. After the first 24 weeks of the study, 39% of eyes in the step-therapy group had switched from bevacizumab to aflibercept injections; after 1 year, 60% of eyes had switched; and by study end, after 2 years, 70% had changed.

The bevacizumab-first group also showed at least comparable if not better safety, with similar rates of prespecified ocular events in both groups, but with a significantly lower rate of serious systemic adverse events, which occurred in 52% of the eyes treated with aflibercept only and 36% of eyes that began treatment on bevacizumab. Serious systemic adverse events occurred in 43% of patients who had two eyes treated as part of the trial.
 

‘Bevacizumab first was noninferior’

The team that designed the trial opted for a superiority design rather than a noninferiority trial and powered the study based on the presumption that aflibercept monotherapy would prove superior, said Dr. Glassman and Dr. Sun. “We feel that the clinical interpretation of these results will be similar to the interpretation if we had conducted a noninferiority study, and we found that bevacizumab first was noninferior to aflibercept monotherapy,” they maintained in an interview.

Dr. Glassman and Dr. Sun said they and their coauthors are now analyzing the results to try to find patient characteristics that could identify eyes most likely to respond to the bevacizumab-first approach. “It would be clinically valuable” to use the results to identify characteristics that could help guide clinicians’ treatment approach and enhance patient counseling, they said.

The study received funding from the National Institutes of Health. Dr. Jhaveri has reported being a consultant for Genentech, Novartis, and Regenxbio. Dr. Glassman has reported receiving grants from Genentech and Regeneron. Dr. Sun has reported receiving grants from Boehringer Ingelheim, Janssen Biotech, KalVista, Optovue, and Physical Sciences, grants and travel support from Novartis and Novo Nordisk, travel support from Merck, writing support from Genentech, and equipment supplied by Adaptive Sensory and Boston Micromachines. Dr. Musch and Dr. Chew have reported no relevant financial relationships.

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

Interventional echocardiographers have become an increasingly critical part of the structural heart team but may be paying the price in terms of radiation exposure, a new study suggests.

Results showed that interventional echocardiographers receive threefold higher head-level radiation doses than interventional cardiologists during left atrial appendage occlusion (LAAO) closures and 11-fold higher doses during mitral valve transcatheter edge-to-edge repair (TEER).

“Over the last 5-10 years there’s been exponential growth in these two procedures, TEER and LAAO, and while that’s been very exciting, I think there hasn’t been as much research into how to protect these individuals,” lead author David A. McNamara, MD, MPH, Spectrum Health, Grand Rapids, Mich., told this news organization. 

The study was published  in JAMA Network Open.

Previous studies have focused largely on radiation exposure and mitigation efforts during coronary interventions, but the room set-up for LAAO and TEER and shielding techniques to mitigate radiation exposure are vastly different, he noted.

A 2017 study reported that radiation exposure was significantly higher for imaging specialists than structural heart specialists and varied by procedure type.

For the current study, Dr. McNamara, an echocardiographer by training, and colleagues collected data from 30 consecutive LAAO and 30 consecutive TEER procedures performed at their institution between July 2016 and January 2018.

Interventional imagers, interventional cardiologists, and sonographers all wore a lead skirt, apron, and thyroid collar, as well as a dosimeter to collect radiation data.

Interventional cardiologists stood immediately adjacent to the procedure table and used a ceiling-mounted, upper-body lead shield and a lower-body shield extending from the table to the floor. The echocardiographer stood at the patient’s head and used a mobile accessory shield raised to a height that allowed the imager to extend their arms over the shield to manipulate a transesophageal echocardiogram probe throughout the case.

The median fluoroscopy time was 9.2 minutes for LAAO and 20.9 minutes for TEER. The median air kerma was 164 mGy and 109 mGy, respectively.

Interventional echocardiographers received a median per case radiation dose of 10.6 µSv, compared with 2.1 µSv for interventional cardiologists. The result was similar for TEER (10.5 vs. 0.9 µSv) and LAAO (10.6 vs. 3.5 µSv; P < .001 for all).

The odds of interventional echocardiographers having a radiation dose greater than 20 µSV were 7.5 times greater than for interventional cardiologists (P < .001).

“It’s not the direction of the association, but really the magnitude is what surprised us,” observed Dr. McNamara.

The team was pleasantly surprised, he said, that sonographers, a “vastly understudied group,” received significantly lower median radiation doses than interventional imagers during LAAO (0.2 µSV) and TEER procedures (0.0 µSv; P < .001 for both).

The average distances from the radiation source were 26 cm (10.2 inches) for the echocardiographer, 36 cm (14.2 inches) for the interventional cardiologist, and 250 cm (8.2 feet) for the sonographer.

“These folks [sonographers] were much further away than both the physicians performing these cases, and that is what we hypothesize drove their very low rates, but that should also help inform our mitigation techniques for physicians and for all other cath lab members in the room,” Dr. McNamara said.

He noted that Spectrum Health has been at the forefront in terms of research into radiation exposure and mitigation, has good institutional radiation safety education, and used dose-lowering fluoroscopy systems (AlluraClarity, Philips) with real-time image noise reduction technology and a frame rate of 15 frames per second for the study. “So we’re hopeful that this actually represents a somewhat best-case scenario for what is being done at multiple institutions throughout the nation.”

Nevertheless, there is a huge amount of variability in radiation exposure, Dr. McNamara observed. “First and foremost, we really just have to identify our problem and highlight that this is something that needs some advocacy from our [professional] groups.”

Sunil Rao, MD, the newly minted president of the Society of Cardiovascular Angiography and Interventions (SCAI), said, “This is a really important study, because it expands the potential occupational hazards outside of what we traditionally think of as the team that does interventional procedures ... we have to recognize that the procedures we’re doing in the cath lab have changed.”

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

Interventional echocardiographers have become an increasingly critical part of the structural heart team but may be paying the price in terms of radiation exposure, a new study suggests.

Results showed that interventional echocardiographers receive threefold higher head-level radiation doses than interventional cardiologists during left atrial appendage occlusion (LAAO) closures and 11-fold higher doses during mitral valve transcatheter edge-to-edge repair (TEER).

“Over the last 5-10 years there’s been exponential growth in these two procedures, TEER and LAAO, and while that’s been very exciting, I think there hasn’t been as much research into how to protect these individuals,” lead author David A. McNamara, MD, MPH, Spectrum Health, Grand Rapids, Mich., told this news organization. 

The study was published  in JAMA Network Open.

Previous studies have focused largely on radiation exposure and mitigation efforts during coronary interventions, but the room set-up for LAAO and TEER and shielding techniques to mitigate radiation exposure are vastly different, he noted.

A 2017 study reported that radiation exposure was significantly higher for imaging specialists than structural heart specialists and varied by procedure type.

For the current study, Dr. McNamara, an echocardiographer by training, and colleagues collected data from 30 consecutive LAAO and 30 consecutive TEER procedures performed at their institution between July 2016 and January 2018.

Interventional imagers, interventional cardiologists, and sonographers all wore a lead skirt, apron, and thyroid collar, as well as a dosimeter to collect radiation data.

Interventional cardiologists stood immediately adjacent to the procedure table and used a ceiling-mounted, upper-body lead shield and a lower-body shield extending from the table to the floor. The echocardiographer stood at the patient’s head and used a mobile accessory shield raised to a height that allowed the imager to extend their arms over the shield to manipulate a transesophageal echocardiogram probe throughout the case.

The median fluoroscopy time was 9.2 minutes for LAAO and 20.9 minutes for TEER. The median air kerma was 164 mGy and 109 mGy, respectively.

Interventional echocardiographers received a median per case radiation dose of 10.6 µSv, compared with 2.1 µSv for interventional cardiologists. The result was similar for TEER (10.5 vs. 0.9 µSv) and LAAO (10.6 vs. 3.5 µSv; P < .001 for all).

The odds of interventional echocardiographers having a radiation dose greater than 20 µSV were 7.5 times greater than for interventional cardiologists (P < .001).

“It’s not the direction of the association, but really the magnitude is what surprised us,” observed Dr. McNamara.

The team was pleasantly surprised, he said, that sonographers, a “vastly understudied group,” received significantly lower median radiation doses than interventional imagers during LAAO (0.2 µSV) and TEER procedures (0.0 µSv; P < .001 for both).

The average distances from the radiation source were 26 cm (10.2 inches) for the echocardiographer, 36 cm (14.2 inches) for the interventional cardiologist, and 250 cm (8.2 feet) for the sonographer.

“These folks [sonographers] were much further away than both the physicians performing these cases, and that is what we hypothesize drove their very low rates, but that should also help inform our mitigation techniques for physicians and for all other cath lab members in the room,” Dr. McNamara said.

He noted that Spectrum Health has been at the forefront in terms of research into radiation exposure and mitigation, has good institutional radiation safety education, and used dose-lowering fluoroscopy systems (AlluraClarity, Philips) with real-time image noise reduction technology and a frame rate of 15 frames per second for the study. “So we’re hopeful that this actually represents a somewhat best-case scenario for what is being done at multiple institutions throughout the nation.”

Nevertheless, there is a huge amount of variability in radiation exposure, Dr. McNamara observed. “First and foremost, we really just have to identify our problem and highlight that this is something that needs some advocacy from our [professional] groups.”

Sunil Rao, MD, the newly minted president of the Society of Cardiovascular Angiography and Interventions (SCAI), said, “This is a really important study, because it expands the potential occupational hazards outside of what we traditionally think of as the team that does interventional procedures ... we have to recognize that the procedures we’re doing in the cath lab have changed.”

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

Interventional echocardiographers have become an increasingly critical part of the structural heart team but may be paying the price in terms of radiation exposure, a new study suggests.

Results showed that interventional echocardiographers receive threefold higher head-level radiation doses than interventional cardiologists during left atrial appendage occlusion (LAAO) closures and 11-fold higher doses during mitral valve transcatheter edge-to-edge repair (TEER).

“Over the last 5-10 years there’s been exponential growth in these two procedures, TEER and LAAO, and while that’s been very exciting, I think there hasn’t been as much research into how to protect these individuals,” lead author David A. McNamara, MD, MPH, Spectrum Health, Grand Rapids, Mich., told this news organization. 

The study was published  in JAMA Network Open.

Previous studies have focused largely on radiation exposure and mitigation efforts during coronary interventions, but the room set-up for LAAO and TEER and shielding techniques to mitigate radiation exposure are vastly different, he noted.

A 2017 study reported that radiation exposure was significantly higher for imaging specialists than structural heart specialists and varied by procedure type.

For the current study, Dr. McNamara, an echocardiographer by training, and colleagues collected data from 30 consecutive LAAO and 30 consecutive TEER procedures performed at their institution between July 2016 and January 2018.

Interventional imagers, interventional cardiologists, and sonographers all wore a lead skirt, apron, and thyroid collar, as well as a dosimeter to collect radiation data.

Interventional cardiologists stood immediately adjacent to the procedure table and used a ceiling-mounted, upper-body lead shield and a lower-body shield extending from the table to the floor. The echocardiographer stood at the patient’s head and used a mobile accessory shield raised to a height that allowed the imager to extend their arms over the shield to manipulate a transesophageal echocardiogram probe throughout the case.

The median fluoroscopy time was 9.2 minutes for LAAO and 20.9 minutes for TEER. The median air kerma was 164 mGy and 109 mGy, respectively.

Interventional echocardiographers received a median per case radiation dose of 10.6 µSv, compared with 2.1 µSv for interventional cardiologists. The result was similar for TEER (10.5 vs. 0.9 µSv) and LAAO (10.6 vs. 3.5 µSv; P < .001 for all).

The odds of interventional echocardiographers having a radiation dose greater than 20 µSV were 7.5 times greater than for interventional cardiologists (P < .001).

“It’s not the direction of the association, but really the magnitude is what surprised us,” observed Dr. McNamara.

The team was pleasantly surprised, he said, that sonographers, a “vastly understudied group,” received significantly lower median radiation doses than interventional imagers during LAAO (0.2 µSV) and TEER procedures (0.0 µSv; P < .001 for both).

The average distances from the radiation source were 26 cm (10.2 inches) for the echocardiographer, 36 cm (14.2 inches) for the interventional cardiologist, and 250 cm (8.2 feet) for the sonographer.

“These folks [sonographers] were much further away than both the physicians performing these cases, and that is what we hypothesize drove their very low rates, but that should also help inform our mitigation techniques for physicians and for all other cath lab members in the room,” Dr. McNamara said.

He noted that Spectrum Health has been at the forefront in terms of research into radiation exposure and mitigation, has good institutional radiation safety education, and used dose-lowering fluoroscopy systems (AlluraClarity, Philips) with real-time image noise reduction technology and a frame rate of 15 frames per second for the study. “So we’re hopeful that this actually represents a somewhat best-case scenario for what is being done at multiple institutions throughout the nation.”

Nevertheless, there is a huge amount of variability in radiation exposure, Dr. McNamara observed. “First and foremost, we really just have to identify our problem and highlight that this is something that needs some advocacy from our [professional] groups.”

Sunil Rao, MD, the newly minted president of the Society of Cardiovascular Angiography and Interventions (SCAI), said, “This is a really important study, because it expands the potential occupational hazards outside of what we traditionally think of as the team that does interventional procedures ... we have to recognize that the procedures we’re doing in the cath lab have changed.”

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

The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.

Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”

He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.

Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m² (range 15.8-36.5 kg/m²).

Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.

They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.

Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.

The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
 

‘Substantial’ effects

“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.

The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.

The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.

“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”

Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.

Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.

“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”

A version of this article first appeared on Medscape UK.

The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.

Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”

He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.

Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m² (range 15.8-36.5 kg/m²).

Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.

They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.

Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.

The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
 

‘Substantial’ effects

“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.

The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.

The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.

“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”

Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.

Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.

“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”

A version of this article first appeared on Medscape UK.

The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.

Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”

He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.

Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m² (range 15.8-36.5 kg/m²).

Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.

They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.

Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.

The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
 

‘Substantial’ effects

“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.

The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.

The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.

“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”

Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.

Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.

“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”

A version of this article first appeared on Medscape UK.

Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.

A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.

The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.

The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.

They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).

“A much smaller portion had lighter periods,” they write.

The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.

Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.

Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
 

No changes found to fertility

The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.

The uterine reproductive system is flexible when the body is under stress, they note.

“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.

However, they acknowledge that investigating these reports is critical in building trust in medicine.

This report includes information that hasn’t been available through the clinical trial follow-up process.

For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”

Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.

Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.

People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.

People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
 

Breakthrough bleeding

For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.

Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.

More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.

The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.

The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.

The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.

Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.

Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.

Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.

She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”

The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.

Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.

Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.

“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.

“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”

Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.

Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.

“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.

She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.

“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”

The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.

Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.

A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.

The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.

The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.

They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).

“A much smaller portion had lighter periods,” they write.

The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.

Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.

Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
 

No changes found to fertility

The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.

The uterine reproductive system is flexible when the body is under stress, they note.

“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.

However, they acknowledge that investigating these reports is critical in building trust in medicine.

This report includes information that hasn’t been available through the clinical trial follow-up process.

For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”

Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.

Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.

People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.

People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
 

Breakthrough bleeding

For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.

Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.

More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.

The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.

The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.

The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.

Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.

Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.

Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.

She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”

The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.

Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.

Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.

“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.

“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”

Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.

Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.

“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.

She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.

“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”

The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.

Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.

A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.

The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.

The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.

They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).

“A much smaller portion had lighter periods,” they write.

The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.

Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.

Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
 

No changes found to fertility

The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.

The uterine reproductive system is flexible when the body is under stress, they note.

“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.

However, they acknowledge that investigating these reports is critical in building trust in medicine.

This report includes information that hasn’t been available through the clinical trial follow-up process.

For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”

Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.

Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.

People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.

People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
 

Breakthrough bleeding

For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.

Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.

More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.

The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.

The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.

The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.

Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.

Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.

Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.

She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”

The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.

Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.

Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.

“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.

“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”

Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.

Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.

“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.

She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.

“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”

The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.

Non-Hispanic Black young adults in a large, ethnically diverse underserved neighborhood in New York City have about twice the prevalence of subclinical atherosclerosis as Hispanic young adults, according to a new cross-sectional study. It was noteworthy for identifying subclinical cardiovascular (CV) disease in the cohorts using 3D intravascular ultrasound (3D IVUS).
 

The study’s 436 Black and Hispanic adults, 82% of them women, completed questionnaires regarding nutrition, lifestyle, medical history, weight, blood pressure, cholesterol levels, and other metrics.

The Black participants, compared with the Hispanic cohort, showed almost triple the rate of hypertension (30.6% vs. 11.1%) and more than twice the rate of current smoking (24.5% vs. 9.3%). Overall Framingham scores for 10-year risk for CV events were not statistically different, at 4.6 and 3.6, respectively.

The presence of atherosclerosis in either the carotid or femoral arteries was identified with 3D IVUS in 8.7% of participants. But its prevalence was about twofold greater in Black than in Hispanic participants (12.9% vs. 6.6%), a finding that persisted after multivariable adjustment and appeared driven by a greater prevalence of carotid disease among Black participants (12.9% vs. 4.8%).

“For the same predicted CV risk, non-Hispanic Black individuals appear to be more vulnerable than people of Hispanic origin to early subclinical atherosclerosis, particularly in the carotid arteries, potentially placing them at increased risk of clinical CV disease,” concludes the report published in the Journal of the American College of Cardiology, with lead author Josep Iglesies-Grau, MD, Montreal Heart Institute.
 

International program

The current analysis from the FAMILIA study is part of a large international project called Science, Health, and Education (SHE), which is designed to promote early intervention in the lives of children, their caretakers, and teachers so they can develop lifelong heart-healthy habits, senior author Valentin Fuster, MD, PhD, physician-in chief, Mount Sinai Hospital, New York, said in an interview.

The SHE program has been presented to more than 50,000 children worldwide, and FAMILIA has delivered successful interventions to more than 500 preschoolers, caretakers, and educators at Head Start schools in the Harlem neighborhood of New York, where the current study was conducted.

‘Expected and unexpected’ findings

Black participants were considerably more likely than their Hispanic counterparts to be hypertensive, to be active smokers, and to have higher BMIs. The Black cohort reported higher consumption of fruits and vegetables (P < .001).

There were no between-group differences in the prevalence of diabetes or in mean fasting glucose or total cholesterol levels.

The mean 10-year Framingham CV risk score across the entire study population was 4.0%, with no significant differences between the two groups. In fact, 89% of participants were classified as low risk on the basis of the score.

The overall prevalence of subclinical atherosclerosis was 8.7%, with a mean global plaque burden of 5.0 mm³. But there were dramatic differences in atherosclerotic burden. Across all 10-year Framingham risk categories, Black participants had twice the odds of having subclinical atherosclerosis as Hispanic participants (odds ratio, 2.11; 95% confidence interval, 1.09-4.08; P = .026).

Black participants also had a greater atherosclerotic disease burden (9.0 mm3 vs. 2.9 mm3), mean total plaque volume (P = .028), and a higher prevalence of disease in both the carotid and femoral arteries (8.2% vs. 3.8%; P = .026).

“Our findings were both expected and completely unexpected,” Dr. Fuster commented. “It was expected that the non-Hispanic Black population would have more hypertension, obesity, and smoking, and might therefore have more [atherosclerotic] disease. But what was unexpected was when we adjusted for the seven risk factors and socioeconomic status, the Black population had three times the amount of disease,” he said.

“We need to take better care of the risk factors already known in the Black population, which is critical.” However, “our challenge today is to identify these new risk factors, which might be genetic or socioeconomic.” Dr. Fuster said his group is “already working with artificial intelligence to identify risk factors beyond the traditional risk factors that are already established.”

Socioeconomic differences?

“The fact that we’re uncovering and demonstrating that this is an issue – especially for African American women at a young age – and we could make a significant interdiction in terms of risk reduction if we have tools and invest the necessary time and effort, that is the important part of this paper,” Keith Churchwell, MD, Yale New Haven Hospital, and Yale School of Medicine, New Haven, Conn., said in an interview.

“If you’re going to evaluate African Americans in Harlem who are socially disadvantaged, I would want to know if there is a difference between them and other African Americans who have a different socioeconomic status, in terms of atherosclerotic disease,” added Dr. Churchwell, who was not involved with the study.

The Framingham 10-year risk score is “inadequate in assessing CV disease risk in all populations and is not generalizable to non-Whites,” contend Ramdas G. Pai, MD, and Vrinda Vyas, MBBS, of the University of California, Riverside, in an accompanying editorial.

“New data are emerging in favor of imaging-based classification of CV disease risk and has been shown to improve patient adherence to and compliance with risk-modifying interventions,” they write. “Subclinical atherosclerosis may help better stratify CV disease risk so that preventive measures can be instituted to reduce cardiovascular events at a population level.”

Dr. Fuster and coauthors, Dr. Ramdas and Dr. Pai, and Dr. Churchwell report no relevant financial relationships.

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

Non-Hispanic Black young adults in a large, ethnically diverse underserved neighborhood in New York City have about twice the prevalence of subclinical atherosclerosis as Hispanic young adults, according to a new cross-sectional study. It was noteworthy for identifying subclinical cardiovascular (CV) disease in the cohorts using 3D intravascular ultrasound (3D IVUS).
 

The study’s 436 Black and Hispanic adults, 82% of them women, completed questionnaires regarding nutrition, lifestyle, medical history, weight, blood pressure, cholesterol levels, and other metrics.

The Black participants, compared with the Hispanic cohort, showed almost triple the rate of hypertension (30.6% vs. 11.1%) and more than twice the rate of current smoking (24.5% vs. 9.3%). Overall Framingham scores for 10-year risk for CV events were not statistically different, at 4.6 and 3.6, respectively.

The presence of atherosclerosis in either the carotid or femoral arteries was identified with 3D IVUS in 8.7% of participants. But its prevalence was about twofold greater in Black than in Hispanic participants (12.9% vs. 6.6%), a finding that persisted after multivariable adjustment and appeared driven by a greater prevalence of carotid disease among Black participants (12.9% vs. 4.8%).

“For the same predicted CV risk, non-Hispanic Black individuals appear to be more vulnerable than people of Hispanic origin to early subclinical atherosclerosis, particularly in the carotid arteries, potentially placing them at increased risk of clinical CV disease,” concludes the report published in the Journal of the American College of Cardiology, with lead author Josep Iglesies-Grau, MD, Montreal Heart Institute.
 

International program

The current analysis from the FAMILIA study is part of a large international project called Science, Health, and Education (SHE), which is designed to promote early intervention in the lives of children, their caretakers, and teachers so they can develop lifelong heart-healthy habits, senior author Valentin Fuster, MD, PhD, physician-in chief, Mount Sinai Hospital, New York, said in an interview.

The SHE program has been presented to more than 50,000 children worldwide, and FAMILIA has delivered successful interventions to more than 500 preschoolers, caretakers, and educators at Head Start schools in the Harlem neighborhood of New York, where the current study was conducted.

‘Expected and unexpected’ findings

Black participants were considerably more likely than their Hispanic counterparts to be hypertensive, to be active smokers, and to have higher BMIs. The Black cohort reported higher consumption of fruits and vegetables (P < .001).

There were no between-group differences in the prevalence of diabetes or in mean fasting glucose or total cholesterol levels.

The mean 10-year Framingham CV risk score across the entire study population was 4.0%, with no significant differences between the two groups. In fact, 89% of participants were classified as low risk on the basis of the score.

The overall prevalence of subclinical atherosclerosis was 8.7%, with a mean global plaque burden of 5.0 mm³. But there were dramatic differences in atherosclerotic burden. Across all 10-year Framingham risk categories, Black participants had twice the odds of having subclinical atherosclerosis as Hispanic participants (odds ratio, 2.11; 95% confidence interval, 1.09-4.08; P = .026).

Black participants also had a greater atherosclerotic disease burden (9.0 mm3 vs. 2.9 mm3), mean total plaque volume (P = .028), and a higher prevalence of disease in both the carotid and femoral arteries (8.2% vs. 3.8%; P = .026).

“Our findings were both expected and completely unexpected,” Dr. Fuster commented. “It was expected that the non-Hispanic Black population would have more hypertension, obesity, and smoking, and might therefore have more [atherosclerotic] disease. But what was unexpected was when we adjusted for the seven risk factors and socioeconomic status, the Black population had three times the amount of disease,” he said.

“We need to take better care of the risk factors already known in the Black population, which is critical.” However, “our challenge today is to identify these new risk factors, which might be genetic or socioeconomic.” Dr. Fuster said his group is “already working with artificial intelligence to identify risk factors beyond the traditional risk factors that are already established.”

Socioeconomic differences?

“The fact that we’re uncovering and demonstrating that this is an issue – especially for African American women at a young age – and we could make a significant interdiction in terms of risk reduction if we have tools and invest the necessary time and effort, that is the important part of this paper,” Keith Churchwell, MD, Yale New Haven Hospital, and Yale School of Medicine, New Haven, Conn., said in an interview.

“If you’re going to evaluate African Americans in Harlem who are socially disadvantaged, I would want to know if there is a difference between them and other African Americans who have a different socioeconomic status, in terms of atherosclerotic disease,” added Dr. Churchwell, who was not involved with the study.

The Framingham 10-year risk score is “inadequate in assessing CV disease risk in all populations and is not generalizable to non-Whites,” contend Ramdas G. Pai, MD, and Vrinda Vyas, MBBS, of the University of California, Riverside, in an accompanying editorial.

“New data are emerging in favor of imaging-based classification of CV disease risk and has been shown to improve patient adherence to and compliance with risk-modifying interventions,” they write. “Subclinical atherosclerosis may help better stratify CV disease risk so that preventive measures can be instituted to reduce cardiovascular events at a population level.”

Dr. Fuster and coauthors, Dr. Ramdas and Dr. Pai, and Dr. Churchwell report no relevant financial relationships.

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

Non-Hispanic Black young adults in a large, ethnically diverse underserved neighborhood in New York City have about twice the prevalence of subclinical atherosclerosis as Hispanic young adults, according to a new cross-sectional study. It was noteworthy for identifying subclinical cardiovascular (CV) disease in the cohorts using 3D intravascular ultrasound (3D IVUS).
 

The study’s 436 Black and Hispanic adults, 82% of them women, completed questionnaires regarding nutrition, lifestyle, medical history, weight, blood pressure, cholesterol levels, and other metrics.

The Black participants, compared with the Hispanic cohort, showed almost triple the rate of hypertension (30.6% vs. 11.1%) and more than twice the rate of current smoking (24.5% vs. 9.3%). Overall Framingham scores for 10-year risk for CV events were not statistically different, at 4.6 and 3.6, respectively.

The presence of atherosclerosis in either the carotid or femoral arteries was identified with 3D IVUS in 8.7% of participants. But its prevalence was about twofold greater in Black than in Hispanic participants (12.9% vs. 6.6%), a finding that persisted after multivariable adjustment and appeared driven by a greater prevalence of carotid disease among Black participants (12.9% vs. 4.8%).

“For the same predicted CV risk, non-Hispanic Black individuals appear to be more vulnerable than people of Hispanic origin to early subclinical atherosclerosis, particularly in the carotid arteries, potentially placing them at increased risk of clinical CV disease,” concludes the report published in the Journal of the American College of Cardiology, with lead author Josep Iglesies-Grau, MD, Montreal Heart Institute.
 

International program

The current analysis from the FAMILIA study is part of a large international project called Science, Health, and Education (SHE), which is designed to promote early intervention in the lives of children, their caretakers, and teachers so they can develop lifelong heart-healthy habits, senior author Valentin Fuster, MD, PhD, physician-in chief, Mount Sinai Hospital, New York, said in an interview.

The SHE program has been presented to more than 50,000 children worldwide, and FAMILIA has delivered successful interventions to more than 500 preschoolers, caretakers, and educators at Head Start schools in the Harlem neighborhood of New York, where the current study was conducted.

‘Expected and unexpected’ findings

Black participants were considerably more likely than their Hispanic counterparts to be hypertensive, to be active smokers, and to have higher BMIs. The Black cohort reported higher consumption of fruits and vegetables (P < .001).

There were no between-group differences in the prevalence of diabetes or in mean fasting glucose or total cholesterol levels.

The mean 10-year Framingham CV risk score across the entire study population was 4.0%, with no significant differences between the two groups. In fact, 89% of participants were classified as low risk on the basis of the score.

The overall prevalence of subclinical atherosclerosis was 8.7%, with a mean global plaque burden of 5.0 mm³. But there were dramatic differences in atherosclerotic burden. Across all 10-year Framingham risk categories, Black participants had twice the odds of having subclinical atherosclerosis as Hispanic participants (odds ratio, 2.11; 95% confidence interval, 1.09-4.08; P = .026).

Black participants also had a greater atherosclerotic disease burden (9.0 mm3 vs. 2.9 mm3), mean total plaque volume (P = .028), and a higher prevalence of disease in both the carotid and femoral arteries (8.2% vs. 3.8%; P = .026).

“Our findings were both expected and completely unexpected,” Dr. Fuster commented. “It was expected that the non-Hispanic Black population would have more hypertension, obesity, and smoking, and might therefore have more [atherosclerotic] disease. But what was unexpected was when we adjusted for the seven risk factors and socioeconomic status, the Black population had three times the amount of disease,” he said.

“We need to take better care of the risk factors already known in the Black population, which is critical.” However, “our challenge today is to identify these new risk factors, which might be genetic or socioeconomic.” Dr. Fuster said his group is “already working with artificial intelligence to identify risk factors beyond the traditional risk factors that are already established.”

Socioeconomic differences?

“The fact that we’re uncovering and demonstrating that this is an issue – especially for African American women at a young age – and we could make a significant interdiction in terms of risk reduction if we have tools and invest the necessary time and effort, that is the important part of this paper,” Keith Churchwell, MD, Yale New Haven Hospital, and Yale School of Medicine, New Haven, Conn., said in an interview.

“If you’re going to evaluate African Americans in Harlem who are socially disadvantaged, I would want to know if there is a difference between them and other African Americans who have a different socioeconomic status, in terms of atherosclerotic disease,” added Dr. Churchwell, who was not involved with the study.

The Framingham 10-year risk score is “inadequate in assessing CV disease risk in all populations and is not generalizable to non-Whites,” contend Ramdas G. Pai, MD, and Vrinda Vyas, MBBS, of the University of California, Riverside, in an accompanying editorial.

“New data are emerging in favor of imaging-based classification of CV disease risk and has been shown to improve patient adherence to and compliance with risk-modifying interventions,” they write. “Subclinical atherosclerosis may help better stratify CV disease risk so that preventive measures can be instituted to reduce cardiovascular events at a population level.”

Dr. Fuster and coauthors, Dr. Ramdas and Dr. Pai, and Dr. Churchwell report no relevant financial relationships.

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

Married for nearly 5 years, Jessica King, 34, and her wife, Sarah, agreed on some things right from the start. “We always knew kids were in the equation,” Jessica says.

Now, Jessica is nearly 20 weeks pregnant, thanks to in vitro fertilization, or IVF. They did “reciprocal” IVF, with Sarah’s egg mixed with donor sperm and the embryo transferred into Jessica. “We’re excited – and terrified,” Jessica says.

But that terror goes beyond the typical concerns of excess weight gain and long labors. They live in Missouri, one of 13 states with so-called trigger laws that went into effect after the Supreme Court overturned Roe v. Wade and the constitutional right to abortion, giving states the power to regulate it. States with trigger laws either banned abortion immediately or within a specified time frame after the ruling. In all, 26 states are expected to have abortion restrictions.

Missouri now allows abortion only for medical emergencies. If her upcoming ultrasound shows serious issues, Jessica says they could easily travel to another state and pay for an abortion. She realizes not everyone can.

However, the concern about trigger laws goes well beyond abortion. Many experts worry about the “spill-over” effects the abortion laws – both the existing ones and future proposals – may have on fertility care and treatments.
 

‘Personhood’ laws drive the concern

“The current trigger laws on the books are not impacting people’s access to IVF,” says Barbara Collura, president and CEO of RESOLVE, an advocacy group for those with fertility issues. “What we are concerned about is they will come back and make them stronger.”

The chief concern for reproductive rights advocates is so-called “personhood” legislation. According to the Guttmacher Institute, at least six bills about personhood have been introduced in five states, including Iowa, Oklahoma, South Carolina, Vermont, and West Virginia. One of the two Oklahoma bills has gone the farthest, passed by one chamber.

Since the Guttmacher report, Ohio introduced its own personhood legislation July 11, recognizing the personhood of an unborn person from conception.

Personhood legislation defines a fertilized egg or embryo as a legal human entity, says Sean Tipton, chief policy and advocacy officer for the Washington-based American Society of Reproductive Medicine, a nonprofit advocacy group.

“If the legal status of fertilized eggs or early embryos is codified, in vitro fertilization procedures may become legally risky for patients, physicians and staff,” Mr. Tipton wrote in late June in Contemporary OB/GYN Journal. The American Society for Reproductive Medicine has posted a report on state abortion trigger laws and their potential implications for reproductive medicine. Of the 13 with trigger laws in effect, the report found concern about the potential effect on IVF only with Utah’s.
 

‘Safe’ states?

Even in states without trigger laws or personhood bills, IVF patients say they are anxious about how the Supreme Court ruling may ultimately affect care. Thanks to IVF, Shelly Battista and her husband Robert are expecting twins in December, little sisters to their daughter Emilia, who is 2½.

They live in Illinois, where abortion is legal. “Even though we are safe now, I think the overturning of Roe has made it clear to all of us that none of our freedoms are safe, especially reproductive rights,” Ms. Shelly says.

About one in eight U.S. couples are infertile, according to RESOLVE, In 2019, 2% of all babies born in the United States, or about 78,000 infants, were conceived with the use of assisted reproductive technologies, according to the Centers for Disease Control and Prevention. The most common assisted reproductive technology is IVF, in which the sperm fertilizes the egg outside the body and an embryo is then transferred. The standard of practice is to transfer a single embryo, freezing others for future use.
 

Trigger state doctors weigh in

Some fertility doctors in those “trigger” states are keeping a close eye on proposed legislation and talking to legislators for interpretation of current and proposed laws.

Eli Reshef, MD, a reproductive endocrinologist and fertility specialist at Bennett Fertility Institute in Oklahoma City, notes that his state has “the strictest abortion law in the land.” The law prohibits all abortions with few exceptions, such as the removal of an ectopic pregnancy (when a fertilized egg implants outside the uterus, such as in the fallopian tubes).

While IVF will not be affected for now, he worries that the Oklahoma law allows a private citizen to sue a health care provider that they feel is performing abortion. The Oklahoma law leaves interpretation of abortion up to the general public, who may be unfamiliar with the language of the law, House Bill 4327.

Dean Moutos, MD, a reproductive endocrinologist and medical director of Arkansas Fertility and Gynecology in Little Rock, says his state’s current trigger law should not affect IVF. “When you read the bill, it says abortion means to terminate the pregnancy of a woman.” Still, he says, “we are concerned about what might happen in the future” and the possibility that some legislators may interpret that differently.
 

A minority approach

John David Gordon, MD, a reproductive endocrinologist and medical director of Southeastern Fertility Center for Fertility and Reproductive Surgery in Knoxville, Tenn., is also in a trigger state. However, it’s not likely any personhood laws would affect his practice.

That’s because his center, which he acknowledges is clearly in the minority, only performs natural-cycle IVF, which usually results in a single egg, or “mini-stim IVF,” which usually results in three to eight eggs in order to limit the number that may be potentially fertilized. Often, he says, patients choose to freeze unfertilized eggs (alone) to avoid creating an excessive number of embryos. He has a “no discard” program, with any viable embryos frozen or transferred. Abandoned embryos are donated to others.

“This may work for young women,” says Marcelle Cedars, MD, director of reproductive endocrinology at the University of California, San Francisco, and president of the American Society of Reproductive Medicine. However, she says, it will be very inefficient for older patients, since they have a higher percentage of abnormal eggs.

Overall, that approach will also drive up costs, especially for older women, Dr. Cedars says. An average cycle of IVF costs $12,400, and most Americans’ insurance plans don’t cover IVF, according to Mr. Tipton.
 

Top concerns for IVF

“Personhood” legislation has the potential to upend many common IVF practices, experts say.

Of greatest concern to fertility practices are potential restrictions on the freezing or discarding of embryos, Dr. Cedars says. “This could have a critical impact on practicing the safest, most evidence-based medicine,” she says.

Most children born in the United States as a result of IVF procedures are born from frozen embryos, according to the Society for Assisted Reproductive Technology, an organization for reproductive specialists.

“The practice of IVF really requires that we generate more embryos than will be used in a given [IVF] cycle,” agrees Kara Goldman, MD, associate professor of obstetrics and gynecology and medical director of the fertility preservation program at Northwestern University, Chicago. She performed the embryo transfer for the Battistas.

In nature, she says, it’s known that only a small number of eggs will be competent to generate a baby. “We see the same thing in IVF.” In a single cycle, 20 eggs may be retrieved, but many fewer typically reach successful fertilization and are able to be implanted.

When patients have completed their family, unused embryos are donated to research, donated for adoption, or destroyed. If embryo destruction is outlawed, Dr. Goldman says, it will have serious ramifications for the practice of IVF.

And if personhood legislation prohibits destroying any embryos, others wonder: Would a lab technician who accidentally dropped and destroyed an embryo be subject to charges? If laws prohibit destruction of embryos, others wonder if will families be forced to pay the embryo storage fees, generally $500-$1,000 a year, in perpetuity.

If an embryo is declared a person, it could also affect a practice called preimplantation genetic testing, or PGT. In PGT, cells are retrieved from an embryo and checked for genetic disorders such as sickle cell anemia and cystic fibrosis, with some parents choosing to discard embryos that are found to be affected.

Some potential parents choose this testing because they know they are carriers for genetic diseases that are serious and even incompatible with life, says Art Caplan, PhD, head of the division of medical ethics at New York University. They may choose to discard embryos that show evidence of the diseases.

Also under fire could be “selective reduction,” reducing multiple fetuses to a single or twin, to reduce risks to babies and mother.

Dr. Caplan predicts if states have many restrictions, some providers will adopt the attitude that “if no one reports, it did not happen.” And those prospective parents with the means, he says, will go to court and fight restrictions. “When they do it, they are saying, ‘You say you are pro-life; I’m trying to have a child. What are you doing getting in my way?’”
 

IVF families: Tough decisions, emotional times

The Battistas, of Illinois, have had an especially rough road. Shelly was diagnosed with a fast-growing breast cancer in 2020, when Emilia was just an infant. Warned that the chemotherapy she needed would suppress her ovaries, Shelly underwent egg retrieval before starting the cancer treatment.

She opted to have a double mastectomy and her ovaries removed after learning she carried the BRCA1 genetic mutation, boosting the risk of both breast and ovarian cancer.

Once she was cancer-free, she was cleared to start IVF. The first two embryo transfers failed. The third transfer, of a single embryo, was successful. But it split, a rare occurrence, producing two embryos. “It was a big shock, but in the best way,” she says about learning they were having twins. “Now we are over the moon.”

Five frozen embryos remain. At the start, the Battistas decided to discard unused embryos. She and Robert are discussing what to do next. If they decide they are done building their family after the twins’ birth, she wonders, “do we need to discard our [other] embryos before that becomes something that isn’t eligible [possible] for us any longer?” She doesn’t want to be rushed into that decision, however, especially with her medical history.

Jessica King and Sarah have 20 more embryos.

The couple had decided to donate unused embryos for research, when the time comes, and for different reasons. Her wife’s decision is based on her belief in science, while Jessica cites her faith. “As a Jew, it is part of our faith, that we should be doing everything we can to advance humanity,” she says.

In the midst of all the uncertainty, Jessica says, only half-jokingly, that she is tempted to claim the frozen embryos as dependents. “If you are truly going to claim these are precious human lives, you should be giving me all the benefits from having children,” she says.

Shelly knows that having one daughter, with two more on the way, affects her thinking about the court’s ruling. “My overall wish would be that Roe v. Wade is reinstated, and my daughters have the same rights and options that I have … or I did have until my current 36 years of life.”

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

Married for nearly 5 years, Jessica King, 34, and her wife, Sarah, agreed on some things right from the start. “We always knew kids were in the equation,” Jessica says.

Now, Jessica is nearly 20 weeks pregnant, thanks to in vitro fertilization, or IVF. They did “reciprocal” IVF, with Sarah’s egg mixed with donor sperm and the embryo transferred into Jessica. “We’re excited – and terrified,” Jessica says.

But that terror goes beyond the typical concerns of excess weight gain and long labors. They live in Missouri, one of 13 states with so-called trigger laws that went into effect after the Supreme Court overturned Roe v. Wade and the constitutional right to abortion, giving states the power to regulate it. States with trigger laws either banned abortion immediately or within a specified time frame after the ruling. In all, 26 states are expected to have abortion restrictions.

Missouri now allows abortion only for medical emergencies. If her upcoming ultrasound shows serious issues, Jessica says they could easily travel to another state and pay for an abortion. She realizes not everyone can.

However, the concern about trigger laws goes well beyond abortion. Many experts worry about the “spill-over” effects the abortion laws – both the existing ones and future proposals – may have on fertility care and treatments.
 

‘Personhood’ laws drive the concern

“The current trigger laws on the books are not impacting people’s access to IVF,” says Barbara Collura, president and CEO of RESOLVE, an advocacy group for those with fertility issues. “What we are concerned about is they will come back and make them stronger.”

The chief concern for reproductive rights advocates is so-called “personhood” legislation. According to the Guttmacher Institute, at least six bills about personhood have been introduced in five states, including Iowa, Oklahoma, South Carolina, Vermont, and West Virginia. One of the two Oklahoma bills has gone the farthest, passed by one chamber.

Since the Guttmacher report, Ohio introduced its own personhood legislation July 11, recognizing the personhood of an unborn person from conception.

Personhood legislation defines a fertilized egg or embryo as a legal human entity, says Sean Tipton, chief policy and advocacy officer for the Washington-based American Society of Reproductive Medicine, a nonprofit advocacy group.

“If the legal status of fertilized eggs or early embryos is codified, in vitro fertilization procedures may become legally risky for patients, physicians and staff,” Mr. Tipton wrote in late June in Contemporary OB/GYN Journal. The American Society for Reproductive Medicine has posted a report on state abortion trigger laws and their potential implications for reproductive medicine. Of the 13 with trigger laws in effect, the report found concern about the potential effect on IVF only with Utah’s.
 

‘Safe’ states?

Even in states without trigger laws or personhood bills, IVF patients say they are anxious about how the Supreme Court ruling may ultimately affect care. Thanks to IVF, Shelly Battista and her husband Robert are expecting twins in December, little sisters to their daughter Emilia, who is 2½.

They live in Illinois, where abortion is legal. “Even though we are safe now, I think the overturning of Roe has made it clear to all of us that none of our freedoms are safe, especially reproductive rights,” Ms. Shelly says.

About one in eight U.S. couples are infertile, according to RESOLVE, In 2019, 2% of all babies born in the United States, or about 78,000 infants, were conceived with the use of assisted reproductive technologies, according to the Centers for Disease Control and Prevention. The most common assisted reproductive technology is IVF, in which the sperm fertilizes the egg outside the body and an embryo is then transferred. The standard of practice is to transfer a single embryo, freezing others for future use.
 

Trigger state doctors weigh in

Some fertility doctors in those “trigger” states are keeping a close eye on proposed legislation and talking to legislators for interpretation of current and proposed laws.

Eli Reshef, MD, a reproductive endocrinologist and fertility specialist at Bennett Fertility Institute in Oklahoma City, notes that his state has “the strictest abortion law in the land.” The law prohibits all abortions with few exceptions, such as the removal of an ectopic pregnancy (when a fertilized egg implants outside the uterus, such as in the fallopian tubes).

While IVF will not be affected for now, he worries that the Oklahoma law allows a private citizen to sue a health care provider that they feel is performing abortion. The Oklahoma law leaves interpretation of abortion up to the general public, who may be unfamiliar with the language of the law, House Bill 4327.

Dean Moutos, MD, a reproductive endocrinologist and medical director of Arkansas Fertility and Gynecology in Little Rock, says his state’s current trigger law should not affect IVF. “When you read the bill, it says abortion means to terminate the pregnancy of a woman.” Still, he says, “we are concerned about what might happen in the future” and the possibility that some legislators may interpret that differently.
 

A minority approach

John David Gordon, MD, a reproductive endocrinologist and medical director of Southeastern Fertility Center for Fertility and Reproductive Surgery in Knoxville, Tenn., is also in a trigger state. However, it’s not likely any personhood laws would affect his practice.

That’s because his center, which he acknowledges is clearly in the minority, only performs natural-cycle IVF, which usually results in a single egg, or “mini-stim IVF,” which usually results in three to eight eggs in order to limit the number that may be potentially fertilized. Often, he says, patients choose to freeze unfertilized eggs (alone) to avoid creating an excessive number of embryos. He has a “no discard” program, with any viable embryos frozen or transferred. Abandoned embryos are donated to others.

“This may work for young women,” says Marcelle Cedars, MD, director of reproductive endocrinology at the University of California, San Francisco, and president of the American Society of Reproductive Medicine. However, she says, it will be very inefficient for older patients, since they have a higher percentage of abnormal eggs.

Overall, that approach will also drive up costs, especially for older women, Dr. Cedars says. An average cycle of IVF costs $12,400, and most Americans’ insurance plans don’t cover IVF, according to Mr. Tipton.
 

Top concerns for IVF

“Personhood” legislation has the potential to upend many common IVF practices, experts say.

Of greatest concern to fertility practices are potential restrictions on the freezing or discarding of embryos, Dr. Cedars says. “This could have a critical impact on practicing the safest, most evidence-based medicine,” she says.

Most children born in the United States as a result of IVF procedures are born from frozen embryos, according to the Society for Assisted Reproductive Technology, an organization for reproductive specialists.

“The practice of IVF really requires that we generate more embryos than will be used in a given [IVF] cycle,” agrees Kara Goldman, MD, associate professor of obstetrics and gynecology and medical director of the fertility preservation program at Northwestern University, Chicago. She performed the embryo transfer for the Battistas.

In nature, she says, it’s known that only a small number of eggs will be competent to generate a baby. “We see the same thing in IVF.” In a single cycle, 20 eggs may be retrieved, but many fewer typically reach successful fertilization and are able to be implanted.

When patients have completed their family, unused embryos are donated to research, donated for adoption, or destroyed. If embryo destruction is outlawed, Dr. Goldman says, it will have serious ramifications for the practice of IVF.

And if personhood legislation prohibits destroying any embryos, others wonder: Would a lab technician who accidentally dropped and destroyed an embryo be subject to charges? If laws prohibit destruction of embryos, others wonder if will families be forced to pay the embryo storage fees, generally $500-$1,000 a year, in perpetuity.

If an embryo is declared a person, it could also affect a practice called preimplantation genetic testing, or PGT. In PGT, cells are retrieved from an embryo and checked for genetic disorders such as sickle cell anemia and cystic fibrosis, with some parents choosing to discard embryos that are found to be affected.

Some potential parents choose this testing because they know they are carriers for genetic diseases that are serious and even incompatible with life, says Art Caplan, PhD, head of the division of medical ethics at New York University. They may choose to discard embryos that show evidence of the diseases.

Also under fire could be “selective reduction,” reducing multiple fetuses to a single or twin, to reduce risks to babies and mother.

Dr. Caplan predicts if states have many restrictions, some providers will adopt the attitude that “if no one reports, it did not happen.” And those prospective parents with the means, he says, will go to court and fight restrictions. “When they do it, they are saying, ‘You say you are pro-life; I’m trying to have a child. What are you doing getting in my way?’”
 

IVF families: Tough decisions, emotional times

The Battistas, of Illinois, have had an especially rough road. Shelly was diagnosed with a fast-growing breast cancer in 2020, when Emilia was just an infant. Warned that the chemotherapy she needed would suppress her ovaries, Shelly underwent egg retrieval before starting the cancer treatment.

She opted to have a double mastectomy and her ovaries removed after learning she carried the BRCA1 genetic mutation, boosting the risk of both breast and ovarian cancer.

Once she was cancer-free, she was cleared to start IVF. The first two embryo transfers failed. The third transfer, of a single embryo, was successful. But it split, a rare occurrence, producing two embryos. “It was a big shock, but in the best way,” she says about learning they were having twins. “Now we are over the moon.”

Five frozen embryos remain. At the start, the Battistas decided to discard unused embryos. She and Robert are discussing what to do next. If they decide they are done building their family after the twins’ birth, she wonders, “do we need to discard our [other] embryos before that becomes something that isn’t eligible [possible] for us any longer?” She doesn’t want to be rushed into that decision, however, especially with her medical history.

Jessica King and Sarah have 20 more embryos.

The couple had decided to donate unused embryos for research, when the time comes, and for different reasons. Her wife’s decision is based on her belief in science, while Jessica cites her faith. “As a Jew, it is part of our faith, that we should be doing everything we can to advance humanity,” she says.

In the midst of all the uncertainty, Jessica says, only half-jokingly, that she is tempted to claim the frozen embryos as dependents. “If you are truly going to claim these are precious human lives, you should be giving me all the benefits from having children,” she says.

Shelly knows that having one daughter, with two more on the way, affects her thinking about the court’s ruling. “My overall wish would be that Roe v. Wade is reinstated, and my daughters have the same rights and options that I have … or I did have until my current 36 years of life.”

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

Married for nearly 5 years, Jessica King, 34, and her wife, Sarah, agreed on some things right from the start. “We always knew kids were in the equation,” Jessica says.

Now, Jessica is nearly 20 weeks pregnant, thanks to in vitro fertilization, or IVF. They did “reciprocal” IVF, with Sarah’s egg mixed with donor sperm and the embryo transferred into Jessica. “We’re excited – and terrified,” Jessica says.

But that terror goes beyond the typical concerns of excess weight gain and long labors. They live in Missouri, one of 13 states with so-called trigger laws that went into effect after the Supreme Court overturned Roe v. Wade and the constitutional right to abortion, giving states the power to regulate it. States with trigger laws either banned abortion immediately or within a specified time frame after the ruling. In all, 26 states are expected to have abortion restrictions.

Missouri now allows abortion only for medical emergencies. If her upcoming ultrasound shows serious issues, Jessica says they could easily travel to another state and pay for an abortion. She realizes not everyone can.

However, the concern about trigger laws goes well beyond abortion. Many experts worry about the “spill-over” effects the abortion laws – both the existing ones and future proposals – may have on fertility care and treatments.
 

‘Personhood’ laws drive the concern

“The current trigger laws on the books are not impacting people’s access to IVF,” says Barbara Collura, president and CEO of RESOLVE, an advocacy group for those with fertility issues. “What we are concerned about is they will come back and make them stronger.”

The chief concern for reproductive rights advocates is so-called “personhood” legislation. According to the Guttmacher Institute, at least six bills about personhood have been introduced in five states, including Iowa, Oklahoma, South Carolina, Vermont, and West Virginia. One of the two Oklahoma bills has gone the farthest, passed by one chamber.

Since the Guttmacher report, Ohio introduced its own personhood legislation July 11, recognizing the personhood of an unborn person from conception.

Personhood legislation defines a fertilized egg or embryo as a legal human entity, says Sean Tipton, chief policy and advocacy officer for the Washington-based American Society of Reproductive Medicine, a nonprofit advocacy group.

“If the legal status of fertilized eggs or early embryos is codified, in vitro fertilization procedures may become legally risky for patients, physicians and staff,” Mr. Tipton wrote in late June in Contemporary OB/GYN Journal. The American Society for Reproductive Medicine has posted a report on state abortion trigger laws and their potential implications for reproductive medicine. Of the 13 with trigger laws in effect, the report found concern about the potential effect on IVF only with Utah’s.
 

‘Safe’ states?

Even in states without trigger laws or personhood bills, IVF patients say they are anxious about how the Supreme Court ruling may ultimately affect care. Thanks to IVF, Shelly Battista and her husband Robert are expecting twins in December, little sisters to their daughter Emilia, who is 2½.

They live in Illinois, where abortion is legal. “Even though we are safe now, I think the overturning of Roe has made it clear to all of us that none of our freedoms are safe, especially reproductive rights,” Ms. Shelly says.

About one in eight U.S. couples are infertile, according to RESOLVE, In 2019, 2% of all babies born in the United States, or about 78,000 infants, were conceived with the use of assisted reproductive technologies, according to the Centers for Disease Control and Prevention. The most common assisted reproductive technology is IVF, in which the sperm fertilizes the egg outside the body and an embryo is then transferred. The standard of practice is to transfer a single embryo, freezing others for future use.
 

Trigger state doctors weigh in

Some fertility doctors in those “trigger” states are keeping a close eye on proposed legislation and talking to legislators for interpretation of current and proposed laws.

Eli Reshef, MD, a reproductive endocrinologist and fertility specialist at Bennett Fertility Institute in Oklahoma City, notes that his state has “the strictest abortion law in the land.” The law prohibits all abortions with few exceptions, such as the removal of an ectopic pregnancy (when a fertilized egg implants outside the uterus, such as in the fallopian tubes).

While IVF will not be affected for now, he worries that the Oklahoma law allows a private citizen to sue a health care provider that they feel is performing abortion. The Oklahoma law leaves interpretation of abortion up to the general public, who may be unfamiliar with the language of the law, House Bill 4327.

Dean Moutos, MD, a reproductive endocrinologist and medical director of Arkansas Fertility and Gynecology in Little Rock, says his state’s current trigger law should not affect IVF. “When you read the bill, it says abortion means to terminate the pregnancy of a woman.” Still, he says, “we are concerned about what might happen in the future” and the possibility that some legislators may interpret that differently.
 

A minority approach

John David Gordon, MD, a reproductive endocrinologist and medical director of Southeastern Fertility Center for Fertility and Reproductive Surgery in Knoxville, Tenn., is also in a trigger state. However, it’s not likely any personhood laws would affect his practice.

That’s because his center, which he acknowledges is clearly in the minority, only performs natural-cycle IVF, which usually results in a single egg, or “mini-stim IVF,” which usually results in three to eight eggs in order to limit the number that may be potentially fertilized. Often, he says, patients choose to freeze unfertilized eggs (alone) to avoid creating an excessive number of embryos. He has a “no discard” program, with any viable embryos frozen or transferred. Abandoned embryos are donated to others.

“This may work for young women,” says Marcelle Cedars, MD, director of reproductive endocrinology at the University of California, San Francisco, and president of the American Society of Reproductive Medicine. However, she says, it will be very inefficient for older patients, since they have a higher percentage of abnormal eggs.

Overall, that approach will also drive up costs, especially for older women, Dr. Cedars says. An average cycle of IVF costs $12,400, and most Americans’ insurance plans don’t cover IVF, according to Mr. Tipton.
 

Top concerns for IVF

“Personhood” legislation has the potential to upend many common IVF practices, experts say.

Of greatest concern to fertility practices are potential restrictions on the freezing or discarding of embryos, Dr. Cedars says. “This could have a critical impact on practicing the safest, most evidence-based medicine,” she says.

Most children born in the United States as a result of IVF procedures are born from frozen embryos, according to the Society for Assisted Reproductive Technology, an organization for reproductive specialists.

“The practice of IVF really requires that we generate more embryos than will be used in a given [IVF] cycle,” agrees Kara Goldman, MD, associate professor of obstetrics and gynecology and medical director of the fertility preservation program at Northwestern University, Chicago. She performed the embryo transfer for the Battistas.

In nature, she says, it’s known that only a small number of eggs will be competent to generate a baby. “We see the same thing in IVF.” In a single cycle, 20 eggs may be retrieved, but many fewer typically reach successful fertilization and are able to be implanted.

When patients have completed their family, unused embryos are donated to research, donated for adoption, or destroyed. If embryo destruction is outlawed, Dr. Goldman says, it will have serious ramifications for the practice of IVF.

And if personhood legislation prohibits destroying any embryos, others wonder: Would a lab technician who accidentally dropped and destroyed an embryo be subject to charges? If laws prohibit destruction of embryos, others wonder if will families be forced to pay the embryo storage fees, generally $500-$1,000 a year, in perpetuity.

If an embryo is declared a person, it could also affect a practice called preimplantation genetic testing, or PGT. In PGT, cells are retrieved from an embryo and checked for genetic disorders such as sickle cell anemia and cystic fibrosis, with some parents choosing to discard embryos that are found to be affected.

Some potential parents choose this testing because they know they are carriers for genetic diseases that are serious and even incompatible with life, says Art Caplan, PhD, head of the division of medical ethics at New York University. They may choose to discard embryos that show evidence of the diseases.

Also under fire could be “selective reduction,” reducing multiple fetuses to a single or twin, to reduce risks to babies and mother.

Dr. Caplan predicts if states have many restrictions, some providers will adopt the attitude that “if no one reports, it did not happen.” And those prospective parents with the means, he says, will go to court and fight restrictions. “When they do it, they are saying, ‘You say you are pro-life; I’m trying to have a child. What are you doing getting in my way?’”
 

IVF families: Tough decisions, emotional times

The Battistas, of Illinois, have had an especially rough road. Shelly was diagnosed with a fast-growing breast cancer in 2020, when Emilia was just an infant. Warned that the chemotherapy she needed would suppress her ovaries, Shelly underwent egg retrieval before starting the cancer treatment.

She opted to have a double mastectomy and her ovaries removed after learning she carried the BRCA1 genetic mutation, boosting the risk of both breast and ovarian cancer.

Once she was cancer-free, she was cleared to start IVF. The first two embryo transfers failed. The third transfer, of a single embryo, was successful. But it split, a rare occurrence, producing two embryos. “It was a big shock, but in the best way,” she says about learning they were having twins. “Now we are over the moon.”

Five frozen embryos remain. At the start, the Battistas decided to discard unused embryos. She and Robert are discussing what to do next. If they decide they are done building their family after the twins’ birth, she wonders, “do we need to discard our [other] embryos before that becomes something that isn’t eligible [possible] for us any longer?” She doesn’t want to be rushed into that decision, however, especially with her medical history.

Jessica King and Sarah have 20 more embryos.

The couple had decided to donate unused embryos for research, when the time comes, and for different reasons. Her wife’s decision is based on her belief in science, while Jessica cites her faith. “As a Jew, it is part of our faith, that we should be doing everything we can to advance humanity,” she says.

In the midst of all the uncertainty, Jessica says, only half-jokingly, that she is tempted to claim the frozen embryos as dependents. “If you are truly going to claim these are precious human lives, you should be giving me all the benefits from having children,” she says.

Shelly knows that having one daughter, with two more on the way, affects her thinking about the court’s ruling. “My overall wish would be that Roe v. Wade is reinstated, and my daughters have the same rights and options that I have … or I did have until my current 36 years of life.”

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

As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).¹ While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.² Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.³

Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.⁴ When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.⁵ Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.⁶

Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.⁷ Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.⁸ Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.

In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.⁶ PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.

Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.

• Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
• For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
• Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
• Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.

Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.

Resources

CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.

References

1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.

2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.

3. Mayer KH et al. Adv Ther. 2020;37:1778-811.

4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.

5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.

6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.

7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.

8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).

As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).¹ While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.² Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.³

Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.⁴ When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.⁵ Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.⁶

Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.⁷ Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.⁸ Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.

In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.⁶ PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.

Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.

• Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
• For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
• Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
• Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.

Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.

Resources

CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.

References

1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.

2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.

3. Mayer KH et al. Adv Ther. 2020;37:1778-811.

4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.

5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.

6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.

7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.

8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).

As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).¹ While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.² Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.³

Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.⁴ When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.⁵ Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.⁶

Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.⁷ Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.⁸ Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.

In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.⁶ PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.

Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.

• Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
• For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
• Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
• Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.

Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.

Resources

CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.

References

1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.

2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.

3. Mayer KH et al. Adv Ther. 2020;37:1778-811.

4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.

5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.

6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.

7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.

8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).

Skin cancer is the most diagnosed cancer in the United States. Nonmelanoma skin cancers (NMSC), which include basal cell carcinoma and squamous cell carcinoma, are usually cured with removal.¹ The incidence of NMSC increases with age and is commonly found in nursing homes and geriatric units. These cancers are not usually metastatic or fatal but can cause local destruction and disfigurement if neglected.² The current standard of care is to treat diagnosed NMSC; however, the dermatology and geriatric care literature have questioned the logic of treating asymptomatic skin cancers that will not affect a patient’s life expectancy.^2-4

Forty-seven percent of the current living veteran population is aged ≥ 65 years.⁵ Older adult patients are frequently referred to the US Department of Veterans Affairs (VA) surgical service for the treatment of NMSC. The veteran population includes a higher percentage of individuals at an elevated risk of skin cancers (older, White, and male) compared with the general population.⁶ World War II veterans deployed in regions closer to the equator have been found to have an elevated risk of melanoma and nonmelanoma skin carcinomas.⁷ A retrospective study of Vietnam veterans exposed to Agent Orange (2,3,7,8-tetrachlorodibenzodioxin) found a significantly higher risk of invasive NMSC in Fitzpatrick skin types I-IV compared with an age-matched subset of the general population.⁸ Younger veterans who were deployed in Afghanistan and Iraq for Operation Enduring Freedom/Operation Iraqi Freedom worked at more equatorial latitudes than the rest of the US population and may be at increased risk of NMSC. Inadequate sunscreen access, immediate safety concerns, outdoor recreational activities, harsh weather, and insufficient emphasis on sun protection have created a multifactorial challenge for the military population. Riemenschneider and colleagues recommended targeted screening for at-risk veteran patients and prioritizing annual skin cancer screenings during medical mission physical examinations for active military.⁷

The plastic surgery service regularly receives consults from dermatology, general surgery, and primary care to remove skin cancers on the face, scalp, hands, and forearms. Skin cancer treatment can create serious hardships for older adult patients and their families with multiple appointments for the consult, procedure, and follow-up. Patients are often told to hold their anticoagulant medications when the surgery will be performed on a highly vascular region, such as the scalp or face. This can create wide swings in their laboratory test values and result in life-threatening complications from either bleeding or clotting. The appropriateness of offering surgery to patients with serious comorbidities and a limited life expectancy has been questioned.^2-4 The purpose of this study was to measure the morbidity and unrelated 5-year mortality for patients with skin cancer referred to the plastic surgery service to help patients and families make a more informed treatment decision, particularly when the patients are aged > 80 years and have significant life-threatening comorbidities.

Methods

The University of Florida and Malcom Randall VA Medical Center Institutional review board in Gainesville, approved a retrospective review of all consults completed by the plastic surgery service for the treatment of NMSC performed from July 1, 2011 to June 30, 2015. Data collected included age and common life-limiting comorbidities at the time of referral. Morbidities were found on the electronic health record, including coronary artery disease (CAD), congestive heart failure (CHF), cerebral vascular disease (CVD), peripheral vascular disease, dementia, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), tobacco use, diabetes mellitus (DM), liver disease, alcohol use, and obstructive sleep apnea.

Treatment, complications, and 5-year mortality were recorded. A χ² analysis with P value < .05 was used to determine statistical significance between individual risk factors and 5-year mortality. The relative risk of 5-year mortality was calculated by combining advanced age (aged > 80 years) with the individual comorbidities.

Results

Over 4 years, 800 consults for NMSC were completed by the plastic surgery service. Treatment decisions included 210 excisions (with or without reconstruction) in the operating room, 402 excisions (with or without reconstruction) under local anesthesia in clinic, 55 Mohs surgical dermatology referrals, 21 other service or hospital referrals, and 112 patient who were observed, declined intervention, or died prior to intervention. Five-year mortality was 28.6%. No patients died of NMSC. The median age at consult submission for patients deceased 5 years later was 78 years. Complication rate was 5% and included wound infection, dehiscence, bleeding, or graft loss. Two patients, both deceased within 5 years, had unplanned admissions due to bleeding from either a skin graft donor site or recipient bleeding. Aged ≥ 80 years, CAD, CHF, CVD, peripheral vascular disease, dementia, CKD, COPD, and DM were all found individually to be statistically significant predictors of 5-year mortality (Table 1). Combining aged ≥ 80 years plus CAD, CHF, or dementia all increased the 5-year mortality by a relative risk of > 3 (Table 2).

Discussion

The standard of care is to treat NMSC. Most NMSCs are treated surgically without consideration of patient age or life expectancy.^2,4,9,10 A prospective cohort study involving a university-based private practice and a VA medical center in San Francisco found a 22.6% overall 5-year mortality and a 43.3% mortality in the group defined as limited life expectancy (LLE) based on age (≥ 85 years) and medical comorbidities. None died due to the NMSC. Leading cause of death was cardiac, cerebrovascular, and respiratory disease, lung and prostate cancer, and Alzheimer disease. The authors suggested the LLE group may be exposed to wound complications without benefiting from the treatment.⁴

Another study of 440 patients receiving excision for biopsy-proven facial NMSC at the Roudebush VA Medical Center in Indianapolis, Indiana, found no residual carcinoma in 35.3% of excisions, and in patients aged > 90 years, more than half of the excisions had no residual carcinoma. More than half of the patients aged > 90 years died within 1 year, not as a result of the NMSC. The authors argued for watchful waiting in select patients to maximize comfort and outcomes.¹⁰

Strengths and Limitations

A strength of this study is that the data were obtained from a closed system. Patients tend to stay long-term within the VA and their health record is accessible throughout the country as long as they are seen at a VA facility. Complications, therefore, return to the treating service or primary care, who would route the patient back to the surgeon.

One limitation of the study is that this is a retrospective review from 2011. The authors are limited to data that are recorded in the patient record. Multiple health care professionals saw the patients and notes lack consistency in detail. Size of the lesions were not consistently recorded and did not get logged into our database for that reason.

Conclusions

Treatment of NMSC in older adult patients has a low morbidity but needs to be balanced against a patient and family’s goals when the patient presents with life-limiting comorbidities. An elevated 5-year mortality in patients aged > 80 years with serious unrelated medical conditions is intuitive, but this study may help put treatment plans into perspective for families and health care professionals who want to provide an indicated service while maximizing patient quality of life.

Acknowledgments

This manuscript is the result of work supported with resources and the use of facilities at the North Florida/South Georgia Veterans Health System, Gainesville, Florida.

Skin cancer is the most diagnosed cancer in the United States. Nonmelanoma skin cancers (NMSC), which include basal cell carcinoma and squamous cell carcinoma, are usually cured with removal.¹ The incidence of NMSC increases with age and is commonly found in nursing homes and geriatric units. These cancers are not usually metastatic or fatal but can cause local destruction and disfigurement if neglected.² The current standard of care is to treat diagnosed NMSC; however, the dermatology and geriatric care literature have questioned the logic of treating asymptomatic skin cancers that will not affect a patient’s life expectancy.^2-4

Forty-seven percent of the current living veteran population is aged ≥ 65 years.⁵ Older adult patients are frequently referred to the US Department of Veterans Affairs (VA) surgical service for the treatment of NMSC. The veteran population includes a higher percentage of individuals at an elevated risk of skin cancers (older, White, and male) compared with the general population.⁶ World War II veterans deployed in regions closer to the equator have been found to have an elevated risk of melanoma and nonmelanoma skin carcinomas.⁷ A retrospective study of Vietnam veterans exposed to Agent Orange (2,3,7,8-tetrachlorodibenzodioxin) found a significantly higher risk of invasive NMSC in Fitzpatrick skin types I-IV compared with an age-matched subset of the general population.⁸ Younger veterans who were deployed in Afghanistan and Iraq for Operation Enduring Freedom/Operation Iraqi Freedom worked at more equatorial latitudes than the rest of the US population and may be at increased risk of NMSC. Inadequate sunscreen access, immediate safety concerns, outdoor recreational activities, harsh weather, and insufficient emphasis on sun protection have created a multifactorial challenge for the military population. Riemenschneider and colleagues recommended targeted screening for at-risk veteran patients and prioritizing annual skin cancer screenings during medical mission physical examinations for active military.⁷

The plastic surgery service regularly receives consults from dermatology, general surgery, and primary care to remove skin cancers on the face, scalp, hands, and forearms. Skin cancer treatment can create serious hardships for older adult patients and their families with multiple appointments for the consult, procedure, and follow-up. Patients are often told to hold their anticoagulant medications when the surgery will be performed on a highly vascular region, such as the scalp or face. This can create wide swings in their laboratory test values and result in life-threatening complications from either bleeding or clotting. The appropriateness of offering surgery to patients with serious comorbidities and a limited life expectancy has been questioned.^2-4 The purpose of this study was to measure the morbidity and unrelated 5-year mortality for patients with skin cancer referred to the plastic surgery service to help patients and families make a more informed treatment decision, particularly when the patients are aged > 80 years and have significant life-threatening comorbidities.

Methods

The University of Florida and Malcom Randall VA Medical Center Institutional review board in Gainesville, approved a retrospective review of all consults completed by the plastic surgery service for the treatment of NMSC performed from July 1, 2011 to June 30, 2015. Data collected included age and common life-limiting comorbidities at the time of referral. Morbidities were found on the electronic health record, including coronary artery disease (CAD), congestive heart failure (CHF), cerebral vascular disease (CVD), peripheral vascular disease, dementia, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), tobacco use, diabetes mellitus (DM), liver disease, alcohol use, and obstructive sleep apnea.

Treatment, complications, and 5-year mortality were recorded. A χ² analysis with P value < .05 was used to determine statistical significance between individual risk factors and 5-year mortality. The relative risk of 5-year mortality was calculated by combining advanced age (aged > 80 years) with the individual comorbidities.

Results

Over 4 years, 800 consults for NMSC were completed by the plastic surgery service. Treatment decisions included 210 excisions (with or without reconstruction) in the operating room, 402 excisions (with or without reconstruction) under local anesthesia in clinic, 55 Mohs surgical dermatology referrals, 21 other service or hospital referrals, and 112 patient who were observed, declined intervention, or died prior to intervention. Five-year mortality was 28.6%. No patients died of NMSC. The median age at consult submission for patients deceased 5 years later was 78 years. Complication rate was 5% and included wound infection, dehiscence, bleeding, or graft loss. Two patients, both deceased within 5 years, had unplanned admissions due to bleeding from either a skin graft donor site or recipient bleeding. Aged ≥ 80 years, CAD, CHF, CVD, peripheral vascular disease, dementia, CKD, COPD, and DM were all found individually to be statistically significant predictors of 5-year mortality (Table 1). Combining aged ≥ 80 years plus CAD, CHF, or dementia all increased the 5-year mortality by a relative risk of > 3 (Table 2).

Discussion

The standard of care is to treat NMSC. Most NMSCs are treated surgically without consideration of patient age or life expectancy.^2,4,9,10 A prospective cohort study involving a university-based private practice and a VA medical center in San Francisco found a 22.6% overall 5-year mortality and a 43.3% mortality in the group defined as limited life expectancy (LLE) based on age (≥ 85 years) and medical comorbidities. None died due to the NMSC. Leading cause of death was cardiac, cerebrovascular, and respiratory disease, lung and prostate cancer, and Alzheimer disease. The authors suggested the LLE group may be exposed to wound complications without benefiting from the treatment.⁴

Another study of 440 patients receiving excision for biopsy-proven facial NMSC at the Roudebush VA Medical Center in Indianapolis, Indiana, found no residual carcinoma in 35.3% of excisions, and in patients aged > 90 years, more than half of the excisions had no residual carcinoma. More than half of the patients aged > 90 years died within 1 year, not as a result of the NMSC. The authors argued for watchful waiting in select patients to maximize comfort and outcomes.¹⁰

Strengths and Limitations

A strength of this study is that the data were obtained from a closed system. Patients tend to stay long-term within the VA and their health record is accessible throughout the country as long as they are seen at a VA facility. Complications, therefore, return to the treating service or primary care, who would route the patient back to the surgeon.

One limitation of the study is that this is a retrospective review from 2011. The authors are limited to data that are recorded in the patient record. Multiple health care professionals saw the patients and notes lack consistency in detail. Size of the lesions were not consistently recorded and did not get logged into our database for that reason.

Conclusions

Treatment of NMSC in older adult patients has a low morbidity but needs to be balanced against a patient and family’s goals when the patient presents with life-limiting comorbidities. An elevated 5-year mortality in patients aged > 80 years with serious unrelated medical conditions is intuitive, but this study may help put treatment plans into perspective for families and health care professionals who want to provide an indicated service while maximizing patient quality of life.

Acknowledgments

This manuscript is the result of work supported with resources and the use of facilities at the North Florida/South Georgia Veterans Health System, Gainesville, Florida.

Skin cancer is the most diagnosed cancer in the United States. Nonmelanoma skin cancers (NMSC), which include basal cell carcinoma and squamous cell carcinoma, are usually cured with removal.¹ The incidence of NMSC increases with age and is commonly found in nursing homes and geriatric units. These cancers are not usually metastatic or fatal but can cause local destruction and disfigurement if neglected.² The current standard of care is to treat diagnosed NMSC; however, the dermatology and geriatric care literature have questioned the logic of treating asymptomatic skin cancers that will not affect a patient’s life expectancy.^2-4

Forty-seven percent of the current living veteran population is aged ≥ 65 years.⁵ Older adult patients are frequently referred to the US Department of Veterans Affairs (VA) surgical service for the treatment of NMSC. The veteran population includes a higher percentage of individuals at an elevated risk of skin cancers (older, White, and male) compared with the general population.⁶ World War II veterans deployed in regions closer to the equator have been found to have an elevated risk of melanoma and nonmelanoma skin carcinomas.⁷ A retrospective study of Vietnam veterans exposed to Agent Orange (2,3,7,8-tetrachlorodibenzodioxin) found a significantly higher risk of invasive NMSC in Fitzpatrick skin types I-IV compared with an age-matched subset of the general population.⁸ Younger veterans who were deployed in Afghanistan and Iraq for Operation Enduring Freedom/Operation Iraqi Freedom worked at more equatorial latitudes than the rest of the US population and may be at increased risk of NMSC. Inadequate sunscreen access, immediate safety concerns, outdoor recreational activities, harsh weather, and insufficient emphasis on sun protection have created a multifactorial challenge for the military population. Riemenschneider and colleagues recommended targeted screening for at-risk veteran patients and prioritizing annual skin cancer screenings during medical mission physical examinations for active military.⁷

The plastic surgery service regularly receives consults from dermatology, general surgery, and primary care to remove skin cancers on the face, scalp, hands, and forearms. Skin cancer treatment can create serious hardships for older adult patients and their families with multiple appointments for the consult, procedure, and follow-up. Patients are often told to hold their anticoagulant medications when the surgery will be performed on a highly vascular region, such as the scalp or face. This can create wide swings in their laboratory test values and result in life-threatening complications from either bleeding or clotting. The appropriateness of offering surgery to patients with serious comorbidities and a limited life expectancy has been questioned.^2-4 The purpose of this study was to measure the morbidity and unrelated 5-year mortality for patients with skin cancer referred to the plastic surgery service to help patients and families make a more informed treatment decision, particularly when the patients are aged > 80 years and have significant life-threatening comorbidities.

Methods

The University of Florida and Malcom Randall VA Medical Center Institutional review board in Gainesville, approved a retrospective review of all consults completed by the plastic surgery service for the treatment of NMSC performed from July 1, 2011 to June 30, 2015. Data collected included age and common life-limiting comorbidities at the time of referral. Morbidities were found on the electronic health record, including coronary artery disease (CAD), congestive heart failure (CHF), cerebral vascular disease (CVD), peripheral vascular disease, dementia, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), tobacco use, diabetes mellitus (DM), liver disease, alcohol use, and obstructive sleep apnea.

Treatment, complications, and 5-year mortality were recorded. A χ² analysis with P value < .05 was used to determine statistical significance between individual risk factors and 5-year mortality. The relative risk of 5-year mortality was calculated by combining advanced age (aged > 80 years) with the individual comorbidities.

Results

Over 4 years, 800 consults for NMSC were completed by the plastic surgery service. Treatment decisions included 210 excisions (with or without reconstruction) in the operating room, 402 excisions (with or without reconstruction) under local anesthesia in clinic, 55 Mohs surgical dermatology referrals, 21 other service or hospital referrals, and 112 patient who were observed, declined intervention, or died prior to intervention. Five-year mortality was 28.6%. No patients died of NMSC. The median age at consult submission for patients deceased 5 years later was 78 years. Complication rate was 5% and included wound infection, dehiscence, bleeding, or graft loss. Two patients, both deceased within 5 years, had unplanned admissions due to bleeding from either a skin graft donor site or recipient bleeding. Aged ≥ 80 years, CAD, CHF, CVD, peripheral vascular disease, dementia, CKD, COPD, and DM were all found individually to be statistically significant predictors of 5-year mortality (Table 1). Combining aged ≥ 80 years plus CAD, CHF, or dementia all increased the 5-year mortality by a relative risk of > 3 (Table 2).

Discussion

The standard of care is to treat NMSC. Most NMSCs are treated surgically without consideration of patient age or life expectancy.^2,4,9,10 A prospective cohort study involving a university-based private practice and a VA medical center in San Francisco found a 22.6% overall 5-year mortality and a 43.3% mortality in the group defined as limited life expectancy (LLE) based on age (≥ 85 years) and medical comorbidities. None died due to the NMSC. Leading cause of death was cardiac, cerebrovascular, and respiratory disease, lung and prostate cancer, and Alzheimer disease. The authors suggested the LLE group may be exposed to wound complications without benefiting from the treatment.⁴

Another study of 440 patients receiving excision for biopsy-proven facial NMSC at the Roudebush VA Medical Center in Indianapolis, Indiana, found no residual carcinoma in 35.3% of excisions, and in patients aged > 90 years, more than half of the excisions had no residual carcinoma. More than half of the patients aged > 90 years died within 1 year, not as a result of the NMSC. The authors argued for watchful waiting in select patients to maximize comfort and outcomes.¹⁰

Strengths and Limitations

A strength of this study is that the data were obtained from a closed system. Patients tend to stay long-term within the VA and their health record is accessible throughout the country as long as they are seen at a VA facility. Complications, therefore, return to the treating service or primary care, who would route the patient back to the surgeon.

One limitation of the study is that this is a retrospective review from 2011. The authors are limited to data that are recorded in the patient record. Multiple health care professionals saw the patients and notes lack consistency in detail. Size of the lesions were not consistently recorded and did not get logged into our database for that reason.

Conclusions

Treatment of NMSC in older adult patients has a low morbidity but needs to be balanced against a patient and family’s goals when the patient presents with life-limiting comorbidities. An elevated 5-year mortality in patients aged > 80 years with serious unrelated medical conditions is intuitive, but this study may help put treatment plans into perspective for families and health care professionals who want to provide an indicated service while maximizing patient quality of life.

Acknowledgments

This manuscript is the result of work supported with resources and the use of facilities at the North Florida/South Georgia Veterans Health System, Gainesville, Florida.