Women's Health

CHICAGO — Being hormone receptor positive is generally a favorable prognostic factor in breast cancer, but that doesn’t seem to be the case in women with BRCA-associated tumors, according to a study presented at the American Society of Clinical Oncology annual meeting.

The conclusion is based on a large international study on how hormone receptor status impacts breast cancer outcomes in young women with germline BRCA pathological variants (PVs).

Overall, “hormone receptor positivity did not seem to have a strong positive prognostic value in young BRCA carriers” with early breast cancer, lead investigator Luca Arecco, MD, an oncology resident at the University of Genoa, Italy, said at the meeting.

Investigators reviewed the records of 4709 women ages 40 years or younger with stage 1-3 BRCA-associated invasive breast cancer treated from 2000 to 2020 at 78 centers in 28 countries across four continents. Median follow-up was about 8 years.
 

Weaker Prognostic Value in Hormone Receptor Status

They found, in general, that hormone receptor–positive breast cancer appears to be biologically more aggressive in patients with BRCA PVs than in the general breast cancer population, generating outcomes similar to those with hormone receptor-negative BRCA tumors.

Specifically, among patients with germline BRCA PVs, while hormone receptor–positive patients had a higher distant recurrence rate (13.1% vs. 9.6%) than hormone receptor–negative patients, 8-year disease free survival (65.8% and 63.4% respectively) and overall survival (a bit under 90% in both groups) were similar.

Hormone receptor–positive patients did have a lower rate of second primary breast cancers (9.1% versus 14.7%).

In the formal write-up of the results published shortly after the meeting in Annals of Oncology, the investigators concluded that “in young BRCA carriers, differences in recurrence pattern and second primary breast cancer among hormone receptor–positive versus negative disease warrant consideration in counseling patients on treatment, follow-up, and risk-reducing surgery.”

The team also found other differences between BRCA-associated breast cancer and sporadic disease. For instance, in the BRCA cohort, luminal A-like breast cancer had a worse long-term prognosis in their BRCA cohort than triple-negative or HER2-positive disease. Luminal A-like tumors are generally considered less aggressive, but in patients with BRCA PVs, “improving neoadjuvant chemotherapy … could be worthwhile,” the investigators said.

Also, although the risk of recurrence for sporadic hormone receptor–negative tumors is highest in the first few years, the team found that the risk in the hormone negative BRCA cohort progressively increased with longer follow-up, driven by the occurrence of second primary breast cancers, especially in patients with BRCA 1 PVs.
 

Greater Clarity in Prognosis in BRCA-Associated Breast Cancer

Overall, study discussant Lisa A. Carey, MD, a breast cancer specialist at the University of North Carolina at Chapel Hill, said, “we now know much more clearly the issues of prognosis in women who are very young and have germline BRCA-associated breast cancer,” about 12% of newly diagnosed cases.

“Young patients with germline BRCA-associated breast cancers have high relapse and high new primary risks, warranting comprehensive multimodality therapy,” she said.

A bit fewer than half of women in the study were hormone receptor–positive, and they tended to be patients with BRCA 2 PVs. The rest were hormone receptor–negative and tended to have BRCA 1 PVs.

Patients with hormone receptor–positive disease had grade 3 cancers in about 50% of cases, while patients with hormone receptor–negative disease had a grade 3 disease in over 80%.

Hormone receptor–positive patients were more likely to have nodal involvement and undergo mastectomies but less likely to receive chemotherapy than hormone receptor–negative patients. It’s likely that few patients in the review received PARP inhibitors, Dr. Carey noted.

Although overall survival at 8 years was similar in both groups, after that point “the prognosis of patients with hormone receptor–positive disease appeared to be worse … This appeared to occur earlier than that described in sporadic disease,” in which the worsening of survival in hormone receptor–positive disease occurs after a follow-up of at least 14-15 years, the investigators noted in their journal report.

The work was funded by the Italian Association for Cancer Research, Institut Jules Bordet, Korea Health Industry Development Institute, Australian National Health and Medical Council, Cancer Australia, US National Institute of Health, and others. Dr. Arecco had no disclosures. Dr. Carey and other coauthors disclosed research funding, speaker honoraria, and other financial relationships with AstraZeneca, Genentech/Roche, Lilly, and other pharmaceutical companies.

CHICAGO — Being hormone receptor positive is generally a favorable prognostic factor in breast cancer, but that doesn’t seem to be the case in women with BRCA-associated tumors, according to a study presented at the American Society of Clinical Oncology annual meeting.

The conclusion is based on a large international study on how hormone receptor status impacts breast cancer outcomes in young women with germline BRCA pathological variants (PVs).

Overall, “hormone receptor positivity did not seem to have a strong positive prognostic value in young BRCA carriers” with early breast cancer, lead investigator Luca Arecco, MD, an oncology resident at the University of Genoa, Italy, said at the meeting.

Investigators reviewed the records of 4709 women ages 40 years or younger with stage 1-3 BRCA-associated invasive breast cancer treated from 2000 to 2020 at 78 centers in 28 countries across four continents. Median follow-up was about 8 years.
 

Weaker Prognostic Value in Hormone Receptor Status

They found, in general, that hormone receptor–positive breast cancer appears to be biologically more aggressive in patients with BRCA PVs than in the general breast cancer population, generating outcomes similar to those with hormone receptor-negative BRCA tumors.

Specifically, among patients with germline BRCA PVs, while hormone receptor–positive patients had a higher distant recurrence rate (13.1% vs. 9.6%) than hormone receptor–negative patients, 8-year disease free survival (65.8% and 63.4% respectively) and overall survival (a bit under 90% in both groups) were similar.

Hormone receptor–positive patients did have a lower rate of second primary breast cancers (9.1% versus 14.7%).

In the formal write-up of the results published shortly after the meeting in Annals of Oncology, the investigators concluded that “in young BRCA carriers, differences in recurrence pattern and second primary breast cancer among hormone receptor–positive versus negative disease warrant consideration in counseling patients on treatment, follow-up, and risk-reducing surgery.”

The team also found other differences between BRCA-associated breast cancer and sporadic disease. For instance, in the BRCA cohort, luminal A-like breast cancer had a worse long-term prognosis in their BRCA cohort than triple-negative or HER2-positive disease. Luminal A-like tumors are generally considered less aggressive, but in patients with BRCA PVs, “improving neoadjuvant chemotherapy … could be worthwhile,” the investigators said.

Also, although the risk of recurrence for sporadic hormone receptor–negative tumors is highest in the first few years, the team found that the risk in the hormone negative BRCA cohort progressively increased with longer follow-up, driven by the occurrence of second primary breast cancers, especially in patients with BRCA 1 PVs.
 

Greater Clarity in Prognosis in BRCA-Associated Breast Cancer

Overall, study discussant Lisa A. Carey, MD, a breast cancer specialist at the University of North Carolina at Chapel Hill, said, “we now know much more clearly the issues of prognosis in women who are very young and have germline BRCA-associated breast cancer,” about 12% of newly diagnosed cases.

“Young patients with germline BRCA-associated breast cancers have high relapse and high new primary risks, warranting comprehensive multimodality therapy,” she said.

A bit fewer than half of women in the study were hormone receptor–positive, and they tended to be patients with BRCA 2 PVs. The rest were hormone receptor–negative and tended to have BRCA 1 PVs.

Patients with hormone receptor–positive disease had grade 3 cancers in about 50% of cases, while patients with hormone receptor–negative disease had a grade 3 disease in over 80%.

Hormone receptor–positive patients were more likely to have nodal involvement and undergo mastectomies but less likely to receive chemotherapy than hormone receptor–negative patients. It’s likely that few patients in the review received PARP inhibitors, Dr. Carey noted.

Although overall survival at 8 years was similar in both groups, after that point “the prognosis of patients with hormone receptor–positive disease appeared to be worse … This appeared to occur earlier than that described in sporadic disease,” in which the worsening of survival in hormone receptor–positive disease occurs after a follow-up of at least 14-15 years, the investigators noted in their journal report.

The work was funded by the Italian Association for Cancer Research, Institut Jules Bordet, Korea Health Industry Development Institute, Australian National Health and Medical Council, Cancer Australia, US National Institute of Health, and others. Dr. Arecco had no disclosures. Dr. Carey and other coauthors disclosed research funding, speaker honoraria, and other financial relationships with AstraZeneca, Genentech/Roche, Lilly, and other pharmaceutical companies.

CHICAGO — Being hormone receptor positive is generally a favorable prognostic factor in breast cancer, but that doesn’t seem to be the case in women with BRCA-associated tumors, according to a study presented at the American Society of Clinical Oncology annual meeting.

The conclusion is based on a large international study on how hormone receptor status impacts breast cancer outcomes in young women with germline BRCA pathological variants (PVs).

Overall, “hormone receptor positivity did not seem to have a strong positive prognostic value in young BRCA carriers” with early breast cancer, lead investigator Luca Arecco, MD, an oncology resident at the University of Genoa, Italy, said at the meeting.

Investigators reviewed the records of 4709 women ages 40 years or younger with stage 1-3 BRCA-associated invasive breast cancer treated from 2000 to 2020 at 78 centers in 28 countries across four continents. Median follow-up was about 8 years.
 

Weaker Prognostic Value in Hormone Receptor Status

They found, in general, that hormone receptor–positive breast cancer appears to be biologically more aggressive in patients with BRCA PVs than in the general breast cancer population, generating outcomes similar to those with hormone receptor-negative BRCA tumors.

Specifically, among patients with germline BRCA PVs, while hormone receptor–positive patients had a higher distant recurrence rate (13.1% vs. 9.6%) than hormone receptor–negative patients, 8-year disease free survival (65.8% and 63.4% respectively) and overall survival (a bit under 90% in both groups) were similar.

Hormone receptor–positive patients did have a lower rate of second primary breast cancers (9.1% versus 14.7%).

In the formal write-up of the results published shortly after the meeting in Annals of Oncology, the investigators concluded that “in young BRCA carriers, differences in recurrence pattern and second primary breast cancer among hormone receptor–positive versus negative disease warrant consideration in counseling patients on treatment, follow-up, and risk-reducing surgery.”

The team also found other differences between BRCA-associated breast cancer and sporadic disease. For instance, in the BRCA cohort, luminal A-like breast cancer had a worse long-term prognosis in their BRCA cohort than triple-negative or HER2-positive disease. Luminal A-like tumors are generally considered less aggressive, but in patients with BRCA PVs, “improving neoadjuvant chemotherapy … could be worthwhile,” the investigators said.

Also, although the risk of recurrence for sporadic hormone receptor–negative tumors is highest in the first few years, the team found that the risk in the hormone negative BRCA cohort progressively increased with longer follow-up, driven by the occurrence of second primary breast cancers, especially in patients with BRCA 1 PVs.
 

Greater Clarity in Prognosis in BRCA-Associated Breast Cancer

Overall, study discussant Lisa A. Carey, MD, a breast cancer specialist at the University of North Carolina at Chapel Hill, said, “we now know much more clearly the issues of prognosis in women who are very young and have germline BRCA-associated breast cancer,” about 12% of newly diagnosed cases.

“Young patients with germline BRCA-associated breast cancers have high relapse and high new primary risks, warranting comprehensive multimodality therapy,” she said.

A bit fewer than half of women in the study were hormone receptor–positive, and they tended to be patients with BRCA 2 PVs. The rest were hormone receptor–negative and tended to have BRCA 1 PVs.

Patients with hormone receptor–positive disease had grade 3 cancers in about 50% of cases, while patients with hormone receptor–negative disease had a grade 3 disease in over 80%.

Hormone receptor–positive patients were more likely to have nodal involvement and undergo mastectomies but less likely to receive chemotherapy than hormone receptor–negative patients. It’s likely that few patients in the review received PARP inhibitors, Dr. Carey noted.

Although overall survival at 8 years was similar in both groups, after that point “the prognosis of patients with hormone receptor–positive disease appeared to be worse … This appeared to occur earlier than that described in sporadic disease,” in which the worsening of survival in hormone receptor–positive disease occurs after a follow-up of at least 14-15 years, the investigators noted in their journal report.

The work was funded by the Italian Association for Cancer Research, Institut Jules Bordet, Korea Health Industry Development Institute, Australian National Health and Medical Council, Cancer Australia, US National Institute of Health, and others. Dr. Arecco had no disclosures. Dr. Carey and other coauthors disclosed research funding, speaker honoraria, and other financial relationships with AstraZeneca, Genentech/Roche, Lilly, and other pharmaceutical companies.

Black metastatic breast cancer patients with PIK3CA mutations were less likely to receive targeted therapy and less likely to be enrolled in clinical trials than White patients and had shorter overall survival, according to a retrospective cohort study. Black and White patients were equally likely to receive other drugs that did not require genomic testing.

“These clinical inequities in the use of targeted therapies and clinical trials ... must be a focus going forward,” said lead investigator Emily Podany, MD, a clinical fellow in hematology-oncology at Washington University in St. Louis, Missouri. “Our consortium is looking for paths forward in order to try and decrease these striking inequities. And it’s a focus of future research for us and future implementation [of] science interventions, hopefully, across the country.”

The study results were presented at the annual meeting of the American Society of Clinical Oncology.
 

Black Women Underrepresented

Black women are generally underrepresented in clinical trials, noted Dr. Podany. “They make up about 2%-5% of the patients in breast cancer clinical trials, and there are documented inequities in treatment and in outcomes for Black patients with metastatic breast cancer. This includes longer treatment delays, it includes fewer sentinel lymph node biopsies, and unfortunately, they’re more likely to discontinue treatment early.”

In terms of PI3K inhibition, PIK3CA mutations are found in about 40% of patients with HR-positive HER2-negative metastatic breast cancer. Alpelisib is FDA-approved as a targeted therapy for these patients, she said.

The study evaluated records of 1327 patients with metastatic breast cancer who also had circulating tumor DNA (ctDNA) results and were treated at Washington University, Massachusetts General Hospital in Boston, and Northwestern University in Chicago. Of these, 795 had an ER-positive, HER2-negative subtype and were included in the analysis. Most (89%) of the patients were White (n = 708), while 11% (n = 87) were Black, and the only baseline difference between patients was that Black patients had significantly more de novo metastatic breast cancer (31% versus 22%).

Use of PI3K, CDK4/6, or mTOR inhibitors was evaluated using manual electronic medical review, and genomic differences were evaluated using logistic regression.

The analysis showed inequities in both treatment and clinical trial enrollment. There were no differences between groups in the use of CDK4/6 or mTOR inhibitors, which do not require a genomic profile, the researchers noted, but Black patients with PIK3CA single nucleotide variants (SNV) were significantly less likely than White patients to use PI3K inhibitors (5.9% versus 28.8%; P = .045), despite no difference in PIK3CA mutations between groups (36% and 34% respectively). Similarly, 11% of White patients with PIK3CA mutations were enrolled in clinical trials, but none of the Black patients was.

Genomic differences were also found, Dr. Podany reported. Black patients with estrogen/progesterone receptor (ER/PR) positive, HER2-negative disease were more likely to have a CCND1 copy number variant. And for ER-positive PR-negative HER2-negative patients, Black patients were more likely to have a GATA3 SNV, while White patients were more likely to have a KRAS copy number variant.
 

Black Survival Less Than Half

The analysis also found significant differences in overall survival from the time of the first liquid biopsy, with White ER-positive, PR-negative, HER2-negative patients living a median of 21 months, versus 9.1 months for Black patients.

There were several limitations to the study beyond its retrospective nature, “so, we may be underestimating the true inequity,” noted Dr. Podany. “These are large urban academic centers, so our patients have access to these treatments. They have access to care. They have access to ctDNA liquid biopsy testing. And the timing of ctDNA, especially the first ctDNA test, is variable and provider-dependant. We were also unable to assess receipt of PI3 kinase inhibitors at future time points after the end of this cohort study.”

Asked for comment, Giuseppe Del Priore, MD, MPH, from Morehouse School of Medicine in Atlanta, Georgia, approved of the study design “with subjects limited to three distinctive institutions. That parameter alone can control for several unknown variables among the studied comparison groups, ie, Black women versus others.”

However, Dr. Del Priore, who is adjunct professor of obstetrics and gynecology, with a specialty in oncology, added, “retrospective studies are not reliable except for generating hypotheses. Therefore, I would like to see a rapid implementation of an intervention trial at these same institutions to ensure equal consideration of, and access to, targeted therapies. Too often a retrospective correlation is reported, but the solution is elusive due to unknown factors. In this case, knowing there is a mutation is far from alleviating the disproportionate burden of disease that many communities face.”

Dr. Podany had no relevant disclosures. Dr. Del Priore reported no conflicts of interest and disclosed that he is chief medical officer at BriaCell.

Black metastatic breast cancer patients with PIK3CA mutations were less likely to receive targeted therapy and less likely to be enrolled in clinical trials than White patients and had shorter overall survival, according to a retrospective cohort study. Black and White patients were equally likely to receive other drugs that did not require genomic testing.

“These clinical inequities in the use of targeted therapies and clinical trials ... must be a focus going forward,” said lead investigator Emily Podany, MD, a clinical fellow in hematology-oncology at Washington University in St. Louis, Missouri. “Our consortium is looking for paths forward in order to try and decrease these striking inequities. And it’s a focus of future research for us and future implementation [of] science interventions, hopefully, across the country.”

The study results were presented at the annual meeting of the American Society of Clinical Oncology.
 

Black Women Underrepresented

Black women are generally underrepresented in clinical trials, noted Dr. Podany. “They make up about 2%-5% of the patients in breast cancer clinical trials, and there are documented inequities in treatment and in outcomes for Black patients with metastatic breast cancer. This includes longer treatment delays, it includes fewer sentinel lymph node biopsies, and unfortunately, they’re more likely to discontinue treatment early.”

In terms of PI3K inhibition, PIK3CA mutations are found in about 40% of patients with HR-positive HER2-negative metastatic breast cancer. Alpelisib is FDA-approved as a targeted therapy for these patients, she said.

The study evaluated records of 1327 patients with metastatic breast cancer who also had circulating tumor DNA (ctDNA) results and were treated at Washington University, Massachusetts General Hospital in Boston, and Northwestern University in Chicago. Of these, 795 had an ER-positive, HER2-negative subtype and were included in the analysis. Most (89%) of the patients were White (n = 708), while 11% (n = 87) were Black, and the only baseline difference between patients was that Black patients had significantly more de novo metastatic breast cancer (31% versus 22%).

Use of PI3K, CDK4/6, or mTOR inhibitors was evaluated using manual electronic medical review, and genomic differences were evaluated using logistic regression.

The analysis showed inequities in both treatment and clinical trial enrollment. There were no differences between groups in the use of CDK4/6 or mTOR inhibitors, which do not require a genomic profile, the researchers noted, but Black patients with PIK3CA single nucleotide variants (SNV) were significantly less likely than White patients to use PI3K inhibitors (5.9% versus 28.8%; P = .045), despite no difference in PIK3CA mutations between groups (36% and 34% respectively). Similarly, 11% of White patients with PIK3CA mutations were enrolled in clinical trials, but none of the Black patients was.

Genomic differences were also found, Dr. Podany reported. Black patients with estrogen/progesterone receptor (ER/PR) positive, HER2-negative disease were more likely to have a CCND1 copy number variant. And for ER-positive PR-negative HER2-negative patients, Black patients were more likely to have a GATA3 SNV, while White patients were more likely to have a KRAS copy number variant.
 

Black Survival Less Than Half

The analysis also found significant differences in overall survival from the time of the first liquid biopsy, with White ER-positive, PR-negative, HER2-negative patients living a median of 21 months, versus 9.1 months for Black patients.

There were several limitations to the study beyond its retrospective nature, “so, we may be underestimating the true inequity,” noted Dr. Podany. “These are large urban academic centers, so our patients have access to these treatments. They have access to care. They have access to ctDNA liquid biopsy testing. And the timing of ctDNA, especially the first ctDNA test, is variable and provider-dependant. We were also unable to assess receipt of PI3 kinase inhibitors at future time points after the end of this cohort study.”

Asked for comment, Giuseppe Del Priore, MD, MPH, from Morehouse School of Medicine in Atlanta, Georgia, approved of the study design “with subjects limited to three distinctive institutions. That parameter alone can control for several unknown variables among the studied comparison groups, ie, Black women versus others.”

However, Dr. Del Priore, who is adjunct professor of obstetrics and gynecology, with a specialty in oncology, added, “retrospective studies are not reliable except for generating hypotheses. Therefore, I would like to see a rapid implementation of an intervention trial at these same institutions to ensure equal consideration of, and access to, targeted therapies. Too often a retrospective correlation is reported, but the solution is elusive due to unknown factors. In this case, knowing there is a mutation is far from alleviating the disproportionate burden of disease that many communities face.”

Dr. Podany had no relevant disclosures. Dr. Del Priore reported no conflicts of interest and disclosed that he is chief medical officer at BriaCell.

Black metastatic breast cancer patients with PIK3CA mutations were less likely to receive targeted therapy and less likely to be enrolled in clinical trials than White patients and had shorter overall survival, according to a retrospective cohort study. Black and White patients were equally likely to receive other drugs that did not require genomic testing.

“These clinical inequities in the use of targeted therapies and clinical trials ... must be a focus going forward,” said lead investigator Emily Podany, MD, a clinical fellow in hematology-oncology at Washington University in St. Louis, Missouri. “Our consortium is looking for paths forward in order to try and decrease these striking inequities. And it’s a focus of future research for us and future implementation [of] science interventions, hopefully, across the country.”

The study results were presented at the annual meeting of the American Society of Clinical Oncology.
 

Black Women Underrepresented

Black women are generally underrepresented in clinical trials, noted Dr. Podany. “They make up about 2%-5% of the patients in breast cancer clinical trials, and there are documented inequities in treatment and in outcomes for Black patients with metastatic breast cancer. This includes longer treatment delays, it includes fewer sentinel lymph node biopsies, and unfortunately, they’re more likely to discontinue treatment early.”

In terms of PI3K inhibition, PIK3CA mutations are found in about 40% of patients with HR-positive HER2-negative metastatic breast cancer. Alpelisib is FDA-approved as a targeted therapy for these patients, she said.

The study evaluated records of 1327 patients with metastatic breast cancer who also had circulating tumor DNA (ctDNA) results and were treated at Washington University, Massachusetts General Hospital in Boston, and Northwestern University in Chicago. Of these, 795 had an ER-positive, HER2-negative subtype and were included in the analysis. Most (89%) of the patients were White (n = 708), while 11% (n = 87) were Black, and the only baseline difference between patients was that Black patients had significantly more de novo metastatic breast cancer (31% versus 22%).

Use of PI3K, CDK4/6, or mTOR inhibitors was evaluated using manual electronic medical review, and genomic differences were evaluated using logistic regression.

The analysis showed inequities in both treatment and clinical trial enrollment. There were no differences between groups in the use of CDK4/6 or mTOR inhibitors, which do not require a genomic profile, the researchers noted, but Black patients with PIK3CA single nucleotide variants (SNV) were significantly less likely than White patients to use PI3K inhibitors (5.9% versus 28.8%; P = .045), despite no difference in PIK3CA mutations between groups (36% and 34% respectively). Similarly, 11% of White patients with PIK3CA mutations were enrolled in clinical trials, but none of the Black patients was.

Genomic differences were also found, Dr. Podany reported. Black patients with estrogen/progesterone receptor (ER/PR) positive, HER2-negative disease were more likely to have a CCND1 copy number variant. And for ER-positive PR-negative HER2-negative patients, Black patients were more likely to have a GATA3 SNV, while White patients were more likely to have a KRAS copy number variant.
 

Black Survival Less Than Half

The analysis also found significant differences in overall survival from the time of the first liquid biopsy, with White ER-positive, PR-negative, HER2-negative patients living a median of 21 months, versus 9.1 months for Black patients.

There were several limitations to the study beyond its retrospective nature, “so, we may be underestimating the true inequity,” noted Dr. Podany. “These are large urban academic centers, so our patients have access to these treatments. They have access to care. They have access to ctDNA liquid biopsy testing. And the timing of ctDNA, especially the first ctDNA test, is variable and provider-dependant. We were also unable to assess receipt of PI3 kinase inhibitors at future time points after the end of this cohort study.”

Asked for comment, Giuseppe Del Priore, MD, MPH, from Morehouse School of Medicine in Atlanta, Georgia, approved of the study design “with subjects limited to three distinctive institutions. That parameter alone can control for several unknown variables among the studied comparison groups, ie, Black women versus others.”

However, Dr. Del Priore, who is adjunct professor of obstetrics and gynecology, with a specialty in oncology, added, “retrospective studies are not reliable except for generating hypotheses. Therefore, I would like to see a rapid implementation of an intervention trial at these same institutions to ensure equal consideration of, and access to, targeted therapies. Too often a retrospective correlation is reported, but the solution is elusive due to unknown factors. In this case, knowing there is a mutation is far from alleviating the disproportionate burden of disease that many communities face.”

Dr. Podany had no relevant disclosures. Dr. Del Priore reported no conflicts of interest and disclosed that he is chief medical officer at BriaCell.

CHICAGO — Circulating tumor DNA (ctDNA) can predict relapse risk in some cases of early, high-risk breast cancer, but it’s too soon to use it to guide adjuvant therapy decisions, according to a study presented at the American Society of Clinical Oncology annual meeting.

Detectable ctDNA is “highly prognostic of worse outcomes, particularly in patients who [remain] persistently positive,” but the correlation isn’t perfect, said lead investigator Sherene Loi, MMBS, PhD, a breast cancer specialist at the Peter MacCallum Cancer Centre in Melbourne, Australia.

Although less likely, relapses also occurred in the study among women without ctDNA elevation. Conversely, there were women with elevated ctDNA who did not relapse, she said. The study was a subanalysis of the monarchE trial of adjuvant abemaciclib, a CDK 4/6 inhibitor.

Eventually, “we would like to use” ctDNA to guide adjuvant treatment decisions, but the research isn’t there yet, Dr. Loi said. It’s possible, for instance, that persistently detectable ctDNA indicates early treatment failure and the need for treatment intensification. Future research should tackle the issue.

Study discussant Francois-Clement Bidard, MD, PhD, a breast cancer specialist at Institut Curie, Paris, agreed that ctDNA isn’t ready for primetime in adjuvant early, high-risk breast cancer.

“There is no clinical evidence to suggest that there is clinical utility in this setting. There are several trials that are ongoing,” he said, but for now “you shouldn’t,” for example, “use ctDNA to de-escalate adjuvant CDK4/6 [inhibitors]. It could be in the future that we could have data on this, but at the moment, [the] clear clinical message [is] no way.”

At 5-year follow-up, the monarchE trial found a 7.6% invasive disease-free survival (IDFS) improvement when abemaciclib was added to the first 2 years of endocrine therapy in women with HR+, HER2-, node positive, high-risk early breast cancer. The combination is now a standard adjuvant option for the disease.

The ctDNA study focused on a subset of 910 subjects with adequate ctDNA testing to run the analysis. The study population was also selected to be enriched for overall IDFS events (27% versus 18% across the trial’s 5,637 subjects). An IDFS event was defined as a local, regional, contralateral or distant invasive recurrence; a new primary tumor; or death from any cause.

Testing was performed using the Signatera ctDNA assay. Baseline samples were taken after completion of adjuvant chemotherapy, then again at 3, 6, or 24 months.

Overall, ctDNA detection was infrequent. Just 8% of patients were positive at baseline and 17% were positive at any point during the trial. Even so, ctDNA detection at any point was adversely prognostic.

Patients who were ctDNA positive at baseline were more likely to experience an IDFS event, compared with those who were ctDNA negative at baseline (80% at 4 years follow-up versus 23%).

Similarly, those who remained positive or became positive during testing were more likely to experience an IDFS event compared with those who became negative or remained negative throughout testing.

For instance, all 34 patients who were positive at baseline and remained positive had an IDFS event by year 4, versus just 40% who started positive but then cleared their ctDNA.

Among women who were negative at baseline and remained negative, 13% had an IDFS event versus 89% who started negative but then turned positive. Subjects who turned positive also had the shortest time to an IDFS event, a median of 7 months.

Among women who recurred, those who were ctDNA negative tended to have local, regional, or contralateral recurrences, while ctDNA positive patients tended to have distant recurrences.

The finding “really highlights that ctDNA antedates the metastatic clinical relapse. What the ctDNA is telling you is that the metastatic process has been completed, and metastases are about to grow,” Dr. Bidard said.

The work was funded by Eli Lilly, maker of abemaciclib, with collaboration from Natera, maker of the Signatera assay. Dr. Loi is an adviser and researcher for Lilly, among other industry ties. Dr. Bidard is a speaker and consultant for Lilly, among other ties.

CHICAGO — Circulating tumor DNA (ctDNA) can predict relapse risk in some cases of early, high-risk breast cancer, but it’s too soon to use it to guide adjuvant therapy decisions, according to a study presented at the American Society of Clinical Oncology annual meeting.

Detectable ctDNA is “highly prognostic of worse outcomes, particularly in patients who [remain] persistently positive,” but the correlation isn’t perfect, said lead investigator Sherene Loi, MMBS, PhD, a breast cancer specialist at the Peter MacCallum Cancer Centre in Melbourne, Australia.

Although less likely, relapses also occurred in the study among women without ctDNA elevation. Conversely, there were women with elevated ctDNA who did not relapse, she said. The study was a subanalysis of the monarchE trial of adjuvant abemaciclib, a CDK 4/6 inhibitor.

Eventually, “we would like to use” ctDNA to guide adjuvant treatment decisions, but the research isn’t there yet, Dr. Loi said. It’s possible, for instance, that persistently detectable ctDNA indicates early treatment failure and the need for treatment intensification. Future research should tackle the issue.

Study discussant Francois-Clement Bidard, MD, PhD, a breast cancer specialist at Institut Curie, Paris, agreed that ctDNA isn’t ready for primetime in adjuvant early, high-risk breast cancer.

“There is no clinical evidence to suggest that there is clinical utility in this setting. There are several trials that are ongoing,” he said, but for now “you shouldn’t,” for example, “use ctDNA to de-escalate adjuvant CDK4/6 [inhibitors]. It could be in the future that we could have data on this, but at the moment, [the] clear clinical message [is] no way.”

At 5-year follow-up, the monarchE trial found a 7.6% invasive disease-free survival (IDFS) improvement when abemaciclib was added to the first 2 years of endocrine therapy in women with HR+, HER2-, node positive, high-risk early breast cancer. The combination is now a standard adjuvant option for the disease.

The ctDNA study focused on a subset of 910 subjects with adequate ctDNA testing to run the analysis. The study population was also selected to be enriched for overall IDFS events (27% versus 18% across the trial’s 5,637 subjects). An IDFS event was defined as a local, regional, contralateral or distant invasive recurrence; a new primary tumor; or death from any cause.

Testing was performed using the Signatera ctDNA assay. Baseline samples were taken after completion of adjuvant chemotherapy, then again at 3, 6, or 24 months.

Overall, ctDNA detection was infrequent. Just 8% of patients were positive at baseline and 17% were positive at any point during the trial. Even so, ctDNA detection at any point was adversely prognostic.

Patients who were ctDNA positive at baseline were more likely to experience an IDFS event, compared with those who were ctDNA negative at baseline (80% at 4 years follow-up versus 23%).

Similarly, those who remained positive or became positive during testing were more likely to experience an IDFS event compared with those who became negative or remained negative throughout testing.

For instance, all 34 patients who were positive at baseline and remained positive had an IDFS event by year 4, versus just 40% who started positive but then cleared their ctDNA.

Among women who were negative at baseline and remained negative, 13% had an IDFS event versus 89% who started negative but then turned positive. Subjects who turned positive also had the shortest time to an IDFS event, a median of 7 months.

Among women who recurred, those who were ctDNA negative tended to have local, regional, or contralateral recurrences, while ctDNA positive patients tended to have distant recurrences.

The finding “really highlights that ctDNA antedates the metastatic clinical relapse. What the ctDNA is telling you is that the metastatic process has been completed, and metastases are about to grow,” Dr. Bidard said.

The work was funded by Eli Lilly, maker of abemaciclib, with collaboration from Natera, maker of the Signatera assay. Dr. Loi is an adviser and researcher for Lilly, among other industry ties. Dr. Bidard is a speaker and consultant for Lilly, among other ties.

CHICAGO — Circulating tumor DNA (ctDNA) can predict relapse risk in some cases of early, high-risk breast cancer, but it’s too soon to use it to guide adjuvant therapy decisions, according to a study presented at the American Society of Clinical Oncology annual meeting.

Detectable ctDNA is “highly prognostic of worse outcomes, particularly in patients who [remain] persistently positive,” but the correlation isn’t perfect, said lead investigator Sherene Loi, MMBS, PhD, a breast cancer specialist at the Peter MacCallum Cancer Centre in Melbourne, Australia.

Although less likely, relapses also occurred in the study among women without ctDNA elevation. Conversely, there were women with elevated ctDNA who did not relapse, she said. The study was a subanalysis of the monarchE trial of adjuvant abemaciclib, a CDK 4/6 inhibitor.

Eventually, “we would like to use” ctDNA to guide adjuvant treatment decisions, but the research isn’t there yet, Dr. Loi said. It’s possible, for instance, that persistently detectable ctDNA indicates early treatment failure and the need for treatment intensification. Future research should tackle the issue.

Study discussant Francois-Clement Bidard, MD, PhD, a breast cancer specialist at Institut Curie, Paris, agreed that ctDNA isn’t ready for primetime in adjuvant early, high-risk breast cancer.

“There is no clinical evidence to suggest that there is clinical utility in this setting. There are several trials that are ongoing,” he said, but for now “you shouldn’t,” for example, “use ctDNA to de-escalate adjuvant CDK4/6 [inhibitors]. It could be in the future that we could have data on this, but at the moment, [the] clear clinical message [is] no way.”

At 5-year follow-up, the monarchE trial found a 7.6% invasive disease-free survival (IDFS) improvement when abemaciclib was added to the first 2 years of endocrine therapy in women with HR+, HER2-, node positive, high-risk early breast cancer. The combination is now a standard adjuvant option for the disease.

The ctDNA study focused on a subset of 910 subjects with adequate ctDNA testing to run the analysis. The study population was also selected to be enriched for overall IDFS events (27% versus 18% across the trial’s 5,637 subjects). An IDFS event was defined as a local, regional, contralateral or distant invasive recurrence; a new primary tumor; or death from any cause.

Testing was performed using the Signatera ctDNA assay. Baseline samples were taken after completion of adjuvant chemotherapy, then again at 3, 6, or 24 months.

Overall, ctDNA detection was infrequent. Just 8% of patients were positive at baseline and 17% were positive at any point during the trial. Even so, ctDNA detection at any point was adversely prognostic.

Patients who were ctDNA positive at baseline were more likely to experience an IDFS event, compared with those who were ctDNA negative at baseline (80% at 4 years follow-up versus 23%).

Similarly, those who remained positive or became positive during testing were more likely to experience an IDFS event compared with those who became negative or remained negative throughout testing.

For instance, all 34 patients who were positive at baseline and remained positive had an IDFS event by year 4, versus just 40% who started positive but then cleared their ctDNA.

Among women who were negative at baseline and remained negative, 13% had an IDFS event versus 89% who started negative but then turned positive. Subjects who turned positive also had the shortest time to an IDFS event, a median of 7 months.

Among women who recurred, those who were ctDNA negative tended to have local, regional, or contralateral recurrences, while ctDNA positive patients tended to have distant recurrences.

The finding “really highlights that ctDNA antedates the metastatic clinical relapse. What the ctDNA is telling you is that the metastatic process has been completed, and metastases are about to grow,” Dr. Bidard said.

The work was funded by Eli Lilly, maker of abemaciclib, with collaboration from Natera, maker of the Signatera assay. Dr. Loi is an adviser and researcher for Lilly, among other industry ties. Dr. Bidard is a speaker and consultant for Lilly, among other ties.

TOPLINE:

The transvaginal ultrasonography triage strategy is unreliable for diagnosing endometrial cancer in high-risk Black women, with a significant risk for false-negative results at different endometrial thickness thresholds.

METHODOLOGY:

• Poor performance of transvaginal ultrasonography-measured endometrial thickness as a diagnostic triage strategy for endometrial cancer may contribute to racial disparity in stage at diagnosis between Black and White women.
• Researchers assessed the false-negative probability using transvaginal ultrasonography-measured endometrial thickness thresholds as triage for endometrial cancer in 1494 Black women (median age, 46 years) who underwent hysterectomy.
• The researchers focused on endometrial thickness measurements recorded within 24 months before hysterectomy, as well as demographic and clinical data.
• The endometrial thickness thresholds were defined as < 3 mm, < 4 mm, and < 5 mm, with the rest grouped as ≥ 5 mm, consistent with guidelines.
• A total of 210 women had endometrial cancer. The most common presenting symptoms were fibroids (78%), vaginal bleeding (71%), and pelvic pain (57%).

TAKEAWAY:

• Twenty-four cases of endometrial cancer were below the 5-mm endometrial thickness threshold that would trigger biopsy, resulting overall in 11.4% of endometrial cancer cases potentially missed.
• The false-negative probability was 9.5% (20 cases) at the < 4-mm threshold and 3.8% (8 cases) at the < 3-mm threshold.
• Classic risk factors for endometrial cancer (postmenopausal bleeding, age ≥ 50 years, and BMI > 40) did not result in improved performance of the endometrial thickness triage strategy.
• False-negative probability was also similar among those with fibroids (12%) but higher in the setting of partial endometrial thickness visibility (26%) and pelvic pain (15%).

IN PRACTICE:

This study reveals a “concerning error rate for a triage strategy that would terminate further workup and provide false reassurance to both patients and physicians.” The results contribute to “an increasing body of work questioning the wisdom of the (transvaginal ultrasonography) triage strategy. It may be the case that the (transvaginal ultrasonography) triage for endometrial biopsy is no longer a preferred strategy in the setting of increasing endometrial cancer rates for all. For Black patients with concerning symptoms, tissue biopsy is recommended to avoid misdiagnosis of endometrial cancer,” the researchers concluded.

SOURCE:

The study, with first author Kemi M. Doll, MD, Fred Hutchinson Cancer Center, University of Washington, Seattle, was published online in JAMA Oncology.

LIMITATIONS:

The study did not include cases where transvaginal ultrasonography reports omitted endometrial thickness measurements or reported nonvisible endometrial thickness, possibly underestimating the failure rate of the transvaginal ultrasonography triage strategy.

The sample did not include endometrial cancer cases that were not treated with hysterectomy, which may occur in young women with grade 1 endometrial cancer, those medically incapable of undergoing surgery, and those with disease so advanced that surgery is no longer an option. 
 

DISCLOSURES:

Funding was provided by Kuni Discovery Grants for Cancer Research: Advancing Innovation and by a grant from the National Institutes of Health. Dr. Doll reported receiving investigator-initiated research grants from the Patient Centered Outcomes Research Institute, American Association of Cancer Research, and Merck.

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

TOPLINE:

The transvaginal ultrasonography triage strategy is unreliable for diagnosing endometrial cancer in high-risk Black women, with a significant risk for false-negative results at different endometrial thickness thresholds.

METHODOLOGY:

• Poor performance of transvaginal ultrasonography-measured endometrial thickness as a diagnostic triage strategy for endometrial cancer may contribute to racial disparity in stage at diagnosis between Black and White women.
• Researchers assessed the false-negative probability using transvaginal ultrasonography-measured endometrial thickness thresholds as triage for endometrial cancer in 1494 Black women (median age, 46 years) who underwent hysterectomy.
• The researchers focused on endometrial thickness measurements recorded within 24 months before hysterectomy, as well as demographic and clinical data.
• The endometrial thickness thresholds were defined as < 3 mm, < 4 mm, and < 5 mm, with the rest grouped as ≥ 5 mm, consistent with guidelines.
• A total of 210 women had endometrial cancer. The most common presenting symptoms were fibroids (78%), vaginal bleeding (71%), and pelvic pain (57%).

TAKEAWAY:

• Twenty-four cases of endometrial cancer were below the 5-mm endometrial thickness threshold that would trigger biopsy, resulting overall in 11.4% of endometrial cancer cases potentially missed.
• The false-negative probability was 9.5% (20 cases) at the < 4-mm threshold and 3.8% (8 cases) at the < 3-mm threshold.
• Classic risk factors for endometrial cancer (postmenopausal bleeding, age ≥ 50 years, and BMI > 40) did not result in improved performance of the endometrial thickness triage strategy.
• False-negative probability was also similar among those with fibroids (12%) but higher in the setting of partial endometrial thickness visibility (26%) and pelvic pain (15%).

IN PRACTICE:

This study reveals a “concerning error rate for a triage strategy that would terminate further workup and provide false reassurance to both patients and physicians.” The results contribute to “an increasing body of work questioning the wisdom of the (transvaginal ultrasonography) triage strategy. It may be the case that the (transvaginal ultrasonography) triage for endometrial biopsy is no longer a preferred strategy in the setting of increasing endometrial cancer rates for all. For Black patients with concerning symptoms, tissue biopsy is recommended to avoid misdiagnosis of endometrial cancer,” the researchers concluded.

SOURCE:

The study, with first author Kemi M. Doll, MD, Fred Hutchinson Cancer Center, University of Washington, Seattle, was published online in JAMA Oncology.

LIMITATIONS:

The study did not include cases where transvaginal ultrasonography reports omitted endometrial thickness measurements or reported nonvisible endometrial thickness, possibly underestimating the failure rate of the transvaginal ultrasonography triage strategy.

The sample did not include endometrial cancer cases that were not treated with hysterectomy, which may occur in young women with grade 1 endometrial cancer, those medically incapable of undergoing surgery, and those with disease so advanced that surgery is no longer an option. 
 

DISCLOSURES:

Funding was provided by Kuni Discovery Grants for Cancer Research: Advancing Innovation and by a grant from the National Institutes of Health. Dr. Doll reported receiving investigator-initiated research grants from the Patient Centered Outcomes Research Institute, American Association of Cancer Research, and Merck.

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

TOPLINE:

The transvaginal ultrasonography triage strategy is unreliable for diagnosing endometrial cancer in high-risk Black women, with a significant risk for false-negative results at different endometrial thickness thresholds.

METHODOLOGY:

• Poor performance of transvaginal ultrasonography-measured endometrial thickness as a diagnostic triage strategy for endometrial cancer may contribute to racial disparity in stage at diagnosis between Black and White women.
• Researchers assessed the false-negative probability using transvaginal ultrasonography-measured endometrial thickness thresholds as triage for endometrial cancer in 1494 Black women (median age, 46 years) who underwent hysterectomy.
• The researchers focused on endometrial thickness measurements recorded within 24 months before hysterectomy, as well as demographic and clinical data.
• The endometrial thickness thresholds were defined as < 3 mm, < 4 mm, and < 5 mm, with the rest grouped as ≥ 5 mm, consistent with guidelines.
• A total of 210 women had endometrial cancer. The most common presenting symptoms were fibroids (78%), vaginal bleeding (71%), and pelvic pain (57%).

TAKEAWAY:

• Twenty-four cases of endometrial cancer were below the 5-mm endometrial thickness threshold that would trigger biopsy, resulting overall in 11.4% of endometrial cancer cases potentially missed.
• The false-negative probability was 9.5% (20 cases) at the < 4-mm threshold and 3.8% (8 cases) at the < 3-mm threshold.
• Classic risk factors for endometrial cancer (postmenopausal bleeding, age ≥ 50 years, and BMI > 40) did not result in improved performance of the endometrial thickness triage strategy.
• False-negative probability was also similar among those with fibroids (12%) but higher in the setting of partial endometrial thickness visibility (26%) and pelvic pain (15%).

IN PRACTICE:

This study reveals a “concerning error rate for a triage strategy that would terminate further workup and provide false reassurance to both patients and physicians.” The results contribute to “an increasing body of work questioning the wisdom of the (transvaginal ultrasonography) triage strategy. It may be the case that the (transvaginal ultrasonography) triage for endometrial biopsy is no longer a preferred strategy in the setting of increasing endometrial cancer rates for all. For Black patients with concerning symptoms, tissue biopsy is recommended to avoid misdiagnosis of endometrial cancer,” the researchers concluded.

SOURCE:

The study, with first author Kemi M. Doll, MD, Fred Hutchinson Cancer Center, University of Washington, Seattle, was published online in JAMA Oncology.

LIMITATIONS:

The study did not include cases where transvaginal ultrasonography reports omitted endometrial thickness measurements or reported nonvisible endometrial thickness, possibly underestimating the failure rate of the transvaginal ultrasonography triage strategy.

The sample did not include endometrial cancer cases that were not treated with hysterectomy, which may occur in young women with grade 1 endometrial cancer, those medically incapable of undergoing surgery, and those with disease so advanced that surgery is no longer an option. 
 

DISCLOSURES:

Funding was provided by Kuni Discovery Grants for Cancer Research: Advancing Innovation and by a grant from the National Institutes of Health. Dr. Doll reported receiving investigator-initiated research grants from the Patient Centered Outcomes Research Institute, American Association of Cancer Research, and Merck.

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

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com. 

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

Tools and Tips for Clinicians: 

• Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
• Illustrated low-carb guides by dietdoctor.com
• Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
• Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
• Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com. 

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

Tools and Tips for Clinicians: 

• Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
• Illustrated low-carb guides by dietdoctor.com
• Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
• Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
• Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com. 

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

Tools and Tips for Clinicians: 

• Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
• Illustrated low-carb guides by dietdoctor.com
• Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
• Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
• Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

A relatively low-resource behavioral intervention may help postpartum women transition to engagement with primary care, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.

Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.

Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
 

Intervention vs Control Group

The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.

For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”

Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.

Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).

Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”

“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”

The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.

Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”

“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
 

Still, Only 40% Used Primary Care

She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.

Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.

Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.

A relatively low-resource behavioral intervention may help postpartum women transition to engagement with primary care, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.

Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.

Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
 

Intervention vs Control Group

The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.

For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”

Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.

Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).

Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”

“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”

The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.

Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”

“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
 

Still, Only 40% Used Primary Care

She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.

Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.

Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.

A relatively low-resource behavioral intervention may help postpartum women transition to engagement with primary care, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.

Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.

Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
 

Intervention vs Control Group

The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.

For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”

Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.

Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).

Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”

“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”

The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.

Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”

“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
 

Still, Only 40% Used Primary Care

She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.

Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.

Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.

An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.

“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”

Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.

In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.

The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.

The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.

Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.

“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”

The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.

Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.

Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.

The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.

Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.

Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.

“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”

Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.

Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”

Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.

“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.

“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”

The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.

*This story was corrected on July 25, 2024.

An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.

“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”

Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.

In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.

The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.

The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.

Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.

“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”

The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.

Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.

Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.

The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.

Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.

Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.

“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”

Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.

Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”

Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.

“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.

“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”

The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.

*This story was corrected on July 25, 2024.

An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.

“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”

Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.

In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.

The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.

The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.

Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.

“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”

The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.

Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.

Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.

The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.

Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.

Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.

“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”

Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.

Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”

Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.

“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.

“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”

The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.

*This story was corrected on July 25, 2024.

An electronic health record (EHR)–based nudge intervention could reduce potentially unnecessary sentinel lymph node biopsies (SLNB) among older women with early-stage breast cancer, the authors of new research say.

Participating surgeons noted that the reminder system added minimal friction to their workflow, as it did not require additional clicks or actions on the day of the patient visit, reported lead author Neil Carleton, PhD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues in JAMA Surgery (JAMA Surg. 2024 Jul 17. doi: 10.1001/jamasurg.2024.2407).

This effort to reduce the rate of SLNB stems from the Choosing Wisely campaign, which recommends against axillary staging in women 70 years and older with early-stage, clinically node-negative (cN0), hormone receptor–positive (HR+) breast cancer, the investigators said.

“These recommendations were developed because axillary staging did not impact survival, and rates of SLN positivity were low because of the tumor’s biological phenotype,” they wrote. “Even in older patients with tumors that exhibit concerning clinicopathologic features, limited nodal involvement does not often alter receipt of chemotherapy independently from genomic testing. Despite these recommendations, most women still receive axillary surgery.”
 

How Did the Nudge System Aim to Reduce the Rate of SLNB?

The nudge intervention involved adding a new column to the Epic schedule view, which flagged eligible patients during their first outpatient surgical consultation. The flag appeared as a caution sign or red clipboard icon. When surgeons hovered over the icon, a text box appeared, reminding them to consider omitting SLNB after a detailed review of core biopsy pathology and ultrasonographic imaging.

The intervention was evaluated at eight outpatient clinics within an integrated healthcare system that included seven breast surgical oncologists.

The study began with a 12-month preintervention period to serve as a control, during which time SLNB rate was determined via 194 patients in the target demographic. SLNB rate was again collected during the 12-month intervention period, which involved 193 patients meeting enrollment criteria. Between these periods, the investigators conducted a brief session lasting less than 30 minutes to introduce the surgeons to the rationale and design of the nudge column.
 

How Effective Was the Nudge System?

The intervention reduced the SLNB rate from 46.9% to 23.8%, representing a 49.3% decrease in use of SLNB. Efficacy was further supported by a significant reduction in SLNB according to an interrupted time series model (adjusted odds ratio, 0.26; 95% confidence interval, 0.07 to 0.90; P = .03). Extended follow-up showed that this effect was durable beyond the intervention period, with a 6-month mean reduction in SLNB of 15.6%.

Omission of SLNB led to higher rates of pathological node positivity during the intervention period (15.2% vs 8.8%), with all positive cases staged as pN1. Adjuvant therapy recommendations were similar between groups and driven by genomic testing, not nodal status. The intervention period also saw a decrease in referrals for lymphedema evaluation (3.6% vs. 6.2%).

How Might the Nudge System Be Implemented in Other Practices?

Although the SLNB nudge system was effective in the present study, likelihood of uptake among practices could vary widely, according to Anne M. Wallace, MD, professor of clinical surgery at UC San Diego Health and director of the Moores Comprehensive Breast Health Program.

On a fundamental level, not all centers use Epic software, which could present issues with compatibility, Dr. Wallace said in an interview. More importantly, she added, many institutions already have EHR-based alerts and reminders in place, so it is not always feasible to add a new nudge for every possible clinical scenario.

“Already there are so many little icons that we have to go through now when we close a note,” she said. “That’s why electronic medical records are becoming one of the leading stressors in medicine.”

This presents a more complex challenge, Dr. Wallace said, particularly as potentially practice-changing data are becoming available, and physicians may not have time to learn about them and integrate them into routine practice. She suggested that the present system may be most appropriate for oncologists in solo practice, or in small group practices where it is more challenging to have routine conversations about changing standards of care.

What Are the Risks of Using the Nudge System?

One of those conversations may surround the validity of the recommendation implemented in the present study.

Although the Society of Surgical Oncology recommends against SLNB in the described demographic, other experts, including Dr. Wallace, take a more nuanced view of the decision.

She noted that some patients with a chronological age of 70 may have a lower biological age, casting doubt on the legitimacy of the age threshold, and those near the threshold may wish to make the decision about staging for themselves.

Beyond these concerns, Dr. Wallace described two potential risks involved in forgoing SLNB.

First, there’s the potential for underestimating the tumor’s severity, she said, as this could mean a trip back to the operating room. A tumor initially thought to be low-grade might later be found to be high-grade, necessitating further surgery. Some patients might refuse additional surgery, leaving the more aggressive tumor untreated.

Second, the nudge system could complicate radiation treatment decisions, Dr. Wallace said. Without full nodal status, some radiation oncologists might push for additional radiation therapy, which incurs a greater treatment burden than SNLB.
 

What Are Some Alternatives to the Nudge System?

After discussing the strengths and weaknesses of the present EHR-based nudge system, and others like it, Dr. Wallace returned to the importance of ongoing communication among colleagues managing complex cases.

At UC San Diego Health, where oncologists meet weekly for a 2-hour breast cancer conference, “we nudge each other,” she said.

This study was supported by the Shear Family Foundation, UPMC eRecord Ambulatory Decision Support and Analytics, UPMC Hillman Cancer Center Biostatistics Facility, and National Institutes of Health. The investigators disclosed relationships with Pfizer, Amgen, the Lewin Group, and Milestone Pennsylvania, and others.

An electronic health record (EHR)–based nudge intervention could reduce potentially unnecessary sentinel lymph node biopsies (SLNB) among older women with early-stage breast cancer, the authors of new research say.

Participating surgeons noted that the reminder system added minimal friction to their workflow, as it did not require additional clicks or actions on the day of the patient visit, reported lead author Neil Carleton, PhD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues in JAMA Surgery (JAMA Surg. 2024 Jul 17. doi: 10.1001/jamasurg.2024.2407).

This effort to reduce the rate of SLNB stems from the Choosing Wisely campaign, which recommends against axillary staging in women 70 years and older with early-stage, clinically node-negative (cN0), hormone receptor–positive (HR+) breast cancer, the investigators said.

“These recommendations were developed because axillary staging did not impact survival, and rates of SLN positivity were low because of the tumor’s biological phenotype,” they wrote. “Even in older patients with tumors that exhibit concerning clinicopathologic features, limited nodal involvement does not often alter receipt of chemotherapy independently from genomic testing. Despite these recommendations, most women still receive axillary surgery.”
 

How Did the Nudge System Aim to Reduce the Rate of SLNB?

The nudge intervention involved adding a new column to the Epic schedule view, which flagged eligible patients during their first outpatient surgical consultation. The flag appeared as a caution sign or red clipboard icon. When surgeons hovered over the icon, a text box appeared, reminding them to consider omitting SLNB after a detailed review of core biopsy pathology and ultrasonographic imaging.

The intervention was evaluated at eight outpatient clinics within an integrated healthcare system that included seven breast surgical oncologists.

The study began with a 12-month preintervention period to serve as a control, during which time SLNB rate was determined via 194 patients in the target demographic. SLNB rate was again collected during the 12-month intervention period, which involved 193 patients meeting enrollment criteria. Between these periods, the investigators conducted a brief session lasting less than 30 minutes to introduce the surgeons to the rationale and design of the nudge column.
 

How Effective Was the Nudge System?

The intervention reduced the SLNB rate from 46.9% to 23.8%, representing a 49.3% decrease in use of SLNB. Efficacy was further supported by a significant reduction in SLNB according to an interrupted time series model (adjusted odds ratio, 0.26; 95% confidence interval, 0.07 to 0.90; P = .03). Extended follow-up showed that this effect was durable beyond the intervention period, with a 6-month mean reduction in SLNB of 15.6%.

Omission of SLNB led to higher rates of pathological node positivity during the intervention period (15.2% vs 8.8%), with all positive cases staged as pN1. Adjuvant therapy recommendations were similar between groups and driven by genomic testing, not nodal status. The intervention period also saw a decrease in referrals for lymphedema evaluation (3.6% vs. 6.2%).

How Might the Nudge System Be Implemented in Other Practices?

Although the SLNB nudge system was effective in the present study, likelihood of uptake among practices could vary widely, according to Anne M. Wallace, MD, professor of clinical surgery at UC San Diego Health and director of the Moores Comprehensive Breast Health Program.

On a fundamental level, not all centers use Epic software, which could present issues with compatibility, Dr. Wallace said in an interview. More importantly, she added, many institutions already have EHR-based alerts and reminders in place, so it is not always feasible to add a new nudge for every possible clinical scenario.

“Already there are so many little icons that we have to go through now when we close a note,” she said. “That’s why electronic medical records are becoming one of the leading stressors in medicine.”

This presents a more complex challenge, Dr. Wallace said, particularly as potentially practice-changing data are becoming available, and physicians may not have time to learn about them and integrate them into routine practice. She suggested that the present system may be most appropriate for oncologists in solo practice, or in small group practices where it is more challenging to have routine conversations about changing standards of care.

What Are the Risks of Using the Nudge System?

One of those conversations may surround the validity of the recommendation implemented in the present study.

Although the Society of Surgical Oncology recommends against SLNB in the described demographic, other experts, including Dr. Wallace, take a more nuanced view of the decision.

She noted that some patients with a chronological age of 70 may have a lower biological age, casting doubt on the legitimacy of the age threshold, and those near the threshold may wish to make the decision about staging for themselves.

Beyond these concerns, Dr. Wallace described two potential risks involved in forgoing SLNB.

First, there’s the potential for underestimating the tumor’s severity, she said, as this could mean a trip back to the operating room. A tumor initially thought to be low-grade might later be found to be high-grade, necessitating further surgery. Some patients might refuse additional surgery, leaving the more aggressive tumor untreated.

Second, the nudge system could complicate radiation treatment decisions, Dr. Wallace said. Without full nodal status, some radiation oncologists might push for additional radiation therapy, which incurs a greater treatment burden than SNLB.
 

What Are Some Alternatives to the Nudge System?

After discussing the strengths and weaknesses of the present EHR-based nudge system, and others like it, Dr. Wallace returned to the importance of ongoing communication among colleagues managing complex cases.

At UC San Diego Health, where oncologists meet weekly for a 2-hour breast cancer conference, “we nudge each other,” she said.

This study was supported by the Shear Family Foundation, UPMC eRecord Ambulatory Decision Support and Analytics, UPMC Hillman Cancer Center Biostatistics Facility, and National Institutes of Health. The investigators disclosed relationships with Pfizer, Amgen, the Lewin Group, and Milestone Pennsylvania, and others.

An electronic health record (EHR)–based nudge intervention could reduce potentially unnecessary sentinel lymph node biopsies (SLNB) among older women with early-stage breast cancer, the authors of new research say.

Participating surgeons noted that the reminder system added minimal friction to their workflow, as it did not require additional clicks or actions on the day of the patient visit, reported lead author Neil Carleton, PhD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues in JAMA Surgery (JAMA Surg. 2024 Jul 17. doi: 10.1001/jamasurg.2024.2407).

This effort to reduce the rate of SLNB stems from the Choosing Wisely campaign, which recommends against axillary staging in women 70 years and older with early-stage, clinically node-negative (cN0), hormone receptor–positive (HR+) breast cancer, the investigators said.

“These recommendations were developed because axillary staging did not impact survival, and rates of SLN positivity were low because of the tumor’s biological phenotype,” they wrote. “Even in older patients with tumors that exhibit concerning clinicopathologic features, limited nodal involvement does not often alter receipt of chemotherapy independently from genomic testing. Despite these recommendations, most women still receive axillary surgery.”
 

How Did the Nudge System Aim to Reduce the Rate of SLNB?

The nudge intervention involved adding a new column to the Epic schedule view, which flagged eligible patients during their first outpatient surgical consultation. The flag appeared as a caution sign or red clipboard icon. When surgeons hovered over the icon, a text box appeared, reminding them to consider omitting SLNB after a detailed review of core biopsy pathology and ultrasonographic imaging.

The intervention was evaluated at eight outpatient clinics within an integrated healthcare system that included seven breast surgical oncologists.

The study began with a 12-month preintervention period to serve as a control, during which time SLNB rate was determined via 194 patients in the target demographic. SLNB rate was again collected during the 12-month intervention period, which involved 193 patients meeting enrollment criteria. Between these periods, the investigators conducted a brief session lasting less than 30 minutes to introduce the surgeons to the rationale and design of the nudge column.
 

How Effective Was the Nudge System?

The intervention reduced the SLNB rate from 46.9% to 23.8%, representing a 49.3% decrease in use of SLNB. Efficacy was further supported by a significant reduction in SLNB according to an interrupted time series model (adjusted odds ratio, 0.26; 95% confidence interval, 0.07 to 0.90; P = .03). Extended follow-up showed that this effect was durable beyond the intervention period, with a 6-month mean reduction in SLNB of 15.6%.

Omission of SLNB led to higher rates of pathological node positivity during the intervention period (15.2% vs 8.8%), with all positive cases staged as pN1. Adjuvant therapy recommendations were similar between groups and driven by genomic testing, not nodal status. The intervention period also saw a decrease in referrals for lymphedema evaluation (3.6% vs. 6.2%).

How Might the Nudge System Be Implemented in Other Practices?

Although the SLNB nudge system was effective in the present study, likelihood of uptake among practices could vary widely, according to Anne M. Wallace, MD, professor of clinical surgery at UC San Diego Health and director of the Moores Comprehensive Breast Health Program.

On a fundamental level, not all centers use Epic software, which could present issues with compatibility, Dr. Wallace said in an interview. More importantly, she added, many institutions already have EHR-based alerts and reminders in place, so it is not always feasible to add a new nudge for every possible clinical scenario.

“Already there are so many little icons that we have to go through now when we close a note,” she said. “That’s why electronic medical records are becoming one of the leading stressors in medicine.”

This presents a more complex challenge, Dr. Wallace said, particularly as potentially practice-changing data are becoming available, and physicians may not have time to learn about them and integrate them into routine practice. She suggested that the present system may be most appropriate for oncologists in solo practice, or in small group practices where it is more challenging to have routine conversations about changing standards of care.

What Are the Risks of Using the Nudge System?

One of those conversations may surround the validity of the recommendation implemented in the present study.

Although the Society of Surgical Oncology recommends against SLNB in the described demographic, other experts, including Dr. Wallace, take a more nuanced view of the decision.

She noted that some patients with a chronological age of 70 may have a lower biological age, casting doubt on the legitimacy of the age threshold, and those near the threshold may wish to make the decision about staging for themselves.

Beyond these concerns, Dr. Wallace described two potential risks involved in forgoing SLNB.

First, there’s the potential for underestimating the tumor’s severity, she said, as this could mean a trip back to the operating room. A tumor initially thought to be low-grade might later be found to be high-grade, necessitating further surgery. Some patients might refuse additional surgery, leaving the more aggressive tumor untreated.

Second, the nudge system could complicate radiation treatment decisions, Dr. Wallace said. Without full nodal status, some radiation oncologists might push for additional radiation therapy, which incurs a greater treatment burden than SNLB.
 

What Are Some Alternatives to the Nudge System?

After discussing the strengths and weaknesses of the present EHR-based nudge system, and others like it, Dr. Wallace returned to the importance of ongoing communication among colleagues managing complex cases.

At UC San Diego Health, where oncologists meet weekly for a 2-hour breast cancer conference, “we nudge each other,” she said.

This study was supported by the Shear Family Foundation, UPMC eRecord Ambulatory Decision Support and Analytics, UPMC Hillman Cancer Center Biostatistics Facility, and National Institutes of Health. The investigators disclosed relationships with Pfizer, Amgen, the Lewin Group, and Milestone Pennsylvania, and others.

Rural regions like the one surrounding a southern Iowa town used to have a lot more babies and many more places to give birth to them.

At least 41 Iowa hospitals have shuttered their labor and delivery units since 2000. Those facilities, representing about a third of all Iowa hospitals, are located mostly in rural areas where birth numbers have plummeted. In some Iowa counties, annual numbers of births have fallen by three quarters since the height of the baby boom in the 1950s and 1960s, when many rural hospitals were built or expanded, state and federal records show.

Similar trends are playing out nationwide, as hospitals struggle to maintain staff and facilities to safely handle dwindling numbers of births. More than half of rural US hospitals now lack the service.

“People just aren’t having as many kids,” said Addie Comegys, who lives in southern Iowa and has regularly traveled 45 minutes each way for prenatal checkups at Oskaloosa’s hospital this summer. Her mother had six children, starting in the 1980s, when big families didn’t seem so rare.

“Now, if you have three kids, people are like, ‘Oh my gosh, are you ever going to stop?’ ” said Ms. Comegys, 29, who is expecting her second child in late August.

These days, many Americans choose to have small families or no children at all. Modern birth control methods help make such decisions stick. The trend is amplified in small towns when young adults move away, taking any childbearing potential with them.

Hospital leaders who close obstetrics units often cite declining birth numbers, along with staffing challenges and financial losses. The closures can be a particular challenge for pregnant women who lack the reliable transportation and flexible schedules needed to travel long distances for prenatal care and birthing services.

The baby boom peaked in 1957, when about 4.3 million children were born in the United States. The annual number of births dropped below 3.7 million by 2022, even though the overall US population nearly doubled over that same period.

West Virginia has seen the steepest decline in births, a 62% drop in those 65 years, according to federal data. Iowa’s births dropped 43% over that period. Of the state’s 99 counties, just four — all urban or suburban — recorded more births.

Births have increased in only 13 states since 1957. Most of them, such as Arizona, California, Florida, and Nevada, are places that have attracted waves of newcomers from other states and countries. But even those states have had obstetrics units close in rural areas.

In Iowa, Oskaloosa’s hospital has bucked the trend and kept its labor and delivery unit open, partly by pulling in patients from 14 other counties. Last year, the hospital even managed the rare feat of recruiting two obstetrician-gynecologists to expand its services.

The publicly owned hospital, called Mahaska Health, expects to deliver 250 babies this year, up from about 160 in previous years, CEO Kevin DeRonde said.

“It’s an essential service, and we needed to keep it going and grow it,” Mr. DeRonde said.

Many of the US hospitals that are now dropping obstetrics units were built or expanded in the mid-1900s, when America went on a rural-hospital building spree, thanks to federal funding from the Hill-Burton Act.

“It was an amazing program,” said Brock Slabach, chief operations officer for the National Rural Health Association. “Basically, if you were a county that wanted a hospital, they gave you the money.”

Mr. Slabach said that in addition to declining birth numbers, obstetrics units are experiencing a drop in occupancy because most patients go home after a night or two. In the past, patients typically spent several days in the hospital after giving birth.

Dwindling caseloads can raise safety concerns for obstetrics units.

A study published in JAMA in 2023 found that women were more likely to suffer serious complications if they gave birth in rural hospitals that handled 110 or fewer births a year. The authors said they didn’t support closing low-volume units because that could lead more women to have complications related to traveling for care. Instead, they recommended improving training and coordination among rural health providers.

Stephanie Radke, MD, a University of Iowa obstetrics and gynecology professor who studies access to birthing services, said it is almost inevitable that when rural birth numbers plunge, some obstetrics units will close. “We talk about that as a bad event, but we don’t really talk about why it happens,” she said.

Dr. Radke said maintaining a set number of obstetrics units is less important than ensuring good care for pregnant women and their babies. It’s difficult to maintain quality of care when the staff doesn’t consistently practice deliveries, she said, but it is hard to define that line. “What is realistic?” she said. “I don’t think a unit should be open that only delivers 50 babies a year.”

In some cases, she said, hospitals near each other have consolidated obstetrics units, pooling their resources into one program that has enough staffers and handles sufficient cases. “You’re not always really creating a care desert when that happens,” she said.

The decline in births has accelerated in many areas in recent years. Kenneth Johnson, a sociology professor and demographer at the University of New Hampshire, said it is understandable that many rural hospitals have closed obstetrics units. “I’m actually surprised some of them have lasted as long as they have,” he said.

Dr. Johnson said rural areas that have seen the steepest population declines tend to be far from cities and lack recreational attractions, such as mountains or large bodies of water. Some have avoided population losses by attracting immigrant workers, who tend to have larger families in the first generation or two after they move to the United States, he said.

Katy B. Kozhimannil, a University of Minnesota health policy professor who studies rural issues, said declining birth numbers and obstetric unit closures can create a vicious cycle. Fewer babies being born in a region can lead a birthing unit to shutter. Then the loss of such a unit can discourage young people from moving to the area, driving birth numbers even lower.

In many regions, people with private insurance, flexible schedules, and reliable transportation choose to travel to larger hospitals for their prenatal care and to give birth, Dr. Kozhimannil said. That leaves rural hospitals with a larger proportion of patients on Medicaid, a public program that pays about half what private insurance pays for the same services, she said.

Iowa ranks near the bottom of all states for obstetrician-gynecologists per capita. But Oskaloosa’s hospital hit the jackpot last year, when it recruited Taylar Swartz Summers, DO, and Garth Summers, DO, a married couple who both recently finished their obstetrics training. Dr. Swartz Summers grew up in the area, and she wanted to return to serve women there.

She hopes the number of obstetrics units will level off after the wave of closures. “It’s not even just for delivery, but we need access just to women’s healthcare in general,” she said. “I would love to see women’s healthcare be at the forefront of our government’s mind.”

Dr. Swartz Summers noted that the state has only one obstetrics training program, which is at the University of Iowa. She said she and her husband plan to help spark interest in rural obstetrics by hosting University of Iowa residency rotations at the Oskaloosa hospital.

Ms. Comegys, a patient of Dr. Swartz Summer’s, could have chosen a hospital birthing center closer to her home, but she wasn’t confident in its quality. Other hospitals in her region had shuttered their obstetrics units. She is grateful to have a flexible job, a reliable car, and a supportive family, so she can travel to Oskaloosa for checkups and to give birth there. She knows many other women are not so lucky, and she worries other obstetrics units are at risk.

“It’s sad, but I could see more closing,” she said.

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

Rural regions like the one surrounding a southern Iowa town used to have a lot more babies and many more places to give birth to them.

At least 41 Iowa hospitals have shuttered their labor and delivery units since 2000. Those facilities, representing about a third of all Iowa hospitals, are located mostly in rural areas where birth numbers have plummeted. In some Iowa counties, annual numbers of births have fallen by three quarters since the height of the baby boom in the 1950s and 1960s, when many rural hospitals were built or expanded, state and federal records show.

Similar trends are playing out nationwide, as hospitals struggle to maintain staff and facilities to safely handle dwindling numbers of births. More than half of rural US hospitals now lack the service.

“People just aren’t having as many kids,” said Addie Comegys, who lives in southern Iowa and has regularly traveled 45 minutes each way for prenatal checkups at Oskaloosa’s hospital this summer. Her mother had six children, starting in the 1980s, when big families didn’t seem so rare.

“Now, if you have three kids, people are like, ‘Oh my gosh, are you ever going to stop?’ ” said Ms. Comegys, 29, who is expecting her second child in late August.

These days, many Americans choose to have small families or no children at all. Modern birth control methods help make such decisions stick. The trend is amplified in small towns when young adults move away, taking any childbearing potential with them.

Hospital leaders who close obstetrics units often cite declining birth numbers, along with staffing challenges and financial losses. The closures can be a particular challenge for pregnant women who lack the reliable transportation and flexible schedules needed to travel long distances for prenatal care and birthing services.

The baby boom peaked in 1957, when about 4.3 million children were born in the United States. The annual number of births dropped below 3.7 million by 2022, even though the overall US population nearly doubled over that same period.

West Virginia has seen the steepest decline in births, a 62% drop in those 65 years, according to federal data. Iowa’s births dropped 43% over that period. Of the state’s 99 counties, just four — all urban or suburban — recorded more births.

Births have increased in only 13 states since 1957. Most of them, such as Arizona, California, Florida, and Nevada, are places that have attracted waves of newcomers from other states and countries. But even those states have had obstetrics units close in rural areas.

In Iowa, Oskaloosa’s hospital has bucked the trend and kept its labor and delivery unit open, partly by pulling in patients from 14 other counties. Last year, the hospital even managed the rare feat of recruiting two obstetrician-gynecologists to expand its services.

The publicly owned hospital, called Mahaska Health, expects to deliver 250 babies this year, up from about 160 in previous years, CEO Kevin DeRonde said.

“It’s an essential service, and we needed to keep it going and grow it,” Mr. DeRonde said.

Many of the US hospitals that are now dropping obstetrics units were built or expanded in the mid-1900s, when America went on a rural-hospital building spree, thanks to federal funding from the Hill-Burton Act.

“It was an amazing program,” said Brock Slabach, chief operations officer for the National Rural Health Association. “Basically, if you were a county that wanted a hospital, they gave you the money.”

Mr. Slabach said that in addition to declining birth numbers, obstetrics units are experiencing a drop in occupancy because most patients go home after a night or two. In the past, patients typically spent several days in the hospital after giving birth.

Dwindling caseloads can raise safety concerns for obstetrics units.

A study published in JAMA in 2023 found that women were more likely to suffer serious complications if they gave birth in rural hospitals that handled 110 or fewer births a year. The authors said they didn’t support closing low-volume units because that could lead more women to have complications related to traveling for care. Instead, they recommended improving training and coordination among rural health providers.

Stephanie Radke, MD, a University of Iowa obstetrics and gynecology professor who studies access to birthing services, said it is almost inevitable that when rural birth numbers plunge, some obstetrics units will close. “We talk about that as a bad event, but we don’t really talk about why it happens,” she said.

Dr. Radke said maintaining a set number of obstetrics units is less important than ensuring good care for pregnant women and their babies. It’s difficult to maintain quality of care when the staff doesn’t consistently practice deliveries, she said, but it is hard to define that line. “What is realistic?” she said. “I don’t think a unit should be open that only delivers 50 babies a year.”

In some cases, she said, hospitals near each other have consolidated obstetrics units, pooling their resources into one program that has enough staffers and handles sufficient cases. “You’re not always really creating a care desert when that happens,” she said.

The decline in births has accelerated in many areas in recent years. Kenneth Johnson, a sociology professor and demographer at the University of New Hampshire, said it is understandable that many rural hospitals have closed obstetrics units. “I’m actually surprised some of them have lasted as long as they have,” he said.

Dr. Johnson said rural areas that have seen the steepest population declines tend to be far from cities and lack recreational attractions, such as mountains or large bodies of water. Some have avoided population losses by attracting immigrant workers, who tend to have larger families in the first generation or two after they move to the United States, he said.

Katy B. Kozhimannil, a University of Minnesota health policy professor who studies rural issues, said declining birth numbers and obstetric unit closures can create a vicious cycle. Fewer babies being born in a region can lead a birthing unit to shutter. Then the loss of such a unit can discourage young people from moving to the area, driving birth numbers even lower.

In many regions, people with private insurance, flexible schedules, and reliable transportation choose to travel to larger hospitals for their prenatal care and to give birth, Dr. Kozhimannil said. That leaves rural hospitals with a larger proportion of patients on Medicaid, a public program that pays about half what private insurance pays for the same services, she said.

Iowa ranks near the bottom of all states for obstetrician-gynecologists per capita. But Oskaloosa’s hospital hit the jackpot last year, when it recruited Taylar Swartz Summers, DO, and Garth Summers, DO, a married couple who both recently finished their obstetrics training. Dr. Swartz Summers grew up in the area, and she wanted to return to serve women there.

She hopes the number of obstetrics units will level off after the wave of closures. “It’s not even just for delivery, but we need access just to women’s healthcare in general,” she said. “I would love to see women’s healthcare be at the forefront of our government’s mind.”

Dr. Swartz Summers noted that the state has only one obstetrics training program, which is at the University of Iowa. She said she and her husband plan to help spark interest in rural obstetrics by hosting University of Iowa residency rotations at the Oskaloosa hospital.

Ms. Comegys, a patient of Dr. Swartz Summer’s, could have chosen a hospital birthing center closer to her home, but she wasn’t confident in its quality. Other hospitals in her region had shuttered their obstetrics units. She is grateful to have a flexible job, a reliable car, and a supportive family, so she can travel to Oskaloosa for checkups and to give birth there. She knows many other women are not so lucky, and she worries other obstetrics units are at risk.

“It’s sad, but I could see more closing,” she said.

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

Rural regions like the one surrounding a southern Iowa town used to have a lot more babies and many more places to give birth to them.

At least 41 Iowa hospitals have shuttered their labor and delivery units since 2000. Those facilities, representing about a third of all Iowa hospitals, are located mostly in rural areas where birth numbers have plummeted. In some Iowa counties, annual numbers of births have fallen by three quarters since the height of the baby boom in the 1950s and 1960s, when many rural hospitals were built or expanded, state and federal records show.

Similar trends are playing out nationwide, as hospitals struggle to maintain staff and facilities to safely handle dwindling numbers of births. More than half of rural US hospitals now lack the service.

“People just aren’t having as many kids,” said Addie Comegys, who lives in southern Iowa and has regularly traveled 45 minutes each way for prenatal checkups at Oskaloosa’s hospital this summer. Her mother had six children, starting in the 1980s, when big families didn’t seem so rare.

“Now, if you have three kids, people are like, ‘Oh my gosh, are you ever going to stop?’ ” said Ms. Comegys, 29, who is expecting her second child in late August.

These days, many Americans choose to have small families or no children at all. Modern birth control methods help make such decisions stick. The trend is amplified in small towns when young adults move away, taking any childbearing potential with them.

Hospital leaders who close obstetrics units often cite declining birth numbers, along with staffing challenges and financial losses. The closures can be a particular challenge for pregnant women who lack the reliable transportation and flexible schedules needed to travel long distances for prenatal care and birthing services.

The baby boom peaked in 1957, when about 4.3 million children were born in the United States. The annual number of births dropped below 3.7 million by 2022, even though the overall US population nearly doubled over that same period.

West Virginia has seen the steepest decline in births, a 62% drop in those 65 years, according to federal data. Iowa’s births dropped 43% over that period. Of the state’s 99 counties, just four — all urban or suburban — recorded more births.

Births have increased in only 13 states since 1957. Most of them, such as Arizona, California, Florida, and Nevada, are places that have attracted waves of newcomers from other states and countries. But even those states have had obstetrics units close in rural areas.

In Iowa, Oskaloosa’s hospital has bucked the trend and kept its labor and delivery unit open, partly by pulling in patients from 14 other counties. Last year, the hospital even managed the rare feat of recruiting two obstetrician-gynecologists to expand its services.

The publicly owned hospital, called Mahaska Health, expects to deliver 250 babies this year, up from about 160 in previous years, CEO Kevin DeRonde said.

“It’s an essential service, and we needed to keep it going and grow it,” Mr. DeRonde said.

Many of the US hospitals that are now dropping obstetrics units were built or expanded in the mid-1900s, when America went on a rural-hospital building spree, thanks to federal funding from the Hill-Burton Act.

“It was an amazing program,” said Brock Slabach, chief operations officer for the National Rural Health Association. “Basically, if you were a county that wanted a hospital, they gave you the money.”

Mr. Slabach said that in addition to declining birth numbers, obstetrics units are experiencing a drop in occupancy because most patients go home after a night or two. In the past, patients typically spent several days in the hospital after giving birth.

Dwindling caseloads can raise safety concerns for obstetrics units.

A study published in JAMA in 2023 found that women were more likely to suffer serious complications if they gave birth in rural hospitals that handled 110 or fewer births a year. The authors said they didn’t support closing low-volume units because that could lead more women to have complications related to traveling for care. Instead, they recommended improving training and coordination among rural health providers.

Stephanie Radke, MD, a University of Iowa obstetrics and gynecology professor who studies access to birthing services, said it is almost inevitable that when rural birth numbers plunge, some obstetrics units will close. “We talk about that as a bad event, but we don’t really talk about why it happens,” she said.

Dr. Radke said maintaining a set number of obstetrics units is less important than ensuring good care for pregnant women and their babies. It’s difficult to maintain quality of care when the staff doesn’t consistently practice deliveries, she said, but it is hard to define that line. “What is realistic?” she said. “I don’t think a unit should be open that only delivers 50 babies a year.”

In some cases, she said, hospitals near each other have consolidated obstetrics units, pooling their resources into one program that has enough staffers and handles sufficient cases. “You’re not always really creating a care desert when that happens,” she said.

The decline in births has accelerated in many areas in recent years. Kenneth Johnson, a sociology professor and demographer at the University of New Hampshire, said it is understandable that many rural hospitals have closed obstetrics units. “I’m actually surprised some of them have lasted as long as they have,” he said.

Dr. Johnson said rural areas that have seen the steepest population declines tend to be far from cities and lack recreational attractions, such as mountains or large bodies of water. Some have avoided population losses by attracting immigrant workers, who tend to have larger families in the first generation or two after they move to the United States, he said.

Katy B. Kozhimannil, a University of Minnesota health policy professor who studies rural issues, said declining birth numbers and obstetric unit closures can create a vicious cycle. Fewer babies being born in a region can lead a birthing unit to shutter. Then the loss of such a unit can discourage young people from moving to the area, driving birth numbers even lower.

In many regions, people with private insurance, flexible schedules, and reliable transportation choose to travel to larger hospitals for their prenatal care and to give birth, Dr. Kozhimannil said. That leaves rural hospitals with a larger proportion of patients on Medicaid, a public program that pays about half what private insurance pays for the same services, she said.

Iowa ranks near the bottom of all states for obstetrician-gynecologists per capita. But Oskaloosa’s hospital hit the jackpot last year, when it recruited Taylar Swartz Summers, DO, and Garth Summers, DO, a married couple who both recently finished their obstetrics training. Dr. Swartz Summers grew up in the area, and she wanted to return to serve women there.

She hopes the number of obstetrics units will level off after the wave of closures. “It’s not even just for delivery, but we need access just to women’s healthcare in general,” she said. “I would love to see women’s healthcare be at the forefront of our government’s mind.”

Dr. Swartz Summers noted that the state has only one obstetrics training program, which is at the University of Iowa. She said she and her husband plan to help spark interest in rural obstetrics by hosting University of Iowa residency rotations at the Oskaloosa hospital.

Ms. Comegys, a patient of Dr. Swartz Summer’s, could have chosen a hospital birthing center closer to her home, but she wasn’t confident in its quality. Other hospitals in her region had shuttered their obstetrics units. She is grateful to have a flexible job, a reliable car, and a supportive family, so she can travel to Oskaloosa for checkups and to give birth there. She knows many other women are not so lucky, and she worries other obstetrics units are at risk.

“It’s sad, but I could see more closing,” she said.

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

Almost 1 in 10 pregnant people infected with COVID-19 end up developing long COVID, according to a study published in Obstetrics & Gynecology.

Researchers at University of Utah Health looked at the medical records of more than 1500 people who got COVID-19 while pregnant and checked their self-reported symptoms at least 6 months after infection, according to a news release from the school.

The scientists discovered that 9.3% of those people reported long COVID symptoms, such as fatigue and issues in their gut. 

To make sure those long COVID symptoms were not actually symptoms of pregnancy, the research team did a second analysis of people who reported symptoms more than 12 weeks after giving birth. The risk of long COVID was about the same as in the first analysis.

“It was surprising to me that the prevalence was that high,” Torri D. Metz, MD, vice chair for research of obstetrics and gynecology at the school and co-leader of the study, said in the release. “This is something that does continue to affect otherwise reasonably healthy and young populations.”

The school said this is the first study to look at long COVID risks in pregnant people. Previous research found other dangers for pregnant people who get COVID, such as a higher chance of hospitalization or death, or complications such as preterm birth.

In the general population, research shows that 10%-20% of people who get COVID develop long COVID.

Dr. Metz said healthcare providers need to remain alert about long COVID, including in pregnant people.

“We need to have this on our radar as we’re seeing patients. It’s something we really don’t want to miss. And we want to get people referred to appropriate specialists who treat long COVID,” she said.
 

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

Almost 1 in 10 pregnant people infected with COVID-19 end up developing long COVID, according to a study published in Obstetrics & Gynecology.

Researchers at University of Utah Health looked at the medical records of more than 1500 people who got COVID-19 while pregnant and checked their self-reported symptoms at least 6 months after infection, according to a news release from the school.

The scientists discovered that 9.3% of those people reported long COVID symptoms, such as fatigue and issues in their gut. 

To make sure those long COVID symptoms were not actually symptoms of pregnancy, the research team did a second analysis of people who reported symptoms more than 12 weeks after giving birth. The risk of long COVID was about the same as in the first analysis.

“It was surprising to me that the prevalence was that high,” Torri D. Metz, MD, vice chair for research of obstetrics and gynecology at the school and co-leader of the study, said in the release. “This is something that does continue to affect otherwise reasonably healthy and young populations.”

The school said this is the first study to look at long COVID risks in pregnant people. Previous research found other dangers for pregnant people who get COVID, such as a higher chance of hospitalization or death, or complications such as preterm birth.

In the general population, research shows that 10%-20% of people who get COVID develop long COVID.

Dr. Metz said healthcare providers need to remain alert about long COVID, including in pregnant people.

“We need to have this on our radar as we’re seeing patients. It’s something we really don’t want to miss. And we want to get people referred to appropriate specialists who treat long COVID,” she said.
 

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

Almost 1 in 10 pregnant people infected with COVID-19 end up developing long COVID, according to a study published in Obstetrics & Gynecology.

Researchers at University of Utah Health looked at the medical records of more than 1500 people who got COVID-19 while pregnant and checked their self-reported symptoms at least 6 months after infection, according to a news release from the school.

The scientists discovered that 9.3% of those people reported long COVID symptoms, such as fatigue and issues in their gut. 

To make sure those long COVID symptoms were not actually symptoms of pregnancy, the research team did a second analysis of people who reported symptoms more than 12 weeks after giving birth. The risk of long COVID was about the same as in the first analysis.

“It was surprising to me that the prevalence was that high,” Torri D. Metz, MD, vice chair for research of obstetrics and gynecology at the school and co-leader of the study, said in the release. “This is something that does continue to affect otherwise reasonably healthy and young populations.”

The school said this is the first study to look at long COVID risks in pregnant people. Previous research found other dangers for pregnant people who get COVID, such as a higher chance of hospitalization or death, or complications such as preterm birth.

In the general population, research shows that 10%-20% of people who get COVID develop long COVID.

Dr. Metz said healthcare providers need to remain alert about long COVID, including in pregnant people.

“We need to have this on our radar as we’re seeing patients. It’s something we really don’t want to miss. And we want to get people referred to appropriate specialists who treat long COVID,” she said.
 

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