Women's Health

The perception of an inadequate milk supply can contribute to a new mother’s decision to cease breastfeeding prematurely, but identifying at-risk women is difficult. Now a new study suggests that, for some women, this impression, known as perceived inadequacy of milk supply (PIMS) appears to have a basis in genetics.

Steven D. Hicks, MD, PhD, associate professor of pediatrics at Penn State University, Hershey, and colleagues found that variations in the MFGE8 gene was associated with perceived breast milk supply.

“Genotyping one lactogenic gene aided identification of mothers at risk for PIMS. If validated in a larger cohort, such an approach could be used to identify mothers who may benefit from increased lactation support.” Dr. Hicks’ group wrote in Breastfeeding Medicine.

A simple 24-hour polymerase chain reaction test around the time of delivery could identify vulnerable mothers, who could receive targeted lactation support including galactagogue supplementation and early scheduling of “nurse and pump” routines.

“Also, if a woman is found to have PIMS, she would definitely want to avoid going on oral contraceptives after delivery as these can affect milk supply,” Dr. Hicks said in an interview. “That would be like a double hit in a woman already at risk.“

In other measures, she would meet once a week with a lactation consultant for the first 6 months to make sure good breastfeeding practices as to frequency and duration of placing the baby on the breast are being maintained, Dr. Hicks continued. “She needs to make sure her supply isn’t going backwards because once it starts to dry up, it’s really hard to turn the ship around.”

Dietary interventions to promote lactation may also help.
 

The study

In the context of a larger study on breast milk factors protecting children from developing allergies, the prospective observational analysis collected data on 221 breastfeeding mothers aged 19-42 years (mean age, 29 years) for 12 months.

All mothers had initially planned to nurse their babies for at least 6 months but some stopped well short of their goal.

“At least a third told us they gave up because they felt their milk supply had run out,” Dr. Hicks said in an interview.

Using salivas swabs, the investigators assessed 18 genes secreted from mammary tissue and previously linked in cows to secretory function for single-nucleotide polymorphisms in 88 age-, race-, and parity-matched women. Of these, 45 had PIMS and 43 had perceived adequate milk supply (PAMS).

Among differences between the two groups:

• PIMS mothers breastfed exclusively for a shorter period than PAMS mothers: 7 ± 12 weeks versus 22 ± 19 weeks(P = .001)
• At 1 month after delivery, their reported milk production was lower: 17.6 ± 13.3 oz/day versus 27.0 ± 12.2 oz/day (P = .0001). This shortfall persisted at 4 months: 16.0 ± 14.1 oz/day versus 27.3 ± 14.9 oz/day (P < .0010.
• Between birth and 1 month, infants of PIMS mothers also showed a smaller average increase in weight-for-length z score between birth and 1 month: 0.74 ± 1.4 versus 1.4 ± 1.5 (P = .038).

Furthermore, maternal genotype for the rs2271714 variant within MFGE8 was associated with PIMS status (P = .009; adjusted P = .09; likelihood ratio, 9.33), and duration of exclusive breastfeeding (P = .009; adjusted P = .09; chi square, 9.39).

Adding the MFGE8 genotype to a model including maternal age, parity, previous breastfeeding duration, body mass index, education, and depression status significantly increased predictive accuracy for PIMS status, the authors noted.

“This is a very exciting observation made by Dr. Hicks and his team, and the first study to identify a genetic variant associated with perceived insufficient milk supply,” said Shannon L. Kelleher, PhD, professor of biological and nutritional sciences at University of Massachusetts, Lowell.

“It provides compelling evidence that insufficient milk supply is very common and supports the urgent need to identify the risk factors and develop interventions to improve breastfeeding success,” added Dr. Kelleher, who was not involved in the study.

“If genetic variants such as the one identified in MFGE8 are confirmed to be common in mothers with insufficient milk supply, the development of lactation-focused genetic tests to identify women at risk for low milk supply would revolutionize our ability to support breastfeeding mothers and help them achieve their breastfeeding goals.”

Although 83% of new mothers initiate breastfeeding, only 57% are still breastfeeding at 6 months and only 35% breastfeed until 12 months, according to the Centers for Disease Control and Prevention’s Breastfeeding Report Card.

This study was funded by grants to Dr. Hicks from the Gerber Foundation and the Center for Research on Women and Newborns Foundation. The authors disclosed no competing interests. Dr. Kelleher reported no conflicts of interest relevant to her comments.

The perception of an inadequate milk supply can contribute to a new mother’s decision to cease breastfeeding prematurely, but identifying at-risk women is difficult. Now a new study suggests that, for some women, this impression, known as perceived inadequacy of milk supply (PIMS) appears to have a basis in genetics.

Steven D. Hicks, MD, PhD, associate professor of pediatrics at Penn State University, Hershey, and colleagues found that variations in the MFGE8 gene was associated with perceived breast milk supply.

“Genotyping one lactogenic gene aided identification of mothers at risk for PIMS. If validated in a larger cohort, such an approach could be used to identify mothers who may benefit from increased lactation support.” Dr. Hicks’ group wrote in Breastfeeding Medicine.

A simple 24-hour polymerase chain reaction test around the time of delivery could identify vulnerable mothers, who could receive targeted lactation support including galactagogue supplementation and early scheduling of “nurse and pump” routines.

“Also, if a woman is found to have PIMS, she would definitely want to avoid going on oral contraceptives after delivery as these can affect milk supply,” Dr. Hicks said in an interview. “That would be like a double hit in a woman already at risk.“

In other measures, she would meet once a week with a lactation consultant for the first 6 months to make sure good breastfeeding practices as to frequency and duration of placing the baby on the breast are being maintained, Dr. Hicks continued. “She needs to make sure her supply isn’t going backwards because once it starts to dry up, it’s really hard to turn the ship around.”

Dietary interventions to promote lactation may also help.
 

The study

In the context of a larger study on breast milk factors protecting children from developing allergies, the prospective observational analysis collected data on 221 breastfeeding mothers aged 19-42 years (mean age, 29 years) for 12 months.

All mothers had initially planned to nurse their babies for at least 6 months but some stopped well short of their goal.

“At least a third told us they gave up because they felt their milk supply had run out,” Dr. Hicks said in an interview.

Using salivas swabs, the investigators assessed 18 genes secreted from mammary tissue and previously linked in cows to secretory function for single-nucleotide polymorphisms in 88 age-, race-, and parity-matched women. Of these, 45 had PIMS and 43 had perceived adequate milk supply (PAMS).

Among differences between the two groups:

• PIMS mothers breastfed exclusively for a shorter period than PAMS mothers: 7 ± 12 weeks versus 22 ± 19 weeks(P = .001)
• At 1 month after delivery, their reported milk production was lower: 17.6 ± 13.3 oz/day versus 27.0 ± 12.2 oz/day (P = .0001). This shortfall persisted at 4 months: 16.0 ± 14.1 oz/day versus 27.3 ± 14.9 oz/day (P < .0010.
• Between birth and 1 month, infants of PIMS mothers also showed a smaller average increase in weight-for-length z score between birth and 1 month: 0.74 ± 1.4 versus 1.4 ± 1.5 (P = .038).

Furthermore, maternal genotype for the rs2271714 variant within MFGE8 was associated with PIMS status (P = .009; adjusted P = .09; likelihood ratio, 9.33), and duration of exclusive breastfeeding (P = .009; adjusted P = .09; chi square, 9.39).

Adding the MFGE8 genotype to a model including maternal age, parity, previous breastfeeding duration, body mass index, education, and depression status significantly increased predictive accuracy for PIMS status, the authors noted.

“This is a very exciting observation made by Dr. Hicks and his team, and the first study to identify a genetic variant associated with perceived insufficient milk supply,” said Shannon L. Kelleher, PhD, professor of biological and nutritional sciences at University of Massachusetts, Lowell.

“It provides compelling evidence that insufficient milk supply is very common and supports the urgent need to identify the risk factors and develop interventions to improve breastfeeding success,” added Dr. Kelleher, who was not involved in the study.

“If genetic variants such as the one identified in MFGE8 are confirmed to be common in mothers with insufficient milk supply, the development of lactation-focused genetic tests to identify women at risk for low milk supply would revolutionize our ability to support breastfeeding mothers and help them achieve their breastfeeding goals.”

Although 83% of new mothers initiate breastfeeding, only 57% are still breastfeeding at 6 months and only 35% breastfeed until 12 months, according to the Centers for Disease Control and Prevention’s Breastfeeding Report Card.

This study was funded by grants to Dr. Hicks from the Gerber Foundation and the Center for Research on Women and Newborns Foundation. The authors disclosed no competing interests. Dr. Kelleher reported no conflicts of interest relevant to her comments.

The perception of an inadequate milk supply can contribute to a new mother’s decision to cease breastfeeding prematurely, but identifying at-risk women is difficult. Now a new study suggests that, for some women, this impression, known as perceived inadequacy of milk supply (PIMS) appears to have a basis in genetics.

Steven D. Hicks, MD, PhD, associate professor of pediatrics at Penn State University, Hershey, and colleagues found that variations in the MFGE8 gene was associated with perceived breast milk supply.

“Genotyping one lactogenic gene aided identification of mothers at risk for PIMS. If validated in a larger cohort, such an approach could be used to identify mothers who may benefit from increased lactation support.” Dr. Hicks’ group wrote in Breastfeeding Medicine.

A simple 24-hour polymerase chain reaction test around the time of delivery could identify vulnerable mothers, who could receive targeted lactation support including galactagogue supplementation and early scheduling of “nurse and pump” routines.

“Also, if a woman is found to have PIMS, she would definitely want to avoid going on oral contraceptives after delivery as these can affect milk supply,” Dr. Hicks said in an interview. “That would be like a double hit in a woman already at risk.“

In other measures, she would meet once a week with a lactation consultant for the first 6 months to make sure good breastfeeding practices as to frequency and duration of placing the baby on the breast are being maintained, Dr. Hicks continued. “She needs to make sure her supply isn’t going backwards because once it starts to dry up, it’s really hard to turn the ship around.”

Dietary interventions to promote lactation may also help.
 

The study

In the context of a larger study on breast milk factors protecting children from developing allergies, the prospective observational analysis collected data on 221 breastfeeding mothers aged 19-42 years (mean age, 29 years) for 12 months.

All mothers had initially planned to nurse their babies for at least 6 months but some stopped well short of their goal.

“At least a third told us they gave up because they felt their milk supply had run out,” Dr. Hicks said in an interview.

Using salivas swabs, the investigators assessed 18 genes secreted from mammary tissue and previously linked in cows to secretory function for single-nucleotide polymorphisms in 88 age-, race-, and parity-matched women. Of these, 45 had PIMS and 43 had perceived adequate milk supply (PAMS).

Among differences between the two groups:

• PIMS mothers breastfed exclusively for a shorter period than PAMS mothers: 7 ± 12 weeks versus 22 ± 19 weeks(P = .001)
• At 1 month after delivery, their reported milk production was lower: 17.6 ± 13.3 oz/day versus 27.0 ± 12.2 oz/day (P = .0001). This shortfall persisted at 4 months: 16.0 ± 14.1 oz/day versus 27.3 ± 14.9 oz/day (P < .0010.
• Between birth and 1 month, infants of PIMS mothers also showed a smaller average increase in weight-for-length z score between birth and 1 month: 0.74 ± 1.4 versus 1.4 ± 1.5 (P = .038).

Furthermore, maternal genotype for the rs2271714 variant within MFGE8 was associated with PIMS status (P = .009; adjusted P = .09; likelihood ratio, 9.33), and duration of exclusive breastfeeding (P = .009; adjusted P = .09; chi square, 9.39).

Adding the MFGE8 genotype to a model including maternal age, parity, previous breastfeeding duration, body mass index, education, and depression status significantly increased predictive accuracy for PIMS status, the authors noted.

“This is a very exciting observation made by Dr. Hicks and his team, and the first study to identify a genetic variant associated with perceived insufficient milk supply,” said Shannon L. Kelleher, PhD, professor of biological and nutritional sciences at University of Massachusetts, Lowell.

“It provides compelling evidence that insufficient milk supply is very common and supports the urgent need to identify the risk factors and develop interventions to improve breastfeeding success,” added Dr. Kelleher, who was not involved in the study.

“If genetic variants such as the one identified in MFGE8 are confirmed to be common in mothers with insufficient milk supply, the development of lactation-focused genetic tests to identify women at risk for low milk supply would revolutionize our ability to support breastfeeding mothers and help them achieve their breastfeeding goals.”

Although 83% of new mothers initiate breastfeeding, only 57% are still breastfeeding at 6 months and only 35% breastfeed until 12 months, according to the Centers for Disease Control and Prevention’s Breastfeeding Report Card.

This study was funded by grants to Dr. Hicks from the Gerber Foundation and the Center for Research on Women and Newborns Foundation. The authors disclosed no competing interests. Dr. Kelleher reported no conflicts of interest relevant to her comments.

Breast cancer risk genes are generally associated with triple-negative and high-grade disease, but differ substantially in their associated pathology, a large case-control analysis shows.

The findings have potential implications for genetic testing, risk prediction, variant classification, and screening, the authors noted.

To assess links between pathogenic germline variants in nine major breast cancer (BC) susceptibility genes and pathological features of nonmetastasized breast tumors, investigators from the Breast Cancer Association Consortium compared 42,680 women with breast cancer and 42,387 population-matched controls from the BRIDGES large-scale sequencing study.

They looked specifically at features relevant to prognosis and distinct therapeutic options, including tumor subtype, morphology, size, stage, and lymph node involvement, and found substantial differences in tumor subtype distribution by gene.

“Pathogenic [protein-truncating variants and pathogenic missense variants] in these ... susceptibility genes were disproportionately associated with more aggressive breast caner, particularly among younger women,” they wrote, noting that carriers of rare genetic variants in the nine genes comprised more than 27% of women diagnosed at age 40 or younger with triple-negative disease (driven mainly by BRCA1) and about 16% of those diagnosed with hormone receptor (HR)–positive, HER2-negative high-grade disease.

All together, the nine genes were associated with 14.4% of tumors in women aged 40 years and younger, but less than 4% in women over age 60 years, and among younger women, the prevalence of variants combined was higher in those with triple-negative and HR-positive, HER2-negative disease versus other subtypes, they said.

The findings were published online on Jan. 27, 2022, in JAMA Oncology.

Study subjects were women aged 18-79 years who were sampled, independently of family history, from 38 international population- or hospital-based studies conducted between 1991 and 2016.

The genes assessed included ATM, BARD1, BRCA1, BRCA2, CHEK2, PALB2, RAD51C, RAD51D, and TP53.

Substantial heterogeneity was observed in the distribution of intrinsic subtypes by gene. For example, RAD51C, RAD51D, and BARD1 variants were associated mainly with triple-negative disease (odds ratios, 6.19, 6.19, and 10.05 respectively), and CHEK2 variants were associated with all subtypes (with ORs ranging from 2.21-3.17) except for triple-negative disease, the authors found.

“For ATM variants, the association was strongest for [HR-positive, HER2-negative]high-grade subtype (OR, 4.99). BRCA1 was associated with increased risk of all subtypes, but the ORs varied widely, being highest for triple-negative disease (OR, 55.32),” they wrote.

BRCA2 and PALB2 variants were also associated with triple-negative disease, TP53 variants were most strongly associated with HR-positive, HER2-negative and HR-negative, HER2-positive subtypes, and tumors occurring in pathogenic variant carriers were of higher grade, they added, noting that for most genes and subtypes, a decline in ORs was observed with increasing age.

All genes except CHEK2 were more strongly associated with high-grade disease.

These and other findings from the study can “inform guidelines for eligibility for gene panel sequencing and breast cancer surveillance in the general population,” the authors explained, adding that tumor characteristics can also be used to determine whether variants of uncertain significance are likely to be pathogenic.

The data should therefore “improve the precision of variant classification algorithms and extend them to a larger set of genes,” they noted.

“This case-control study suggests that rare variants in BC susceptibility genes display marked heterogeneity with respect to tumor phenotype, but also similarities between genes that are consistent with known biological functions. This present study provides detailed quantification of subtype-specific breast cancer risks; these can potentially improve risk prediction models and breast cancer prevention strategies,” they concluded.

More specifically, women found to be carrying variants in these genes may be offered enhanced screening, including by MRI, risk-reducing surgery, chemoprevention, and genetic counseling, corresponding author Nasim Mavaddat, MBBS, PhD, explained in an interview.

“Understanding tumor pathology associated with the genes can inform breast cancer risk prediction models, and management and treatment of women harboring pathogenic variants,” she noted.

The findings “enhance our understanding of breast cancer biology and aid efforts to classify whether genetic variants of uncertain significance are also likely to be pathogenic,” added Dr. Mavaddat, a senior research associate at the University of Cambridge (England).

She also said the investigators are taking steps to include the results in “CanRisk,” a cancer risk prediction model used by genetic counselors and other clinicians, and are “exploring whether variants in these genes are associated with contralateral breast cancer risk and survival after a breast cancer.”

As most participants were European, analyses should be extended to women of other racial and ethnic groups, she added.

The BRIDGES panel sequencing was supported by the European Union Horizon 2020 research and innovation program BRIDGES and the Wellcome Trust. The Breast Cancer Association Consortium is also funded by the European Union Horizon 2020 research and innovation program, the PERSPECTIVE I&I project, which is funded by the Government of Canada, and the Confluence project, which is funded with intramural funds from the National Cancer Institute. Dr. Mavaddat reported grants from the University of Cambridge, European Union Horizon 2020, Wellcome Trust, Genome Canada, Canadian Institutes of Health Research, and National Cancer Institute during the conduct of the study.

Breast cancer risk genes are generally associated with triple-negative and high-grade disease, but differ substantially in their associated pathology, a large case-control analysis shows.

The findings have potential implications for genetic testing, risk prediction, variant classification, and screening, the authors noted.

To assess links between pathogenic germline variants in nine major breast cancer (BC) susceptibility genes and pathological features of nonmetastasized breast tumors, investigators from the Breast Cancer Association Consortium compared 42,680 women with breast cancer and 42,387 population-matched controls from the BRIDGES large-scale sequencing study.

They looked specifically at features relevant to prognosis and distinct therapeutic options, including tumor subtype, morphology, size, stage, and lymph node involvement, and found substantial differences in tumor subtype distribution by gene.

“Pathogenic [protein-truncating variants and pathogenic missense variants] in these ... susceptibility genes were disproportionately associated with more aggressive breast caner, particularly among younger women,” they wrote, noting that carriers of rare genetic variants in the nine genes comprised more than 27% of women diagnosed at age 40 or younger with triple-negative disease (driven mainly by BRCA1) and about 16% of those diagnosed with hormone receptor (HR)–positive, HER2-negative high-grade disease.

All together, the nine genes were associated with 14.4% of tumors in women aged 40 years and younger, but less than 4% in women over age 60 years, and among younger women, the prevalence of variants combined was higher in those with triple-negative and HR-positive, HER2-negative disease versus other subtypes, they said.

The findings were published online on Jan. 27, 2022, in JAMA Oncology.

Study subjects were women aged 18-79 years who were sampled, independently of family history, from 38 international population- or hospital-based studies conducted between 1991 and 2016.

The genes assessed included ATM, BARD1, BRCA1, BRCA2, CHEK2, PALB2, RAD51C, RAD51D, and TP53.

Substantial heterogeneity was observed in the distribution of intrinsic subtypes by gene. For example, RAD51C, RAD51D, and BARD1 variants were associated mainly with triple-negative disease (odds ratios, 6.19, 6.19, and 10.05 respectively), and CHEK2 variants were associated with all subtypes (with ORs ranging from 2.21-3.17) except for triple-negative disease, the authors found.

“For ATM variants, the association was strongest for [HR-positive, HER2-negative]high-grade subtype (OR, 4.99). BRCA1 was associated with increased risk of all subtypes, but the ORs varied widely, being highest for triple-negative disease (OR, 55.32),” they wrote.

BRCA2 and PALB2 variants were also associated with triple-negative disease, TP53 variants were most strongly associated with HR-positive, HER2-negative and HR-negative, HER2-positive subtypes, and tumors occurring in pathogenic variant carriers were of higher grade, they added, noting that for most genes and subtypes, a decline in ORs was observed with increasing age.

All genes except CHEK2 were more strongly associated with high-grade disease.

These and other findings from the study can “inform guidelines for eligibility for gene panel sequencing and breast cancer surveillance in the general population,” the authors explained, adding that tumor characteristics can also be used to determine whether variants of uncertain significance are likely to be pathogenic.

The data should therefore “improve the precision of variant classification algorithms and extend them to a larger set of genes,” they noted.

“This case-control study suggests that rare variants in BC susceptibility genes display marked heterogeneity with respect to tumor phenotype, but also similarities between genes that are consistent with known biological functions. This present study provides detailed quantification of subtype-specific breast cancer risks; these can potentially improve risk prediction models and breast cancer prevention strategies,” they concluded.

More specifically, women found to be carrying variants in these genes may be offered enhanced screening, including by MRI, risk-reducing surgery, chemoprevention, and genetic counseling, corresponding author Nasim Mavaddat, MBBS, PhD, explained in an interview.

“Understanding tumor pathology associated with the genes can inform breast cancer risk prediction models, and management and treatment of women harboring pathogenic variants,” she noted.

The findings “enhance our understanding of breast cancer biology and aid efforts to classify whether genetic variants of uncertain significance are also likely to be pathogenic,” added Dr. Mavaddat, a senior research associate at the University of Cambridge (England).

She also said the investigators are taking steps to include the results in “CanRisk,” a cancer risk prediction model used by genetic counselors and other clinicians, and are “exploring whether variants in these genes are associated with contralateral breast cancer risk and survival after a breast cancer.”

As most participants were European, analyses should be extended to women of other racial and ethnic groups, she added.

The BRIDGES panel sequencing was supported by the European Union Horizon 2020 research and innovation program BRIDGES and the Wellcome Trust. The Breast Cancer Association Consortium is also funded by the European Union Horizon 2020 research and innovation program, the PERSPECTIVE I&I project, which is funded by the Government of Canada, and the Confluence project, which is funded with intramural funds from the National Cancer Institute. Dr. Mavaddat reported grants from the University of Cambridge, European Union Horizon 2020, Wellcome Trust, Genome Canada, Canadian Institutes of Health Research, and National Cancer Institute during the conduct of the study.

Breast cancer risk genes are generally associated with triple-negative and high-grade disease, but differ substantially in their associated pathology, a large case-control analysis shows.

The findings have potential implications for genetic testing, risk prediction, variant classification, and screening, the authors noted.

To assess links between pathogenic germline variants in nine major breast cancer (BC) susceptibility genes and pathological features of nonmetastasized breast tumors, investigators from the Breast Cancer Association Consortium compared 42,680 women with breast cancer and 42,387 population-matched controls from the BRIDGES large-scale sequencing study.

They looked specifically at features relevant to prognosis and distinct therapeutic options, including tumor subtype, morphology, size, stage, and lymph node involvement, and found substantial differences in tumor subtype distribution by gene.

“Pathogenic [protein-truncating variants and pathogenic missense variants] in these ... susceptibility genes were disproportionately associated with more aggressive breast caner, particularly among younger women,” they wrote, noting that carriers of rare genetic variants in the nine genes comprised more than 27% of women diagnosed at age 40 or younger with triple-negative disease (driven mainly by BRCA1) and about 16% of those diagnosed with hormone receptor (HR)–positive, HER2-negative high-grade disease.

All together, the nine genes were associated with 14.4% of tumors in women aged 40 years and younger, but less than 4% in women over age 60 years, and among younger women, the prevalence of variants combined was higher in those with triple-negative and HR-positive, HER2-negative disease versus other subtypes, they said.

The findings were published online on Jan. 27, 2022, in JAMA Oncology.

Study subjects were women aged 18-79 years who were sampled, independently of family history, from 38 international population- or hospital-based studies conducted between 1991 and 2016.

The genes assessed included ATM, BARD1, BRCA1, BRCA2, CHEK2, PALB2, RAD51C, RAD51D, and TP53.

Substantial heterogeneity was observed in the distribution of intrinsic subtypes by gene. For example, RAD51C, RAD51D, and BARD1 variants were associated mainly with triple-negative disease (odds ratios, 6.19, 6.19, and 10.05 respectively), and CHEK2 variants were associated with all subtypes (with ORs ranging from 2.21-3.17) except for triple-negative disease, the authors found.

“For ATM variants, the association was strongest for [HR-positive, HER2-negative]high-grade subtype (OR, 4.99). BRCA1 was associated with increased risk of all subtypes, but the ORs varied widely, being highest for triple-negative disease (OR, 55.32),” they wrote.

BRCA2 and PALB2 variants were also associated with triple-negative disease, TP53 variants were most strongly associated with HR-positive, HER2-negative and HR-negative, HER2-positive subtypes, and tumors occurring in pathogenic variant carriers were of higher grade, they added, noting that for most genes and subtypes, a decline in ORs was observed with increasing age.

All genes except CHEK2 were more strongly associated with high-grade disease.

These and other findings from the study can “inform guidelines for eligibility for gene panel sequencing and breast cancer surveillance in the general population,” the authors explained, adding that tumor characteristics can also be used to determine whether variants of uncertain significance are likely to be pathogenic.

The data should therefore “improve the precision of variant classification algorithms and extend them to a larger set of genes,” they noted.

“This case-control study suggests that rare variants in BC susceptibility genes display marked heterogeneity with respect to tumor phenotype, but also similarities between genes that are consistent with known biological functions. This present study provides detailed quantification of subtype-specific breast cancer risks; these can potentially improve risk prediction models and breast cancer prevention strategies,” they concluded.

More specifically, women found to be carrying variants in these genes may be offered enhanced screening, including by MRI, risk-reducing surgery, chemoprevention, and genetic counseling, corresponding author Nasim Mavaddat, MBBS, PhD, explained in an interview.

“Understanding tumor pathology associated with the genes can inform breast cancer risk prediction models, and management and treatment of women harboring pathogenic variants,” she noted.

The findings “enhance our understanding of breast cancer biology and aid efforts to classify whether genetic variants of uncertain significance are also likely to be pathogenic,” added Dr. Mavaddat, a senior research associate at the University of Cambridge (England).

She also said the investigators are taking steps to include the results in “CanRisk,” a cancer risk prediction model used by genetic counselors and other clinicians, and are “exploring whether variants in these genes are associated with contralateral breast cancer risk and survival after a breast cancer.”

As most participants were European, analyses should be extended to women of other racial and ethnic groups, she added.

The BRIDGES panel sequencing was supported by the European Union Horizon 2020 research and innovation program BRIDGES and the Wellcome Trust. The Breast Cancer Association Consortium is also funded by the European Union Horizon 2020 research and innovation program, the PERSPECTIVE I&I project, which is funded by the Government of Canada, and the Confluence project, which is funded with intramural funds from the National Cancer Institute. Dr. Mavaddat reported grants from the University of Cambridge, European Union Horizon 2020, Wellcome Trust, Genome Canada, Canadian Institutes of Health Research, and National Cancer Institute during the conduct of the study.

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Group prenatal care did not reduce preterm birth among low-income patients compared to patients receiving individual prenatal care, but the different care models did shrink racial disparities in low-birth-weight and preterm births, according to a study presented Feb. 3 at the annual meeting sponsored by the Society for Maternal-Fetal Medicine. Patients who attended more group prenatal care visits also had better outcomes, reported Amy Crockett, MD, professor of ob.gyn. and director of the Maternal-Fetal Medicine Fellowship Program at the University of South Carolina in Greenville.

Though the results did not show group prenatal care to be the “silver bullet” they might have hoped for in reducing preterm birth and low birth weight among Black women, the study did show group prenatal care to have some clinical effect, Dr. Crockett suggested.

Ilina Pluym, MD, assistant professor of maternal-fetal medicine at the University of California Los Angeles, said that preterm birth and low birth weight are complex problems that cannot be solved by a single fix.

“In terms of the racial disparities, it is difficult to prove that 9 months of good access to prenatal care will undo the years of limited health care and life stressors that, as a whole, possibly contribute more to the overall risk profile of the patient,” Dr. Pluym said. “But as providers, we want to intervene and help in the portion that we can, and optimizing prenatal care is one tangible thing we can try.”

The racial disparities that exist in preterm birth, low birth weight, and infant and maternal mortality are not caused by biologic or genetic factors, Dr. Crockett told attendees.

”Rather, they are the result of long-standing systemic racism and discrimination deeply embedded in the culture of the United States,” she said. “To achieve racial equity, we need reform at the societal level.” But she noted that it might be possible for individual practices to play a role as well, which led her to design a study comparing outcomes from group versus individual prenatal care.

The group care model used for the study is called Centering Pregnancy, in which 8-10 pregnant patients who are due in the same month attend 10 two-hour prenatal care sessions together. Dr. Crockett noted that other research has identified potential reductions in preterm birth with group care models, but some are underpowered while others are observational and limited by confounding, selection bias, or small sample sizes.

The researchers aimed to recruit 3,160 patients to ensure an adequately powered study after estimated losses to follow-up, but they were able to recruit only 2,350 patients, resulting in potentially underpowered results. All the patients were receiving care at a single obstetric practice for a medically low-risk singleton pregnancy of 20 or fewer weeks gestation. A total of 1,176 patients were randomly assigned to attend group prenatal care appointments, and 1,174 patients were assigned to individual prenatal care.

The patients in both groups were an average age of 25 with a prepregnancy body mass index of 29. A similar proportion in both the group and individual care were married (24%) patients and had a government payer (96%-97%). Approximately 41%were Black patients, 37% were White patients, and 21% were Hispanic patients in both groups. Rates of chronic hypertension, smoking, vaginal infection in pregnancy, parity, cervix length, and use of cerclage were similar in both groups.

Gestational age outcomes were available for 1,099 group care patients (94%) and 1,120 individual care patients (95%), and birth weight outcomes were available for 1,028 group care patients (87%) and 1,044 individual care patients (89%).

In the individual care group, 8.7% of the patients had a preterm birth, compared to 10.4% who attended group prenatal care, but the findings did not reach significance (odds ratio [OR], 1.22; 95% confidence interval [CI]: 0.92-1.63). The difference between the 9.6% of group care patients and 8.9% of individual care patients who had babies with low birth weights were not significantly different.

While no significant difference in preterm birth occurred between the groups, the secondary outcome looking at racial disparities yielded one statistically significant result. Black women receiving individual prenatal care were twice as likely as were White women to have an infant with a low birth weight (OR, 2.1; 95% CI: 1.29-3.5). Among those receiving group care, however, the 12.5% of Black women and 8.9% of White women whose infants had a low birth weight were not significantly different.

There was a trend toward narrower disparities in preterm birth in the group versus individual care groups. Among those receiving group care, 11.4% of Black women and 10.8% of White women had a preterm birth, compared to 10.2% of Black women and 7.7% of White women in the individual care group.

Then the researchers compared the groups with regard to compliance while adjusting for baseline differences. “We saw decreasing rates of preterm birth for Black patients relative to White patients, particularly after attending five or more sessions in the group care arm with the rates of preterm birth narrowing and the disparity becoming nonsignificant with more exposure to group care,” Dr. Crockett said. “In individual care, the rate of preterm birth remained the highest for Black women regardless of the number of visits attended.”

The idea of trying group prenatal care is appealing, Dr. Pluym said in an interview, though both models have their advantages.

”The strength of individual care is the focus on the patient exam and individual patient questions,” Dr. Pluym said. “The strengths of group prenatal care are the consolidation of the patient education aspect of prenatal care that is uniform for all patients, the sense of community patients feel, and the opportunity to hear other patients questions that you may not have thought of. It sounds like, anecdotally, patients and providers really found the group sessions valuable and they helped dampen implicit bias and build relationships.”

One potential limitation of this randomized controlled trial is that the providers were the same for both group and individual care, potentially causing some confounding, Dr. Pluym noted. But the study does have one clear clinical message, she said.

“My take away is more prenatal care is better – individual or group,” Dr. Pluym said. “Every clinic should evaluate their own structure and see if group care would be feasible for their patient population. There may be a benefit globally, but is it is not the ‘silver bullet,’ as they said, for lowering preterm birth or growth restriction.”

The research was funded by the Institute of Child Health and Development. The study researchers and Dr. Pluym reported no disclosures.

Group prenatal care did not reduce preterm birth among low-income patients compared to patients receiving individual prenatal care, but the different care models did shrink racial disparities in low-birth-weight and preterm births, according to a study presented Feb. 3 at the annual meeting sponsored by the Society for Maternal-Fetal Medicine. Patients who attended more group prenatal care visits also had better outcomes, reported Amy Crockett, MD, professor of ob.gyn. and director of the Maternal-Fetal Medicine Fellowship Program at the University of South Carolina in Greenville.

Though the results did not show group prenatal care to be the “silver bullet” they might have hoped for in reducing preterm birth and low birth weight among Black women, the study did show group prenatal care to have some clinical effect, Dr. Crockett suggested.

Ilina Pluym, MD, assistant professor of maternal-fetal medicine at the University of California Los Angeles, said that preterm birth and low birth weight are complex problems that cannot be solved by a single fix.

“In terms of the racial disparities, it is difficult to prove that 9 months of good access to prenatal care will undo the years of limited health care and life stressors that, as a whole, possibly contribute more to the overall risk profile of the patient,” Dr. Pluym said. “But as providers, we want to intervene and help in the portion that we can, and optimizing prenatal care is one tangible thing we can try.”

The racial disparities that exist in preterm birth, low birth weight, and infant and maternal mortality are not caused by biologic or genetic factors, Dr. Crockett told attendees.

”Rather, they are the result of long-standing systemic racism and discrimination deeply embedded in the culture of the United States,” she said. “To achieve racial equity, we need reform at the societal level.” But she noted that it might be possible for individual practices to play a role as well, which led her to design a study comparing outcomes from group versus individual prenatal care.

The group care model used for the study is called Centering Pregnancy, in which 8-10 pregnant patients who are due in the same month attend 10 two-hour prenatal care sessions together. Dr. Crockett noted that other research has identified potential reductions in preterm birth with group care models, but some are underpowered while others are observational and limited by confounding, selection bias, or small sample sizes.

The researchers aimed to recruit 3,160 patients to ensure an adequately powered study after estimated losses to follow-up, but they were able to recruit only 2,350 patients, resulting in potentially underpowered results. All the patients were receiving care at a single obstetric practice for a medically low-risk singleton pregnancy of 20 or fewer weeks gestation. A total of 1,176 patients were randomly assigned to attend group prenatal care appointments, and 1,174 patients were assigned to individual prenatal care.

The patients in both groups were an average age of 25 with a prepregnancy body mass index of 29. A similar proportion in both the group and individual care were married (24%) patients and had a government payer (96%-97%). Approximately 41%were Black patients, 37% were White patients, and 21% were Hispanic patients in both groups. Rates of chronic hypertension, smoking, vaginal infection in pregnancy, parity, cervix length, and use of cerclage were similar in both groups.

Gestational age outcomes were available for 1,099 group care patients (94%) and 1,120 individual care patients (95%), and birth weight outcomes were available for 1,028 group care patients (87%) and 1,044 individual care patients (89%).

In the individual care group, 8.7% of the patients had a preterm birth, compared to 10.4% who attended group prenatal care, but the findings did not reach significance (odds ratio [OR], 1.22; 95% confidence interval [CI]: 0.92-1.63). The difference between the 9.6% of group care patients and 8.9% of individual care patients who had babies with low birth weights were not significantly different.

While no significant difference in preterm birth occurred between the groups, the secondary outcome looking at racial disparities yielded one statistically significant result. Black women receiving individual prenatal care were twice as likely as were White women to have an infant with a low birth weight (OR, 2.1; 95% CI: 1.29-3.5). Among those receiving group care, however, the 12.5% of Black women and 8.9% of White women whose infants had a low birth weight were not significantly different.

There was a trend toward narrower disparities in preterm birth in the group versus individual care groups. Among those receiving group care, 11.4% of Black women and 10.8% of White women had a preterm birth, compared to 10.2% of Black women and 7.7% of White women in the individual care group.

Then the researchers compared the groups with regard to compliance while adjusting for baseline differences. “We saw decreasing rates of preterm birth for Black patients relative to White patients, particularly after attending five or more sessions in the group care arm with the rates of preterm birth narrowing and the disparity becoming nonsignificant with more exposure to group care,” Dr. Crockett said. “In individual care, the rate of preterm birth remained the highest for Black women regardless of the number of visits attended.”

The idea of trying group prenatal care is appealing, Dr. Pluym said in an interview, though both models have their advantages.

”The strength of individual care is the focus on the patient exam and individual patient questions,” Dr. Pluym said. “The strengths of group prenatal care are the consolidation of the patient education aspect of prenatal care that is uniform for all patients, the sense of community patients feel, and the opportunity to hear other patients questions that you may not have thought of. It sounds like, anecdotally, patients and providers really found the group sessions valuable and they helped dampen implicit bias and build relationships.”

One potential limitation of this randomized controlled trial is that the providers were the same for both group and individual care, potentially causing some confounding, Dr. Pluym noted. But the study does have one clear clinical message, she said.

“My take away is more prenatal care is better – individual or group,” Dr. Pluym said. “Every clinic should evaluate their own structure and see if group care would be feasible for their patient population. There may be a benefit globally, but is it is not the ‘silver bullet,’ as they said, for lowering preterm birth or growth restriction.”

The research was funded by the Institute of Child Health and Development. The study researchers and Dr. Pluym reported no disclosures.

Group prenatal care did not reduce preterm birth among low-income patients compared to patients receiving individual prenatal care, but the different care models did shrink racial disparities in low-birth-weight and preterm births, according to a study presented Feb. 3 at the annual meeting sponsored by the Society for Maternal-Fetal Medicine. Patients who attended more group prenatal care visits also had better outcomes, reported Amy Crockett, MD, professor of ob.gyn. and director of the Maternal-Fetal Medicine Fellowship Program at the University of South Carolina in Greenville.

Though the results did not show group prenatal care to be the “silver bullet” they might have hoped for in reducing preterm birth and low birth weight among Black women, the study did show group prenatal care to have some clinical effect, Dr. Crockett suggested.

Ilina Pluym, MD, assistant professor of maternal-fetal medicine at the University of California Los Angeles, said that preterm birth and low birth weight are complex problems that cannot be solved by a single fix.

“In terms of the racial disparities, it is difficult to prove that 9 months of good access to prenatal care will undo the years of limited health care and life stressors that, as a whole, possibly contribute more to the overall risk profile of the patient,” Dr. Pluym said. “But as providers, we want to intervene and help in the portion that we can, and optimizing prenatal care is one tangible thing we can try.”

The racial disparities that exist in preterm birth, low birth weight, and infant and maternal mortality are not caused by biologic or genetic factors, Dr. Crockett told attendees.

”Rather, they are the result of long-standing systemic racism and discrimination deeply embedded in the culture of the United States,” she said. “To achieve racial equity, we need reform at the societal level.” But she noted that it might be possible for individual practices to play a role as well, which led her to design a study comparing outcomes from group versus individual prenatal care.

The group care model used for the study is called Centering Pregnancy, in which 8-10 pregnant patients who are due in the same month attend 10 two-hour prenatal care sessions together. Dr. Crockett noted that other research has identified potential reductions in preterm birth with group care models, but some are underpowered while others are observational and limited by confounding, selection bias, or small sample sizes.

The researchers aimed to recruit 3,160 patients to ensure an adequately powered study after estimated losses to follow-up, but they were able to recruit only 2,350 patients, resulting in potentially underpowered results. All the patients were receiving care at a single obstetric practice for a medically low-risk singleton pregnancy of 20 or fewer weeks gestation. A total of 1,176 patients were randomly assigned to attend group prenatal care appointments, and 1,174 patients were assigned to individual prenatal care.

The patients in both groups were an average age of 25 with a prepregnancy body mass index of 29. A similar proportion in both the group and individual care were married (24%) patients and had a government payer (96%-97%). Approximately 41%were Black patients, 37% were White patients, and 21% were Hispanic patients in both groups. Rates of chronic hypertension, smoking, vaginal infection in pregnancy, parity, cervix length, and use of cerclage were similar in both groups.

Gestational age outcomes were available for 1,099 group care patients (94%) and 1,120 individual care patients (95%), and birth weight outcomes were available for 1,028 group care patients (87%) and 1,044 individual care patients (89%).

In the individual care group, 8.7% of the patients had a preterm birth, compared to 10.4% who attended group prenatal care, but the findings did not reach significance (odds ratio [OR], 1.22; 95% confidence interval [CI]: 0.92-1.63). The difference between the 9.6% of group care patients and 8.9% of individual care patients who had babies with low birth weights were not significantly different.

While no significant difference in preterm birth occurred between the groups, the secondary outcome looking at racial disparities yielded one statistically significant result. Black women receiving individual prenatal care were twice as likely as were White women to have an infant with a low birth weight (OR, 2.1; 95% CI: 1.29-3.5). Among those receiving group care, however, the 12.5% of Black women and 8.9% of White women whose infants had a low birth weight were not significantly different.

There was a trend toward narrower disparities in preterm birth in the group versus individual care groups. Among those receiving group care, 11.4% of Black women and 10.8% of White women had a preterm birth, compared to 10.2% of Black women and 7.7% of White women in the individual care group.

Then the researchers compared the groups with regard to compliance while adjusting for baseline differences. “We saw decreasing rates of preterm birth for Black patients relative to White patients, particularly after attending five or more sessions in the group care arm with the rates of preterm birth narrowing and the disparity becoming nonsignificant with more exposure to group care,” Dr. Crockett said. “In individual care, the rate of preterm birth remained the highest for Black women regardless of the number of visits attended.”

The idea of trying group prenatal care is appealing, Dr. Pluym said in an interview, though both models have their advantages.

”The strength of individual care is the focus on the patient exam and individual patient questions,” Dr. Pluym said. “The strengths of group prenatal care are the consolidation of the patient education aspect of prenatal care that is uniform for all patients, the sense of community patients feel, and the opportunity to hear other patients questions that you may not have thought of. It sounds like, anecdotally, patients and providers really found the group sessions valuable and they helped dampen implicit bias and build relationships.”

One potential limitation of this randomized controlled trial is that the providers were the same for both group and individual care, potentially causing some confounding, Dr. Pluym noted. But the study does have one clear clinical message, she said.

“My take away is more prenatal care is better – individual or group,” Dr. Pluym said. “Every clinic should evaluate their own structure and see if group care would be feasible for their patient population. There may be a benefit globally, but is it is not the ‘silver bullet,’ as they said, for lowering preterm birth or growth restriction.”

The research was funded by the Institute of Child Health and Development. The study researchers and Dr. Pluym reported no disclosures.

From the American Medical Association to the Centers for Disease Control and Prevention, health equity is the topic de jour. But how do you get health professionals, lawmakers, lactation providers, and the community on the same page, especially when it comes to addressing breastfeeding disparities?

It depends on who you ask.

In Georgia, a 2018 lawsuit challenging a State Legislature Bill directed toward lactation providers sits on the desk of a trial court judge, with a decision due any day now. The bill requires these providers to be licensed in order to continue to practice and receive compensation, a move that not only threatens the health of mothers and infants, but also jeopardizes a key component of Healthy People 2030: improving breastfeeding initiation, duration, and exclusivity among African American women. A similar bill is in Committee in the New York State Legislature.

“If the Act takes effect, it will force an estimated 800 different practitioners out of business and leave only 162 International Board Certified Lactation Counselors (IBCLCs) for the whole state,” Jaimie Cavanaugh, an attorney at the Institute for Justice and plaintiff coattorney said in an interview.

Ms. Cavanaugh also said that geographical data for the 162 IBCLCs demonstrate that they primarily work in urban vs. rural areas, and mostly in formal settings, factors that will further exacerbate disparities and limit access to much needed resources.
 

Bridging the breastfeeding divide

While overall breastfeeding initiation rates in the United States have steadily increased over the past decade from 72% to roughly 84%, only a quarter of infants are exclusively breastfed through 6 months, a rate well below the Healthy People 2030 goal of 42.4% (and American Academy of Pediatrics recommendations). Comparatively, breastfeeding initiation (75.8%) and exclusivity (17.2%) rates among African-American women are considerably lower.

The effects are great: Breastfed infants have lower risks for asthma, obesity, and type 1 diabetes, while mothers who breastfeed have lower risks for hypertension, type 2 diabetes, and gynecological cancers. Notably, most of these conditions disproportionately affect African Americans, compared with Whites and other ethnicities.

A key to changing these disparities appears to lie with the type of health care provided as well as the ease by which mothers can access it.

For example, findings of a small cross-sectional study published Jan. 31 in the Journal of Racial and Ethnic Health Disparities highlight the importance of a broad umbrella of support for African American mothers’ feeding choices. Not only does this umbrella include medical professionals and IBCLCs, but also certified lactation counselors (CLCs), peer counselors trained under the National Special Supplemental Nutrition Program for Women, Infants, and Children, partners, family, and the community at-large.

“We thought we were doing it right,” Lydia Furman, MD, lead study author and pediatric specialist at University Hospitals Rainbow Babies & Children’s Ahuja Center for Women & Children in Cleveland, told this news organization. “We have a WIC peer helper, an African American IBCLC and an African American CLC, and a breastfeeding support group twice a week but nobody was using these resources.”

One of the most important findings of the study – which aimed to understand factors driving breastfeeding practices and identify supports – was that women want help when they need it. “It doesn’t mean that you can’t have resources that are available during the day, but it means that a patient support group at 11 a.m. on Tuesday doesn’t help at all if you need it Monday at 2 a.m.” Dr. Furman said.

Take TaNeeka Davis, a 34-year-old mother of three residing outside of Atlanta whose personal experience mimics those of the women in Dr. Furman’s study. “I did breastfeed my first child; when I was in the hospital. I saw lactation one time and he latched perfectly but when I left the hospital, I couldn’t get him to latch anymore,” she said.

Precious T. Photography, Atlanta

Ms. Davis explained that she was told that she would have to wait 2-3 weeks before she was able to meet again with a lactation specialist, so she found herself supplementing with formula, and eventually seeking nontraditional help.

“The traditional medical model does not allow for me to be able to reach out and talk to my doctor immediately, does not allow me to be like, ‘Hey, can you call me back in the next 15-20 minutes or an hour because my baby’s very fussy,’ ” Ms. Davis said. “I don’t have that kind of support.”
 

It takes a village

A 2017 Cochrane review reinforces the value of providing women with predictable, tailored, and multifaceted breastfeeding support offered by professional or lay/peer people or a combination of both.

This model is embodied in ROSE, a nonprofit organization dedicated to eliminating breastfeeding disparities and barriers experienced by mothers of color, including inadequate medical or family support, lack of shared decision-making, recognition of financial or psychological challenges, and historical antecedents. Many of these women’s ancestors were forced to wet-nurse slave masters’ children instead of breastfeeding their own children.

One of several national organizations solely dedicated to this issue, ROSE offers a variety of services and resources ranging from lactation counseling and peer support training programs to training for health professionals (for example, pediatricians, nurses) that serve communities of color. A companion arm (ROBE, Reaching Our Brothers Everywhere) aims to bring men into the fold through breastfeeding education and peer-to-peer connection. All of these services are provided in a judgment-free, culturally sensitive environment.

“We need to look not only into maternal health issues ... but also offer support to people who are working in the birthing community,” cofounder Mary N. Jackson, a CLC, WIC lactation consultant, and former president of the Georgia Breastfeeding Coalition said in an interview.

“We have Morehouse pediatricians coming to us just to talk to moms on how they can support them in the community. We have training – Community Transformers – where we talk to moms regardless of their social backgrounds; they’re working in the community helping other moms with breastfeeding, or moms will call them (with) their questions,” Ms. Jackson explained. Ms. Davis is now one of these women.

“Having the women of ROSE support me ... was such a game-changer,” she said. “Sometimes that support that you need, that is helpful, is peer-to-peer,” she noted, adding that ROSE does a lot more than fill in the gaps medically, but also psychologically.”
 

More pillars, less judgment

TaNeeka Davis pointed out that removing a pillar in the community like ROSE and other grassroots support outside of traditional models will likely have the opposite effect that lawmakers and the lobbyists fighting for certification and licensing aim to achieve, especially if other states adopt the same approach.

“The disparities are going to get even greater, you are going to see bigger gaps, less women even initiating breastfeeding. Why start something that you can’t finish? You can’t tell me that making laws that limit the amount of help we are able to get when it comes to breastfeeding will not have a detrimental effect – health effects – later in life,” she said.

Neither Ms. Jackson nor Ms. Davis believe that medical professionals should be replaced but rather that adjunctive, community-based help is integral for bridging the breastfeeding divide.

As clinicians, “we have to go beyond not judging to trying to figure out where people are, to meet your patients where they are,” said Dr. Furman. “It’s like the difference between cultural competence and cultural humility, which is more of an ongoing process.

Dr. Furman and Ms. Davis report no relevant financial relationships. Ms. Cavanaugh is the coattorney on the lawsuit. Ms. Jackson is employed by ROSE.

*This story was updated on Feb. 11, 2022.

From the American Medical Association to the Centers for Disease Control and Prevention, health equity is the topic de jour. But how do you get health professionals, lawmakers, lactation providers, and the community on the same page, especially when it comes to addressing breastfeeding disparities?

It depends on who you ask.

In Georgia, a 2018 lawsuit challenging a State Legislature Bill directed toward lactation providers sits on the desk of a trial court judge, with a decision due any day now. The bill requires these providers to be licensed in order to continue to practice and receive compensation, a move that not only threatens the health of mothers and infants, but also jeopardizes a key component of Healthy People 2030: improving breastfeeding initiation, duration, and exclusivity among African American women. A similar bill is in Committee in the New York State Legislature.

“If the Act takes effect, it will force an estimated 800 different practitioners out of business and leave only 162 International Board Certified Lactation Counselors (IBCLCs) for the whole state,” Jaimie Cavanaugh, an attorney at the Institute for Justice and plaintiff coattorney said in an interview.

Ms. Cavanaugh also said that geographical data for the 162 IBCLCs demonstrate that they primarily work in urban vs. rural areas, and mostly in formal settings, factors that will further exacerbate disparities and limit access to much needed resources.
 

Bridging the breastfeeding divide

While overall breastfeeding initiation rates in the United States have steadily increased over the past decade from 72% to roughly 84%, only a quarter of infants are exclusively breastfed through 6 months, a rate well below the Healthy People 2030 goal of 42.4% (and American Academy of Pediatrics recommendations). Comparatively, breastfeeding initiation (75.8%) and exclusivity (17.2%) rates among African-American women are considerably lower.

The effects are great: Breastfed infants have lower risks for asthma, obesity, and type 1 diabetes, while mothers who breastfeed have lower risks for hypertension, type 2 diabetes, and gynecological cancers. Notably, most of these conditions disproportionately affect African Americans, compared with Whites and other ethnicities.

A key to changing these disparities appears to lie with the type of health care provided as well as the ease by which mothers can access it.

For example, findings of a small cross-sectional study published Jan. 31 in the Journal of Racial and Ethnic Health Disparities highlight the importance of a broad umbrella of support for African American mothers’ feeding choices. Not only does this umbrella include medical professionals and IBCLCs, but also certified lactation counselors (CLCs), peer counselors trained under the National Special Supplemental Nutrition Program for Women, Infants, and Children, partners, family, and the community at-large.

“We thought we were doing it right,” Lydia Furman, MD, lead study author and pediatric specialist at University Hospitals Rainbow Babies & Children’s Ahuja Center for Women & Children in Cleveland, told this news organization. “We have a WIC peer helper, an African American IBCLC and an African American CLC, and a breastfeeding support group twice a week but nobody was using these resources.”

One of the most important findings of the study – which aimed to understand factors driving breastfeeding practices and identify supports – was that women want help when they need it. “It doesn’t mean that you can’t have resources that are available during the day, but it means that a patient support group at 11 a.m. on Tuesday doesn’t help at all if you need it Monday at 2 a.m.” Dr. Furman said.

Take TaNeeka Davis, a 34-year-old mother of three residing outside of Atlanta whose personal experience mimics those of the women in Dr. Furman’s study. “I did breastfeed my first child; when I was in the hospital. I saw lactation one time and he latched perfectly but when I left the hospital, I couldn’t get him to latch anymore,” she said.

Precious T. Photography, Atlanta

Ms. Davis explained that she was told that she would have to wait 2-3 weeks before she was able to meet again with a lactation specialist, so she found herself supplementing with formula, and eventually seeking nontraditional help.

“The traditional medical model does not allow for me to be able to reach out and talk to my doctor immediately, does not allow me to be like, ‘Hey, can you call me back in the next 15-20 minutes or an hour because my baby’s very fussy,’ ” Ms. Davis said. “I don’t have that kind of support.”
 

It takes a village

A 2017 Cochrane review reinforces the value of providing women with predictable, tailored, and multifaceted breastfeeding support offered by professional or lay/peer people or a combination of both.

This model is embodied in ROSE, a nonprofit organization dedicated to eliminating breastfeeding disparities and barriers experienced by mothers of color, including inadequate medical or family support, lack of shared decision-making, recognition of financial or psychological challenges, and historical antecedents. Many of these women’s ancestors were forced to wet-nurse slave masters’ children instead of breastfeeding their own children.

One of several national organizations solely dedicated to this issue, ROSE offers a variety of services and resources ranging from lactation counseling and peer support training programs to training for health professionals (for example, pediatricians, nurses) that serve communities of color. A companion arm (ROBE, Reaching Our Brothers Everywhere) aims to bring men into the fold through breastfeeding education and peer-to-peer connection. All of these services are provided in a judgment-free, culturally sensitive environment.

“We need to look not only into maternal health issues ... but also offer support to people who are working in the birthing community,” cofounder Mary N. Jackson, a CLC, WIC lactation consultant, and former president of the Georgia Breastfeeding Coalition said in an interview.

“We have Morehouse pediatricians coming to us just to talk to moms on how they can support them in the community. We have training – Community Transformers – where we talk to moms regardless of their social backgrounds; they’re working in the community helping other moms with breastfeeding, or moms will call them (with) their questions,” Ms. Jackson explained. Ms. Davis is now one of these women.

“Having the women of ROSE support me ... was such a game-changer,” she said. “Sometimes that support that you need, that is helpful, is peer-to-peer,” she noted, adding that ROSE does a lot more than fill in the gaps medically, but also psychologically.”
 

More pillars, less judgment

TaNeeka Davis pointed out that removing a pillar in the community like ROSE and other grassroots support outside of traditional models will likely have the opposite effect that lawmakers and the lobbyists fighting for certification and licensing aim to achieve, especially if other states adopt the same approach.

“The disparities are going to get even greater, you are going to see bigger gaps, less women even initiating breastfeeding. Why start something that you can’t finish? You can’t tell me that making laws that limit the amount of help we are able to get when it comes to breastfeeding will not have a detrimental effect – health effects – later in life,” she said.

Neither Ms. Jackson nor Ms. Davis believe that medical professionals should be replaced but rather that adjunctive, community-based help is integral for bridging the breastfeeding divide.

As clinicians, “we have to go beyond not judging to trying to figure out where people are, to meet your patients where they are,” said Dr. Furman. “It’s like the difference between cultural competence and cultural humility, which is more of an ongoing process.

Dr. Furman and Ms. Davis report no relevant financial relationships. Ms. Cavanaugh is the coattorney on the lawsuit. Ms. Jackson is employed by ROSE.

*This story was updated on Feb. 11, 2022.

From the American Medical Association to the Centers for Disease Control and Prevention, health equity is the topic de jour. But how do you get health professionals, lawmakers, lactation providers, and the community on the same page, especially when it comes to addressing breastfeeding disparities?

It depends on who you ask.

In Georgia, a 2018 lawsuit challenging a State Legislature Bill directed toward lactation providers sits on the desk of a trial court judge, with a decision due any day now. The bill requires these providers to be licensed in order to continue to practice and receive compensation, a move that not only threatens the health of mothers and infants, but also jeopardizes a key component of Healthy People 2030: improving breastfeeding initiation, duration, and exclusivity among African American women. A similar bill is in Committee in the New York State Legislature.

“If the Act takes effect, it will force an estimated 800 different practitioners out of business and leave only 162 International Board Certified Lactation Counselors (IBCLCs) for the whole state,” Jaimie Cavanaugh, an attorney at the Institute for Justice and plaintiff coattorney said in an interview.

Ms. Cavanaugh also said that geographical data for the 162 IBCLCs demonstrate that they primarily work in urban vs. rural areas, and mostly in formal settings, factors that will further exacerbate disparities and limit access to much needed resources.
 

Bridging the breastfeeding divide

While overall breastfeeding initiation rates in the United States have steadily increased over the past decade from 72% to roughly 84%, only a quarter of infants are exclusively breastfed through 6 months, a rate well below the Healthy People 2030 goal of 42.4% (and American Academy of Pediatrics recommendations). Comparatively, breastfeeding initiation (75.8%) and exclusivity (17.2%) rates among African-American women are considerably lower.

The effects are great: Breastfed infants have lower risks for asthma, obesity, and type 1 diabetes, while mothers who breastfeed have lower risks for hypertension, type 2 diabetes, and gynecological cancers. Notably, most of these conditions disproportionately affect African Americans, compared with Whites and other ethnicities.

A key to changing these disparities appears to lie with the type of health care provided as well as the ease by which mothers can access it.

For example, findings of a small cross-sectional study published Jan. 31 in the Journal of Racial and Ethnic Health Disparities highlight the importance of a broad umbrella of support for African American mothers’ feeding choices. Not only does this umbrella include medical professionals and IBCLCs, but also certified lactation counselors (CLCs), peer counselors trained under the National Special Supplemental Nutrition Program for Women, Infants, and Children, partners, family, and the community at-large.

“We thought we were doing it right,” Lydia Furman, MD, lead study author and pediatric specialist at University Hospitals Rainbow Babies & Children’s Ahuja Center for Women & Children in Cleveland, told this news organization. “We have a WIC peer helper, an African American IBCLC and an African American CLC, and a breastfeeding support group twice a week but nobody was using these resources.”

One of the most important findings of the study – which aimed to understand factors driving breastfeeding practices and identify supports – was that women want help when they need it. “It doesn’t mean that you can’t have resources that are available during the day, but it means that a patient support group at 11 a.m. on Tuesday doesn’t help at all if you need it Monday at 2 a.m.” Dr. Furman said.

Take TaNeeka Davis, a 34-year-old mother of three residing outside of Atlanta whose personal experience mimics those of the women in Dr. Furman’s study. “I did breastfeed my first child; when I was in the hospital. I saw lactation one time and he latched perfectly but when I left the hospital, I couldn’t get him to latch anymore,” she said.

Precious T. Photography, Atlanta

Ms. Davis explained that she was told that she would have to wait 2-3 weeks before she was able to meet again with a lactation specialist, so she found herself supplementing with formula, and eventually seeking nontraditional help.

“The traditional medical model does not allow for me to be able to reach out and talk to my doctor immediately, does not allow me to be like, ‘Hey, can you call me back in the next 15-20 minutes or an hour because my baby’s very fussy,’ ” Ms. Davis said. “I don’t have that kind of support.”
 

It takes a village

A 2017 Cochrane review reinforces the value of providing women with predictable, tailored, and multifaceted breastfeeding support offered by professional or lay/peer people or a combination of both.

This model is embodied in ROSE, a nonprofit organization dedicated to eliminating breastfeeding disparities and barriers experienced by mothers of color, including inadequate medical or family support, lack of shared decision-making, recognition of financial or psychological challenges, and historical antecedents. Many of these women’s ancestors were forced to wet-nurse slave masters’ children instead of breastfeeding their own children.

One of several national organizations solely dedicated to this issue, ROSE offers a variety of services and resources ranging from lactation counseling and peer support training programs to training for health professionals (for example, pediatricians, nurses) that serve communities of color. A companion arm (ROBE, Reaching Our Brothers Everywhere) aims to bring men into the fold through breastfeeding education and peer-to-peer connection. All of these services are provided in a judgment-free, culturally sensitive environment.

“We need to look not only into maternal health issues ... but also offer support to people who are working in the birthing community,” cofounder Mary N. Jackson, a CLC, WIC lactation consultant, and former president of the Georgia Breastfeeding Coalition said in an interview.

“We have Morehouse pediatricians coming to us just to talk to moms on how they can support them in the community. We have training – Community Transformers – where we talk to moms regardless of their social backgrounds; they’re working in the community helping other moms with breastfeeding, or moms will call them (with) their questions,” Ms. Jackson explained. Ms. Davis is now one of these women.

“Having the women of ROSE support me ... was such a game-changer,” she said. “Sometimes that support that you need, that is helpful, is peer-to-peer,” she noted, adding that ROSE does a lot more than fill in the gaps medically, but also psychologically.”
 

More pillars, less judgment

TaNeeka Davis pointed out that removing a pillar in the community like ROSE and other grassroots support outside of traditional models will likely have the opposite effect that lawmakers and the lobbyists fighting for certification and licensing aim to achieve, especially if other states adopt the same approach.

“The disparities are going to get even greater, you are going to see bigger gaps, less women even initiating breastfeeding. Why start something that you can’t finish? You can’t tell me that making laws that limit the amount of help we are able to get when it comes to breastfeeding will not have a detrimental effect – health effects – later in life,” she said.

Neither Ms. Jackson nor Ms. Davis believe that medical professionals should be replaced but rather that adjunctive, community-based help is integral for bridging the breastfeeding divide.

As clinicians, “we have to go beyond not judging to trying to figure out where people are, to meet your patients where they are,” said Dr. Furman. “It’s like the difference between cultural competence and cultural humility, which is more of an ongoing process.

Dr. Furman and Ms. Davis report no relevant financial relationships. Ms. Cavanaugh is the coattorney on the lawsuit. Ms. Jackson is employed by ROSE.

*This story was updated on Feb. 11, 2022.

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Engaging with a “chatbot,” a computer program that simulates human conversation, helps prevent eating disorders (EDs) in at-risk individuals, new research suggests.

Results of a randomized trial show that at-risk women who interacted with the chatbot showed lower concern about their weight and body shape compared to a wait-list control group.

“Chatbots are widely used in industry and have begun to be used in medical settings, although few studies have examined their effectiveness for mental health issues and none address EDs or ED prevention,” senior investigator C. Barr Taylor, MD, a research faculty member at Palo Alto (Calif.) University, said in a press release.

“We found that the group with access to the chatbot had a greater reduction in weight and shape concerns, both right after using it at 3 months and at the 6-month follow-up. The effects had sustainability over time, and we also found indication that the chatbot may reduce ED onset more so than the control group, where there was a greater incidence of EDs,” Dr. Taylor told this news organization.

The study was published online Dec. 28, 2021, in the International Journal of Eating Disorders.
 

Deadly disorders

“EDs are a common problem with huge risk factors; and, given how widespread they are, we need scalable tools that can reach a lot of people at low cost, reduce risk factors for developing an ED – which is the second most deadly of all psychiatric illnesses – so prevention is of the utmost importance,” Dr. Taylor said.

The investigators developed a targeted Internet-based preventive program called StudentBodies that utilizes cognitive-behavioral therapy approaches. The program was successful in reducing weight/shape concerns in women at high risk for the onset of an ED, and it reduced ED onset in the highest-risk women.

However, it required trained moderators who spent over 45 minutes with participants. Given the large number of people at risk for an ED who might benefit, the researchers noted that it is unlikely that a human-moderated version would be widely disseminated.

A chatbot may represent a “possible solution to reducing delivery costs” because it mimics aspects of human moderation in simulating conversations, the investigators noted.

“We wanted to take the earlier program we developed into this century and program it for delivery in this new format that would allow for bite-size pieces of information for the chatbot to communicate to the user,” lead author Ellen Fitzsimmons-Craft, PhD, assistant professor of psychiatry, Washington University, St. Louis, told this news organization.

“Our ED prevention online version was more effective when there was guidance from a human moderator who could provide feedback on progress, encourage you to go on, and apply the skills in daily life. But that’s not the most scalable. So we thought that a chatbot, in addition to providing content in this perhaps more engaging format, could also provide some aspect of human moderation, although the person is chatting with a robot,” added Dr. Fitzsimmons-Craft, associate director of the Center for Healthy Weight and Wellness.
 

Tessa will speak to you now

Participants (n = 700 women; mean [SD] age, 21.08 [3.09] years; 84.6% White; 53.8% heterosexual; 31.08% bisexual), were randomized to an intervention group or a wait-list control group (n = 352 and 348, respectively). There were no significant differences between groups in age, race, ethnicity, education, or sexual orientation.

The StudentBodies program was adapted for delivery via a chatbot named Tessa “while retaining the core intervention principles” and referred to as “Body Positive.”

It consisted of several components programmed into the chatbot, which initiated each conversation in a predetermined order. Participants were encouraged to engage in two conversations weekly. The program included an introduction and eight sessions as well as a crisis module that provided users with a referral to a crisis hotline in case of emergency. Referral was triggered on the basis of “recognized keywords,” such as “hurting myself.”

The researchers used the Weight Concerns Scale questionnaire to assess weight and shape concerns and the Internalization: Thin/Low Body Fat subscale of the Sociocultural Attitudes Toward Appearance Questionnaire–4 to “assess the cognitive aspect of thin-ideal internalization.”

Secondary outcomes tested the hypothesis that the chatbot would be more likely to reduce clinical outcomes (ED psychopathology, depression, and anxiety) and prevent ED onset, compared to the control condition.
 

Ready for prime time

At 3- and 6-month follow-up, there was significantly greater reduction in the intervention group compared with the control group in weight/shape concerns (d = -.20, P = .03 and d = -.19, P = .04, respectively), although there were no differences in thin-ideal internalization change.

The chatbot intervention was associated with significantly greater reductions in overall ED psychopathology at 3 months (d = -.29, P = .003) compared to the control condition, but not at 6 months.

Notably, the intervention group had significantly higher odds than the control group of remaining nonclinical for EDs at 3- and 6-month follow-up (OR, 2.37 [95% confidence interval, 1.37-4.11] and OR, 2.13 [95% CI,1.26-3.59], respectively).

“We were very excited about the study, and frankly, I was surprised by the effectiveness [of the chatbot intervention] because I didn’t think it would have as much of an impact as it did,” said Dr. Taylor. “Prevention gets short shrift everywhere, and I think we succeeded very well.”

Dr. Fitzsimmons-Craft added that the National Eating Disorders Association (NEDA) has agreed to make the chatbot available on its website for people who screen positive for having an ED or for being at high risk, and so their group is working with their industry partner, a company called X2AI, which developed the chatbot, to make this happen.

“This is definitely the fastest research-to-practice translation I’ve ever seen, where we can so quickly show that it works and make it available to tens of thousands almost immediately.”

Dr. Fitzsimmons-Craft is optimistic that it will be available to launch the week of Feb. 21, which is National Eating Disorders Week.
 

Innovative, creative research

Commenting on the research, Evelyn Attia, MD, professor of psychiatry, Columbia University Medical Center, and director of the Columbia Center for Eating Disorders New York–Presbyterian Hospital, New York, described the study as “innovative and creative.”

New York-Presbyterian Hospital

Dr. Attia, a member of the Research Advisory Council of the NEDA, noted that the structure of the study is “very preliminary” and that the comparison to a wait-list control makes it hard to know whether this is an effective intervention compared with other types of interventions, rather than compared with no intervention.

“But I’m sure that when the researchers are set up and primed to study this more robustly, they will consider a more active control intervention to see whether this preliminary finding holds up,” she said.

Also commenting on the study, Deborah R. Glasofer, PhD, associate professor of clinical medical psychology (in psychiatry), Columbia Center for Eating Disorders, said, “Higher-than-average concern about appearance – body shape, size, or weight – and a tightly held belief that it is ideal to be thin are known risk factors for the development of an eating disorder.

“This study offers an indication that technology can be leveraged to fill a gap and help folks before unhelpful and sometimes misguided thoughts about food, eating, and appearance evolve into a full-blown eating disorder,” said Dr. Glasofer, who was not involved with the study.

The study was supported by the NEDA Feeding Hope Fund, the National Institute of Mental Health, the National Heart, Lung, and Blood Institute, and the Swedish Research Council. The authors and Dr. Glasofer have disclosed no relevant financial relationships. Dr. Attia is on the board and the Research Advisory Council of NEDA.

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

Engaging with a “chatbot,” a computer program that simulates human conversation, helps prevent eating disorders (EDs) in at-risk individuals, new research suggests.

Results of a randomized trial show that at-risk women who interacted with the chatbot showed lower concern about their weight and body shape compared to a wait-list control group.

“Chatbots are widely used in industry and have begun to be used in medical settings, although few studies have examined their effectiveness for mental health issues and none address EDs or ED prevention,” senior investigator C. Barr Taylor, MD, a research faculty member at Palo Alto (Calif.) University, said in a press release.

“We found that the group with access to the chatbot had a greater reduction in weight and shape concerns, both right after using it at 3 months and at the 6-month follow-up. The effects had sustainability over time, and we also found indication that the chatbot may reduce ED onset more so than the control group, where there was a greater incidence of EDs,” Dr. Taylor told this news organization.

The study was published online Dec. 28, 2021, in the International Journal of Eating Disorders.
 

Deadly disorders

“EDs are a common problem with huge risk factors; and, given how widespread they are, we need scalable tools that can reach a lot of people at low cost, reduce risk factors for developing an ED – which is the second most deadly of all psychiatric illnesses – so prevention is of the utmost importance,” Dr. Taylor said.

The investigators developed a targeted Internet-based preventive program called StudentBodies that utilizes cognitive-behavioral therapy approaches. The program was successful in reducing weight/shape concerns in women at high risk for the onset of an ED, and it reduced ED onset in the highest-risk women.

However, it required trained moderators who spent over 45 minutes with participants. Given the large number of people at risk for an ED who might benefit, the researchers noted that it is unlikely that a human-moderated version would be widely disseminated.

A chatbot may represent a “possible solution to reducing delivery costs” because it mimics aspects of human moderation in simulating conversations, the investigators noted.

“We wanted to take the earlier program we developed into this century and program it for delivery in this new format that would allow for bite-size pieces of information for the chatbot to communicate to the user,” lead author Ellen Fitzsimmons-Craft, PhD, assistant professor of psychiatry, Washington University, St. Louis, told this news organization.

“Our ED prevention online version was more effective when there was guidance from a human moderator who could provide feedback on progress, encourage you to go on, and apply the skills in daily life. But that’s not the most scalable. So we thought that a chatbot, in addition to providing content in this perhaps more engaging format, could also provide some aspect of human moderation, although the person is chatting with a robot,” added Dr. Fitzsimmons-Craft, associate director of the Center for Healthy Weight and Wellness.
 

Tessa will speak to you now

Participants (n = 700 women; mean [SD] age, 21.08 [3.09] years; 84.6% White; 53.8% heterosexual; 31.08% bisexual), were randomized to an intervention group or a wait-list control group (n = 352 and 348, respectively). There were no significant differences between groups in age, race, ethnicity, education, or sexual orientation.

The StudentBodies program was adapted for delivery via a chatbot named Tessa “while retaining the core intervention principles” and referred to as “Body Positive.”

It consisted of several components programmed into the chatbot, which initiated each conversation in a predetermined order. Participants were encouraged to engage in two conversations weekly. The program included an introduction and eight sessions as well as a crisis module that provided users with a referral to a crisis hotline in case of emergency. Referral was triggered on the basis of “recognized keywords,” such as “hurting myself.”

The researchers used the Weight Concerns Scale questionnaire to assess weight and shape concerns and the Internalization: Thin/Low Body Fat subscale of the Sociocultural Attitudes Toward Appearance Questionnaire–4 to “assess the cognitive aspect of thin-ideal internalization.”

Secondary outcomes tested the hypothesis that the chatbot would be more likely to reduce clinical outcomes (ED psychopathology, depression, and anxiety) and prevent ED onset, compared to the control condition.
 

Ready for prime time

At 3- and 6-month follow-up, there was significantly greater reduction in the intervention group compared with the control group in weight/shape concerns (d = -.20, P = .03 and d = -.19, P = .04, respectively), although there were no differences in thin-ideal internalization change.

The chatbot intervention was associated with significantly greater reductions in overall ED psychopathology at 3 months (d = -.29, P = .003) compared to the control condition, but not at 6 months.

Notably, the intervention group had significantly higher odds than the control group of remaining nonclinical for EDs at 3- and 6-month follow-up (OR, 2.37 [95% confidence interval, 1.37-4.11] and OR, 2.13 [95% CI,1.26-3.59], respectively).

“We were very excited about the study, and frankly, I was surprised by the effectiveness [of the chatbot intervention] because I didn’t think it would have as much of an impact as it did,” said Dr. Taylor. “Prevention gets short shrift everywhere, and I think we succeeded very well.”

Dr. Fitzsimmons-Craft added that the National Eating Disorders Association (NEDA) has agreed to make the chatbot available on its website for people who screen positive for having an ED or for being at high risk, and so their group is working with their industry partner, a company called X2AI, which developed the chatbot, to make this happen.

“This is definitely the fastest research-to-practice translation I’ve ever seen, where we can so quickly show that it works and make it available to tens of thousands almost immediately.”

Dr. Fitzsimmons-Craft is optimistic that it will be available to launch the week of Feb. 21, which is National Eating Disorders Week.
 

Innovative, creative research

Commenting on the research, Evelyn Attia, MD, professor of psychiatry, Columbia University Medical Center, and director of the Columbia Center for Eating Disorders New York–Presbyterian Hospital, New York, described the study as “innovative and creative.”

New York-Presbyterian Hospital

Dr. Attia, a member of the Research Advisory Council of the NEDA, noted that the structure of the study is “very preliminary” and that the comparison to a wait-list control makes it hard to know whether this is an effective intervention compared with other types of interventions, rather than compared with no intervention.

“But I’m sure that when the researchers are set up and primed to study this more robustly, they will consider a more active control intervention to see whether this preliminary finding holds up,” she said.

Also commenting on the study, Deborah R. Glasofer, PhD, associate professor of clinical medical psychology (in psychiatry), Columbia Center for Eating Disorders, said, “Higher-than-average concern about appearance – body shape, size, or weight – and a tightly held belief that it is ideal to be thin are known risk factors for the development of an eating disorder.

“This study offers an indication that technology can be leveraged to fill a gap and help folks before unhelpful and sometimes misguided thoughts about food, eating, and appearance evolve into a full-blown eating disorder,” said Dr. Glasofer, who was not involved with the study.

The study was supported by the NEDA Feeding Hope Fund, the National Institute of Mental Health, the National Heart, Lung, and Blood Institute, and the Swedish Research Council. The authors and Dr. Glasofer have disclosed no relevant financial relationships. Dr. Attia is on the board and the Research Advisory Council of NEDA.

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

Engaging with a “chatbot,” a computer program that simulates human conversation, helps prevent eating disorders (EDs) in at-risk individuals, new research suggests.

Results of a randomized trial show that at-risk women who interacted with the chatbot showed lower concern about their weight and body shape compared to a wait-list control group.

“Chatbots are widely used in industry and have begun to be used in medical settings, although few studies have examined their effectiveness for mental health issues and none address EDs or ED prevention,” senior investigator C. Barr Taylor, MD, a research faculty member at Palo Alto (Calif.) University, said in a press release.

“We found that the group with access to the chatbot had a greater reduction in weight and shape concerns, both right after using it at 3 months and at the 6-month follow-up. The effects had sustainability over time, and we also found indication that the chatbot may reduce ED onset more so than the control group, where there was a greater incidence of EDs,” Dr. Taylor told this news organization.

The study was published online Dec. 28, 2021, in the International Journal of Eating Disorders.
 

Deadly disorders

“EDs are a common problem with huge risk factors; and, given how widespread they are, we need scalable tools that can reach a lot of people at low cost, reduce risk factors for developing an ED – which is the second most deadly of all psychiatric illnesses – so prevention is of the utmost importance,” Dr. Taylor said.

The investigators developed a targeted Internet-based preventive program called StudentBodies that utilizes cognitive-behavioral therapy approaches. The program was successful in reducing weight/shape concerns in women at high risk for the onset of an ED, and it reduced ED onset in the highest-risk women.

However, it required trained moderators who spent over 45 minutes with participants. Given the large number of people at risk for an ED who might benefit, the researchers noted that it is unlikely that a human-moderated version would be widely disseminated.

A chatbot may represent a “possible solution to reducing delivery costs” because it mimics aspects of human moderation in simulating conversations, the investigators noted.

“We wanted to take the earlier program we developed into this century and program it for delivery in this new format that would allow for bite-size pieces of information for the chatbot to communicate to the user,” lead author Ellen Fitzsimmons-Craft, PhD, assistant professor of psychiatry, Washington University, St. Louis, told this news organization.

“Our ED prevention online version was more effective when there was guidance from a human moderator who could provide feedback on progress, encourage you to go on, and apply the skills in daily life. But that’s not the most scalable. So we thought that a chatbot, in addition to providing content in this perhaps more engaging format, could also provide some aspect of human moderation, although the person is chatting with a robot,” added Dr. Fitzsimmons-Craft, associate director of the Center for Healthy Weight and Wellness.
 

Tessa will speak to you now

Participants (n = 700 women; mean [SD] age, 21.08 [3.09] years; 84.6% White; 53.8% heterosexual; 31.08% bisexual), were randomized to an intervention group or a wait-list control group (n = 352 and 348, respectively). There were no significant differences between groups in age, race, ethnicity, education, or sexual orientation.

The StudentBodies program was adapted for delivery via a chatbot named Tessa “while retaining the core intervention principles” and referred to as “Body Positive.”

It consisted of several components programmed into the chatbot, which initiated each conversation in a predetermined order. Participants were encouraged to engage in two conversations weekly. The program included an introduction and eight sessions as well as a crisis module that provided users with a referral to a crisis hotline in case of emergency. Referral was triggered on the basis of “recognized keywords,” such as “hurting myself.”

The researchers used the Weight Concerns Scale questionnaire to assess weight and shape concerns and the Internalization: Thin/Low Body Fat subscale of the Sociocultural Attitudes Toward Appearance Questionnaire–4 to “assess the cognitive aspect of thin-ideal internalization.”

Secondary outcomes tested the hypothesis that the chatbot would be more likely to reduce clinical outcomes (ED psychopathology, depression, and anxiety) and prevent ED onset, compared to the control condition.
 

Ready for prime time

At 3- and 6-month follow-up, there was significantly greater reduction in the intervention group compared with the control group in weight/shape concerns (d = -.20, P = .03 and d = -.19, P = .04, respectively), although there were no differences in thin-ideal internalization change.

The chatbot intervention was associated with significantly greater reductions in overall ED psychopathology at 3 months (d = -.29, P = .003) compared to the control condition, but not at 6 months.

Notably, the intervention group had significantly higher odds than the control group of remaining nonclinical for EDs at 3- and 6-month follow-up (OR, 2.37 [95% confidence interval, 1.37-4.11] and OR, 2.13 [95% CI,1.26-3.59], respectively).

“We were very excited about the study, and frankly, I was surprised by the effectiveness [of the chatbot intervention] because I didn’t think it would have as much of an impact as it did,” said Dr. Taylor. “Prevention gets short shrift everywhere, and I think we succeeded very well.”

Dr. Fitzsimmons-Craft added that the National Eating Disorders Association (NEDA) has agreed to make the chatbot available on its website for people who screen positive for having an ED or for being at high risk, and so their group is working with their industry partner, a company called X2AI, which developed the chatbot, to make this happen.

“This is definitely the fastest research-to-practice translation I’ve ever seen, where we can so quickly show that it works and make it available to tens of thousands almost immediately.”

Dr. Fitzsimmons-Craft is optimistic that it will be available to launch the week of Feb. 21, which is National Eating Disorders Week.
 

Innovative, creative research

Commenting on the research, Evelyn Attia, MD, professor of psychiatry, Columbia University Medical Center, and director of the Columbia Center for Eating Disorders New York–Presbyterian Hospital, New York, described the study as “innovative and creative.”

New York-Presbyterian Hospital

Dr. Attia, a member of the Research Advisory Council of the NEDA, noted that the structure of the study is “very preliminary” and that the comparison to a wait-list control makes it hard to know whether this is an effective intervention compared with other types of interventions, rather than compared with no intervention.

“But I’m sure that when the researchers are set up and primed to study this more robustly, they will consider a more active control intervention to see whether this preliminary finding holds up,” she said.

Also commenting on the study, Deborah R. Glasofer, PhD, associate professor of clinical medical psychology (in psychiatry), Columbia Center for Eating Disorders, said, “Higher-than-average concern about appearance – body shape, size, or weight – and a tightly held belief that it is ideal to be thin are known risk factors for the development of an eating disorder.

“This study offers an indication that technology can be leveraged to fill a gap and help folks before unhelpful and sometimes misguided thoughts about food, eating, and appearance evolve into a full-blown eating disorder,” said Dr. Glasofer, who was not involved with the study.

The study was supported by the NEDA Feeding Hope Fund, the National Institute of Mental Health, the National Heart, Lung, and Blood Institute, and the Swedish Research Council. The authors and Dr. Glasofer have disclosed no relevant financial relationships. Dr. Attia is on the board and the Research Advisory Council of NEDA.

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

Polycystic ovary syndrome is common in girls with type 2 diabetes, findings of a new study suggest, and authors say screening for PCOS is critical in this group.

In a systematic review and meta-analysis involving 470 girls (average age 12.9-16.1 years) with type 2 diabetes in six studies, the prevalence of PCOS was nearly 1 in 5 (19.58%; 95% confidence interval, 12.02%-27.14%; P = .002), substantially higher than that of PCOS in the general adolescent population.

PCOS, a complex endocrine disorder, occurs in 1.14%-11.04% of adolescent girls globally, according to the paper published online in JAMA Network Open.

The secondary outcome studied links to prevalence of PCOS with race and obesity.

Insulin resistance and compensatory hyperinsulinemia are present in 44%-70% of women with PCOS, suggesting that they are more likely to develop type 2 diabetes, according to the researchers led by Milena Cioana, BHSc, with the department of pediatrics, McMaster University, Hamilton, Ont.

Kelly A. Curran, MD, an assistant professor of pediatrics at the University of Oklahoma Health Sciences Center in Oklahoma City, where she practices adolescent medicine, said in an interview that it has been known that women with PCOS have higher rates of diabetes and many in the field have suspected the relationship is bidirectional.

“In my clinical practice, I’ve seen a high percentage of women with type 2 diabetes present with irregular menses, some of whom have gone on to be diagnosed with PCOS,” said Dr. Curran, who was not involved with the study.

However, she said, she was surprised the prevalence of PCOS reported in this paper – nearly one in five – was so high. Early diagnosis is important for PCOS to prevent complications such as hypertension, hyperglycemia, and dyslipidemia.

Psychiatric conditions are also prevalent in patients with PCOS, including anxiety (18%), depression (16%), and ADHD (9%).

Dr. Curran agreed there is a need to screen for PCOS and to evaluate for other causes of irregular periods in patients with type 2 diabetes.

“Menstrual irregularities are often overlooked in young women without further work-up, especially in patients who have chronic illnesses,” she noted.
 

Results come with a caveat

However, the authors said, results should be viewed with caution because “studies including the larger numbers of girls did not report the criteria used to diagnose PCOS, which is a challenge during adolescence.”

Diagnostic criteria for PCOS during adolescence include the combination of menstrual irregularities according to time since their first period and clinical or biochemical hyperandrogenism after excluding other potential causes.

Dr. Curran explained that PCOS symptoms include irregular periods and acne which can overlap with normal changes in puberty. In her experience, PCOS is often diagnosed without patients meeting full criteria. She agreed further research with standardized criteria is urgently needed.

The European Society of Human Reproduction and Embryology/American Society of Reproductive Medicine, the Pediatric Endocrine Society, and the International Consortium of Paediatric Endocrinology guidelines suggest that using ultrasound to check the size of ovaries could help diagnose PCOS, but other guidelines are more conservative, the authors noted.

They added that “there is a need for a consensus to establish the pediatric criteria for diagnosing PCOS in adolescents to ensure accurate diagnosis and lower the misclassification rates.”
 

Assessing links to obesity and race

Still unclear, the authors wrote, is whether and how obesity and race affect prevalence of PCOS among girls with type 2 diabetes.

The authors wrote: “Although earlier studies suggested that obesity-related insulin resistance and hyperinsulinemia can contribute to PCOS pathogenesis, insulin resistance in patients with PCOS may be present independently of [body mass index]. Obesity seems to increase the risk of PCOS only slightly and might represent a referral bias for PCOS.”

Few studies included in the meta-analysis had race-specific data, so the authors were limited in assessing associations between race and PCOS prevalence.

“However,” they wrote, “our data demonstrate that Indian girls had the highest prevalence, followed by White girls, and then Indigenous girls in Canada.”

Further studies are needed to help define at-risk subgroups and evaluate treatment strategies, the authors noted.

They reported having no relevant financial relationships. Dr. Curran had no conflicts of interest.

Polycystic ovary syndrome is common in girls with type 2 diabetes, findings of a new study suggest, and authors say screening for PCOS is critical in this group.

In a systematic review and meta-analysis involving 470 girls (average age 12.9-16.1 years) with type 2 diabetes in six studies, the prevalence of PCOS was nearly 1 in 5 (19.58%; 95% confidence interval, 12.02%-27.14%; P = .002), substantially higher than that of PCOS in the general adolescent population.

PCOS, a complex endocrine disorder, occurs in 1.14%-11.04% of adolescent girls globally, according to the paper published online in JAMA Network Open.

The secondary outcome studied links to prevalence of PCOS with race and obesity.

Insulin resistance and compensatory hyperinsulinemia are present in 44%-70% of women with PCOS, suggesting that they are more likely to develop type 2 diabetes, according to the researchers led by Milena Cioana, BHSc, with the department of pediatrics, McMaster University, Hamilton, Ont.

Kelly A. Curran, MD, an assistant professor of pediatrics at the University of Oklahoma Health Sciences Center in Oklahoma City, where she practices adolescent medicine, said in an interview that it has been known that women with PCOS have higher rates of diabetes and many in the field have suspected the relationship is bidirectional.

“In my clinical practice, I’ve seen a high percentage of women with type 2 diabetes present with irregular menses, some of whom have gone on to be diagnosed with PCOS,” said Dr. Curran, who was not involved with the study.

However, she said, she was surprised the prevalence of PCOS reported in this paper – nearly one in five – was so high. Early diagnosis is important for PCOS to prevent complications such as hypertension, hyperglycemia, and dyslipidemia.

Psychiatric conditions are also prevalent in patients with PCOS, including anxiety (18%), depression (16%), and ADHD (9%).

Dr. Curran agreed there is a need to screen for PCOS and to evaluate for other causes of irregular periods in patients with type 2 diabetes.

“Menstrual irregularities are often overlooked in young women without further work-up, especially in patients who have chronic illnesses,” she noted.
 

Results come with a caveat

However, the authors said, results should be viewed with caution because “studies including the larger numbers of girls did not report the criteria used to diagnose PCOS, which is a challenge during adolescence.”

Diagnostic criteria for PCOS during adolescence include the combination of menstrual irregularities according to time since their first period and clinical or biochemical hyperandrogenism after excluding other potential causes.

Dr. Curran explained that PCOS symptoms include irregular periods and acne which can overlap with normal changes in puberty. In her experience, PCOS is often diagnosed without patients meeting full criteria. She agreed further research with standardized criteria is urgently needed.

The European Society of Human Reproduction and Embryology/American Society of Reproductive Medicine, the Pediatric Endocrine Society, and the International Consortium of Paediatric Endocrinology guidelines suggest that using ultrasound to check the size of ovaries could help diagnose PCOS, but other guidelines are more conservative, the authors noted.

They added that “there is a need for a consensus to establish the pediatric criteria for diagnosing PCOS in adolescents to ensure accurate diagnosis and lower the misclassification rates.”
 

Assessing links to obesity and race

Still unclear, the authors wrote, is whether and how obesity and race affect prevalence of PCOS among girls with type 2 diabetes.

The authors wrote: “Although earlier studies suggested that obesity-related insulin resistance and hyperinsulinemia can contribute to PCOS pathogenesis, insulin resistance in patients with PCOS may be present independently of [body mass index]. Obesity seems to increase the risk of PCOS only slightly and might represent a referral bias for PCOS.”

Few studies included in the meta-analysis had race-specific data, so the authors were limited in assessing associations between race and PCOS prevalence.

“However,” they wrote, “our data demonstrate that Indian girls had the highest prevalence, followed by White girls, and then Indigenous girls in Canada.”

Further studies are needed to help define at-risk subgroups and evaluate treatment strategies, the authors noted.

They reported having no relevant financial relationships. Dr. Curran had no conflicts of interest.

Polycystic ovary syndrome is common in girls with type 2 diabetes, findings of a new study suggest, and authors say screening for PCOS is critical in this group.

In a systematic review and meta-analysis involving 470 girls (average age 12.9-16.1 years) with type 2 diabetes in six studies, the prevalence of PCOS was nearly 1 in 5 (19.58%; 95% confidence interval, 12.02%-27.14%; P = .002), substantially higher than that of PCOS in the general adolescent population.

PCOS, a complex endocrine disorder, occurs in 1.14%-11.04% of adolescent girls globally, according to the paper published online in JAMA Network Open.

The secondary outcome studied links to prevalence of PCOS with race and obesity.

Insulin resistance and compensatory hyperinsulinemia are present in 44%-70% of women with PCOS, suggesting that they are more likely to develop type 2 diabetes, according to the researchers led by Milena Cioana, BHSc, with the department of pediatrics, McMaster University, Hamilton, Ont.

Kelly A. Curran, MD, an assistant professor of pediatrics at the University of Oklahoma Health Sciences Center in Oklahoma City, where she practices adolescent medicine, said in an interview that it has been known that women with PCOS have higher rates of diabetes and many in the field have suspected the relationship is bidirectional.

“In my clinical practice, I’ve seen a high percentage of women with type 2 diabetes present with irregular menses, some of whom have gone on to be diagnosed with PCOS,” said Dr. Curran, who was not involved with the study.

However, she said, she was surprised the prevalence of PCOS reported in this paper – nearly one in five – was so high. Early diagnosis is important for PCOS to prevent complications such as hypertension, hyperglycemia, and dyslipidemia.

Psychiatric conditions are also prevalent in patients with PCOS, including anxiety (18%), depression (16%), and ADHD (9%).

Dr. Curran agreed there is a need to screen for PCOS and to evaluate for other causes of irregular periods in patients with type 2 diabetes.

“Menstrual irregularities are often overlooked in young women without further work-up, especially in patients who have chronic illnesses,” she noted.
 

Results come with a caveat

However, the authors said, results should be viewed with caution because “studies including the larger numbers of girls did not report the criteria used to diagnose PCOS, which is a challenge during adolescence.”

Diagnostic criteria for PCOS during adolescence include the combination of menstrual irregularities according to time since their first period and clinical or biochemical hyperandrogenism after excluding other potential causes.

Dr. Curran explained that PCOS symptoms include irregular periods and acne which can overlap with normal changes in puberty. In her experience, PCOS is often diagnosed without patients meeting full criteria. She agreed further research with standardized criteria is urgently needed.

The European Society of Human Reproduction and Embryology/American Society of Reproductive Medicine, the Pediatric Endocrine Society, and the International Consortium of Paediatric Endocrinology guidelines suggest that using ultrasound to check the size of ovaries could help diagnose PCOS, but other guidelines are more conservative, the authors noted.

They added that “there is a need for a consensus to establish the pediatric criteria for diagnosing PCOS in adolescents to ensure accurate diagnosis and lower the misclassification rates.”
 

Assessing links to obesity and race

Still unclear, the authors wrote, is whether and how obesity and race affect prevalence of PCOS among girls with type 2 diabetes.

The authors wrote: “Although earlier studies suggested that obesity-related insulin resistance and hyperinsulinemia can contribute to PCOS pathogenesis, insulin resistance in patients with PCOS may be present independently of [body mass index]. Obesity seems to increase the risk of PCOS only slightly and might represent a referral bias for PCOS.”

Few studies included in the meta-analysis had race-specific data, so the authors were limited in assessing associations between race and PCOS prevalence.

“However,” they wrote, “our data demonstrate that Indian girls had the highest prevalence, followed by White girls, and then Indigenous girls in Canada.”

Further studies are needed to help define at-risk subgroups and evaluate treatment strategies, the authors noted.

They reported having no relevant financial relationships. Dr. Curran had no conflicts of interest.

As an Advanced Practice Provider, when and why might a patient with uterine fibroids be scheduled to visit with you?

Ms. Haibach: Typically, with the flow of how our practice runs, a patient would schedule with me as an initial visit to explore their abnormal or heavy bleeding. Oftentimes, a patient is unsure with what they have going on medically and will view APPs as a safe place to start. Other times, I will see a patient for a general wellness exam who will mention heavier menses over the years or just a change in their bleeding pattern-- longer flow, things like that.

It may stem from something that seems out of the ordinary for them or a symptom impacting their life. For example, if a patient says, “I have to run home and change my clothes,” or “I'm bleeding through my bed sheets.” Those statements prompt further evaluation. At times, patients who have already been diagnosed with fibroids, will come to see me if they have chosen medical management over surgical management of their fibroids. They continue to follow up with me to reevaluate the success of their treatment plan periodically. So, whether I start them on a plan, or a physician does, they can follow up with me to revisit their medical plan and ensure it remains appropriate.

You touched on this a bit, but can you dive deeper into exactly what you are looking for as part of that visit? 

Ms. Haibach: Definitely. With an initial consult to me, the number one question that I would ask my patients first is, what is your most bothersome symptom? With this question, I'm looking to determine: is it pain that brought you to me? Is it heavy bleeding? Do you feel bulk and bloaty? Are you having issues getting pregnant? Do you have bowel or bladder issues?

The information I get from that one initial question, helps guide the remainder of my visit. If bleeding is the main concern, we would focus on getting that under control. So, we need to suppress the menses with medication options. If bulk and bloating is the main concern, for instance the patient feels like they have a pregnant-looking abdomen, typically surgical options are warranted. If the main complaint is infertility, we do have fertility specialists in our practice who remove fibroids to aid patients in achieving pregnancy.

The most important purpose of this visit is to really listen to the patient to find out how these symptoms are impacting their daily lives. From there, I can use that information to guide my treatment plan.

So, once it is determined that the patient is a good surgical candidate, what would be the next steps?

Ms. Haibach: If at the end of my visit, I determine that a patient is potentially a suitable surgical candidate, the first thing I would do is order appropriate imaging. For example, if the patient is interested in uterine preservation for future fertility, she is likely going to opt for a laparoscopic myomectomy, where fibroids would be removed, and her uterus would be left in place. In that case, she would require an MRI for fibroid mapping. If a woman has completed childbearing, then oftentimes a pelvic ultrasound would suffice, at least to start, since she'd likely elect hysterectomy if she has reached her fertility goals.

I would also perform an endometrial biopsy to rule out malignant process before going into surgery. To optimize a patient for our MIGS surgeons, I gather a thorough medical history to ensure their comorbidities are appropriately managed. For example, diabetes is under control, sleep apnea is being treated, no active infections. If there is anything else going on that needs to be addressed, I'd refer them to the appropriate provider first.

Once I have acceptable imaging, a negative endometrial biopsy and an adequate medical history, I would then assist the patient in scheduling with one of the surgeons on my team for a consult and physical exam to determine surgery planning. Once they see our physician, a surgery date is booked. The patient would come back to see me within 30 days of surgery, and we would do a preoperative education appointment. I see them again 2 weeks after surgery for a post-op visit. We’d perform the post-of visit virtually in our practice. We would see the patient sooner if there are any other concerns that arise post-operatively.

What if the patient is not a surgical candidate? How do you as an APP assist in ongoing medical management?

Ms. Haibach: The presence of fibroids alone, without symptoms, often does not require surgical intervention. There are occasions where a patient is, for example, seen in the emergency room for abdominal pain, whereas they’ll get a CT scan of the abdomen pelvis, and a fibroid is incidentally found. At that point, they are instructed to see gynecology for follow-up. If the patient was unaware of the fibroid, has no symptoms and there's no concerning imaging features, then management with ongoing surveillance (repeat imaging and office follow up) and instructions on when to return is usually appropriate.

Depending on the symptoms, medical management typically includes hormonal suppression of menses in the form of a birth control pill or an IUD. If bleeding is the main concern, it is my goal to at least slow her bleeding, if not try to stop it. Not all women are good candidates for hormone therapy, so there is a medication option that is non-hormonal. In my role, I would start a medication plan for a patient and initiate a new medication such as hormonal suppression in the form of birth control, IUD, non-hormonal medications etc.

Typically, when I do that, I'll have the patient follow up with me in about two to three months to reassess the medication’s effectiveness. The goal of the reassessment is to determine if it is working for her life, to be sure there are no major side-effects, and just to make sure she is amenable to the plan. As part of the medical management, sometimes it is necessary to monitor blood counts for anemia to be certain that medical management is still appropriate for her.

From your experience in practicing, are you more likely to be visited by one age bracket or ethnicity over another? 

Ms. Haibach: Actually, data tells us that most fibroids occur in women of reproductive age. They are also diagnosed in African American women two to three times more frequently than in white women. Fibroids are infrequently seen in premenstrual women. A relief of symptoms of the fibroids often occurs at the time of menopause, when the menstrual cyclicity seizes and steroid hormone levels decrease. My demographic is consistent with the above statistics. I tend to see women within the ages of  20’s-50’s and more often African Americans.

Was there anything else that you'd like to mention?

Ms. Haibach: Abnormal bleeding can be very stressful for women. APPs are a great place to start an abnormal bleeding or fibroid work-up. Patients should rest assure that although we cannot perform surgery, APPs can help get them in the right direction for the best care possible.

As an Advanced Practice Provider, when and why might a patient with uterine fibroids be scheduled to visit with you?

Ms. Haibach: Typically, with the flow of how our practice runs, a patient would schedule with me as an initial visit to explore their abnormal or heavy bleeding. Oftentimes, a patient is unsure with what they have going on medically and will view APPs as a safe place to start. Other times, I will see a patient for a general wellness exam who will mention heavier menses over the years or just a change in their bleeding pattern-- longer flow, things like that.

It may stem from something that seems out of the ordinary for them or a symptom impacting their life. For example, if a patient says, “I have to run home and change my clothes,” or “I'm bleeding through my bed sheets.” Those statements prompt further evaluation. At times, patients who have already been diagnosed with fibroids, will come to see me if they have chosen medical management over surgical management of their fibroids. They continue to follow up with me to reevaluate the success of their treatment plan periodically. So, whether I start them on a plan, or a physician does, they can follow up with me to revisit their medical plan and ensure it remains appropriate.

You touched on this a bit, but can you dive deeper into exactly what you are looking for as part of that visit? 

Ms. Haibach: Definitely. With an initial consult to me, the number one question that I would ask my patients first is, what is your most bothersome symptom? With this question, I'm looking to determine: is it pain that brought you to me? Is it heavy bleeding? Do you feel bulk and bloaty? Are you having issues getting pregnant? Do you have bowel or bladder issues?

The information I get from that one initial question, helps guide the remainder of my visit. If bleeding is the main concern, we would focus on getting that under control. So, we need to suppress the menses with medication options. If bulk and bloating is the main concern, for instance the patient feels like they have a pregnant-looking abdomen, typically surgical options are warranted. If the main complaint is infertility, we do have fertility specialists in our practice who remove fibroids to aid patients in achieving pregnancy.

The most important purpose of this visit is to really listen to the patient to find out how these symptoms are impacting their daily lives. From there, I can use that information to guide my treatment plan.

So, once it is determined that the patient is a good surgical candidate, what would be the next steps?

Ms. Haibach: If at the end of my visit, I determine that a patient is potentially a suitable surgical candidate, the first thing I would do is order appropriate imaging. For example, if the patient is interested in uterine preservation for future fertility, she is likely going to opt for a laparoscopic myomectomy, where fibroids would be removed, and her uterus would be left in place. In that case, she would require an MRI for fibroid mapping. If a woman has completed childbearing, then oftentimes a pelvic ultrasound would suffice, at least to start, since she'd likely elect hysterectomy if she has reached her fertility goals.

I would also perform an endometrial biopsy to rule out malignant process before going into surgery. To optimize a patient for our MIGS surgeons, I gather a thorough medical history to ensure their comorbidities are appropriately managed. For example, diabetes is under control, sleep apnea is being treated, no active infections. If there is anything else going on that needs to be addressed, I'd refer them to the appropriate provider first.

Once I have acceptable imaging, a negative endometrial biopsy and an adequate medical history, I would then assist the patient in scheduling with one of the surgeons on my team for a consult and physical exam to determine surgery planning. Once they see our physician, a surgery date is booked. The patient would come back to see me within 30 days of surgery, and we would do a preoperative education appointment. I see them again 2 weeks after surgery for a post-op visit. We’d perform the post-of visit virtually in our practice. We would see the patient sooner if there are any other concerns that arise post-operatively.

What if the patient is not a surgical candidate? How do you as an APP assist in ongoing medical management?

Ms. Haibach: The presence of fibroids alone, without symptoms, often does not require surgical intervention. There are occasions where a patient is, for example, seen in the emergency room for abdominal pain, whereas they’ll get a CT scan of the abdomen pelvis, and a fibroid is incidentally found. At that point, they are instructed to see gynecology for follow-up. If the patient was unaware of the fibroid, has no symptoms and there's no concerning imaging features, then management with ongoing surveillance (repeat imaging and office follow up) and instructions on when to return is usually appropriate.

Depending on the symptoms, medical management typically includes hormonal suppression of menses in the form of a birth control pill or an IUD. If bleeding is the main concern, it is my goal to at least slow her bleeding, if not try to stop it. Not all women are good candidates for hormone therapy, so there is a medication option that is non-hormonal. In my role, I would start a medication plan for a patient and initiate a new medication such as hormonal suppression in the form of birth control, IUD, non-hormonal medications etc.

Typically, when I do that, I'll have the patient follow up with me in about two to three months to reassess the medication’s effectiveness. The goal of the reassessment is to determine if it is working for her life, to be sure there are no major side-effects, and just to make sure she is amenable to the plan. As part of the medical management, sometimes it is necessary to monitor blood counts for anemia to be certain that medical management is still appropriate for her.

From your experience in practicing, are you more likely to be visited by one age bracket or ethnicity over another? 

Ms. Haibach: Actually, data tells us that most fibroids occur in women of reproductive age. They are also diagnosed in African American women two to three times more frequently than in white women. Fibroids are infrequently seen in premenstrual women. A relief of symptoms of the fibroids often occurs at the time of menopause, when the menstrual cyclicity seizes and steroid hormone levels decrease. My demographic is consistent with the above statistics. I tend to see women within the ages of  20’s-50’s and more often African Americans.

Was there anything else that you'd like to mention?

Ms. Haibach: Abnormal bleeding can be very stressful for women. APPs are a great place to start an abnormal bleeding or fibroid work-up. Patients should rest assure that although we cannot perform surgery, APPs can help get them in the right direction for the best care possible.

As an Advanced Practice Provider, when and why might a patient with uterine fibroids be scheduled to visit with you?

Ms. Haibach: Typically, with the flow of how our practice runs, a patient would schedule with me as an initial visit to explore their abnormal or heavy bleeding. Oftentimes, a patient is unsure with what they have going on medically and will view APPs as a safe place to start. Other times, I will see a patient for a general wellness exam who will mention heavier menses over the years or just a change in their bleeding pattern-- longer flow, things like that.

It may stem from something that seems out of the ordinary for them or a symptom impacting their life. For example, if a patient says, “I have to run home and change my clothes,” or “I'm bleeding through my bed sheets.” Those statements prompt further evaluation. At times, patients who have already been diagnosed with fibroids, will come to see me if they have chosen medical management over surgical management of their fibroids. They continue to follow up with me to reevaluate the success of their treatment plan periodically. So, whether I start them on a plan, or a physician does, they can follow up with me to revisit their medical plan and ensure it remains appropriate.

You touched on this a bit, but can you dive deeper into exactly what you are looking for as part of that visit? 

Ms. Haibach: Definitely. With an initial consult to me, the number one question that I would ask my patients first is, what is your most bothersome symptom? With this question, I'm looking to determine: is it pain that brought you to me? Is it heavy bleeding? Do you feel bulk and bloaty? Are you having issues getting pregnant? Do you have bowel or bladder issues?

The information I get from that one initial question, helps guide the remainder of my visit. If bleeding is the main concern, we would focus on getting that under control. So, we need to suppress the menses with medication options. If bulk and bloating is the main concern, for instance the patient feels like they have a pregnant-looking abdomen, typically surgical options are warranted. If the main complaint is infertility, we do have fertility specialists in our practice who remove fibroids to aid patients in achieving pregnancy.

The most important purpose of this visit is to really listen to the patient to find out how these symptoms are impacting their daily lives. From there, I can use that information to guide my treatment plan.

So, once it is determined that the patient is a good surgical candidate, what would be the next steps?

Ms. Haibach: If at the end of my visit, I determine that a patient is potentially a suitable surgical candidate, the first thing I would do is order appropriate imaging. For example, if the patient is interested in uterine preservation for future fertility, she is likely going to opt for a laparoscopic myomectomy, where fibroids would be removed, and her uterus would be left in place. In that case, she would require an MRI for fibroid mapping. If a woman has completed childbearing, then oftentimes a pelvic ultrasound would suffice, at least to start, since she'd likely elect hysterectomy if she has reached her fertility goals.

I would also perform an endometrial biopsy to rule out malignant process before going into surgery. To optimize a patient for our MIGS surgeons, I gather a thorough medical history to ensure their comorbidities are appropriately managed. For example, diabetes is under control, sleep apnea is being treated, no active infections. If there is anything else going on that needs to be addressed, I'd refer them to the appropriate provider first.

Once I have acceptable imaging, a negative endometrial biopsy and an adequate medical history, I would then assist the patient in scheduling with one of the surgeons on my team for a consult and physical exam to determine surgery planning. Once they see our physician, a surgery date is booked. The patient would come back to see me within 30 days of surgery, and we would do a preoperative education appointment. I see them again 2 weeks after surgery for a post-op visit. We’d perform the post-of visit virtually in our practice. We would see the patient sooner if there are any other concerns that arise post-operatively.

What if the patient is not a surgical candidate? How do you as an APP assist in ongoing medical management?

Ms. Haibach: The presence of fibroids alone, without symptoms, often does not require surgical intervention. There are occasions where a patient is, for example, seen in the emergency room for abdominal pain, whereas they’ll get a CT scan of the abdomen pelvis, and a fibroid is incidentally found. At that point, they are instructed to see gynecology for follow-up. If the patient was unaware of the fibroid, has no symptoms and there's no concerning imaging features, then management with ongoing surveillance (repeat imaging and office follow up) and instructions on when to return is usually appropriate.

Depending on the symptoms, medical management typically includes hormonal suppression of menses in the form of a birth control pill or an IUD. If bleeding is the main concern, it is my goal to at least slow her bleeding, if not try to stop it. Not all women are good candidates for hormone therapy, so there is a medication option that is non-hormonal. In my role, I would start a medication plan for a patient and initiate a new medication such as hormonal suppression in the form of birth control, IUD, non-hormonal medications etc.

Typically, when I do that, I'll have the patient follow up with me in about two to three months to reassess the medication’s effectiveness. The goal of the reassessment is to determine if it is working for her life, to be sure there are no major side-effects, and just to make sure she is amenable to the plan. As part of the medical management, sometimes it is necessary to monitor blood counts for anemia to be certain that medical management is still appropriate for her.

From your experience in practicing, are you more likely to be visited by one age bracket or ethnicity over another? 

Ms. Haibach: Actually, data tells us that most fibroids occur in women of reproductive age. They are also diagnosed in African American women two to three times more frequently than in white women. Fibroids are infrequently seen in premenstrual women. A relief of symptoms of the fibroids often occurs at the time of menopause, when the menstrual cyclicity seizes and steroid hormone levels decrease. My demographic is consistent with the above statistics. I tend to see women within the ages of  20’s-50’s and more often African Americans.

Was there anything else that you'd like to mention?

Ms. Haibach: Abnormal bleeding can be very stressful for women. APPs are a great place to start an abnormal bleeding or fibroid work-up. Patients should rest assure that although we cannot perform surgery, APPs can help get them in the right direction for the best care possible.