Women's Health

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

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

In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

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

In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

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

Policies increasing access to immediate postpartum long-acting reversible contraception (LARC) were associated with reductions in preterm birth and low birth weight, based on data from South Carolina’s Medicaid program.

Preterm birth and low birth weight represent the second-leading cause of infant mortality in the United States, wrote Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues. Previous policy interventions to reduce preterm birth and low birth weight have focused on services before and during pregnancy, they said. LARC is a safe and effective postpartum intervention, but cost has been a limiting factor, they noted.

In 2012, the Medicaid program in South Carolina began reimbursing hospitals for immediate postpartum LARC independent of global maternity payments. In a previous study, the researchers found that the implementation of this policy had reduced the number of short-interval births among adolescents.

The goal of the current study, published in JAMA Pediatrics, was to analyze the association between South Carolina’s policy change and rates of preterm birth and low birth weight among individuals with Medicaid coverage during childbirth. The researchers analyzed data from 186,953 Medicaid-paid births between January 2009 and December 2015 in South Carolina. Of these, 46,414 births (24.8%) occurred in hospitals that provided immediate postpartum LARC in response to the policy change. Overall, the implementing hospitals had more annual births paid for by Medicaid compared to nonimplementing hospitals (1,105 vs. 511) and were less likely to be rural (33.3% vs. 46.8%) and had a greater share of preterm births (15.5% vs. 9.5%). Prior to the policy change, the probability of a preterm birth in the next 4 years was 4.4% for patients at implementing hospitals and 3.5% for those in nonimplementing hospitals, and the probability of a low-birth-weight birth was 3.6% and 2.9%, respectively.

The policy change was associated with a decrease of 0.4 percentage points for preterm birth and 0.3 percentage points for subsequent low-birth-weight birth.

When the results were stratified based on race and ethnicity, the policy change was associated with a decrease of 0.5 percentage points in the probability of preterm birth in both non-Hispanic Blacks and non-Hispanic Whites. No significant differences appeared in the association between the policy change and rates of preterm birth or low-birth-weight birth between non-Hispanic Black and non-Hispanic White individuals.

However, the policy was associated with a significant decrease of 0.6 percentage points in the probability of short-interval birth among non-Hispanic Blacks, and a decrease of 1.6 percentage points in the probability of another birth within 4 years overall. The policy change also was associated with a significant increase of 27 days between births among non-Hispanic Blacks, but not with any significant change among non-Hispanic Whites or the study population overall.

“In addition, although our data cannot speak to this, the policy may have affected the intendedness of subsequent pregnancies, leading to healthier behaviors before and during pregnancy, such as early initiation of prenatal care,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on pregnancy intention or abortion, and the lack of data on patient-reported outcomes, notably the provision of patient-centered counseling and whether such counseling was biased, the researchers noted. Other limitations included a lack of data on infant mortality and potential confounding from risk profiles of patients in implementing vs. nonimplementing hospitals, they wrote.

Also, the study provides population-level data, which does not guide clinical decision-making about intervals between childbirth and subsequent pregnancy, the researchers emphasized.

Although the data support the value of postpartum contraception in improving birth outcomes, “it is imperative that efforts to expand access focus on assuring comprehensive access to all forms of contraception without coercion,” the researchers concluded. “Additional policy solutions are needed to improve infant health, including those that directly address structural and interpersonal racism to reduce racial disparities in infant health,” they said.

The study is important because, although immediate postpartum LARC policies were first implemented almost a decade ago in the United States, population-level evidence on the effects of these policies remains scarce, Dr. Steenland said in an interview.  

Existing barriers to improving access to immediate postpartum LARC include health professional training and logistics within hospitals, as well as ensuring correct billing and timely reimbursements, Dr. Steenland said. “Simple and clear billing procedures, and advanced reimbursement so that hospitals can have devices stocked would make it easier to provide this service,” she noted.

“This service has gone from being almost completely unavailable, to available in some hospitals, mainly those that are urban, teaching, and high volume,” said Dr. Steenland. “Additional research is needed to determine how health systems can make this service available to all birthing persons,” she said. “Also, critically, additional research is needed to identify strategies to ensure that counseling for immediate postpartum LARC, and family planning more generally, is patient-centered, so that the availability of immediate postpartum LARC increases, rather than restricts, choice,” she added. “Finally, additional research is needed to determine whether postpartum people have affordable and accessible access to LARC removal services,” Dr. Steenland emphasized.
 

Immediate post partum is critical period

The immediate postpartum period is a critical time for access to contraception because many women do not return for postpartum visits after hospital discharge, Tracey A. Wilkinson, MD, and Jeffrey F. Peipert, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. “The focus on contraception access during the postpartum period prior to hospital discharge is important because of the potential sequelae of a subsequent unintended pregnancy or short interpregnancy intervals,” they noted. These issues may be more acute in marginalized communities, and policies to expand immediate postpartum LARC are in place in a majority of states, the editorialists said.

However, they agreed with the authors’ statements that implementation of LARC must be done in a manner that supports patient choice and avoids coercion. Given the baseline disparities of the infant outcomes studied, increased access to immediate postpartum LARC must be provided in a way that does not exacerbate these disparities, they said. “This ultimately means that plans to increase access to contraception should emphasize availability while avoiding coercion, and if a patient ultimately decides to discontinue a method, enable that to occur easily and seamlessly, including LARC device removal,” they explained.

“Future studies examining patient centeredness of these postpartum LARC implementation efforts would be an important element to augment these data and show the impact in additional spheres beyond infant outcomes,” they added.
 

Overcome trust barriers and offer options

“In a time of restrictive access to abortion and contraception in many states, any additional increase in access can potentially be meaningful,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Additionally, given the significantly higher rates of infant and maternal morbidity and mortality among the non-Hispanic Black population, seeing an intervention that can improve outcomes for both mothers and babies is also potentially very positive,” she said.

Dr. Prager said she was not surprised by the study findings, as immediate LARC is much more common in other countries and has shown similar outcomes. “Additionally, I am reassured by the fact that the increased number of days until the next pregnancy is not higher, as this indirectly indicates that patients were able to get their LARC removed when they desired another pregnancy,” she noted.

Barriers to improving access to immediate postpartum LARC in the Medicaid population may include mistrust for any long-acting contraception, “especially if they perceive that cessation of the method will be difficult to achieve,” Dr. Prager noted. “Certainly, counseling about LARC removal should be an element of counseling prior to any initiation, and lack of access to removal of an IUD or implant can be categorized as a form of reproductive coercion,” she said. Dr. Prager said that such counseling might be more effective if it occurred during prenatal visits, “so if providers are not talking about this during routine OB visits and patients only hear about immediate postpartum LARC when they are in the hospital for delivery, they may be less likely to accept the practice,” she said. “Finally, although Medicaid will cover the cost of immediate postpartum LARC, private insurers do not do so consistently in all states, so some hospitals may find this process too difficult to navigate and therefore not offer immediate postpartum LARC,” Dr. Prager emphasized.

As for additional research, Dr. Prager said she would like to see more studies in an overall United States population of pregnant people, both Medicaid patients and others, on whether the immediate postpartum timing of LARC is desired.

“I would like to couple that with patients’ impressions or experiences of their ability to access contraception outside of the immediate postpartum time period, and also their impressions or experience with ability to have LARC removed, since they are the only contraceptives not necessarily within personal control for initiation or cessation,” Dr. Prager said.

The study was supported by the National Institute for Child Health and Development, and lead author Dr. Steenland received support from other National Institutes of Health grants. The researchers had no financial conflicts to disclose. The editorial was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Peipert disclosed serving on advisory boards for Bayer and CooperSurgical, and receiving research support from Merck, Bayer, and CooperSurgical/Teva. Dr. Wilkinson had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Policies increasing access to immediate postpartum long-acting reversible contraception (LARC) were associated with reductions in preterm birth and low birth weight, based on data from South Carolina’s Medicaid program.

Preterm birth and low birth weight represent the second-leading cause of infant mortality in the United States, wrote Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues. Previous policy interventions to reduce preterm birth and low birth weight have focused on services before and during pregnancy, they said. LARC is a safe and effective postpartum intervention, but cost has been a limiting factor, they noted.

In 2012, the Medicaid program in South Carolina began reimbursing hospitals for immediate postpartum LARC independent of global maternity payments. In a previous study, the researchers found that the implementation of this policy had reduced the number of short-interval births among adolescents.

The goal of the current study, published in JAMA Pediatrics, was to analyze the association between South Carolina’s policy change and rates of preterm birth and low birth weight among individuals with Medicaid coverage during childbirth. The researchers analyzed data from 186,953 Medicaid-paid births between January 2009 and December 2015 in South Carolina. Of these, 46,414 births (24.8%) occurred in hospitals that provided immediate postpartum LARC in response to the policy change. Overall, the implementing hospitals had more annual births paid for by Medicaid compared to nonimplementing hospitals (1,105 vs. 511) and were less likely to be rural (33.3% vs. 46.8%) and had a greater share of preterm births (15.5% vs. 9.5%). Prior to the policy change, the probability of a preterm birth in the next 4 years was 4.4% for patients at implementing hospitals and 3.5% for those in nonimplementing hospitals, and the probability of a low-birth-weight birth was 3.6% and 2.9%, respectively.

The policy change was associated with a decrease of 0.4 percentage points for preterm birth and 0.3 percentage points for subsequent low-birth-weight birth.

When the results were stratified based on race and ethnicity, the policy change was associated with a decrease of 0.5 percentage points in the probability of preterm birth in both non-Hispanic Blacks and non-Hispanic Whites. No significant differences appeared in the association between the policy change and rates of preterm birth or low-birth-weight birth between non-Hispanic Black and non-Hispanic White individuals.

However, the policy was associated with a significant decrease of 0.6 percentage points in the probability of short-interval birth among non-Hispanic Blacks, and a decrease of 1.6 percentage points in the probability of another birth within 4 years overall. The policy change also was associated with a significant increase of 27 days between births among non-Hispanic Blacks, but not with any significant change among non-Hispanic Whites or the study population overall.

“In addition, although our data cannot speak to this, the policy may have affected the intendedness of subsequent pregnancies, leading to healthier behaviors before and during pregnancy, such as early initiation of prenatal care,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on pregnancy intention or abortion, and the lack of data on patient-reported outcomes, notably the provision of patient-centered counseling and whether such counseling was biased, the researchers noted. Other limitations included a lack of data on infant mortality and potential confounding from risk profiles of patients in implementing vs. nonimplementing hospitals, they wrote.

Also, the study provides population-level data, which does not guide clinical decision-making about intervals between childbirth and subsequent pregnancy, the researchers emphasized.

Although the data support the value of postpartum contraception in improving birth outcomes, “it is imperative that efforts to expand access focus on assuring comprehensive access to all forms of contraception without coercion,” the researchers concluded. “Additional policy solutions are needed to improve infant health, including those that directly address structural and interpersonal racism to reduce racial disparities in infant health,” they said.

The study is important because, although immediate postpartum LARC policies were first implemented almost a decade ago in the United States, population-level evidence on the effects of these policies remains scarce, Dr. Steenland said in an interview.  

Existing barriers to improving access to immediate postpartum LARC include health professional training and logistics within hospitals, as well as ensuring correct billing and timely reimbursements, Dr. Steenland said. “Simple and clear billing procedures, and advanced reimbursement so that hospitals can have devices stocked would make it easier to provide this service,” she noted.

“This service has gone from being almost completely unavailable, to available in some hospitals, mainly those that are urban, teaching, and high volume,” said Dr. Steenland. “Additional research is needed to determine how health systems can make this service available to all birthing persons,” she said. “Also, critically, additional research is needed to identify strategies to ensure that counseling for immediate postpartum LARC, and family planning more generally, is patient-centered, so that the availability of immediate postpartum LARC increases, rather than restricts, choice,” she added. “Finally, additional research is needed to determine whether postpartum people have affordable and accessible access to LARC removal services,” Dr. Steenland emphasized.
 

Immediate post partum is critical period

The immediate postpartum period is a critical time for access to contraception because many women do not return for postpartum visits after hospital discharge, Tracey A. Wilkinson, MD, and Jeffrey F. Peipert, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. “The focus on contraception access during the postpartum period prior to hospital discharge is important because of the potential sequelae of a subsequent unintended pregnancy or short interpregnancy intervals,” they noted. These issues may be more acute in marginalized communities, and policies to expand immediate postpartum LARC are in place in a majority of states, the editorialists said.

However, they agreed with the authors’ statements that implementation of LARC must be done in a manner that supports patient choice and avoids coercion. Given the baseline disparities of the infant outcomes studied, increased access to immediate postpartum LARC must be provided in a way that does not exacerbate these disparities, they said. “This ultimately means that plans to increase access to contraception should emphasize availability while avoiding coercion, and if a patient ultimately decides to discontinue a method, enable that to occur easily and seamlessly, including LARC device removal,” they explained.

“Future studies examining patient centeredness of these postpartum LARC implementation efforts would be an important element to augment these data and show the impact in additional spheres beyond infant outcomes,” they added.
 

Overcome trust barriers and offer options

“In a time of restrictive access to abortion and contraception in many states, any additional increase in access can potentially be meaningful,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Additionally, given the significantly higher rates of infant and maternal morbidity and mortality among the non-Hispanic Black population, seeing an intervention that can improve outcomes for both mothers and babies is also potentially very positive,” she said.

Dr. Prager said she was not surprised by the study findings, as immediate LARC is much more common in other countries and has shown similar outcomes. “Additionally, I am reassured by the fact that the increased number of days until the next pregnancy is not higher, as this indirectly indicates that patients were able to get their LARC removed when they desired another pregnancy,” she noted.

Barriers to improving access to immediate postpartum LARC in the Medicaid population may include mistrust for any long-acting contraception, “especially if they perceive that cessation of the method will be difficult to achieve,” Dr. Prager noted. “Certainly, counseling about LARC removal should be an element of counseling prior to any initiation, and lack of access to removal of an IUD or implant can be categorized as a form of reproductive coercion,” she said. Dr. Prager said that such counseling might be more effective if it occurred during prenatal visits, “so if providers are not talking about this during routine OB visits and patients only hear about immediate postpartum LARC when they are in the hospital for delivery, they may be less likely to accept the practice,” she said. “Finally, although Medicaid will cover the cost of immediate postpartum LARC, private insurers do not do so consistently in all states, so some hospitals may find this process too difficult to navigate and therefore not offer immediate postpartum LARC,” Dr. Prager emphasized.

As for additional research, Dr. Prager said she would like to see more studies in an overall United States population of pregnant people, both Medicaid patients and others, on whether the immediate postpartum timing of LARC is desired.

“I would like to couple that with patients’ impressions or experiences of their ability to access contraception outside of the immediate postpartum time period, and also their impressions or experience with ability to have LARC removed, since they are the only contraceptives not necessarily within personal control for initiation or cessation,” Dr. Prager said.

The study was supported by the National Institute for Child Health and Development, and lead author Dr. Steenland received support from other National Institutes of Health grants. The researchers had no financial conflicts to disclose. The editorial was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Peipert disclosed serving on advisory boards for Bayer and CooperSurgical, and receiving research support from Merck, Bayer, and CooperSurgical/Teva. Dr. Wilkinson had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Policies increasing access to immediate postpartum long-acting reversible contraception (LARC) were associated with reductions in preterm birth and low birth weight, based on data from South Carolina’s Medicaid program.

Preterm birth and low birth weight represent the second-leading cause of infant mortality in the United States, wrote Maria W. Steenland, SD, of Brown University, Providence, R.I., and colleagues. Previous policy interventions to reduce preterm birth and low birth weight have focused on services before and during pregnancy, they said. LARC is a safe and effective postpartum intervention, but cost has been a limiting factor, they noted.

In 2012, the Medicaid program in South Carolina began reimbursing hospitals for immediate postpartum LARC independent of global maternity payments. In a previous study, the researchers found that the implementation of this policy had reduced the number of short-interval births among adolescents.

The goal of the current study, published in JAMA Pediatrics, was to analyze the association between South Carolina’s policy change and rates of preterm birth and low birth weight among individuals with Medicaid coverage during childbirth. The researchers analyzed data from 186,953 Medicaid-paid births between January 2009 and December 2015 in South Carolina. Of these, 46,414 births (24.8%) occurred in hospitals that provided immediate postpartum LARC in response to the policy change. Overall, the implementing hospitals had more annual births paid for by Medicaid compared to nonimplementing hospitals (1,105 vs. 511) and were less likely to be rural (33.3% vs. 46.8%) and had a greater share of preterm births (15.5% vs. 9.5%). Prior to the policy change, the probability of a preterm birth in the next 4 years was 4.4% for patients at implementing hospitals and 3.5% for those in nonimplementing hospitals, and the probability of a low-birth-weight birth was 3.6% and 2.9%, respectively.

The policy change was associated with a decrease of 0.4 percentage points for preterm birth and 0.3 percentage points for subsequent low-birth-weight birth.

When the results were stratified based on race and ethnicity, the policy change was associated with a decrease of 0.5 percentage points in the probability of preterm birth in both non-Hispanic Blacks and non-Hispanic Whites. No significant differences appeared in the association between the policy change and rates of preterm birth or low-birth-weight birth between non-Hispanic Black and non-Hispanic White individuals.

However, the policy was associated with a significant decrease of 0.6 percentage points in the probability of short-interval birth among non-Hispanic Blacks, and a decrease of 1.6 percentage points in the probability of another birth within 4 years overall. The policy change also was associated with a significant increase of 27 days between births among non-Hispanic Blacks, but not with any significant change among non-Hispanic Whites or the study population overall.

“In addition, although our data cannot speak to this, the policy may have affected the intendedness of subsequent pregnancies, leading to healthier behaviors before and during pregnancy, such as early initiation of prenatal care,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on pregnancy intention or abortion, and the lack of data on patient-reported outcomes, notably the provision of patient-centered counseling and whether such counseling was biased, the researchers noted. Other limitations included a lack of data on infant mortality and potential confounding from risk profiles of patients in implementing vs. nonimplementing hospitals, they wrote.

Also, the study provides population-level data, which does not guide clinical decision-making about intervals between childbirth and subsequent pregnancy, the researchers emphasized.

Although the data support the value of postpartum contraception in improving birth outcomes, “it is imperative that efforts to expand access focus on assuring comprehensive access to all forms of contraception without coercion,” the researchers concluded. “Additional policy solutions are needed to improve infant health, including those that directly address structural and interpersonal racism to reduce racial disparities in infant health,” they said.

The study is important because, although immediate postpartum LARC policies were first implemented almost a decade ago in the United States, population-level evidence on the effects of these policies remains scarce, Dr. Steenland said in an interview.  

Existing barriers to improving access to immediate postpartum LARC include health professional training and logistics within hospitals, as well as ensuring correct billing and timely reimbursements, Dr. Steenland said. “Simple and clear billing procedures, and advanced reimbursement so that hospitals can have devices stocked would make it easier to provide this service,” she noted.

“This service has gone from being almost completely unavailable, to available in some hospitals, mainly those that are urban, teaching, and high volume,” said Dr. Steenland. “Additional research is needed to determine how health systems can make this service available to all birthing persons,” she said. “Also, critically, additional research is needed to identify strategies to ensure that counseling for immediate postpartum LARC, and family planning more generally, is patient-centered, so that the availability of immediate postpartum LARC increases, rather than restricts, choice,” she added. “Finally, additional research is needed to determine whether postpartum people have affordable and accessible access to LARC removal services,” Dr. Steenland emphasized.
 

Immediate post partum is critical period

The immediate postpartum period is a critical time for access to contraception because many women do not return for postpartum visits after hospital discharge, Tracey A. Wilkinson, MD, and Jeffrey F. Peipert, MD, of Indiana University, Indianapolis, wrote in an accompanying editorial. “The focus on contraception access during the postpartum period prior to hospital discharge is important because of the potential sequelae of a subsequent unintended pregnancy or short interpregnancy intervals,” they noted. These issues may be more acute in marginalized communities, and policies to expand immediate postpartum LARC are in place in a majority of states, the editorialists said.

However, they agreed with the authors’ statements that implementation of LARC must be done in a manner that supports patient choice and avoids coercion. Given the baseline disparities of the infant outcomes studied, increased access to immediate postpartum LARC must be provided in a way that does not exacerbate these disparities, they said. “This ultimately means that plans to increase access to contraception should emphasize availability while avoiding coercion, and if a patient ultimately decides to discontinue a method, enable that to occur easily and seamlessly, including LARC device removal,” they explained.

“Future studies examining patient centeredness of these postpartum LARC implementation efforts would be an important element to augment these data and show the impact in additional spheres beyond infant outcomes,” they added.
 

Overcome trust barriers and offer options

“In a time of restrictive access to abortion and contraception in many states, any additional increase in access can potentially be meaningful,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Additionally, given the significantly higher rates of infant and maternal morbidity and mortality among the non-Hispanic Black population, seeing an intervention that can improve outcomes for both mothers and babies is also potentially very positive,” she said.

Dr. Prager said she was not surprised by the study findings, as immediate LARC is much more common in other countries and has shown similar outcomes. “Additionally, I am reassured by the fact that the increased number of days until the next pregnancy is not higher, as this indirectly indicates that patients were able to get their LARC removed when they desired another pregnancy,” she noted.

Barriers to improving access to immediate postpartum LARC in the Medicaid population may include mistrust for any long-acting contraception, “especially if they perceive that cessation of the method will be difficult to achieve,” Dr. Prager noted. “Certainly, counseling about LARC removal should be an element of counseling prior to any initiation, and lack of access to removal of an IUD or implant can be categorized as a form of reproductive coercion,” she said. Dr. Prager said that such counseling might be more effective if it occurred during prenatal visits, “so if providers are not talking about this during routine OB visits and patients only hear about immediate postpartum LARC when they are in the hospital for delivery, they may be less likely to accept the practice,” she said. “Finally, although Medicaid will cover the cost of immediate postpartum LARC, private insurers do not do so consistently in all states, so some hospitals may find this process too difficult to navigate and therefore not offer immediate postpartum LARC,” Dr. Prager emphasized.

As for additional research, Dr. Prager said she would like to see more studies in an overall United States population of pregnant people, both Medicaid patients and others, on whether the immediate postpartum timing of LARC is desired.

“I would like to couple that with patients’ impressions or experiences of their ability to access contraception outside of the immediate postpartum time period, and also their impressions or experience with ability to have LARC removed, since they are the only contraceptives not necessarily within personal control for initiation or cessation,” Dr. Prager said.

The study was supported by the National Institute for Child Health and Development, and lead author Dr. Steenland received support from other National Institutes of Health grants. The researchers had no financial conflicts to disclose. The editorial was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Peipert disclosed serving on advisory boards for Bayer and CooperSurgical, and receiving research support from Merck, Bayer, and CooperSurgical/Teva. Dr. Wilkinson had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

A new study offers fresh insight into early indications of high-risk, early-stage, epithelial ovarian cancer: More than 70% have at least one symptom such as abdominal/pelvic pain or increased girth/fullness, and women with larger tumors have more symptoms.

“Even in early-stage disease, ovarian cancer is not necessarily a silent disease,” said lead author and gynecologic oncologist/surgeon John K. Chan, MD, of Palo Alto Medical Foundation/California Pacific/Sutter Research Institute.

The study appeared online Jan. 6, in the journal Obstetrics & Gynecology.*

According to Dr. Chan, most previous studies of symptoms in ovarian cancer have focused on those with advanced disease since that’s when it’s typically diagnosed. “Given these gaps in knowledge from prior reports, we performed this analysis to evaluate the presentation and characteristic symptoms of early-stage ovarian cancer and to attempt to identify the relationship between these symptoms with respect to clinicopathologic characteristics and prognosis in early-stage disease.”

Dr. Chan and colleagues retrospectively tracked 419 patients who were subjects in a clinical trial of chemotherapy doses. The patients all had high-risk, early-stage epithelial ovarian cancer (stage IA-IB and grade 3, any clear cell, stage IC or II).

Of the patients, 40% presented with one symptom, while 32% had multiple symptoms. The other 28% had no symptoms, and their masses were diagnosed upon discovery during physical examination. “Other investigators have found that nearly 95% of patients with ovarian cancer were symptomatic,” Dr. Chan said. “The lower percentage of symptomatic patients in our study may be because all 419 patients had early-stage disease as opposed to advanced-stage disease.”

The most common symptoms were abdominal or pelvic pain (31%; 95% confidence interval, 27%-36%), fullness or increased abdominal girth (27%; 95% CI, 22%-31%), abnormal vaginal bleeding (13%; 95% CI, 10%-17%), urinary problems (10%; 95% CI, 8%-14%), and gastrointestinal problems (6%; 95% CI, 4%-8%).

There was no statistically significant link between number of symptoms and age (younger than 60 or 60 or older), cancer stage, or histologic subtype. However, patients with the largest tumors (>15 cm) were more likely to have multiple symptoms than those with the smallest tumors (10 cm or smaller): 46% vs. 21% (P < .001).

Also, 79% of those with the largest tumors (>15 cm) had at least one symptom, compared with 65% of those with the smallest tumors (10 cm or smaller, P < .001)

Unlike other studies, this report didn’t find a link between the number of symptoms and mortality. This finding surprised the researchers, Dr. Chan said, as did the lack of connections between symptoms and age, stage, or histologic subtype. “We were expecting that the younger patients may have more symptoms given the association with endometriosis and clear cell cancers,” he said. “We also thought that those who are less symptomatic may have more stage I and low-grade indolent tumors with better survival, but we did not find that.”

The researchers noted limitations such as the lack of standardization in the patient data.

In the big picture, Dr. Chan said, “patients and health care professionals need to have a higher index of suspicion in symptomatic ovarian cancer patients to increase early detection and potentially improve cures. Ovarian cancer does not always kill. In fact, up to 80% of our early-stage disease patients are cured.”

He called for “additional research to evaluate symptom awareness in early-stage cancers and possibly incorporating novel serum biomarkers and wearable monitoring devices. Wearables may be able to assess for frequency or duration of symptoms, which may be an important factor in distinguishing symptoms that are more concerning for ovarian cancer.”

In an adjoining commentary, Barbara A. Goff, MD, chair of obstetrics and gynecology at the University of Washington, Seattle, noted that, while ovarian cancers diagnosed early have a high survival rate, prospective randomized trials of transvaginal ultrasonography and tumor marker screening strategies have failed to reduce mortality. There’s currently no recommended screening test for women at average risk.

There are other challenges, she wrote. For one, “many health care professionals are seemingly unaware of the symptoms typically associated with ovarian cancer, so misdiagnosis remains common.” And “one of the concerns about the symptoms of ovarian cancer is that they can be vague and commonly present in the general population.”

Dr. Goff praised the study, called for more education about the symptoms of ovarian cancer, and wrote that “symptom recognition with appropriate diagnostic testing remains very important in our efforts to improve outcomes.”

The National Institutes of Health funded the study. Several study authors, including Dr. Chan, reported various disclosures.

Correction, 1/31/22: An earlier version of this article misstated the date of publication.

A new study offers fresh insight into early indications of high-risk, early-stage, epithelial ovarian cancer: More than 70% have at least one symptom such as abdominal/pelvic pain or increased girth/fullness, and women with larger tumors have more symptoms.

“Even in early-stage disease, ovarian cancer is not necessarily a silent disease,” said lead author and gynecologic oncologist/surgeon John K. Chan, MD, of Palo Alto Medical Foundation/California Pacific/Sutter Research Institute.

The study appeared online Jan. 6, in the journal Obstetrics & Gynecology.*

According to Dr. Chan, most previous studies of symptoms in ovarian cancer have focused on those with advanced disease since that’s when it’s typically diagnosed. “Given these gaps in knowledge from prior reports, we performed this analysis to evaluate the presentation and characteristic symptoms of early-stage ovarian cancer and to attempt to identify the relationship between these symptoms with respect to clinicopathologic characteristics and prognosis in early-stage disease.”

Dr. Chan and colleagues retrospectively tracked 419 patients who were subjects in a clinical trial of chemotherapy doses. The patients all had high-risk, early-stage epithelial ovarian cancer (stage IA-IB and grade 3, any clear cell, stage IC or II).

Of the patients, 40% presented with one symptom, while 32% had multiple symptoms. The other 28% had no symptoms, and their masses were diagnosed upon discovery during physical examination. “Other investigators have found that nearly 95% of patients with ovarian cancer were symptomatic,” Dr. Chan said. “The lower percentage of symptomatic patients in our study may be because all 419 patients had early-stage disease as opposed to advanced-stage disease.”

The most common symptoms were abdominal or pelvic pain (31%; 95% confidence interval, 27%-36%), fullness or increased abdominal girth (27%; 95% CI, 22%-31%), abnormal vaginal bleeding (13%; 95% CI, 10%-17%), urinary problems (10%; 95% CI, 8%-14%), and gastrointestinal problems (6%; 95% CI, 4%-8%).

There was no statistically significant link between number of symptoms and age (younger than 60 or 60 or older), cancer stage, or histologic subtype. However, patients with the largest tumors (>15 cm) were more likely to have multiple symptoms than those with the smallest tumors (10 cm or smaller): 46% vs. 21% (P < .001).

Also, 79% of those with the largest tumors (>15 cm) had at least one symptom, compared with 65% of those with the smallest tumors (10 cm or smaller, P < .001)

Unlike other studies, this report didn’t find a link between the number of symptoms and mortality. This finding surprised the researchers, Dr. Chan said, as did the lack of connections between symptoms and age, stage, or histologic subtype. “We were expecting that the younger patients may have more symptoms given the association with endometriosis and clear cell cancers,” he said. “We also thought that those who are less symptomatic may have more stage I and low-grade indolent tumors with better survival, but we did not find that.”

The researchers noted limitations such as the lack of standardization in the patient data.

In the big picture, Dr. Chan said, “patients and health care professionals need to have a higher index of suspicion in symptomatic ovarian cancer patients to increase early detection and potentially improve cures. Ovarian cancer does not always kill. In fact, up to 80% of our early-stage disease patients are cured.”

He called for “additional research to evaluate symptom awareness in early-stage cancers and possibly incorporating novel serum biomarkers and wearable monitoring devices. Wearables may be able to assess for frequency or duration of symptoms, which may be an important factor in distinguishing symptoms that are more concerning for ovarian cancer.”

In an adjoining commentary, Barbara A. Goff, MD, chair of obstetrics and gynecology at the University of Washington, Seattle, noted that, while ovarian cancers diagnosed early have a high survival rate, prospective randomized trials of transvaginal ultrasonography and tumor marker screening strategies have failed to reduce mortality. There’s currently no recommended screening test for women at average risk.

There are other challenges, she wrote. For one, “many health care professionals are seemingly unaware of the symptoms typically associated with ovarian cancer, so misdiagnosis remains common.” And “one of the concerns about the symptoms of ovarian cancer is that they can be vague and commonly present in the general population.”

Dr. Goff praised the study, called for more education about the symptoms of ovarian cancer, and wrote that “symptom recognition with appropriate diagnostic testing remains very important in our efforts to improve outcomes.”

The National Institutes of Health funded the study. Several study authors, including Dr. Chan, reported various disclosures.

Correction, 1/31/22: An earlier version of this article misstated the date of publication.

A new study offers fresh insight into early indications of high-risk, early-stage, epithelial ovarian cancer: More than 70% have at least one symptom such as abdominal/pelvic pain or increased girth/fullness, and women with larger tumors have more symptoms.

“Even in early-stage disease, ovarian cancer is not necessarily a silent disease,” said lead author and gynecologic oncologist/surgeon John K. Chan, MD, of Palo Alto Medical Foundation/California Pacific/Sutter Research Institute.

The study appeared online Jan. 6, in the journal Obstetrics & Gynecology.*

According to Dr. Chan, most previous studies of symptoms in ovarian cancer have focused on those with advanced disease since that’s when it’s typically diagnosed. “Given these gaps in knowledge from prior reports, we performed this analysis to evaluate the presentation and characteristic symptoms of early-stage ovarian cancer and to attempt to identify the relationship between these symptoms with respect to clinicopathologic characteristics and prognosis in early-stage disease.”

Dr. Chan and colleagues retrospectively tracked 419 patients who were subjects in a clinical trial of chemotherapy doses. The patients all had high-risk, early-stage epithelial ovarian cancer (stage IA-IB and grade 3, any clear cell, stage IC or II).

Of the patients, 40% presented with one symptom, while 32% had multiple symptoms. The other 28% had no symptoms, and their masses were diagnosed upon discovery during physical examination. “Other investigators have found that nearly 95% of patients with ovarian cancer were symptomatic,” Dr. Chan said. “The lower percentage of symptomatic patients in our study may be because all 419 patients had early-stage disease as opposed to advanced-stage disease.”

The most common symptoms were abdominal or pelvic pain (31%; 95% confidence interval, 27%-36%), fullness or increased abdominal girth (27%; 95% CI, 22%-31%), abnormal vaginal bleeding (13%; 95% CI, 10%-17%), urinary problems (10%; 95% CI, 8%-14%), and gastrointestinal problems (6%; 95% CI, 4%-8%).

There was no statistically significant link between number of symptoms and age (younger than 60 or 60 or older), cancer stage, or histologic subtype. However, patients with the largest tumors (>15 cm) were more likely to have multiple symptoms than those with the smallest tumors (10 cm or smaller): 46% vs. 21% (P < .001).

Also, 79% of those with the largest tumors (>15 cm) had at least one symptom, compared with 65% of those with the smallest tumors (10 cm or smaller, P < .001)

Unlike other studies, this report didn’t find a link between the number of symptoms and mortality. This finding surprised the researchers, Dr. Chan said, as did the lack of connections between symptoms and age, stage, or histologic subtype. “We were expecting that the younger patients may have more symptoms given the association with endometriosis and clear cell cancers,” he said. “We also thought that those who are less symptomatic may have more stage I and low-grade indolent tumors with better survival, but we did not find that.”

The researchers noted limitations such as the lack of standardization in the patient data.

In the big picture, Dr. Chan said, “patients and health care professionals need to have a higher index of suspicion in symptomatic ovarian cancer patients to increase early detection and potentially improve cures. Ovarian cancer does not always kill. In fact, up to 80% of our early-stage disease patients are cured.”

He called for “additional research to evaluate symptom awareness in early-stage cancers and possibly incorporating novel serum biomarkers and wearable monitoring devices. Wearables may be able to assess for frequency or duration of symptoms, which may be an important factor in distinguishing symptoms that are more concerning for ovarian cancer.”

In an adjoining commentary, Barbara A. Goff, MD, chair of obstetrics and gynecology at the University of Washington, Seattle, noted that, while ovarian cancers diagnosed early have a high survival rate, prospective randomized trials of transvaginal ultrasonography and tumor marker screening strategies have failed to reduce mortality. There’s currently no recommended screening test for women at average risk.

There are other challenges, she wrote. For one, “many health care professionals are seemingly unaware of the symptoms typically associated with ovarian cancer, so misdiagnosis remains common.” And “one of the concerns about the symptoms of ovarian cancer is that they can be vague and commonly present in the general population.”

Dr. Goff praised the study, called for more education about the symptoms of ovarian cancer, and wrote that “symptom recognition with appropriate diagnostic testing remains very important in our efforts to improve outcomes.”

The National Institutes of Health funded the study. Several study authors, including Dr. Chan, reported various disclosures.

Correction, 1/31/22: An earlier version of this article misstated the date of publication.

Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.

While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.

“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.

“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.

Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.

For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.

Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.

Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.

The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.

The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.

“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.

Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.

However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.

In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.

“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”

The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.

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

Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.

While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.

“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.

“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.

Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.

For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.

Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.

Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.

The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.

The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.

“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.

Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.

However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.

In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.

“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”

The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.

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

Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.

While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.

“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.

“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.

Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.

For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.

Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.

Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.

The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.

The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.

“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.

Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.

However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.

In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.

“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”

The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.

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

Combining high-risk human papillomavirus (hrHPV)–based screening with cytologic triage detected two times more cases of grade 2+ cervical intraepithelial neoplasia (CIN2+) than cytology alone, according to a new study.

The study, which analyzed data from Mexico’s population-based hrHPV screening program over 6 years, confirms the importance of HPV screening for catching high-grade cervical lesions early.

“Our results provide evidence that hrHPV testing is the best strategy for a timely diagnosis of CIN2+ lesions while avoiding overtreatment of young women,” the study authors write. “Many countries now use hrHPV testing as the primary screening method, given it has higher sensitivity and detects more cervical cancer precursor lesions, such as CIN2+.”

According to Erik Jansen, MSc, the analysis supports recent updates to U.S. screening standards and confirms findings from previous trials, which show that HPV testing significantly improves prevention of cervical cancer.

“The significance of this paper is that the data reported is from a long follow-up in a country that implemented HPV screening on a large scale,” Mr. Jansen, PhD candidate in the Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization.

The study, conducted by Mexico’s National Institute of Public Health, analyzed screening data from the country’s public cervical cancer prevention program from 2010 to 2015. More than 2 million women aged 34 to 65 who had hrHPV-based screening tests followed by cytologic triage if they were HPV positive were included, as were 2.8 million women of the same age who received cytologic testing alone.

In the hrHPV group, 1.2% of women (n = 24,276) received referrals to colposcopy versus 3.1% of women (n = 90,980) in the cytology group. And among all women, only 0.8% who had abnormal results (n = 16,459) in the HPV went for a colposcopy versus 1.5% (n = 43,638) in the cytology group.

Overall, the authors found that 13.3 colposcopies were required to detect a single CIN2+ case in the cytology group compared to 5.7 colposcopies in the hrHPV with cytologic triage group.

The authors also note that the cost of colposcopies was three times lower in the HPV testing group and that the positive predictive value of hrHPV testing with cytologic triage was 17.5% versus 7.5% for cytology alone.

“The positive predictive value did not change for either screening strategy whether or not women lost to follow-up were taken into account,” the authors write.

Although Mr. Jansen noted that the findings are important, he also pointed to several limitations – namely, the significant loss to follow-up in the HPV group.

The HPV testing and cytologic triage happened in separate visits, and under the two-visit protocol, more than 50% of women who tested positive for HPV didn’t return for cytology. Such a significant loss to follow-up may call some of the findings into question, Mr. Jansen noted.

For instance, the rate of colposcopy referrals does not account for HPV-positive women who skipped their cytology screening. Assuming the same HPV risk for women who received cytology and those who did not, Mr. Jansen calculated that without any loss to follow-up, the colposcopy referral rate would have increased from the reported 1.2% to 2.6%, which is much closer to the 3.1% of the women referred in the cytology arm.

The lower colposcopy costs in the HPV group were also likely due, in part, to the loss to follow-up, which is not necessarily a good thing, Mr. Jansen said.

Still, “this study does confirm the finding that a primary HPV screening program is more effective than cytology [alone],” Mr. Jansen said.

Co-author Eduardo Franco reported receiving grants and personal fees from MSD and has a pending patent, “Methylation Markers in Cervical Cancer.” All other authors reported no conflicts of interest.

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

Combining high-risk human papillomavirus (hrHPV)–based screening with cytologic triage detected two times more cases of grade 2+ cervical intraepithelial neoplasia (CIN2+) than cytology alone, according to a new study.

The study, which analyzed data from Mexico’s population-based hrHPV screening program over 6 years, confirms the importance of HPV screening for catching high-grade cervical lesions early.

“Our results provide evidence that hrHPV testing is the best strategy for a timely diagnosis of CIN2+ lesions while avoiding overtreatment of young women,” the study authors write. “Many countries now use hrHPV testing as the primary screening method, given it has higher sensitivity and detects more cervical cancer precursor lesions, such as CIN2+.”

According to Erik Jansen, MSc, the analysis supports recent updates to U.S. screening standards and confirms findings from previous trials, which show that HPV testing significantly improves prevention of cervical cancer.

“The significance of this paper is that the data reported is from a long follow-up in a country that implemented HPV screening on a large scale,” Mr. Jansen, PhD candidate in the Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization.

The study, conducted by Mexico’s National Institute of Public Health, analyzed screening data from the country’s public cervical cancer prevention program from 2010 to 2015. More than 2 million women aged 34 to 65 who had hrHPV-based screening tests followed by cytologic triage if they were HPV positive were included, as were 2.8 million women of the same age who received cytologic testing alone.

In the hrHPV group, 1.2% of women (n = 24,276) received referrals to colposcopy versus 3.1% of women (n = 90,980) in the cytology group. And among all women, only 0.8% who had abnormal results (n = 16,459) in the HPV went for a colposcopy versus 1.5% (n = 43,638) in the cytology group.

Overall, the authors found that 13.3 colposcopies were required to detect a single CIN2+ case in the cytology group compared to 5.7 colposcopies in the hrHPV with cytologic triage group.

The authors also note that the cost of colposcopies was three times lower in the HPV testing group and that the positive predictive value of hrHPV testing with cytologic triage was 17.5% versus 7.5% for cytology alone.

“The positive predictive value did not change for either screening strategy whether or not women lost to follow-up were taken into account,” the authors write.

Although Mr. Jansen noted that the findings are important, he also pointed to several limitations – namely, the significant loss to follow-up in the HPV group.

The HPV testing and cytologic triage happened in separate visits, and under the two-visit protocol, more than 50% of women who tested positive for HPV didn’t return for cytology. Such a significant loss to follow-up may call some of the findings into question, Mr. Jansen noted.

For instance, the rate of colposcopy referrals does not account for HPV-positive women who skipped their cytology screening. Assuming the same HPV risk for women who received cytology and those who did not, Mr. Jansen calculated that without any loss to follow-up, the colposcopy referral rate would have increased from the reported 1.2% to 2.6%, which is much closer to the 3.1% of the women referred in the cytology arm.

The lower colposcopy costs in the HPV group were also likely due, in part, to the loss to follow-up, which is not necessarily a good thing, Mr. Jansen said.

Still, “this study does confirm the finding that a primary HPV screening program is more effective than cytology [alone],” Mr. Jansen said.

Co-author Eduardo Franco reported receiving grants and personal fees from MSD and has a pending patent, “Methylation Markers in Cervical Cancer.” All other authors reported no conflicts of interest.

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

Combining high-risk human papillomavirus (hrHPV)–based screening with cytologic triage detected two times more cases of grade 2+ cervical intraepithelial neoplasia (CIN2+) than cytology alone, according to a new study.

The study, which analyzed data from Mexico’s population-based hrHPV screening program over 6 years, confirms the importance of HPV screening for catching high-grade cervical lesions early.

“Our results provide evidence that hrHPV testing is the best strategy for a timely diagnosis of CIN2+ lesions while avoiding overtreatment of young women,” the study authors write. “Many countries now use hrHPV testing as the primary screening method, given it has higher sensitivity and detects more cervical cancer precursor lesions, such as CIN2+.”

According to Erik Jansen, MSc, the analysis supports recent updates to U.S. screening standards and confirms findings from previous trials, which show that HPV testing significantly improves prevention of cervical cancer.

“The significance of this paper is that the data reported is from a long follow-up in a country that implemented HPV screening on a large scale,” Mr. Jansen, PhD candidate in the Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization.

The study, conducted by Mexico’s National Institute of Public Health, analyzed screening data from the country’s public cervical cancer prevention program from 2010 to 2015. More than 2 million women aged 34 to 65 who had hrHPV-based screening tests followed by cytologic triage if they were HPV positive were included, as were 2.8 million women of the same age who received cytologic testing alone.

In the hrHPV group, 1.2% of women (n = 24,276) received referrals to colposcopy versus 3.1% of women (n = 90,980) in the cytology group. And among all women, only 0.8% who had abnormal results (n = 16,459) in the HPV went for a colposcopy versus 1.5% (n = 43,638) in the cytology group.

Overall, the authors found that 13.3 colposcopies were required to detect a single CIN2+ case in the cytology group compared to 5.7 colposcopies in the hrHPV with cytologic triage group.

The authors also note that the cost of colposcopies was three times lower in the HPV testing group and that the positive predictive value of hrHPV testing with cytologic triage was 17.5% versus 7.5% for cytology alone.

“The positive predictive value did not change for either screening strategy whether or not women lost to follow-up were taken into account,” the authors write.

Although Mr. Jansen noted that the findings are important, he also pointed to several limitations – namely, the significant loss to follow-up in the HPV group.

The HPV testing and cytologic triage happened in separate visits, and under the two-visit protocol, more than 50% of women who tested positive for HPV didn’t return for cytology. Such a significant loss to follow-up may call some of the findings into question, Mr. Jansen noted.

For instance, the rate of colposcopy referrals does not account for HPV-positive women who skipped their cytology screening. Assuming the same HPV risk for women who received cytology and those who did not, Mr. Jansen calculated that without any loss to follow-up, the colposcopy referral rate would have increased from the reported 1.2% to 2.6%, which is much closer to the 3.1% of the women referred in the cytology arm.

The lower colposcopy costs in the HPV group were also likely due, in part, to the loss to follow-up, which is not necessarily a good thing, Mr. Jansen said.

Still, “this study does confirm the finding that a primary HPV screening program is more effective than cytology [alone],” Mr. Jansen said.

Co-author Eduardo Franco reported receiving grants and personal fees from MSD and has a pending patent, “Methylation Markers in Cervical Cancer.” All other authors reported no conflicts of interest.

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

Having specific health issues, including depressive symptoms and cardiovascular disease, as a middle-aged woman was associated with experiencing clinically important declines in health later in life, a new study finds.

The most predictive parameters of poorer health at age 65 were cardiovascular disease, clinically significant depressive symptoms, and current smoking. Osteoarthritis, lower education level, and higher body mass index (BMI) also were associated with poorer health status 10 years on, Daniel H. Solomon, MD, MPH and colleagues wrote in their observational study, which was published in JAMA Network Open.

Determining a patient’s score on a health-related quality of life measure based on these variables might be useful in clinical practice to recognize midlife patients at increased risk for later health deterioration, Dr. Solomon, of the division of rheumatology, inflammation, and immunity at Brigham and Women’s Hospital, Boston, said in a statement. This measure is called the Short Form 36 (SF-36), and the researchers specifically focused on the physical component summary score (PCS) of this measure. The SF-36 is similar to the Framingham 10-year coronary heart disease risk prediction score, according to Dr. Solomon, who is a professor of medicine at Harvard Medical School, also in Boston.

Based on their risk scores, women could preemptively target modifiable risk factors before they enter old age, the investigators wrote.

“Age 55-65 may be a critical decade. A person’s health and factors during this period may set them on a path for their later adult years,” Dr. Solomon said in a statement. “The good news is that a large proportion of women at midlife are very stable and will not go on to experience declines. But being able to identify women at higher risk could help lead to interventions targeted to them.”
 

Study details

The study included a cohort of 1,091 women drawn from the 3,302-participant Study of Women’s Health Across the Nation (SWAN), a racially and ethnically diverse group enrolled from six U.S. sites at or immediately before transition to menopause and followed for 10 years from age 55 to 65. The study sample, consisting of 24.6% Black, 24% Japanese or Chinese, and 51.9% White, had a median baseline age of 54.8 years and median BMI of 27 kg/m² at entry. The median baseline PCS score was 53.1 (interquartile range, 46.8-56.7).

Over 10 years, 206 (18.9%) of the women in the study experienced clinically important declines of at least 8 points in baseline characteristics at around age 55. The following were significantly associated with these declines:

• Having a higher BMI.
• Having osteoarthritis.
• Having a lower educational level.
• Being a current smoker.
• Having clinically significant depressive symptoms.
• Having cardiovascular disease.
• Having better (or higher) physical health and function score on the PCS.

The association between a higher PCS score and a greater decline might seem like an anomaly, Dr. Solomon said in an interview, but one interpretation of this finding is that women with higher or better scores at baseline have further to fall once other risk factors take effect.

With data analyzed from October 2020 to March 2021, the median 10-year change in PCS was –1.02 points, but 206 women experienced declines of 8 points or more.

Those with health declines were more likely to be Black and less likely to be Japanese. They were also more likely to have other comorbidities such as diabetes, hypertension, and osteoporosis, and to report less physical activity.
 

Scoring system should not replace individualized evaluation, outside expert said

Commenting on the findings, Margaret J. Nachtigall, MD, a clinical associate professor in the department of obstetrics and gynecology at New York University Langone Health, cautioned that a generalized scoring system should not replace individualized evaluation of women at midlife.

“I assess women around age 55 on a daily basis for health risk factors going forward. And while a number such as BMI can be helpful, I worry that reliance on a score could miss treating the individual,” Dr. Nachtigall said an interview. For instance, one woman might have a high BMI owing to greater muscle mass, which is heavy, while another may have a lower BMI but more fat-related weight, as well as exacerbating conditions such as hypertension that would elevate her risk. “You have to make the calculation for each person.”

Dr. Nachtigall, who was not involved in the SWAN analysis, noted, however, that a big-data scoring system might be a useful adjunct to individual patient evaluation in that “it would make physicians look at all these many risk factors to identify those prone to decline.”
 

Study includes racially diverse population

According to the authors, while other studies have identified similar and other risk factors such as poor sleep, most have not included such a racially diverse population and have focused on women already in their senior years when the window of opportunity may already have closed.

“As a clinician and epidemiologist, I often think about the window of opportunity at midlife, when people are vital, engaged, and resilient,” said Dr. Solomon in the statement. “If we can identify risk factors and determine who is at risk, we may be able to find interventions that can stave off health declines and help put people on a better health trajectory.”

Eric M. Ascher, DO, who practices family medicine at Lenox Hill Hospital in New York and was not involved in the SWAN research, agreed with Dr. Solomon.

“Doctors who treat chronic conditions often meet patients when they are already suffering from a medical problem,” he said in an interview. “It is key to decrease your risk factors before it is too late.”

Dr. Ascher added that many primary care providers already rely heavily on scoring systems when determining level of risk and type of intervention. “Any additional risk factor-scoring systems that are easy to implement and will prevent chronic diseases would be something providers would want to use with their patients.”

Detailed analyses of larger at-risk populations are needed to validate these risk factors and identify others, the authors said.

SWAN is supported by the National Institute on Aging, the National Institute of Nursing Research, and the National Institutes of Heath’s Office of Research on Women’s Health. Dr. Solomon reported financial ties to Amgen, AbbVie and Moderna, UpToDate, and Arthritis & Rheumatology; as well as serving on the board of directors for the Childhood Arthritis and Rheumatology Research Alliance and an advisory committee for the Food and Drug Administration outside of this work. Dr. Nachtigall and Dr. Ascher disclosed no conflicts of interest with regard to their comments.

Having specific health issues, including depressive symptoms and cardiovascular disease, as a middle-aged woman was associated with experiencing clinically important declines in health later in life, a new study finds.

The most predictive parameters of poorer health at age 65 were cardiovascular disease, clinically significant depressive symptoms, and current smoking. Osteoarthritis, lower education level, and higher body mass index (BMI) also were associated with poorer health status 10 years on, Daniel H. Solomon, MD, MPH and colleagues wrote in their observational study, which was published in JAMA Network Open.

Determining a patient’s score on a health-related quality of life measure based on these variables might be useful in clinical practice to recognize midlife patients at increased risk for later health deterioration, Dr. Solomon, of the division of rheumatology, inflammation, and immunity at Brigham and Women’s Hospital, Boston, said in a statement. This measure is called the Short Form 36 (SF-36), and the researchers specifically focused on the physical component summary score (PCS) of this measure. The SF-36 is similar to the Framingham 10-year coronary heart disease risk prediction score, according to Dr. Solomon, who is a professor of medicine at Harvard Medical School, also in Boston.

Based on their risk scores, women could preemptively target modifiable risk factors before they enter old age, the investigators wrote.

“Age 55-65 may be a critical decade. A person’s health and factors during this period may set them on a path for their later adult years,” Dr. Solomon said in a statement. “The good news is that a large proportion of women at midlife are very stable and will not go on to experience declines. But being able to identify women at higher risk could help lead to interventions targeted to them.”
 

Study details

The study included a cohort of 1,091 women drawn from the 3,302-participant Study of Women’s Health Across the Nation (SWAN), a racially and ethnically diverse group enrolled from six U.S. sites at or immediately before transition to menopause and followed for 10 years from age 55 to 65. The study sample, consisting of 24.6% Black, 24% Japanese or Chinese, and 51.9% White, had a median baseline age of 54.8 years and median BMI of 27 kg/m² at entry. The median baseline PCS score was 53.1 (interquartile range, 46.8-56.7).

Over 10 years, 206 (18.9%) of the women in the study experienced clinically important declines of at least 8 points in baseline characteristics at around age 55. The following were significantly associated with these declines:

• Having a higher BMI.
• Having osteoarthritis.
• Having a lower educational level.
• Being a current smoker.
• Having clinically significant depressive symptoms.
• Having cardiovascular disease.
• Having better (or higher) physical health and function score on the PCS.

The association between a higher PCS score and a greater decline might seem like an anomaly, Dr. Solomon said in an interview, but one interpretation of this finding is that women with higher or better scores at baseline have further to fall once other risk factors take effect.

With data analyzed from October 2020 to March 2021, the median 10-year change in PCS was –1.02 points, but 206 women experienced declines of 8 points or more.

Those with health declines were more likely to be Black and less likely to be Japanese. They were also more likely to have other comorbidities such as diabetes, hypertension, and osteoporosis, and to report less physical activity.
 

Scoring system should not replace individualized evaluation, outside expert said

Commenting on the findings, Margaret J. Nachtigall, MD, a clinical associate professor in the department of obstetrics and gynecology at New York University Langone Health, cautioned that a generalized scoring system should not replace individualized evaluation of women at midlife.

“I assess women around age 55 on a daily basis for health risk factors going forward. And while a number such as BMI can be helpful, I worry that reliance on a score could miss treating the individual,” Dr. Nachtigall said an interview. For instance, one woman might have a high BMI owing to greater muscle mass, which is heavy, while another may have a lower BMI but more fat-related weight, as well as exacerbating conditions such as hypertension that would elevate her risk. “You have to make the calculation for each person.”

Dr. Nachtigall, who was not involved in the SWAN analysis, noted, however, that a big-data scoring system might be a useful adjunct to individual patient evaluation in that “it would make physicians look at all these many risk factors to identify those prone to decline.”
 

Study includes racially diverse population

According to the authors, while other studies have identified similar and other risk factors such as poor sleep, most have not included such a racially diverse population and have focused on women already in their senior years when the window of opportunity may already have closed.

“As a clinician and epidemiologist, I often think about the window of opportunity at midlife, when people are vital, engaged, and resilient,” said Dr. Solomon in the statement. “If we can identify risk factors and determine who is at risk, we may be able to find interventions that can stave off health declines and help put people on a better health trajectory.”

Eric M. Ascher, DO, who practices family medicine at Lenox Hill Hospital in New York and was not involved in the SWAN research, agreed with Dr. Solomon.

“Doctors who treat chronic conditions often meet patients when they are already suffering from a medical problem,” he said in an interview. “It is key to decrease your risk factors before it is too late.”

Dr. Ascher added that many primary care providers already rely heavily on scoring systems when determining level of risk and type of intervention. “Any additional risk factor-scoring systems that are easy to implement and will prevent chronic diseases would be something providers would want to use with their patients.”

Detailed analyses of larger at-risk populations are needed to validate these risk factors and identify others, the authors said.

SWAN is supported by the National Institute on Aging, the National Institute of Nursing Research, and the National Institutes of Heath’s Office of Research on Women’s Health. Dr. Solomon reported financial ties to Amgen, AbbVie and Moderna, UpToDate, and Arthritis & Rheumatology; as well as serving on the board of directors for the Childhood Arthritis and Rheumatology Research Alliance and an advisory committee for the Food and Drug Administration outside of this work. Dr. Nachtigall and Dr. Ascher disclosed no conflicts of interest with regard to their comments.

Having specific health issues, including depressive symptoms and cardiovascular disease, as a middle-aged woman was associated with experiencing clinically important declines in health later in life, a new study finds.

The most predictive parameters of poorer health at age 65 were cardiovascular disease, clinically significant depressive symptoms, and current smoking. Osteoarthritis, lower education level, and higher body mass index (BMI) also were associated with poorer health status 10 years on, Daniel H. Solomon, MD, MPH and colleagues wrote in their observational study, which was published in JAMA Network Open.

Determining a patient’s score on a health-related quality of life measure based on these variables might be useful in clinical practice to recognize midlife patients at increased risk for later health deterioration, Dr. Solomon, of the division of rheumatology, inflammation, and immunity at Brigham and Women’s Hospital, Boston, said in a statement. This measure is called the Short Form 36 (SF-36), and the researchers specifically focused on the physical component summary score (PCS) of this measure. The SF-36 is similar to the Framingham 10-year coronary heart disease risk prediction score, according to Dr. Solomon, who is a professor of medicine at Harvard Medical School, also in Boston.

Based on their risk scores, women could preemptively target modifiable risk factors before they enter old age, the investigators wrote.

“Age 55-65 may be a critical decade. A person’s health and factors during this period may set them on a path for their later adult years,” Dr. Solomon said in a statement. “The good news is that a large proportion of women at midlife are very stable and will not go on to experience declines. But being able to identify women at higher risk could help lead to interventions targeted to them.”
 

Study details

The study included a cohort of 1,091 women drawn from the 3,302-participant Study of Women’s Health Across the Nation (SWAN), a racially and ethnically diverse group enrolled from six U.S. sites at or immediately before transition to menopause and followed for 10 years from age 55 to 65. The study sample, consisting of 24.6% Black, 24% Japanese or Chinese, and 51.9% White, had a median baseline age of 54.8 years and median BMI of 27 kg/m² at entry. The median baseline PCS score was 53.1 (interquartile range, 46.8-56.7).

Over 10 years, 206 (18.9%) of the women in the study experienced clinically important declines of at least 8 points in baseline characteristics at around age 55. The following were significantly associated with these declines:

• Having a higher BMI.
• Having osteoarthritis.
• Having a lower educational level.
• Being a current smoker.
• Having clinically significant depressive symptoms.
• Having cardiovascular disease.
• Having better (or higher) physical health and function score on the PCS.

The association between a higher PCS score and a greater decline might seem like an anomaly, Dr. Solomon said in an interview, but one interpretation of this finding is that women with higher or better scores at baseline have further to fall once other risk factors take effect.

With data analyzed from October 2020 to March 2021, the median 10-year change in PCS was –1.02 points, but 206 women experienced declines of 8 points or more.

Those with health declines were more likely to be Black and less likely to be Japanese. They were also more likely to have other comorbidities such as diabetes, hypertension, and osteoporosis, and to report less physical activity.
 

Scoring system should not replace individualized evaluation, outside expert said

Commenting on the findings, Margaret J. Nachtigall, MD, a clinical associate professor in the department of obstetrics and gynecology at New York University Langone Health, cautioned that a generalized scoring system should not replace individualized evaluation of women at midlife.

“I assess women around age 55 on a daily basis for health risk factors going forward. And while a number such as BMI can be helpful, I worry that reliance on a score could miss treating the individual,” Dr. Nachtigall said an interview. For instance, one woman might have a high BMI owing to greater muscle mass, which is heavy, while another may have a lower BMI but more fat-related weight, as well as exacerbating conditions such as hypertension that would elevate her risk. “You have to make the calculation for each person.”

Dr. Nachtigall, who was not involved in the SWAN analysis, noted, however, that a big-data scoring system might be a useful adjunct to individual patient evaluation in that “it would make physicians look at all these many risk factors to identify those prone to decline.”
 

Study includes racially diverse population

According to the authors, while other studies have identified similar and other risk factors such as poor sleep, most have not included such a racially diverse population and have focused on women already in their senior years when the window of opportunity may already have closed.

“As a clinician and epidemiologist, I often think about the window of opportunity at midlife, when people are vital, engaged, and resilient,” said Dr. Solomon in the statement. “If we can identify risk factors and determine who is at risk, we may be able to find interventions that can stave off health declines and help put people on a better health trajectory.”

Eric M. Ascher, DO, who practices family medicine at Lenox Hill Hospital in New York and was not involved in the SWAN research, agreed with Dr. Solomon.

“Doctors who treat chronic conditions often meet patients when they are already suffering from a medical problem,” he said in an interview. “It is key to decrease your risk factors before it is too late.”

Dr. Ascher added that many primary care providers already rely heavily on scoring systems when determining level of risk and type of intervention. “Any additional risk factor-scoring systems that are easy to implement and will prevent chronic diseases would be something providers would want to use with their patients.”

Detailed analyses of larger at-risk populations are needed to validate these risk factors and identify others, the authors said.

SWAN is supported by the National Institute on Aging, the National Institute of Nursing Research, and the National Institutes of Heath’s Office of Research on Women’s Health. Dr. Solomon reported financial ties to Amgen, AbbVie and Moderna, UpToDate, and Arthritis & Rheumatology; as well as serving on the board of directors for the Childhood Arthritis and Rheumatology Research Alliance and an advisory committee for the Food and Drug Administration outside of this work. Dr. Nachtigall and Dr. Ascher disclosed no conflicts of interest with regard to their comments.

Severe maternal sleep-disordered breathing (SDB) is a known risk factor for gestational diabetes, which is commonly diagnosed in the second or third trimester of pregnancy.

Now, a new study suggests that increases in insulin resistance, a precursor for gestational diabetes, may take place as early as the first trimester of pregnancy in women with risk factors for obstructive sleep apnea (OSA), such as overweight and habitual snoring.

This finding could potentially provide physicians with a window of opportunity to improve outcomes by screening at-risk women early in pregnancy or even prior to conception, Laura Sanapo, MD, assistant professor of medicine (research) at Brown University, Providence, R.I., and colleagues wrote in Sleep.

“Further studies are needed to investigate the association and its impact on the development of gestational diabetes, and to establish whether early-gestation or pregestational treatment of SDB would improve glucose metabolic outcomes in pregnancy,” they wrote.

”What this paper demonstrates is that the changes that predate gestational diabetes are seen much earlier in pregnancy,” senior study author Ghada Bourjeily, MD, professor of medicine at Brown University, said in an interview. Women should be screened for SDB rather than insulin resistance in early pregnancy since continuous positive airway pressure therapy (CPAP) is a highly effective intervention.

Waiting until midpregnancy to screen for OSA “is too late to make significant changes in the care of these women,” said Dr. Bourjeily, who is also director of research and training at the Women’s Medicine Collaborative at The Miriam Hospital in Providence, R.I. “By the time you diagnose gestational diabetes, the cat is out of the bag.”

For the study, women with early singleton pregnancies and risk factors for OSA such as habitual snoring and a median body mass index (BMI) of at least 27 kg/m² were recruited from two prospective clinical trial studies enriched for OSA positivity. Women with a history of pregestational diabetes and those using CPAP or receiving chronic steroid therapy were excluded from the current study.

A total of 192 study participants underwent in-home sleep study (HSAT) and homeostatic model assessment (HOMA) between 11 and 15 gestational weeks, respectively. The association between continuous measures of SDB as a respiratory-event index as well as oxygen-desaturation index and glucose metabolism parameters such as insulin resistance (HOMA-IR) were analyzed after adjusting for gestational age, maternal age, BMI, ethnicity, race, and parity.

In all, 61 women (32%) were diagnosed with OSA based on respiratory event index values greater than or equal to five events per hour. These participants were more likely to be older, to have a high BMI, and to be multipara, compared with women who didn’t have a diagnosis of OSA. Women with a diagnosis of OSA exhibited higher glucose and C-peptide values and a higher degree of insulin resistance, compared with women without OSA, the researchers found. An increase of 0.3 in HOMA-IR related to maternal SDB in early pregnancy may significantly affect glucose metabolism.

Although the findings of the current study cannot be extrapolated to women who don’t have overweight or obesity, some women with normal-range BMI (18.5-24.9) are also at increased risk of glucose metabolism changes, Dr. Bourjeily pointed out. This includes those of Southeast Asian descent. “We found that the association of SDB parameters with insulin resistance was actually happening independently of BMI and other factors.”

Ideally, screening for SDB would begin prior to pregnancy, Dr. Bourjeily said. A BMI greater than 25 should be taken into account and patients asked if they snore and if so, whether it’s loud enough to wake their partner. They should also be asked about experiencing daytime sleepiness.

“Based on these answers, especially in women screened prior to pregnancy, there will be time to make the diagnosis of sleep apnea and get the patient on CPAP,” Dr. Bourjeily said.

“This is an interesting study and one of the rare ones looking at early pregnancy and some of the mechanisms that could possibly be contributing to gestational diabetes,” commented Grenye O’Malley, MD, assistant professor in the division of endocrinology, diabetes, and bone disease at the Icahn School of Medicine at Mount Sinai, New York. Dr. O’Malley was not involved in the study.

“It confirms our suspicions that there’s probably a lot of things happening earlier in pregnancy before a diagnosis of gestational diabetes. It also confirms that some of the mechanisms are probably very similar to those involved in the association between disordered sleep and the development of type 2 diabetes.”

However, it’s too early to determine whether screening for SDB and the use of CPAP will prevent glycemic changes, Dr. O’Malley said in an interview. “Whenever we screen, we ask whether we have an intervention that changes outcomes and we don’t know that yet.”

Some of the symptoms of SDB are also common in early pregnancy, such as a BMI greater than 25 and daytime sleepiness, Dr. O’Malley pointed out. It was unclear whether the study participants had a propensity to develop type 2 diabetes or whether they were at risk of gestational diabetes.

This study was funded by the National Heart, Lung, and Blood Institute; the National Institute for Child Health; and the National Institute of General Medical Sciences. Dr. Bourjeily and colleagues, as well as Dr. O’Malley, reported having no potential financial conflicts of interest.

Severe maternal sleep-disordered breathing (SDB) is a known risk factor for gestational diabetes, which is commonly diagnosed in the second or third trimester of pregnancy.

Now, a new study suggests that increases in insulin resistance, a precursor for gestational diabetes, may take place as early as the first trimester of pregnancy in women with risk factors for obstructive sleep apnea (OSA), such as overweight and habitual snoring.

This finding could potentially provide physicians with a window of opportunity to improve outcomes by screening at-risk women early in pregnancy or even prior to conception, Laura Sanapo, MD, assistant professor of medicine (research) at Brown University, Providence, R.I., and colleagues wrote in Sleep.

“Further studies are needed to investigate the association and its impact on the development of gestational diabetes, and to establish whether early-gestation or pregestational treatment of SDB would improve glucose metabolic outcomes in pregnancy,” they wrote.

”What this paper demonstrates is that the changes that predate gestational diabetes are seen much earlier in pregnancy,” senior study author Ghada Bourjeily, MD, professor of medicine at Brown University, said in an interview. Women should be screened for SDB rather than insulin resistance in early pregnancy since continuous positive airway pressure therapy (CPAP) is a highly effective intervention.

Waiting until midpregnancy to screen for OSA “is too late to make significant changes in the care of these women,” said Dr. Bourjeily, who is also director of research and training at the Women’s Medicine Collaborative at The Miriam Hospital in Providence, R.I. “By the time you diagnose gestational diabetes, the cat is out of the bag.”

For the study, women with early singleton pregnancies and risk factors for OSA such as habitual snoring and a median body mass index (BMI) of at least 27 kg/m² were recruited from two prospective clinical trial studies enriched for OSA positivity. Women with a history of pregestational diabetes and those using CPAP or receiving chronic steroid therapy were excluded from the current study.

A total of 192 study participants underwent in-home sleep study (HSAT) and homeostatic model assessment (HOMA) between 11 and 15 gestational weeks, respectively. The association between continuous measures of SDB as a respiratory-event index as well as oxygen-desaturation index and glucose metabolism parameters such as insulin resistance (HOMA-IR) were analyzed after adjusting for gestational age, maternal age, BMI, ethnicity, race, and parity.

In all, 61 women (32%) were diagnosed with OSA based on respiratory event index values greater than or equal to five events per hour. These participants were more likely to be older, to have a high BMI, and to be multipara, compared with women who didn’t have a diagnosis of OSA. Women with a diagnosis of OSA exhibited higher glucose and C-peptide values and a higher degree of insulin resistance, compared with women without OSA, the researchers found. An increase of 0.3 in HOMA-IR related to maternal SDB in early pregnancy may significantly affect glucose metabolism.

Although the findings of the current study cannot be extrapolated to women who don’t have overweight or obesity, some women with normal-range BMI (18.5-24.9) are also at increased risk of glucose metabolism changes, Dr. Bourjeily pointed out. This includes those of Southeast Asian descent. “We found that the association of SDB parameters with insulin resistance was actually happening independently of BMI and other factors.”

Ideally, screening for SDB would begin prior to pregnancy, Dr. Bourjeily said. A BMI greater than 25 should be taken into account and patients asked if they snore and if so, whether it’s loud enough to wake their partner. They should also be asked about experiencing daytime sleepiness.

“Based on these answers, especially in women screened prior to pregnancy, there will be time to make the diagnosis of sleep apnea and get the patient on CPAP,” Dr. Bourjeily said.

“This is an interesting study and one of the rare ones looking at early pregnancy and some of the mechanisms that could possibly be contributing to gestational diabetes,” commented Grenye O’Malley, MD, assistant professor in the division of endocrinology, diabetes, and bone disease at the Icahn School of Medicine at Mount Sinai, New York. Dr. O’Malley was not involved in the study.

“It confirms our suspicions that there’s probably a lot of things happening earlier in pregnancy before a diagnosis of gestational diabetes. It also confirms that some of the mechanisms are probably very similar to those involved in the association between disordered sleep and the development of type 2 diabetes.”

However, it’s too early to determine whether screening for SDB and the use of CPAP will prevent glycemic changes, Dr. O’Malley said in an interview. “Whenever we screen, we ask whether we have an intervention that changes outcomes and we don’t know that yet.”

Some of the symptoms of SDB are also common in early pregnancy, such as a BMI greater than 25 and daytime sleepiness, Dr. O’Malley pointed out. It was unclear whether the study participants had a propensity to develop type 2 diabetes or whether they were at risk of gestational diabetes.

This study was funded by the National Heart, Lung, and Blood Institute; the National Institute for Child Health; and the National Institute of General Medical Sciences. Dr. Bourjeily and colleagues, as well as Dr. O’Malley, reported having no potential financial conflicts of interest.

Severe maternal sleep-disordered breathing (SDB) is a known risk factor for gestational diabetes, which is commonly diagnosed in the second or third trimester of pregnancy.

Now, a new study suggests that increases in insulin resistance, a precursor for gestational diabetes, may take place as early as the first trimester of pregnancy in women with risk factors for obstructive sleep apnea (OSA), such as overweight and habitual snoring.

This finding could potentially provide physicians with a window of opportunity to improve outcomes by screening at-risk women early in pregnancy or even prior to conception, Laura Sanapo, MD, assistant professor of medicine (research) at Brown University, Providence, R.I., and colleagues wrote in Sleep.

“Further studies are needed to investigate the association and its impact on the development of gestational diabetes, and to establish whether early-gestation or pregestational treatment of SDB would improve glucose metabolic outcomes in pregnancy,” they wrote.

”What this paper demonstrates is that the changes that predate gestational diabetes are seen much earlier in pregnancy,” senior study author Ghada Bourjeily, MD, professor of medicine at Brown University, said in an interview. Women should be screened for SDB rather than insulin resistance in early pregnancy since continuous positive airway pressure therapy (CPAP) is a highly effective intervention.

Waiting until midpregnancy to screen for OSA “is too late to make significant changes in the care of these women,” said Dr. Bourjeily, who is also director of research and training at the Women’s Medicine Collaborative at The Miriam Hospital in Providence, R.I. “By the time you diagnose gestational diabetes, the cat is out of the bag.”

For the study, women with early singleton pregnancies and risk factors for OSA such as habitual snoring and a median body mass index (BMI) of at least 27 kg/m² were recruited from two prospective clinical trial studies enriched for OSA positivity. Women with a history of pregestational diabetes and those using CPAP or receiving chronic steroid therapy were excluded from the current study.

A total of 192 study participants underwent in-home sleep study (HSAT) and homeostatic model assessment (HOMA) between 11 and 15 gestational weeks, respectively. The association between continuous measures of SDB as a respiratory-event index as well as oxygen-desaturation index and glucose metabolism parameters such as insulin resistance (HOMA-IR) were analyzed after adjusting for gestational age, maternal age, BMI, ethnicity, race, and parity.

In all, 61 women (32%) were diagnosed with OSA based on respiratory event index values greater than or equal to five events per hour. These participants were more likely to be older, to have a high BMI, and to be multipara, compared with women who didn’t have a diagnosis of OSA. Women with a diagnosis of OSA exhibited higher glucose and C-peptide values and a higher degree of insulin resistance, compared with women without OSA, the researchers found. An increase of 0.3 in HOMA-IR related to maternal SDB in early pregnancy may significantly affect glucose metabolism.

Although the findings of the current study cannot be extrapolated to women who don’t have overweight or obesity, some women with normal-range BMI (18.5-24.9) are also at increased risk of glucose metabolism changes, Dr. Bourjeily pointed out. This includes those of Southeast Asian descent. “We found that the association of SDB parameters with insulin resistance was actually happening independently of BMI and other factors.”

Ideally, screening for SDB would begin prior to pregnancy, Dr. Bourjeily said. A BMI greater than 25 should be taken into account and patients asked if they snore and if so, whether it’s loud enough to wake their partner. They should also be asked about experiencing daytime sleepiness.

“Based on these answers, especially in women screened prior to pregnancy, there will be time to make the diagnosis of sleep apnea and get the patient on CPAP,” Dr. Bourjeily said.

“This is an interesting study and one of the rare ones looking at early pregnancy and some of the mechanisms that could possibly be contributing to gestational diabetes,” commented Grenye O’Malley, MD, assistant professor in the division of endocrinology, diabetes, and bone disease at the Icahn School of Medicine at Mount Sinai, New York. Dr. O’Malley was not involved in the study.

“It confirms our suspicions that there’s probably a lot of things happening earlier in pregnancy before a diagnosis of gestational diabetes. It also confirms that some of the mechanisms are probably very similar to those involved in the association between disordered sleep and the development of type 2 diabetes.”

However, it’s too early to determine whether screening for SDB and the use of CPAP will prevent glycemic changes, Dr. O’Malley said in an interview. “Whenever we screen, we ask whether we have an intervention that changes outcomes and we don’t know that yet.”

Some of the symptoms of SDB are also common in early pregnancy, such as a BMI greater than 25 and daytime sleepiness, Dr. O’Malley pointed out. It was unclear whether the study participants had a propensity to develop type 2 diabetes or whether they were at risk of gestational diabetes.

This study was funded by the National Heart, Lung, and Blood Institute; the National Institute for Child Health; and the National Institute of General Medical Sciences. Dr. Bourjeily and colleagues, as well as Dr. O’Malley, reported having no potential financial conflicts of interest.

SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.