Barbara Levy, MD

Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273-282. doi:10.1016/j.ajcnut.2023.05.011.

EXPERT COMMENTARY

Preservation of function, both physical and cognitive, is key to long-term health and well-being. Age-related loss of function drives millions of people to spend an enormous amount of money each year on unregulated therapies—vitamins, supplements, infusions, hormones, and “natural” products—all toward the promise of improvement or preservation of physical strength, sexual function, and maintenance of lean body mass and cognitive abilities. Yeung and colleagues set out to determine whether the daily use of a multivitamin/mineral supplement (Centrum Silver) would impact memory in older adults.¹

Details of the study

The COSMOS-Web study was designed to test the authors’ primary hypothesis that daily dietary flavanols would improve memory over 1 year.¹ This study was embedded within the larger COSMOS (COcoa Supplement and Multivitamin Outcomes Study) trial, in which 21,442 people were recruited to assess the impact of flavanols and multivitamin supplements on cardiovascular and cancer outcomes.

Results of another ancillary study, the COSMOS-Mind trial (n = 2,262, average age 73, 60% female), reported no improvement with flavanols compared with placebo on a battery of tests of cognitive function administered by phone. In COSMOS-Mind, however, it was concluded that a daily multivitamin/mineral supplement improved the composite score of cognitive tests compared with placebo, particularly in participants with a history of cardiovascular disease.²

The COSMOS-Web trial recruited an additional cohort within the larger COSMOS trial from 2016–2017 (n = 3,562, average age 71, 67% female) to participate in this study specifically geared to assess memory, using the web-based ModRey test (a test of memory validated for use in a nonimpaired population). To qualify for enrollment, participants had to have access to an internet-connected computer. They were randomly assigned in a 2 x 2 study design to receive a daily multivitamin supplement or placebo; each of these cohorts was further divided into a flavanol supplementation or a placebo group. Analysis of the data showed no association between flavanol use and performance on any of the measures of memory or cognitive function.³

The COSMOS-Web trial assessed episodic recall, a function of hippocampus-mediated cognition that is particularly vulnerable to the effects of aging as demonstrated previously by neuroimaging and neuropsychological studies. The authors deployed a battery of 3 tests via a web platform for patients to complete online and independently.

The prespecified primary outcome was performance on episodic recall as measured by the ModRey test after 1 year of supplementation with multivitamins versus placebo. The ModRey test presents a series of 20 words at 3-second intervals to participants. At the conclusion of the last word, participants were asked to recall as many words as they could; after completing the 2 additional tasks, participants were asked again to recall the words. A secondary outcome of this test is the ratio of delayed to immediate recall.

Two additional tests were administered to assess cognitive performance related to different brain regions, the ModBent test (assessing novel object recognition) and the Flanker task (a measure of executive function). There was a placebo run-in phase during which participants’ adherence to daily supplement intake was ascertained. Participants were excluded if they demonstrated less than 75% adherence to study pills during the run-in placebo phase. The cognitive tasks were presented at study initiation and at yearly intervals for 3 years. The authors chose to use the results at 1 year as their primary outcome to assess the impact of supplementation during the period when adherence would be highest.

Results. At baseline, the placebo cohort recalled 7.2 words of 20 compared with 7.1 in the supplement group. In both groups there was a practice effect, with improvement in scores in the placebo group to 7.65 words and in the multivitamin group to 7.81 words. The improvement from baseline was statistically significantly better (0.71 words) in the multivitamin cohort than in the placebo group (0.45 words). There was no improvement in either group in the ModRey memory retention test (ability to recall the words after 15 minutes) or in the ModBent or Flanker tests. At 3 years of treatment, the placebo group improved by 0.92 words (SD, 3.22) whereas the multivitamin group improved by 1.13 words (SD, 3.39). These changes remained statistically significant.

The group with cardiovascular disease had lower baseline performance on the ModRey test. With supplementation, however, the improvement in this cohort was significantly greater than in those without cardiovascular disease at 1 year. The authors acknowledged that the changes were small and may not have been noticeable to the individuals, but they argued that even small changes as demonstrated in this study can have large health benefits at a population level.

The results of the COSMOS-Web trial corroborate the findings of the COSMOS-Mind study with respect to the benefits of multivitamin/mineral supplementation on cognitive test performance, particularly in a population with preexisting cardiovascular disease. The tests used across the 2 studies were different, which lends greater reliability to the findings.

Study strengths and limitations

A major strength of this study is its careful, rigorous design as a double-blind, placebo-controlled trial in a large patient population. Great care was devoted to ensuring study medication adherence. Another strength is that the cognitive tests chosen for the COSMOS-Web trial have been validated in cognitively normal populations, not those already impaired.

A limitation, however, is in the demographics of the study. The patient population was overwhelmingly White (93%), 67% were female, and they were well educated (94.8% having completed some college or beyond). Their baseline health was good; only 4.7% had a history of cardiovascular disease. Although generalizability of the study results from this population may be concerning,relative benefits of supplementation in this healthy, generally well-nourished and educated group may be lower than might be expected in a more nutritionally and educationally challenged population.

Finally, the difference between the placebo and active supplementation groups was small. Whether this less-than-1-word difference in immediate memory recall is noticeable by a patient is questionable. Both groups improved in their test performance over time—a consequence of serial cognitive tests of any kind. Although the authors calculated that the difference in recall translates to a 3-year reduction in age-related memory decline, it is hard to reconcile that with the fact that both groups actually improved over the 3 years of the study. ●

Acknowledgement

The author would like to thank JoAnn Manson, MD, DrPH, NCMP, for her assistance in evaluating the study.

Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273-282. doi:10.1016/j.ajcnut.2023.05.011.

EXPERT COMMENTARY

Preservation of function, both physical and cognitive, is key to long-term health and well-being. Age-related loss of function drives millions of people to spend an enormous amount of money each year on unregulated therapies—vitamins, supplements, infusions, hormones, and “natural” products—all toward the promise of improvement or preservation of physical strength, sexual function, and maintenance of lean body mass and cognitive abilities. Yeung and colleagues set out to determine whether the daily use of a multivitamin/mineral supplement (Centrum Silver) would impact memory in older adults.¹

Details of the study

The COSMOS-Web study was designed to test the authors’ primary hypothesis that daily dietary flavanols would improve memory over 1 year.¹ This study was embedded within the larger COSMOS (COcoa Supplement and Multivitamin Outcomes Study) trial, in which 21,442 people were recruited to assess the impact of flavanols and multivitamin supplements on cardiovascular and cancer outcomes.

Results of another ancillary study, the COSMOS-Mind trial (n = 2,262, average age 73, 60% female), reported no improvement with flavanols compared with placebo on a battery of tests of cognitive function administered by phone. In COSMOS-Mind, however, it was concluded that a daily multivitamin/mineral supplement improved the composite score of cognitive tests compared with placebo, particularly in participants with a history of cardiovascular disease.²

The COSMOS-Web trial recruited an additional cohort within the larger COSMOS trial from 2016–2017 (n = 3,562, average age 71, 67% female) to participate in this study specifically geared to assess memory, using the web-based ModRey test (a test of memory validated for use in a nonimpaired population). To qualify for enrollment, participants had to have access to an internet-connected computer. They were randomly assigned in a 2 x 2 study design to receive a daily multivitamin supplement or placebo; each of these cohorts was further divided into a flavanol supplementation or a placebo group. Analysis of the data showed no association between flavanol use and performance on any of the measures of memory or cognitive function.³

The COSMOS-Web trial assessed episodic recall, a function of hippocampus-mediated cognition that is particularly vulnerable to the effects of aging as demonstrated previously by neuroimaging and neuropsychological studies. The authors deployed a battery of 3 tests via a web platform for patients to complete online and independently.

The prespecified primary outcome was performance on episodic recall as measured by the ModRey test after 1 year of supplementation with multivitamins versus placebo. The ModRey test presents a series of 20 words at 3-second intervals to participants. At the conclusion of the last word, participants were asked to recall as many words as they could; after completing the 2 additional tasks, participants were asked again to recall the words. A secondary outcome of this test is the ratio of delayed to immediate recall.

Two additional tests were administered to assess cognitive performance related to different brain regions, the ModBent test (assessing novel object recognition) and the Flanker task (a measure of executive function). There was a placebo run-in phase during which participants’ adherence to daily supplement intake was ascertained. Participants were excluded if they demonstrated less than 75% adherence to study pills during the run-in placebo phase. The cognitive tasks were presented at study initiation and at yearly intervals for 3 years. The authors chose to use the results at 1 year as their primary outcome to assess the impact of supplementation during the period when adherence would be highest.

Results. At baseline, the placebo cohort recalled 7.2 words of 20 compared with 7.1 in the supplement group. In both groups there was a practice effect, with improvement in scores in the placebo group to 7.65 words and in the multivitamin group to 7.81 words. The improvement from baseline was statistically significantly better (0.71 words) in the multivitamin cohort than in the placebo group (0.45 words). There was no improvement in either group in the ModRey memory retention test (ability to recall the words after 15 minutes) or in the ModBent or Flanker tests. At 3 years of treatment, the placebo group improved by 0.92 words (SD, 3.22) whereas the multivitamin group improved by 1.13 words (SD, 3.39). These changes remained statistically significant.

The group with cardiovascular disease had lower baseline performance on the ModRey test. With supplementation, however, the improvement in this cohort was significantly greater than in those without cardiovascular disease at 1 year. The authors acknowledged that the changes were small and may not have been noticeable to the individuals, but they argued that even small changes as demonstrated in this study can have large health benefits at a population level.

The results of the COSMOS-Web trial corroborate the findings of the COSMOS-Mind study with respect to the benefits of multivitamin/mineral supplementation on cognitive test performance, particularly in a population with preexisting cardiovascular disease. The tests used across the 2 studies were different, which lends greater reliability to the findings.

Study strengths and limitations

A major strength of this study is its careful, rigorous design as a double-blind, placebo-controlled trial in a large patient population. Great care was devoted to ensuring study medication adherence. Another strength is that the cognitive tests chosen for the COSMOS-Web trial have been validated in cognitively normal populations, not those already impaired.

A limitation, however, is in the demographics of the study. The patient population was overwhelmingly White (93%), 67% were female, and they were well educated (94.8% having completed some college or beyond). Their baseline health was good; only 4.7% had a history of cardiovascular disease. Although generalizability of the study results from this population may be concerning,relative benefits of supplementation in this healthy, generally well-nourished and educated group may be lower than might be expected in a more nutritionally and educationally challenged population.

Finally, the difference between the placebo and active supplementation groups was small. Whether this less-than-1-word difference in immediate memory recall is noticeable by a patient is questionable. Both groups improved in their test performance over time—a consequence of serial cognitive tests of any kind. Although the authors calculated that the difference in recall translates to a 3-year reduction in age-related memory decline, it is hard to reconcile that with the fact that both groups actually improved over the 3 years of the study. ●

Acknowledgement

The author would like to thank JoAnn Manson, MD, DrPH, NCMP, for her assistance in evaluating the study.

Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273-282. doi:10.1016/j.ajcnut.2023.05.011.

EXPERT COMMENTARY

Preservation of function, both physical and cognitive, is key to long-term health and well-being. Age-related loss of function drives millions of people to spend an enormous amount of money each year on unregulated therapies—vitamins, supplements, infusions, hormones, and “natural” products—all toward the promise of improvement or preservation of physical strength, sexual function, and maintenance of lean body mass and cognitive abilities. Yeung and colleagues set out to determine whether the daily use of a multivitamin/mineral supplement (Centrum Silver) would impact memory in older adults.¹

Details of the study

The COSMOS-Web study was designed to test the authors’ primary hypothesis that daily dietary flavanols would improve memory over 1 year.¹ This study was embedded within the larger COSMOS (COcoa Supplement and Multivitamin Outcomes Study) trial, in which 21,442 people were recruited to assess the impact of flavanols and multivitamin supplements on cardiovascular and cancer outcomes.

Results of another ancillary study, the COSMOS-Mind trial (n = 2,262, average age 73, 60% female), reported no improvement with flavanols compared with placebo on a battery of tests of cognitive function administered by phone. In COSMOS-Mind, however, it was concluded that a daily multivitamin/mineral supplement improved the composite score of cognitive tests compared with placebo, particularly in participants with a history of cardiovascular disease.²

The COSMOS-Web trial recruited an additional cohort within the larger COSMOS trial from 2016–2017 (n = 3,562, average age 71, 67% female) to participate in this study specifically geared to assess memory, using the web-based ModRey test (a test of memory validated for use in a nonimpaired population). To qualify for enrollment, participants had to have access to an internet-connected computer. They were randomly assigned in a 2 x 2 study design to receive a daily multivitamin supplement or placebo; each of these cohorts was further divided into a flavanol supplementation or a placebo group. Analysis of the data showed no association between flavanol use and performance on any of the measures of memory or cognitive function.³

The COSMOS-Web trial assessed episodic recall, a function of hippocampus-mediated cognition that is particularly vulnerable to the effects of aging as demonstrated previously by neuroimaging and neuropsychological studies. The authors deployed a battery of 3 tests via a web platform for patients to complete online and independently.

The prespecified primary outcome was performance on episodic recall as measured by the ModRey test after 1 year of supplementation with multivitamins versus placebo. The ModRey test presents a series of 20 words at 3-second intervals to participants. At the conclusion of the last word, participants were asked to recall as many words as they could; after completing the 2 additional tasks, participants were asked again to recall the words. A secondary outcome of this test is the ratio of delayed to immediate recall.

Two additional tests were administered to assess cognitive performance related to different brain regions, the ModBent test (assessing novel object recognition) and the Flanker task (a measure of executive function). There was a placebo run-in phase during which participants’ adherence to daily supplement intake was ascertained. Participants were excluded if they demonstrated less than 75% adherence to study pills during the run-in placebo phase. The cognitive tasks were presented at study initiation and at yearly intervals for 3 years. The authors chose to use the results at 1 year as their primary outcome to assess the impact of supplementation during the period when adherence would be highest.

Results. At baseline, the placebo cohort recalled 7.2 words of 20 compared with 7.1 in the supplement group. In both groups there was a practice effect, with improvement in scores in the placebo group to 7.65 words and in the multivitamin group to 7.81 words. The improvement from baseline was statistically significantly better (0.71 words) in the multivitamin cohort than in the placebo group (0.45 words). There was no improvement in either group in the ModRey memory retention test (ability to recall the words after 15 minutes) or in the ModBent or Flanker tests. At 3 years of treatment, the placebo group improved by 0.92 words (SD, 3.22) whereas the multivitamin group improved by 1.13 words (SD, 3.39). These changes remained statistically significant.

The group with cardiovascular disease had lower baseline performance on the ModRey test. With supplementation, however, the improvement in this cohort was significantly greater than in those without cardiovascular disease at 1 year. The authors acknowledged that the changes were small and may not have been noticeable to the individuals, but they argued that even small changes as demonstrated in this study can have large health benefits at a population level.

The results of the COSMOS-Web trial corroborate the findings of the COSMOS-Mind study with respect to the benefits of multivitamin/mineral supplementation on cognitive test performance, particularly in a population with preexisting cardiovascular disease. The tests used across the 2 studies were different, which lends greater reliability to the findings.

Study strengths and limitations

A major strength of this study is its careful, rigorous design as a double-blind, placebo-controlled trial in a large patient population. Great care was devoted to ensuring study medication adherence. Another strength is that the cognitive tests chosen for the COSMOS-Web trial have been validated in cognitively normal populations, not those already impaired.

A limitation, however, is in the demographics of the study. The patient population was overwhelmingly White (93%), 67% were female, and they were well educated (94.8% having completed some college or beyond). Their baseline health was good; only 4.7% had a history of cardiovascular disease. Although generalizability of the study results from this population may be concerning,relative benefits of supplementation in this healthy, generally well-nourished and educated group may be lower than might be expected in a more nutritionally and educationally challenged population.

Finally, the difference between the placebo and active supplementation groups was small. Whether this less-than-1-word difference in immediate memory recall is noticeable by a patient is questionable. Both groups improved in their test performance over time—a consequence of serial cognitive tests of any kind. Although the authors calculated that the difference in recall translates to a 3-year reduction in age-related memory decline, it is hard to reconcile that with the fact that both groups actually improved over the 3 years of the study. ●

Acknowledgement

The author would like to thank JoAnn Manson, MD, DrPH, NCMP, for her assistance in evaluating the study.

Thoma ME, Declercq ER. Changes in pregnancy-related mortality associated with the coronavirus disease 2019 (COVID-19) pandemic in the United States. Obstet Gynecol. 2023. doi:10.1097/AOG0000000000005182.

EXPERT COMMENTARY

Maternal mortality rates in the United States were embarrassingly high and rising compared with other high-income countries prior to the onset of the COVID-19 pandemic. Recently, Thoma and Declercq aimed to assess the impact of COVID-19 on pregnancy-related deaths within 42 days of childbirth as well as out to 12 months postpartum.¹

During the pandemic, many issues may have affected maternity care and birthing experiences, including changes in prenatal care, restrictions that prevented support people from attending labor, and staffing shortages related to hospital overcrowding with personnel assignments away from labor and delivery. The study by Thoma and Declercq looked at maternal mortality from prior to the onset of the pandemic through changes in the health care environment, availability of vaccines, and emergence of more highly contagious and potentially more lethal viral variants.¹ All data were stratified by race, ethnicity, and locale. Death rates were compared between urban, metropolitan regions; suburban, mid-size regions; and rural locations.

Details of the study

Data were collected from the Centers for Disease Control and Prevention’s (CDC) publicly available WONDER database from 2019 to 2021. Because the absolute number of deaths within the American Indian/Alaska Native community was relatively small during that timeframe, data from 2018 also were accessed in order to verify reliability. The authors used the CDC’s definition of pregnancy-related death as “a death while pregnant or within 1 year of the end of pregnancy from any cause related to or aggravated by the pregnancy.”² International Classification of Diseases, Tenth Revision (ICD-10) codes were used to identify maternal deaths. The multiple causes of death file was queried to match maternal deaths with COVID-19 as a contributory cause.

Patterns of maternal deaths were compared with overall COVID-19 cases and COVID-19 death rates for reproductive-age women (ages 15 to 44) by quarters beginning in quarter 1 of 2019. Quarters through the first quarter of 2020 were prepandemic, then quarterly statistics were analyzed from the second quarter of 2020 through the end of 2021 to assess the impact of COVID-19 on early and late maternal mortality.

Findings. Overall maternal mortality rose by 26% from the beginning of 2020 to the second quarter, remained stable through mid-2021, then increased dramatically in the second half of 2021. Maternal mortality unrelated to COVID-19 remained fairly consistent at prior levels, whereas the COVID-19 associateddeaths mirrored the pattern of mortality among reproductive-age nonpregnant women attributed to COVID-19. In addition, the disparities in health outcomes observed in the population at large related to COVID-19 were similar among pregnant people.

American Indian/Alaska Native populations had the largest increase in mortality—more than doubling between early 2020 and the end of 2021. Black people experienced the largest absolute increase in mortality (up to 97.7/100,000 births) while Hispanic birthing people had the highest relative increase (from 19.3 to 29.8/100,000 births). While there were increases in maternal mortality among White and Asian birthing people, these variances were much smaller than for Black, Hispanic, and American Indian/Alaska Native populations.

When comparing mortality stratified by residence areas, early pandemic deaths were higher among birthing people in large urban areas (a 33% increase in 2020); however, later in the pandemic the rates increased substantially in medium-small metropolitan areas (39%) and rural areas (21%).

Study strengths and limitations

The administrative data used to inform this study is a relatively reliable dataset, although errors in both coding for COVID-19 as a contributory cause of maternal death and appropriate ascertainment of race and ethnicity may have occurred. Administrative data can highlight the trends in maternal mortality but cannot identify the root causes of these deaths. We are left with many questions regarding the contribution of staffing, support in labor, changes in prenatal care, and instability in food, housing, and comorbid medical conditions to this devastating rise in maternal mortality. ●

Thoma ME, Declercq ER. Changes in pregnancy-related mortality associated with the coronavirus disease 2019 (COVID-19) pandemic in the United States. Obstet Gynecol. 2023. doi:10.1097/AOG0000000000005182.

EXPERT COMMENTARY

Maternal mortality rates in the United States were embarrassingly high and rising compared with other high-income countries prior to the onset of the COVID-19 pandemic. Recently, Thoma and Declercq aimed to assess the impact of COVID-19 on pregnancy-related deaths within 42 days of childbirth as well as out to 12 months postpartum.¹

During the pandemic, many issues may have affected maternity care and birthing experiences, including changes in prenatal care, restrictions that prevented support people from attending labor, and staffing shortages related to hospital overcrowding with personnel assignments away from labor and delivery. The study by Thoma and Declercq looked at maternal mortality from prior to the onset of the pandemic through changes in the health care environment, availability of vaccines, and emergence of more highly contagious and potentially more lethal viral variants.¹ All data were stratified by race, ethnicity, and locale. Death rates were compared between urban, metropolitan regions; suburban, mid-size regions; and rural locations.

Details of the study

Data were collected from the Centers for Disease Control and Prevention’s (CDC) publicly available WONDER database from 2019 to 2021. Because the absolute number of deaths within the American Indian/Alaska Native community was relatively small during that timeframe, data from 2018 also were accessed in order to verify reliability. The authors used the CDC’s definition of pregnancy-related death as “a death while pregnant or within 1 year of the end of pregnancy from any cause related to or aggravated by the pregnancy.”² International Classification of Diseases, Tenth Revision (ICD-10) codes were used to identify maternal deaths. The multiple causes of death file was queried to match maternal deaths with COVID-19 as a contributory cause.

Patterns of maternal deaths were compared with overall COVID-19 cases and COVID-19 death rates for reproductive-age women (ages 15 to 44) by quarters beginning in quarter 1 of 2019. Quarters through the first quarter of 2020 were prepandemic, then quarterly statistics were analyzed from the second quarter of 2020 through the end of 2021 to assess the impact of COVID-19 on early and late maternal mortality.

Findings. Overall maternal mortality rose by 26% from the beginning of 2020 to the second quarter, remained stable through mid-2021, then increased dramatically in the second half of 2021. Maternal mortality unrelated to COVID-19 remained fairly consistent at prior levels, whereas the COVID-19 associateddeaths mirrored the pattern of mortality among reproductive-age nonpregnant women attributed to COVID-19. In addition, the disparities in health outcomes observed in the population at large related to COVID-19 were similar among pregnant people.

American Indian/Alaska Native populations had the largest increase in mortality—more than doubling between early 2020 and the end of 2021. Black people experienced the largest absolute increase in mortality (up to 97.7/100,000 births) while Hispanic birthing people had the highest relative increase (from 19.3 to 29.8/100,000 births). While there were increases in maternal mortality among White and Asian birthing people, these variances were much smaller than for Black, Hispanic, and American Indian/Alaska Native populations.

When comparing mortality stratified by residence areas, early pandemic deaths were higher among birthing people in large urban areas (a 33% increase in 2020); however, later in the pandemic the rates increased substantially in medium-small metropolitan areas (39%) and rural areas (21%).

Study strengths and limitations

The administrative data used to inform this study is a relatively reliable dataset, although errors in both coding for COVID-19 as a contributory cause of maternal death and appropriate ascertainment of race and ethnicity may have occurred. Administrative data can highlight the trends in maternal mortality but cannot identify the root causes of these deaths. We are left with many questions regarding the contribution of staffing, support in labor, changes in prenatal care, and instability in food, housing, and comorbid medical conditions to this devastating rise in maternal mortality. ●

Thoma ME, Declercq ER. Changes in pregnancy-related mortality associated with the coronavirus disease 2019 (COVID-19) pandemic in the United States. Obstet Gynecol. 2023. doi:10.1097/AOG0000000000005182.

EXPERT COMMENTARY

Maternal mortality rates in the United States were embarrassingly high and rising compared with other high-income countries prior to the onset of the COVID-19 pandemic. Recently, Thoma and Declercq aimed to assess the impact of COVID-19 on pregnancy-related deaths within 42 days of childbirth as well as out to 12 months postpartum.¹

During the pandemic, many issues may have affected maternity care and birthing experiences, including changes in prenatal care, restrictions that prevented support people from attending labor, and staffing shortages related to hospital overcrowding with personnel assignments away from labor and delivery. The study by Thoma and Declercq looked at maternal mortality from prior to the onset of the pandemic through changes in the health care environment, availability of vaccines, and emergence of more highly contagious and potentially more lethal viral variants.¹ All data were stratified by race, ethnicity, and locale. Death rates were compared between urban, metropolitan regions; suburban, mid-size regions; and rural locations.

Details of the study

Data were collected from the Centers for Disease Control and Prevention’s (CDC) publicly available WONDER database from 2019 to 2021. Because the absolute number of deaths within the American Indian/Alaska Native community was relatively small during that timeframe, data from 2018 also were accessed in order to verify reliability. The authors used the CDC’s definition of pregnancy-related death as “a death while pregnant or within 1 year of the end of pregnancy from any cause related to or aggravated by the pregnancy.”² International Classification of Diseases, Tenth Revision (ICD-10) codes were used to identify maternal deaths. The multiple causes of death file was queried to match maternal deaths with COVID-19 as a contributory cause.

Patterns of maternal deaths were compared with overall COVID-19 cases and COVID-19 death rates for reproductive-age women (ages 15 to 44) by quarters beginning in quarter 1 of 2019. Quarters through the first quarter of 2020 were prepandemic, then quarterly statistics were analyzed from the second quarter of 2020 through the end of 2021 to assess the impact of COVID-19 on early and late maternal mortality.

Findings. Overall maternal mortality rose by 26% from the beginning of 2020 to the second quarter, remained stable through mid-2021, then increased dramatically in the second half of 2021. Maternal mortality unrelated to COVID-19 remained fairly consistent at prior levels, whereas the COVID-19 associateddeaths mirrored the pattern of mortality among reproductive-age nonpregnant women attributed to COVID-19. In addition, the disparities in health outcomes observed in the population at large related to COVID-19 were similar among pregnant people.

American Indian/Alaska Native populations had the largest increase in mortality—more than doubling between early 2020 and the end of 2021. Black people experienced the largest absolute increase in mortality (up to 97.7/100,000 births) while Hispanic birthing people had the highest relative increase (from 19.3 to 29.8/100,000 births). While there were increases in maternal mortality among White and Asian birthing people, these variances were much smaller than for Black, Hispanic, and American Indian/Alaska Native populations.

When comparing mortality stratified by residence areas, early pandemic deaths were higher among birthing people in large urban areas (a 33% increase in 2020); however, later in the pandemic the rates increased substantially in medium-small metropolitan areas (39%) and rural areas (21%).

Study strengths and limitations

The administrative data used to inform this study is a relatively reliable dataset, although errors in both coding for COVID-19 as a contributory cause of maternal death and appropriate ascertainment of race and ethnicity may have occurred. Administrative data can highlight the trends in maternal mortality but cannot identify the root causes of these deaths. We are left with many questions regarding the contribution of staffing, support in labor, changes in prenatal care, and instability in food, housing, and comorbid medical conditions to this devastating rise in maternal mortality. ●

Many authors have commented on the lack of research into female sexual dysfunction, especially when compared with the hundreds of research publications related to male sexual health and dysfunction. Not surprisingly, very little has been published in the past year on the subject of female sexual health.

Recently, the International Society for the Study of Women’s Sexual Health (ISSWSH) published 2 important papers: a guideline on the use of testosterone for hypoactive sexual desire disorder (HSDD) in women and a consensus document on the management of persistent genital arousal disorder (PGAD). The lack of funding and support for female sexual health leaves women’s health professionals with little education or guidance on how to identify and treat conditions that are likely as common in women as erectile dysfunction is in men. While we would like to rely on randomized trials to inform our clinical care, the very limited literature on female sexual health makes this difficult. Bringing together experienced clinicians who focus their practices on sexual health, ISSWSH has provided some much-needed recommendations for the management of difficult conditions.

ISSWSH provides clinical guidance on testosterone therapy for women with HSDD

Parish S, Simon J, Davis S, et al. International Society for the Study of Women’s Sexual Health clinical practice guideline for the use of systemic testosterone for hypoactive sexual desire disorder in women. J Sex Med. 2021;18:849-867.

For development of the ISSWSH clinical practice guideline on testosterone therapy for women with HSDD, 16 international researchers and clinicians were convened. A modified Delphi method was used to establish consensus at the meeting on the recommended indications for testosterone treatment, formulations, and when measurement of testosterone levels is appropriate.

An extensive evidence-based literature review was performed, which included original research, meta-analyses, reviews, and clinical practice guidelines, to address the use of testosterone in women for management of HSDD. Notably, in 2019, representatives of  10 medical societies published a Global Consensus Position Statement on the Use of Testosterone Therapy for Women that reviewed the existing literature on testosterone’s effects on sexual dysfunction, mood, cognition, musculoskeletal, cardiovascular, and breast health as well as androgenic side effects and adverse events.¹ Based on their review, the only evidence-based indication for testosterone use is for the treatment of HSDD.

Testosterone formulations, HSDD diagnosis, and sex steroid physiology

More than 10 years ago, the US Food and Drug Administration (FDA) reviewed an application for the use of a transdermal testosterone patch (Intrinsa) in women for the treatment of HSDD. Efficacy of treatment was clearly demonstrated, and no safety signals were found in the placebo-controlled trial. Based, however, on the opinions of regulators who were “concerned” about the potential for cardiovascular adverse outcomes and worry that the peripheral conversion of testosterone to estradiol might lead to an increase in breast cancer—worry generated from the findings of the Women’s Health Initiative (which did not demonstrate an increase in breast cancer risk with estrogen alone but only when estrogen was combined with medroxyprogesterone acetate)—the FDA declined to approve the testosterone patch for women.

The Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) defined HSDD as “persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity with marked distress or interpersonal difficulty.” The guideline authors noted that although the DSM-5 edition merged female arousal disorder with desire disorder into a single diagnosis, they used the DSM-IV definition as it had been the basis for the studies and literature reviewed. HSDD is a prevalent condition worldwide that affects between 12% and  53% of peri- and postmenopausal women.

The consensus guideline authors extensively reviewed the physiology and mechanism of action of sex steroids in women, particularly their impact on sexual function and the biologic alterations that occur during peri- and postmenopause.

Continue to: Consensus position  and recommendations...

Consensus position  and recommendations

The ISSWSH consensus guideline concluded that there is a moderate therapeutic benefit in adding testosterone therapy to achieve up to premenopausal levels in postmenopausal women with self-reported reduction in sexual desire that is causing distress as determined by a validated instrument.

The authors advise baseline hormone testing to rule out androgen excess and baseline renal, lipid, liver, and metabolic testing, even though transdermal testosterone therapy was not shown to alter these parameters in randomized trials of more than 3,000 women. Laboratory assays for both total and free testosterone are “highly unreliable” in the female range as they have been calibrated for male levels of hormone.

FDA-approved testosterone treatments for men with hypogonadism include transdermal gels, patches, intramuscular injection, and an oral formulation. Dosing for women is approximately one-tenth the dosage for treatment of men. Patients should be informed that this treatment is off-label and that long-term studies to establish safety are not available. The authors advised against the use of compounded formulations based on the National Academies of Science, Engineering, and Medicine guidelines, but they went on to say that if compounded products are used, the pharmacy should adhere to Good Manufacturing Practice and Active Pharmaceutical Ingredients standards.

Rare, complex sexual function disorder requires integrated biopsychosocial approach, says ISSWSH

Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) review of epidemiology and pathophysiology, and a consensus nomenclature and process of care for the management of persistent genital arousal disorder/genito-pelvic dyesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.

Persistent genital arousal disorder is a poorly understood and relatively rare sexual dysfunction in women. The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin on Female Sexual Dysfunction does not mention this condition, leaving women’s health practitioners with little guidance as to diagnosis or management.² Prevalence for the condition is estimated at 1% to 3%. The symptoms may be intermittent or continuous.

In a recent ISSWSH review, a consensus panel defined 5 criteria for this disorder: the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient. The panel made a clear distinction between PGAD/ genito-pelvic dysesthesia (GPD) and Compulsive Sexual Behavior Disorder (defined by the International Classification of Diseases revision 11 as “a persistent pattern of failure to control intense, repetitive sexual impulses or urges). Because there is considerable overlap with syndromes of genital dysesthesia—itching, burning, tingling, or pain— the consensus panel elected to expand the nomenclature to describe both persistent genital arousal and genito-pelvic dysesthesia as a single syndrome, namely, PGAD/GPD.

Continue to: Negative impact of PGAD/GPD...

Negative impact of PGAD/GPD

The consensus panel identified several contributors to the overall morbidity of this complex disorder, including end organ pathology, peripheral nerve, spinal cord and central sensory processing malfunction, and significant psychological issues. PGAD/GPD also may be associated with spinal cysts, cauda equina pathology, and withdrawal from selective serotonin reuptake inhibitors (SSRIs). Functional magnetic resonance imaging has identified specific brain regions (for example, the paracentral lobule) that are active during clitoral stimulation and that also activate during patients’ experience of persistent genital arousal.

PGAD/GPD negatively impacts sexual function, mental health, and ability to function in daily life. Of major importance is that a large proportion of people with this disorder have significant mental health disorders; in a survey, 54% of patients with PGAD reported suicidal ideation, compared with 25% of participants in a control group.

Evaluation and management recommendations

Diagnosis and management of PGAD/GPD are directed at the 5 areas of evaluation:

• end organ
• pelvis and perineum (assess for pelvic floor tension myalgia, pudendal neuropathy, pelvic congestion syndrome, or pelvic arteriovenous malformation)
• cauda equina (evaluate for neurologic deficits related to cysts compressing S2-S3 nerve roots)
• spinal cord (serotonin and norepinephrine pathways modulate nociceptive sensory activity; either SSRI/serotonin and norepinephrine reuptake inhibitor (SNRI) withdrawal or treatment could impact PGAD/ GPD based on their actions in the spinal cord)
• brain.

The consensus panel recommends an integrated biopsychosocial model for evaluation and treatment of PGAD/GPD. Comorbid mental health conditions, such as depression and anxiety, are common. Small studies suggest that a history of sexual trauma may contribute to catastrophizing and the experience of distressing persistent genital sensations, either arousal or dyesthesia, with 46.7% to 52.6% of patients reporting childhood sexual abuse.³

Future possibilities and current  actualities for patient care

Research dollars and investment in female sexual dysfunction remain inadequate to address the considerable gaps that exist in evidence-based clinical guidelines. ISSWSH is working to help clinicians approach these evidence gaps with guidelines and consensus statements to help women’s health professionals identify and manage our patients with sexual concerns and symptoms. An expert consensus guideline on the assessment and management of female orgasmic disorder is currently under development (personal communication, Dr. Sheryl Kingsberg). In addition, a phase 2b trial is underway to assess the impact of topical sildenafil cream for the treatment of female arousal disorder. Stay tuned for the results of these studies.

For now, women’s health professionals have 2 FDA-approved treatment options for premenopausal women with arousal disorder, flibanserin (a daily oral medication that requires abstinence from alcohol) and bremelanotide (an injectable medication that can be used just prior to a sexual encounter). For postmenopausal women, there are no FDA-approved therapies; however, based on the ISSWSH guideline summarized above, transdermal testosterone may be offered to postmenopausal women with distressing loss of sexual desire in doses approximately one-tenth those used to treat men with androgen deficiency. These small doses are challenging to achieve consistently with the delivery systems available for FDA-approved products sold for men.

The National Academies of Science, Engineering, and Medicine advise against the use of compounded hormonal products due to the potential for inconsistency and lack of FDA oversight in the manufacturing/compounding process. I have found and used some compounding pharmacies that are dedicated to safety, quality control, and compliance; test their products; and provide consistent, reliable compounded drugs for my patients. Consideration of compounded testosterone should be discussed with patients, and they should be informed of the current professional association guidelines. Testosterone creams may be compounded to a 1% product—20 mg/mL. Researchers in Australia have demonstrated that 5 mg of transdermal testosterone cream (one-quarter of a mL) results in typical premenopausal testosterone levels.⁴ When prescribing testosterone for postmenopausal women, check in with them after 6 weeks of treatment to assess impact and check blood levels to ensure that levels are not too high.

Testosterone pellets and intramuscular testosterone are not recommended and in fact should be actively avoided. These methods of administration are associated with extreme variation in hormone levels over time. There are typically supraphysiologic and quite high levels immediately after implantation or injection, followed by fairly significant drop-offs and rapid return of symptoms over time. This may lead to more and more frequent dosing and markedly elevated serum levels.

Management of PGAD/GPD is difficult, but knowing it exists as a valid syndrome will help clinicians validate patients’ symptoms and begin to approach appropriate evaluation and workup targeted to the 5 domains suggested by the ISSWSH expert panel. It is useful to understand the possible relationship to initiation or withdrawal from SSRIs or SNRIs and how aberrant norepinephrine signaling along the sensory pathways may contribute to genital dysesthesia or chronic sensations of arousal. Nonpharmacologic therapies, such as cognitive-behavioral therapy and others, are essential components of the multifaceted approach to treatment. Finally, many complex problems, such as chronic pelvic pain, vestibulodynia, vulvodynia, and chronic fatigue syndrome, are associated with childhood adverse experiences and sexual trauma. Approaching these patients with trauma-informed care is important to create the trust and therapeutic environment they need for successful multidisciplinary care. ●

Many authors have commented on the lack of research into female sexual dysfunction, especially when compared with the hundreds of research publications related to male sexual health and dysfunction. Not surprisingly, very little has been published in the past year on the subject of female sexual health.

Recently, the International Society for the Study of Women’s Sexual Health (ISSWSH) published 2 important papers: a guideline on the use of testosterone for hypoactive sexual desire disorder (HSDD) in women and a consensus document on the management of persistent genital arousal disorder (PGAD). The lack of funding and support for female sexual health leaves women’s health professionals with little education or guidance on how to identify and treat conditions that are likely as common in women as erectile dysfunction is in men. While we would like to rely on randomized trials to inform our clinical care, the very limited literature on female sexual health makes this difficult. Bringing together experienced clinicians who focus their practices on sexual health, ISSWSH has provided some much-needed recommendations for the management of difficult conditions.

ISSWSH provides clinical guidance on testosterone therapy for women with HSDD

Parish S, Simon J, Davis S, et al. International Society for the Study of Women’s Sexual Health clinical practice guideline for the use of systemic testosterone for hypoactive sexual desire disorder in women. J Sex Med. 2021;18:849-867.

For development of the ISSWSH clinical practice guideline on testosterone therapy for women with HSDD, 16 international researchers and clinicians were convened. A modified Delphi method was used to establish consensus at the meeting on the recommended indications for testosterone treatment, formulations, and when measurement of testosterone levels is appropriate.

An extensive evidence-based literature review was performed, which included original research, meta-analyses, reviews, and clinical practice guidelines, to address the use of testosterone in women for management of HSDD. Notably, in 2019, representatives of  10 medical societies published a Global Consensus Position Statement on the Use of Testosterone Therapy for Women that reviewed the existing literature on testosterone’s effects on sexual dysfunction, mood, cognition, musculoskeletal, cardiovascular, and breast health as well as androgenic side effects and adverse events.¹ Based on their review, the only evidence-based indication for testosterone use is for the treatment of HSDD.

Testosterone formulations, HSDD diagnosis, and sex steroid physiology

More than 10 years ago, the US Food and Drug Administration (FDA) reviewed an application for the use of a transdermal testosterone patch (Intrinsa) in women for the treatment of HSDD. Efficacy of treatment was clearly demonstrated, and no safety signals were found in the placebo-controlled trial. Based, however, on the opinions of regulators who were “concerned” about the potential for cardiovascular adverse outcomes and worry that the peripheral conversion of testosterone to estradiol might lead to an increase in breast cancer—worry generated from the findings of the Women’s Health Initiative (which did not demonstrate an increase in breast cancer risk with estrogen alone but only when estrogen was combined with medroxyprogesterone acetate)—the FDA declined to approve the testosterone patch for women.

The Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) defined HSDD as “persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity with marked distress or interpersonal difficulty.” The guideline authors noted that although the DSM-5 edition merged female arousal disorder with desire disorder into a single diagnosis, they used the DSM-IV definition as it had been the basis for the studies and literature reviewed. HSDD is a prevalent condition worldwide that affects between 12% and  53% of peri- and postmenopausal women.

The consensus guideline authors extensively reviewed the physiology and mechanism of action of sex steroids in women, particularly their impact on sexual function and the biologic alterations that occur during peri- and postmenopause.

Continue to: Consensus position  and recommendations...

Consensus position  and recommendations

The ISSWSH consensus guideline concluded that there is a moderate therapeutic benefit in adding testosterone therapy to achieve up to premenopausal levels in postmenopausal women with self-reported reduction in sexual desire that is causing distress as determined by a validated instrument.

The authors advise baseline hormone testing to rule out androgen excess and baseline renal, lipid, liver, and metabolic testing, even though transdermal testosterone therapy was not shown to alter these parameters in randomized trials of more than 3,000 women. Laboratory assays for both total and free testosterone are “highly unreliable” in the female range as they have been calibrated for male levels of hormone.

FDA-approved testosterone treatments for men with hypogonadism include transdermal gels, patches, intramuscular injection, and an oral formulation. Dosing for women is approximately one-tenth the dosage for treatment of men. Patients should be informed that this treatment is off-label and that long-term studies to establish safety are not available. The authors advised against the use of compounded formulations based on the National Academies of Science, Engineering, and Medicine guidelines, but they went on to say that if compounded products are used, the pharmacy should adhere to Good Manufacturing Practice and Active Pharmaceutical Ingredients standards.

Rare, complex sexual function disorder requires integrated biopsychosocial approach, says ISSWSH

Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) review of epidemiology and pathophysiology, and a consensus nomenclature and process of care for the management of persistent genital arousal disorder/genito-pelvic dyesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.

Persistent genital arousal disorder is a poorly understood and relatively rare sexual dysfunction in women. The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin on Female Sexual Dysfunction does not mention this condition, leaving women’s health practitioners with little guidance as to diagnosis or management.² Prevalence for the condition is estimated at 1% to 3%. The symptoms may be intermittent or continuous.

In a recent ISSWSH review, a consensus panel defined 5 criteria for this disorder: the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient. The panel made a clear distinction between PGAD/ genito-pelvic dysesthesia (GPD) and Compulsive Sexual Behavior Disorder (defined by the International Classification of Diseases revision 11 as “a persistent pattern of failure to control intense, repetitive sexual impulses or urges). Because there is considerable overlap with syndromes of genital dysesthesia—itching, burning, tingling, or pain— the consensus panel elected to expand the nomenclature to describe both persistent genital arousal and genito-pelvic dysesthesia as a single syndrome, namely, PGAD/GPD.

Continue to: Negative impact of PGAD/GPD...

Negative impact of PGAD/GPD

The consensus panel identified several contributors to the overall morbidity of this complex disorder, including end organ pathology, peripheral nerve, spinal cord and central sensory processing malfunction, and significant psychological issues. PGAD/GPD also may be associated with spinal cysts, cauda equina pathology, and withdrawal from selective serotonin reuptake inhibitors (SSRIs). Functional magnetic resonance imaging has identified specific brain regions (for example, the paracentral lobule) that are active during clitoral stimulation and that also activate during patients’ experience of persistent genital arousal.

PGAD/GPD negatively impacts sexual function, mental health, and ability to function in daily life. Of major importance is that a large proportion of people with this disorder have significant mental health disorders; in a survey, 54% of patients with PGAD reported suicidal ideation, compared with 25% of participants in a control group.

Evaluation and management recommendations

Diagnosis and management of PGAD/GPD are directed at the 5 areas of evaluation:

• end organ
• pelvis and perineum (assess for pelvic floor tension myalgia, pudendal neuropathy, pelvic congestion syndrome, or pelvic arteriovenous malformation)
• cauda equina (evaluate for neurologic deficits related to cysts compressing S2-S3 nerve roots)
• spinal cord (serotonin and norepinephrine pathways modulate nociceptive sensory activity; either SSRI/serotonin and norepinephrine reuptake inhibitor (SNRI) withdrawal or treatment could impact PGAD/ GPD based on their actions in the spinal cord)
• brain.

The consensus panel recommends an integrated biopsychosocial model for evaluation and treatment of PGAD/GPD. Comorbid mental health conditions, such as depression and anxiety, are common. Small studies suggest that a history of sexual trauma may contribute to catastrophizing and the experience of distressing persistent genital sensations, either arousal or dyesthesia, with 46.7% to 52.6% of patients reporting childhood sexual abuse.³

Future possibilities and current  actualities for patient care

Research dollars and investment in female sexual dysfunction remain inadequate to address the considerable gaps that exist in evidence-based clinical guidelines. ISSWSH is working to help clinicians approach these evidence gaps with guidelines and consensus statements to help women’s health professionals identify and manage our patients with sexual concerns and symptoms. An expert consensus guideline on the assessment and management of female orgasmic disorder is currently under development (personal communication, Dr. Sheryl Kingsberg). In addition, a phase 2b trial is underway to assess the impact of topical sildenafil cream for the treatment of female arousal disorder. Stay tuned for the results of these studies.

For now, women’s health professionals have 2 FDA-approved treatment options for premenopausal women with arousal disorder, flibanserin (a daily oral medication that requires abstinence from alcohol) and bremelanotide (an injectable medication that can be used just prior to a sexual encounter). For postmenopausal women, there are no FDA-approved therapies; however, based on the ISSWSH guideline summarized above, transdermal testosterone may be offered to postmenopausal women with distressing loss of sexual desire in doses approximately one-tenth those used to treat men with androgen deficiency. These small doses are challenging to achieve consistently with the delivery systems available for FDA-approved products sold for men.

The National Academies of Science, Engineering, and Medicine advise against the use of compounded hormonal products due to the potential for inconsistency and lack of FDA oversight in the manufacturing/compounding process. I have found and used some compounding pharmacies that are dedicated to safety, quality control, and compliance; test their products; and provide consistent, reliable compounded drugs for my patients. Consideration of compounded testosterone should be discussed with patients, and they should be informed of the current professional association guidelines. Testosterone creams may be compounded to a 1% product—20 mg/mL. Researchers in Australia have demonstrated that 5 mg of transdermal testosterone cream (one-quarter of a mL) results in typical premenopausal testosterone levels.⁴ When prescribing testosterone for postmenopausal women, check in with them after 6 weeks of treatment to assess impact and check blood levels to ensure that levels are not too high.

Testosterone pellets and intramuscular testosterone are not recommended and in fact should be actively avoided. These methods of administration are associated with extreme variation in hormone levels over time. There are typically supraphysiologic and quite high levels immediately after implantation or injection, followed by fairly significant drop-offs and rapid return of symptoms over time. This may lead to more and more frequent dosing and markedly elevated serum levels.

Management of PGAD/GPD is difficult, but knowing it exists as a valid syndrome will help clinicians validate patients’ symptoms and begin to approach appropriate evaluation and workup targeted to the 5 domains suggested by the ISSWSH expert panel. It is useful to understand the possible relationship to initiation or withdrawal from SSRIs or SNRIs and how aberrant norepinephrine signaling along the sensory pathways may contribute to genital dysesthesia or chronic sensations of arousal. Nonpharmacologic therapies, such as cognitive-behavioral therapy and others, are essential components of the multifaceted approach to treatment. Finally, many complex problems, such as chronic pelvic pain, vestibulodynia, vulvodynia, and chronic fatigue syndrome, are associated with childhood adverse experiences and sexual trauma. Approaching these patients with trauma-informed care is important to create the trust and therapeutic environment they need for successful multidisciplinary care. ●

Many authors have commented on the lack of research into female sexual dysfunction, especially when compared with the hundreds of research publications related to male sexual health and dysfunction. Not surprisingly, very little has been published in the past year on the subject of female sexual health.

Recently, the International Society for the Study of Women’s Sexual Health (ISSWSH) published 2 important papers: a guideline on the use of testosterone for hypoactive sexual desire disorder (HSDD) in women and a consensus document on the management of persistent genital arousal disorder (PGAD). The lack of funding and support for female sexual health leaves women’s health professionals with little education or guidance on how to identify and treat conditions that are likely as common in women as erectile dysfunction is in men. While we would like to rely on randomized trials to inform our clinical care, the very limited literature on female sexual health makes this difficult. Bringing together experienced clinicians who focus their practices on sexual health, ISSWSH has provided some much-needed recommendations for the management of difficult conditions.

ISSWSH provides clinical guidance on testosterone therapy for women with HSDD

Parish S, Simon J, Davis S, et al. International Society for the Study of Women’s Sexual Health clinical practice guideline for the use of systemic testosterone for hypoactive sexual desire disorder in women. J Sex Med. 2021;18:849-867.

For development of the ISSWSH clinical practice guideline on testosterone therapy for women with HSDD, 16 international researchers and clinicians were convened. A modified Delphi method was used to establish consensus at the meeting on the recommended indications for testosterone treatment, formulations, and when measurement of testosterone levels is appropriate.

An extensive evidence-based literature review was performed, which included original research, meta-analyses, reviews, and clinical practice guidelines, to address the use of testosterone in women for management of HSDD. Notably, in 2019, representatives of  10 medical societies published a Global Consensus Position Statement on the Use of Testosterone Therapy for Women that reviewed the existing literature on testosterone’s effects on sexual dysfunction, mood, cognition, musculoskeletal, cardiovascular, and breast health as well as androgenic side effects and adverse events.¹ Based on their review, the only evidence-based indication for testosterone use is for the treatment of HSDD.

Testosterone formulations, HSDD diagnosis, and sex steroid physiology

More than 10 years ago, the US Food and Drug Administration (FDA) reviewed an application for the use of a transdermal testosterone patch (Intrinsa) in women for the treatment of HSDD. Efficacy of treatment was clearly demonstrated, and no safety signals were found in the placebo-controlled trial. Based, however, on the opinions of regulators who were “concerned” about the potential for cardiovascular adverse outcomes and worry that the peripheral conversion of testosterone to estradiol might lead to an increase in breast cancer—worry generated from the findings of the Women’s Health Initiative (which did not demonstrate an increase in breast cancer risk with estrogen alone but only when estrogen was combined with medroxyprogesterone acetate)—the FDA declined to approve the testosterone patch for women.

The Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) defined HSDD as “persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity with marked distress or interpersonal difficulty.” The guideline authors noted that although the DSM-5 edition merged female arousal disorder with desire disorder into a single diagnosis, they used the DSM-IV definition as it had been the basis for the studies and literature reviewed. HSDD is a prevalent condition worldwide that affects between 12% and  53% of peri- and postmenopausal women.

The consensus guideline authors extensively reviewed the physiology and mechanism of action of sex steroids in women, particularly their impact on sexual function and the biologic alterations that occur during peri- and postmenopause.

Continue to: Consensus position  and recommendations...

Consensus position  and recommendations

The ISSWSH consensus guideline concluded that there is a moderate therapeutic benefit in adding testosterone therapy to achieve up to premenopausal levels in postmenopausal women with self-reported reduction in sexual desire that is causing distress as determined by a validated instrument.

The authors advise baseline hormone testing to rule out androgen excess and baseline renal, lipid, liver, and metabolic testing, even though transdermal testosterone therapy was not shown to alter these parameters in randomized trials of more than 3,000 women. Laboratory assays for both total and free testosterone are “highly unreliable” in the female range as they have been calibrated for male levels of hormone.

FDA-approved testosterone treatments for men with hypogonadism include transdermal gels, patches, intramuscular injection, and an oral formulation. Dosing for women is approximately one-tenth the dosage for treatment of men. Patients should be informed that this treatment is off-label and that long-term studies to establish safety are not available. The authors advised against the use of compounded formulations based on the National Academies of Science, Engineering, and Medicine guidelines, but they went on to say that if compounded products are used, the pharmacy should adhere to Good Manufacturing Practice and Active Pharmaceutical Ingredients standards.

Rare, complex sexual function disorder requires integrated biopsychosocial approach, says ISSWSH

Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) review of epidemiology and pathophysiology, and a consensus nomenclature and process of care for the management of persistent genital arousal disorder/genito-pelvic dyesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.

Persistent genital arousal disorder is a poorly understood and relatively rare sexual dysfunction in women. The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin on Female Sexual Dysfunction does not mention this condition, leaving women’s health practitioners with little guidance as to diagnosis or management.² Prevalence for the condition is estimated at 1% to 3%. The symptoms may be intermittent or continuous.

In a recent ISSWSH review, a consensus panel defined 5 criteria for this disorder: the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient. The panel made a clear distinction between PGAD/ genito-pelvic dysesthesia (GPD) and Compulsive Sexual Behavior Disorder (defined by the International Classification of Diseases revision 11 as “a persistent pattern of failure to control intense, repetitive sexual impulses or urges). Because there is considerable overlap with syndromes of genital dysesthesia—itching, burning, tingling, or pain— the consensus panel elected to expand the nomenclature to describe both persistent genital arousal and genito-pelvic dysesthesia as a single syndrome, namely, PGAD/GPD.

Continue to: Negative impact of PGAD/GPD...

Negative impact of PGAD/GPD

The consensus panel identified several contributors to the overall morbidity of this complex disorder, including end organ pathology, peripheral nerve, spinal cord and central sensory processing malfunction, and significant psychological issues. PGAD/GPD also may be associated with spinal cysts, cauda equina pathology, and withdrawal from selective serotonin reuptake inhibitors (SSRIs). Functional magnetic resonance imaging has identified specific brain regions (for example, the paracentral lobule) that are active during clitoral stimulation and that also activate during patients’ experience of persistent genital arousal.

PGAD/GPD negatively impacts sexual function, mental health, and ability to function in daily life. Of major importance is that a large proportion of people with this disorder have significant mental health disorders; in a survey, 54% of patients with PGAD reported suicidal ideation, compared with 25% of participants in a control group.

Evaluation and management recommendations

Diagnosis and management of PGAD/GPD are directed at the 5 areas of evaluation:

• end organ
• pelvis and perineum (assess for pelvic floor tension myalgia, pudendal neuropathy, pelvic congestion syndrome, or pelvic arteriovenous malformation)
• cauda equina (evaluate for neurologic deficits related to cysts compressing S2-S3 nerve roots)
• spinal cord (serotonin and norepinephrine pathways modulate nociceptive sensory activity; either SSRI/serotonin and norepinephrine reuptake inhibitor (SNRI) withdrawal or treatment could impact PGAD/ GPD based on their actions in the spinal cord)
• brain.

The consensus panel recommends an integrated biopsychosocial model for evaluation and treatment of PGAD/GPD. Comorbid mental health conditions, such as depression and anxiety, are common. Small studies suggest that a history of sexual trauma may contribute to catastrophizing and the experience of distressing persistent genital sensations, either arousal or dyesthesia, with 46.7% to 52.6% of patients reporting childhood sexual abuse.³

Future possibilities and current  actualities for patient care

Research dollars and investment in female sexual dysfunction remain inadequate to address the considerable gaps that exist in evidence-based clinical guidelines. ISSWSH is working to help clinicians approach these evidence gaps with guidelines and consensus statements to help women’s health professionals identify and manage our patients with sexual concerns and symptoms. An expert consensus guideline on the assessment and management of female orgasmic disorder is currently under development (personal communication, Dr. Sheryl Kingsberg). In addition, a phase 2b trial is underway to assess the impact of topical sildenafil cream for the treatment of female arousal disorder. Stay tuned for the results of these studies.

For now, women’s health professionals have 2 FDA-approved treatment options for premenopausal women with arousal disorder, flibanserin (a daily oral medication that requires abstinence from alcohol) and bremelanotide (an injectable medication that can be used just prior to a sexual encounter). For postmenopausal women, there are no FDA-approved therapies; however, based on the ISSWSH guideline summarized above, transdermal testosterone may be offered to postmenopausal women with distressing loss of sexual desire in doses approximately one-tenth those used to treat men with androgen deficiency. These small doses are challenging to achieve consistently with the delivery systems available for FDA-approved products sold for men.

The National Academies of Science, Engineering, and Medicine advise against the use of compounded hormonal products due to the potential for inconsistency and lack of FDA oversight in the manufacturing/compounding process. I have found and used some compounding pharmacies that are dedicated to safety, quality control, and compliance; test their products; and provide consistent, reliable compounded drugs for my patients. Consideration of compounded testosterone should be discussed with patients, and they should be informed of the current professional association guidelines. Testosterone creams may be compounded to a 1% product—20 mg/mL. Researchers in Australia have demonstrated that 5 mg of transdermal testosterone cream (one-quarter of a mL) results in typical premenopausal testosterone levels.⁴ When prescribing testosterone for postmenopausal women, check in with them after 6 weeks of treatment to assess impact and check blood levels to ensure that levels are not too high.

Testosterone pellets and intramuscular testosterone are not recommended and in fact should be actively avoided. These methods of administration are associated with extreme variation in hormone levels over time. There are typically supraphysiologic and quite high levels immediately after implantation or injection, followed by fairly significant drop-offs and rapid return of symptoms over time. This may lead to more and more frequent dosing and markedly elevated serum levels.

Management of PGAD/GPD is difficult, but knowing it exists as a valid syndrome will help clinicians validate patients’ symptoms and begin to approach appropriate evaluation and workup targeted to the 5 domains suggested by the ISSWSH expert panel. It is useful to understand the possible relationship to initiation or withdrawal from SSRIs or SNRIs and how aberrant norepinephrine signaling along the sensory pathways may contribute to genital dysesthesia or chronic sensations of arousal. Nonpharmacologic therapies, such as cognitive-behavioral therapy and others, are essential components of the multifaceted approach to treatment. Finally, many complex problems, such as chronic pelvic pain, vestibulodynia, vulvodynia, and chronic fatigue syndrome, are associated with childhood adverse experiences and sexual trauma. Approaching these patients with trauma-informed care is important to create the trust and therapeutic environment they need for successful multidisciplinary care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

We have been interested in the quiz series focused on breast cancer screening for women with dense breasts presented in OBG Management by DenseBreast-Info.org. However, we have concerns with the answer as presented in the December 2021 issue, “Average-risk women with dense breasts—What breast screening is appropriate?” (OBG Manag. 2021;33(12):18-19. doi: 10.12788/obgm.0155.) The main question asks about appropriate imaging beyond mammography/tomosynthesis for women with extremely dense breasts and no other risk factors for breast cancer. The authors recommend magnetic resonance imaging (MRI), ultrasonography, or contrast-enhanced mammography (if MRI is not an option). This advice, however, does not follow current guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other professional organizations. We can certainly understand that an advocacy group would want ObGyns to be proactive about adjunctive imaging in average-risk women with heterogeneously dense or extremely dense breasts. However, at this point in time, there are no clear data to support a recommendation for adding universal MRI in this population, for many reasons that we will discuss herein.

The concerns with breast cancer in particular

Breast cancer is not cervical cancer. It isn’t one disease. It is a multitude of diseases that happen to show up in the breast. Some are relatively slow-growing—the kinds of cancers that lend themselves to screening and to early intervention. But other cancers are rapidly-growing; they show up no matter how often or what modality we use for screening. Our goal should be to find an approach to screening that can diagnose breast cancer at a stage where we can intervene and positively impact breast cancer specific and overall mortality.

Screening guidelines vary

The variety of screening guidelines published by different professional organizations reflect differing assumptions and sets of values related to the early diagnosis and treatment of breast cancer. (For a comprehensive table of current screening guidelines, see https://www.cdc.gov/cancer/breast/pdf/breast-cancer-screening-guidelines-508.pdf.)

ACOG’s approach—to offer screening at age 40 but to begin by at least age 50 and, through shared decision making with the patient, screen every 1 or 2 years—is focused on capturing as many cases as we can identify, while minimizing the harms of false-positives.¹ The perspective of the US Preventive Services Task Force (USPSTF) recommendations (to screen every 2 years beginning at age 50) is at the population level, a cost-effective approach that will have the greatest benefit while minimizing harms in the population at large.² The American Society of Breast Surgeons recommends screening to begin by age 40.³ Like the breast surgeons, radiologists dedicated to breast imaging are focused on an individual rather than a population level. They strive to identify each and every instance of possible cancer, and therefore recommend annual screening beginning at age 40.⁴ However, with more aggressive screening in average-risk women many cases of ductal carcinoma in situ (DCIS) are identified—a lesion that, if not detected, may not impact the woman’s health during her lifetime—representing what some might call “overdiagnosis.” Yet there may be some instances in which the DCIS might affect an individual woman’s health. Unfortunately, we can’t prospectively distinguish between the first and the second types of cases.

Continue to: Research on breast cancer screening varies by design...

Research on breast cancer screening varies by design

There has not been a randomized clinical trial conducted on screening mammography since the days of the analog mammogram. The research that has been conducted is difficult to compare due to variations in screening ages and intervals, technology sensitivity, and patient adherence with recommended screening. Treatments for breast cancer also have changed dramatically over time, so the findings of older studies may no longer be relevant to current breast cancer screening. The kind of analysis that needs to be done is an interrupted time series, where you can look at the trajectory of breast cancer survival and whether screening mammography shifts that survival in any way.

One specific study from Australia measured the impact of newer available breast cancer treatments, including tamoxifen for women with receptor-positive tumors and newer chemotherapy strategies.⁵ The authors analyzed screening mammography trends in one large province where women aged 50 to 69 were offered biennial screening. Trends from the 1990s showed that more women were being screened over time. Simultaneously, however, advances in therapy were entering clinical practice. The researchers pointed to a substantial decline in mortality from breast cancer from the early 1980s until 2013. But their conclusion was that none of the decline in mortality for breast cancer could be attributed to screening mammography when they looked at time trends; from their perspective all of the important decline in breast cancer mortality resulted from better treatment. They concluded that government programs should not support screening mammography.⁵

That is a recommendation that we do not support. However, we do recognize the conundrum that mammography is less sensitive among those who have dense breasts. In order to have congruent professional guidelines, we support research funding to determine which types, starting ages, and intervals of screening would be best in various patient populations. The USPSTF cites data from studies performed in the 1980s based on outdated technology; more recent (and relevant) randomized clinical trials have not been performed, and yet this information is critical to provide sufficient evidence to develop appropriate guidelines.

Our recommendations for gathering new data

The kind of data we would find most valuable would assess how different screening strategies impact overall mortality and breast cancer-specific mortality. It would require decades of follow-up—which of course means that screening technology will change over that time. A surrogate for evaluating overall survival is to look at interval cancers, which are all breast cancers diagnosed following negative mammograms and prior to the next screening. These cancers may or may not be biologically active, again focusing us on the need to look at overall survival of the patient. In addition, reducing breast cancer mortality may not reduce overall mortality, because the treatment for breast cancer may cause heart disease, or osteoporosis, or something else that impacts overall survival. These are important considerations for women and physicians who are making choices on treatment. What matters to a patient are 2 overlapping questions:

• Do I have a life-threatening condition or do I not?
• Has screening identified a condition that might lead to treatment that’s unnecessary?

The problem is that with breast cancer we can’t tell the difference. We do not understand the biological potential of a lesion when we evaluate an image on MRI, or computed tomography (CT), or mammography.

A re-look at presented data

A trial conducted by Bakker and colleagues⁶ was discussed by the authors of the DenseBreast-info.org quiz in which they recommended breast MRI for all women with extremely dense breasts (but no other risk factors for breast cancer) detected on screening mammograms.⁷ The Bakker study was large and conducted in the Netherlands. The primary outcome of the trial was to compare the incidence of interval breast cancers of women aged 50 to 75 randomly assigned to MRI versus those assigned to continued screening mammography every 2 years. Importantly, among the more than 8,000 women who were assigned to MRI, 59%, or fewer than two-thirds, chose to actually undergo MRI.

Among women randomized to MRI, 20 interval cancers were found—4 were diagnosed in those who actually had MRIs, and 16 were diagnosed among women who were randomized to MRI but didn’t undergo the study. Among women assigned to screening mammography only, 161 interval cancers were diagnosed among more than 32,000 women screened. The primary outcome findings were 2.5 interval cancers per 1,000 screenings among women randomly assigned to MRI, and 5 interval cancers per 1,000 screenings among those randomly assigned to mammography only.⁶

Because the trial included women aged 50 and older, we can’t apply these results to younger women, who often undergo screening mammography in the United States. In addition, the majority of the population in the Netherlands are of Western European ethnicity, a less-diverse population of women than in the United States. Furthermore, among the tumors that were detected in the MRI group, a larger proportion were DCIS, early-stage tumors, well differentiated, and hormone receptor-positive. This observation supports that many of the MRI-detected tumors were cases of overdiagnosis, or the detection of tumors destined not to cause clinical problems for the patient during her lifetime, or for which earlier diagnosis would impact survival.

We also know that treatment of these small ER-positive tumors carries risks for patients, as we may treat them by depriving a patient of estrogen for the rest of her life, with potential consequences of sexual dysfunction, osteoporosis, and perhaps cardiovascular disease depending on her age at the time of that diagnosis. Weighing the risks and benefits of not only treatment but also use of more sensitive screening techniques such as MRI is extremely important. Although Bakker and colleagues’ study results are interesting, we do not feel they support routinely recommending MRI for women found to have extremely dense breasts with mammography.

Overdiagnosis: A difficult concept

One reason overdiagnosis is so challenging to understand is that it can’t be directly measured, which makes comprehending it that much more problematic for clinicians and our patients.

One way to help grasp the overall issue is to compare screening mammography with cervical and colon cancer screening.

We are well aware that cervical cancer screening has reduced the incidence of mortality from invasive cervical cancer.⁸ We can argue very validly that the biggest success in any cancer screening program in history and globally has been cervical cancer screening. Our specialty, in particular, should feel proud about this. Screening colonoscopy also has repeatedly been found to reduce colon cancer mortality.⁹ For breast cancer, decades of media messaging have emphasized the benefits of screening mammograms; however, in contrast with cervical cancer screening and colonoscopy, screening mammography has not reduced the incidence of breast cancer presenting with metastatic or advanced disease. Danish authors pointed out in 2017 that screening mammography has not achieved the hoped for or the promised reduction in breast cancer mortality.¹⁰

A report published in the March 2022, issue of Annals of Internal Medicine used modeling techniques to estimate the incidence of overdiagnosis and concluded that, among women aged 50-74 years receiving biennial screening mammograms (consistent with USPSTF recommendations), more than 15% of screen-detected breast cancers would represent cases of overdiagnosis. Of note, the study authors found that, among screen-detected cancers, the proportion representing overdiagnosis among women in their 60s (16.7%) and early 70s (23.6%) was higher than among women in their 50s-60s (11.5%-11.6%).¹¹

The former Chief Medical and Scientific Officer for the American Cancer Society Otis Brawley, MD, has stated that, at the same time that breast cancer screening should not be abandoned, “We must acknowledge that overdiagnosis is common. The benefits of screening have been overstated, and some patients considered as ‘cured’ from breast cancer have, in fact, been harmed by unneeded treatment.”¹²

“Everybody loves early detection,” said Donald Berry, PhD, from MD Anderson Cancer Center, “but it comes with harms.” He points out that mortality rates have improved for breast cancer, but he attributes it to improved treatment. “The harms [of screening] we know, but the benefits of screening are very uncertain.”¹³

Continue to: Limitations of breast MRI...

Limitations of breast MRI

Overall, MRI is a diagnostic and monitoring test. It is costlier than mammography, and because it is not recommended in guidelines as a screening modality for most women, it is not typically covered by insurance. Abbreviated (rapid) MRI is a non-standardized imaging strategy being used at a few health centers. It has a shorter protocol overall than MRI, so it takes less time than current MRI and is less expensive, but there are few data on sensitivity and specificity. It is yet to be determined which populations could benefit from this newer technology.

As mentioned, 41% of women in the Bakker et al trial who were randomly assigned to breast MRI chose not to proceed with that exam even though it would have been at no cost to them.⁶ Anecdotally, some patients who have undergone MRI say they would forgo it a second time as a screening modality because it was a very unpleasant, stressful experience. It’s not a perfect test, although it is more sensitive than mammography.

Other options for following up dense-breast screening. Besides MRI and abbreviated MRI, the following modalities can be used to evaluate women found to have dense breasts with screening mammograms: CT mammography with contrast, molecular breast imaging, and ultrasonography.

Screening and treatment advances

3D mammography. In the US, the great majority of screening mammography now is performed with tomosynthesis, or what our patients sometimes call 3D mammography. In fact, it is approaching standard of care. Women whose screening mammography includes tomosynthesis are less likely to experience a so-called callback for additional imaging with diagnostic mammography or breast ultrasonography.¹⁴

Liquid biopsy. A potential major advancement for making decisions about when to treat cancers in general involves determining the biological behavior of a tumor, based on analysis of either circulating tumor DNA or proteins in the blood. As more experience with this new technology accumulates, the role of liquid biopsies for breast cancer will expand.¹⁵ Liquid biopsies for screening remain investigational for now, but they hold tremendous potential.

Noninvasive proteomics. With the development of noninvasive proteomic biomarkers obtained from blood, saliva, or nipple aspiration fluid, there exists the possibility of not just evaluating an image of a tumor seen on a mammogram, but actually studying the biological characteristics of that lesion.¹⁶ The cost of this technology is far less in terms of resources than MRI or molecular-based imaging, and actually reveals the flaws with using image-based screening. With proteomics, we can tell whether or not a lump is generating proteins that are going to make that disease biologically meaningful, and treatment decisions can be based on that information. This idea has the potential to disrupt our current breast cancer screening paradigm.

Advocacy’s role in mandating legislation

Many advocacy groups lobby on Capitol Hill for legislation related to health care, but we don’t feel that is the best way to make scientific decisions, and it’s not the way to do medicine. Passionate people, who truly believe that their outcome would have been different had something else been done, have every right to advocate, and should. However, without longer-term data focusing on breast cancer and overall mortality, rather than surrogate outcomes like interval cancers, it is not clear that routinely recommending supplemental MRI will improve survival for women with extremely dense breasts. Unfortunately, overall, earlier diagnosis of highly aggressive breast cancer tumors does not result in better outcomes for patients. ●

We have been interested in the quiz series focused on breast cancer screening for women with dense breasts presented in OBG Management by DenseBreast-Info.org. However, we have concerns with the answer as presented in the December 2021 issue, “Average-risk women with dense breasts—What breast screening is appropriate?” (OBG Manag. 2021;33(12):18-19. doi: 10.12788/obgm.0155.) The main question asks about appropriate imaging beyond mammography/tomosynthesis for women with extremely dense breasts and no other risk factors for breast cancer. The authors recommend magnetic resonance imaging (MRI), ultrasonography, or contrast-enhanced mammography (if MRI is not an option). This advice, however, does not follow current guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other professional organizations. We can certainly understand that an advocacy group would want ObGyns to be proactive about adjunctive imaging in average-risk women with heterogeneously dense or extremely dense breasts. However, at this point in time, there are no clear data to support a recommendation for adding universal MRI in this population, for many reasons that we will discuss herein.

The concerns with breast cancer in particular

Breast cancer is not cervical cancer. It isn’t one disease. It is a multitude of diseases that happen to show up in the breast. Some are relatively slow-growing—the kinds of cancers that lend themselves to screening and to early intervention. But other cancers are rapidly-growing; they show up no matter how often or what modality we use for screening. Our goal should be to find an approach to screening that can diagnose breast cancer at a stage where we can intervene and positively impact breast cancer specific and overall mortality.

Screening guidelines vary

The variety of screening guidelines published by different professional organizations reflect differing assumptions and sets of values related to the early diagnosis and treatment of breast cancer. (For a comprehensive table of current screening guidelines, see https://www.cdc.gov/cancer/breast/pdf/breast-cancer-screening-guidelines-508.pdf.)

ACOG’s approach—to offer screening at age 40 but to begin by at least age 50 and, through shared decision making with the patient, screen every 1 or 2 years—is focused on capturing as many cases as we can identify, while minimizing the harms of false-positives.¹ The perspective of the US Preventive Services Task Force (USPSTF) recommendations (to screen every 2 years beginning at age 50) is at the population level, a cost-effective approach that will have the greatest benefit while minimizing harms in the population at large.² The American Society of Breast Surgeons recommends screening to begin by age 40.³ Like the breast surgeons, radiologists dedicated to breast imaging are focused on an individual rather than a population level. They strive to identify each and every instance of possible cancer, and therefore recommend annual screening beginning at age 40.⁴ However, with more aggressive screening in average-risk women many cases of ductal carcinoma in situ (DCIS) are identified—a lesion that, if not detected, may not impact the woman’s health during her lifetime—representing what some might call “overdiagnosis.” Yet there may be some instances in which the DCIS might affect an individual woman’s health. Unfortunately, we can’t prospectively distinguish between the first and the second types of cases.

Continue to: Research on breast cancer screening varies by design...

Research on breast cancer screening varies by design

There has not been a randomized clinical trial conducted on screening mammography since the days of the analog mammogram. The research that has been conducted is difficult to compare due to variations in screening ages and intervals, technology sensitivity, and patient adherence with recommended screening. Treatments for breast cancer also have changed dramatically over time, so the findings of older studies may no longer be relevant to current breast cancer screening. The kind of analysis that needs to be done is an interrupted time series, where you can look at the trajectory of breast cancer survival and whether screening mammography shifts that survival in any way.

One specific study from Australia measured the impact of newer available breast cancer treatments, including tamoxifen for women with receptor-positive tumors and newer chemotherapy strategies.⁵ The authors analyzed screening mammography trends in one large province where women aged 50 to 69 were offered biennial screening. Trends from the 1990s showed that more women were being screened over time. Simultaneously, however, advances in therapy were entering clinical practice. The researchers pointed to a substantial decline in mortality from breast cancer from the early 1980s until 2013. But their conclusion was that none of the decline in mortality for breast cancer could be attributed to screening mammography when they looked at time trends; from their perspective all of the important decline in breast cancer mortality resulted from better treatment. They concluded that government programs should not support screening mammography.⁵

That is a recommendation that we do not support. However, we do recognize the conundrum that mammography is less sensitive among those who have dense breasts. In order to have congruent professional guidelines, we support research funding to determine which types, starting ages, and intervals of screening would be best in various patient populations. The USPSTF cites data from studies performed in the 1980s based on outdated technology; more recent (and relevant) randomized clinical trials have not been performed, and yet this information is critical to provide sufficient evidence to develop appropriate guidelines.

Our recommendations for gathering new data

The kind of data we would find most valuable would assess how different screening strategies impact overall mortality and breast cancer-specific mortality. It would require decades of follow-up—which of course means that screening technology will change over that time. A surrogate for evaluating overall survival is to look at interval cancers, which are all breast cancers diagnosed following negative mammograms and prior to the next screening. These cancers may or may not be biologically active, again focusing us on the need to look at overall survival of the patient. In addition, reducing breast cancer mortality may not reduce overall mortality, because the treatment for breast cancer may cause heart disease, or osteoporosis, or something else that impacts overall survival. These are important considerations for women and physicians who are making choices on treatment. What matters to a patient are 2 overlapping questions:

• Do I have a life-threatening condition or do I not?
• Has screening identified a condition that might lead to treatment that’s unnecessary?

The problem is that with breast cancer we can’t tell the difference. We do not understand the biological potential of a lesion when we evaluate an image on MRI, or computed tomography (CT), or mammography.

A re-look at presented data

A trial conducted by Bakker and colleagues⁶ was discussed by the authors of the DenseBreast-info.org quiz in which they recommended breast MRI for all women with extremely dense breasts (but no other risk factors for breast cancer) detected on screening mammograms.⁷ The Bakker study was large and conducted in the Netherlands. The primary outcome of the trial was to compare the incidence of interval breast cancers of women aged 50 to 75 randomly assigned to MRI versus those assigned to continued screening mammography every 2 years. Importantly, among the more than 8,000 women who were assigned to MRI, 59%, or fewer than two-thirds, chose to actually undergo MRI.

Among women randomized to MRI, 20 interval cancers were found—4 were diagnosed in those who actually had MRIs, and 16 were diagnosed among women who were randomized to MRI but didn’t undergo the study. Among women assigned to screening mammography only, 161 interval cancers were diagnosed among more than 32,000 women screened. The primary outcome findings were 2.5 interval cancers per 1,000 screenings among women randomly assigned to MRI, and 5 interval cancers per 1,000 screenings among those randomly assigned to mammography only.⁶

Because the trial included women aged 50 and older, we can’t apply these results to younger women, who often undergo screening mammography in the United States. In addition, the majority of the population in the Netherlands are of Western European ethnicity, a less-diverse population of women than in the United States. Furthermore, among the tumors that were detected in the MRI group, a larger proportion were DCIS, early-stage tumors, well differentiated, and hormone receptor-positive. This observation supports that many of the MRI-detected tumors were cases of overdiagnosis, or the detection of tumors destined not to cause clinical problems for the patient during her lifetime, or for which earlier diagnosis would impact survival.

We also know that treatment of these small ER-positive tumors carries risks for patients, as we may treat them by depriving a patient of estrogen for the rest of her life, with potential consequences of sexual dysfunction, osteoporosis, and perhaps cardiovascular disease depending on her age at the time of that diagnosis. Weighing the risks and benefits of not only treatment but also use of more sensitive screening techniques such as MRI is extremely important. Although Bakker and colleagues’ study results are interesting, we do not feel they support routinely recommending MRI for women found to have extremely dense breasts with mammography.

Overdiagnosis: A difficult concept

One reason overdiagnosis is so challenging to understand is that it can’t be directly measured, which makes comprehending it that much more problematic for clinicians and our patients.

One way to help grasp the overall issue is to compare screening mammography with cervical and colon cancer screening.

We are well aware that cervical cancer screening has reduced the incidence of mortality from invasive cervical cancer.⁸ We can argue very validly that the biggest success in any cancer screening program in history and globally has been cervical cancer screening. Our specialty, in particular, should feel proud about this. Screening colonoscopy also has repeatedly been found to reduce colon cancer mortality.⁹ For breast cancer, decades of media messaging have emphasized the benefits of screening mammograms; however, in contrast with cervical cancer screening and colonoscopy, screening mammography has not reduced the incidence of breast cancer presenting with metastatic or advanced disease. Danish authors pointed out in 2017 that screening mammography has not achieved the hoped for or the promised reduction in breast cancer mortality.¹⁰

A report published in the March 2022, issue of Annals of Internal Medicine used modeling techniques to estimate the incidence of overdiagnosis and concluded that, among women aged 50-74 years receiving biennial screening mammograms (consistent with USPSTF recommendations), more than 15% of screen-detected breast cancers would represent cases of overdiagnosis. Of note, the study authors found that, among screen-detected cancers, the proportion representing overdiagnosis among women in their 60s (16.7%) and early 70s (23.6%) was higher than among women in their 50s-60s (11.5%-11.6%).¹¹

The former Chief Medical and Scientific Officer for the American Cancer Society Otis Brawley, MD, has stated that, at the same time that breast cancer screening should not be abandoned, “We must acknowledge that overdiagnosis is common. The benefits of screening have been overstated, and some patients considered as ‘cured’ from breast cancer have, in fact, been harmed by unneeded treatment.”¹²

“Everybody loves early detection,” said Donald Berry, PhD, from MD Anderson Cancer Center, “but it comes with harms.” He points out that mortality rates have improved for breast cancer, but he attributes it to improved treatment. “The harms [of screening] we know, but the benefits of screening are very uncertain.”¹³

Continue to: Limitations of breast MRI...

Limitations of breast MRI

Overall, MRI is a diagnostic and monitoring test. It is costlier than mammography, and because it is not recommended in guidelines as a screening modality for most women, it is not typically covered by insurance. Abbreviated (rapid) MRI is a non-standardized imaging strategy being used at a few health centers. It has a shorter protocol overall than MRI, so it takes less time than current MRI and is less expensive, but there are few data on sensitivity and specificity. It is yet to be determined which populations could benefit from this newer technology.

As mentioned, 41% of women in the Bakker et al trial who were randomly assigned to breast MRI chose not to proceed with that exam even though it would have been at no cost to them.⁶ Anecdotally, some patients who have undergone MRI say they would forgo it a second time as a screening modality because it was a very unpleasant, stressful experience. It’s not a perfect test, although it is more sensitive than mammography.

Other options for following up dense-breast screening. Besides MRI and abbreviated MRI, the following modalities can be used to evaluate women found to have dense breasts with screening mammograms: CT mammography with contrast, molecular breast imaging, and ultrasonography.

Screening and treatment advances

3D mammography. In the US, the great majority of screening mammography now is performed with tomosynthesis, or what our patients sometimes call 3D mammography. In fact, it is approaching standard of care. Women whose screening mammography includes tomosynthesis are less likely to experience a so-called callback for additional imaging with diagnostic mammography or breast ultrasonography.¹⁴

Liquid biopsy. A potential major advancement for making decisions about when to treat cancers in general involves determining the biological behavior of a tumor, based on analysis of either circulating tumor DNA or proteins in the blood. As more experience with this new technology accumulates, the role of liquid biopsies for breast cancer will expand.¹⁵ Liquid biopsies for screening remain investigational for now, but they hold tremendous potential.

Noninvasive proteomics. With the development of noninvasive proteomic biomarkers obtained from blood, saliva, or nipple aspiration fluid, there exists the possibility of not just evaluating an image of a tumor seen on a mammogram, but actually studying the biological characteristics of that lesion.¹⁶ The cost of this technology is far less in terms of resources than MRI or molecular-based imaging, and actually reveals the flaws with using image-based screening. With proteomics, we can tell whether or not a lump is generating proteins that are going to make that disease biologically meaningful, and treatment decisions can be based on that information. This idea has the potential to disrupt our current breast cancer screening paradigm.

Advocacy’s role in mandating legislation

Many advocacy groups lobby on Capitol Hill for legislation related to health care, but we don’t feel that is the best way to make scientific decisions, and it’s not the way to do medicine. Passionate people, who truly believe that their outcome would have been different had something else been done, have every right to advocate, and should. However, without longer-term data focusing on breast cancer and overall mortality, rather than surrogate outcomes like interval cancers, it is not clear that routinely recommending supplemental MRI will improve survival for women with extremely dense breasts. Unfortunately, overall, earlier diagnosis of highly aggressive breast cancer tumors does not result in better outcomes for patients. ●

We have been interested in the quiz series focused on breast cancer screening for women with dense breasts presented in OBG Management by DenseBreast-Info.org. However, we have concerns with the answer as presented in the December 2021 issue, “Average-risk women with dense breasts—What breast screening is appropriate?” (OBG Manag. 2021;33(12):18-19. doi: 10.12788/obgm.0155.) The main question asks about appropriate imaging beyond mammography/tomosynthesis for women with extremely dense breasts and no other risk factors for breast cancer. The authors recommend magnetic resonance imaging (MRI), ultrasonography, or contrast-enhanced mammography (if MRI is not an option). This advice, however, does not follow current guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other professional organizations. We can certainly understand that an advocacy group would want ObGyns to be proactive about adjunctive imaging in average-risk women with heterogeneously dense or extremely dense breasts. However, at this point in time, there are no clear data to support a recommendation for adding universal MRI in this population, for many reasons that we will discuss herein.

The concerns with breast cancer in particular

Breast cancer is not cervical cancer. It isn’t one disease. It is a multitude of diseases that happen to show up in the breast. Some are relatively slow-growing—the kinds of cancers that lend themselves to screening and to early intervention. But other cancers are rapidly-growing; they show up no matter how often or what modality we use for screening. Our goal should be to find an approach to screening that can diagnose breast cancer at a stage where we can intervene and positively impact breast cancer specific and overall mortality.

Screening guidelines vary

The variety of screening guidelines published by different professional organizations reflect differing assumptions and sets of values related to the early diagnosis and treatment of breast cancer. (For a comprehensive table of current screening guidelines, see https://www.cdc.gov/cancer/breast/pdf/breast-cancer-screening-guidelines-508.pdf.)

ACOG’s approach—to offer screening at age 40 but to begin by at least age 50 and, through shared decision making with the patient, screen every 1 or 2 years—is focused on capturing as many cases as we can identify, while minimizing the harms of false-positives.¹ The perspective of the US Preventive Services Task Force (USPSTF) recommendations (to screen every 2 years beginning at age 50) is at the population level, a cost-effective approach that will have the greatest benefit while minimizing harms in the population at large.² The American Society of Breast Surgeons recommends screening to begin by age 40.³ Like the breast surgeons, radiologists dedicated to breast imaging are focused on an individual rather than a population level. They strive to identify each and every instance of possible cancer, and therefore recommend annual screening beginning at age 40.⁴ However, with more aggressive screening in average-risk women many cases of ductal carcinoma in situ (DCIS) are identified—a lesion that, if not detected, may not impact the woman’s health during her lifetime—representing what some might call “overdiagnosis.” Yet there may be some instances in which the DCIS might affect an individual woman’s health. Unfortunately, we can’t prospectively distinguish between the first and the second types of cases.

Continue to: Research on breast cancer screening varies by design...

Research on breast cancer screening varies by design

There has not been a randomized clinical trial conducted on screening mammography since the days of the analog mammogram. The research that has been conducted is difficult to compare due to variations in screening ages and intervals, technology sensitivity, and patient adherence with recommended screening. Treatments for breast cancer also have changed dramatically over time, so the findings of older studies may no longer be relevant to current breast cancer screening. The kind of analysis that needs to be done is an interrupted time series, where you can look at the trajectory of breast cancer survival and whether screening mammography shifts that survival in any way.

One specific study from Australia measured the impact of newer available breast cancer treatments, including tamoxifen for women with receptor-positive tumors and newer chemotherapy strategies.⁵ The authors analyzed screening mammography trends in one large province where women aged 50 to 69 were offered biennial screening. Trends from the 1990s showed that more women were being screened over time. Simultaneously, however, advances in therapy were entering clinical practice. The researchers pointed to a substantial decline in mortality from breast cancer from the early 1980s until 2013. But their conclusion was that none of the decline in mortality for breast cancer could be attributed to screening mammography when they looked at time trends; from their perspective all of the important decline in breast cancer mortality resulted from better treatment. They concluded that government programs should not support screening mammography.⁵

That is a recommendation that we do not support. However, we do recognize the conundrum that mammography is less sensitive among those who have dense breasts. In order to have congruent professional guidelines, we support research funding to determine which types, starting ages, and intervals of screening would be best in various patient populations. The USPSTF cites data from studies performed in the 1980s based on outdated technology; more recent (and relevant) randomized clinical trials have not been performed, and yet this information is critical to provide sufficient evidence to develop appropriate guidelines.

Our recommendations for gathering new data

The kind of data we would find most valuable would assess how different screening strategies impact overall mortality and breast cancer-specific mortality. It would require decades of follow-up—which of course means that screening technology will change over that time. A surrogate for evaluating overall survival is to look at interval cancers, which are all breast cancers diagnosed following negative mammograms and prior to the next screening. These cancers may or may not be biologically active, again focusing us on the need to look at overall survival of the patient. In addition, reducing breast cancer mortality may not reduce overall mortality, because the treatment for breast cancer may cause heart disease, or osteoporosis, or something else that impacts overall survival. These are important considerations for women and physicians who are making choices on treatment. What matters to a patient are 2 overlapping questions:

• Do I have a life-threatening condition or do I not?
• Has screening identified a condition that might lead to treatment that’s unnecessary?

The problem is that with breast cancer we can’t tell the difference. We do not understand the biological potential of a lesion when we evaluate an image on MRI, or computed tomography (CT), or mammography.

A re-look at presented data

A trial conducted by Bakker and colleagues⁶ was discussed by the authors of the DenseBreast-info.org quiz in which they recommended breast MRI for all women with extremely dense breasts (but no other risk factors for breast cancer) detected on screening mammograms.⁷ The Bakker study was large and conducted in the Netherlands. The primary outcome of the trial was to compare the incidence of interval breast cancers of women aged 50 to 75 randomly assigned to MRI versus those assigned to continued screening mammography every 2 years. Importantly, among the more than 8,000 women who were assigned to MRI, 59%, or fewer than two-thirds, chose to actually undergo MRI.

Among women randomized to MRI, 20 interval cancers were found—4 were diagnosed in those who actually had MRIs, and 16 were diagnosed among women who were randomized to MRI but didn’t undergo the study. Among women assigned to screening mammography only, 161 interval cancers were diagnosed among more than 32,000 women screened. The primary outcome findings were 2.5 interval cancers per 1,000 screenings among women randomly assigned to MRI, and 5 interval cancers per 1,000 screenings among those randomly assigned to mammography only.⁶

Because the trial included women aged 50 and older, we can’t apply these results to younger women, who often undergo screening mammography in the United States. In addition, the majority of the population in the Netherlands are of Western European ethnicity, a less-diverse population of women than in the United States. Furthermore, among the tumors that were detected in the MRI group, a larger proportion were DCIS, early-stage tumors, well differentiated, and hormone receptor-positive. This observation supports that many of the MRI-detected tumors were cases of overdiagnosis, or the detection of tumors destined not to cause clinical problems for the patient during her lifetime, or for which earlier diagnosis would impact survival.

We also know that treatment of these small ER-positive tumors carries risks for patients, as we may treat them by depriving a patient of estrogen for the rest of her life, with potential consequences of sexual dysfunction, osteoporosis, and perhaps cardiovascular disease depending on her age at the time of that diagnosis. Weighing the risks and benefits of not only treatment but also use of more sensitive screening techniques such as MRI is extremely important. Although Bakker and colleagues’ study results are interesting, we do not feel they support routinely recommending MRI for women found to have extremely dense breasts with mammography.

Overdiagnosis: A difficult concept

One reason overdiagnosis is so challenging to understand is that it can’t be directly measured, which makes comprehending it that much more problematic for clinicians and our patients.

One way to help grasp the overall issue is to compare screening mammography with cervical and colon cancer screening.

We are well aware that cervical cancer screening has reduced the incidence of mortality from invasive cervical cancer.⁸ We can argue very validly that the biggest success in any cancer screening program in history and globally has been cervical cancer screening. Our specialty, in particular, should feel proud about this. Screening colonoscopy also has repeatedly been found to reduce colon cancer mortality.⁹ For breast cancer, decades of media messaging have emphasized the benefits of screening mammograms; however, in contrast with cervical cancer screening and colonoscopy, screening mammography has not reduced the incidence of breast cancer presenting with metastatic or advanced disease. Danish authors pointed out in 2017 that screening mammography has not achieved the hoped for or the promised reduction in breast cancer mortality.¹⁰

A report published in the March 2022, issue of Annals of Internal Medicine used modeling techniques to estimate the incidence of overdiagnosis and concluded that, among women aged 50-74 years receiving biennial screening mammograms (consistent with USPSTF recommendations), more than 15% of screen-detected breast cancers would represent cases of overdiagnosis. Of note, the study authors found that, among screen-detected cancers, the proportion representing overdiagnosis among women in their 60s (16.7%) and early 70s (23.6%) was higher than among women in their 50s-60s (11.5%-11.6%).¹¹

The former Chief Medical and Scientific Officer for the American Cancer Society Otis Brawley, MD, has stated that, at the same time that breast cancer screening should not be abandoned, “We must acknowledge that overdiagnosis is common. The benefits of screening have been overstated, and some patients considered as ‘cured’ from breast cancer have, in fact, been harmed by unneeded treatment.”¹²

“Everybody loves early detection,” said Donald Berry, PhD, from MD Anderson Cancer Center, “but it comes with harms.” He points out that mortality rates have improved for breast cancer, but he attributes it to improved treatment. “The harms [of screening] we know, but the benefits of screening are very uncertain.”¹³

Continue to: Limitations of breast MRI...

Limitations of breast MRI

Overall, MRI is a diagnostic and monitoring test. It is costlier than mammography, and because it is not recommended in guidelines as a screening modality for most women, it is not typically covered by insurance. Abbreviated (rapid) MRI is a non-standardized imaging strategy being used at a few health centers. It has a shorter protocol overall than MRI, so it takes less time than current MRI and is less expensive, but there are few data on sensitivity and specificity. It is yet to be determined which populations could benefit from this newer technology.

As mentioned, 41% of women in the Bakker et al trial who were randomly assigned to breast MRI chose not to proceed with that exam even though it would have been at no cost to them.⁶ Anecdotally, some patients who have undergone MRI say they would forgo it a second time as a screening modality because it was a very unpleasant, stressful experience. It’s not a perfect test, although it is more sensitive than mammography.

Other options for following up dense-breast screening. Besides MRI and abbreviated MRI, the following modalities can be used to evaluate women found to have dense breasts with screening mammograms: CT mammography with contrast, molecular breast imaging, and ultrasonography.

Screening and treatment advances

3D mammography. In the US, the great majority of screening mammography now is performed with tomosynthesis, or what our patients sometimes call 3D mammography. In fact, it is approaching standard of care. Women whose screening mammography includes tomosynthesis are less likely to experience a so-called callback for additional imaging with diagnostic mammography or breast ultrasonography.¹⁴

Liquid biopsy. A potential major advancement for making decisions about when to treat cancers in general involves determining the biological behavior of a tumor, based on analysis of either circulating tumor DNA or proteins in the blood. As more experience with this new technology accumulates, the role of liquid biopsies for breast cancer will expand.¹⁵ Liquid biopsies for screening remain investigational for now, but they hold tremendous potential.

Noninvasive proteomics. With the development of noninvasive proteomic biomarkers obtained from blood, saliva, or nipple aspiration fluid, there exists the possibility of not just evaluating an image of a tumor seen on a mammogram, but actually studying the biological characteristics of that lesion.¹⁶ The cost of this technology is far less in terms of resources than MRI or molecular-based imaging, and actually reveals the flaws with using image-based screening. With proteomics, we can tell whether or not a lump is generating proteins that are going to make that disease biologically meaningful, and treatment decisions can be based on that information. This idea has the potential to disrupt our current breast cancer screening paradigm.

Advocacy’s role in mandating legislation

Many advocacy groups lobby on Capitol Hill for legislation related to health care, but we don’t feel that is the best way to make scientific decisions, and it’s not the way to do medicine. Passionate people, who truly believe that their outcome would have been different had something else been done, have every right to advocate, and should. However, without longer-term data focusing on breast cancer and overall mortality, rather than surrogate outcomes like interval cancers, it is not clear that routinely recommending supplemental MRI will improve survival for women with extremely dense breasts. Unfortunately, overall, earlier diagnosis of highly aggressive breast cancer tumors does not result in better outcomes for patients. ●

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

Expert insights on new data

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Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.¹

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”²

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.²

A problem with our VeLVET trial,³ which was published in Menopause, and the Cruz and colleagues’ trial from South America,⁴ both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.⁵ For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.² According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.⁵

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,² and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,⁴ or even our trial that compared vaginal estrogen with laser,³ when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

Expert insights on new data

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Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.¹

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”²

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.²

A problem with our VeLVET trial,³ which was published in Menopause, and the Cruz and colleagues’ trial from South America,⁴ both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.⁵ For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.² According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.⁵

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,² and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,⁴ or even our trial that compared vaginal estrogen with laser,³ when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

Expert insights on new data

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Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.¹

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”²

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.²

A problem with our VeLVET trial,³ which was published in Menopause, and the Cruz and colleagues’ trial from South America,⁴ both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.⁵ For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.² According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.⁵

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,² and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,⁴ or even our trial that compared vaginal estrogen with laser,³ when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

OBG Management takes the issues of systemic and structural racism incredibly seriously--not just by talking about it but by trying to highlight areas in medicine, particularly in obstetrics and gynecology, that are barriers to progress. In this new series for OBG Management, Board Member Barbara Levy, MD, faces the issues head-on, beginning with this peer-to-peer interview with Pierre Johnson, MD, ObGyn in Chicago, Illinois. Watch for future installments in upcoming issues of OBG Management.

Finding inspiration among life’s challenges

Barbara Levy, MD: I am fortunate to have met Pierre serendipitously at a training that we were both attending and was impressed by Dr. Johnson’s life story, his passion and commitment, and his dedication—not only to his personal career but also to raising up other young men of color by trying to break down barriers that face them. His life story highlights those areas of systemic and structural problems that all of us together need to address if we are going to make any progress.

Pierre Johnson, MD: Thank you, Barbara. A little about myself: I am a board-certified ObGyn, and I specialize in minimally invasive surgery. I was born on the South side of Chicago, experiencing gang violence, drugs, and substandard, underserved schools. Long story short, I had a very rough upbringing. I had a single mom and several different issues at home. I am the oldest of 5 siblings, and life was tough.

But I knew that I wanted to do something different with my life. I saw that there was a need in my community as far as health care was concerned, in particular women’s health and childbirth. I knew early on that I wanted to be an ObGyn, and the reason had a lot to do with The Cosby Show. It was the only example of a positive, successful Black man that I saw. No one graduated from college in my family. There weren’t any models of young Black excellence around me. Saying that I wanted to be a doctor planted a seed. I was 9 when my mom became pregnant with my first sibling, and it was fascinating to me. The physiology of pregnancy, and eventually childbirth, was extremely fascinating to me; it set me off on my journey to be an ObGyn.

As I got older, things didn’t get any easier. I went to high school in one of the toughest areas on the South side of Chicago. Gang violence, and violence in and of itself, were all around me, but I was able to stay focused. I went on to Xavier University in Louisiana.

Dr. Levy: There are some important things that I learned from your book and from talking to you at our first meeting. Your mom’s ObGyn, when she was pregnant with your next youngest sibling, was also a Black ObGyn. He took some time to take you under wing?

Dr. Johnson: He did. My mom’s ObGyn was a Black man. Other than The Cosby Show, that’s the only time I saw something like that. When I spoke to him, he really took the time to answer my questions and show me that he was like me; he wasn’t just a far-off mythical person, or something that I could not obtain.

Continue to: Seeing is believing when it comes to success...

Seeing is believing when it comes to success

Dr. Levy: Do you think it was important to have a role model who wasn’t a sports star?

Dr. Johnson: If you can’t see it, you can’t achieve it. He took his time to really talk to me, and it’s the little things for kids that go a long way in their life experience. I still have a relationship with him to this day. How he handled me as a kid made me realize that this is something that I could do. That was extremely important for me.

Dr. Levy: One of the structural things I think we need to point out is that the ability to see yourself as someone successful is critical. When we see 1,000 images a day and they are all White, and they are all so different from where we are that it gets incorporated into our sense of being. I think that’s really difficult for those of us of with privilege to understand what that privilege is.

Dr. Johnson: Absolutely, and I’ll even go further. In residency, 2 White females were my classmates, and both of their parents were doctors. They had grandparents who were doctors. My mom was addicted to drugs; my father was not around. They had been talking medicine since they were 5. You have to make things equitable, but in medicine it’s really not equitable. In medicine, what we don’t realize is that there is an importance for all aspects of someone’s upbringing and environment, and it’s not just what they can regurgitate on a standardized test. If a patient can’t relate to you and tell you what is wrong with them, how can you adequately treat them?

Dr. Levy: Even if they are trying to tell me, but I can’t hear it because I don’t have the language and I don’t have the background. There are really good data to show, in fact, that Black male physicians do a better job at engaging Black men to manage their hypertension.¹ When we look at the inequities in birth outcomes for women of color, indigenous women and Black women, there’s evidence that providers who come from a similar background do a better job.

Dr. Johnson: There was the study of Black infants that just came out about them dying at a 3-time higher rate in non-Black physicians’ hands.² These things need to be recognized. They need to be discussed, and they need to be identified as issues and then, realistically, we need to start talking about solutions, not get offended by what actual statistics are saying.

Foundational inequities in education

Dr. Levy: To address some of the barriers that you faced: I know that you went to a high school that was not geared toward pushing students into professional careers. Your colleagues, however, had educations that prepared them for the standardized tests and other things that they would face academically.

Dr. Johnson: People think I am kidding when I say it, but when I went into college, I didn’t know what a periodic table was. I saw it, but I had no idea what these things meant. I didn’t have any sciences or any AP classes in high school. I did well, but grades are smoke and mirrors. The true test of medicine comes with testing. From the MCATs to the boards, every step of the way there is a standardized test.

Knowledge is something that you can obtain, but test taking is a cultivated skill that happens from a very early age. Trying to teach an adult or someone in their late teens a skill that they should have learned as a kid is difficult. For me, I did not have that, so I had to program myself. I had to learn how to fundamentally take tests as an adult, where most people understand how to do that going into college and professional school.

Dr. Levy: I was impressed with your resilience. I think all of us as human beings, if we fail a test, we take it personally and think it’s about our lack of knowledge. One of the insights that you came to was that failure on those things was not that you didn’t study hard enough. In fact, you probably studied 4 times harder than most other people. You had the knowledge. Being able to get that knowledge into a standardized structured test score was the huge challenge for you.

Dr. Johnson: That’s it. I can remember taking the MCAT, and if you looked at the step 1 book, I could regurgitate to you everything on that page. However, it’s not a test about do you know it or not. It’s an understanding of the English language and how to break things down to make things fit into particular scenarios.

Continue to: A college experience focused on growth and exposure...

Dr. Levy: I was impressed by the distinction between your experience at Xavier University where there was a lot of support and guidance and help in your premed program, and what happened to you when you hit medical school.

Dr. Johnson: Xavier University in Louisiana is the number 1 institution in the country for getting minorities into professional school. They understand that they have kids that are brilliant but underprepared, and just have not had the background to actually tackle some of these tough curriculums. I always had good grades in school. But by not being challenged, I didn’t know what I didn’t really know. So now that I was seeing biology, chemistry for the first time, and trying to tackle it; there’s a failure point. I didn’t know how to take tests, and I didn’t know how to study properly. The harder I tried, the worse things got for me.

Xavier has seen that story a multitude of times. If I went to a bigger or predominantly White university, a counselor would have told me, “Well, medicine’s maybe not for you. You can’t handle a premed curriculum.” Instead, I said, “Listen, I’m studying. I’m doing all of these things, and I’m not hacking it.” And they broke it down: “Let’s get you into study groups with kids that have had these type of AP classes before. We’ll have you watch how they study,” and everything started to click. That facilitation of how to adjust to this curriculum was a godsend. It’s the only reason I’m here. I am a prime example of being brilliant enough to be able to do it, but needing the infrastructure and a system set up.

Dr. Levy: There’s a great book by Carol Dweck called Mindset that talks about education of young kids and putting them into silos so early in life; the brilliant kids go into the AP courses and the rest are labeled as inadequate. It’s assumed in a fixed mindset based on their heredity and IQ, and not based on the fact that they have not been exposed to the right things.

Xavier was growing you into the man who could, in fact, do all of those things. I think that is one of the systemic and structural issues that we have—that fixed mindset that frames a kid who is not succeeding as therefore unable to succeed, as opposed to framing that child as not having the correct tools.

New tribulations of medical school

Dr. Johnson: Absolutely. I think what Xavier did for me is to at least let me understand what I needed to do, how to comprehend and retain information, which I never had been exposed to before. Those years were very important to establishing a foundation. When going to medical school, it was like, “There’s no more excuses. What could be the problem now?” Well, now let’s talk about taking tests—a whole different skill. Xavier focused on getting me to understand how to structure my thought process and knowledge base. In medical school I had to apply those skills (because if you can’t apply them, there’s no fit).

My second through fourth year of medical school, I was the only African-American kid in my class. I was spending 20-hour days sometimes just studying, trying to overcompensate by knowing as much as I possibly could and thinking that would propel me from the test-taking standpoint. Even though I didn’t have a lot of classmates in medical school that looked like me, I did have mentors that looked similarly, who really saw potential in me. Dr. Frederick Horvath, a nephrologist in Peoria said, “What are you doing? I want you to get out of these books, and let’s go out to lunch.”

He ended up buying me some instrumental books, really talked to me, listening to my background and understanding how driven I was as a person. He took me under his wing for the rest of medical school and said, “This is how you navigate through these spaces. Yes, you need to have a fund of knowledge to be able to take these tests, but you need to start understanding how to apply it to these questions.” I’m forever grateful to Dr. Horvath for doing that because it was a point in time where I was lost and struggling.

Continue to: Hitting a stride but facing racism head-on...

Dr. Levy: You talk about the systemic and pervasive racism that was on the wards when you hit them in fourth year. If you don’t mind sharing just a little bit of that, it would help people reading this to have a better understanding of the kinds of barriers that are out there.

Dr. Johnson: Even when I talk about it today, it bothers me.

I went to medical school in Peoria, Illinois, not far from the home of the Ku Klux Klan. At that time, once you got out of Chicago it was a very brutal place, with systemic racism throughout. I was a young Black kid going through a process that not many young Black kids from the South side of Chicago go through, and you had people who had never seen anyone like me. When I was going through my clinical rotations, I knew what I was up against. I was dressed “to the T” every day, arriving early, leaving late, trying to answer questions. I would look at the evaluations, and they would be disparaging. I would look at my counterparts, how their evaluations were, and how people would respond to them, and it would be completely different.

Surgery was the part of ObGyn that I really grew to love more than anything, even more than obstetrics. When general surgery came, I wanted to take it very seriously and learn as much as I possibly could. From the beginning, I knew there was a problem because the chief resident, an older White man, wouldn’t look me in the eye or talk to me. He would make disparaging remarks. The thing that stuck out in my mind the most was when I was in the operating room transporting patients, just like a medical student did, and he came up behind me and said, “You know, Pierre, this is where a small mind and a strong back come into play.” For me, it took me to a place where I had to corral my emotions and thoughts because I just wanted to lash out and just tell him how racist and horrible that was for him to say that to me. I explained this to the powers that be, the director of the department, and they basically blew it off to the side.

When it came down to the end of the evaluation period, I passed with flying colors. But they gave me an incomplete because of that chief resident and his remarks on my evaluations. He had 3 pages of report about me as a person and as a student. He said that he had difficulty in expressing his opinions about me because of possible cultural biases that he may have had. He put “cultural biases” in an evaluation, and they looked at that and said that was enough for me to have to remediate my time. I was required to do an extra month in Pontiac, Illinois, which is even more rural than Peoria, because of a racist person that did not give me a fair opportunity because I was Black.

Like everything else in life, it was a learning experience. It’s why I fight so hard today. It’s why I’m so passionate about equity, not only in medicine but also in all aspects of society. It shows why we have police brutality and Black men dying in the streets. It shows how this happens because there are cultural and implicit biases that play out in every part of life, and we are not honest about it. Until we are honest about it and until we say that this is happening and there is something that needs to be done to address it, it’s going to continue to happen. That is my fight.

Exposing the unspoken power struggle

Dr. Levy: I couldn’t agree more. Attributing things like that to the individual, where you talk about a White man in power and a power structure that didn’t literally physically beat you but did beat you into submission. You talk about how to succeed in medical school, and how you had to suck it up and submit to something that was incredibly unfair. You understood, you were old enough, mature enough, to understand that if you fought back, you were going to lose. The only opportunity you had was to submit to that inequity and push forward.

Dr. Johnson: When I did try to fight, the chair of the department told me that either I accept the consequences or I would not graduate from medical school and be forced to do another year. That struck a chord with me. I think that happens a lot in our society, and it needs to be exposed.

Past experiences reflected in today’s society

Dr. Levy: Can you talk about what you faced in your ObGyn residency in terms of the systemic pushback, people not taking your orders, people questioning you. I know that I have heard that a great deal, and I experienced that myself as a woman.

Dr. Johnson: We look at the things that are happening now, everything from George Floyd’s murder to Colin Kaepernick taking a knee. These things are 10 years past when I first started residency. The year before I started residency, there was a noose hanging on the capitol lawn of Springfield, Illinois’ capital city. There’s systemic racism and hatred there. When I first started on the wards of my first year of ObGyn, again, I was the very first Black resident of my program’s history. Nobody could relate to me.

I went from a year-long general surgery internship at Washington Hospital Center in Washington, DC, to ObGyn residency. In the first 2 months, there were complaints of, “He’s not answering his pages. He’s not being prompt.” I went to my program director and said, “Listen, I have never had one complaint like this. There’s a problem here. And there’s a problem when I’m on the floor: When trying to give orders to nurses, they’re not taking them. I had to tell a couple of nurses, ‘I’m Dr. Johnson. Don’t call me by my first name, especially not in front of patients.’”

My director was just not hearing me, because the entire scenario was something they had never been exposed to. Systemic racism is real, and unless you experience it, it’s very difficult to accept that it is happening. But biases happen when you are not cognizant. People are used to things a certain way. Things play out in the media that make your mind think a certain way, and you don’t even realize it. You may not even want to be that way.

Continue to: Unconscious bias is a barrier to ensuring equity...

Dr. Levy: One very important point you just made is that we as the system need to be able to recognize those unconscious things, the language that we use, the disparaging remarks, the things that put people down, as well as the things that keep people out of promotion.

There are some interesting data about both race and gender and the language that we use when we write recommendations for people, that we do things unconsciously. The big message to all of us at the end is to open our minds to where those things can occur. For myself, professionally, I keep a list of words that I use when I write recommendations. I measure myself to ensure that I am using the same language for men and women, for Black and White. I think we need to overcome the system and the structure to create real equity—not equality but equity.

It begins with being real about the issues

Dr. Johnson: It’s a bigger problem than the existence of bias and racism. I think these are systemic issues that have been cultivated over centuries that have never been addressed. The true issue is that we deny that these are problems and refuse to talk about it because it makes us uncomfortable. To truly make things more equitable, we have to push our levels of comfort to be able to talk about things in a healthy manner, be open and transparent, and to start to understand how we are thinking about certain things. When you can see it, you can start to implement changes and start to change mentalities and thought processes.

For me, people say, “You don’t look like a doctor.” I get that all the time—because I have tattoos and earrings. I wear my hair in a mohawk. The image of what success looks like has been manifested through our media and culture, and it has imprinted on our minds as to how things are supposed to be. If someone doesn’t fit those molds, we start to shun them out, or we start to exhibit biases against those things. What I am trying to do is change that thought process of what a successful or a professional person looks like. It doesn’t have a look. It is not a White or Black thing. It’s an intellect, a mindset, a way of living. You have to treat every person as an individual and take all the biases out of it and understand where they are coming from and what they have to offer to the profession.

Dr. Levy: I personally was so impressed by you when I met you. I was impressed by the tattoos and the earrings, and my initial response to them was exactly that biased, “Oh, who is this person?” I checked that at the door, listened to you, and was really impressed at your surgical skill, your knowledge, your background. I am really grateful that you have been willing to spend the time to share that with everyone.

Dr. Johnson: Thank you for this discussion.

To watch the full interview between Drs. Levy and Johnson, visit: https://www.mdedge.com/obgyn/article/228507/facing-systemic-racism-health-care-inequities-medical-education. ●

OBG Management takes the issues of systemic and structural racism incredibly seriously--not just by talking about it but by trying to highlight areas in medicine, particularly in obstetrics and gynecology, that are barriers to progress. In this new series for OBG Management, Board Member Barbara Levy, MD, faces the issues head-on, beginning with this peer-to-peer interview with Pierre Johnson, MD, ObGyn in Chicago, Illinois. Watch for future installments in upcoming issues of OBG Management.

Finding inspiration among life’s challenges

Barbara Levy, MD: I am fortunate to have met Pierre serendipitously at a training that we were both attending and was impressed by Dr. Johnson’s life story, his passion and commitment, and his dedication—not only to his personal career but also to raising up other young men of color by trying to break down barriers that face them. His life story highlights those areas of systemic and structural problems that all of us together need to address if we are going to make any progress.

Pierre Johnson, MD: Thank you, Barbara. A little about myself: I am a board-certified ObGyn, and I specialize in minimally invasive surgery. I was born on the South side of Chicago, experiencing gang violence, drugs, and substandard, underserved schools. Long story short, I had a very rough upbringing. I had a single mom and several different issues at home. I am the oldest of 5 siblings, and life was tough.

But I knew that I wanted to do something different with my life. I saw that there was a need in my community as far as health care was concerned, in particular women’s health and childbirth. I knew early on that I wanted to be an ObGyn, and the reason had a lot to do with The Cosby Show. It was the only example of a positive, successful Black man that I saw. No one graduated from college in my family. There weren’t any models of young Black excellence around me. Saying that I wanted to be a doctor planted a seed. I was 9 when my mom became pregnant with my first sibling, and it was fascinating to me. The physiology of pregnancy, and eventually childbirth, was extremely fascinating to me; it set me off on my journey to be an ObGyn.

As I got older, things didn’t get any easier. I went to high school in one of the toughest areas on the South side of Chicago. Gang violence, and violence in and of itself, were all around me, but I was able to stay focused. I went on to Xavier University in Louisiana.

Dr. Levy: There are some important things that I learned from your book and from talking to you at our first meeting. Your mom’s ObGyn, when she was pregnant with your next youngest sibling, was also a Black ObGyn. He took some time to take you under wing?

Dr. Johnson: He did. My mom’s ObGyn was a Black man. Other than The Cosby Show, that’s the only time I saw something like that. When I spoke to him, he really took the time to answer my questions and show me that he was like me; he wasn’t just a far-off mythical person, or something that I could not obtain.

Continue to: Seeing is believing when it comes to success...

Seeing is believing when it comes to success

Dr. Levy: Do you think it was important to have a role model who wasn’t a sports star?

Dr. Johnson: If you can’t see it, you can’t achieve it. He took his time to really talk to me, and it’s the little things for kids that go a long way in their life experience. I still have a relationship with him to this day. How he handled me as a kid made me realize that this is something that I could do. That was extremely important for me.

Dr. Levy: One of the structural things I think we need to point out is that the ability to see yourself as someone successful is critical. When we see 1,000 images a day and they are all White, and they are all so different from where we are that it gets incorporated into our sense of being. I think that’s really difficult for those of us of with privilege to understand what that privilege is.

Dr. Johnson: Absolutely, and I’ll even go further. In residency, 2 White females were my classmates, and both of their parents were doctors. They had grandparents who were doctors. My mom was addicted to drugs; my father was not around. They had been talking medicine since they were 5. You have to make things equitable, but in medicine it’s really not equitable. In medicine, what we don’t realize is that there is an importance for all aspects of someone’s upbringing and environment, and it’s not just what they can regurgitate on a standardized test. If a patient can’t relate to you and tell you what is wrong with them, how can you adequately treat them?

Dr. Levy: Even if they are trying to tell me, but I can’t hear it because I don’t have the language and I don’t have the background. There are really good data to show, in fact, that Black male physicians do a better job at engaging Black men to manage their hypertension.¹ When we look at the inequities in birth outcomes for women of color, indigenous women and Black women, there’s evidence that providers who come from a similar background do a better job.

Dr. Johnson: There was the study of Black infants that just came out about them dying at a 3-time higher rate in non-Black physicians’ hands.² These things need to be recognized. They need to be discussed, and they need to be identified as issues and then, realistically, we need to start talking about solutions, not get offended by what actual statistics are saying.

Foundational inequities in education

Dr. Levy: To address some of the barriers that you faced: I know that you went to a high school that was not geared toward pushing students into professional careers. Your colleagues, however, had educations that prepared them for the standardized tests and other things that they would face academically.

Dr. Johnson: People think I am kidding when I say it, but when I went into college, I didn’t know what a periodic table was. I saw it, but I had no idea what these things meant. I didn’t have any sciences or any AP classes in high school. I did well, but grades are smoke and mirrors. The true test of medicine comes with testing. From the MCATs to the boards, every step of the way there is a standardized test.

Knowledge is something that you can obtain, but test taking is a cultivated skill that happens from a very early age. Trying to teach an adult or someone in their late teens a skill that they should have learned as a kid is difficult. For me, I did not have that, so I had to program myself. I had to learn how to fundamentally take tests as an adult, where most people understand how to do that going into college and professional school.

Dr. Levy: I was impressed with your resilience. I think all of us as human beings, if we fail a test, we take it personally and think it’s about our lack of knowledge. One of the insights that you came to was that failure on those things was not that you didn’t study hard enough. In fact, you probably studied 4 times harder than most other people. You had the knowledge. Being able to get that knowledge into a standardized structured test score was the huge challenge for you.

Dr. Johnson: That’s it. I can remember taking the MCAT, and if you looked at the step 1 book, I could regurgitate to you everything on that page. However, it’s not a test about do you know it or not. It’s an understanding of the English language and how to break things down to make things fit into particular scenarios.

Continue to: A college experience focused on growth and exposure...

Dr. Levy: I was impressed by the distinction between your experience at Xavier University where there was a lot of support and guidance and help in your premed program, and what happened to you when you hit medical school.

Dr. Johnson: Xavier University in Louisiana is the number 1 institution in the country for getting minorities into professional school. They understand that they have kids that are brilliant but underprepared, and just have not had the background to actually tackle some of these tough curriculums. I always had good grades in school. But by not being challenged, I didn’t know what I didn’t really know. So now that I was seeing biology, chemistry for the first time, and trying to tackle it; there’s a failure point. I didn’t know how to take tests, and I didn’t know how to study properly. The harder I tried, the worse things got for me.

Xavier has seen that story a multitude of times. If I went to a bigger or predominantly White university, a counselor would have told me, “Well, medicine’s maybe not for you. You can’t handle a premed curriculum.” Instead, I said, “Listen, I’m studying. I’m doing all of these things, and I’m not hacking it.” And they broke it down: “Let’s get you into study groups with kids that have had these type of AP classes before. We’ll have you watch how they study,” and everything started to click. That facilitation of how to adjust to this curriculum was a godsend. It’s the only reason I’m here. I am a prime example of being brilliant enough to be able to do it, but needing the infrastructure and a system set up.

Dr. Levy: There’s a great book by Carol Dweck called Mindset that talks about education of young kids and putting them into silos so early in life; the brilliant kids go into the AP courses and the rest are labeled as inadequate. It’s assumed in a fixed mindset based on their heredity and IQ, and not based on the fact that they have not been exposed to the right things.

Xavier was growing you into the man who could, in fact, do all of those things. I think that is one of the systemic and structural issues that we have—that fixed mindset that frames a kid who is not succeeding as therefore unable to succeed, as opposed to framing that child as not having the correct tools.

New tribulations of medical school

Dr. Johnson: Absolutely. I think what Xavier did for me is to at least let me understand what I needed to do, how to comprehend and retain information, which I never had been exposed to before. Those years were very important to establishing a foundation. When going to medical school, it was like, “There’s no more excuses. What could be the problem now?” Well, now let’s talk about taking tests—a whole different skill. Xavier focused on getting me to understand how to structure my thought process and knowledge base. In medical school I had to apply those skills (because if you can’t apply them, there’s no fit).

My second through fourth year of medical school, I was the only African-American kid in my class. I was spending 20-hour days sometimes just studying, trying to overcompensate by knowing as much as I possibly could and thinking that would propel me from the test-taking standpoint. Even though I didn’t have a lot of classmates in medical school that looked like me, I did have mentors that looked similarly, who really saw potential in me. Dr. Frederick Horvath, a nephrologist in Peoria said, “What are you doing? I want you to get out of these books, and let’s go out to lunch.”

He ended up buying me some instrumental books, really talked to me, listening to my background and understanding how driven I was as a person. He took me under his wing for the rest of medical school and said, “This is how you navigate through these spaces. Yes, you need to have a fund of knowledge to be able to take these tests, but you need to start understanding how to apply it to these questions.” I’m forever grateful to Dr. Horvath for doing that because it was a point in time where I was lost and struggling.

Continue to: Hitting a stride but facing racism head-on...

Dr. Levy: You talk about the systemic and pervasive racism that was on the wards when you hit them in fourth year. If you don’t mind sharing just a little bit of that, it would help people reading this to have a better understanding of the kinds of barriers that are out there.

Dr. Johnson: Even when I talk about it today, it bothers me.

I went to medical school in Peoria, Illinois, not far from the home of the Ku Klux Klan. At that time, once you got out of Chicago it was a very brutal place, with systemic racism throughout. I was a young Black kid going through a process that not many young Black kids from the South side of Chicago go through, and you had people who had never seen anyone like me. When I was going through my clinical rotations, I knew what I was up against. I was dressed “to the T” every day, arriving early, leaving late, trying to answer questions. I would look at the evaluations, and they would be disparaging. I would look at my counterparts, how their evaluations were, and how people would respond to them, and it would be completely different.

Surgery was the part of ObGyn that I really grew to love more than anything, even more than obstetrics. When general surgery came, I wanted to take it very seriously and learn as much as I possibly could. From the beginning, I knew there was a problem because the chief resident, an older White man, wouldn’t look me in the eye or talk to me. He would make disparaging remarks. The thing that stuck out in my mind the most was when I was in the operating room transporting patients, just like a medical student did, and he came up behind me and said, “You know, Pierre, this is where a small mind and a strong back come into play.” For me, it took me to a place where I had to corral my emotions and thoughts because I just wanted to lash out and just tell him how racist and horrible that was for him to say that to me. I explained this to the powers that be, the director of the department, and they basically blew it off to the side.

When it came down to the end of the evaluation period, I passed with flying colors. But they gave me an incomplete because of that chief resident and his remarks on my evaluations. He had 3 pages of report about me as a person and as a student. He said that he had difficulty in expressing his opinions about me because of possible cultural biases that he may have had. He put “cultural biases” in an evaluation, and they looked at that and said that was enough for me to have to remediate my time. I was required to do an extra month in Pontiac, Illinois, which is even more rural than Peoria, because of a racist person that did not give me a fair opportunity because I was Black.

Like everything else in life, it was a learning experience. It’s why I fight so hard today. It’s why I’m so passionate about equity, not only in medicine but also in all aspects of society. It shows why we have police brutality and Black men dying in the streets. It shows how this happens because there are cultural and implicit biases that play out in every part of life, and we are not honest about it. Until we are honest about it and until we say that this is happening and there is something that needs to be done to address it, it’s going to continue to happen. That is my fight.

Exposing the unspoken power struggle

Dr. Levy: I couldn’t agree more. Attributing things like that to the individual, where you talk about a White man in power and a power structure that didn’t literally physically beat you but did beat you into submission. You talk about how to succeed in medical school, and how you had to suck it up and submit to something that was incredibly unfair. You understood, you were old enough, mature enough, to understand that if you fought back, you were going to lose. The only opportunity you had was to submit to that inequity and push forward.

Dr. Johnson: When I did try to fight, the chair of the department told me that either I accept the consequences or I would not graduate from medical school and be forced to do another year. That struck a chord with me. I think that happens a lot in our society, and it needs to be exposed.

Past experiences reflected in today’s society

Dr. Levy: Can you talk about what you faced in your ObGyn residency in terms of the systemic pushback, people not taking your orders, people questioning you. I know that I have heard that a great deal, and I experienced that myself as a woman.

Dr. Johnson: We look at the things that are happening now, everything from George Floyd’s murder to Colin Kaepernick taking a knee. These things are 10 years past when I first started residency. The year before I started residency, there was a noose hanging on the capitol lawn of Springfield, Illinois’ capital city. There’s systemic racism and hatred there. When I first started on the wards of my first year of ObGyn, again, I was the very first Black resident of my program’s history. Nobody could relate to me.

I went from a year-long general surgery internship at Washington Hospital Center in Washington, DC, to ObGyn residency. In the first 2 months, there were complaints of, “He’s not answering his pages. He’s not being prompt.” I went to my program director and said, “Listen, I have never had one complaint like this. There’s a problem here. And there’s a problem when I’m on the floor: When trying to give orders to nurses, they’re not taking them. I had to tell a couple of nurses, ‘I’m Dr. Johnson. Don’t call me by my first name, especially not in front of patients.’”

My director was just not hearing me, because the entire scenario was something they had never been exposed to. Systemic racism is real, and unless you experience it, it’s very difficult to accept that it is happening. But biases happen when you are not cognizant. People are used to things a certain way. Things play out in the media that make your mind think a certain way, and you don’t even realize it. You may not even want to be that way.

Continue to: Unconscious bias is a barrier to ensuring equity...

Dr. Levy: One very important point you just made is that we as the system need to be able to recognize those unconscious things, the language that we use, the disparaging remarks, the things that put people down, as well as the things that keep people out of promotion.

There are some interesting data about both race and gender and the language that we use when we write recommendations for people, that we do things unconsciously. The big message to all of us at the end is to open our minds to where those things can occur. For myself, professionally, I keep a list of words that I use when I write recommendations. I measure myself to ensure that I am using the same language for men and women, for Black and White. I think we need to overcome the system and the structure to create real equity—not equality but equity.

It begins with being real about the issues

Dr. Johnson: It’s a bigger problem than the existence of bias and racism. I think these are systemic issues that have been cultivated over centuries that have never been addressed. The true issue is that we deny that these are problems and refuse to talk about it because it makes us uncomfortable. To truly make things more equitable, we have to push our levels of comfort to be able to talk about things in a healthy manner, be open and transparent, and to start to understand how we are thinking about certain things. When you can see it, you can start to implement changes and start to change mentalities and thought processes.

For me, people say, “You don’t look like a doctor.” I get that all the time—because I have tattoos and earrings. I wear my hair in a mohawk. The image of what success looks like has been manifested through our media and culture, and it has imprinted on our minds as to how things are supposed to be. If someone doesn’t fit those molds, we start to shun them out, or we start to exhibit biases against those things. What I am trying to do is change that thought process of what a successful or a professional person looks like. It doesn’t have a look. It is not a White or Black thing. It’s an intellect, a mindset, a way of living. You have to treat every person as an individual and take all the biases out of it and understand where they are coming from and what they have to offer to the profession.

Dr. Levy: I personally was so impressed by you when I met you. I was impressed by the tattoos and the earrings, and my initial response to them was exactly that biased, “Oh, who is this person?” I checked that at the door, listened to you, and was really impressed at your surgical skill, your knowledge, your background. I am really grateful that you have been willing to spend the time to share that with everyone.

Dr. Johnson: Thank you for this discussion.

To watch the full interview between Drs. Levy and Johnson, visit: https://www.mdedge.com/obgyn/article/228507/facing-systemic-racism-health-care-inequities-medical-education. ●

OBG Management takes the issues of systemic and structural racism incredibly seriously--not just by talking about it but by trying to highlight areas in medicine, particularly in obstetrics and gynecology, that are barriers to progress. In this new series for OBG Management, Board Member Barbara Levy, MD, faces the issues head-on, beginning with this peer-to-peer interview with Pierre Johnson, MD, ObGyn in Chicago, Illinois. Watch for future installments in upcoming issues of OBG Management.

Finding inspiration among life’s challenges

Barbara Levy, MD: I am fortunate to have met Pierre serendipitously at a training that we were both attending and was impressed by Dr. Johnson’s life story, his passion and commitment, and his dedication—not only to his personal career but also to raising up other young men of color by trying to break down barriers that face them. His life story highlights those areas of systemic and structural problems that all of us together need to address if we are going to make any progress.

Pierre Johnson, MD: Thank you, Barbara. A little about myself: I am a board-certified ObGyn, and I specialize in minimally invasive surgery. I was born on the South side of Chicago, experiencing gang violence, drugs, and substandard, underserved schools. Long story short, I had a very rough upbringing. I had a single mom and several different issues at home. I am the oldest of 5 siblings, and life was tough.

But I knew that I wanted to do something different with my life. I saw that there was a need in my community as far as health care was concerned, in particular women’s health and childbirth. I knew early on that I wanted to be an ObGyn, and the reason had a lot to do with The Cosby Show. It was the only example of a positive, successful Black man that I saw. No one graduated from college in my family. There weren’t any models of young Black excellence around me. Saying that I wanted to be a doctor planted a seed. I was 9 when my mom became pregnant with my first sibling, and it was fascinating to me. The physiology of pregnancy, and eventually childbirth, was extremely fascinating to me; it set me off on my journey to be an ObGyn.

As I got older, things didn’t get any easier. I went to high school in one of the toughest areas on the South side of Chicago. Gang violence, and violence in and of itself, were all around me, but I was able to stay focused. I went on to Xavier University in Louisiana.

Dr. Levy: There are some important things that I learned from your book and from talking to you at our first meeting. Your mom’s ObGyn, when she was pregnant with your next youngest sibling, was also a Black ObGyn. He took some time to take you under wing?

Dr. Johnson: He did. My mom’s ObGyn was a Black man. Other than The Cosby Show, that’s the only time I saw something like that. When I spoke to him, he really took the time to answer my questions and show me that he was like me; he wasn’t just a far-off mythical person, or something that I could not obtain.

Continue to: Seeing is believing when it comes to success...

Seeing is believing when it comes to success

Dr. Levy: Do you think it was important to have a role model who wasn’t a sports star?

Dr. Johnson: If you can’t see it, you can’t achieve it. He took his time to really talk to me, and it’s the little things for kids that go a long way in their life experience. I still have a relationship with him to this day. How he handled me as a kid made me realize that this is something that I could do. That was extremely important for me.

Dr. Levy: One of the structural things I think we need to point out is that the ability to see yourself as someone successful is critical. When we see 1,000 images a day and they are all White, and they are all so different from where we are that it gets incorporated into our sense of being. I think that’s really difficult for those of us of with privilege to understand what that privilege is.

Dr. Johnson: Absolutely, and I’ll even go further. In residency, 2 White females were my classmates, and both of their parents were doctors. They had grandparents who were doctors. My mom was addicted to drugs; my father was not around. They had been talking medicine since they were 5. You have to make things equitable, but in medicine it’s really not equitable. In medicine, what we don’t realize is that there is an importance for all aspects of someone’s upbringing and environment, and it’s not just what they can regurgitate on a standardized test. If a patient can’t relate to you and tell you what is wrong with them, how can you adequately treat them?

Dr. Levy: Even if they are trying to tell me, but I can’t hear it because I don’t have the language and I don’t have the background. There are really good data to show, in fact, that Black male physicians do a better job at engaging Black men to manage their hypertension.¹ When we look at the inequities in birth outcomes for women of color, indigenous women and Black women, there’s evidence that providers who come from a similar background do a better job.

Dr. Johnson: There was the study of Black infants that just came out about them dying at a 3-time higher rate in non-Black physicians’ hands.² These things need to be recognized. They need to be discussed, and they need to be identified as issues and then, realistically, we need to start talking about solutions, not get offended by what actual statistics are saying.

Foundational inequities in education

Dr. Levy: To address some of the barriers that you faced: I know that you went to a high school that was not geared toward pushing students into professional careers. Your colleagues, however, had educations that prepared them for the standardized tests and other things that they would face academically.

Dr. Johnson: People think I am kidding when I say it, but when I went into college, I didn’t know what a periodic table was. I saw it, but I had no idea what these things meant. I didn’t have any sciences or any AP classes in high school. I did well, but grades are smoke and mirrors. The true test of medicine comes with testing. From the MCATs to the boards, every step of the way there is a standardized test.

Knowledge is something that you can obtain, but test taking is a cultivated skill that happens from a very early age. Trying to teach an adult or someone in their late teens a skill that they should have learned as a kid is difficult. For me, I did not have that, so I had to program myself. I had to learn how to fundamentally take tests as an adult, where most people understand how to do that going into college and professional school.

Dr. Levy: I was impressed with your resilience. I think all of us as human beings, if we fail a test, we take it personally and think it’s about our lack of knowledge. One of the insights that you came to was that failure on those things was not that you didn’t study hard enough. In fact, you probably studied 4 times harder than most other people. You had the knowledge. Being able to get that knowledge into a standardized structured test score was the huge challenge for you.

Dr. Johnson: That’s it. I can remember taking the MCAT, and if you looked at the step 1 book, I could regurgitate to you everything on that page. However, it’s not a test about do you know it or not. It’s an understanding of the English language and how to break things down to make things fit into particular scenarios.

Continue to: A college experience focused on growth and exposure...

Dr. Levy: I was impressed by the distinction between your experience at Xavier University where there was a lot of support and guidance and help in your premed program, and what happened to you when you hit medical school.

Dr. Johnson: Xavier University in Louisiana is the number 1 institution in the country for getting minorities into professional school. They understand that they have kids that are brilliant but underprepared, and just have not had the background to actually tackle some of these tough curriculums. I always had good grades in school. But by not being challenged, I didn’t know what I didn’t really know. So now that I was seeing biology, chemistry for the first time, and trying to tackle it; there’s a failure point. I didn’t know how to take tests, and I didn’t know how to study properly. The harder I tried, the worse things got for me.

Xavier has seen that story a multitude of times. If I went to a bigger or predominantly White university, a counselor would have told me, “Well, medicine’s maybe not for you. You can’t handle a premed curriculum.” Instead, I said, “Listen, I’m studying. I’m doing all of these things, and I’m not hacking it.” And they broke it down: “Let’s get you into study groups with kids that have had these type of AP classes before. We’ll have you watch how they study,” and everything started to click. That facilitation of how to adjust to this curriculum was a godsend. It’s the only reason I’m here. I am a prime example of being brilliant enough to be able to do it, but needing the infrastructure and a system set up.

Dr. Levy: There’s a great book by Carol Dweck called Mindset that talks about education of young kids and putting them into silos so early in life; the brilliant kids go into the AP courses and the rest are labeled as inadequate. It’s assumed in a fixed mindset based on their heredity and IQ, and not based on the fact that they have not been exposed to the right things.

Xavier was growing you into the man who could, in fact, do all of those things. I think that is one of the systemic and structural issues that we have—that fixed mindset that frames a kid who is not succeeding as therefore unable to succeed, as opposed to framing that child as not having the correct tools.

New tribulations of medical school

Dr. Johnson: Absolutely. I think what Xavier did for me is to at least let me understand what I needed to do, how to comprehend and retain information, which I never had been exposed to before. Those years were very important to establishing a foundation. When going to medical school, it was like, “There’s no more excuses. What could be the problem now?” Well, now let’s talk about taking tests—a whole different skill. Xavier focused on getting me to understand how to structure my thought process and knowledge base. In medical school I had to apply those skills (because if you can’t apply them, there’s no fit).

My second through fourth year of medical school, I was the only African-American kid in my class. I was spending 20-hour days sometimes just studying, trying to overcompensate by knowing as much as I possibly could and thinking that would propel me from the test-taking standpoint. Even though I didn’t have a lot of classmates in medical school that looked like me, I did have mentors that looked similarly, who really saw potential in me. Dr. Frederick Horvath, a nephrologist in Peoria said, “What are you doing? I want you to get out of these books, and let’s go out to lunch.”

He ended up buying me some instrumental books, really talked to me, listening to my background and understanding how driven I was as a person. He took me under his wing for the rest of medical school and said, “This is how you navigate through these spaces. Yes, you need to have a fund of knowledge to be able to take these tests, but you need to start understanding how to apply it to these questions.” I’m forever grateful to Dr. Horvath for doing that because it was a point in time where I was lost and struggling.

Continue to: Hitting a stride but facing racism head-on...

Dr. Levy: You talk about the systemic and pervasive racism that was on the wards when you hit them in fourth year. If you don’t mind sharing just a little bit of that, it would help people reading this to have a better understanding of the kinds of barriers that are out there.

Dr. Johnson: Even when I talk about it today, it bothers me.

I went to medical school in Peoria, Illinois, not far from the home of the Ku Klux Klan. At that time, once you got out of Chicago it was a very brutal place, with systemic racism throughout. I was a young Black kid going through a process that not many young Black kids from the South side of Chicago go through, and you had people who had never seen anyone like me. When I was going through my clinical rotations, I knew what I was up against. I was dressed “to the T” every day, arriving early, leaving late, trying to answer questions. I would look at the evaluations, and they would be disparaging. I would look at my counterparts, how their evaluations were, and how people would respond to them, and it would be completely different.

Surgery was the part of ObGyn that I really grew to love more than anything, even more than obstetrics. When general surgery came, I wanted to take it very seriously and learn as much as I possibly could. From the beginning, I knew there was a problem because the chief resident, an older White man, wouldn’t look me in the eye or talk to me. He would make disparaging remarks. The thing that stuck out in my mind the most was when I was in the operating room transporting patients, just like a medical student did, and he came up behind me and said, “You know, Pierre, this is where a small mind and a strong back come into play.” For me, it took me to a place where I had to corral my emotions and thoughts because I just wanted to lash out and just tell him how racist and horrible that was for him to say that to me. I explained this to the powers that be, the director of the department, and they basically blew it off to the side.

When it came down to the end of the evaluation period, I passed with flying colors. But they gave me an incomplete because of that chief resident and his remarks on my evaluations. He had 3 pages of report about me as a person and as a student. He said that he had difficulty in expressing his opinions about me because of possible cultural biases that he may have had. He put “cultural biases” in an evaluation, and they looked at that and said that was enough for me to have to remediate my time. I was required to do an extra month in Pontiac, Illinois, which is even more rural than Peoria, because of a racist person that did not give me a fair opportunity because I was Black.

Like everything else in life, it was a learning experience. It’s why I fight so hard today. It’s why I’m so passionate about equity, not only in medicine but also in all aspects of society. It shows why we have police brutality and Black men dying in the streets. It shows how this happens because there are cultural and implicit biases that play out in every part of life, and we are not honest about it. Until we are honest about it and until we say that this is happening and there is something that needs to be done to address it, it’s going to continue to happen. That is my fight.

Exposing the unspoken power struggle

Dr. Levy: I couldn’t agree more. Attributing things like that to the individual, where you talk about a White man in power and a power structure that didn’t literally physically beat you but did beat you into submission. You talk about how to succeed in medical school, and how you had to suck it up and submit to something that was incredibly unfair. You understood, you were old enough, mature enough, to understand that if you fought back, you were going to lose. The only opportunity you had was to submit to that inequity and push forward.

Dr. Johnson: When I did try to fight, the chair of the department told me that either I accept the consequences or I would not graduate from medical school and be forced to do another year. That struck a chord with me. I think that happens a lot in our society, and it needs to be exposed.

Past experiences reflected in today’s society

Dr. Levy: Can you talk about what you faced in your ObGyn residency in terms of the systemic pushback, people not taking your orders, people questioning you. I know that I have heard that a great deal, and I experienced that myself as a woman.

Dr. Johnson: We look at the things that are happening now, everything from George Floyd’s murder to Colin Kaepernick taking a knee. These things are 10 years past when I first started residency. The year before I started residency, there was a noose hanging on the capitol lawn of Springfield, Illinois’ capital city. There’s systemic racism and hatred there. When I first started on the wards of my first year of ObGyn, again, I was the very first Black resident of my program’s history. Nobody could relate to me.

I went from a year-long general surgery internship at Washington Hospital Center in Washington, DC, to ObGyn residency. In the first 2 months, there were complaints of, “He’s not answering his pages. He’s not being prompt.” I went to my program director and said, “Listen, I have never had one complaint like this. There’s a problem here. And there’s a problem when I’m on the floor: When trying to give orders to nurses, they’re not taking them. I had to tell a couple of nurses, ‘I’m Dr. Johnson. Don’t call me by my first name, especially not in front of patients.’”

My director was just not hearing me, because the entire scenario was something they had never been exposed to. Systemic racism is real, and unless you experience it, it’s very difficult to accept that it is happening. But biases happen when you are not cognizant. People are used to things a certain way. Things play out in the media that make your mind think a certain way, and you don’t even realize it. You may not even want to be that way.

Continue to: Unconscious bias is a barrier to ensuring equity...

Dr. Levy: One very important point you just made is that we as the system need to be able to recognize those unconscious things, the language that we use, the disparaging remarks, the things that put people down, as well as the things that keep people out of promotion.

There are some interesting data about both race and gender and the language that we use when we write recommendations for people, that we do things unconsciously. The big message to all of us at the end is to open our minds to where those things can occur. For myself, professionally, I keep a list of words that I use when I write recommendations. I measure myself to ensure that I am using the same language for men and women, for Black and White. I think we need to overcome the system and the structure to create real equity—not equality but equity.

It begins with being real about the issues

Dr. Johnson: It’s a bigger problem than the existence of bias and racism. I think these are systemic issues that have been cultivated over centuries that have never been addressed. The true issue is that we deny that these are problems and refuse to talk about it because it makes us uncomfortable. To truly make things more equitable, we have to push our levels of comfort to be able to talk about things in a healthy manner, be open and transparent, and to start to understand how we are thinking about certain things. When you can see it, you can start to implement changes and start to change mentalities and thought processes.

For me, people say, “You don’t look like a doctor.” I get that all the time—because I have tattoos and earrings. I wear my hair in a mohawk. The image of what success looks like has been manifested through our media and culture, and it has imprinted on our minds as to how things are supposed to be. If someone doesn’t fit those molds, we start to shun them out, or we start to exhibit biases against those things. What I am trying to do is change that thought process of what a successful or a professional person looks like. It doesn’t have a look. It is not a White or Black thing. It’s an intellect, a mindset, a way of living. You have to treat every person as an individual and take all the biases out of it and understand where they are coming from and what they have to offer to the profession.

Dr. Levy: I personally was so impressed by you when I met you. I was impressed by the tattoos and the earrings, and my initial response to them was exactly that biased, “Oh, who is this person?” I checked that at the door, listened to you, and was really impressed at your surgical skill, your knowledge, your background. I am really grateful that you have been willing to spend the time to share that with everyone.

Dr. Johnson: Thank you for this discussion.

To watch the full interview between Drs. Levy and Johnson, visit: https://www.mdedge.com/obgyn/article/228507/facing-systemic-racism-health-care-inequities-medical-education. ●

The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.

In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.

Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).¹ In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.¹

In January, CMS plans the following major changes to coding and documentation^2,3:

1. Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
2. For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.⁴ However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.^2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
3. For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
4. History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
5. Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.

Continue to: Refocusing practice on MDM complexity...

Refocusing practice on MDM complexity

The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.

Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.

In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.² Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.² The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.

Increase in the valuation of office-based E/M services

The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:

• work of the clinician
• practice expense for technical components
• cost of professional liability insurance.

Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).

Continue to: Decreased payments for procedural services...

Decreased payments for procedural services

Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.

Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the corona­virus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.

If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).⁶ Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line

Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●

What do the Medicare billing changes mean for the Obstetrical Bundled services?

---

The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.

Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.

With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.

In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.

Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).¹ In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.¹

In January, CMS plans the following major changes to coding and documentation^2,3:

1. Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
2. For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.⁴ However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.^2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
3. For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
4. History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
5. Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.

Continue to: Refocusing practice on MDM complexity...

Refocusing practice on MDM complexity

The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.

Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.

In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.² Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.² The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.

Increase in the valuation of office-based E/M services

The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:

• work of the clinician
• practice expense for technical components
• cost of professional liability insurance.

Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).

Continue to: Decreased payments for procedural services...

Decreased payments for procedural services

Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.

Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the corona­virus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.

If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).⁶ Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line

Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●

What do the Medicare billing changes mean for the Obstetrical Bundled services?

---

The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.

Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.

With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.

In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.

Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).¹ In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.¹

In January, CMS plans the following major changes to coding and documentation^2,3:

1. Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
2. For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.⁴ However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.^2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
3. For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
4. History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
5. Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.

Continue to: Refocusing practice on MDM complexity...

Refocusing practice on MDM complexity

The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.

Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.

In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.² Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.² The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.

Increase in the valuation of office-based E/M services

The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:

• work of the clinician
• practice expense for technical components
• cost of professional liability insurance.

Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).

Continue to: Decreased payments for procedural services...

Decreased payments for procedural services

Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.

Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the corona­virus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.

If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).⁶ Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line

Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●

What do the Medicare billing changes mean for the Obstetrical Bundled services?

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The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.

Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.

With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●