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How dogs can teach parenting
Have you ever wished you could prescribe dog training classes to any of the parents of your pediatric patients? As one of the myriad people adopting a dog during COVID-19 quarantine, I have had the amusing and poignant chance to relive the principles basic to effective parenting of young children that I have been coaching about for decades.
Managing a dog instead of a child strips away layers that obfuscate parenting (e.g. child from unwanted pregnancy, fears about health issues, hopes for Harvard, wishes for the other gender, projection of expectations based on relatives, etc.) thereby making the lessons crystal clear. Unlike our perceptions for children, dog behavior does not mean anything (dog aficionados who differ, please allow poetic license). When a dog is hyper it indicates time to play or eat, not intentional defiance. Understanding this, we tend to respond more rationally.
With a dog of any age post weaning, one starts with the same basic learning abilities that will ever be present. An infant soaks up one’s caregiving for months before much training can begin, lulling parents into a mindset of having perfect skills that later requires a wrenching transition and new techniques when toddlerhood strikes.
Without expressive language feedback from a dog, we are forced to observe closely, and consciously use behavior modification techniques to get the desired behavior, but we have the advantage of seeing the effects of our management in days, not years later as for children!
Get her attention
It becomes obvious that to teach something, we need to get a dog’s attention first. A smell, appearance of a rabbit during a walk, a raindrop on the dog’s head all need to pass before a verbal command has a chance. Somehow the fact that children from toddler age on understand language (most of the time) makes parents forget that something else may be more interesting at the moment. We understand we need to teach a dog in a nondistracting environment without judging them for this requirement. In fact, trying to see what is engaging a dog or a toddler can enhance our appreciation of the world. But we stay curious about a dog’s distraction – not expecting to sense all a dog can – yet we may label a child’s repeated distraction as a flaw. Not being dogs ourselves allows us to give them the gift of being nonjudgmental.
Humans are inclined to talk to their young from birth, and, in general, the more talk the better for the child’s long-term development. Dogs can readily learn some human language but dog trainers all instruct us, when trying to teach a command, to give a single word instruction once, the same way each time, maintaining the animal’s attention, then waiting for at least a partially correct response (shaping) before rewarding. Inherent in this method is consistency and avoiding messages that are confusing because of extraneous words or emotions. While providing complex language that includes emotions is important for children overall, parents often do not differentiate times when they are actually giving an instruction from general banter, yet are upset when the child fails to follow through.
Be positive
Rather than relying on words to teach, using routines is the secret to desirable behavior in dogs. Dogs quickly develop habits (such as pooping on a certain rug) that can take many repetitions of humans supplying an alternative acceptable routine (pooping only in part of the yard) to change. Supplying an approximate alternative (rag toy instead of shoelaces), particularly if it is more exciting by being relatively novel and unavailable at other times, is far more effective than saying “No.” In fact, yelling at or hitting a dog is rarely effective because of short memory and lack of causal thinking and, in addition, can result in anxiety, shying away from interacting, or aggression; all consequences of harsh punishment in children as well.
Reinforcement works
Whatever your beliefs about dogs loving their humans, dogs understand only a small human vocabulary and are instead reinforced mainly by our attention to them that has become strongly associated with getting food or treats through instrumental conditioning. Because dogs have short memories, the most effective tools in changing their behavior are immediate attention, praise, and treats; this is also is true for children. The opposite of attention – ignoring – is very powerful in extinguishing an undesired behavior. We are told to wait at least 2 minutes after an undesired dog behavior before re-engaging. Why does this not seem to work in child rearing? Actually, it works well but is very hard for parents to do as our hearts go out to the begging child, who is part of our soul and closest kin. Soft-hearted dog owners have the same problem and often create obnoxious barking, begging, and nipping dogs as a result. These are all behaviors that could otherwise be extinguished.
Consistency is key
Behavior management works best and fastest if all the humans agree on the rules and follow them. This kind of consistency can be difficult for people training dogs as well as raising children, for many reasons. Most often there is a failure to take the time to explicitly decide on the rules; in other cases, it is lower thresholds for being annoyed and an inability to ignore a behavior. There may have been past experiences with being harshly punished, ignored, or coddled that people are are trying to overcome or reproduce; covert disagreements or desires to undermine a plan whether for the dog, the child, or the relationship; or even a desire for the dog or child to favor them by giving more treats. Sound familiar in pediatrics? With animals, objectivity and agreement may be easier to achieve because unwanted animal behavior is immediately more obviously related to training consistency than for children and may include big disincentives for humans such as barking, biting, or defecating. When these overt or covert disagreements occur in parenting children, our pediatric counseling or even family therapy may be needed. A similar acceleration plan may be available for people and their dogs (but not covered by insurance)!
While a dog may run down the stairs after a ball or a treat day after day, having forgotten that he will inevitably end up being locked in the basement for the night, we are taking advantage of the fact that dogs generally do not anticipate consequences. Yet, parents often scold even young children for a similar level of comprehension: “Didn’t you know that would break?” Fortunately, talking about consequences is educational over time for children but it needs to be done kindly with the understanding that, as with dogs, doing the same undesirable thing repeatedly is not necessarily defiance in young children but failure of our teaching. If behavior is not what you hoped for, look at what you are doing to promote it.
Much of what we call temperament is genetic in children as well as dogs. People know what to expect adopting a Jack Russell Terrier vs. a Labrador Retriever. With children we just don’t get to pick. Acceptance of what we got will make the journey easier.
We have much to cherish about dogs and children. If we lose it over the location of their poop, their forgiveness is quick. There is no such thing as too much affection. And joy is always available from both.
So why do I wish I could recommend dog training? Besides all the principles above, raising a dog together allows adults to discover mismatches in behavior management philosophies and to have a chance to see if they can negotiate a plan acceptable to both. Maybe it should be a premarital recommendation.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Have you ever wished you could prescribe dog training classes to any of the parents of your pediatric patients? As one of the myriad people adopting a dog during COVID-19 quarantine, I have had the amusing and poignant chance to relive the principles basic to effective parenting of young children that I have been coaching about for decades.
Managing a dog instead of a child strips away layers that obfuscate parenting (e.g. child from unwanted pregnancy, fears about health issues, hopes for Harvard, wishes for the other gender, projection of expectations based on relatives, etc.) thereby making the lessons crystal clear. Unlike our perceptions for children, dog behavior does not mean anything (dog aficionados who differ, please allow poetic license). When a dog is hyper it indicates time to play or eat, not intentional defiance. Understanding this, we tend to respond more rationally.
With a dog of any age post weaning, one starts with the same basic learning abilities that will ever be present. An infant soaks up one’s caregiving for months before much training can begin, lulling parents into a mindset of having perfect skills that later requires a wrenching transition and new techniques when toddlerhood strikes.
Without expressive language feedback from a dog, we are forced to observe closely, and consciously use behavior modification techniques to get the desired behavior, but we have the advantage of seeing the effects of our management in days, not years later as for children!
Get her attention
It becomes obvious that to teach something, we need to get a dog’s attention first. A smell, appearance of a rabbit during a walk, a raindrop on the dog’s head all need to pass before a verbal command has a chance. Somehow the fact that children from toddler age on understand language (most of the time) makes parents forget that something else may be more interesting at the moment. We understand we need to teach a dog in a nondistracting environment without judging them for this requirement. In fact, trying to see what is engaging a dog or a toddler can enhance our appreciation of the world. But we stay curious about a dog’s distraction – not expecting to sense all a dog can – yet we may label a child’s repeated distraction as a flaw. Not being dogs ourselves allows us to give them the gift of being nonjudgmental.
Humans are inclined to talk to their young from birth, and, in general, the more talk the better for the child’s long-term development. Dogs can readily learn some human language but dog trainers all instruct us, when trying to teach a command, to give a single word instruction once, the same way each time, maintaining the animal’s attention, then waiting for at least a partially correct response (shaping) before rewarding. Inherent in this method is consistency and avoiding messages that are confusing because of extraneous words or emotions. While providing complex language that includes emotions is important for children overall, parents often do not differentiate times when they are actually giving an instruction from general banter, yet are upset when the child fails to follow through.
Be positive
Rather than relying on words to teach, using routines is the secret to desirable behavior in dogs. Dogs quickly develop habits (such as pooping on a certain rug) that can take many repetitions of humans supplying an alternative acceptable routine (pooping only in part of the yard) to change. Supplying an approximate alternative (rag toy instead of shoelaces), particularly if it is more exciting by being relatively novel and unavailable at other times, is far more effective than saying “No.” In fact, yelling at or hitting a dog is rarely effective because of short memory and lack of causal thinking and, in addition, can result in anxiety, shying away from interacting, or aggression; all consequences of harsh punishment in children as well.
Reinforcement works
Whatever your beliefs about dogs loving their humans, dogs understand only a small human vocabulary and are instead reinforced mainly by our attention to them that has become strongly associated with getting food or treats through instrumental conditioning. Because dogs have short memories, the most effective tools in changing their behavior are immediate attention, praise, and treats; this is also is true for children. The opposite of attention – ignoring – is very powerful in extinguishing an undesired behavior. We are told to wait at least 2 minutes after an undesired dog behavior before re-engaging. Why does this not seem to work in child rearing? Actually, it works well but is very hard for parents to do as our hearts go out to the begging child, who is part of our soul and closest kin. Soft-hearted dog owners have the same problem and often create obnoxious barking, begging, and nipping dogs as a result. These are all behaviors that could otherwise be extinguished.
Consistency is key
Behavior management works best and fastest if all the humans agree on the rules and follow them. This kind of consistency can be difficult for people training dogs as well as raising children, for many reasons. Most often there is a failure to take the time to explicitly decide on the rules; in other cases, it is lower thresholds for being annoyed and an inability to ignore a behavior. There may have been past experiences with being harshly punished, ignored, or coddled that people are are trying to overcome or reproduce; covert disagreements or desires to undermine a plan whether for the dog, the child, or the relationship; or even a desire for the dog or child to favor them by giving more treats. Sound familiar in pediatrics? With animals, objectivity and agreement may be easier to achieve because unwanted animal behavior is immediately more obviously related to training consistency than for children and may include big disincentives for humans such as barking, biting, or defecating. When these overt or covert disagreements occur in parenting children, our pediatric counseling or even family therapy may be needed. A similar acceleration plan may be available for people and their dogs (but not covered by insurance)!
While a dog may run down the stairs after a ball or a treat day after day, having forgotten that he will inevitably end up being locked in the basement for the night, we are taking advantage of the fact that dogs generally do not anticipate consequences. Yet, parents often scold even young children for a similar level of comprehension: “Didn’t you know that would break?” Fortunately, talking about consequences is educational over time for children but it needs to be done kindly with the understanding that, as with dogs, doing the same undesirable thing repeatedly is not necessarily defiance in young children but failure of our teaching. If behavior is not what you hoped for, look at what you are doing to promote it.
Much of what we call temperament is genetic in children as well as dogs. People know what to expect adopting a Jack Russell Terrier vs. a Labrador Retriever. With children we just don’t get to pick. Acceptance of what we got will make the journey easier.
We have much to cherish about dogs and children. If we lose it over the location of their poop, their forgiveness is quick. There is no such thing as too much affection. And joy is always available from both.
So why do I wish I could recommend dog training? Besides all the principles above, raising a dog together allows adults to discover mismatches in behavior management philosophies and to have a chance to see if they can negotiate a plan acceptable to both. Maybe it should be a premarital recommendation.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Have you ever wished you could prescribe dog training classes to any of the parents of your pediatric patients? As one of the myriad people adopting a dog during COVID-19 quarantine, I have had the amusing and poignant chance to relive the principles basic to effective parenting of young children that I have been coaching about for decades.
Managing a dog instead of a child strips away layers that obfuscate parenting (e.g. child from unwanted pregnancy, fears about health issues, hopes for Harvard, wishes for the other gender, projection of expectations based on relatives, etc.) thereby making the lessons crystal clear. Unlike our perceptions for children, dog behavior does not mean anything (dog aficionados who differ, please allow poetic license). When a dog is hyper it indicates time to play or eat, not intentional defiance. Understanding this, we tend to respond more rationally.
With a dog of any age post weaning, one starts with the same basic learning abilities that will ever be present. An infant soaks up one’s caregiving for months before much training can begin, lulling parents into a mindset of having perfect skills that later requires a wrenching transition and new techniques when toddlerhood strikes.
Without expressive language feedback from a dog, we are forced to observe closely, and consciously use behavior modification techniques to get the desired behavior, but we have the advantage of seeing the effects of our management in days, not years later as for children!
Get her attention
It becomes obvious that to teach something, we need to get a dog’s attention first. A smell, appearance of a rabbit during a walk, a raindrop on the dog’s head all need to pass before a verbal command has a chance. Somehow the fact that children from toddler age on understand language (most of the time) makes parents forget that something else may be more interesting at the moment. We understand we need to teach a dog in a nondistracting environment without judging them for this requirement. In fact, trying to see what is engaging a dog or a toddler can enhance our appreciation of the world. But we stay curious about a dog’s distraction – not expecting to sense all a dog can – yet we may label a child’s repeated distraction as a flaw. Not being dogs ourselves allows us to give them the gift of being nonjudgmental.
Humans are inclined to talk to their young from birth, and, in general, the more talk the better for the child’s long-term development. Dogs can readily learn some human language but dog trainers all instruct us, when trying to teach a command, to give a single word instruction once, the same way each time, maintaining the animal’s attention, then waiting for at least a partially correct response (shaping) before rewarding. Inherent in this method is consistency and avoiding messages that are confusing because of extraneous words or emotions. While providing complex language that includes emotions is important for children overall, parents often do not differentiate times when they are actually giving an instruction from general banter, yet are upset when the child fails to follow through.
Be positive
Rather than relying on words to teach, using routines is the secret to desirable behavior in dogs. Dogs quickly develop habits (such as pooping on a certain rug) that can take many repetitions of humans supplying an alternative acceptable routine (pooping only in part of the yard) to change. Supplying an approximate alternative (rag toy instead of shoelaces), particularly if it is more exciting by being relatively novel and unavailable at other times, is far more effective than saying “No.” In fact, yelling at or hitting a dog is rarely effective because of short memory and lack of causal thinking and, in addition, can result in anxiety, shying away from interacting, or aggression; all consequences of harsh punishment in children as well.
Reinforcement works
Whatever your beliefs about dogs loving their humans, dogs understand only a small human vocabulary and are instead reinforced mainly by our attention to them that has become strongly associated with getting food or treats through instrumental conditioning. Because dogs have short memories, the most effective tools in changing their behavior are immediate attention, praise, and treats; this is also is true for children. The opposite of attention – ignoring – is very powerful in extinguishing an undesired behavior. We are told to wait at least 2 minutes after an undesired dog behavior before re-engaging. Why does this not seem to work in child rearing? Actually, it works well but is very hard for parents to do as our hearts go out to the begging child, who is part of our soul and closest kin. Soft-hearted dog owners have the same problem and often create obnoxious barking, begging, and nipping dogs as a result. These are all behaviors that could otherwise be extinguished.
Consistency is key
Behavior management works best and fastest if all the humans agree on the rules and follow them. This kind of consistency can be difficult for people training dogs as well as raising children, for many reasons. Most often there is a failure to take the time to explicitly decide on the rules; in other cases, it is lower thresholds for being annoyed and an inability to ignore a behavior. There may have been past experiences with being harshly punished, ignored, or coddled that people are are trying to overcome or reproduce; covert disagreements or desires to undermine a plan whether for the dog, the child, or the relationship; or even a desire for the dog or child to favor them by giving more treats. Sound familiar in pediatrics? With animals, objectivity and agreement may be easier to achieve because unwanted animal behavior is immediately more obviously related to training consistency than for children and may include big disincentives for humans such as barking, biting, or defecating. When these overt or covert disagreements occur in parenting children, our pediatric counseling or even family therapy may be needed. A similar acceleration plan may be available for people and their dogs (but not covered by insurance)!
While a dog may run down the stairs after a ball or a treat day after day, having forgotten that he will inevitably end up being locked in the basement for the night, we are taking advantage of the fact that dogs generally do not anticipate consequences. Yet, parents often scold even young children for a similar level of comprehension: “Didn’t you know that would break?” Fortunately, talking about consequences is educational over time for children but it needs to be done kindly with the understanding that, as with dogs, doing the same undesirable thing repeatedly is not necessarily defiance in young children but failure of our teaching. If behavior is not what you hoped for, look at what you are doing to promote it.
Much of what we call temperament is genetic in children as well as dogs. People know what to expect adopting a Jack Russell Terrier vs. a Labrador Retriever. With children we just don’t get to pick. Acceptance of what we got will make the journey easier.
We have much to cherish about dogs and children. If we lose it over the location of their poop, their forgiveness is quick. There is no such thing as too much affection. And joy is always available from both.
So why do I wish I could recommend dog training? Besides all the principles above, raising a dog together allows adults to discover mismatches in behavior management philosophies and to have a chance to see if they can negotiate a plan acceptable to both. Maybe it should be a premarital recommendation.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Beyond baseline, DBT no better than mammography for dense breasts
In women with extremely dense breasts, digital breast tomosynthesis (DBT) does not outperform digital mammography (DM) after the baseline exam, according to a review of nearly 1.6 million screenings.
At baseline, DBT improved recall and cancer detection rates for all women. On subsequent exams, differences in screening performance between DBT and DM varied by age and density subgroups. However, there were no significant differences in recall or cancer detection rates among women with extremely dense breasts in any age group.
Kathryn Lowry, MD, of the University of Washington in Seattle, and colleagues reported these findings in JAMA Network Open.
“Our findings suggest that density likely should not be used as a criterion to triage use of DBT for routine screening in settings where DBT is not universally available, as has been reported in physician surveys,” the authors wrote. “The largest absolute improvements of DBT screening were achieved on the baseline screening examination, suggesting that women presenting for their first screening examination are particularly important to prioritize for DBT,” regardless of breast density or age.
Study details
Dr. Lowry and colleagues reviewed 1,584,079 screenings in women aged 40-79 years. The exams were done from January 2010 to April 2018 at Breast Cancer Surveillance Consortium facilities across the United States.
Sixty-five percent of the exams were in White, non-Hispanic women, 25.2% were in women younger than 50 years, and 42.4% were in women with heterogeneously dense or extremely dense breasts. Subjects had no history of breast cancer, mastectomy, or breast augmentation.
The investigators compared the performance of 1,273,492 DMs with 310,587 DBTs across the four Breast Imaging Reporting and Database System density types: almost entirely fatty, scattered fibroglandular density, heterogeneously dense, and extremely dense.
Findings were adjusted for race, family breast cancer history, and other potential confounders.
Recall and cancer detection rates
At baseline, recall and cancer detection rates were better with DBT than with DM, regardless of breast density subtype or patient age.
For instance, in women aged 50-59 years, screening recalls per 1,000 exams dropped from 241 with DM to 204 with DBT (relative risk, 0.84; 95% confidence interval, 0.73-0.98). Cancer detection rates per 1,000 exams in this age group increased from 5.9 with DM to 8.8 with DBT (RR, 1.50; 95% CI, 1.10-2.08).
On follow-up exams, recall rates were lower with DBT for women with scattered fibroglandular density and heterogeneously dense breasts in all age groups, as well as in women with almost entirely fatty breasts aged 50-79 years.
“By contrast, there were no significant differences in recall rates in women with extremely dense breasts in any age group,” the authors wrote.
Cancer detection rates on follow-up exams varied by age and breast density.
Cancer detection rates were higher with DBT than with DM in women with heterogeneously dense breasts in all age groups and in women with scattered fibroglandular density at 50-59 years of age and 60-79 years of age. However, cancer detection rates were not significantly different with DBT or DM for women with almost entirely fatty breasts or extremely dense breasts of any age.
Implications and next steps
Dr. Lowry and colleagues noted that use of DBT has increased steadily since it was approved by the Food and Drug Administration in 2011, driven by studies demonstrating, among other things, earlier detection of invasive cancers.
The problem has been that previous investigations “largely dichotomized dense (heterogeneously dense and extremely dense) and nondense (almost entirely fat and scattered fibroglandular densities) categories,” the authors wrote. Therefore, the nuance of benefit across density subtypes hasn’t been clear.
The finding that “screening benefits of DBT differ for women with heterogeneously dense breasts [versus] extremely dense breasts is especially important in the current landscape of density legislation and demand for supplemental screening tests beyond mammography. To date, most state mandates and ... proposed federal legislation have uniformly grouped women with heterogeneously dense breasts and those with extremely dense breasts as a single population,” the authors wrote.
As the new findings suggest, “there are important differences in performance that may not be appreciated by combining density categories,” the authors added.
The results “suggest that women with extremely dense breast tissue may benefit more from additional screening than women with heterogeneously dense breasts who undergo tomosynthesis mammography,” Catherine Tuite, MD, of Fox Chase Cancer Center in Philadelphia, and colleagues wrote in a related editorial.
“Research to determine density and risk-specific outcomes for supplemental screening methods, such as magnetic resonance imaging ... molecular breast imaging, or ultrasonography is necessary to understand which screening method beyond DBT is best for average-risk women with heterogeneous or extremely dense breasts,” the editorialists wrote.
This research was funded by the National Cancer Institute and the Patient-Centered Outcomes Research Institute through the Breast Cancer Surveillance Consortium. Dr. Lowry reported grants from GE Healthcare outside the submitted work. The editorialists didn’t have any disclosures.
SOURCE: Lowry K et al. JAMA Netw Open. 2020 Jul 1;3(7):e2011792.
In women with extremely dense breasts, digital breast tomosynthesis (DBT) does not outperform digital mammography (DM) after the baseline exam, according to a review of nearly 1.6 million screenings.
At baseline, DBT improved recall and cancer detection rates for all women. On subsequent exams, differences in screening performance between DBT and DM varied by age and density subgroups. However, there were no significant differences in recall or cancer detection rates among women with extremely dense breasts in any age group.
Kathryn Lowry, MD, of the University of Washington in Seattle, and colleagues reported these findings in JAMA Network Open.
“Our findings suggest that density likely should not be used as a criterion to triage use of DBT for routine screening in settings where DBT is not universally available, as has been reported in physician surveys,” the authors wrote. “The largest absolute improvements of DBT screening were achieved on the baseline screening examination, suggesting that women presenting for their first screening examination are particularly important to prioritize for DBT,” regardless of breast density or age.
Study details
Dr. Lowry and colleagues reviewed 1,584,079 screenings in women aged 40-79 years. The exams were done from January 2010 to April 2018 at Breast Cancer Surveillance Consortium facilities across the United States.
Sixty-five percent of the exams were in White, non-Hispanic women, 25.2% were in women younger than 50 years, and 42.4% were in women with heterogeneously dense or extremely dense breasts. Subjects had no history of breast cancer, mastectomy, or breast augmentation.
The investigators compared the performance of 1,273,492 DMs with 310,587 DBTs across the four Breast Imaging Reporting and Database System density types: almost entirely fatty, scattered fibroglandular density, heterogeneously dense, and extremely dense.
Findings were adjusted for race, family breast cancer history, and other potential confounders.
Recall and cancer detection rates
At baseline, recall and cancer detection rates were better with DBT than with DM, regardless of breast density subtype or patient age.
For instance, in women aged 50-59 years, screening recalls per 1,000 exams dropped from 241 with DM to 204 with DBT (relative risk, 0.84; 95% confidence interval, 0.73-0.98). Cancer detection rates per 1,000 exams in this age group increased from 5.9 with DM to 8.8 with DBT (RR, 1.50; 95% CI, 1.10-2.08).
On follow-up exams, recall rates were lower with DBT for women with scattered fibroglandular density and heterogeneously dense breasts in all age groups, as well as in women with almost entirely fatty breasts aged 50-79 years.
“By contrast, there were no significant differences in recall rates in women with extremely dense breasts in any age group,” the authors wrote.
Cancer detection rates on follow-up exams varied by age and breast density.
Cancer detection rates were higher with DBT than with DM in women with heterogeneously dense breasts in all age groups and in women with scattered fibroglandular density at 50-59 years of age and 60-79 years of age. However, cancer detection rates were not significantly different with DBT or DM for women with almost entirely fatty breasts or extremely dense breasts of any age.
Implications and next steps
Dr. Lowry and colleagues noted that use of DBT has increased steadily since it was approved by the Food and Drug Administration in 2011, driven by studies demonstrating, among other things, earlier detection of invasive cancers.
The problem has been that previous investigations “largely dichotomized dense (heterogeneously dense and extremely dense) and nondense (almost entirely fat and scattered fibroglandular densities) categories,” the authors wrote. Therefore, the nuance of benefit across density subtypes hasn’t been clear.
The finding that “screening benefits of DBT differ for women with heterogeneously dense breasts [versus] extremely dense breasts is especially important in the current landscape of density legislation and demand for supplemental screening tests beyond mammography. To date, most state mandates and ... proposed federal legislation have uniformly grouped women with heterogeneously dense breasts and those with extremely dense breasts as a single population,” the authors wrote.
As the new findings suggest, “there are important differences in performance that may not be appreciated by combining density categories,” the authors added.
The results “suggest that women with extremely dense breast tissue may benefit more from additional screening than women with heterogeneously dense breasts who undergo tomosynthesis mammography,” Catherine Tuite, MD, of Fox Chase Cancer Center in Philadelphia, and colleagues wrote in a related editorial.
“Research to determine density and risk-specific outcomes for supplemental screening methods, such as magnetic resonance imaging ... molecular breast imaging, or ultrasonography is necessary to understand which screening method beyond DBT is best for average-risk women with heterogeneous or extremely dense breasts,” the editorialists wrote.
This research was funded by the National Cancer Institute and the Patient-Centered Outcomes Research Institute through the Breast Cancer Surveillance Consortium. Dr. Lowry reported grants from GE Healthcare outside the submitted work. The editorialists didn’t have any disclosures.
SOURCE: Lowry K et al. JAMA Netw Open. 2020 Jul 1;3(7):e2011792.
In women with extremely dense breasts, digital breast tomosynthesis (DBT) does not outperform digital mammography (DM) after the baseline exam, according to a review of nearly 1.6 million screenings.
At baseline, DBT improved recall and cancer detection rates for all women. On subsequent exams, differences in screening performance between DBT and DM varied by age and density subgroups. However, there were no significant differences in recall or cancer detection rates among women with extremely dense breasts in any age group.
Kathryn Lowry, MD, of the University of Washington in Seattle, and colleagues reported these findings in JAMA Network Open.
“Our findings suggest that density likely should not be used as a criterion to triage use of DBT for routine screening in settings where DBT is not universally available, as has been reported in physician surveys,” the authors wrote. “The largest absolute improvements of DBT screening were achieved on the baseline screening examination, suggesting that women presenting for their first screening examination are particularly important to prioritize for DBT,” regardless of breast density or age.
Study details
Dr. Lowry and colleagues reviewed 1,584,079 screenings in women aged 40-79 years. The exams were done from January 2010 to April 2018 at Breast Cancer Surveillance Consortium facilities across the United States.
Sixty-five percent of the exams were in White, non-Hispanic women, 25.2% were in women younger than 50 years, and 42.4% were in women with heterogeneously dense or extremely dense breasts. Subjects had no history of breast cancer, mastectomy, or breast augmentation.
The investigators compared the performance of 1,273,492 DMs with 310,587 DBTs across the four Breast Imaging Reporting and Database System density types: almost entirely fatty, scattered fibroglandular density, heterogeneously dense, and extremely dense.
Findings were adjusted for race, family breast cancer history, and other potential confounders.
Recall and cancer detection rates
At baseline, recall and cancer detection rates were better with DBT than with DM, regardless of breast density subtype or patient age.
For instance, in women aged 50-59 years, screening recalls per 1,000 exams dropped from 241 with DM to 204 with DBT (relative risk, 0.84; 95% confidence interval, 0.73-0.98). Cancer detection rates per 1,000 exams in this age group increased from 5.9 with DM to 8.8 with DBT (RR, 1.50; 95% CI, 1.10-2.08).
On follow-up exams, recall rates were lower with DBT for women with scattered fibroglandular density and heterogeneously dense breasts in all age groups, as well as in women with almost entirely fatty breasts aged 50-79 years.
“By contrast, there were no significant differences in recall rates in women with extremely dense breasts in any age group,” the authors wrote.
Cancer detection rates on follow-up exams varied by age and breast density.
Cancer detection rates were higher with DBT than with DM in women with heterogeneously dense breasts in all age groups and in women with scattered fibroglandular density at 50-59 years of age and 60-79 years of age. However, cancer detection rates were not significantly different with DBT or DM for women with almost entirely fatty breasts or extremely dense breasts of any age.
Implications and next steps
Dr. Lowry and colleagues noted that use of DBT has increased steadily since it was approved by the Food and Drug Administration in 2011, driven by studies demonstrating, among other things, earlier detection of invasive cancers.
The problem has been that previous investigations “largely dichotomized dense (heterogeneously dense and extremely dense) and nondense (almost entirely fat and scattered fibroglandular densities) categories,” the authors wrote. Therefore, the nuance of benefit across density subtypes hasn’t been clear.
The finding that “screening benefits of DBT differ for women with heterogeneously dense breasts [versus] extremely dense breasts is especially important in the current landscape of density legislation and demand for supplemental screening tests beyond mammography. To date, most state mandates and ... proposed federal legislation have uniformly grouped women with heterogeneously dense breasts and those with extremely dense breasts as a single population,” the authors wrote.
As the new findings suggest, “there are important differences in performance that may not be appreciated by combining density categories,” the authors added.
The results “suggest that women with extremely dense breast tissue may benefit more from additional screening than women with heterogeneously dense breasts who undergo tomosynthesis mammography,” Catherine Tuite, MD, of Fox Chase Cancer Center in Philadelphia, and colleagues wrote in a related editorial.
“Research to determine density and risk-specific outcomes for supplemental screening methods, such as magnetic resonance imaging ... molecular breast imaging, or ultrasonography is necessary to understand which screening method beyond DBT is best for average-risk women with heterogeneous or extremely dense breasts,” the editorialists wrote.
This research was funded by the National Cancer Institute and the Patient-Centered Outcomes Research Institute through the Breast Cancer Surveillance Consortium. Dr. Lowry reported grants from GE Healthcare outside the submitted work. The editorialists didn’t have any disclosures.
SOURCE: Lowry K et al. JAMA Netw Open. 2020 Jul 1;3(7):e2011792.
FROM THE JAMA OPEN NETWORK
Quality improvement program expands early childhood screening
Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.
Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.
To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.
In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.
The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.
Overall, Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).
Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).
In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
EHR packages deficiencies seen as barrier
“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.
Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.
The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.
“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.
Making measurable, meaningful practice change
Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.
“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.
“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.
This study not only showed the effectiveness of change management, but also detailed the effort it required, including:
- Use of monthly team meetings.
- Collecting data from patients and team members.
- Soliciting parent feedback.
- Implementing new templates for care.
- Use of tool translations or translator support.
- Involving colocated professionals, residents, and students.
- Assembling resources.
- Attempting to invoke change in EHR vendor.
“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.
“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.
“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.
Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”
The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.
SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.
Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.
Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.
To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.
In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.
The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.
Overall, Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).
Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).
In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
EHR packages deficiencies seen as barrier
“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.
Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.
The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.
“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.
Making measurable, meaningful practice change
Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.
“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.
“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.
This study not only showed the effectiveness of change management, but also detailed the effort it required, including:
- Use of monthly team meetings.
- Collecting data from patients and team members.
- Soliciting parent feedback.
- Implementing new templates for care.
- Use of tool translations or translator support.
- Involving colocated professionals, residents, and students.
- Assembling resources.
- Attempting to invoke change in EHR vendor.
“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.
“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.
“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.
Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”
The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.
SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.
Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.
Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.
To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.
In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.
The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.
Overall, Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).
Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).
In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
EHR packages deficiencies seen as barrier
“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.
Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.
The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.
“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.
Making measurable, meaningful practice change
Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.
“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.
“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.
This study not only showed the effectiveness of change management, but also detailed the effort it required, including:
- Use of monthly team meetings.
- Collecting data from patients and team members.
- Soliciting parent feedback.
- Implementing new templates for care.
- Use of tool translations or translator support.
- Involving colocated professionals, residents, and students.
- Assembling resources.
- Attempting to invoke change in EHR vendor.
“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.
“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.
“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.
Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”
The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.
SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.
FROM PEDIATRICS
Coping with COVID-19, racism, and other stressors
The start of a new school year is usually a time of excitement and return to routine, structure, and consistency for children, teenagers, and families. With the current COVID-19 pandemic, this year is anything but typical. Face masks, hand washing, physical distancing, remote learning, and restrictions on extracurricular activities are just a few of the changes experienced by children in schools. At home, the disruptions and uncertainty for families are equally dramatic with loss of employment, limited child care, risk of eviction and foreclosure, food insecurity, and growing numbers of families directly impacted by loss of health and life due to the coronavirus.
While every family is impacted by the current global pandemic, the realities of the pandemic have thrown increasing light on the racial, social, and structural injustices in our system. People of color are much more likely to be infected, have more severe disease, and die from COVID-19; they are more likely to experience the socioeconomic impacts.1 Centuries of racial injustice and inequity have been highlighted not just by this pandemic but by ongoing differential treatment of people of color in our education, health, justice, economic, and housing systems. The murders of George Floyd, Breonna Taylor, Ahmaud Arbery, and too many others are just one source of the constant stress facing children and families of color.
While each family and individual currently faces a distinct combination of stressors and adversity, no one has been spared from these disruptions. International, national, and local communities all need to continue efforts to overcome the current pandemic and systemic racism. As providers, we have a profound opportunity and responsibility to engage both in advocacy for our communities and the individual care of children and families. We are aware of the negative impacts of acute and chronic stress on long-term health outcomes but are equally familiar with the power of resilience.
Resilience has broadly been defined as the “process of adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress.”2 Some have argued that resilience should be further defined to include an individual making a “conscious effort to move forward” after or during adversity.3 Another definition with particular utility in considering how to develop and promote resilience describes it as “a process to harness resources to sustain well-being.”3 This definition not only discusses the end result, but the need to reach beyond the current capacity of an individual by harnessing both internal and external resources. These resources may be as tangible as money, food, infrastructure, or treatment, but also can include relationships, social capital, and the lived experience of others. Social supports, mature mentors, and solid bonds with parents/caregivers are critical resources for the development of child and adolescent resilience.4,5
by both being a resource and helping them harness other resources that can lead to physical, emotional, and relationship well-being. To do this, consider incorporating the following into your practice:
Help children and adolescents identify and reach out to positive supports
Research has shown the importance of a stable adult figure in the development of resilience in children.4,5 Ideally, parents will be a major positive support to their children in times of crisis. When parents are not appropriate supports, teachers, coaches, mentors, grandparents, or other extended family members can provide the needed support for children to be resilient across educational, emotional, and relationship domains.4 To find out who your patients have as a stable adult figure, ask the following or a related question: “Who do you have in your life who you can talk to or get support from on a regular basis?”
Screen for substance use and mental health challenges
Do this for children, adolescents, AND adults. Then treat and refer to appropriate treatment as indicated. Rates of depression, anxiety, suicide, substance use, and overdose all have increased with recent events.6 Treating parents with mental health and substance use disorders will not only facilitate their ability to be a positive support and role model for their children and promote resilience, but it has been shown to decrease child psychopathology.7 Providing parents with referrals for substance use and mental health services as well as educating them on the importance of self-care is vital for helping the development of children.
Provide parents with resources on how to cope with ongoing stressors
These stressors may be related to the COVID-19 pandemic, racism, or both. By providing resources to parents, they can better help their children overcome stressors. Multiple organizations have free online collections to support parents and families including the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and many others (See below for a list of resources).
Encourage families to find and develop purpose and meaning during this time. Children and families have devoted their time to many activities, some more adaptive and health promoting than others. If we think of resilience as the process of “moving forward” then developing goals and plans to be productive can be helpful and “meaning-making.”3 Spending time together as families, developing skills, accomplishing goals, becoming involved in important social movements, or volunteering all can be ways that individuals and families can develop feelings of self-worth, purpose, and accomplishment.2
Dr. Heward is a child and adolescent psychiatrist at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email him at [email protected].
Resources: Coping with COVID-19
1. American Academy of Pediatrics HealthyChildren.org page on COVID-19.
2. American Academy of Child and Adolescent Psychiatry COVID-19 Resources for Families.
3. American Psychiatric Association COVID-19 Resources for Families.
4. American Psychological Association COVID-19 Information and Resources.
Resources: Racism and discrimination
1. American Academy of Pediatrics Talking to Children About Racial Bias.
2. American Academy of Child and Adolescent Psychiatry Racism Resource Library.
3. American Psychological Association Bias, Discrimination, and Equity Resources.
References
1. “Double jeopardy: COVID-19 and behavioral health disparities for Black and Latino communities in the U.S.” Substance Abuse and Mental Health Services Administration. (Submitted by Office of Behavioral Health Equity).
2. “Building your resilience.” American Psychological Association.
3. Eur J Psychotraumatol. 2014 Oct 1. doi: 10.3402/ejpt.v5.25338.
4. Psychological and biological factors associated with resilience to stress and trauma, in “The Unbroken Soul: Tragedy, Trauma, and Human Resilience” (Lanham, Md.: Jason Aronson, 2008, pp.129-51).
5. Biol Psychiatry. 2019 Sep 15. doi: 10.1016/j.biopsych.2019.07.012.
6. MMWR Morb Mortal Wkly Rep. 2020;69:1049-57.
7. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):379-89.
The start of a new school year is usually a time of excitement and return to routine, structure, and consistency for children, teenagers, and families. With the current COVID-19 pandemic, this year is anything but typical. Face masks, hand washing, physical distancing, remote learning, and restrictions on extracurricular activities are just a few of the changes experienced by children in schools. At home, the disruptions and uncertainty for families are equally dramatic with loss of employment, limited child care, risk of eviction and foreclosure, food insecurity, and growing numbers of families directly impacted by loss of health and life due to the coronavirus.
While every family is impacted by the current global pandemic, the realities of the pandemic have thrown increasing light on the racial, social, and structural injustices in our system. People of color are much more likely to be infected, have more severe disease, and die from COVID-19; they are more likely to experience the socioeconomic impacts.1 Centuries of racial injustice and inequity have been highlighted not just by this pandemic but by ongoing differential treatment of people of color in our education, health, justice, economic, and housing systems. The murders of George Floyd, Breonna Taylor, Ahmaud Arbery, and too many others are just one source of the constant stress facing children and families of color.
While each family and individual currently faces a distinct combination of stressors and adversity, no one has been spared from these disruptions. International, national, and local communities all need to continue efforts to overcome the current pandemic and systemic racism. As providers, we have a profound opportunity and responsibility to engage both in advocacy for our communities and the individual care of children and families. We are aware of the negative impacts of acute and chronic stress on long-term health outcomes but are equally familiar with the power of resilience.
Resilience has broadly been defined as the “process of adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress.”2 Some have argued that resilience should be further defined to include an individual making a “conscious effort to move forward” after or during adversity.3 Another definition with particular utility in considering how to develop and promote resilience describes it as “a process to harness resources to sustain well-being.”3 This definition not only discusses the end result, but the need to reach beyond the current capacity of an individual by harnessing both internal and external resources. These resources may be as tangible as money, food, infrastructure, or treatment, but also can include relationships, social capital, and the lived experience of others. Social supports, mature mentors, and solid bonds with parents/caregivers are critical resources for the development of child and adolescent resilience.4,5
by both being a resource and helping them harness other resources that can lead to physical, emotional, and relationship well-being. To do this, consider incorporating the following into your practice:
Help children and adolescents identify and reach out to positive supports
Research has shown the importance of a stable adult figure in the development of resilience in children.4,5 Ideally, parents will be a major positive support to their children in times of crisis. When parents are not appropriate supports, teachers, coaches, mentors, grandparents, or other extended family members can provide the needed support for children to be resilient across educational, emotional, and relationship domains.4 To find out who your patients have as a stable adult figure, ask the following or a related question: “Who do you have in your life who you can talk to or get support from on a regular basis?”
Screen for substance use and mental health challenges
Do this for children, adolescents, AND adults. Then treat and refer to appropriate treatment as indicated. Rates of depression, anxiety, suicide, substance use, and overdose all have increased with recent events.6 Treating parents with mental health and substance use disorders will not only facilitate their ability to be a positive support and role model for their children and promote resilience, but it has been shown to decrease child psychopathology.7 Providing parents with referrals for substance use and mental health services as well as educating them on the importance of self-care is vital for helping the development of children.
Provide parents with resources on how to cope with ongoing stressors
These stressors may be related to the COVID-19 pandemic, racism, or both. By providing resources to parents, they can better help their children overcome stressors. Multiple organizations have free online collections to support parents and families including the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and many others (See below for a list of resources).
Encourage families to find and develop purpose and meaning during this time. Children and families have devoted their time to many activities, some more adaptive and health promoting than others. If we think of resilience as the process of “moving forward” then developing goals and plans to be productive can be helpful and “meaning-making.”3 Spending time together as families, developing skills, accomplishing goals, becoming involved in important social movements, or volunteering all can be ways that individuals and families can develop feelings of self-worth, purpose, and accomplishment.2
Dr. Heward is a child and adolescent psychiatrist at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email him at [email protected].
Resources: Coping with COVID-19
1. American Academy of Pediatrics HealthyChildren.org page on COVID-19.
2. American Academy of Child and Adolescent Psychiatry COVID-19 Resources for Families.
3. American Psychiatric Association COVID-19 Resources for Families.
4. American Psychological Association COVID-19 Information and Resources.
Resources: Racism and discrimination
1. American Academy of Pediatrics Talking to Children About Racial Bias.
2. American Academy of Child and Adolescent Psychiatry Racism Resource Library.
3. American Psychological Association Bias, Discrimination, and Equity Resources.
References
1. “Double jeopardy: COVID-19 and behavioral health disparities for Black and Latino communities in the U.S.” Substance Abuse and Mental Health Services Administration. (Submitted by Office of Behavioral Health Equity).
2. “Building your resilience.” American Psychological Association.
3. Eur J Psychotraumatol. 2014 Oct 1. doi: 10.3402/ejpt.v5.25338.
4. Psychological and biological factors associated with resilience to stress and trauma, in “The Unbroken Soul: Tragedy, Trauma, and Human Resilience” (Lanham, Md.: Jason Aronson, 2008, pp.129-51).
5. Biol Psychiatry. 2019 Sep 15. doi: 10.1016/j.biopsych.2019.07.012.
6. MMWR Morb Mortal Wkly Rep. 2020;69:1049-57.
7. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):379-89.
The start of a new school year is usually a time of excitement and return to routine, structure, and consistency for children, teenagers, and families. With the current COVID-19 pandemic, this year is anything but typical. Face masks, hand washing, physical distancing, remote learning, and restrictions on extracurricular activities are just a few of the changes experienced by children in schools. At home, the disruptions and uncertainty for families are equally dramatic with loss of employment, limited child care, risk of eviction and foreclosure, food insecurity, and growing numbers of families directly impacted by loss of health and life due to the coronavirus.
While every family is impacted by the current global pandemic, the realities of the pandemic have thrown increasing light on the racial, social, and structural injustices in our system. People of color are much more likely to be infected, have more severe disease, and die from COVID-19; they are more likely to experience the socioeconomic impacts.1 Centuries of racial injustice and inequity have been highlighted not just by this pandemic but by ongoing differential treatment of people of color in our education, health, justice, economic, and housing systems. The murders of George Floyd, Breonna Taylor, Ahmaud Arbery, and too many others are just one source of the constant stress facing children and families of color.
While each family and individual currently faces a distinct combination of stressors and adversity, no one has been spared from these disruptions. International, national, and local communities all need to continue efforts to overcome the current pandemic and systemic racism. As providers, we have a profound opportunity and responsibility to engage both in advocacy for our communities and the individual care of children and families. We are aware of the negative impacts of acute and chronic stress on long-term health outcomes but are equally familiar with the power of resilience.
Resilience has broadly been defined as the “process of adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress.”2 Some have argued that resilience should be further defined to include an individual making a “conscious effort to move forward” after or during adversity.3 Another definition with particular utility in considering how to develop and promote resilience describes it as “a process to harness resources to sustain well-being.”3 This definition not only discusses the end result, but the need to reach beyond the current capacity of an individual by harnessing both internal and external resources. These resources may be as tangible as money, food, infrastructure, or treatment, but also can include relationships, social capital, and the lived experience of others. Social supports, mature mentors, and solid bonds with parents/caregivers are critical resources for the development of child and adolescent resilience.4,5
by both being a resource and helping them harness other resources that can lead to physical, emotional, and relationship well-being. To do this, consider incorporating the following into your practice:
Help children and adolescents identify and reach out to positive supports
Research has shown the importance of a stable adult figure in the development of resilience in children.4,5 Ideally, parents will be a major positive support to their children in times of crisis. When parents are not appropriate supports, teachers, coaches, mentors, grandparents, or other extended family members can provide the needed support for children to be resilient across educational, emotional, and relationship domains.4 To find out who your patients have as a stable adult figure, ask the following or a related question: “Who do you have in your life who you can talk to or get support from on a regular basis?”
Screen for substance use and mental health challenges
Do this for children, adolescents, AND adults. Then treat and refer to appropriate treatment as indicated. Rates of depression, anxiety, suicide, substance use, and overdose all have increased with recent events.6 Treating parents with mental health and substance use disorders will not only facilitate their ability to be a positive support and role model for their children and promote resilience, but it has been shown to decrease child psychopathology.7 Providing parents with referrals for substance use and mental health services as well as educating them on the importance of self-care is vital for helping the development of children.
Provide parents with resources on how to cope with ongoing stressors
These stressors may be related to the COVID-19 pandemic, racism, or both. By providing resources to parents, they can better help their children overcome stressors. Multiple organizations have free online collections to support parents and families including the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and many others (See below for a list of resources).
Encourage families to find and develop purpose and meaning during this time. Children and families have devoted their time to many activities, some more adaptive and health promoting than others. If we think of resilience as the process of “moving forward” then developing goals and plans to be productive can be helpful and “meaning-making.”3 Spending time together as families, developing skills, accomplishing goals, becoming involved in important social movements, or volunteering all can be ways that individuals and families can develop feelings of self-worth, purpose, and accomplishment.2
Dr. Heward is a child and adolescent psychiatrist at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email him at [email protected].
Resources: Coping with COVID-19
1. American Academy of Pediatrics HealthyChildren.org page on COVID-19.
2. American Academy of Child and Adolescent Psychiatry COVID-19 Resources for Families.
3. American Psychiatric Association COVID-19 Resources for Families.
4. American Psychological Association COVID-19 Information and Resources.
Resources: Racism and discrimination
1. American Academy of Pediatrics Talking to Children About Racial Bias.
2. American Academy of Child and Adolescent Psychiatry Racism Resource Library.
3. American Psychological Association Bias, Discrimination, and Equity Resources.
References
1. “Double jeopardy: COVID-19 and behavioral health disparities for Black and Latino communities in the U.S.” Substance Abuse and Mental Health Services Administration. (Submitted by Office of Behavioral Health Equity).
2. “Building your resilience.” American Psychological Association.
3. Eur J Psychotraumatol. 2014 Oct 1. doi: 10.3402/ejpt.v5.25338.
4. Psychological and biological factors associated with resilience to stress and trauma, in “The Unbroken Soul: Tragedy, Trauma, and Human Resilience” (Lanham, Md.: Jason Aronson, 2008, pp.129-51).
5. Biol Psychiatry. 2019 Sep 15. doi: 10.1016/j.biopsych.2019.07.012.
6. MMWR Morb Mortal Wkly Rep. 2020;69:1049-57.
7. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):379-89.
Dear 2020, where do we go from here?
The first few months of 2020 have shone a light on the challenges we face in this new decade as a health care industry and society. As the new decade dawned, we glimpsed at just the tip of the iceberg of social injustice and longstanding inequality in our society as the COVID-19 pandemic gripped our world. The evident health disparities revealed what we have always known: that our health care system is a microcosm of our society, and that this crisis laid bare the systematic bias present in our everyday lives.
The events of early 2020 have allowed hospitalists to take our rightful place among the few who can and will be the problem solvers of the most complex puzzles. Any discussion of the year 2020 would be incomplete without talking about COVID-19, the first modern pandemic. The rapid global spread, severity, and transmissibility of the novel coronavirus presented unique clinical and operational challenges.
Hospitalists in my communities not only stepped up to care for our most acutely ill, but also our critically ill COVID-19 patients. We were in lockstep with our emergency medicine and critical care medicine colleagues to ensure that patients – COVID-19 positive or negative – received the right care at the right time in the right place. We partnered with our disaster and emergency preparedness colleagues, some of us members or leaders within our hospital, system, regional, state, or national emergency operations centers.
As further evidence of health disparities emerged in the outcomes of care of patients with COVID-19 and the homicide of George Floyd raised the alarm (again) that racism is alive and well in this country, hospitalists grieved, kneeled, and then stood with our colleagues, patients, and fellow humans to advocate for change. At the front lines, we ensured that crisis standards of care action plans would not disadvantage any person for whom we may care during acute illness. Behind closed doors and in open forums, we spoke in defense of the most vulnerable and wrote about how each and every person can throw a wrench into the existing system of bias and discrimination to produce lasting, real change for the better.
I am proud to be a hospitalist, a member of this club, with game changers like Kimberly Manning, Samir Shah, Tracy Cardin, Jason Persoff, Charlie Wray, Chris Moriates, and Vineet Arora – to name just a few. Even more so, I am grateful to be a new member of the Society of Hospital Medicine’s board of directors, where I find myself in the company of admired colleagues as we chart the course of SHM into the new decade. With such a jarring launch, we face a daunting task. In the short term, the board must guide SHM in weathering the economic storm kicked off by COVID-19 and the new social distanced norms we all practice. In the long run, we have to stay the ambitious and steep course of excellence and accomplishment set by our founders.
If we as a community of hospitalists intend to lead our field – and health care in general – each one of us must individually commit to the following pursuits:
1. Maintaining excellence in our clinical practice. First and foremost, our impact on patients happens at the bedside. Honing our clinical skills, staying up to date on the latest, breaking changes in best practices in caring for hospitalized patients and establishing the kind of relationship with their patients that we would wish for ourselves must be a core function. With the staggering volume of knowledge and the rapidity with which new information is constantly added to that existing body, this may seem like an impossibly daunting task. Thankfully, SHM recognizes this vital need and provides resources to allow each one of us to succeed in this endeavor. The Journal of Hospital Medicine brings us the best and most relevant evidence for our practice, ensuring that studies are rigorously performed and reviewed and that the outcomes produced are the ones that we are after. We can maintain board certification with a focused practice in hospital medicine by utilizing the multimodal study tools available through Spark. And, when we are once again able to gather together as a community, the annual conference will provide the best education about hospital medicine available. In the meantime, feel free to explore HM20 Virtual, featuring select offerings from the original HM20 course schedule and the opportunity to earn CME.
2. Guide our future hospitalist colleagues to be 21st-century practitioners. Medical students and residents are entering our profession in a very dynamic time. The competencies they must have in order to succeed as hospitalists in 2020 and onward are different than they were when I went through training. COVID-19 has shown us that hospitalists must be “digital doctors” – they must be facile in utilizing virtual health tools, be capable of harnessing the power of health information technology in the electronic medical record to provide care, and also be able to incorporate and interpret the incredible amount of information in health care “big data.” It is our responsibility today to prepare and coach our trainees so that they may be successful tomorrow.
3. Change the system to ensure that each patient gets the safest, most equitable care we can provide. Each one of us can be at the top of our game, but if we practice in a health care system that has gaps, we may still fail in providing the safest, highest-quality care possible. It is each of our responsibility to use every patient interaction to discover the systemic forces, including the social and cultural biases, that can lead to patient harm. In that, it is our duty to protect the most vulnerable, to redesign systems such that every person can be healthy. Only through this work of improvement do we have hope to eliminate the health disparities that exist.
4. Advocate for our patients. We each have seen the incredible impact that the Affordable Care Act has had on health care delivery in the day-to-day interactions we have with our patients. Yet it is not enough. We still have room to improve the American health care system to allow better access to care, more timely provision of care, and better outcomes for our communities. Sometimes, this takes a change in policy. For each of us, it starts with being aware of how our state policy can impact how care is delivered to our patients. In addition to your own personal advocacy work, you can join forces with SHM’s Advocacy & Public Policy team to use our society to amplify your voice.
The year 2020 began with eye-opening crises that exposed the depth and breadth of the work we have before us in hospital medicine. We have an important role to play in the next decade – surely to be the most interesting time to be a hospitalist.
Dr. Tad-y is a hospitalist and director of GME quality and safety programs at the University of Colorado at Denver, Aurora. She is a member of the SHM board of directors.
The first few months of 2020 have shone a light on the challenges we face in this new decade as a health care industry and society. As the new decade dawned, we glimpsed at just the tip of the iceberg of social injustice and longstanding inequality in our society as the COVID-19 pandemic gripped our world. The evident health disparities revealed what we have always known: that our health care system is a microcosm of our society, and that this crisis laid bare the systematic bias present in our everyday lives.
The events of early 2020 have allowed hospitalists to take our rightful place among the few who can and will be the problem solvers of the most complex puzzles. Any discussion of the year 2020 would be incomplete without talking about COVID-19, the first modern pandemic. The rapid global spread, severity, and transmissibility of the novel coronavirus presented unique clinical and operational challenges.
Hospitalists in my communities not only stepped up to care for our most acutely ill, but also our critically ill COVID-19 patients. We were in lockstep with our emergency medicine and critical care medicine colleagues to ensure that patients – COVID-19 positive or negative – received the right care at the right time in the right place. We partnered with our disaster and emergency preparedness colleagues, some of us members or leaders within our hospital, system, regional, state, or national emergency operations centers.
As further evidence of health disparities emerged in the outcomes of care of patients with COVID-19 and the homicide of George Floyd raised the alarm (again) that racism is alive and well in this country, hospitalists grieved, kneeled, and then stood with our colleagues, patients, and fellow humans to advocate for change. At the front lines, we ensured that crisis standards of care action plans would not disadvantage any person for whom we may care during acute illness. Behind closed doors and in open forums, we spoke in defense of the most vulnerable and wrote about how each and every person can throw a wrench into the existing system of bias and discrimination to produce lasting, real change for the better.
I am proud to be a hospitalist, a member of this club, with game changers like Kimberly Manning, Samir Shah, Tracy Cardin, Jason Persoff, Charlie Wray, Chris Moriates, and Vineet Arora – to name just a few. Even more so, I am grateful to be a new member of the Society of Hospital Medicine’s board of directors, where I find myself in the company of admired colleagues as we chart the course of SHM into the new decade. With such a jarring launch, we face a daunting task. In the short term, the board must guide SHM in weathering the economic storm kicked off by COVID-19 and the new social distanced norms we all practice. In the long run, we have to stay the ambitious and steep course of excellence and accomplishment set by our founders.
If we as a community of hospitalists intend to lead our field – and health care in general – each one of us must individually commit to the following pursuits:
1. Maintaining excellence in our clinical practice. First and foremost, our impact on patients happens at the bedside. Honing our clinical skills, staying up to date on the latest, breaking changes in best practices in caring for hospitalized patients and establishing the kind of relationship with their patients that we would wish for ourselves must be a core function. With the staggering volume of knowledge and the rapidity with which new information is constantly added to that existing body, this may seem like an impossibly daunting task. Thankfully, SHM recognizes this vital need and provides resources to allow each one of us to succeed in this endeavor. The Journal of Hospital Medicine brings us the best and most relevant evidence for our practice, ensuring that studies are rigorously performed and reviewed and that the outcomes produced are the ones that we are after. We can maintain board certification with a focused practice in hospital medicine by utilizing the multimodal study tools available through Spark. And, when we are once again able to gather together as a community, the annual conference will provide the best education about hospital medicine available. In the meantime, feel free to explore HM20 Virtual, featuring select offerings from the original HM20 course schedule and the opportunity to earn CME.
2. Guide our future hospitalist colleagues to be 21st-century practitioners. Medical students and residents are entering our profession in a very dynamic time. The competencies they must have in order to succeed as hospitalists in 2020 and onward are different than they were when I went through training. COVID-19 has shown us that hospitalists must be “digital doctors” – they must be facile in utilizing virtual health tools, be capable of harnessing the power of health information technology in the electronic medical record to provide care, and also be able to incorporate and interpret the incredible amount of information in health care “big data.” It is our responsibility today to prepare and coach our trainees so that they may be successful tomorrow.
3. Change the system to ensure that each patient gets the safest, most equitable care we can provide. Each one of us can be at the top of our game, but if we practice in a health care system that has gaps, we may still fail in providing the safest, highest-quality care possible. It is each of our responsibility to use every patient interaction to discover the systemic forces, including the social and cultural biases, that can lead to patient harm. In that, it is our duty to protect the most vulnerable, to redesign systems such that every person can be healthy. Only through this work of improvement do we have hope to eliminate the health disparities that exist.
4. Advocate for our patients. We each have seen the incredible impact that the Affordable Care Act has had on health care delivery in the day-to-day interactions we have with our patients. Yet it is not enough. We still have room to improve the American health care system to allow better access to care, more timely provision of care, and better outcomes for our communities. Sometimes, this takes a change in policy. For each of us, it starts with being aware of how our state policy can impact how care is delivered to our patients. In addition to your own personal advocacy work, you can join forces with SHM’s Advocacy & Public Policy team to use our society to amplify your voice.
The year 2020 began with eye-opening crises that exposed the depth and breadth of the work we have before us in hospital medicine. We have an important role to play in the next decade – surely to be the most interesting time to be a hospitalist.
Dr. Tad-y is a hospitalist and director of GME quality and safety programs at the University of Colorado at Denver, Aurora. She is a member of the SHM board of directors.
The first few months of 2020 have shone a light on the challenges we face in this new decade as a health care industry and society. As the new decade dawned, we glimpsed at just the tip of the iceberg of social injustice and longstanding inequality in our society as the COVID-19 pandemic gripped our world. The evident health disparities revealed what we have always known: that our health care system is a microcosm of our society, and that this crisis laid bare the systematic bias present in our everyday lives.
The events of early 2020 have allowed hospitalists to take our rightful place among the few who can and will be the problem solvers of the most complex puzzles. Any discussion of the year 2020 would be incomplete without talking about COVID-19, the first modern pandemic. The rapid global spread, severity, and transmissibility of the novel coronavirus presented unique clinical and operational challenges.
Hospitalists in my communities not only stepped up to care for our most acutely ill, but also our critically ill COVID-19 patients. We were in lockstep with our emergency medicine and critical care medicine colleagues to ensure that patients – COVID-19 positive or negative – received the right care at the right time in the right place. We partnered with our disaster and emergency preparedness colleagues, some of us members or leaders within our hospital, system, regional, state, or national emergency operations centers.
As further evidence of health disparities emerged in the outcomes of care of patients with COVID-19 and the homicide of George Floyd raised the alarm (again) that racism is alive and well in this country, hospitalists grieved, kneeled, and then stood with our colleagues, patients, and fellow humans to advocate for change. At the front lines, we ensured that crisis standards of care action plans would not disadvantage any person for whom we may care during acute illness. Behind closed doors and in open forums, we spoke in defense of the most vulnerable and wrote about how each and every person can throw a wrench into the existing system of bias and discrimination to produce lasting, real change for the better.
I am proud to be a hospitalist, a member of this club, with game changers like Kimberly Manning, Samir Shah, Tracy Cardin, Jason Persoff, Charlie Wray, Chris Moriates, and Vineet Arora – to name just a few. Even more so, I am grateful to be a new member of the Society of Hospital Medicine’s board of directors, where I find myself in the company of admired colleagues as we chart the course of SHM into the new decade. With such a jarring launch, we face a daunting task. In the short term, the board must guide SHM in weathering the economic storm kicked off by COVID-19 and the new social distanced norms we all practice. In the long run, we have to stay the ambitious and steep course of excellence and accomplishment set by our founders.
If we as a community of hospitalists intend to lead our field – and health care in general – each one of us must individually commit to the following pursuits:
1. Maintaining excellence in our clinical practice. First and foremost, our impact on patients happens at the bedside. Honing our clinical skills, staying up to date on the latest, breaking changes in best practices in caring for hospitalized patients and establishing the kind of relationship with their patients that we would wish for ourselves must be a core function. With the staggering volume of knowledge and the rapidity with which new information is constantly added to that existing body, this may seem like an impossibly daunting task. Thankfully, SHM recognizes this vital need and provides resources to allow each one of us to succeed in this endeavor. The Journal of Hospital Medicine brings us the best and most relevant evidence for our practice, ensuring that studies are rigorously performed and reviewed and that the outcomes produced are the ones that we are after. We can maintain board certification with a focused practice in hospital medicine by utilizing the multimodal study tools available through Spark. And, when we are once again able to gather together as a community, the annual conference will provide the best education about hospital medicine available. In the meantime, feel free to explore HM20 Virtual, featuring select offerings from the original HM20 course schedule and the opportunity to earn CME.
2. Guide our future hospitalist colleagues to be 21st-century practitioners. Medical students and residents are entering our profession in a very dynamic time. The competencies they must have in order to succeed as hospitalists in 2020 and onward are different than they were when I went through training. COVID-19 has shown us that hospitalists must be “digital doctors” – they must be facile in utilizing virtual health tools, be capable of harnessing the power of health information technology in the electronic medical record to provide care, and also be able to incorporate and interpret the incredible amount of information in health care “big data.” It is our responsibility today to prepare and coach our trainees so that they may be successful tomorrow.
3. Change the system to ensure that each patient gets the safest, most equitable care we can provide. Each one of us can be at the top of our game, but if we practice in a health care system that has gaps, we may still fail in providing the safest, highest-quality care possible. It is each of our responsibility to use every patient interaction to discover the systemic forces, including the social and cultural biases, that can lead to patient harm. In that, it is our duty to protect the most vulnerable, to redesign systems such that every person can be healthy. Only through this work of improvement do we have hope to eliminate the health disparities that exist.
4. Advocate for our patients. We each have seen the incredible impact that the Affordable Care Act has had on health care delivery in the day-to-day interactions we have with our patients. Yet it is not enough. We still have room to improve the American health care system to allow better access to care, more timely provision of care, and better outcomes for our communities. Sometimes, this takes a change in policy. For each of us, it starts with being aware of how our state policy can impact how care is delivered to our patients. In addition to your own personal advocacy work, you can join forces with SHM’s Advocacy & Public Policy team to use our society to amplify your voice.
The year 2020 began with eye-opening crises that exposed the depth and breadth of the work we have before us in hospital medicine. We have an important role to play in the next decade – surely to be the most interesting time to be a hospitalist.
Dr. Tad-y is a hospitalist and director of GME quality and safety programs at the University of Colorado at Denver, Aurora. She is a member of the SHM board of directors.
COX2 inhibitor and beta blocker combo to reduce CRC metastasis?
in a randomized, placebo-controlled study.
The study included 34 patients (median age, 58 years) who underwent colorectal tumor resection in Israel. It was published online June 13 in Cancer.
On intent-to-treat analysis, 3-year recurrence rates were 12.5% in the placebo group (n = 16) and 33.3% in the treatment group (n = 18). This difference was not statistically significant (P = .239). However, in protocol-compliant patients, the respective rates were 0% and 29.4% (P = .054), but the study was not powered to assess drug effects on recurrence and survival, the researchers note.
With regard to tumor molecular markers, results showed that the combination reduced epithelial-to-mesenchymal transition and tumor-infiltrating CD14-positive monocytes and CD19-positive B cells. There was an increase in tumor-infiltrating CD56-positive natural killer cells, Rita Haldar, MA, of Tel Aviv University, Israel, and her colleagues note.
Transcriptional activity analysis showed a favorable effect on 12 of 19 potential colorectal cancer–related transcription factors, with alterations that have previously been linked with improved outcomes.
In the trial, the patients in the treatment group received oral etodolac 400 mg twice daily for 20 perioperative days beginning 5 days before surgery and oral propranolol at twice-daily doses of 20 mg for the 5 days before surgery, 80 mg on the day of surgery, 40 mg on postoperative days 1 to 7, and 20 mg for the last 7 days.
The treatments were well tolerated. Minor complications occurred at similar rates in the treatment and placebo groups, note the researchers. No severe surgical complications occurred in the treatment group; one occurred in the placebo group.
The findings indicate that the treatment protocol is “empirically safe, easy to administer, and inexpensive and has overall favorable molecular impacts on tumor tissues,” the researchers conclude.
Data from the study provide a strong rationale for future trials powered to assess the impact of this combination on disease-free and overall survival in patients with colorectal cancer.
“Haldar et al should be applauded for their steadfast pursuit of repurposed drugs for the treatment of cancer,” Michael Low, MD, and his colleagues at Morningside Center for Innovative and Affordable Medicine at Emory University, Atlanta, Georgia, write in an accompanying editorial.
The concept of using perioperative interventions “to alter the deleterious effects of surgery” is not new, and evidence of potential benefit is abundant, the editorialists note.
The focus of the current study on beta-adrenergic blockade and COX2 inhibition is supported both by the agents’ known suppressive effects on relevant pathways and by preclinical data, the editorialists write.
The study is limited by several factors, including small sample size, patient-reported compliance, and a failure to account for use of chemotherapy. The editorialists emphasize that use of these agents in the perioperative period “is of paramount importance and may have long-lasting antitumoral effects.” They hope “that larger trials focusing on these and other agents will soon prove that to be true.”
The study was supported by an Israel Science Foundation grant. The authors and Lowe have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
in a randomized, placebo-controlled study.
The study included 34 patients (median age, 58 years) who underwent colorectal tumor resection in Israel. It was published online June 13 in Cancer.
On intent-to-treat analysis, 3-year recurrence rates were 12.5% in the placebo group (n = 16) and 33.3% in the treatment group (n = 18). This difference was not statistically significant (P = .239). However, in protocol-compliant patients, the respective rates were 0% and 29.4% (P = .054), but the study was not powered to assess drug effects on recurrence and survival, the researchers note.
With regard to tumor molecular markers, results showed that the combination reduced epithelial-to-mesenchymal transition and tumor-infiltrating CD14-positive monocytes and CD19-positive B cells. There was an increase in tumor-infiltrating CD56-positive natural killer cells, Rita Haldar, MA, of Tel Aviv University, Israel, and her colleagues note.
Transcriptional activity analysis showed a favorable effect on 12 of 19 potential colorectal cancer–related transcription factors, with alterations that have previously been linked with improved outcomes.
In the trial, the patients in the treatment group received oral etodolac 400 mg twice daily for 20 perioperative days beginning 5 days before surgery and oral propranolol at twice-daily doses of 20 mg for the 5 days before surgery, 80 mg on the day of surgery, 40 mg on postoperative days 1 to 7, and 20 mg for the last 7 days.
The treatments were well tolerated. Minor complications occurred at similar rates in the treatment and placebo groups, note the researchers. No severe surgical complications occurred in the treatment group; one occurred in the placebo group.
The findings indicate that the treatment protocol is “empirically safe, easy to administer, and inexpensive and has overall favorable molecular impacts on tumor tissues,” the researchers conclude.
Data from the study provide a strong rationale for future trials powered to assess the impact of this combination on disease-free and overall survival in patients with colorectal cancer.
“Haldar et al should be applauded for their steadfast pursuit of repurposed drugs for the treatment of cancer,” Michael Low, MD, and his colleagues at Morningside Center for Innovative and Affordable Medicine at Emory University, Atlanta, Georgia, write in an accompanying editorial.
The concept of using perioperative interventions “to alter the deleterious effects of surgery” is not new, and evidence of potential benefit is abundant, the editorialists note.
The focus of the current study on beta-adrenergic blockade and COX2 inhibition is supported both by the agents’ known suppressive effects on relevant pathways and by preclinical data, the editorialists write.
The study is limited by several factors, including small sample size, patient-reported compliance, and a failure to account for use of chemotherapy. The editorialists emphasize that use of these agents in the perioperative period “is of paramount importance and may have long-lasting antitumoral effects.” They hope “that larger trials focusing on these and other agents will soon prove that to be true.”
The study was supported by an Israel Science Foundation grant. The authors and Lowe have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
in a randomized, placebo-controlled study.
The study included 34 patients (median age, 58 years) who underwent colorectal tumor resection in Israel. It was published online June 13 in Cancer.
On intent-to-treat analysis, 3-year recurrence rates were 12.5% in the placebo group (n = 16) and 33.3% in the treatment group (n = 18). This difference was not statistically significant (P = .239). However, in protocol-compliant patients, the respective rates were 0% and 29.4% (P = .054), but the study was not powered to assess drug effects on recurrence and survival, the researchers note.
With regard to tumor molecular markers, results showed that the combination reduced epithelial-to-mesenchymal transition and tumor-infiltrating CD14-positive monocytes and CD19-positive B cells. There was an increase in tumor-infiltrating CD56-positive natural killer cells, Rita Haldar, MA, of Tel Aviv University, Israel, and her colleagues note.
Transcriptional activity analysis showed a favorable effect on 12 of 19 potential colorectal cancer–related transcription factors, with alterations that have previously been linked with improved outcomes.
In the trial, the patients in the treatment group received oral etodolac 400 mg twice daily for 20 perioperative days beginning 5 days before surgery and oral propranolol at twice-daily doses of 20 mg for the 5 days before surgery, 80 mg on the day of surgery, 40 mg on postoperative days 1 to 7, and 20 mg for the last 7 days.
The treatments were well tolerated. Minor complications occurred at similar rates in the treatment and placebo groups, note the researchers. No severe surgical complications occurred in the treatment group; one occurred in the placebo group.
The findings indicate that the treatment protocol is “empirically safe, easy to administer, and inexpensive and has overall favorable molecular impacts on tumor tissues,” the researchers conclude.
Data from the study provide a strong rationale for future trials powered to assess the impact of this combination on disease-free and overall survival in patients with colorectal cancer.
“Haldar et al should be applauded for their steadfast pursuit of repurposed drugs for the treatment of cancer,” Michael Low, MD, and his colleagues at Morningside Center for Innovative and Affordable Medicine at Emory University, Atlanta, Georgia, write in an accompanying editorial.
The concept of using perioperative interventions “to alter the deleterious effects of surgery” is not new, and evidence of potential benefit is abundant, the editorialists note.
The focus of the current study on beta-adrenergic blockade and COX2 inhibition is supported both by the agents’ known suppressive effects on relevant pathways and by preclinical data, the editorialists write.
The study is limited by several factors, including small sample size, patient-reported compliance, and a failure to account for use of chemotherapy. The editorialists emphasize that use of these agents in the perioperative period “is of paramount importance and may have long-lasting antitumoral effects.” They hope “that larger trials focusing on these and other agents will soon prove that to be true.”
The study was supported by an Israel Science Foundation grant. The authors and Lowe have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Severe obesity ups risk for death in younger men with COVID-19
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
Restructuring health care delivery for the future: What we need to do post–COVID-19
Recently,
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...
ObGyn services: Primary care or specialty?
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...
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...
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. ●
- Gawande A. Big med. The New Yorker. August 13, 2012. https://www.newyorker.com/magazine/2012/08/13/big-med. Accessed July 24, 2020.
OBG Management Expert Panel
Barbara Levy, MD
Clinical Professor, Obstetrics and Gynecology
The George Washington University School of Medicine and Health Sciences
Washington, DC
Member, OBG Management Board of Editors
Scott D. Hayworth, MD
President and Chief Executive Officer
CareMount Medical, PC
Chappaqua, New York
Clinical Assistant Professor
Department of Obstetrics and Gynecology
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hofstra University
Hempstead, New York
Janice Huckaby, MD
Chief Medical Officer for Maternal-Child Health
Optum/UnitedHealth Group
Eden Prairie, Minnesota
Errol R. Norwitz, MD, PhD, MBA
President and Chief Executive Officer
Newton-Wellesley Hospital
Newton, Massachusetts
Professor, Obstetrics and Gynecology
Tufts University School of Medicine
Boston, Massachusetts
Cynthia A. Pearson
Executive Director
National Women's Health Network
Washington, DC
Dr. Hayworth reports receiving grant or research support from BioIVT, CVS/Aetna, IKS Health, My Medical Images, TractManager, US Digestive Health, and WCG Clinical. Dr. Norwitz reports serving as an author for UpToDate. The other authors report no financial relationships relevant to this article.
OBG Management Expert Panel
Barbara Levy, MD
Clinical Professor, Obstetrics and Gynecology
The George Washington University School of Medicine and Health Sciences
Washington, DC
Member, OBG Management Board of Editors
Scott D. Hayworth, MD
President and Chief Executive Officer
CareMount Medical, PC
Chappaqua, New York
Clinical Assistant Professor
Department of Obstetrics and Gynecology
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hofstra University
Hempstead, New York
Janice Huckaby, MD
Chief Medical Officer for Maternal-Child Health
Optum/UnitedHealth Group
Eden Prairie, Minnesota
Errol R. Norwitz, MD, PhD, MBA
President and Chief Executive Officer
Newton-Wellesley Hospital
Newton, Massachusetts
Professor, Obstetrics and Gynecology
Tufts University School of Medicine
Boston, Massachusetts
Cynthia A. Pearson
Executive Director
National Women's Health Network
Washington, DC
Dr. Hayworth reports receiving grant or research support from BioIVT, CVS/Aetna, IKS Health, My Medical Images, TractManager, US Digestive Health, and WCG Clinical. Dr. Norwitz reports serving as an author for UpToDate. The other authors report no financial relationships relevant to this article.
OBG Management Expert Panel
Barbara Levy, MD
Clinical Professor, Obstetrics and Gynecology
The George Washington University School of Medicine and Health Sciences
Washington, DC
Member, OBG Management Board of Editors
Scott D. Hayworth, MD
President and Chief Executive Officer
CareMount Medical, PC
Chappaqua, New York
Clinical Assistant Professor
Department of Obstetrics and Gynecology
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hofstra University
Hempstead, New York
Janice Huckaby, MD
Chief Medical Officer for Maternal-Child Health
Optum/UnitedHealth Group
Eden Prairie, Minnesota
Errol R. Norwitz, MD, PhD, MBA
President and Chief Executive Officer
Newton-Wellesley Hospital
Newton, Massachusetts
Professor, Obstetrics and Gynecology
Tufts University School of Medicine
Boston, Massachusetts
Cynthia A. Pearson
Executive Director
National Women's Health Network
Washington, DC
Dr. Hayworth reports receiving grant or research support from BioIVT, CVS/Aetna, IKS Health, My Medical Images, TractManager, US Digestive Health, and WCG Clinical. Dr. Norwitz reports serving as an author for UpToDate. The other authors report no financial relationships relevant to this article.
Recently,
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...
ObGyn services: Primary care or specialty?
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...
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...
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,
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...
ObGyn services: Primary care or specialty?
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...
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...
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. ●
- Gawande A. Big med. The New Yorker. August 13, 2012. https://www.newyorker.com/magazine/2012/08/13/big-med. Accessed July 24, 2020.
- Gawande A. Big med. The New Yorker. August 13, 2012. https://www.newyorker.com/magazine/2012/08/13/big-med. Accessed July 24, 2020.
How effective is screening mammography for preventing breast cancer mortality?
EXPERT COMMENTARY
Although recommending screening mammograms continues to represent the standard of care, studies from the United States and abroad have questioned their value.1-3
In the June issue of JAMA Network Open, Australian investigators assessed the relative impacts of mammography screening and adjuvant therapy on breast cancer mortality, using data from population-based studies from 1982 through 2013.4 In recent decades, screening has increased substantially among Australian women.
Details of the study
Burton and Stevenson identified 76,630 women included in the Victorian Cancer Registry with invasive breast cancer in the state of Victoria, where women aged 50 to 69 are offered biennial screening.4 During the study’s time period, the use of adjuvant tamoxifen and chemotherapy increased substantially.
In the 31-year period assessed in this study, breast cancer mortality declined considerably. During the same period, however, the incidence of advanced breast cancer doubled.
These findings from Australia parallel those from the United States, Holland, and Norway, where the incidence of advanced breast cancer was stable or increased after screening mammography was introduced.1-3
According to Burton and Stevenson, the increased incidence of advanced cancer clarifies that screening mammography is not responsible for declining breast cancer mortality, but all of the decline in mortality can be attributed to increased uptake of adjuvant therapy.
The authors concluded that since screening mammography does not reduce breast cancer mortality, state-sponsored screens should be discontinued.
Study strengths and limitations
Relevant data for this study were obtained from large population-based surveys for premenopausal and postmenopausal women with breast cancer.
The authors noted, however, that this analysis of observational data examining time trends across the study period can show only associations among breast cancer mortality, mammography screening participation, and adjuvant therapy uptake, and that causality can only be inferred.
The study in perspective
Although some will view the findings and recommendations of these Australian authors with skepticism or even hostility, I view their findings as good news—we have improved the treatment of breast cancer so dramatically that the benefits of finding early tumors with screening mammography have become attenuated.
Although it is challenging given the time constraints of office visits, I try to engage in shared decision making with my patients regarding when to start and how often to have screening mammography. ●
Given our evolving understanding regarding the value of screening mammograms, it is time to stop pressuring patients who are reluctant or unwilling to undergo screening. Likewise, insurance companies and government agencies should stop using screening mammography as a quality metric.
ANDREW M. KAUNITZ, MD
- Bleyer A, Welch GH. Effect of three decades of screening mammography on breast cancer-incidence. N Engl J Med. 2012;367:1998-2005.
- Autier P, Boniol M, Koechlin A, et al. Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ. 2017;359:j5224.
- Kalager M, Zelen M, Langmark F, et al. Effect of screening mammography on breast-cancer mortality in Norway. N Engl J Med. 2010;363:1203-1210.
- Burton R, Stevenson C. Assessment of breast cancer mortality trends associated with mammographic screening and adjuvant therapy from 1986 to 2013 in the state of Victoria, Australia. JAMA Netw Open. 2020;3:e208249.
EXPERT COMMENTARY
Although recommending screening mammograms continues to represent the standard of care, studies from the United States and abroad have questioned their value.1-3
In the June issue of JAMA Network Open, Australian investigators assessed the relative impacts of mammography screening and adjuvant therapy on breast cancer mortality, using data from population-based studies from 1982 through 2013.4 In recent decades, screening has increased substantially among Australian women.
Details of the study
Burton and Stevenson identified 76,630 women included in the Victorian Cancer Registry with invasive breast cancer in the state of Victoria, where women aged 50 to 69 are offered biennial screening.4 During the study’s time period, the use of adjuvant tamoxifen and chemotherapy increased substantially.
In the 31-year period assessed in this study, breast cancer mortality declined considerably. During the same period, however, the incidence of advanced breast cancer doubled.
These findings from Australia parallel those from the United States, Holland, and Norway, where the incidence of advanced breast cancer was stable or increased after screening mammography was introduced.1-3
According to Burton and Stevenson, the increased incidence of advanced cancer clarifies that screening mammography is not responsible for declining breast cancer mortality, but all of the decline in mortality can be attributed to increased uptake of adjuvant therapy.
The authors concluded that since screening mammography does not reduce breast cancer mortality, state-sponsored screens should be discontinued.
Study strengths and limitations
Relevant data for this study were obtained from large population-based surveys for premenopausal and postmenopausal women with breast cancer.
The authors noted, however, that this analysis of observational data examining time trends across the study period can show only associations among breast cancer mortality, mammography screening participation, and adjuvant therapy uptake, and that causality can only be inferred.
The study in perspective
Although some will view the findings and recommendations of these Australian authors with skepticism or even hostility, I view their findings as good news—we have improved the treatment of breast cancer so dramatically that the benefits of finding early tumors with screening mammography have become attenuated.
Although it is challenging given the time constraints of office visits, I try to engage in shared decision making with my patients regarding when to start and how often to have screening mammography. ●
Given our evolving understanding regarding the value of screening mammograms, it is time to stop pressuring patients who are reluctant or unwilling to undergo screening. Likewise, insurance companies and government agencies should stop using screening mammography as a quality metric.
ANDREW M. KAUNITZ, MD
EXPERT COMMENTARY
Although recommending screening mammograms continues to represent the standard of care, studies from the United States and abroad have questioned their value.1-3
In the June issue of JAMA Network Open, Australian investigators assessed the relative impacts of mammography screening and adjuvant therapy on breast cancer mortality, using data from population-based studies from 1982 through 2013.4 In recent decades, screening has increased substantially among Australian women.
Details of the study
Burton and Stevenson identified 76,630 women included in the Victorian Cancer Registry with invasive breast cancer in the state of Victoria, where women aged 50 to 69 are offered biennial screening.4 During the study’s time period, the use of adjuvant tamoxifen and chemotherapy increased substantially.
In the 31-year period assessed in this study, breast cancer mortality declined considerably. During the same period, however, the incidence of advanced breast cancer doubled.
These findings from Australia parallel those from the United States, Holland, and Norway, where the incidence of advanced breast cancer was stable or increased after screening mammography was introduced.1-3
According to Burton and Stevenson, the increased incidence of advanced cancer clarifies that screening mammography is not responsible for declining breast cancer mortality, but all of the decline in mortality can be attributed to increased uptake of adjuvant therapy.
The authors concluded that since screening mammography does not reduce breast cancer mortality, state-sponsored screens should be discontinued.
Study strengths and limitations
Relevant data for this study were obtained from large population-based surveys for premenopausal and postmenopausal women with breast cancer.
The authors noted, however, that this analysis of observational data examining time trends across the study period can show only associations among breast cancer mortality, mammography screening participation, and adjuvant therapy uptake, and that causality can only be inferred.
The study in perspective
Although some will view the findings and recommendations of these Australian authors with skepticism or even hostility, I view their findings as good news—we have improved the treatment of breast cancer so dramatically that the benefits of finding early tumors with screening mammography have become attenuated.
Although it is challenging given the time constraints of office visits, I try to engage in shared decision making with my patients regarding when to start and how often to have screening mammography. ●
Given our evolving understanding regarding the value of screening mammograms, it is time to stop pressuring patients who are reluctant or unwilling to undergo screening. Likewise, insurance companies and government agencies should stop using screening mammography as a quality metric.
ANDREW M. KAUNITZ, MD
- Bleyer A, Welch GH. Effect of three decades of screening mammography on breast cancer-incidence. N Engl J Med. 2012;367:1998-2005.
- Autier P, Boniol M, Koechlin A, et al. Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ. 2017;359:j5224.
- Kalager M, Zelen M, Langmark F, et al. Effect of screening mammography on breast-cancer mortality in Norway. N Engl J Med. 2010;363:1203-1210.
- Burton R, Stevenson C. Assessment of breast cancer mortality trends associated with mammographic screening and adjuvant therapy from 1986 to 2013 in the state of Victoria, Australia. JAMA Netw Open. 2020;3:e208249.
- Bleyer A, Welch GH. Effect of three decades of screening mammography on breast cancer-incidence. N Engl J Med. 2012;367:1998-2005.
- Autier P, Boniol M, Koechlin A, et al. Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ. 2017;359:j5224.
- Kalager M, Zelen M, Langmark F, et al. Effect of screening mammography on breast-cancer mortality in Norway. N Engl J Med. 2010;363:1203-1210.
- Burton R, Stevenson C. Assessment of breast cancer mortality trends associated with mammographic screening and adjuvant therapy from 1986 to 2013 in the state of Victoria, Australia. JAMA Netw Open. 2020;3:e208249.
New hormonal medical treatment is an important advance for AUB caused by uterine fibroids
Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.1 Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).1 Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.
Gene dysregulation contributes to fibroid development
Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).2
Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome
Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.3 Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,3 or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.
Estrogen and progesterone influence fibroid size and cell activity
Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.4 Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).
Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.5 In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.6 Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.6 This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.
Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.10
Continue to: Leuprolide acetate...
Leuprolide acetate
Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.11 Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.11 The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.
Elagolix plus estradiol plus norethindrone acetate (Oriahnn)
GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.
Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.
To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,12 in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:
- elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
- elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
- placebo for 6 months.12
Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.12
The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).13 Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.13
Continue to: Contraindications to Oriahnn include known allergies...
Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.14 Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.14 Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).14 In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).14 The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).14
It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.
AUB caused by fibroids is a common problem in gyn practice
There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●
Black women are more likely to develop fibroids and experience more severe fibroid symptoms. Obstetrician-gynecologists are experts in the diagnosis and treatment of fibroids. We play a key role in partnering with Black women to reduce fibroid disease burden.
Factors that increase the risk of developing fibroids include: increasing age, Black race, nulliparity, early menarche (<10 years of age), obesity, and consumption of red meat.1 The Nurses Health Study II is the largest prospective study of the factors that influence fibroid development.2 A total of 95,061 premenopausal nurses aged 25 to 44 years were followed from September 1989 through May 1993. Review of a sample of medical records demonstrated that the nurses participating in the study were reliable reporters of whether or not they had been diagnosed with fibroids. Based on a report of an ultrasound or hysterectomy diagnosis, the incidence rate for fibroids increased with age. Incidence rate per 1,000 women-years was 4.3 (age 25 to 29 years), 9.0 (30 to 34 years), 14.7 (age 35 to 39 years), and 22.5 (40 to 44 years). Compared with White race, Black race (but not Hispanic ethnicity or Asian race) was associated with an increased incidence of fibroids. Incidence rate per 1,000 women-years was 12.5 (White race), 37.9 (Black race), 14.5 (Hispanic ethnicity), and 10.4 (Asian race). The risk of developing fibroids was 3.25 times (95% CI, 2.71 to 3.88) greater among Black compared with White women after controlling for body mass index, age at first birth, years since last birth, history of infertility, age at first oral contraceptive use, marital status, and current alcohol use.2
Other epidemiology studies also report an increased incidence of fibroids among Black women.3,4 The size of the uterus, the size and number of fibroids, and the severity of fibroid symptoms are greater among Black versus White women.5,6 The molecular factors that increase fibroid incidence among Black women are unknown. Given the burden of fibroid disease among Black women, obstetrician-gynecologists are best positioned to ensure early diagnosis and to develop an effective follow-up and treatment plan for affected women.
References
1. Stewart EA, Laughlin-Tommaso SK, Catherino WH, et al. Uterine fibroids. Nat Rev Dis Primers. 2016;2:16043.
2. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973.
3. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
4. Brett KM, Marsh JV, Madans JH. Epidemiology of hysterectomy in the United States: demographic and reproductive factors in a nationally representative sample. J Womens Health. 1997;6:309-316.
5. Peddada SD, Laughlin SK, Miner K, et al. Growth of uterine leiomyomata among premenopausal black and white women. Proc Natl Acad Sci USA. 2008;105:1988719892.
6. Huyck KL, Panhuysen CI, Cuenco KT, et al. The impact of race as a risk factor for symptom severity and age at diagnosis of uterine leiomyomata among affected sisters. Am J Obstet Gynecol. 2008;198:168.e1-e9.
- Stewart EA. Uterine fibroids. N Engl J Med. 2015;372:1646-1655.
- Mehine M, Makinen N, Heinonen HR, et al. Genomics of uterine leiomyomas: insights from high-throughput sequencing. Fertil Steril. 2014;102:621-629.
- Mehine M, Kaasinen E, Makinen N, et al. Characterization of uterine leiomyomas by whole-genome sequencing. N Engl J Med. 2013;369:43-53.
- Moravek MB, Bulun SE. Endocrinology of uterine fibroids: steroid hormones, stem cells and genetic contribution. Curr Opin Obstet Gynecol. 2015;27:276-283.
- Rein MS. Advances in uterine leiomyoma research: the progesterone hypothesis. Environ Health Perspect. 2000;108(suppl 5):791-793.
- Friedman AJ, Barbieri RL, Doubilet PM, et al. A randomized double-blind trial of a gonadotropin-releasing hormone agonist (leuprolide) with or without medroxyprogesterone acetate in the treatment of leiomyomata uteri. Fertil Steril. 1988;49:404-409.
- Donnez J, Hudecek R, Donnez O, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015;103:519-527.
- Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012;366:409-420.
- Donnez J, Tomaszewski J, Vazquez F, et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012;366:421-432.
- European Medicines Agency. Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk. March 13, 2020. https://www.ema.europa.eu/en/news/suspension-ulipristal-acetate-uterine-fibroids-during-ongoing-ema-review-liver-injury-risk#:~:text=EMA's%20safety%20committee%20(PRAC)%20has,the%20EU%20during%20the%20review. Accessed July 24, 2020.
- Lupron Depot [package insert]. Osaka, Japan: Takeda; Revised March 2012.
- Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.
- Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.
- Oriahnn [package insert]. North Chicago, IL: AbbVie; 2020.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women’s Hospital
Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School
Dr. Barbieri reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women’s Hospital
Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School
Dr. Barbieri reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women’s Hospital
Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School
Dr. Barbieri reports no financial relationships relevant to this article.
Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.1 Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).1 Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.
Gene dysregulation contributes to fibroid development
Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).2
Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome
Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.3 Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,3 or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.
Estrogen and progesterone influence fibroid size and cell activity
Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.4 Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).
Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.5 In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.6 Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.6 This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.
Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.10
Continue to: Leuprolide acetate...
Leuprolide acetate
Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.11 Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.11 The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.
Elagolix plus estradiol plus norethindrone acetate (Oriahnn)
GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.
Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.
To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,12 in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:
- elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
- elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
- placebo for 6 months.12
Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.12
The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).13 Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.13
Continue to: Contraindications to Oriahnn include known allergies...
Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.14 Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.14 Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).14 In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).14 The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).14
It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.
AUB caused by fibroids is a common problem in gyn practice
There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●
Black women are more likely to develop fibroids and experience more severe fibroid symptoms. Obstetrician-gynecologists are experts in the diagnosis and treatment of fibroids. We play a key role in partnering with Black women to reduce fibroid disease burden.
Factors that increase the risk of developing fibroids include: increasing age, Black race, nulliparity, early menarche (<10 years of age), obesity, and consumption of red meat.1 The Nurses Health Study II is the largest prospective study of the factors that influence fibroid development.2 A total of 95,061 premenopausal nurses aged 25 to 44 years were followed from September 1989 through May 1993. Review of a sample of medical records demonstrated that the nurses participating in the study were reliable reporters of whether or not they had been diagnosed with fibroids. Based on a report of an ultrasound or hysterectomy diagnosis, the incidence rate for fibroids increased with age. Incidence rate per 1,000 women-years was 4.3 (age 25 to 29 years), 9.0 (30 to 34 years), 14.7 (age 35 to 39 years), and 22.5 (40 to 44 years). Compared with White race, Black race (but not Hispanic ethnicity or Asian race) was associated with an increased incidence of fibroids. Incidence rate per 1,000 women-years was 12.5 (White race), 37.9 (Black race), 14.5 (Hispanic ethnicity), and 10.4 (Asian race). The risk of developing fibroids was 3.25 times (95% CI, 2.71 to 3.88) greater among Black compared with White women after controlling for body mass index, age at first birth, years since last birth, history of infertility, age at first oral contraceptive use, marital status, and current alcohol use.2
Other epidemiology studies also report an increased incidence of fibroids among Black women.3,4 The size of the uterus, the size and number of fibroids, and the severity of fibroid symptoms are greater among Black versus White women.5,6 The molecular factors that increase fibroid incidence among Black women are unknown. Given the burden of fibroid disease among Black women, obstetrician-gynecologists are best positioned to ensure early diagnosis and to develop an effective follow-up and treatment plan for affected women.
References
1. Stewart EA, Laughlin-Tommaso SK, Catherino WH, et al. Uterine fibroids. Nat Rev Dis Primers. 2016;2:16043.
2. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973.
3. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
4. Brett KM, Marsh JV, Madans JH. Epidemiology of hysterectomy in the United States: demographic and reproductive factors in a nationally representative sample. J Womens Health. 1997;6:309-316.
5. Peddada SD, Laughlin SK, Miner K, et al. Growth of uterine leiomyomata among premenopausal black and white women. Proc Natl Acad Sci USA. 2008;105:1988719892.
6. Huyck KL, Panhuysen CI, Cuenco KT, et al. The impact of race as a risk factor for symptom severity and age at diagnosis of uterine leiomyomata among affected sisters. Am J Obstet Gynecol. 2008;198:168.e1-e9.
Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.1 Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).1 Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.
Gene dysregulation contributes to fibroid development
Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).2
Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome
Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.3 Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,3 or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.
Estrogen and progesterone influence fibroid size and cell activity
Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.4 Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).
Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.5 In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.6 Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.6 This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.
Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.10
Continue to: Leuprolide acetate...
Leuprolide acetate
Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.11 Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.11 The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.
Elagolix plus estradiol plus norethindrone acetate (Oriahnn)
GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.
Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.
To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,12 in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:
- elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
- elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
- placebo for 6 months.12
Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.12
The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).13 Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.13
Continue to: Contraindications to Oriahnn include known allergies...
Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.14 Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.14 Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).14 In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).14 The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).14
It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.
AUB caused by fibroids is a common problem in gyn practice
There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●
Black women are more likely to develop fibroids and experience more severe fibroid symptoms. Obstetrician-gynecologists are experts in the diagnosis and treatment of fibroids. We play a key role in partnering with Black women to reduce fibroid disease burden.
Factors that increase the risk of developing fibroids include: increasing age, Black race, nulliparity, early menarche (<10 years of age), obesity, and consumption of red meat.1 The Nurses Health Study II is the largest prospective study of the factors that influence fibroid development.2 A total of 95,061 premenopausal nurses aged 25 to 44 years were followed from September 1989 through May 1993. Review of a sample of medical records demonstrated that the nurses participating in the study were reliable reporters of whether or not they had been diagnosed with fibroids. Based on a report of an ultrasound or hysterectomy diagnosis, the incidence rate for fibroids increased with age. Incidence rate per 1,000 women-years was 4.3 (age 25 to 29 years), 9.0 (30 to 34 years), 14.7 (age 35 to 39 years), and 22.5 (40 to 44 years). Compared with White race, Black race (but not Hispanic ethnicity or Asian race) was associated with an increased incidence of fibroids. Incidence rate per 1,000 women-years was 12.5 (White race), 37.9 (Black race), 14.5 (Hispanic ethnicity), and 10.4 (Asian race). The risk of developing fibroids was 3.25 times (95% CI, 2.71 to 3.88) greater among Black compared with White women after controlling for body mass index, age at first birth, years since last birth, history of infertility, age at first oral contraceptive use, marital status, and current alcohol use.2
Other epidemiology studies also report an increased incidence of fibroids among Black women.3,4 The size of the uterus, the size and number of fibroids, and the severity of fibroid symptoms are greater among Black versus White women.5,6 The molecular factors that increase fibroid incidence among Black women are unknown. Given the burden of fibroid disease among Black women, obstetrician-gynecologists are best positioned to ensure early diagnosis and to develop an effective follow-up and treatment plan for affected women.
References
1. Stewart EA, Laughlin-Tommaso SK, Catherino WH, et al. Uterine fibroids. Nat Rev Dis Primers. 2016;2:16043.
2. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973.
3. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
4. Brett KM, Marsh JV, Madans JH. Epidemiology of hysterectomy in the United States: demographic and reproductive factors in a nationally representative sample. J Womens Health. 1997;6:309-316.
5. Peddada SD, Laughlin SK, Miner K, et al. Growth of uterine leiomyomata among premenopausal black and white women. Proc Natl Acad Sci USA. 2008;105:1988719892.
6. Huyck KL, Panhuysen CI, Cuenco KT, et al. The impact of race as a risk factor for symptom severity and age at diagnosis of uterine leiomyomata among affected sisters. Am J Obstet Gynecol. 2008;198:168.e1-e9.
- Stewart EA. Uterine fibroids. N Engl J Med. 2015;372:1646-1655.
- Mehine M, Makinen N, Heinonen HR, et al. Genomics of uterine leiomyomas: insights from high-throughput sequencing. Fertil Steril. 2014;102:621-629.
- Mehine M, Kaasinen E, Makinen N, et al. Characterization of uterine leiomyomas by whole-genome sequencing. N Engl J Med. 2013;369:43-53.
- Moravek MB, Bulun SE. Endocrinology of uterine fibroids: steroid hormones, stem cells and genetic contribution. Curr Opin Obstet Gynecol. 2015;27:276-283.
- Rein MS. Advances in uterine leiomyoma research: the progesterone hypothesis. Environ Health Perspect. 2000;108(suppl 5):791-793.
- Friedman AJ, Barbieri RL, Doubilet PM, et al. A randomized double-blind trial of a gonadotropin-releasing hormone agonist (leuprolide) with or without medroxyprogesterone acetate in the treatment of leiomyomata uteri. Fertil Steril. 1988;49:404-409.
- Donnez J, Hudecek R, Donnez O, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015;103:519-527.
- Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012;366:409-420.
- Donnez J, Tomaszewski J, Vazquez F, et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012;366:421-432.
- European Medicines Agency. Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk. March 13, 2020. https://www.ema.europa.eu/en/news/suspension-ulipristal-acetate-uterine-fibroids-during-ongoing-ema-review-liver-injury-risk#:~:text=EMA's%20safety%20committee%20(PRAC)%20has,the%20EU%20during%20the%20review. Accessed July 24, 2020.
- Lupron Depot [package insert]. Osaka, Japan: Takeda; Revised March 2012.
- Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.
- Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.
- Oriahnn [package insert]. North Chicago, IL: AbbVie; 2020.
- Stewart EA. Uterine fibroids. N Engl J Med. 2015;372:1646-1655.
- Mehine M, Makinen N, Heinonen HR, et al. Genomics of uterine leiomyomas: insights from high-throughput sequencing. Fertil Steril. 2014;102:621-629.
- Mehine M, Kaasinen E, Makinen N, et al. Characterization of uterine leiomyomas by whole-genome sequencing. N Engl J Med. 2013;369:43-53.
- Moravek MB, Bulun SE. Endocrinology of uterine fibroids: steroid hormones, stem cells and genetic contribution. Curr Opin Obstet Gynecol. 2015;27:276-283.
- Rein MS. Advances in uterine leiomyoma research: the progesterone hypothesis. Environ Health Perspect. 2000;108(suppl 5):791-793.
- Friedman AJ, Barbieri RL, Doubilet PM, et al. A randomized double-blind trial of a gonadotropin-releasing hormone agonist (leuprolide) with or without medroxyprogesterone acetate in the treatment of leiomyomata uteri. Fertil Steril. 1988;49:404-409.
- Donnez J, Hudecek R, Donnez O, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015;103:519-527.
- Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012;366:409-420.
- Donnez J, Tomaszewski J, Vazquez F, et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012;366:421-432.
- European Medicines Agency. Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk. March 13, 2020. https://www.ema.europa.eu/en/news/suspension-ulipristal-acetate-uterine-fibroids-during-ongoing-ema-review-liver-injury-risk#:~:text=EMA's%20safety%20committee%20(PRAC)%20has,the%20EU%20during%20the%20review. Accessed July 24, 2020.
- Lupron Depot [package insert]. Osaka, Japan: Takeda; Revised March 2012.
- Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.
- Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.
- Oriahnn [package insert]. North Chicago, IL: AbbVie; 2020.
