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Colorism can lead to intrafamily conflict
The color hue of a person’s skin is the most obvious criteria for society to judge a person and has always been deeply rooted in racism. Discrimination based on skin color is called colorism and is usually meted out by members of the same race and in the same family. The general belief is that someone with a lighter complexion is more beautiful, intelligent, or valuable than someone with a darker complexion. The term colorism can be widely applied in our assessment of conflict within families and society. The following case example gives guidance for psychiatrists faced with a family where colorism fuels family conflict.
Meeting the family
The Jaspers, a Black family, arrive at the psychiatrist’s office. They come in and look around before they choose their seats. Dr. Sally watches who sits next to whom and how they organize themselves in the office. After brief introductions, Mr. Jaspers begins, explaining why they are there.
“We are always fighting. We need this to stop. She, my wife, contradicts me all the time. Our kids are getting frustrated, and Bruce is acting out in school. He got in a fight again last week.”
Everyone looks at Bruce. He is darker skinned than the other siblings and carries all the African features in a family that favors the lighter end of the color spectrum. He sits next to his mother who leans into him. Mrs. Jaspers speaks next.
“Bruce gets picked on in school.”
Mr. Jaspers responds, “Well, if you didn’t run in there all the time and take him out, maybe he would learn how to deal with it better!”
“But they are mistreating him,” Mrs. Jaspers says.
The other children look away and play with their phones. Dr. Sally wonders whether this is a pattern: The parents fighting about how to deal with Bruce and his difficulties in the world – and the other siblings getting ignored and not included.
Dr. Sally asks Mrs. Jaspers for more details. She tells a narrative that is a strong thread in this family’s story.
“As you can see, Bruce is darker than the rest of our children. When we see the rest of our family, they all comment on what good skin and light coloring and good hair the other children have. Bruce just sits there. He is always being left out. He doesn’t speak up for himself. Maybe they think he can’t hear them, but I know he does and it affects him. They say the others are more intelligent, but I don’t think that is true. Bruce just gets picked on in school and he doesn’t feel like he matters. He doesn’t say anything, so maybe people think he doesn’t care, but I know he does.”
Dr. Sally turns to Bruce, who is still sitting silently next to his mother, his head down.
“Bruce, what do you have to say?”
Bruce shrugs his shoulders. His siblings still do not want to be drawn in and are otherwise occupied.
At this point, Dr. Sally might be thinking that she could see Bruce alone to assess his depression/self-esteem and maybe find ways to try to build him up. She does not want this to be an opportunity wasted. The goal is to work with the family to get Bruce where he needs to be faster and help the whole family.
Dr. Sally presses on. “Mr. Jaspers, what is your opinion?”
“She babies him. She treats him differently from the other kids. She is driving a wedge between him and his siblings. We fight about it all the time. She is driving a wedge between us, too.”
Mrs. Jaspers jumps in: “But you don’t know what it is like! When I was the only Black person in math class, I got picked on all the time! It made me self-conscious, and I couldn’t do my work. “
The other siblings look up briefly then back down at their devices. Dr. Sally asks them as a group:
“Can I ask you a question as a family? Can I ask the children a question?” They look up again. “Is this what goes on at home?” They all nod but offer no details.
Dr. Sally asks the oldest: “How does this affect your relationship with Bruce?”
They all look back and forth at each other. There is another long silence.
“See!” says Mr. Jaspers! “You can't protect him forever, and you are just ostracizing him from the rest of us! “
“But, but, he, he needs to learn different things. He is different. He faces different struggles. The police will stop him more. I am afraid for him.” Mrs. Jaspers starts to cry.
“You can’t protect him forever,” says her husband, gently reaching over to her.
Bruce has psychologically disappeared from the room, hiding behind his mother, who is now the largest and neediest presence in the room. Mr. Jaspers looks at Dr. Sally helplessly.
Dr. Sally asks the important question to the whole family.
“How do you all think this should work? If you don’t think Mrs. Jaspers is right, what do you think should be the way forward?”
This question is the turning point and indicates that Dr. Sally sees that the solution lies in how the family wants to manage things.
“I believe that your whole family has the answers, that you all have thought through this situation much more deeply and for much longer than I have. I am just hearing about it, and I am White and don’t have this experience. I have faith in your family, that with an opportunity to openly discuss this issue, that this knot can be unraveled. It does not mean that there are not more knots to unravel. For today, how to help you all help Bruce, is the work."
Dr. Sally talks to everyone but finishes up by looking at Mr. Jaspers, who has indicated that Bruce is part of the family and should not be treated differently from the other children.
Sean, the oldest sibling, now pipes up: “Bruce gets everything he wants. Mum spoils him; she always takes his side if there are arguments. Bruce knows this, and he steals our stuff because he knows he will get away with it.”
Bruce is quiet and leans in more to his mother. Dr. Sally motions to the mother not to speak.
“Is this true, Bruce?” Silence speaks that the answer is yes. The disparities in the family are aired for a while longer.
“Mrs. Jaspers, it is now your turn to respond.”
“Bruce is darker and faces more challenges than the others; he needs more protection and to know that he is loved.”
“Your family seems to think otherwise. They seem to think that your protection, while admirable, needs to be tempered to allow him to grow into a man who can stand on his own feet.”
Dr. Sally guides the family as a whole to a place where they can agree on the problem. The problem is now framed as a mother who cares too much and is too protective of Bruce but now her love and care need to be tempered. As a mother, she feels that it is her duty to protect her most vulnerable son. The family knows that Bruce will face more social scrutiny than the others, that he will have more internal struggles with self-worth than the others. How can the family help?
This conceptualization causes the family to look searchingly at one another. It is nothing they haven’t thought about privately, but this is the first time they are together thinking about it.
Dr. Sally says that she can help by providing time and space for them to wok through this together. They all agree to come back the following week with some thoughts about moving forward.
Offering perspective on colorism
In her book “Facing the Black Shadow,” couples and family therapist Marlene F. Watson, PhD, discusses colorism.
“African Americans still have a tough time talking about slavery – the origin of colorism. Seriously, what can we really expect to change without acknowledging and challenging the psychological residuals of slavery in our families and communities? What doesn’t get resolved in one generation is passed on to the next so our issues from slavery go from one generation to the next.”
Dr. Watson continues: “Confronting the secret about skin color in our families and communities is necessary for all Black girls to feel lovable, worthy, and deserving of care and for all Black boys to feel their value lies within them, not a dark, light, bright, near-white or White woman. African Americans need to get that preferring light over dark or dark over light is problematic for all of us. Skin color preferences in the African American community follow society’s racial hierarchy. African Americans as a group are at the bottom in the larger society and dark-skinned African Americans are at the bottom in the Black community.”
and patterns about skin color. Her advice is to ask each family member, from oldest to youngest, to identify the spoken and unspoken skin color beliefs he or she experiences in the family. Ask about skin color beliefs from outside that affect family members, and what each person thinks the family could do to stop promoting the “less than/better than” mentality that is often present with skin color assignment.
Thank you to Lynette Ramsingh Barros, who collaborated on creating the case.
Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest.
The color hue of a person’s skin is the most obvious criteria for society to judge a person and has always been deeply rooted in racism. Discrimination based on skin color is called colorism and is usually meted out by members of the same race and in the same family. The general belief is that someone with a lighter complexion is more beautiful, intelligent, or valuable than someone with a darker complexion. The term colorism can be widely applied in our assessment of conflict within families and society. The following case example gives guidance for psychiatrists faced with a family where colorism fuels family conflict.
Meeting the family
The Jaspers, a Black family, arrive at the psychiatrist’s office. They come in and look around before they choose their seats. Dr. Sally watches who sits next to whom and how they organize themselves in the office. After brief introductions, Mr. Jaspers begins, explaining why they are there.
“We are always fighting. We need this to stop. She, my wife, contradicts me all the time. Our kids are getting frustrated, and Bruce is acting out in school. He got in a fight again last week.”
Everyone looks at Bruce. He is darker skinned than the other siblings and carries all the African features in a family that favors the lighter end of the color spectrum. He sits next to his mother who leans into him. Mrs. Jaspers speaks next.
“Bruce gets picked on in school.”
Mr. Jaspers responds, “Well, if you didn’t run in there all the time and take him out, maybe he would learn how to deal with it better!”
“But they are mistreating him,” Mrs. Jaspers says.
The other children look away and play with their phones. Dr. Sally wonders whether this is a pattern: The parents fighting about how to deal with Bruce and his difficulties in the world – and the other siblings getting ignored and not included.
Dr. Sally asks Mrs. Jaspers for more details. She tells a narrative that is a strong thread in this family’s story.
“As you can see, Bruce is darker than the rest of our children. When we see the rest of our family, they all comment on what good skin and light coloring and good hair the other children have. Bruce just sits there. He is always being left out. He doesn’t speak up for himself. Maybe they think he can’t hear them, but I know he does and it affects him. They say the others are more intelligent, but I don’t think that is true. Bruce just gets picked on in school and he doesn’t feel like he matters. He doesn’t say anything, so maybe people think he doesn’t care, but I know he does.”
Dr. Sally turns to Bruce, who is still sitting silently next to his mother, his head down.
“Bruce, what do you have to say?”
Bruce shrugs his shoulders. His siblings still do not want to be drawn in and are otherwise occupied.
At this point, Dr. Sally might be thinking that she could see Bruce alone to assess his depression/self-esteem and maybe find ways to try to build him up. She does not want this to be an opportunity wasted. The goal is to work with the family to get Bruce where he needs to be faster and help the whole family.
Dr. Sally presses on. “Mr. Jaspers, what is your opinion?”
“She babies him. She treats him differently from the other kids. She is driving a wedge between him and his siblings. We fight about it all the time. She is driving a wedge between us, too.”
Mrs. Jaspers jumps in: “But you don’t know what it is like! When I was the only Black person in math class, I got picked on all the time! It made me self-conscious, and I couldn’t do my work. “
The other siblings look up briefly then back down at their devices. Dr. Sally asks them as a group:
“Can I ask you a question as a family? Can I ask the children a question?” They look up again. “Is this what goes on at home?” They all nod but offer no details.
Dr. Sally asks the oldest: “How does this affect your relationship with Bruce?”
They all look back and forth at each other. There is another long silence.
“See!” says Mr. Jaspers! “You can't protect him forever, and you are just ostracizing him from the rest of us! “
“But, but, he, he needs to learn different things. He is different. He faces different struggles. The police will stop him more. I am afraid for him.” Mrs. Jaspers starts to cry.
“You can’t protect him forever,” says her husband, gently reaching over to her.
Bruce has psychologically disappeared from the room, hiding behind his mother, who is now the largest and neediest presence in the room. Mr. Jaspers looks at Dr. Sally helplessly.
Dr. Sally asks the important question to the whole family.
“How do you all think this should work? If you don’t think Mrs. Jaspers is right, what do you think should be the way forward?”
This question is the turning point and indicates that Dr. Sally sees that the solution lies in how the family wants to manage things.
“I believe that your whole family has the answers, that you all have thought through this situation much more deeply and for much longer than I have. I am just hearing about it, and I am White and don’t have this experience. I have faith in your family, that with an opportunity to openly discuss this issue, that this knot can be unraveled. It does not mean that there are not more knots to unravel. For today, how to help you all help Bruce, is the work."
Dr. Sally talks to everyone but finishes up by looking at Mr. Jaspers, who has indicated that Bruce is part of the family and should not be treated differently from the other children.
Sean, the oldest sibling, now pipes up: “Bruce gets everything he wants. Mum spoils him; she always takes his side if there are arguments. Bruce knows this, and he steals our stuff because he knows he will get away with it.”
Bruce is quiet and leans in more to his mother. Dr. Sally motions to the mother not to speak.
“Is this true, Bruce?” Silence speaks that the answer is yes. The disparities in the family are aired for a while longer.
“Mrs. Jaspers, it is now your turn to respond.”
“Bruce is darker and faces more challenges than the others; he needs more protection and to know that he is loved.”
“Your family seems to think otherwise. They seem to think that your protection, while admirable, needs to be tempered to allow him to grow into a man who can stand on his own feet.”
Dr. Sally guides the family as a whole to a place where they can agree on the problem. The problem is now framed as a mother who cares too much and is too protective of Bruce but now her love and care need to be tempered. As a mother, she feels that it is her duty to protect her most vulnerable son. The family knows that Bruce will face more social scrutiny than the others, that he will have more internal struggles with self-worth than the others. How can the family help?
This conceptualization causes the family to look searchingly at one another. It is nothing they haven’t thought about privately, but this is the first time they are together thinking about it.
Dr. Sally says that she can help by providing time and space for them to wok through this together. They all agree to come back the following week with some thoughts about moving forward.
Offering perspective on colorism
In her book “Facing the Black Shadow,” couples and family therapist Marlene F. Watson, PhD, discusses colorism.
“African Americans still have a tough time talking about slavery – the origin of colorism. Seriously, what can we really expect to change without acknowledging and challenging the psychological residuals of slavery in our families and communities? What doesn’t get resolved in one generation is passed on to the next so our issues from slavery go from one generation to the next.”
Dr. Watson continues: “Confronting the secret about skin color in our families and communities is necessary for all Black girls to feel lovable, worthy, and deserving of care and for all Black boys to feel their value lies within them, not a dark, light, bright, near-white or White woman. African Americans need to get that preferring light over dark or dark over light is problematic for all of us. Skin color preferences in the African American community follow society’s racial hierarchy. African Americans as a group are at the bottom in the larger society and dark-skinned African Americans are at the bottom in the Black community.”
and patterns about skin color. Her advice is to ask each family member, from oldest to youngest, to identify the spoken and unspoken skin color beliefs he or she experiences in the family. Ask about skin color beliefs from outside that affect family members, and what each person thinks the family could do to stop promoting the “less than/better than” mentality that is often present with skin color assignment.
Thank you to Lynette Ramsingh Barros, who collaborated on creating the case.
Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest.
The color hue of a person’s skin is the most obvious criteria for society to judge a person and has always been deeply rooted in racism. Discrimination based on skin color is called colorism and is usually meted out by members of the same race and in the same family. The general belief is that someone with a lighter complexion is more beautiful, intelligent, or valuable than someone with a darker complexion. The term colorism can be widely applied in our assessment of conflict within families and society. The following case example gives guidance for psychiatrists faced with a family where colorism fuels family conflict.
Meeting the family
The Jaspers, a Black family, arrive at the psychiatrist’s office. They come in and look around before they choose their seats. Dr. Sally watches who sits next to whom and how they organize themselves in the office. After brief introductions, Mr. Jaspers begins, explaining why they are there.
“We are always fighting. We need this to stop. She, my wife, contradicts me all the time. Our kids are getting frustrated, and Bruce is acting out in school. He got in a fight again last week.”
Everyone looks at Bruce. He is darker skinned than the other siblings and carries all the African features in a family that favors the lighter end of the color spectrum. He sits next to his mother who leans into him. Mrs. Jaspers speaks next.
“Bruce gets picked on in school.”
Mr. Jaspers responds, “Well, if you didn’t run in there all the time and take him out, maybe he would learn how to deal with it better!”
“But they are mistreating him,” Mrs. Jaspers says.
The other children look away and play with their phones. Dr. Sally wonders whether this is a pattern: The parents fighting about how to deal with Bruce and his difficulties in the world – and the other siblings getting ignored and not included.
Dr. Sally asks Mrs. Jaspers for more details. She tells a narrative that is a strong thread in this family’s story.
“As you can see, Bruce is darker than the rest of our children. When we see the rest of our family, they all comment on what good skin and light coloring and good hair the other children have. Bruce just sits there. He is always being left out. He doesn’t speak up for himself. Maybe they think he can’t hear them, but I know he does and it affects him. They say the others are more intelligent, but I don’t think that is true. Bruce just gets picked on in school and he doesn’t feel like he matters. He doesn’t say anything, so maybe people think he doesn’t care, but I know he does.”
Dr. Sally turns to Bruce, who is still sitting silently next to his mother, his head down.
“Bruce, what do you have to say?”
Bruce shrugs his shoulders. His siblings still do not want to be drawn in and are otherwise occupied.
At this point, Dr. Sally might be thinking that she could see Bruce alone to assess his depression/self-esteem and maybe find ways to try to build him up. She does not want this to be an opportunity wasted. The goal is to work with the family to get Bruce where he needs to be faster and help the whole family.
Dr. Sally presses on. “Mr. Jaspers, what is your opinion?”
“She babies him. She treats him differently from the other kids. She is driving a wedge between him and his siblings. We fight about it all the time. She is driving a wedge between us, too.”
Mrs. Jaspers jumps in: “But you don’t know what it is like! When I was the only Black person in math class, I got picked on all the time! It made me self-conscious, and I couldn’t do my work. “
The other siblings look up briefly then back down at their devices. Dr. Sally asks them as a group:
“Can I ask you a question as a family? Can I ask the children a question?” They look up again. “Is this what goes on at home?” They all nod but offer no details.
Dr. Sally asks the oldest: “How does this affect your relationship with Bruce?”
They all look back and forth at each other. There is another long silence.
“See!” says Mr. Jaspers! “You can't protect him forever, and you are just ostracizing him from the rest of us! “
“But, but, he, he needs to learn different things. He is different. He faces different struggles. The police will stop him more. I am afraid for him.” Mrs. Jaspers starts to cry.
“You can’t protect him forever,” says her husband, gently reaching over to her.
Bruce has psychologically disappeared from the room, hiding behind his mother, who is now the largest and neediest presence in the room. Mr. Jaspers looks at Dr. Sally helplessly.
Dr. Sally asks the important question to the whole family.
“How do you all think this should work? If you don’t think Mrs. Jaspers is right, what do you think should be the way forward?”
This question is the turning point and indicates that Dr. Sally sees that the solution lies in how the family wants to manage things.
“I believe that your whole family has the answers, that you all have thought through this situation much more deeply and for much longer than I have. I am just hearing about it, and I am White and don’t have this experience. I have faith in your family, that with an opportunity to openly discuss this issue, that this knot can be unraveled. It does not mean that there are not more knots to unravel. For today, how to help you all help Bruce, is the work."
Dr. Sally talks to everyone but finishes up by looking at Mr. Jaspers, who has indicated that Bruce is part of the family and should not be treated differently from the other children.
Sean, the oldest sibling, now pipes up: “Bruce gets everything he wants. Mum spoils him; she always takes his side if there are arguments. Bruce knows this, and he steals our stuff because he knows he will get away with it.”
Bruce is quiet and leans in more to his mother. Dr. Sally motions to the mother not to speak.
“Is this true, Bruce?” Silence speaks that the answer is yes. The disparities in the family are aired for a while longer.
“Mrs. Jaspers, it is now your turn to respond.”
“Bruce is darker and faces more challenges than the others; he needs more protection and to know that he is loved.”
“Your family seems to think otherwise. They seem to think that your protection, while admirable, needs to be tempered to allow him to grow into a man who can stand on his own feet.”
Dr. Sally guides the family as a whole to a place where they can agree on the problem. The problem is now framed as a mother who cares too much and is too protective of Bruce but now her love and care need to be tempered. As a mother, she feels that it is her duty to protect her most vulnerable son. The family knows that Bruce will face more social scrutiny than the others, that he will have more internal struggles with self-worth than the others. How can the family help?
This conceptualization causes the family to look searchingly at one another. It is nothing they haven’t thought about privately, but this is the first time they are together thinking about it.
Dr. Sally says that she can help by providing time and space for them to wok through this together. They all agree to come back the following week with some thoughts about moving forward.
Offering perspective on colorism
In her book “Facing the Black Shadow,” couples and family therapist Marlene F. Watson, PhD, discusses colorism.
“African Americans still have a tough time talking about slavery – the origin of colorism. Seriously, what can we really expect to change without acknowledging and challenging the psychological residuals of slavery in our families and communities? What doesn’t get resolved in one generation is passed on to the next so our issues from slavery go from one generation to the next.”
Dr. Watson continues: “Confronting the secret about skin color in our families and communities is necessary for all Black girls to feel lovable, worthy, and deserving of care and for all Black boys to feel their value lies within them, not a dark, light, bright, near-white or White woman. African Americans need to get that preferring light over dark or dark over light is problematic for all of us. Skin color preferences in the African American community follow society’s racial hierarchy. African Americans as a group are at the bottom in the larger society and dark-skinned African Americans are at the bottom in the Black community.”
and patterns about skin color. Her advice is to ask each family member, from oldest to youngest, to identify the spoken and unspoken skin color beliefs he or she experiences in the family. Ask about skin color beliefs from outside that affect family members, and what each person thinks the family could do to stop promoting the “less than/better than” mentality that is often present with skin color assignment.
Thank you to Lynette Ramsingh Barros, who collaborated on creating the case.
Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest.
REALITY trial supports restrictive transfusion in anemic MI
in the landmark REALITY trial.
Randomized trial data already support a restrictive transfusion strategy in patients undergoing cardiac and noncardiac surgery, as well as in other settings. Those trials deliberately excluded patients with acute myocardial ischemia.
Cardiologists have been loath to adopt a restrictive strategy in the absence of persuasive supporting evidence because of a theoretic concern that low hemoglobin might be particularly harmful to ischemic myocardium. Anemia occurs in 5%-10% patients with MI, and clinicians have been eager for evidence-based guidance on how to best manage it.
“Blood is a precious resource and transfusion is costly, logistically cumbersome, and has side effects,” Philippe Gabriel Steg, MD, chair of the REALITY trial, noted in presenting the study results at the virtual annual congress of the European Society of Cardiology.
REALITY was the first-ever large randomized trial of a restrictive versus liberal transfusion strategy in acute MI. The study, which featured a noninferiority design, included 668 stable patients with acute MI and anemia with a hemoglobin of 7-10 g/dL at 35 hospitals in France and Spain. Participants were randomized to a restrictive strategy in which transfusion was withheld unless the hemoglobin dropped to 8 g/dL or less, or to a conventional liberal strategy triggered by a hemoglobin of 10 g/dL or lower. The transfusion target was a hemoglobin level of 8-10 g/dL in the restrictive strategy group and greater than 11 g/dL in the liberal transfusion group. In the restrictive transfusion group, 36% received at least one RBC transfusion, as did 87% in the liberal transfusion study arm. The restrictive strategy group used 414 fewer units of blood.
The two coprimary endpoints were 30-day major adverse cardiovascular events and cost-effectiveness. The 30-day composite of all-cause mortality, reinfarction, stroke, and emergency percutaneous coronary intervention for myocardial ischemia occurred in 11% of the restrictive transfusion group and 14% of the liberal transfusion group. The resultant 21% relative risk reduction established that the restrictive strategy was noninferior. Of note, all of the individual components of the composite endpoint numerically favored the restrictive approach.
In terms of safety, patients in the restrictive transfusion group were significantly less likely to develop an infection, by a margin of 0% versus 1.5%. The rate of acute lung injury was also significantly lower in the restrictive group: 0.3%, compared with 2.2%. The median hospital length of stay was identical at 7 days in both groups.
The cost-effectiveness analysis concluded that the restrictive transfusion strategy had an 84% probability of being both less expensive and more effective.
Patients were enrolled in REALITY regardless of whether they had active bleeding, as long as the bleeding wasn’t deemed massive and life-threatening. Notably, there was no difference in the results of restrictive versus liberal transfusion regardless of whether active bleeding was present, nor did baseline hemoglobin or the presence or absence of preexisting anemia affect the results.
Dr. Steg noted that a much larger randomized trial of restrictive versus liberal transfusion in the setting of acute MI with anemia is underway in the United States and Canada. The 3,000-patient MINT trial, sponsored by the National Institutes of Health, is testing the superiority of restrictive transfusion, rather than its noninferiority, as in REALITY. Results are a couple of years away.
“I think that will be an important piece of additional evidence,” he said.
Discussant Marco Roffi, MD, didn’t mince words.
“I really love the REALITY trial,” declared Dr. Roffi, professor and vice chairman of the cardiology department and director of the interventional cardiology unit at University Hospital of Geneva.
He ticked off a series of reasons: The trial addressed a common clinical dilemma about which there has been essentially no prior high-quality evidence, it provided convincing results, and it carried important implications for responsible stewardship of the blood supply.
“REALITY allows clinicians to comfortably refrain from transfusing anemic patients presenting with myocardial infarction, and this should lead to a reduction in the consumption of blood products,” Dr. Roffi said.
He applauded the investigators for their success in obtaining public funding for a study lacking a commercial hook. And as a clinical investigator, he was particularly impressed by one of the technical details about the REALITY trial: “I was amazed by the fact that the observed event rates virtually corresponded to the estimated ones used for the power calculations. This is rarely the case in such a trial.”
Dr. Roffi said the REALITY findings should have an immediate impact on clinical practice, as well as on the brand new 2020 ESC guidelines on the management of non–ST-elevation ACS issued during the ESC virtual congress.
The freshly inked guidelines state: “Based on inconsistent study results and the lack of adequately powered randomized, controlled trials, a restrictive policy of transfusion in anemic patients with MI may be considered.” As of today, Dr. Roffi argued, the phrase “may be considered” ought to be replaced by the stronger phrase “should be considered.”
During the discussion period, he was asked if it’s appropriate to extrapolate the REALITY results to patients undergoing transcatheter aortic valve replacement, among whom anemia is highly prevalent.
“I think this is a different patient population. Nevertheless, the concept of being restrictive is one that in my opinion now remains until proven otherwise. So we are being very restrictive in these patients,” he replied.
Asked about possible mechanisms by which liberal transfusion might have detrimental effects in acute MI patients, Dr. Steg cited several, including evidence that transfusion may not improve oxygen delivery to as great an extent as traditionally thought. There is also the risk of volume overload, increased blood viscosity, and enhanced platelet aggregation and activation, which could promote myocardial ischemia.
The REALITY trial was funded by the French Ministry of Health and the Spanish Ministry of Economy and Competitiveness with no commercial support. Outside the scope of the trial, Dr. Steg reported receiving research grants from Bayer, Merck, Servier, and Sanofi as well as serving as a consultant to numerous pharmaceutical companies.
in the landmark REALITY trial.
Randomized trial data already support a restrictive transfusion strategy in patients undergoing cardiac and noncardiac surgery, as well as in other settings. Those trials deliberately excluded patients with acute myocardial ischemia.
Cardiologists have been loath to adopt a restrictive strategy in the absence of persuasive supporting evidence because of a theoretic concern that low hemoglobin might be particularly harmful to ischemic myocardium. Anemia occurs in 5%-10% patients with MI, and clinicians have been eager for evidence-based guidance on how to best manage it.
“Blood is a precious resource and transfusion is costly, logistically cumbersome, and has side effects,” Philippe Gabriel Steg, MD, chair of the REALITY trial, noted in presenting the study results at the virtual annual congress of the European Society of Cardiology.
REALITY was the first-ever large randomized trial of a restrictive versus liberal transfusion strategy in acute MI. The study, which featured a noninferiority design, included 668 stable patients with acute MI and anemia with a hemoglobin of 7-10 g/dL at 35 hospitals in France and Spain. Participants were randomized to a restrictive strategy in which transfusion was withheld unless the hemoglobin dropped to 8 g/dL or less, or to a conventional liberal strategy triggered by a hemoglobin of 10 g/dL or lower. The transfusion target was a hemoglobin level of 8-10 g/dL in the restrictive strategy group and greater than 11 g/dL in the liberal transfusion group. In the restrictive transfusion group, 36% received at least one RBC transfusion, as did 87% in the liberal transfusion study arm. The restrictive strategy group used 414 fewer units of blood.
The two coprimary endpoints were 30-day major adverse cardiovascular events and cost-effectiveness. The 30-day composite of all-cause mortality, reinfarction, stroke, and emergency percutaneous coronary intervention for myocardial ischemia occurred in 11% of the restrictive transfusion group and 14% of the liberal transfusion group. The resultant 21% relative risk reduction established that the restrictive strategy was noninferior. Of note, all of the individual components of the composite endpoint numerically favored the restrictive approach.
In terms of safety, patients in the restrictive transfusion group were significantly less likely to develop an infection, by a margin of 0% versus 1.5%. The rate of acute lung injury was also significantly lower in the restrictive group: 0.3%, compared with 2.2%. The median hospital length of stay was identical at 7 days in both groups.
The cost-effectiveness analysis concluded that the restrictive transfusion strategy had an 84% probability of being both less expensive and more effective.
Patients were enrolled in REALITY regardless of whether they had active bleeding, as long as the bleeding wasn’t deemed massive and life-threatening. Notably, there was no difference in the results of restrictive versus liberal transfusion regardless of whether active bleeding was present, nor did baseline hemoglobin or the presence or absence of preexisting anemia affect the results.
Dr. Steg noted that a much larger randomized trial of restrictive versus liberal transfusion in the setting of acute MI with anemia is underway in the United States and Canada. The 3,000-patient MINT trial, sponsored by the National Institutes of Health, is testing the superiority of restrictive transfusion, rather than its noninferiority, as in REALITY. Results are a couple of years away.
“I think that will be an important piece of additional evidence,” he said.
Discussant Marco Roffi, MD, didn’t mince words.
“I really love the REALITY trial,” declared Dr. Roffi, professor and vice chairman of the cardiology department and director of the interventional cardiology unit at University Hospital of Geneva.
He ticked off a series of reasons: The trial addressed a common clinical dilemma about which there has been essentially no prior high-quality evidence, it provided convincing results, and it carried important implications for responsible stewardship of the blood supply.
“REALITY allows clinicians to comfortably refrain from transfusing anemic patients presenting with myocardial infarction, and this should lead to a reduction in the consumption of blood products,” Dr. Roffi said.
He applauded the investigators for their success in obtaining public funding for a study lacking a commercial hook. And as a clinical investigator, he was particularly impressed by one of the technical details about the REALITY trial: “I was amazed by the fact that the observed event rates virtually corresponded to the estimated ones used for the power calculations. This is rarely the case in such a trial.”
Dr. Roffi said the REALITY findings should have an immediate impact on clinical practice, as well as on the brand new 2020 ESC guidelines on the management of non–ST-elevation ACS issued during the ESC virtual congress.
The freshly inked guidelines state: “Based on inconsistent study results and the lack of adequately powered randomized, controlled trials, a restrictive policy of transfusion in anemic patients with MI may be considered.” As of today, Dr. Roffi argued, the phrase “may be considered” ought to be replaced by the stronger phrase “should be considered.”
During the discussion period, he was asked if it’s appropriate to extrapolate the REALITY results to patients undergoing transcatheter aortic valve replacement, among whom anemia is highly prevalent.
“I think this is a different patient population. Nevertheless, the concept of being restrictive is one that in my opinion now remains until proven otherwise. So we are being very restrictive in these patients,” he replied.
Asked about possible mechanisms by which liberal transfusion might have detrimental effects in acute MI patients, Dr. Steg cited several, including evidence that transfusion may not improve oxygen delivery to as great an extent as traditionally thought. There is also the risk of volume overload, increased blood viscosity, and enhanced platelet aggregation and activation, which could promote myocardial ischemia.
The REALITY trial was funded by the French Ministry of Health and the Spanish Ministry of Economy and Competitiveness with no commercial support. Outside the scope of the trial, Dr. Steg reported receiving research grants from Bayer, Merck, Servier, and Sanofi as well as serving as a consultant to numerous pharmaceutical companies.
in the landmark REALITY trial.
Randomized trial data already support a restrictive transfusion strategy in patients undergoing cardiac and noncardiac surgery, as well as in other settings. Those trials deliberately excluded patients with acute myocardial ischemia.
Cardiologists have been loath to adopt a restrictive strategy in the absence of persuasive supporting evidence because of a theoretic concern that low hemoglobin might be particularly harmful to ischemic myocardium. Anemia occurs in 5%-10% patients with MI, and clinicians have been eager for evidence-based guidance on how to best manage it.
“Blood is a precious resource and transfusion is costly, logistically cumbersome, and has side effects,” Philippe Gabriel Steg, MD, chair of the REALITY trial, noted in presenting the study results at the virtual annual congress of the European Society of Cardiology.
REALITY was the first-ever large randomized trial of a restrictive versus liberal transfusion strategy in acute MI. The study, which featured a noninferiority design, included 668 stable patients with acute MI and anemia with a hemoglobin of 7-10 g/dL at 35 hospitals in France and Spain. Participants were randomized to a restrictive strategy in which transfusion was withheld unless the hemoglobin dropped to 8 g/dL or less, or to a conventional liberal strategy triggered by a hemoglobin of 10 g/dL or lower. The transfusion target was a hemoglobin level of 8-10 g/dL in the restrictive strategy group and greater than 11 g/dL in the liberal transfusion group. In the restrictive transfusion group, 36% received at least one RBC transfusion, as did 87% in the liberal transfusion study arm. The restrictive strategy group used 414 fewer units of blood.
The two coprimary endpoints were 30-day major adverse cardiovascular events and cost-effectiveness. The 30-day composite of all-cause mortality, reinfarction, stroke, and emergency percutaneous coronary intervention for myocardial ischemia occurred in 11% of the restrictive transfusion group and 14% of the liberal transfusion group. The resultant 21% relative risk reduction established that the restrictive strategy was noninferior. Of note, all of the individual components of the composite endpoint numerically favored the restrictive approach.
In terms of safety, patients in the restrictive transfusion group were significantly less likely to develop an infection, by a margin of 0% versus 1.5%. The rate of acute lung injury was also significantly lower in the restrictive group: 0.3%, compared with 2.2%. The median hospital length of stay was identical at 7 days in both groups.
The cost-effectiveness analysis concluded that the restrictive transfusion strategy had an 84% probability of being both less expensive and more effective.
Patients were enrolled in REALITY regardless of whether they had active bleeding, as long as the bleeding wasn’t deemed massive and life-threatening. Notably, there was no difference in the results of restrictive versus liberal transfusion regardless of whether active bleeding was present, nor did baseline hemoglobin or the presence or absence of preexisting anemia affect the results.
Dr. Steg noted that a much larger randomized trial of restrictive versus liberal transfusion in the setting of acute MI with anemia is underway in the United States and Canada. The 3,000-patient MINT trial, sponsored by the National Institutes of Health, is testing the superiority of restrictive transfusion, rather than its noninferiority, as in REALITY. Results are a couple of years away.
“I think that will be an important piece of additional evidence,” he said.
Discussant Marco Roffi, MD, didn’t mince words.
“I really love the REALITY trial,” declared Dr. Roffi, professor and vice chairman of the cardiology department and director of the interventional cardiology unit at University Hospital of Geneva.
He ticked off a series of reasons: The trial addressed a common clinical dilemma about which there has been essentially no prior high-quality evidence, it provided convincing results, and it carried important implications for responsible stewardship of the blood supply.
“REALITY allows clinicians to comfortably refrain from transfusing anemic patients presenting with myocardial infarction, and this should lead to a reduction in the consumption of blood products,” Dr. Roffi said.
He applauded the investigators for their success in obtaining public funding for a study lacking a commercial hook. And as a clinical investigator, he was particularly impressed by one of the technical details about the REALITY trial: “I was amazed by the fact that the observed event rates virtually corresponded to the estimated ones used for the power calculations. This is rarely the case in such a trial.”
Dr. Roffi said the REALITY findings should have an immediate impact on clinical practice, as well as on the brand new 2020 ESC guidelines on the management of non–ST-elevation ACS issued during the ESC virtual congress.
The freshly inked guidelines state: “Based on inconsistent study results and the lack of adequately powered randomized, controlled trials, a restrictive policy of transfusion in anemic patients with MI may be considered.” As of today, Dr. Roffi argued, the phrase “may be considered” ought to be replaced by the stronger phrase “should be considered.”
During the discussion period, he was asked if it’s appropriate to extrapolate the REALITY results to patients undergoing transcatheter aortic valve replacement, among whom anemia is highly prevalent.
“I think this is a different patient population. Nevertheless, the concept of being restrictive is one that in my opinion now remains until proven otherwise. So we are being very restrictive in these patients,” he replied.
Asked about possible mechanisms by which liberal transfusion might have detrimental effects in acute MI patients, Dr. Steg cited several, including evidence that transfusion may not improve oxygen delivery to as great an extent as traditionally thought. There is also the risk of volume overload, increased blood viscosity, and enhanced platelet aggregation and activation, which could promote myocardial ischemia.
The REALITY trial was funded by the French Ministry of Health and the Spanish Ministry of Economy and Competitiveness with no commercial support. Outside the scope of the trial, Dr. Steg reported receiving research grants from Bayer, Merck, Servier, and Sanofi as well as serving as a consultant to numerous pharmaceutical companies.
REPORTING FROM ESC CONGRESS 2020
Latest report adds almost 44,000 child COVID-19 cases in 1 week
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The new cases bring the cumulative number of infected children to over 476,000, and that figure represents 9.5% of the over 5 million COVID-19 cases reported among all ages, the AAP and the CHA said in their weekly report. The cumulative number of children covers 49 states (New York is not reporting age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.
From lowest to highest, the states occupying opposite ends of the cumulative proportion spectrum are New Jersey at 3.4% – New York City was lower with a 3.2% figure but is not a state – and Wyoming at 18.3%, the report showed.
Children represent more than 15% of all reported COVID-19 cases in five other states: Tennessee (17.1%), North Dakota (16.0%), Alaska (15.9%), New Mexico (15.7%), and Minnesota (15.1%). The states just above New Jersey are Florida (5.8%), Connecticut (5.9%), and Massachusetts (6.7%). Texas has a rate of 5.6% but has reported age for only 8% of confirmed cases, the AAP and CHA noted.
Children make up a much lower share of COVID-19 hospitalizations – 1.7% of the cumulative number for all ages – although that figure has been slowly rising over the course of the pandemic: it was 1.2% on July 9 and 0.9% on May 8. Arizona (4.1%) is the highest of the 22 states reporting age for hospitalizations and Hawaii (0.6%) is the lowest, based on the AAP/CHA data.
Mortality figures for children continue to be even lower. Nationwide, 0.07% of all COVID-19 deaths occurred in children, and 19 of the 43 states reporting age distributions have had no deaths yet. Pediatric deaths totaled 101 as of Aug. 27, the two groups reported.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The new cases bring the cumulative number of infected children to over 476,000, and that figure represents 9.5% of the over 5 million COVID-19 cases reported among all ages, the AAP and the CHA said in their weekly report. The cumulative number of children covers 49 states (New York is not reporting age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.
From lowest to highest, the states occupying opposite ends of the cumulative proportion spectrum are New Jersey at 3.4% – New York City was lower with a 3.2% figure but is not a state – and Wyoming at 18.3%, the report showed.
Children represent more than 15% of all reported COVID-19 cases in five other states: Tennessee (17.1%), North Dakota (16.0%), Alaska (15.9%), New Mexico (15.7%), and Minnesota (15.1%). The states just above New Jersey are Florida (5.8%), Connecticut (5.9%), and Massachusetts (6.7%). Texas has a rate of 5.6% but has reported age for only 8% of confirmed cases, the AAP and CHA noted.
Children make up a much lower share of COVID-19 hospitalizations – 1.7% of the cumulative number for all ages – although that figure has been slowly rising over the course of the pandemic: it was 1.2% on July 9 and 0.9% on May 8. Arizona (4.1%) is the highest of the 22 states reporting age for hospitalizations and Hawaii (0.6%) is the lowest, based on the AAP/CHA data.
Mortality figures for children continue to be even lower. Nationwide, 0.07% of all COVID-19 deaths occurred in children, and 19 of the 43 states reporting age distributions have had no deaths yet. Pediatric deaths totaled 101 as of Aug. 27, the two groups reported.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The new cases bring the cumulative number of infected children to over 476,000, and that figure represents 9.5% of the over 5 million COVID-19 cases reported among all ages, the AAP and the CHA said in their weekly report. The cumulative number of children covers 49 states (New York is not reporting age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.
From lowest to highest, the states occupying opposite ends of the cumulative proportion spectrum are New Jersey at 3.4% – New York City was lower with a 3.2% figure but is not a state – and Wyoming at 18.3%, the report showed.
Children represent more than 15% of all reported COVID-19 cases in five other states: Tennessee (17.1%), North Dakota (16.0%), Alaska (15.9%), New Mexico (15.7%), and Minnesota (15.1%). The states just above New Jersey are Florida (5.8%), Connecticut (5.9%), and Massachusetts (6.7%). Texas has a rate of 5.6% but has reported age for only 8% of confirmed cases, the AAP and CHA noted.
Children make up a much lower share of COVID-19 hospitalizations – 1.7% of the cumulative number for all ages – although that figure has been slowly rising over the course of the pandemic: it was 1.2% on July 9 and 0.9% on May 8. Arizona (4.1%) is the highest of the 22 states reporting age for hospitalizations and Hawaii (0.6%) is the lowest, based on the AAP/CHA data.
Mortality figures for children continue to be even lower. Nationwide, 0.07% of all COVID-19 deaths occurred in children, and 19 of the 43 states reporting age distributions have had no deaths yet. Pediatric deaths totaled 101 as of Aug. 27, the two groups reported.
First randomized trial reassures on ACEIs, ARBs in COVID-19
The first randomized study to compare continuing versus stopping ACE inhibitors or angiotensin receptor blockers (ARBs) for patients with COVID-19 has shown no difference in key outcomes between the two approaches.
The BRACE CORONA trial – conducted in patients had been taking an ACE inhibitor or an ARB on a long-term basis and who were subsequently hospitalized with COVID-19 – showed no difference in the primary endpoint of number of days alive and out of hospital among those whose medication was suspended for 30 days and those who continued undergoing treatment with these agents.
“Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalized patients with mild to moderate COVID-19, they should generally be continued for those with an indication,” principal investigator Renato Lopes, MD, of Duke Clinical Research Institute, Durham, N.C., concluded.
The BRACE CORONA trial was presented at the European Society of Cardiology Congress 2020 on Sept. 1.
Dr. Lopes explained that there are two conflicting hypotheses about the role of ACE inhibitors and ARBs in COVID-19.
One hypothesis suggests that use of these drugs could be harmful by increasing the expression of ACE2 receptors (which the SARS-CoV-2 virus uses to gain entry into cells), thus potentially enhancing viral binding and viral entry. The other suggests that ACE inhibitors and ARBs could be protective by reducing production of angiotensin II and enhancing the generation of angiotensin 1-7, which attenuates inflammation and fibrosis and therefore could attenuate lung injury.
The BRACE CORONA trial was an academic-led randomized study that tested two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days or continuing these drugs for patients who had been taking these medications on a long-term basis and were hospitalized with a confirmed diagnosis of COVID-19.
The primary outcome was the number of days alive and out of hospital at 30 days. Patients who were using more than three antihypertensive drugs or sacubitril/valsartan or who were hemodynamically unstable at presentation were excluded from the study.
The trial enrolled 659 patients from 29 sites in Brazil. The mean age of patients was 56 years, 40% were women, and 52% were obese. ACE inhibitors were being taken by 15% of the trial participants; ARBs were being taken by 85%. The median duration of ACE inhibitor/ARB treatment was 5 years.
Patients were a median of 6 days from COVID-19 symptom onset. For 30% of the patients, oxygen saturation was below 94% at entry. In terms of COVID-19 symptoms, 57% were classified as mild, and 43% as moderate.
Those with severe COVID-19 symptoms who needed intubation or vasoactive drugs were excluded. Antihypertensive therapy would generally be discontinued in these patients anyway, Dr. Lopes said.
Results showed that the average number of days alive and out of hospital was 21.9 days for patients who stopped taking ACE inhibitors/ARBs and 22.9 days for patients who continued taking these medications. The average difference between groups was –1.1 days.
The average ratio of days alive and out of hospital between the suspending and continuing groups was 0.95 (95% CI, 0.90-1.01; P = .09).
The proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group.
A similar 30-day mortality rate was seen for patients who continued and those who suspended ACE inhibitor/ARB therapy, at 2.8% and 2.7%, respectively (hazard ratio, 0.97). The median number of days that patients were alive and out of hospital was 25 in both groups.
Dr. Lopes said that there was no difference between the two groups with regard to many other secondary outcomes. These included COVID-19 disease progression (need for intubation, ventilation, need for vasoactive drugs, or imaging results) and cardiovascular endpoints (MI, stroke, thromboembolic events, worsening heart failure, myocarditis, or hypertensive crisis).
“Our results endorse with reliable and more definitive data what most medical and cardiovascular societies are recommending – that patients do not stop ACE inhibitor or ARB medication. This has been based on observational data so far, but BRACE CORONA now provides randomized data to support this recommendation,” Dr. Lopes concluded.
Dr. Lopes noted that several subgroups had been prespecified for analysis. Factors included age, obesity, difference between ACE inhibitors/ARBs, difference in oxygen saturation at presentation, time since COVID-19 symptom onset, degree of lung involvement on CT, and symptom severity on presentation.
“We saw very consistent effects of our main findings across all these subgroups, and we plan to report more details of these in the near future,” he said.
Protective for older patients?
The discussant of the study at the ESC Hotline session, Gianfranco Parati, MD, University of Milan-Bicocca and San Luca Hospital, Milan, congratulated Lopes and his team for conducting this important trial at such a difficult time.
He pointed out that patients in the BRACE CORONA trial were quite young (average age, 56 years) and that observational data so far suggest that ACE inhibitors and ARBs have a stronger protective effect in older COVID-19 patients.
He also noted that the percentage of patients alive and out of hospital at 30 days was higher for the patients who continued on treatment in this study (95% vs. 91.8%), which suggested an advantage in maintaining the medication.
Dr. Lopes replied that one-quarter of the population in the BRACE CORONA trial was older than 65 years, which he said was a “reasonable number.”
“Subgroup analysis by age did not show a significant interaction, but the effect of continuing treatment does seem to be more favorable in older patients and also in those who were sicker and had more comorbidities,” he added.
Dr. Parati also suggested that it would have been difficult to discern differences between ACE inhibitors and ARBs in the BRACE CORONA trial, because so few patents were taking ACE inhibitors; the follow-up period of 30 days was relatively short, inasmuch as these drugs may have long-term effects; and it would have been difficult to show differences in the main outcomes used in the study – mortality and time out of hospital – in these patients with mild to moderate disease.
Franz H. Messerli, MD, and Christoph Gräni, MD, University of Bern (Switzerland), said in a joint statement: “The BRACE CORONA trial provides answers to what we know from retrospective studies: if you have already COVID, don’t stop renin-angiotensin system blocker medication.”
But they added that the study does not answer the question about the risk/benefit of ACE inhibitors or ARBs with regard to possible enhanced viral entry through the ACE2 receptor. “What about all those on these drugs who are not infected with COVID? Do they need to stop them? We simply don’t know yet,” they said.
Dr. Messerli and Dr. Gräni added that they would like to see a study that compared patients before SARS-CoV-2 infection who were without hypertension, patients with hypertension who were taking ACE inhibitors or ARBs, and patients with hypertension taking other antihypertensive drugs.
The BRACE CORONA trial was sponsored by D’Or Institute for Research and Education and the Brazilian Clinical Research Institute. Dr. Lopes has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The first randomized study to compare continuing versus stopping ACE inhibitors or angiotensin receptor blockers (ARBs) for patients with COVID-19 has shown no difference in key outcomes between the two approaches.
The BRACE CORONA trial – conducted in patients had been taking an ACE inhibitor or an ARB on a long-term basis and who were subsequently hospitalized with COVID-19 – showed no difference in the primary endpoint of number of days alive and out of hospital among those whose medication was suspended for 30 days and those who continued undergoing treatment with these agents.
“Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalized patients with mild to moderate COVID-19, they should generally be continued for those with an indication,” principal investigator Renato Lopes, MD, of Duke Clinical Research Institute, Durham, N.C., concluded.
The BRACE CORONA trial was presented at the European Society of Cardiology Congress 2020 on Sept. 1.
Dr. Lopes explained that there are two conflicting hypotheses about the role of ACE inhibitors and ARBs in COVID-19.
One hypothesis suggests that use of these drugs could be harmful by increasing the expression of ACE2 receptors (which the SARS-CoV-2 virus uses to gain entry into cells), thus potentially enhancing viral binding and viral entry. The other suggests that ACE inhibitors and ARBs could be protective by reducing production of angiotensin II and enhancing the generation of angiotensin 1-7, which attenuates inflammation and fibrosis and therefore could attenuate lung injury.
The BRACE CORONA trial was an academic-led randomized study that tested two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days or continuing these drugs for patients who had been taking these medications on a long-term basis and were hospitalized with a confirmed diagnosis of COVID-19.
The primary outcome was the number of days alive and out of hospital at 30 days. Patients who were using more than three antihypertensive drugs or sacubitril/valsartan or who were hemodynamically unstable at presentation were excluded from the study.
The trial enrolled 659 patients from 29 sites in Brazil. The mean age of patients was 56 years, 40% were women, and 52% were obese. ACE inhibitors were being taken by 15% of the trial participants; ARBs were being taken by 85%. The median duration of ACE inhibitor/ARB treatment was 5 years.
Patients were a median of 6 days from COVID-19 symptom onset. For 30% of the patients, oxygen saturation was below 94% at entry. In terms of COVID-19 symptoms, 57% were classified as mild, and 43% as moderate.
Those with severe COVID-19 symptoms who needed intubation or vasoactive drugs were excluded. Antihypertensive therapy would generally be discontinued in these patients anyway, Dr. Lopes said.
Results showed that the average number of days alive and out of hospital was 21.9 days for patients who stopped taking ACE inhibitors/ARBs and 22.9 days for patients who continued taking these medications. The average difference between groups was –1.1 days.
The average ratio of days alive and out of hospital between the suspending and continuing groups was 0.95 (95% CI, 0.90-1.01; P = .09).
The proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group.
A similar 30-day mortality rate was seen for patients who continued and those who suspended ACE inhibitor/ARB therapy, at 2.8% and 2.7%, respectively (hazard ratio, 0.97). The median number of days that patients were alive and out of hospital was 25 in both groups.
Dr. Lopes said that there was no difference between the two groups with regard to many other secondary outcomes. These included COVID-19 disease progression (need for intubation, ventilation, need for vasoactive drugs, or imaging results) and cardiovascular endpoints (MI, stroke, thromboembolic events, worsening heart failure, myocarditis, or hypertensive crisis).
“Our results endorse with reliable and more definitive data what most medical and cardiovascular societies are recommending – that patients do not stop ACE inhibitor or ARB medication. This has been based on observational data so far, but BRACE CORONA now provides randomized data to support this recommendation,” Dr. Lopes concluded.
Dr. Lopes noted that several subgroups had been prespecified for analysis. Factors included age, obesity, difference between ACE inhibitors/ARBs, difference in oxygen saturation at presentation, time since COVID-19 symptom onset, degree of lung involvement on CT, and symptom severity on presentation.
“We saw very consistent effects of our main findings across all these subgroups, and we plan to report more details of these in the near future,” he said.
Protective for older patients?
The discussant of the study at the ESC Hotline session, Gianfranco Parati, MD, University of Milan-Bicocca and San Luca Hospital, Milan, congratulated Lopes and his team for conducting this important trial at such a difficult time.
He pointed out that patients in the BRACE CORONA trial were quite young (average age, 56 years) and that observational data so far suggest that ACE inhibitors and ARBs have a stronger protective effect in older COVID-19 patients.
He also noted that the percentage of patients alive and out of hospital at 30 days was higher for the patients who continued on treatment in this study (95% vs. 91.8%), which suggested an advantage in maintaining the medication.
Dr. Lopes replied that one-quarter of the population in the BRACE CORONA trial was older than 65 years, which he said was a “reasonable number.”
“Subgroup analysis by age did not show a significant interaction, but the effect of continuing treatment does seem to be more favorable in older patients and also in those who were sicker and had more comorbidities,” he added.
Dr. Parati also suggested that it would have been difficult to discern differences between ACE inhibitors and ARBs in the BRACE CORONA trial, because so few patents were taking ACE inhibitors; the follow-up period of 30 days was relatively short, inasmuch as these drugs may have long-term effects; and it would have been difficult to show differences in the main outcomes used in the study – mortality and time out of hospital – in these patients with mild to moderate disease.
Franz H. Messerli, MD, and Christoph Gräni, MD, University of Bern (Switzerland), said in a joint statement: “The BRACE CORONA trial provides answers to what we know from retrospective studies: if you have already COVID, don’t stop renin-angiotensin system blocker medication.”
But they added that the study does not answer the question about the risk/benefit of ACE inhibitors or ARBs with regard to possible enhanced viral entry through the ACE2 receptor. “What about all those on these drugs who are not infected with COVID? Do they need to stop them? We simply don’t know yet,” they said.
Dr. Messerli and Dr. Gräni added that they would like to see a study that compared patients before SARS-CoV-2 infection who were without hypertension, patients with hypertension who were taking ACE inhibitors or ARBs, and patients with hypertension taking other antihypertensive drugs.
The BRACE CORONA trial was sponsored by D’Or Institute for Research and Education and the Brazilian Clinical Research Institute. Dr. Lopes has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The first randomized study to compare continuing versus stopping ACE inhibitors or angiotensin receptor blockers (ARBs) for patients with COVID-19 has shown no difference in key outcomes between the two approaches.
The BRACE CORONA trial – conducted in patients had been taking an ACE inhibitor or an ARB on a long-term basis and who were subsequently hospitalized with COVID-19 – showed no difference in the primary endpoint of number of days alive and out of hospital among those whose medication was suspended for 30 days and those who continued undergoing treatment with these agents.
“Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalized patients with mild to moderate COVID-19, they should generally be continued for those with an indication,” principal investigator Renato Lopes, MD, of Duke Clinical Research Institute, Durham, N.C., concluded.
The BRACE CORONA trial was presented at the European Society of Cardiology Congress 2020 on Sept. 1.
Dr. Lopes explained that there are two conflicting hypotheses about the role of ACE inhibitors and ARBs in COVID-19.
One hypothesis suggests that use of these drugs could be harmful by increasing the expression of ACE2 receptors (which the SARS-CoV-2 virus uses to gain entry into cells), thus potentially enhancing viral binding and viral entry. The other suggests that ACE inhibitors and ARBs could be protective by reducing production of angiotensin II and enhancing the generation of angiotensin 1-7, which attenuates inflammation and fibrosis and therefore could attenuate lung injury.
The BRACE CORONA trial was an academic-led randomized study that tested two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days or continuing these drugs for patients who had been taking these medications on a long-term basis and were hospitalized with a confirmed diagnosis of COVID-19.
The primary outcome was the number of days alive and out of hospital at 30 days. Patients who were using more than three antihypertensive drugs or sacubitril/valsartan or who were hemodynamically unstable at presentation were excluded from the study.
The trial enrolled 659 patients from 29 sites in Brazil. The mean age of patients was 56 years, 40% were women, and 52% were obese. ACE inhibitors were being taken by 15% of the trial participants; ARBs were being taken by 85%. The median duration of ACE inhibitor/ARB treatment was 5 years.
Patients were a median of 6 days from COVID-19 symptom onset. For 30% of the patients, oxygen saturation was below 94% at entry. In terms of COVID-19 symptoms, 57% were classified as mild, and 43% as moderate.
Those with severe COVID-19 symptoms who needed intubation or vasoactive drugs were excluded. Antihypertensive therapy would generally be discontinued in these patients anyway, Dr. Lopes said.
Results showed that the average number of days alive and out of hospital was 21.9 days for patients who stopped taking ACE inhibitors/ARBs and 22.9 days for patients who continued taking these medications. The average difference between groups was –1.1 days.
The average ratio of days alive and out of hospital between the suspending and continuing groups was 0.95 (95% CI, 0.90-1.01; P = .09).
The proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group.
A similar 30-day mortality rate was seen for patients who continued and those who suspended ACE inhibitor/ARB therapy, at 2.8% and 2.7%, respectively (hazard ratio, 0.97). The median number of days that patients were alive and out of hospital was 25 in both groups.
Dr. Lopes said that there was no difference between the two groups with regard to many other secondary outcomes. These included COVID-19 disease progression (need for intubation, ventilation, need for vasoactive drugs, or imaging results) and cardiovascular endpoints (MI, stroke, thromboembolic events, worsening heart failure, myocarditis, or hypertensive crisis).
“Our results endorse with reliable and more definitive data what most medical and cardiovascular societies are recommending – that patients do not stop ACE inhibitor or ARB medication. This has been based on observational data so far, but BRACE CORONA now provides randomized data to support this recommendation,” Dr. Lopes concluded.
Dr. Lopes noted that several subgroups had been prespecified for analysis. Factors included age, obesity, difference between ACE inhibitors/ARBs, difference in oxygen saturation at presentation, time since COVID-19 symptom onset, degree of lung involvement on CT, and symptom severity on presentation.
“We saw very consistent effects of our main findings across all these subgroups, and we plan to report more details of these in the near future,” he said.
Protective for older patients?
The discussant of the study at the ESC Hotline session, Gianfranco Parati, MD, University of Milan-Bicocca and San Luca Hospital, Milan, congratulated Lopes and his team for conducting this important trial at such a difficult time.
He pointed out that patients in the BRACE CORONA trial were quite young (average age, 56 years) and that observational data so far suggest that ACE inhibitors and ARBs have a stronger protective effect in older COVID-19 patients.
He also noted that the percentage of patients alive and out of hospital at 30 days was higher for the patients who continued on treatment in this study (95% vs. 91.8%), which suggested an advantage in maintaining the medication.
Dr. Lopes replied that one-quarter of the population in the BRACE CORONA trial was older than 65 years, which he said was a “reasonable number.”
“Subgroup analysis by age did not show a significant interaction, but the effect of continuing treatment does seem to be more favorable in older patients and also in those who were sicker and had more comorbidities,” he added.
Dr. Parati also suggested that it would have been difficult to discern differences between ACE inhibitors and ARBs in the BRACE CORONA trial, because so few patents were taking ACE inhibitors; the follow-up period of 30 days was relatively short, inasmuch as these drugs may have long-term effects; and it would have been difficult to show differences in the main outcomes used in the study – mortality and time out of hospital – in these patients with mild to moderate disease.
Franz H. Messerli, MD, and Christoph Gräni, MD, University of Bern (Switzerland), said in a joint statement: “The BRACE CORONA trial provides answers to what we know from retrospective studies: if you have already COVID, don’t stop renin-angiotensin system blocker medication.”
But they added that the study does not answer the question about the risk/benefit of ACE inhibitors or ARBs with regard to possible enhanced viral entry through the ACE2 receptor. “What about all those on these drugs who are not infected with COVID? Do they need to stop them? We simply don’t know yet,” they said.
Dr. Messerli and Dr. Gräni added that they would like to see a study that compared patients before SARS-CoV-2 infection who were without hypertension, patients with hypertension who were taking ACE inhibitors or ARBs, and patients with hypertension taking other antihypertensive drugs.
The BRACE CORONA trial was sponsored by D’Or Institute for Research and Education and the Brazilian Clinical Research Institute. Dr. Lopes has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
COVID-19: In-hospital mortality data miss bigger picture of racial inequality
A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.
During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.
While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”
According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.
“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”
Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”
“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.
According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.
“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.
Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.
For each, Dr. Gray encouraged comprehensive and nuanced assessment.
“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”
Dr. Gray said that such obstacles are not outside the scope of the medical community.
“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.
When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.
First, he suggested that clinicians and researchers listen to affected patient populations.
“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.
Second, Dr. Gray encouraged those who have learned to teach others.
“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”
Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.
“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”
Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.
“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”
The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.
During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.
While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”
According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.
“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”
Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”
“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.
According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.
“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.
Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.
For each, Dr. Gray encouraged comprehensive and nuanced assessment.
“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”
Dr. Gray said that such obstacles are not outside the scope of the medical community.
“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.
When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.
First, he suggested that clinicians and researchers listen to affected patient populations.
“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.
Second, Dr. Gray encouraged those who have learned to teach others.
“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”
Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.
“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”
Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.
“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”
The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.
During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.
While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”
According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.
“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”
Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”
“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.
According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.
“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.
Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.
For each, Dr. Gray encouraged comprehensive and nuanced assessment.
“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”
Dr. Gray said that such obstacles are not outside the scope of the medical community.
“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.
When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.
First, he suggested that clinicians and researchers listen to affected patient populations.
“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.
Second, Dr. Gray encouraged those who have learned to teach others.
“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”
Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.
“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”
Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.
“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”
The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
FROM THE AGA FORWARD PROGRAM
Molecular developments in treatment of UPSC
Uterine papillary serous carcinoma (UPSC) is an infrequent but deadly form of endometrial cancer comprising 10% of cases but contributing 40% of deaths from the disease. Recurrence rates are high for this disease. Five-year survival is 55% for all patients and only 70% for stage I disease.1 Patterns of recurrence tend to be distant (extrapelvic and extraabdominal) as frequently as they are localized to the pelvis, and metastases and recurrences are unrelated to the extent of uterine disease (such as myometrial invasion). It is for these reasons that the recommended course of adjuvant therapy for this disease is systemic therapy (typically six doses of carboplatin and paclitaxel chemotherapy) with consideration for radiation to the vagina or pelvis to consolidate pelvic and vaginal control.2 This differs from early-stage high/intermediate–risk endometrioid adenocarcinomas, for which adjuvant chemotherapy has not been found to be helpful.
Because of the lower incidence of UPSC, it frequently has been studied alongside endometrioid cell types in clinical trials which explore novel adjuvant therapies. However, UPSC is biologically distinct from endometrioid endometrial cancers, which likely results in inferior clinical responses to conventional interventions. Fortunately we are beginning to better understand UPSC at a molecular level, and advancements are being made in the targeted therapies for these patients that are unique, compared with those applied to other cancer subtypes.
As discussed above, UPSC is a particularly aggressive form of uterine cancer. Histologically it is characterized by a precursor lesion of endometrial glandular dysplasia progressing to endometrial intraepithelial neoplasia (EIC). Histologically it presents with a highly atypical slit-like glandular configuration, which appears similar to serous carcinomas of the fallopian tube and ovary. Molecularly these tumors commonly manifest mutations in tumor protein p53 (TP53) and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), which are both genes associated with oncogenic potential.1 While most UPSC tumors have loss of expression in hormone receptors such as estrogen and progesterone, 25%-30% of cases overexpress the tyrosine kinase receptor human epidermal growth factor receptor 2 (HER2).3-5 This has proven to provide an exciting target for therapeutic interventions.
A target for therapeutic intervention
HER2 is a transmembrane receptor which, when activated, signals complex downstream pathways responsible for cellular proliferation, dedifferentiation, and metastasis. In a recent multi-institutional analysis of early-stage UPSC, HER2 overexpression was identified among 25% of cases.4 Approximately 30% of cases of advanced disease manifest overexpression of this biomarker.5 HER2 overexpression (HER2-positive status) is significantly associated with higher rates of recurrence and mortality, even among patients treated with conventional therapies.3 Thus HER2-positive status is obviously an indicator of particularly aggressive disease.
Fortunately this particular biomarker is one for which we have established and developing therapeutics. The humanized monoclonal antibody, trastuzumab, has been highly effective in improving survival for HER2-positive breast cancer.6 More recently, it was studied in a phase 2 trial with carboplatin and paclitaxel chemotherapy for advanced or recurrent HER2-positive UPSC.5 This trial showed that the addition of this targeted therapy to conventional chemotherapy improved recurrence-free survival from 8 months to 12 months, and improved overall survival from 24.4 months to 29.6 months.5
One discovery leads to another treatment
This discovery led to the approval of trastuzumab to be used in addition to chemotherapy for advanced or recurrent disease.2 The most significant effects appear to be among those who have not received prior therapies, with a doubling of progression-free survival among these patients, and a more modest response among patients treated for recurrent, mostly pretreated disease.
Work currently is underway to explore an array of antibody or small-molecule blockades of HER2 in addition to vaccines against the protein or treatment with conjugate compounds in which an antibody to HER2 is paired with a cytotoxic drug able to be internalized into HER2-expressing cells.7 This represents a form of personalized medicine referred to as biomarker-driven targeted therapy, in which therapies are prescribed based on the expression of specific molecular markers (such as HER2 expression) typically in combination with other clinical markers such as surgical staging results, race, age, etc. These approaches can be very effective strategies in rare tumor subtypes with distinct molecular and clinical behaviors.
As previously mentioned, the targeting of HER2 overexpression with trastuzumab has been shown to be highly effective in the treatment of HER2-positive breast cancers where even patients with early-stage disease receive a multimodal therapy approach including antibody, chemotherapy, surgical, and often radiation treatments.6 We are moving towards a similar multimodal comprehensive treatment strategy for UPSC. If it is as successful as it is in breast cancer, it will be long overdue, and desperately necessary given the poor prognosis of this disease for all stages because of the inadequacies of current treatments strategies.
Routine testing of UPSC for HER2 expression is now a part of routine molecular substaging of uterine cancers in the same way we have embraced testing for microsatellite instability and hormone-receptor status. While a diagnosis of HER2 overexpression in UPSC portends a poor prognosis, patients can be reassured that treatment strategies exist that can target this malignant mechanism in advanced disease and more are under further development for early-stage disease.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Curr Opin Obstet Gynecol. 2010 Feb. doi: 10.1097/GCO.0b013e328334d8a3.
2. National Comprehensive Cancer Network. Uterine Neoplasms (version 2.2020).
3. Cancer 2005 Oct 1. doi: 10.1002/cncr.21308.
4. Gynecol Oncol 2020 doi: 10.1016/j.ygyno.2020.07.016.
5. J Clin Oncol 2018. doi: 10.1200/JCO.2017.76.5966.
6. N Engl J Med 2011. doi: 10.1056/NEJMoa0910383.
7. Discov Med. 2016 Apr;21(116):293-303.
Uterine papillary serous carcinoma (UPSC) is an infrequent but deadly form of endometrial cancer comprising 10% of cases but contributing 40% of deaths from the disease. Recurrence rates are high for this disease. Five-year survival is 55% for all patients and only 70% for stage I disease.1 Patterns of recurrence tend to be distant (extrapelvic and extraabdominal) as frequently as they are localized to the pelvis, and metastases and recurrences are unrelated to the extent of uterine disease (such as myometrial invasion). It is for these reasons that the recommended course of adjuvant therapy for this disease is systemic therapy (typically six doses of carboplatin and paclitaxel chemotherapy) with consideration for radiation to the vagina or pelvis to consolidate pelvic and vaginal control.2 This differs from early-stage high/intermediate–risk endometrioid adenocarcinomas, for which adjuvant chemotherapy has not been found to be helpful.
Because of the lower incidence of UPSC, it frequently has been studied alongside endometrioid cell types in clinical trials which explore novel adjuvant therapies. However, UPSC is biologically distinct from endometrioid endometrial cancers, which likely results in inferior clinical responses to conventional interventions. Fortunately we are beginning to better understand UPSC at a molecular level, and advancements are being made in the targeted therapies for these patients that are unique, compared with those applied to other cancer subtypes.
As discussed above, UPSC is a particularly aggressive form of uterine cancer. Histologically it is characterized by a precursor lesion of endometrial glandular dysplasia progressing to endometrial intraepithelial neoplasia (EIC). Histologically it presents with a highly atypical slit-like glandular configuration, which appears similar to serous carcinomas of the fallopian tube and ovary. Molecularly these tumors commonly manifest mutations in tumor protein p53 (TP53) and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), which are both genes associated with oncogenic potential.1 While most UPSC tumors have loss of expression in hormone receptors such as estrogen and progesterone, 25%-30% of cases overexpress the tyrosine kinase receptor human epidermal growth factor receptor 2 (HER2).3-5 This has proven to provide an exciting target for therapeutic interventions.
A target for therapeutic intervention
HER2 is a transmembrane receptor which, when activated, signals complex downstream pathways responsible for cellular proliferation, dedifferentiation, and metastasis. In a recent multi-institutional analysis of early-stage UPSC, HER2 overexpression was identified among 25% of cases.4 Approximately 30% of cases of advanced disease manifest overexpression of this biomarker.5 HER2 overexpression (HER2-positive status) is significantly associated with higher rates of recurrence and mortality, even among patients treated with conventional therapies.3 Thus HER2-positive status is obviously an indicator of particularly aggressive disease.
Fortunately this particular biomarker is one for which we have established and developing therapeutics. The humanized monoclonal antibody, trastuzumab, has been highly effective in improving survival for HER2-positive breast cancer.6 More recently, it was studied in a phase 2 trial with carboplatin and paclitaxel chemotherapy for advanced or recurrent HER2-positive UPSC.5 This trial showed that the addition of this targeted therapy to conventional chemotherapy improved recurrence-free survival from 8 months to 12 months, and improved overall survival from 24.4 months to 29.6 months.5
One discovery leads to another treatment
This discovery led to the approval of trastuzumab to be used in addition to chemotherapy for advanced or recurrent disease.2 The most significant effects appear to be among those who have not received prior therapies, with a doubling of progression-free survival among these patients, and a more modest response among patients treated for recurrent, mostly pretreated disease.
Work currently is underway to explore an array of antibody or small-molecule blockades of HER2 in addition to vaccines against the protein or treatment with conjugate compounds in which an antibody to HER2 is paired with a cytotoxic drug able to be internalized into HER2-expressing cells.7 This represents a form of personalized medicine referred to as biomarker-driven targeted therapy, in which therapies are prescribed based on the expression of specific molecular markers (such as HER2 expression) typically in combination with other clinical markers such as surgical staging results, race, age, etc. These approaches can be very effective strategies in rare tumor subtypes with distinct molecular and clinical behaviors.
As previously mentioned, the targeting of HER2 overexpression with trastuzumab has been shown to be highly effective in the treatment of HER2-positive breast cancers where even patients with early-stage disease receive a multimodal therapy approach including antibody, chemotherapy, surgical, and often radiation treatments.6 We are moving towards a similar multimodal comprehensive treatment strategy for UPSC. If it is as successful as it is in breast cancer, it will be long overdue, and desperately necessary given the poor prognosis of this disease for all stages because of the inadequacies of current treatments strategies.
Routine testing of UPSC for HER2 expression is now a part of routine molecular substaging of uterine cancers in the same way we have embraced testing for microsatellite instability and hormone-receptor status. While a diagnosis of HER2 overexpression in UPSC portends a poor prognosis, patients can be reassured that treatment strategies exist that can target this malignant mechanism in advanced disease and more are under further development for early-stage disease.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Curr Opin Obstet Gynecol. 2010 Feb. doi: 10.1097/GCO.0b013e328334d8a3.
2. National Comprehensive Cancer Network. Uterine Neoplasms (version 2.2020).
3. Cancer 2005 Oct 1. doi: 10.1002/cncr.21308.
4. Gynecol Oncol 2020 doi: 10.1016/j.ygyno.2020.07.016.
5. J Clin Oncol 2018. doi: 10.1200/JCO.2017.76.5966.
6. N Engl J Med 2011. doi: 10.1056/NEJMoa0910383.
7. Discov Med. 2016 Apr;21(116):293-303.
Uterine papillary serous carcinoma (UPSC) is an infrequent but deadly form of endometrial cancer comprising 10% of cases but contributing 40% of deaths from the disease. Recurrence rates are high for this disease. Five-year survival is 55% for all patients and only 70% for stage I disease.1 Patterns of recurrence tend to be distant (extrapelvic and extraabdominal) as frequently as they are localized to the pelvis, and metastases and recurrences are unrelated to the extent of uterine disease (such as myometrial invasion). It is for these reasons that the recommended course of adjuvant therapy for this disease is systemic therapy (typically six doses of carboplatin and paclitaxel chemotherapy) with consideration for radiation to the vagina or pelvis to consolidate pelvic and vaginal control.2 This differs from early-stage high/intermediate–risk endometrioid adenocarcinomas, for which adjuvant chemotherapy has not been found to be helpful.
Because of the lower incidence of UPSC, it frequently has been studied alongside endometrioid cell types in clinical trials which explore novel adjuvant therapies. However, UPSC is biologically distinct from endometrioid endometrial cancers, which likely results in inferior clinical responses to conventional interventions. Fortunately we are beginning to better understand UPSC at a molecular level, and advancements are being made in the targeted therapies for these patients that are unique, compared with those applied to other cancer subtypes.
As discussed above, UPSC is a particularly aggressive form of uterine cancer. Histologically it is characterized by a precursor lesion of endometrial glandular dysplasia progressing to endometrial intraepithelial neoplasia (EIC). Histologically it presents with a highly atypical slit-like glandular configuration, which appears similar to serous carcinomas of the fallopian tube and ovary. Molecularly these tumors commonly manifest mutations in tumor protein p53 (TP53) and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), which are both genes associated with oncogenic potential.1 While most UPSC tumors have loss of expression in hormone receptors such as estrogen and progesterone, 25%-30% of cases overexpress the tyrosine kinase receptor human epidermal growth factor receptor 2 (HER2).3-5 This has proven to provide an exciting target for therapeutic interventions.
A target for therapeutic intervention
HER2 is a transmembrane receptor which, when activated, signals complex downstream pathways responsible for cellular proliferation, dedifferentiation, and metastasis. In a recent multi-institutional analysis of early-stage UPSC, HER2 overexpression was identified among 25% of cases.4 Approximately 30% of cases of advanced disease manifest overexpression of this biomarker.5 HER2 overexpression (HER2-positive status) is significantly associated with higher rates of recurrence and mortality, even among patients treated with conventional therapies.3 Thus HER2-positive status is obviously an indicator of particularly aggressive disease.
Fortunately this particular biomarker is one for which we have established and developing therapeutics. The humanized monoclonal antibody, trastuzumab, has been highly effective in improving survival for HER2-positive breast cancer.6 More recently, it was studied in a phase 2 trial with carboplatin and paclitaxel chemotherapy for advanced or recurrent HER2-positive UPSC.5 This trial showed that the addition of this targeted therapy to conventional chemotherapy improved recurrence-free survival from 8 months to 12 months, and improved overall survival from 24.4 months to 29.6 months.5
One discovery leads to another treatment
This discovery led to the approval of trastuzumab to be used in addition to chemotherapy for advanced or recurrent disease.2 The most significant effects appear to be among those who have not received prior therapies, with a doubling of progression-free survival among these patients, and a more modest response among patients treated for recurrent, mostly pretreated disease.
Work currently is underway to explore an array of antibody or small-molecule blockades of HER2 in addition to vaccines against the protein or treatment with conjugate compounds in which an antibody to HER2 is paired with a cytotoxic drug able to be internalized into HER2-expressing cells.7 This represents a form of personalized medicine referred to as biomarker-driven targeted therapy, in which therapies are prescribed based on the expression of specific molecular markers (such as HER2 expression) typically in combination with other clinical markers such as surgical staging results, race, age, etc. These approaches can be very effective strategies in rare tumor subtypes with distinct molecular and clinical behaviors.
As previously mentioned, the targeting of HER2 overexpression with trastuzumab has been shown to be highly effective in the treatment of HER2-positive breast cancers where even patients with early-stage disease receive a multimodal therapy approach including antibody, chemotherapy, surgical, and often radiation treatments.6 We are moving towards a similar multimodal comprehensive treatment strategy for UPSC. If it is as successful as it is in breast cancer, it will be long overdue, and desperately necessary given the poor prognosis of this disease for all stages because of the inadequacies of current treatments strategies.
Routine testing of UPSC for HER2 expression is now a part of routine molecular substaging of uterine cancers in the same way we have embraced testing for microsatellite instability and hormone-receptor status. While a diagnosis of HER2 overexpression in UPSC portends a poor prognosis, patients can be reassured that treatment strategies exist that can target this malignant mechanism in advanced disease and more are under further development for early-stage disease.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Curr Opin Obstet Gynecol. 2010 Feb. doi: 10.1097/GCO.0b013e328334d8a3.
2. National Comprehensive Cancer Network. Uterine Neoplasms (version 2.2020).
3. Cancer 2005 Oct 1. doi: 10.1002/cncr.21308.
4. Gynecol Oncol 2020 doi: 10.1016/j.ygyno.2020.07.016.
5. J Clin Oncol 2018. doi: 10.1200/JCO.2017.76.5966.
6. N Engl J Med 2011. doi: 10.1056/NEJMoa0910383.
7. Discov Med. 2016 Apr;21(116):293-303.
Three malpractice risks of video visits
During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.
The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.
The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.
“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.
According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology.
“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
Three problems in not being able to touch the patient
1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.
said Dr. Einbinder, a practicing internist.
Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.
Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.
“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.”
2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.
“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”
Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.
“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”
3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.
“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.
A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.
Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.
“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
Waivers may be weak protection
Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.
Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.
“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”
Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.
In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.
But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.
“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.
In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.
But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.
“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules.
“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
How you can avoid a lawsuit
As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.
“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”
Data should be at the center of that conclusion, Dr. Kvedar advises.
“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”
An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.
For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed.
“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.”
Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.
“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”
Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.
“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.
Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:
- Names and credentials of staff participating.
- The right to stop or refuse treatment by telemedicine.
- Technology that will be used.
- Privacy and security risks.
- Technology-specific risks and permission to bill.
- Alternative care in case of an emergency or technology malfunction.
- Any state-specific requirements.
“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
Consider these extra precautions
Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.
“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”
Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end.
“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”
Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said.
“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.”
A version of this article originally appeared on Medscape.com.
During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.
The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.
The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.
“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.
According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology.
“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
Three problems in not being able to touch the patient
1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.
said Dr. Einbinder, a practicing internist.
Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.
Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.
“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.”
2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.
“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”
Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.
“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”
3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.
“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.
A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.
Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.
“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
Waivers may be weak protection
Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.
Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.
“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”
Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.
In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.
But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.
“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.
In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.
But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.
“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules.
“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
How you can avoid a lawsuit
As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.
“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”
Data should be at the center of that conclusion, Dr. Kvedar advises.
“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”
An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.
For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed.
“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.”
Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.
“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”
Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.
“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.
Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:
- Names and credentials of staff participating.
- The right to stop or refuse treatment by telemedicine.
- Technology that will be used.
- Privacy and security risks.
- Technology-specific risks and permission to bill.
- Alternative care in case of an emergency or technology malfunction.
- Any state-specific requirements.
“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
Consider these extra precautions
Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.
“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”
Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end.
“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”
Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said.
“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.”
A version of this article originally appeared on Medscape.com.
During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.
The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.
The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.
“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.
According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology.
“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
Three problems in not being able to touch the patient
1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.
said Dr. Einbinder, a practicing internist.
Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.
Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.
“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.”
2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.
“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”
Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.
“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”
3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.
“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.
A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.
Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.
“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
Waivers may be weak protection
Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.
Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.
“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”
Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.
In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.
But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.
“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.
In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.
But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.
“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules.
“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
How you can avoid a lawsuit
As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.
“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”
Data should be at the center of that conclusion, Dr. Kvedar advises.
“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”
An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.
For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed.
“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.”
Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.
“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”
Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.
“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.
Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:
- Names and credentials of staff participating.
- The right to stop or refuse treatment by telemedicine.
- Technology that will be used.
- Privacy and security risks.
- Technology-specific risks and permission to bill.
- Alternative care in case of an emergency or technology malfunction.
- Any state-specific requirements.
“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
Consider these extra precautions
Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.
“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”
Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end.
“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”
Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said.
“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.”
A version of this article originally appeared on Medscape.com.
The long road to a PsA prevention trial
About one-third of all patients with psoriasis will develop psoriatic arthritis (PsA), a condition that comes with a host of vague symptoms and no definitive blood test for diagnosis. Prevention trials could help to identify higher-risk groups for PsA, with a goal to catch disease early and improve outcomes. The challenge is finding enough participants in a disease that lacks a clear clinical profile, then tracking them for long periods of time to generate any significant data.
Researchers have been taking several approaches to improve outcomes in PsA, Christopher Ritchlin, MD, MPH, chief of the allergy/immunology and rheumatology division at the University of Rochester (N.Y.), said in an interview. “We are in the process of identifying biomarkers and imaging findings that characterize psoriasis patients at high risk to develop PsA.”
The next step would be to design an interventional trial to treat high-risk patients before they develop musculoskeletal inflammation, with a goal to delay onset, attenuate severity, or completely prevent arthritis. The issue now is “we don’t know which agents would be most effective in this prevention effort,” Dr. Ritchlin said. Biologics that target specific pathways significant in PsA pathogenesis are an appealing prospect. However, “it may be that alternative therapies such as methotrexate or ultraviolet A radiation therapy, for example, may help arrest the development of joint inflammation.”
Underdiagnosis impedes research
Several factors may undermine this important research.
For one, psoriasis patients are often unaware that they have PsA. “Many times they are diagnosed incorrectly by nonspecialists. As a consequence, they do not get access to appropriate medications,” said Lihi Eder, MD, PhD, staff rheumatologist and director of the psoriatic arthritis research program at the University of Toronto’s Women’s College Research Institute.
The condition also lacks a good diagnostic tool, Dr. Eder said. There’s no blood test that identifies this condition in the same manner as RA and lupus, for example. For these conditions, a general practitioner such as a family physician may conduct a blood test, and if positive, refer them to a rheumatologist. Such a system doesn’t exist for PsA. “Instead, nonspecialists are ordering tests and when they’re negative, they assume wrongly that these patients don’t have a rheumatic condition,” she explained.
Many clinicians aren’t that well versed in PsA, although dermatology has taken steps to become better educated. As a result, more dermatologists are referring patients to rheumatologists for PsA. Despite this small step forward, the heterogeneous clinical presentation of this condition makes diagnosis especially difficult. Unlike RA, which presents with inflammation in the joints, PsA can present as back or joint pain, “which makes our life as rheumatologists much more complex,” Dr. Eder said.
Defining a risk group
Most experts agree that the presence of psoriasis isn’t sufficient to conduct a prevention trial. Ideally, the goal of a prevention study would be to identify a critical subgroup of psoriasis patients at high risk of developing PsA.
However, this presents a challenging task, Dr. Eder said. Psoriasis is a risk factor for PsA, but most patients with psoriasis won’t actually develop it. Given that there’s an incidence rate of 2.7% a year, “you would need to recruit many hundreds of psoriasis patients and follow them for a long period of time until you have enough events.”
Moving forward with prevention studies calls for a better definition of the PsA risk group, according to Georg Schett, MD, chair of internal medicine in the department of internal medicine, rheumatology, and immunology at Friedrich‐Alexander University, Erlangen, Germany. “That’s very important, because you need to define such a group to make a prevention trial feasible. The whole benefit of such an approach is to catch the disease early, to say that psoriasis is a biomarker that’s linked to psoriatic arthritis.”
Indicators of risk other than psoriasis, such as pain, inflammation seen in ultrasound or MRI, and other specificities of psoriasis, could be used to define a population where interception can take place, Dr. Schett added. Although it’s not always clinically recognized, the combination of pain and structural lesions can be an indicator for developing PsA.
One prospective study he and his colleagues conducted in 114 psoriasis patients cited structural entheseal lesions and low cortical volumetric bone mineral density as risk factors in developing PsA. Keeping these factors in mind, Dr. Schett expects to see more studies in biointervention in these populations, “with the idea to prevent the onset of PsA and also decrease pain and subcutaneous inflammation.”
Researchers are currently working to identify those high-risk patients to include in an interventional trial, Dr. Ritchlin said.
That said, there’s been a great deal of “clinical trial angst” among investigators, Dr. Ritchlin noted. Outcomes in clinical trials for a wide range of biologic agents have not demonstrated significant advances in outcomes, compared with initial studies with anti–tumor necrosis factor–alpha (TNF-alpha) agents 20 years ago.
Combination biologics
One approach that’s generated some interest is the use of combination biologics medications. Sequential inhibition of cytokines such as interleukin-17A and TNF-alpha is of interest given their central contribution in joint inflammation and damage. “The challenge here of course is toxicity,” Dr. Ritchlin said. Trials that combined blockade of IL-1 and TNF-alpha in a RA trial years ago resulted in significant adverse events without improving outcomes.
Comparatively, a recent study in The Lancet Rheumatology reported success in using the IL-17A inhibitor secukinumab (Cosentyx) to reduce PsA symptoms. Tested on patients in the FUTURE 2 trial, investigators demonstrated that secukinumab in 300- and 150-mg doses safely reduced PsA signs and symptoms over a period of 5 years. Secukinumab also outperformed the TNF-alpha inhibitor adalimumab in 853 PsA patients in the 52-week, randomized, head-to-head, phase 3b EXCEED study, which was recently reported in The Lancet. Articular outcomes were similar between the two therapies, yet the secukinumab group did markedly better in Psoriasis Area and Severity Index scores, compared with the adalimumab group.
Based on these findings, “I suspect that studies examining the efficacy of combination biologics for treatment of PsA will surface in the near future,” Dr. Ritchlin said.
Yet another approach encompasses the spirit of personalized medicine. Clinicians often treat PsA patients empirically because they lack biomarkers that indicate which drug may be most effective for an individual patient, Dr. Ritchlin said. However, the technologies for investigating specific cell subsets in both the blood and tissues have advanced greatly over the last decade. “I am confident that a more precision medicine–based approach to the diagnosis and treatment of PsA is on the near horizon.”
Diet as an intervention
Other research has looked at the strong link between metabolic abnormalities and psoriasis and PsA. Some diets, such as the Mediterranean diet, show promise in improving the metabolic profile of these patients, making it a candidate as a potential intervention to reduce PsA risk. Another strategy would be to focus on limiting calories and promoting weight reduction.
One study in the British Journal of Dermatology looked at the associations between PsA and smoking, alcohol, and body mass index, identifying obesity as an important risk factor. Analyzing more than 90,000 psoriasis cases from the U.K. Clinical Practice Research Datalink between 1998 and 2014, researchers identified 1,409 PsA diagnoses. Among this cohort, researchers found an association between PsA and increased body mass index and moderate drinking. This finding underscores the need to support weight-reduction programs to reduce risk, Dr. Eder and Alexis Ogdie, MD, of the University of Pennsylvania, Philadelphia, wrote in a related editorial.
While observational studies such as this one provide further guidance for interventional trials, confounders can affect results. “Patients who lost weight could have made a positive lifestyle change (e.g., a dietary change) that was associated with the decreased risk for PsA rather than weight loss specifically, or they could have lost weight for unhealthy reasons,” Dr. Eder and Dr. Ogdie explained. Future research could address whether weight loss or other interventional factors may reduce PsA progression.
To make this work, “we would need to select patients that would benefit from diet. Secondly, we’d need to identify what kind of diet would be good for preventing PsA. And we don’t know that yet,” Dr. Eder further elaborated.
As with any prevention trial, the challenge is to follow patients over a long period of time, making sure they comply with the restrictions of the prescribed diet, Dr. Eder noted. “I do think it’s a really exciting type of intervention because it’s something that people are very interested in. There’s little risk of side effects, and it’s not very expensive.”
In other research on weight-loss methods, an observational study from Denmark found that bariatric surgery, especially gastric bypass, reduced the risk of developing PsA. This suggests that weight reduction by itself is important, “although we don’t know that yet,” Dr. Eder said.
A risk model for PsA
Dr. Eder and colleagues have been working on an algorithm that will incorporate clinical information (for example, the presence of nail lesions and the severity of psoriasis) to provide an estimated risk of developing PsA over the next 5 years. Subsequently, this information could be used to identify high-risk psoriasis patients as candidates for a prevention trial.
Other groups are looking at laboratory or imaging biomarkers to help develop PsA prediction models, she said. “Once we have these tools, we can move to next steps of prevention trials. What kinds of interventions should we apply? Are we talking biologic medications or other lifestyle interventions like diet? We are still at the early stages. However, with an improved understanding of the underlying mechanisms and risk factors we are expected to see prevention trials for PsA in the future.”
About one-third of all patients with psoriasis will develop psoriatic arthritis (PsA), a condition that comes with a host of vague symptoms and no definitive blood test for diagnosis. Prevention trials could help to identify higher-risk groups for PsA, with a goal to catch disease early and improve outcomes. The challenge is finding enough participants in a disease that lacks a clear clinical profile, then tracking them for long periods of time to generate any significant data.
Researchers have been taking several approaches to improve outcomes in PsA, Christopher Ritchlin, MD, MPH, chief of the allergy/immunology and rheumatology division at the University of Rochester (N.Y.), said in an interview. “We are in the process of identifying biomarkers and imaging findings that characterize psoriasis patients at high risk to develop PsA.”
The next step would be to design an interventional trial to treat high-risk patients before they develop musculoskeletal inflammation, with a goal to delay onset, attenuate severity, or completely prevent arthritis. The issue now is “we don’t know which agents would be most effective in this prevention effort,” Dr. Ritchlin said. Biologics that target specific pathways significant in PsA pathogenesis are an appealing prospect. However, “it may be that alternative therapies such as methotrexate or ultraviolet A radiation therapy, for example, may help arrest the development of joint inflammation.”
Underdiagnosis impedes research
Several factors may undermine this important research.
For one, psoriasis patients are often unaware that they have PsA. “Many times they are diagnosed incorrectly by nonspecialists. As a consequence, they do not get access to appropriate medications,” said Lihi Eder, MD, PhD, staff rheumatologist and director of the psoriatic arthritis research program at the University of Toronto’s Women’s College Research Institute.
The condition also lacks a good diagnostic tool, Dr. Eder said. There’s no blood test that identifies this condition in the same manner as RA and lupus, for example. For these conditions, a general practitioner such as a family physician may conduct a blood test, and if positive, refer them to a rheumatologist. Such a system doesn’t exist for PsA. “Instead, nonspecialists are ordering tests and when they’re negative, they assume wrongly that these patients don’t have a rheumatic condition,” she explained.
Many clinicians aren’t that well versed in PsA, although dermatology has taken steps to become better educated. As a result, more dermatologists are referring patients to rheumatologists for PsA. Despite this small step forward, the heterogeneous clinical presentation of this condition makes diagnosis especially difficult. Unlike RA, which presents with inflammation in the joints, PsA can present as back or joint pain, “which makes our life as rheumatologists much more complex,” Dr. Eder said.
Defining a risk group
Most experts agree that the presence of psoriasis isn’t sufficient to conduct a prevention trial. Ideally, the goal of a prevention study would be to identify a critical subgroup of psoriasis patients at high risk of developing PsA.
However, this presents a challenging task, Dr. Eder said. Psoriasis is a risk factor for PsA, but most patients with psoriasis won’t actually develop it. Given that there’s an incidence rate of 2.7% a year, “you would need to recruit many hundreds of psoriasis patients and follow them for a long period of time until you have enough events.”
Moving forward with prevention studies calls for a better definition of the PsA risk group, according to Georg Schett, MD, chair of internal medicine in the department of internal medicine, rheumatology, and immunology at Friedrich‐Alexander University, Erlangen, Germany. “That’s very important, because you need to define such a group to make a prevention trial feasible. The whole benefit of such an approach is to catch the disease early, to say that psoriasis is a biomarker that’s linked to psoriatic arthritis.”
Indicators of risk other than psoriasis, such as pain, inflammation seen in ultrasound or MRI, and other specificities of psoriasis, could be used to define a population where interception can take place, Dr. Schett added. Although it’s not always clinically recognized, the combination of pain and structural lesions can be an indicator for developing PsA.
One prospective study he and his colleagues conducted in 114 psoriasis patients cited structural entheseal lesions and low cortical volumetric bone mineral density as risk factors in developing PsA. Keeping these factors in mind, Dr. Schett expects to see more studies in biointervention in these populations, “with the idea to prevent the onset of PsA and also decrease pain and subcutaneous inflammation.”
Researchers are currently working to identify those high-risk patients to include in an interventional trial, Dr. Ritchlin said.
That said, there’s been a great deal of “clinical trial angst” among investigators, Dr. Ritchlin noted. Outcomes in clinical trials for a wide range of biologic agents have not demonstrated significant advances in outcomes, compared with initial studies with anti–tumor necrosis factor–alpha (TNF-alpha) agents 20 years ago.
Combination biologics
One approach that’s generated some interest is the use of combination biologics medications. Sequential inhibition of cytokines such as interleukin-17A and TNF-alpha is of interest given their central contribution in joint inflammation and damage. “The challenge here of course is toxicity,” Dr. Ritchlin said. Trials that combined blockade of IL-1 and TNF-alpha in a RA trial years ago resulted in significant adverse events without improving outcomes.
Comparatively, a recent study in The Lancet Rheumatology reported success in using the IL-17A inhibitor secukinumab (Cosentyx) to reduce PsA symptoms. Tested on patients in the FUTURE 2 trial, investigators demonstrated that secukinumab in 300- and 150-mg doses safely reduced PsA signs and symptoms over a period of 5 years. Secukinumab also outperformed the TNF-alpha inhibitor adalimumab in 853 PsA patients in the 52-week, randomized, head-to-head, phase 3b EXCEED study, which was recently reported in The Lancet. Articular outcomes were similar between the two therapies, yet the secukinumab group did markedly better in Psoriasis Area and Severity Index scores, compared with the adalimumab group.
Based on these findings, “I suspect that studies examining the efficacy of combination biologics for treatment of PsA will surface in the near future,” Dr. Ritchlin said.
Yet another approach encompasses the spirit of personalized medicine. Clinicians often treat PsA patients empirically because they lack biomarkers that indicate which drug may be most effective for an individual patient, Dr. Ritchlin said. However, the technologies for investigating specific cell subsets in both the blood and tissues have advanced greatly over the last decade. “I am confident that a more precision medicine–based approach to the diagnosis and treatment of PsA is on the near horizon.”
Diet as an intervention
Other research has looked at the strong link between metabolic abnormalities and psoriasis and PsA. Some diets, such as the Mediterranean diet, show promise in improving the metabolic profile of these patients, making it a candidate as a potential intervention to reduce PsA risk. Another strategy would be to focus on limiting calories and promoting weight reduction.
One study in the British Journal of Dermatology looked at the associations between PsA and smoking, alcohol, and body mass index, identifying obesity as an important risk factor. Analyzing more than 90,000 psoriasis cases from the U.K. Clinical Practice Research Datalink between 1998 and 2014, researchers identified 1,409 PsA diagnoses. Among this cohort, researchers found an association between PsA and increased body mass index and moderate drinking. This finding underscores the need to support weight-reduction programs to reduce risk, Dr. Eder and Alexis Ogdie, MD, of the University of Pennsylvania, Philadelphia, wrote in a related editorial.
While observational studies such as this one provide further guidance for interventional trials, confounders can affect results. “Patients who lost weight could have made a positive lifestyle change (e.g., a dietary change) that was associated with the decreased risk for PsA rather than weight loss specifically, or they could have lost weight for unhealthy reasons,” Dr. Eder and Dr. Ogdie explained. Future research could address whether weight loss or other interventional factors may reduce PsA progression.
To make this work, “we would need to select patients that would benefit from diet. Secondly, we’d need to identify what kind of diet would be good for preventing PsA. And we don’t know that yet,” Dr. Eder further elaborated.
As with any prevention trial, the challenge is to follow patients over a long period of time, making sure they comply with the restrictions of the prescribed diet, Dr. Eder noted. “I do think it’s a really exciting type of intervention because it’s something that people are very interested in. There’s little risk of side effects, and it’s not very expensive.”
In other research on weight-loss methods, an observational study from Denmark found that bariatric surgery, especially gastric bypass, reduced the risk of developing PsA. This suggests that weight reduction by itself is important, “although we don’t know that yet,” Dr. Eder said.
A risk model for PsA
Dr. Eder and colleagues have been working on an algorithm that will incorporate clinical information (for example, the presence of nail lesions and the severity of psoriasis) to provide an estimated risk of developing PsA over the next 5 years. Subsequently, this information could be used to identify high-risk psoriasis patients as candidates for a prevention trial.
Other groups are looking at laboratory or imaging biomarkers to help develop PsA prediction models, she said. “Once we have these tools, we can move to next steps of prevention trials. What kinds of interventions should we apply? Are we talking biologic medications or other lifestyle interventions like diet? We are still at the early stages. However, with an improved understanding of the underlying mechanisms and risk factors we are expected to see prevention trials for PsA in the future.”
About one-third of all patients with psoriasis will develop psoriatic arthritis (PsA), a condition that comes with a host of vague symptoms and no definitive blood test for diagnosis. Prevention trials could help to identify higher-risk groups for PsA, with a goal to catch disease early and improve outcomes. The challenge is finding enough participants in a disease that lacks a clear clinical profile, then tracking them for long periods of time to generate any significant data.
Researchers have been taking several approaches to improve outcomes in PsA, Christopher Ritchlin, MD, MPH, chief of the allergy/immunology and rheumatology division at the University of Rochester (N.Y.), said in an interview. “We are in the process of identifying biomarkers and imaging findings that characterize psoriasis patients at high risk to develop PsA.”
The next step would be to design an interventional trial to treat high-risk patients before they develop musculoskeletal inflammation, with a goal to delay onset, attenuate severity, or completely prevent arthritis. The issue now is “we don’t know which agents would be most effective in this prevention effort,” Dr. Ritchlin said. Biologics that target specific pathways significant in PsA pathogenesis are an appealing prospect. However, “it may be that alternative therapies such as methotrexate or ultraviolet A radiation therapy, for example, may help arrest the development of joint inflammation.”
Underdiagnosis impedes research
Several factors may undermine this important research.
For one, psoriasis patients are often unaware that they have PsA. “Many times they are diagnosed incorrectly by nonspecialists. As a consequence, they do not get access to appropriate medications,” said Lihi Eder, MD, PhD, staff rheumatologist and director of the psoriatic arthritis research program at the University of Toronto’s Women’s College Research Institute.
The condition also lacks a good diagnostic tool, Dr. Eder said. There’s no blood test that identifies this condition in the same manner as RA and lupus, for example. For these conditions, a general practitioner such as a family physician may conduct a blood test, and if positive, refer them to a rheumatologist. Such a system doesn’t exist for PsA. “Instead, nonspecialists are ordering tests and when they’re negative, they assume wrongly that these patients don’t have a rheumatic condition,” she explained.
Many clinicians aren’t that well versed in PsA, although dermatology has taken steps to become better educated. As a result, more dermatologists are referring patients to rheumatologists for PsA. Despite this small step forward, the heterogeneous clinical presentation of this condition makes diagnosis especially difficult. Unlike RA, which presents with inflammation in the joints, PsA can present as back or joint pain, “which makes our life as rheumatologists much more complex,” Dr. Eder said.
Defining a risk group
Most experts agree that the presence of psoriasis isn’t sufficient to conduct a prevention trial. Ideally, the goal of a prevention study would be to identify a critical subgroup of psoriasis patients at high risk of developing PsA.
However, this presents a challenging task, Dr. Eder said. Psoriasis is a risk factor for PsA, but most patients with psoriasis won’t actually develop it. Given that there’s an incidence rate of 2.7% a year, “you would need to recruit many hundreds of psoriasis patients and follow them for a long period of time until you have enough events.”
Moving forward with prevention studies calls for a better definition of the PsA risk group, according to Georg Schett, MD, chair of internal medicine in the department of internal medicine, rheumatology, and immunology at Friedrich‐Alexander University, Erlangen, Germany. “That’s very important, because you need to define such a group to make a prevention trial feasible. The whole benefit of such an approach is to catch the disease early, to say that psoriasis is a biomarker that’s linked to psoriatic arthritis.”
Indicators of risk other than psoriasis, such as pain, inflammation seen in ultrasound or MRI, and other specificities of psoriasis, could be used to define a population where interception can take place, Dr. Schett added. Although it’s not always clinically recognized, the combination of pain and structural lesions can be an indicator for developing PsA.
One prospective study he and his colleagues conducted in 114 psoriasis patients cited structural entheseal lesions and low cortical volumetric bone mineral density as risk factors in developing PsA. Keeping these factors in mind, Dr. Schett expects to see more studies in biointervention in these populations, “with the idea to prevent the onset of PsA and also decrease pain and subcutaneous inflammation.”
Researchers are currently working to identify those high-risk patients to include in an interventional trial, Dr. Ritchlin said.
That said, there’s been a great deal of “clinical trial angst” among investigators, Dr. Ritchlin noted. Outcomes in clinical trials for a wide range of biologic agents have not demonstrated significant advances in outcomes, compared with initial studies with anti–tumor necrosis factor–alpha (TNF-alpha) agents 20 years ago.
Combination biologics
One approach that’s generated some interest is the use of combination biologics medications. Sequential inhibition of cytokines such as interleukin-17A and TNF-alpha is of interest given their central contribution in joint inflammation and damage. “The challenge here of course is toxicity,” Dr. Ritchlin said. Trials that combined blockade of IL-1 and TNF-alpha in a RA trial years ago resulted in significant adverse events without improving outcomes.
Comparatively, a recent study in The Lancet Rheumatology reported success in using the IL-17A inhibitor secukinumab (Cosentyx) to reduce PsA symptoms. Tested on patients in the FUTURE 2 trial, investigators demonstrated that secukinumab in 300- and 150-mg doses safely reduced PsA signs and symptoms over a period of 5 years. Secukinumab also outperformed the TNF-alpha inhibitor adalimumab in 853 PsA patients in the 52-week, randomized, head-to-head, phase 3b EXCEED study, which was recently reported in The Lancet. Articular outcomes were similar between the two therapies, yet the secukinumab group did markedly better in Psoriasis Area and Severity Index scores, compared with the adalimumab group.
Based on these findings, “I suspect that studies examining the efficacy of combination biologics for treatment of PsA will surface in the near future,” Dr. Ritchlin said.
Yet another approach encompasses the spirit of personalized medicine. Clinicians often treat PsA patients empirically because they lack biomarkers that indicate which drug may be most effective for an individual patient, Dr. Ritchlin said. However, the technologies for investigating specific cell subsets in both the blood and tissues have advanced greatly over the last decade. “I am confident that a more precision medicine–based approach to the diagnosis and treatment of PsA is on the near horizon.”
Diet as an intervention
Other research has looked at the strong link between metabolic abnormalities and psoriasis and PsA. Some diets, such as the Mediterranean diet, show promise in improving the metabolic profile of these patients, making it a candidate as a potential intervention to reduce PsA risk. Another strategy would be to focus on limiting calories and promoting weight reduction.
One study in the British Journal of Dermatology looked at the associations between PsA and smoking, alcohol, and body mass index, identifying obesity as an important risk factor. Analyzing more than 90,000 psoriasis cases from the U.K. Clinical Practice Research Datalink between 1998 and 2014, researchers identified 1,409 PsA diagnoses. Among this cohort, researchers found an association between PsA and increased body mass index and moderate drinking. This finding underscores the need to support weight-reduction programs to reduce risk, Dr. Eder and Alexis Ogdie, MD, of the University of Pennsylvania, Philadelphia, wrote in a related editorial.
While observational studies such as this one provide further guidance for interventional trials, confounders can affect results. “Patients who lost weight could have made a positive lifestyle change (e.g., a dietary change) that was associated with the decreased risk for PsA rather than weight loss specifically, or they could have lost weight for unhealthy reasons,” Dr. Eder and Dr. Ogdie explained. Future research could address whether weight loss or other interventional factors may reduce PsA progression.
To make this work, “we would need to select patients that would benefit from diet. Secondly, we’d need to identify what kind of diet would be good for preventing PsA. And we don’t know that yet,” Dr. Eder further elaborated.
As with any prevention trial, the challenge is to follow patients over a long period of time, making sure they comply with the restrictions of the prescribed diet, Dr. Eder noted. “I do think it’s a really exciting type of intervention because it’s something that people are very interested in. There’s little risk of side effects, and it’s not very expensive.”
In other research on weight-loss methods, an observational study from Denmark found that bariatric surgery, especially gastric bypass, reduced the risk of developing PsA. This suggests that weight reduction by itself is important, “although we don’t know that yet,” Dr. Eder said.
A risk model for PsA
Dr. Eder and colleagues have been working on an algorithm that will incorporate clinical information (for example, the presence of nail lesions and the severity of psoriasis) to provide an estimated risk of developing PsA over the next 5 years. Subsequently, this information could be used to identify high-risk psoriasis patients as candidates for a prevention trial.
Other groups are looking at laboratory or imaging biomarkers to help develop PsA prediction models, she said. “Once we have these tools, we can move to next steps of prevention trials. What kinds of interventions should we apply? Are we talking biologic medications or other lifestyle interventions like diet? We are still at the early stages. However, with an improved understanding of the underlying mechanisms and risk factors we are expected to see prevention trials for PsA in the future.”
Hot Topics in Primary Care 2020
Click here to read Hot Topics in Primary Care.
This supplement includes 7 CME credits (scroll down for more information).
Topics include:
- Nutritional Gaps
- Irritable Bowel Syndrome
- Asthma Management
- Hyperlipidemia
- Heart Failure
- Efficacy and Safety of Naproxen
- Dementia-Related Delusions and Hallucinations
- Insomnia
- Autosomal Dominant Polycystic Kidney Disease
- Hypoglycemia Management
- Chronic Obstructive Pulmonary Disease
- Diabetic Kidney Disease
- Burden of Overweight
This supplement offers the opportunity to earn a total of 7 CME credits.
Credit is awarded for successful completion of the online evaluations at the links below. These links may also be found within the supplement on the first page of each article.
- Addressing Nutritional Gaps: Simple Steps for the Primary Care Provider
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/nutrition to complete the online post-test and receive your certificate of credit.
- An Individualized, Case-Based Approach to the Management of Irritable Bowel Syndrome
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/ibs to complete the online post-test and receive your certificate of credit.
- Managing the Burden of Dementia-Related Delusions and Hallucinations
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/dementia to complete the online post-test and receive your certificate of credit.
- Overcoming Barriers to the Diagnosis and Treatment of Insomnia
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/insomnia2 to complete the online post-test and receive your certificate of credit.
- Recognition and Management of a Less Common Cause of Chronic Kidney Disease: Autosomal Dominant Polycystic Kidney Disease
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/ADPKD to complete the online post-test and receive your certificate of credit.
- Review of LDL-C-Lowering with Focus on New and Emerging Agents
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/hyper to complete the online post-test and receive your certificate of credit.
- Stemming the Progression of Diabetic Kidney Disease: The Role of the Primary Care Clinician
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/DKD2 to complete the online post-test and receive your certificate of credit.
Click here to read Hot Topics in Primary Care.
This supplement includes 7 CME credits (scroll down for more information).
Topics include:
- Nutritional Gaps
- Irritable Bowel Syndrome
- Asthma Management
- Hyperlipidemia
- Heart Failure
- Efficacy and Safety of Naproxen
- Dementia-Related Delusions and Hallucinations
- Insomnia
- Autosomal Dominant Polycystic Kidney Disease
- Hypoglycemia Management
- Chronic Obstructive Pulmonary Disease
- Diabetic Kidney Disease
- Burden of Overweight
This supplement offers the opportunity to earn a total of 7 CME credits.
Credit is awarded for successful completion of the online evaluations at the links below. These links may also be found within the supplement on the first page of each article.
- Addressing Nutritional Gaps: Simple Steps for the Primary Care Provider
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/nutrition to complete the online post-test and receive your certificate of credit.
- An Individualized, Case-Based Approach to the Management of Irritable Bowel Syndrome
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/ibs to complete the online post-test and receive your certificate of credit.
- Managing the Burden of Dementia-Related Delusions and Hallucinations
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/dementia to complete the online post-test and receive your certificate of credit.
- Overcoming Barriers to the Diagnosis and Treatment of Insomnia
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/insomnia2 to complete the online post-test and receive your certificate of credit.
- Recognition and Management of a Less Common Cause of Chronic Kidney Disease: Autosomal Dominant Polycystic Kidney Disease
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/ADPKD to complete the online post-test and receive your certificate of credit.
- Review of LDL-C-Lowering with Focus on New and Emerging Agents
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/hyper to complete the online post-test and receive your certificate of credit.
- Stemming the Progression of Diabetic Kidney Disease: The Role of the Primary Care Clinician
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/DKD2 to complete the online post-test and receive your certificate of credit.
Click here to read Hot Topics in Primary Care.
This supplement includes 7 CME credits (scroll down for more information).
Topics include:
- Nutritional Gaps
- Irritable Bowel Syndrome
- Asthma Management
- Hyperlipidemia
- Heart Failure
- Efficacy and Safety of Naproxen
- Dementia-Related Delusions and Hallucinations
- Insomnia
- Autosomal Dominant Polycystic Kidney Disease
- Hypoglycemia Management
- Chronic Obstructive Pulmonary Disease
- Diabetic Kidney Disease
- Burden of Overweight
This supplement offers the opportunity to earn a total of 7 CME credits.
Credit is awarded for successful completion of the online evaluations at the links below. These links may also be found within the supplement on the first page of each article.
- Addressing Nutritional Gaps: Simple Steps for the Primary Care Provider
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/nutrition to complete the online post-test and receive your certificate of credit.
- An Individualized, Case-Based Approach to the Management of Irritable Bowel Syndrome
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/ibs to complete the online post-test and receive your certificate of credit.
- Managing the Burden of Dementia-Related Delusions and Hallucinations
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/dementia to complete the online post-test and receive your certificate of credit.
- Overcoming Barriers to the Diagnosis and Treatment of Insomnia
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/insomnia2 to complete the online post-test and receive your certificate of credit.
- Recognition and Management of a Less Common Cause of Chronic Kidney Disease: Autosomal Dominant Polycystic Kidney Disease
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/ADPKD to complete the online post-test and receive your certificate of credit.
- Review of LDL-C-Lowering with Focus on New and Emerging Agents
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/hyper to complete the online post-test and receive your certificate of credit.
- Stemming the Progression of Diabetic Kidney Disease: The Role of the Primary Care Clinician
- To receive CME credit, please read the journal article and, upon completion, go to www.pceconsortium.org/DKD2 to complete the online post-test and receive your certificate of credit.
Pandemic worsens disparities in GI and liver disease
Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.
Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.
“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.
“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.
During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).
The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.
“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.
Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.
“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.
Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.
“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.
To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.
For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.
More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.
“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”
Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.
“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”
Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.
“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.
The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.
SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.
Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.
Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.
“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.
“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.
During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).
The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.
“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.
Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.
“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.
Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.
“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.
To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.
For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.
More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.
“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”
Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.
“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”
Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.
“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.
The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.
SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.
Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.
Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.
“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.
“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.
During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).
The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.
“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.
Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.
“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.
Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.
“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.
To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.
For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.
More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.
“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”
Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.
“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”
Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.
“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.
The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.
SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.
FROM THE AGA FORWARD PROGRAM