Conference Coverage

Even as dozens of state legislature bills attempt to limit the rights of sexual-diverse and gender-diverse youth, researchers are learning more and more that can help pediatricians better support this population in their practices, according to David Inwards-Breland, MD, MPH, a professor of clinical pediatrics at the University of California, San Diego.

Dr. Inwards-Breland highlighted two key studies in recent years during the LGBTQ+ section at the annual meeting of the American Academy of Pediatrics, held virtually in 2020.
 

High suicide rates among sexual minority youth

Past research has found that adolescents who identify as sexual minorities have nearly five times the rate of suicide attempts, compared with their heterosexual peers, Dr. Inwards-Breland said as he introduced a recent study on disparities in adolescent suicide.

“This may be from a disproportionate burden of poor mental health that has been linked to stigma,” he said, adding that an estimated 125 state bills have been introduced in the United States that would restrict the rights of sexual minorities.

The study, published in Pediatrics in March 2020, compiled data from 110,243 adolescents in six states on sexual orientation identity; 25,994 adolescents in four states on same-sex sexual contact and sexual assault; and 20,655 adolescents in three states on sexual orientation identity, the sex of sexual contacts, and sexual assault.

The authors found that heterosexual identity dropped from 93% to 86% between 2009 and 2017, but sexual minority youth accounted for an increasing share of suicide attempts over the same period. A quarter of adolescents who attempted suicide in 2009 were sexual minorities, which increased to 36% in 2017. Similarly, among sexually active teens who attempted suicide, the proportion of those who had same-sex contact nearly doubled, from 16% to 30%.

The good news, Dr. Inwards-Breland said, was that overall suicide attempts declined among sexual minorities, but they remain three times as likely to attempt suicide, compared with their heterosexual counterparts.

“As the number of adolescents increase in our country, there will be increasing numbers of adolescents identifying as sexual minorities or who have had same-sex sexual contact,” Dr. Inwards-Breland said. “Therefore, providing confidential services is even more important to allow youth to feel comfortable with their health care provider.” He also emphasized the importance of consistent universal depression screening and advocacy to eliminate and prevent policies that harm these youth.
 

Using youths’ chosen names

Transgender and nonbinary youth – those who do not identify as male or female – have a higher risk of poor mental health and higher levels of suicidal ideation and behaviors, compared with their “cis” peers, those who identify with the gender they were assigned at birth, Dr. Inwards-Breland said. However, using the chosen, or assertive, name of transgender and nonbinary youth predicted fewer depressive symptoms and less suicidal ideation and behavior in a study published in the Journal of Adolescent Health in October 2018.

“Choosing a name is an important part of social transition of transgender individuals, yet they’re unable to use their name because of interpersonal or institutional barriers,” he said. In addition, using a name other than their legally given name can subject them to discrimination and victimization.

The study, drawing from a larger cohort of LGBTQ youth, involved 129 transgender and nonbinary adolescents, aged 15-21, of whom 74 had a chosen name. No other differences in personal characteristics were associated with depressive symptoms or suicidal ideation besides increased use of their assertive name in different life contexts.

An increase in one context where chosen name could be used predicted a 5.37-unit decrease in depressive symptoms, a 29% decrease in suicidal ideation, and a 56% decrease in suicidal behavior, the study found. All three outcomes were at their lowest levels when chosen names were used in all four contexts explored in the study.

“The chosen name affirms their gender identity,” Dr. Inwards-Breland said, but “the legal name change process is very onerous.” He highlighted the need for institutions to adjust regulations and information systems, for policies that promote the transition process, and for youths’ names to be affirmed in multiple contexts.

“We as pediatricians, specialists, and primary care doctors can support families as they adjust the transition process by helping them with assertive names and pronouns and giving them resources,” Dr. Inwards-Breland said. He also called for school policies and teacher/staff training that promote the use of assertive names and pronouns, and ensuring that the assertive name and pronouns are in the medical record and used by office staff and other medical professionals.
 

‘A light in the dark’ for LGBTQ+ youth

Clair Kronk of the University of Cincinnati and Cincinnati Children’s Hospital and Medical Center attended the LGBTQ+ section at the AAP meeting because of concerns about she and her transgender siblings have been treated by the medical community.

“It has always been important to be ‘on the pulse’ of what is happening in the medical community, especially with new, more discriminatory policies being passed seemingly willy-nilly these days, both in the medical realm and outside of it,” Ms. Kronk said in an interview. “I was overjoyed to see how many people seemed to care so much about the transgender community and LGBTQIA+ people generally.”

As an ontologist and bioinformatician, she did not recall many big clinical takeaways for her particular work, but she appreciated how many areas the session covered, especially given the dearth of instruction about LGBTQ+ care in medical training.

“This session was a bit of a light in the dark given the state of LGBTQIA+ health care rights,” she said. “There is a lot at stake in the next year or so, and providers’ and LGBTQIA+ persons’ voices need to be heard right now more than ever.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., also attended the session and came away feeling invigorated.

“These data make me feel more optimistic than I have been in ages in terms of increasing the safety of young people being able to come out,” Dr. Khan said in the comments during the session. “These last 4 years felt so regressive. [It’s] good to get the big picture.”

The presenters and commentators had no disclosures.

Even as dozens of state legislature bills attempt to limit the rights of sexual-diverse and gender-diverse youth, researchers are learning more and more that can help pediatricians better support this population in their practices, according to David Inwards-Breland, MD, MPH, a professor of clinical pediatrics at the University of California, San Diego.

Dr. Inwards-Breland highlighted two key studies in recent years during the LGBTQ+ section at the annual meeting of the American Academy of Pediatrics, held virtually in 2020.
 

High suicide rates among sexual minority youth

Past research has found that adolescents who identify as sexual minorities have nearly five times the rate of suicide attempts, compared with their heterosexual peers, Dr. Inwards-Breland said as he introduced a recent study on disparities in adolescent suicide.

“This may be from a disproportionate burden of poor mental health that has been linked to stigma,” he said, adding that an estimated 125 state bills have been introduced in the United States that would restrict the rights of sexual minorities.

The study, published in Pediatrics in March 2020, compiled data from 110,243 adolescents in six states on sexual orientation identity; 25,994 adolescents in four states on same-sex sexual contact and sexual assault; and 20,655 adolescents in three states on sexual orientation identity, the sex of sexual contacts, and sexual assault.

The authors found that heterosexual identity dropped from 93% to 86% between 2009 and 2017, but sexual minority youth accounted for an increasing share of suicide attempts over the same period. A quarter of adolescents who attempted suicide in 2009 were sexual minorities, which increased to 36% in 2017. Similarly, among sexually active teens who attempted suicide, the proportion of those who had same-sex contact nearly doubled, from 16% to 30%.

The good news, Dr. Inwards-Breland said, was that overall suicide attempts declined among sexual minorities, but they remain three times as likely to attempt suicide, compared with their heterosexual counterparts.

“As the number of adolescents increase in our country, there will be increasing numbers of adolescents identifying as sexual minorities or who have had same-sex sexual contact,” Dr. Inwards-Breland said. “Therefore, providing confidential services is even more important to allow youth to feel comfortable with their health care provider.” He also emphasized the importance of consistent universal depression screening and advocacy to eliminate and prevent policies that harm these youth.
 

Using youths’ chosen names

Transgender and nonbinary youth – those who do not identify as male or female – have a higher risk of poor mental health and higher levels of suicidal ideation and behaviors, compared with their “cis” peers, those who identify with the gender they were assigned at birth, Dr. Inwards-Breland said. However, using the chosen, or assertive, name of transgender and nonbinary youth predicted fewer depressive symptoms and less suicidal ideation and behavior in a study published in the Journal of Adolescent Health in October 2018.

“Choosing a name is an important part of social transition of transgender individuals, yet they’re unable to use their name because of interpersonal or institutional barriers,” he said. In addition, using a name other than their legally given name can subject them to discrimination and victimization.

The study, drawing from a larger cohort of LGBTQ youth, involved 129 transgender and nonbinary adolescents, aged 15-21, of whom 74 had a chosen name. No other differences in personal characteristics were associated with depressive symptoms or suicidal ideation besides increased use of their assertive name in different life contexts.

An increase in one context where chosen name could be used predicted a 5.37-unit decrease in depressive symptoms, a 29% decrease in suicidal ideation, and a 56% decrease in suicidal behavior, the study found. All three outcomes were at their lowest levels when chosen names were used in all four contexts explored in the study.

“The chosen name affirms their gender identity,” Dr. Inwards-Breland said, but “the legal name change process is very onerous.” He highlighted the need for institutions to adjust regulations and information systems, for policies that promote the transition process, and for youths’ names to be affirmed in multiple contexts.

“We as pediatricians, specialists, and primary care doctors can support families as they adjust the transition process by helping them with assertive names and pronouns and giving them resources,” Dr. Inwards-Breland said. He also called for school policies and teacher/staff training that promote the use of assertive names and pronouns, and ensuring that the assertive name and pronouns are in the medical record and used by office staff and other medical professionals.
 

‘A light in the dark’ for LGBTQ+ youth

Clair Kronk of the University of Cincinnati and Cincinnati Children’s Hospital and Medical Center attended the LGBTQ+ section at the AAP meeting because of concerns about she and her transgender siblings have been treated by the medical community.

“It has always been important to be ‘on the pulse’ of what is happening in the medical community, especially with new, more discriminatory policies being passed seemingly willy-nilly these days, both in the medical realm and outside of it,” Ms. Kronk said in an interview. “I was overjoyed to see how many people seemed to care so much about the transgender community and LGBTQIA+ people generally.”

As an ontologist and bioinformatician, she did not recall many big clinical takeaways for her particular work, but she appreciated how many areas the session covered, especially given the dearth of instruction about LGBTQ+ care in medical training.

“This session was a bit of a light in the dark given the state of LGBTQIA+ health care rights,” she said. “There is a lot at stake in the next year or so, and providers’ and LGBTQIA+ persons’ voices need to be heard right now more than ever.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., also attended the session and came away feeling invigorated.

“These data make me feel more optimistic than I have been in ages in terms of increasing the safety of young people being able to come out,” Dr. Khan said in the comments during the session. “These last 4 years felt so regressive. [It’s] good to get the big picture.”

The presenters and commentators had no disclosures.

Even as dozens of state legislature bills attempt to limit the rights of sexual-diverse and gender-diverse youth, researchers are learning more and more that can help pediatricians better support this population in their practices, according to David Inwards-Breland, MD, MPH, a professor of clinical pediatrics at the University of California, San Diego.

Dr. Inwards-Breland highlighted two key studies in recent years during the LGBTQ+ section at the annual meeting of the American Academy of Pediatrics, held virtually in 2020.
 

High suicide rates among sexual minority youth

Past research has found that adolescents who identify as sexual minorities have nearly five times the rate of suicide attempts, compared with their heterosexual peers, Dr. Inwards-Breland said as he introduced a recent study on disparities in adolescent suicide.

“This may be from a disproportionate burden of poor mental health that has been linked to stigma,” he said, adding that an estimated 125 state bills have been introduced in the United States that would restrict the rights of sexual minorities.

The study, published in Pediatrics in March 2020, compiled data from 110,243 adolescents in six states on sexual orientation identity; 25,994 adolescents in four states on same-sex sexual contact and sexual assault; and 20,655 adolescents in three states on sexual orientation identity, the sex of sexual contacts, and sexual assault.

The authors found that heterosexual identity dropped from 93% to 86% between 2009 and 2017, but sexual minority youth accounted for an increasing share of suicide attempts over the same period. A quarter of adolescents who attempted suicide in 2009 were sexual minorities, which increased to 36% in 2017. Similarly, among sexually active teens who attempted suicide, the proportion of those who had same-sex contact nearly doubled, from 16% to 30%.

The good news, Dr. Inwards-Breland said, was that overall suicide attempts declined among sexual minorities, but they remain three times as likely to attempt suicide, compared with their heterosexual counterparts.

“As the number of adolescents increase in our country, there will be increasing numbers of adolescents identifying as sexual minorities or who have had same-sex sexual contact,” Dr. Inwards-Breland said. “Therefore, providing confidential services is even more important to allow youth to feel comfortable with their health care provider.” He also emphasized the importance of consistent universal depression screening and advocacy to eliminate and prevent policies that harm these youth.
 

Using youths’ chosen names

Transgender and nonbinary youth – those who do not identify as male or female – have a higher risk of poor mental health and higher levels of suicidal ideation and behaviors, compared with their “cis” peers, those who identify with the gender they were assigned at birth, Dr. Inwards-Breland said. However, using the chosen, or assertive, name of transgender and nonbinary youth predicted fewer depressive symptoms and less suicidal ideation and behavior in a study published in the Journal of Adolescent Health in October 2018.

“Choosing a name is an important part of social transition of transgender individuals, yet they’re unable to use their name because of interpersonal or institutional barriers,” he said. In addition, using a name other than their legally given name can subject them to discrimination and victimization.

The study, drawing from a larger cohort of LGBTQ youth, involved 129 transgender and nonbinary adolescents, aged 15-21, of whom 74 had a chosen name. No other differences in personal characteristics were associated with depressive symptoms or suicidal ideation besides increased use of their assertive name in different life contexts.

An increase in one context where chosen name could be used predicted a 5.37-unit decrease in depressive symptoms, a 29% decrease in suicidal ideation, and a 56% decrease in suicidal behavior, the study found. All three outcomes were at their lowest levels when chosen names were used in all four contexts explored in the study.

“The chosen name affirms their gender identity,” Dr. Inwards-Breland said, but “the legal name change process is very onerous.” He highlighted the need for institutions to adjust regulations and information systems, for policies that promote the transition process, and for youths’ names to be affirmed in multiple contexts.

“We as pediatricians, specialists, and primary care doctors can support families as they adjust the transition process by helping them with assertive names and pronouns and giving them resources,” Dr. Inwards-Breland said. He also called for school policies and teacher/staff training that promote the use of assertive names and pronouns, and ensuring that the assertive name and pronouns are in the medical record and used by office staff and other medical professionals.
 

‘A light in the dark’ for LGBTQ+ youth

Clair Kronk of the University of Cincinnati and Cincinnati Children’s Hospital and Medical Center attended the LGBTQ+ section at the AAP meeting because of concerns about she and her transgender siblings have been treated by the medical community.

“It has always been important to be ‘on the pulse’ of what is happening in the medical community, especially with new, more discriminatory policies being passed seemingly willy-nilly these days, both in the medical realm and outside of it,” Ms. Kronk said in an interview. “I was overjoyed to see how many people seemed to care so much about the transgender community and LGBTQIA+ people generally.”

As an ontologist and bioinformatician, she did not recall many big clinical takeaways for her particular work, but she appreciated how many areas the session covered, especially given the dearth of instruction about LGBTQ+ care in medical training.

“This session was a bit of a light in the dark given the state of LGBTQIA+ health care rights,” she said. “There is a lot at stake in the next year or so, and providers’ and LGBTQIA+ persons’ voices need to be heard right now more than ever.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., also attended the session and came away feeling invigorated.

“These data make me feel more optimistic than I have been in ages in terms of increasing the safety of young people being able to come out,” Dr. Khan said in the comments during the session. “These last 4 years felt so regressive. [It’s] good to get the big picture.”

The presenters and commentators had no disclosures.

While it’s important not to think immediately of zebras when hearing hoofbeats, it’s just as important not to assume it’s always a horse. The delicate balance between not jumping to the seemingly obvious diagnosis without overanalyzing and overtesting is familiar to all physicians, and it’s far easier to avoid diagnostic mistakes when you understand the cognitive biases that can lead doctors astray.

sturti/Getty Images

“When these errors are made, it’s not because physicians lack knowledge, but they go down a wrong path in their thinking process,” Richard Scarfone, MD, a pediatric emergency medicine physician at the Children’s Hospital of Philadelphia, told attendees at the annual meeting of the American Academy of Pediatrics, held virtually this year. “An important point to be made here is that how physicians think seems to be much more important than what physicians know.”

Dr. Scarfone and Joshua Nagler, MD, MHPEd, director, pediatric emergency medicine fellowship program at Children’s Hospital Boston, presented a session on the cognitive biases that can trip up clinicians when making diagnoses and how to avoid them. Research shows that the rate of diagnostic error is approximately 15%. Although those findings come from studies in adults, the rates are likely similar in pediatrics, Dr. Scarfone said.

A wide range of clinical factors contribute to diagnostic errors: limited information, vague or undifferentiated symptoms, incomplete history, multiple transitions of care, diagnostic uncertainty, daily decision density, and reliance on pattern recognition, among others. Personal contributing factors can play a role as well, such as atypical work hours, fatigue, one’s emotional or affective state, a high cognitive load, and others. On top of all that, medical decision-making can be really complex on its own, Dr. Scarfone said. He compared differential diagnosis with a tree where a single leaf is the correct diagnosis.
 

System 1 thinking: Pros and cons

Dr. Scarfone and Dr. Nagler explained system 1 and system 2 thinking, two different ways of thinking that can influence decision-making that Daniel Kahneman explained in his book “Thinking, Fast and Slow.” System 1 refers to the snap judgments that rely on heuristics while system 2 refers to a more analytic, slower process.

gzorgz/iStock/Getty Images

Neither system 1 nor 2 is inherently “right or wrong,” Dr. Scarfone said. “The diagnostic sweet spot is to try to apply the correct system to the correct patient.”

Heuristics are the mental shortcuts people use to make decisions based on past experience. They exist because they’re useful, enabling people to focus only on what they need to accomplish everyday tasks, such as driving or brushing teeth. But heuristics can also lead to predictable cognitive errors.

“The good news about heuristics and system 1 thinking is that it’s efficient and simple, and we desire that in a busy practice or ED setting, but we should recognize that the trade-off is that it may be at the expense of accuracy,” Dr. Scarfone said.

The advantage to system 1 thinking is easy, simple, rapid, and efficient decision-making that rejects ambiguity. It’s also usually accurate, which rewards the approach, and accuracy increases with time based on memory, experience, and pattern recognition. Doctors develop “illness scripts” that help in identifying diagnoses.

“Illness scripts are common patterns of clinical presentations that usually lead us to a diagnostic possibility,” Dr. Scarfone said. “A classic illness script might be a 4-week-old firstborn male with forceful vomiting, and immediately your mind may go to pyloric stenosis as a likely diagnosis.” But the patient may have a different diagnosis than the initial impression your system 1 thinking leads you to believe.

“Generally, the more experience a clinician has, the more accurate they’ll be in using system 1,” he said. “Seasoned physicians are much more likely to employ system 1 than a newer physician or trainee,” which is why heuristics shouldn’t be thought of as hindrances. Dr. Scarfone quoted Kevin Eva in a 2005 review on clinical reasoning: “Successful heuristics should be embraced rather than overcome.”

A drawback to system 1 thinking, however, is thinking that “what you see is all there is,” which can lead to cognitive errors. Feeling wrong feels the same as feeling right, so you may not realize when you’re off target and therefore neglect to consider alternatives.

“When we learn a little about our patient’s complaint, it’s easier to fit everything into a coherent explanation,” Dr. Scarfone said, but “don’t ask, don’t tell doesn’t work in medicine.”

Another challenge with system 1 thinking is that pattern recognition can be unreliable because it’s dependent on context. For example, consider the difference in assessing a patient’s sore throat in a primary care office versus a resuscitation bay. “Clearly our consideration of what may be going on with the patient and what the diagnosis may be is likely to vary in those two settings,” he said.
 

System 2 thinking: Of zebras and horses

System 2 is the analytic thinking that involves pondering and seek out the optimal answer rather than the “good-enough” answer.

“The good news about system 2 is that it really can monitor system 1,” said Dr. Nagler, who has a master’s degree in health professions education. “If you spend the time to do analytic reasoning, you can actually mitigate some of those errors that may occur from intuitive judgments from system 1 thinking. System 2 spends the time to say ‘let’s make sure we’re doing this right.’ ” In multiple-choice tests, for example, people are twice as likely to change a wrong answer to a right one than a right one to a wrong one.

System 2 thinking allows for the reasoning to assess questions in the gray zone. It’s vigilant, it’s reliable, it’s effective, it acknowledges uncertainty and doubt, it can be safe in terms of providing care, and it has high scientific rigor. But it also has disadvantages, starting with the fact that it’s slower and more time-consuming. System 2 thinking is resource intensive, requiring a higher cognitive demand and more time and effort.

“Sometimes the quick judgment is the best judgment,” Dr. Nagler said. System 2 thinking also is sometimes unnecessary and counter to value-based care. “If you start to think about all the possibilities of what a presentation may be, all of a sudden you might find yourself wanting to do all kinds of tests and all kinds of referrals and other things, which is not necessarily value-based care.” When system 2 thinking goes astray, it makes us think everything we see is a zebra rather than a horse.

Sonia Khan, MD, a pediatrician in Fremont, Calif., found this session particularly worthwhile.

“It really tries to explain the difference between leaping to conclusions and learning how to hold your horses and do a bit more, to double check that you’re not locking everything into a horse stall and missing a zebra, and avoiding go too far with system 2 and thinking that everything’s a zebra,” Dr. Khan said. “It’s a difficult talk to have because you’re asking pediatricians to look in the mirror and own up, to learn to step back and reconsider the picture, and consider the biases that may come into your decision-making; then learn to extrude them, and rethink the case to be sure your knee-jerk diagnostic response is correct.”
 

Types of cognitive errors

The presenters listed some of the most common cognitive errors, although their list is far from exhaustive.

• Affective error. Avoiding unpleasant but necessary tests or examinations because of sympathy for the patient, such as avoiding blood work to spare a needle stick in a cancer patient with abdominal pain because the mother is convinced it’s constipation from opioids. This is similar to omission bias, which places excessive concern on avoiding a therapy’s adverse effects when the therapy could be highly effective.
• Anchoring. Clinging to an initial impression or salient features of initial presentation, even as conflicting and contradictory data accumulate, such as diagnosing a patient with fever and vomiting with gastroenteritis even when the patient has an oxygen saturation of 94% and tachypnea.
• Attribution errors. Negative stereotypes lead clinicians to ignore or minimize the possibility of serious disease, such as evaluating a confused teen covered in piercings and tattoos for drug ingestion when the actual diagnosis is new-onset diabetic ketoacidosis.
• Availability bias. Overestimating or underestimating the probability of disease because of recent experience, what was most recently “available” to your brain cognitively, such as getting head imaging on several vomiting patients in a row because you recently had one with a new brain tumor diagnosis.
• Bandwagon effect. Accepting the group’s opinion without assessing a clinical situation yourself, such as sending home a crying, vomiting infant with a presumed viral infection only to see the infant return later with intussusception.
• Base rate neglect. Ignoring the true prevalence of disease by either inflating it or reducing it, such as searching for cardiac disease in all pediatric patients with chest pain.
• Commission. A tendency toward action with the belief that harm may only be prevented by action, such as ordering every possible test for a patient with fever to “rule everything out.”
• Confirmation bias. Subconscious cherry-picking: A tendency to look for, notice, and remember information that fits with preexisting expectations while disregarding information that contradicts those expectations.
• Diagnostic momentum. Clinging to that initial diagnostic impression that may have been generated by others, which is particularly common during transitions of care.
• Premature closure. Narrowing down to a diagnosis without thinking about other diagnoses or asking enough questions about other symptoms that may have opened up other diagnostic possibilities.
• Representation bias. Making a decision in the absence of appropriate context by incorrectly comparing two situations because of a perceived similarity between them, or on the flip side, evaluating a situation without comparing it with other situations.
• Overconfidence. Making a decision without enough supportive evidence yet feeling confident about the diagnosis.
• Search satisfying. Stopping the search for additional diagnoses after the anticipated diagnosis has been made.

Cognitive pills for cognitive ills

Being aware of the pitfalls of cognitive errors is the first step to avoiding and mitigating them. “It really does start with preparation and awareness,” Dr. Scarfone said before presenting strategies to build a cognitive “firewall” that can help physicians practice reflectively instead of reflexively.

First, be aware of your cognitive style. People usually have the same thinking pattern in everyday life as in the clinical setting, so determine whether you’re more of a system 1 or system 2 thinker. System 1 thinkers need to watch out for framing (relying too heavily on context), premature closure, diagnostic momentum, anchoring, and confirmation bias. System 2 thinkers need to watch out for commission, availability bias, and base rate neglect.

“Neither system is inherently right or wrong,” Dr. Scarfone reiterated. “In the perfect world, you may use system 1 to form an initial impression, but then system 2 should really act as a check and balance system to cause you to reflect on your initial diagnostic impressions.”

Additional strategies include being a good history taker and performing a meticulous physical exam: be a good listener, clarify unclear aspects of the history, and identify and address the main concern.

“Remember children and families have a story to tell, and if we listen carefully enough, the diagnostic clues are there,” Dr. Scarfone said. “Sometimes they may be quite subtle.” He recommended doctors perform each part of the physical exam as if expecting an abnormality.

Another strategy is using meta-cognition, a forced analysis of the thinking that led to a diagnosis. It involves asking: “If I had to explain my medical decision-making to others, would this make inherent sense?” Dr. Scarfone said. “If you’re testing, try to avoid anchoring and confirmation biases.”

Finally, take a diagnostic time-out with a checklist that asks these questions:

• Does my presumptive diagnosis make sense?
• What evidence supports or refutes it?
• Did I arrive at it via cognitive biases?
• Are there other diagnostic possibilities that should be considered?

One way to do this is creating a table listing the complaint/finding, diagnostic possibilities with system 1 thinking, diagnostic possibilities with system 2 thinking, and then going beyond system 2 – the potential zebras – when even system 2 diagnostic possibilities don’t account for what the patient is saying or what the exam shows.

Enough overlap exists between these cognitive biases and the intrinsic bias related to individual characteristics that Dr. Khan appreciated the talk on another level as well.

“For me, as a brown Muslim immigrant woman of color, I can sometimes see cognitive biases in action with my colleagues and realize that they are oblivious to it,” Dr. Khan said. “It’s really refreshing to see this issue come up and being discussed at the [AAP] National Conference and Exhibition.”

Dr. Scarfone, Dr. Nagler and Dr. Khan have no relevant financial disclosures.

This article was updated 12/8/2020.
 

While it’s important not to think immediately of zebras when hearing hoofbeats, it’s just as important not to assume it’s always a horse. The delicate balance between not jumping to the seemingly obvious diagnosis without overanalyzing and overtesting is familiar to all physicians, and it’s far easier to avoid diagnostic mistakes when you understand the cognitive biases that can lead doctors astray.

sturti/Getty Images

“When these errors are made, it’s not because physicians lack knowledge, but they go down a wrong path in their thinking process,” Richard Scarfone, MD, a pediatric emergency medicine physician at the Children’s Hospital of Philadelphia, told attendees at the annual meeting of the American Academy of Pediatrics, held virtually this year. “An important point to be made here is that how physicians think seems to be much more important than what physicians know.”

Dr. Scarfone and Joshua Nagler, MD, MHPEd, director, pediatric emergency medicine fellowship program at Children’s Hospital Boston, presented a session on the cognitive biases that can trip up clinicians when making diagnoses and how to avoid them. Research shows that the rate of diagnostic error is approximately 15%. Although those findings come from studies in adults, the rates are likely similar in pediatrics, Dr. Scarfone said.

A wide range of clinical factors contribute to diagnostic errors: limited information, vague or undifferentiated symptoms, incomplete history, multiple transitions of care, diagnostic uncertainty, daily decision density, and reliance on pattern recognition, among others. Personal contributing factors can play a role as well, such as atypical work hours, fatigue, one’s emotional or affective state, a high cognitive load, and others. On top of all that, medical decision-making can be really complex on its own, Dr. Scarfone said. He compared differential diagnosis with a tree where a single leaf is the correct diagnosis.
 

System 1 thinking: Pros and cons

Dr. Scarfone and Dr. Nagler explained system 1 and system 2 thinking, two different ways of thinking that can influence decision-making that Daniel Kahneman explained in his book “Thinking, Fast and Slow.” System 1 refers to the snap judgments that rely on heuristics while system 2 refers to a more analytic, slower process.

gzorgz/iStock/Getty Images

Neither system 1 nor 2 is inherently “right or wrong,” Dr. Scarfone said. “The diagnostic sweet spot is to try to apply the correct system to the correct patient.”

Heuristics are the mental shortcuts people use to make decisions based on past experience. They exist because they’re useful, enabling people to focus only on what they need to accomplish everyday tasks, such as driving or brushing teeth. But heuristics can also lead to predictable cognitive errors.

“The good news about heuristics and system 1 thinking is that it’s efficient and simple, and we desire that in a busy practice or ED setting, but we should recognize that the trade-off is that it may be at the expense of accuracy,” Dr. Scarfone said.

The advantage to system 1 thinking is easy, simple, rapid, and efficient decision-making that rejects ambiguity. It’s also usually accurate, which rewards the approach, and accuracy increases with time based on memory, experience, and pattern recognition. Doctors develop “illness scripts” that help in identifying diagnoses.

“Illness scripts are common patterns of clinical presentations that usually lead us to a diagnostic possibility,” Dr. Scarfone said. “A classic illness script might be a 4-week-old firstborn male with forceful vomiting, and immediately your mind may go to pyloric stenosis as a likely diagnosis.” But the patient may have a different diagnosis than the initial impression your system 1 thinking leads you to believe.

“Generally, the more experience a clinician has, the more accurate they’ll be in using system 1,” he said. “Seasoned physicians are much more likely to employ system 1 than a newer physician or trainee,” which is why heuristics shouldn’t be thought of as hindrances. Dr. Scarfone quoted Kevin Eva in a 2005 review on clinical reasoning: “Successful heuristics should be embraced rather than overcome.”

A drawback to system 1 thinking, however, is thinking that “what you see is all there is,” which can lead to cognitive errors. Feeling wrong feels the same as feeling right, so you may not realize when you’re off target and therefore neglect to consider alternatives.

“When we learn a little about our patient’s complaint, it’s easier to fit everything into a coherent explanation,” Dr. Scarfone said, but “don’t ask, don’t tell doesn’t work in medicine.”

Another challenge with system 1 thinking is that pattern recognition can be unreliable because it’s dependent on context. For example, consider the difference in assessing a patient’s sore throat in a primary care office versus a resuscitation bay. “Clearly our consideration of what may be going on with the patient and what the diagnosis may be is likely to vary in those two settings,” he said.
 

System 2 thinking: Of zebras and horses

System 2 is the analytic thinking that involves pondering and seek out the optimal answer rather than the “good-enough” answer.

“The good news about system 2 is that it really can monitor system 1,” said Dr. Nagler, who has a master’s degree in health professions education. “If you spend the time to do analytic reasoning, you can actually mitigate some of those errors that may occur from intuitive judgments from system 1 thinking. System 2 spends the time to say ‘let’s make sure we’re doing this right.’ ” In multiple-choice tests, for example, people are twice as likely to change a wrong answer to a right one than a right one to a wrong one.

System 2 thinking allows for the reasoning to assess questions in the gray zone. It’s vigilant, it’s reliable, it’s effective, it acknowledges uncertainty and doubt, it can be safe in terms of providing care, and it has high scientific rigor. But it also has disadvantages, starting with the fact that it’s slower and more time-consuming. System 2 thinking is resource intensive, requiring a higher cognitive demand and more time and effort.

“Sometimes the quick judgment is the best judgment,” Dr. Nagler said. System 2 thinking also is sometimes unnecessary and counter to value-based care. “If you start to think about all the possibilities of what a presentation may be, all of a sudden you might find yourself wanting to do all kinds of tests and all kinds of referrals and other things, which is not necessarily value-based care.” When system 2 thinking goes astray, it makes us think everything we see is a zebra rather than a horse.

Sonia Khan, MD, a pediatrician in Fremont, Calif., found this session particularly worthwhile.

“It really tries to explain the difference between leaping to conclusions and learning how to hold your horses and do a bit more, to double check that you’re not locking everything into a horse stall and missing a zebra, and avoiding go too far with system 2 and thinking that everything’s a zebra,” Dr. Khan said. “It’s a difficult talk to have because you’re asking pediatricians to look in the mirror and own up, to learn to step back and reconsider the picture, and consider the biases that may come into your decision-making; then learn to extrude them, and rethink the case to be sure your knee-jerk diagnostic response is correct.”
 

Types of cognitive errors

The presenters listed some of the most common cognitive errors, although their list is far from exhaustive.

• Affective error. Avoiding unpleasant but necessary tests or examinations because of sympathy for the patient, such as avoiding blood work to spare a needle stick in a cancer patient with abdominal pain because the mother is convinced it’s constipation from opioids. This is similar to omission bias, which places excessive concern on avoiding a therapy’s adverse effects when the therapy could be highly effective.
• Anchoring. Clinging to an initial impression or salient features of initial presentation, even as conflicting and contradictory data accumulate, such as diagnosing a patient with fever and vomiting with gastroenteritis even when the patient has an oxygen saturation of 94% and tachypnea.
• Attribution errors. Negative stereotypes lead clinicians to ignore or minimize the possibility of serious disease, such as evaluating a confused teen covered in piercings and tattoos for drug ingestion when the actual diagnosis is new-onset diabetic ketoacidosis.
• Availability bias. Overestimating or underestimating the probability of disease because of recent experience, what was most recently “available” to your brain cognitively, such as getting head imaging on several vomiting patients in a row because you recently had one with a new brain tumor diagnosis.
• Bandwagon effect. Accepting the group’s opinion without assessing a clinical situation yourself, such as sending home a crying, vomiting infant with a presumed viral infection only to see the infant return later with intussusception.
• Base rate neglect. Ignoring the true prevalence of disease by either inflating it or reducing it, such as searching for cardiac disease in all pediatric patients with chest pain.
• Commission. A tendency toward action with the belief that harm may only be prevented by action, such as ordering every possible test for a patient with fever to “rule everything out.”
• Confirmation bias. Subconscious cherry-picking: A tendency to look for, notice, and remember information that fits with preexisting expectations while disregarding information that contradicts those expectations.
• Diagnostic momentum. Clinging to that initial diagnostic impression that may have been generated by others, which is particularly common during transitions of care.
• Premature closure. Narrowing down to a diagnosis without thinking about other diagnoses or asking enough questions about other symptoms that may have opened up other diagnostic possibilities.
• Representation bias. Making a decision in the absence of appropriate context by incorrectly comparing two situations because of a perceived similarity between them, or on the flip side, evaluating a situation without comparing it with other situations.
• Overconfidence. Making a decision without enough supportive evidence yet feeling confident about the diagnosis.
• Search satisfying. Stopping the search for additional diagnoses after the anticipated diagnosis has been made.

Cognitive pills for cognitive ills

Being aware of the pitfalls of cognitive errors is the first step to avoiding and mitigating them. “It really does start with preparation and awareness,” Dr. Scarfone said before presenting strategies to build a cognitive “firewall” that can help physicians practice reflectively instead of reflexively.

First, be aware of your cognitive style. People usually have the same thinking pattern in everyday life as in the clinical setting, so determine whether you’re more of a system 1 or system 2 thinker. System 1 thinkers need to watch out for framing (relying too heavily on context), premature closure, diagnostic momentum, anchoring, and confirmation bias. System 2 thinkers need to watch out for commission, availability bias, and base rate neglect.

“Neither system is inherently right or wrong,” Dr. Scarfone reiterated. “In the perfect world, you may use system 1 to form an initial impression, but then system 2 should really act as a check and balance system to cause you to reflect on your initial diagnostic impressions.”

Additional strategies include being a good history taker and performing a meticulous physical exam: be a good listener, clarify unclear aspects of the history, and identify and address the main concern.

“Remember children and families have a story to tell, and if we listen carefully enough, the diagnostic clues are there,” Dr. Scarfone said. “Sometimes they may be quite subtle.” He recommended doctors perform each part of the physical exam as if expecting an abnormality.

Another strategy is using meta-cognition, a forced analysis of the thinking that led to a diagnosis. It involves asking: “If I had to explain my medical decision-making to others, would this make inherent sense?” Dr. Scarfone said. “If you’re testing, try to avoid anchoring and confirmation biases.”

Finally, take a diagnostic time-out with a checklist that asks these questions:

• Does my presumptive diagnosis make sense?
• What evidence supports or refutes it?
• Did I arrive at it via cognitive biases?
• Are there other diagnostic possibilities that should be considered?

One way to do this is creating a table listing the complaint/finding, diagnostic possibilities with system 1 thinking, diagnostic possibilities with system 2 thinking, and then going beyond system 2 – the potential zebras – when even system 2 diagnostic possibilities don’t account for what the patient is saying or what the exam shows.

Enough overlap exists between these cognitive biases and the intrinsic bias related to individual characteristics that Dr. Khan appreciated the talk on another level as well.

“For me, as a brown Muslim immigrant woman of color, I can sometimes see cognitive biases in action with my colleagues and realize that they are oblivious to it,” Dr. Khan said. “It’s really refreshing to see this issue come up and being discussed at the [AAP] National Conference and Exhibition.”

Dr. Scarfone, Dr. Nagler and Dr. Khan have no relevant financial disclosures.

This article was updated 12/8/2020.
 

While it’s important not to think immediately of zebras when hearing hoofbeats, it’s just as important not to assume it’s always a horse. The delicate balance between not jumping to the seemingly obvious diagnosis without overanalyzing and overtesting is familiar to all physicians, and it’s far easier to avoid diagnostic mistakes when you understand the cognitive biases that can lead doctors astray.

sturti/Getty Images

“When these errors are made, it’s not because physicians lack knowledge, but they go down a wrong path in their thinking process,” Richard Scarfone, MD, a pediatric emergency medicine physician at the Children’s Hospital of Philadelphia, told attendees at the annual meeting of the American Academy of Pediatrics, held virtually this year. “An important point to be made here is that how physicians think seems to be much more important than what physicians know.”

Dr. Scarfone and Joshua Nagler, MD, MHPEd, director, pediatric emergency medicine fellowship program at Children’s Hospital Boston, presented a session on the cognitive biases that can trip up clinicians when making diagnoses and how to avoid them. Research shows that the rate of diagnostic error is approximately 15%. Although those findings come from studies in adults, the rates are likely similar in pediatrics, Dr. Scarfone said.

A wide range of clinical factors contribute to diagnostic errors: limited information, vague or undifferentiated symptoms, incomplete history, multiple transitions of care, diagnostic uncertainty, daily decision density, and reliance on pattern recognition, among others. Personal contributing factors can play a role as well, such as atypical work hours, fatigue, one’s emotional or affective state, a high cognitive load, and others. On top of all that, medical decision-making can be really complex on its own, Dr. Scarfone said. He compared differential diagnosis with a tree where a single leaf is the correct diagnosis.
 

System 1 thinking: Pros and cons

Dr. Scarfone and Dr. Nagler explained system 1 and system 2 thinking, two different ways of thinking that can influence decision-making that Daniel Kahneman explained in his book “Thinking, Fast and Slow.” System 1 refers to the snap judgments that rely on heuristics while system 2 refers to a more analytic, slower process.

gzorgz/iStock/Getty Images

Neither system 1 nor 2 is inherently “right or wrong,” Dr. Scarfone said. “The diagnostic sweet spot is to try to apply the correct system to the correct patient.”

Heuristics are the mental shortcuts people use to make decisions based on past experience. They exist because they’re useful, enabling people to focus only on what they need to accomplish everyday tasks, such as driving or brushing teeth. But heuristics can also lead to predictable cognitive errors.

“The good news about heuristics and system 1 thinking is that it’s efficient and simple, and we desire that in a busy practice or ED setting, but we should recognize that the trade-off is that it may be at the expense of accuracy,” Dr. Scarfone said.

The advantage to system 1 thinking is easy, simple, rapid, and efficient decision-making that rejects ambiguity. It’s also usually accurate, which rewards the approach, and accuracy increases with time based on memory, experience, and pattern recognition. Doctors develop “illness scripts” that help in identifying diagnoses.

“Illness scripts are common patterns of clinical presentations that usually lead us to a diagnostic possibility,” Dr. Scarfone said. “A classic illness script might be a 4-week-old firstborn male with forceful vomiting, and immediately your mind may go to pyloric stenosis as a likely diagnosis.” But the patient may have a different diagnosis than the initial impression your system 1 thinking leads you to believe.

“Generally, the more experience a clinician has, the more accurate they’ll be in using system 1,” he said. “Seasoned physicians are much more likely to employ system 1 than a newer physician or trainee,” which is why heuristics shouldn’t be thought of as hindrances. Dr. Scarfone quoted Kevin Eva in a 2005 review on clinical reasoning: “Successful heuristics should be embraced rather than overcome.”

A drawback to system 1 thinking, however, is thinking that “what you see is all there is,” which can lead to cognitive errors. Feeling wrong feels the same as feeling right, so you may not realize when you’re off target and therefore neglect to consider alternatives.

“When we learn a little about our patient’s complaint, it’s easier to fit everything into a coherent explanation,” Dr. Scarfone said, but “don’t ask, don’t tell doesn’t work in medicine.”

Another challenge with system 1 thinking is that pattern recognition can be unreliable because it’s dependent on context. For example, consider the difference in assessing a patient’s sore throat in a primary care office versus a resuscitation bay. “Clearly our consideration of what may be going on with the patient and what the diagnosis may be is likely to vary in those two settings,” he said.
 

System 2 thinking: Of zebras and horses

System 2 is the analytic thinking that involves pondering and seek out the optimal answer rather than the “good-enough” answer.

“The good news about system 2 is that it really can monitor system 1,” said Dr. Nagler, who has a master’s degree in health professions education. “If you spend the time to do analytic reasoning, you can actually mitigate some of those errors that may occur from intuitive judgments from system 1 thinking. System 2 spends the time to say ‘let’s make sure we’re doing this right.’ ” In multiple-choice tests, for example, people are twice as likely to change a wrong answer to a right one than a right one to a wrong one.

System 2 thinking allows for the reasoning to assess questions in the gray zone. It’s vigilant, it’s reliable, it’s effective, it acknowledges uncertainty and doubt, it can be safe in terms of providing care, and it has high scientific rigor. But it also has disadvantages, starting with the fact that it’s slower and more time-consuming. System 2 thinking is resource intensive, requiring a higher cognitive demand and more time and effort.

“Sometimes the quick judgment is the best judgment,” Dr. Nagler said. System 2 thinking also is sometimes unnecessary and counter to value-based care. “If you start to think about all the possibilities of what a presentation may be, all of a sudden you might find yourself wanting to do all kinds of tests and all kinds of referrals and other things, which is not necessarily value-based care.” When system 2 thinking goes astray, it makes us think everything we see is a zebra rather than a horse.

Sonia Khan, MD, a pediatrician in Fremont, Calif., found this session particularly worthwhile.

“It really tries to explain the difference between leaping to conclusions and learning how to hold your horses and do a bit more, to double check that you’re not locking everything into a horse stall and missing a zebra, and avoiding go too far with system 2 and thinking that everything’s a zebra,” Dr. Khan said. “It’s a difficult talk to have because you’re asking pediatricians to look in the mirror and own up, to learn to step back and reconsider the picture, and consider the biases that may come into your decision-making; then learn to extrude them, and rethink the case to be sure your knee-jerk diagnostic response is correct.”
 

Types of cognitive errors

The presenters listed some of the most common cognitive errors, although their list is far from exhaustive.

• Affective error. Avoiding unpleasant but necessary tests or examinations because of sympathy for the patient, such as avoiding blood work to spare a needle stick in a cancer patient with abdominal pain because the mother is convinced it’s constipation from opioids. This is similar to omission bias, which places excessive concern on avoiding a therapy’s adverse effects when the therapy could be highly effective.
• Anchoring. Clinging to an initial impression or salient features of initial presentation, even as conflicting and contradictory data accumulate, such as diagnosing a patient with fever and vomiting with gastroenteritis even when the patient has an oxygen saturation of 94% and tachypnea.
• Attribution errors. Negative stereotypes lead clinicians to ignore or minimize the possibility of serious disease, such as evaluating a confused teen covered in piercings and tattoos for drug ingestion when the actual diagnosis is new-onset diabetic ketoacidosis.
• Availability bias. Overestimating or underestimating the probability of disease because of recent experience, what was most recently “available” to your brain cognitively, such as getting head imaging on several vomiting patients in a row because you recently had one with a new brain tumor diagnosis.
• Bandwagon effect. Accepting the group’s opinion without assessing a clinical situation yourself, such as sending home a crying, vomiting infant with a presumed viral infection only to see the infant return later with intussusception.
• Base rate neglect. Ignoring the true prevalence of disease by either inflating it or reducing it, such as searching for cardiac disease in all pediatric patients with chest pain.
• Commission. A tendency toward action with the belief that harm may only be prevented by action, such as ordering every possible test for a patient with fever to “rule everything out.”
• Confirmation bias. Subconscious cherry-picking: A tendency to look for, notice, and remember information that fits with preexisting expectations while disregarding information that contradicts those expectations.
• Diagnostic momentum. Clinging to that initial diagnostic impression that may have been generated by others, which is particularly common during transitions of care.
• Premature closure. Narrowing down to a diagnosis without thinking about other diagnoses or asking enough questions about other symptoms that may have opened up other diagnostic possibilities.
• Representation bias. Making a decision in the absence of appropriate context by incorrectly comparing two situations because of a perceived similarity between them, or on the flip side, evaluating a situation without comparing it with other situations.
• Overconfidence. Making a decision without enough supportive evidence yet feeling confident about the diagnosis.
• Search satisfying. Stopping the search for additional diagnoses after the anticipated diagnosis has been made.

Cognitive pills for cognitive ills

Being aware of the pitfalls of cognitive errors is the first step to avoiding and mitigating them. “It really does start with preparation and awareness,” Dr. Scarfone said before presenting strategies to build a cognitive “firewall” that can help physicians practice reflectively instead of reflexively.

First, be aware of your cognitive style. People usually have the same thinking pattern in everyday life as in the clinical setting, so determine whether you’re more of a system 1 or system 2 thinker. System 1 thinkers need to watch out for framing (relying too heavily on context), premature closure, diagnostic momentum, anchoring, and confirmation bias. System 2 thinkers need to watch out for commission, availability bias, and base rate neglect.

“Neither system is inherently right or wrong,” Dr. Scarfone reiterated. “In the perfect world, you may use system 1 to form an initial impression, but then system 2 should really act as a check and balance system to cause you to reflect on your initial diagnostic impressions.”

Additional strategies include being a good history taker and performing a meticulous physical exam: be a good listener, clarify unclear aspects of the history, and identify and address the main concern.

“Remember children and families have a story to tell, and if we listen carefully enough, the diagnostic clues are there,” Dr. Scarfone said. “Sometimes they may be quite subtle.” He recommended doctors perform each part of the physical exam as if expecting an abnormality.

Another strategy is using meta-cognition, a forced analysis of the thinking that led to a diagnosis. It involves asking: “If I had to explain my medical decision-making to others, would this make inherent sense?” Dr. Scarfone said. “If you’re testing, try to avoid anchoring and confirmation biases.”

Finally, take a diagnostic time-out with a checklist that asks these questions:

• Does my presumptive diagnosis make sense?
• What evidence supports or refutes it?
• Did I arrive at it via cognitive biases?
• Are there other diagnostic possibilities that should be considered?

One way to do this is creating a table listing the complaint/finding, diagnostic possibilities with system 1 thinking, diagnostic possibilities with system 2 thinking, and then going beyond system 2 – the potential zebras – when even system 2 diagnostic possibilities don’t account for what the patient is saying or what the exam shows.

Enough overlap exists between these cognitive biases and the intrinsic bias related to individual characteristics that Dr. Khan appreciated the talk on another level as well.

“For me, as a brown Muslim immigrant woman of color, I can sometimes see cognitive biases in action with my colleagues and realize that they are oblivious to it,” Dr. Khan said. “It’s really refreshing to see this issue come up and being discussed at the [AAP] National Conference and Exhibition.”

Dr. Scarfone, Dr. Nagler and Dr. Khan have no relevant financial disclosures.

This article was updated 12/8/2020.
 

A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.

After classifying 68 patients into one of four obesity phenotypes through a series of tests and then tailoring drug treatment to the identified phenotype of each patient, researchers observed a 79% rate of greater than 10% weight loss versus baseline after 12 months. In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.

The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.

A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”

Personalized weight loss treatment isn’t new

“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.

The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.

The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.

Four obesity phenotypes

The researchers categorized patients into one of four types:

• Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
• Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
• “Emotional hunger,” assessed with two questionnaires.
• Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.

Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.

The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.

Phenotype-guided treatments

They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m².

The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.

The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).

Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.

“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”

“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?

“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.

mzoler@mdedge.com

A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.

After classifying 68 patients into one of four obesity phenotypes through a series of tests and then tailoring drug treatment to the identified phenotype of each patient, researchers observed a 79% rate of greater than 10% weight loss versus baseline after 12 months. In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.

The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.

A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”

Personalized weight loss treatment isn’t new

“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.

The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.

The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.

Four obesity phenotypes

The researchers categorized patients into one of four types:

• Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
• Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
• “Emotional hunger,” assessed with two questionnaires.
• Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.

Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.

The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.

Phenotype-guided treatments

They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m².

The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.

The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).

Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.

“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”

“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?

“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.

mzoler@mdedge.com

A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.

After classifying 68 patients into one of four obesity phenotypes through a series of tests and then tailoring drug treatment to the identified phenotype of each patient, researchers observed a 79% rate of greater than 10% weight loss versus baseline after 12 months. In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.

The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.

A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”

Personalized weight loss treatment isn’t new

“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.

The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.

The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.

Four obesity phenotypes

The researchers categorized patients into one of four types:

• Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
• Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
• “Emotional hunger,” assessed with two questionnaires.
• Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.

Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.

The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.

Phenotype-guided treatments

They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m².

The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.

The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).

Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.

“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”

“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?

“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.

mzoler@mdedge.com

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Recurrence tended to occur sooner after minimally invasive surgery than after open abdominal surgery for cervical cancer, according to a propensity-matched analysis of data from 105 patients with recurrence.

And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.

The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.

To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).

The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.

As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.

Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).

The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.

Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.

It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.

Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.

Dr. Bogani and Dr. Azodi had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.

When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Recurrence tended to occur sooner after minimally invasive surgery than after open abdominal surgery for cervical cancer, according to a propensity-matched analysis of data from 105 patients with recurrence.

And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.

The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.

To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).

The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.

As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.

Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).

The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.

Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.

It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.

Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.

Dr. Bogani and Dr. Azodi had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.

When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Recurrence tended to occur sooner after minimally invasive surgery than after open abdominal surgery for cervical cancer, according to a propensity-matched analysis of data from 105 patients with recurrence.

And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.

The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.

To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).

The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.

As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.

Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).

The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.

Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.

It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.

Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.

Dr. Bogani and Dr. Azodi had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.

Activated circulating basophils appear to play a key role in mediating the underappreciated phenomenon of acute-on-chronic itch flares in atopic dermatitis, Brian S. Kim, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Recent years have brought enormous progress in understanding how chronic itch in patients with atopic dermatitis (AD) is mediated by type 2 cytokines, including interleukin-13, IL-4, and IL-31, as well as by Janus kinase (JAK) signaling. This has led to development of potent therapies targeting these mediators, including dupilumab (Dupixent) and the investigational agents tralokinumab, lebrikizumab, abrocitinib, upadacitinib, baricitinib, and the IL-31 inhibitor nemolizumab.

“This is now one of the most active areas in the field of dermatology,” observed Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch and Sensory Disorders at Washington University in St. Louis.

He has figured prominently in this effort. He and his coinvestigators conducted translational studies in mouse models which unraveled key mechanisms by which the immune system responsible for skin inflammation in AD communicates with the nervous system to trigger the neural sensation of itch. He also led a phase 2 randomized trial in 307 patients with AD, which demonstrated that the investigational JAK1/JAK2 inhibitor ruxolitinib cream markedly improved itch within 36 hours, well before subsequent improvement in skin inflammation – and the topical JAK inhibitor did so with minimal systemic absorption.

Compared with chronic itch, much less research attention has been devoted to the phenomenon of acute itch flares superimposed upon the chronic itch of AD. These acute-on-chronic itch flares are a common feature of the disease. In a soon-to-be-published study of 159 AD patients in the placebo arm of a clinical trial, Dr. Kim and coinvestigators found that 26% exhibited a pattern of acute itch flares during the course of a single month. During the next month, 3.1% of patients under study went from an acute-on-chronic itch pattern in month 1 to a nonflare pattern, 20% went from a nonflare pattern in month 1 to acute itch flares in month 2, and 23% of the overall study population retained their pattern of acute itch flares through both months.

“This does not seem to be just a static phenotype, but rather these patients can evolve over time. And we think that this can be driven by allergen-specific IgE,” according to Dr. Kim.

Indeed, the investigators found that patients with allergen-specific IgE in their serum were roughly twice as likely to exhibit the acute-on-chronic itch flare pattern than those without allergen-specific IgE.

The classical thinking has been that IgE binds to its receptors on mast cells, causing mast cell degranulation and release of histamine and other itch-inducing molecules. Yet antihistamines have proven notoriously ineffective for the treatment of AD.

Circulating basophils capable of working their way into inflamed skin also have IgE receptors. Dr. Kim and colleagues have shown that allergen-specific IgE in mice binds to those receptors, causing the basophils to degenerate, releasing itch-promoting chemicals. They have subsequently carried over this work into the clinical arena.

“We’ve found that patients with atopic dermatitis have significantly higher expression of receptors for IgE in their basophils than in the basophils of healthy controls, indicating perhaps that the basophils in patients with atopic dermatitis are much more prone to stimulation by allergen by way of IgE. This is a new concept that we’re exploring,” Dr. Kim said.

“We haven’t really known before what IgE does in atopic dermatitis, but it turns out that it may actually play a very important role in triggering acute flares of itch,” the dermatologist explained. “What’s been surprising is that the IgE activity is not mediated so much by mast cells, which are tissue-resident; the predominant means appears to be that IgE acts on basophils. That then creates release not of histamine, but of leukotriene C4, which is a very potent pruritogen. This may be responsible for those acute itch flares.”

Asked during an audience Q&A how allergen-specific IgE–mediated basophil activation might be targeted therapeutically in order to prevent acute-on-chronic itch flares in patients with AD, Dr. Kim mentioned two possibilities. One is treatment with potent anti-IgE agents, which to date have not been adequately tested for their antipruritic prowess in AD.

“Also, there’s another molecule that seems to be relatively basophil-selective and -specific that’s just been discovered by my colleague Xinzhong Dong at Johns Hopkins University [in Baltimore] – called MRGPRX2 – that may actually be a potentially viable way to go after basophils, maybe even by depleting them if you had an antibody against that,” Dr. Kim said. He was a coinvestigator in Dr. Dong’s recent study characterizing MRGPRX2, the mast-cell-expressed Mas-related G-protein–coupled receptor activator.

Dr. Kim reported receiving research funding from Cara Therapeutics and LEO Pharma, holding a patent for the use of JAK inhibitors in chronic itch, and serving as a consultant to numerous pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

Activated circulating basophils appear to play a key role in mediating the underappreciated phenomenon of acute-on-chronic itch flares in atopic dermatitis, Brian S. Kim, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Recent years have brought enormous progress in understanding how chronic itch in patients with atopic dermatitis (AD) is mediated by type 2 cytokines, including interleukin-13, IL-4, and IL-31, as well as by Janus kinase (JAK) signaling. This has led to development of potent therapies targeting these mediators, including dupilumab (Dupixent) and the investigational agents tralokinumab, lebrikizumab, abrocitinib, upadacitinib, baricitinib, and the IL-31 inhibitor nemolizumab.

“This is now one of the most active areas in the field of dermatology,” observed Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch and Sensory Disorders at Washington University in St. Louis.

He has figured prominently in this effort. He and his coinvestigators conducted translational studies in mouse models which unraveled key mechanisms by which the immune system responsible for skin inflammation in AD communicates with the nervous system to trigger the neural sensation of itch. He also led a phase 2 randomized trial in 307 patients with AD, which demonstrated that the investigational JAK1/JAK2 inhibitor ruxolitinib cream markedly improved itch within 36 hours, well before subsequent improvement in skin inflammation – and the topical JAK inhibitor did so with minimal systemic absorption.

Compared with chronic itch, much less research attention has been devoted to the phenomenon of acute itch flares superimposed upon the chronic itch of AD. These acute-on-chronic itch flares are a common feature of the disease. In a soon-to-be-published study of 159 AD patients in the placebo arm of a clinical trial, Dr. Kim and coinvestigators found that 26% exhibited a pattern of acute itch flares during the course of a single month. During the next month, 3.1% of patients under study went from an acute-on-chronic itch pattern in month 1 to a nonflare pattern, 20% went from a nonflare pattern in month 1 to acute itch flares in month 2, and 23% of the overall study population retained their pattern of acute itch flares through both months.

“This does not seem to be just a static phenotype, but rather these patients can evolve over time. And we think that this can be driven by allergen-specific IgE,” according to Dr. Kim.

Indeed, the investigators found that patients with allergen-specific IgE in their serum were roughly twice as likely to exhibit the acute-on-chronic itch flare pattern than those without allergen-specific IgE.

The classical thinking has been that IgE binds to its receptors on mast cells, causing mast cell degranulation and release of histamine and other itch-inducing molecules. Yet antihistamines have proven notoriously ineffective for the treatment of AD.

Circulating basophils capable of working their way into inflamed skin also have IgE receptors. Dr. Kim and colleagues have shown that allergen-specific IgE in mice binds to those receptors, causing the basophils to degenerate, releasing itch-promoting chemicals. They have subsequently carried over this work into the clinical arena.

“We’ve found that patients with atopic dermatitis have significantly higher expression of receptors for IgE in their basophils than in the basophils of healthy controls, indicating perhaps that the basophils in patients with atopic dermatitis are much more prone to stimulation by allergen by way of IgE. This is a new concept that we’re exploring,” Dr. Kim said.

“We haven’t really known before what IgE does in atopic dermatitis, but it turns out that it may actually play a very important role in triggering acute flares of itch,” the dermatologist explained. “What’s been surprising is that the IgE activity is not mediated so much by mast cells, which are tissue-resident; the predominant means appears to be that IgE acts on basophils. That then creates release not of histamine, but of leukotriene C4, which is a very potent pruritogen. This may be responsible for those acute itch flares.”

Asked during an audience Q&A how allergen-specific IgE–mediated basophil activation might be targeted therapeutically in order to prevent acute-on-chronic itch flares in patients with AD, Dr. Kim mentioned two possibilities. One is treatment with potent anti-IgE agents, which to date have not been adequately tested for their antipruritic prowess in AD.

“Also, there’s another molecule that seems to be relatively basophil-selective and -specific that’s just been discovered by my colleague Xinzhong Dong at Johns Hopkins University [in Baltimore] – called MRGPRX2 – that may actually be a potentially viable way to go after basophils, maybe even by depleting them if you had an antibody against that,” Dr. Kim said. He was a coinvestigator in Dr. Dong’s recent study characterizing MRGPRX2, the mast-cell-expressed Mas-related G-protein–coupled receptor activator.

Dr. Kim reported receiving research funding from Cara Therapeutics and LEO Pharma, holding a patent for the use of JAK inhibitors in chronic itch, and serving as a consultant to numerous pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

Activated circulating basophils appear to play a key role in mediating the underappreciated phenomenon of acute-on-chronic itch flares in atopic dermatitis, Brian S. Kim, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Recent years have brought enormous progress in understanding how chronic itch in patients with atopic dermatitis (AD) is mediated by type 2 cytokines, including interleukin-13, IL-4, and IL-31, as well as by Janus kinase (JAK) signaling. This has led to development of potent therapies targeting these mediators, including dupilumab (Dupixent) and the investigational agents tralokinumab, lebrikizumab, abrocitinib, upadacitinib, baricitinib, and the IL-31 inhibitor nemolizumab.

“This is now one of the most active areas in the field of dermatology,” observed Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch and Sensory Disorders at Washington University in St. Louis.

He has figured prominently in this effort. He and his coinvestigators conducted translational studies in mouse models which unraveled key mechanisms by which the immune system responsible for skin inflammation in AD communicates with the nervous system to trigger the neural sensation of itch. He also led a phase 2 randomized trial in 307 patients with AD, which demonstrated that the investigational JAK1/JAK2 inhibitor ruxolitinib cream markedly improved itch within 36 hours, well before subsequent improvement in skin inflammation – and the topical JAK inhibitor did so with minimal systemic absorption.

Compared with chronic itch, much less research attention has been devoted to the phenomenon of acute itch flares superimposed upon the chronic itch of AD. These acute-on-chronic itch flares are a common feature of the disease. In a soon-to-be-published study of 159 AD patients in the placebo arm of a clinical trial, Dr. Kim and coinvestigators found that 26% exhibited a pattern of acute itch flares during the course of a single month. During the next month, 3.1% of patients under study went from an acute-on-chronic itch pattern in month 1 to a nonflare pattern, 20% went from a nonflare pattern in month 1 to acute itch flares in month 2, and 23% of the overall study population retained their pattern of acute itch flares through both months.

“This does not seem to be just a static phenotype, but rather these patients can evolve over time. And we think that this can be driven by allergen-specific IgE,” according to Dr. Kim.

Indeed, the investigators found that patients with allergen-specific IgE in their serum were roughly twice as likely to exhibit the acute-on-chronic itch flare pattern than those without allergen-specific IgE.

The classical thinking has been that IgE binds to its receptors on mast cells, causing mast cell degranulation and release of histamine and other itch-inducing molecules. Yet antihistamines have proven notoriously ineffective for the treatment of AD.

Circulating basophils capable of working their way into inflamed skin also have IgE receptors. Dr. Kim and colleagues have shown that allergen-specific IgE in mice binds to those receptors, causing the basophils to degenerate, releasing itch-promoting chemicals. They have subsequently carried over this work into the clinical arena.

“We’ve found that patients with atopic dermatitis have significantly higher expression of receptors for IgE in their basophils than in the basophils of healthy controls, indicating perhaps that the basophils in patients with atopic dermatitis are much more prone to stimulation by allergen by way of IgE. This is a new concept that we’re exploring,” Dr. Kim said.

“We haven’t really known before what IgE does in atopic dermatitis, but it turns out that it may actually play a very important role in triggering acute flares of itch,” the dermatologist explained. “What’s been surprising is that the IgE activity is not mediated so much by mast cells, which are tissue-resident; the predominant means appears to be that IgE acts on basophils. That then creates release not of histamine, but of leukotriene C4, which is a very potent pruritogen. This may be responsible for those acute itch flares.”

Asked during an audience Q&A how allergen-specific IgE–mediated basophil activation might be targeted therapeutically in order to prevent acute-on-chronic itch flares in patients with AD, Dr. Kim mentioned two possibilities. One is treatment with potent anti-IgE agents, which to date have not been adequately tested for their antipruritic prowess in AD.

“Also, there’s another molecule that seems to be relatively basophil-selective and -specific that’s just been discovered by my colleague Xinzhong Dong at Johns Hopkins University [in Baltimore] – called MRGPRX2 – that may actually be a potentially viable way to go after basophils, maybe even by depleting them if you had an antibody against that,” Dr. Kim said. He was a coinvestigator in Dr. Dong’s recent study characterizing MRGPRX2, the mast-cell-expressed Mas-related G-protein–coupled receptor activator.

Dr. Kim reported receiving research funding from Cara Therapeutics and LEO Pharma, holding a patent for the use of JAK inhibitors in chronic itch, and serving as a consultant to numerous pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

A novel proprietary topical combination of microencapsulated 3% benzoyl peroxide and microencapsulated 0.1% tretinoin achieved its efficacy and safety endpoints in two large pivotal phase 3 clinical acne trials, James Del Rosso, MD, reported at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

olavs/Thinkstock

Sol-Gel Technologies, the Israeli company developing the fixed-dose cream, called Twyneo, has applied to the Food and Drug Administration for marketing approval.

The product combines two workhorse topical agents for the treatment of acne, which are ordinarily incompatible, since benzoyl peroxide degrades tretinoin and reduces its effectiveness. The company’s silica-based microencapsulation technology overcomes that obstacle, explained Dr. Del Rosso, a dermatologist at JDR Research in Las Vegas.

The two identical phase 3, randomized, double-blind, vehicle-controlled clinical trials included a total of 858 patients ages 9 years and older with moderate to severe acne enrolled at 63 U.S. sites. Participants were randomized 2:1 to once-daily application of Twyneo or its vehicle cream for 12 weeks.

In one trial, the coprimary endpoint of at least a two-grade reduction and clear or almost clear skin at week 12 on a 5-point Investigator Global Assessment (IGA) scale was achieved in 38.5% of patients on Twyneo and 11.5% of controls. In the other trial, the IGA success rates were 25.4% and 14.7%. In both trials, the between-group difference was statistically significant.

The other coprimary endpoints were the absolute change from baseline in inflammatory and noninflammatory lesion counts. Inflammatory lesions were reduced by 21.6% and 16.2% in the active treatment arms of the two trials, compared with 14.8% and 14.1% reductions in the control groups. Noninflammatory lesion counts fell by 29.7% and 24.2% in patients on active treatment, versus 19.8% and 17.4% reductions in controls. The between-group differences were statistically significant.

Skin tolerability of Twyneo was “very good” and similar to vehicle, according to Dr. Del Rosso.

He reported receiving research funding from Sol-Gel, the studies’ sponsor.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

A novel proprietary topical combination of microencapsulated 3% benzoyl peroxide and microencapsulated 0.1% tretinoin achieved its efficacy and safety endpoints in two large pivotal phase 3 clinical acne trials, James Del Rosso, MD, reported at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

olavs/Thinkstock

Sol-Gel Technologies, the Israeli company developing the fixed-dose cream, called Twyneo, has applied to the Food and Drug Administration for marketing approval.

The product combines two workhorse topical agents for the treatment of acne, which are ordinarily incompatible, since benzoyl peroxide degrades tretinoin and reduces its effectiveness. The company’s silica-based microencapsulation technology overcomes that obstacle, explained Dr. Del Rosso, a dermatologist at JDR Research in Las Vegas.

The two identical phase 3, randomized, double-blind, vehicle-controlled clinical trials included a total of 858 patients ages 9 years and older with moderate to severe acne enrolled at 63 U.S. sites. Participants were randomized 2:1 to once-daily application of Twyneo or its vehicle cream for 12 weeks.

In one trial, the coprimary endpoint of at least a two-grade reduction and clear or almost clear skin at week 12 on a 5-point Investigator Global Assessment (IGA) scale was achieved in 38.5% of patients on Twyneo and 11.5% of controls. In the other trial, the IGA success rates were 25.4% and 14.7%. In both trials, the between-group difference was statistically significant.

The other coprimary endpoints were the absolute change from baseline in inflammatory and noninflammatory lesion counts. Inflammatory lesions were reduced by 21.6% and 16.2% in the active treatment arms of the two trials, compared with 14.8% and 14.1% reductions in the control groups. Noninflammatory lesion counts fell by 29.7% and 24.2% in patients on active treatment, versus 19.8% and 17.4% reductions in controls. The between-group differences were statistically significant.

Skin tolerability of Twyneo was “very good” and similar to vehicle, according to Dr. Del Rosso.

He reported receiving research funding from Sol-Gel, the studies’ sponsor.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

A novel proprietary topical combination of microencapsulated 3% benzoyl peroxide and microencapsulated 0.1% tretinoin achieved its efficacy and safety endpoints in two large pivotal phase 3 clinical acne trials, James Del Rosso, MD, reported at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

olavs/Thinkstock

Sol-Gel Technologies, the Israeli company developing the fixed-dose cream, called Twyneo, has applied to the Food and Drug Administration for marketing approval.

The product combines two workhorse topical agents for the treatment of acne, which are ordinarily incompatible, since benzoyl peroxide degrades tretinoin and reduces its effectiveness. The company’s silica-based microencapsulation technology overcomes that obstacle, explained Dr. Del Rosso, a dermatologist at JDR Research in Las Vegas.

The two identical phase 3, randomized, double-blind, vehicle-controlled clinical trials included a total of 858 patients ages 9 years and older with moderate to severe acne enrolled at 63 U.S. sites. Participants were randomized 2:1 to once-daily application of Twyneo or its vehicle cream for 12 weeks.

In one trial, the coprimary endpoint of at least a two-grade reduction and clear or almost clear skin at week 12 on a 5-point Investigator Global Assessment (IGA) scale was achieved in 38.5% of patients on Twyneo and 11.5% of controls. In the other trial, the IGA success rates were 25.4% and 14.7%. In both trials, the between-group difference was statistically significant.

The other coprimary endpoints were the absolute change from baseline in inflammatory and noninflammatory lesion counts. Inflammatory lesions were reduced by 21.6% and 16.2% in the active treatment arms of the two trials, compared with 14.8% and 14.1% reductions in the control groups. Noninflammatory lesion counts fell by 29.7% and 24.2% in patients on active treatment, versus 19.8% and 17.4% reductions in controls. The between-group differences were statistically significant.

Skin tolerability of Twyneo was “very good” and similar to vehicle, according to Dr. Del Rosso.

He reported receiving research funding from Sol-Gel, the studies’ sponsor.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

The dramatic advances in targeted therapies for late-stage melanoma capture the headlines, but a recent Australian study quietly concluded that the most cost-effective way to lower both the incidence of melanoma and deaths caused by the malignancy over the long haul is through primary prevention in the form of daily sunscreen use, according to Laura Korb Ferris, MD, PhD, a dermatologist and director of clinical trials in the department of dermatology at the University of Pittsburgh.

Wavebreakmedia Ltd/Thinkstock

“I think it’s really important that we recognize the importance of preventing skin cancer, and not just early detection, not just treatment of late disease,” Dr. Ferris said at a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medical Education.

She highlighted the Australian cost-effectiveness analysis, which used Markov modeling of data from two published population-based, randomized controlled trials carried out in Queensland, Australia.

The cost-effectiveness study compared the estimated long-term impact of three different approaches to control of melanoma: a primary prevention strategy, which basically consisted of promoting daily sunscreen use and other forms of sun protection; early detection through annual whole-body skin examinations by physicians starting at age 50; and no intervention. The analysis provided estimates of the number of cases of melanoma, deaths caused by melanoma, nonmelanoma skin cancers, and quality of life outcomes over the course of 30 years starting in 50-year-old men and women.

Primary prevention through sun protection was the clear winner, as shown by the results:

• A 44% reduction in the incidence of melanoma, compared with early detection via annual physician skin examinations.
• A 39% reduction in projected melanoma deaths compared with early detection, which in turn achieved only a 2% reduction when compared with no intervention.
• 27% fewer keratinocyte cancers excised than with annual skin examinations.
• A 21.7% reduction in societal costs, compared with an early-detection program.

Daily sunscreen use for primary prevention was also associated with a modest 0.1% increase in quality-adjusted life-years. “Prevention is low cost, low risk, and effective,” Dr. Ferris observed.

The investigators noted that, while residents of the Australian state of Queensland are mainly fair-skinned and confront high UV radiation levels throughout the year, somewhat limiting the generalizability of the study findings, the relationships between the costs of interventional strategies and their outcomes should be proportional in other countries.

True enough, but a strategy of annual skin examinations starting at age 50 years as modeled in the Australian study is not the most productive way to conduct a melanoma early-detection program, Dr. Ferris said. She noted that data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program show that the median age at diagnosis of melanoma in the United States is 65 years, while the median age at death caused by the malignancy is 71 years. That information is helpful in formulating strategies to improve early detection through more focused, higher-yield screening.

UPMC

Case in point: European investigators have estimated that, by screening everyone age 50 years and older, 475 people need to be screened and an average of 19.6 lesions must be biopsied in order to detect one melanoma. But by reserving screening for those age 50 years and up who have any one of three risk factors – a personal history of melanoma, atypical nevi, or at least 40 common nevi – those numbers drop dramatically: 98 people need to be screened and 13.5 lesions biopsied to detect one melanoma. And by further narrowing the screened population to those age 65 years or older with any of the three risk factors, 63 seniors would need to be screened and 9.2 lesions excised to find one melanoma.

Total-body skin examinations are time-consuming for dermatologists. In a recent U.S. study, investigators determined that the additional face-to-face time required per skin cancer detected by doing a total-body skin exam in adults who present to a dermatologist for another reason is 4.5 hours. And that’s just the time involved in detecting any type of skin cancer.

“To get that number for melanoma, multiply by 15 to 20,” Dr. Ferris said.

The investigators also determined that, for each decade of advancing age and increment in lighter skin phototype, the number-needed-to-examine in order to identify one skin cancer of any type decreased.

“By focusing on patients who are older and have fair skin types we can get that time down to about 1 hour,” commented Dr. Ferris, who penned an editorial perspective on the study.

While many dermatologists recommend that people with a high common nevus count undergo frequent screening for melanoma because they are at particularly high risk for invasive disease, a couple of recent studies challenge that notion, she pointed out. One was a retrospective study of 326 consecutive new melanoma patients which found that patients with a higher nevus count had thinner melanomas and a greater likelihood of in situ melanoma. Patients who presented with invasive melanoma had a mean total nevus count of 31.5 lesions, while those with in situ melanoma averaged 57.2 nevi. Each additional nevus was associated with a 4% reduction in the likelihood of invasive melanoma, independent of age and sex.

The other study included 566 newly diagnosed melanoma patients in two U.S. centers. Among the 56% of patients who were younger than 60 years, those who had more than 50 total nevi were 68% less likely to have a thick melanoma in a logistic regression analysis that controlled for demographic factors, as well as anatomic location of the melanoma, histologic subtype, and skin cancer screening frequency. In contrast, younger patients with more than 5 atypical nevi were 2.43-fold more likely to have thicker melanomas than were those with no such lesions. The lesson, according to the investigators, is that total nevus count isn’t a reliable determinant of a patient’s risk status or the need for skin examinations.

Dr. Ferris reported no financial conflicts of interest regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.

bjancin@mdedge.com

The dramatic advances in targeted therapies for late-stage melanoma capture the headlines, but a recent Australian study quietly concluded that the most cost-effective way to lower both the incidence of melanoma and deaths caused by the malignancy over the long haul is through primary prevention in the form of daily sunscreen use, according to Laura Korb Ferris, MD, PhD, a dermatologist and director of clinical trials in the department of dermatology at the University of Pittsburgh.

Wavebreakmedia Ltd/Thinkstock

“I think it’s really important that we recognize the importance of preventing skin cancer, and not just early detection, not just treatment of late disease,” Dr. Ferris said at a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medical Education.

She highlighted the Australian cost-effectiveness analysis, which used Markov modeling of data from two published population-based, randomized controlled trials carried out in Queensland, Australia.

The cost-effectiveness study compared the estimated long-term impact of three different approaches to control of melanoma: a primary prevention strategy, which basically consisted of promoting daily sunscreen use and other forms of sun protection; early detection through annual whole-body skin examinations by physicians starting at age 50; and no intervention. The analysis provided estimates of the number of cases of melanoma, deaths caused by melanoma, nonmelanoma skin cancers, and quality of life outcomes over the course of 30 years starting in 50-year-old men and women.

Primary prevention through sun protection was the clear winner, as shown by the results:

• A 44% reduction in the incidence of melanoma, compared with early detection via annual physician skin examinations.
• A 39% reduction in projected melanoma deaths compared with early detection, which in turn achieved only a 2% reduction when compared with no intervention.
• 27% fewer keratinocyte cancers excised than with annual skin examinations.
• A 21.7% reduction in societal costs, compared with an early-detection program.

Daily sunscreen use for primary prevention was also associated with a modest 0.1% increase in quality-adjusted life-years. “Prevention is low cost, low risk, and effective,” Dr. Ferris observed.

The investigators noted that, while residents of the Australian state of Queensland are mainly fair-skinned and confront high UV radiation levels throughout the year, somewhat limiting the generalizability of the study findings, the relationships between the costs of interventional strategies and their outcomes should be proportional in other countries.

True enough, but a strategy of annual skin examinations starting at age 50 years as modeled in the Australian study is not the most productive way to conduct a melanoma early-detection program, Dr. Ferris said. She noted that data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program show that the median age at diagnosis of melanoma in the United States is 65 years, while the median age at death caused by the malignancy is 71 years. That information is helpful in formulating strategies to improve early detection through more focused, higher-yield screening.

UPMC

Case in point: European investigators have estimated that, by screening everyone age 50 years and older, 475 people need to be screened and an average of 19.6 lesions must be biopsied in order to detect one melanoma. But by reserving screening for those age 50 years and up who have any one of three risk factors – a personal history of melanoma, atypical nevi, or at least 40 common nevi – those numbers drop dramatically: 98 people need to be screened and 13.5 lesions biopsied to detect one melanoma. And by further narrowing the screened population to those age 65 years or older with any of the three risk factors, 63 seniors would need to be screened and 9.2 lesions excised to find one melanoma.

Total-body skin examinations are time-consuming for dermatologists. In a recent U.S. study, investigators determined that the additional face-to-face time required per skin cancer detected by doing a total-body skin exam in adults who present to a dermatologist for another reason is 4.5 hours. And that’s just the time involved in detecting any type of skin cancer.

“To get that number for melanoma, multiply by 15 to 20,” Dr. Ferris said.

The investigators also determined that, for each decade of advancing age and increment in lighter skin phototype, the number-needed-to-examine in order to identify one skin cancer of any type decreased.

“By focusing on patients who are older and have fair skin types we can get that time down to about 1 hour,” commented Dr. Ferris, who penned an editorial perspective on the study.

While many dermatologists recommend that people with a high common nevus count undergo frequent screening for melanoma because they are at particularly high risk for invasive disease, a couple of recent studies challenge that notion, she pointed out. One was a retrospective study of 326 consecutive new melanoma patients which found that patients with a higher nevus count had thinner melanomas and a greater likelihood of in situ melanoma. Patients who presented with invasive melanoma had a mean total nevus count of 31.5 lesions, while those with in situ melanoma averaged 57.2 nevi. Each additional nevus was associated with a 4% reduction in the likelihood of invasive melanoma, independent of age and sex.

The other study included 566 newly diagnosed melanoma patients in two U.S. centers. Among the 56% of patients who were younger than 60 years, those who had more than 50 total nevi were 68% less likely to have a thick melanoma in a logistic regression analysis that controlled for demographic factors, as well as anatomic location of the melanoma, histologic subtype, and skin cancer screening frequency. In contrast, younger patients with more than 5 atypical nevi were 2.43-fold more likely to have thicker melanomas than were those with no such lesions. The lesson, according to the investigators, is that total nevus count isn’t a reliable determinant of a patient’s risk status or the need for skin examinations.

Dr. Ferris reported no financial conflicts of interest regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.

bjancin@mdedge.com

The dramatic advances in targeted therapies for late-stage melanoma capture the headlines, but a recent Australian study quietly concluded that the most cost-effective way to lower both the incidence of melanoma and deaths caused by the malignancy over the long haul is through primary prevention in the form of daily sunscreen use, according to Laura Korb Ferris, MD, PhD, a dermatologist and director of clinical trials in the department of dermatology at the University of Pittsburgh.

Wavebreakmedia Ltd/Thinkstock

“I think it’s really important that we recognize the importance of preventing skin cancer, and not just early detection, not just treatment of late disease,” Dr. Ferris said at a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medical Education.

She highlighted the Australian cost-effectiveness analysis, which used Markov modeling of data from two published population-based, randomized controlled trials carried out in Queensland, Australia.

The cost-effectiveness study compared the estimated long-term impact of three different approaches to control of melanoma: a primary prevention strategy, which basically consisted of promoting daily sunscreen use and other forms of sun protection; early detection through annual whole-body skin examinations by physicians starting at age 50; and no intervention. The analysis provided estimates of the number of cases of melanoma, deaths caused by melanoma, nonmelanoma skin cancers, and quality of life outcomes over the course of 30 years starting in 50-year-old men and women.

Primary prevention through sun protection was the clear winner, as shown by the results:

• A 44% reduction in the incidence of melanoma, compared with early detection via annual physician skin examinations.
• A 39% reduction in projected melanoma deaths compared with early detection, which in turn achieved only a 2% reduction when compared with no intervention.
• 27% fewer keratinocyte cancers excised than with annual skin examinations.
• A 21.7% reduction in societal costs, compared with an early-detection program.

Daily sunscreen use for primary prevention was also associated with a modest 0.1% increase in quality-adjusted life-years. “Prevention is low cost, low risk, and effective,” Dr. Ferris observed.

The investigators noted that, while residents of the Australian state of Queensland are mainly fair-skinned and confront high UV radiation levels throughout the year, somewhat limiting the generalizability of the study findings, the relationships between the costs of interventional strategies and their outcomes should be proportional in other countries.

True enough, but a strategy of annual skin examinations starting at age 50 years as modeled in the Australian study is not the most productive way to conduct a melanoma early-detection program, Dr. Ferris said. She noted that data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program show that the median age at diagnosis of melanoma in the United States is 65 years, while the median age at death caused by the malignancy is 71 years. That information is helpful in formulating strategies to improve early detection through more focused, higher-yield screening.

UPMC

Case in point: European investigators have estimated that, by screening everyone age 50 years and older, 475 people need to be screened and an average of 19.6 lesions must be biopsied in order to detect one melanoma. But by reserving screening for those age 50 years and up who have any one of three risk factors – a personal history of melanoma, atypical nevi, or at least 40 common nevi – those numbers drop dramatically: 98 people need to be screened and 13.5 lesions biopsied to detect one melanoma. And by further narrowing the screened population to those age 65 years or older with any of the three risk factors, 63 seniors would need to be screened and 9.2 lesions excised to find one melanoma.

Total-body skin examinations are time-consuming for dermatologists. In a recent U.S. study, investigators determined that the additional face-to-face time required per skin cancer detected by doing a total-body skin exam in adults who present to a dermatologist for another reason is 4.5 hours. And that’s just the time involved in detecting any type of skin cancer.

“To get that number for melanoma, multiply by 15 to 20,” Dr. Ferris said.

The investigators also determined that, for each decade of advancing age and increment in lighter skin phototype, the number-needed-to-examine in order to identify one skin cancer of any type decreased.

“By focusing on patients who are older and have fair skin types we can get that time down to about 1 hour,” commented Dr. Ferris, who penned an editorial perspective on the study.

While many dermatologists recommend that people with a high common nevus count undergo frequent screening for melanoma because they are at particularly high risk for invasive disease, a couple of recent studies challenge that notion, she pointed out. One was a retrospective study of 326 consecutive new melanoma patients which found that patients with a higher nevus count had thinner melanomas and a greater likelihood of in situ melanoma. Patients who presented with invasive melanoma had a mean total nevus count of 31.5 lesions, while those with in situ melanoma averaged 57.2 nevi. Each additional nevus was associated with a 4% reduction in the likelihood of invasive melanoma, independent of age and sex.

The other study included 566 newly diagnosed melanoma patients in two U.S. centers. Among the 56% of patients who were younger than 60 years, those who had more than 50 total nevi were 68% less likely to have a thick melanoma in a logistic regression analysis that controlled for demographic factors, as well as anatomic location of the melanoma, histologic subtype, and skin cancer screening frequency. In contrast, younger patients with more than 5 atypical nevi were 2.43-fold more likely to have thicker melanomas than were those with no such lesions. The lesson, according to the investigators, is that total nevus count isn’t a reliable determinant of a patient’s risk status or the need for skin examinations.

Dr. Ferris reported no financial conflicts of interest regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.

bjancin@mdedge.com

A two-layer vaginal cuff closure during total laparoscopic hysterectomy is associated with fewer postoperative complications, compared with a standard one-layer closure, according to a retrospective study of approximately 3,000 patients.

The difference is driven by fewer vaginal cuff complications among patients whose surgeons used the two-layer technique, said Ann Peters, MD, of Magee-Womens Hospital at the University of Pittsburgh Medical Center.

In light of these findings, Dr. Peters switched to using a two-layer closure. More surgeons may adopt this method, she said at the annual meeting sponsored by AAGL, held virtually this year.
 

Modifiable factors

Complications after total laparoscopic hysterectomy may be associated with modifiable surgical risk factors such as surgical volume, expertise, and suture material. The method of vaginal cuff closure also plays an important role, but few studies have compared multilayer and single-layer vaginal cuff closure, Dr. Peters said.

To investigate this question, Dr. Peters and colleagues analyzed data from 2,973 women who underwent total laparoscopic hysterectomy for benign indications during a 6-year period at their institution.

The analysis included 1,760 patients (59%) who underwent single-layer closure and 1,213 (41%) who underwent two-layer closure. The closure method was a matter of surgeon preference. Aside from the closure technique, other aspects of the surgeries were standardized.

The primary outcome was the rate of 30-day postoperative complications. Secondary outcomes included vaginal cuff complications during 6 months of follow-up.

The groups generally had similar baseline characteristics, although patients in the two-layer group had lower body mass index and were less likely to use tobacco.

Intraoperative complications and postoperative readmissions did not differ between the groups. The rate of postoperative complications, however, was lower in the two-layer group: 3.5% versus 5.6%. Likewise, the rate of vaginal cuff complications was lower in the two-layer group: 0.9% versus 2.5%.

No instances of vaginal cuff dehiscence or mucosal separation occurred in the two-layer group, whereas 12 cases of dehiscence and 4 cases of mucosal separation occurred in the one-layer group.

Two-layer closure was associated with a decreased likelihood of complications, with an odds ratio of 0.36. Although the study is limited by its retrospective design, the surgeons had similar training and many variables, including the sutures used, were equal or standardized, Dr. Peters noted.

Avoiding rare complications

Grace M. Janik, MD, of Reproductive Specialty Center in Milwaukee, has long theorized that two-layer closure may be beneficial. This study provides data to support that theory, Dr. Janik said in a discussion following the research presentation.

Given that hysterectomy is a common procedure, “any optimization ... has implications for a large number of women,” Dr. Janik said. Although rare outcomes such as dehiscence are difficult to study, the large number of patients in this analysis allowed the investigators to detect differences between the groups.

Studies of vaginal cuff closure have yielded mixed results. For example, various studies have suggested that laparoscopic closure may be inferior to, equal to, or superior to vaginal closure. Together, the findings indicate that “what we are doing is probably more important than the route,” said Dr. Janik.

Along with multilayer closure, the use of delayed absorbable sutures and adequate tissue bites are other factors that may lead to fewer complications, Dr. Janik noted.

Dr. Peters and Dr. Janik had no relevant financial disclosures. A study coauthor is a consultant for Medtronic and Olympus. The statistical analysis was supported by the National Institutes of Health.

jremaly@mdedge.com

SOURCE: Ali R et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.603.

A two-layer vaginal cuff closure during total laparoscopic hysterectomy is associated with fewer postoperative complications, compared with a standard one-layer closure, according to a retrospective study of approximately 3,000 patients.

The difference is driven by fewer vaginal cuff complications among patients whose surgeons used the two-layer technique, said Ann Peters, MD, of Magee-Womens Hospital at the University of Pittsburgh Medical Center.

In light of these findings, Dr. Peters switched to using a two-layer closure. More surgeons may adopt this method, she said at the annual meeting sponsored by AAGL, held virtually this year.
 

Modifiable factors

Complications after total laparoscopic hysterectomy may be associated with modifiable surgical risk factors such as surgical volume, expertise, and suture material. The method of vaginal cuff closure also plays an important role, but few studies have compared multilayer and single-layer vaginal cuff closure, Dr. Peters said.

To investigate this question, Dr. Peters and colleagues analyzed data from 2,973 women who underwent total laparoscopic hysterectomy for benign indications during a 6-year period at their institution.

The analysis included 1,760 patients (59%) who underwent single-layer closure and 1,213 (41%) who underwent two-layer closure. The closure method was a matter of surgeon preference. Aside from the closure technique, other aspects of the surgeries were standardized.

The primary outcome was the rate of 30-day postoperative complications. Secondary outcomes included vaginal cuff complications during 6 months of follow-up.

The groups generally had similar baseline characteristics, although patients in the two-layer group had lower body mass index and were less likely to use tobacco.

Intraoperative complications and postoperative readmissions did not differ between the groups. The rate of postoperative complications, however, was lower in the two-layer group: 3.5% versus 5.6%. Likewise, the rate of vaginal cuff complications was lower in the two-layer group: 0.9% versus 2.5%.

No instances of vaginal cuff dehiscence or mucosal separation occurred in the two-layer group, whereas 12 cases of dehiscence and 4 cases of mucosal separation occurred in the one-layer group.

Two-layer closure was associated with a decreased likelihood of complications, with an odds ratio of 0.36. Although the study is limited by its retrospective design, the surgeons had similar training and many variables, including the sutures used, were equal or standardized, Dr. Peters noted.

Avoiding rare complications

Grace M. Janik, MD, of Reproductive Specialty Center in Milwaukee, has long theorized that two-layer closure may be beneficial. This study provides data to support that theory, Dr. Janik said in a discussion following the research presentation.

Given that hysterectomy is a common procedure, “any optimization ... has implications for a large number of women,” Dr. Janik said. Although rare outcomes such as dehiscence are difficult to study, the large number of patients in this analysis allowed the investigators to detect differences between the groups.

Studies of vaginal cuff closure have yielded mixed results. For example, various studies have suggested that laparoscopic closure may be inferior to, equal to, or superior to vaginal closure. Together, the findings indicate that “what we are doing is probably more important than the route,” said Dr. Janik.

Along with multilayer closure, the use of delayed absorbable sutures and adequate tissue bites are other factors that may lead to fewer complications, Dr. Janik noted.

Dr. Peters and Dr. Janik had no relevant financial disclosures. A study coauthor is a consultant for Medtronic and Olympus. The statistical analysis was supported by the National Institutes of Health.

jremaly@mdedge.com

SOURCE: Ali R et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.603.

A two-layer vaginal cuff closure during total laparoscopic hysterectomy is associated with fewer postoperative complications, compared with a standard one-layer closure, according to a retrospective study of approximately 3,000 patients.

The difference is driven by fewer vaginal cuff complications among patients whose surgeons used the two-layer technique, said Ann Peters, MD, of Magee-Womens Hospital at the University of Pittsburgh Medical Center.

In light of these findings, Dr. Peters switched to using a two-layer closure. More surgeons may adopt this method, she said at the annual meeting sponsored by AAGL, held virtually this year.
 

Modifiable factors

Complications after total laparoscopic hysterectomy may be associated with modifiable surgical risk factors such as surgical volume, expertise, and suture material. The method of vaginal cuff closure also plays an important role, but few studies have compared multilayer and single-layer vaginal cuff closure, Dr. Peters said.

To investigate this question, Dr. Peters and colleagues analyzed data from 2,973 women who underwent total laparoscopic hysterectomy for benign indications during a 6-year period at their institution.

The analysis included 1,760 patients (59%) who underwent single-layer closure and 1,213 (41%) who underwent two-layer closure. The closure method was a matter of surgeon preference. Aside from the closure technique, other aspects of the surgeries were standardized.

The primary outcome was the rate of 30-day postoperative complications. Secondary outcomes included vaginal cuff complications during 6 months of follow-up.

The groups generally had similar baseline characteristics, although patients in the two-layer group had lower body mass index and were less likely to use tobacco.

Intraoperative complications and postoperative readmissions did not differ between the groups. The rate of postoperative complications, however, was lower in the two-layer group: 3.5% versus 5.6%. Likewise, the rate of vaginal cuff complications was lower in the two-layer group: 0.9% versus 2.5%.

No instances of vaginal cuff dehiscence or mucosal separation occurred in the two-layer group, whereas 12 cases of dehiscence and 4 cases of mucosal separation occurred in the one-layer group.

Two-layer closure was associated with a decreased likelihood of complications, with an odds ratio of 0.36. Although the study is limited by its retrospective design, the surgeons had similar training and many variables, including the sutures used, were equal or standardized, Dr. Peters noted.

Avoiding rare complications

Grace M. Janik, MD, of Reproductive Specialty Center in Milwaukee, has long theorized that two-layer closure may be beneficial. This study provides data to support that theory, Dr. Janik said in a discussion following the research presentation.

Given that hysterectomy is a common procedure, “any optimization ... has implications for a large number of women,” Dr. Janik said. Although rare outcomes such as dehiscence are difficult to study, the large number of patients in this analysis allowed the investigators to detect differences between the groups.

Studies of vaginal cuff closure have yielded mixed results. For example, various studies have suggested that laparoscopic closure may be inferior to, equal to, or superior to vaginal closure. Together, the findings indicate that “what we are doing is probably more important than the route,” said Dr. Janik.

Along with multilayer closure, the use of delayed absorbable sutures and adequate tissue bites are other factors that may lead to fewer complications, Dr. Janik noted.

Dr. Peters and Dr. Janik had no relevant financial disclosures. A study coauthor is a consultant for Medtronic and Olympus. The statistical analysis was supported by the National Institutes of Health.

jremaly@mdedge.com

SOURCE: Ali R et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.603.